[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Proposed Rules]
[Pages 7664-7889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1620]
[[Page 7663]]
Vol. 77
Monday,
No. 29
February 13, 2012
Part II
Regulatory Information Service Center
-----------------------------------------------------------------------
Introduction to the Regulatory Plan and the Unified Agenda of Federal
Regulatory and Deregulatory Actions
Federal Register / Vol. 77 , No. 29 / Monday, February 13, 2012 / The
Regulatory Plan
[[Page 7664]]
-----------------------------------------------------------------------
REGULATORY INFORMATION SERVICE CENTER
Introduction to the Unified Agenda of Federal Regulatory and
Deregulatory Actions
AGENCY: Regulatory Information Service Center.
ACTION: Introduction to the Unified Agenda of Federal Regulatory and
Deregulatory Actions.
-----------------------------------------------------------------------
SUMMARY: The Regulatory Flexibility Act requires that agencies publish
semiannual regulatory agendas in the Federal Register describing
regulatory actions they are developing that may have a significant
economic impact on a substantial number of small entities (5 U.S.C.
602). Executive Order 12866 ``Regulatory Planning and Review,'' signed
September 30, 1993 (58 FR 51735), and Office of Management and Budget
memoranda implementing section 4 of that Order establish minimum
standards for agencies' agendas, including specific types of
information for each entry.
The Unified Agenda of Federal Regulatory and Deregulatory Actions
(Unified Agenda) helps agencies fulfill these requirements. All Federal
regulatory agencies have chosen to publish their regulatory agendas as
part of the Unified Agenda.
Editions of the Unified Agenda prior to fall 2007 were printed in
their entirety in the Federal Register. Beginning with the fall 2007
edition, the Internet is the basic means for conveying regulatory
agenda information to the maximum extent legally permissible. The
complete Unified Agenda for fall 2011, which contains the regulatory
agendas for 59 Federal agencies, is available to the public at http://reginfo.gov.
The fall 2011 Unified Agenda publication appearing in the Federal
Register consists of agency regulatory flexibility agendas, in
accordance with the publication requirements of the Regulatory
Flexibility Act. Agency regulatory flexibility agendas contain only
those Agenda entries for rules that are likely to have a significant
economic impact on a substantial number of small entities and entries
that have been selected for periodic review under section 610 of the
Regulatory Flexibility Act.
ADDRESSES: Regulatory Information Service Center (MI), General Services
Administration, One Constitution Square, 1275 First Street NE., 651A,
Washington, DC 20417.
FOR FURTHER INFORMATION CONTACT: For further information about specific
regulatory actions, please refer to the agency contact listed for each
entry.
To provide comment on or to obtain further information about this
publication, contact: John C. Thomas, Executive Director, Regulatory
Information Service Center (MI), General Services Administration, One
Constitution Square, 1275 First Street NE., 642, Washington, DC 20417,
202 482-7340. You may also send comments to us by email at:
[email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
Introduction to the Regulatory Plan and the Unified Agenda of Federal
Regulatory and Deregulatory Actions
I. What Are the Regulatory Plan and the Unified Agenda?
II. Why Are the Regulatory Plan and the Unified Agenda Published?
III. How Are the Regulatory Plan and the Unified Agenda Organized?
IV. What Information Appears for Each Entry?
V. Abbreviations
VI. How Can Users Get Copies of the Plan and the Agenda?
Introduction to the Fall 2011 Regulatory Plan
AGENCY REGULATORY PLANS
Cabinet Departments
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Department of Homeland Security
Department of Housing and Urban Development
Department of the Interior
Department of Justice
Department of Labor
Department of Transportation
Department of the Treasury
Department of Veterans Affairs
Other Executive Agencies
Architectural and Transportation Barriers Compliance Board
Environmental Protection Agency
Equal Employment Opportunity Commission
Financial Stability Oversight Council
General Services Administration
National Aeronautics and Space Administration
National Archives and Records Administration
Office of Personnel Management
Pension Benefit Guaranty Corporation
Small Business Administration
Social Security Administration
Independent Regulatory Agencies
Consumer Financial Protection Bureau
Consumer Product Safety Commission
Federal Trade Commission
National Indian Gaming Commission
Nuclear Regulatory Commission
AGENCY AGENDAS
Cabinet Departments
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Department of Homeland Security
Department of the Interior
Department of Justice
Department of Labor
Department of Transportation
Department of the Treasury
Other Executive Agencies
Architectural and Transportation Barriers Compliance Board
Environmental Protection Agency
General Services Administration
National Aeronautics and Space Administration
Small Business Administration
Joint Authority
Department of Defense/General Services Administration/National
Aeronautics and Space Administration (Federal Acquisition
Regulation)
Independent Regulatory Agencies
Consumer Financial Protection Bureau
Federal Communications Commission
Federal Deposit Insurance Corporation
Federal Reserve System
Nuclear Regulatory Commission
Securities and Exchange Commission
Introduction to the Unified Agenda of Federal Regulatory and
Deregulatory Actions
I. What Is the Unified Agenda?
The Unified Agenda provides information about regulations that the
Government is considering or reviewing. The Unified Agenda has appeared
in the Federal Register twice each year since 1983 and has been
available online since 1995. To further the objective of using modern
technology to deliver better service to the American people for lower
cost, beginning with the fall 2007 edition, the Internet is the basic
means for conveying regulatory agenda information to the maximum extent
legally permissible. The complete Unified Agenda is available to the
public at http://reginfo.gov. The online Unified Agenda offers flexible
search tools and will soon offer access to the entire historic Unified
Agenda database.
The fall 2011 Unified Agenda publication appearing in the Federal
Register consists of agency regulatory flexibility agendas, in
accordance with the publication requirements of the Regulatory
Flexibility Act. Agency regulatory flexibility agendas contain only
those Agenda entries for rules that are likely to have a significant
economic impact on a substantial number of small
[[Page 7665]]
entities and entries that have been selected for periodic review under
section 610 of the Regulatory Flexibility Act. Printed entries display
only the fields required by the Regulatory Flexibility Act. Complete
agenda information for those entries appears, in a uniform format, in
the online Unified Agenda at http://reginfo.gov.
These publication formats meet the publication mandates of the
Regulatory Flexibility Act and Executive Order 12866, as well as move
the Agenda process toward the goal of e-Government, at a substantially
reduced printing cost compared with prior editions. The current format
does not reduce the amount of information available to the public, but
it does limit most of the content of the Agenda to online access. The
complete online edition of the Unified Agenda includes regulatory
agendas from 59 Federal agencies. Agencies of the United States
Congress are not included.
The following agencies have no entries identified for inclusion in
the printed regulatory flexibility agenda. An asterisk (*) indicates
agencies that appear in The Regulatory Plan. The regulatory agendas of
these agencies are available to the public at http://reginfo.gov.
Department of Housing and Urban Development*
Department of State
Department of Veterans Affairs*
Agency for International Development
Commission on Civil Rights
Committee for Purchase From People Who Are Blind or Severely
Disabled
Corporation for National and Community Service
Court Services and Offender Supervision Agency for the District of
Columbia
Equal Employment Opportunity Commission*
Federal Mediation and Conciliation Service
Financial Stability Oversight Council*
Institute of Museum and Library Services
National Archives and Records Administration*
National Endowment for the Humanities
National Science Foundation
Office of Government Ethics
Office of Management and Budget
Office of Personnel Management*
Peace Corps
Pension Benefit Guaranty Corporation*
Railroad Retirement Board
Selective Service System
Social Security Administration*
Commodity Futures Trading Commission
Consumer Product Safety Commission*
Farm Credit Administration
Federal Energy Regulatory Commission
Federal Housing Finance Agency
Federal Maritime Commission
Federal Trade Commission*
National Credit Union Administration
National Indian Gaming Commission*
National Labor Relations Board
Postal Regulatory Commission
Surface Transportation Board
The Regulatory Information Service Center (the Center) compiles the
Unified Agenda for the Office of Information and Regulatory Affairs
(OIRA), part of the Office of Management and Budget. OIRA is
responsible for overseeing the Federal Government's regulatory,
paperwork, and information resource management activities, including
implementation of Executive Order 12866. The Center also provides
information about Federal regulatory activity to the President and his
Executive Office, the Congress, agency managers, and the public.
The activities included in the Agenda are, in general, those that
will have a regulatory action within the next 12 months. Agencies may
choose to include activities that will have a longer timeframe than 12
months. Agency agendas also show actions or reviews completed or
withdrawn since the last Unified Agenda. Executive Order 12866 does not
require agencies to include regulations concerning military or foreign
affairs functions or regulations related to agency organization,
management, or personnel matters.
Agencies prepared entries for this publication to give the public
notice of their plans to review, propose, and issue regulations. They
have tried to predict their activities over the next 12 months as
accurately as possible, but dates and schedules are subject to change.
Agencies may withdraw some of the regulations now under development,
and they may issue or propose other regulations not included in their
agendas. Agency actions in the rulemaking process may occur before or
after the dates they have listed. The Unified Agenda does not create a
legal obligation on agencies to adhere to schedules in this publication
or to confine their regulatory activities to those regulations that
appear within it.
II. Why Is the Unified Agenda Published?
The Unified Agenda helps agencies comply with their obligations
under the Regulatory Flexibility Act and various Executive orders and
other statutes.
Regulatory Flexibility Act
The Regulatory Flexibility Act requires agencies to identify those
rules that may have a significant economic impact on a substantial
number of small entities (5 U.S.C. 602). Agencies meet that requirement
by including the information in their submissions for the Unified
Agenda. Agencies may also indicate those regulations that they are
reviewing as part of their periodic review of existing rules under the
Regulatory Flexibility Act (5 U.S.C. 610). Executive Order 13272
entitled ``Proper Consideration of Small Entities in Agency
Rulemaking,'' signed August 13, 2002 (67 FR 53461), provides additional
guidance on compliance with the Act.
Executive Order 12866
Executive Order 12866 entitled ``Regulatory Planning and Review,''
signed September 30, 1993 (58 FR 51735), requires covered agencies to
prepare an agenda of all regulations under development or review. The
Order also requires that certain agencies prepare annually a regulatory
plan of their ``most important significant regulatory actions,'' which
appears as part of the fall Unified Agenda. Executive Order 13497,
signed January 30, 2009 (74 FR 6113), revoked the amendments to
Executive Order 12866 that were contained in Executive Order 13258 and
Executive Order 13422.
Executive Order 13132
Executive Order 13132 entitled ``Federalism,'' signed August 4,
1999 (64 FR 43255), directs agencies to have an accountable process to
ensure meaningful and timely input by State and local officials in the
development of regulatory policies that have ``federalism
implications'' as defined in the Order. Under the Order, an agency that
is proposing a regulation with federalism implications, which either
preempt State law or impose nonstatutory unfunded substantial direct
compliance costs on State and local governments, must consult with
State and local officials early in the process of developing the
regulation. In addition, the agency must provide to the Director of the
Office of Management and Budget a federalism summary impact statement
for such a regulation, which consists of a description of the extent of
the agency's prior consultation with State and local officials, a
summary of their concerns and the agency's position supporting the need
to issue the regulation, and a statement of the extent to which those
concerns have been met. As part of this effort, agencies include in
their submissions for the Unified Agenda information on whether their
regulatory actions may have an effect on the various levels of
government and whether those actions have federalism implications.
Executive Order 13563
Executive Order 13563 entitled ``Improving Regulation and
Regulatory Review,'' signed January 18, 2011, supplements and reaffirms
the
[[Page 7666]]
principles, structures, and definitions governing contemporary
regulatory review that were established in Executive Order 12866, which
includes the general principles of regulation and public participation,
and orders integration and innovation in coordination across agencies;
flexible approaches where relevant, feasible, and consistent with
regulatory approaches; scientific integrity in any scientific or
technological information and processes used to support the agencies'
regulatory actions; and retrospective analysis of existing regulations.
Unfunded Mandates Reform Act of 1995
The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, title II)
requires agencies to prepare written assessments of the costs and
benefits of significant regulatory actions ``that may result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more * * * in any 1 year *
* *.'' The requirement does not apply to independent regulatory
agencies, nor does it apply to certain subject areas excluded by
section 4 of the Act. Affected agencies identify in the Unified Agenda
those regulatory actions they believe are subject to title II of the
Act.
Executive Order 13211
Executive Order 13211 entitled ``Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use,'' signed
May 18, 2001 (66 FR 28355), directs agencies to provide, to the extent
possible, information regarding the adverse effects that agency actions
may have on the supply, distribution, and use of energy. Under the
Order, the agency must prepare and submit a Statement of Energy Effects
to the Administrator of the Office of Information and Regulatory
Affairs, Office of Management and Budget, for ``those matters
identified as significant energy actions.'' As part of this effort,
agencies may optionally include in their submissions for the Unified
Agenda information on whether they have prepared or plan to prepare a
Statement of Energy Effects for their regulatory actions.
Small Business Regulatory Enforcement Fairness Act
The Small Business Regulatory Enforcement Fairness Act (Pub. L.
104-121, title II) established a procedure for congressional review of
rules (5 U.S.C. 801 et seq.), which defers, unless exempted, the
effective date of a ``major'' rule for at least 60 days from the
publication of the final rule in the Federal Register. The Act
specifies that a rule is ``major'' if it has resulted, or is likely to
result, in an annual effect on the economy of $100 million or more or
meets other criteria specified in that Act. The Act provides that the
Administrator of OIRA will make the final determination as to whether a
rule is major.
III. How Is the Unified Agenda Organized?
Agency regulatory flexibility agendas are printed in a single daily
edition of the Federal Register. A regulatory flexibility agenda is
printed for each agency whose agenda includes entries for rules which
are likely to have a significant economic impact on a substantial
number of small entities or rules that have been selected for periodic
review under section 610 of the Regulatory Flexibility Act. Each
printed agenda appears as a separate part. The parts are organized
alphabetically in four groups: Cabinet departments; other executive
agencies; the Federal Acquisition Regulation, a joint authority; and
independent regulatory agencies. Agencies may in turn be divided into
subagencies. Each agency's part of the Agenda contains a preamble
providing information specific to that agency. Each printed agency
agenda has a table of contents listing the agency's printed entries
that follow.
The online, complete Unified Agenda contains the preambles of all
participating agencies. Unlike the printed edition, the online Agenda
has no fixed ordering. In the online Agenda, users can select the
particular agencies whose agendas they want to see. Users have broad
flexibility to specify the characteristics of the entries of interest
to them by choosing the desired responses to individual data fields. To
see a listing of all of an agency's entries, a user can select the
agency without specifying any particular characteristics of entries.
Each entry in the Agenda is associated with one of five rulemaking
stages. The rulemaking stages are:
1. Prerule Stage--actions agencies will undertake to determine
whether or how to initiate rulemaking. Such actions occur prior to a
Notice of Proposed Rulemaking (NPRM) and may include Advance Notices of
Proposed Rulemaking (ANPRMs) and reviews of existing regulations.
2. Proposed Rule Stage--actions for which agencies plan to publish
a Notice of Proposed Rulemaking as the next step in their rulemaking
process or for which the closing date of the NPRM Comment Period is the
next step.
3. Final Rule Stage--actions for which agencies plan to publish a
final rule or an interim final rule or to take other final action as
the next step.
4. Long-Term Actions--items under development but for which the
agency does not expect to have a regulatory action within the 12 months
after publication of this edition of the Unified Agenda. Some of the
entries in this section may contain abbreviated information.
5. Completed Actions--actions or reviews the agency has completed
or withdrawn since publishing its last agenda. This section also
includes items the agency began and completed between issues of the
Agenda.
Long-Term Actions are rulemakings reported during the publication
cycle that are outside of the required 12-month reporting period for
which the Agenda was intended. Completed Actions in the publication
cycle are rulemakings that are ending their lifecycle either by
Withdrawal or completion of the rulemaking process. Therefore, the
Long-Term and Completed RINs do not represent the ongoing, forward-
looking nature intended for reporting developing rulemakings in the
Agenda pursuant to Executive Order 12866, section 4(b) and 4(c). To
further differentiate these two stages of rulemaking in the Unified
Agenda from active rulemakings, Long-Term and Completed Actions are
reported separately from active rulemakings, which can be any of the
first three stages of rulemaking listed above. A separate search
function is provided on reginfo.gov to search for Completed and Long-
Term Actions apart from each other and active RINs.
A bullet () preceding the title of an entry indicates that
the entry is appearing in the Unified Agenda for the first time.
In the printed edition, all entries are numbered sequentially from
the beginning to the end of the publication. The sequence number
preceding the title of each entry identifies the location of the entry
in this edition. The sequence number is used as the reference in the
printed table of contents. Sequence numbers are not used in the online
Unified Agenda because the unique Regulation Identifier Number (RIN) is
able to provide this cross-reference capability.
Editions of the Unified Agenda prior to fall 2007 contained several
indexes, which identified entries with various characteristics. These
included regulatory actions for which agencies believe that the
Regulatory Flexibility Act may require a Regulatory Flexibility
Analysis, actions selected for periodic review under section 610(c) of
the Regulatory Flexibility Act, and actions
[[Page 7667]]
that may have federalism implications as defined in Executive Order
13132 or other effects on levels of government. These indexes are no
longer compiled, because users of the online Unified Agenda have the
flexibility to search for entries with any combination of desired
characteristics. The online edition retains the Unified Agenda's
subject index based on the Federal Register Thesaurus of Indexing
Terms. In addition, online users have the option of searching Agenda
text fields for words or phrases.
IV. What Information Appears for Each Entry?
All entries in the online Unified Agenda contain uniform data
elements including, at a minimum, the following information:
Title of the Regulation--a brief description of the subject of the
regulation. In the printed edition, the notation ``Section 610 Review''
following the title indicates that the agency has selected the rule for
its periodic review of existing rules under the Regulatory Flexibility
Act (5 U.S.C. 610(c)). Some agencies have indicated completions of
section 610 reviews or rulemaking actions resulting from completed
section 610 reviews. In the online edition, these notations appear in a
separate field.
Priority--an indication of the significance of the regulation.
Agencies assign each entry to one of the following five categories of
significance.
(1) Economically Significant
As defined in Executive Order 12866, a rulemaking action that will
have an annual effect on the economy of $100 million or more or will
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities. The definition of an ``economically significant'' rule is
similar but not identical to the definition of a ``major'' rule under 5
U.S.C. 801 (Pub. L. 104-121). (See below.)
(2) Other Significant
A rulemaking that is not Economically Significant but is considered
Significant by the agency. This category includes rules that the agency
anticipates will be reviewed under Executive Order 12866 or rules that
are a priority of the agency head. These rules may or may not be
included in the agency's regulatory plan.
(3) Substantive, Nonsignificant
A rulemaking that has substantive impacts but is neither
Significant, nor Routine and Frequent, nor Informational/
Administrative/Other.
(4) Routine and Frequent
A rulemaking that is a specific case of a multiple recurring
application of a regulatory program in the Code of Federal Regulations
and that does not alter the body of the regulation.
(5) Informational/Administrative/Other
A rulemaking that is primarily informational or pertains to agency
matters not central to accomplishing the agency's regulatory mandate
but that the agency places in the Unified Agenda to inform the public
of the activity.
Major--whether the rule is ``major'' under 5 U.S.C. 801 (Pub. L.
104-121) because it has resulted or is likely to result in an annual
effect on the economy of $100 million or more or meets other criteria
specified in that Act. The Act provides that the Administrator of the
Office of Information and Regulatory Affairs will make the final
determination as to whether a rule is major.
Unfunded Mandates--whether the rule is covered by section 202 of
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). The Act
requires that, before issuing an NPRM likely to result in a mandate
that may result in expenditures by State, local, and tribal
governments, in the aggregate, or by the private sector of more than
$100 million in 1 year, agencies, other than independent regulatory
agencies, shall prepare a written statement containing an assessment of
the anticipated costs and benefits of the Federal mandate.
Legal Authority--the section(s) of the United States Code (U.S.C.)
or Public Law (Pub. L.) or the Executive order (E.O.) that authorize(s)
the regulatory action. Agencies may provide popular name references to
laws in addition to these citations.
CFR Citation--the section(s) of the Code of Federal Regulations
that will be affected by the action.
Legal Deadline--whether the action is subject to a statutory or
judicial deadline, the date of that deadline, and whether the deadline
pertains to an NPRM, a Final Action, or some other action.
Abstract--a brief description of the problem the regulation will
address; the need for a Federal solution; to the extent available,
alternatives that the agency is considering to address the problem; and
potential costs and benefits of the action.
Timetable--the dates and citations (if available) for all past
steps and a projected date for at least the next step for the
regulatory action. A date displayed in the form 12/00/11 means the
agency is predicting the month and year the action will take place but
not the day it will occur. In some instances, agencies may indicate
what the next action will be, but the date of that action is ``To Be
Determined.'' ``Next Action Undetermined'' indicates the agency does
not know what action it will take next.
Regulatory Flexibility Analysis Required--whether an analysis is
required by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
because the rulemaking action is likely to have a significant economic
impact on a substantial number of small entities as defined by the Act.
Small Entities Affected--the types of small entities (businesses,
governmental jurisdictions, or organizations) on which the rulemaking
action is likely to have an impact as defined by the Regulatory
Flexibility Act. Some agencies have chosen to indicate likely effects
on small entities even though they believe that a Regulatory
Flexibility Analysis will not be required.
Government Levels Affected--whether the action is expected to
affect levels of government and, if so, whether the governments are
State, local, tribal, or Federal.
International Impacts--whether the regulation is expected to have
international trade and investment effects, or otherwise may be of
interest to the Nation's international trading partners.
Federalism--whether the action has ``federalism implications'' as
defined in Executive Order 13132. This term refers to actions ``that
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government.''
Independent regulatory agencies are not required to supply this
information.
Included in the Regulatory Plan--whether the rulemaking was
included in the agency's current regulatory plan published in fall
2010.
Agency Contact--the name and phone number of at least one person in
the agency who is knowledgeable about the rulemaking action. The agency
may also provide the title, address, fax number, email address, and TDD
for each agency contact.
Some agencies have provided the following optional information:
[[Page 7668]]
RIN Information URL--the Internet address of a site that provides
more information about the entry.
Public Comment URL--the Internet address of a site that will accept
public comments on the entry. Alternatively, timely public comments may
be submitted at the Governmentwide e-rulemaking site, http://www.regulations.gov.
Additional Information--any information an agency wishes to include
that does not have a specific corresponding data element.
Compliance Cost to the Public--the estimated gross compliance cost
of the action.
Affected Sectors--the industrial sectors that the action may most
affect, either directly or indirectly. Affected sectors are identified
by North American Industry Classification System (NAICS) codes.
Energy Effects--an indication of whether the agency has prepared or
plans to prepare a Statement of Energy Effects for the action, as
required by Executive Order 13211 ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use,'' signed May
18, 2001 (66 FR 28355).
Related RINs--one or more past or current RIN(s) associated with
activity related to this action, such as merged RINs, split RINs, new
activity for previously completed RINs, or duplicate RINs.
Some agencies that participated in the fall 2010 edition of The
Regulatory Plan have chosen to include the following information for
those entries that appeared in the Plan:
Statement of Need--a description of the need for the regulatory
action.
Summary of the Legal Basis--a description of the legal basis for
the action, including whether any aspect of the action is required by
statute or court order.
Alternatives--a description of the alternatives the agency has
considered or will consider as required by section 4(c)(1)(B) of
Executive Order 12866.
Anticipated Costs and Benefits--a description of preliminary
estimates of the anticipated costs and benefits of the action.
Risks--a description of the magnitude of the risk the action
addresses, the amount by which the agency expects the action to reduce
this risk, and the relation of the risk and this risk reduction effort
to other risks and risk reduction efforts within the agency's
jurisdiction.
V. Abbreviations
The following abbreviations appear throughout this publication:
ANPRM--An Advance Notice of Proposed Rulemaking is a preliminary
notice, published in the Federal Register, announcing that an agency is
considering a regulatory action. An agency may issue an ANPRM before it
develops a detailed proposed rule. An ANPRM describes the general area
that may be subject to regulation and usually asks for public comment
on the issues and options being discussed. An ANPRM is issued only when
an agency believes it needs to gather more information before
proceeding to a notice of proposed rulemaking.
CFR--The Code of Federal Regulations is an annual codification of
the general and permanent regulations published in the Federal Register
by the agencies of the Federal Government. The Code is divided into 50
titles, each title covering a broad area subject to Federal regulation.
The CFR is keyed to and kept up to date by the daily issues of the
Federal Register.
EO--An Executive order is a directive from the President to
Executive agencies, issued under constitutional or statutory authority.
Executive orders are published in the Federal Register and in title 3
of the Code of Federal Regulations.
FR--The Federal Register is a daily Federal Government publication
that provides a uniform system for publishing Presidential documents,
all proposed and final regulations, notices of meetings, and other
official documents issued by Federal agencies.
FY--The Federal fiscal year runs from October 1 to September 30.
NPRM--A Notice of Proposed Rulemaking is the document an agency
issues and publishes in the Federal Register that describes and
solicits public comments on a proposed regulatory action. Under the
Administrative Procedure Act (5 U.S.C. 553), an NPRM must include, at a
minimum:
A statement of the time, place, and nature of the public
rulemaking proceeding;
A reference to the legal authority under which the rule is
proposed; and
Either the terms or substance of the proposed rule or a
description of the subjects and issues involved.
PL (or Pub. L.)--A public law is a law passed by Congress and
signed by the President or enacted over his veto. It has general
applicability, unlike a private law that applies only to those persons
or entities specifically designated. Public laws are numbered in
sequence throughout the 2-year life of each Congress; for example, Pub.
L. 112-4 is the fourth public law of the 112th Congress.
RFA--A Regulatory Flexibility Analysis is a description and
analysis of the impact of a rule on small entities, including small
businesses, small governmental jurisdictions, and certain small not-
for-profit organizations. The Regulatory Flexibility Act (5 U.S.C. 601
et seq.) requires each agency to prepare an initial RFA for public
comment when it is required to publish an NPRM and to make available a
final RFA when the final rule is published, unless the agency head
certifies that the rule would not have a significant economic impact on
a substantial number of small entities.
RIN--The Regulation Identifier Number is assigned by the Regulatory
Information Service Center to identify each regulatory action listed in
the Unified Agenda, as directed by Executive Order 12866 (section
4(b)). Additionally, OMB has asked agencies to include RINs in the
headings of their Rule and Proposed Rule documents when publishing them
in the Federal Register, to make it easier for the public and agency
officials to track the publication history of regulatory actions
throughout their development.
Seq. No.--The sequence number identifies the location of an entry
in the printed edition of the Unified Agenda. Note that a specific
regulatory action will have the same RIN throughout its development but
will generally have different sequence numbers if it appears in
different printed editions of the Unified Agenda. Sequence numbers are
not used in the online Unified Agenda.
U.S.C.--The United States Code is a consolidation and codification
of all general and permanent laws of the United States. The U.S.C. is
divided into 50 titles, each title covering a broad area of Federal
law.
VI. How Can Users Get Copies of the Agenda?
Copies of the Federal Register issue containing the printed edition
of the Unified Agenda (agency regulatory flexibility agendas) are
available from the Superintendent of Documents, U.S. Government
Printing Office, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone:
202 512-1800 or 1 866 512-1800 (toll-free).
Copies of individual agency materials may be available directly
from the agency or may be found on the agency's Web site. Please
contact the particular agency for further information.
All editions of The Regulatory Plan and the Unified Agenda of
Federal
[[Page 7669]]
Regulatory and Deregulatory Actions since fall 1995 are available in
electronic form at http://reginfo.gov, along with flexible search
tools.
In accordance with regulations for the Federal Register, the
Government Printing Office's GPO FDsys Web site contains copies of the
Agendas and Regulatory Plans that have been printed in the Federal
Register. These documents are available at http://www.fdsys.gov.
Dated: December 19, 2011.
John C. Thomas,
Director.
Introduction to the Fall 2011 Regulatory Plan
Executive Order 12866, issued in 1993, requires the annual
production of a Unified Regulatory Agenda and Regulatory Plan. It does
so to promote transparency--or in the words of the Executive Order
itself, ``to have an effective regulatory program, to provide for
coordination of regulations, to maximize consultation and the
resolution of potential conflicts at an early stage, to involve the
public and its State, local, and tribal officials in regulatory
planning, and to ensure that new or revised regulations promote the
President's priorities and the principles set forth in this Executive
order.''
The requirements of Executive Order 12866 were reaffirmed in
Executive Order 13563, issued in 2011. Consistent with Executive Orders
13563 and 12866, we are now providing the Unified Regulatory Agenda and
the Regulatory Plan for public scrutiny and review. Such scrutiny and
review are closely connected with the general goal, central to
Executive Order 13563, of promoting public participation in the
rulemaking process.
It is important to understand that the Agenda and Plan are intended
merely to serve as a preliminary statement, for public understanding
and assessment, of regulatory and deregulatory policies and priorities
that are now under contemplation. This preliminary statement often
includes a number of rules that are not issued in the following year
and that may well not be issued at all. This year, we have taken
several new steps to clarify the purposes and uses of the Agenda and
Plan and to improve its presentation. Among other things, we have
narrowed the list of ``active rulemakings'' to rules that are not
merely under some form of contemplation but that also have at least
some possibility of issuance over the next year. We have also made it
easier to understand which rules are active rulemakings rather than
long-term actions or completed actions. But it remains true that rules
on this list, designed among other things ``to involve the public and
its State, local, and tribal officials in regulatory planning,'' must
undergo serious internal and external scrutiny before they are issued--
and that there are rules on the list that may never be issued.
In this light, it should be clear that this preliminary statement
of policies and priorities has extremely important limitations. No
regulatory action can be made effective until it has gone through
legally required processes, including those that involve public
scrutiny and review. For this reason, the inclusion of a regulatory
action here does not necessarily mean that it will be finalized or even
proposed. Any proposed or final action must satisfy the requirements of
relevant statutes, Executive Orders, and Presidential Memoranda. Those
requirements, public comments, and new information may or may not lead
an agency to go forward with an action that is currently under
contemplation and that is included here. For example, the directives of
Executive Order 13563, emphasizing the importance of careful
consideration of costs and benefits, may lead an agency to decline to
proceed with a regulatory action that is presented here.
It is also important to note that under Executive Order 12866,
whether a regulation counts as ``economically significant'' is not an
adequate measure of whether it imposes high costs on the private
sector. Economically significant actions may impose small costs or even
no costs. For example, regulations may count as economically
significant not because they impose significant costs, but because they
confer large benefits. Moreover, many regulations count as economically
significant not because they impose significant regulatory costs on the
private sector, but because they involve transfer payments as required
or authorized by law.
It should be observed that the number of economically significant
actions listed as under active consideration here--138--is lower than
the corresponding figure for Spring 2011 (149) and for Fall 2010 (140).
It is notable that the number of such rules has not grown even taking
account of rules implementing the Affordable Care Act and the Wall
Street Reform and Consumer Protection Act. We also note that the net
benefits of regulation were unusually high in Fiscal Year 2011 (well
over $50 billion for the year alone). In addition, the aggregate costs
for that year (under $8 billion) were lower than in Fiscal Year 2010
and were not out of line with those in recent years, including during
the Bush Administration.
With these notes and qualifications, the Regulatory Plan provides a
list of important regulatory actions that are now under contemplation
for issuance in proposed or final form during the upcoming fiscal year.
In contrast, the Unified Agenda is a more inclusive list, including
numerous ministerial actions and routine rulemakings, as well as long-
term initiatives that agencies do not plan to complete in the coming
year.
We hope that public scrutiny of the Regulatory Plan and the Unified
Agenda might help ensure, in the words of Executive Order 13563, a
regulatory system that protects ``public health, welfare, safety, and
our environment while promoting economic growth, innovation,
competitiveness, and job creation.''
As discussed below, a large number of significant recent steps have
been taken, consistent with Executive Order 13563, to reduce regulatory
costs and ensure that our regulatory system is consistent with
promoting growth and job creation. At the same time, a number of steps
have been taken to promote public health, welfare, safety, and our
environment. It is important to emphasize that the net benefits of
recent rules, including the monetized benefits, are high--over the
first two fiscal years of this Administration, in excess of $35
billion. Rules have been issued and initiatives have been undertaken
that are saving lives on the highways and in workplaces; reducing air
and water pollution, preventing thousands of deaths in the process;
increasing fuel economy, thus saving money while reducing pollution;
making both trains and planes safer; increasing energy efficiency,
saving billions of dollars while increasing energy security; combating
childhood obesity; and creating a ``race to the top'' in education.
Consider, as merely one example, the fact that in 2010, the rates of
roadway fatalities and injuries fell to their lowest recorded levels
and to their lowest numbers since 1949. The decrease is attributable,
in part, to a range of regulatory actions and to private-public
partnerships that have increased safety.
Since President Reagan's Executive Order 12291, issued in 1981, a
principal focus of the Office of Information and Regulatory Affairs,
and of regulatory policy in general, has been on maximizing net
benefits. In this Administration, agencies and OMB have worked together
to issue a number of rules for which the benefits exceed the costs, and
by a large margin. Consider the following figure:
[[Page 7670]]
[GRAPHIC] [TIFF OMITTED] TP13FE12.000
These figures reflect the numbers for 2009 and 2010. As noted, the
net benefits for 2011 are expected to be unusually high (in excess of
$50 billion); they will be discussed in detail in the 2012 Report to
Congress on the Benefits and Costs of Federal Regulations.
The recent steps build on a great deal of new learning about
regulation. As a result of conceptual and empirical advances, we know
far more than during the New Deal and the Great Society. We have also
learned much since the 1980s and 1990s. These lessons have informed the
Administration's efforts to protect public health and safety while also
promoting economic growth and job creation. Eight points are
particularly important:
1. We are now equipped with state-of-the-art techniques for
anticipating, cataloguing, and monetizing the consequences of
regulation, including both benefits and costs.
2. We know that risks are part of systems, and that efforts to
reduce a certain risk may increase other risks, perhaps even deadly
ones, thus producing ancillary harms--and that efforts to reduce a
certain risk may reduce other risks, perhaps even deadly ones, thus
producing ancillary benefits.
3. We know that flexible, innovative approaches, maintaining
freedom of choice and respecting heterogeneity and the fact that one
size may not fit all, are often desirable, both because they preserve
liberty and because they frequently cost less.
4. We know that large benefits can come from seemingly modest and
small steps, including simplification of regulatory requirements,
provision of information, and sensible default rules, such as automatic
enrollment for retirement savings.
5. We know, more clearly than ever before, that it is important to
allow public participation in the design of rules, because members of
the public have valuable information about likely effects, existing
problems, creative solutions, and possible unintended consequences.
6. We know that if carefully designed, disclosure policies can
promote informed choices and save both money and lives.
7. We know that intuitions and anecdotes are unreliable, and that
advance testing of the effects of rules, as through pilot programs or
randomized controlled experiments, can be highly illuminating.
8. We know that it is important to explore the effects of
regulation in the real world, to learn whether they are having
beneficial consequences or producing unintended harm. We need to
consult, and to learn from, those who are affected by rules.
Executive Order 13563 draws on these understandings and emphasizes
the importance of protecting ``public health, welfare, safety, and our
environment while promoting economic growth, innovation,
competitiveness, and job creation.'' Executive Order 13563 explicitly
points to the need for predictability and for certainty, and for use of
the least burdensome tools for achieving regulatory ends. It indicates
that agencies ``must take into account benefits and costs, both
quantitative and qualitative.'' It explicitly draws attention to the
need to measure and to improve ``the actual results of regulatory
requirements''--a clear reference to the importance of retrospective
evaluation.
Executive Order 13563 reaffirms the principles, structures, and
definitions in Executive Order 12866, which has long governed
regulatory review. In addition, it endorses, and quotes, a number of
[[Page 7671]]
provisions of that Executive Order that specifically emphasize the
importance of considering costs--including the requirement that to the
extent permitted by law, agencies should not proceed in the absence of
a reasoned determination that the benefits justify the costs.
Importantly, Executive Order 13563 directs agencies ``to use the best
available techniques to quantify anticipated present and future
benefits and costs as accurately as possible.'' This direction reflects
a strong emphasis on quantitative analysis as a means of improving
regulatory choices and increasing transparency.
Among other things, Executive Order 13563 sets out five sets of
requirements to guide regulatory decision making:
Public participation. Agencies are directed to promote
public participation, in part by making supporting documents available
on Regulations.gov in order to promote transparency and public comment.
Executive Order 13563 also directs agencies, where feasible and
appropriate, to engage the public, including affected stakeholders,
before rulemaking is initiated.
Integration and innovation. Agencies are directed to
attempt to reduce ``redundant, inconsistent, or overlapping''
requirements, in part by working with one another to simplify and
harmonize rules. This important provision is designed to reduce
confusion, redundancy, and excessive cost. An important goal of
simplification and harmonization is to promote rather than to hamper
innovation, which is a foundation of both growth and job creation.
Different offices within the same agency might work together to
harmonize their rules; different agencies might work together to
achieve the same objective. Such steps can also promote predictability
and certainty.
Flexible approaches. Agencies are directed to identify and
consider flexible approaches to regulatory problems, including
warnings, appropriate default rules, and disclosure requirements. Such
approaches may ``reduce burdens and maintain flexibility and freedom of
choice for the public.'' In certain settings, they may be far
preferable to mandates and bans, precisely because they maintain
freedom of choice and reduce costs. The reference to ``appropriate
default rules'' signals the possibility that important social goals can
be obtained through simplification--as, for example, in the form of
automatic enrollment, direct certification, or reduced paperwork
burdens.
Science. Agencies are directed to promote scientific
integrity, and in a way that ensures a clear separation between
judgments of science and judgments of policy.
Retrospective analysis of existing rules. Agencies are
directed to produce preliminary plans to engage in retrospective
analysis of existing significant regulations to determine whether they
should be modified, streamlined, expanded, or repealed.
Executive Order 13563 addresses both the ``flow'' of new
regulations that are under development and the ``stock'' of existing
regulations that are already in place. Executive Order 13563 emphasizes
the importance of promoting predictability, of carefully considering
costs, of choosing the least burdensome approach, and of selecting the
most flexible, least costly tools. In addition, Executive Order 13563
calls for careful reassessment, based on empirical analysis. It is
understood that the prospective analysis required by Executive Order
13563 may depend on a degree of speculation and that the actual costs
and benefits of a regulation may be lower or higher than what was
anticipated when the rule was originally developed. It is also
understood that circumstances may change in a way that requires
reconsideration of regulatory requirements. After retrospective
analysis has been undertaken, agencies will be in a position to
reevaluate existing rules and to streamline, modify, or eliminate those
that do not make sense in their current form.
In August 2011, over two dozen agencies released final plans to
remove what the President has called unjustified rules and ``absurd and
unnecessary paperwork requirements that waste time and money.'' Over
the next five years, billions of dollars in savings are anticipated
from just a few initiatives from the Department of Transportation, the
Department of Labor, the Department of Health and Human Services, and
the Environmental Protection Agency. And all in all, the plans'
initiatives will save tens of millions of hours in annual paperwork
burdens on individuals, businesses, and state and local governments.
The plans span over 800 pages and offer more than 500 proposals.
Some plans list well over 50 reforms. Many of the proposals focus on
small business. Indeed, a number of the initiatives are specifically
designed to reduce burdens on small business and to enable them to do
what they do best, which is to create jobs. Some of the proposed
initiatives represent a fundamental rethinking of how things have long
been done--as, for example, with numerous efforts to move from paper to
electronic reporting. For both private and public sectors, those
efforts can save a great deal of money. Over the next five years, the
Department of Treasury's paperless initiative will be saving $400
million and 12 million pounds of paper.
Many of the reforms will have a significant economic impact:
The Occupational Safety and Health Administration has
announced a final rule that will remove over 1.9 million annual hours
of redundant reporting burdens on employers and save more than $40
million in annual costs. Businesses will no longer be saddled with the
obligation to fill out unnecessary government forms, meaning that their
employees will have more time to be productive and do their real work.
To eliminate unjustified economic burdens on railroads,
the Department of Transportation is reconsidering parts of a rule that
requires railroads to install equipment on trains. DOT has proposed to
refine the requirements so that the equipment is installed only where
it is really needed on grounds of safety. DOT expects initial savings
of up to $325 million, with total 20-year savings of up to $755
million.
EPA has proposed to eliminate the obligation for many
states to require air pollution vapor recovery systems at local gas
stations, on the ground that modern vehicles already have effective air
pollution control technologies. The anticipated annual savings are $87
million.
The Departments of Commerce and State are undertaking a
series of steps to eliminate unnecessary barriers to exports, including
duplicative and unnecessary regulatory requirements, thus reducing the
cumulative burden and uncertainty faced by American companies and their
trading partners. These steps will make it a lot easier for American
companies to reach new markets, increasing our exports while creating
jobs here at home.
To promote flexibility, the Department of Health and Human
Services has proposed two rules, and finalized another, to reduce
burdensome regulatory requirements now placed on hospitals and doctors.
These reforms are expected to save more than $1 billion annually.
The regulatory lookback is not merely a one-time exercise. Regular
reporting, about recent progress and coming initiatives, is required.
The goal is to change the regulatory culture to ensure that rules on
the books are reevaluated and are effective, cost-justified, and based
on the best available science. By creating regulatory review teams at
agencies, we will continue to examine what is working and what is not
and to
[[Page 7672]]
eliminate unjustified and outdated regulations.
In addition to looking back at existing regulations, we are looking
forward to ensure that future regulations are well-justified. Executive
Order 13563 provides critical guidance with its emphasis on careful
consideration of costs and benefits, public participation, integration
and innovation, flexible approaches, and science. These requirements
are meant to produce a regulatory system that draws on recent learning,
that is driven by evidence, and that is suited to the distinctive
circumstances of the twenty-first century.
Department of Agriculture
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
1............................. Wholesale Pork Reporting 0581-AD07 Proposed Rule Stage.
Program.
2............................. National Organic Program: 0581-AD17 Proposed Rule Stage.
Sunset Review for
Nutrient Vitamins and
Minerals (NOP-10-0083).
3............................. Animal Welfare; 0579-AC02 Proposed Rule Stage.
Regulations and
Standards for Birds.
4............................. Plant Pest Regulations; 0579-AC98 Proposed Rule Stage.
Update of General
Provisions.
5............................. Importation of Live Dogs. 0579-AD23 Final Rule Stage.
6............................. Animal Disease 0579-AD24 Final Rule Stage.
Traceability.
7............................. Supplemental Nutrition 0584-AD88 Proposed Rule Stage.
Assistance Program: Farm
Bill of 2008 Retailer
Sanctions.
8............................. National School Lunch and 0584-AE09 Proposed Rule Stage.
School Breakfast
Programs: Nutrition
Standards for All Foods
Sold in School, as
Required by the Healthy,
Hunger-Free Kids Act of
2010.
9............................. WIC: Electronic Benefit 0584-AE21 Proposed Rule Stage.
Transfer (EBT)
Implementation.
10............................ Nutrition Standards in 0584-AD59 Final Rule Stage.
the National School
Lunch and School
Breakfast Programs.
11............................ Direct Certification of 0584-AD60 Final Rule Stage.
Children in Food Stamp
Households and
Certification of
Homeless, Migrant, and
Runaway Children for
Free Meals.
12............................ Eligibility, 0584-AD87 Final Rule Stage.
Certification, and
Employment and Training
Provisions of the Food,
Conservation, and Energy
Act of 2008.
13............................ Supplemental Nutrition 0584-AE07 Final Rule Stage.
Assistance Program:
Nutrition Education and
Obesity Prevention Grant.
14............................ Prior Labeling Approval 0583-AC59 Proposed Rule Stage.
System: Generic Label
Approval.
15............................ Product Labeling: Use of 0583-AD30 Proposed Rule Stage.
the Voluntary Claim
``Natural'' on the
Labeling of Meat and
Poultry Products.
16............................ New Poultry Slaughter 0583-AD32 Proposed Rule Stage.
Inspection.
17............................ Electronic Imported 0583-AD39 Proposed Rule Stage.
Product Inspection
Application and
Certification of
Imported Product and
Foreign Establishments;
Amendments to Facilitate
the Public Health
Information System
(PHIS).
18............................ Electronic Export 0583-AD41 Proposed Rule Stage.
Application and
Certification as a
Reimbursable Service and
Flexibility in the
Requirements for
Official Export
Inspection Marks,
Devices, and
Certificates.
19............................ Performance Standards for 0583-AC46 Final Rule Stage.
the Production of
Processed Meat and
Poultry Products;
Control of Listeria
Monocytogenes in Ready-
To-Eat Meat and Poultry
Products.
20............................ Notification, 0583-AD34 Final Rule Stage.
Documentation, and
Recordkeeping
Requirements for
Inspected Establishments.
----------------------------------------------------------------------------------------------------------------
Department of Commerce
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
21............................ Revisions to the Export 0694-AF17 Final Rule Stage.
Administration
Regulations (EAR):
Control of Military
Vehicles and Related
Items That the President
Determines do not
Warrant Control on the
United States Munitions
List.
22............................ Fishery Management Plan 0648-AS65 Proposed Rule Stage.
for Regulating Offshore
Marine Aquaculture in
the Gulf of Mexico.
23............................ Reducing Disturbances to 0648-AU02 Proposed Rule Stage.
Hawaiian Spinner
Dolphins From Human
Interactions.
24............................ Designation of Critical 0648-AY54 Proposed Rule Stage.
Habitat for the North
Atlantic Right Whale.
25............................ Regulatory Amendments To 0648-BA89 Proposed Rule Stage.
Implement the Shark
Conservation Act and
Revise the Definition of
Illegal, Unreported, and
Unregulated Fishing.
----------------------------------------------------------------------------------------------------------------
Department of Education
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
26............................ Title IV of the Higher 1840-AD05 Proposed Rule Stage.
Education Act of 1965,
as Amended.
----------------------------------------------------------------------------------------------------------------
[[Page 7673]]
Department of Energy
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
27............................ Energy Efficiency 1904-AB57 Proposed Rule Stage.
Standards for Battery
Chargers and External
Power Supplies.
28............................ Energy Conservation 1904-AB86 Proposed Rule Stage.
Standards for Walk-In
Coolers and Walk-In
Freezers.
29............................ Energy Efficiency 1904-AC11 Proposed Rule Stage.
Standards for
Manufactured Housing.
30............................ Energy Conservation 1904-AC15 Proposed Rule Stage.
Standards for ER, BR,
and Small Diameter
Incandescent Reflector
Lamps.
31............................ Energy Efficiency 1904-AB50 Final Rule Stage.
Standards for
Fluorescent Lamp
Ballasts.
----------------------------------------------------------------------------------------------------------------
Department of Health and Human Services
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
32............................ Health Information 0991-AB82 Proposed Rule Stage.
Technology: New and
Revised Standards,
Implementation
Specifications, and
Certification Criteria
for Electronic Health
Record Technology.
33............................ Electronic Submission of 0910-AC52 Proposed Rule Stage.
Data From Studies
Evaluating Human Drugs
and Biologics.
34............................ Current Good 0910-AG10 Proposed Rule Stage.
Manufacturing Practice
and Hazard Analysis and
Risk-Benefit Preventive
Controls for Food for
Animals.
35............................ Unique Device 0910-AG31 Proposed Rule Stage.
Identification.
36............................ Produce Safety Regulation 0910-AG35 Proposed Rule Stage.
37............................ Hazard Analysis and Risk- 0910-AG36 Proposed Rule Stage.
Based Preventive
Controls.
38............................ Foreign Supplier 0910-AG64 Proposed Rule Stage.
Verification Program.
39............................ Accreditation of Third 0910-AG66 Proposed Rule Stage.
Parties to Conduct Food
Safety Audits and for
Other Related Purposes.
40............................ Infant Formula: Current 0910-AF27 Final Rule Stage.
Good Manufacturing
Practices; Quality
Control Procedures;
Notification
Requirements; Records
and Reports; and Quality
Factors.
41............................ Medical Device Reporting; 0910-AF86 Final Rule Stage.
Electronic Submission
Requirements.
42............................ Electronic Registration 0910-AF88 Final Rule Stage.
and Listing for Devices.
43............................ Food Labeling: Nutrition 0910-AG56 Final Rule Stage.
Labeling for Food Sold
in Vending Machines.
44............................ Food Labeling: Nutrition 0910-AG57 Final Rule Stage.
Labeling of Standard
Menu Items in
Restaurants and Similar
Retail Food
Establishments.
45............................ Medicare and Medicaid 0938-AQ89 Proposed Rule Stage.
Programs: Reform of
Hospital and Critical
Access Hospital
Conditions of
Participation (CMS-3244-
P).
46............................ Regulatory Provisions To 0938-AQ96 Proposed Rule Stage.
Promote Program
Efficiency,
Transparency, and Burden
Reduction (CMS-9070-P).
47............................ Proposed Changes to 0938-AR10 Proposed Rule Stage.
Hospital OPPS and CY
2013 Payment Rates; ASC
Payment System and CY
2013 Payment Rates (CMS-
1589-P).
48............................ Revisions to Payment 0938-AR11 Proposed Rule Stage.
Policies Under the
Physician Fee Schedule
and Part B for CY 2013
(CMS-1590-P).
49............................ Changes to the Hospital 0938-AR12 Proposed Rule Stage.
Inpatient an Long-Term
Care Prospective Payment
System for FY 2013 (CMS-
1588-P).
50............................ Medicaid Eligibility 0938-AQ62 Final Rule Stage.
Expansion Under the
Affordable Care Act of
2010 (CMS-2349-F).
51............................ Establishment of 0938-AQ67 Final Rule Stage.
Exchanges and Qualified
Health Plans Part I (CMS-
9989-F).
52............................ State Requirements for 0938-AR07 Final Rule Stage.
Exchange--Reinsurance
and Risk Adjustments
(CMS-9975-F).
----------------------------------------------------------------------------------------------------------------
Department of Homeland Security
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
53............................ Secure Handling of 1601-AA52 Proposed Rule Stage.
Ammonium Nitrate Program.
54............................ Asylum and Withholding 1615-AA41 Proposed Rule Stage.
Definitions.
55............................ New Classification for 1615-AA67 Proposed Rule Stage.
Victims of Criminal
Activity; Eligibility
for the U Nonimmigrant
Status.
56............................ Exception to the 1615-AB89 Proposed Rule Stage.
Persecution Bar for
Asylum, Refugee, and
Temporary Protected
Status, and Withholding
of Removal.
57............................ Electronic Filing of 1615-AB94 Proposed Rule Stage.
Requests for Immigration
Benefits; Requiring an
Application To Change or
Extend Nonimmigrant
Status To Be Filed
Electronically.
58............................ Immigration Benefits 1615-AB95 Proposed Rule Stage.
Business Transformation:
Nonimmigrants; Student
and Exchange Visitor
Program.
59............................ Application of the 1615-AB96 Proposed Rule Stage.
William Wilberforce
Trafficking Victims
Protection
Reauthorization Act of
2008 to Unaccompanied
Alien Children Seeking
Asylum.
60............................ Administrative Appeals 1615-AB98 Proposed Rule Stage.
Office: Procedural
Reforms To Improve
Efficiency.
61............................ New Classification for 1615-AA59 Final Rule Stage.
Victims of Severe Forms
of Trafficking in
Persons; Eligibility for
T Nonimmigrant Status.
[[Page 7674]]
62............................ Adjustment of Status to 1615-AA60 Final Rule Stage.
Lawful Permanent
Resident for Aliens in T
and U Nonimmigrant
Status.
63............................ Application of 1615-AB77 Final Rule Stage.
Immigration Regulations
to the Commonwealth of
the Northern Mariana
Islands.
64............................ Implementation of the 1625-AA16 Final Rule Stage.
1995 Amendments to the
International Convention
on Standards of
Training, Certification,
and Watchkeeping (STCW)
for Seafarers, 1978.
65............................ Vessel Requirements for 1625-AA99 Final Rule Stage.
Notices of Arrival and
Departure, and Automatic
Identification System.
66............................ Nontank Vessel Response 1625-AB27 Final Rule Stage.
Plans and Other Vessel
Response Plan
Requirements.
67............................ Offshore Supply Vessels 1625-AB62 Final Rule Stage.
of At Least 6000 GT ITC.
68............................ Revision to 1625-AB80 Final Rule Stage.
Transportation Worker
Identification
Credential (TWIC)
Requirements for
Mariners.
69............................ Importer Security Filing 1651-AA70 Final Rule Stage.
and Additional Carrier
Requirements.
70............................ Changes to the Visa 1651-AA72 Final Rule Stage.
Waiver Program To
Implement the Electronic
System for Travel
Authorization (ESTA)
Program.
71............................ Establishment of Global 1651-AA73 Final Rule Stage.
Entry Program.
72............................ Implementation of the 1651-AA77 Final Rule Stage.
Guam-CNMI Visa Waiver
Program.
73............................ General Aviation Security 1652-AA53 Proposed Rule Stage.
and Other Aircraft
Operator Security.
74............................ Freight Railroads, Public 1652-AA55 Proposed Rule Stage.
Transportation and
Passenger Railroads, and
Over-the-Road Buses--
Security Training of
Employees.
75............................ Freight Railroads and 1652-AA56 Proposed Rule Stage.
Passenger Railroads--
Vulnerability Assessment
and Security Plan.
76............................ Standardized Vetting, 1652-AA61 Proposed Rule Stage.
Adjudication, and
Redress Services.
77............................ Aircraft Repair Station 1652-AA38 Final Rule Stage.
Security.
78............................ Continued Detention of 1653-AA60 Proposed Rule Stage.
Aliens Subject to Final
Orders of Removal.
79............................ Continued Detention of 1653-AA13 Final Rule Stage.
Aliens Subject to Final
Orders of Removal.
80............................ Extending Period for 1653-AA56 Final Rule Stage.
Optional Practical
Training by 17 Months
for F-1 Nonimmigrant
Students With STEM
Degrees and Expanding
the CAP-GAP Relief for
All F-1 Students With
Pending H-1B Petitions.
81............................ Update of FEMA's Public 1660-AA51 Proposed Rule Stage.
Assistance Regulations.
----------------------------------------------------------------------------------------------------------------
Department of Housing and Urban Development
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
82............................ Federal Housing 2502-AI79 Proposed Rule Stage.
Administration (FHA):
Strengthening the Home
Equity Conversion
Mortgages (HECM) Program
to Promote Sustained
Homeownership (FR-5353).
83............................ Supportive Housing for 2502-AJ10 Proposed Rule Stage.
Persons With
Disabilities
Implementing New Project
Rental Assistance
Authority (FR-5576).
84............................ Tenant-Based Rental 2577-AC76 Proposed Rule Stage.
Assistance; Improving
Performance Through a
Strengthened Section 8
Management Assessment
Program (FR-5201).
----------------------------------------------------------------------------------------------------------------
Department of Justice
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
85............................ National Standards to 1105-AB34 Final Rule Stage.
Prevent, Detect, and
Respond to Prison Rape.
----------------------------------------------------------------------------------------------------------------
Department of Labor
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
86............................ Construction Contractors' 1250-AA01 Proposed Rule Stage.
Affirmative Action
Requirements.
87............................ Persuader Agreements: 1245-AA03 Final Rule Stage.
Employer and Labor
Relations Consultant
Reporting Under the
LMRDA.
88............................ Equal Employment 1205-AB59 Proposed Rule Stage.
Opportunity in
Apprenticeship Amendment
of Regulations.
89............................ Labor Certification 1205-AB58 Final Rule Stage.
Process and Enforcement
for Temporary Employment
in Occupations Other
Than Agriculture or
Registered Nursing in
the United States (H-2B
Workers).
90............................ Definition of 1210-AB32 Proposed Rule Stage.
``Fiduciary''.
91............................ Respirable Crystalline 1219-AB36 Proposed Rule Stage.
Silica.
92............................ Criteria and Procedures 1219-AB72 Proposed Rule Stage.
for Proposed Assessment
of Civil Penalties.
93............................ Proximity Detection 1219-AB78 Proposed Rule Stage.
Systems for Mobile
Machines in Underground
Mines.
[[Page 7675]]
94............................ Lowering Miners' Exposure 1219-AB64 Final Rule Stage.
to Coal Mine Dust,
Including Continuous
Personal Dust Monitors.
95............................ Proximity Detection 1219-AB65 Final Rule Stage.
Systems for Continuous
Mining Machines in
Underground Coal Mines.
96............................ Pattern of Violations.... 1219-AB73 Final Rule Stage.
97............................ Examination of Work Areas 1219-AB75 Final Rule Stage.
in Underground Coal
Mines for Violations of
Mandatory Health or
Safety Standards.
98............................ Infectious Diseases...... 1218-AC46 Prerule Stage.
99............................ Injury and Illness 1218-AC48 Prerule Stage.
Prevention Program.
100........................... Occupational Exposure to 1218-AB70 Proposed Rule Stage.
Crystalline Silica.
101........................... Improve Tracking of 1218-AC49 Proposed Rule Stage.
Workplace Injuries and
Illnesses.
102........................... Hazard Communication..... 1218-AC20 Final Rule Stage.
----------------------------------------------------------------------------------------------------------------
Department of Transportation
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
103........................... Accessibility of Carrier 2105-AD96 Proposed Rule Stage.
Websites and Ticket
Kiosks.
104........................... Enhancing Airline 2105-AE11 Proposed Rule Stage.
Passenger Protections
III.
105........................... Carrier-Supplied Medical 2105-AE12 Proposed Rule Stage.
Oxygen, Accessible In-
Flight Entertainment
Systems, Service
Animals, and Accessible
Lavatories on Single-
Aisle Aircraft.
106........................... Qualification, Service, 2120-AJ00 Proposed Rule Stage.
and Use of Crewmembers
and Aircraft Dispatchers.
107........................... New York Congestion 2120-AJ89 Proposed Rule Stage.
Management Rule for
LaGuardia Airport, John
F. Kennedy International
Airport, and Newark
Liberty International
Airport.
108........................... Air Ambulance and 2120-AJ53 Final Rule Stage.
Commercial Helicopter
Operations; Safety
Initiatives and
Miscellaneous Amendments.
109........................... Safety Management Systems 2120-AJ86 Final Rule Stage.
for Certificate Holders.
110........................... Carrier Safety Fitness 2126-AB11 Proposed Rule Stage.
Determination.
111........................... National Registry of 2126-AA97 Final Rule Stage.
Certified Medical
Examiners.
112........................... Passenger Car and Light 2127-AK79 Proposed Rule Stage.
Truck Corporate Average
Fuel Economy Standards
MYs 2017 and Beyond.
113........................... Sound for Hybrid and 2127-AK93 Proposed Rule Stage.
Electric Vehicles.
114........................... Motorcoach Rollover 2127-AK96 Proposed Rule Stage.
Structural Integrity.
115........................... Electronic Stability 2127-AK97 Proposed Rule Stage.
Control Systems for
Heavy Vehicles.
116........................... Require Installation of 2127-AK56 Final Rule Stage.
Seat Belts on
Motorcoaches, FMVSS No.
208.
117........................... Major Capital Investment 2132-AB02 Proposed Rule Stage.
Projects (RRR).
118........................... Regulations To Be 2133-AB74 Proposed Rule Stage.
Followed by All
Departments, Agencies,
and Shippers Having
Responsibility To
Provide a Preference for
U.S.-Flag Vessels in the
Shipment of Cargoes on
Ocean Vessels.
----------------------------------------------------------------------------------------------------------------
Department of Veterans Affairs
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
119........................... VA Compensation and 2900-AO13 Proposed Rule Stage.
Pension Regulation
Rewrite Project.
120........................... Caregivers Program....... 2900-AN94 Final Rule Stage.
----------------------------------------------------------------------------------------------------------------
Architectural and Transportation Barriers Compliance Board
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
121........................... Accessibility Standards 3014-AA40 Proposed Rule Stage.
for Medical Diagnostic
Equipment.
----------------------------------------------------------------------------------------------------------------
Environmental Protection Agency
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
122........................... Risk and Technology 2060-AQ41 Proposed Rule Stage.
Review for National
Emission Standards for
Hazardous Air Pollutants
From the Pulp and Paper
Industry.
123........................... Joint Rulemaking To 2060-AQ54 Proposed Rule Stage.
Establish 2017 and Later
Model Year Light Duty
Vehicle GHG Emissions
and CAFE Standards.
124........................... Petroleum Refinery Sector 2060-AQ75 Proposed Rule Stage.
Risk and Technology
Review and NSPS.
125........................... Control of Air Pollution 2060-AQ86 Proposed Rule Stage.
From Motor Vehicles:
Tier 3 Motor Vehicle
Emission and Fuel
Standards.
[[Page 7676]]
126........................... Greenhouse Gas New Source 2060-AQ91 Proposed Rule Stage.
Performance Standard for
Electric Generating
Units for New Sources.
127........................... National Emission 2060-AR02 Proposed Rule Stage.
Standards for Hazardous
Air Pollutant Emissions:
Group IV Polymers and
Resins, Pesticide Active
Ingredient Production,
and Polyether Polyols
Production Risk and
Technology Review.
128........................... National Emission 2060-AR13 Proposed Rule Stage.
Standards for Hazardous
Air Pollutants for Major
Sources: Industrial,
Commercial, and
Institutional Boilers
and Process Heaters;
Proposed Reconsideration.
129........................... National Emission 2060-AR14 Proposed Rule Stage.
Standards for Hazardous
Air Pollutants for Area
Sources: Industrial,
Commercial, and
Institutional Boilers;
Reconsideration and
Proposed Rule Amendments.
130........................... Standards of Performance 2060-AR15 Proposed Rule Stage.
for New Stationary
Sources and Emission
Guidelines for Existing
Sources: Commercial and
Industrial Solid Waste
Incineration Units;
Reconsideration and
Proposed Amendments.
131........................... NPDES Electronic 2020-AA47 Proposed Rule Stage.
Reporting Rule.
132........................... Pesticides; Certification 2070-AJ20 Proposed Rule Stage.
of Pesticide Applicators.
133........................... Pesticides; Agricultural 2070-AJ22 Proposed Rule Stage.
Worker Protection
Standard Revisions.
134........................... Formaldehyde; Third-Party 2070-AJ44 Proposed Rule Stage
Certification Framework
for the Formaldehyde
Standards for Composite
Wood Products.
135........................... Mercury; Regulation of 2070-AJ46 Proposed Rule Stage.
Use in Certain Products.
136........................... Lead; Renovation, Repair, 2070-AJ56 Proposed Rule Stage.
and Painting Program for
Public and Commercial
Buildings.
137........................... Revisions to the National 2050-AE87 Proposed Rule Stage.
Oil and Hazardous
Substances Pollution
Contingency Plan;
Subpart J Product
Schedule Listing
Requirements.
138........................... Stormwater Regulations 2040-AF13 Proposed Rule Stage.
Revision To Address
Discharges From
Developed Sites.
139........................... Effluent Limitations 2040-AF14 Proposed Rule Stage.
Guidelines and Standards
for the Steam Electric
Power Generating Point
Source Category.
140........................... National Pollutant 2040-AF22 Proposed Rule Stage.
Discharge Elimination
System (NPDES)
Concentrated Animal
Feeding Operation (CAFO)
Reporting Rule.
141........................... National Pollutant 2040-AF25 Proposed Rule Stage.
Discharge Elimination
System (NPDES)
Application and Program
Updates Rule.
142........................... Review of the Secondary 2060-AO72 Final Rule Stage.
National Ambient Air
Quality Standards for
Oxides of Nitrogen and
Oxides of Sulfur.
143........................... National Emission 2060-AP52 Final Rule Stage.
Standards for Hazardous
Air Pollutants From Coal-
and Oil-Fired Electric
Utility Steam Generating
Units and Standards of
Performance for Electric
Utility Steam Generating
Units.
144........................... Oil and Natural Gas 2060-AP76 Final Rule Stage.
Sector--New Source
Performance Standards
and National Emission
Standards for Hazardous
Air Pollutants.
145........................... Criteria and Standards 2040-AE95 Final Rule Stage.
for Cooling Water Intake
Structures.
----------------------------------------------------------------------------------------------------------------
Equal Employment Opportunity Commission
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
146........................... Disparate Impact and 3046-AA76 Final Rule Stage.
Reasonable Factors Other
Than Age Under the Age
Discrimination in
Employment Act.
----------------------------------------------------------------------------------------------------------------
National Archives and Records Administration
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
147........................... Federal Records 3095-AB74 Proposed Rule Stage.
Management; Electronic
Records Archives (ERA).
----------------------------------------------------------------------------------------------------------------
Small Business Administration
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
148........................... Small Business Technology 3245-AF45 Proposed Rule Stage.
Transfer (STTR) Policy
Directive.
149........................... Small Business Innovation 3245-AF84 Proposed Rule Stage.
Research (SBIR) Program
Policy Directive.
150........................... Acquisition Process: Task 3245-AG20 Proposed Rule Stage.
and Delivery Order
Contracts, Bundling,
Consolidation.
151........................... Small Business Jobs Act: 3245-AG24 Proposed Rule Stage.
Small Business Mentor-
Prot[eacute]g[eacute]
Programs.
----------------------------------------------------------------------------------------------------------------
[[Page 7677]]
Social Security Administration
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
152........................... Revised Medical Criteria 0960-AF58 Proposed Rule Stage.
for Evaluating
Respiratory System
Disorders (859P).
153........................... Revised Medical Criteria 0960-AF88 Proposed Rule Stage.
for Evaluating
Hematological Disorders
(974P).
154........................... Revised Medical Criteria 0960-AF69 Final Rule Stage.
for Evaluating Mental
Disorders (886F).
155........................... How We Collect and 0960-AG89 Final Rule Stage.
Consider Evidence of
Disability (3487P).
156........................... Amendments to Regulations 0960-AH07 Final Rule Stage.
Regarding Withdrawals of
Applications and
Voluntary Suspension of
Benefits (3573F).
157........................... Expedited Vocational 0960-AH26 Final Rule Stage.
Assessment Under the
Sequential Evaluation
Process (3684P).
----------------------------------------------------------------------------------------------------------------
Nuclear Regulatory Commission
----------------------------------------------------------------------------------------------------------------
Regulation
Sequence No. Title Identifier No. Rulemaking Stage
----------------------------------------------------------------------------------------------------------------
158........................... Medical Use of Byproduct 3150-AI26 Proposed Rule Stage.
Material--Amendments/
Medical Event Definition
[NRC-2008-0071].
159........................... Fitness-For-Duty Programs 3150-AI58 Proposed Rule Stage.
[NRC-2009-0090].
160........................... U.S. Evolutionary Power 3150-AI82 Proposed Rule Stage.
Reactor (EPR) Design
Certification Amendment
[NRC-2010-0132].
161........................... Disposal of Unique Waste 3150-AI92 Proposed Rule Stage.
Streams [NRC-2011-0012].
162........................... Revision of Fee 3150-AJ03 Proposed Rule Stage.
Schedules: Fee Recovery
for FY 2012 [NRC-2011-
0207].
163........................... Risk-Informed Changes to 3150-AH29 Final Rule Stage.
Loss-of-Coolant Accident
Technical Requirements
[NRC-2004-0006].
164........................... Physical Protection of 3150-AI12 Final Rule Stage.
Byproduct Material [NRC-
2008-0120].
165........................... Environmental Effect of 3150-AI42 Final Rule Stage.
Renewing the Operating
License of a Nuclear
Power Plant [NRC-2008-
0608].
166........................... AP1000 Design 3150-AI81 Final Rule Stage.
Certification Amendment
[NRC-2010-0131].
167........................... U.S. Advanced Boiling 3150-AI84 Final Rule Stage.
Water Reactor (ABWR)
Aircraft Impact Design
Certification Amendment
[NRC-2010-0134].
168........................... Economic Simplified 3150-AI85 Final Rule Stage.
Boiling-Water Reactor
(ESBWR) Design
Certification [NRC-2010-
0135].
169........................... List of Approved Spent 3150-AI91 Final Rule Stage.
Fuel Storage Casks--
MAGNASTOR, Revision 2
[NRC-2011-0008].
----------------------------------------------------------------------------------------------------------------
BILLING CODE 6820-27-P
DEPARTMENT OF AGRICULTURE (USDA)
Statement of Regulatory Priorities
USDA's focus in 2012 will be on programs that create/save jobs,
particularly in rural America, while identifying and taking action on
those programs that could be modified, streamlined, and simplified, or
reporting burdens reduced, particularly with the public's access to
USDA programs. In addition, USDA's regulatory efforts in the coming
year will be focused on achieving the Department's goals identified in
the Department's Strategic Plan for 2010 to 2015.
Assist rural communities to create prosperity so they are
self-sustaining, re-populating, and economically thriving. USDA is the
leading advocate for rural America. The Department supports rural
communities and enhances quality of life for rural residents by
improving their economic opportunities, community infrastructure,
environmental health, and the sustainability of agricultural
production. The common goal is to help create thriving rural
communities with good jobs where people want to live and raise
families, and where children have economic opportunities and a bright
future.
Ensure that all of America's children have access to safe,
nutritious, and balanced meals. A plentiful supply of safe and
nutritious food is essential to the well-being of every family and the
healthy development of every child in America. USDA provides nutrition
assistance to children and low-income people who need it and works to
improve the healthy eating habits of all Americans, especially
children. In addition, the Department safeguards the quality and
wholesomeness of meat, poultry, and egg products and addresses and
prevents loss and damage from pests and disease outbreaks.
Ensure our national forests and private working lands are
conserved, restored, and made more resilient to climate change, while
enhancing our water resources. America's prosperity is inextricably
linked to the health of our lands and natural resources. Forests,
farms, ranches, and grasslands offer enormous environmental benefits as
a source of clean air, clean and abundant water, and wildlife habitat.
These lands generate economic value by supporting the vital agriculture
and forestry sectors, attracting tourism and recreation visitors,
sustaining green jobs, and producing ecosystem services, food, fiber,
timber and non-timber products, and energy. They are also of immense
social importance, enhancing rural quality of life, sustaining scenic
and culturally important landscapes, and providing opportunities to
engage in outdoor activity and reconnect with the land.
Help America promote agricultural production and
biotechnology exports as America works to increase food security. A
productive agricultural sector is critical to increasing global food
security. For many crops, a substantial portion of domestic production
is bound for overseas markets. USDA helps American farmers and ranchers
use efficient, sustainable production, biotechnology, and other
emergent technologies to enhance food security around the world and
find export markets for their products.
[[Page 7678]]
Important regulatory activities supporting the accomplishment of
these goals in 2012 will include the following:
Rural Development and Renewable Energy. USDA priority
regulatory actions for the Rural Development mission will be to revise
regulations for the Business and Industry Guaranteed Loan Program,
Rural Development's flagship job creation and capital expansion
business program, and finalize regulations for the bioenergy programs.
USDA will continue to promote sustainable economic
opportunities to create jobs in rural communities through the purchase
and use of biobased products through the BioPreferred[supreg] program.
USDA will continue to designate groups of biobased products to receive
procurement preference from Federal agencies and contractors.
BioPreferred has made serious efforts to minimize burdens on small
business by providing a standard mechanism for product testing, an
online application process, and individual assistance for small
manufacturers when needed. Both the Federal preferred procurement and
the certified label parts of the program are voluntary, and both are
designed to assist biobased businesses in securing additional sales.
Nutrition Assistance. As changes are made to the nutrition
assistance programs, USDA will work to foster actions that ensure
access to program benefits, improve program integrity, improve diets
and healthy eating through nutrition education, and promote physical
activity consistent with the national effort to reduce obesity. In
support of these activities in 2012, the Food and Nutrition Service
(FNS) plans to publish the final rule regarding the nutrition standards
in the school meals programs; finalize a rule updating the WIC food
packages; and establish permanent rules for the Fresh Fruit and
Vegetable Program. FNS will continue to work to implement rules that
minimize participant and vendor fraud in its nutrition assistance
programs.
Food Safety. In the area of food safety, USDA will
continue to develop science-based regulations that improve the safety
of meat, poultry, and processed egg products in the least burdensome
and most cost-effective manner. Regulations will be revised to address
emerging food safety challenges, streamlined to remove excessively
prescriptive regulations, and updated to be made consistent with hazard
analysis and critical control point principles. In 2012, the Food
Safety and Inspection Service (FSIS) plans to propose regulations to
establish new systems for poultry slaughter inspection, requirements
for federally inspected egg product plants to develop and implement
hazard analysis and critical control point systems and sanitation
standard operating procedures, and finalize regulations on catfish
inspection. To assist small entities to comply with food safety
requirements, the FSIS will continue to collaborate with other USDA
agencies and State partners in the enhanced small business outreach
program.
Farm Loans, Disaster Designation, and Environmental
Compliance. USDA will work to ensure a strong U.S. agricultural system
through farm income support and farm loan programs. In addition, USDA
will streamline the disaster designation process and update and
consolidate the environmental compliance regulations.
Forestry and Conservation. In the conservation area, USDA
plans to finalize regulations that would provide financial assistance
grants to local governments, tribal governments, and nonprofit
organizations to establish community forests by acquiring and
protecting private forestlands.
Marketing and Regulatory Programs. USDA will work to
support the organic sector and continue regulatory work to protect the
health and value of U.S. agricultural and natural resources. USDA will
also implement regulations to enhance enforcement of the Packers and
Stockyards Act. In addition, USDA plans to finalize acceptable animal
disease traceability standards. Regarding plant health, USDA
anticipates revising the permitting of movement of plant pests and
biological control organisms. For the Animal Welfare Act, USDA will
propose specific standards for the humane care of birds and finalize
specific standards for the humane care of dogs imported for resale.
Retrospective Review and Executive Order 13563
In January 2011, President Obama issued Executive Order (E.O.)
13563 on Improving Regulation and Regulatory Review. As part of this
E.O., agencies were asked to review existing rules that may be
outmoded, ineffective, insufficient, or excessively burdensome, and to
modify, streamline, expand, or repeal them accordingly. Reducing the
regulatory burden on the American people and our trading partners is a
priority for USDA, and we will continually work to improve the
effectiveness of our existing regulations. As a result of our
regulatory review efforts in 2011, USDA will make regulatory changes in
2012, including the following:
Labeling--Generic Approval and Regulations Consolidation. FSIS is
developing a rule that will expand the circumstances in which the
labels of meat and poultry products will be deemed to be generically
approved by FSIS. The rule will reduce duplication and streamline the
regulations on this subject by combining them into a single part of the
Code of Federal Regulations (CFR);
Electronic Export Application and Certification Fee. FSIS is
planning a rule to provide for the electronic transmittal of foreign
establishment certifications between FSIS and foreign governments. The
rule will consolidate four inspection certificates (meat, meat by-
products, poultry, and egg products) into one certificate. The
rulemaking is intended, in part, to accommodate the Agency's electronic
Public Health Information System.
Environmental Compliance. The Farm Service Agency (FSA) will
consolidate and update the environmental compliance regulations to
ensure regulations are consistent and current for all FSA programs and
remove obsolete regulations;
National Environmental Policy Act (NEPA) Streamlining. The Natural
Resources and Environment mission area and the Forest Service (FS), in
cooperation with the Council on Environmental Quality (CEQ), is
considering a series of initiatives to improve and streamline the NEPA
process as it applies to FS projects;
Rural Energy for America Program. This new program will modify the
existing grant and guaranteed loan program for renewable energy system
(RES) and energy efficiency improvement (EEI) projects. In addition, it
would add a grant program for RES feasibility studies and a grant
program for energy audits and renewable energy development assistance.
This rulemaking will streamline the process for smaller grants,
lessening the burden to the customer. It will also make the guaranteed
portion of the rule consistent with other programs Rural Development
(RD) manages and allow applications to be accepted year around;
Business and Industry Loan Guaranteed Program. RD plans to rewrite
the regulations, which will result in improved efficiency and
effectiveness of the program, fewer errors because the guidelines and
requirements will be clearer, and items will be more easily found in a
better organized volume of regulations; and
Water and Waste Loans and Grants. RD will update the operations
aspects of
[[Page 7679]]
the loan and grant program to reduce the burden on the borrower.
Reducing the Paperwork Burden on Customers and Executive Order 13563
USDA has continued to make substantial progress in realizing the
goal of the Paperwork Reduction Act. For example, the Farm and Foreign
Agricultural Services (FFAS) mission area will reduce the paperwork
burden on program participants by consolidating the information
collections required to participate in farm programs administered by
FSA and the Federal crop insurance program administered by the Risk
Management Agency (RMA).
FFAS will evaluate methods to simplify and standardize, to the
extent practical, acreage reporting processes, program dates, and data
definitions across the various USDA programs and agencies. FFAS expects
to allow producers to use information from their farm-management and
precision agriculture systems for reporting production, planted and
harvested acreage, and other key information needed to participate in
USDA programs. FFAS will also streamline the collection of producer
information by FSA and RMA with the agricultural production information
collected by National Agricultural Statistics Service.
These process changes will allow for program data that is common
across agencies to be collected once and utilized or redistributed to
Agency programs in which the producer chooses to participate. FFAS
plans to implement the Acreage and Crop Reporting Streamlining
Initiative (ACRSI) in an incremental approach starting in late 2012
with a pilot in Kansas for growers of winter wheat when OMB approves
the information collection. Full implementation is planned for 2013.
When specific changes are identified, FSA and RMA will make any
required conforming changes in their respective regulations.
Increasingly, USDA is providing electronic alternatives to its
traditionally paper-based customer transactions. As a result, customers
increasingly have the option to electronically file forms and other
documentation online, allowing them to choose when and where to conduct
business with USDA.
For example, Rural Development continues to review its regulations
to determine which application procedures for Business Programs,
Community Facilities Programs, Energy Programs, and Water and
Environmental Programs can be streamlined and its requirements
synchronized. RD is approaching the exercise from the perspective of
the people it serves, by communicating with stakeholders on two common
areas of regulation that can provide the basis of reform.
The first area provides support for entrepreneurship and business
innovation. This initiative would provide for the streamlining and
reformulating of the Business & Industry Loan Guarantee Program and the
Intermediary Relending Program--the first such overhauls in over 20
years. The second area would provide for streamlining programs being
made available to municipalities, tribes, and non-profit organizations;
specifically Water and Waste Disposal, Community Facilities, and Rural
Business Enterprise Grants, plus programs such as Electric and
Telecommunications loans that provide basic community needs. This
regulatory reform initiative has the potential to significantly reduce
the burden to respondents (lenders and borrowers).
To the extent practicable, each reform initiative will consist of a
common application and uniform documentation requirements making it
easier for constituency groups to apply for multiple programs. In
addition, there will be associated regulations for each program that
will contain program specific information.
Natural Resources Conservation Service will also improve the
delivery of technical and financial assistance by simplifying customer
access to NRCS' technical and financial assistance programs,
streamlining the delivery and timeliness of conservation assistance to
clients, and enhancing the technical quality of its conservation
planning and services. The streamlining initiatives will allow NRCS
field staff to spend more time on conservation planning in the field
with customers, reduce the time needed to implement cost-share
contracts, and provide more flexibility for customers to work with NRCS
in different ways. NRCS estimates that this initiative has the
potential to reduce the amount of time required for producers to
participate in USDA's conservation programs by almost 800,000 hours
annually. This includes efficiencies from reduced paperwork, data entry
by the client, and reduced travel time to and from the local office to
complete forms and other administrative tasks. Improvements being
considered include the following:
Providing an online portal that will allow customers to
apply for programs or services, review their plans and contracts, view
and assess natural resource information specifically about their farm,
evaluate the costs and benefits for various conservation treatment
alternatives, notify NRCS of installed practices, and check on contract
payments at their convenience;
Creating an e-customer profile that will improve customer
service by allowing the client to view, finalize, and electronically
sign documents using remote electronic signature, on-site rather than
at a local office;
Providing clients with more timely and specific
information on alternative conservation treatments, including the
environmental benefits of their planned and applied practices;
Accelerating payments to clients; and
Simplifying conservation plan documents to more
specifically address client needs and goals.
Major Regulatory Priorities
This document represents summary information on prospective
significant regulations as called for in E.O.s 12866 and 13563. The
following USDA agencies are represented in this regulatory plan, along
with a summary of their mission and key regulatory priorities in 2012:
Food and Nutrition Service
Mission: FNS increases food security and reduces hunger in
partnership with cooperating organizations by providing children and
low-income people access to food, a healthful diet, and nutrition
education in a manner that supports American agriculture and inspires
public confidence.
Priorities: In addition to responding to provisions of legislation
authorizing and modifying Federal nutrition assistance programs, FNS'
2012 regulatory plan supports USDA's Strategic Goal ``Ensure that all
of America's children have access to safe, nutritious, and balanced
meals,'' and its two related objectives:
Access to Nutritious Food. This objective represents FNS's efforts
to improve nutrition by providing access to program benefits (food
consumed at home, school meals, commodities) and distributing State
administrative funds to support program operations. To advance this
objective, FNS plans to publish a final rule of the 2008 Farm Bill that
ensures access to SNAP benefits and addresses other eligibility,
certification, employment, and training issues. An interim rule,
implementing provisions of the Child Nutrition and WIC Reauthorization
Act of 2004 to establish automatic eligibility for homeless children
for school meals, further supports this objective.
Promote Healthy Diet and Physical Activity Behaviors. This
objective represents FNS' efforts to improve the
[[Page 7680]]
diets of its clients through nutrition education, support the national
effort to reduce obesity by promoting healthy eating and physical
activity, and to ensure that program benefits meet appropriate
standards to effectively improve nutrition for program participants. In
support of this objective, FNS plans to publish the final rule
regarding the nutrition standards in the school meals programs,
finalize a rule updating the WIC food packages, and establish permanent
rules for the Fresh Fruit and Vegetable Program, which currently
operates in a select number of schools in each State, the District of
Columbia, Guam, Puerto Rico, and the Virgin Islands.
Food Safety and Inspection Service
Mission: FSIS is responsible for ensuring that meat, poultry, egg,
and catfish products in interstate and foreign commerce are wholesome,
not adulterated, and properly marked, labeled, and packaged.
Priorities: FSIS is committed to developing and issuing science-
based regulations intended to ensure that meat, poultry, egg, and
catfish products are wholesome and not adulterated or misbranded. FSIS
regulatory actions support the objective to protect public health by
ensuring that food is safe under USDA's goal to ensure access to safe
food. To reduce the number of foodborne illnesses and increase program
efficiencies, FSIS will continue to review its existing authorities and
regulations to ensure that it can address emerging food safety
challenges, to streamline excessively prescriptive regulations, and to
revise or remove regulations that are inconsistent with the FSIS'
hazard analysis and critical control point (HACCP) regulations. FSIS is
also working with the Food and Drug Administration (FDA) to improve
coordination and increase the effectiveness of inspection activities.
FSIS' priority initiatives are as follows:
[rtarr8] Rulemakings that support initiatives of the President's
Food Safety Working Group:
Poultry Slaughter Inspection. Based on the
Administration's top-to-bottom review of food safety activities, the
Food Safety and Inspection Service will issue regulations that will
prevent thousands of food-borne illnesses by more clearly focusing FSIS
inspection activities on improving food safety, streamline poultry
inspections, and reduce Government spending.
Revision of Egg Products Inspection Regulations. FSIS is
planning to propose requirements for federally inspected egg product
plants to develop and implement HACCP systems and sanitation standard
operating procedures. FSIS will be proposing pathogen reduction
performance standards for egg products and will remove prescriptive
requirements for egg product plants.
[rtarr8] Initiatives that provide for disclosure or that enable
economic growth. FSIS plans to issue two rules to promote disclosure of
information to the public or that provide flexibility for the adoption
of new technologies:
Product Labeling; Use of the Voluntary Claim ``Natural''
in the Labeling of Meat and Poultry Products. FSIS will propose to
amend the meat and poultry products regulations to define the
conditions under which the voluntary claim ``natural'' may be used on
meat and poultry product labeling.
Food Ingredients and Sources of Radiation Listed and
Approved for Use in the Production of Meat and Poultry Products. FSIS
will propose to amend its food ingredient regulations to provide for
the use under certain conditions of benzoic acid, sodium propionate, or
sodium benzoate.
Notification, Documentation, and Recordkeeping Requirements for
Inspected Establishments. As authorized by the 2008 Farm Bill, FSIS
will issue final regulations that will require establishments that are
subject to inspection to promptly notify FSIS when an adulterated or
misbranded product received by or originating from the establishment
has entered into commerce. The regulations also will require the
establishments to prepare and maintain current procedures for the
recall of all products produced and shipped by the establishments and
to document each reassessment of the establishments' process control
plans.
Catfish Inspection. FSIS is developing final regulations to
implement provisions of the 2008 Farm Bill provisions that make catfish
an amenable species under the Federal Meat Inspection Act (FMIA).
Public Health Information System. To support its food safety
inspection activities, FSIS is implementing the Public Health
Information System (PHIS). PHIS, which is user-friendly and Web-based,
will replace many of FSIS' current systems and automate many business
processes. PHIS also will improve FSIS' ability to systematically
verify the effectiveness of foreign food safety systems and enable
greater exchange of information between FSIS and other Federal agencies
(such as U.S. Customs and Border Protection) involved in tracking
cross-border movement of import and export shipments of meat, poultry,
and processed egg products. To facilitate the implementation of some
PHIS components, FSIS is proposing to provide for electronic export and
import application and certification processes as alternatives to the
current paper-based systems for these certifications.
Other Planned Initiatives. FSIS plans to finalize a February 2001
proposed rule to establish food safety performance standards for all
processed ready-to-eat (RTE) meat and poultry products and for
partially heat-treated meat and poultry products that are not ready-to-
eat. Some provisions of the proposal addressed post-lethality
contamination of RTE products with Listeria monocytogenes. In June
2003, FSIS published an interim final rule requiring establishments to
prevent L. monocytogenes contamination of RTE products. FSIS has
carefully reviewed its economic analysis of the interim final rule and
is planning to affirm the interim rule as a final rule with changes.
FSIS Small Business Implications. The great majority of businesses
regulated by FSIS are small businesses. Some of the regulations listed
above substantially affect small businesses. FSIS conducts a small
business outreach program that provides critical training, access to
food safety experts, and information resources (such as compliance
guidance and questions and answers on various topics) in forms that are
uniform, easily comprehended, and consistent. FSIS collaborates in this
effort with other USDA agencies and cooperating State partners. For
example, FSIS makes plant owners and operators aware of loan programs,
available through USDA's Rural Business and Cooperative programs, to
help them in upgrading their facilities. FSIS employees meet with small
and very small plant operators to learn more about their specific needs
and provide joint training sessions for small and very small plants and
FSIS employees.
Animal and Plant Health Inspection Service
Mission: A major part of the mission of the Animal and Plant Health
Inspection Service (APHIS) is to protect the health and value of
American agricultural and natural resources. APHIS conducts programs to
prevent the introduction of exotic pests and diseases into the U.S. and
conducts surveillance, monitoring, control, and eradication programs
for pests and diseases in this country. These activities enhance
agricultural productivity and competitiveness and contribute to the
national economy and the public health. APHIS also conducts programs to
ensure the humane handling, care,
[[Page 7681]]
treatment, and transportation of animals under the Animal Welfare Act.
Priorities: With respect to animal health, APHIS is continuing work
to revise its regulations concerning bovine spongiform encephalopathy
(BSE) to provide a more comprehensive and universally applicable
framework for the importation of certain animals and products. In the
area of plant health, APHIS is in the midst of a revision to its
regulations for the importation and interstate movement of plant pests
and biological control organisms to clarify the factors that would be
considered when assessing the risks associated with the movement of
certain organisms, facilitate the movement of regulated organisms and
articles in a manner that also protects U.S. agriculture, and address
gaps in the current regulations. APHIS also plans to propose standards
for the humane handling, care, treatment, and transportation of birds
covered under the Animal Welfare Act.
Additional information about APHIS and its programs is available on
the Internet at http://www.aphis.usda.gov.
Agricultural Marketing Service
Mission: The Agricultural Marketing Service (AMS) provides
marketing services to producers, manufacturers, distributors,
importers, exporters, and consumers of food products. The AMS also
manages the Government's food purchases, supervises food quality
grading, maintains food quality standards, and supervises the Federal
research and promotion programs.
Priorities: AMS' priority items for the next year include
rulemaking that impact the organic industry, as well as the wholesale
pork industry. Rulemakings the Agency intends to initiate within the
next 12 months include:
Sunset Review (2012)--Nutrient Vitamins and Minerals. On March 26,
2010, the National Organic Program (NOP) issued an Advanced Notice of
Proposed Rulemaking (ANPRM) announcing the National Organic Standards
Board's (NOSB) sunset review of exempted and prohibited substances
codified at the National List of Allowed and Prohibited Substances of
the NOP regulations. This review included a listing for ``Nutrient
vitamins and minerals'' scheduled to sunset on October 21, 2012. AMS
intends to publish a proposed rule to address a recommendation
submitted by the NOSB for this listing. This proposed rule would
continue the exemption (use) for nutrient vitamins and minerals for 5
years after the October 21, 2012, sunset date. This proposed rule would
amend the annotation for nutrient vitamins and minerals to correct an
inaccurate cross reference to U.S. Food and Drug Administration (FDA)
regulations as AMS determined that the current exemption for the use of
nutrient vitamins and minerals in organic products in the NOP
regulations is inaccurate. In effect, the proposed amendment would
clarify what synthetic substances are allowed as nutrient vitamins and
minerals in organic products. Further, the NOP regulations do not
correctly provide for the fortification of infant formula that would
meet FDA requirements. This proposed rule would incorporate the correct
FDA citation with respect to the addition of required vitamins and
minerals to organic infant formula.
Livestock Mandatory Reporting; Establishing Regulations for
Wholesale Pork. As directed by the 2008 Farm Bill, the Secretary
conducted a study to determine advantages, drawbacks, and potential
implementation issues associated with adopting mandatory wholesale pork
reporting. The report from this study concluded that negotiated
wholesale pork price reporting is thin and becoming thinner and found
some degree of support for moving to mandatory price reporting exists
at every segment of the industry interviewed. That study also concluded
that the benefits likely would exceed the cost of moving from a
voluntary to a mandatory reporting program for wholesale pork.
Subsequently, the Mandatory Price Reporting Act of 2010 (2010
Reauthorization Act) (Pub. L. 111-239), was signed into law on
September 28, 2010, and reauthorized Livestock Mandatory Reporting for
5 years and added a provision for mandatory reporting of wholesale pork
cuts. The 2010 Reauthorization Act directed the Secretary to engage in
negotiated rulemaking to make required regulatory changes for mandatory
wholesale pork reporting.
Further, the 2010 Reauthorization Act directed the Secretary to
establish a Committee that represented the spectrum of interests within
the pork industry, as well as related stakeholders, to ensure all
parties had input into the regulatory framework. Specifically, the
statute required that the Committee include representatives from (i)
organizations representing swine producers; (ii) organizations
representing packers of pork, processors of pork, retailers of pork,
and buyers of wholesale pork; (iii) Department of Agriculture; and (iv)
interested parties that participate in swine or pork production.
The Agricultural Marketing Service (AMS) convened the Wholesale
Pork Reporting Negotiated Rulemaking Committee (Committee) through
notice in the Federal Register on January 26, 2011. The Committee met
three times over the period February through May of 2011 to develop the
regulatory framework necessary to implement a mandatory program of
wholesale pork reporting.
The regulatory text developed by the Committee will serve as the
primary basis for the proposed rule, consistent with both the intent of
Congress and the Negotiated Rulemaking Act. It is important to note
that the Committee reached consensus on all items included in the
proposed rule--where consensus was defined by the Committee bylaws as
being unanimous agreement. Therefore, AMS is confident the proposed
rule to implement wholesale pork reporting will be met with little or
no resistance from the industry members who will be required to report
under the mandatory system.
Grain Inspection, Packers, and Stockyards Administration
Mission: The Grain Inspection, Packers, and Stockyards
Administration (GIPSA) facilitates the marketing of livestock, poultry,
meat, cereals, oilseeds, and related agricultural products and promotes
fair and competitive trading practices for the overall benefit of
consumers and American agriculture. GIPSA's activities contribute
significantly to USDA's goal to increase prosperity in rural areas by
supporting a competitive agricultural system.
Priorities: GIPSA intends to issue a final rule that will define
practices or conduct that are unfair, unjustly discriminatory, or
deceptive, and/or that represent the making or giving of an undue or
unreasonable preference or advantage, and ensure that producers and
growers can fully participate in any arbitration process that may arise
relating to livestock or poultry contracts. This regulation is being
finalized in accordance with the authority granted to the Secretary by
the Packers and Stockyards Act of 1921 and with the requirements of
sections 11005 and 11006 of the 2008 Farm Bill.
Farm Service Agency
Mission: FSA's mission is to equitably serve all farmers, ranchers,
and agricultural partners through the delivery of effective, efficient
agricultural programs, which contributes to two USDA goals: Assist
rural communities in creating prosperity so they are self-sustaining,
re-
[[Page 7682]]
populating, and economically thriving; and enhance the Nation's natural
resource base by assisting owners and operators of farms and ranches to
conserve and enhance soil, water, and related natural resources. FSA
supports the first goal by stabilizing farm income, providing credit to
new or existing farmers and ranchers who are temporarily unable to
obtain credit from commercial sources, and helping farm operations
recover from the effects of disaster. FSA supports the second goal by
administering several conservation programs directed toward
agricultural producers. The largest program is the Conservation Reserve
Program (CRP), which protects nearly 32 million acres of
environmentally sensitive land.
Priorities: Farm Loan Programs. FSA will develop and issue
regulations to amend programs for farm operating loans, down payment
loans, and emergency loans to include socially disadvantaged farmers,
increase loan limits, loan size, funding targets, interest rates, and
graduating borrowers to commercial credit. In addition, FSA will
further streamline normal loan servicing activities and reduce burden
on borrowers while still protecting the loan security.
Disaster Designation. FSA will revise the disaster designation
process to streamline it and reduce the burden on States and tribes
requesting disaster designations. One result may be fewer delays in
delivering disaster assistance to help farm operations recover from the
effects of disaster.
Forest Service
Mission: The mission of the Forest Service is to sustain the
health, productivity, and diversity of the Nation's forests and
rangelands to meet the needs of present and future generations. This
includes protecting and managing National Forest System lands,
providing technical and financial assistance to States, communities,
and private forest landowners, and developing and providing scientific
and technical assistance and scientific exchanges in support of
international forest and range conservation. FS' regulatory priorities
support the accomplishment of USDA's goal to ensure our national
forests are conserved, restored, and made more resilient to climate
change, while enhancing our water resources.
Priorities: Special Areas; State-Specific Inventoried Roadless Area
Management: Colorado. FS planned final rulemaking would establish a
State-specific rule to provide management direction for conserving and
managing inventoried roadless areas on National Forest System lands in
the State of Colorado.
Land Management Planning Rule. FS is required to issue rulemaking
for National Forest System land management planning under 16 U.S.C.
1604. The first planning rule was adopted in 1979, and amended in 1982.
FS published a new planning rule on April 21, 2008 (73 FR 21468). On
June 30, 2009, the United States District Court for the Northern
District of California invalidated FS' 2008 Planning Rule published at
36 CFR 219 based on violations of NEPA and the Endangered Species Act
in the rulemaking process. The District Court vacated the 2008 rule,
enjoined USDA from further implementing it, and remanded it to USDA for
further proceedings. USDA has determined that the 2000 planning rule is
now in effect, including its transition provisions as amended in 2002
and 2003, and as clarified by interpretative rules issued in 2001 and
2004, which allows the use of the provisions of the 1982 planning rule
to amend or revise plans. FS is now in the 2000 planning rule
transition period. FS published a proposed planning rule on February
14, 2011 (76 FR 8480). The final rule is expected to be published
December 2011. In so doing, FS plans to correct deficiencies that have
been identified over two decades of forest planning and update planning
procedures to reflect contemporary collaborative planning practices.
Community Forest and Open Space Conservation Program. The purpose
of the Community Forest Program is to achieve community benefits
through financial assistance grants to local governments, tribal
governments, and nonprofit organizations to establish community forests
by acquiring and protecting private forestlands. Community forest
benefits are specified in the authorizing statute and include economic
benefits from sustainable forest management, natural resource
conservation, forest-based educational programs, model forest
stewardship activities, and recreational opportunities.
Rural Business-Cooperative Service
Mission: Promoting a dynamic business environment in rural America
is the goal of the Rural Business-Cooperative Service (RBS). Business
Programs works in partnership with the private sector and the
community-based organizations to provide financial assistance and
business planning, and helps fund projects that create or preserve
quality jobs and/or promote a clean rural environment. The financial
resources are often leveraged with those of other public and private
credit source lenders to meet business and credit needs in under-served
areas. Recipients of these programs may include individuals,
corporations, partnerships, cooperatives, public bodies, nonprofit
corporations, Indian tribes, and private companies. The mission of
Cooperative Programs of RBS is to promote understanding and use of the
cooperative form of business as a viable organizational option for
marketing and distributing agricultural products.
Priorities: In support USDA's goal to increase the prosperity of
rural communities, RBS regulatory priorities will facilitate
sustainable renewable energy development and enhance the opportunities
necessary for rural families to thrive economically. RBS' priority will
be to publish regulations to fully implement the 2008 Farm Bill. This
includes promulgating regulations for the Biorefinery Assistance
Program (sec. 9003), the Repowering Assistance Program (sec. 9004), the
Bioenergy Program for Advanced Biofuels (sec. 9005), and the Rural
Microentrepreneur Assistance Program (RMAP). RBS has been administering
sections 9003, 9004, and 9005 through the use of Notices of Funds
Availability and Notices of Contract Proposals. Revisions to the Rural
Energy for America Program (sec. 9007) will be made to incorporate
Energy Audits and Renewable Energy Development Assistance and
Feasibility Studies for Rural Energy Systems as eligible grant
purposes, as well as other Farm Bill initiatives and various technical
changes throughout the rule. In addition, revisions to the Business and
Industry Guaranteed Loan Program will be made to implement 2008 Farm
Bill provisions and other program initiatives. These rules will
minimize program complexity and burden on the public while enhancing
program delivery and RBS oversight.
Rural Utilities Service
Mission: The mission of the Rural Utilities Service (RUS) is to
improve the quality of life in rural America by providing investment
capital for the deployment of critical rural utilities
telecommunications, electric, and water and waste disposal
infrastructure. Financial assistance is provided to rural utilities,
municipalities, commercial corporations, limited liability companies,
public utility districts, Indian tribes, and cooperative, non-profit,
limited-dividend, or mutual associations. The public-private
partnership, which is forged between RUS and these industries, results
in billions of dollars in rural infrastructure
[[Page 7683]]
development and creates thousands of jobs for the American economy.
Priorities: RUS' regulatory priorities will be to achieve the
President's goal to bring affordable broadband to all rural Americans.
To accomplish this, RUS will continue to improve the Broadband Program
established by the 2002 Farm Bill. The 2002 Farm Bill authorized RUS to
approve loans and loan guarantees for the costs of construction,
improvement, and acquisition of facilities and equipment for broadband
service in eligible rural communities. The 2008 Farm Bill significantly
changed the statutory requirements of the Broadband Loan Program. As
such, RUS issued an interim rule to implement the statutory changes and
requested comments on the section of the rule that was not part of the
proposed rule published in May 2007. Comments were received and the
agency will analyze the comments and finalize the rule.
Departmental Management
Mission: Departmental Management's mission is to provide management
leadership to ensure that USDA administrative programs, policies,
advice, and counsel meet the needs of USDA program organizations,
consistent with laws and mandates, and provide safe and efficient
facilities and services to customers.
Priorities: In support of the Department's goal to increase rural
prosperity, USDA's departmental management will finalize regulations to
revise the BioPreferred program guidelines to continue adding
designated product categories to the preferred procurement program,
including intermediates and feedstocks and finished products made of
intermediates and feedstocks.
Aggregate Costs and Benefits
USDA will ensure that its regulations provide benefits that exceed
costs but is unable to provide an estimate of the aggregated impacts of
its regulations. Problems with aggregation arise due to differing
baselines, data gaps, and inconsistencies in methodology and the type
of regulatory costs and benefits considered. Some benefits and costs
associated with rules listed in the regulatory plan cannot currently be
quantified as the rules are still being formulated. For 2012, USDA's
focus will be to implement the changes to programs in such a way as to
provide benefits while minimizing program complexity and regulatory
burden for program participants.
USDA--Agricultural Marketing Service (AMS)
Proposed Rule Stage
1. Wholesale Pork Reporting Program
Priority: Other Significant.
Legal Authority: 7 U.S.C. 1635 to 1636
CFR Citation: 7 CFR 59.
Legal Deadline: Final, Statutory, March 28, 2012.
With the passage of S. 3656, the Mandatory Price Reporting Act of
2010, the Secretary of Agriculture is required to amend chapter 3 of
subtitle B of the Agricultural Marketing Act of 1946 by adding a new
section for mandatory reporting of wholesale pork cuts. To make these
amendments, the Secretary was directed to promulgate a final rule no
later than 1\1/2\ years after the date of the enactment of the Act.
Accordingly, a final rule will be promulgated by March 28, 2012.
Abstract: On September 15, 2010, Congress passed the Mandatory
Price Reporting Act of 2010 reauthorizing Livestock Mandatory Reporting
for 5 years and adding a provision for mandatory reporting of wholesale
pork cuts. The Act was signed by the President on September 28, 2010.
Congress directed the Secretary to engage in negotiated rulemaking to
make required regulatory changes for mandatory wholesale pork
reporting. Further, Congress required that the negotiated rulemaking
committee include representatives from (i) organizations representing
swine producers; (ii) organizations representing packers of pork,
processors of pork, retailers of pork, and buyers of wholesale pork;
(iii) the Department of Agriculture; and (iv) interested parties that
participate in swine or pork production.
Statement of Need: Implementation of mandatory pork reporting is
required by Congress. Congress delegated responsibility to the
Secretary for determining what information is necessary and
appropriate. The Food, Conservation, and Energy Act of 2008 (Pub. L.
110-234) directed the Secretary to conduct a study to determine
advantages, drawbacks, and potential implementation issues associated
with adopting mandatory wholesale pork reporting. The report from this
study generally concluded that voluntary wholesale pork price reporting
is thin and becoming thinner, and some degree of support for moving to
mandatory price reporting exists at every segment of the industry
interviewed. The report was delivered to Congress on March 25, 2010.
Summary of Legal Basis: Livestock Mandatory Reporting is authorized
under the Agricultural Marketing Act (7 U.S.C. 1635 to 1636). The
Livestock and Seed Program of USDA's Agricultural Marketing Service has
day-to-day responsibility for collecting and disseminating LMR data.
Alternatives: There are no alternatives, as this rulemaking is a
matter of law based on the Mandatory Price Reporting Act of 2010.
Anticipated Cost and Benefits: Estimation of costs will follow the
previous methodology used in earlier Livestock Mandatory Reporting
rulemaking. The focus of the cost estimation is the burden placed on
reporting companies in providing pork marketing data to the Livestock
and Seed Program. Previous rulemaking cost estimates of boxed beef
reporting of similar data found the burden to be an annual total of 65
hours in additional reporting requirements per firm. Because no
official USDA grade standards are used in the marketing of pork, and
there are fewer cutting styles, the burden for pork reporting firms in
comparison with beef reporting firms could be lower. However, the
impact is not truly known at this stage.
Risks: Implementing wholesale pork reporting presents few risks to
the Agency and the impacted industry. Members of the industry who
served on the negotiated rulemaking committee expressed some concern
with reporting prices under a different reporting basis than what is
used for voluntary pork reporting. However, ultimately the committee
reached consensus on having prices reporting on both an FOB Omaha and
FOB Plant basis in order to reduce market volatility.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Changes to Livestock Mandatory 11/24/10 75 FR 71568
Reporting.
Wholesale Pork Reporting; Notice of 01/26/11 76 FR 4554
Meeting.
NPRM................................ 02/00/12
Final Action........................ 10/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Michael P. Lynch, Department of Agriculture,
Agricultural Marketing Service, 14th and Independence Avenue SW.,
Washington, DC 20250, Phone: 202 720-6231.
RIN: 0581-AD07
[[Page 7684]]
USDA--AMS
2. National Organic Program: Sunset Review for Nutrient
Vitamins and Minerals (NOP-10-0083)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 7 U.S.C. 6501
CFR Citation: 7 CFR 205.
Legal Deadline: None.
Abstract: This proposed rule would address a recommendation
submitted to the Secretary of Agriculture (Secretary) by the National
Organic Standards Board (NOSB) on April 29, 2011. The recommendation
pertains to the 2012 Sunset Review of the listing for nutrient vitamins
and minerals on the U.S. Department of Agriculture's (USDA) National
List of Allowed and Prohibited Substances (National List). As
recommended by the NOSB, the proposed rule would continue the exemption
(use) for nutrient vitamins and minerals for 5 years after the October
21, 2012, sunset date. In addition, the proposed rule would amend the
annotation to correct an inaccurate cross reference to U.S. Food and
Drug Administration regulations. The proposed amendment to the
annotation would clarify what synthetic substances are allowed as
nutrient vitamins and minerals in organic products labeled as
``organic'' or ``made with organic (specified ingredients or food
group(s)).''
Statement of Need: The Agricultural Marketing Service (AMS) has
determined that the current exemption for the use of nutrient vitamins
and minerals in organic products in the National Organic Program (NOP)
regulations (7 CFR part 205) is inaccurate. The proposed rule would
amend the annotation for nutrient vitamins and minerals to correct an
inaccurate cross reference to U.S. Food and Drug Administration (FDA)
regulations. In effect, the proposed amendment would clarify what
synthetic substances are allowed as nutrient vitamins and minerals in
organic products. Further, the NOP regulations do not correctly provide
for the fortification of infant formula that would meet FDA
requirements. This proposed rule would incorporate the correct FDA
citation with respect to the addition of required vitamins and minerals
to organic infant formula.
Summary of Legal Basis: This proposed rule would address a
recommendation submitted to the Secretary of Agriculture by the
National Organic Standards Board (NOSB) on April 29, 2011, to continue
the exemption for nutrient vitamins and minerals in organic products as
provided by the NOP National List of Allowed and Prohibited Substances
(National List). The Organic Foods Production Act of 1990 (OFPA)
authorizes the Secretary to amend the National List based on proposed
amendments developed by the NOSB. The Sunset Provision, in section
6517(e) of the OFPA, provides that no exemption or prohibition on the
National List will remain valid after 5 years unless the exemption or
prohibition has been reviewed and the Secretary renews the listing. The
exemption for nutrient vitamins and minerals is scheduled to sunset on
October 21, 2012.
Alternatives: AMS considered two alternatives to this proposed
rulemaking: (1) Renew the existing listing for nutrient vitamins and
minerals or (2), in lieu of a rule, issue guidance stating NOP's intent
to interpret the current listing for nutrient vitamins and minerals as
proposed in this action. AMS determined that neither alternative is
viable as both would retain a regulatory provision that is inaccurate
and remains vulnerable to misinterpretations of what substances are
permitted in organic products.
Anticipated Cost and Benefits: This proposed rule would establish a
finite list of essential and required vitamins and minerals for use in
organic food and infant formula. The action addresses the requests of a
broad spectrum of public commenters for clarification on the parameters
for adding nutrient vitamins and minerals to organic products and is
expected to reduce the submission of consumer complaints alleging the
unlawful addition of substances to organic products. This proposed rule
would also provide more certainty to certifying agents and organic
operations in determining whether substances are acceptable for use in
organic products. Further, this proposed action also would foster
greater transparency by ensuring that exemptions for the use of
vitamins, minerals, and other nutrients are subject to National Organic
Standards Board (NOSB) evaluation in accordance with the criteria
established in OFPA.
This action could directly impact a subset of certified organic
operations, which add substances to organic products that are not
essential vitamins and minerals for human nutrition (21 CFR 101.9) or
required vitamins and minerals for infant formula (21 CFR 107.100 or
107.10), as enumerated by FDA regulation. AMS believes the impacts will
be concentrated within five categories of organic products in which
nutrient supplementation has been more prevalent: Infant formula, baby
food, milk, breakfast cereal, and pet food. The proposed rule could
indirectly impact producers who supply organic agricultural commodities
to affected product categories. However, AMS expects that there will be
opportunities for producers to divert organic agricultural products to
other purchasers to buffer the impact of any disruption to the
manufacture of certain processed organic products as a result of this
proposed action.
There are several impact mitigation factors which are expected to
reduce the costs of complying with this proposed action. AMS is
proposing a 2-year implementation phase, which is intended to provide
time for NOSB to consider petitions for substances that are affected by
this action and for AMS to conclude any rulemaking to add substances to
the National List. The implementation phase would also provide entities
the time to explore reformulation of affected products. Further, if
some products are discontinued as a result of this proposed rule, AMS
anticipates that some consumers will purchase, as an alternative, an
organic product within the same category rather than a nonorganic
product.
Risks: For the 2-year implementation phase to function as a
mitigation measure, the timeframe may be tight to complete the review
of petitions received by publication of this proposed rule and for any
rulemaking action recommended by NOSB. Therefore, AMS has requested
comments on the length of the implementation phase as part of this
proposed rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/12/12 77 FR 1980
NPRM Comment Period End............. 03/12/12 .......................
Final Action........................ 10/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Local, State.
Agency Contact: Melissa R. Bailey, Director, Standards Division,
Department of Agriculture, Agricultural Marketing Service, Washington,
DC 20250, Phone: 202 720-3252, Fax: 202 205-7808, Email:
[email protected].
Related RIN: Split from 0581-AC96.
RIN: 0581-AD17
[[Page 7685]]
USDA--ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS)
Proposed Rule Stage
3. Animal Welfare; Regulations and Standards for Birds
Priority: Other Significant.
Legal Authority: 7 U.S.C. 2131 to 2159
CFR Citation: 9 CFR 1 to 3.
Legal Deadline: None.
Abstract: APHIS intends to establish standards for the humane
handling, care, treatment, and transportation of birds other than birds
bred for use in research.
Statement of Need: The Farm Security and Rural Investment Act of
2002 amended the definition of animal in the Animal Welfare Act (AWA)
by specifically excluding birds, rats of the genus Rattus, and mice of
the genus Mus, bred for use in research. While the definition of animal
in the regulations contained in 9 CFR part 1 has excluded rats of the
genus Rattus and mice of the genus Mus bred for use in research, that
definition has also excluded all birds (i.e., not just those birds bred
for use in research). In line with this change to the definition of
animal in the AWA, APHIS intends to establish standards in 9 CFR part 3
for the humane handling, care, treatment, and transportation of birds
other than those birds bred for use in research and to revise the
regulations in 9 CFR parts 1 and 2 to make them applicable to birds.
Summary of Legal Basis: The Animal Welfare Act (AWA) authorizes the
Secretary of Agriculture to promulgate standards and other requirements
governing the humane handling, care, treatment, and transportation of
certain animals by dealers, research facilities, exhibitors, operators
of auction sales, and carriers and immediate handlers. Animals covered
by the AWA include birds that are not bred for use in research.
Alternatives: To be identified.
Anticipated Cost and Benefits: Benefits of the rule would stem from
improvements in the humane handling and care of birds by affected
dealers, exhibitors, carriers, and intermediate handlers. At a minimum,
these entities would be required to satisfy certain reporting
provisions and undergo periodic compliance inspections by APHIS--
measures that they are not subject to now with respect to birds.
Regulated entities, therefore, may incur certain costs because of the
proposed rule. Most facilities that use birds in research, such as
pharmaceutical companies, universities, and research institutes, would
not be affected. Retail pet stores could be affected to the extent that
regulatory costs are passed on to them by breeders and other suppliers.
Most entities affected by the proposal are likely to be small in
size, based on Small Business Administration standards. We have not
been able to conduct a comprehensive analysis of the rule's potential
economic impact because of the paucity of available data on the
affected industries. APHIS welcomes public comment that would permit a
more complete assessment of the proposed rule's impact.
Risks: Not applicable.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/12 .......................
NPRM Comment Period End............. 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Undetermined.
Additional Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
Agency Contact: Johanna Briscoe, Veterinary Medical Officer and
Avian Specialist, Animal Care, Department of Agriculture, Animal and
Plant Health Inspection Service, 4700 River Road, Unit 84, Riverdale,
MD 20737-1234, Phone: 301 734-0658.
RIN: 0579-AC02
USDA--APHIS
4. Plant Pest Regulations; Update of General Provisions
Priority: Other Significant.
Legal Authority: 7 U.S.C. 450; 7 U.S.C. 2260; 7 U.S.C. 7701 to
7772; 7 U.S.C. 7781 to 7786; 7 U.S.C. 8301 to 8817; 19 U.S.C. 136; 21
U.S.C. 111; 21 U.S.C. 114a; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 42
U.S.C. 4331 and 4332
CFR Citation: 7 CFR 318 and 319; 7 CFR 330; 7 CFR 352.
Legal Deadline: None.
Abstract: We are proposing to revise our regulations regarding the
movement of plant pests. We are proposing to regulate the movement of,
not only plant pests, but also biological control organisms and
associated articles. We are proposing risk-based criteria regarding the
movement of biological control organisms and are proposing to exempt
certain types of plant pests from permitting requirements for their
interstate movement and movement for environmental release. We are also
proposing to revise our regulations regarding the movement of soil and
to establish regulations governing the biocontainment facilities in
which plant pests, biological control organisms, and associated
articles are held. This proposed rule replaces a previously published
proposed rule, which we are withdrawing as part of this document. This
proposal would clarify the factors that would be considered when
assessing the risks associated with the movement of certain organisms,
facilitate the movement of regulated organisms and articles in a manner
that also protects U.S. agriculture, and address gaps in the current
regulations.
Statement of Need: APHIS is preparing a proposed rule to revise its
regulations regarding the movement of plant pests. The revised
regulations would address the importation and interstate movement of
plant pests, biological control organisms, and associated articles, and
the release into the environment of biological control organisms. The
revision would also address the movement of soil and establish
regulations governing the biocontainment facilities in which plant
pests, biological control organisms, and associated articles are held.
This proposal would clarify the factors that would be considered when
assessing the risks associated with the movement of certain organisms,
facilitate the movement of regulated organisms and articles in a manner
that also protects U.S. agriculture, and address gaps in the current
regulations.
Summary of Legal Basis: Under section 411(a) of the Plant
Protection Act (PPA), no person shall import, enter, export, or move in
interstate commerce any plant pest, unless the importation, entry,
exportation, or movement is authorized under a general or specific
permit and in accordance with such regulations as the Secretary of
Agriculture may issue to prevent the introduction of plant pests into
the United States or the dissemination of plant pests within the United
States.
Under section 412 of the PPA, the Secretary may restrict the
importation or movement in interstate commerce of biological control
organisms by requiring the organisms to be accompanied by a permit
authorizing such movement and by subjecting the organisms to quarantine
conditions or other remedial measures deemed necessary to prevent the
spread of plant pests or noxious weeds. That same section of the PPA
also gives the Secretary explicit authority to regulate the movement of
associated articles.
Alternatives: The alternatives we considered were taking no action
at this time or implementing a comprehensive
[[Page 7686]]
risk reduction plan. This latter alternative would be characterized as
a broad risk mitigation strategy that could involve various options
such as increased inspection, regulations specific to a certain
organism or group of related organisms, or extensive biocontainment
requirements.
We decided against the first alternative because leaving the
regulations unchanged would not address the needs identified
immediately above. We decided against the latter alternative, because
available scientific information, personnel, and resources suggest that
it would be impracticable at this time.
Anticipated Cost and Benefits: To be determined.
Risks: Unless we issue such a proposal, the regulations will not
provide a clear protocol for obtaining permits that authorize the
movement and environmental release of biological control organisms.
This, in turn, could impede research to explore biological control
options for various plant pests and noxious weeds known to exist within
the United States, and could indirectly lead to the further
dissemination of such pests and weeds.
Moreover, unless we revise the soil regulations, certain provisions
in the regulations will not adequately address the risk to plants,
plant parts, and plant products within the United States that such soil
might present.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice of Intent To Prepare an 10/20/09 74 FR 53673
Environmental Impact Statement.
Notice Comment Period End........... 11/19/09 .......................
NPRM................................ 05/00/12 .......................
NPRM Comment Period End............. 07/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses, Organizations.
Government Levels Affected: Local, State, Tribal.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Additional Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
Agency Contact: Shirley Wager--Page Chief, Pest Permitting Branch,
Plant Health Programs, PPQ, Department of Agriculture, Animal and Plant
Health Inspection Service, 4700 River Road, Unit 131, Riverdale, MD
20737-1236, Phone: 301 734-8453.
RIN: 0579-AC98
USDA--APHIS
Final Rule Stage
5. Importation of Live Dogs
Priority: Other Significant.
Legal Authority: 7 U.S.C. 2148
CFR Citation: 9 CFR 1 and 2.
Legal Deadline: None.
Abstract: This rulemaking would amend the Animal Welfare Act (AWA)
regulations to regulate dogs imported for resale as required by a
recent amendment to the AWA. Importation of dogs for resale would be
prohibited unless the dogs are in good health, have all necessary
vaccinations, and are 6 months of age or older. This proposal would
also reflect the exemptions provided in the amendment to the AWA for
dogs imported for research purposes or veterinary treatment and for
dogs legally imported into the State of Hawaii from the British Isles,
Australia, Guam, or New Zealand.
Statement of Need: The Food, Conservation, and Energy Act of 2008
mandates that the Secretary of Agriculture promulgate regulations to
implement and enforce new provisions of the Animal Welfare Act (AWA)
regarding the importation of dogs for resale. In line with the changes
to the AWA, APHIS intends to amend the regulations in 9 CFR parts 1 and
2 to regulate the importation of dogs for resale.
Summary of Legal Basis: The Food, Conservation, and Energy Act of
2008 (Pub. L. 110-246, signed into law on Jun. 18, 2008) added a new
section to the Animal Welfare Act (7 U.S.C. 2147) to restrict the
importation of live dogs for resale. As amended, the AWA now prohibits
the importation of dogs into the United States for resale unless the
Secretary of Agriculture determines that the dogs are in good health,
have received all necessary vaccinations, and are at least 6 months of
age. Exceptions are provided for dogs imported for research purposes or
veterinary treatment. An exception to the 6-month age requirement is
also provided for dogs that are lawfully imported into Hawaii for
resale purposes from the British Isles, Australia, Guam, or New Zealand
in compliance with the applicable regulations of Hawaii, provided the
dogs are vaccinated, are in good health, and are not transported out of
Hawaii for resale purposes at less than 6 months of age.
Alternatives: To be identified.
Anticipated Cost and Benefits: To be determined.
Risks: Not applicable.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 09/01/11 76 FR 54392
NPRM Comment Period End............. 10/31/11 .......................
Final Rule.......................... 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
Additional Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
Agency Contact: Gerald Rushin, Veterinary Medical Officer, Animal
Care, Department of Agriculture, Animal and Plant Health Inspection
Service, 4700 River Road, Unit 84, Riverdale, MD 20737-1234, Phone: 301
734-0954.
RIN: 0579-AD23
USDA--APHIS
6. Animal Disease Traceability
Priority: Other Significant.
Legal Authority: 7 U.S.C. 8305
CFR Citation: 9 CFR 90.
Legal Deadline: None.
Abstract: This rulemaking would establish a new part in the Code of
Federal Regulations containing minimum national identification and
documentation requirements for livestock moving interstate. The
proposed regulations specify approved forms of official identification
for each species covered under this rulemaking but would allow such
livestock to be moved interstate with another form of identification,
as agreed upon by animal health officials in the shipping and receiving
States or tribes. The purpose of the new regulations is to improve our
ability to trace livestock in the event that disease is found.
Statement of Need: Preventing and controlling animal disease is the
cornerstone of protecting American animal agriculture. While ranchers
and farmers work hard to protect their animals and their livelihoods,
there is never a guarantee that their animals will be spared from
disease. To support their efforts, USDA has enacted regulations to
prevent, control, and eradicate disease, and to increase foreign and
domestic confidence in the safety of animals and animal products.
Traceability helps give
[[Page 7687]]
that reassurance. Traceability does not prevent disease, but knowing
where diseased and at-risk animals are, where they have been, and when,
is indispensable in emergency response and in ongoing disease programs.
The primary objective of these proposed regulations is to improve our
ability to trace livestock in the event that disease is found in a
manner that continues to ensure the smooth flow of livestock in
interstate commerce.
Summary of Legal Basis: Under the Animal Health Protection Act (7
U.S.C. 8301 et seq.), the Secretary of Agriculture may prohibit or
restrict the interstate movement of any animal to prevent the
introduction or dissemination of any pest or disease of livestock, and
may carry out operations and measures to detect, control, or eradicate
any pest or disease of livestock. The Secretary may promulgate such
regulations as may be necessary to carry out the Act.
Alternatives: As part of its ongoing efforts to safeguard animal
health, APHIS initiated implementation of the National Animal
Identification System (NAIS) in 2004. More recently, the Agency
launched an effort to assess the level of acceptance of NAIS through
meetings with the Secretary, listening sessions in 14 cities, and
public comments. Although there was some support for NAIS, the vast
majority of participants were highly critical of the program and of
USDA's implementation efforts. The feedback revealed that NAIS has
become a barrier to achieving meaningful animal disease traceability in
the United States in partnership with America's producers.
The option we are proposing pertains strictly to interstate
movement and gives States and tribes the flexibility to identify and
implement the traceability approaches that work best for them.
Anticipated Cost and Benefits: A workable and effective animal
traceability system would enhance animal health programs, leading to
more secure market access and other societal gains. Traceability can
reduce the cost of disease outbreaks, minimizing losses to producers
and industries by enabling current and previous locations of
potentially exposed animals to be readily identified. Trade benefits
can include increased competitiveness in global markets generally, and
when outbreaks do occur, the mitigation of export market losses through
regionalization. Markets benefit through more efficient and timely
epidemiological investigation of animal health issues.
Other societal benefits include improved animal welfare during
natural disasters.
The main economic effect of the rule is expected to be on the beef
and cattle industry. For other species such as horses and other equine
species, poultry, sheep and goats, swine, and captive cervids, APHIS
would largely maintain and build on the identification requirements of
existing disease program regulations.
Costs of an animal traceability system would include those for tags
and interstate certificates of veterinary inspection (ICVIs) or other
movement documentation, for animals moved interstate. Incremental costs
incurred are expected to vary depending upon a number of factors,
including whether an enterprise does or does not already use eartags to
identify individual cattle. For many operators, costs of official
animal identification and ICVIs would be similar, respectively, to
costs associated with current animal identification practices and the
in-shipment documentation currently required by individual States. To
the extent that official animal identification and ICVIs would simply
replace current requirements, the incremental costs of the rule for
private enterprises would be minimal.
Risks: This rulemaking is being undertaken to address the animal
health risks posed by gaps in the existing regulations concerning
identification of livestock being moved interstate. The current lack of
a comprehensive animal traceability program is impairing our ability to
trace animals that may be infected with disease.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/11/11 76 FR 50082
NPRM Comment Period End............. 11/09/11 .......................
Final Rule.......................... 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: State, Tribal.
Additional Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov.
Agency Contact: Neil Hammerschmidt, Program Manager, Animal Disease
Traceability, VS, Department of Agriculture, Animal and Plant Health
Inspection Service, 4700 River Road, Unit 46, Riverdale, MD 20737-1231,
Phone: 301 734-5571.
RIN: 0579-AD24
USDA--FOOD AND NUTRITION SERVICE (FNS)
Proposed Rule Stage
7. Supplemental Nutrition Assistance Program: Farm Bill of 2008
Retailer Sanctions
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 110-246
CFR Citation: 7 CFR 276.
Legal Deadline: None.
Abstract: This proposed rule would implement provisions under
section 4132 of the Food, Conservation, and Energy Act of 2008, also
referred to as the Farm Bill of 2008. Under section 4132, the
Department of Agriculture's Food and Nutrition Service (FNS) is
provided with greater authority and flexibility when sanctioning retail
or wholesale food stores that violate Supplemental Nutrition Assistance
Program (SNAP) rules. Specifically, the Department is authorized to
assess a civil penalty and to disqualify a retail or wholesale food
store authorized to participate in SNAP. Previously, the Department
could assess a civil penalty or disqualification but not both. Section
4132 also eliminates the minimum disqualification period, which was
previously set at 6 months.
Statement of Need: This proposed rule would implement provisions
under section 4132 of the Food, Conservation, and Energy Act of 2008,
also referred to as the Farm Bill of 2008. Under section 4132, the
Department of Agriculture's Food and Nutrition Service (FNS) is
provided with greater authority and flexibility when sanctioning retail
or wholesale food stores that violate Supplemental Nutrition Assistance
Program (SNAP) rules. Specifically, the Department is authorized to
assess a civil penalty and to disqualify a retail or wholesale food
store authorized to participate in SNAP. Previously, the Department
could assess a civil penalty or disqualification, but not both. Section
4132 also eliminates the minimum disqualification period, which was
previously set at 6 months. In addition to implementing statutory
provisions, this rule proposes to provide a clear administrative
penalty when an authorized retailer or wholesale food store redeems a
SNAP participant's program benefits without the knowledge of the
participant. All program benefits are issued through the Electronic
Benefits Transfer (EBT) system. The EBT system establishes data that
may be used to identify fraud committed by retail food stores. While
stealing program benefits could be prosecuted under current statute,
program
[[Page 7688]]
regulations do not provide a clear penalty for these thefts. The
proposed rule would establish an administrative penalty for such thefts
equivalent to the penalty for trafficking in program benefits, which is
the permanent disqualification of a retailer or wholesale food store
from SNAP participation. Finally, the Department proposes to identify
additional administrative retail violations and the associated sanction
that would be imposed against the retail food store for committing the
violation. For instance, to maintain integrity, FNS requires retail and
wholesale food stores to key enter EBT card data in the presence of the
actual EBT card. The proposed rule would codify this requirement and
identify the specific sanction that would be imposed if retail food
stores are found to be in violation.
Summary of Legal Basis: Section 4132, Food, Conservation, and
Energy Act of 2008 (Pub. L. 110-246).
Alternatives: Because this proposed rule is under development,
alternatives are not yet articulated.
Anticipated Cost and Benefits: Because this proposed rule is under
development, anticipated costs and benefits have not yet been
articulated.
Risks: The risk that retail or wholesale food stores will violate
SNAP rules, or continue to violate SNAP rules, is expected to be
reduced by refining program sanctions for participating retailers and
wholesalers.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Additional Information: Note: This RIN replaces the previously
issued RIN 0584-AD78.
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
[email protected].
RIN: 0584-AD88
USDA--FNS
8. National School Lunch and School Breakfast Programs:
Nutrition Standards for All Foods Sold in School, as Required by the
Healthy, Hunger-Free Kids Act of 2010
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: Pub. L. 111-296
CFR Citation: 7 CFR 210; 7 CFR 220.
Legal Deadline: None.
Abstract: This proposed rule would codify the following provisions
of the Healthy, Hunger-Free Kids Act (Pub. L. 111-296; the Act) as
appropriate, under 7 CFR parts 210 and 220.
Section 203 requires schools participating in the National School
Lunch Program to make available to children free of charge, as
nutritionally appropriate, potable water for consumption in the place
where meals are served during meal service.
Section 208 requires the Secretary to promulgate proposed
regulations to establish science-based nutrition standards for all
foods sold in schools not later than December 13, 2011. The nutrition
standards would apply to all food sold outside the school meal
programs, on the school campus, and at any time during the school day.
(11-004)
Statement of Need: This proposed rule would codify the following
provisions of the Healthy, Hunger-Free Kids Act (Pub. L. 111-296; the
Act) as appropriate, under 7 CFR parts 210 and 220.
Section 203 requires schools participating in the National School
Lunch Program to make available to children free of charge, as
nutritionally appropriate, potable water for consumption in the place
where meals are served during meal service.
Section 208 requires the Secretary to promulgate proposed
regulations to establish science-based nutrition standards for all
foods sold in schools not later than December 13, 2011. The nutrition
standards would apply to all food sold outside the school meal
programs, on the school campus, and at any time during the school day.
Summary of Legal Basis: There is no existing regulatory requirement
to make water available where meals are served. Regulations at 7 CFR
parts 210.11 direct State agencies and school food authorities to
establish such rules or regulations necessary to control the sale of
foods in competition with lunches served under the NSLP. Such rules or
regulations shall prohibit the sale of foods of minimal nutritional
value in the food service areas during the lunch periods. The sale of
other competitive foods may, at the discretion of the State agency and
school food authority, be allowed in the food service area during the
lunch period only if all income from the sale of such foods accrues to
the benefit of the nonprofit school food service or the school or
student organizations approved by the school. State agencies and school
food authorities may impose additional restrictions on the sale of and
income from all foods sold at any time throughout schools participating
in the Program.
Alternatives: None.
Anticipated Cost and Benefits: Expected Costs Analysis and
Budgetary Effects Statement: The Congressional Budget Office determined
these provisions would incur no Federal costs.
Expected Benefits of the Proposed Action: The provisions in this
proposed rulemaking would result in better nutrition for all school
children.
Risks: None known.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Governmental Jurisdictions.
Government Levels Affected: Local, State.
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
[email protected].
RIN: 0584-AE09
USDA--FNS
9. WIC: Electronic Benefit Transfer (EBT) Implementation
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: Pub. L. 111-296
CFR Citation: 7 CFR 246.
Legal Deadline: NPRM, Statutory, October 1, 2020, Require all WIC
State agencies to implement EBT Statewide.
Abstract: This proposed rule would revise and expand regulations
regarding WIC EBT at 7 CFR 246 and implement statutory provisions
related to EBT as defined in the Healthy, Hunger-Free Kids Act of 2010,
Public Law 11-296. The EBT requirements addressed in the proposed rule
would promote improved access to Program benefits, standardize EBT
operations, and establish
[[Page 7689]]
implementation guidelines and timeframes.
Statement of Need: This proposed rule would revise and expand
regulations regarding WIC EBT at 7 CFR 246 and implement statutory
provisions related to EBT as defined in the Healthy, Hunger-Free Kids
Act of 2010, Public Law 11-296. The EBT requirements addressed in the
proposed rule would promote improved access to program benefits,
standardize EBT operations, and establish implementation guidelines and
timeframes.
WIC EBT has been an ongoing effort within the WIC community for
several years. The proposed rule would address the following:
Set forth the definition of EBT.
Require all WIC State agencies to implement EBT statewide
by October 1, 2020.
Require State agencies to submit status reports
demonstrating their progress toward Statewide EBT implementation.
Revise the current provision regarding the imposition of
EBT costs to vendors to include: (1) The formation of cost-sharing
criteria associated with any equipment or system not solely dedicated
to EBT; (2) the allowance of the payment of fees imposed by a third-
party processor for EBT transactions; (3) the disallowance of the
payment of interchange fees; (4) clarification of EBT cost impositions
after Statewide implementation; (5) elimination of the requirement for
State agencies to fund ongoing maintenance costs for vendors using
multi-function EBT equipment; and (6) require vendors to demonstrate
the capability to accept program benefits electronically prior to
authorization after Statewide implementation of EBT.
Establish minimum lane coverage guidelines for vendor
equipment, as set forth in the operating rules, and require State
agencies to provide the necessary EBT-only equipment if vendors do not
wish to acquire multi-function equipment.
Require that EBT technical standards and operating rules
be established and adhered to by State agencies.
Require all State agencies to use the universal product
code database.
Summary of Legal Basis: Healthy, Hunger-Free Kids Act of 2010 (Pub.
L. 111-296).
Alternatives: None.
Anticipated Cost and Benefits: Expected Costs Analysis and
Budgetary Effects Statement:
FNS estimates costs of approximately $30 to $60 million per fiscal
year (as reflected in the program's budget) for State agencies to
comply with the mandate. The costs will vary depending on
implementation activity and are expected to decline as more State
agencies adopt WIC EBT.
Expected Benefits of the Proposed Action: The EBT requirements
addressed in the proposed rule would promote improved access to program
benefits, standardize EBT operations, and establish implementation
guidelines and timeframes.
Risks: None known.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
[email protected].
RIN: 0584-AE21
USDA--FNS
Final Rule Stage
10. Nutrition Standards in the National School Lunch and School
Breakfast Programs
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 108-265, sec 103
CFR Citation: 7 CFR 210; 7 CFR 220.
Legal Deadline: None.
Abstract: Public Law 108-265 requires the Secretary to issue
regulations that reflect specific recommendations for increased
consumption of foods and food ingredients in school nutrition programs
based on the most recent Dietary Guidelines for Americans.
The current regulations require that reimbursable meals offered by
schools meet the applicable recommendations of the Dietary Guidelines
for Americans. This rule would revise the regulations on meal patterns
and nutrition standards to ensure that school meals reflect the 2005
Dietary Guidelines for Americans (04-017).
Statement of Need: This final rule will implement the requirement
in section 201 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L.
111-296) (the Act) that USDA promulgate regulations to update the meal
patterns and nutrition standards for school lunches and breakfasts
based on recommendations made by the Institute of Medicine (IOM). USDA
issued a proposed rule on January 13, 2011. The Act requires USDA to
issue interim or final regulations not later than 18 months after
promulgation of the proposed regulation.
This final rule will implement meal patterns and nutrition
standards recommended by IOM in its report ``School Meals: Building
Blocks for Healthy Children.'' In addition, the final rule will address
the comments submitted by the public in response to USDA's proposed
rule.
Summary of Legal Basis: The meal patterns and nutrition standards
for school lunches and breakfast are established in 7 CFR 210.10 and 7
CFR 220.8, respectively. State agencies monitor compliance with the
meal patterns and nutrition standards through program reviews
authorized in 7 CFR 210.19.
Alternatives: None.
Anticipated Cost and Benefits: Expected Costs Analysis and
Budgetary Effects Statement:
While there are no increased Federal costs associated with
implementation of this final rule, the Act provides schools that comply
with the new meal requirements with an increased Federal reimbursement.
The Act also provides Federal funding for training, technical
assistance, certification, and oversight activities related to
compliance with this rule. It is expected that the total costs of
compliance with the final rule will exceed $100 million per year.
Expected Benefits of the Proposed Action: The final rule is
projected to make substantial improvements to the meals served daily in
over 101,000 schools nationwide to more than 31 million children. It
will align school meals with national nutrition guidelines and help
safeguard the health of school children.
Risks: None known.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/13/11 76 FR 2494
NPRM Comment Period End............. 04/13/11 .......................
Final Action........................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Local, State.
Federalism: This action may have federalism implications as defined
in EO 13132.
[[Page 7690]]
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
[email protected].
RIN: 0584-AD59
USDA--FNS
11. Direct Certification of Children in Food Stamp Households and
Certification of Homeless, Migrant, and Runaway Children for Free Meals
Priority: Other Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 108-265, sec 104
CFR Citation: 7 CFR 210; 7 CFR 215; 7 CFR 220; 7 CFR 225; 7 CFR
226; 7 CFR 245.
Legal Deadline: None.
Abstract: In response to Public Law 108-265, which amended the
Richard B. Russell National School Lunch Act, 7 CFR 245, Determining
Eligibility for Free and Reduced Price Meals and Free Milk in Schools,
is amended to establish categorical (automatic) eligibility for free
meals and free milk upon documentation that a child is (1) homeless as
defined by the McKinney-Vento Homeless Assistance Act; (2) a runaway
served by grant programs under the Runaway and Homeless Youth Act; or
(3) migratory as defined in section 1309(2) of the Elementary and
Secondary Education Act. The rule also requires phase-in of mandatory
direct certification for children who are members of households
receiving benefits from the Supplemental Nutrition Assistance Program
and continues discretionary direct certification for other
categorically eligible children (04-018).
Statement of Need: The changes made to the Richard B. Russell
National School Lunch Act concerning direct certification are intended
to improve program access, reduce paperwork, and improve the accuracy
of the delivery of free meal benefits. This regulation will implement
the statutory changes and provide State agencies and local educational
agencies with the policies and procedures to conduct mandatory and
discretionary direct certification.
Summary of Legal Basis: These changes are being made in response to
provisions in Public Law 108-265.
Alternatives: None; statutory requirements.
Anticipated Cost and Benefits: This regulation will reduce
paperwork, target benefits more precisely, and will improve program
access of eligible school children.
Risks: This regulation may require adjustments to existing computer
systems to more readily share information between schools and
assistance agencies.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 04/25/11 76 FR 22785
Interim Final Rule Effective........ 06/24/11 .......................
Interim Final Rule Comment Period 10/24/11 .......................
End.
Final Rule.......................... 05/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Local, State.
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
[email protected].
Related RIN: Merged with 0584-AD62.
RIN: 0584-AD60
USDA--FNS
12. Eligibility, Certification, and Employment and Training Provisions
of the Food, Conservation, and Energy Act of 2008
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 110-246; Pub. L. 104-121
CFR Citation: 7 CFR 273.
Legal Deadline: None.
Abstract: This proposed rule would amend the regulations governing
the Supplemental Nutrition Assistance Program (SNAP) to implement
provisions from the Food, Conservation, and Energy Act of 2008 (Pub. L.
110-246) (FCEA) concerning the eligibility and certification of SNAP
applicants and participants and SNAP employment and training. In
addition, this proposed rule would revise the SNAP regulations
throughout 7 CFR part 273 to change the program name from the Food
Stamp Program to SNAP and to make other nomenclature changes as
mandated by the FCEA. The statutory effective date of these provisions
was October 1, 2008. Food and Nutrition Service (FNS) is also proposing
two discretionary revisions to SNAP regulations to provide State
agencies options that are currently available only through waivers.
These provisions would allow State agencies to average student work
hours and to provide telephone interviews in lieu of face-to-face
interviews. FNS anticipates that this rule would impact the associated
paperwork burdens (08-006).
Statement of Need: This proposed rule would amend the regulations
governing SNAP to implement provisions from the FCEA concerning the
eligibility and certification of SNAP applicants and participants and
SNAP employment and training. In addition, this proposed rule would
revise the SNAP regulations throughout 7 CFR part 273 to change the
program name from the Food Stamp Program to SNAP and to make other
nomenclature changes as mandated by the FCEA. The statutory effective
date of these provisions was October 1, 2008. FNS is also proposing two
discretionary revisions to SNAP regulations to provide State agencies
options that are currently available only through waivers. These
provisions would allow State agencies to average student work hours and
to provide telephone interviews in lieu of face-to-face interviews. FNS
anticipates that this rule would impact the associated paperwork
burdens.
Summary of Legal Basis: Food, Conservation, and Energy Act of 2008
(Pub. L. 110-246).
Alternatives: Most aspects of the rule are non-discretionary and
tie to explicit, specific requirements for SNAP in the FCEA. However,
FNS did consider alternatives in implementing section 4103 of the FCEA,
Elimination of Dependent Care Deduction Caps. FNS considered whether to
limit deductible expenses to costs paid directly to the care provider
or whether to permit households to deduct other expenses associated
with dependent care in addition to the direct costs. FNS chose to allow
households to deduct the cost of transportation to and from the
dependent care provider and the cost of separately identified activity
fees that are associated with dependent care. Section 4103 signaled an
important shift in congressional recognition that dependent care costs
constitute major expenses for working households. In addition, it was
noted during the floor discussion in both houses of Congress prior to
passage of the FCEA that some States already counted transportation
costs as part of dependent care expenditures.
Anticipated Cost and Benefits: The estimated total SNAP costs to
the Government of the FCEA provisions implemented in the rule are
estimated to be $831 million in FY 2010 and
[[Page 7691]]
$5.619 billion over the 5 years FY 2010 through FY 2014. These impacts
are already incorporated into the President's budget baseline.
There are many potential societal benefits of this rule. Some
provisions may make some households newly eligible for SNAP benefits.
Other provisions may increase SNAP benefits for certain households.
Certain provisions in the rule will reduce the administrative burden
for households and State agencies.
Risks: The statutory changes and discretionary ones under
consideration would streamline program operations. The changes are
expected to reduce the risk of inefficient operations.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/04/11 76 FR 25414
NPRM Comment Period End............. 07/05/11 .......................
Final Action........................ 10/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Local, State.
Agency Contact: Kevin Kwon, Chief, Planning and Regulatory Affairs
Branch, Department of Agriculture, Food and Nutrition Service, 10th
Floor, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-
0800, Email: [email protected].
RIN: 0584-AD87
USDA--FNS
13. Supplemental Nutrition Assistance Program: Nutrition
Education and Obesity Prevention Grant
Priority: Other Significant.
Legal Authority: Pub. L. 111-296
CFR Citation: 7 CFR 272.
Legal Deadline: Final, Statutory, January 1, 2012, Pub. L. 111-296
Abstract: [Pub. L. 111-296, The Healthy, Hunger-Free Kids Act of
2001, title II; Reducing Childhood Obesity and Improving the Diets of
Children, subtitle D; Miscellaneous, sec. 241.] The Nutrition Education
and Obesity Prevention Grant Program amends the Food and Nutrition Act
of 2008 to replace the current nutrition education program under the
Act with a program providing grants to States for the implementation of
a nutrition education and obesity prevention program that promotes
healthy food choices consistent with the most recent Dietary Guidelines
for Americans.
Statement of Need: The Nutrition Education and Obesity Prevention
Grant Program rule amends the Food and Nutrition Act of 2008 to replace
the current nutrition education program under the Act with a program
providing grants to States for the implementation of a nutrition
education and obesity prevention program that promotes healthy food
choices consistent with the most recent Dietary Guidelines for
Americans. This rule will implement all requirements of the law. It
makes eligible for program participation: (1) Supplemental Nutrition
Assistance Program (SNAP) participants, (2) participants in the school
lunch or breakfast programs, and (3) individuals who reside in low-
income communities or are low-income individuals. The rule continues
commitment to serving low-income populations while focusing on the
issue of obesity, a priority of this Administration. It ensures that
interventions implemented as part of State nutrition education plans
recognize the constrained resources of the eligible population.
The rule requires activities be science-based and outcome-driven
and provides for accountability and transparency through State plans.
It will require coordination and collaboration among Federal agencies
and stakeholders, including the Centers for Disease Control and
Prevention, the public health community, the academic and research
communities, nutrition education practitioners, representatives of
State and local governments, and community organizations that serve the
low-income populations. The rule allows for 100 percent Federal
funding, and States will not have to provide matching funds. The grant
funding will be based on 2009 expenditures. For 3 years after
enactment, States will receive grant funds based on their level of
funds expended for the 2009 base year with funds indexed for inflation
thereafter. The new funding structure is phased in over a 7-year
period. From fiscal year 2014 forward, funds will be allocated based on
a formula that considers participation.
Summary of Legal Basis: Section 241, Healthy, Hunger-Free Kids Act
of 2010 (Pub. L. 111-296).
Alternatives: None.
Anticipated Cost and Benefits: Expected Costs Analysis and
Budgetary Effects Statement:
The action allows for 100 percent Federal funding which gives
States more flexibility to target services where they can be most
effective without the constraints of a State match. For 3 years after
enactment, States will receive grant funds based on their level of
funds expended for the 2009 base year with funds indexed for inflation
thereafter. The new funding structure is phased in over a 7-year
period. From fiscal year 2014 forward, funds will be allocated based on
a formula that considers participation.
Expected Benefits of the Proposed Action: This regulatory action
seeks to improve the effectiveness of the program and make it easier
for the States to administer, while still allowing funding to grow. It
allows for 100 percent Federal funding, which gives States more
flexibility to target services where they can be most effective without
the constraints of a State match. It allows grantees to adopt
individual and group-based nutrition education, as well as community
and public health approaches. It allows coordinated services to be
provided to participants in all the Federal food assistance programs
and to other low-income persons.
Risks: None known.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: State.
Agency Contact: James F. Herbert, Regulatory Review Specialist,
Department of Agriculture, Food and Nutrition Service, 10th Floor, 3101
Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email:
[email protected].
RIN: 0584-AE07
USDA--FOOD SAFETY AND INSPECTION SERVICE (FSIS)
Proposed Rule Stage
14. Prior Labeling Approval System: Generic Label Approval
Priority: Other Significant.
Legal Authority: 21 U.S.C. 451 to 470; 21 U.S.C. 601 to 695
CFR Citation: 9 CFR 317; 9 CFR 327; 9 CFR 381; 9 CFR 412.
Legal Deadline: None.
Abstract: This rulemaking will continue an effort initiated several
years ago by amending FSIS' regulations to expand the types of labeling
that are generically approved. FSIS plans to propose that the
submission of labeling for approval prior to use be limited to certain
types of labeling, as specified in the regulations. In addition, FSIS
plans to reorganize and amend the regulations by consolidating the
nutrition labeling rules that currently are stated separately
[[Page 7692]]
for meat and poultry products (in part 317, subpart B, and part 381,
subpart Y, respectively) and by amending their provisions to set out
clearly various circumstances under which these products are
misbranded.
Statement of Need: Expanding the types of labeling that are
generically approved would permit Agency personnel to focus their
resources on evaluating only those claims or special statements that
have health and safety or economic implications. This would essentially
eliminate the time needed for FSIS personnel to evaluate labeling
features and allocate more time for staff to work on other duties and
responsibilities. A major advantage of this proposal is that it is
consistent with FSIS' current regulatory approach, which separates
industry and Agency responsibilities.
Summary of Legal Basis: 21 U.S.C. 457 and 607.
Alternatives: FSIS considered several options. The first was to
expand the types of labeling that would be generically approved and
consolidate into one part all of the labeling regulations applicable to
products regulated under the FMIA and PPIA and the policies currently
contained in FSIS Directive 7220.1, Revision 3. The second option FSIS
considered was to consolidate only the meat and poultry regulations
that are similar and to expand the types of generically approved
labeling that can be applied by Federal and certified foreign
establishments. The third option, and the one favored by FSIS, was to
amend the prior labeling approval system in an incremental three-phase
approach.
Anticipated Cost and Benefits: The proposed rule would permit the
Agency to realize an estimated discounted cost savings of $2.9 million
over 10 years. The proposed rule would be beneficial because it would
streamline the generic labeling process, while imposing no additional
cost burden on establishments. Consumers would benefit because industry
would have the ability to introduce products into the marketplace more
quickly.
Risks: None
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/05/11 76 FR 75809
NPRM Comment Period End............. 02/03/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Jeff Canavan, Labeling and Program Delivery
Division, Department of Agriculture, Food Safety and Inspection
Service, Patriots Plaza 3, 8th Floor, 8-146, Stop 5273, 1400
Independence Avenue SW., Washington, DC 20250-5273, Phone: 301 504-
0878, Fax: 301 504-0872, Email: [email protected].
RIN: 0583-AC59
USDA--FSIS
15. Product Labeling: Use of the Voluntary Claim ``Natural'' on the
Labeling of Meat and Poultry Products
Priority: Other Significant.
Legal Authority: 21 U.S.C. 601 et seq.; 21 U.S.C. 451 et seq.
CFR Citation: 9 CFR 317; 9 CFR 381.
Legal Deadline: None.
Abstract: The Food Safety and Inspection Service (FSIS) is
proposing to amend the Federal meat and poultry products inspection
regulations to define the conditions under which it will permit the
voluntary claim ``natural'' to be used in the labeling of meat and
poultry products. FSIS is also proposing that label approval requests
for labels that contain ``natural'' claims include documentation to
demonstrate that the products meet the criteria to bear a ``natural''
claim. FSIS is proposing to require that meat or poultry products meet
these conditions to qualify for a ``natural'' claim to make the claim
more meaningful to consumers.
Statement of Need: A codified ``natural'' claim definition will
reduce uncertainty about which products qualify to be labeled as
``natural'' and will increase consumer confidence in the claim. A
codified ``natural'' definition that clearly articulates the criteria
that meat and poultry products must meet to qualify to be labeled as
``natural'' will make the Agency's approval of ``natural'' claims more
transparent and will allow the Agency to review labels that contain
``natural'' claims in a more efficient and consistent manner. A
codified ``natural'' definition will also make the claim more
meaningful to consumers.
Summary of Legal Basis: 21 U.S.C. 601 et seq.; 21 U.S.C. 451 et
seq.
Alternatives: The Agency has considered not proceeding with
rulemaking and maintaining the existing policy guidance on ``natural''
claims and using that policy guidance to evaluate ``natural'' claims on
a case-by-case basis. The Agency has also considered alternative
definitions of ``natural'' and establishing separate codified
definitions of ``natural,'' ``natural * * * minimally processed,'' and
``natural * * * minimally processed/all natural ingredients.''
Anticipated Cost and Benefits: FSIS anticipates that a clear and
simple definition of ``natural'' will minimize cognitive costs to
consumers. FSIS also anticipates benefits from a consistent USDA policy
on ``natural'' claims. FSIS anticipates costs to establishments to
change their labels or change their production practices.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 09/14/09 74 FR 46951
ANPRM Comment Period End............ 11/13/09
NPRM................................ 09/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Rosalyn Murphy-Jenkins, Director, Labeling and
Program Delivery Division, Department of Agriculture, Food Safety and
Inspection Service, Patriots Plaza 3, 8th Floor, Room 8-148, Stop 5273,
1400 Independence Avenue SW, Washington, DC 20250-5273, Phone: 301 504-
0878, Fax: 301 504-0872, Email: [email protected].
RIN: 0583-AD30
USDA--FSIS
16. New Poultry Slaughter Inspection
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 451 et seq.
CFR Citation: 9 CFR 381.66; 9 CFR 381.67; 9 CFR 381.76; 9 CFR
381.83; 9 CFR 381.91; 9 CFR 381.94.
Legal Deadline: None.
Abstract: FSIS is proposing a new inspection system for young
poultry slaughter establishments that would facilitate public health-
based inspection. This new system would be available initially only to
young chicken and turkey slaughter establishments. Establishments that
slaughter broilers, fryers, roasters, and Cornish game hens (as defined
in 9 CFR 381.170) would be considered as ``young chicken
establishments.'' FSIS is also proposing to revoke the provisions that
allow young chicken slaughter establishments to operate under the
current Streamlined Inspection System (SIS) or the New Line Speed
(NELS) Inspection System, and to revoke the New Turkey Inspection
System (NTIS). FSIS anticipates that this proposed rule would provide
the framework for action
[[Page 7693]]
to provide public health-based inspection in all establishments that
slaughter amenable poultry species.
Under the proposed new system, young chicken slaughter
establishments would be required to sort chicken carcasses and to
conduct other activities to ensure that carcasses are not adulterated
before they enter the chilling tank.
Statement of Need: Because of the risk to the public health
associated with pathogens on young chicken carcasses, FSIS is proposing
a new inspection system that would allow for more effective inspection
of young chicken carcasses, would allow the Agency to more effectively
allocate its resources, would encourage industry to more readily use
new technology, and would include new performance standards to reduce
pathogens.
This proposed rule is an example of regulatory reform because it
would facilitate technological innovation in young chicken slaughter
establishments. It would likely result in more cost-effective dressing
of young chickens that are ready to cook or ready for further
processing. Similarly, it would likely result in more efficient and
effective use of Agency resources.
Summary of Legal Basis: 21 U.S.C. 451 to 470.
Alternatives: FSIS considered the following options in developing
this proposal:
(1) No action.
(2) Propose to implement HACCP-based Inspection Models Pilot in
regulations.
(3) Propose to establish a mandatory, rather than a voluntary, new
inspection system for young chicken slaughter establishments.
Anticipated Cost and Benefits: Not publicly available at this time.
Risks: Salmonella and other pathogens are present on a substantial
portion of poultry carcasses inspected by FSIS. Foodborne salmonella
cause a large number of human illnesses that at times lead to
hospitalization and even death. There is an apparent relationship
between human illness and prevalence levels for salmonella in young
chicken carcasses. FSIS believes that through better allocation of
inspection resources and the use of performance standards, it would be
able to better address the prevalence of salmonella and other pathogens
in young chickens.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Dr. Daniel L. Engeljohn, Assistant Administrator,
Office of Policy and Program Development, Department of Agriculture,
Food Safety and Inspection Service, 1400 Independence Avenue SW.,
Washington, DC 20250, Phone: 202 205-0495, Fax: 202 401-1760, Email:
[email protected].
RIN: 0583-AD32
USDA--FSIS
17. Electronic Imported Product Inspection Application and
Certification of Imported Product and Foreign Establishments;
Amendments To Facilitate the Public Health Information System (PHIS)
Priority: Other Significant.
Legal Authority: Federal Meat Inspection Act (FMIA) (21 U.S.C. 601
to 695), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to
470); Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 to 1056)
CFR Citation: 9 CFR 304.3; 9 CFR 327.2 and 327.4; 9 CFR 381.196 to
381.198; 9 CFR 590.915 and 590.920.
Legal Deadline: None.
Abstract: FSIS is proposing to amend the meat, poultry, and egg
products import inspection regulations to provide for an electronic
import inspection application, and electronic imported product foreign
inspection and foreign establishment certification system. FSIS is also
proposing to delete the ``streamlined'' import inspection procedures
for Canadian product. In addition, the Agency is proposing that
official import inspection establishment must develop, implement, and
maintain written Sanitation SOPs, as provided in 9 CFR 416.11 through
416.17. FSIS is also announcing that it is discontinuing its practice
of conducting imported product reinspection based on a foreign
government's guarantee.
Statement of Need: FSIS is proposing these regulations to provide
for the electronic import system, which will be available through the
Agency's Public Health Information System (PHIS), a computerized, Web-
based inspection information system. The import system will enable
applicants to electronically submit and track import inspection
applications that are required for all commercial entries of FSIS-
regulated products imported into the U.S. FSIS inspection program
personnel will be able to access the PHIS system to assign appropriate
imported product inspection activities. The electronic import system
will also facilitate the imported product foreign inspection and annual
foreign establishment certifications by providing immediate and direct
electronic government-to-government exchange of information. The Agency
is proposing to delete the Canadian streamlined import inspection
procedures because they have not been in use since 1990 and are
obsolete. Sanitation SOPs are written procedures establishments
develop, implement, and maintain to prevent direct contamination or
adulteration of meat or poultry products. To ensure that imported meat
and poultry products do not become contaminated while undergoing
reinspection prior to entering the U.S., FSIS is proposing to clarify
that official import inspection establishments must develop written
Sanitation SOPs.
Summary of Legal Basis: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470;
21 U.S.C. 1031 to 1056.
Alternatives: The use of the electronic import system is voluntary.
The Agency will continue to accept and process paper import inspection
applications, and foreign establishment and imported product foreign
inspection certificates. The Canadian streamlined import inspection
procedures are not currently in use. Proposing Sanitation SOPs in
official import inspection establishments will prevent direct
contamination or adulteration of product. Therefore, no alternatives
were considered.
Anticipated Cost and Benefits: Under this proposed rule, the
industry will have the option of filing inspection applications
electronically and submitting electronic imported foreign inspection
product and establishment certificates through the PHIS. Since the
electronic option is voluntary, applicants and the foreign countries
that choose to file electronically will do so only if the benefits
outweigh the cost. Sanitation SOPs are a condition of approval for
official import inspection establishments and as a requirement for
official import inspection establishments to continue to operate under
Federal inspection. The proposed rule will clarify that official import
inspection establishments must have developed written Sanitation SOPs
before being granted approval and that existing official import
inspection establishments must meet Sanitation SOP requirements. Since,
in practice, FSIS has always expected official import inspection
establishments to maintain Sanitation SOPs during the reinspection of
imported products, the proposed amendment for these
[[Page 7694]]
sanitation requirements will have little, if any, cost impact on the
industry.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Mary Stanley, Director, International Policy
Division Office of Policy and Program, Department of Agriculture, Food
Safety and Inspection Service, Room 2125, 1400 Independence Avenue SW.,
Washington, DC 20250, Phone: 202 720-0287.
RIN: 0583-AD39
USDA--FSIS
18. Electronic Export Application and Certification as a Reimbursable
Service and Flexibility in the Requirements for Official Export
Inspection Marks, Devices, and Certificates
Priority: Other Significant.
Legal Authority: Federal Meat Inspection Act (FMIA) (21 U.S.C. 601
to 695); Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to 470);
Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 to 1056)
CFR Citation: 9 CFR 312.8; 9 CFR 322.1 and 322.2; 9 CFR 350.7; 9
CFR 362.5; 9 CFR 381.104 to 381.106; 9 CFR 590.407; 9 CFR 592.20 and
592.500.
Legal Deadline: None.
Abstract: The Food Safety and Inspection Service (FSIS) is
proposing to amend the meat, poultry, and egg product inspection
regulations to provide an electronic export application and
certification system. The electronic export application and
certification system will be a component of the Agency's Public Health
Information System (PHIS). The export component of PHIS will be
available as an alternative to the paper-based application and
certification process. FSIS is proposing to charge users for the use of
the proposed system. FSIS is proposing to establish a formula for
calculating the fee. FSIS is also proposing to provide establishments
that export meat, poultry, and egg products with flexibility in the
official export inspection marks, devices, and certificates. In
addition, FSIS is proposing egg product export regulations that
parallel the meat and poultry export regulations.
Statement of Need: FSIS is proposing these regulations to
facilitate the electronic processing of export applications and
certificates through the Public Health Information System (PHIS), a
computerized, Web-based inspection information system. The current
export application and certification regulations provide only for a
paper-based process. This proposed rule will provide this electronic
export system as a reimbursable certification service charged to the
exporter.
Summary of Legal Basis: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470;
21 U.S.C. 1031 to 1056; 7 U.S.C. 1622(h).
Alternatives: The electronic export applications and certification
system is being proposed as a voluntary service; therefore, exporters
have the option of continuing to use the current paper-based system.
Therefore, no alternatives were considered.
Anticipated Cost and Benefits: FSIS is proposing to charge
exporters an application fee for the electronic system. Automating the
export application and certification process will facilitate the
exportation of U.S. meat, poultry, and egg products by streamlining and
automating the processes that are in use while ensuring that foreign
regulatory requirements are met. The cost to an exporter would depend
on the number of electronic applications submitted. An exporter that
submits only a few applications per year would not be likely to
experience a significant economic impact. Under this proposal,
inspection personnel workload is reduced through the elimination of the
physical handling and processing of applications and certificates. When
an electronic government-to-government system interface or data
exchange is used, fraudulent transactions, such as false alterations
and reproductions, will be significantly reduced, if not eliminated.
The electronic export system is designed to ensure authenticity,
integrity, and confidentiality. Exporters will be provided a more
efficient and effective application and certification process. The
proposed egg product export regulations provide the same export
requirements across all products regulated by FSIS and consistency in
the export application and certification process. The total annual
paperwork burden to egg processing industry to fill out the paper-based
export application is approximately $32,340 per year for a total of 924
hours a year. The average establishment burden would be 11 hours, and
$385.00 per establishment.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Dr. Ron Jones, Assistant Administrator, Office of
International Affairs, Department of Agriculture, Food Safety and
Inspection Service, 1400 Independence Avenue SW., Washington, DC 20250,
Phone: 202 720-3473.
RIN: 0583-AD41
USDA--FSIS
Final Rule Stage
19. Performance Standards for the Production of Processed Meat and
Poultry Products; Control of Listeria Monocytogenes in Ready-to-Eat
Meat and Poultry Products
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 451 et seq.; 21 U.S.C. 601 et seq.
CFR Citation: 9 CFR 301; 9 CFR 303; 9 CFR 317; 9 CFR 318; 9 CFR
319; 9 CFR 320; 9 CFR 325; 9 CFR 331; 9 CFR 381; 9 CFR 417; 9 CFR 430;
9 CFR 431.
Legal Deadline: None.
Abstract: FSIS has proposed to establish pathogen reduction
performance standards for all ready-to-eat (RTE) and partially heat-
treated meat and poultry products, and measures, including testing, to
control Listeria monocytogenes in RTE products. The performance
standards spell out the objective level of pathogen reduction that
establishments must meet during their operations in order to produce
safe products, but allow the use of customized, plant-specific
processing procedures other than those prescribed in the earlier
regulations. With HACCP, food safety performance standards give
establishments the incentive and flexibility to adopt innovative,
science-based food safety processing procedures and controls, while
providing objective, measurable standards that can be verified by
Agency inspectional oversight. This set of performance
[[Page 7695]]
standards will include and be consistent with standards already in
place for certain ready-to-eat meat and poultry products.
Statement of Need: Although FSIS routinely samples and tests some
ready-to-eat products for the presence of pathogens prior to
distribution, there are no specific regulatory pathogen reduction
requirements for most of these products. The proposed performance
standards are necessary to help ensure the safety of these products;
give establishments the incentive and flexibility to adopt innovative,
science-based food safety processing procedures and controls; and
provide objective, measurable standards that can be verified by Agency
oversight.
Summary of Legal Basis: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470.
Alternatives: As an alternative to all of the proposed
requirements, FSIS considered taking no action. As alternatives to the
proposed performance standard requirements, FSIS considered end-product
testing and requiring ``use-by'' date labeling on ready-to-eat
products.
Anticipated Cost and Benefits: Benefits are expected to result from
fewer contaminated products entering commercial food distribution
channels as a result of improved sanitation and process controls and
in-plant verification. FSIS believes that the benefits of the rule
would exceed the total costs of implementing its provisions. FSIS
currently estimates net benefits from the 2003 interim final rule at
$470 to $575 million, with annual recurring costs at $150.4 million, if
FSIS discounts the capital cost at 7 percent. FSIS is continuing to
analyze the potential impact of the other provisions of the proposal.
The other main provisions of the proposed rule are: Lethality
performance standards for Salmonella and E. coli O157:H7 and
stabilization performance standards for C. perfringens that firms must
meet when producing RTE meat and poultry products. Most of the costs of
these requirements would be associated with one-time process
performance validation in the first year of implementation of the rule
and with revision of HACCP plans. Benefits are expected to result from
the entry into commercial food distribution channels of product with
lower levels of contamination resulting from improved in-plant process
verification and sanitation. Consequently, there will be fewer cases of
foodborne illness.
Risks: Before FSIS published the proposed rule, FDA and FSIS had
estimated that each year L. monocytogenes caused 2,540 cases of
foodborne illness, including 500 fatalities. The Agencies estimated
that about 65.3 percent of these cases, or 1660 cases and 322 deaths
per year, were attributable to RTE meat and poultry products. The
analysis of the interim final rule on control of L. monocytogenes
conservatively estimated that implementation of the rule would lead to
an annual reduction of 27.3 deaths and 136.7 illnesses at the median.
FSIS is continuing to analyze data on production volume and Listeria
controls in the RTE meat and poultry products industry and is using the
FSIS risk assessment model for L. monocytogenes to determine the likely
risk reduction effects of the rule. Preliminary results indicate that
the risk reductions being achieved are substantially greater than those
estimated in the analysis of the interim rule.
FSIS is also analyzing the potential risk reductions that might be
achieved by implementing the lethality and stabilization performance
standards for products that would be subject to the proposed rule. The
risk reductions to be achieved by the proposed rule and that are being
achieved by the interim rule are intended to contribute to the Agency's
public health protection effort.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/27/01 66 FR 12590
NPRM Comment Period End............. 05/29/01 .......................
NPRM Comment Period Extended........ 07/03/01 66 FR 35112
NPRM Comment Period Extended End.... 09/10/01 .......................
Interim Final Rule.................. 06/06/03 68 FR 34208
Interim Final Rule Effective........ 10/06/03 .......................
Interim Final Rule Comment Period 01/31/05 .......................
End.
NPRM Comment Period Reopened........ 03/24/05 70 FR 15017
NPRM Comment Period Reopened End.... 05/09/05 .......................
Affirmation of Interim Final Rule... 01/00/12 .......................
Final Action........................ 09/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Dr. Daniel L. Engeljohn, Assistant Administrator,
Office of Policy and Program Development,Department of Agriculture,
Food Safety and Inspection Service, 1400 Independence Avenue SW.,
Washington, DC 20250, Phone: 202 205-0495, Fax: 202 401-1760, Email:
[email protected].
RIN: 0583-AC46
USDA--FSIS
20. Notification, Documentation, and Recordkeeping Requirements for
Inspected Establishments
Priority: Other Significant.
Legal Authority: 21 U.S.C. 612 to 613; 21 U.S.C. 459
CFR Citation: 9 CFR 417.4; 9 CFR 418.
Legal Deadline: None.
Abstract: The Food Safety and Inspection Service (FSIS) has
proposed to require establishments subject to inspection under the
Federal Meat Inspection Act and the Poultry Products Inspection Act to
promptly notify the Secretary of Agriculture that an adulterated or
misbranded product received by or originating from the establishment
has entered into commerce, if the establishment believes or has reason
to believe that this has happened. FSIS has also proposed to require
these establishments to: (1) Prepare and maintain current procedures
for the recall of all products produced and shipped by the
establishment and (2) document each reassessment of the process control
plans of the establishment.
Statement of Need: The Food, Conservation, and Energy Act of 2008
(Pub. L. 110-246, sec. 11017), known as the 2008 Farm Bill, amended the
Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection
Act (PPIA) to require establishments subject to inspection under these
Acts to promptly notify the Secretary that an adulterated or misbranded
product received by or originating from the establishment has entered
into commerce, if the establishment believes or has reason to believe
that this has happened. Section 11017 also requires establishments
subject to inspection under the FMIA and PPIA to: (1) Prepare and
maintain current procedures for the recall of all products produced and
shipped by the establishment and (2) document each reassessment of the
process control plans of the establishment.
Summary of Legal Basis: 21 U.S.C. 612 and 613; 21 U.S.C. 459, and
Public Law 110-246, section 11017.
Alternatives: The option of no rulemaking is unavailable.
Anticipated Cost and Benefits: Approximate costs: $5.0 million for
[[Page 7696]]
labor and costs; $5.2 million for first-year costs; $0.7 million
average costs adjusted with a 3.0 percent inflation rate for following
years. Total approximate costs: $10.2 million. The average cost of this
final rule to small entities is expected to be less than 1/10 of 1 cent
of meat and poultry food products per annum. Therefore, FSIS has
determined that this rule will not have a significant economic impact
on a substantial number of small entities. Approximate benefits:
Benefits have not been monetized because quantified data on benefits
attributable to this final rule are not available. Non-monetary
benefits include improved protection of the public health, improved
HACCP plans, and improved recall effectiveness.
Risks: In preparing regulations on the shipment of adulterated meat
and poultry products by meat and poultry establishments, the
preparation and maintenance of procedures for recalled products
produced and shipped by establishments, and the documentation of each
reassessment of the process control plans by the establishment, the
Agency considered any risks to public health or other pertinent risks
associated with these actions.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/25/10 75 FR 14361
NPRM Comment Period End............. 05/24/10 .......................
Final Action........................ 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Victoria Levine, Program Analyst, Policy Issuances
Division, Department of Agriculture, Food Safety and Inspection
Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202
720-5627, Fax: 202 690-0486, Email: [email protected].
RIN: 0583-AD34
BILLING CODE 3410-90-P
DEPARTMENT OF COMMERCE (DOC)
Statement of Regulatory and Deregulatory Priorities
Established in 1903, the Department of Commerce is one of the
oldest Cabinet-level agencies in the Federal Government. The
Department's mission is to create the conditions for economic growth
and opportunity by promoting innovation, entrepreneurship,
competitiveness, and environmental stewardship. Commerce has 12
operating units, which are responsible for managing a diverse portfolio
of programs and services, ranging from trade promotion and economic
development assistance to broadband and the National Weather Service.
The Department touches Americans daily, in many ways--making
possible the daily weather reports and survey research; facilitating
technology that all of us use in the workplace and in the home each
day; supporting the development, gathering, and transmission of
information essential to competitive business; enabling the diversity
of companies and goods found in America's and the world's marketplace;
and supporting environmental and economic health for the communities in
which Americans live.
Commerce has a clear and compelling vision for itself, for its role
in the Federal Government, and for its roles supporting the American
people, now and in the future. To achieve this vision, the Department
works in partnership with businesses, universities, communities, and
workers to:
Innovate by creating new ideas through cutting-edge
science and technology from advances in nanotechnology, to ocean
exploration, to broadband deployment, and by protecting American
innovations through the patent and trademark system;
Support entrepreneurship and commercialization by enabling
community development and strengthening minority businesses and small
manufacturers;
Maintain U.S. economic competitiveness in the global
marketplace by promoting exports, ensuring a level playing field for
U.S. businesses, and ensuring that technology transfer is consistent
with our Nation's economic and security interests;
Provide effective management and stewardship of our
Nation's resources and assets to ensure sustainable economic
opportunities; and
Make informed policy decisions and enable better
understanding of the economy by providing accurate economic and
demographic data.
The Department is a vital resource base, a tireless advocate, and
Cabinet-level voice for job creation.
The Regulatory Plan tracks the most important regulations that
implement these policy and program priorities, several of which involve
regulation of the private sector by the Department.
Responding to the Administration's Regulatory Philosophy and Principles
The vast majority of the Department's programs and activities do
not involve regulation. Of the Department's 12 primary operating units,
only the National Oceanic and Atmospheric Administration (NOAA) will be
planning actions that are considered the ``most important'' significant
preregulatory or regulatory actions for FY 2012. During the next year,
NOAA plans to publish four rulemaking actions that are designated as
regulatory plan actions. The Bureau of Industry and Security (BIS) will
also publish rulemaking actions designated as regulatory plan actions.
Further information on these actions is provided below.
The Department has a long-standing policy to prohibit the issuance
of any regulation that discriminates on the basis of race, religion,
gender, or any other suspect category and requires that all regulations
be written so as to be understandable to those affected by them. The
Secretary also requires that the Department afford the public the
maximum possible opportunity to participate in departmental
rulemakings, even where public participation is not required by law.
National Oceanic and Atmospheric Administration
NOAA establishes and administers Federal policy for the
conservation and management of the Nation's oceanic, coastal, and
atmospheric resources. It provides a variety of essential environmental
and climate services vital to public safety and to the Nation's
economy, such as weather forecasts, drought forecasts, and storm
warnings. It is a source of objective information on the state of the
environment. NOAA plays the lead role in achieving the Departmental
goal of promoting stewardship by providing assessments of the global
environment.
Recognizing that economic growth must go hand-in-hand with
environmental stewardship, the Department, through NOAA, conducts
programs designed to provide a better understanding of the connections
between environmental health, economics, and national security.
Commerce's emphasis on ``sustainable fisheries'' is designed to boost
long-term economic growth in a vital sector of the U.S. economy while
conserving the resources in the public trust and minimizing any
economic dislocation necessary to ensure long-term economic growth. The
Department is where business and environmental interests
[[Page 7697]]
intersect, and the classic debate on the use of natural resources is
transformed into a ``win-win'' situation for the environment and the
economy.
Three of NOAA's major components, the National Marine Fisheries
Service (NMFS), the National Ocean Service (NOS), and the National
Environmental Satellite, Data, and Information Service (NESDIS),
exercise regulatory authority.
NMFS oversees the management and conservation of the Nation's
marine fisheries, protects threatened and endangered marine and
anadromous species and marine mammals, and promotes economic
development of the U.S. fishing industry. NOS assists the coastal
States in their management of land and ocean resources in their coastal
zones, including estuarine research reserves; manages the national
marine sanctuaries; monitors marine pollution; and directs the national
program for deep-seabed minerals and ocean thermal energy. NESDIS
administers the civilian weather satellite program and licenses private
organizations to operate commercial land-remote sensing satellite
systems.
The Department, through NOAA, has a unique role in promoting
stewardship of the global environment through effective management of
the Nation's marine and coastal resources and in monitoring and
predicting changes in the Earth's environment, thus linking trade,
development, and technology with environmental issues. NOAA has the
primary Federal responsibility for providing sound scientific
observations, assessments, and forecasts of environmental phenomena on
which resource management, adaptation, and other societal decisions can
be made.
In the environmental stewardship area, NOAA's goals include:
Rebuilding and maintaining strong U.S. fisheries by using market-based
tools and ecosystem approaches to management; increasing the
populations of depleted, threatened, or endangered species and marine
mammals by implementing recovery plans that provide for their recovery
while still allowing for economic and recreational opportunities;
promoting healthy coastal ecosystems by ensuring that economic
development is managed in ways that maintain biodiversity and long-term
productivity for sustained use; and modernizing navigation and
positioning services. In the environmental assessment and prediction
area, goals include: Understanding climate change science and impacts,
and communicating that understanding to government and private sector
stakeholders enabling them to adapt; continually improving the National
Weather Service; implementing reliable seasonal and interannual climate
forecasts to guide economic planning; providing science-based policy
advice on options to deal with very long-term (decadal to centennial)
changes in the environment; and advancing and improving short-term
warning and forecast services for the entire environment.
Magnuson-Stevens Fishery Conservation and Management Act
Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-
Stevens Act) rulemakings concern the conservation and management of
fishery resources in the U.S. Exclusive Economic Zone (generally 3-200
nautical miles). Among the several hundred rulemakings that NOAA plans
to issue in FY 2012, a number of the preregulatory and regulatory
actions will be significant. The exact number of such rulemakings is
unknown, since they are usually initiated by the actions of eight
regional Fishery Management Councils (FMCs) that are responsible for
preparing fishery management plans (FMPs) and FMP amendments, and for
drafting implementing regulations for each managed fishery. NOAA issues
regulations to implement FMPs and FMP amendments. Once a rulemaking is
triggered by an FMC, the Magnuson-Stevens Act places stringent
deadlines upon NOAA by which it must exercise its rulemaking
responsibilities. FMPs and FMP amendments for Atlantic highly migratory
species, such as bluefin tuna, swordfish, and sharks, are developed
directly by NOAA, not by FMCs.
FMPs address a variety of issues including maximizing fishing
opportunities on healthy stocks, rebuilding overfished stocks, and
addressing gear conflicts. One of the problems that FMPs may address is
preventing overcapitalization (preventing excess fishing capacity) of
fisheries. This may be resolved by market-based systems such as catch
shares, which permit shareholders to harvest a quantity of fish and
which can be traded on the open market. Harvest limits based on the
best available scientific information, whether as a total fishing limit
for a species in a fishery or as a share assigned to each vessel
participant, enable stressed stocks to rebuild. Other measures include
staggering fishing seasons or limiting gear types to avoid gear
conflicts on the fishing grounds and establishing seasonal and area
closures to protect fishery stocks.
The FMCs provide a forum for public debate and, using the best
scientific information available, make the judgments needed to
determine optimum yield on a fishery-by-fishery basis. Optional
management measures are examined and selected in accordance with the
national standards set forth in the Magnuson-Stevens Act. This process,
including the selection of the preferred management measures,
constitutes the development, in simplified form, of an FMP. The FMP,
together with draft implementing regulations and supporting
documentation, is submitted to NMFS for review against the national
standards set forth in the Magnuson-Stevens Act, in other provisions of
the Act, and other applicable laws. The same process applies to
amending an existing approved FMP.
Marine Mammal Protection Act
The Marine Mammal Protection Act of 1972 (MMPA) provides the
authority for the conservation and management of marine mammals under
U.S. jurisdiction. It expressly prohibits, with certain exceptions, the
take of marine mammals. Exceptions allow for permitting the collection
of wild animals for scientific research or public display or to enhance
the survival of a species or stock. NMFS initiates rulemakings under
the MMPA to establish a management regime to reduce marine mammal
mortalities and injuries as a result of interactions with fisheries.
The MMPA also established the Marine Mammal Commission, which makes
recommendations to the Secretaries of the Departments of Commerce and
the Interior and other Federal officials on protecting and conserving
marine mammals. The Act underwent significant changes in 1994 to allow
for takings incidental to commercial fishing operations, to provide
certain exemptions for subsistence and scientific uses, and to require
the preparation of stock assessments for all marine mammal stocks in
waters under U.S. jurisdiction.
Endangered Species Act
The Endangered Species Act of 1973 (ESA) provides for the
conservation of species that are determined to be ``endangered'' or
``threatened,'' and the conservation of the ecosystems on which these
species depend. The ESA authorizes both NMFS and the Fish and Wildlife
Service (FWS) to jointly administer the provisions of the MMPA. NMFS
manages marine and ``anadromous'' species, and FWS manages land and
freshwater species. Together, NMFS and FWS work to protect critically
imperiled species from extinction. Of the 1,310 listed species
[[Page 7698]]
found in part or entirely in the United States and its waters, NMFS has
jurisdiction over approximately 60 species. NMFS' rulemaking actions
are focused on determining whether any species under its responsibility
is an endangered or threatened species and whether those species must
be added to the list of protected species. NMFS is also responsible for
designating, reviewing, and revising critical habitat for any listed
species. In addition, under the ESA's procedural framework, Federal
agencies consult with NMFS on any proposed action authorized, funded,
or carried out by that agency that may affect one of the listed species
or designated critical habitat, or is likely to jeopardize proposed
species or adversely modify proposed critical habitat that is under
NMFS' jurisdiction.
NOAA's Regulatory Plan Actions
While most of the rulemakings undertaken by NOAA do not rise to the
level necessary to be included in the Department's regulatory plan,
NMFS is undertaking four actions that rise to the level of ``most
important'' of the Department's significant regulatory actions and thus
are included in this year's regulatory plan. The four actions implement
provisions of the Magnuson-Stevens Fishery Conservation and Management
Act, as reauthorized in 2006. The third action may be of particular
interest to international trading partners as it concerns the
Certification of Nations Whose Fishing Vessels are Engaged in Illegal,
Unreported, and Unregulated Fishing or Bycatch of Protected Living
Marine Resources. A description of the four regulatory plan actions is
provided below.
1. Fishery Management Plan for Regulating Offshore Marine
Aquaculture in the Gulf of Mexico (0648-AS65): In January 2009, the
Gulf of Mexico Fishery Management Council approved the Aquaculture
Fishery Management Plan, which authorizes NMFS to issue permits to
culture species managed by the Council (except shrimp and corals). This
was the first time a regional Fishery Management Council approved a
comprehensive regulatory program for offshore aquaculture in U.S.
Federal waters. On September 3, 2009, the Aquaculture Fishery
Management Plan entered into effect by operation of law and Dr.
Lubchenco announced that NOAA would develop a new National Aquaculture
Policy, which would provide context for the Aquaculture Fishery
Management Plan. On June 9, 2011, NOAA released the final National
Aquaculture Policy and announced that the Agency will move forward with
the rulemaking to implement the Aquaculture Fishery Management Plan.
The Aquaculture Plan has received regional and national media attention
and was challenged in two lawsuits. Although the lawsuits were
dismissed, additional legal challenges are anticipated when the final
rule is issued. A vocal coalition of environmental, non-governmental
organizations and fishermen's groups opposed to marine aquaculture has
been actively following the process. Others, including some fishing and
seafood groups, support the Aquaculture Fishery Management Plan.
2. Amend the Definition of Illegal, Unreported, and Unregulated
Fishing Under the High Seas Driftnet Fishing Moratorium Protection Act
to Include International Provisions of the Shark Conservation Act
(0648-BA89): As required under the international provisions of the
Shark Conservation Act, the rule would amend the identification and
certification procedures under the High Seas Driftnet Fishing
Moratorium Protection to include the identification of a foreign nation
whose fishing vessels engaged during the preceding calendar year in
fishing activities in areas beyond any national jurisdiction that
target or incidentally catch sharks if that nation has not adopted a
regulatory program to provide for the conservation of sharks that is
comparable to that of the United States, taking into account different
conditions. NMFS also intends to amend the regulatory definition of
``illegal, unreported, and unregulated (IUU) fishing'' for purposes of
the identification and certification procedures under the Moratorium
Protection Act.
3. Critical Habitat for North Atlantic Right Whale (0648-AY54): In
1994, NMFS designated critical habitat for the northern right whale in
the North Atlantic Ocean. This critical habitat designation includes
portions of Cape Cod Bay and Stellwagen Bank, the Great South Channel,
and waters adjacent to the coasts of Georgia and Florida. In 2008, NMFS
published final determinations listing right whales in the North
Atlantic and North Pacific as separate endangered species under the ESA
and initiated work on new critical habitat designations triggered by
these 2008 listings. On October 1, 2009, NMFS received a petition from
the Center for Biological Diversity, Defenders of Wildlife, Humane
Society of the United States, Ocean Conservancy, and the Whale and
Dolphin Conservation Society to revise the designated critical habitat
of the North Atlantic right whale. The petition seeks an expansion of
the areas designated as critical feeding and calving habitats and also
seeks to include a migratory corridor as part of the critical habitat
designation. On October 6, 2010, NMFS published a 90-day finding and
12-month determination stating the intent to proceed with publishing a
proposed rule to revise critical habitat.
4. Reduce Disturbance to Hawaiian Spinner Dolphins from Human
Interactions (0648-AU02): Spinner dolphins are being disturbed in their
natural resting habitats by human activities, which may be altering the
dolphins' normal behavioral patterns. NMFS is proposing time-area
closures to protect the essential resting habitat of spinner dolphins
and to reduce the human activities that cause unauthorized taking of
these dolphins under the Marine Mammal Protection Act and its
implementing regulations. The proposed rule lists time-area closures
including four bays on the island of Hawaii, and one on the island of
Maui. Adaptive management strategies will be used to monitor the
effectiveness of the proposed rule and allow for necessary
improvements. This proposed action will set a precedent for NMFS'
management of wildlife viewing activities. This proposed action
represents the first proposal by NMFS to use regulated area closures to
reduce harassment of non-ESA listed marine mammals resulting from
activities aimed at viewing and interacting with these animals.
At this time, NOAA is unable to determine the aggregate cost of the
identified Regulatory Plan actions as several of these actions are
currently under development.
Bureau of Industry and Security
The Bureau of Industry and Security (BIS) advances U.S. national
security, foreign policy, and economic objectives by maintaining and
strengthening adaptable, efficient, and effective export control and
treaty compliance systems, as well as by administering programs to
prioritize certain contracts to promote the national defense and to
protect and enhance the defense industrial base.
In August 2009, the President directed a broad-based interagency
review of the U.S. export control system with the goal of strengthening
national security and the competitiveness of key U.S. manufacturing and
technology sectors by focusing on the current threats and adapting to
the changing economic and technological landscape. In August 2010, the
President outlined an approach under which agencies that administer
export controls will apply
[[Page 7699]]
new criteria for determining what items need to be controlled and a
common set of policies for determining when an export license is
required. The control list criteria are to be based on transparent
rules, which will reduce the uncertainty faced by our Allies, U.S.
industry and its foreign customers, and will allow the Government to
erect higher walls around the most sensitive export items in order to
enhance national security.
Under the President's approach, agencies will apply the criteria
and revise the lists of munitions and dual use items that are
controlled for export so that they:
Are ``tiered'' to distinguish the types of items that should be
subject to stricter or more permissive levels of control for different
destinations, end-uses, and end-users;
Create a ``bright line'' between the two current control lists to
clarify jurisdictional determinations and reduce government and
industry uncertainty about whether particular items are subject to the
control of the State Department or the Commerce Department; and
Are structurally aligned so that they potentially can be combined
into a single list of controlled items.
BIS' current regulatory plan action is designed to implement the
initial phase of the President's directive.
Major Programs and Activities
BIS administers four sets of regulations. The Export Administration
Regulations (EAR) regulate exports and reexports to protect national
security, foreign policy, and short supply interests. The EAR also
regulates participation of U.S. persons in certain boycotts
administered by foreign governments. The National Defense Industrial
Base Regulations provide for prioritization of certain contracts and
allocations of resources to promote the national defense, require
reporting of foreign government-imposed offsets in defense sales, and
address the effect of imports on the defense industrial base. The
Chemical Weapons Convention Regulations implement declaration,
reporting, and on-site inspection requirements in the private sector
necessary to meet United States treaty obligations under the Chemical
Weapons Convention treaty. The Additional Protocol Regulations
implement similar requirements with respect to an agreement between the
United States and the International Atomic Energy Agency.
BIS also has an enforcement component with eight field offices in
the United States. BIS export control officers are also stationed at
several U.S. embassies and consulates abroad. BIS works with other U.S.
Government agencies to promote coordinated U.S. Government efforts in
export controls and other programs. BIS participates in U.S. Government
efforts to strengthen multilateral export control regimes and to
promote effective export controls through cooperation with other
governments.
BIS' Regulatory Plan Actions
As the agency responsible for leading the administration and
enforcement of the U.S. dual-use export control system, BIS plays a
central role in the Administration's efforts to fundamentally reform
the export control system. Changing what we control, how we control it,
and how we enforce and manage our controls will help strengthen our
national security by focusing our efforts on controlling the most
critical products and technologies, and by enhancing the
competitiveness of key U.S. manufacturing and technology sectors.
In FY 2011, BIS took several steps to implement the President's
Export Control Reform Initiative. BIS published a final rule (76 FR
35276, June 16, 2011) implementing a license exception that authorizes
exports, reexports, and transfers to destinations that do not pose a
national security concern, provided certain safeguards against
diversion to other destinations are taken. BIS also proposed a rule
that provides a framework for controlling militarily less significant
defense articles, largely generic parts and components, on the Commerce
Control List (CCL) rather than the United States Munitions List. In the
immediate future, BIS will work with other agencies to implement
transfers of such items to the CCL and to make the CCL a more positive
list. Looking further ahead BIS will work with other agencies to place
items on the CCL into one of three tiers, corresponding to different
levels of sensitivity.
Tier 1 will include the most sensitive items. These are items that
provide a critical military or intelligence advantage to the United
States and are available almost exclusively from the United States, or
are items that are a weapon of mass destruction.
Tier 2 will include items that are sensitive but not as sensitive,
as those in Tier 1. These are items that provide a substantial military
or intelligence advantage to the United States and are available almost
exclusively from either the United States or our partners and allies.
Tier 3 will include items that are less sensitive than those in
Tier 2. These items will be those that provide a significant military
or intelligence advantage but are available more broadly. BIS will also
be developing other rules to implement additional aspects of the export
control reform as those aspects are identified and decided.
Retrospective Review of Existing Regulations
Pursuant to section 6 of Executive Order 13563 ``Improving
Regulation and Regulatory Review'' (Jan. 18, 2011), the following
Regulatory Identifier Numbers (RINs) have been identified as associated
with retrospective review and analysis in the Department's final
retrospective review of regulations plan. Accordingly, the Agency is
reviewing these rules to determine whether action under E.O. 13563 is
appropriate. Some of these entries on this list may be completed
actions, which do not appear in The Regulatory Plan. However, more
information can be found about these completed rulemakings in past
publications of the Unified Agenda on Reginfo.gov in the Completed
Actions section for the Agency. These rulemakings can also be found on
Regulations.gov. The final Agency retrospective analysis plan can be
found at: http://open.commerce.gov/sites/default/files/Commerce%20Plan%20for%20Retrospective%20Analysis%20of%20Existing%20Rules%20-%202011-08-22%20Final.pdf.
------------------------------------------------------------------------
Expected To Significantly
RIN Title Reduce Burdens on Small
Businesses?
------------------------------------------------------------------------
0610-AA66.................. Revisions to Yes.
EDA's
Regulations.
0625-AA81.................. Foreign Trade Yes.
Zones.
0648-AN55.................. Amendments 61/
61/13/8 to
Implement
Major
Provisions of
the American
Fisheries Act.
0648-AL92.................. Western Alaska
Community
Development
Quota Program.
[[Page 7700]]
0648-AP12.................. Atlantic Yes.
Mackerel,
Squid and
Butterfish
Fisheries;
Framework
Adjustment 2.
0648-AO62.................. Reef Fish Yes.
Fishery of the
Gulf of
Mexico:
Charter Vessel
and Headboat
Permit
Moratorium.
0648-AL41.................. Nearshore Area
Closures
Around
American Samoa
by Vessels
More Than 50
Feet in Length.
0648-AP78.................. Fisheries of
the
Northeastern
United States:
Northeast
Multispecies
Fishery.
0648-AN75.................. Pelagic
Longline Gear
Restrictions,
Seasonal Area
Closure, and
Other Sea
Turtle
Mitigation
Measures.
0648-AP37.................. Atlantic
Herring
Fishery; 2002
Specifications.
0648-AO35.................. Measures To
Reduce the
Incidental
Catch of
Seabirds in
the Hawaii
Pelagic
Longline
Fishery.
0648-AP76.................. Atlantic Deep-
Sea Red Crab
Fishery
Management
Plan.
0648-AP39.................. Pacific Coast
Groundfish
Fishery:
Experimental
Setnet
Sablefish
Landings To
Qualify
Limited Entry
Sablefish-
Endorsed
permits for
Tier
Assignment.
0648-AO20.................. Fisheries of Yes.
the Exclusive
Economic Zone
off Alaska:
Revisions to
Recordkeeping
and Reporting
Requirements.
0648-AQ05.................. Extend the
Interim
Groundfish
Observer
Program
Through
December 31,
2007, and
Amend
Regulations
for the North
Pacific
Groundfish
Observer
Program.
0648-AN88.................. Taking of
Marine Mammals
Incidental to
Commercial
Fishing
Operations:
Atlantic Large
Whale Take
Reduction Plan
Regulations.
0648-AK23.................. Fisheries Off
West Coast
States and in
the Western
Pacific:
Precious
Corals
Fisheries;
Harvest
Quotas,
Definitions,
Size Limits,
Gear
Restrictions,
and Bed
Classification.
0648-AP21.................. Implementation
of the Shark
Finning
Prohibition
Act.
0648-AP49.................. Atlantic Highly
Migratory
Species;
Pelagic
Longline
Fishery; Shark
Gillnet
Fishery: Sea
Turtle and
Whale
Protection
Measures.
0648-AM40.................. License
Limitation
Program for
Groundfish of
the Bering Sea
and Aleutian
Islands Area.
0648-AP79.................. Prohibition of
Non-pelagic
Trawl Gear in
Cook Inlet in
the Gulf of
Alaska.
0648-AO69.................. Fisheries Off
the West Coast
States and in
the Western
Pacific;
Pacific Coast
Groundfish
Fishery:
Annual
Specifications
and Management
Measures.
0648-AK70.................. Fisheries of
the Exclusive
Economic Zone
Off Alaska:
Individual
Fishing Quota
Program.
0648-AP81.................. Sea Turtle
Conservation
Measures of
the Pound Net
Fishery in
Virginia
Waters.
0648-AP17.................. Take of Four
Threatened
Evolutionarily
Significant
Units of West
Coast Salmon.
0648-AP68.................. Atlantic Large
Whale Seasonal
Area
Management
Program.
0648-AN29.................. Regulations
Governing the
Approach to
Humpback
Whales in
Alaska.
0648-AK50.................. Fisheries of
the Exclusive
Economic Zone
Off Alaska:
Improved
Individual
Fishing Quota
Program.
0648-AM72.................. Western Alaska
Community
Development
Quota Program.
0648-AN23.................. Fisheries of
the Exclusive
Economic Zone
Off Alaska:
Revisions to
Definition of
Length Overall
of a Vessel.
0648-AL95.................. Fisheries of
the Exclusive
Economic Zone
Off Alaska:
License
Limitation
Program.
0648-AO02.................. Atlantic
Coastal
Fisheries
Cooperative
Management Act
Provisions:
Horseshoe Crab
Fishery--Close
d Area.
0648-AF87.................. Fisheries of
the
Northeastern
United States:
Fishery
Management
Plan for
Tilefish.
0648-AN27.................. Pacific Coast
Groundfish
Fishery:
Groundfish
Observer
Program.
0648-AL51.................. West Coast
Salmon
Fisheries:
Amendment 14.
0648-AO41.................. Pacific Coast
Groundfish
Fishery:
Amendment 13.
0648-AO97.................. Pacific Coast
Groundfish
Fishery:
Amendment 14.
0648-AO42.................. International
Fisheries
Regulations:
Pacific Tuna
Fisheries.
0648-BA42.................. Fisheries of
the
Northeastern
United States;
Tilefish Cost
Recovery
Regulatory
Amendment.
0648-BA06.................. Fisheries of Yes.
the Caribbean,
Gulf of
Mexico, and
South
Atlantic; Reef
Fish Fishery
of the Gulf of
Mexico;
Emergency Rule
To Authorize
Re-Opening the
Recreational
Red Snapper
Season.
0694-AF03.................. Export Control
Reform
Initiative:
Strategic
Trade
Authorization
License
Exception.
0694-AF17.................. Revisions to Yes.
the Export
Administration
Regulations
(EAR): Control
of Items the
President
Determines No
Longer Warrant
Control Under
the United
States
Munitions List
(USML).
------------------------------------------------------------------------
DOC--BUREAU OF INDUSTRY AND SECURITY (BIS)
Final Rule Stage
21. Revisions to the Export Administration Regulations (EAR): Control
of Military Vehicles and Related Items That the President Determines Do
Not Warrant Control on the United States Munitions List
Priority: Other Significant.
Legal Authority: 10 U.S.C. 7420; 10 U.S.C. 7430(e); 15 U.S.C.
1824a; 22 U.S.C. 287c; 22 U.S.C. 6004; 22 U.S.C. 7201 et seq.; 22
U.S.C. 7210; 30 U.S.C. 185(s); 42 U.S.C. 2139a; 42 U.S.C. 2139a; 42
U.S.C. 6212; 43 U.S.C. 1354; 50 U.S.C. 1701 et seq.; 50 U.S.C. 2401 et
seq.; 50 U.S.C. 5; EO 12058; EO 12851; EO 12938; EO 12947; EO 13026; EO
13099; EO 13222; EO 13224; 22 U.S.C. 2151 note; 22 U.S.C. 3201 et seq.;
EO 11912; EO 12002; EO 12214; EO 12854; EO 12918; EO 12918; EO 12981;
EO 13020; EO 13338; 30 U.S.C. 185(u)
CFR Citation: 15 CFR 740; 15 CFR 743; 15 CFR 744; 15 CFR 748; 15
CFR 774; 15 CFR 730; 15 CFR 732; 15 CFR 738; 15 CFR 742; 15 CFR 746; 15
CFR 756; 15 CFR 762; 15 CFR 770; 15 CFR 772.
Legal Deadline: None.
Abstract: In August 2009, President Obama directed a fundamental
review of the U.S. Export control system be conducted. This review
included a fundamental review of the two primary control lists of the
U.S. Export control system; i.e., the Commerce Control List (CCL) and
the United States Munitions List (USML). In December 2010, the
Departments of Commerce and State each published an Advanced Notice of
Proposed Rulemaking (ANPRM)
[[Page 7701]]
requesting public comments on creating more ``positive'' and clear
control lists and recommendations for how items listed on the two
control lists could be tiered based on criteria developed during the
Export Control Reform (ECR) initiative.
An integral part of creating a ``positive'' USML requires a proper
control structure be put into place under the EAR to appropriately
control the less significant items moved from the USML to the CCL,
which is the subject of this proposed rule. This rule outlines the
control structure developed under the ECR initiative to ensure
appropriate controls are in place for these less significant items
moved from the USML to the CCL.
Statement of Need: This rule is needed to describe how items that
no longer warrant ITAR control--but, because they are specially
designed for military applications, warrant some degree of control--
will be made subject to the EAR and listed on the CCL. In particular,
this rule establishes the framework within which items that are
transferred from the ITAR to the EAR will be identified in and
controlled by the EAR. Such ready identification is needed to allow for
public understanding of the changes and to facilitate executive branch
compliance with the requirements to notify Congress when items are
removed from the ITAR. Such controls are needed to accomplish the
national security and foreign policy objectives of controlling
transfers of military items, which includes complying with statutory
and international obligations to prevent the transfer of such items to
certain countries, end uses, and end users.
Summary of Legal Basis: The Export Administration Act of 1979, as
amended, authorizes the President to prohibit or curtail exports for
national security or foreign policy reasons. Section 3(1) of that Act
provides that ``It is the policy of the United States to minimize
uncertainties in export control policy and to encourage trade with all
countries with which the United States has diplomatic or trading
relations, except those countries with which such trade has been
determined by the President to be against the national interest.''
Although the Export Administration Act of 1979 (EAA), as amended,
expired on August 20, 2001, Executive Order 13222 of August 17, 2001 (3
CFR, 2001 Comp., p. 783 (2002)) as extended by Notice of August 12,
2010, 75 FR 50681 (Aug. 16, 2010) continues the EAR in effect under the
International Emergency Economic Powers Act (IEEPA). The EAA and the
IEEPA provide the President with the discretion to tailor controls,
such as through the use of license exceptions and the creation of
country groups in the implementing regulations, over different types of
items based on their significance or other factors relevant to the
national interest.
The Arms Export Control Act (22 U.S.C. 2778) gives the President
the authority to identify any item as a ``defense article.'' The list
of ``defense articles'' is identified on the U.S. Munitions List (USML)
of the International Traffic in Arms Regulations (ITAR) (22 CFR chapter
I, subchapter M). Section 38(f) of the AECA requires the President to
periodically review the list of defense articles and determine which,
if any, should be removed from the list. Section 38(f) authorizes the
President to remove defense articles from the USML and control them
under other statutory and regulatory authorities, such as the export
control regulations administered by the Commerce Department, after
completing a 30-day congressional notification.
Alternatives: BIS considered several alternative regulatory
structures for the items that would be moved from the ITAR to the EAR,
including creating a separate Commerce Munitions List in the EAR and
attempting to insert all items transferred into the existing ECCN
structure. BIS selected the ``600 series'' structure because it
provided the best balance between ease of use and the need to readily
identify items moved or to be moved from the ITAR to the EAR for
congressional notification purposes. A separate Commerce Munitions List
would have readily identified items moved from the ITAR, but would have
required the public to consult two lists to assess whether license
requirements applied to a particular item. Attempting to place all
transferred items within the existing ECCN structure would have
minimized the number of ECCNs to be consulted but would have unduly
obscured the ITAR origin of the transferred items.
Anticipated Cost and Benefits: The underlying policy motivation for
the reform effort is not a traditional economic cost/benefit analysis.
Rather, it is a national security effort. When the Administration first
began to consider how the export control system should be reformed to
enhance national security, it did not take into account whether there
would be particular economic benefits or costs. After conducting the
review, the Administration ultimately determined that our national
security will be strengthened if (i) our export control system allows
for more interoperability with our NATO and other close allies; (ii)
our industrial base is enhanced by, for example, reducing the current
incentives created by the export control rules for foreign companies to
design out or avoid U.S.-origin content; and (iii) our resources are
more focused on controlling or prohibiting, as needed, the items that
provide at least a significant military or intelligence advantage to
the United States. Items made subject to the EAR as a result of this
rule generally would require a license to all destinations except
Canada and exporters, reexporters and transferors would incur the costs
associated with applying for such licenses. BIS would need additional
resources to review the additional licenses and to handle the related
compliance activities that will accompany the planned change in
jurisdictional status of items. The net burden on the government and
that the government imposes on industry, however, would be
substantially reduced because this rule would apply to items that
currently are subject to strict, generally inflexible ITAR license
requirements that impose many collateral compliance burdens and costs
on exporters and the U.S. Government. BIS believes that replacing such
ITAR license requirements with the more flexible EAR license
requirements is not likely to result in any net increase in costs.
However, the benefits of the move would be substantial, although not
readily quantifiable.
Risks: Not all items currently subject to the ITAR are appropriate
for movement to the EAR. Care must be taken to ensure that large
sophisticated weapons and other inherently military items (as opposed
to items unique to defense articles merely because of a change in form
or fit) are not moved to the EAR. BIS believes that the ongoing
interagency review process is adequate to guard against any transfers
contrary to national security and foreign policy interests. At the same
time, one must consider the risks of not transferring to the EAR
defense articles that no longer warrant ITAR controls. These risks
include continued excessive costs to exporters in complying with
unnecessarily restrictive rules, continued disincentives for defense
manufacturers to use U.S. origin parts and components, and continued
excessive costs associated with supplying allied armed forces with U.S.
origin parts and components. BIS believes that this rule sets up a
structure for controls that will allow for the appropriate balance
between the risks of
[[Page 7702]]
continuing the status quo and the risks of unwarranted relaxation of
controls.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/15/11 76 FR 41958
NPRM Comment Period End............. 09/13/11 .......................
Final Rule.......................... 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Timothy Mooney, Export Policy Analyst, Department
of Commerce, Bureau of Industry and Security, 14th Street and
Pennsylvania Avenue NW., Washington, DC 20230, Phone: 202 482-3371,
Fax: 202 482-3355, Email: [email protected].
Related RIN: Merged with 0694-AF09.
RIN: 0694-AF17
DOC--NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION (NOAA)
Proposed Rule Stage
22. Fishery Management Plan for Regulating Offshore Marine Aquaculture
in the Gulf of Mexico
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1801 et seq.
CFR Citation: 50 CFR 622.
Legal Deadline: None.
Abstract: The purpose of this fishery management plan (FMP) is to
develop a regional permitting process for regulating and promoting
environmentally sound and economically sustainable aquaculture in the
Gulf of Mexico (Gulf) exclusive economic zone. This FMP consists of ten
actions, each with an associated range of management alternatives,
which would facilitate the permitting of an estimated 5 to 20 offshore
aquaculture operations in the Gulf over the next 10 years, with an
estimated annual production of up to 64 million pounds. By establishing
a regional permitting process for aquaculture, the Gulf of Mexico
Fishery Management Council will be positioned to achieve their primary
goal of increasing maximum sustainable yield and optimum yield of
federal fisheries in the Gulf by supplementing harvest of wild caught
species with cultured product.
Statement of Need: Demand for protein is increasing in the United
States and commercial wild-capture fisheries will not likely be
adequate to meet this growing demand. Aquaculture is one method to meet
current and future demands for seafood. Supplementing the harvest of
domestic fisheries with cultured product will help the U.S. meet
consumers' growing demand for seafood and may reduce the Nation's
dependence on seafood imports.
Currently, the U.S. imports over 80 percent of the seafood consumed
in the country, and the annual U.S. seafood trade deficit is at an all
time high of over $9 billion.
Summary of Legal Basis: Magnuson-Stevens Fishery Conservation and
Management Act, 16 U.S.C. 1801 et seq.
Alternatives: The Council's Aquaculture FMP includes 10 actions,
each with an associated range of alternatives. These actions and
alternatives are collectively intended to establish a regional
permitting process for offshore aquaculture. Management actions in the
FMP include: (1) Aquaculture permit requirements, eligibility, and
transferability; (2) duration aquaculture permits are effective; (3)
aquaculture application requirements, operational requirements, and
restrictions; (4) species allowed for aquaculture; (5) allowable
aquaculture systems; (6) marine aquaculture siting requirements and
conditions; (7) restricted access zones for aquaculture facilities; (8)
recordkeeping and reporting requirements; (9) biological reference
points and status determination criteria; and (10) framework procedures
for modifying biological reference points and regulatory measures.
Anticipated Cost and Benefits: Environmental and social/economic
costs and benefits are described in detail in the Council's Aquaculture
FMP. Potential benefits include: establishing a rigorous review process
for reviewing and approving/denying aquaculture permits; increasing
optimum yield by supplementing the harvest of wild domestic fisheries
with cultured products; and reducing the nation's dependence on
imported seafood. Anticipated costs include increased administration
and oversight of an aquaculture permitting process, and potential
negative environmental impacts to wild marine resources. Approval of an
aquaculture permitting system may also benefit fishing communities by
creating new jobs or impact fishing communities if cultured products
economically displace domestic seafood.
Risks: National offshore aquaculture legislation has also been
previously proposed by the Administration. This action may reduce the
need for uniform national legislation and allow aquaculture regulations
to vary by region.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice of Availability (NOA)........ 06/04/09 74 FR 26829
NOA Comment Period End.............. 08/03/09 .......................
NPRM................................ 12/00/11 .......................
Final Action........................ 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Roy E. Crabtree, Southeast Regional Administrator,
Department of Commerce, National Oceanic and Atmospheric
Administration, 263 13th Avenue South, St. Petersburg, FL 33701, Phone:
727 824-5305, Fax: 727 824-5308, Email: [email protected].
RIN: 0648-AS65
DOC--NOAA
23. Reducing Disturbances to Hawaiian Spinner Dolphins From Human
Interactions
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1361 et seq.
CFR Citation: 50 CFR 216.
Legal Deadline: None.
Abstract: The National Marine Fisheries Service proposes
regulations to protect the essential resting habitat of wild spinner
dolphins (Stenella longirostris) in the main Hawaiian Islands, and to
reduce the human activities that may cause ``take,'' as defined in the
Marine Mammal Protection Act (MMPA) and its implementing regulations,
or from other actions that otherwise adversely affect the dolphins, by
proposing time-area closures in four bays on the island of Hawaii, and
one on the island of Maui.
Statement of Need: NMFS is concerned about the cumulative impacts
on Hawaiian spinner dolphin populations from human interactions. Human
interactions with dolphins in their resting habitats has increased over
the past decade, with spinner dolphins now being the target of viewing
or swim-with-wild-dolphins tours on a daily basis. Because spinner
dolphins routinely use the same habitats, and stay in the bays for most
of the day to rest, these same animals may be disturbed multiple times
per day from the multiple tours that seek these animals daily. The
unauthorized taking of spinner dolphins is occurring at these
[[Page 7703]]
bays, with many adverse impacts as a result including: behavioral
changes, shorter resting periods, and displacement from primary resting
habitats. By protecting the essential resting habitat of the spinner
dolphins, NMFS proposes to prevent the taking of these animals.
Summary of Legal Basis: All marine mammals are protected under the
Marine Mammal Protection Act (MMPA). NMFS is proposing these
regulations pursuant to its rulemaking authority under MMPA 16 U.S.C.
1361 et seq.; 16 U.S.C. 1372 et seq., which generally prohibits the
take of any marine mammals; and 16 U.S.C. 1382 et seq.
Alternatives:
1. No Action.
2. Regulate human behaviors and activities.
3. Implement time-area closures in specified spinner dolphin
resting habitats.
4. Combine limits on specified human behaviors with time-area
closures.
5. Full closure of all identified spinner dolphin resting habitats.
6. Codify the West Hawaii Voluntary Standards for Marine Tourism.
Anticipated Cost and Benefits: The primary benefit of this action
would be to reduce the unauthorized taking of spinner dolphins in their
primary resting habitat. These animals are being disturbed in an area
that is significant to their health, reproduction and survival.
Managing the amount of interactions humans can have with spinner
dolphins will help protect the animals in their natural environment.
Costs with this proposed rule would affect humans as their use of these
particular bays would be limited. Commercial tour operators, kayak
companies, and spiritual retreat operators may be negatively
economically impacted. The public at large would not be allowed to
engage in activities in the closure areas, and they may therefore
associate a cost with this proposed action.
Risks: No risks to public health, safety or the environment were
identified with implementation of this rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 12/12/05 70 FR 73426
ANPRM Comment Period End............ 01/11/06 .......................
NPRM................................ 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Melissa Andersen. Fishery Biologist, Management,
Department of Commerce, National Oceanic and Atmospheric
Administration, 1315 East-West Highway, Silver Spring, MD 20910, Phone:
301 713-2322, Fax: 301 713-2521, Email: [email protected].
RIN: 0648-AU02
DOC--NOAA
24. Designation of Critical Habitat for the North Atlantic Right Whale
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1361 et seq.; 16 U.S.C. 1531 to 1543
CFR Citation: 50 CFR 226; 50 CFR 229.
Legal Deadline: None.
Abstract: In June 1970, the northern right whale was listed as
endangered under the Endangered Species Conservation Act, the precursor
to the Endangered Species Act (ESA) (35 FR 8495; codified at 50 CFR
17.11). Subsequently, right whales were listed as endangered under the
ESA in 1973, and as depleted under the Marine Mammal Protection Act
(MMPA) the same year. In 1994, NMFS designated critical habitat for the
northern right whale, a single species thought at the time to include
right whales in both the north Atlantic and the North Pacific.
In 2006, NMFS published a comprehensive right whale status review
that concluded that recent genetic data provided unequivocal support to
distinguish three right whale lineages (including the southern right
whale) as separate phylogenetic species (Rosenbaum et al. 2000).
Rosenbaum et al. (2000), concluded that the right whale should be
regarded as the following three separate species: (1) The North
Atlantic right whale (Eubalaena glacialis) ranging in the North
Atlantic Ocean; (2) the North Pacific right whale (Eubalaena japonica),
ranging in the North Pacific Ocean; and (3) the southern right whale
(Eubalaena australis), historically ranging throughout the southern
hemisphere's oceans.
Based on these findings, NMFS published a proposed and final
determination listing right whales in the North Atlantic and North
Pacific as separate endangered species under the ESA (71 FR 77704, Dec.
27, 2006; 73 FR 12024, Mar. 6, 2008). Based on the new listing
determination, NMFS is required by the ESA to designate critical
habitat separately for both the North Atlantic right whale and the
North Pacific right whale.
In April 2008, a final critical habitat determination was published
for the North Pacific right whale (73 FR 19000; Apr. 8, 2008). At this
time, NMFS is preparing a proposal to designate critical habitat for
the North Atlantic right whale.
Statement of Need: Under section 4 of the Endangered Species Act,
NOAA Fisheries is required to designate critical habitat for newly
listed species.
Summary of Legal Basis: Endangered Species Act.
Alternatives: Because this rule is presently in the beginning
stages of development, no alternatives have been formulated or analyzed
at this time.
Anticipated Cost and Benefits: Because this rule is presently in
the beginning stages of development, no analysis has been completed at
this time to assess costs and benefits.
Risks: Loss of critical habitat for a species listed as protected
under the ESA and MMPA, as well as potential loss of right whales due
to habitat loss.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Marta Nammack, Office of Protected Resources,
Department of Commerce, National Oceanic and Atmospheric
Administration, 1315 East-West Highway, Silver Spring, MD 20910, Phone:
301 713-1401, Fax: 301 427-2523, Email: [email protected].
RIN: 0648-AY54
DOC--NOAA
25. Regulatory Amendments To Implement the Shark Conservation Act and
Revise the Definition of Illegal, Unreported, and Unregulated Fishing
Priority: Other Significant.
Legal Authority: 16 U.S.C. 1826d to 1826k
CFR Citation: 50 CFR 300.
Legal Deadline: Final, Statutory, January 4, 2012, The rule needs
to be published by December 4, 2011, due to the 30-day delay in
effectiveness.
Abstract: NMFS is amending identification and certification
procedures under the High Seas Driftnet Fishing Moratorium Protection
Act to help achieve shark conservation in international fisheries. NMFS
must identify nations whose fishing vessels
[[Page 7704]]
have engaged in high seas fisheries targeting or incidentally catching
sharks not subject to a regulatory program for the conservation of
sharks comparable to that of the United States, taking into account
different conditions, as required under the Shark Conservation Act
(Pub. L. 111-348). NMFS would subsequently certify whether identified
nations have adopted regulatory programs governing the conservation of
sharks that are comparable to U.S. programs, taking into account
different conditions, and established management plans for sharks. The
absence of sufficient steps may lead to prohibitions on the importation
of certain fisheries products into the United States and other
measures.
NMFS is also amending the regulatory definition of ``illegal,
unreported, and unregulated fishing'' under the High Seas Driftnet
Fishing Moratorium Protection Act.
The procedures for identification and certification would entail a
multilateral approach of consultations and negotiations with other
nations to achieve shark conservation.
This action is not expected to have adverse economic impacts, and
any such impacts would be well below the economic threshold of impact
pursuant to E.O. 12866. In addition, there are no novel legal or policy
issues associated with this action since identification and
certification procedures have already been established in regulations
(50 CFR part 300). However, this action is significant under the
meaning of E.O. 12866 because it could lead to trade restrictive
measures applied against foreign nations.
Statement of Need: These regulatory amendments are required to
implement the international provisions of the Shark Conservation Act to
identify and certify nations whose vessels are engaged in shark finning
and/or fishing for sharks in a manner that is not consistent with
international management efforts. Additionally, this rule would revise
the definition of Illegal, Unreported, and Unregulated (IUU) Fishing in
response to comments on a prior rulemaking (0648-AV51) that set out the
regulatory definition of IUU fishing.
Summary of Legal Basis: Shark Conservation Act (Pub. L. 111-348)
and 16 U.S.C. 1826d to 1826k.
Alternatives: This action is categorically excluded from analysis
under the National Environmental Policy Act because the proposed action
is the promulgation of regulations of an administrative, financial,
legal, technical, or procedural nature and the environmental effects of
which are too broad, speculative, or conjectural to lend themselves to
meaningful analysis and for which any potential cumulative effects are
negligible. Consequently, no alternatives were analyzed.
Anticipated Cost and Benefits: This action is not expected to have
adverse economic impacts, and any such impacts would be well below the
economic threshold of impact pursuant to E.O. 12866. Potential
benefits, if any, would be indirect and accrue to internationally
managed fisheries by strengthening Regional Fishery Management
Organizations and by restricting U.S. market access through prohibiting
illegally harvested fishery products.
Risks: There are no novel legal or policy issues associated with
this action since identification and certification procedures have
already been established in regulations (50 CFR part 300). However,
this action is significant under the meaning of E.O. 12866 because it
could lead to trade restrictive measures applied against foreign
nations.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/11 .......................
Final Action........................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Christopher Rogers, Division Chief, Department of
Commerce, National Oceanic and Atmospheric Administration, 1315 East-
West Highway, Silver Spring, MD 20910, Phone: 301 713-9090, Fax: 301
713-9106, Email: [email protected].
RIN: 0648-BA89
BILLING CODE 3510-12-P
DEPARTMENT OF DEFENSE
Statement of Regulatory Priorities
Background
The Department of Defense (DoD) is the largest Federal department,
consisting of 3 Military departments (Army, Navy, and Air Force), 10
Unified Combatant Commands, 14 Defense Agencies, and 10 DoD Field
Activities. It has 1,434,450 military personnel and 782,386 civilians
assigned as of March 31, 2011, and over 200 large and medium
installations in the continental United States, U. S. territories, and
foreign countries. The overall size, composition, and dispersion of
DoD, coupled with an innovative regulatory program, presents a
challenge to the management of the Defense regulatory efforts under
Executive Order (E.O.) 12866 ``Regulatory Planning and Review'' of
September 30, 1993.
Because of its diversified nature, DoD is affected by the
regulations issued by regulatory agencies such as the Departments of
Energy, Health and Human Services, Housing and Urban Development,
Labor, Transportation, and the Environmental Protection Agency. In
order to develop the best possible regulations that embody the
principles and objectives embedded in E.O. 12866, there must be
coordination of proposed regulations among the regulatory agencies and
the affected DoD components. Coordinating the proposed regulations in
advance throughout an organization as large as DoD is straightforward,
yet a formidable undertaking.
DoD is not a regulatory agency, but occasionally it issues
regulations that have an effect on the public. These regulations, while
small in number compared to the regulating agencies, can be significant
as defined in E.O. 12866. In addition, some of DoD's regulations may
affect the regulatory agencies. DoD, as an integral part of its
program, not only receives coordinating actions from the regulating
agencies, but coordinates with the agencies that are affected by its
regulations as well.
Overall Priorities
The Department needs to function at a reasonable cost, while
ensuring that it does not impose ineffective and unnecessarily
burdensome regulations on the public. The rulemaking process should be
responsive, efficient, cost-effective, and both fair and perceived as
fair. This is being done in DoD while reacting to the contradictory
pressures of providing more services with fewer resources. The
Department of Defense, as a matter of overall priority for its
regulatory program, fully incorporates the provisions of the
President's priorities and objectives under Executive Order (E.O.)
12866.
Retrospective Review of Existing Regulations
Pursuant to section 6 of Executive Order 13563 ``Improving
Regulation and Regulatory Review (January 18, 2011), the following
Regulatory Identifier Numbers (RINs) have been identified as associated
with retrospective review and analysis in the Department's final
[[Page 7705]]
retrospective review of regulations plan. All are of particular
interest to small businesses. Some of these entries on this list may be
completed actions, which do not appear in The Regulatory Plan. However,
more information can be found about these completed rulemakings in past
publications of the Unified Agenda on Reginfo.gov in the Completed
Actions section for that agency. These rulemakings can also be found on
Regulations.gov. The final agency plans can be found at: http://www.regulations.gov/exchange/topic/eo-13563
0750-AH19--Accelerated Payments to Small Business (DFARS
Case 2011-D008)
0750-AH44--Extension of DoD Mentor-Prot[eacute]g[eacute]
Pilot Program (DFARS Case 2011-D050)
0750-AH45--Deletion of Text Implementing 10 U.S.C. 2323
(DFARS Case 2011-D038)
Administration Priorities
1. Rulemakings That Are Expected To Have High Net Benefits Well in
Excess of Costs
The Department plans to--
Finalize the DFARS rule to permit offerors to propose an
alternative line item structure to reflect the offeror's business
practices for selling and billing commercial items, and initial
provisioning of spares for weapon systems. This rule should prevent
misalignment of line item structure in receipt documents and invoices,
which causes manual intervention and can delay payment;
Finalize the DFARS rule to conduct discussions prior to
contract award for source selections of $100 million or more. A DoD
study showed a significant positive correlation between high-dollar
source selections that were conducted without discussions and protests
sustained. This rule should reduce the number of protests filed and
their resultant costs to contractors and the Government; and
Finalize the DFARS rule to implement section 866 of the
National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011
establishing a pilot program to acquire military purpose
nondevelopmental items. This pilot program is designed to test whether
the streamlined procedures, similar to those available for commercial
items, can serve as an effective incentive for nontraditional defense
contractors to (1) channel investment and innovation into areas that
are useful to DoD and (2) provide items developed exclusively at
private expense to meet validated military requirements. (2011-D034)
2. Rulemakings That Promote Open Government and Use Disclosure as a
Regulatory Tool
The Department plans to--
Finalize the Federal Acquisition Regulation (FAR) to
inform contractors of the statutory requirement of section 3010 of
Public Law 111-212, to make Federal Awardee Performance and Integrity
Information System information, excluding past performance reviews,
available to the public;
Finalize the FAR rule that implements section 743 of
Division C of the Fiscal Year 2010 Consolidated Appropriations Act,
which requires agencies to develop inventories of their service
contacts, including number and work location of contractor employees;
Finalize the FAR rule to establish standard evaluation
factors and rating scales for documenting contractor performance;
Finalize the FAR rule that implements the Federal Funding
Accountability and Transparency Act of 2006, which requires the Office
of Management and Budget (OMB) to establish a free, public, Web site
containing full disclosure of all Federal contract award information.
This rule requires contractors to report executive compensation and
first-tier subcontractor awards on unclassified contracts expected to
be $25,000 or more, except contracts with individuals;
Finalize the FAR rule that implements section 811 of the
NDAA for FY 2010, which requires a written justification and approval
prior to awarding a sole-source contract in an amount over $20 million
under the 8(a) program; and
Finalize the DFARS rule to implement section 814 of the
NDAA for FY 2010, which imposed additional reporting requirements for
awards of single task and delivery-order contracts.
3. Rulemakings That Streamline Regulations and Reduce Unjustified
Burdens
The Department plans to--
Finalize the DFARS rule to remove the requirement to use
DD Forms 2626 and 2631 to report past performance information for
construction and architect-engineer services and to instead provide the
performance reports electronically;
Finalize the DFARS rule to amend the definition of
``qualifying country end product'' to make it comparable to the change
in the definition of ``domestic end product'' by waiving the component
test for qualifying country end products;
Finalize the DFARS rule to update appendix F, Material
Inspection and Receiving Report, to incorporate procedures for using
the electronic Wide Area WorkFlow (WAWF) Receiving Report, which is
required for use in most contracts in lieu of the DD Form 250. WAWF is
the electronic tool for documenting receipt and acceptance of supplies
and services and for electronic invoicing; and
Finalize the rule for DFARS coverage of patents, data, and
copyrights, which significantly reduces the amount of regulatory text
and the number of required clauses.
4. Efforts To Minimize Burdens on Small Businesses
Of interest to Small Businesses are regulations to--
Finalize the DFARS rule to accelerate payments to all DoD
small business contractors.
5. Rules To Be Modified, Streamlined, Expanded, or Repealed To Make the
Agency's Regulatory Program More Effective or Less Burdensome in
Achieving the Regulatory Objectives
DFARS Case 2011-D028--Removes component test for COTS
items that are qualifying country end products. Require only
determination of country of origin of the COTS item, not the components
of the COTS item.
DFARS Case 2011-D013--Only One Offer. Motivate effective
competition by driving behavior to allow sufficient time for submission
of offers.
DFARS Case 2011-D008--Accelerate Small Business Payments.
Accelerate payments to all small businesses, not just small
disadvantaged businesses.
DFARS Case 2010-D018--Responsibility and Liability for
Government Property. Includes fixed-price contracts that are awarded on
the basis of adequate competition on the list of contract types whereby
contractors are not held liable for loss of Government property.
DFARS Case 2010-D001--Patents, Data, and Copyrights.
Rewrite of DFARS part 227, Patents, Data, and Copyrights.
DFARS Case 2009-D026--Multiyear Contracting. Comprehensive
review of DFARS subpart 217.1 to simplify and clarify the coverage of
multiyear acquisition.
Specific DoD Priorities
For this regulatory plan, there are six specific DoD priorities,
all of which reflect the established regulatory
[[Page 7706]]
principles. In those areas where rulemaking or participation in the
regulatory process is required, DoD has studied and developed policy
and regulations that incorporate the provisions of the President's
priorities and objectives under the Executive order.
DoD has focused its regulatory resources on the most serious
environmental, health, and safety risks. Perhaps most significant is
that each of the priorities described below promulgates regulations to
offset the resource impacts of Federal decisions on the public or to
improve the quality of public life, such as those regulations
concerning acquisition, security, energy projects, education, and
health affairs.
1. Defense Procurement and Acquisition Policy
The Department of Defense continuously reviews the DFARS and
continues to lead Government efforts to--
Revise the DFARS to specify circumstances under which the
U.S. Government needs to obtain data other than certified cost or
pricing data from Canadian contractors via the Canadian Commercial
Corporation.
Revise the DFARS to provide detailed guidance and
instruction to DoD contracting officers for the use of DoD's
performance-based payments analysis tool when contemplating the use of
performance-based payments on new fixed-price type contracts.
Revise the DFARS to implement a DoD Better Buying Power
initiative by providing a proposal-adequacy checklist in a provision to
ensure offerors take responsibility for providing thorough, accurate,
and complete proposals.
Revise the DFARS to address standards and structures for
the safeguarding of unclassified DoD information.
Revise the DFARS to implement the DoD Better Buying Power
initiative to address acquisitions using competitive procedures in
which only one offer is received. With some exceptions, the contracting
officer must resolicit for an additional period of at least 30 days, if
the solicitation allowed fewer than 30 days for receipt of proposals
and only one offer is received. If a period of at least 30 days was
allowed for receipt of proposals, the contracting officer must
determine prices to be fair and reasonable through price or cost
analysis or enter negotiations with the offeror.
Revise the DFARS to implement a DoD Better Buying Power
initiative by requiring contractors to submit annual technical
descriptions for their independent research and development projects.
Revise the DFARS to establish means for cleared
contractors, who have unclassified U.S. Government information resident
on or transiting through contractor information systems, to share cyber
threat information.
Revise the FAR to implement section 841 of the National
Defense Authorization Act for FY 2009, which required a review of the
FAR coverage on organizational conflicts of interest (OCIs).
Finalize the DFARS rule to clarify DoD policy regarding
the definition and administration of contractor business systems to
improve the effectiveness of DCMA/DCAA oversight of contractor business
systems;
Finalize the DFARS rule to implement a DoD Better Buying
Power initiative to increase the use of fixed-price incentive (firm
target) contracts;
2. Logistics and Materiel Readiness, Department of Defense
The Department of Defense published or plans to publish rules on
contractors supporting the military in contingency operations:
Final Rule: Private Security Contractors (PSCs) Operating
in Contingency Operations, Combat Operations or Other Significant
Military Operations. In order to meet the mandate of section 862 of the
2008 National Defense Authorization Act (NDAA) (as amended by section
813 (b) of the 2010 NDAA and section 832 of the 2011 NDAA), this rule
establishes policy, assigns responsibilities, and provides procedures
for the regulation of the selection, accountability, training,
equipping, and conduct of personnel performing private security
functions under a covered contract during contingency operations,
combat operations, or other significant military operations. It also
assigns responsibilities and establishes procedures for incident
reporting, use of and accountability for equipment, rules for the use
of force, and a process for administrative action or the removal, as
appropriate, of PSCs and PSC personnel. DoD published an interim final
rule on July 17, 2009 (74 FR 34690 to 34694), with an effective date of
July 17, 2009. The comment period ended August 31, 2009. DoD, in
coordination with the Department of State and the United States Agency
for International Development, prepared a final rule, which included
the responses to the public comments, and incorporated changes to the
interim final rule, where appropriate. The final rule also incorporated
the legislative changes required by section 813 (b) of the 2010 NDAA
and section 832 of the 2011 NDAA. The final rule was published August
11, 2011 (76 FR 49650), with an effective date of September 12, 2011.
Interim Final Rule: Operational Contract Support. This
rule will incorporate the latest changes and lessons learned into
policy and procedures for operational contract support (OCS), including
OCS program management, contract support integration, and the
integration of DoD contractor personnel into contingency operations
outside the United States. DoD anticipates publishing the interim final
rule in the first or second quarter of FY 2012.
3. Installations and Environment, Department of Defense
The Department of Defense will publish a rule regarding the process
for evaluating the impact of certain types of structures on military
operations and readiness:
Interim Final Rule: This rule implements policy, assigns
responsibilities, and prescribes procedures for the establishment and
operation of a process for evaluation of proposed projects submitted to
the Secretary of Transportation under section 44718 of title 49, United
States Code. The evaluation process is established for the purpose of
identifying any adverse impact of proposed projects on military
operations and readiness, minimizing or mitigating such adverse
impacts, and determining if any such projects pose an unacceptable risk
to the national security of the United States. The rule also includes
procedures for the operation of a central DoD siting clearinghouse to
facilitate both informal and formal reviews of proposed projects. This
rule was required by section 358 of Public Law 111-383. DoD anticipates
publishing an interim final rule in fourth quarter of FY 2011.
4. Military Community and Family Policy, Department of Defense
The Department of Defense plans to publish a final rule to
implement policy, assign responsibilities, and prescribe procedures for
the operation of voluntary education programs within DoD:
Final Rule: Voluntary Education Programs. In this rule,
the Department of Defense (DoD) implements policy, assigns
responsibilities, and prescribes procedures for the operation of
voluntary education programs within DoD. Several of the subject areas
in this rule include: Procedures for Service members participating in
education
[[Page 7707]]
programs; guidelines for establishing, maintaining, and operating
voluntary education programs including, but not limited to, instructor-
led courses offered on-installation and off-installation, as well as
via distance learning; procedures for obtaining on-base voluntary
education programs and services; minimum criteria for selecting
institutions to deliver higher education programs and services on
military installations; the establishment of a DoD Voluntary Education
Partnership Memorandum of Understanding (MOU) between DoD and
educational institutions receiving tuition assistance payments; and
procedures for other education programs for Service members and their
adult family members. The new requirement for a signed MOU with DoD
from participating educational institutions will be effective January
1, 2012. The Department published a proposed rule on August 6, 2010 (75
FR 47504 to 47514). The comment period ended October 10, 2010, which
contained a total of 110 comments. Several comments from the general
public were accepted, including suggestions to clarify terms such as
``one single tuition rate'' and a ``needs assessment.'' DoD anticipates
publishing the final rule during the first quarter of FY 2012.
5. Health Affairs, Department of Defense
The Department of Defense is able to meet its dual mission of
wartime readiness and peacetime health care by operating an extensive
network of medical treatment facilities. This network includes DoD's
own military treatment facilities supplemented by civilian health care
providers, facilities, and services under contract to DoD through the
TRICARE program. TRICARE is a major health care program designed to
improve the management and integration of DoD's health care delivery
system. The program's goal is to increase access to health care
services, improve health care quality, and control health care costs.
The TRICARE Management Activity has published or plans to publish
the following rules:
Final rule on TRICARE: Reimbursement of Sole Community
Hospitals and Adjustment to Reimbursement of Critical Access Hospitals.
The rule implements the statutory provision in 10 United States Code
1079(j)(2) that TRICARE payment methods for institutional care shall be
determined to the extent practicable in accordance with the same
reimbursement rules as those that apply to payments to providers of
services of the same type under Medicare. This rule implements a
reimbursement methodology similar to that furnished to Medicare
beneficiaries for services provided by sole community hospitals. It is
projected that implementation of this rule will result in a health care
savings of $31 million per year with proposed phase-in period and an
estimated initial start-up cost of $200,000. Any on-going
administrative costs would be minimal and there are no applicable risks
to the public. The proposed rule was published July 5, 2011 (76 FR
39043). The comment period ended on September 6, 2011. DoD anticipates
publishing a final rule in the second quarter of FY 2012.
Final rule on TRICARE: TRICARE Young Adult. The purpose of
this interim final rule is to establish the TRICARE Young Adult program
implementing section 702 of the Ike Skelton NDAA for FY 2011 (Pub. L.
111-383) to provide medical coverage to unmarried children under the
age of 26 who no longer meet the age requirements for TRICARE
eligibility (age 21, or 23 if enrolled in a full-time course of study
at an institution of higher learning approved by the Secretary of
Defense) and who are not eligible for medical coverage from an eligible
employer-sponsored plan (as defined in section 5000A(f)(2) of the
Internal Revenue Code of 1986). If qualified, they can purchase TRICARE
Standard/Extra or TRICARE Prime benefits coverage. The particular
TRICARE plan available depends on the military sponsor's eligibility
and the availability of the TRICARE plan in the dependent's geographic
location. It is projected that implementation of this rule will result
in an estimated initial start-up cost of $3,000,000. Premiums are
designed to cover the anticipated health care costs, as well as ongoing
administrative costs. The interim final rule was published April 27,
2011 (76 FR 23479), with an immediate effective date. The comment
period ended June 27, 2011. DoD anticipates publishing a final rule in
the first quarter of FY 2012.
6. Personnel and Readiness, Department of Defense
The Department of Defense will publish a rule regarding Service
Academies:
Final Rule: Service Academies. This rule establishes
policy, assigns responsibilities, and prescribes procedures for
Department of Defense oversight of the Service Academies.
Administrative costs are negligible and benefits are clear, concise
rules that enable the Secretary of Defense to insure that the Service
Academies are efficiently operated and meet the needs of the armed
forces. The proposed rule was published October 18, 2007 (72 FR 59053),
and included policy that has since changed. The final rule,
particularly the explanation of separation policy, will reflect recent
changes in the Don't Ask, Don't Tell policy. DoD anticipates publishing
the final rule in the second quarter of FY 2012.
BILLING CODE 5001-06-P
DEPARTMENT OF EDUCATION (DOE)
Statement of Regulatory Priorities
I. Introduction
The U.S. Department of Education (Department) supports States,
local communities, institutions of higher education, and others in
improving education nationwide and in helping to ensure that all
Americans receive a quality education. We provide leadership and
financial assistance pertaining to education at all levels to a wide
range of stakeholders and individuals, including State educational
agencies, local school districts, providers of early learning programs,
elementary and secondary schools, institutions of higher education,
career and technical schools, nonprofit organizations, postsecondary
students, members of the public, families, and many others. These
efforts are helping to ensure that all children and students from pre-
kindergarten through grade 12 will be ready for, and succeed in,
postsecondary education and that students attending postsecondary
institutions are prepared for a profession or career.
We also vigorously monitor and enforce the implementation of
Federal civil rights laws in educational programs and activities that
receive Federal financial assistance, and support innovative programs,
research and evaluation activities, technical assistance, and the
dissemination of research and evaluation findings to improve the
quality of education.
Overall, the laws, regulations, and programs we administer will
affect nearly every American during his or her life. Indeed, in the
2011 to 2012 school year, about 55 million students will attend an
estimated 99,000 elementary and secondary schools in approximately
13,800 public school districts, and about 21 million students will
enroll in degree-granting postsecondary schools. All of these students
may benefit from some degree of financial assistance or support from
the Department.
[[Page 7708]]
In developing and implementing regulations, guidance, technical
assistance, and monitoring related to our programs, we are committed to
working closely with affected persons and groups. Specifically, we work
with a broad range of interested parties and the general public
including families, students, and educators; State, local, and tribal
governments; and neighborhood groups, community-based early learning
programs, elementary and secondary schools, colleges, rehabilitation
service providers, adult education providers, professional
associations, advocacy organizations, businesses, and labor
organizations.
We also continue to seek greater and more useful public
participation in our rulemaking activities through the use of
transparent and interactive rulemaking procedures and new technologies.
If we determine that it is necessary to develop regulations, we seek
public participation at the key stages in the rulemaking process. We
invite the public to submit comments on all proposed regulations
through the Internet or by regular mail.
To facilitate the public's involvement, we participate in the
Federal Docketing Management System (FDMS), an electronic single
Governmentwide access point (www.regulations.gov) that enables the
public to submit comments on different types of Federal regulatory
documents and read and respond to comments submitted by other members
of the public during the public comment period. This system provides
the public with the opportunity to submit comments electronically on
any notice of proposed rulemaking or interim final regulations open for
comment, as well as read and print any supporting regulatory documents.
We are continuing to streamline information collections, reduce the
burden on information providers involved in our programs, and make
information easily accessible to the public.
II. Regulatory Priorities
A. American Recovery and Reinvestment Act of 2009
On February 17, 2009, President Obama signed into law the American
Recovery and Reinvestment Act of 2009 (ARRA), historic legislation
designed, in part, to invest in critical sectors, including education.
ARRA laid the foundation for education reform by supporting investments
in innovative strategies that are most likely to lead to improved
results for students, long-term gains in school and school system
capacity, and increased productivity and effectiveness. ARRA provided
funding for several key discretionary grant programs, including the
Race to the Top Fund and the Investing in Innovation Fund (i3)
programs.
The Race to the Top Fund program, the largest competitive education
grant program in U.S. history, is designed to provide incentives to
States to implement system-changing reforms that result in improved
student achievement, narrowed achievement gaps, and increased high
school graduation and college enrollment rates. Congress authorized and
provided $4.35 billion for ARRA in 2010, and the Department awarded
approximately $4 billion in Race to the Top State grant funds in two
phases. The Department awarded $600 million to Delaware and Tennessee
under the Race to the Top Phase 1 competition and approximately $3.4
billion to the winners of the Phase 2 competition: The District of
Columbia, Florida, Georgia, Hawaii, Maryland, Massachusetts, New York,
North Carolina, Ohio, and Rhode Island.
In announcing the winners of the Race to the Top Phase 2
competition, the Secretary noted that ``[we] had many more competitive
applications than money to fund them in this round'' and expressed the
hope that any Race to the Top funding included in the Department's FY
2011 appropriations would be available for Race to the Top Phase 3
awards. In particular, there were nine finalists in the Phase 2
competition that did not receive funding despite submitting bold and
ambitious plans for comprehensive reforms and innovations in their
systems of elementary and secondary education. These nine finalists
were: Arizona, California, Colorado, Illinois, Kentucky, Louisiana, New
Jersey, Pennsylvania, and South Carolina.
On April 15, 2011, President Obama signed into law Public Law 112-
10, the Department of Defense and Full-Year Continuing Appropriations
Act, 2011 (FY 2011 Appropriations Act), which made $698.6 million
available for the Race to the Top Fund, authorized the Secretary to
make awards on ``the basis of previously submitted applications,'' and
amended ARRA to permit the Secretary to make grants for improving early
childhood care and learning under the program.
Race to the Top--Early Learning Challenge (RTT-ELC). On May 25,
2011, Secretary Duncan and the Secretary of Health and Human Services,
Kathleen Sebelius, announced the RTT-ELC, a new $500 million State-
level grant competition to be held in 2011 and authorized under ARRA
and the FY 2011 Appropriations Act. The Departments of Education and
Health and Human Services are administering this competition jointly.
At its core is a strong commitment by the Administration to stimulate a
national effort to make sure all children enter kindergarten ready to
succeed. Through the RTT-ELC, the Administration seeks to help close
the achievement gap between children with high needs and their peers by
supporting State efforts to build strong systems of early learning and
development that provide increased access to high-quality programs for
the children who need it most. This competition represents an
unprecedented opportunity for States to focus deeply on their early
learning and development systems for children from birth through age
five. It is an opportunity to build a more unified approach to
supporting young children and their families--an approach that
increases access to high-quality early learning and development
programs and services, and helps ensure that children enter
kindergarten with the skills, knowledge, and dispositions toward
learning that they need to be successful.
The Departments of Education and Health and Human Services have
published requirements for the FY 2011 competition and will complete
the competition and make awards by the end of 2011.
Race to the Top Phase 3. On May 25, 2011, the Department also
announced that approximately $200 million of the FY 2011 Race to the
Top funds would be made available to some or all of the nine unfunded
finalists from the 2010 Race to the Top Phase 2 competition. The
Department recognizes that $200 million is not sufficient to support
full implementation of the plans submitted during the Phase 2
competition, and therefore believes that making these funds available
to the remaining nine finalists is the best way to create incentives
for these States to carry out the bold reforms proposed in their
applications. We have issued final eligibility requirements for the
nine unfunded finalists to apply for Race to the Top Phase 3 funds.
B. Elementary and Secondary Education Act of 1965, as Amended
In 2010, the Administration released the Blueprint for Reform: The
Reauthorization of the Elementary and Secondary Education Act, the
President's plan for revising the Elementary and Secondary Education
Act of 1965 (ESEA) and replacing the No Child Left Behind Act of 2001
(NCLB). The blueprint can be found at the following Web site: http://
www2.ed.
[[Page 7709]]
gov/policy/elsec/leg/blueprint/index.html.
We look forward to congressional reauthorization of the ESEA that
will build on many of the reforms States and LEAs will be implementing
under the ARRA grant programs. In the interim, we may propose
amendments to our current regulations implementing the ESEA.
Additionally, as we continue to work with Congress on
reauthorization of the ESEA, we are currently implementing a plan to
provide flexibility on certain provisions of current law for States and
school districts that are willing to embrace reform. The mechanisms we
are implementing will ensure continued accountability and commitment to
quality education for all students while at the same time providing
States and school districts with increased flexibility to implement
State and local reforms to improve student achievement.
C. Higher Education Act of 1965, as Amended
Changes to the FFEL and Direct Loan Programs. On March 30, 2010,
the President signed into law the Health Care and Education
Reconciliation Act of 2010, Public Law 111-152, title II of which is
the SAFRA Act. SAFRA made a number of changes to the Federal student
financial aid programs under title IV of the Higher Education Act of
1965, as amended (HEA). One of the most significant changes made by
SAFRA is that it ended new loans under the Federal Family Education
Loan (FFEL) Program authorized by title IV, part B, of the HEA as of
July 1, 2010.
On May 5, 2011, ED announced through a notice in the Federal
Register that it was beginning a negotiated rulemaking process to
streamline the loan program regulations by repealing unnecessary FFEL
Program regulations and incorporating and modifying necessary
requirements within the Direct Loan Program regulations, as
appropriate. ED held four public hearings in May 2011 to obtain public
feedback on proposed amendments, as well as on possible amendments to
other ED regulations, including those governing income-based and
income-contingent loan repayment plans and loan discharges based on the
total and permanent disability of the borrower. Based on the feedback
received from these hearings, ED will soon form a negotiated rulemaking
committee to consider proposed amendments and intends to conduct these
negotiations in 2012.
Approval of New Gainful Employment Programs. Over the last 2 years,
the Department has conducted two significant rulemakings to enhance its
program integrity regulations related to the title IV, student aid
programs. As part of this effort, on October 29, 2010, the Department
issued regulations that included requirements for an institution to
notify the Department before offering a new educational program that
provides training leading to gainful employment in a recognized
occupation (Gainful Employment--New Programs). The Department
established the notification requirement out of concern that some
institutions might attempt to circumvent proposed regulations regarding
gainful employment standards by adding new programs before those
standards could take effect. The Department explained that the
notification process requirements were intended to remain in effect
until the final regulations that established eligibility measures for
gainful employment programs would take effect.
We published the final regulations establishing the gainful
employment eligibility measures on June 13, 2011 (Gainful Employment--
Debt Measures). In those regulations, the Department established
measures for gainful employment programs that are intended to identify
the worst performing programs. We believe that when these new
regulations go into effect on July 1, 2013, the notification process
for all new gainful employment programs established in the Gainful
Employment--New Programs final regulations will no longer be needed.
Accordingly, the Department has issued a new NPRM, which among other
changes, proposes to reduce burden for institutions by amending the
Gainful Employment--New Programs final regulations to establish a
smaller group of gainful employment programs for which an institution
must obtain approval from the Department.
Title II of the HEA. The Secretary intends to develop regulations
under title II of the HEA to streamline the program, institutional, and
State report cards; prescribe data quality standards to ensure
reliability, validity, and accuracy of the data submitted; and
establish standards for identifying low-performing teacher preparation
programs.
D. Individuals With Disabilities Education Act
We have issued final regulations that revise the regulations
implementing the Early Intervention Program for Infants and Toddlers
with Disabilities authorized under part C of the Individuals with
Disabilities Education Act (IDEA) to make changes needed for the
appropriate implementation of the early intervention program. The final
part C regulations incorporate provisions from the 2004 amendments to
part C of the IDEA. Additionally, the final regulations provide States
with flexibility in some areas, while ensuring State accountability to
improve results, and needed services for infants and toddlers with
disabilities and their families.
The Department has also issued a notice of proposed rulemaking to
revise the regulations implementing the Assistance to States for the
Education of Children with Disabilities program authorized under part B
of the IDEA and intends to issue final regulations in the coming year.
Specifically, over the last 6 months, we engaged in a review of one
particular provision of the part B regulations, relating to the use of
public benefits or insurance to pay for services provided to children
under part B. IDEA and the part B regulations allow public agencies to
use public benefits or insurance (e.g., Medicaid) to provide or pay for
services required under part B with the consent of the parent of a
child who is enrolled in a public benefits or insurance program. Public
insurance is an important source of financial support for services
required under part B. With respect to the use of public insurance, our
current regulations specifically provide that a public agency must
obtain parental consent each time access to public benefits or
insurance is sought.
We are now proposing to amend the regulations to provide that,
instead of having to obtain parental consent each time access to public
benefits or insurance is sought, the public agency responsible for
providing special education and related services to a child would be
required, before accessing a child's or parent's public benefits or
insurance, to provide written notification to the child's parents. The
notification would inform parents of their rights under the part B
regulations regarding the use of public benefits or insurance to pay
for part B services, including information about the limitations on a
public agency's billing of public benefits or insurance programs, as
well as parents' rights under the Family Educational Rights and Privacy
Act and IDEA to consent prior to the disclosure of personally
identifiable information.
We are proposing these amendments to reduce unnecessary burden on a
public agency's ability to access public benefits or insurance in
appropriate circumstances but still maintain critical parent
protections, and we do this for
[[Page 7710]]
several reasons. Specifically, we are mindful of the importance of
ensuring that parents have sufficient information to make decisions
about a public agency's use of their public benefits or insurance and
the disclosure of their child's educational records for that purpose.
At the same time, these proposed amendments are designed to address the
concern expressed to the Department by many State personnel and other
interested parties that, since the publication of the part B
regulations in 2006, the inability to obtain parental consent has
contributed to public agencies' failure to claim all of the Federal
financial assistance available for part B services covered under
Medicaid. In addition, public agencies have expressed concern over
using limited resources and the significant administrative burden of
obtaining parental consent for the use of Medicaid and other public
benefits or insurance each time that access to public benefits or
insurance is sought. Consequently, many of these parties have requested
that the Department remove the parental consent requirement.
E. Family Educational Rights and Privacy Act
Given the President's emphasis on improving the collection and use
of data as a key element of educational reform, we intend to issue
final regulations in the coming year to amend our current regulations
for the Family Educational Rights and Privacy Act of 1974 (FERPA) to
ensure that States are able to effectively establish and expand robust
statewide longitudinal data systems while protecting student privacy.
F. Other Potential Regulatory Activities
Congress may reauthorize the Adult Education and Family Literacy
Act (AEFLA) (title II of the Workforce Investment Act of 1998) and the
Rehabilitation Act of 1973 (title IV of the Workforce Investment Act of
1998). The Administration is working with Congress to ensure that any
changes to these laws (1) improve the State grant and other programs
providing assistance for adult education under the AEFLA and for
vocational rehabilitation and independent living services for persons
with disabilities under the Rehabilitation Act of 1973; and (2) provide
greater accountability in the administration of programs under both
statutes. Changes to our regulations may be necessary as a result of
the reauthorization of these two statutes.
III. Retrospective Review of Existing Regulations
Pursuant to section 6 of Executive Order 13563 ``Improving
Regulation and Regulatory Review'' (Jan. 18, 2011), the following
Regulatory Identifier Numbers (RINs) have been identified as associated
with retrospective review and analysis in the Department's final
retrospective review of regulations plan. Some of the entries on this
list may be completed actions, which do not appear in The Regulatory
Plan. However, more information can be found about these completed
rulemakings in past publications of the Unified Agenda on Reginfo.gov
in the Completed Actions section for that agency. These rulemakings can
also be found on Regulations.gov. The final agency plans can be found
at: http://www2.ed.gov/about/open.html.
------------------------------------------------------------------------
Do we expect this
rulemaking to
RIN Title of significantly reduce
Rulemaking burden on small
businesses?
------------------------------------------------------------------------
1820-AB64.................. Assistance to No.
States for the
Education of
Children With
Disabilities.
1840-AD01.................. High School No.
Equivalency
Program and
College
Assistance
Migrant
Program, the
Federal TRIO
Programs, and
Gaining Early
Awareness, and
Readiness for
Undergraduate
Program.
1848-AD02.................. Program No.
Integrity
Issues.
1840-AD05.................. Title IV of the No.
Higher
Education Act
of 1965, as
Amended.
1840-AD06.................. Program No.
Integrity:
Gainful
Employment--Me
asures.
1840-AD08.................. Titles III and No.
V of the
Higher
Education Act
of 1965, as
Amended.
1840-AD10.................. Application and Yes.
Approval
Process for
New Programs.
1880-AA86.................. Family No.
Educational
Rights and
Privacy.
1880-AA84.................. The Freedom of No.
Information
Act.
1890-AA14.................. Direct Grant No.
Programs and
Definitions
That Apply to
Department
Regulations.
1890-AA16.................. Department of No.
Education
Acquisition
Regulations.
------------------------------------------------------------------------
IV. Principles for Regulating
Over the next year, other regulations may be needed because of new
legislation or programmatic changes. In developing and promulgating
regulations we follow our Principles for Regulating, which determine
when and how we will regulate. Through consistent application of the
following principles, we have eliminated unnecessary regulations and
identified situations in which major programs could be implemented
without regulations or with limited regulatory action.
In deciding when to regulate, we consider the following:
Whether regulations are essential to promote quality and
equality of opportunity in education.
Whether a demonstrated problem cannot be resolved without
regulation.
Whether regulations are necessary to provide a legally
binding interpretation to resolve ambiguity.
Whether entities or situations subject to regulation are
similar enough that a uniform approach through regulation would be
meaningful and do more good than harm.
Whether regulations are needed to protect the Federal
interest; that is, to ensure that Federal funds are used for their
intended purpose and to eliminate fraud, waste, and abuse.
In deciding how to regulate, we are mindful of the following
principles:
Regulate no more than necessary.
Minimize burden, to the extent possible, and promote
multiple approaches to meeting statutory requirements if possible.
Encourage coordination of federally funded activities with
State and local reform activities.
Ensure that the benefits justify the costs of regulating.
To the extent possible, establish performance objectives
rather than specify compliance behavior.
Encourage flexibility, to the extent possible, and as
needed to enable institutional forces to achieve desired results.
[[Page 7711]]
ED--OFFICE OF POSTSECONDARY EDUCATION (OPE)
Proposed Rule Stage
26. Title IV of the Higher Education Act of 1965, as Amended
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 20 U.S.C. 1070a; 20 U.S.C. 1071 to 1087-4; 20
U.S.C. 1087a to 1087j; 20 U.S.C. 1098e; Pub. L. 111-152
CFR Citation: 34 CFR chapter VI.
Legal Deadline: None.
Abstract: The Secretary proposes to amend the title IV, HEA student
assistance regulations to (1) reflect that, as of July 1, 2010, under
title II of the Health Care and Education Reconciliation Act of 2010
(the SAFRA Act), no new Federal Family Education Loan Program loans
will be made and (2) to reflect other changes to improve the
effectiveness and efficiency of the student loan programs, particularly
with regard to the discharge of loans for persons with total and
permanent disabilities.
Statement of Need: These regulations are needed to reflect the
provisions of the SAFRA Act (title II of the Health Care and Education
Reconciliation Act of 2010) and to reflect other amendments to the HEA
resulting from the SAFRA Act.
Summary of Legal Basis: Health Care and Education Reconciliation
Act of 2010, Public Law 111-152.
Alternatives: The Department is still developing these proposed
regulations; our discussion of alternatives will be included in the
notice of proposed rulemaking.
Anticipated Cost and Benefits: Estimates of the costs and benefits
are currently under development and will be included in the notice of
proposed rulemaking.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
URL for Public Comments: www.regulations.gov.
Agency Contact: David Bergeron, Department of Education, Office of
Postsecondary Education, Room 8022, 1990 K Street NW., Washington, DC
20006, Phone: 202 502-7815, Email: [email protected].
RIN: 1840-AD05
BILLING CODE 4000-01-P
DEPARTMENT OF ENERGY (DOE)
Fall 2011 Statement of Regulatory and Deregulatory Priorities
The Department of Energy (Department or DOE) makes vital
contributions to the Nation's welfare through its activities focused on
improving national security, energy supply, energy efficiency,
environmental remediation, and energy research. The Department's
mission is to:
Promote dependable, affordable, and environmentally sound
production and distribution of energy;
Advance energy efficiency and conservation;
Provide responsible stewardship of the Nation's nuclear
weapons;
Provide a responsible resolution to the environmental
legacy of nuclear weapons production;
Strengthen U.S. scientific discovery, economic
competitiveness, and improving quality of life through innovations in
science and technology.
The Department's regulatory activities are essential to achieving
its critical mission and to implementing major initiatives of the
President's National Energy Policy. Among other things, the Regulatory
Plan and the Unified Agenda contain the rulemakings the Department will
be engaged in during the coming year to fulfill the Department's
commitment to meeting deadlines for issuance of energy conservation
standards and related test procedures. The Regulatory Plan and Unified
Agenda also reflect the Department's continuing commitment to cut
costs, reduce regulatory burden, and increase responsiveness to the
public.
Energy Efficiency Program for Consumer Products and Commercial
Equipment
The Energy Policy and Conservation Act (EPCA) requires DOE to set
appliance efficiency standards at levels that achieve the maximum
improvement in energy efficiency that is technologically feasible and
economically justified. The standards already published in 2011 have an
estimated net benefit to the Nation of up to $16.6 billion over 30
years. By 2045, these standards are expected to save enough energy to
operate all U.S. homes for more than 7 months.
The Department continues to follow its schedule for setting new
appliance efficiency standards. These rulemakings are expected to save
American consumers billions of dollars in energy costs. The schedule
outlines how DOE will address the various appliance standards
rulemakings necessary to meet statutory requirements established in
EPCA, the Energy Policy Act of 2005 (EPACT 2005), and the Energy
Independence and Security Act of 2007 (EISA 2007).
The overall plan for implementing the schedule is contained in the
Report to Congress under section 141 of EPACT 2005 that was released on
January 31, 2006. This plan was last updated in the August 2011 report
to Congress and now includes the requirements of the Energy
Independence and Security Act of 2007 (EISA 2007). The reports to
Congress are posted at: http://www.eere.energy.gov/buildings/appliance_standards/schedule_setting.html. The August 2011 report
identifies all products for which DOE has missed the deadlines
established in EPCA (42 U.S.C. section 6291 et seq.). It also describes
the reasons for such delays and the Department's plan for expeditiously
prescribing new or amended standards. Information and timetables
concerning these actions can also be found in the Department's
regulatory agenda, which is posted online at: www.reginfo.gov.
Estimate of Combined Aggregate Costs and Benefits
The regulatory actions included in this regulatory plan are
expected to provide significant benefits to the Nation for product
categories including: Fluorescent lamp ballasts, manufactured housing,
battery chargers and external power supplies, walk-in coolers and
freezers, and incandescent reflector lamps. DOE believes that the
benefits to the Nation of the proposed energy standards for fluorescent
lamp ballasts (energy savings, consumer average lifecycle cost savings,
national net present value increase, and emission reductions) outweigh
the costs (loss of industry net present value and life-cycle cost
increases for some consumers). DOE estimates that these regulations
will produce an energy savings between 3.7 and 6.3 quads over 30 years.
The benefit to the Nation will be between $8.1 billion (7% discount
rate) and $24.7 billion (3% discount rate). DOE believes that the
proposed energy standards for manufactured housing, battery chargers
and external power supplies, walk-in coolers and freezers, and
incandescent reflector lamps will also be beneficial to the Nation.
However, because DOE has not yet proposed candidate standard levels for
this equipment, DOE cannot provide an estimate of combined aggregate
costs and benefits for these actions. DOE will, however, in compliance
with all applicable law, issue standards that provide the maximum
energy savings that are technologically feasible and economically
justified. Estimates of
[[Page 7712]]
energy savings will be provided when DOE issues the notices of proposed
rulemaking for this equipment.
DOE--ENERGY EFFICIENCY AND RENEWABLE ENERGY (EE)
Proposed Rule Stage
27. Energy Efficiency Standards for Battery Chargers and External Power
Supplies
Priority: Economically Significant. Major status under 5 U.S.C. 801
is undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 6295(u)
CFR Citation: 10 CFR 430.
Legal Deadline: Final, Statutory, July 1, 2011.
Abstract: In addition to the existing general definition of
``external power supply,'' the Energy Independence and Security Act of
2007 (EISA) defines a ``Class A external power supply'' and sets
efficiency standards for those products. EISA directs DOE to publish a
final rule to determine whether the standards set for Class A external
power supplies should be amended. EISA also requires DOE to issue a
final rule prescribing energy conservation standards for battery
chargers, if technologically feasible and economically justified.
Statement of Need: The Energy Policy and Conservation Act (EPCA)
requires minimum energy standards for appliances, which has the effect
of eliminating inefficient appliances and equipment from the market.
Summary of Legal Basis: Title III of EPCA sets forth a variety of
provisions designed to improve energy efficiency. Part A of title III
(42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program
for Consumer Products other than Automobiles. EPCA directs DOE to
conduct a rulemaking to establish energy conservation standards for
battery chargers or determine that no energy conservation standard is
technically feasible and economically justified (42 U.S.C. 6295
(u)(1)(E)(i) and (ii)).
In addition to the existing general definition of ``external power
supply,'' EPCA defines a ``Class A external power supply'' (42 U.S.C.
6291(36)(C)) and sets efficiency standards for those products (42
U.S.C. 6295(u)(3)). EPCA directs DOE to publish a final rule to
determine whether amended standards should be set for Class A external
power supplies, or new standards set for other classes of external
power supplies. If such determination is positive, DOE must include any
amended or new standards as part of that final rule.
DOE is bundling the two requirements to establish energy
conservation standards for battery chargers and to consider amended or
new standards for external power supplies into a single rulemaking.
Alternatives: The statute requires the Department to conduct
rulemakings to review standards and to revise standards to achieve the
maximum improvement in energy efficiency that the Secretary determines
is technologically feasible and economically justified. In making this
determination, the Department conducts a thorough analysis of the
alternative standard levels, including the existing standard, based on
the criteria specified by the statute.
Anticipated Cost and Benefits: Because DOE has not yet proposed
candidate standard levels for this equipment, DOE cannot provide an
estimate of combined aggregate costs and benefits for these actions.
DOE will, however, in compliance with all applicable law, issue
standards that provide the maximum energy savings that are
technologically feasible and economically justified. Estimates of
energy savings will be provided when DOE issues the notices of proposed
rulemaking for this equipment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice: Public Meeting, Framework 06/04/09 74 FR 26816
Document Availability.
Comment Period End.................. 07/20/09 .......................
Notice: Public Meeting, Data 09/15/10 75 FR 56021
Availability.
Comment Period End.................. 10/15/10 .......................
Final Rule (Technical Amendment).... 09/19/11 76 FR 57897
NPRM................................ 12/00/11 .......................
Final Action........................ 07/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local, State.
Federalism: Undetermined.
URL for More Information: www1.eere.energy.gov/buildings/appliance_standards/residential/battery_external.html.
Agency Contact: Victor Petrolati, Office of Building Technologies
Program, EE-2J, Department of Energy, Energy Efficiency and Renewable
Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202
586-4549, Email: [email protected].
Related RIN: Related to 1904-AB75.
RIN: 1904-AB57
DOE--EE
28. Energy Conservation Standards for Walk-In Coolers and Walk-In
Freezers
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 6313(f)(4)
CFR Citation: 10 CFR 431.
Legal Deadline: Final, Statutory, January 1, 2012.
Abstract: The Energy Independence and Security Act of 2007
amendments to the Energy Policy and Conservation Act require that DOE
establish maximum energy consumption levels for walk-in coolers and
walk-in freezers.
Statement of Need: The Energy Policy and Conservation Act requires
minimum energy efficiency standards for appliances, which has the
effect of eliminating inefficient appliances and equipment from the
market.
Summary of Legal Basis: Section 312 of the Energy Independence and
Security Act of 2007 (EISA) establishes definitions and standards for
walk-in coolers and walk-in freezers. EISA directs DOE to establish
performance-based standards not later than January 1, 2012 (42 U.S.C.
6313 (f)(4)).
Alternatives: The statute requires the Department to conduct
rulemakings to review standards and to revise standards to achieve the
maximum improvement in energy efficiency that the Secretary determines
is technologically feasible and economically justified. In making this
determination, the Department conducts a thorough analysis of the
alternative standard levels, including the existing standard, based on
the criteria specified by the statute.
Anticipated Cost and Benefits: Because DOE has not yet proposed
candidate standard levels for this equipment, DOE cannot provide an
estimate of combined aggregate costs and benefits for these actions.
DOE will, however, in compliance with all applicable law, issue
standards that provide the maximum energy savings that are
technologically feasible and economically justified. Estimates of
energy savings will be provided when DOE issues the notice of proposed
rulemaking for this equipment.
Timetable:
[[Page 7713]]
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice: Public Meeting, Framework 01/06/09 74 FR 411
Document Availability.
Notice: Public Meeting, Data 04/05/10 75 FR 17080
Availability.
Comment Period End.................. 05/20/10 .......................
NPRM................................ 12/00/11 .......................
Final Action........................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local, State.
Federalism: Undetermined.
Additional Information: Comments pertaining to this rule may be
submitted electronically to [email protected].
URL for More Information: www.eere.energy.gov/buildings/appliance_standards/commercial/wicf.html.
URL for Public Comments: www.regulations.gov.
Agency Contact: Charles Llenza, Office of Building Technologies
Program, EE-2J, Department of Energy, Energy Efficiency and Renewable
Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202
586-2192, Email: [email protected].
Related RIN: Related to 1904-AB85.
RIN: 1904-AB86
DOE--EE
29. Energy Efficiency Standards for Manufactured Housing
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 17071
CFR Citation: 10 CFR 460.
Legal Deadline: Final, Statutory, December 19, 2011.
Abstract: The rule would establish energy efficiency standards for
manufactured housing and a system to ensure compliance with, and
enforcement of, the standards.
Statement of Need: The Energy Independence and Security Act
requires increased energy efficiency standards for manufactured
housing.
Summary of Legal Basis: Section 413 of the Energy Independence and
Security Act of 2007 (EISA), 42 U.S.C. 17071, directs DOE to develop
and publish energy standards for manufactured housing.
Alternatives: The statute requires DOE to conduct a rulemaking to
establish standards to achieve the maximum improvement in energy
efficiency that the Secretary determines is technologically feasible
and economically justified. In making this determination, DOE conducts
a thorough analysis of the alternative standard levels, including the
existing standard, based on the criteria specified by the statute.
Anticipated Cost and Benefits: Because DOE has not yet proposed
candidate standard levels, DOE cannot provide an estimate of combined
aggregate costs and benefits for these actions. DOE will, however, in
compliance with all applicable law, issue standards that provide the
increased energy savings that are technologically feasible and
economically justified. Estimates of energy savings will be provided
when DOE issues the notice of proposed rulemaking.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 02/22/10 75 FR 7556
ANPRM Comment Period End............ 03/24/10 .......................
NPRM................................ 02/00/12 .......................
Final Action........................ 12/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
URL for More Information: www.energycodes.gov/status/mfg_housing.stm.
URL for Public Comments: www.regulations.gov.
Agency Contact: Ronald B. Majette, Program Manager, Office of
Building Technologies Program, EE-2J, Department of Energy, Energy
Efficiency and Renewable Energy, 1000 Independence Avenue SW.,
Washington, DC 20585, Phone: 202 586-7935, Email:
[email protected].
RIN: 1904-AC11
DOE--EE
30. Energy Conservation Standards for ER, BR, and Small Diameter
Incandescent Reflector Lamps
Priority: Other Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: 42 U.S.C. 6291(30)(C)(ii) and (F); 42 U.S.C.
6295(i)
CFR Citation: 10 CFR 430.
Legal Deadline: None.
Abstract: Amendments to Energy Policy and Conservation Act (EPCA)
in the Energy Independence and Security Act of 2007 (EISA) amended the
energy conservation standards to extend coverage to certain classes of
IRL that had previously been outside the statutory definition of
``incandescent reflector lamp'' although these lamps were excluded from
the statutory standard levels. However, EISA 2007 authorized DOE to
amend these standards if such amendments were warranted. Specifically,
as amended, EPCA exempted certain small diameter, ellipsoidal reflector
(ER) and bulged reflector (BR) lamps from standards. In June 2009, DOE
published a final rule amending existing standards for IRL. In earlier
stages of the June 2009 rulemaking, DOE had interpreted its authority
with regard to IRL as limited to amending congressionally established
standard levels only, and not to the exemptions set by Congress for
certain explicitly identified small diameter ER and BR lamps, commonly
used in track lighting and recessed cans. On further review, DOE has
concluded that DOE has authority to establish efficiency standards for
these currently exempt small diameter ER and BR lamps. However, as a
practical matter, DOE could not consider these lamps as part of the
previous rulemaking because it had not conducted the requisite analyses
to set appropriate standard levels. Pursuant to EPCA, DOE is now
conducting a rulemaking as to energy conservation standards for certain
incandescent reflector lamps (IRL) that have ER or BR bulb shapes, and
for certain IRL with diameters less than 2.25 inches.
Statement of Need: The Energy Policy and Conservation Act requires
minimum energy efficiency standards for appliances, which has the
effect of eliminating inefficient appliances and equipment from the
market.
Summary of Legal Basis: Section 322 of the Energy Independence and
Security Act of 2007 (EISA) establishes definitions and standards for
ER, BR, and BPAR incandescent reflector lamps. (42 U.S.C. 6291(54) to
6291(56), 42 U.S.C. 6295 (i)) Furthermore, section 305 of EISA directs
DOE to, not later than 6 years after issuance of any final rule
establishing or amending a standard, publish either a notice of
determination that standards do not need to be amended or a notice of
proposed rulemaking including new proposed standards. (42 U.S.C. 6295
(m))
Alternatives: The statute requires the Department to conduct
rulemakings to review standards and to revise standards to achieve the
maximum improvement in energy efficiency that the Secretary determines
is technologically feasible and
[[Page 7714]]
economically justified. In making this determination, the Department
conducts a thorough analysis of the alternative standard levels,
including the existing standard, based on the criteria specified by the
statute.
Anticipated Cost and Benefits: Because DOE has not yet proposed
candidate standard levels for this equipment, DOE cannot provide an
estimate of combined aggregate costs and benefits for these actions.
DOE will, however, in compliance with all applicable law, issue
standards that provide the maximum energy savings that are
technologically feasible and economically justified. Estimates of
energy savings will be provided when DOE issues the notice of proposed
rulemaking for this equipment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice: Public Meeting, Framework 05/03/10 75 FR 23191
Document Availability.
Comment Period End.................. 06/17/10 .......................
NPRM................................ 12/00/11 .......................
Final Action........................ 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
URL for More Information: www1.eere.energy.gov/buildings/appliance_standards/residential/incandescent_lamps.html.
URL for Public Comments: www.regulations.gov.
Agency Contact: Lucy Debutts, Office of Building Technologies
Program, EE-2J, Department of Energy, Energy Efficiency and Renewable
Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202
287-1604, Email: [email protected].
Related RIN: Related to 1904-AA92.
RIN: 1904-AC15
DOE--EE
Final Rule Stage
31. Energy Efficiency Standards for Fluorescent Lamp Ballasts
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 42 U.S.C. 6295(g)
CFR Citation: 10 CFR 430.
Legal Deadline: Final, Judicial, October 28, 2011.
Abstract: DOE is reviewing and updating energy efficiency
standards, as required by the Energy Policy and Conservation Act, to
reflect technological advances. All amended energy efficiency standards
must be technologically feasible and economically justified. This is
the second review of the statutory standards for fluorescent lamp
ballasts.
Statement of Need: The Energy Policy and Conservation Act requires
minimum energy efficiency standards for appliances, which has the
effect of eliminating inefficient appliances and equipment from the
market.
Summary of Legal Basis: The Energy Policy and Conservation Act
(EPCA) of 1975 (42 U.S.C. 6291 to 6309) established an energy
conservation program for major household appliances. Amendments to EPCA
in the National Appliance Energy Conservation Amendments of 1988 (NAECA
1988) established energy conservation standards for fluorescent lamp
ballasts. These amendments also required that DOE (1) conduct two
rulemaking cycles to determine whether these standards should be
amended, and (2) for each rulemaking cycle, determine whether the
standards in effect for fluorescent lamp ballasts should be amended to
apply to additional fluorescent lamp ballasts. (42 U.S.C. 6295(g)(7)(A)
and (B)). On September 19, 2000, DOE published a final rule in the
Federal Register, which completed the first rulemaking cycle to amend
energy conservation standards for fluorescent lamp ballasts. 65 FR
56740. This rulemaking encompasses DOE's second cycle of review to
determine whether the standards in effect for fluorescent lamp ballasts
should be amended and whether the standards should be applicable to
additional fluorescent lamp ballasts.
Alternatives: The statute requires DOE to conduct rulemakings to
review standards and to revise standards to achieve the maximum
improvement in energy efficiency that the Secretary determines is
technologically feasible and economically justified. In making this
determination, DOE conducts a thorough analysis of the alternative
standard levels, including the existing standard, based on the criteria
specified by the statute.
Anticipated Cost and Benefits: DOE believes that the benefits to
the Nation from energy standards for fluorescent lamp ballasts (energy
savings, consumer average lifecycle cost (LCC) savings, national net
present value (NPV) increase, and emission reductions) outweigh the
burdens (loss of NPV and LCC increases of some small electric motor
users). DOE estimates that energy savings from electricity will be
between 3.7 and 6.3 quads over 30 years and the benefits to the Nation
will be between $8.1 and $24.7 billion.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice: Public Meeting, Framework 01/22/08 73 FR 3653
Document Availability.
Notice: Public Meetings, Data 03/24/10 75 FR 14319
Availability.
NPRM................................ 04/11/11 76 FR 20090
NPRM Comment Period End............. 06/11/11 .......................
Notice of Data Availability (NODA); 08/24/11 76 FR 52892
Request for Comments.
NODA Comment Period End............. 09/14/11 .......................
Final Action........................ 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local, State.
Federalism: This action may have federalism implications as defined
in EO 13132.
URL for More Information: www1.eere.energy.gov/buildings/appliance_standards/residential/fluorescent_lamp_ballasts.html
URL for Public Comments: www.regulations.gov.
Agency Contact: Tina Kaarsberg, Office of Building Technologies
Program, EE-2J, Department of Energy, Energy Efficiency and Renewable
Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202
287-1393, Email: [email protected].
Related RIN: Related to 1904-AB77, Related to 1904-AA99.
RIN: 1904-AB50
BILLING CODE 6450-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Statement of Regulatory Priorities for FY 2012
The Department of Health and Human Services is the Federal
Government's principal agency charged with protecting the health of all
Americans and providing essential human services, especially for those
least able to help
[[Page 7715]]
themselves. The Department operates more than 300 programs covering a
wide spectrum of activities, manages almost a quarter of all Federal
outlays, and administers more grant dollars than all other Federal
agencies combined. The Department's major program responsibilities
include: Medicare and Medicaid; control and prevention of communicable
and chronic disease; support for public health preparedness and
emergency response; biomedical research; substance abuse and mental
health treatment and prevention; assuring safe and effective drugs,
devices, and other medical products; protecting the food supply;
assistance to low-income families; the Head Start program; and
improving access to health care services to the uninsured, isolated, or
medically vulnerable. Currently, the Department is the principal agency
charged with implementing one of the President's signature
achievements--transformative health care reform through the Affordable
Care Act of 2010.
To implement this vast program portfolio, the Department develops
an active regulatory agenda each year, driven largely by statutory
mandates and interactions with stakeholders. The President also called
upon Federal agencies to reform the regulatory process in his January
18, 2011, Executive Order 13563 ``Improving Regulation and Regulatory
Review.'' A key directive in that Executive order was to require
agencies to conduct an inventory of existing regulations to determine
whether such regulations should be modified, streamlined, expanded, or
repealed to make an agency's regulatory scheme more effective or less
burdensome in achieving its programmatic objectives.
With these regulatory drivers in mind, Secretary Kathleen Sebelius
has worked with HHS agencies to craft a regulatory agenda that reflects
her commitments to implementing meaningful health care reform, access
to health care coverage, and high value health care services that are
safe and effective for all Americans. The agenda also reflects her
other strategic initiatives, which include securing and maintaining
health care coverage for all Americans; improving quality and patient
safety; more rapidly responding to adverse events; implementing a 21st
century food safety system; helping Americans achieve and maintain
healthy living habits; advancing scientific research; and streamlining
regulations to reduce the regulatory burden on industry and States.
Within this agenda, the Secretary has also been mindful of the need to
reform the ongoing regulatory process through retrospective review of
existing regulations, and this agenda reflects her commitment to that
review by incorporating some of the most significant burden reduction
reforms across all Federal agencies. In fact, of the $10 billion in
savings from retrospective regulatory review across all Federal
agencies announced by the Administrator of the Office of Information
and Regulatory Affairs, $5 billion was attributable to regulations
contained within this Department's current regulatory agenda.
What follows is an overview of the Department's regulatory
priorities for FY 2012 and some of the regulations on the agenda that
best exemplify these priorities.
Making Health Insurance Coverage More Secure for Those Who Have
Insurance and Extending Coverage to the Uninsured
As a result of the Affordable Care Act, the Department is making
affordable health care coverage more stable and secure through
insurance market reforms designed to protect consumers against
unreasonable insurance premium increases, provide them with more
comprehensive and understandable information with which to make
decisions, and enable eligible consumers to receive financial support
for health insurance easily and seamlessly. In 2014, all people who
suffer from chronic conditions will no longer be excluded from
insurance coverage or charged higher premiums because of a pre-existing
condition or medical history.
Already, insurers are prohibited from putting lifetime dollar
limits and restrictive annual caps on what they will pay for health
care services needed by the people they insure, ensuring that those
people have access to medical care throughout their lives, especially
when it is most needed. HHS is working with States to help identify and
put a stop to unreasonable health insurance premium rate increases and
will require new health plans to implement a comprehensive appeals
process for those beneficiaries who have been denied coverage or
payment by the insurance plan. New health insurers will also be
required to spend the majority of health insurance premiums on medical
care and health care quality improvement, not on administration and
overhead. As well, the Affordable Care Act is providing reimbursement
to employers that offer health benefits to early retirees, providing
insurance coverage through the Pre-existing Condition Insurance Plan to
people who would otherwise be locked out of the insurance market
because of their pre-existing health conditions, and requiring plans
that offer dependent coverage to make that coverage available to young
adults up to age 26.
Moving forward this year, the Department will continue to implement
the Affordable Care Act to promote consumer protections, improve
quality and safety, provide incentives for more efficient care
delivery, and slow the growth of health care costs. The Centers for
Medicare & Medicaid Services (CMS) will finalize three rules that will
expand access to health insurance and provide consumers with better
options and information about insurance:
CMS will issue standards for the establishment of the
Affordable Insurance Exchanges (Exchanges) to provide competitive
marketplaces for individuals and small employers to directly compare
available private health insurance options on the basis of price and
quality. These Exchanges will help enhance competition in the health
insurance market, improve choice of affordable health insurance, and
give small businesses the same purchasing clout as large businesses.
Another rule helps to make coverage more secure by
offsetting market uncertainty and risk selection to maintain the
viability of Exchanges. Under risk adjustment, HHS, in consultation
with the States, will establish criteria and methods to be used by
States in determining the actuarial risk of plans within a State to
minimize the negative effects of adverse selection. Under reinsurance,
all health insurance issuers, and third-party administrators on behalf
of self-insured group health plans, will contribute to a nonprofit
reinsurance entity to support reinsurance payments to individual market
issuers that cover high risk individuals.
To extend health insurance to greater numbers of low-
income people, Medicaid eligibility in 2014 will expand to cover adults
under the age of 65 earning up to 133 percent of the Federal poverty
level, and those who earn above that level may be eligible for tax
credits through the Exchanges to help pay their premiums. New,
simplified procedures for determining Medicaid, CHIP, and tax credit
eligibility will be forthcoming in 2012. CMS will simplify eligibility
rules to make it easier for eligible individuals and families to obtain
premium tax credits and Medicaid coverage, including ensuring that
Medicaid uses the same eligibility standards as other insurance
affordability programs available through the Exchange, as directed by
law. The rule further outlines how Medicaid and CHIP will coordinate
closely with the Exchange,
[[Page 7716]]
including sharing data to ensure that individuals are determined
eligible for the appropriate insurance affordability program regardless
of where an applicant submits the application.
Improving Health Care Quality and Patient Safety
Across America and for all Americans, the Department is working to
improve patient outcomes, ensure patient safety, promote efficiency and
accountability, encourage shared responsibility, and reduce health care
costs. Through improved administrative processes, reforms, innovations,
and additional information to support consumer decisionmaking, HHS is
supporting high-value, safe, and effective care across health care
settings and in the community.
In 2011, the Department published a key regulation to advance this
priority--the final rule for Accountable Care Organizations. This rule
establishes a system of shared savings for qualified organizations that
deliver primary care services to a given patient population. The
objective is to promote accountability and shared responsibility for
the delivery of care, especially to those with co-morbidities of
chronic health problems in order to prevent unnecessary and costly in-
patient hospital care, reduce health care acquired conditions, and
improve the quality of life for those individuals. This rule serves as
a companion to additional demonstration programs designed to explore
alternative services delivery and payment systems that are being
sponsored by the new Center for Medicare and Medicaid Innovation.
Several more key regulations are on the agenda to move forward in
meeting these quality and patient safety goals:
CMS is implementing value-based purchasing programs
throughout its payment structure in order to reward hospitals and other
health care providers for delivering high-quality care, rather than
just a high volume of services. The payment rules scheduled for
publication this year will reflect a mix of standards, processes,
outcomes, and patient experience of care measures, including measures
of care transition and changes in patient functional status.
The Department continues to encourage health care
providers to become meaningful users of health information technology
(IT) by accelerating health IT adoption and promoting electronic health
records to help improve the quality of health care, reduce costs, and
ultimately, improve health outcomes. Electronic health records and
health information exchange can help clinicians provide higher quality
and safer care for their patients. By adopting electronic health
records in a meaningful way, clinicians will know more about their
patients to better coordinate and improve the quality of patient care,
and they can make better decisions about treatments and conditions.
Improving Response to Adverse Events
In a related activity, the FDA will be proposing a new rule to
establish a unique identification system for medical devices in order
to track a device from pre-market application through distribution and
use. This system will allow FDA and other public health entities to
track individual devices so that when an adverse event occurs,
epidemiologists can quickly track down and identify other users of the
device to provide guidance and recommendations on what steps to take to
prevent additional adverse actions.
Implementing a 21st Century Food Safety System
The Food Safety Modernization Act of 2010, signed into law by the
President in January 2011, directs the Food and Drug Administration
(FDA), working with a wide range of public and private partners, to
build a new system of food safety oversight--one focused on applying
the best available science and good common sense to prevent the
problems that can make people sick. In implementing that Act, the
Department's goal is to shift emphasis from removing unsafe products
from the market place to keeping unsafe food from entering commerce in
the first place.
FDA will propose several new rules to establish a robust, enhanced
food safety program.
FDA will propose regulations establishing preventive
controls in the manufacture and distribution of human foods and of
animal feeds. These regulations will constitute the heart of the food
safety program by instituting, for the first time, good manufacturing
practices for the manufacture and distribution of food products to
ensure that those products are safe for consumption and will not cause
or spread disease.
Perhaps most anticipated in light of food borne illnesses
occurring in 2011, FDA will introduce a rule addressing produce safety
to ensure that produce sold in the marketplace meets rigorous safety
standards. The regulation will set enforceable, science-based standards
for the safe production and harvesting of fresh produce at the farm and
the packing house to minimize the risk of serious adverse health
consequences.
In another proposed rule, FDA will require food importers
to have a foreign supplier verification program that will be adequate
to provide assurances that each foreign supplier produces food in a
manner that provides the same level of protection as required for
domestic production under the Food Drug and Cosmetic Act.
FDA will establish a program to accredit third-party
auditors to conduct food safety audits of foreign entities. Such a
program will relieve importers of having to establish such programs
themselves and, instead, allow them to contract with an accredited
auditor to meet the audit requirements.
Empowering Americans To Make Healthy Choices in the Marketplace
Roughly two-thirds of adults and one-third of children in the
United States are overweight or obese, increasing their risk for
chronic diseases, including heart disease, type 2 diabetes, certain
cancers, stroke, and arthritis. Almost 10 percent of all medical
spending is used to treat obesity-related conditions. In order to
reverse the obesity epidemic, HHS is employing a comprehensive approach
that includes both clinical and public health strategies and touches
people where they live, work, learn, and play.
To help advance this agenda, FDA will finalize two rules aimed at
empowering consumers to make healthy eating choices. The rules require
nutrition labeling on standard menu items in restaurants and similar
retail food establishments, as well as on food sold in vending
machines. One rule will require restaurants and similar retail food
establishments with 20 or more locations to list calorie content
information for standard menu items on restaurant menus and menu
boards, including drive-through menu boards. Other nutrient
information--total calories, fat, saturated fat, cholesterol, sodium,
total carbohydrates, sugars, fiber and total protein--would have to be
made available in writing upon request. The other rule will require
vending machine operators who own or operate 20 or more vending
machines to disclose calorie content for some items. The Department
anticipates that such information will ensure that patrons of chain
restaurants and vending machines have nutritional information about the
food they are consuming.
Two additional rules will also improve dietary information
available to consumers. One is a revision to the nutrition and
supplement facts labels. Much of the information found on the Nutrition
Facts label has not been updated since 1993 when mandatory
[[Page 7717]]
nutrition labeling of food was first required. The aim of the proposed
revision is to provide updated and easier to read nutrition information
on the label to help consumers maintain healthy dietary practices. The
other proposed rule will focus on the serving sizes of foods that can
reasonably consumed in one serving. This rule would amend the labeling
regulations to provide updated reference amounts for certain food
categories with new consumption data derived from the current National
Health and Nutrition Survey.
Advancing Scientific Research
To effectively address the challenges the Department faces in
crafting the best, evidence-based approaches to advance health services
delivery, protect the public health, ensure essential human services,
promote biomedical research, and ensure the availability of safe
medical and food products, the Department must rely on research. The
lynchpin of this research is found in the ethical rules governing
research on human subjects.
In a major undertaking, the Department is in the process of
reviewing and revising those ethical rules, commonly referred to as the
Common Rule. The Common Rule serves to guide researchers and
investigators in the Department, but also throughout the Federal
Government, in the conduct and protocols for doing research on human
subjects. The proposed revisions will be designed to better protect
human subjects who are involved in research, while facilitating
research and reducing burden, delay, and ambiguity for investigators.
Streamlining Regulations To Reduce Regulatory Burdens
Consistent with the President's Executive Order 13563, the
Department continues its commitment to reducing the regulatory burden
on the health care industry through the use of modern technology. As
part of this effort, FDA will advance several rules designed to reduce
the reporting and data submission requirements from manufacturers of
drugs and medical devices.
In one such rule, FDA will permit manufacturers, importers, and
users of medical devices to submit reports of adverse events to the FDA
electronically. This proposed change will not only reduce the paper
reporting burden on industry, but also allow FDA to more quickly review
safety reports and identify emerging public health issues. Under
another proposed rule, FDA would revise existing regulations to allow
clinical study data and bioequivalence data for new drug applications
and biological license applications to be provided electronically.
Again, this rule will reduce the reporting burden on industry and also
permit FDA to more readily process and review applications.
CMS is also engaged in regulatory reduction and streamlining
activities. Of particular note are several rules on conditions of
participation for hospitals and other providers. The most comprehensive
of these rules is the one reducing regulatory burdens on hospitals,
which is expected to save as much as $940 million annually over the
next 5 years. This rule will implement changes to hospital conditions
of participation to reflect substantial advances in health care
delivery and patient safety knowledge and practices.
HHS--OFFICE OF THE SECRETARY (OS)
Proposed Rule Stage
32. Health Information Technology: New and Revised Standards,
Implementation Specifications, and Certification Criteria for
Electronic Health Record Technology
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 42 U.S.C. 300jj-14
CFR Citation: 45 CFR 170.
Legal Deadline: None.
Abstract: The final rule that established the initial set of
standards, implementation specifications, and certification criteria
was published in the Federal Register on July 28, 2010. The initial set
represented the first round of an incremental approach to adopting
future sets of standards, implementation specifications, and
certification criteria to enhance electronic health record (EHR)
interoperability, functionality, and utility. Under the authority
provided by section 3004 of the Public Health Service Act (PHSA), this
notice of proposed rulemaking would propose that the Secretary adopt
revisions to the initial set as well as new standards, implementation
specifications and certification criteria. The proposed new and revised
standards, implementation specifications, and certification criteria
would establish the technical capabilities that certified EHR
technology would need to include to support meaningful use under the
CMS Medicare and Medicaid EHR Incentive Programs.
Statement of Need: The final rule that established the initial set
of standards, implementation specifications, and certification criteria
was published in the Federal Register on July 28, 2010. The initial set
represented the first round of an incremental approach to adopting
future sets of standards, implementation specifications, and
certification criteria for electronic health record (EHR) technology.
In a notice of proposed rulemaking, the Secretary would propose new and
revised standards, implementation specifications, and certification
criteria that would establish the technical capabilities that certified
EHR technology would need to include in order to support meaningful use
under the CMS Medicare and Medicaid EHR Incentive Programs.
Summary of Legal Basis: Under the authority provided by section
3004 of the Public Health Service Act (PHSA), the Secretary would
propose to adopt revisions to the initial set of standards,
implementation specifications, and certification criteria and propose
new standards, implementation specifications and certification
criteria.
Alternatives: No alternatives are available because eligible
professionals, eligible hospitals, and critical access hospitals under
the CMS Medicare and Medicaid EHR Incentive Programs are required to
demonstrate meaningful use of certified EHR technology. This rule
ensures that the certification requirements necessary to support the
achievement of meaningful use Stage 2 keep pace with the changes to the
requirements in the CMS Medicare and Medicaid EHR Incentive Programs.
Anticipated Cost and Benefits: EHR technology developers seeking
certification are expected to incur costs related to EHR technology
redesign, reprogramming, and new capability development. Benefits
include greater standardization and increased EHR technology
interoperability and functionality.
Risks: Absent a rulemaking, it is unlikely that currently certified
EHR technology would include the requisite capacities to support an
eligible professional's, eligible hospital's, or critical access
hospital's achievement of meaningful use under the CMS Medicare and
Medicaid EHR Incentive Programs.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
[[Page 7718]]
Government Levels Affected: None.
Agency Contact: Steven Posnack, Policy Analyst, Department of
Health and Human Services, Office of the Secretary, Office of the
National Coordinator for Health Information Technology, 200
Independence Avenue SW., Washington, DC 20201, Phone: 202 690-7151.
RIN: 0991-AB82
HHS--FOOD AND DRUG ADMINISTRATION (FDA)
Proposed Rule Stage
33. Electronic Submission of Data From Studies Evaluating Human Drugs
and Biologics
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262
CFR Citation: 21 CFR 314.50; 21 CFR 601.12; 21 CFR 314.94; 21 CFR
314.96.
Legal Deadline: None.
Abstract: The Food and Drug Administration is proposing to amend
the regulations governing the format in which clinical study data and
bioequivalence data are required to be submitted for new drug
applications (NDAs), biological license applications (BLAs), and
abbreviated new drug applications (ANDAs). The proposal would revise
our regulations to require that data submitted for NDAs, BLAs, and
ANDAs, and their supplements and amendments, be provided in an
electronic format that FDA can process, review, and archive.
Statement of Need: Before a drug is approved for marketing, FDA
must determine that the drug is safe and effective for its intended
use. This determination is based in part on clinical study data and
bioequivalence data that are submitted as part of the marketing
application. Study data submitted to FDA in electronic format have
generally been more efficient to process and review.
FDA's proposed rule would address the submission of study data in a
standardized electronic format. Electronic submission of study data
would improve patient safety and enhance health care delivery by
enabling FDA to process, review, and archive data more efficiently.
Standardization would also enhance the ability to share study data and
communicate results. Investigators and industry would benefit from the
use of standards throughout the lifecycle of a study--in data
collection, reporting, and analysis. The proposal would work in concert
with ongoing Agency and national initiatives to support increased use
of electronic technology as a means to improve patient safety and
enhance health care delivery.
Summary of Legal Basis: Our legal authority to amend our
regulations governing the submission and format of clinical study data
and bioequivalence data for human drugs and biologics derives from
sections 505 and 701 of the Act (21 U.S.C. 355 and 371) and section 351
of the Public Health Service Act (42 U.S.C. 262).
Alternatives: FDA considered issuing a guidance document outlining
the electronic submission and the standardization of study data, but
not requiring electronic submission of the data in the standardized
format. This alternative was rejected because the Agency would not
fully benefit from standardization until it became the industry
standard, which could take up to 20 years.
We also considered a number of different implementation scenarios,
from shorter to longer time-periods. The 2-year time-period was
selected because the Agency believes it would provide ample time for
applicants to comply without too long a delay in the effective date. A
longer time-period would delay the benefit from the increased
efficiencies, such as standardization of review tools across
applications, and the incremental cost savings to industry would be
small.
Anticipated Cost and Benefits: Standardization of clinical data
structure, terminology, and code sets will increase the efficiency of
the Agency review process. FDA estimates that the costs resulting from
the proposal would include substantial one-time costs, additional waves
of one-time costs as standards mature, and possibly some annual
recurring costs. One-time costs would include, among other things, the
cost of converting data to standard structures, terminology, and cost
sets (i.e., purchase of software to convert data); the cost of
submitting electronic data (i.e., purchase of file transfer programs);
and the cost of installing and validating the software and training
personnel. Additional annual recurring costs may result from software
purchases and licensing agreements for use of proprietary
terminologies. The proposal could result in many long-term benefits
associated with reduced time for preparing applications, including
reduced preparation costs and faster time to market for beneficial
products. In addition, the proposed rule would improve patient safety
through faster, more efficient, comprehensive and accurate data review,
as well as enhanced communication among sponsors and clinicians.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Martha Nguyen, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Drug Evaluation and Research, WO 51, Room 6352, 10903 New Hampshire
Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3471, Fax: 301
847-8440, Email: [email protected].
RIN: 0910-AC52
HHS--FDA
34. Current Good Manufacturing Practice and Hazard Analysis and Risk-
Benefit Preventive Controls for Food for Animals
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350e; 21 U.S.C. 371; 21
U.S.C. 374; 42 U.S.C. 264; Pub. L. 110-85, sec 1002(a)(2); Pub. L. 111-
353
CFR Citation: 21 CFR 228.
Legal Deadline: Final, Statutory, September 27, 2009, FDA is
directed to issue proposed and final regulations under FDA Amendments
Act by the statutory deadline.
The legal deadline for FDA under the Food Safety and Modernization
Act to promulgate regulations is July 2012.
Abstract: The Food and Drug Administration (FDA) is proposing
regulations for preventive controls for animal feed ingredients and
mixed animal feed to provide greater assurance that marketed animal
feed ingredients and mixed feeds intended for all animals, including
pets, are safe. This action is being taken as part of the FDA's Animal
Feed Safety System initiative. This action is also being taken to carry
out the requirements of the Food and Drug Administration Amendments Act
of 2007, under section 1002(a), and the Food Safety Modernization Act
of 2010 (FSMA), under section 103.
Statement of Need: Regulatory oversight of the animal food industry
has traditionally been limited and
[[Page 7719]]
focused on a few known safety issues, so there could be potential human
and animal health problems that remain unaddressed. The massive pet
food recall due to adulteration of pet food with melamine and cyanuric
acid in 2007 is a prime example. The actions taken by two protein
suppliers in China affected a large number of pet food suppliers in the
United States and created a nationwide problem. By the time the cause
of the problem was identified, melamine and cyanuric acid contaminated
ingredients resulted in the adulteration of millions of individual
servings of pet food. Congress passed FSMA which the President signed
into law on January 4, 2011 (Pub. L. 111-353). Section 103 of FSMA
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding
section 418 (21 U.S.C. 350g) Hazard Analysis and Risk Based Preventive
Controls. In enacting FSMA, Congress sought to improve the safety of
food in the United States by taking a risk-based approach to food
safety, emphasizing prevention. Section 418 of the FD&C Act requires
owners, operators, or agents in charge of food facilities to develop
and implement a written plan that describes and documents how their
facility will implement the hazard analysis and preventive controls
required by this section.
Summary of Legal Basis: FDA's authority for issuing this rule is
provided in FSMA (Pub. L. 111-353), which amended the FD&C Act by
establishing section 418, which directed FDA to publish implementing
regulations. FSMA also amended section 301 of the FD&C Act to add
301(uu) that states the operation of a facility that manufactures,
processes, packs, or holds food for sale in the United States if the
owner, operator, or agent in charge of such facility is not in
compliance with section 418 of the FD&C Act is a prohibited act.
Further authority comes from section 1002(a) of title X of the FDAAA of
2007 (21 U.S.C. 2102) requiring the Secretary to update standards for
the processing of pet food.
FDA is also issuing this rule under the general requirements of
section 402 of the FD&C Act (21 U.S.C. 342) for adulterated food.
In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a))
authorizes the Agency to issue regulations for the efficient
enforcement of the Act.
Alternatives: The 2011 FSMA limited the Agency's flexibility to
exclude many requirements. It described in detail its requirements for
subpart C, concerning the hazard analysis and risk-based preventive
controls part of the proposed rule. Alternatives include certain
requirements listed in subpart B concerning operations and practices.
Anticipated Cost and Benefits: The benefits of the proposed rule
would result from fewer cases of contaminated animal food ingredients
or finished animal food products. Discovering contaminated food
ingredients before they are used in a finished product would reduce the
number of recalls of contaminated animal food products. Benefits would
include reduced medical treatment costs for animals and humans, reduced
loss of market value of live animals, reduced loss of animal
companionship, and reduced loss in value of animal food products. More
stringent requirements for animal food manufacturing would maintain
public confidence in the safety of animal foods and protect animal and
human health. FDA lacks sufficient data to quantify the benefits of the
proposed rule.
The compliance costs of the proposed rule would result from the
additional labor and capital required to perform the hazard analyses,
write and implement the preventive controls, monitor and verify the
preventive controls, take corrective actions if preventive controls
fail to prevent feeds from becoming contaminated, and implement
requirements from the operations and practices section.
Risks: FDA is proposing this rule to provide greater assurance that
food intended for animals is safe and will not cause illness or injury
to animals or humans. This rule would implement a risk-based,
preventive controls food safety system intended to prevent animal food
containing hazards, which may cause illness or injury to animals or
humans, from entering into the food supply. The rule would apply to
domestic and imported animal food (including raw materials and
ingredients). Fewer cases of animal food contamination would (1) reduce
the risk of serious illness and death to animals, (2) reduce the risk
of adverse health effects to humans handling animal food, and (3)
reduce the risk of consuming human food from animals that consumed
contaminated food.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Kim Young, Deputy Director, Division of Compliance,
Department of Health and Human Services, Food and Drug Administration,
Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519
Standish Place, Rockville, MD 20855, Phone: 240 276-9207, Email:
[email protected].
RIN: 0910-AG10
HHS--FDA
35. Unique Device Identification
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Not Yet Determined
CFR Citation: 21 CFR 16; 21 CFR 801; 21 CFR 803; 21 CFR 806; 21 CFR
810; 21 CFR 814; 21 CFR 820; 21 CFR 821; 21 CFR 822.
Legal Deadline: None.
Abstract: The Food and Drug Administration Amendments Act of 2007
(FDAAA), amended the Federal Food, Drug, and Cosmetic Act by adding
section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to
promulgate regulations establishing a unique identification system for
medical devices requiring the label of medical devices to bear a unique
identifier, unless FDA specifies an alternative placement or provides
for exceptions. The unique identifier must adequately identify the
device through distribution and use, and may include information on the
lot or serial number.
Statement of Need: A unique device identification system will help
reduce medical errors; will allow FDA, the healthcare community, and
industry to more rapidly review and organize adverse event reports;
identify problems relating to a particular device (even down to a
particular lot or batch, range of serial numbers, or range of
manufacturing or expiration dates); and thereby allow for more rapid,
effective, corrective actions that focus sharply on the specific
devices that are of concern.
Summary of Legal Basis: Section 519(f) of the FD&C Act (added by
sec. 226 of the Food and Drug Administration Amendments Act of 2007)
directs the Secretary to promulgate regulations establishing a unique
device identification (UDI) system for medical devices, requiring the
label of devices to bear a unique identifier that will adequately
identify the device through its distribution and use.
Alternatives: FDA considered several alternatives that would allow
certain
[[Page 7720]]
requirements of the proposed rule to vary, such as the required
elements of a UDI and the scope of affected devices.
Anticipated Cost and Benefits: FDA estimates that the affected
industry would incur one-time and recurring costs, including
administrative costs, to change and print labels that include the
required elements of a UDI, costs to purchase equipment to print and
verify the UDI, and costs to purchase software and integrate and
validate the UDI into existing IT systems. FDA anticipates that
implementation of a UDI system would help improve the efficiency and
accuracy of medical device recalls and medical device adverse event
reporting. The proposed rule would also standardize how medical devices
are identified and contribute to future potential public health
benefits of initiatives aimed at optimizing the use of automated
systems in healthcare. Most of these benefits, however, require
complementary developments and innovations in the private and public
sectors.
Risks: This rule is intended to substantially eliminate existing
obstacles to the consistent identification of medical devices used in
the United States. By providing the means to rapidly and accurately
identify a device and key attributes that affect its safe and effective
use, the rule would reduce medical errors that result from
misidentification of a device or confusion concerning its appropriate
use. The rule will fulfill a statutory directive to establish a unique
device identification system.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Federalism: Undetermined.
Agency Contact: John J. Crowley, Senior Advisor for Patient Safety,
Department of Health and Human Services, Food and Drug Administration,
Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New
Hampshire Avenue, Silver Spring, MD 20993, Phone: 301 980-1936, Email:
[email protected].
RIN: 0910-AG31
HHS--FDA
36. Produce Safety Regulation
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42
U.S.C. 264; Pub. L. 111-353 (signed on Jan. 4, 2011)
CFR Citation: Not Yet Determined.
Legal Deadline: NPRM, Statutory, January 4, 2012, Proposed rule not
later than 12 months after the date of enactment of the Food Safety
Modernization Act.
Abstract: The Food Safety Modernization Act requires the Secretary
to establish and publish science-based minimum standards for the safe
production and harvesting of those types of fruits and vegetables,
including specific mixes or categories of fruits and vegetables, that
are raw agricultural commodities for which the Secretary has determined
that such standards minimize the risk of serious adverse health
consequences or death. FDA is proposing to promulgate regulations
setting enforceable standards for fresh produce safety at the farm and
packing house. The purpose of the proposed rule is to reduce the risk
of illness associated with contaminated fresh produce. The proposed
rule will be based on prevention-oriented public health principles and
incorporate what we have learned in the past decade since the Agency
issued general good agricultural practice guidelines entitled ``Guide
to Minimize Microbial Food Safety Hazards for Fresh Fruits and
Vegetables'' (GAPs Guide). The proposed rule also will reflect comments
received on the Agency's 1998 update of its GAPs guide and its July
2009 draft commodity specific guidances for tomatoes, leafy greens, and
melons. Although the proposed rule will be based on recommendations
that are included in the GAPs guide, FDA does not intend to make the
entire guidance mandatory. FDA's proposed rule would, however, set out
clear standards for implementation of modern preventive controls. The
proposed rule also would emphasize the importance of environmental
assessments to identify hazards and possible pathways of contamination
and provide examples of risk reduction practices recognizing that
operators must tailor their preventive controls to particular hazards
and conditions affecting their operations. The requirements of the
proposed rule would be scale appropriate and commensurate with the
relative risks and complexity of individual operations. FDA intends to
issue guidance to assist industry in complying with the requirements of
the new regulation.
Statement of Need: FDA is taking this action to meet the
requirements of the FSMA and to address the food safety challenges
associated with fresh produce and thereby protect the public health.
Data indicate that between 1973 and 1997, outbreaks of foodborne
illness in the U.S. associated with fresh produce increased in absolute
numbers and as a proportion of all reported foodborne illness
outbreaks. The Agency issued general good agricultural practice
guidelines for fresh fruits and vegetables over a decade ago.
Incorporating prevention-oriented public heath principles and
incorporating what we have learned in the past decade into a regulation
is a critical step in establishing standards for the growing,
harvesting, packing, and storing of produce and reducing the foodborne
illness attributed to fresh produce.
Summary of Legal Basis: FDA is relying on the amendments to the
Federal Food, Drug, and Cosmetic Act (the FD&C Act), provided by
section 105 of the Food Safety Modernization Act (codified primarily in
sec. 419 of the FD&C Act (21 U.S.C. 350h)). FDA's legal basis also
derives in part from sections 402(a)(4) and 701(a) of the FD&C Act (21
U.S.C. 342(a)(4) and 371(a)). FDA also intends to rely on section 361
of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives
FDA authority to promulgate regulations to control the spread of
communicable disease.
Alternatives: Section 105 of the Food Safety Modernization Act
requires FDA to conduct this rulemaking.
Anticipated Cost and Benefits: FDA estimates that the costs to more
than 300,000 domestic and foreign producers and packers of fresh
produce from the proposal would include one-time costs (e.g., new tools
and equipment) and recurring costs (e.g., monitoring, training,
recordkeeping). FDA anticipates that the benefits would be a reduction
in foodborne illness and deaths associated with fresh produce.
Monetized estimates of costs and benefits are not available at this
time.
Risks: This regulation would directly and materially advance the
Federal Government's substantial interest in reducing the risks for
illness and death associated with foodborne infections associated with
the consumption of fresh produce. Less restrictive and less
comprehensive approaches have not been sufficiently effective in
reducing the problems addressed by this
[[Page 7721]]
regulation. FDA anticipates that the regulation would lead to a
significant decrease in foodborne illness associated with fresh produce
consumed in the U.S.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Federalism: Undetermined.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Samir Assar, Supervisory Consumer Safety Officer,
Department of Health and Human Services, Food and Drug Administration,
Center for Food Safety and Applied Nutrition, Office of Food Safety,
5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1636,
Email: [email protected].
RIN: 0910-AG35
HHS--FDA
37. Hazard Analysis and Risk-Based Preventive Controls
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 342; 21 U.S.C. 371; 42 U.S.C. 264; Pub.
L. 111-353 (signed on Jan. 4, 2011)
CFR Citation: 21 CFR 110.
Legal Deadline: Final, Statutory, July 4, 2012, Final rule must be
published no later than 18 months after the date of enactment of the
FDA Food Safety Modernizaton Act.
Not later than 9 months after the date of enactment of the FDA Food
Safety Modernization Act.
Abstract: The Food and Drug Administration (FDA) Food Safety
Modernization Act (the FSMA) requires the Secretary of Health and Human
Services to promulgate regulations to establish science-based minimum
standards for conducting a hazard analysis, documenting hazards,
implementing preventive controls, and documenting the implementation of
the preventive controls; and to define the terms ``small business'' and
``very small business.'' The FSMA also requires the Secretary to
promulgate regulations with respect to activities that constitute on-
farm packing or holding of food that is not grown, raised, or consumed
on a farm or another farm under the same ownership and activities that
constitute on farm manufacturing or processing of food that is not
grown, raised, or consumed on a farm or another farm under the same
ownership.
FDA is proposing to amend its current good manufacturing practice
(CGMP) regulations (21 CFR part 110) for manufacturing, packing, or
holding human food to require food facilities to develop and implement
a written food safety plan. This proposed rule would require a food
facility to have and implement preventive controls to significantly
minimize or prevent the occurrence of hazards that could affect food
manufactured, processed, packed, or held by the facility and to provide
assurances that such food will not be adulterated under section 402 or
misbranded under section 403(w).
Statement of Need: FDA is taking this action to meet the
requirements of the FSMA and to better address changes that have
occurred in the food industry and thereby protect public health.
FDA last updated its food CGMP regulations for the manufacturing,
packing, or holding of human food in 1986. Modernizing these food CGMP
regulations to address risk-based preventive controls and more
explicitly address issues such as environmental pathogens, food
allergens, mandatory employee training, and sanitation of food contact
surfaces, would be a critical step in raising the standards for food
production and distribution. By amending 21 CFR 110 to modernize good
manufacturing practices, the agency could focus the attention of food
processors on measures that have been proven to significantly reduce
the risk of food-borne illness. An amended regulation also would allow
the agency to better focus its regulatory efforts on ensuring industry
compliance with controls that have a significant food safety impact.
Summary of Legal Basis: FDA is relying on section 103 of the FSMA.
FDA is also relying on sections 402(a)(3), (a)(4) and 701(a) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
342(a)(3), (a)(4), and 371(a)). Under section 402(a)(3) of the FD&C
Act, a food is adulterated if it consists in whole or in part of any
filthy, putrid, or decomposed substance, or if it is otherwise unfit
for food. Under section 402(a)(4), a food is adulterated if it has been
prepared, packed, or held under unsanitary conditions whereby it may
have become contaminated with filth or may have been rendered injurious
to health. Under section 701(a) of the FD&C Act, FDA is authorized to
issue regulations for the efficient enforcement of the FD&C Act. FDA's
legal basis also derives from section 361 of the Public Health Service
Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate
regulations to control the spread of communicable disease.
Alternatives: An alternative to this rulemaking is not to update
the CGMP regulations, and instead issue separate regulations to
implement the FDA Food Safety Modernization Act.
Anticipated Cost and Benefits: FDA estimates that the costs from
the proposal to domestic and foreign producers and packers of processed
foods would include new one-time costs (e.g., adoption of written food
safety plans, setting up training programs, implementing allergen
controls, and purchasing new tools and equipment) and recurring costs
(e.g., auditing and monitoring suppliers of sensitive raw materials and
ingredients, training employees, and completing and maintaining records
used throughout the facility). FDA anticipates that the benefits would
be a reduced risk of food-borne illness and death from processed foods
and a reduction in the number of safety related recalls.
Risks: This regulation will directly and materially advance the
Federal Government's substantial interest in reducing the risks for
illness and death associated with food-borne infections. Less
restrictive and less comprehensive approaches have not been effective
in reducing the problems addressed by this regulation. The regulation
will lead to a significant decrease in foodborne illness in the U.S.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Federalism: Undetermined.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: John F. Sheehan, Director, Office of Food Safety,
Division of Plant and Dairy Food Safety, Department of Health and Human
Services, Food and Drug Administration, Center for Food Safety and
Applied Nutrition (HFS-315), 5100 Paint Branch Parkway, College Park,
MD 20740, Phone: 240 402-1488, Fax: 301 436-2632, Email:
[email protected].
[[Page 7722]]
RIN: 0910-AG36
HHS--FDA
38. Foreign Supplier Verification Program
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: Title III, sec 301 of FDA Food Safety
Modernization Act, Pub. L. 111-353, establishing sec 805 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act)
CFR Citation: Not Yet Determined.
Legal Deadline: Final, Statutory, January 4, 2012.
Abstract: The proposed rule would establish regulations concerning
the content of foreign supplier verification programs. The regulations
will require that each importer have a foreign supplier verification
program that is adequate to provide assurances that each foreign
supplier produces food in compliance with: (1) Processes and procedures
that provide the same level of public health protection as those
required under section 418 (concerning hazard analysis and risk-based
preventative controls) or section 419 (concerning produce safety
standards) of the FD&C Act; and (2) sections 402 (concerning
adulteration) and 403(w) (concerning major food allergens) of the FD&C
Act. In promulgating the foreign supplier verification regulations, we
will, as appropriate, take into account differences among importers and
types of imported foods, including differences related to the level of
risk posed by an imported food. Methods of foreign supplier
verification may include monitoring records for shipments, lot-by-lot
certifications of compliance, annual on-site inspections, checking the
hazard analysis and risk-based preventive control plans of foreign
suppliers, and periodically testing and sampling shipments.
Statement of Need: The proposed rule is needed to help improve the
safety of food that is imported into the United States. Imported food
products have increased dramatically over the last several decades.
Data indicate that about 15% of the U.S. food supply is imported. FSMA
provides the Agency with additional tools and authorities to help
ensure that imported foods are safe for U.S. consumers. Included among
these tools and authorities is a requirement that importers perform
risk-based foreign supplier verification activities to verify that the
food they import is produced in compliance with U.S. requirements and
is not adulterated or misbranded. This proposed rule on the content of
foreign supplier verification program (FSVPs) sets forth the proposed
steps that food importers would be required to take to fulfill their
responsibility to ensure the safety of the food they bring into this
country.
Summary of Legal Basis: Section 805(c) of the FD&C Act (21 U.S.C.
384a(c)) directs FDA, not later than 1 year after the date of enactment
of FSMA, to issue regulations on the content of FSVPs. Section
805(c)(4) states that verification activities under such programs may
include monitoring records for shipments, lot-by-lot certification of
compliance, annual onsite inspections, checking the hazard analysis and
risk-based preventive control plans of foreign suppliers, and
periodically testing and sampling shipments of imported products.
Section 301(b) of FSMA amends section 301 of the FD&C Act (21 U.S.C.
331) by adding section 301(zz), which designates as a prohibited act
the importation or offering for importation of a food if the importer
(as defined in section 805) does not have in place an FSVP in
compliance with section 805. In addition, section 301(c) of FSMA amends
section 801(a) of the FD&C Act (21 U.S.C. 381(a)) by stating that an
article of food being imported or offered for import into the United
States shall be refused admission if it appears from an examination of
a sample of such an article or otherwise that the importer is in
violation of section 805.
Alternatives: We are considering a range of alternative approaches
to the requirements for foreign supplier verification activities. These
might include: (1) Establishing a general requirement that importers
determine and conduct whatever verification activity that would
adequately address the risks associated with the foods they import; (2)
allowing importers to choose from a list of possible verification
mechanisms, such as the activities listed in section 805(c)(4) of the
FD&C Act; (3) requiring importers to conduct particular verification
activities for certain types of foods or risks (e.g., for high-risk
foods) but allowing flexibility in verification activities for other
types of foods or risks; and (4) specifying use of a particular
verification activity for each particular kind of food or risk. To the
extent possible while still ensuring that verification activities are
adequate to ensure that foreign suppliers are producing food in
accordance with U.S. requirements, we will seek to give importers the
flexibility to choose verification procedures that are appropriate to
adequately address the risks associated with the importation of a
particular food.
Anticipated Cost and Benefits: We have not yet quantified the cost
and benefits for this proposed rule. However, the available information
suggests that the costs will be significant. Our preliminary analysis
of FY10 OASIS data suggests that this rule will cover about 60,000
importers, 240,000 unique combinations of importers and foreign
suppliers, and 540,000 unique combinations of importers, products, and
foreign suppliers. These numbers imply that provisions that require
activity for each importer, each unique combination of importer and
foreign supplier, or each unique combination of importer, product, and
foreign supplier will generate significant costs. An example of a
provision linked to combinations of importers and foreign suppliers
would be a requirement to conduct a verification activity, such as an
onsite audit, under certain conditions. The cost of onsite audits will
depend in part on whether foreign suppliers can provide the same onsite
audit results to different importers or whether every importer will
need to take some action with respect to each of their foreign
suppliers. The benefits of this proposed rule will consist of the
reduction of adverse health events linked to imported food that could
result from compliance with the FSVP requirements. We have not yet
estimated the benefits of the rule.
Risks: As stated above, about 15 percent of the U.S. food supply is
imported, and many of these imported foods are high-risk commodities.
According to recent data from the Centers for Disease Control and
Prevention, each year, about 48 million Americans get sick, 128,000 are
hospitalized, and 3,000 die from foodborne diseases. From July 1, 2007,
through June 30, 2008, FDA oversaw 40 recalls of imported foods that
were so contaminated that the Agency deemed them to be an imminent
threat. We expect that the adoption of FSVPs by food importers will
lead to a significant reduction to the threat to public health posed by
unsafe imported food, though we are still in the process of trying to
quantify the reduction in risk that will occur through importer
compliance with the FSVP regulations.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
[[Page 7723]]
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Brian L. Pendleton, Senior Policy Advisor,
Department of Health and Human Services, Food and Drug Administration,
Office of Policy, WO32, Room 4245, 10903 New Hampshire Avenue, Silver
Spring, MD 20993-0002, Phone: 301 796-4614, Fax: 301 847-8616, Email:
[email protected].
RIN: 0910-AG64.
HHS--FDA
39. Accreditation of Third Parties To Conduct Food Safety Audits and
for Other Related Purposes
Priority: Other Significant.
Legal Authority: Pub. L. 111-353, sec 307, FDA Food Safety
Modernization Act; Other sections of FDA Food Safety Modernization Act,
as appropriate.
CFR Citation: Not Yet Determined.
Legal Deadline: Final, Statutory, July 2012, Promulgate
implementing regulations. Per Public Law 111-353, section 307(c)(5)(C),
promulgate, within 18 months of enactment, implementing regulations for
accreditation of third-party auditors to conduct food safety audits.
Abstract: The Food and Drug Administration (FDA) is proposing
regulations relating to the accreditation of third-party auditors to
conduct food safety audits of foreign entities, including foreign
facilities in the food import supply chain. The proposed regulations
will include provisions to protect against conflicts of interest
between accredited auditors and audited entities, as described in
section 307 of the FDA Food Safety Modernization Act (FSMA), Public Law
111-353. As part of this rulemaking, FDA may propose regulations
relating to the accreditation of third parties to perform related
activities, such as conducting laboratory analyses of food, authorized
by other sections of FSMA.
Statement of Need: The use of accredited third-party auditors to
certify high-risk food imports to assist in ensuring the safety of food
from foreign origin entering U.S. commerce. Accredited third-party
auditors auditing foreign process facilities may be viewed as
increasing FDA's ``coverage'' of foreign facilities that FDA may not
have adequate resources to inspect in a particular year while using
identified standards creating overall uniformity to complete the task.
Audits that result in issuance of facility certificates will provide
FDA information about the compliance status of the facility.
Additionally, auditors will be required to submit audit reports that
may be reviewed by FDA for purposes of compliance assessment and work
planning.
Summary of Legal Basis: Not later than 2 years after the date of
enactment, establish a system for the recognition of accreditation
bodies that accredit third-party auditors, certifying that their
eligible entities meet the requirements, directly accredit third-party
auditors should none be identified and recognized by the 2-year date of
enactment, obtain a list of all accredited third-party auditors and
their agents from recognized accreditation bodies, and determine
requirements for regulatory audit reports while avoiding unnecessary
duplication of efforts and costs.
Alternatives: FSMA described in detail the framework for, and
requirements of, the accredited third-party auditor program.
Alternatives include certain oversight activities required of
recognized accreditation bodies that accredit third-party auditors, as
distinguished from third-party auditors directly accredited by FDA.
Another alternative relates to the nature of the required standards and
the degree to which those standards are prescriptive or flexible.
Anticipated Cost and Benefits: The benefits of the proposed rule
would result from fewer cases of unsafe or misbranded food entering
U.S. commerce. Additional benefits include the increased flow of
credible information to FDA regarding the compliance status of foreign
firms and their foods that are ultimately offered for import Into the
United States, which information in turn would inform FDA's work
planning for inspection of foreign food facilities and might result in
a signal of possible problems with a particular firm or its products,
and with sufficient signals, might raise questions about the rigor of
the food safety regulatory system of the country of origin.
The compliance costs of the proposed rule would result from the
additional labor and capital required of accreditation bodies seeking
FDA recognition and of third-party auditors seeking accreditation to
the extent that will involve the assembling of information for an
application unique to the FDA third-party program. The compliance costs
associated with certification will be accounted for separately under
the costs associated with participation In the foreign supplier
verification program and the costs associated with mandatory
certification for high-risk food imports. The third-party program is
funded through revenue neutral user fees, which will be developed by
FDA through rulemaklng. User fee costs will be accounted for in that
rulemaklng.
Risks: FDA is proposing this rule to provide greater assurance the
food offered for import into the United States is safe and will not
cause injury or illness to animals or humans. The rule would implement
a program for accrediting third-party auditors to conduct food safety
audits of foreign food entities, including registered foreign food
facilities, and based on the findings of the regulatory audit, to issue
certifications to foreign food entities found to be in compliance with
FDA requirements. The certifications would be used by importers seeking
to participate in the Voluntary Qualified Importer Program for
expedited review and entry of product and would be a means to provide
assurance of compliance as required by FDA based on risk-related
considerations. The rule would apply to any foreign or domestic
accreditation body seeking FDA recognition, any foreign or domestic
third-party auditor seeking accreditation, any registered foreign food
facility or other foreign food entity subject to a food safety audit
(including a regulatory audit conducted for purposes of certification),
and any importer seeking to participate in the Voluntary Qualified
Importer Program. Fewer cases of unsafe or misbranded food entering
U.S. commerce would reduce the risk of serious illness and death to
humans and animals.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Undetermined.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Charlotte A. Christin, Senior Policy Advisor,
Department of Health and Human Services, Food and Drug Administration,
Office of Policy WO32, Room 4234, 10903 New Hampshire Avenue, Silver
Spring, MD 20993, Phone: 301 796-4718, Fax: 301
[[Page 7724]]
847-3541, Email: [email protected].
RIN: 0910-AG66
HHS--FDA
Final Rule Stage
40. Infant Formula: Current Good Manufacturing Practices; Quality
Control Procedures; Notification Requirements; Records and Reports; and
Quality Factors
Priority: Other Significant.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 350a; 21 U.S.C. 371
CFR Citation: 21 CFR 106 and 107.
Legal Deadline: None.
Abstract: The Food and Drug Administration (FDA) is revising its
infant formula regulations in 21 CFR parts 106 and 107 to establish
requirements for current good manufacturing practices (CGMP), including
audits; to establish requirements for quality factors; and to amend
FDA's quality control procedures, notification, and record and
reporting requirements for infant formula. FDA is taking this action to
improve the protection of infants who consume infant formula products.
Statement of Need: The Agency published a proposed rule on July 9,
1996, that would establish current good manufacturing practice
regulations, quality control procedures, quality factors, notification
requirements, records, and reports for the production of infant
formula. This proposal was issued in response to the 1986 Amendments to
the Infant Formula Act of 1980. On April 28, 2003, FDA reopened the
comment period to update comments on the proposal. The comment was
extended on June 27, 2003, and ended on August 26, 2003. The comment
period was reopened on August 1, 2006, and ended on September 15, 2006.
Summary of Legal Basis: The Infant Formula Act of 1980 (the 1980
Act) (Pub. L. 96-359) amended the Federal Food, Drug, and Cosmetic Act
(the Act) to include section 412 (21 U.S.C. 350a). This law is intended
to improve protection of infants consuming infant formula products by
establishing greater regulatory control over the formulation and
production of infant formula. In 1982, FDA adopted infant formula
recall procedures in subpart D of 21 CFR part 107 of its regulations
(47 FR 18832, Apr. 30, 1982), and infant formula quality control
procedures in subpart B of 21 CFR part 106 (47 FR 17016, Apr. 20,
1982). In 1985, FDA further implemented the 1980 Act by establishing
subparts B, C, and D in 21 CFR part 107 regarding the labeling of
infant formula, exempt infant formulas, and nutrient requirements for
infant formula, respectively (50 FR 1833, Jan. 14, 1985; 50 FR 48183,
Nov. 22, 1985; and 50 FR 45106, Oct. 30, 1985).
In 1986, Congress, as part of the Anti-Drug Abuse Act of 1986 (Pub.
L. 99-570) (the 1986 amendments), amended section 412 of the act to
address concerns that had been expressed by Congress and consumers
about the 1980 Act and its implementation related to the sufficiency of
quality control testing, CGMP, recordkeeping, and recall requirements.
The 1986 amendments: (1) State that an infant formula is deemed to be
adulterated if it fails to provide certain required nutrients, fails to
meet quality factor requirements established by the Secretary (and, by
delegation, FDA), or if it is not processed in compliance with the CGMP
and quality control procedures established by the Secretary; (2)
require that the Secretary issue regulations establishing requirements
for quality factors and CGMP, including quality control procedures; (3)
require that infant formula manufacturers regularly audit their
operations to ensure that those operations comply with CGMP and quality
control procedure regulations; (4) expand the circumstances in which
firms must make a submission to the Agency to include when there is a
major change in an infant formula or a change that may affect whether
the formula is adulterated; (5) specify the nutrient quality control
testing that must be done on each batch of infant formula; (6) modify
the infant formula recall requirements; and (7) give the Secretary
authority to establish requirements for retention of records, including
records necessary to demonstrate compliance with CGMP and quality
control procedures. In 1989, the Agency implemented the provisions on
recalls (secs. 412(f) and (g) of the Act) by establishing subpart E in
21 CFR part 107 (54 FR 4006, Jan. 27, 1989). In 1991, the Agency
implemented the provisions on record and record retention requirements
by revising 21 CFR 106.100 (56 FR 66566, Dec. 24, 1991).
The Agency has already promulgated regulations that respond to a
number of the provisions of the 1986 amendments. The final rule would
address additional provisions of these amendments.
Alternatives: The 1986 amendments require the Secretary (and, by
delegation, FDA) to establish, by regulation, requirements for quality
factors and CGMPs, including quality control procedures. Therefore,
there are no alternatives to rulemaking.
Anticipated Cost and Benefits: FDA estimates that the costs from
the final rule to producers of infant formula would include first year
and recurring costs (e.g., administrative costs, implementation of
quality controls, records, audit plans, and assurances of quality
factors in new infant formulas). FDA anticipates that the primary
benefits would be a reduced risk of illness due to Cronobacter
sakazakii and Salmonella spp in infant formula. Additional benefits
stem from the quality factors requirements that would assure the
healthy growth of infants consuming infant formula. Monetized estimates
of costs and benefits for this final rule are not available at this
time. The analysis for the proposed rule estimated costs of less than
$1 million per year. FDA was not able to quantify benefits in the
analysis for the proposed rule.
Risks: Special controls for infant formula manufacturing are
especially important because infant formula, particularly powdered
infant formula, is an ideal medium for bacterial growth and because
infants are at high risk of foodborne illness because of their immature
immune systems. In addition, quality factors are of critical need to
assure that the infant formula supports healthy growth in the first
months of life when infant formula may be an infant's sole source of
nutrition. The provisions of this rule will address weaknesses in
production that may allow contamination of infant formula, including,
contamination with C. sakazakii and Salmonella spp which can lead to
serious illness with devastating sequelae and/or death. The provisions
would also assure that new infant formulas support healthy growth in
infants.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/09/96 61 FR 36154
NPRM Comment Period End............. 12/06/96
NPRM Comment Period Reopened........ 04/28/03 68 FR 22341
NPRM Comment Period Extended........ 06/27/03 68 FR 38247
NPRM Comment Period End............. 08/26/03
NPRM Comment Period Reopened........ 08/01/06 71 FR 43392
NPRM Comment Period End............. 09/15/06
Final Action........................ 03/00/12
------------------------------------------------------------------------
[[Page 7725]]
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Benson Silverman, Department of Health and Human
Services, Food and Drug Administration, Center for Food Safety and
Applied Nutrition (HFS-850), 5100 Paint Branch Parkway, College Park,
MD 20740, Phone: 240 402-1459, Email: [email protected].
Related RIN: Split from 0910-AA04.
RIN: 0910-AF27
HHS--FDA
41. Medical Device Reporting; Electronic Submission Requirements
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374
CFR Citation: 21 CFR 803.
Legal Deadline: None.
Abstract: The Food and Drug Administration (FDA) is amending its
postmarket medical device reporting (MDR) regulations to require that
manufacturers, importers, and user facilities submit mandatory reports
of medical device adverse events to the Agency in an electronic format
that FDA can process, review, and archive. FDA is taking this action to
improve the Agency's systems for collecting and analyzing postmarketing
safety reports. The proposed change would help the Agency to more
quickly review safety reports and identify emerging public health
issues.
Statement of Need: The final rule would require user facilities and
medical device manufacturers and importers to submit medical device
adverse event reports in electronic format instead of using a paper
form. FDA is taking this action to improve its adverse event reporting
program by enabling it to more quickly receive and process these
reports.
Summary of Legal Basis: The Agency has legal authority under
section 519 of the Federal Food, Drug, and Cosmetic Act to require
adverse event reports. The final rule would require manufacturers,
importers, and user facilities to change their procedures to send
reports of medical device adverse events to FDA in electronic format
instead of using a hard copy form.
Alternatives: There are two alternatives. The first alternative is
to allow the voluntary submission of electronic MDRs. If a substantial
number of reporters fail to voluntarily submit electronic MDRs, FDA
will not obtain the benefits of standardized formats and quicker access
to medical device adverse event data. The second alternative is to
allow small entities more time to comply. This would significantly
postpone the benefits of the rule; moreover, it would only delay,
rather than reduce or eliminate, the costs of compliance.
Anticipated Cost and Benefits: The principal benefit would be to
public health, due to the increased speed in the processing and
analysis of medical device reports currently submitted annually on
paper. In addition, requiring electronic submission would reduce FDA
annual operating costs and generate industry savings.
The one-time costs are for modifying standard operating procedures
and establishing electronic submission capabilities. Annually recurring
costs include maintenance of electronic submission capabilities,
including renewing the electronic certificate, and for some firms, the
incremental cost to maintain high-speed Internet access.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/21/09 74 FR 42203
NPRM Comment Period End............. 11/19/09
Final Action........................ 03/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: [email protected].
RIN: 0910-AF86
HHS--FDA
42. Electronic Registration and Listing for Devices
Priority: Other Significant.
Legal Authority: Pub. L. 110-85; Pub. L. 107-188, sec 321; Pub. L.
107-250, sec 207; 21 U.S.C. 360(a) through 360(j); 21 U.S.C. 360(p)
CFR Citation: 21 CFR 807.
Legal Deadline: None.
Abstract: This rule would codify the requirements for electronic
registration and listing. However, for those companies that do not have
access to the Web, FDA will offer an avenue by which they can register,
list, and update information with a paper submission. The rule also
will amend part 807 to reflect the timeframes for device establishment
registration and listing established by sections 222 and 223 of Food
and Drug Administration Amendment Act (FDAAA) and to reflect the
requirement in section 510(i) of the Act, as amended by section 321 of
the Public Health Security and Bioterrorism Preparedness and Response
Act (BT Act), that foreign establishments provide FDA with additional
pieces of information as part of their registration.
Statement of Need: FDA is amending the medical device establishment
registration and listing requirements under 21 CFR part 807 to reflect
the electronic submission requirements in section 510(p) of the Act,
which was added by section 207 of MDUFMA and later amended by section
224 of FDAAA. FDA also is amending 21 CFR part 807 to reflect the
requirements in section 321 of the BT Act for foreign establishments to
furnish additional information as part of their registration. This rule
will improve FDA's device establishment registration and listing system
and utilize the latest technology in the collection of this
information.
Summary of Legal Basis: The statutory basis for our authority
includes sections 510(a) through (j), 510(p), 701, 801, and 1003 of the
Act.
Alternatives: The alternatives to this rulemaking include not
updating the registration and listing regulations. Because of the new
FDAAA statutory requirements and the advances in data collection and
transmission technology, FDA believes this rulemaking is the preferable
alternative.
Anticipated Cost and Benefits: The Agency believes that there may
be some one-time costs associated with the rulemaking, which involve
resource costs of familiarizing users with the electronic system.
Recurring costs related to submission of the information by domestic
firms would probably remain the same or decrease because a paper
submission and postage is not required. There might be some increase in
the financial burden on foreign firms since they will have to supply
additional registration information as required by section 321 of the
BT Act.
Risks: None.
Timetable:.
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/26/10 75 FR 14510
[[Page 7726]]
NPRM Comment Period End............. 06/24/10 .......................
Final Rule.......................... 05/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: Nancy Pirt, Regulatory Counsel, Department of
Health and Human Services, Food and Drug Administration, Center for
Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire
Avenue, Silver Spring, MD 20993, Phone: 301 796-6248, Fax: 301 847-
8145, Email: [email protected].
RIN: 0910-AF88
HHS--FDA
43. Food Labeling: Nutrition Labeling for Food Sold in Vending Machines
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Food and Drug Administration (FDA) published a
proposed rule in the Federal Register of April 6, 2011 (72 FR 19238) to
establish requirements for nutrition labeling of certain food items
sold in certain vending machines. FDA also proposed the terms and
conditions for vending machine operators registering to voluntarily be
subject to the requirements. FDA took this action to carry out section
4205 of the Patient Protection and Affordable Care Act (``Affordable
Care Act'' or ``ACA''), which was signed into law on March 23, 2010.
Statement of Need: This rulemaking was mandated by section 4205 of
the Patient Protection and Affordable Care Act (Affordable Care Act).
Summary of Legal Basis: On March 23, 2010, the Affordable Care Act
(Pub. L. 111-148) was signed into law. Section 4205 amended 403(q)(5)
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other
things, creating new clause (H) to require that vending machine
operators, who own or operate 20 or more machines, disclose calories
for certain food items. FDA has the authority to issue this rule under
sections 403(q)(5)(H) and 701(a) of the FD&C Act (21 U.S.C.
343(q)(5)(H), and 371(a)). Section 701(a) of the FD&C Act vests the
Secretary of Health and Human Services, and, by delegation, the Food
and Drug Administration (FDA) with the authority to issue regulations
for the efficient enforcement of the FD&C Act.
Alternatives: Section 4205 of the Affordable Care Act requires the
Secretary (and by delegation, the FDA) to establish by regulation
requirements for calorie labeling of articles of food sold from covered
vending machines. Therefore, there are no alternatives to rulemaking.
FDA has analyzed alternatives that may reduce the burden of the
rulemaking, including analyzing the benefits and costs of: Restricting
the flexibility of the format for calorie disclosure, lengthening the
compliance time, and extending the coverage of the rule to bulk vending
machines without selection buttons.
Anticipated Cost and Benefits: Any vending machine operator
operating fewer than 20 machines may voluntarily choose to be covered
by the national standard. It is anticipated that vending machine
operators that own or operate 20 or more vending machines will bear
costs associated with adding calorie information to vending machines.
FDA estimates that the total cost of complying with section 4205 of the
Affordable Care Act and this rulemaking will be approximately $25.8
million initially, with a recurring cost of approximately $24 million.
Because comprehensive national data for the effects of vending
machine labeling do not exist, FDA has not quantified the benefits
associated with section 4205 of the Affordable Care Act and this
rulemaking. Some studies have shown that some consumers consume fewer
calories when calorie content information is displayed at the point of
purchase. Consumers will benefit from having this important nutrition
information to assist them in making healthier choices when consuming
food away from home. Given the very high costs associated with obesity
and its associated health risks, FDA estimates that if 0.02 percent of
the adult obese population reduces energy intake by at least 100
calories per week, then the benefits of Section 4205 of the Affordable
Care Act and this rulemaking will be at least as large as the costs.
Risks: Americans now consume an estimated one-third of their total
calories from foods prepared outside the home and spend almost half of
their food dollars on such foods. This rule will provide consumers with
information about the nutritional content of food to enable them to
make healthier food choices, and may help mitigate the trend of
increasing obesity in America.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/06/11 76 FR 19238
NPRM Comment Period End............. 07/05/11 .......................
Final Action........................ 11/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses, Governmental Jurisdictions.
Government Levels Affected: Federal, Local, State.
Federalism: This action may have federalism implications as defined
in EO 13132.
Agency Contact: Daniel Reese, Department of Health and Human
Services, Food and Drug Administration, Center for Food Safety and
Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, College Park,
MD 20740, Phone: 240 402-2126, Email: [email protected].
RIN: 0910-AG56
HHS--FDA
44. Food Labeling: Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Food and Drug Administration (FDA) published a
proposed rule in the Federal Register of April 6, 2011 (72 FR 19192),
to establish requirements for nutrition labeling of standard menu items
in chain restaurants and similar retail food establishments. FDA also
proposed the terms and conditions for restaurants and similar retail
food establishments registering to voluntarily be subject to the
Federal requirements. FDA took this action to carry out section 4205 of
the Patient Protection and Affordable Care Act (``Affordable Care Act''
or ``ACA''), which was signed into law on March 23, 2010.
Statement of Need: This rulemaking was mandated by section 4205 of
the Patient Protection and Affordable Care Act (Affordable Care Act).
Summary of Legal Basis: On March 23, 2010, the Affordable Care Act
(Pub. L. 111-148) was signed into law. Section 4205 of the Affordable
Care Act amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by, among other things, creating new clause
[[Page 7727]]
(H) to require that certain chain restaurants and similar retail food
establishments with 20 or more locations disclose certain nutrient
information for standard menu items. FDA has the authority to issue
this rule under sections 403(a)(1), 403(q)(5)(H), and 701(a) of the
FD&C Act (21 U.S.C. 343(a)(1), 343(q)(5)(H), and 371(a)). Section
701(a) of the FD&C Act vests the Secretary of Health and Human
Services, and, by delegation, the Food and Drug Administration (FDA)
with the authority to issue regulations for the efficient enforcement
of the FD&C Act.
Alternatives: Section 4205 of the Affordable Care Act requires the
Secretary, and by delegation the FDA, to establish by regulation
requirements for nutrition labeling of standard menu items for covered
restaurants and similar retail food establishments. Therefore, there
are no alternatives to rulemaking. FDA has analyzed alternatives that
may reduce the burden of this rulemaking, including analyzing the
benefits and costs of expanding and contracting the set of
establishments automatically covered by this rule and shortening or
lengthening the compliance time relative to the rulemaking.
Anticipated Cost and Benefits: Chain restaurants and similar retail
food establishments operating in local jurisdictions that impose
different nutrition labeling requirements will benefit from having a
uniform national standard. Any restaurant or similar retail food
establishment with fewer than 20 locations may voluntarily choose to be
covered by the national standard. It is anticipated that chain
restaurants with 20 or more locations will bear costs for adding
nutrition information to menus and menu boards. FDA estimates that the
total cost of section 4205 and this rulemaking will be approximately
$80 million, annualized over 10 years, with a low annualized estimate
of approximately $33 million and a high annualized estimate of
approximately $125 million over 10 years. These costs include an
initial cost of approximately $320 million with an annually recurring
cost of $45 million.
Because comprehensive national data for the effects of menu
labeling do not exist, FDA has not quantified the benefits associated
with section 4205 of the Affordable Care Act and this rulemaking. Some
studies have shown that some consumers consume fewer calories when
menus have information about calorie content displayed. Consumers will
benefit from having important nutrition information for the
approximately 30 percent of calories consumed away from home. Given the
very high costs associated with obesity and its associated health
risks, FDA estimates that if 0.6 percent of the adult obese population
reduces energy intake by at least 100 calories per week, then the
benefits of section 4205 of the Affordable Care Act and this rule will
be at least as large as the costs.
Risks: Americans now consume an estimated one-third of their total
calories on foods prepared outside the home and spend almost half of
their food dollars on such foods. Unlike packaged foods that are
labeled with nutrition information, foods in restaurants, for the most
part, do not have nutrition information that is readily available when
ordered. Dietary intake data have shown that obese Americans consume
over 100 calories per meal more when eating food away from home rather
than food at home. This rule will provide consumers information about
the nutritional content of food to enable them to make healthier food
choices and may help mitigate the trend of increasing obesity in
America.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/06/11 76 FR 19192
NPRM Comment Period End............. 07/05/11 .......................
Final Action........................ 11/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses, Governmental Jurisdictions.
Government Levels Affected: Federal, Local, State.
Federalism: This action may have federalism implications as defined
in EO 13132.
Agency Contact: Geraldine A. June, Supervisor, Product Evaluation
and Labeling Team, Department of Health and Human Services, Food and
Drug Administration, Center for Food Safety and Applied Nutrition,
(HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone:
240 402-1802, Fax: 301 436-2636, Email: [email protected].
RIN: 0910-AG57
HHS--CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)
Proposed Rule Stage
45. Medicare and Medicaid Programs: Reform of Hospital and Critical
Access Hospital Conditions of Participation (CMS-3244-P)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh and 1395rr
CFR Citation: 42 CFR 482; 42 CFR 485.
Legal Deadline: None.
Abstract: This proposed rule would revise the requirements that
hospitals and critical access hospitals (CAHs) must meet to participate
in the Medicare and Medicaid programs. These changes are necessary to
reflect substantial advances in health care delivery and in patient
safety knowledge and practices. They are also an integral part of our
efforts to achieve broad-based improvements in the quality of health
care furnished through Federal programs and in patient safety, while at
the same time reducing procedural burdens on providers.
Statement of Need: CMS is revising many of the hospital CoPs to
ensure that they meet the needs of hospital and CAH patients in an
effective and efficient manner. CMS is proposing changes to reduce
unnecessary, obsolete, or burdensome regulations on U.S. hospitals.
This retrospective review of existing regulations meets the President's
Executive Order that all Federal agencies identify such rules and make
proposals to ``modify, streamline, expand, or repeal them.'' CMS is
also proposing additional quality and safety requirements to protect
patients.
Summary of Legal Basis: The provisions that are included in this
proposed rule are necessary to implement the requirements of Executive
Order 13563 ``Improving Regulations and Regulatory Review.''
Alternatives: To date, nearly 90 specific reforms have been
identified and scheduled for action. These reforms impact hospitals,
physicians, home health agencies, ambulance providers, clinical labs,
skilled nursing facilities, intermediate care facilities, managed care
plans, Medicare Advantage organizations, and States. Many of these
reforms will be included in proposed rules that relate to particular
categories of regulations or types of providers. Other reforms are
being implemented without the need for regulations.
This proposed rule includes reforms that do not fit directly in
other rules scheduled for publication.
[[Page 7728]]
Anticipated Cost and Benefits: This proposed rule would reduce
costs to tens of thousands of physicians, ambulatory surgical centers,
End Stage Renal Disease facilities, and other small entities. Achieving
the full scope of potential savings will depend on future decisions by
hospitals, by State regulators, and others. Many other factors will
influence long-term results. We believe, however, that likely savings
and benefits will reach many billions of dollars. Our primary estimate
of the net savings to hospitals from reductions in regulatory
requirements that we can quantify at this time, offset by increases in
other regulatory costs, are approximately $940 million a year.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/24/11 76 FR 65891
NPRM Comment Period End............. 12/23/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Agency Contact: CDR Scott Cooper, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Clinical Standards Group, Mail Stop S3-05-15, 7500
Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9465, Email:
[email protected].
RIN: 0938-AQ89
HHS--CMS
46. Regulatory Provisions To Promote Program Efficiency, Transparency,
and Burden Reduction (CMS-9070-P)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 42 U.S.C. 1302 and 1395hh and 44 U.S.C. 35
CFR Citation: 42 CFR 400, 405, 416, 418, 423; 42 CFR 424, 440, 442,
486, 494.
Legal Deadline: None.
Abstract: This proposed rule identifies and proposes reforms in
Medicare and Medicaid regulations that CMS has identified as
unnecessary, obsolete, or excessively burdensome on health care
providers and beneficiaries. This proposed rule would increase the
ability of health care professionals to devote resources to improving
patient care, by eliminating or reducing requirements that impede
quality patient care or that divert providing high quality patient
care.
Statement of Need: In January 2011, the President issued an
Executive order that requires agencies to identify rules that may be
``outmoded, ineffective, insufficient, or excessively burdensome, and
to modify, streamline, expand, or repeal them in accordance with what
has been learned.'' In accordance with the Executive order, we
identified obsolete and unnecessarily burdensome rules that could be
eliminated or reformed to achieve similar objectives, with a particular
focus on freeing up resources that health care providers, health plans,
and States could use to improve or enhance patient health and safety.
We examined policies and practices not codified in rules that could be
changed or streamlined to achieve better outcomes for patients while
reducing burden on providers of care. We also sought to increase
transparency and become a better business partner.
Summary of Legal Basis: The provisions that are included in this
proposed rule are necessary to implement the requirements of Executive
Order 13563 ``Improving Regulations and Regulatory Review.''
Alternatives: To date, nearly 90 specific reforms have been
identified and scheduled for action. These reforms impact hospitals,
physicians, home health agencies, ambulance providers, clinical labs,
skilled nursing facilities, intermediate care facilities, managed care
plans, Medicare Advantage organizations, and States. Many of these
reforms will be included in proposed rules that relate to particular
categories of regulations or types of providers. Other reforms are
being implemented without the need for regulations. This proposed rule
includes reforms that do not fit directly in other rules scheduled for
publication.
Anticipated Cost and Benefits: We anticipate that the provider
industry and health professionals would welcome the proposed changes
and reductions in burden. We also expect that health professionals
would experience increased efficiencies and resources to appropriately
devote to improving patient care, increasing accessibility to care, and
reducing associated health care costs.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/24/11 76 FR 65909
NPRM Comment Period End............. 12/23/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: Businesses, Governmental Jurisdictions,
Organizations.
Government Levels Affected: Federal, State.
Agency Contact: Michelle Shortt, Director, Regulations Development
Group, OSORA, Department of Health and Human Services, Centers for
Medicare & Medicaid Services, Mailstop C4-26-05, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 410 786-4675, Email:
[email protected].
RIN: 0938-AQ96
HHS--CMS
47. Proposed Changes to Hospital OPPS and CY 2013 Payment
Rates; ASC Payment System and CY 2013 Payment Rates (CMS-1589-P)
(Section 610 Review)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: Sec 1833 of the Social Security Act
CFR Citation: 42 CFR 410; 42 CFR 416; 42 CFR 419.
Legal Deadline: Final, Statutory, November 1, 2012.
Abstract: This final rule would revise the Medicare hospital
outpatient prospective payment system to implement applicable statutory
requirements and changes arising from our continuing experience with
this system. The proposed rule also describes changes to the amounts
and factors used to determine payment rates for services. In addition,
the rule proposes changes to the Ambulatory Surgical Center Payment
System list of services and rates.
Statement of Need: Medicare pays over 4,000 hospitals for
outpatient department services under the hospital outpatient
prospective payment system (OPPS). The OPPS is based on groups of
clinically similar services called ambulatory payment classification
groups (APCs). CMS annually revises the APC payment amounts based on
the most recent claims data, proposes new payment policies, and updates
the payments for inflation using the hospital operating market basket.
The proposed rule solicits comments on the proposed OPPS payment rates
and new policies. Medicare pays roughly 5,000 Ambulatory Surgical
Centers (ASCs) under the ASC payment system. CMS annually revises the
payment under the ASC payment system, proposes new policies, and
updates payments for inflation using the Consumer Price Index for All
Urban Consumers (CPI-U). CMS will issue a final rule containing the
payment rates for the 2013 OPPS
[[Page 7729]]
and ASC payment system at least 60 days before January 1, 2013.
Summary of Legal Basis: Section 1833 of the Social Security Act
establishes Medicare payment for hospital outpatient services and ASC
services. The final rule revises the Medicare hospital OPPS and ASC
payment system to implement applicable statutory requirements. In
addition, the proposed and final rules describe changes to the
outpatient APC system, relative payment weights, outlier adjustments,
and other amounts and factors used to determine the payment rates for
Medicare hospital outpatient services paid under the prospective
payment system, as well as changes to the rates and services paid under
the ASC payment system. These changes would be applicable to services
furnished on or after January 1, 2013.
Alternatives: None. This is a statutory requirement.
Anticipated Cost and Benefits: Total expenditures will be adjusted
for CY 2013.
Risks: If this regulation is not published timely, outpatient
hospital and ASC services will not be paid appropriately beginning
January 1, 2013.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Federalism: Undetermined.
Agency Contact: Paula Smith, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop C4-05-13, 7500 Security Blvd., Baltimore,
MD 21244, Phone: 410 786-4709, Email: [email protected].
RIN: 0938-AR10
HHS--CMS
48. Revisions to Payment Policies Under the Physician Fee
Schedule and Part B for CY 2013 (CMS-1590-P) (Section 610 Review)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: Social Security Act, secs 1102, 1871, 1848
CFR Citation: Not Yet Determined.
Legal Deadline: Final, Statutory, November 1, 2012.
Abstract: This annual proposed rule would revise payment polices
under the physician fee schedule, as well as other policy changes to
payment under Part B. These changes would be applicable to services
furnished on or after January 1.
Statement of Need: The statute requires that we establish each
year, by regulation, payment amounts for all physicians' services
furnished in all fee schedule areas. This major proposed rule would
implement changes affecting Medicare Part B payment to physicians and
other Part B suppliers. The final rule has a statutory publication date
of November 1, 2012, and an implementation date of January 1, 2013.
Summary of Legal Basis: Section 1848 of the Social Security Act
(the Act) establishes the payment for physician services provided under
Medicare. Section 1848 of the Act imposes a deadline of no later than
November 1 for publication of the final rule or final physician fee
schedule.
Alternatives: None. This implements a statutory requirement.
Anticipated Cost and Benefits: Total expenditures will be adjusted
for CY 2013.
Risks: If this regulation is not published timely, physician
services will not be paid appropriately, beginning January 1, 2013.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Christina Ritter, Director, Division of
Practitioner Services, Department of Health and Human Services, Centers
for Medicare & Medicaid Services, Mail Stop C4-03-06, 7500 Security
Blvd., Baltimore, MD 21244, Phone: 410 786-4636, Email:
[email protected].
RIN: 0938-AR11
HHS--CMS
49. Changes to the Hospital Inpatient an Long-Term Care
Prospective Payment System for FY 2013 (CMS-1588-P) (Section 610
Review)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: Undetermined.
Legal Authority: Sec 1886(d) of the Social Security Act
CFR Citation: 42 CFR 412.
Legal Deadline: NPRM, Statutory, April 1, 2012. Final, Statutory,
August 1, 2012.
Abstract: This annual major proposed rule would revise the Medicare
hospital inpatient and long-term care hospital prospective payment
systems for operating and capital-related costs. This proposed rule
would implement changes arising from our continuing experience with
these systems.
Statement of Need: CMS annually revises the Medicare hospital
inpatient prospective payment systems (IPPS) for operating and capital-
related costs to implement changes arising from our continuing
experience with these systems. In addition, we describe the proposed
changes to the amounts and factors used to determine the rates for
Medicare hospital inpatient services for operating costs and capital-
related costs. Also, CMS annually updates the payment rates for the
Medicare prospective payment system (PPS) for inpatient hospital
services provided by long-term care hospitals (LTCHs). The proposed
rule solicits comments on the proposed IPPS and LTCH payment rates and
new policies. CMS will issue a final rule containing the payment rates
for the FY 2013 IPPS and LTCHs at least 60 days before October 1, 2012.
Summary of Legal Basis: The Social Security Act (the Act) sets
forth a system of payment for the operating costs of acute care
hospital inpatient stays under Medicare Part A (Hospital Insurance)
based on prospectively set rates. The Act requires the Secretary to pay
for the capital-related costs of hospital inpatient and Long Term Care
stays under a PPS. Under these systems, Medicare payment for hospital
inpatient and Long Term Care operating and capital-related costs is
made at predetermined, specific rates for each hospital discharge.
These changes would be applicable to services furnished on or after
October 1, 2012.
Alternatives: None. This implements a statutory requirement.
Anticipated Cost and Benefits: Total expenditures will be adjusted
for FY 2013.
Risks: If this regulation is not published timely, inpatient
hospital and LTCH services will not be paid appropriately beginning
October 1, 2012.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Agency Contact: Ankit Patel, Health Insurance Specialist, Division
of Acute
[[Page 7730]]
Care, Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Hospital and Ambulatory Policy Group, Mail Stop, C4-
25-11, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-
4537, Email: [email protected].
RIN: 0938-AR12
HHS--CMS
Final Rule Stage
50. Medicaid Eligibility Expansion Under the Affordable Care Act of
2010 (CMS-2349-F)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 111-148, secs 1413, 1414, 2001, 2002,
2101, 2201
CFR Citation: 42 CFR 431, 435, 457.
Legal Deadline: Final, Statutory, January 1, 2014.
Abstract: This rule implements provisions of the Affordable Care
Act expanding access to health insurance through improvements in
Medicaid, the establishment of American Health Benefit Exchanges
(``Exchanges''), and coordination between Medicaid, the Children's
Health Insurance Program (CHIP), and Exchanges. This rule also
implements sections of the Affordable Care Act related to Medicaid
eligibility, enrollment simplification, and coordination.
Statement of Need: This rule expands Medicaid eligibility,
simplifies Medicaid eligibility procedures, and streamlines Medicaid
enrollment processes. It also coordinates eligibility processes and
policies with the processes for premium tax credits for Exchange
coverage. Millions of uninsured low-income persons who do not have
access to, or could not afford, health insurance will obtain coverage.
Summary of Legal Basis: The provisions that are included in this
rule are necessary to implement the requirements of sections 1413,
1414, 2001, 2002, 2101, and 2201 of the Affordable Care Act.
Alternatives: None. This is a statutory requirement.
Anticipated Cost and Benefits: We anticipate that this rule
provides significant benefits to low-income individuals by expanding
the availability of affordable health coverage. We expect that States
may incur short term increases in administrative costs (depending on
their current systems and practices) but that these costs will be
wholly offset by administrative savings over the longer term.
Risks: None.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/17/11 76 FR 51148
NPRM Comment Period End............. 10/31/11
Final Action........................ 02/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Governmental Jurisdictions.
Government Levels Affected: Federal, Local, State, Tribal.
Agency Contact: Sarah DeLone, Health Insurance Specialist,
Department of Health and Human Services, Centers for Medicare &
Medicaid Services, Mail Stop S2-01-16, 7500 Security Boulevard,
Baltimore, MD 21244, Phone: 410 786-0615, Email:
[email protected].
RIN: 0938-AQ62.
HHS--CMS
51. Establishment of Exchanges and Qualified Health Plans Part I (CMS-
9989-F)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Affordable Care Act, secs 1301 to 1343, secs 1401
to 1413
CFR Citation: 45 CFR 155 to 157.
Legal Deadline: Final, Statutory, January 1, 2014.
Abstract: This rule implements the new Affordable Insurance
Exchanges (``Exchanges''), consistent with title I of the Affordable
Care Act of 2010, referred to collectively as the Affordable Care Act.
The Exchanges will provide competitive marketplaces for individuals and
small employers to directly compare available private health insurance
options on the basis of price, quality, and other factors. The
Exchanges, which will become operational by January 1, 2014, will help
enhance competition in the health insurance market, improve choice of
affordable health insurance, and give small businesses the same
purchasing clout as large businesses.
Statement of Need: A central aim of Title I of the Affordable Care
Act is to expand access to health insurance coverage through the
establishment of Exchanges. The number of uninsured Americans is rising
due to the lack of affordable insurance, barriers to insurance for
people with pre-existing conditions, and high prices due to limited
competition and market failures. Millions of people without health
insurance use health care services for which they do not pay, shifting
the uncompensated cost of their care to health care providers.
Providers pass much of this cost to insurance companies, resulting in
higher premiums that make insurance unaffordable to even more people.
The Affordable Care Act includes a number of policies to address these
problems, including the creating of Affordable Insurance Exchanges.
Summary of Legal Basis: This rule implements the new Affordable
Insurance Exchanges consistent with title I of the Affordable Care Act
of 2010.
Alternatives: None. This is a statutory requirement.
Anticipated Cost and Benefits: This rule will help enhance
competition in the health insurance market, promote the choice of
affordable health insurance, and give small businesses the same
purchasing clout as large businesses. States seeking to operate an
Exchange will incur administrative expenses as a result of implementing
and subsequently maintaining Exchanges. There is no Federal requirement
that each State establish an Exchange.
Risks: If this regulation is not published, the Exchanges will not
become operational by January 1, 2014, thereby violating the statute.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/15/11 76 FR 41866
NPRM Comment Period End............. 09/28/11
Final Action........................ 02/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Businesses, Governmental Jurisdictions.
Government Levels Affected: Federal, State, Tribal.
Federalism: This action may have federalism implications as defined
in EO 13132.
Agency Contact: Alissa DeBoy, Department of Health and Human
Services, Centers for Medicare & Medicaid Services, 7500 Security
Boulevard, Baltimore, MD 21244, Phone: 301 492-4428, Email:
[email protected].
RIN: 0938-AQ67
HHS--CMS
52. State Requirements for Exchange--Reinsurance and Risk
Adjustments (CMS-9975-F)
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 111-148, secs 1341 and 1342
[[Page 7731]]
CFR Citation: 45 CFR 155, 156.
Legal Deadline: Final, Statutory, January 1, 2014.
Abstract: This rule implements requirements for States related to
reinsurance, risk corridors, and a permanent risk adjustment. The goals
of these programs are to minimize negative impacts of adverse selection
inside the Exchanges.
Statement of Need: This rule finalizes guidelines for the
transitional risk-sharing programs, reinsurance and risk corridors, as
well as for the risk adjustment program that will continue beyond the
first 3 years of Exchange operation. The purpose of these programs is
to protect health insurance issuers from the negative effects of
adverse selection and to protect consumers from increases in premiums
due to uncertainty for issuers.
Summary of Legal Basis: This rule implements the new Affordable
Insurance Exchanges consistent with title I of the Affordable Care Act
of 2010.
Alternatives: None. This is a statutory requirement.
Anticipated Cost and Benefits: Payments through reinsurance, risk
adjustment, and risk corridors reduce the increased risk of financial
loss that health insurance issuers might otherwise expect to incur in
2014 due to market reforms such as guaranteed issue and the elimination
of medical underwriting. These payments reduce the risk to the issuer
and the issuer can pass on a reduced risk premium to enrollees.
Administrative costs will vary across States and health insurance
issuers depending on the sophistication of technical infrastructure and
prior experience with data collection and risk adjustment. States and
issuers that already have systems in place for data collection and
reporting will have reduced administrative costs.
Risks: If this regulation is not published, the Exchanges will not
become operational by January 1, 2014, thereby violating the statute.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 07/15/11 76 FR 41866
NPRM Comment Period End............. 09/28/11
Final Action........................ 01/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Governmental Jurisdictions.
Government Levels Affected: State.
Federalism: This action may have federalism implications as defined
in EO 13132.
Agency Contact: Alissa DeBoy, Health Insurance Specialist, Center
for Consumer Information & Insurance Oversight, Department of Health
and Human Services, Centers for Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4428, Email:
[email protected].
RIN: 0938-AR07
BILLING CODE 4150-24-P
DEPARTMENT OF HOMELAND SECURITY (DHS)
Fall 2011 Statement of Regulatory Priorities
The Department of Homeland Security (DHS or Department) was created
in 2003 pursuant to the Homeland Security Act of 2002, Public Law 107-
296. DHS has a vital mission: To secure the Nation from the many
threats we face. This requires the dedication of more than 225,000
employees in jobs that range from aviation and border security to
emergency response, from cybersecurity analyst to chemical facility
inspector. Our duties are wide-ranging, but our goal is clear--keeping
America safe.
Our mission gives us six main areas of responsibility:
1. Prevent Terrorism and Enhance Security,
2. Secure and Manage Our Borders,
3. Enforce and Administer our Immigration Laws,
4. Safeguard and Secure Cyberspace,
5. Ensure Resilience to Disasters, and
6. Mature and Strengthen DHS.
In achieving these goals, we are continually strengthening our
partnerships with communities, first responders, law enforcement, and
government agencies--at the State, local, tribal, Federal, and
international levels. We are accelerating the deployment of science,
technology, and innovation in order to make America more secure, and we
are becoming leaner, smarter, and more efficient, ensuring that every
security resource is used as effectively as possible. For a further
discussion of our main areas of responsibility, see the DHS Web site at
http://www.dhs.gov/xabout/responsibilities.shtm.
The regulations we have summarized below in the Department's fall
2011 regulatory plan and in the agenda support the Department's
responsibility areas listed above. These regulations will improve the
Department's ability to accomplish its mission.
The regulations we have identified in this year's fall regulatory
plan continue to address legislative initiatives including, but not
limited to, the following acts: The Implementing Recommendations of the
9/11 Commission Act of 2008 (9/11 Act), Public Law 110-53 (Aug. 3,
2007); the Post-Katrina Emergency Management Reform Act of 2006
(PKEMRA), Public Law 109-295 (Oct. 4, 2006); the Consolidated Natural
Resources Act of 2008 (CNRA), Public Law 110-220 (May 7, 2008); the
Security and Accountability for Every Port Act of 2006 (SAFE Port Act),
Public Law 109-347 (Oct. 13, 2006); and the Consolidated Security,
Disaster Assistance, and Continuing Appropriations Act, 2009, Public
Law 110-329 (Sep. 30, 2008).
DHS strives for organizational excellence and uses a centralized
and unified approach in managing its regulatory resources. The Office
of the General Counsel manages the Department's regulatory program,
including the agenda and regulatory plan. In addition, DHS senior
leadership reviews each significant regulatory project to ensure that
the project fosters and supports the Department's mission.
The Department is committed to ensuring that all of its regulatory
initiatives are aligned with its guiding principles to protect civil
rights and civil liberties, integrate our actions, build coalitions and
partnerships, develop human resources, innovate, and be accountable to
the American public.
DHS is also committed to the principles described in Executive
Orders 13563 and 12866 (as amended). Both Executive orders direct
agencies to assess the costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety effects, distributive impacts,
and equity). Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. Many of the regulations in DHS'
regulatory plan support the Department's efforts pursuant to the DHS
Final Plan for the Retrospective Review of Existing Regulations. DHS
issued its final plan on August 22, 2011.
Finally, the Department values public involvement in the
development of its regulatory plan, agenda, and regulations, and takes
particular concern with the impact its rules have on small businesses.
DHS and each of its components continue to emphasize the use of plain
language in our notices and rulemaking documents to promote
[[Page 7732]]
a better understanding of regulations and increased public
participation in the Department's rulemakings.
Retrospective Review of Existing Regulations
Pursuant to section 6 of Executive Order 13563 ``Improving
Regulation and Regulatory Review'' (Jan. 18, 2011), DHS identified the
following regulatory actions in the Department's Final Plan for the
Retrospective Review of Existing Regulations (``DHS Final Plan''). DHS
has identified these regulatory actions as associated with
retrospective review and analysis. You can view the DHS Final Plan on
www.regulations.gov by searching for docket number DHS-2011-0015. Some
of the regulatory actions on the below list may be completed actions,
which do not appear in The Regulatory Plan. You can find more
information about these completed rulemakings in past publications of
the Unified Agenda (search the Completed Actions sections) on
www.reginfo.gov. Some of the entries on this list, however, are active
rulemakings. You can find entries for these rulemakings on
www.regulations.gov.
------------------------------------------------------------------------
Significantly Reduces
RIN Rule Burdens on Small
Businesses
------------------------------------------------------------------------
1615-AB71.................. Registration No.
Requirement
for
Petitioners
Seeking to
File H-1B
Petitions on
Behalf of
Aliens Subject
to Numerical
Limitations.
1615-AB76.................. Commonwealth of No.
the Northern
Mariana
Islands
Transitional
Worker
Classification.
1615-AB83.................. Immigration No.
Benefits
Business
Transformation
, Increment I.
1615-AB95.................. Immigration No.
Benefits
Business
Transformation
:
Nonimmigrants;
Student and
Exchange
Visitor
Program.
1625-AA16.................. Implementation No.
of the 1995
Amendments to
the
International
Convention on
Standards of
Training,
Certification,
and
Watchkeeping
(STCW) for
Seafarers,
1978.
1625-AB38.................. Updates to No.
Maritime
Security.
TBD........................ Elimination of No.
TWIC for
Certain
Mariner
Populations
(Implementatio
n of Section
809 of the
2010 Coast
Guard
Authorization
Act).
1651-AA73.................. Establishment No.
of Global
Entry Program.
1651-AA93.................. Closing of the No.
Port of
Whitetail,
Montana.
1651-AA94.................. Internet No.
Publication of
Administrative
Seizure/
Forfeiture
Notices.
1652-AA01.................. Aviation No.
Security
Infrastructure
Fee (ASIF).
1652-AA35.................. Flight Training No.
for Aliens and
Other
Designated
Individuals;
Security
Awareness
Training for
Flight School
Employees.
1653-AA44.................. Clarification No.
of Eligibility
Criteria for F
and M Students
and for
Schools
Certified by
the Student
and Exchange
Visitor
Program To
Enroll F and/
or M Students.
------------------------------------------------------------------------
The fall 2011 regulatory plan for DHS includes regulations from DHS
components--including U.S. Citizenship and Immigration Services
(USCIS), the U.S. Coast Guard (Coast Guard), U.S. Customs and Border
Protection (CBP), the Federal Emergency Management Agency (FEMA), the
U.S. Immigration and Customs Enforcement (ICE), and the Transportation
Security Administration (TSA), which have active regulatory programs.
In addition, it includes regulations from the Department's major
offices and directorates such as the National Protection and Programs
Directorate (NPPD). Below is a discussion of the fall 2011 regulatory
plan for DHS regulatory components, as well as for DHS offices and
directorates.
United States Citizenship and Immigration Services
U.S. Citizenship and Immigration Services (USCIS) administers
immigration benefits and services while protecting and securing our
homeland. USCIS has a strong commitment to welcoming individuals who
seek entry through the U.S. immigration system, providing clear and
useful information regarding the immigration process, promoting the
values of citizenship, and assisting those in need of humanitarian
protection. Based on a comprehensive review of the planned USCIS
regulatory agenda, USCIS will promulgate several rulemakings to
directly support these commitments and goals.
Improvements to the Immigration System. USCIS is currently engaged
in a multi-year transformation effort to create a more efficient,
effective, and customer-focused organization by improving our business
processes and technology. In the coming years, USCIS will publish rules
to facilitate that effort, including rules that will remove references
to form numbers, form titles, expired regulatory provisions, and
descriptions of internal procedure; will mandate electronic filing in
certain circumstances; and will comprehensively reorganize 8 CFR part
214. In addition, to streamline processes and improve efficiency, USCIS
plans to revise its regulations governing appeals and motions before
the Administrative Appeals Office. USCIS will also finalize a final
rule related to the extension of immigration law to the Commonwealth of
the Northern Mariana Islands.
Requirements for Filing Motions and Administrative Appeals. USCIS
will propose to revise the procedural regulations governing appeals and
motions to reopen or reconsider before its Administrative Appeals
Office, and to require that applicants and petitioners exhaust
administrative remedies before seeking judicial review of an
unfavorable decision. The changes proposed by the rule will streamline
the procedures before the Administrative Appeals Office and improve the
efficiency of the adjudication process.
Regulations Related to the Commonwealth of Northern Mariana
Islands. During 2009, USCIS issued three regulations to implement the
extension of U.S. immigration law to the Commonwealth of Northern
Mariana Islands (CNMI), as required under title VII of the Consolidated
Natural Resources Act of 2008. During fiscal year 2011, USCIS issued
two final rules related to the extension of the U.S. immigration law to
the CNMI. In fiscal year 2012, USCIS will issue the following CNMI
final rule: The joint USCIS/Department of Justice (DOJ) regulation
``Application of Immigration Regulations to the CNMI.''
Regulatory Changes Involving Humanitarian Benefits. USCIS offers
protection to individuals who face persecution by adjudicating
applications for refugees and asylees. Other humanitarian benefits are
available to individuals who have been victims of severe forms of
trafficking or criminal activity.
[[Page 7733]]
Asylum and Withholding Definitions. USCIS plans a regulatory
proposal to amend the regulations that govern asylum eligibility and
refugee status determinations. The amendments are expected to focus on
portions of the regulations that deal with determinations of whether
suffered or feared persecution is on account of a protected ground, the
requirements for establishing that the government is unable or
unwilling to protect the applicant, and the definition of membership in
a particular social group. This effort should provide greater clarity
and consistency in this important area of the law.
Exception to the Persecutor Bar for Asylum, Refugee, or Temporary
Protected Status, and Withholding of Removal. In a joint rulemaking,
DHS and DOJ will propose amendments to existing DHS and DOJ regulations
to resolve ambiguity in the statutory language precluding eligibility
for asylum, refugee resettlement, temporary protected status, and
withholding or removal of an applicant who ordered, incited, assisted,
or otherwise participated in the persecution of others. The proposed
rule would provide a limited exception for persecutory actions taken by
the applicant under duress and would clarify the required level of the
applicant's knowledge of the persecution.
``T'' and ``U'' Nonimmigrants. USCIS plans additional regulatory
initiatives related to T nonimmigrants (victims of trafficking), U
nonimmigrants (victims of criminal activity), and Adjustment of Status
for T and U status holders. By promulgating additional regulations
related to these victims of specified crimes or severe forms of human
trafficking, USCIS hopes to provide greater consistency for these
vulnerable groups, their advocates, and the community. These
rulemakings will contain provisions to adjust documentary requirements
for this vulnerable population and provide greater clarity to the law
enforcement community.
Application of the William Wilberforce Trafficking Victims
Protection Act of 2008. In a joint rulemaking, DHS and DOJ will propose
amendments to implement the William Wilberforce Trafficking Victims
Protection Act of 2008 (TVPRA). Among other things, this statute
specified that USCIS has initial jurisdiction over an asylum
application filed by an unaccompanied alien child in removal
proceedings before an immigration judge in DOJ. The agencies
implemented this legislation with interim procedures that the TVPRA
mandated within 90 days after enactment. The proposed rule would amend
both agencies' regulations to finalize the procedures to determine when
an alien child is unaccompanied and how jurisdiction is transferred to
USCIS for initial adjudication of the child's asylum application. In
addition, this rule would address adjustment of status for special
immigrant juveniles and voluntary departure for unaccompanied alien
children in removal proceedings.
United States Coast Guard
The U.S. Coast Guard (Coast Guard) is a military, multi-mission,
maritime service of the United States and the only military
organization within DHS. It is the principal Federal agency responsible
for maritime safety, security, and stewardship, and delivers daily
value to the Nation through multi-mission resources, authorities, and
capabilities.
Effective governance in the maritime domain hinges upon an
integrated approach to safety, security, and stewardship. The Coast
Guard's policies and capabilities are integrated and interdependent,
delivering results through a network of enduring partnerships. The
Coast Guard's ability to field versatile capabilities and highly-
trained personnel is one of the U.S. Government's most significant and
important strengths in the maritime environment.
America is a maritime nation, and our security, resilience, and
economic prosperity are intrinsically linked to the oceans. Safety,
efficient waterways, and freedom of transit on the high seas are
essential to our well-being. The Coast Guard is leaning forward, poised
to meet the demands of the modern maritime environment. The Coast Guard
creates value for the public through solid prevention and response
efforts. Activities involving oversight and regulation, enforcement,
maritime presence, and public and private partnership foster increased
maritime safety, security, and stewardship.
The statutory responsibilities of the Coast Guard include ensuring
marine safety and security, preserving maritime mobility, protecting
the marine environment, enforcing U.S. laws and international treaties,
and performing search and rescue. The Coast Guard supports the
Department's overarching goals of mobilizing and organizing our Nation
to secure the homeland from terrorist attacks, natural disasters, and
other emergencies. The rulemaking projects identified for the Coast
Guard in the Unified Agenda, and the rules appearing in the fall 2011
regulatory plan below, contribute to the fulfillment of those
responsibilities and reflect our regulatory policies.
Implementation of the 1995 Amendments to the International
Convention on Standards of Training, Certification, and Watchkeeping
(STCW) for Seafarers, 1978. The Coast Guard proposed to amend its
regulations to implement changes to an interim rule published on June
26, 1997. These proposed amendments go beyond changes found in the
interim rule and seek to more fully incorporate the requirements of the
STCW in the requirements for the credentialing of U.S. merchant
mariners. The proposed changes are primarily substantive and: (1) Are
necessary to continue to give full and complete effect to the STCW
Convention; (2) incorporate lessons learned from implementation of the
STCW through the interim rule and through policy letters and Navigation
and Vessel Inspection Circulars (NVICs); and (3) attempt to clarify
regulations that have generated confusion. The Coast Guard published
this proposal as a Supplemental Notice of Proposed Rulemaking (SNPRM)
on August 1, 2011. The Coast Guard intends to review and analyze
comments received on that SNPRM, and publish a subsequent rule
complying with the requirements of the newly amended STCW Convention.
DHS included this rulemaking in the DHS Final Plan for the
Retrospective Review of Existing Regulations, which DHS released on
August 22, 2011.
Vessel Requirements for Notices of Arrival and Departure, and
Automatic Identification System. The Coast Guard intends to expand the
applicability of notice of arrival and departure (NOAD) and automatic
identification system (AIS) requirements to include more commercial
vessels. This rule, once final, would expand the applicability of
notice of arrival (NOA) requirements to include additional vessels,
establish a separate requirement for vessels to submit notices of
departure (NOD) when departing for a foreign port or place, set forth a
mandatory method for electronic submission of NOA and NOD, and modify
related reporting content, timeframes, and procedures. This rule would
also extend the applicability of AIS requirements beyond Vessel Traffic
Service (VTS) areas to all U.S. navigable waters and require additional
commercial vessels install and use AIS. These changes are intended to
improve navigation safety, enhance Coast Guard's ability to identify
and track vessels, and heighten the Coast Guard's overall maritime
domain awareness, thus helping the Coast Guard address
[[Page 7734]]
threats to maritime transportation safety and security and mitigate the
possible harm from such threats.
Nontank Vessel Response Plans and Other Vessel Response Plan
Requirements. The Coast Guard intends to promulgate a rule to further
protect the Nation from the threat of oil spills in U.S. waters, which
supports the strategic goals of protection of natural resources and
maritime mobility. The rule, once final, would require owners and
operators of nontank vessels to prepare and submit oil spill response
plans. The Federal Water Pollution Control Act defines nontank vessels
as self-propelled vessels of 400 gross tons or greater that operate on
the navigable waters of the United States, carry oil of any kind as
fuel for main propulsion, and are not tank vessels. The rule would
specify the content of a response plan and would address, among other
issues, the requirement that a plan for responding to a worst case
discharge and a substantial threat of such a discharge. Additionally,
the rule would require vessel owners and operators to submit their
vessel response plan control number as part of already required notice
of arrival information.
Revision to Transportation Worker Identification Credential (TWIC)
Requirements for Mariners. The Coast Guard is developing revisions to
its merchant mariner credentialing regulations, to implement changes
made by section 809 of the Coast Guard Authorization Act of 2010.
Section 809 eliminated the requirement for certain mariner populations
to obtain TWIC. The Coast Guard is also considering revising its
regulations to provide an exemption for certain fees associated with
merchant mariner credentialing for those mariners not required to hold
a TWIC who may still be required to visit a TWIC enrollment center to
provide the information necessary to obtain a Merchant Mariner
Credential. DHS highlighted this rulemaking in the DHS Final Plan for
the Retrospective Review of Existing Regulations, which DHS released on
August 22, 2011.
Offshore Supply Vessels of 6,000 or more GT ITC. The Coast Guard
Authorization Act of 2010 (the Act) removed the size limit on offshore
supply vessels (OSVs) and directed the Coast Guard to issue, as soon as
practicable, regulations to implement section 617 of the Act. As
required by the Act, this regulation would provide for the safe
carriage of oil, hazardous substances, and individuals in addition to
crew on OSVs of at least 6,000 gross tonnage as measured under the
International Convention on Tonnage Measurement of Ships (6,000 GT
ITC). In developing the regulations, the Coast Guard is taking into
account the characteristics of offshore supply vessels, their methods
of operation, and their service in support of exploration,
exploitation, or production of offshore mineral or energy resources.
United States Customs and Border Protection
U.S. Customs and Border Protection (CBP) is the Federal agency
principally responsible for the security of our Nation's borders at and
between the ports of entry and at official crossings into the United
States. CBP must accomplish its border security and enforcement mission
while facilitating the flow of legitimate trade and travel. The primary
mission of CBP is its homeland security mission; that is, to prevent
terrorists and terrorist weapons from entering the United States. An
important aspect of this priority mission involves improving security
at our borders and ports of entry, but it also means extending our zone
of security beyond our physical borders.
CBP is also responsible for administering laws concerning the
import and export of goods into and out of the United States, and
enforcing the laws concerning the entry of persons into and out of the
United States. This includes regulating and facilitating international
trade; collecting import duties; enforcing U.S. trade, immigration, and
other laws of the United States at our borders; inspecting imports and
exports; overseeing the activities of persons and businesses engaged in
importing; enforcing the laws concerning smuggling and trafficking in
contraband; apprehending individuals attempting to enter the United
States illegally; protecting our agriculture and economic interests
from harmful pests and diseases; conducting inspections of all people,
vehicles, and cargo entering the United States; enforcing export
controls; and protecting U.S. businesses from theft of their
intellectual property.
In carrying out its priority mission, CBP's goal is to facilitate
the processing of legitimate trade and people efficiently without
compromising security. Consistent with its primary mission of homeland
security, CBP intends to finalize several rules during the next fiscal
year that are intended to improve security at our borders and ports of
entry. We have highlighted some of these rules below.
Electronic System for Travel Authorization (ESTA). On June 9, 2008,
CBP published an interim final rule amending DHS regulations to
implement the Electronic System for Travel Authorization (ESTA) for
aliens who wish to enter the United States under the Visa Waiver
Program (VWP) at air or sea ports of entry. This rule is intended to
fulfill the requirements of section 711 of the Implementing
Recommendations of the 9/11 Commission Act of 2007 (9/11 Act). The rule
establishes ESTA and delineates the data field DHS has determined will
be collected by the system. The rule requires that each alien traveling
to the United States under the VWP must obtain electronic travel
authorization via the ESTA in advance of such travel. VWP travelers may
obtain the required ESTA authorization by electronically submitting to
CBP biographic and other information as currently required by the I-94W
Nonimmigrant Alien Arrival/Departure Form (I-94W). By Federal Register
notice dated November 13, 2008, the Secretary of Homeland Security
informed the public that ESTA would become mandatory beginning January
12, 2009. This means that all VWP travelers must either obtain travel
authorization in advance of travel under ESTA or obtain a visa prior to
traveling to the United States.
By shifting from a paper to an electronic form and requiring the
data in advance of travel, CBP will be able to determine before the
alien departs for the U.S. the eligibility of nationals from VWP
countries to travel to the United States and to determine whether such
travel poses a law enforcement or security risk. By modernizing the
VWP, the ESTA is intended to increase national security and provide for
greater efficiencies in the screening of international travelers by
allowing for vetting of subjects of potential interest well before
boarding, thereby reducing traveler delays based on lengthy processes
at ports of entry. On August 9, 2010, CBP published an interim final
rule amending the ESTA regulations to require ESTA applicants to pay a
congressionally mandated fee, which is the sum of two amounts, a $10
travel promotion fee for an approved ESTA and a $4.00 operational fee
for the use of ESTA set by the Secretary of Homeland Security to at
least ensure the recovery of the full costs of providing and
administering the ESTA system. During the next fiscal year, CBP intends
to issue a final rule on ESTA and the ESTA fee.
Importer Security Filing and Additional Carrier Requirements. The
Security and Accountability for Every Port Act of 2006 (SAFE Port Act)
calls for CBP to promulgate regulations to require the electronic
transmission of additional data elements for improved high-risk
targeting. See Public Law 109-
[[Page 7735]]
347, section 203 (October 13, 2006). This includes appropriate security
elements of entry data for cargo destined for the United States by
vessel prior to loading of such cargo on vessels at foreign seaports.
The SAFE Port Act requires that the information collected reasonably
improve CBP's ability to identify high-risk shipments to prevent
smuggling and ensure cargo safety and security.
On November 25, 2008, CBP published an interim final rule
``Importer Security Filing and Additional Carrier Requirements,''
amending CBP Regulations to require carriers and importers to provide
to CBP via a CBP-approved electronic data interchange system,
information necessary to enable CBP to identify high-risk shipments to
prevent smuggling, and ensure cargo safety and security. This rule,
which became effective on January 26, 2009, improves CBP risk
assessment and targeting capabilities, facilitates the prompt release
of legitimate cargo following its arrival in the United States, and
assists CBP in increasing the security of the global trading system.
The comment period for the interim final rule concluded on June 1,
2009. CBP is analyzing comments and conducting a structured review of
certain flexibility provided in the interim final rule. CBP intends to
publish a final rule during the next fiscal year.
Implementation of the Guam-CNMI Visa Waiver Program. CBP published
an interim final rule in November 2008 amending the DHS regulations to
replace the current Guam Visa Waiver Program with a new Guam-CNMI Visa
Waiver program. This rule implements portions of the Consolidated
National Resources Act of 2008 (CNRA), which extends the immigration
laws of the United States to the Commonwealth of the Northern Mariana
Islands (CNMI) and, among others things, provides for a visa waiver
program for travel to Guam and the CNMI. The amended regulations set
forth the requirements for nonimmigrant visitors who seek admission for
business or pleasure and solely for entry into and stay on Guam or the
CNMI without a visa. The rule also establishes six ports of entry in
the CNMI for purposes of administering and enforcing the Guam-CNMI Visa
Waiver program. CBP intends to issue a final rule during the next
fiscal year.
Global Entry Program. In the fall of 2009, pursuant to section
7208(k) of the Intelligence Reform and Terrorism Prevention Act of
2004, as amended, CBP issued a Notice of Proposed Rulemaking (NPRM),
proposing to establish an international trusted traveler program,
called Global Entry. This voluntary program would allow CBP to expedite
clearance of pre-approved, low-risk air travelers into the United
States. CBP has been operating the Global Entry program as a pilot at
several airports since June 6, 2008. Based on the successful operation
of the pilot, CBP proposed to establish Global Entry as a permanent
voluntary regulatory program. CBP has evaluated the public comments
received in response to the NPRM and intends to issue a final rule
during the next fiscal year.
In the above paragraphs, DHS discusses the CBP regulations that
foster DHS's mission. CBP also issues regulations related to the
mission of the Department of the Treasury. Under section 403(1) of the
Homeland Security Act of 2002, the former U.S. Customs Service,
including functions of the Secretary of the Treasury relating thereto,
transferred to the Secretary of Homeland Security. As part of the
initial organization of DHS, the Customs Service inspection and trade
functions were combined with the immigration and agricultural
inspection functions and the Border Patrol and transferred into CBP. It
is noted that certain regulatory authority of the United States Customs
Service relating to customs revenue function was retained by the
Department of the Treasury (see the Department of the Treasury
regulatory plan). In addition to its plans to continue issuing
regulations to enhance border security, CBP, during fiscal year 2012,
expects to continue to issue regulatory documents that will facilitate
legitimate trade and implement the trade benefit program. CBP
regulations regarding the customs revenue function are discussed in the
regulatory plan of the Department of the Treasury.
Federal Emergency Management Agency
The mission of the Federal Emergency Management Agency (FEMA) is to
support our citizens and first responders to ensure that, as a Nation,
we work together to build, sustain, and improve our capability to
prepare for, protect against, respond to, recover from, and mitigate
all hazards. In fiscal year 2012, FEMA will continue to serve that
mission and promote the Department of Homeland Security's goals. In
furtherance of the Department and Agency's goals, in the upcoming
fiscal year, FEMA will work on regulations to implement provisions of
the Post-Katrina Emergency Management Reform Act of 2006 (PKEMRA) (Pub.
L. 109-295, Oct. 4, 2006) and to implement lessons learned from past
events.
Public Assistance Program Regulations. FEMA will work to revise the
Public Assistance Program regulations in 44 CFR part 206 to reflect
changes made to the Robert T. Stafford Disaster Relief and Emergency
Assistance Act by PKEMRA, the Pets Evacuation and Transportation
Standards Act of 2006 (PETS Act) (Pub. L. 109-308, Oct. 6, 2006), the
Local Community Recovery Act of 2006 (Pub. L. 109-218, Apr. 20, 2006),
and the Security and Accountability for Every Port Act of 2006 (SAFE
Port Act) (Pub. L. 109-347, Oct. 13, 2006), and to make other
substantive and nonsubstantive clarifications and corrections to the
Public Assistance regulations. The proposed changes would expand
eligibility to include performing arts facilities and community arts
centers pursuant to section 688 of PKEMRA; include education in the
list of critical services pursuant to section 689(h) of PKEMRA, thus
allowing private nonprofit educational facilities to be eligible for
restoration funding; add accelerated Federal assistance to available
assistance pursuant to section 681 of PKEMRA; include household pets
and service animals in essential assistance pursuant to section 689 of
PKEMRA and section 4 of the PETS Act; provide for expedited payments of
grant assistance for the removal of debris pursuant to section 610 of
the SAFE Port Act; and allow for a contract to be set aside for award
based on a specific geographic area pursuant to section 2 of the Local
Community Recovery Act of 2006. Other changes would include adding or
changing requirements to improve and streamline the Public Assistance
grant application process.
Federal Law Enforcement Training Center
The Federal Law Enforcement Training Center (FLETC) does not have
any significant regulatory actions planned for fiscal year 2012.
United States Immigration and Customs Enforcement
ICE is the principal criminal investigative arm of the Department
of Homeland Security and one of the three Department components charged
with the civil enforcement of the Nation's immigration laws. Its
primary mission is to protect national security, public safety, and the
integrity of our borders through the criminal and civil enforcement of
Federal law governing border control, customs, trade, and immigration.
During fiscal year 2012, ICE will pursue rulemaking actions that
improve two critical subject areas: The detention
[[Page 7736]]
of aliens who are subject to final orders of removal and the processes
for the Student and Exchange Visitor Program (SEVP).
Continued Detention of Aliens Subject to Final Orders of Removal.
ICE will improve the post order custody review process in a Final Rule
related to the continued detention of aliens subject to final orders of
removal in light of the U.S. Supreme Court's decisions in Zadvydas v.
Davis, 533 U.S. 678 (2001) and Clark v. Martinez, 543 U.S. 371 (2005),
as well as changes pursuant to the enactment of the Homeland Security
Act of 2002. During fiscal year 2012, ICE will also issue a companion
Notice of Proposed Rulemaking (NPRM) that will allow the public an
opportunity to comment on new sections of the custody determination
process not previously published for comment.
Processes for the Student and Exchange Visitor Program. ICE will
improve SEVP processes by publishing a final Optional Practical
Training (OPT) rule, which will respond to comments on the OPT Interim
Final Rule (IFR). The IFR increased the maximum period of OPT from 12
months to 29 months for nonimmigrant students who have completed a
science, technology, engineering, or mathematics degree and who accept
employment with employers who participate in USCIS's E-Verify
employment verification program.
National Protection and Programs Directorate
The goal of the National Protection and Programs Directorate (NPPD)
is to advance the Department's risk-reduction mission. Reducing risk
requires an integrated approach that encompasses both physical and
virtual threats and their associated human elements.
Ammonium Nitrate Security Program. The Secure Handling of Ammonium
Nitrate Act, section 563 of the Fiscal Year 2008 Department of Homeland
Security Appropriations Act, Public Law 110-161, amended the Homeland
Security Act of 2002 to provide DHS with the authority to ``regulate
the sale and transfer of ammonium nitrate by an ammonium nitrate
facility * * * to prevent the misappropriation or use of ammonium
nitrate in an act of terrorism.''
The Secure Handling of Ammonium Nitrate Act directs DHS to
promulgate regulations requiring potential buyers and sellers of
ammonium nitrate to register with DHS. As part of the registration
process, the statute directs DHS to screen registration applicants
against the Federal Government's Terrorist Screening Database. The
statute also requires sellers of ammonium nitrate to verify the
identities of those seeking to purchase it; to record certain
information about each sale or transfer of ammonium nitrate; and to
report thefts and losses of ammonium nitrate to DHS.
The Ammonium Nitrate Security Program Notice of Proposed Rulemaking
proposes requirements that would implement the Secure Handling of
Ammonium Nitrate Act. The rule would aid the Federal Government in its
efforts to prevent the misappropriation of ammonium nitrate for use in
acts of terrorism. By preventing such misappropriation, this rule aims
to limit terrorists' abilities to threaten the public and to threaten
the Nation's critical infrastructure and key resources. By securing the
Nation's supply of ammonium nitrate, it will be more difficult for
terrorists to obtain ammonium nitrate materials for use in terrorist
acts.
On October 29, 2008, DHS published an Advance Notice of Proposed
Rulemaking (ANPRM) for the Secure Handling of Ammonium Nitrate Program,
and received a number of public comments on that ANPRM. DHS reviewed
those comments and published a Notice of Proposed Rulemaking (NPRM) on
August 3, 2011. NPPD will accept public comment on until December 1,
2011, after which NPPD will review the public comments and develop a
Final Rule related to the Security Handling of Ammonium Nitrate
Program.
Transportation Security Administration
The Transportation Security Administration (TSA) protects the
Nation's transportation systems to ensure freedom of movement for
people and commerce. TSA is committed to continuously setting the
standard for excellence in transportation security through its people,
processes, and technology as we work to meet the immediate and long-
term needs of the transportation sector.
In fiscal year 2012, TSA will promote the DHS mission by
emphasizing regulatory efforts that allow TSA to better identify,
detect, and protect against threats against various modes of the
transportation system, while facilitating the efficient movement of the
traveling public, transportation workers, and cargo.
General Aviation Security and Other Aircraft Operator Security. TSA
plans to issue a Supplemental Notice of Proposed Rulemaking (SNPRM) to
propose amendments to current aviation transportation security
regulations to enhance the security of general aviation (GA) by
expanding the scope of current requirements and by adding new
requirements for certain GA aircraft operators. To date, the
Government's focus with regard to aviation security generally has been
on air carriers and commercial operators. As vulnerabilities and risks
associated with air carriers and commercial operators have been reduced
or mitigated, terrorists may perceive that GA aircraft are more
vulnerable and may view them as attractive targets. This rule would
enhance aviation security by requiring operators of certain GA aircraft
to adopt a security program and to undertake other security measures.
TSA published a Notice of Proposed Rulemaking on October 30, 2008, and
received over 7,000 public comments, generally urging significant
changes to the proposal. The SNPRM will respond to the comments and
contain proposals on addressing security in the GA sector.
Security Training for Surface Mode Employees. TSA will propose
regulations to enhance the security of several non-aviation modes of
transportation. In particular, TSA will propose regulations requiring
freight railroad carriers, public transportation agencies (including
rail mass transit and bus systems), passenger railroad carriers, and
over-the-road bus operators to conduct security training for front line
employees. This regulation would implement sections 1408 (Public
Transportation), 1517 (Freight Railroads), and 1534(a) (Over the Road
Buses) of the Implementing Recommendations of the 9/11 Commission Act
of 2008 (9/11 Act), Public Law 110-53 (Aug. 3, 2007). In compliance
with the definitions of frontline employees in the pertinent provisions
of the 9/11 Act, the Notice of Proposed Rulemaking (NPRM) would define
which employees are required to undergo training. The NPRM would also
propose definitions for transportation security-sensitive materials, as
required by section 1501 of the 9/11 Act.
Railroad Carrier Vulnerability Assessment and Security Plans. TSA
will also propose regulations requiring high-risk freight and passenger
railroads to conduct vulnerability self-assessments, as well as develop
and implement comprehensive security plans. TSA would need to approve
both the vulnerability assessment and security plan. This regulation,
implementing section 1512 of the 9/11 Act, would include proposed
provisions to identify which railroads would be considered high-risk
and include proposed provisions about the associated vulnerability
assessment and security planning requirements.
[[Page 7737]]
Aircraft Repair Station Security. TSA will finalize a rule
requiring repair stations that are certificated by the Federal Aviation
Administration under 14 CFR part 145 to adopt and implement standard
security programs and to comply with security directives issued by TSA.
TSA issued an Notice of Proposed Rulemaking (NPRM) on November 18,
2009. The final rule will also codify the scope of TSA's existing
inspection program and could require regulated parties to allow DHS
officials to enter, inspect, and test property, facilities, and records
relevant to repair stations. This rulemaking action will implement
section 1616 of the 9/11 Act.
Standardized Vetting, Adjudication, and Redress Process and Fees.
TSA is developing a proposed rule to revise and standardize the
procedures, adjudication criteria, and fees for most of the security
threat assessments (STA) of individuals that TSA conducts. DHS is
considering a proposal that would include procedures for conducting
STAs for transportation workers from almost all modes of
transportation, including those covered under the 9/11 Act. In
addition, TSA will propose equitable fees to cover the cost of the STAs
and credentials for some personnel. TSA plans to identify new
efficiencies in processing STAs and ways to streamline existing
regulations by simplifying language and removing redundancies.
As part of this proposed rule, TSA will propose revisions to the
Alien Flight Student Program (AFSP) regulations. TSA published an
interim final rule for ASFP on September 20, 2004. TSA regulations
require aliens seeking to train at Federal Aviation Administration-
regulated flight schools to complete an application and undergo an STA
prior to beginning flight training. There are four categories under
which students currently fall; the nature of the STA depends on the
student's category. TSA is considering changes to the AFSP that would
improve equity among fee payers and enable the implementation of new
technologies to support vetting.
United States Secret Service
The United States Secret Service does not have any significant
regulatory actions planned for fiscal year 2012.
DHS Regulatory Plan for Fiscal Year 2012
A more detailed description of the priority regulations that
comprise DHS's fall 2011 regulatory plan follows.
DHS--OFFICE OF THE SECRETARY (OS)
Proposed Rule Stage
53. Secure Handling of Ammonium Nitrate Program
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 2008 Consolidated Appropriations Act, sec 563,
subtitle J--Secure Handling of Ammonium Nitrate, Pub. L. 110-161
CFR Citation: 6 CFR 31.
Legal Deadline: NPRM, Statutory, May 26, 2008, Publication of
Notice of Proposed Rulemaking.
Abstract: This rulemaking will implement the December 2007
amendment to the Homeland Security Act entitled ``Secure Handling of
Ammonium Nitrate.'' The amendment requires the Department of Homeland
Security to ``regulate the sale and transfer of ammonium nitrate by an
ammonium nitrate facility * * * to prevent the misappropriation or use
of ammonium nitrate in an act of terrorism.''
Statement of Need: Pursuant to section 563 of the 2008 Consolidated
Appropriations Act, subtitle J--Secure Handling of Ammonium Nitrate,
Public Law 110-161, the Department of Homeland Security is required to
promulgate a rulemaking to create a registration regime for certain
buyers and sellers of ammonium nitrate. The rule, as proposed by this
NPRM, would create that regime, and would aid the Federal Government in
its efforts to prevent the misappropriation of ammonium nitrate for use
in acts of terrorism. By preventing such misappropriation, this rule
could limit terrorists' abilities to threaten the public and to
threaten the Nation's critical infrastructure and key resources. By
securing the Nation's supply of ammonium nitrate, it should be much
more difficult for terrorists to obtain ammonium nitrate materials for
use in improvised explosive devices. As a result, there is a direct
value in the deterrence of a catastrophic terrorist attack using
ammonium nitrate, such as the Oklahoma City attack that killed over 160
and injured 853 people.
Summary of Legal Basis: Section 563 of the 2008 Consolidated
Appropriations Act, subtitle J--Secure Handling of Ammonium Nitrate,
Public Law 110-161, authorizes and requires this rulemaking.
Alternatives: The Department considered several alternatives when
developing the Ammonium Nitrate Security Program proposed rule. The
alternatives considered were: (a) Register individuals applying for an
AN Registered User Number using a paper application (via facsimile or
the U.S. mail) rather than through in person application at a local
Cooperative Extension office or only through a web-based portal; (b)
verify AN Purchasers through both an Internet based verification portal
and call center rather than only a verification portal or call center;
(c) communicate with applicants for an AN Registered User Number
through U.S. Mail rather than only through email or a secure web-based
portal; (d) establish a specific capability within the Department to
receive, process, and respond to reports of theft or loss rather than
leverage a similar capability which already exists with the ATF; (e)
require AN Facilities to maintain records electronically in a central
database provided by the Department rather than providing flexibility
to the AN Facility to maintain their own records either in paper or
electronically; (f) require agents to register with the Department
prior to the sale or transfer of ammonium nitrate involving an agent
rather than allow oral confirmation of the agent with the AN Purchaser
on whose behalf the agent is working; and (g) exempt explosives from
this regulation rather than not exempting them. As part of its notice
of proposed rulemaking, the Department seeks public comment on the
numerous alternative ways in which the final Secure Handling of
Ammonium Nitrate Program could carry out the requirements of the Secure
Handling of Ammonium Nitrate Act.
Anticipated Cost and Benefits: The Department estimates the number
of entities that purchase ammonium nitrate to range from 64,950 to
106,200. These purchasers include farms, fertilizer mixers, farm supply
wholesalers and cooperatives (co-ops), golf courses, landscaping
services, explosives distributors, mines, retail garden centers, and
lab supply wholesalers. The Department estimates the number of entities
that sell ammonium nitrate to be between 2,486 and 6,236, many of which
are also purchasers. These sellers include ammonium nitrate fertilizer
and explosive manufacturers, fertilizer mixers, farm supply wholesalers
and co-ops, retail garden centers, explosives distributors, fertilizer
applicator services, and lab supply wholesalers. Individuals or firms
that provide transportation services within the distribution chain may
be categorized as
[[Page 7738]]
sellers, agents, or facilities depending upon their business
relationship with the other parties to the transaction. The total
number of potentially regulated farms and other businesses ranges from
64,986 to 106,236 (including overlap between the categories).
The cost of this proposed rule ranges from $300 million to $1,041
million over 10 years at a 7 percent discount rate. The primary
estimate is the mean which is $670.6 million. For comparison, at a 3
percent discount rate, the cost of the program ranges from $364 million
to $1.3 billion with a primary (mean) estimate of $814 million. The
average annualized cost for the program ranges from $43 million to $148
million (with a mean of $96 million), also employing a 7 percent
discount rate.
Because the value of the benefits of reducing risk of a terrorist
attack is a function of both the probability of an attack and the value
of the consequence, it is difficult to identify the particular risk
reduction associated with the implementation of this rule. These
elements and related qualitative benefits include point of sale
identification requirements and requiring individuals to be screened
against the Terrorist Screening Database (TSDB) resulting in known bad
actors being denied the ability to purchase ammonium nitrate.
The Department of Homeland Security aims to prevent terrorist
attacks within the United States and to reduce the vulnerability of the
United States to terrorism. By preventing the misappropriation or use
of ammonium nitrate in acts of terrorism, this rulemaking will support
the Department's efforts to prevent terrorist attacks and to reduce the
Nation's vulnerability to terrorist attacks. This rulemaking is
complementary to other Department programs seeking to reduce the risks
posed by terrorism, including the Chemical Facility Anti-Terrorism
Standards program (which seeks in part to prevent terrorists from
gaining access to dangerous chemicals) and the Transportation Worker
Identification Credential program (which seeks in part to prevent
terrorists from gaining access to certain critical infrastructure),
among other programs.
Risks: Explosives containing ammonium nitrate are commonly used in
terrorist attacks. Such attacks have been carried out both domestically
and internationally. The 1995 Murrah Federal Building attack in
Oklahoma City claimed the lives of 167 individuals and demonstrated
firsthand to America how ammonium nitrate could be misused by
terrorists. In addition to the Murrah Building attack, the Provisional
Irish Republican Army used ammonium nitrate as part of its London,
England bombing campaign in the early 1980s. More recently, ammonium
nitrate was used in the 1998 East African Embassy bombings and in
November 2003 bombings in Istanbul, Turkey. Additionally, since the
events of 9/11, stores of ammonium nitrate have been confiscated during
raids on terrorist sites around the world, including sites in Canada,
England, India, and the Philippines.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
ANPRM............................... 10/29/08 73 FR 64280
Correction.......................... 11/05/08 73 FR 65783
ANPRM Comment Period End............ 12/29/08 .......................
NPRM................................ 08/03/11 76 FR 46908
Notice of Public Meetings........... 10/07/11 76 FR 62311
Notice of Public Meetings........... 11/14/11 76 FR 70366
NPRM Comment Period End............. 12/01/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Federal.
Federalism: This action may have federalism implications as defined
in EO 13132.
URL For More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Jon MacLaren, Ammonium Nitrate Program Manager,
Department of Homeland Security, Office of the Secretary,
Infrastructure Security Compliance Division (NPPD/ISCD), Mail Stop
0610, 245 Murray Lane SW., Arlington, VA 20598-0610, Phone: 703 235-
5263, Email: [email protected].
RIN: 1601-AA52
DHS--U.S. CITIZENSHIP AND IMMIGRATION SERVICES (USCIS)
Proposed Rule Stage
54. Asylum and Withholding Definitions
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1158; 8 U.S.C. 1226; 8
U.S.C. 1252; 8 U.S.C. 1282
CFR Citation: 8 CFR 2; 8 CFR 208.
Legal Deadline: None.
Abstract: This rule proposes to amend Department of Homeland
Security regulations that govern asylum eligibility. The amendments
focus on portions of the regulations that deal with the definitions of
membership in a particular social group, the requirements for failure
of State protection, and determinations about whether persecution is
inflicted on account of a protected ground. This rule codifies long-
standing concepts of the definitions. It clarifies that gender can be a
basis for membership in a particular social group. It also clarifies
that a person who has suffered or fears domestic violence may under
certain circumstances be eligible for asylum on that basis. After the
Board of Immigration Appeals published a decision on this issue in
1999, Matter of R-A-, Int. Dec. 3403 (BIA 1999), it became clear that
the governing regulatory standards required clarification. The
Department of Justice began this regulatory initiative by publishing a
proposed rule addressing these issues in 2000.
Statement of Need: This rule provides guidance on a number of key
interpretive issues of the refugee definition used by adjudicators
deciding asylum and withholding of removal (withholding) claims. The
interpretive issues include whether persecution is inflicted on account
of a protected ground, the requirements for establishing the failure of
State protection, and the parameters for defining membership in a
particular social group. This rule will aid in the adjudication of
claims made by applicants whose claims fall outside of the rubric of
the protected grounds of race, religion, nationality, or political
opinion. One example of such claims which often fall within the
particular social group ground concerns people who have suffered or
fear domestic violence. This rule is expected to consolidate issues
raised in a proposed rule in 2000 and to address issues that have
developed since the publication of the proposed rule. This rule should
provide greater stability and clarity in this important area of the
law.
Summary of Legal Basis: The purpose of this rule is to provide
guidance on certain issues that have arisen in the context of asylum
and withholding adjudications. The 1951 Geneva Convention relating to
the Status of Refugees contains the internationally accepted definition
of a refugee. United States immigration law incorporates an almost
identical definition of a refugee as a person outside his or her
country of origin ``who is unable or unwilling to return to, and is
unable or unwilling to avail himself or herself of the protection of,
that country because of persecution or a well-founded fear of
persecution on account of race, religion, nationality, membership in a
particular social group,
[[Page 7739]]
or political opinion.'' Section 101(a)(42) of the Immigration and
Nationality Act.
Alternatives: A sizable body of interpretive case law has developed
around the meaning of the refugee definition. Historically, much of
this case law has addressed more traditional asylum and withholding
claims based on the protected grounds of race, religion, nationality,
or political opinion. In recent years, however, the United States
increasingly has encountered asylum and withholding applications with
more varied bases, related, for example, to an applicant's gender or
sexual orientation. Many of these new types of claims are based on the
ground of ``membership in a particular social group,'' which is the
least well-defined of the five protected grounds within the refugee
definition.
On December 7, 2000, DOJ published a proposed rule in the Federal
Register providing guidance on the definitions of ``persecution'' and
``membership in a particular social group.'' Prior to publishing a new
proposed rule, the Department will be considering how the nexus between
persecution and a protected ground might be further conceptualized; how
membership in a particular social group might be defined and evaluated;
and what constitutes a State's inability or unwillingness to protect
the applicant where the persecution arises from a non-State actor. This
rule will provide guidance to the following adjudicators: USCIS asylum
officers, Department of Justice Executive Office for Immigration Review
(EOIR) immigration judges, and members of the EOIR Board of Immigration
Appeals. The alternative to publishing this rule would be to allow the
standards governing this area of law to continue to develop piecemeal
through administrative and judicial precedent. This approach has
resulted in inconsistent and confusing standards, and the Department
has therefore determined that promulgation of the new proposed rule is
necessary.
Anticipated Cost and Benefits: By providing a clear framework for
key asylum and withholding issues, we anticipate that adjudicators will
have clear guidance, increasing administrative efficiency and
consistency in adjudicating these cases. The rule will also promote a
more consistent and predictable body of administrative and judicial
precedent governing these types of cases. We anticipate that this will
enable applicants to better assess their potential eligibility for
asylum, and to present their claims more efficiently when they believe
that they may qualify, thus reducing the resources spent on
adjudicating claims that do not qualify. In addition, a more consistent
and predictable body of law on these issues will likely result in fewer
appeals, both administrative and judicial, and reduce associated
litigation costs. The Department has no way of accurately predicting
how this rule will impact the number of asylum applications filed in
the United States. Based on anecdotal evidence and on the reported
experience of other nations that have adopted standards under which the
results are similar to those we anticipate for this rule, we do not
believe this rule will cause a change in the number of asylum
applications filed.
Risks: The failure to promulgate a final rule in this area presents
significant risks of further inconsistency and confusion in the law.
The Government's interests in fair, efficient, and consistent
adjudications would be compromised.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/07/00 65 FR 76588
NPRM Comment Period End............. 01/22/01 .......................
NPRM................................ 05/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: CIS No. 2092-00, Transferred from RIN 1115-
AF92.
Agency Contact: Ted Kim, Deputy Chief, Asylum Division, Department
of Homeland Security, U.S. Citizenship and Immigration Services, Office
of Refugee, Asylum, and International Operations, Suite 3200, 20
Massachusetts Avenue NW., Washington, DC 20259, Phone: 202 272-1614,
Fax: 202 272-1994, Email: [email protected].
RIN: 1615-AA41
DHS--USCIS
55. New Classification for Victims of Criminal Activity; Eligibility
for the U Nonimmigrant Status
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8
U.S.C. 1101 note; 8 U.S.C. 1102
CFR Citation: 8 CFR 103; 8 CFR 204; 8 CFR 212; 8 CFR 214; 8 CFR
299.
Legal Deadline: None.
Abstract: This rule sets forth application requirements for a new
nonimmigrant status. The U classification is for non-U.S. Citizen/
Lawful Permanent Resident victims of certain crimes who cooperate with
an investigation or prosecution of those crimes. There is a limit of
10,000 principals per year.
This rule establishes the procedures to be followed in order to
petition for the U nonimmigrant classifications. Specifically, the rule
addresses the essential elements that must be demonstrated to receive
the nonimmigrant classification, procedures that must be followed to
make an application, and evidentiary guidance to assist in the
petitioning process. Eligible victims will be allowed to remain in the
United States. The Trafficking Victims Protection Reauthorization Act
of 2008, Public Law 110-457, made amendments to the T nonimmigrant
status provisions of the Immigration and Nationality Act. The
Department will issue a proposed rule to make the changes required by
recent legislation and to provide the opportunity for notice and
comment.
Statement of Need: This rule provides requirements and procedures
for aliens seeking U nonimmigrant status. U nonimmigrant classification
is available to alien victims of certain criminal activity who assist
government officials in the investigation or prosecution of that
criminal activity. The purpose of the U nonimmigrant classification is
to strengthen the ability of law enforcement agencies to investigate
and prosecute such crimes as domestic violence, sexual assault, and
trafficking in persons, while offering protection to alien crime
victims in keeping with the humanitarian interests of the United
States.
Summary of Legal Basis: Congress created the U nonimmigrant
classification in the Battered Immigrant Women Protection Act of 2000
(BIWPA). Congress intended to strengthen the ability of law enforcement
agencies to investigate and prosecute cases of domestic violence,
sexual assault, trafficking of aliens, and other crimes, while offering
protection to victims of such crimes. Congress also sought to encourage
law enforcement officials to better serve immigrant crime victims.
Alternatives: USCIS has identified four alternatives, the first
being chosen for the rule:
1. USCIS would adjudicate petitions on a first in, first out basis.
Petitions received after the limit has been reached would be reviewed
to determine whether or not they are approvable, but for the numerical
cap. Approvable petitions that are reviewed after the numerical cap has
been reached would be placed on a waiting list and written notice sent
to the petitioner. Priority on
[[Page 7740]]
the waiting list would be based upon the date on which the petition is
filed. USCIS would provide petitioners on the waiting list with interim
relief until the start of the next fiscal year in the form of deferred
action, parole, or a stay of removal.
2. USCIS would adjudicate petitions on a first in, first out basis,
establishing a waiting list for petitions that are pending or received
after the numerical cap has been reached. Priority on the waiting list
would be based upon the date on which the petition was filed. USCIS
would not provide interim relief to petitioners whose petitions are
placed on the waiting list.
3. USCIS would adjudicate petitions on a first in, first out basis.
However, new filings would be reviewed to identify particularly
compelling cases for adjudication. New filings would be rejected once
the numerical cap is reached. No official waiting list would be
established; however, interim relief until the start of the next fiscal
year would be provided for some compelling cases. If a case was not
particularly compelling, the filing would be denied or rejected.
4. USCIS would adjudicate petitions on a first in, first out basis.
However, new filings would be rejected once the numerical cap is
reached. No waiting list would be established nor would interim relief
be granted.
Anticipated Cost and Benefits: USCIS estimates the total annual
cost of this interim rule to applicants to be $6.2 million. This cost
includes the biometric services fee that petitioners must pay to USCIS,
the opportunity cost of time needed to submit the required forms, the
opportunity cost of time required for a visit to an Application Support
Center, and the cost of traveling to an Application Support Center.
This rule will strengthen the ability of law enforcement agencies
to investigate and prosecute such crimes as domestic violence, sexual
assault, and trafficking in persons, while offering protection to alien
crime victims in keeping with the humanitarian interests of the United
States.
Risks: In the case of witness tampering, obstruction of justice, or
perjury, the interpretive challenge for USCIS was to determine whom the
BIWPA was meant to protect, given that these criminal activities are
not targeted against a person. Accordingly it was determined that a
victim of witness tampering, obstruction of justice, or perjury is an
alien who has been directly and proximately harmed by the perpetrator
of one of these three crimes, where there are reasonable grounds to
conclude that the perpetrator principally committed the offense as a
means: (1) To avoid or frustrate efforts to investigate, arrest,
prosecute, or otherwise bring him or her to justice for other criminal
activity; or (2) to further his or her abuse or exploitation of, or
undue control over, the alien through manipulation of the legal system.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 09/17/07 72 FR 53013
Interim Final Rule Effective........ 10/17/07 .......................
Interim Final Rule Comment Period 11/17/07 .......................
End.
NPRM................................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal, Local, State.
Additional Information: Transferred from RIN 1115-AG39.
Agency Contact: Laura M. Dawkins, Chief, Family Immigration and
Victim Protection Division, Department of Homeland Security, U.S.
Citizenship and Immigration Services, Suite 1200, 20 Massachusetts
Avenue NW., Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-
1480, Email: [email protected].
RIN: 1615-AA67
DHS--USCIS
56. Exception to the Persecution Bar for Asylum, Refugee, and Temporary
Protected Status, and Withholding of Removal
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1158; 8
U.S.C. 1226; Pub. L. 107-26; Pub. L. 110-229
CFR Citation: 8 CFR 1; 8 CFR 208; 8 CFR 244; 8 CFR 1244.
Legal Deadline: None.
Abstract: This joint rule proposes amendments to Department of
Homeland Security (DHS) and Department of Justice (DOJ) regulations to
describe the circumstances under which an applicant will continue to be
eligible for asylum, refugee, or temporary protected status, special
rule cancellation of removal under the Nicaraguan Adjustment and
Central American Relief Act, and withholding of removal, even if DHS or
DOJ has determined that the applicant's actions contributed, in some
way, to the persecution of others. The purpose of this rule is to
resolve ambiguity in the statutory language precluding eligibility for
asylum, refugee, and temporary protected status of an applicant who
ordered, incited, assisted, or otherwise participated in the
persecution of others. The proposed amendment would provide a limited
exception for actions taken by the applicant under duress and clarify
the required levels of the applicant's knowledge of the persecution.
Statement of Need: This rule resolves ambiguity in the statutory
language precluding eligibility for asylum, refugee, and temporary
protected status of an applicant who ordered, incited, assisted, or
otherwise participated in the persecution of others. The proposed
amendment would provide a limited exception for actions taken by the
applicant under duress and clarify the required levels of the
applicant's knowledge of the persecution.
Summary of Legal Basis: In Negusie v. Holder, 129 S. Ct. 1159
(2009), the Supreme Court addressed whether the persecutor bar should
apply where an alien's actions were taken under duress. DHS believes
that this is an appropriate subject for rulemaking and proposes to
amend the applicable regulations to set out its interpretation of the
statute. In developing this regulatory initiative, DHS has carefully
considered the purpose and history behind enactment of the persecutor
bar, including its international law origins and the criminal law
concepts upon which they are based.
Alternatives: DHS did consider the alternative of not publishing a
rulemaking on these issues. To leave this important area of the law
without an administrative interpretation would confuse adjudicators and
the public.
Anticipated Cost and Benefits: The programs affected by this rule
exist so that the United States may respond effectively to global
humanitarian situations and assist people who are in need. USCIS
provides a number of humanitarian programs and protection to assist
individuals in need of shelter or aid from disasters, oppression,
emergency medical issues, and other urgent circumstances. This rule
will advance the humanitarian goals of the asylum/refugee program, and
other specialized programs. The main benefits of such goals tend to be
intangible and difficult to quantify in economic and monetary terms.
These forms of relief have not been available to certain persecutors.
This rule will allow an exception to this bar from protection for
applicants who can meet the appropriate evidentiary standard.
Consequently, this rule may result in a small increase in the number of
applicants for humanitarian programs.
[[Page 7741]]
To the extent a small increase in applicants occurs, there could be
additional fee costs incurred by these applicants.
Risks: If DHS were not to publish a regulation, the public would
face a lengthy period of confusion on these issues. There could also be
inconsistent interpretations of the statutory language, leading to
significant litigation and delay for the affected public.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Molly Groom, Office of the Chief Counsel Department
of Homeland Security, U.S. Citizenship and Immigration Services, 20
Massachusetts Avenue NW., Washington, DC 20259, Phone: 202 272-1400,
Fax: 202 272-1408, Email: [email protected].
RIN: 1615-AB89
DHS--USCIS
57. Electronic Filing of Requests for Immigration Benefits;
Requiring an Application To Change or Extend Nonimmigrant Status To Be
Filed Electronically
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1151; 8
U.S.C. 1153
CFR Citation: 8 CFR 103; 8 CFR 204.
Legal Deadline: None.
Abstract: The Department of Homeland Security (DHS) is proposing
regulations to govern the electronic filing of requests for immigration
benefit requests with the U.S. Citizenship and Immigration Services
(USCIS). DHS also proposes to mandate electronic applications in the
new Integrated Operating Environment that is under development, with
limited exceptions, for an Application to Extend/Change Nonimmigrant
Status from any individual in the M, J, B-1, and B-2 classifications;
change of status requests to the F, M, J, B-1, or B-2 classifications;
and reinstatement of status requests in the F or M classification.
Statement of Need: USCIS is in the process of transforming its
operations to improve service, operational efficiency, and national
security. This rule will allow USCIS to modernize its processes, which
will provide applicants and petitioners with better and faster services
and enhance the ability of USCIS to process cases with greater
accuracy, security, and timeliness.
Summary of Legal Basis: Authority for this rule falls within the
broad authority of the Secretary of Homeland Security to administer
DHS, the administration of immigration and nationality laws, and other
delegated authority. See Homeland Security Act of 2002, Public Law 107-
296 section 102 (Nov. 25, 2002), 6 U.S.C. 112, and the Immigration and
Nationality Act of 1952, as amended, section 103, 8 U.S.C. 1103.
The Government Paperwork Elimination Act provides that, when
possible, Federal agencies are directed to make available electronic
forms and provide for electronic filing and submissions when conducting
agency business with the public. See Public Law 105-277, section 1703
(Oct. 21, 1998), 44 U.S.C. 3504. GPEA also establishes the means for
the use and acceptance of electronic signatures.
The INA provides a detailed list of classes of nonimmigrant aliens.
See, e.g., INA sections 101(a)(15)(B), (C), (F), and (M); 8 U.S.C.
1101(a)(15) (B), (C), (F), and (M). The Secretary of Homeland Security
may authorize a change to any other nonimmigrant classification in the
case of any alien who is lawfully admitted to the United States as a
nonimmigrant, maintains his or her lawful status, does not fall under
certain nonimmigrant visa categories that are listed in the statute,
and is not inadmissible or whose inadmissibility has been waived under
the pertinent sections of the immigration and nationality laws of the
United States. See INA section 248(a); 8 U.S.C. 1258(a).
This rule is also proposed in compliance with Executive Order 13571
``Streamlining Service Delivery and Improving Customer Service.'' See
Executive Order No. 13571, 76 FR 24339 (Apr. 27, 2011). Executive Order
13571 tasks each Federal department and agency with establishing an
initiative that uses technology to improve the experience of
individuals and entities receiving services from that Federal
department or agency. See Executive Order No. 13571, section 2(a).
Alternatives: DHS has examined the alternative of maintaining paper
processing for applications to extend/change status (Form I-539) and
has determined that the continuation of legacy data systems and current
processes do not meet the need for USCIS to modernize operations.
Anticipated Cost and Benefits: DHS is proposing to mandate the
electronic filing of stand-alone Applications to Extend/Change
Nonimmigrant Status. Only a limited number of nonimmigrants would be
impacted by this change. Specifically, those individuals in the
following nonimmigrant classifications would be required to file this
application electronically: B-1, B-2, F, M, or J. In transforming its
immigration benefit processes into a paperless system, DHS anticipates
the following benefits:
Streamlined operations
More timely submission and adjudication of the benefit
requested
Reduced requests for additional or missing information
Enhanced security for the applicant
Enhanced customer service
For those applicants that do not currently possess or have access
to the tools needed to submit immigration benefit requests
electronically--namely, computer, Internet service, and a scanner--this
rule would result in additional costs to these petitioners or
applicants. DHS is in the process of examining the potential monetary
costs and benefits of the proposed rule.
Risks: Populations with no or limited Internet access and
individuals with no or limited English proficiency may be affected by
this rule. This risk can be mitigated by including a waiver process.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Dan Konnerth, Policy and Coordination Chief, Office
of Transformation Coordination, Department of Homeland Security, U.S.
Citizenship and Immigration Services, 6th Floor, 633 Third Street NW.,
Washington, DC 20529, Phone: 202 233-2381, Email: [email protected].
RIN: 1615-AB94
DHS--USCIS
58. Immigration Benefits Business Transformation:
Nonimmigrants; Student and Exchange Visitor Program
Priority: Other Significant.
Legal Authority: 5 U.S.C. 301; 5 U.S.C. 552; 5 U.S.C. 552a; 8
U.S.C. 1101; 8 U.S.C. 1103
CFR Citation: 8 CFR 103; 8 CFR 212; 8 CFR 214; 8 CFR 245; 8 CFR
248; 8 CFR 274a.
Legal Deadline: None.
Abstract: The Department of Homeland Security (DHS) is amending
[[Page 7742]]
its nonimmigrant regulations to enable U.S. Citizenship and Immigration
Services (USCIS) to migrate from a paper file-based, non-integrated
systems environment to an electronic, customer-focused, centralized
case management environment for benefit processing. This rulemaking,
the second in a series of business transformation rules, primarily
focuses on 8 CFR part 214, reorganizes and streamlines general
information relating to nonimmigrant classifications, and relocates
other information relating to specific, individual nonimmigrant
classifications to a separate subpart for each major nonimmigrant
classification. DHS is making these amendments because part 214
contains more than 20 nonimmigrant classifications, and it has become
very large and complex to navigate. This regulation will provide the
public with simpler, better organized regulatory requirements for each
nonimmigrant classification and facilitate future revisions.
Statement of Need: USCIS is in the process of transforming its
operations to improve service, operational efficiency, and national
security. This rule will provide the public with clearly written,
better organized regulatory requirements for each nonimmigrant
classification.
Summary of Legal Basis: The Homeland Security Act of 2002, Public
Law 107-296, section 102, 116 Stat. 2135 (Nov. 25, 2002), 6 U.S.C. 112,
and the Immigration and Nationality Act of 1952 (INA), charge the
Secretary of Homeland Security (Secretary) with administration and
enforcement of the immigration and nationality laws. See INA section
103, 8 U.S.C. 1103.
This rule will significantly enhance the ability of USCIS to fully
implement the Government Paperwork Elimination Act (GPEA). See Public
Law 105-277, tit. XVII, section 1701 to 1710, 112 Stat. 2681 at 2681-
749, (Oct. 21, 1998) (codified at 44 U.S.C. 3504 & note). GPEA provides
that, when possible, Federal agencies use electronic forms, electronic
filing, and electronic submissions to conduct agency business with the
public. Id. The USCIS modernization and transformation effort will move
its operations away from a paper-based system to an electronic
environment wherever possible in an effort to implement the
requirements of GPEA.
Alternatives: The regulations for the more than 20 nonimmigrant
classifications are included in 8 CFR 214. As more nonimmigrant
classifications have been added to the Act and as the statutory
requirements for existing classifications have become more complex,
sections within 8 CFR 214 have become increasingly difficult to read,
comprehend and cite. DHS will reorganize 8 CFR 214 to address this lack
of clarity.
Anticipated Cost and Benefits: DHS will amend its regulations at 8
CFR part 214 to streamline and reorganize the content into a more
reader-friendly and logical format. DHS is not making substantive
changes to the content or requirements of existing regulations. There
are no additional costs anticipated as a result of this rulemaking.
Risks: This rule may initially lead to confusion of those who are
familiar with the previous organization of 8 CFR 214. USCIS can
mitigate this risk by informing the public of these changes.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: CIS 2505-11. This rule (RIN 1615-
AB95) is adopting the following three rules as final rules: 1615-AA35,
1615-AA56, and 1615-AA53.
Agency Contact: Dan Konnerth, Policy and Coordination Chief, Office
of Transformation Coordination, Department of Homeland Security, U.S.
Citizenship and Immigration Services, 6th Floor, 633 Third Street NW.,
Washington, DC 20529, Phone: 202 233-2381, Email: [email protected].
RIN: 1615-AB95
DHS--USCIS
59. Application of the William Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008 to Unaccompanied Alien Children
Seeking Asylum
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: Pub. L. 110-457
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: This rule implements the provisions of the William
Wilberforce Trafficking Victims Protection Reauthorization Act of 2008
(TVPRA), Public Law 110-457, 122 Stat. 5074 (Dec. 23, 2008) relating to
unaccompanied alien children seeking asylum. Specifically, the rule
proposes to amend Department of Homeland Security and Department of
Justice regulations relating to asylum applications filed by
unaccompanied alien children. The rule will amend both Departments'
regulations to reflect that U.S. Citizenship and Immigration Services
(USCIS) has initial jurisdiction over any asylum application filed by
an unaccompanied alien child. The rule will also add new special
procedures for all children in interviews before USCIS officers and for
unaccompanied alien children in proceedings before immigration judges
in the Executive Office for Immigration Review.
Statement of Need: The TVPRA mandated promulgation of regulations
taking into account the specialized needs of unaccompanied alien
children and addressing both procedural and substantive aspects of
handling unaccompanied alien children's cases. This rule will codify
existing agency guidance on the specialized needs of unaccompanied
alien children. The rule will also codify agency guidance implementing
the TVPRA. Such guidance has been in effect since March 2009 and, based
on experience gained in following the guidance, will be revised in the
rule.
Summary of Legal Basis: The purpose of this rule is to comply with
the TVPRA mandate to promulgate regulations taking into account the
specialized needs of unaccompanied alien children and addressing both
procedural and substantive aspects of handling unaccompanied alien
children's cases.
Alternatives: N/A.
Anticipated Cost and Benefits: Congress has given USCIS initial
jurisdiction over the asylum claims of unaccompanied alien children.
New costs can accrue when EOIR immigration judges transfer cases
involving unaccompanied alien minors to USCIS for asylum interviews and
adjudication if USCIS does not grant the asylum application and the
case is returned to EOIR for further adjudication. This additional cost
is offset, however, when USCIS grants such an application because the
costs of USCIS asylum adjudications are generally much lower than the
processing of immigration court applications for that benefit. In
addition, USCIS provides a non-adversarial setting for asylum seeker
interviews and has recently developed extensive and ongoing training in
children's issues. These factors can assist unaccompanied children in
expressing their fear of return to their native countries.
Unaccompanied alien children also compose a uniquely vulnerable
population with often compelling protection issues; therefore,
affording unaccompanied alien children every
[[Page 7743]]
consideration in the asylum process greatly benefits them. Finally,
benefits will also accrue because the regulation will improve upon the
process initially implemented upon passage of the TVPRA, incorporating
lessons learned and optimizing the procedures for USCIS and EOIR.
Risks: N/A.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Federal.
Agency Contact: Ted Kim, Deputy Chief, Asylum Division, Department
of Homeland Security, U.S. Citizenship and Immigration Services, Office
of Refugee, Asylum, and International Operations, Suite 3200, 20
Massachusetts Avenue NW., Washington, DC 20259, Phone: 202 272-1614,
Fax: 202 272-1994, Email: [email protected].
RIN: 1615-AB96
DHS--USCIS
60. Administrative Appeals Office: Procedural Reforms To
Improve Efficiency
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8
U.S.C. 1103; 8 U.S.C. 1304; 6 U.S.C. 112
CFR Citation: 8 CFR 103; 8 CFR 204; 8 CFR 205; 8 CFR 210; 8 CFR
214; 8 CFR 245a; 8 CFR 320; 8 CFR 105 (new); * * *.
Legal Deadline: None.
Abstract: This proposed rule revises the requirements and
procedures for the filing of motions and appeals before the
Department's U.S. Citizenship and Immigration Services and its
Administrative Appeals Office. The proposed changes are intended to
streamline the existing processes for filing motions and appeals and
will reduce delays in the review and appellate process. This rule also
makes additional changes necessitated by the establishment of the
Department of Homeland Security and its components.
Statement of Need: This rule proposes to make numerous changes to
streamline the current appeal and motion processes which: (1) Will
result in cost savings to the Government, applicants, and petitioners;
and (2) will provide for a more efficient use of USCIS officer and
clerical staff time, as well as more uniformity with Board of
Immigration Appeals appeal and motion processes.
Summary of Legal Basis: 5 U.S.C. 301; 5 U.S.C. 552; 5 U.S.C. 552a;
8 U.S.C. 1101 and note 1102, 1103, 1151, 1153, 1154, 1182, 1184, 1185
note (sec. 7209 of Pub. L. 108-458; title VII of Pub. L. 110-229),
1186a, 1187, 1221,1223, 1225 to 1227, 1255a, and 1255a note, 1281,
1282, 1301 to 1305, 1324a, 1356, 1372, 1379, 1409(c), 1443 to 1444,
1448, 1452, 1455, 1641, 1731 to 1732; 31 U.S.C. 9701; 48 U.S.C. 1901,
1931 note; section 643, Public Law 104-208, 110 Stat. 3009-708; section
141 of the Compacts of Free Association with the Federated States of
Micronesia and the Republic of the Marshall Islands, and with the
Government of Palau,; title VII of Public Law 110-229; Public Law 107-
296, 116 Stat. 2135 (6 U.S.C. 1 et seq.); Public Law 82-414, 66 Stat.
173, 238, 254, 264; title VII of Public Law 110-229; E.O. 12356.
Alternatives: The alternative to this rule would be to continue
under the current process without change.
Anticipated Cost and Benefits: As a result of streamlining the
appeal and motion process, USCIS anticipates quantitative and
qualitative benefits to DHS and the public. We also anticipate cost
savings to DHS and applicants as a result of the proposed changes.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: None.
Additional Information: Previously 1615-AB29 (CIS 2311-04), which
was withdrawn in 2007. DHS has included this rule in its Final Plan for
the Retrospective Review of Existing Regulations, which DHS issued on
August 22, 2011.
Agency Contact: William K Renwick, Supervisory Citizenship and
Immigration Appeals Officer, Department of Homeland Security, U.S.
Citizenship and Immigration Services, Administrative Appeals Office,
Washington, DC 20529-2090, Phone: 703 224-4501, Email:
[email protected].
Related RIN: Duplicate of 1615-AB29.
RIN: 1615-AB98
DHS--USCIS
Final Rule Stage
61. New Classification for Victims of Severe Forms of Trafficking in
Persons; Eligibility for T Nonimmigrant Status
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101 to
1104; 8 U.S.C. 1182; 8 U.S.C. 1184; 8 U.S.C. 1187; 8 U.S.C. 1201; 8
U.S.C. 1224 to 1227; 8 U.S.C. 1252 to 1252a; 22 U.S.C. 7101; 22 U.S.C.
7105
CFR Citation: 8 CFR 103; 8 CFR 212; 8 CFR 214; 8 CFR 274a; 8 CFR
299.
Legal Deadline: None.
Abstract: T classification was created by 107(e) of the Victims of
Trafficking and Violence Protection Act of 2000 (VTVPA), Public Law
106-386. The T nonimmigrant classification was designed for eligible
victims of severe forms of trafficking in persons who aid law
enforcement with their investigation or prosecution of the traffickers,
and who can establish that they would suffer extreme hardship involving
unusual and severe harm if they were removed from the United States.
The rule establishes application procedures and responsibilities for
the Department of Homeland Security and provides guidance to the public
on how to meet certain requirements to obtain T nonimmigrant status.
The Trafficking Victims Protection Reauthorization Act of 2008, Public
Law 110-457, made amendments to the T nonimmigrant status provisions of
the Immigration and Naturalization Act. The Department will issue
another interim final rule to make the changes required by recent
legislation and to provide the opportunity for notice and comment.
Statement of Need: T nonimmigrant status is available to eligible
victims of severe forms of trafficking in persons who have complied
with any reasonable request for assistance in the investigation or
prosecution of acts of trafficking in persons, and who can demonstrate
that they would suffer extreme hardship involving unusual and severe
harm if removed from the United States. This rule addresses the
essential elements that must be demonstrated for classification as a T
nonimmigrant alien; the procedures to be followed by applicants to
apply for T nonimmigrant status; and evidentiary guidance to assist in
the application process.
Summary of Legal Basis: Section 107(e) of the Trafficking Victims
Protection Act (TVPA), Public Law 106-386, as amended, established the
T classification to create a safe haven for certain eligible victims of
severe forms
[[Page 7744]]
of trafficking in persons, who assist law enforcement authorities in
investigating and prosecuting the perpetrators of these crimes.
Alternatives: To develop a comprehensive Federal approach to
identifying victims of severe forms of trafficking in persons, to
provide them with benefits and services, and to enhance the Department
of Justice's ability to prosecute traffickers and prevent trafficking
in persons in the first place, a series of meetings with stakeholders
were conducted with representatives from key Federal agencies;
national, State, and local law enforcement associations; non-profit,
community-based victim rights organizations; and other groups.
Suggestions from these stakeholders were used in the drafting of this
regulation.
Anticipated Cost and Benefits: There is no cost to applicants
associated with this regulation. Applicants for T nonimmigrant status
do not pay application or biometric fees.
The anticipated benefits of these expenditures include: Assistance
to trafficked victims and their families, prosecution of traffickers in
persons, and the elimination of abuses caused by trafficking
activities.
Benefits which may be attributed to the implementation of this rule
are expected to be:
1. An increase in the number of cases brought forward for
investigation and/or prosecution;
2. Heightened awareness by the law enforcement community of
trafficking in persons;
3. Enhanced ability to develop and work cases in trafficking in
persons cross-organizationally and multi-jurisdictionally, which may
begin to influence changes in trafficking patterns.
Risks: There is a 5,000-person limit to the number of individuals
who can be granted T-1 status per fiscal year. Eligible applicants who
are not granted T-1 status due solely to the numerical limit will be
placed on a waiting list to be maintained by U.S. Citizenship and
Immigration Services (USCIS).
To protect T-1 applicants and their families, USCIS will use
various means to prevent the removal of T-1 applicants on the waiting
list, and their family members who are eligible for derivative T
status, including its existing authority to grant deferred action,
parole, and stays of removal.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 01/31/02 67 FR 4784
Interim Final Rule Effective........ 03/04/02 .......................
Interim Final Rule Comment Period 04/01/02 .......................
End.
Interim Final Rule.................. 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal, Local, State.
Additional Information: CIS No. 2132-01; AG Order No. 2554-2002.
There is a related rulemaking, CIS No. 2170-01, the new U nonimmigrant
status (RIN 1615-AA67). Transferred from RIN 1115-AG19.
Agency Contact: Laura M. Dawkins, Chief, Family Immigration and
Victim Protection Division, Department of Homeland Security, U.S.
Citizenship and Immigration Services, Suite 1200, 20 Massachusetts
Avenue NW., Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-
1480, Email: [email protected].
Related RIN: Related to 1615-AA67.
RIN: 1615-AA59
DHS--USCIS
62. Adjustment of Status to Lawful Permanent Resident for Aliens in T
and U Nonimmigrant Status
Priority: Other Significant.
Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101 to
1104; 8 U.S.C. 1182; 8 U.S.C. 1184; 8 U.S.C. 1187; 8 U.S.C. 1201; 8
U.S.C. 1224 to 1227; 8 U.S.C. 1252 to 1252a; 8 U.S.C. 1255; 22 U.S.C.
7101; 22 U.S.C. 7105
CFR Citation: 8 CFR 204; 8 CFR 214; 8 CFR 245.
Legal Deadline: None.
Abstract: This rule sets forth measures by which certain victims of
severe forms of trafficking who have been granted T nonimmigrant status
and victims of certain criminal activity who have been granted U
nonimmigrant status may apply for adjustment to permanent resident
status in accordance with Public Law 106-386, Victims of Trafficking
and Violence Protection Act of 2000; and Public Law 109-162, Violence
Against Women and Department of Justice Reauthorization Act of 2005.
The Trafficking Victims Protection Reauthorization Act of 2008, Public
Law 110-457, made amendments to the T nonimmigrant status provisions of
the Immigration and Naturalization Act. The Department will issue
another interim final rule to make the changes required by recent
legislation and to provide the opportunity for notice and comment.
Statement of Need: This regulation is necessary to permit aliens in
lawful T or U nonimmigrant status to apply for adjustment of status to
that of lawful permanent residents. T nonimmigrant status is available
to aliens who are victims of a severe form of trafficking in persons
and who are assisting law enforcement in the investigation or
prosecution of the acts of trafficking. U nonimmigrant status is
available to aliens who are victims of certain crimes and are being
helpful to the investigation or prosecution of those crimes.
Summary of Legal Basis: This rule implements the Victims of
Trafficking and Violence Protection Act of 2000 (VTVPA), Public Law
106-386, 114 Stat. 1464 (Oct. 28, 2000), as amended, to permit aliens
in lawful T or U nonimmigrant status to apply for adjustment of status
to that of lawful permanent residents.
Alternatives: USCIS did not consider alternatives to managing T and
U applications for adjustment of status. Ease of administration
dictates that adjustment of status applications from T and U
nonimmigrants would be best handled on a first in, first out basis,
because that is the way applications for T and U status are currently
handled.
Anticipated Cost and Benefits: USCIS uses fees to fund the cost of
processing applications and associated support benefits. The fees to be
collected resulting from this rule will be approximately $3 million in
the first year, $1.9 million in the second year, and an average of
about $32 million in the third and subsequent years. To estimate the
new fee collections to be generated by this rule, USCIS estimated the
fees to be collected for new applications for adjustment of status from
T and U nonimmigrants and their eligible family members. After that,
USCIS estimated fees from associated applications that are required
such as biometrics, and others that are likely to occur in direct
connection with applications for adjustment, such as employment
authorization or travel authorization.
The anticipated benefits of these expenditures include: Continued
assistance to trafficked victims and their families, increased
investigation and prosecution of traffickers in persons, and the
elimination of abuses caused by trafficking activities.
Benefits that may be attributed to the implementation of this rule
are expected to be:
[[Page 7745]]
1. An increase in the number of cases brought forward for
investigation and/or prosecution;
2. Heightened awareness of trafficking-in-persons issues by the law
enforcement community; and
3. Enhanced ability to develop and work cases in trafficking in
persons cross-organizationally and multi-jurisdictionally, which may
begin to influence changes in trafficking patterns.
Risks: Congress created the U nonimmigrant status (``U visa'') to
provide immigration protection to crime victims who assist in the
investigation and prosecution of those crimes. Although there are no
specific data on alien crime victims, statistics maintained by the
Department of Justice have shown that aliens, especially those aliens
without legal status, are often reluctant to help in the investigation
or prosecution of crimes. U visas are intended to help overcome this
reluctance and aid law enforcement accordingly.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 12/12/08 73 FR 75540
Interim Final Rule Effective........ 01/12/09 .......................
Interim Final Rule Comment Period 02/10/09 .......................
End.
Interim Final Rule.................. 06/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal, Local, State.
Additional Information: CIS No. 2134-01. Transferred from RIN 1115-
AG21.
Agency Contact: Laura M. Dawkins, Chief, Family Immigration and
Victim Protection Division, Department of Homeland Security, U.S.
Citizenship and Immigration Services, Suite 1200, 20 Massachusetts
Avenue NW., Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-
1480, Email: [email protected].
RIN: 1615-AA60
DHS--USCIS
63. Application of Immigration Regulations to the Commonwealth of the
Northern Mariana Islands
Priority: Other Significant.
Legal Authority: Pub. L. 110-229
CFR Citation: 8 CFR 208 and 209; 8 CFR 214 and 215; 8 CFR 217; 8
CFR 235; 8 CFR 248; 8 CFR 264; 8 CFR 274a.
Legal Deadline: Final, Statutory, November 28, 2009, Consolidated
Natural Resources Act (CNRA) of 2008.
Abstract: This final rule amends the Department of Homeland
Security (DHS) and the Department of Justice (DOJ) regulations to
comply with the Consolidated Natural Resources Act of 2008 (CNRA). The
CNRA extends the immigration laws of the United States to the
Commonwealth of the Northern Mariana Islands (CNMI). This rule
finalizes the interim rule and implements conforming amendments to
their respective regulations.
Statement of Need: This rule finalizes the interim rule to conform
existing regulations with the CNRA. Some of the changes implemented
under the CNRA affect existing regulations governing both DHS
immigration policy and procedures and proceedings before the
immigration judges and the Board. Accordingly, it is necessary to make
amendments both to the DHS regulations and to the DOJ regulations. The
Secretary and the Attorney General are making conforming amendments to
their respective regulations in this single rulemaking document.
Summary of Legal Basis: Congress extended the immigration laws of
the United States to the CNMI. The stated purpose of the CNRA is to
ensure effective border control procedures, to properly address
national security and homeland security concerns by extending U.S.
immigration law to the CNMI (phasing-out the CNMI's nonresident
contract worker program while minimizing to the greatest extent
practicable the potential adverse economic and fiscal effects of that
phase-out), to maximize the CNMI's potential for future economic and
business growth, and to assure worker protections from the potential
for abuse and exploitation.
Anticipated Cost and Benefits: Costs: The interim rule established
basic provisions necessary for the application of the INA to the CNMI
and updated definitions and existing DHS and DOJ regulations in areas
that were confusing or in conflict with how they are to be applied to
implement the INA in the CNMI. As such, that rule made no changes that
had identifiable direct or indirect economic impacts that could be
quantified.
Benefits: This final rule makes additional regulatory changes in
order to lessen the adverse impacts of the CNRA on employers and
employees in the CNMI and assist the CNMI in its transition to the INA.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 10/28/09 74 FR 55725
Interim Final Rule Comment Period 11/27/09
End.
Correction.......................... 12/22/09 74 FR 67969
Final Action........................ 03/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: CIS 2460-08.
Agency Contact: Kevin Cummings, Branch Chief, Business and Trade
Services, Department of Homeland Security, U.S. Citizenship and
Immigration Services, Second Floor, Office of Program and Regulations
Development, 20 Massachusetts Avenue NW., Washington, DC 20529, Phone:
202 272-1470, Fax: 202 272-1480, Email: [email protected].
Related RIN: Related to 1615-AB76, Related to 1615-AB75.
RIN: 1615-AB77
DHS--U.S. COAST GUARD (USCG)
Final Rule Stage
64. Implementation of the 1995 Amendments to the International
Convention on Standards of Training, Certification, and Watchkeeping
(STCW) for Seafarers, 1978
Priority: Other Significant.
Legal Authority: 46 U.S.C. 2103; 46 U.S.C. chapters 71 and 73; DHS
Delegation No. 0170.1
CFR Citation: 46 CFR 10; 46 CFR 11; 46 CFR 12; 46 CFR 15.
Legal Deadline: None.
Abstract: The International Maritime Organization (IMO)
comprehensively amended the International Convention on Standards of
Training, Certification, and Watchkeeping (STCW) for Seafarers, 1978,
in 1995 and 2010. The 1995 amendments came into force on February 1,
1997. This project implements those amendments by revising current
rules to ensure that the United States complies with their requirements
on: The training of merchant mariners, the documenting of their
qualifications, and watch-standing and other arrangements aboard
seagoing merchant ships of the United States. In addition, the Coast
Guard has identified the need for additional changes to the interim
rule issued in 1997. This project supports the Coast Guard's broad role
and responsibility of maritime safety. It also supports the roles and
responsibilities of the Coast Guard of reducing deaths and injuries of
crew
[[Page 7746]]
members on domestic merchant vessels and eliminating substandard
vessels from the navigable waters of the United States. The Coast Guard
published an NPRM on November 17, 2009, and Supplemental NPRM (SNPRM)
on March 23, 2010.
At a June 2010 diplomatic conference, the IMO adopted additional
amendments to the STCW convention, which change the minimum training
requirements for seafarers. In response to feedback and to the adoption
of those amendments, the Coast Guard developed a second Supplemental
NPRM to incorporate the 2010 Amendments into the 1990 interim rule.
Statement of Need: The Coast Guard proposed to amend its
regulations to implement changes to its interim rule published on June
26, 1997. These proposed amendments go beyond changes found in the
interim rule and seek to more fully incorporate the requirements of the
International Convention on Standards of Training, Certification and
Watchkeeping for Seafarers, 1978, as amended (STCW), in the
requirements for the credentialing of United States merchant mariners.
The new changes are primarily substantive and: (1) Are necessary to
continue to give full and complete effect to the STCW Convention; (2)
Incorporate lessons learned from implementation of the STCW through the
interim rule and through policy letters and NVICs; and (3) Attempt to
clarify regulations that have generated confusion.
Summary of Legal Basis: The authority for the Coast Guard to
prescribe, change, revise, or amend these regulations is provided under
46 U.S.C. 2103 and 46 U.S.C. chapters 71 and 73; and Department of
Homeland Security Delegation No. 0170.1.
Alternatives: For each proposed change, the Coast Guard has
considered various alternatives. We considered using policy statements,
but they are not enforceable. We also considered taking no action, but
this does not support the Coast Guard's fundamental safety and security
mission. Additionally, we considered comments made during our 1997
rulemaking to formulate our alternatives. When we analyzed issues, such
as license progression and tonnage equivalency, the alternatives chosen
were those that most closely met the requirements of STCW.
Anticipated Cost and Benefits: In the SNPRM, we estimated the
annualized cost of this rule over a 10-year period to be $32.8 million
per year at a 7 percent discount rate. We estimate the total 10-year
cost of this rulemaking to be $230.7 million at a 7 percent discount
rate and $274.3 million at a 3 percent discount rate.
The changes in anticipated costs since the publication of 2009 NPRM
are due to the 2010 amendments to the STCW Convention: Medical
examinations and endorsements, leadership and management skills, engine
room management training, tankerman endorsements, safety refresher
training and able seafarer deck and engine certification requirements.
However, there would be potential savings from the costs of training
requirements as the Coast Guard would accept various methods for
demonstrating competence, including the on-the-job training and
preservation of the ``hawsepipe'' programs.
We anticipate the primary benefit of this rulemaking is to ensure
that the U.S. meets its obligations under the STCW Convention. Another
benefit is an increase in vessel safety and a resulting decrease in the
risk of shipping casualties.
Risks: No risks.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice of Meeting................... 08/02/95 60 FR 39306
Supplemental NPRM Comment Period End 09/29/95
Notice of Inquiry................... 11/13/95 60 FR 56970
Comment Period End.................. 01/12/96
NPRM................................ 03/26/96 61 FR 13284
Notice of Public Meetings........... 04/08/96 61 FR 15438
NPRM Comment Period End............. 07/24/96
Notice of Intent.................... 02/04/97 62 FR 5197
Interim Final Rule.................. 06/26/97 62 FR 34505
Interim Final Rule Effective........ 07/28/97
NPRM................................ 11/17/09 74 FR 59353
NPRM Comment Period End............. 02/16/10
Supplemental NPRM................... 03/23/10 75 FR 13715
Supplemental NPRM................... 08/01/11 76 FR 45908
Public Meeting Notice............... 08/02/11 76 FR 46217
Comment Period End.................. 09/30/11
Final Action........................ 01/00/12
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Additional Information: The docket number for this rulemaking is
USCG-2004-17914. The docket is located at www.regulations.gov. The old
docket number is CGD 95-062.
Include Retrospective Review under E.O. 13563.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Mark Gould, Project Manager, CG-5221, Department of
Homeland Security, U.S. Coast Guard, 2100 Second Street SW., STOP 7126,
Washington, DC 20593-7126, Phone: 202 372-1409.
RIN: 1625-AA16
DHS--USCG
65. Vessel Requirements for Notices of Arrival and Departure, and
Automatic Identification System
Priority: Other Significant.
Legal Authority: 33 U.S.C. 1223; 33 U.S.C. 1225; 33 U.S.C. 1231; 46
U.S.C. 3716; 46 U.S.C. 8502 and ch 701; sec 102 of Pub. L. 107-295; EO
1223
CFR Citation: 33 CFR 62; 33 CFR 66; 33 CFR 160; 33 CFR 161; 33 CFR
164; 33 CFR 165.
Legal Deadline: None.
Abstract: This rulemaking would expand the applicability for Notice
of Arrival and Departure (NOAD) and Automatic Identification System
(AIS) requirements. These expanded requirements would better enable the
Coast Guard to correlate vessel AIS data with NOAD data, enhance our
ability to identify and track vessels, detect anomalies, improve
navigation safety, and heighten our overall maritime domain awareness.
The NOAD portion of this rulemaking could expand the applicability
of the NOAD regulations by changing the minimum size of vessels covered
below the current 300 gross tons, require a notice of departure when a
vessel is departing for a foreign port or place, and mandate electronic
submission of NOAD notices to the National Vessel Movement Center. The
AIS portion of this rulemaking would expand current AIS carriage
requirements for the population identified in the Safety of Life at Sea
(SOLAS) Convention and the Marine Transportation Marine Transportation
Security Act (MTSA) of 2002.
Statement of Need: There is no central mechanism in place to
capture vessel, crew, passenger, or specific cargo information on
vessels less than or equal to 300 gross tons (GT) intending to arrive
at or depart from U.S. ports unless they are arriving with certain
[[Page 7747]]
dangerous cargo (CDC) or at a port in the 7th Coast Guard District; nor
is there a requirement for vessels to submit notification of departure
information. The lack of NOAD information of this large and diverse
population of vessels represents a substantial gap in our maritime
domain awareness (MDA). We can minimize this gap and enhance MDA by
expanding NOAD applicability to vessels greater than 300 GT, all
foreign commercial vessels and all U.S. commercial vessels coming from
a foreign port, and further enhance (and corroborate) MDA by tracking
those vessels (and others) with AIS. This information is necessary in
order to expand our MDA and provide Nation maritime safety and
security.
Summary of Legal Basis: This rulemaking is based on congressional
authority provided in the Ports and Waterways Safety Act and the
Maritime Transportation Security Act of 2002.
Alternatives: Our goal is to extend our MDA and to identify
anomalies by correlating vessel NOAD data with AIS data. NOAD and AIS
information from a greater number of vessels, as proposed in this
rulemaking, would expand our MDA. We considered expanding NOAD and AIS
to even more vessels, but we determined we needed additional
legislative authority to expand AIS beyond what we propose in this
rulemaking; and that it was best to combine additional NOAD expansion
with future AIS expansion. Although not in conjunction with a proposed
rule, the Coast Guard sought comment regarding expansion of AIS
carriage to other waters and other vessels not subject to the current
requirements (68 FR 39369, Jul. 1, 2003; USCG 2003-14878; see also 68
FR 39355). Those comments were reviewed and considered in drafting this
rule and are available in this docket. To fulfill our agency
obligations, the Coast Guard needs to receive AIS reports and NOADs
from vessels identified in this rulemaking that currently are not
required to provide this information. Policy or other non-binding
statements by the Coast Guard addressed to the owners of these vessels
would not produce the information required to sufficiently enhance our
MDA to produce the information required to fulfill our Agency
obligations.
Anticipated Cost and Benefits: This rulemaking will enhance the
Coast Guard's regulatory program by making it more effective in
achieving the regulatory objectives, which, in this case, is improved
MDA. We provide flexibility in the type of AIS system that can be used,
allowing for reduced cost burden. This rule is also streamlined to
correspond with Customs and Border Protection's APIS requirements,
thereby reducing unjustified burdens. We are further developing
estimates of cost and benefit that were published in 2008. In the 2008
NPRM, we estimated that both segments of the proposed rule would affect
approximately 42,607 vessels. The total number of domestic vessels
affected is approximately 17,323 and the total number of foreign
vessels affected is approximately 25,284. We estimated that the 10-year
total present discounted value or cost of the proposed rule to U.S.
vessel owners is between $132.2 and $163.7 million (7 and 3 percent
discount rates, respectively, 2006 dollars) over the period of
analysis.
The Coast Guard believes that this rule, through a combination of
NOAD and AIS, would strengthen and enhance maritime security. The
combination of NOAD and AIS would create a synergistic effect between
the two requirements. Ancillary or secondary benefits exist in the form
of avoided injuries, fatalities, and barrels of oil not spilled into
the marine environment. In the 2008 NPRM, we estimated that the total
discounted benefit (injuries and fatalities) derived from 68 marine
casualty cases analyzed over an 8-year data period from 1996 to 2003
for the AIS portion of the proposed rule is between $24.7 and $30.6
million using $6.3 million for the value of statistical life (VSL) at
seven and three percent discount rates, respectively. Just based on
barrels of oil not spilled, we expect the AIS portion of the proposed
rule to prevent 22 barrels of oil from being spilled annually.
Risks: Considering the economic utility of U.S. ports, waterways,
and coastal approaches, it is clear that a terrorist incident against
our U.S. Maritime Transportation System (MTS) would have a direct
impact on U.S. users and consumers and could potentially have a
disastrous impact on global shipping, international trade, and the
world economy. By improving the ability of the Coast Guard both to
identify potential terrorists coming to the United States while the
terrorists are far from our shores and to coordinate appropriate
responses and intercepts before the vessel reaches a U.S. port, this
rulemaking would contribute significantly to the expansion of MDA, and
consequently is instrumental in addressing the threat posed by
terrorist actions against the MTS.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/16/08 73 FR 76295
Notice of Public Meeting............ 01/21/09 74 FR 3534
Notice of Second Public Meeting..... 03/02/09 74 FR 9071
NPRM Comment Period End............. 04/15/09 .......................
Notice of Second Public Meeting 04/15/09 .......................
Comment Period End.
Final Rule.......................... 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Additional Information: We have indicated in past notices and
rulemaking documents, and it remains the case that we have worked to
coordinate implementation of AIS MTSA requirements with the development
of our ability to take advantage of AIS data (68 FR 39355 and 39370,
Jul. 1, 2003).
The docket number for this rulemaking is USCG-2005-21869. The
docket can be found at www.regulations.gov.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: LT Sharmine Jones, Program Manager, Office of
Vessel Activities, Foreign and Offshore Vessel Activities Div. (CG-
5432), Department of Homeland Security, U.S. Coast Guard, 2100 2nd
Street SW., STOP 7581, Washington, DC 20593-7581, Phone: 202 372-1234,
Email: [email protected].
Jorge Arroyo, Project Manager, Office of Navigation Systems CG-
5531, Department of Homeland Security, U.S. Coast Guard, 2100 2nd
Street SW., STOP 7683, Washington, DC 20593-7683, Phone: 202 372-1563,
Email: [email protected].
Related RIN: Related to 1625-AA93, Related to 1625-AB28.
RIN: 1625-AA99
DHS--USCG
66. Nontank Vessel Response Plans and Other Vessel Response Plan
Requirements
Priority: Other Significant.
Unfunded Mandates: Undetermined.
Legal Authority: 3 U.S.C. 301 to 303; 33 U.S.C. 1223; 33 U.S.C.
1231; 33 U.S.C. 3121; 33 U.S.C. 1903; 33 U.S.C. 1908; 46 U.S.C. 6101
CFR Citation: 33 CFR 151; 33 CFR 155; 33 CFR 160.
[[Page 7748]]
Legal Deadline: Final, Statutory, April 15, 2012, Coast Guard
Authorization Act of 2010.
Abstract: This rulemaking would establish regulations requiring
owners or operators of nontank vessels to prepare and submit oil spill
response plans. The Federal Water Pollution Control Act defines nontank
vessels as self-propelled vessels of 400 gross tons or greater that
operate on the navigable waters of the United States, carry oil of any
kind as fuel for main propulsion, and are not tank vessels. The NPRM
proposed to specify the content of a response plan, and among other
issues, address the requirement to plan for responding to a worst case
discharge and a substantial threat of such a discharge. Additionally,
the NPRM proposed to update International Shipboard Oil Pollution
Emergency Plan (SOPEP) requirements that apply to certain nontank
vessels and tank vessels. Finally, the NPRM proposed to require vessel
owners and operators to submit their vessel response plan control
number as part of the notice of arrival information. This project
supports the Coast Guard's broad roles and responsibilities of maritime
stewardship.
Statement of Need: This rule implements the statutory requirement
for an owner or operator of a self-propelled, nontank vessel of 400
gross tons or greater, which operates on the navigable waters of the
United States, to prepare and submit an oil spill response plan to the
Coast Guard. This rule specifies the content of a vessel response plan
(VRP), including the requirement to plan for responding to a worst-case
discharge (WCD) and a substantial threat of such a discharge as
mandated in statute. The rule also specifies the procedures for
submitting a VRP to the Coast Guard. This rule will improve our
Nation's pollution response planning and preparedness posture, and help
limit the environmental damage resulting from nontank vessel marine
casualties.
Summary of Legal Basis: Section 311(j)(5) of the Federal Water
Pollution Control Act (FWPCA) (33 U.S.C. 1321(j)(5)), as amended by
section 4202 of the Oil Pollution Act of 1990 (OPA 90) (Pub. L. 101-
380, 104 Stat. 484); the Coast Guard and Maritime Transportation Act of
2004 (Pub. L. 108-293, 118 Stat. 102); and the Coast Guard and Maritime
Transportation Act of 2006 (Pub. L. 109-241, 120 Stat. 516) sets out
the statutory mandate requiring tank and nontank vessel owners or
operators to prepare and submit oil or hazardous substance discharge
response plans for certain vessels operating on the navigable waters of
the United States.
Alternatives: In the development of these regulations, the Coast
Guard considered four alternatives: Three regulatory alternatives and
one non-regulatory alternative. The alternatives are--(1) Establish
regulations for the submission of NTVRPs to the USCG; (2) amend the
tank vessel response plan (TVRP) regulations to incorporate NTVRPs; (3)
acceptance of flag-approved SOPEPs; and (4) provide interpretive
guidance through a USCG's Navigation and Vessel Inspection Circular
(NVIC).
Anticipated Cost and Benefits: We are developing the cost and
benefit estimates associated with this step of the rulemaking. The cost
elements associated with this rule include: (1) Nontank vessel plan
development, maintenance, and submission; (2) the service of an Oil
Spill Response Organization (OSRO); (3) the contract with a Qualified
Individual (QI) along with a Spill Management Team; and (4) training
and exercises. We expect this proposed rule to provide quantifiable
benefits in the form of barrels of oil not spilled into the water in
addition to qualitative benefits, which include improved preparedness
and reaction to an incident, including a worst-case discharge and
improved effectiveness of onboard and shore-side response activities.
In the 2009 NPRM, we estimated that the rulemaking would affect
about 2,951 U.S. flag vessels and 1,228 associated planholders. We
estimated the total 10-year present value cost of the proposed rule to
U.S. flag nontank vessel owners and operators to be about $111.4
million at a 7 percent discount rate and $134.8 million at a 3 percent
discount rate. We found the training and exercise requirements to be
the most costly element or over 90 percent of the total discounted cost
of the proposed rule for vessel owners. We estimated the total U.S.
annualized cost of the proposed rule over the 10-year period of
analysis to be about $15.8 million at both 7 and 3 percent discount
rates.
Risks: Response plans are required by statute. A response plan will
not prevent a discharge of oil, but it may help minimize the discharge
and resulting damage to the environment. We estimate the proposed rule
would prevent between 2,014 and 2,446 barrels of oil from being spilled
into the water during the 10-year period of analysis.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/31/09 74 FR 44970
Public Meeting...................... 09/25/09 74 FR 48891
NPRM Comment Period End............. 11/30/09 .......................
Final Rule.......................... 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
Additional Information: The docket number for this rulemaking is
USCG-2008-1070. The docket can be found at www.regulations.gov.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: LCDR Kevin B. Ferrie, Project Manager, Department
of Homeland Security, U.S. Coast Guard, 2100 2nd Street SW., Stop 7581,
Washington, DC 20593-7581, Phone: 202 372-1000, Email:
[email protected].
Related RIN: Related to 1625-AA19, Related to 1625-AA26.
RIN: 1625-AB27
DHS--USCG
67. Offshore Supply Vessels of at Least 6000 GT ITC
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: Pub. L. 111-281, sec 617
CFR Citation: Not Yet Determined.
Legal Deadline: Other, Statutory, January 1, 2012, Coast Guard
Authorization Act of 2010.
Abstract: The Coast Guard Authorization Act of 2010 removed the
size limit on offshore supply vessels (OSVs). The Act also directed the
Coast Guard to issue, as soon as is practicable, a regulation to
implement section 617 of the Act and to ensure the safe carriage of
oil, hazardous substances, and individuals in addition to the crew on
vessels of at least 6,000 gross tonnage as measured under the
International Convention on Tonnage Measurement of Ships (6,000 GT
ITC). Accordingly, the Coast Guard's rule will address design, manning,
carriage of personnel, and related topics for OSVs of at least 6,000 GT
ITC. This rulemaking will meet the requirements of the Act and will
support the Coast Guard's mission of marine safety, security, and
stewardship.
Statement of Need: In section 617 of Public Law 111-281, Congress
removed OSV tonnage limits and instructed the Coast Guard to promulgate
regulations
[[Page 7749]]
to implement the amendments and authorities of section 617.
Additionally, Congress directed the Coast Guard to ensure the safe
carriage of oil, hazardous substances, and individuals in addition to
the crew on OSVs of at least 6,000 GT ITC.
Summary of Legal Basis: The statutory authority to promulgate these
regulations is found in section 617(f) of Public Law 111-281.
Alternatives: The Coast Guard Authorization Act removed OSV tonnage
limits and the Coast Guard will examine alternatives during the
development of the regulatory analysis.
Anticipated Cost and Benefits: The Coast Guard is currently
developing a regulatory impact analysis of regulations that ensure the
safe carriage of oil, hazardous substances, and individuals in addition
to the crew on OSVs of at least 6,000 GT ITC. A potential benefit of
this rulemaking is the ability of industry to expand and take advantage
of new commercial opportunities in the building of larger OSVs.
Risks: No risks.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 01/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Thomas L. Neyhart, Program Manager, Department of
Homeland Security, U.S. Coast Guard, 2100 2nd Street SW., STOP 7126,
Washington, DC 20593-7126, Phone: 202 372-1360, Email:
[email protected].
RIN: 1625-AB62
DHS--USCG
68. Revision to Transportation Worker Identification
Credential (TWIC) Requirements for Mariners
Priority: Other Significant.
Legal Authority: sec 809 of the Coast Guard Authorization Act of
2010, Pub. L. 111-281, codified at 46 U.S.C. 70105(b)(2); 46 U.S.C.
2110(g)
CFR Citation: 46 CFR 10; 46 CFR 11; 46 CFR 12; 46 CFR 15.
Legal Deadline: None.
Abstract: This Policy Letter describes both short-term and long-
term steps that the Coast Guard is taking to implement the requirements
of section 809 of Coast Guard Authorization Act of 2010, Public Law
111-281. Section 809 excludes certain mariners from the statutory
requirement to obtain and hold a Transportation Worker Identification
Credential (TWIC) in order to receive a Merchant Mariner Credential
(MMC).
In the short-term, while working to promulgate implementing
regulations, the Coast Guard is relaxing its enforcement posture for
mariners without a valid TWIC who operate on board vessels that do not
have a security plan. The Coast Guard is also altering its policies to
allow these mariners to obtain a MMC without holding a valid TWIC.
Specifically, mariners already hold or held a TWIC, and who no longer
require a TWIC, may skip the TWIC enrollment process and apply for a
renewal MMC directly with a Regional Examination Center (REC), in
accordance with title 46 CFR, section 10.209. However, mariners that
are being issued an initial MMC, or who never held a TWIC, will need to
enroll for a TWIC at a TWIC enrollment center. They will also have to
pay all applicable fees associated with getting a TWIC. This is
required because the TWIC enrollment center is the only place where the
Coast Guard can obtain biometric information (fingerprints) from the
applicant.
In the long-term, as part of a rulemaking to promulgate
implementing regulations, the Coast Guard is considering waiving a
portion of the fees for a MMC in order to compensate the mariner for
the cost of enrolling for a TWIC. However, it is emphasized that such
action is contingent on the promulgation of a regulation to adjust the
fee structure.
Statement of Need: The Coast Guard is revising its merchant mariner
credentialing regulations to implement changes made by section 809 of
the Coast Guard Authorization Act of 2010, codified at 46 U.S.C.
70105(b)(2), which reduces the population of mariners who are required
to obtain and hold a valid Transportation Worker Identification
Credential (TWIC). Prior to section 809, 46 U.S.C. 70105(b)(2) required
each mariner required to hold an MMC issued by the Coast Guard to also
obtain and hold a valid TWIC issued by the Transportation Security
Administration (TSA). Section 809 removes this requirement, and now a
TWIC is statutorily required if the mariner is ``allowed unescorted
access to a secure area designated in a vessel security plan approved
under section 70103 of title 46 [U.S.C.]''
The Coast Guard is revising the applicability of the TWIC
requirements in Coast Guard merchant mariner credentialing regulations
as well as revising some of its merchant mariner credentialing
processes contained in Coast Guard regulations. Current Coast Guard
regulations in 46 CFR parts 10, 11, 12, and 15 contain the processes
for issuing an MMC that are intertwined with TSA processes for issuing
a TWIC. The Coast Guard utilizes the TWIC enrollment process to capture
information necessary to issue an MMC. Although the Coast Guard is
changing some of its processes for obtaining an MMC, some mariners no
longer required to hold a TWIC may still have to complete the TWIC
enrollment process in order to provide information necessary to obtain
an MMC. For any such mariner that must still go through the TWIC
enrollment process, including paying the full TWIC enrollment fee, the
Coast Guard is revising its regulations to exempt these mariners from
paying a portion of the MMC fees in order to offset the TWIC fee and to
minimize the burden on those mariners of paying for a TWIC when the
mariner is no longer statutorily required to hold one.
Summary of Legal Basis: The Coast Guard's statutory authority to
promulgate regulations addressing TWIC requirements for mariners is
found in 46 U.S.C. 70105(a) and (b). The Coast Guard's statutory
authority to promulgate regulations addressing fee exemptions is found
in 46 U.S.C. 2110(g).
Alternatives: This rulemaking implements section 809 of the 2010
Coast Guard Authorization Act. The Coast Guard is currently evaluating
the alternatives as we complete the Regulatory Impact Analysis.
Anticipated Cost and Benefits: This rulemaking would provide
certain mariner populations a fee exemption when applying or renewing
an MMC. These mariner populations would also benefit from cost savings
associated with reduced travels to TWIC enrollment centers.
Risks: No risks.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: Federal.
Additional Information: DHS has included this rule in its Final
Plan for the Retrospective Review of Existing Regulations, which DHS
issued on August 22, 2011.
Agency Contact: Davis Breyer, Project Manager, Department of
Homeland Security, U.S. Coast Guard, CG-5221,
[[Page 7750]]
2100 2nd Street SW., Washington, DC 20593, Phone: 202 372-1445, Email:
[email protected].
RIN: 1625-AB80
DHS--U.S. CUSTOMS AND BORDER PROTECTION (USCBP)
Final Rule Stage
69. Importer Security Filing and Additional Carrier Requirements
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: Pub. L. 109-347, sec 203; 5 U.S.C. 301; 19 U.S.C.
66; 19 U.S.C. 1431; 19 U.S.C. 1433 to 1434; 19 U.S.C. 1624; 19 U.S.C.
2071 note; 46 U.S.C. 60105
CFR Citation: 19 CFR 4; 19 CFR 12.3; 19 CFR 18.5; 19 CFR 103.31a;
19 CFR 113; 19 CFR 123.92; 19 CFR 141.113; 19 CFR 146.32; 19 CFR 149;
19 CFR 192.14.
Legal Deadline: None.
Abstract: This interim final rule implements the provisions of
section 203 of the Security and Accountability for Every Port Act of
2006. It amended CBP Regulations to require carriers and importers to
provide to CBP, via a CBP-approved electronic data interchange system,
information necessary to enable CBP to identify high-risk shipments to
prevent smuggling and insure cargo safety and security. Under the rule,
importers and carriers must submit specified information to CBP before
the cargo is brought into the United States by vessel. This advance
information will improve CBP's risk assessment and targeting
capabilities, assist CBP in increasing the security of the global
trading system, and facilitate the prompt release of legitimate cargo
following its arrival in the United States. The interim final rule
requested comments on those required data elements for which CBP
provided certain flexibilities for compliance and on the revised costs
and benefits and Regulatory Flexibility Analysis. CBP plans to issue a
final rule after CBP completes a structured review of the flexibilities
and analyzes the comments.
Statement of Need: Vessel carriers are currently required to
transmit certain manifest information by way of the CBP Vessel
Automated Manifest System (AMS) 24 hours prior to lading of
containerized and non-exempt break bulk cargo at a foreign port. For
the most part, this is the ocean carrier's or non-vessel operating
common carrier's (NVOCC) cargo declaration. CBP analyzes this
information to generate its risk assessment for targeting purposes.
Internal and external government reviews have concluded that more
complete advance shipment data would produce even more effective and
vigorous cargo risk assessments. In addition, pursuant to section 203
of the Security and Accountability for Every Port Act of 2006 (Pub. L.
109-347, 6 U.S.C. 943) (SAFE Port Act), the Secretary of Homeland
Security, acting through the Commissioner of CBP, must promulgate
regulations to require the electronic transmission of additional data
elements for improved high-risk targeting, including appropriate
security elements of entry data for cargo destined to the United States
by vessel prior to loading of such cargo on vessels at foreign
seaports.
Based upon its analysis, as well as the requirements under the SAFE
Port Act, CBP is requiring the electronic transmission of additional
data for improved high-risk targeting. Some of these data elements are
being required from carriers (Container Status Messages and Vessel Stow
Plan) and others are being required from ``importers,'' as that term is
defined for purposes of the regulations.
This rule intends to improve CBP's risk assessment and targeting
capabilities and enables the agency to facilitate the prompt release of
legitimate cargo following its arrival in the United States. The
information will assist CBP in increasing the security of the global
trading system and, thereby, reducing the threat to the United States
and world economy.
Summary of Legal Basis: Pursuant to section 203 of the Security and
Accountability for Every Port Act of 2006 (Pub. L. 109-347, 6 U.S.C.
943) (SAFE Port Act), the Secretary of Homeland Security, acting
through the Commissioner of CBP, must promulgate regulations to require
the electronic transmission of additional data elements for improved
high-risk targeting, including appropriate security elements of entry
data for cargo destined to the United States by vessel prior to loading
of such cargo on vessels at foreign seaports.
Alternatives: CBP considered and evaluated the following four
alternatives:
Alternative 1 (the chosen alternative): Importer Security Filings
and Additional Carrier Requirements are required. Bulk cargo is exempt
from the Importer Security Filing requirements;
Alternative 2: Importer Security Filings and Additional Carrier
Requirements are required. Bulk cargo is not exempt from the Importer
Security Filing requirements;
Alternative 3: Only Importer Security Filings are required. Bulk
cargo is exempt from the Importer Security Filing requirements; and
Alternative 4: Only the Additional Carrier Requirements are
required.
Anticipated Cost and Benefits: When the NPRM was published, CBP
estimated that approximately 11 million import shipments conveyed by
1,000 different carrier companies operating 37,000 unique voyages or
vessel-trips to the United States will be subject to the rule.
Annualized costs range from $890 million to $7.0 billion (7 percent
discount rate over 10 years).
The annualized cost range estimate resulted from varying
assumptions about the importers' estimated security filing transaction
costs or fees charged to the importers by the filing parties, the
potential for supply chain delays, and the estimated costs to carriers
for transmitting additional data to CBP.
The regulation may increase the time shipments are in transit,
particularly for shipments consolidated in containers. For such
shipments, the supply chain is generally more complex and the importer
has less control of the flow of goods and associated security filing
information. Foreign cargo consolidators may be consolidating multiple
shipments from one or more shippers in a container destined for one or
more buyers or consignees. In order to ensure that the security filing
data is provided by the shippers to the importers (or their designated
agents) and is then transmitted to and accepted by CBP in advance of
the 24-hour deadline, consolidators may advance their cut-off times for
receipt of shipments and associated security filing data.
These advanced cut-off times would help prevent a consolidator or
carrier from having to unpack or unload a container in the event the
security filing for one of the shipments contained in the container is
inadequate or not accepted by CBP. For example, consolidators may
require shippers to submit, transmit, or obtain CBP approval of their
security filing data before their shipments are stuffed in the
container, before the container is sealed, or before the container is
delivered to the port for lading. In such cases, importers would likely
have to increase the times they hold their goods as inventory, and thus
incur additional inventory carrying costs to sufficiently meet these
advanced cut-off times imposed by their foreign consolidators. The high
end of the cost ranges presented assumes an initial supply chain delay
of 2 days for the first year
[[Page 7751]]
of implementation (2008) and a delay of 1 day for years 2 through 10
(2009 to 2017).
Ideally, the quantification and monetization of the benefits of
this regulation would involve estimating the current level of risk of a
successful terrorist attack, absent this regulation, and the
incremental reduction in risk resulting from implementation of the
regulation. CBP would then multiply the change by an estimate of the
value individuals place on such a risk reduction to produce a monetary
estimate of direct benefits. However, existing data limitations and a
lack of complete understanding of the true risks posed by terrorists
prevent us from establishing the incremental risk reduction
attributable to this rule. As a result, CBP has undertaken a ``break-
even'' analysis to inform decisionmakers of the necessary incremental
change in the probability of such an event occurring that would result
in direct benefits equal to the costs of the proposed rule. CBP's
analysis finds that the incremental costs of this regulation are
relatively small compared to the median value of a shipment of goods,
despite the rather large absolute estimate of present value cost.
The benefit of this rule is the improvement of CBP's risk
assessment and targeting capabilities, while at the same time, enabling
CBP to facilitate the prompt release of legitimate cargo following its
arrival in the United States. The information will assist CBP in
increasing the security of the global trading system, and thereby
reducing the threat to the United States and the world economy.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 01/02/08 73 FR 90
NPRM Comment Period End............. 03/03/08 .......................
NPRM Comment Period Extended........ 02/01/08 73 FR 6061
NPRM Comment Period End............. 03/18/08 .......................
Interim Final Rule.................. 11/25/08 73 FR 71730
Interim Final Rule Effective........ 01/26/09 .......................
Interim Final Rule Comment Period 06/01/09 .......................
End.
Correction.......................... 07/14/09 74 FR 33920
Correction.......................... 12/24/09 74 FR 68376
Final Action........................ 10/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Christopher Kennally, Acting Director, Cargo
Control, Office of Field Operations, CBP, Department of Homeland
Security, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue
NW., Washington, DC 20229, Phone: 202 344-2476, Email:
[email protected].
RIN: 1651-AA70
DHS--USCBP
70. Changes to the Visa Waiver Program To Implement the Electronic
System for Travel Authorization (ESTA) Program
Priority: Economically Significant. Major under 5 U.S.C. 801.
Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1187
CFR Citation: 8 CFR 217.5.
Legal Deadline: None.
Abstract: This interim final rule implements the Electronic System
for Travel Authorization (ESTA) for aliens who travel to the United
States under the Visa Waiver Program (VWP) at air or sea ports of
entry. Under the rule, VWP travelers are required to provide certain
biographical information to CBP electronically before departing for the
United States. This allows CBP to determine before their departure
whether these travelers are eligible to travel to the United States
under the VWP and whether such travel poses a security risk. The rule
is intended to fulfill the requirements of section 711 of the
Implementing recommendations of the 9/11 Commission Act of 2007 (9/11
Act). In addition to fulfilling a statutory mandate, the rule serves
the twin goals of promoting border security and legitimate travel to
the United States. By modernizing the VWP, the ESTA is intended to
increase national security and to provide for greater efficiencies in
the screening of international travelers by allowing for vetting of
subjects of potential interest well before boarding, thereby reducing
traveler delays at the ports of entry. CBP requested comments on all
aspects of the interim final rule and plans to issue a final rule after
completion of the comment analysis.
Statement of Need: Section 711 of the 9/11 Act requires the
Secretary of Homeland Security, in consultation with the Secretary of
State, to develop and implement a fully automated electronic travel
authorization system that will collect biographical and other
information in advance of travel to determine the eligibility of the
alien to travel to the United States, and to determine whether such
travel poses a law enforcement or security risk. ESTA is intended to
fulfill these statutory requirements.
Under this rule, VWP travelers provide certain information to CBP
electronically before departing for the United States. VWP travelers
who receive travel authorization under ESTA are not required to
complete the paper Form I-94W when arriving on a carrier that is
capable of receiving and validating messages pertaining to the
traveler's ESTA status as part of the traveler's boarding status. By
automating the I-94W process and establishing a system to provide VWP
traveler data in advance of travel, CBP is able to determine the
eligibility of citizens and eligible nationals from VWP countries to
travel to the United States and to determine whether such travel poses
a law enforcement or security risk, before such individuals begin
travel to the United States. ESTA provides for greater efficiencies in
the screening of international travelers by allowing CBP to identify
subjects of potential interest before they depart for the United
States, thereby increasing security and reducing traveler delays upon
arrival at U.S. ports of entry.
Summary of Legal Basis: The ESTA program is based on congressional
authority provided under section 711 of the Implementing
Recommendations of the 9/11 Commission Act of 2007 and section 217 of
the Immigration and Nationality Act (INA).
Alternatives: CBP considered three alternatives to this rule:
1. The ESTA requirements in the rule, but with a $1.50 fee per each
travel authorization (more costly).
2. The ESTA requirements in the rule, but with only the name of the
passenger and the admissibility questions on the I-94W form (less
burdensome).
3. The ESTA requirements in the rule, but only for the countries
entering the VWP after 2009 (no new requirements for VWP, reduced
burden for newly entering countries).
CBP determined that the rule provides the greatest level of
enhanced security and efficiency at an acceptable cost to traveling
public and potentially affected air carriers.
Anticipated Cost and Benefits: The purpose of ESTA is to allow DHS
and CBP to establish the eligibility of certain
[[Page 7752]]
foreign travelers to travel to the United States under the VWP, and
whether the alien's proposed travel to the United States poses a law
enforcement or security risk. Upon review of such information, DHS will
determine whether the alien is eligible to travel to the United States
under the VWP.
Costs to Air & Sea Carriers
CBP estimated that eight U.S.-based air carriers and eleven sea
carriers will be affected by the rule. An additional 35 foreign-based
air carriers and five sea carriers will be affected. CBP concluded that
costs to air and sea carriers to support the requirements of the ESTA
program could cost $137 million to $1.1 billion over the next 10 years
depending on the level of effort required to integrate their systems
with ESTA, how many passengers they need to assist in applying for
travel authorizations, and the discount rate applied to annual costs.
Costs to Travelers
ESTA will present new costs and burdens to travelers in VWP
countries who were not previously required to submit any information to
the U.S. Government in advance of travel to the United States.
Travelers from Roadmap countries who become VWP countries will also
incur costs and burdens, though these are much less than obtaining a
nonimmigrant visa (category B1/B2), which is currently required for
short-term pleasure or business to travel to the United States. CBP
estimated that the total quantified costs to travelers will range from
$1.1 billion to $3.5 billion depending on the number of travelers, the
value of time, and the discount rate. Annualized costs are estimated to
range from $133 million to $366 million.
Benefits
As set forth in section 711 of the 9/11 Act, it was the intent of
Congress to modernize and strengthen the security of the Visa Waiver
Program under section 217 of the Immigration and Nationality Act (INA,
8 U.S.C. 1187) by simultaneously enhancing program security
requirements and extending visa-free travel privileges to citizens and
eligible nationals of eligible foreign countries that are partners in
the war on terrorism.
By requiring passenger data in advance of travel, CBP may be able
to determine, before the alien departs for the United States, the
eligibility of citizens and eligible nationals from VWP countries to
travel to the United States under the VWP, and whether such travel
poses a law enforcement or security risk. In addition to fulfilling a
statutory mandate, the rule serves the twin goals of promoting border
security and legitimate travel to the United States. By modernizing the
VWP, ESTA is intended to both increase national security and provide
for greater efficiencies in the screening of international travelers by
allowing for the screening of subjects of potential interest well
before boarding, thereby reducing traveler delays based on potentially
lengthy processes at U.S. ports of entry.
CBP concluded that the total benefits to travelers could total $1.1
billion to $3.3 billion over the period of analysis. Annualized
benefits could range from $134 million to $345 million.
In addition to these benefits to travelers, CBP and the carriers
should also experience the benefit of not having to administer the I-
94W except in limited situations. While CBP has not conducted an
analysis of the potential savings, it should accrue benefits from not
having to produce, ship, and store blank forms. CBP should also be able
to accrue savings related to data entry and archiving. Carriers should
realize some savings as well, though carriers will still have to
administer the I-94 for those passengers not traveling under the VWP
and the Customs Declaration forms for all passengers aboard the
aircraft and vessel.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Action................ 06/09/08 73 FR 32440
Interim Final Rule Effective........ 08/08/08 .......................
Interim Final Rule Comment Period 08/08/08 .......................
End.
Notice--Announcing Date Rule Becomes 11/13/08 73 FR 67354
Mandatory.
Final Action........................ 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Additional Information: http://www.cbp.gov/xp/cgov/travel/id_visa/esta/.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Suzanne Shepherd, Director, Electronic System for
Travel Authorization, Department of Homeland Security, U.S. Customs and
Border Protection, 1300 Pennsylvania Avenue NW., Washington, DC 20229,
Phone: 202 344-2073, Email: [email protected].
Related RIN: Related to 1651-AA83.
RIN: 1651-AA72
DHS--USCBP
71. Establishment of Global Entry Program
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1365b(k)(1); 8 U.S.C. 1365b(k)(3); 8
U.S.C. 1225; 8 U.S.C. 1185(b)
CFR Citation: 8 CFR 235; 8 CFR 103.
Legal Deadline: None.
Abstract: CBP already operates several regulatory and non-
regulatory international registered traveler programs, also known as
trusted traveler programs. In order to comply with the Intelligence
Reform Terrorism Prevention Act of 2004 (IRPTA), CBP is proposing to
amend its regulations to establish another international registered
traveler program called Global Entry. The Global Entry program would
expedite the movement of low-risk, frequent international air travelers
by providing an expedited inspection process for pre-approved, pre-
screened travelers. These travelers would proceed directly to automated
Global Entry kiosks upon their arrival in the United States. This
Global Entry Program, along with the other programs that have already
been established, are consistent with CBP's strategic goal of
facilitating legitimate trade and travel while securing the homeland. A
pilot of Global Entry has been operating since June 6, 2008.
Statement of Need: CBP has been operating the Global Entry program
as a pilot at several airports since June 6, 2008, and the pilot has
been very successful. As a result, there is a desire on the part of the
public that CBP establish the program as a permanent program, and
expanded the program to additional airports and to citizens from other
countries if possible. By establishing this program, CBP will make
great strides toward facilitating the movement of people in a more
efficient manner, thereby accomplishing our strategic goal of balancing
legitimate travel with security. Through the use of biometric and
recordkeeping technologies, the risk of terrorists entering the United
States would be reduced. Improving security and facilitating travel at
the border, both of which are accomplished by Global Entry, are primary
concerns within CBP jurisdiction.
[[Page 7753]]
Summary of Legal Basis: The Global Entry program is based on
section 7208(k) of the Intelligence Reform and Terrorism Prevention Act
of 2004 (IRTPA), as amended by section 565 of the Consolidated
Appropriations Act, which requires the Secretary of Homeland Security
to create a program to expedite the screening and processing of pre-
approved low risk air travelers into the United States.
Anticipated Cost and Benefits: Global Entry is a voluntary program
that provides a benefit to the public by speeding the CBP processing
time for participating travelers. Travelers who are otherwise
admissible to the United States will be able to enter or exit the
country regardless of whether they participate in Global Entry. CBP
estimates that over a 5-year period, 250,000 enrollees will be
processed (an annual average of 50,000 individuals). CBP estimates that
each application will require 40 minutes (0.67 hours) of the enrollee's
time to search existing data resources, gather the data needed, and
complete and review the application form. Additionally, an enrollee
will experience an ``opportunity cost of time'' to travel to an
Enrollment Center upon acceptance of the initial application. We assume
that 1 hour will be required for this time spent at the Enrollment
Center and travel to and from the Center, though we note that during
the pilot program, many applicants coordinated their trip to an
Enrollment Center with their travel at the airport. CBP has used 1 hour
of travel time so as not to underestimate potential opportunity costs
for enrolling in the program. CBP used a value of $28.60 for the
opportunity cost for this time, which is taken from the Federal
Aviation Administration's ``Economic Values for FAA Investment and
Regulatory Decisions, A Guide.'' (Jul. 3, 2007) This value is the
weighted average for U.S. business and leisure travelers. For this
evaluation, CBP assumed that all enrollees will be U.S. citizens, U.S.
nationals, or Lawful Permanent Residents.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 11/19/09 74 FR 59932
NPRM Comment Period End............. 01/19/10 .......................
Final Rule.......................... 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: Includes Retrospective Review under E.O.
13563.
URL for More Information: www.globalentry.gov
Agency Contact: John P. Wagner, Executive Director, Admissibility
and Passenger Programs, Department of Homeland Security, U.S. Customs
and Border Protection, Office of Field Operations, 1300 Pennsylvania
Avenue NW., Washington, DC 20229, Phone: 202 344-2118, Email:
[email protected].
RIN: 1651-AA73
DHS--USCBP
72. Implementation of the Guam-CNMI Visa Waiver Program
Priority: Other Significant. Major under 5 U.S.C. 801.
Legal Authority: Pub. L. 110-229, sec 702
CFR Citation: 8 CFR 100.4; 8 CFR 212.1; 8 CFR 233.5; 8 CFR 235.5;
19 CFR 4.7b; 19 CFR 122.49a
Legal Deadline: Final, Statutory, November 4, 2008, Pub. L. 110-
229.
Abstract: This rule amends Department of Homeland Security (DHS)
regulations to implement section 702 of the Consolidated Natural
Resources Act of 2008 (CNRA). This law extends the immigration laws of
the United States to the Commonwealth of the Northern Mariana Islands
(CNMI) and provides for a joint visa waiver program for travel to Guam
and the CNMI. This rule implements section 702 of the CNRA by amending
the regulations to replace the current Guam Visa Waiver Program with a
new Guam-CNMI Visa Waiver Program. The amended regulations set forth
the requirements for nonimmigrant visitors who seek admission for
business or pleasure and solely for entry into and stay on Guam or the
CNMI without a visa. This rule also establishes six ports of entry in
the CNMI for purposes of administering and enforcing the Guam-CNMI Visa
Waiver Program.
Statement of Need: Currently, aliens who are citizens of eligible
countries may apply for admission to Guam at a Guam port of entry as
nonimmigrant visitors for a period of fifteen (15) days or less, for
business or pleasure, without first obtaining a nonimmigrant visa,
provided that they are otherwise eligible for admission. Section 702(b)
of the Consolidated Natural Resources Act of 2008 (CNRA), supersedes
the Guam visa waiver program by providing for a visa waiver program for
Guam and the Commonwealth of the Northern Mariana Islands (Guam-CNMI
Visa Waiver Program). Section 702(b) requires DHS to promulgate
regulations within 180 days of enactment of the CNRA to allow
nonimmigrant visitors from eligible countries to apply for admission
into Guam and the CNMI, for business or pleasure, without a visa, for a
period of authorized stay of no longer than 45 days.
Summary of Legal Basis: The Guam-CNMI Visa Waiver Program is based
on congressional authority provided under 702(b) of the Consolidated
Natural Resources Act of 2008 (CNRA).
Alternatives: None.
Anticipated Cost and Benefits: The most significant change for
admission to the CNMI as a result of the rule will be for visitors from
those countries who are not included in either the existing U.S. Visa
Waiver Program or the Guam-CNMI Visa Waiver Program established by the
rule. These visitors must apply for U.S. visas, which require in-person
interviews at U.S. embassies or consulates and higher fees than the
CNMI currently assesses for its visitor entry permits. CBP anticipates
that the annual cost to the CNMI will be $6 million. These are losses
associated with the reduced visits from foreign travelers who may no
longer visit the CNMI upon implementation of this rule. In addition, we
estimate Government implementation costs of between $87 and 91 million
over the 5-year period of analysis.
The anticipated benefits of the rule are enhanced security that
will result from the federalization of the immigration functions in the
CNMI.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 01/16/09 74 FR 2824
Interim Final Rule Effective........ 01/16/09 .......................
Interim Final Rule Comment Period 03/17/09 .......................
End.
Technical Amendment; Change of 05/28/09 74 FR 25387
Implementation Date.
Final Action........................ 10/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Agency Contact: Erin Martin, Program Manager, Office of Field
Operations, Department of Homeland Security, U.S. Customs and Border
Protection, 1300 Pennsylvania Avenue NW., Washington,
[[Page 7754]]
DC 20229, Phone: 202 344-2728, Email: [email protected].
Related RIN: Related to 1651-AA81.
RIN: 1651-AA77
DHS--TRANSPORTATION SECURITY ADMINISTRATION (TSA)
Proposed Rule Stage
73. General Aviation Security and Other Aircraft Operator Security
Priority: Economically Significant. Major under 5 U.S.C. 801.
Unfunded Mandates: This action may affect the private sector under
Public Law 104-4.
Legal Authority: 6 U.S.C. 469; 18 U.S.C. 842; 18 U.S.C. 845; 46
U.S.C. 70102 to 70106; 46 U.S.C. 70117; 49 U.S.C. 114; 49 U.S.C.
114(f)(3); 49 U.S.C. 5103; 49 U.S.C. 5103a; 49 U.S.C. 40113; 49 U.S.C.
44901 to 44907; 49 U.S.C. 44913 to 44914; 49 U.S.C. 44916 to 44918; 49
U.S.C. 44932; 49 U.S.C. 44935 to 44936; 49 U.S.C. 44942; 49 U.S.C.
46105
CFR Citation: 49 CFR 1515; 49 CFR 1520; 49 CFR 1522; 49 CFR 1540;
49 CFR 1542; 49 CFR 1544; 49 CFR 1550.
Legal Deadline: None.
Abstract: On October 30, 2008, the Transportation Security
Administration (TSA) issued a Notice of Proposed Rulemaking (NPRM),
proposing to amend current aviation transportation security regulations
to enhance the security of general aviation by expanding the scope of
current requirements, and by adding new requirements for certain large
aircraft operators and airports serving those aircraft. TSA also
proposed that all aircraft operations, including corporate and private
charter operations, with aircraft having a maximum certificated takeoff
weight (MTOW) above 12,500 pounds (large aircraft) be required to adopt
a large aircraft security program. TSA also proposed to require certain
airports that serve large aircraft to adopt security programs. TSA is
preparing a supplemental NPRM (SNPRM), which will include a comment
period for public comments.
After considering comments received on the NPRM and meeting with
stakeholders, TSA decided to revise the original proposal to tailor
security requirements to the general aviation industry. TSA is
considering alternatives to the following proposed provisions in the
SNPRM: (1) The type of aircraft subject to TSA regulation; (2)
compliance oversight; (3) watch list matching of passengers; (4)
prohibited items; (5) scope of the background check requirements and
the procedures used to implement the requirement; and (6) other issues.
Additionally, in the SNPRM, TSA plans to propose security measures for
foreign aircraft operators. U.S. and foreign operators would implement
commensurate measures under the proposed rule.
Statement of Need: This rule would enhance current security
measures and might apply security measures currently in place for
operators of certain types of aircraft to operators of other aircraft,
including general aviation operators. While the focus of TSA's existing
aviation security programs has been on air carriers and commercial
operators, TSA is aware that general aviation aircraft of sufficient
size and weight may inflict significant damage and loss of lives if
they are hijacked and used as missiles. TSA has current regulations
that apply to large aircraft operated by air carriers and commercial
operators, including the twelve-five program, the partial program, and
the private charter program. However, the current regulations in 49 CFR
part 1544 do not cover all general aviation operations, such as those
operated by corporations and individuals, and such operations do not
have the features that are necessary to enhance security. Therefore,
TSA is preparing a SNPRM which proposes to establish new security
measures for operators, including general aviation operators, that are
not covered under TSA's current regulations.
Summary of Legal Basis: 49 U.S.C. 114, 40113, 44903.
Alternatives: DHS considered continuing to use voluntary guidance
to secure general aviation, but determined that to ensure that each
aircraft operator maintains an appropriate level of security, these
security measures would need to be mandatory requirements.
Anticipated Cost and Benefits: TSA has not quantified benefits.
Unquantified benefits of this rule include those in the areas of
security and quality governance. The rule would enhance security by
expanding the mandatory use of security measures to certain operators
of large aircraft that are not currently required to have a security
plan. These measures would deter malicious individuals from
perpetrating acts that might compromise transportation or national
security by using large aircraft for these purposes.
As stated above, TSA is revising this proposed rule and preparing a
SNPRM. Aircraft operators, passengers, and TSA would incur costs to
comply with the requirements of the proposed rule. TSA is currently
evaluating the costs of the revised rule which will be published in the
SNPRM.
TSA uses a break-even analysis to assess the trade-off between the
beneficial effects of the SNPRM and the costs of implementing the
rulemaking. This break-even analysis uses scenarios extracted from the
TSA Transportation Sector Security Risk Assessment (TSSRA) to determine
the degree to which the SNPRM must reduce the overall risk of a
terrorist attack in order for the expected benefits of the SNPRM to
justify the estimated costs. For its analyses, TSA uses scenarios with
varying levels of risk, but only details the consequence estimates. To
maintain consistency, TSA developed the analyses with a method similar
to that used for the break-even analyses conducted in earlier DHS
rules. After estimating the total consequences of each scenario by
monetizing lives lost, injuries incurred, capital replacement, and
clean-up, TSA will use this figure and the annualized cost of the SNPRM
to calculate the frequency of attacks averted in order for the SNPRM to
break even.
Risks: This rulemaking addresses the national security risk of
general aviation aircraft being used as a weapon or as a means to
transport persons or weapons that could pose a threat to the United
States.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 10/30/08 73 FR 64790
NPRM Comment Period End............. 12/29/08 .......................
Notice--NPRM Comment Period Extended 11/25/08 73 FR 71590
NPRM Extended Comment Period End.... 02/27/09 .......................
Notice--Public Meetings; Requests 12/28/08 73 FR 77045
for Comments.
Supplemental NPRM................... 09/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: Local.
International Impacts: This regulatory action will be likely to
have international trade and investment effects, or otherwise be of
international interest.
Additional Information: Public Meetings held on: Jan. 6, 2009, at
White Plains, NY; Jan. 8, 2009, at Atlanta, GA; Jan 16, 2009, at
Chicago, IL; Jan. 23, 2009, at Burbank, CA; and Jan. 28, 2009, at
Houston, TX.
Additional Comment Sessions held in Arlington, VA, on April 16,
2009, May 6, 2009, and June 15, 2009.
[[Page 7755]]
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Erik Jensen, Assistant General Manager, General
Aviation Security, Department of Homeland Security, Transportation
Security Administration, Office of Transportation Sector Network
Management, TSA-28, HQ, E10-132S, 601 South 12th Street, Arlington, VA
20598-6028, Phone: 571 227-2154, Fax: 571 227-1923, Email:
[email protected].
Thomas Philson, Deputy Director, Regulatory and Economic Analysis,
Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
TSA-28, HQ, E10-411N, 601 South 12th Street, Arlington, VA 20598-6028,
Phone: 571 227-3236, Fax: 571 227-1362, Email: [email protected].
Denise Daniels, Attorney, Regulations and Security Standards
Division, Department of Homeland Security, Transportation Security
Administration, Office of the Chief Counsel, TSA-2, HQ, E12-127S, 601
South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-3443, Fax:
571 227-1381, Email: [email protected].
Kiersten Ols, Attorney, Regulations and Security Standards
Division, Department of Homeland Security, Transportation Security
Administration, Office of the Chief Counsel, TSA-2, HQ, E12-316N, 601
South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-2403, Fax:
571 227-1378, Email: [email protected].
Related RIN: Related to 1652-AA03, Related to 1652-AA04.
RIN: 1652-AA53
DHS--TSA
74. Freight Railroads, Public Transportation and Passenger Railroads,
and Over-the-Road Buses--Security Training of Employees
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 49 U.S.C. 114; Pub. L. 110-53, secs 1408, 1517,
and 1534
CFR Citation: 49 CFR 1520; 49 CFR 1570; 49 CFR 1580; 49 CFR 1582
(New); 49 CFR 1584 (New).
Legal Deadline: Final, Statutory, November 1, 2007, Interim Rule
for public transportation agencies is due 90 days after date of
enactment.
Final, Statutory, February 3, 2008, Rule for railroads and over-
the-road buses are due 6 months after date of enactment.
Final, Statutory, August 3, 2008, Rule for public transportation
agencies is due 1 year after date of enactment.
According to section 1408 of Public Law 110-53, Implementing
Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007; 121
Stat. 266), interim final regulations for public transportation
agencies are due 90 days after the date of enactment (Nov. 1, 2007),
and final regulations are due 1 year after the date of enactment of
this Act.
Abstract: The Transportation Security Administration (TSA) will
propose a new regulation to improve the security of freight railroads,
public transportation and passenger railroads, and over-the-road buses
in accordance with the Implementing Recommendations of the 9/11
Commission Act of 2007. This rulemaking will propose general
requirements for the owner/operators of a freight railroad, a public
transportation system or passenger railroad, and over-the-road bus
operation determined by TSA to be high-risk to develop and implement a
security training program to prepare security-sensitive employees,
including frontline employees identified in sections 1402 and 1501 of
the Act, for potential security threats and conditions. The rulemaking
will also propose extending the security coordinator and reporting
security incident requirements applicable to rail operators under
current 49 CFR part 1580 to the non-rail transportation components of
covered public transportation agencies. In addition, the rulemaking
will also propose requiring the affected over-the-road bus owner/
operators to identify security coordinators and report security
incidents, similar to the requirements for rail in current 49 CFR 1580.
The regulation will take into consideration any current security
training requirements or best practices.
Statement of Need: A security training program for freight
railroads, public transportation agencies and passenger railroads, and
over-the-road bus operations is proposed to prepare freight railroad
security-sensitive employees, public transportation and passenger
railroad security-sensitive employees, and over-the-road bus security
sensitive employees for potential security threats and conditions.
Summary of Legal Basis: 49 U.S.C. 114; sections 1408, 1517, and
1534 of Public Law 110-53, Implementing Recommendations of the 9/11
Commission Act of 2007 (Aug. 3, 2007; 121 Stat. 266).
Alternatives: TSA is required by statute to publish regulations
requiring security training programs for these owner/operators. As part
of its notice of proposed rulemaking, TSA will seek public comment on
the alternative ways in which the final rule could carry out the
requirements of the statute.
Anticipated Cost and Benefits: TSA will estimate the costs that the
freight railroad systems, public transportation agencies and passenger
railroads, and over-the-road bus (OTRB) entities covered by this
proposed rule would incur following its implementation. These costs
will include estimates for the following elements: (1) Creating or
modifying a security training program and submitting it to TSA; (2)
Training (initial and recurrent) all security-sensitive employees; (3)
Maintaining records of employee training; (4) Being available for
inspections; (5) As applicable, providing information on security
coordinators and alternates; and (6) As applicable, reporting security
concerns. TSA will also estimate the costs TSA itself would expect to
incur with the implementation of this rule.
TSA has not quantified benefits. However, the primary benefit of
the Security Training NPRM will be to enhance United States surface
transportation security by reducing the vulnerability of freight
railroad systems, public transportation agencies, and passenger
railroads to terrorist activity through the training of security-
sensitive employees. TSA uses a break-even analysis to assess the
trade-off between the beneficial effects of the Security Training NPRM
and the costs of implementing the rulemaking. This break-even analysis
uses scenarios extracted from the TSA Transportation Sector Security
Risk Assessment (TSSRA) to determine the degree to which the Security
Training NPRM must reduce the overall risk of a terrorist attack in
order for the expected benefits of the NPRM to justify the estimated
costs. For its analyses, TSA uses scenarios with varying levels of
risk, but only details the consequence estimates. To maintain
consistency, TSA developed the analyses with a method similar to that
used for the break-even analyses conducted in earlier DHS rules.
After estimating the total consequence of each scenario by
monetizing lives lost, injuries incurred, and capital replacement and
clean-up, TSA will use this figure and the annualized cost of the NPRM
for freight rail, public transportation and passenger rail, and
[[Page 7756]]
OTRB operators to calculate a breakeven annual likelihood of attack.
Risks: The Department of Homeland Security aims to prevent
terrorist attacks within the United States and to reduce the
vulnerability of the United States to terrorism. By providing for
security training for personnel, TSA intends in this rulemaking to
reduce the risk of a terrorist attack on this transportation sector.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 05/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Local.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Scott Gorton, Policy and Plans Branch Chief for
Freight Rail, Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
TSA-28, HQ, E10-423N, 601 South 12th Street, Arlington, VA 20598-6028,
Phone: 571 227-1251, Fax: 571 227-2930, Email: [email protected].
David Kasminoff, Sr. Counsel, Regulations and Security Standards
Division, Department of Homeland Security, Transportation Security
Administration, Office of the Chief Counsel, TSA-2, HQ, E12-310N, 601
South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-3583, Fax:
571 227-1378, Email: [email protected].
Steve Sprague, Highway Passenger, Infrastructure and Licensing
Branch Chief, Highway and Motor Carrier Programs, Department of
Homeland Security, Transportation Security Administration, Office of
Transportation Sector Network Management, TSA-28, HQ, E, 601 South 12th
Street, Arlington, VA 20598-6028, Phone: 571 227-1468, Email:
[email protected].
Related RIN: Related to 1652-AA57, Related to 1652-AA59.
RIN: 1652-AA55
DHS--TSA
75. Freight Railroads and Passenger Railroads--Vulnerability Assessment
and Security Plan
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 49 U.S.C. 114; Pub. L. 110-53, sec 1512
CFR Citation: 49 CFR 1520; 49 CFR 1570; 49 CFR 1580; 49 CFR 1582
(New).
Legal Deadline: Final, Statutory, August 3, 2008, Rule for freight
railroads and passenger railroads is due no later than 12 months after
date of enactment.
According to section 1512 of Public Law 110-53, Implementing
Recommendations of the 9/11 Commission Act of 2007 (Aug. 3, 2007; 121
Stat. 266), a final regulation for freight railroads and passenger
railroads is due no later than 12 months after the date of enactment of
the Act.
Abstract: The Transportation Security Administration (TSA) will
propose a new regulation to improve the security of freight railroads
and passenger railroads in accordance with the Implementing
Recommendations of the 9/11 Commission Act of 2007. This rulemaking
will propose thresholds for which a risk determination can be made to
determine whether a freight railroad and passenger railroad should be
considered ``high risk.'' The rulemaking will also propose requirements
for vulnerability assessments and security plans for owner/operators of
those railroads. The proposed requirements include procedures for TSA's
review and approval of these assessments and plans, and recordkeeping
requirements. The regulation will take into consideration any current
security assessment and planning requirements or best practices.
Statement of Need: The rulemaking will propose requirements for
owner/operators of high-risk freight railroads and high-risk passenger
railroads to conduct vulnerability assessments and carry-out security
plans to address the railroad carrier's preparedness and response for
potential security threats and conditions.
Summary of Legal Basis: 49 U.S.C. 114; section 1512 of Public Law
110-53, Implementing Recommendations of the 9/11 Commission Act of 2007
(Aug. 3, 2007; 121 Stat. 266).
Alternatives: TSA is required by statute to publish regulations
requiring vulnerability assessments and security plans for owner/
operators of high-risk freight railroads and high-risk passenger
railroads. As part of its notice of proposed rulemaking, TSA will seek
public comment on the alternative ways in which the final rule could
carry out the requirements of the statute.
Anticipated Cost and Benefits: TSA will estimate the costs that the
freight rail systems and passenger railroad carriers covered by this
proposed rule would incur following its implementation. These costs
will include estimates for the following elements: (1) Completing,
modifying, or updating a vulnerability assessment and submitting it to
TSA; (2) Developing, modifying, or updating a security plan and
submitting it to TSA; (3) Implementing a security plan; (4) Maintaining
records, including master copies of the vulnerability assessment and
security plan and all plans or documents referenced in the security
plan; and (5) Being available for inspection.
The expected primary benefit of the Vulnerability Assessment and
Security Plan NPRM will be to enhance U.S. surface transportation
security by reducing vulnerability to terrorist attacks in two
different ways. First, vulnerability assessments, as required in this
proposed rule, would identify assets and infrastructure that are
critical to owner/operators and provide an assessment of security risks
that need to be mitigated at these locations. Second, in an effort to
mitigate security risks, security plans would help target resources and
mitigation strategies toward security gaps in an owner/operator's
specific freight or passenger railroad operation to address the risks
identified by the vulnerability assessments.
TSA has not quantified benefits. For the purposes of this
rulemaking, TSA employs a break even analysis to compare the cost of
the risk reduction resulting from the proposed rule with the dollar
value of the type of terrorist attacks that could potentially be
averted due to the requirements in the proposed rule. This provides a
framework for evaluating the tradeoff between program costs and
benefits. For purposes of this analysis, TSA evaluates three scenarios
in the freight rail mode of surface transportation and three scenarios
in the passenger railroad mode of surface transportation covered by the
proposed rule. For each scenario, TSA calculates a total monetary
consequence from an estimated statistical value of the human casualties
and capital replacement resulting from the attack. TSA compared an
expected value of the monetary cost of an attack to the each rail mode
and TSA's annualized cost of conducting vulnerability assessments and
implementing security plans, discounted at 7 percent, to estimate how
often an attack of that nature would need to be averted for the
expected benefits to equal estimated costs. For a given level of pre-
existing or baseline risk of an attack, the calculation of the break-
even point--the reduction in baseline risk for which the estimated
costs and expected benefits are equal--
[[Page 7757]]
and a detailed description of each scenario is presented in the
regulatory evaluation for this NPRM.
Risks: The Department of Homeland Security aims to prevent
terrorist attacks within the United States and to reduce the
vulnerability of the United States to terrorism. By providing for
owner/operators of high-risk freight railroads and owner/operators of
high-risk passenger railroads to conduct vulnerability assessments and
adopt and carry out security plans, TSA intends in this rulemaking to
reduce the risk of a terrorist attack on the passenger rail
transportation sector.
Timetable:
------------------------------------------------------------------------
FR
Action Date Cite
------------------------------------------------------------------------
NPRM.................................. 09/00/12.................. ....
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Local.
Federalism: Undetermined.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Scott Gorton, Policy and Plans Branch Chief for
Freight Rail, Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
TSA-28, HQ, E10-423N, 601 South 12th Street, Arlington, VA 20598-6028,
Phone: 571 227-1251, Fax: 571 227-2930, Email: [email protected].
David Kasminoff, Sr. Counsel, Regulations and Security Standards
Division, Department of Homeland Security, Transportation Security
Administration, Office of the Chief Counsel, TSA-2, HQ, E12-310N, 601
South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-3583, Fax:
571 227-1378, Email: [email protected].
Morvarid Zolghadr, Branch Chief, Policy and Plans, Mass Transit and
Passenger Rail Security, Department of Homeland Security,
Transportation Security Administration, Office of Transportation Sector
Network Management, TSA-28, E10-113S, 601 South 12th Street, Arlington,
VA 20598-6028, Phone: 571 227-2957, Fax: 571 227-0729, Email:
[email protected].
Related RIN: Related to 1652-AA58, Related to 1652-AA60.
RIN: 1652-AA56
DHS--TSA
76. Standardized Vetting, Adjudication, and Redress Services
Priority: Economically Significant. Major status under 5 U.S.C. 801
is undetermined.
Unfunded Mandates: Undetermined.
Legal Authority: 49 U.S.C. 114; Pub. L. 110-53, secs 1411, 1414,
1520, 1522, 1602; 6 U.S.C. 469
CFR Citation: Not Yet Determined.
Legal Deadline: None.
Abstract: The Transportation Security Administration (TSA) will
propose new regulations to revise and standardize the procedures,
adjudication criteria, and fees for most of the security threat
assessments (STA) of individuals for which TSA is responsible. In
accordance with the Implementing Recommendations of the 9/11 Commission
Act of 2007 (9/11 Act), the scope of the rulemaking will include
transportation workers from all modes of transportation who are
required to undergo an STA in other regulatory programs, including
certain aviation workers and frontline employees for public
transportation agencies and railroads.
In addition, TSA will propose fees to cover the cost of the STAs,
and credentials for some personnel. TSA plans to improve efficiencies
in processing STAs and streamline existing regulations by simplifying
language and removing redundancies.
As part of this proposed rule, TSA will propose revisions to the
Alien Flight Student Program (AFSP) regulations. TSA published an
interim final rule for ASFP on September 20, 2004. TSA regulations
require aliens seeking to train at Federal Aviation Administration-
regulated flight schools to complete an application and undergo an STA
prior to beginning flight training. There are four categories under
which students currently fall; the nature of the STA depends on the
student's category. TSA is considering changes to the AFSP that would
improve the equity among fee payers and enable the implementation of
new technologies to support vetting.
Statement of Need: Through this rulemaking, TSA proposes to carry
out statutory mandates to perform security threat assessments (STA) of
certain transportation workers pursuant to the 9/11 Act. Also, TSA
proposes to fully satisfy 6 U.S.C. 469, which requires TSA to fund
security threat assessment and credentialing activities through user
fees. The proposed rulemaking would increase transportation security by
enhancing identification and immigration verification standards,
providing for more thorough vetting, improving the reliability and
consistency of the vetting process, and increasing fairness to vetted
individuals by providing more robust redress and reducing redundant STA
requirements.
Summary of Legal Basis: 49 U.S.C. 114(f): Under the Aviation and
Transportation Security Act (ATSA) (Pub. L. 170-71, Nov. 19, 2001, 115
Stat. 597), TSA assumed responsibility to oversee the vetting of
certain aviation workers. See 49 U.S.C. 44936.
Under the Maritime Transportation Security Act (MTSA), (Pub. L.
107-295, sec. 102, Nov. 25, 2002, 116 Stat. 2064), codified at 46
U.S.C. 70105, TSA vets certain merchant mariners and individuals who
require unescorted access to secure areas of vessels and maritime
facilities.
Under the Uniting and Strengthening America by Providing
Appropriate Tools Required to Intercept and Obstruct Terrorism Act (USA
PATRIOT Act) (Pub. L. 107-56, Oct. 25, 2001, 115 Stat. 272), TSA vets
individuals seeking hazardous materials endorsements (HME) to
commercial driver's licenses (CDL) issued by the States.
In the Implementing Recommendation of the 9/11 Commission Act of
2007 (Pub. L. 110-53, Aug. 3, 2007, 121 Stat. 266), Congress directed
TSA to vet additional populations of transportation workers, including
certain public transportation and railroad workers.
In 6 U.S.C. 469, Congress directed TSA to fund vetting and
credentialing programs through user fees.
Alternatives: TSA considered a number of viable alternatives to
lessen the impact of the proposed on entities deemed ``small'' by the
Small Business Administration (SBA) standards. This included: (1)
Extending phone pre-enrollment to populations eligible to enroll via
the web; and (2) changing the current delivery and activation process
and instituting centralized activation of biometric credentials that
allow applicants to receive their credentials through the mail rather
than returning to the enrollment center to pick up the credential.
These alternatives are discussed in detail in the rule and regulatory
evaluation.
Anticipated Cost and Benefits: TSA conducted a regulatory
evaluation to estimate the costs regulated entities, individuals, and
TSA would incur to comply with the requirements of the NPRM. The NPRM
would impose new requirements for some individuals, codify existing
requirements not included in the Code of Federal Regulations (CFR), and
modify current STA requirements for many
[[Page 7758]]
transportation workers. The primary benefit of the NPRM would be that
it will improve TSA's vetting product, process, and structure by
improving STAs, increasing equity, decreasing reliance on appropriated
funds, and improving reusability of STAs and mitigating redundant STAs.
TSA has not quantified benefits. TSA uses a break-even analysis to
assess the trade-off between the beneficial effects of the NPRM and the
costs of implementing the rulemaking. This break-even analysis uses
scenarios from the TSA Transportation Sector Security Risk Assessment
(TSSRA) to determine the degree to which the NPRM must reduce the
overall risk of a terrorist attack in order for the expected benefits
of the NPRM to justify the estimated costs. For its analyses, TSA uses
scenarios with varying levels of risk, but only details the consequence
estimates. To maintain consistency, TSA developed the analyses with a
method similar to that used for the break-even analyses conducted in
earlier DHS rules. After estimating the total consequences of each
scenario by monetizing lives lost, injuries incurred, capital
replacement, and clean-up, TSA will use this figure and the annualized
cost of the NPRM to calculate the frequency of attacks averted in order
for the NPRM to break even.
TSA estimates that the total savings to the alien flight students,
over a 5-year period, will be $18,107 at a 7 percent discount rate.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Undetermined.
Government Levels Affected: Undetermined.
Federalism: Undetermined.
Agency Contact: Hao-y Tran Froemling, Program Manager, Maritime and
Surface Credentialing, Department of Homeland Security, Transportation
Security Administration, Office of Transportation Threat Assessment and
Credentialing, TSA-19, HQ, E3-401N, 601 South 12th Street, Arlington,
VA 20598-6019, Phone: 571 227-2782, Email: [email protected].
Thomas Philson, Deputy Director, Regulatory and Economic Analysis,
Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
TSA-28, HQ, E10-411N, 601 South 12th Street, Arlington, VA 20598-6028,
Phone: 571 227-3236, Fax: 571 227-1362, Email: [email protected].
John Vergelli, Attorney, Regulations and Security Standards
Division, Department of Homeland Security, Transportation Security
Administration, DHS, TSA, Office of the Chief Counsel, TSA-2, HQ, E12-
309N, 601 South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-
4416, Fax: 571 227-1378, Email: [email protected].
Related RIN: Related to 1652-AA35.
RIN: 1652-AA61
DHS--TSA
Final Rule Stage
77. Aircraft Repair Station Security
Priority: Other Significant. Major under 5 U.S.C. 801.
Legal Authority: 49 U.S.C. 114; 49 U.S.C. 44924
CFR Citation: 49 CFR 1554.
Legal Deadline: Final, Statutory, August 8, 2004, Rule within 240
days of the date of enactment of Vision 100.
Final, Statutory, August 3, 2008, Rule within 1 year after the date
of enactment of 9/11 Commission Act. Section 611(b)(1) of Vision 100--
Century of Aviation Reauthorization Act (Pub. L. 108-176; Dec. 12,
2003; 117 Stat. 2490), codified at 49 U.S.C. 44924, requires TSA issue
``final regulations to ensure the security of foreign and domestic
aircraft repair stations.'' Section 1616 of the Implementing
Recommendations of the 9/11 Commission Act of 2007 (Pub. L. 110-531;
Aug. 3, 2007; 21 Stat. 266) requires TSA issue a final rule on foreign
repair station security.
Abstract: The Transportation Security Administration (TSA) proposed
to add a new regulation to improve the security of domestic and foreign
aircraft repair stations, as required by the section 611 of Vision
100--Century of Aviation Reauthorization Act and section 1616 of the 9/
11 Commission Act of 2007. The regulation proposed general requirements
for security programs to be adopted and implemented by repair stations
certificated by the Federal Aviation Administration (FAA). A notice of
proposed rulemaking (NPRM) was published in the Federal Register on
November 18, 2009, requesting public comments to be submitted by
January 19, 2010. The comment period was extended to February 19, 2010,
on request of the stakeholders to allow the aviation industry and other
interested entities and individuals additional time to complete their
comments.
TSA has coordinated its efforts with the FAA throughout the
rulemaking process to ensure that the final rule does not interfere
with FAA's ability or authority to regulate part 145 repair station
safety matters.
Statement of Need: The Transportation Security Administration (TSA)
is proposing regulations to improve the security of domestic and
foreign aircraft repair stations. The NPRM proposed to require repair
stations that are certificated by the Federal Aviation Administration
to adopt and carry out a security program. The proposal will codify the
scope of TSA's existing inspection program. The proposal also provides
procedures for repair stations to seek review of any TSA determination
that security measures are deficient.
Summary of Legal Basis: Section 611(b)(1) of Vision 100--Century of
Aviation Reauthorization Act (Pub. L. 108-176; Dec. 12, 2003; 117 Stat.
2490), codified at 49 U.S.C. 44924, requires TSA to issue ``final
regulations to ensure the security of foreign and domestic aircraft
repair stations'' within 240 days from date of enactment of Vision 100.
Section 1616 of Public Law 110-53, Implementing Recommendations of the
9/11 Commission Act of 2007 (Aug. 3, 2007; 121 Stat. 266) requires that
the FAA may not certify any foreign repair stations if the regulations
are not issued within 1 year after the date of enactment of the 9/11
Commission Act unless the repair station was previously certificated or
is in the process of certification.
Alternatives: TSA is required by statute to publish regulations
requiring security programs for aircraft repair stations. As part of
its notice of proposed rulemaking, TSA sought public comment on the
numerous alternative ways in which the final rule could carry out the
requirements of the statute.
Anticipated Cost and Benefits: TSA anticipates costs to aircraft
repair stations mainly related to the establishment of security
programs, which may include adding such measures as access controls, a
personnel identification system, security awareness training, the
designation of a security coordinator, employee background
verification, and contingency plan.
The NPRM estimated the total 10-year undiscounted cost of the
program at $344 million. The cost of the program, annualized and
discounted at 7 percent, is $241 million. Security coordinator and
training costs represent the largest portions of the program.
TSA has not quantified benefits. However, a major line of defense
against an aviation-related terrorist act is the prevention of
explosives, weapons, and/
[[Page 7759]]
or incendiary devices from getting on board a plane. To date, efforts
have been primarily related to inspection of baggage, passengers, and
cargo, and security measures at airports that serve air carriers. With
this rule, attention is given to aircraft that are located at repair
stations, and to aircraft parts that are at repair stations themselves,
to reduce the likelihood of an attack against aviation and the country.
Since repair station personnel have direct access to all parts of an
aircraft, the potential exists for a terrorist to seek to commandeer or
compromise an aircraft when the aircraft is at one of these facilities.
Moreover, as TSA tightens security in other areas of aviation, repair
stations increasingly may become attractive targets for terrorist
organizations attempting to evade aviation security protections
currently in place.
TSA uses a break-even analysis to assess the trade-off between the
beneficial effects of the final rule and the costs of implementing the
rulemaking. This break-even analysis uses three attack scenarios to
determine the degree to which the final rule must reduce the overall
risk of a terrorist attack in order for the expected benefits of the
final rule to justify the estimated costs. For its analyses, TSA uses
scenarios with varying levels of risk, but only details the consequence
estimates. To maintain consistency, TSA developed the analyses with a
method similar to that used for the break-even analyses conducted in
earlier DHS rules. After estimating the total consequences of each
scenario by monetizing lives lost, injuries incurred, and capital
replacement, TSA will use this figure and the annualized cost of the
final rule to calculate the frequency of attacks averted in order for
the final rule to break even.
Risks: The Department of Homeland Security aims to prevent
terrorist attacks within the United States and to reduce the
vulnerability of the United States to terrorism. By requiring security
programs for aircraft repair stations, TSA will focus on preventing
unauthorized access to repair work and to aircraft to prevent sabotage
or hijacking.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Notice--Public Meeting; Request for 02/24/04 69 FR 8357
Comments.
Report to Congress.................. 08/24/04 .......................
NPRM................................ 11/18/09 74 FR 59873
NPRM Comment Period End............. 01/19/10 .......................
NPRM Comment Period Extended........ 12/29/09 74 FR 68774
NPRM Extended Comment Period End.... 02/19/10 .......................
Final Rule.......................... 09/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: Yes.
Small Entities Affected: Businesses.
Government Levels Affected: None.
URL for More Information: www.regulations.gov.
URL for Public Comments: www.regulations.gov.
Agency Contact: Celio Young, Program Manager, Repair Stations,
Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
General Aviation Division, TSA-28, HQ, E5, 601 South 12th Street,
Arlington, VA 20598-6028, Phone: 571 227-3580, Fax: 571 227-1362,
Email: [email protected].
Thomas Philson, Deputy Director, Regulatory and Economic Analysis,
Department of Homeland Security, Transportation Security
Administration, Office of Transportation Sector Network Management,
TSA-28, HQ, E10-411N, 601 South 12th Street, Arlington, VA 20598-6028,
Phone: 571 227-3236, Fax: 571 227-1362, Email: [email protected].
Linda L. Kent, Assistant Chief Counsel, Regulations and Security
Standards Division, Department of Homeland Security, Transportation
Security Administration, Office of the Chief Counsel, TSA-2, HQ, E12-
126S, 601 South 12th Street, Arlington, VA 20598-6002, Phone: 571 227-
2675, Fax: 571 227-1381, Email: [email protected].
RIN: 1652-AA38
DHS--U.S. IMMIGRATION AND CUSTOMS ENFORCEMENT (USICE)
Proposed Rule Stage
78. Continued Detention of Aliens Subject to Final Orders of Removal
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1223; 8 U.S.C. 1227; 8
U.S.C. 1231; 8 U.S.C. 1253
CFR Citation: 8 CFR 241.
Legal Deadline: None.
Abstract: This notice of proposed rulemaking (NPRM) is proposing to
amend the Department of Homeland Security (DHS) regulatory provisions
for custody determinations for aliens in immigration detention who are
subject to an administratively final order of removal. The proposed
amendment would add a paragraph to 8 CFR 241.4(g) providing that U.S.
Immigration and Customs Enforcement (ICE) shall have a reasonable
period of time to effectuate an alien's removal where the alien is not
in immigration custody when the order of removal becomes
administratively final. The proposed rule would also clarify the
removal period time frame afforded to the agency following an alien's
compliance with his or her obligations regarding removal subsequent to
a period of obstruction or failure to cooperate. The rule proposes to
make conforming changes to 241.13(b)(2). Lastly, the rule proposes to
add a paragraph to 8 CFR 241.13(b)(3) to make clear that aliens
certified by the Secretary under section 236A of the Immigration and
Nationality Act, 8 U.S.C. 1226a, are not subject to the provisions of 8
CFR 241.13, in accordance with the separate detention standard provided
under the Act.
Statement of Need: The companion final rule will improve the post
order custody review process in the final rule related to the Detention
of Aliens Subject to Final Orders of Removal in light of the U.S.
Supreme Court's decisions in Zadvydas v. Davis, 533 U.S. 678 (2001),
Clark v. Martinez, 543 U.S. 371 (2005) and conforming changes as
required by the enactment of the Homeland Security Act of 2002 (HSA).
This notice of proposed rulemaking (NPRM) will propose to amend 8 CFR
241.1(g) to provide for a new 90-day removal period once an alien comes
into compliance with his or her obligation to make timely application
in good faith for travel or other documents and not conspire or act to
prevent removal.
Anticipated Cost and Benefits: This proposed rule will clarify the
regulatory provisions concerning the removal of aliens that are subject
to an administratively final order of removal. DHS does not anticipate
there will be cost impacts to the public as a result of the rule.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Alexander Hartman, Regulatory Coordinator,
Department of Homeland Security, U.S. Immigration
[[Page 7760]]
and Customs Enforcement, 500 12th Street SW., Washington, DC 20536,
Phone: 202 732-6202, Email: [email protected].
Related RIN: Related to 1653-AA13.
RIN: 1653-AA60
DHS--USICE
Final Rule Stage
79. Continued Detention of Aliens Subject to Final Orders of Removal
Priority: Other Significant.
Legal Authority: 8 U.S.C. 1103; 8 U.S.C. 1223; 8 U.S.C. 1227; 8
U.S.C. 1231; 8 U.S.C. 1253; * * *
CFR Citation: 8 CFR 241.
Legal Deadline: None.
Abstract: The U.S. Department of Homeland Security is finalizing,
with amendments, the interim rule that was published on November 14,
2001, by the former Immigration and Naturalization Service (Service).
The interim rule included procedures for conducting custody
determinations in light of the U.S. Supreme Court's decision in
Zadvydas v. Davis, 533 U.S. 678 (2001), which held that the detention
period of certain aliens who are subject to a final administrative
order of removal is limited under section 241(a)(6) of the Immigration
and Nationality Act (Act) to the period reasonably necessary to effect
their removal. The interim rule amended section 241.4 of title 8, Code
of Federal Regulations (CFR), in addition to creating two new sections:
8 CFR 241.13 (establishing custody review procedures based on the
significant likelihood of the alien's removal in the reasonably
foreseeable future) and 241.14 (establishing custody review procedures
for special circumstances cases). Subsequently, in the case of Clark v.
Martinez, 543 U.S. 371 (2005), the Supreme Court clarified a question
left open in Zadvydas, and held that section 241(a)(6) of the Act
applies equally to all aliens described in that section. This rule
amends the interim rule to conform to the requirements of Martinez.
Further, the procedures for custody determinations for post-removal
period aliens who are subject to an administratively final order of
removal, and who have not been released from detention or repatriated,
have been revised in response to comments received and experience
gained from administration of the interim rule published in 2001. This
final rule also makes conforming changes as required by the enactment
of the Homeland Security Act of 2002 (HSA). Additionally, certain
portions of the final rule were determined to require public comment
and, for this reason, have been developed into a separate/companion
notice of proposed rulemaking; RIN 1653-AA60.
Statement of Need: This rule will improve the post order custody
review process in the final rule related to the Detention of Aliens
Subject to Final Orders of Removal in light of the U.S. Supreme Court's
decisions in Zadvydas v. Davis, 533 U.S. 678 (2001), Clark v. Martinez,
543 U.S. 371 (2005) and conforming changes as required by the enactment
of the Homeland Security Act of 2002 (HSA). A companion notice of
proposed rulemaking (NPRM) will propose to amend 8 CFR 241.1(g) to
provide for a new 90-day removal period once an alien comes into
compliance with his or her obligation to make timely application in
good faith for travel or other documents and not conspire or act to
prevent removal.
Anticipated Cost and Benefits: The changes are administrative and
procedural in nature, and will not result in cost impacts to the
public. The benefits of making these changes to the regulations will
allow for expedited review of the post-order custody review process.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 11/14/01 66 FR 56967
Interim Final Rule Comment Period 01/14/02 .......................
End.
Final Action........................ 04/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Additional Information: INS No. 2156-01. Transferred from RIN 1115-
AG29.
Agency Contact: Alexander Hartman, Regulatory Coordinator,
Department of Homeland Security, U.S. Immigration and Customs
Enforcement, 500 12th Street SW., Washington, DC 20536, Phone: 202 732-
6202, Email: [email protected].
RIN: 1653-AA13
DHS--USICE
80. Extending Period for Optional Practical Training by 17 Months for
F-1 Nonimmigrant Students With STEM Degrees and Expanding the Cap-Gap
Relief for All F-1 Students With Pending H-1B Petitions
Priority: Other Significant. Major status under 5 U.S.C. 801 is
undetermined.
Legal Authority: 8 U.S.C. 1101 to 1103; 8 U.S.C. 1182; 8 U.S.C.
1184 to 1187; 8 U.S.C. 1221; 8 U.S.C. 1281 and 1282; 8 U.S.C. 1301 to
1305
CFR Citation: 8 CFR 214.
Legal Deadline: None.
Abstract: Currently, foreign students in F-1 nonimmigrant status
who have been enrolled on a full-time basis for at least one full
academic year in a college, university, conservatory, or seminary
certified by U.S. Immigration and Custom Enforcement's (ICE) Student
and Exchange Visitor Program (SEVP) are eligible for 12 months of
optional practical training (OPT) to work for a U.S. employer in a job
directly related to the student's major area of study. The maximum
period of OPT is 29 months for F-1 students who have completed a
science, technology, engineering, or mathematics (STEM) degree and
accept employment with employers enrolled in U.S. Citizenship and
Immigration Services' (USCIS') E-Verify employment verification
program. Employers of F-1 students with an extension of post-completion
OPT authorization must report to the student's designated school
official (DSO) within 48 hours after the OPT student has been
terminated from, or otherwise leaves, his or her employment with that
employer prior to end of the authorized period of OPT.
The final rule will respond to public comments and may make
adjustments to the regulations.
Statement of Need: ICE will improve SEVP processes by publishing
the Final Optional Practical Training (OPT) rule, which will respond to
comments on the OPT interim final rule (IFR). The IFR increased the
maximum period of OPT from 12 months to 29 months for nonimmigrant
students who have completed a science, technology, engineering, or
mathematics (STEM) degree and who accept employment with employers who
participate in the U.S. Citizenship and Immigration Services' (USCIS')
E-Verify employment verification program.
Alternatives: DHS is considering several alternatives to the 17-
month extension of OPT and cap-gap extension, ranging from taking no
action to further extension for a larger populace. The interim final
rule addressed an immediate competitive disadvantage faced by U.S.
industries and ameliorated some of the adverse impacts on the U.S.
economy. DHS continues to evaluate both quantitative and qualitative
alternatives.
Anticipated Cost and Benefits: Based on an estimated 12,000
students per year that will receive an OPT extension and an estimated
5,300 employers that will need to enroll in E-Verify, DHS
[[Page 7761]]
projects that this rule will cost students approximately $1.49 million
per year in additional information collection burdens, $4,080,000 in
fees, and cost employers $1,240,000 to enroll in E-Verify and $168,540
per year thereafter to verify the status of new hires. However, this
rule will increase the availability of qualified workers in science,
technology, engineering, and mathematical fields; reduce delays that
place U.S. employers at a disadvantage when recruiting foreign job
candidates, thereby improving strategic and resource planning
capabilities; increase the quality of life for participating students,
and increase the integrity of the student visa program.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
Interim Final Rule.................. 04/08/08 73 FR 18944
Interim Final Rule Comment Period 06/09/08 .......................
End.
Final Rule.......................... 08/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
URL for More Information: www.dhs.gov/sevis/.
Agency Contact: Sharon Snyder, Acting Branch Chief, SEVP Policy,
Student and Exchange Visitor Program, Department of Homeland Security,
U.S. Immigration and Customs Enforcement, Potomac Center North, 500
12th Street SW., Washington, DC 20024-6121, Phone: 703 603-3415.
RIN: 1653-AA56
DHS--FEDERAL EMERGENCY MANAGEMENT AGENCY (FEMA)
Proposed Rule Stage
81. Update of FEMA's Public Assistance Regulations
Priority: Other Significant.
Legal Authority: 42 U.S.C. 5121 to 5207
CFR Citation: 44 CFR 206.
Legal Deadline: None.
Abstract: This proposed rule would revise the Federal Emergency
Management Agency's Public Assistance program regulations. Many of
these changes reflect amendments made to the Robert T. Stafford
Disaster Relief and Emergency Assistance Act by the Post-Katrina
Emergency Management Reform Act of 2006 and the Security and
Accountability For Every Port Act of 2006. The proposed rule also
proposes to reflect lessons learned from recent events, and propose
further substantive and non-substantive clarifications and corrections
to improve upon the Public Assistance regulations. This proposed rule
is intended to improve the efficiency and consistency of the Public
Assistance program, as well as implement new statutory authority by
expanding Federal assistance, improving the Project Worksheet process,
empowering grantees, and improving State Administrative Plans.
Statement of Need: The proposed changes implement new statutory
authorities and incorporate necessary clarifications and corrections to
streamline and improve the Public Assistance program. Portions of
FEMA's Public Assistance regulations have become out of date and do not
implement all of FEMA's available statutory authorities. The current
regulations inhibit FEMA's ability to clearly articulate its regulatory
requirements, and the Public Assistance applicants' understanding of
the program. The proposed changes are intended to improve the
efficiency and consistency of the Public Assistance program.
Summary of Legal Basis: The legal authority for the changes in this
proposed rule is contained in the Robert T. Stafford Disaster Relief
and Emergency Assistance Act, 42 U.S.C. 5121 to 5207, as amended by the
Post-Katrina Emergency Management Reform Act of 2006, Public Law 109-
295, the Security and Accountability For Every Port Act of 2006, 6
U.S.C. 901 note, the Local Community Recovery Act of 2006, Public Law
109-218, 120 Stat. 333, and the Pets Evacuation and Transportation
Standards Act of 2006, Public Law 109-308, 120 Stat. 1725.
Alternatives: One alternative is to revise some of the current
regulatory requirements (such as application deadlines) in addition to
implementing the amendments made to the Stafford Act by (1) the Post-
Katrina Emergency Management Reform Act of 2006 (PKEMRA), Public Law
109-295, 120 Stat. 1394; (2) the Security and Accountability For Every
Port Act of 2006 (SAFE Port Act), Public Law 109-347, 120 Stat. 1884;
(3) the Local Community Recovery Act of 2006, Public Law 109-218, 120
Stat. 333; and (4) the Pets Evacuation and Transportation Standards Act
of 2006 (PETS Act), Public Law 109-308, 120 Stat. 1725. Another
alternative is to expand funding by expanding force account labor cost
eligibility to Category A Projects (debris removal).
Anticipated Cost and Benefits: The proposed rule is expected to
have economic impacts on the public, grantees, subgrantees, and FEMA.
The expected benefits are a reduction in property damages, societal
losses, and losses to local businesses, as well as improved efficiency
and consistency of the Public Assistance program. FEMA estimates the
primary economic impact of the proposed rule is the additional transfer
of funding from FEMA through the Public Assistance program to grantees
and subgrantees that is effectuated by this rulemaking.
Risks: This action does not adversely affect public health, safety,
or the environment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 03/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: Federal, Local, State, Tribal.
Federalism: This action may have federalism implications as defined
in EO 13132.
Agency Contact: Tod Wells, Recovery Directorate, Department of
Homeland Security, Federal Emergency Management Agency, 500 C Street
SW., Washington, DC 20472-3100, Phone: 202 646-3936, Fax: 202 646-3363,
Email: [email protected].
RIN: 1660-AA51
BILLING CODE 9110-9B-P
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
Statement of Regulatory Priorities
The regulatory plan for the Department of Housing and Urban
Development (HUD) for fiscal year (FY) 2012 highlights the most
significant regulations and policy initiatives that HUD seeks to
complete during the upcoming fiscal year. As the Federal agency that
serves as the Nation's housing agency, HUD's mission is to create
strong, sustainable, inclusive communities and quality affordable homes
for all. HUD strives to meet the challenges of this mission by focusing
on people and places through policies and initiatives that address the
unique conditions and needs of communities. For example, HUD recognizes
that the ``American Dream'' no longer refers to a singular vision of
success, such as owning a home, and, therefore, through programs such
as HUD's Housing Counseling program, HUD assists individuals and
families to make decisions about owning or renting that are financially
appropriate to the
[[Page 7762]]
individual or family.\1\ HUD also has been placing greater focus on
improving locational outcomes for households receiving rental
assistance. HUD's Choice Neighborhood initiative provides funding for
plans that link housing to schools, jobs, and affordable transportation
in order to transform neighborhoods of concentrated poverty into
sustainable mixed-income communities with well-functioning services,
public assets, and access to opportunity. HUD's Neighborhood
Stabilization Program helps communities acquire, rehabilitate, and
resell foreclosed and abandoned properties in order to more quickly
prevent decline in neighborhoods hard-hit by the foreclosure process.
---------------------------------------------------------------------------
\1\ This statement is based on language found on page 4,
paragraph 2, of the Introduction to HUD's FY 2010 to 2015 Strategic
Plan. (See http://portal.hud.gov/hudportal/documents/huddoc?id=DOC_4436.pdf.)
---------------------------------------------------------------------------
In addition to meeting the challenges of HUD's mission through
revitalized policies and initiatives, President Obama challenged all
agencies to identify opportunities to significantly improve near-term
performance. These opportunities were incorporated as key outcome
measures into HUD's strategic plan, representing challenging, near-
term, high-impact outcomes that reflect HUD's commitment to addressing
some of the most fundamental housing and community challenges facing
America. Building on the directions to improve performance, but on a
longer-term basis, President Obama issued Executive Order 13563
entitled ``Improving Regulation and Regulatory Review.'' Executive
Order 13563 supplements and reaffirms the rulemaking principles of
Executive Order 12866 ``Regulatory Planning and Review,'' which include
identifying regulatory approaches that reduce burden, considering the
costs and benefits of rules, and encouraging public participation, but
also directs agencies to undertake a retrospective analysis of rules
that may be outmoded, ineffective, insufficient, or excessively
burdensome, and to modify, streamline, expand, or repeal such
regulations as appropriate. The Executive order recognizes the
significant role that regulations play in protecting public health,
welfare, safety, and the environment, and in promoting economic growth,
innovation, competitiveness, and job creation, but also that
regulations cannot remain stagnant. Agencies must frequently review
regulations to ensure that they are meeting the challenges of today and
not addressing conditions, whether housing, health, business, labor, or
environmental, that are no longer reflected in today's economy. In this
regard, Executive Order 13563 directed agencies to undertake periodic
retrospective review of their regulations, and to develop, prepare, and
post their plans for retrospective review of rules. HUD's plan and that
of all agencies can be found at http://www.whitehouse.gov/21stcenturygov/actions/21st-century-regulatory-system. HUD's semiannual
agenda of regulations includes the rules highlighted in HUD's
retrospective review of rules plans.
The rules highlighted in HUD's regulatory plan for FY 2011 reflect
both HUD's continuing efforts to fulfill its mission and improve
performance, including by addressing regulations that necessitate
update and modification. HUD's FY 2011 regulatory plan reflects HUD's
retrospective review of the regulations governing one of HUD's major
mortgage insurance programs. Another rule highlighted in this
regulatory plan revises the regulations of another significant program
to address the unique conditions and needs of participants in one of
HUD's major assistance programs. The third rule related to a
significant HUD program is designed to implement flexibility provided
by a recently enacted statute.
Priority: Create Financially Sustainable Homeownership Opportunities
HUD's HECM program was established by statute to assist in
alleviating economic hardship caused by the increasing costs of health,
housing, and other needs at a time in life when one's income is
reduced. The HECM program, administered through HUD's Federal Housing
Administration (FHA), enables older homeowners to withdraw some of the
equity in their home in the form of monthly payments for life or a
fixed term, or in a lump sum, or through a line of credit. In addition,
the HECM mortgage can be used to purchase a primary home when the
borrower is 62 years of age or older and is able to use cash in hand,
money from the sale of assets, or money from an allowable FHA funding
source to pay the difference between the reverse mortgage and the sales
price plus closing costs for the property.
To be eligible for a HECM mortgage, current homeowners must be 62
years of age or older, own their home outright, or have a low mortgage
balance that can be paid off at closing with proceeds from the reverse
mortgage. Homeowners can only have one HECM at any one time and the
home must be their principal residence. In addition, the HECM can be
used to purchase a primary home if the borrower is able to pay the
difference between the HECM and the sales price and closing costs for
the property. The borrower remains the owner of the home and may sell
it and move at any time, keeping the sales proceeds that exceed the
mortgage balance. A borrower cannot be forced to sell the home to pay
off the mortgage, even if the mortgage balance grows to exceed the
value of the property, unless they fail to perform an obligation of the
mortgage.
As the Nation's population has increased in age, the attraction of
the HECM has increased as well. In 1990, there were approximately 157
HECMs. By 2008, there were more than 112,000 HECMs. The situation that
HUD has confronted recently with increasing frequency is that HECM
homeowners are not paying property taxes, insurance, and other property
charges. Payment of these items is the responsibility of the homeowner,
and failure to pay places the homeowner in default of its obligations
under the mortgage and makes the homeowner vulnerable to loss of his or
her home. FHA-approved lenders are responsible for keeping all tax and
insurance payments current, in compliance with the HECM regulations. If
homeowners stop making payments, lenders are allowed to access any
remaining home equity to pay taxes and insurance premiums. Once
homeowner funds are exhausted, lenders are legally required to advance
their own funds for such payments and seek reimbursement from
homeowners.
With the same recognition that homeownership may not be the best
choice for every individual or family, a HECM may not be the best
choice for every senior homeowner. The security that the HECM program
was designed to bring to seniors may be lost if the senior homeowner
cannot maintain payment of taxes and insurance payments.
Regulatory Action: Strengthening the Home Equity Conversion Mortgage
(HECM) Program To Promote Sustained Homeownership
To address this growing issue in the HECM program, HUD proposes to
require FHA-approved mortgagees that originate HECM mortgages to
perform a financial capacity and credit history assessment of
prospective HECM mortgagors prior to loan approval and closing.
Mortgagees will be required to evaluate whether the HECM mortgagor's
cash flow and credit history support the mortgagor's ability to comply
with the obligations of the HECM and are sufficient to meet recurring
living expenses. The proposed rule would also
[[Page 7763]]
cap the amount of insurance benefits paid in connection with a claim
involving amounts advanced by the mortgagee on behalf of a HECM
mortgagor who fails to pay such property charges when the HECM proceeds
have been exhausted, and establish a new property inspection
requirement to insure that homes secured with a HECM mortgage are
adequately maintained and meet applicable property standards.
These changes to the HECM program are necessary to ensure that
senior homeowners do not enter a program seeking security in their
later life only to find themselves without a home. Additionally,
without such changes, the HECM program will place the FHA Insurance
Fund at significant risk, with the possible result being the
unavailability of HECMs in the future.
Priority: Improve the Quality of Affordable Rental Housing
In an era when more than one-third of all American families rent
their homes, the current housing market does not create and sustain a
sufficient supply of affordable rental homes, especially for low-income
households. In many communities, affordable rental housing does not
exist without public support. Despite significant improvements in
housing quality in recent decades, much of America's rental housing
stock is not energy efficient or even accessible to people with
disabilities, and pockets of severely substandard housing remain across
the country. Even before the recent recession, the number of households
with severe housing cost burdens had increased substantially since
2000, and homelessness among families with children is a growing
problem throughout our Nation. When it comes to strong, safe, and
healthy communities, lower-cost rental housing is particularly scarce.
As the lead Federal housing agency, HUD will work with its Federal,
State, local, and private partners to meet affordable and quality
rental housing needs for all.\2\ In this regard, HUD will strengthen
the indicators by which HUD measures the performance of public housing
agencies in administering its Section 8 rental assistance program,
referred to as the Housing Choice Voucher program.
---------------------------------------------------------------------------
\2\ This statement is taken from the first column of page 19 of
section 2 of HUD's FY 2010 to 2015 Strategic Plan. (See http://portal.hud.gov/hudportal/documents/huddoc?id=DOC_4436.pdf.)
---------------------------------------------------------------------------
HUD's Housing Choice Voucher program is the Federal Government's
major program for assisting very low-income families, the elderly, and
the disabled to afford decent, safe, and sanitary housing in the
private market. Since housing assistance is provided on behalf of the
family or individual, participants are able to find their own housing,
including single-family homes, townhouses, and apartments. The
participant is free to choose any housing that meets the requirements
of the program and is not limited to units located in subsidized
housing projects. Housing choice vouchers are administered locally by
public housing agencies (PHAs). The PHAs receive Federal funds from HUD
to administer the voucher program. A family that is issued a housing
voucher is responsible for finding a suitable housing unit of the
family's choice where the owner agrees to rent under the program.
Rental units must meet minimum standards of health and safety, as
determined by the PHA.\3\
---------------------------------------------------------------------------
\3\ The information in this paragraph is taken from HUD's Web
page on Housing Choice Vouchers found at http://portal.hud.gov/hudportal/HUD?src=/program_offices/public_indian_housing/programs/hcv/about/fact_sheet.)
---------------------------------------------------------------------------
Through HUD's Section Eight Management Assessment Program (SEMAP),
HUD measures the performance of PHAs in their administration of the
Housing Choice Voucher program in key areas. The areas of review
indicate whether PHAs are helping eligible families to afford decent
rental units at a reasonable subsidy cost. SEMAP requires PHAs to
undertake an annual Housing Quality Standard (HQS) inspection of units.
Regulatory Action: Tenant-Based Rental Assistance; Improving
Performance Through a Strengthened SEMAP
HUD recognizes that SEMAP is more process-oriented than results-
oriented. To make SEMAP a more effective assessment tool, HUD is
proposing to revise the management indicators used by HUD to measure
the performance of PHAs. For example, the proposed rule would revise
the indicator that measures Section 8 voucher use to encourage PHAs to
maximize the number of Section 8 families served. Under this revised
indicator, HUD will not only consider the number of vouchers available
to a PHA, but also the funds available to the PHA, including budget
authority and a portion of reserves. HUD also proposes to assume
responsibility for conducting the inspections used to measure a PHA's
compliance with housing quality standards (HQS). Currently, HUD
measures HQS compliance through a reporting requirement for PHA self-
conducted inspections. The proposed rule would also establish a new
deconcentration indicator that will evaluate the ability of Section 8
families with children to access neighborhoods with below-average
poverty rates or neighborhoods with above-average schools.
Priority: Utilize Housing as a Platform for Improving the Quality of
Life
Stable housing, made possible with HUD support, provides an ideal
platform for delivering a wide variety of health and social services to
improve health, education, and economic outcomes. HUD housing serves at
least two broad populations: People who are in a position to markedly
increase their self-sufficiency and people who will need long-term
support (for example, the frail elderly and people with severe
disabilities). For those individuals who are able, increasing self-
sufficiency requires access to life-skills training, wealth-creation
and asset-building opportunities, job training, and career services.
For those who need long-term support, HUD housing will provide access
to income support and other benefits that can enhance an individual's
quality of life.
HUD's Supportive Housing for Persons with Disabilities Program
(Section 811) is a critical HUD program that allows persons with
disabilities to live as independently as possible in the community by
increasing the supply of rental housing with the availability of
supportive services. HUD increases the supply of rental housing for
persons with disabilities by providing interest-free capital advances
to nonprofit sponsors to help them finance the development of rental
housing such as independent living projects, condominium units, and
small group homes with the availability of supportive services for
persons with disabilities. The capital advance can finance the
construction, rehabilitation, or acquisition with or without
rehabilitation of supportive housing. The advance does not have to be
repaid as long as the housing remains available for very low-income
persons with disabilities for at least 40 years. Over the last several
years, the Section 811 program has not been as effective as desired
because the underlying statutory foundation for the program required
substantial reform and improvements to meet the challenges of current
market conditions and reflect modern practices with respect to
production of housing.
The Frank Melville Supportive Housing Investment Act of 2010 (Pub.
L. 111-374) (Melville Act), which was enacted on January 4, 2011,
amended section 811 of the Cranston-Gonzalez National Affordable
Housing Act (42 U.S.C. 8013), which authorizes the supportive housing
program for persons
[[Page 7764]]
with disabilities (Section 811 program). The Melville Act made
significant changes to the Section 811 program, with one of the most
significant changes being the establishment of new project rental
assistance authority. This new authority allows HUD to make Section 811
program operating assistance available to State housing agencies and
similar organizations for the purposes of granting funds to the
development of supportive housing for persons with disabilities, and
overseeing compliance with the requirements applicable to such housing.
Regulatory Action: Supportive Housing for Persons With Disabilities:
Implementing New Project Rental Assistance Authority
While the Melville Act makes many important changes to the Section
811 program, HUD's first priority is to implement the requirements for
the new project rental assistance authority. Project rental assistance
has long been part of eligible assistance for the Section 811 program,
and the existing Section 811 program regulations provide that project
rental assistance is available for operating costs. The new project
rental assistance provided by the Melville Act offers another method of
financing for supportive housing for persons with disabilities for
projects that do not receive capital advances. The new project rental
assistance is designed to promote and facilitate the creation of
integrated supportive housing units, which is achieved by making funds
available to State housing agencies and other appropriate entities. As
provided by the Melville Act, projects eligible for the new project
rental assistance can be either new or existing multifamily housing
projects.
HUD's proposed rule establishes the requirements and procedures
that would govern the eligibility and use of the new project rental
assistance authority in HUD's Section 811 program.
Retrospective Review of Agency Regulations
Pursuant to section 6 of Executive Order 13563 ``Improving
Regulation and Regulatory Review'' (Jan. 18, 2011), the following
Regulatory Identifier Numbers (RINs) have been identified as associated
with retrospective review and analysis in the Department's final
retrospective review of regulations plan. Some of these entries on this
list may be completed actions, which do not appear in The Regulatory
Plan. However, more information can be found about these completed
rulemakings in past publications of the Unified Agenda on Reginfo.gov
in the Completed Actions section for that agency. These rulemakings can
also be found on Regulations.gov. HUD's retrospective review plan can
be found at: http://portal.hud.gov/hudportal/HUD?src=/program_offices/general_counsel/Review_of_Regulations.
------------------------------------------------------------------------
Regulation Identifier Anticipated Reductions
No. (RIN) Title in Regulatory Burden
------------------------------------------------------------------------
2502-AI92.............. Federal Housing Removes a
Administration (FHA): regulatory
Refinancing an restriction on FHA
Existing Cooperative refinancing of
Under Section 207 existing mortgage
Pursuant to Section debt by owners of
223(f) of the National multifamily
Housing Act; Final cooperative projects,
Rule. thus expanding the
number of individuals
eligible to
participate in FHA
programs.
2502-AJ03.............. Streamlining Inspection Removes the
and Warranty regulations for the
Requirements for FHA Inspector Roster,
Federal Housing making it easier for
Administration (FHA) lenders and borrowers
Single Family Mortgage to have inspections
Insurance: Removal of performed and
the FHA Inspector streamlining the
Roster and of the 10- mortgage insurance
Year Protection Plan application process.
Requirements for High Removes the
Loan-to-Value Ratio outdated 10-year
Mortgages; Proposed protection plan
Rule. requirement for high
Loan-to-Value newly
constructed single
family homes securing
FHA-insured
mortgages. This
eliminates an
unnecessary layer of
regulatory burden.
2502-AI91.............. Approval of Farm Credit Enables
System Lending direct lending
Institutions in FHA institutions of the
Mortgage Insurance Farm Credit System to
Programs; Proposed seek approval as FHA
Rule. mortgagees and
lenders, removing a
regulatory barrier to
participation in FHA
programs.
2502-AJ06.............. Expansion of Expands
Eligibility of roster eligibility to
Nonprofit include nonprofit
Organizations To organizations created
Participate in FHA by State and local
Single Family Mortgage governments that
Insurance Programs; qualify for tax
Proposed Rule. exemption under
section 115 of the
Internal Revenue
Code.
Removes
requirement that a
nonprofit
organization have a
voluntary board in
order to be eligible
for roster placement.
2502-AJ02.............. Federal Housing Brings
Administration (FHA) certainty to and
Single Family Mortgage streamlines the
Insurance: Removal of announced maximum
Requests for mortgage amounts for
Alternative Mortgage each calendar year by
Amounts; Proposed Rule. removing a regulation
that is no longer
relevant.
2502-AI99.............. Federal Housing Removes
Administration (FHA): permanent time
Suspension of FHA's restrictions on
Regulation Placing resale of FHA-insured
Time Restrictions on properties, thus
Resale of FHA-Insured lifting burdensome
Property; Proposed regulatory
Rule. impediments to
receiving FHA
mortgage insurance.
2502-AJ01.............. Federal Housing Removes
Administration (FHA): regulations for an
Suspension of Single underutilized
Family Mortgage program, streamlining
Insurance for Military the application
Impacted Areas; process for FHA-
Proposed Rule. insured.
2502-AJ00.............. Federal Housing Removes
Administration (FHA): overly burdensome
Approval of Lending reporting
Institutions and requirements for
Mortgagees--Alternativ small lenders wishing
e Reporting to participate in FHA
Requirements for Small programs.
Supervised Lenders. Eliminates
duplicative reporting
requirements for
lenders who already
report to other
Federal agencies,
thus reducing
paperwork and
minimizing the burden
of the process of
becoming an FHA-
approved.
2502-AI98.............. Section 8 New By reducing
Construction and regulatory barriers,
Substantial this change removes a
Rehabilitation disincentive for
Programs: Changes to nonprofit owners to
Limitation on promote affordable
Distributions of housing.
Project Funds and
Adjustment of Initial
Equity; Proposed Rule.
[[Page 7765]]
2502-AI67.............. Streamlining Removes
Requirements Governing restrictions on the
the Use of Funding for portions of
Supportive Housing for developments not
the Elderly and funded through
Persons With capital advances.
Disabilities Programs; Removes
Proposed Rule. regulatory barriers
on participations by
creating new
exemptions to the
conflict of interest
provisions.
Provides
flexibility regarding
amenities that may be
provided in projects.
Streamlines
requirements for
release of capital
advance funds upon
completion.
2577-AC68.............. Public Housing Consolidates
Assessment System assessment
(PHAS); Final Rule. regulations in 24 CFR
part 902.
Removes
outdated Public
Housing Management
Assessment Program
(PHMAP) regulations
at 24 CFR part 901.
2577-AC50.............. Public Housing Capital Streamlines
Fund Program; Final public housing
Rule. modernization
requirements.
Consolidates
the modernization
requirements for the
public housing
programs in HUD's
Capital Fund Program
regulations at 24 CFR
part 905.
Removes
outdated parts 941,
968, 969, which
currently codify the
legacy modernization
program requirements.
2577-AC88.............. Streamlined Application Reduces
Process in Public/ document submission
Private Partnerships burdens on Public
for Mixed-Finance Housing Agencies
Development of Public (PHAs).
Housing Units;
Proposed Rule.
2577-AC89.............. Revisions to the Enables PHAs
Consortia of Public to establish cross-
Housing Agencies; jurisdictional
Proposed Rule. consortia that would
be treated as a
single PHA, with a
single jurisdiction
and a single set of
reporting and audit
requirements, for
purposes of
administering the
Housing Choice
Voucher program in a
more streamlined and
less burdensome
fashion.
2577-AC87.............. Removal of the Indian Removes
HOME Investment outdated regulations
Partnerships Program for the legacy Indian
Regulations; Final HOME program.
Rule.
2577-AC86.............. Public Housing and Removes the
Section 8 Programs: administrative
Housing Choice burdens involved with
Voucher--Improving processing
Portability for portability requests.
Voucher Families
Proposed Rule.
2577-AC76.............. Revision to the Section Removes
8 Management complexity and
Assessment Program administrative burden
(SEMAP) Lease-Up caused by use of both
Indicator; Proposed the fiscal year and
Rule. calendar year
systems.
Provides a
critical
synchronization of
administration of the
voucher program,
which will reduce
program
inefficiencies.
2506-AC26, 2506-AC29, Implementation of the Provides for
2506-AC31, 2506-AC32, Homeless Emergency consolidated grant
2506-AC33. Assistance and Rapid application and
Transition to Housing administration to
Act of 2009 (HEARTH ease administrative
Act). burden and improve
coordination among
providers and,
consequently,
increase the
effectiveness of
responses to the
needs of homeless
persons.
Provides for
increased
coordination and
planning between
programs to better
meet the needs of
homeless persons.
Modernizes
the Continuum of Care
program and Emergency
Shelter Grants
program.
2501-AC94.............. HOME Investment This proposed
Partnerships--Improvin rule would update
g Performance and HUD's program
Accountability; regulations to
Updating Property reflect current legal
Standards and requirements with
Instituting Energy respect to HOME
Efficiency Standards. projects.
------------------------------------------------------------------------
Aggregate Costs and Benefits
Executive Order 12866, as amended, requires the agency to provide
its best estimate of the combined aggregate costs and benefits of all
regulations included in the agency's regulatory plan that will be made
effective in calendar year 2011. HUD expects that neither the total
economic costs nor the total efficiency gains will exceed $100 million.
None of the rules on HUD's regulatory plan is anticipated to have an
economically significant impact. The revisions proposed to be made to
HUD's HECM program are anticipated to strengthen the program, keep
seniors in their homes, and protect the FHA Insurance Fund, but the
proposed changes are prospective and are not expected to result in an
economic impact of $100 million or more annually. The changes proposed
to be made to the SEMAP program are similarly designed to strengthen
the program and are intended to have the Housing Choice Voucher program
be administered more effectively and efficiently but will also not
result in an economic impact of $100 million or more. Implementation of
the new project rental assistance authority in the Section 811 program,
as authorized by the Melville Act, will open up another source of
financing for supportive housing for persons with disabilities but not
at a level of $100 million or more.
The Priority Regulations That Comprise HUD's Regulatory Plan
A more detailed description of the priority regulations that
comprise HUD's regulatory plan follows.
HUD--OFFICE OF HOUSING (OH)
Proposed Rule Stage
82. Federal Housing Administration (FHA): Strengthening the Home Equity
Conversion Mortgages (HECM) Program To Promote Sustained Homeownership
(FR-5353)
Priority: Other Significant.
Legal Authority: 12 U.S.C. 1715b, 1715z to 1720; 42 U.S.C. 3535(d)
[[Page 7766]]
CFR Citation: 24 CFR 206.19; 24 CFR 206.32; 24 CFR 206.25; 24 CFR
206.27; 24 CFR 206.29; 24 CFR 206.38.24; 24 CFR 206.51; 24 CFR 206.53;
24 CFR 206.105; 24 CFR 206.107; 24 CFR 206.124; 24 CFR 206.129; 24 CFR
206.140, 206.142; 24 CFR 206.203, 19; 24 CFR 206.58; 24 CFR 206.47.
Legal Deadline: None.
Abstract: HUD is taking another step to reform and strengthen the
mortgage insurance functions and responsibilities of the Federal
Housing Administration (FHA), and concomitantly protect the individuals
and families that use FHA-mortgage products. This proposed rule would
revise the regulations governing FHA's Home Equity Conversion Mortgage
(HECM) program, which is FHA's reverse mortgage program that enables
senior homeowners who have equity in their homes to withdraw a portion
of the accumulated equity. Most significantly, this rule proposes to
require FHA-approved mortgagees that originate HECM mortgages (HECM
mortgagees) to perform a financial capacity and credit history
assessment of prospective HECM mortgagors prior to loan approval and
closing. Mortgagees will be required to evaluate whether the HECM
mortgagor's cash flow and credit history support the mortgagor's
ability to comply with the obligations of the HECM and are sufficient
to meet recurring living expenses. A mortgagee may deny the HECM loan
application if the prospective mortgagor fails either the financial
capacity or credit history assessment. As an alternative to declining
the HECM loan application, the mortgagee may require the establishment
of a principal limit set-aside for payment of property charges. The
proposed rule would also cap the amount of insurance benefits paid in
connection with a claim involving amounts advanced by the mortgagee on
behalf of a HECM mortgagor who fails to pay such property charges when
the HECM proceeds have been exhausted and establish a new property
inspection requirement to insure that home secured with a HECM mortgage
are adequately maintained and meet applicable property standards. The
proposed rule would also make several non-substantive changes to
reflect the statutory flexibility provided to HUD in establishing the
mortgage insurance premiums for FHA-insured mortgages, conform the
regulations to existing HUD interpretations and industry practices
regarding HECM program requirements, and reduce administrative
paperwork.
Statement of Need: HUD does not currently require HECM mortgagees
to verify the mortgagor's income, assets, and debt obligations. Neither
do the HECM regulations require a mortgagee to assess the mortgagor's
credit history and capacity to pay future living expenses and meet all
other future financial obligations related to the property under the
HECM loan. Such a financial capacity and credit history assessment is a
prudent underwriting practice currently required by mortgagees for FHA
forward mortgage products. Based on data available to HUD, HECM
delinquencies are growing and occurring soon after origination. This
data also indicates that these delinquencies are largely the result of
the failure of mortgagors to pay recurring property charges. The
proposed rule would address these concerns by requiring that mortgagees
determine whether the potential mortgagor has the capacity to pay
recurring property charges and meet recurring living expenses.
Summary of Legal Basis: The HECM program is authorized under
section 255 of the National Housing Act (12 U.S.C. 1715z to 1720). This
rulemaking is undertaken pursuant to the general rulemaking authority
granted to the Secretary under section 7(d) of the Department of HUD
Act (42 U.S.C. 35335(d)), which authorizes the Secretary to make ``such
rules and regulations as may be necessary to carry out his functions,
powers, and duties.'' In addition, the National Housing Act at 12
U.S.C. 1701c(a) uses the exact wording in conferring general rulemaking
authority to the Secretary for implementing the insured mortgage
programs authorized under the National Housing Act.
Alternatives: Rulemaking is required to ensure that the financial
capacity and credit history requirements are generally applicable and
enforceable by HUD. Where appropriate, HUD will provide mortgagees with
flexibility in determining the method for conducting the required
assessments and for considering additional factors in determining and
verifying the financial capacity and credit history of prospective HECM
mortgagors.
Anticipated Cost and Benefits: The benefits of this rule would be
the reduced transaction costs and externalities associated with
foreclosure. The costs of the rule would be the additional
administrative and financial costs associated with carrying out the
required assessments.
Risks: This rule poses no risk to public health, safety, or the
environment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 12/00/11 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Kari B. Hill, Director, Office of Single Family
Program Development, Department of Housing and Urban Development,
Office of Housing, 451 7th Street SW., Washington, DC 20410, Phone: 202
708-2121.
RIN: 2502-AI79
HUD--OH
83. Supportive Housing for Persons With Disabilities
Implementing New Project Rental Assistance Authority (FR-5576)
Priority: Other Significant.
Legal Authority: 12 U.S.C. 1701q; 42 U.S.C. 1437f, 3535(d), and
8013
CFR Citation: 24 CFR 891.
Legal Deadline: None.
Abstract: This proposed rule commences the rulemaking process to
implement the project rental assistance authority as provided under the
Frank Melville Supportive Housing Investment Act of 2010 (Pub. L. 111-
374) (Melville Act), which was enacted on January 4, 2011. The Melville
Act amended section 811 of the Cranston-Gonzalez National Affordable
Housing Act (42 U.S.C. 8013), which authorizes the supportive housing
program for persons with disabilities (Section 811 program). The
Melville Act made significant changes to the Section 811 program, with
one of the most significant changes being the establishment of new
project rental assistance authority. This new authority allows HUD to
make Section 811 program operating assistance available to State
housing agencies and similar organizations for the purposes of granting
funds to the development of supportive housing for persons with
disabilities and overseeing compliance with the requirements applicable
to such housing. This proposed rule establishes the requirements and
procedures that would govern the eligibility and use of project rental
assistance in HUD's supportive housing program for persons with
disabilities.
Statement of Need: The Melville Act makes many important reforms
and improvements to the Section 811 program. One of the most
significant new features introduced by the Melville Act is the
establishment of new project
[[Page 7767]]
rental assistance authority (section 811(b)(3) of the Cranston-Gonzalez
National Affordable Housing Act, as amended by the Melville Act) that
is separate from the existing project rental assistance under the
Section 811 program that is available to cover operating costs.
Although the Melville Act establishes the prerequisite statutory
framework, the full and successful implementation of the new project
rental assistance authority requires rulemaking. This proposed rule
addresses the need for rulemaking by establishing the necessary
policies, procedures, and other requirements that will govern the
eligibility and use of project rental assistance. HUD intends to
implement other changes made by the Melville Act through separate
rulemaking.
Summary of Legal Basis: As noted, the Melville Act amended section
811 of the Cranston-Gonzalez National Affordable Housing Act to
establish new project rental assistance authority. This rulemaking is
undertaken pursuant to the general rulemaking authority granted to the
Secretary under section 7(d) of the Department of HUD Act (42 U.S.C.
35335(d)), which authorizes the Secretary to make ``such rules and
regulations as may be necessary to carry out his functions, powers, and
duties.''
Alternatives: Rulemaking is required to ensure that the new
requirements and procedures governing the eligibility and use of
project rental assistance are generally applicable to participants in
HUD's supportive housing program for persons with disabilities and
enforceable by HUD.
Anticipated Cost and Benefits: The new project rental assistance
authority offers another method of financing for supportive housing for
persons with disabilities for projects that do not receive capital
advances. The new authority is designed to promote and facilitate the
creation of integrated supportive housing units, which is achieved by
making funds available to State housing agencies and other appropriate
entities. While there may be incremental costs associated with
compliance with the new requirements, to the extent that program
participants incur such costs, it will be as a result of their
voluntary participation in the project rental assistance component of
the Section 811 program. The benefits are increased affordability of
providing housing for persons with disabilities.
Risks: This rule poses no risk to public health, safety, or the
environment
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Small Entities Affected: No.
Government Levels Affected: None.
Agency Contact: Benjamin T. Metcalf, Senior Advisor, Office of
Multifamily Houisng Programs, Department of Housing and Urban
Development, Office of Housing, 451 7th Street SW., Washington, DC
20410, Phone: 202 708-2495.
RIN: 2502-AJ10
HUD--OFFICE OF PUBLIC AND INDIAN HOUSING (PIH)
Proposed Rule Stage
84. Tenant-Based Rental Assistance; Improving Performance Through a
Strengthened Section 8 Management Assessment Program (FR-5201)
Priority: Other Significant.
Legal Authority: 42 U.S.C. 1437a, 1437c, 1437f; 42 U.S.C. 3535(d)
CFR Citation: 24 CFR 985.
Legal Deadline: None.
Abstract: SEMAP establishes the management indicators used by HUD
to measure the performance of public housing agencies (PHA) in key
areas of the Section 8 rental assistance programs and to assign
performance ratings. The proposed rule would revise the indicator that
measures Section 8 voucher use to encourage PHAs to maximize the number
of Section 8 families served. Specifically, under this revised
indicator, HUD will not only consider the number of vouchers available
to a PHA, but also the funds available to the PHA, including budget
authority and a portion of reserves. HUD also proposes to assume
responsibility for conducting the inspections used to measure a PHA's
compliance with housing quality standards (HQS). Currently, HUD
measures HQS compliance through a reporting requirement for PHA self-
conducted inspections. The proposed rule would also establish a new
deconcentration indicator that will evaluate the ability of Section 8
families with children to access neighborhoods with below-average
poverty rates or neighborhoods with above-average schools.
Statement of Need: While the SEMAP is currently an effective
oversight tool, HUD's experience indicates that modifications are
needed to increase its utility and to better reflect policy priorities.
The proposed regulatory amendments address these needs. For example,
the change to the voucher utilization indicator will allow HUD to
better assess whether PHAs are maximizing their use of available
voucher authority and funds to assist families. By assuming
responsibility for HQS inspections, HUD will be in a better position to
assess their quality and accuracy. The new deconcentration indicator
addresses one of HUD's highest priorities; namely, improving the
housing and educational opportunities afforded to families receiving
HUD assistance.
Summary of Legal Basis: The Section 8 rental assistance programs
are authorized under section 8 of the United States Housing Act of 1937
(42 U.S.C. 1437f). This rulemaking is undertaken pursuant to the
general rulemaking authority granted to the Secretary under section
7(d) of the Department of HUD Act (42 U.S.C. 35335(d)), which
authorizes the Secretary to make ``such rules and regulations as may be
necessary to carry out his functions, powers, and duties.''
Alternatives: Rulemaking is required to ensure that revised SEMAP
indicators are generally applicable to all PHAs administering Section 8
programs, and are enforceable by HUD. Moreover, the current SEMAP
requirements are codified in regulation and, therefore, notice and
comment rulemaking is required for their revision.
Anticipated Cost and Benefits: There may be some incremental
administrative costs borne by PHAs as a result of revised indicators.
The benefits are the cost savings of no longer having to conduct HQS
inspections, resulting in a net economic benefit. HUD will assume the
costs of conducting these inspections, but these costs will be balanced
by the management and operational benefits resulting from the proposed
SEMAP enhancements. Moreover, HUD is considering whether HQS
inspections should be conducted less frequently than on an annual
basis, in order to allow for the best use of departmental resources.
Risks: This rule poses no risk to public health, safety, or the
environment.
Timetable:
------------------------------------------------------------------------
Action Date FR Cite
------------------------------------------------------------------------
NPRM................................ 02/00/12 .......................
------------------------------------------------------------------------
Regulatory Flexibility Analysis Required: No.
Government Levels Affected: None.
Additional Information: Includes retrospective review under
Executive Order 13563.
[[Page 7768]]
Agency Contact: Laure Rawson, Director, Housing Voucher Management
and Operations Division, Department of Housing and Urban Development,
Office of Public and Indian Housing, 451 7th Street SW., Washington, DC
20410, Phone: 202 402-2425.
RIN: 2577-AC76
BILLING CODE 4210-67-P
DEPARTMENT OF THE INTERIOR (DOI)
Statement of Regulatory Priorities
The Department of the Interior (DOI) is the principal Federal
steward of our Nation's public lands and resources, including many of
our cultural treasures. DOI serves as trustee to Native Americans and
Alaska natives and is responsible for relations with the island
territories under United States jurisdiction. The Department manages
more than 500 million acres of Federal lands, including 397 park units,
555 wildlife refuges, and approximately 1.7 billion of submerged
offshore acres. This includes some of the highest quality renewable
energy resources available to help the United States achieve the
President's goal of energy independence, including geothermal, solar,
and wind.
The Department protects and recovers endangered species; protects
natural, historic, and cultural resources; manages water projects that
are a lifeline and economic engine for many communities in the West;
manages forests and fights wildfires; manages Federal energy resources;
regulates surface coal mining operations; reclaims abandoned coal
mines; educates children in Indian schools; and provides recreational
opportunities for over 400 million visitors annually in the Nation's
national parks, public lands, national wildlife refuges, and recreation
areas.
The DOI will continue to review and update its regulations and
policies to ensure that they are effective and efficient, and that they
promote accountability and sustainability. The DOI will emphasize
regulations and policies that:
Promote environmentally responsible, safe, and balanced
development of renewable and conventional energy on our public lands
and the Outer Continental Shelf (OCS);
Use the best available science to ensure that public
resources are protected, conserved, and used wisely;
Adopt performance approaches focused on achieving cost-
effective, timely results;
Improve the nation-to-nation relationship with American
Indian tribes;
Promote partnerships with States, tribes, local
governments, other groups, and individuals to achieve common goals;
Promote transparency, fairness, accountability, and the
highest ethical standards while maintaining performance goals.
Major Regulatory Areas
The DOI bureaus implement congressionally mandated programs through
their regulations. Some of these regulatory programs include:
Developing onshore and offshore energy, including
renewable, minerals, oil and gas, and other energy resources;
Regulating surface coal mining and reclamation operations
on public and private lands;
Managing migratory birds and preserving marine mammals and
endangered species;
Managing dedicated lands, such as national parks, wildlife
refuges, National Landscape Conservation System lands, and American
Indian trust lands;
Managing public lands open to multiple use;
Managing revenues from American Indian and Federal
minerals;
Fulfilling trust and other responsibilities pertaining to
American Indians;
Managing natural resource damage assessments; and
Managing assistance programs.
Regulatory Policy
How DOI Regulatory Priorities Support the President's Energy, Resource
Management, Environmental Sustainability, and Economic Recovery Goals
The DOI's regulatory programs seek to operate programs
transparently, efficiently, and cooperatively while maximizing
protection of our land, resources, and environment in a fiscally
responsible way by:
(1) Protecting Natural, Cultural, and Heritage Resources
The Department's mission includes protecting and providing access
to our Nation's natural and cultural heritage and honoring our trust
responsibilities to tribes. We are committed to this mission and to
applying laws and regulations fairly and effectively. Our priorities
include protecting public health and safety, restoring and maintaining
public lands, protecting threatened and endangered species,
ameliorating land- and resource-management problems on public lands,
and ensuring accountability and compliance with Federal laws and
regulations.
The Bureau of Land Management (BLM) Wildlife Program continues to
focus on maintaining and managing wildlife habitat to ensure self-
sustaining populations and a natural abundance and diversity of
wildlife resources on public lands. The BLM-managed lands are vital to
game species and hundreds of species of non-game mammals, reptiles, and
amphibians. In order to provide for long-term protection of wildlife
resources, especially given other mandated land use requirements, the
Wildlife Program supports aggressive habitat conservation and
restoration activities, many funded by partnerships with Federal,
State, and non-governmental organizations. For instance, the Wildlife
Program is restoring wildlife habitat across a multi-state region to
support species that depend upon sagebrush vegetation. Projects are
tailored to address regional issues such as fire (as in the western
portion of the sagebrush biome) or habitat degradation and loss (as in
the eastern portion of the sagebrush biome). Additionally, BLM
undertakes habitat improvement projects in partnership with a variety
of stakeholders and consistent with State fish and game wildlife action
plans and local working group plans.
The National Park Service (NPS) is working with BLM and the U.S.
Fish and Wildlife Service (FWS) to finalize a rule implementing Public
Law 106-206, which directs the Secretary to establish a system of
location fees for commercial filming and still photography activities
on public lands. While commercial filming and still photography are
generally allowed on Federal lands, managing this activity through a
permitting process will minimize damage to cultural or natural
resources and interference with other visitors to the area. This
regulation would standardize location fee rates and collection for all
DOI agencies.
The NPS is proposing a new winter use rule for Yellowstone National
Park. This rule is proposed to replace an interim rule that expired at
the end of the 2010 to 2011 winter season and that was recently
reauthorized for the current (2011-2012) winter season. It would allow
a variety of winter uses for visitors while protecting park resources
by establishing maximum numbers of snowmobiles and snowcoaches
permitted in the Park on a given day. It would also require most
snowmobiles and snowcoaches operating in the Park
[[Page 7769]]
to meet air and sound emission requirements and would require a
commercial guide. The NPS intends to publish a final rule by mid-
November 2012.
The NPS is prepared to publish final rules for Off Road Vehicle use
at Cape Hatteras National Seashore and bicycle routes at Mammoth Cave
National Park. Proposed rules for bicycle routes are pending for other
park areas. These rules would manage use to protect and preserve
natural and cultural resources, and natural processes, and provide a
variety of safe visitor experiences while minimizing conflicts among
various users.
(2) Sustainably Using Energy, Water, and Natural Resources
The BLM has identified approximately 20.6 million acres of public
land with wind energy potential in the 11 western States and
approximately 29.5 million acres with solar energy potential in the six
southwestern States. There are over 140 million acres of public land in
western States and Alaska with geothermal resource potential. There is
also significant wind and wave potential in our offshore waters. The
National Renewable Energy Lab, a Department of Energy national
laboratory, has identified more than 1,000 gigawatts of wind potential
off the Atlantic coast--roughly equivalent to the Nation's existing
installed electric generating capacity--and more than 900 gigawatts of
wind potential off the Pacific Coast. Because public lands are
extensive and widely distributed, the Department has an important role,
in consultation with Federal, State, regional, and local authorities,
in approving and building new transmission lines that are crucial to
deliver renewable energy to America's homes and businesses.
Since the beginning of the Obama Administration, the Department has
focused on renewable energy issues and has established priorities for
environmentally responsible development of renewable energy on public
lands and the OCS. Industry has started to respond by investing in
development of wind farms off the Atlantic seacoast and solar, wind,
and geothermal energy facilities throughout the west. Power generation
from these new energy sources produces virtually no greenhouse gases
and, when done in an environmentally sensitive manner, harnesses with
minimum impact abundant renewable energy that nature itself provides.
The Department will continue its intra- and inter-departmental efforts
to move forward with the environmentally responsible review and
permitting of renewable energy projects on public lands.
The Secretary issued his first Secretarial Order on March 11, 2009,
making renewable energy on public lands and the OCS top priorities at
the Department. These remain top priorities. In implementing these
priorities through its regulations, the Department will continue to
create jobs and contribute to a healthy economy while protecting our
signature landscapes, natural resources, wildlife, and cultural
resources.
(3) Empowering People and Communities
The Department strongly encourages public participation in the
regulatory process. For example, every year the FWS establishes
migratory bird hunting seasons in partnership with flyway councils
composed of State fish and wildlife agencies. The FWS also holds a
series of public meetings to give other interested parties, including
hunters and other groups, opportunities to participate in establishing
the upcoming season's regulations.
Similarly, the BLM uses Resource Advisory Councils made up of
affected parties to help prepare land management plans and regulations.
The NPS has begun revising its rules on non-Federal development of
gas and oil in units of the National Park System. Of the approximately
700 gas and oil wells in 13 NPS units, 55 percent, or 385 wells, are
exempt from current regulations. The NPS is revising the regulations to
improve protection of NPS resources. The NPS actively sought public
input into designing the rule and published an Advance Notice of
Proposed Rulemaking with a comment period from November 15, 2009,
through January 25, 2010. Interested members of the public were able to
make suggestions for the content of the rule, which NPS will consider
in writing the proposed rule. After developing a proposed rule, NPS
will solicit further public comment. The NPS expects to publish a
proposed rule in 2012.
In October 2010, NPS published an interim final rule with request
for comments revising the former regulations for management of
demonstrations and the sale or distribution of printed matter in most
areas of the National Park System to allow a small-group exception to
permit requirements. In essence, under specific criteria,
demonstrations, and the sale or distribution of printed matter
involving 25 or fewer persons may be held in designated areas, without
first obtaining a permit; i.e. making it easier for individuals and
small groups to express their views. The NPS has analyzed the comments
and expects to publish a final rule in early 2012.
Retrospective Review of Regulations
President Obama's Executive Order 13563 directs agencies to make
the regulatory system work better for the American public. Regulations
should ``* * * protect public health, welfare, safety, and our
environment while promoting economic growth, innovation,
competitiveness, and job creation.'' DOI's plan for retrospective
regulatory review identifies specific efforts to relieve regulatory
burdens, add jobs to the economy, and make regulations work better for
the American public while protecting our environment and resources. The
DOI plan seeks to strengthen and maintain a culture of retrospective
review by consolidating all regulatory review requirements \1\ into
DOI's annual regulatory plan. DOI has selected the following regulatory
efforts to focus on over the next 2 years:
---------------------------------------------------------------------------
\1\ DOI conducts regulatory review under numerous statutes,
Executive orders, memoranda, and policies, including but not limited
to the Regulatory Flexibility Act of 1980 (RFA), the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), Executive
Orders 12866 and 13563, and the DOI Departmental Manual.
---------------------------------------------------------------------------
Oil and Gas Royalty Valuation Rules (Office of Natural
Resources Revenue)--DOI is exploring a simplified market-based approach
to arrive at the value of oil and gas for royalty purposes that could
dramatically reduce accounting and paperwork requirements and costs on
industry and better ensure proper royalty valuation by creating a more
transparent royalty calculation method.
Endangered Species Act Rules (Fish and Wildlife Service)--
The Fish and Wildlife Service (FWS), working in conjunction with the
National Marine Fisheries Service, will revise and update the ESA
implementing regulations and policies to improve conservation
effectiveness, reduce administrative burden, enhance clarity and
consistency for impacted stakeholders and agency staff, and encourage
partnerships, innovation, and cooperation. FWS has already proposed a
rule on May 17, 2011, that would minimize the requirements for written
descriptions of critical habitat boundaries in favor of map and
Internet-based descriptions. FWS anticipates issuing the final rule in
the spring of 2012. Additionally, FWS will develop proposed rules and/
or policies to amend existing regulations related to:
Habitat conservation plans;
[[Page 7770]]
Safe harbor agreements;
Candidate conservation agreements;
The process and procedures for designation of critical
habitat;
Section 7 consultation to revise the definition of
``destruction or adverse modification'' of critical habitat; and
Issuance of incidental take permits during section 7
consultation.
Commercial Filming on Public Land Rules--This joint effort
between the National Park Service (NPS), Fish and Wildlife Service
(FWS), Bureau of Land Management (BLM), Bureau of Reclamation (BOR),
and Bureau of Indian Affairs (BIA) will create consistent regulations
and a unified fee schedule for commercial filming and still photography
on public land. It will provide the commercial filming industry with a
predictable fee for using Federal lands, while earning the Government a
fair return for the use of that land.
Offshore Energy Safety and Environmental Rules (BSEE)--In
the wake of the Deepwater Horizon oil spill, DOI immediately instituted
regulatory reforms that strengthened the protection of workers' health
and safety and enhanced environmental safeguards. The Bureau of Safety
and Environmental Enforcement (BSEE), formerly part of the Bureau of
Ocean Energy Management, Regulation, and Enforcement (BOEMRE) is now
considering ways to apply ``safety case''-type performance standards,
such as those widely applied internationally, to the U.S. offshore
drilling regulatory regime. A hybrid combination of performance-based
and prescriptive standards will provide flexibility to adapt to
changing technologies and increasingly complex operational conditions,
while maintaining worker and environmental protections.
Leasing (BIA)--BIA is amending its leasing regulations to
eliminate the need to follow multiple cross-references in the
regulations. The amendments will also delete the requirement for BIA
review of permits, which some view as unjustified and excessively
burdensome.
Land Classification Regulations (BLM)--BLM is amending its
regulations to remove obsolete land classification regulations and
consolidate these regulations into the existing planning system
regulations. These changes will benefit the public by consolidating all
land use decisions into one systematic process.
DOI bureaus work to make our regulations easier to comply with and
understand. Our regulatory process ensures that bureaus share ideas on
how to reduce regulatory burdens while meeting the requirements of the
laws they enforce and improving their stewardship of the environment
and resources. Results include:
Effective stewardship of our Nation's resources in a way
that is responsive to the needs of small businesses;
Increased benefits per dollars spent by carefully
evaluating the economic effects of planned rules; and
Improved compliance and transparency by use of plain
language in our regulations and guidance documents.
Bureaus and Offices Within DOI
The focus of DOI's major regulatory bureaus and offices is
summarized below.
Bureau of Indian Affairs
The Bureau of Indian Affairs (BIA) administers and manages 56
million acres of land held in trust by the United States for Indians
and Indian tribes, providing services to approximately 1.9 million
Indians and Alaska Natives, and maintaining a government-to-government
relationship with the 565 federally recognized Indian tribes. The BIA's
mission is to enhance the quality of life, to promote economic
opportunity, and to carry out the responsibility to protect and improve
the trust assets of American Indians, Indian tribes, and Alaska
Natives, as well as to provide quality education opportunities to
students in Indian schools.
In the coming year, BIA will continue its regulatory focus on
improved management of trust responsibilities and promotion of economic
development in Indian communities. In addition, BIA will focus on
updating Indian education regulations and on other regulatory changes
to increase transparency in support of the President's Open Government
Initiative.
With the input of tribal leaders, individual Indian beneficiaries,
and other subject matter experts, BIA has been examining better ways to
serve its beneficiaries. The American Indian Probate Reform Act of 2004
(AIPRA) made clear that regulatory changes were necessary. BIA has
promulgated regulations implementing the probate-related provisions of
AIPRA and will now focus on regulations to implement other AIPRA
provisions related to managing Indian land.
The focus on promoting economic development in Indian communities
is a core component of BIA's mission. Economic development initiatives
can attract businesses to Indian communities that provide jobs and fund
services that support the health and well-being of tribal members.
Economic development can enable tribes to attain self-sufficiency,
strengthen their governments, and reduce crime.
Indian education is a top priority of the Assistant Secretary for
Indian Affairs. BIA will review Indian education regulations to ensure
that they adequately support efforts to provide students of BIA-funded
schools with the best education possible.
Finally, BIA's regulatory focus on increasing transparency
implements the President's Open Government Initiative. BIA will ensure
that all regulations that it drafts or revises meet high standards of
readability and accurately and clearly describe BIA processes.
BIA's regulatory priorities are to:
Develop regulations to meet the Indian trust reform goals
for land consolidation and land use management.
BIA is amending regulations affecting land title and records,
conveyances of trust or restricted land, leasing, grazing, trespass,
rights-of-way, and energy and minerals. These regulatory changes will
help the Department better serve beneficiaries and will standardize
procedures for consistent execution of fiduciary responsibilities
across the BIA.
Identify and develop regulatory changes necessary for
improved Indian education.
BIA is reviewing regulations addressing grants to tribally
controlled community colleges and other Indian education regulations.
The review will identify provisions that need to be updated to comply
with applicable statutes and ensure that the proper regulatory
framework is in place to support students of Bureau-funded schools.
Develop regulatory changes to reform the process for
Federal acknowledgment of Indian tribes.
Over the years, BIA has received significant comments from American
Indian groups and members of Congress on the Federal acknowledgment
process. Most of these comments claim that the current process is
cumbersome and overly restrictive. The BIA is reviewing the Federal
acknowledgment regulations to determine if any regulatory changes are
appropriate.
Revise regulations governing administrative appeals and
other processes to increase transparency.
The BIA is making a concentrated effort to improve the readability
and precision of its regulations. Because trust beneficiaries often
turn to the regulations for guidance on how a given BIA process works,
BIA is ensuring that each revised regulation is written as
[[Page 7771]]
clearly as possible and accurately reflects the current organization of
the Bureau. A few of the regulations BIA will be focusing this effort
on include the regulation governing administrative appeals (25 CFR part
2), the land use management regulations mentioned above, and
regulations addressing various Indian services.
The Bureau of Land Management
The BLM manages the 245-million-acre National System of Public
Lands, located primarily in the western States, including Alaska, and
the 700-million-acre subsurface mineral estate located throughout the
Nation. BLM's complex multiple-use mission affects the lives of a great
number of Americans, including those who live near and visit the public
lands, as well as millions of Americans who benefit from commodities,
such as minerals, energy, or timber, produced from the lands' rich
resources.
The BLM's multiple-use mission conserves the lands' natural and
cultural resources and sustains the health and productivity of the
public lands for the use and enjoyment of present and future
generations. The BLM manages such varied uses as energy and mineral
development, outdoor recreation, livestock grazing, and forestry and
woodlands products.
The BLM has identified the following three areas of regulatory
priorities.
Energy Independence
Treasured Landscapes
Native American Nations
The summaries that follow explain how these three areas promote the
BLM mission and the priorities of the Department.
Energy Independence
BLM manages more Federal land than any other agency--more than 245
million surface acres and 700 million subsurface acres of mineral
estate. Thus, it plays a key role in ensuring that the Nation's energy
needs are met by managing both Federal renewable and non-renewable
sources of energy. The BLM is analyzing proposals for increasing
renewable energy development on public lands. The BLM will manage these
proposals to assure they proceed in an environmentally and fiscally
sound way that protects our natural resources and critical wildlife
habitat for such species as the sage grouse and lynx. These projects
will create environmentally friendly jobs and help sustain the quality
of life that Americans enjoy today.
Another BLM priority is siting and authorizing transmission
corridors to assist the national effort to move renewable energy from
production sites to market. The BLM has already designated more than
5,000 miles of energy transport corridors. The BLM will authorize
rights-of-way across public lands through these energy transport
corridors to allow development of transmission lines.
Treasured Landscapes
Protecting the landscapes of the National System of Public Lands
involves numerous BLM programs as the agency moves toward a holistic,
landscape-level approach to managing multiple public land uses. The BLM
also engages partners interested in working on a broader scale across
jurisdictional lines to achieve a common landscape vision. For the past
several years, BLM, which manages the largest amount and the greatest
diversity of fish and wildlife habitat of any Federal agency, has
focused on restoring healthy landscapes in a number of ways, including:
Reducing the number of wild horses and burros on public
lands, particularly in areas most affected by drought and wildfire.
Maintaining the wild horse and burro population at appropriate
management levels is critical in the effort to conserve forage
resources that also sustain native wildlife and livestock.
Restoring habitat for sensitive, rare, threatened, and
endangered species, such as sage grouse, desert tortoise, and salmon.
Supporting greater biodiversity through noxious weed and
invasive species treatments to bring back native plants.
Improving water quality by restoring riparian areas and
protecting watersheds. Enhanced water quality aids in the restoration
of habitat for fish and other aquatic and riparian species.
Conducting post-fire recovery efforts to promote healthy
landscapes and discourage the spread of invasive species.
Native American Nations
BLM consults with Indian tribes on a government-to-government basis
under multiple authorities and is continually working to assess and
improve its tribal consultation practices. The BLM held listening
sessions throughout the West on this important issue in 2009 and 2010
and received many valuable comments. BLM has continued its efforts to
improve its tribal consultation practices by participating with the
Department in multiple listening sessions with tribes throughout the
country.
The Native American Graves Protection and Repatriation Act
(NAGPRA), enacted in 1990, addresses the rights of lineal descendants,
Indian tribes, and Native Hawaiian organizations to certain Native
American human remains, funerary objects, associated funerary objects,
sacred objects, and objects of cultural patrimony with which they are
affiliated. The statute and implementing regulations represent a
careful balance between the legitimate interests of lineal descendants,
Indian tribes, and Native Hawaiian organizations to control the remains
of their ancestors and cultural property and the legitimate public
interests in scientific and educational information associated with the
human remains and cultural items.
BLM is complying with the new NAGPRA regulations, including
inventorying and repatriating human remains and other cultural items
that are in BLM museum collections. BLM also consults with Indian
tribes on implementing appropriate actions when human remains and other
cultural items subject to NAGPRA are inadvertently discovered or
intentionally excavated on the public lands.
Additionally, BLM, in cooperation with the Bureau of Indian
Affairs, helps tribes and individual Indian allottees develop their
solid and fluid mineral resources. BLM is responsible for development,
product measurement, and inspection and enforcement of extracting
operations of the mineral estate on trust properties.
BLM's Regulatory Priorities
The BLM's regulatory focus is directed primarily by the priorities
of the President and Congress, which include:
Generating jobs and promoting a healthy economy by
facilitating domestic production of various sources of energy,
including biomass, wind, solar, and other alternative sources.
Providing for a wide variety of public uses while
maintaining the long-term health and diversity of the land.
Preserving significant natural, cultural, and historic
resource values.
Understanding the arid, semi-arid, arctic, and other
ecosystems that BLM manages.
Using the best scientific and technical information to
make resource management decisions.
Understanding the needs of the people who use and enjoy
BLM-managed public lands and providing them with quality service.
Securing the recovery of a fair return for using publicly
owned resources, and avoiding the creation of long-term liabilities for
American taxpayers.
[[Page 7772]]
Resolving problems and implementing decisions in
cooperation with other agencies, states, tribal governments, and the
public.
In developing regulations, BLM recognizes the need to ensure
communication, coordination, and consultation with the public,
including affected interests, tribes, and other stakeholders. BLM also
works to draft regulations that are easy for the public to understand
and that provide clarity to those most affected by them.
The BLM's specific regulatory priorities include:
Revising onshore oil and gas operating standards.
The BLM expects to publish rules to revise several existing onshore
oil and gas operating orders and propose one new onshore order. Onshore
orders establish requirements and minimum standards and provide
standard operating procedures. The orders are binding on operating
rights owners and operators of Federal and Indian (except the Osage
Nation) oil and gas leases and on all wells and facilities on state or
private lands committed to Federal agreements. The BLM is responsible
for ensuring that oil or gas produced and sold from Federal or Indian
leases is accurately measured for quantity and quality. The volume and
quality of oil or gas sold from leases is key to determining the proper
royalty to be paid by the lessee to the Office of Natural Resources
Revenue. Existing Onshore Orders Number 3, 4, and 5 would be revised to
use new industry standards so that they reflect current operating
procedures and to require that proper verification and accounting
practices are used consistently. New Onshore Order Number 9 would cover
waste prevention and beneficial use. The revisions would ensure that
proper royalties are paid on oil and gas removed from Federal and Trust
lands.
Revising coal-management regulations.
The BLM plans to publish a proposed rule to amend the coal-
management regulations that pertain to the administration of Federal
coal leases and logical mining units. The rule would primarily
implement provisions of the Energy Policy Act of 2005 that pertain to
administering coal leases. The rule also would clarify the royalty rate
applicable to continuous highwall mining, a new coal-mining method in
use on some Federal coal leases.
Publishing rules on paleontological resources
preservation.
The 2009 omnibus public lands law included provisions on permitting
for the collection of paleontological resources. The BLM and the
National Park Service are co-leads of a team with the U.S. Forest
Service that will be drafting a paleontological resources rule. The
rule would address the protection of paleontological resources and how
BLM would permit the collection of these resources. The rule would also
address other issues such as administering permits, casual collection
of rocks and minerals, hobby collection of common invertebrate plants
and fossils, and civil and criminal penalties for violation of these
rules.
Amending rules on royalty rate increases for new Federal
Onshore Competitive Oil and Gas Leases.
The BLM will consider amending its oil and gas regulations to set
higher royalty rates for new Federal onshore competitive oil and gas
leases issued on or after the effective date of the rule. This rule
would revise existing regulations by increasing royalty rates based on
the options set out in the proposed rule.
The Bureau of Ocean Energy Management, Regulation, and Enforcement
The Bureau of Ocean Energy Management, Regulation, and Enforcement
(BOEMRE) replaced the former Minerals Management Service (MMS). On
October 1, 2011, BOEMRE was reorganized and divided into two new
Bureaus, under the Assistant Secretary for Land and Minerals
Management:
(1) The Bureau of Ocean Energy Management (BOEM) now functions as
the resource manager for the conventional and renewable energy and
mineral resources on the OCS. It fosters environmentally responsible
and appropriate development of the OCS for both conventional and
renewable energy and mineral resources in an efficient and effective
manner that ensures fair market value for the rights conveyed.
(2) The Bureau of Safety and Environmental Enforcement (BSEE)
applies independent regulation, oversight, and enforcement powers to
promote and enforce safety in offshore energy exploration and
production operations and ensure that potentially negative
environmental impacts on marine ecosystems and coastal communities are
appropriately considered and mitigated.
Our regulatory focus for fiscal year 2012 is directed by
Presidential and legislative priorities that emphasize contributing to
America's energy supply, protecting the environment, and ensuring a
fair return for taxpayers for energy production from Federal and Indian
lands.
BOEM's regulatory priorities are to:
Finalize Regulations for Leasing of Sulphur or Oil and Gas
and Bonding Requirements in the Outer Continental Shelf
This final rule updates and streamlines the existing OCS leasing
regulations and clarifies implementation of the Federal Oil and Gas
Royalty Simplification and Fairness Act of 1996. This final rule
reorganizes leasing requirements to communicate more effectively the
leasing process, as it has evolved over the years. This final rule
makes changes to 30 CFR parts 250, 256, and 260 that relate to the oil
and gas leasing and bonding requirements.
BSEE's regulatory priorities are to:
Establish Additional Requirements for Safety Measures for
Drilling and Other Well Operations for Oil and Gas
This will be an Advance Notice of Proposed Rulemaking to address
recommendations from the ``Increased Safety Measures for Energy
Development on the Outer Continental Shelf'' report that were not
covered by an Interim Final Rule BOEMRE, BSEE's predecessor, published
on October 14, 2010. The safety measures recommendations include
additional requirements for blowout preventers, remotely operated
vehicles, secondary control systems, and cement evaluation techniques.
Detailed responses to the questions and ideas posed in this Advance
Notice of Proposed Rulemaking would allow BSEE to develop more
comprehensive regulations, if needed, and have a better understanding
of the impacts.
Revise Regulations on Safety and Environmental Management
Programs for Offshore Operations and Facilities
This rulemaking proposes to revise 30 CFR part 250 (subpart S)
regulations to require operators to develop and implement additional
provisions in their Safety and Environmental Management Systems (SEMS)
programs for oil, gas, and sulphur operations in the Outer Continental
Shelf (OCS). These revisions pertain to developing and implementing:
(1) Stop work authority, (2) ultimate work authority, (3) requiring
employee participation in the development and implementation of SEMS
programs, and (4) establishing requirements for reporting unsafe
working conditions. In addition, this proposed rule (5) requires
independent third parties to conduct audits of operators' SEMS programs
and (6) establishes further requirements relating to conducting job
safety analyses (JSA) for activities identified in an operator's SEMS
program. BSEE believes that these new requirements will further reduce
the likelihood of accidents, injuries, and spills in connection with
OCS activities,
[[Page 7773]]
by requiring OCS operators to specifically address issues associated
with human behavior as it applies to their SEMS program.
Develop additional rules and regulations as a result of
ongoing reviews of BSEE's offshore regulatory regime.
Several investigations and reviews of BOEMRE, now BSEE, have been
and are being conducted by various agencies and entities--including the
Safety Oversight Board, the Office of Inspector General, the
President's Deepwater Horizon Commission, the National Academy of
Engineering, and the joint BOEMRE/United States Coast Guard (USCG)
investigation of Deepwater Horizon. Some of these investigations and
reviews focus narrowly on the Deepwater Horizon explosion; others are
broader in focus and include many aspects of the current regulatory
system. BSEE expects that recommendations for regulatory changes--both
substantive and procedural--will be generated by these investigations
and reviews, and will need to be reviewed, analyzed, and potentially
incorporated in new or modified regulations. The Secretary established
the Ocean Energy Safety Advisory Committee to provide advice on matters
related to drilling and workplace safety, and spill containment and
response. This Committee is expected to make recommendations for new or
modified regulations.
Office of Natural Resources Revenue
The revenue responsibilities of the former MMS now are located in
the Office of Natural Resources Revenue (ONRR), which will continue to
collect, account for, and disburse revenues from Federal offshore
energy and mineral leases and from onshore mineral leases on Federal
and Indian lands. The program operates nationwide and is primarily
responsible for timely and accurate collection, distribution, and
accounting for revenues associated with mineral and energy production.
The regulatory program of ONRR seeks to:
Simplify valuation regulations.
ONRR plans to simplify the regulations at 30 CFR part 1206 for
establishing the value for royalty purposes of (1) oil and natural gas
produced from Federal leases; and (2) coal and geothermal resources
produced from Federal and Indian leases. Additionally, the proposed
rules would consolidate sections of the regulations common to all
minerals, such as definitions and instructions regarding how a payor
should request a valuation determination. ONRR published Advance
Notices of Proposed Rulemaking (ANPRMs) to initiate the rulemaking
process and to obtain input from interested parties.
Finalize debt collection regulations.
ONRR is preparing regulations governing collection of delinquent
royalties, rentals, bonuses, and other amounts due under Federal and
Indian oil, gas, and other mineral leases. The regulations would
include provisions for administrative offset and would clarify and
codify the provisions of the Debt Collection Act of 1982 and the Debt
Collection Improvement Act of 1996.
Continue to meet Indian trust responsibilities.
ONRR has a trust responsibility to accurately collect and disburse
oil and gas royalties on Indian lands. ONRR will increase royalty
certainty by addressing oil valuation for Indian lands through a
negotiated rulemaking process involving key stakeholders.
Office of Surface Mining Reclamation and Enforcement
The Office of Surface Mining Reclamation and Enforcement (OSM) was
created by the Surface Mining Control and Reclamation Act of 1977
(SMCRA). Under SMCRA, OSM has two principal functions. They are:
The regulation of surface coal mining and reclamation
operations; and
The reclamation and restoration of abandoned coal mine
lands.
In enacting SMCRA, Congress directed OSM to ``strike a balance
between protection of the environment and agricultural productivity and
the Nation's need for coal as an essential source of energy.'' In
response to its statutory mandate, OSM has sought to develop and
maintain a stable regulatory program that is safe, cost-effective, and
environmentally sound. A stable regulatory program ensures that the
coal mining industry has clear guidelines for operation and
reclamation, and that citizens know how the program is being
implemented.
OSM's Federal regulatory program sets minimum requirements for
obtaining a permit for surface and underground coal mining operations,
sets performance standards for those operations, requires reclamation
of lands and waters disturbed by mining, and requires enforcement to
ensure that the standards are met.
OSM is the primary regulatory authority for SMCRA enforcement until
a State or Indian tribe develops its own regulatory program, which is
no less effective than the Federal program. When a State or Indian
tribe achieves ``primacy,'' it assumes direct responsibility for
permitting, inspection, and enforcement activities under its federally
approved regulatory program. Today, 24 of the 26 coal-producing States
have primacy. In the 2006 amendments to SMCRA, Indian tribes with coal
resources were provided the opportunity to assume primacy. No tribes
have done so to date, although three tribes have expressed an interest
in submitting a tribal program.
OSM's regulatory priorities for the coming year will focus on:
Stream Protection.
Protect streams from the adverse effects of surface coal mining
operations; and
Coal Combustion Residues
Establish Federal standards for the beneficial use of coal
combustion residues on active and abandoned coal mines.
U.S. Fish and Wildlife Service
The mission of the U.S. Fish and Wildlife Service (FWS) is to work
with others to conserve, protect, and enhance fish, wildlife, and
plants and their habitats for the continuing benefit of the American
people. FWS also helps ensure a healthy environment for people by
providing opportunities for Americans to enjoy the outdoors and our
shared natural heritage.
FWS fulfills its responsibilities through a diverse array of
programs that:
Protect and recover endangered and threatened species;
Monitor and manage migratory birds;
Restore native aquatic populations and nationally
significant fisheries;
Enforce Federal wildlife laws and regulate international
trade;
Conserve and restore wildlife habitat such as wetlands;
Help foreign governments conserve wildlife through
international conservation efforts;
Distribute Federal funds to States, territories, and
tribes for fish and wildlife conservation projects; and
Manage the almost 150-million-acre National Wildlife
Refuge System, which includes 555 National Wildlife Refuges and which
protects and conserves fish and wildlife and their habitats and allows
the public to engage in outdoor recreational activities.
Critical challenges to the work of FWS include global climate
change; shortages of clean water suitable for wildlife; invasive
species that are harmful to our fish, wildlife, and plant resources and
their habitats; and the alienation of children and adults from the
natural world. To address these challenges, FWS has identified six
priorities:
The National Wildlife Refuge System--conserving our lands
and resources;
[[Page 7774]]
Landscape conservation--working with others;
Migratory birds--conservation and management;
Threatened and endangered species--achieving recovery and
preventing extinction;
Connecting people with nature--ensuring the future of
conservation; and
Aquatic species--the National Fish Habitat Action Plan (a
plan that brings public and private partners together to restore U.S.
waterways to sustainable health).
To carry out these priorities, FWS has a large regulatory agenda
that will, among other things:
List, delist, and reclassify species on the Lists of
Endangered and Threatened Wildlife and Plants and designate critical
habitat for certain listed species;
Update our regulations to carry out the Convention on
International Trade in Wild Fauna and Flora;
Manage migratory bird populations;
Administer the subsistence program for harvest of fish and
wildlife in Alaska;
Update our regulations governing the Wildlife and Sport
Fish Restoration Program; and
Set forth hunting and sport fishing regulations for the
National Wildlife Refuge System.
Additionally, FWS is working with the National Oceanic and
Atmospheric Administration and the Environmental Protection Agency, via
a contract with the National Research Council (NRC), to review
scientific issues associated with the Federal Insecticide, Fungicide,
and Rodenticide Act. Once the NRC's report is completed, the agencies
will work together to develop an approach that produces efficient,
scientifically defensible biological evaluations protective of listed
species.
Further, the FWS' Regional Directors and/or Ecological Services
State Supervisors or Project leaders will be meeting with their State
counterparts to discuss the role of State agencies in ESA initiatives
to enhance their involvement in implementing the ESA's provisions.
National Park Service
The NPS preserves unimpaired the natural and cultural resources and
values within almost 400 units of the National Park System encompassing
nearly 84 million acres of lands and waters for the enjoyment,
education, and inspiration of this and future generations. The NPS also
cooperates with partners to extend the benefits of natural and resource
conservation and outdoor recreation throughout the United States and
the world.
To achieve this mission the NPS adheres to the following guiding
principles:
Excellent Service: Providing the best possible service to
park visitors and partners.
Productive Partnerships: Collaborating with Federal,
State, tribal, and local governments, private organizations, and
businesses to work toward common goals.
Citizen Involvement: Providing opportunities for citizens
to participate in the decisions and actions of the National Park
Service.
Heritage Education: Educating park visitors and the
general public about their history and common heritage.