[The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions]
[The Regulatory Plan]
[From the U.S. Government Printing Office, www.gpo.gov]
The Regulatory Plan
____________________________________________________________________
[[Page 72725]]
INTRODUCTION TO THE FALL 2006 REGULATORY PLAN
Federal regulation is a fundamental instrument of
national policy. It is one of the three major tools --
in addition to spending and taxing -- used to implement
policy. It is used to advance numerous public
objectives, including homeland security, environmental
protection, educational quality, food safety,
transportation safety, health care quality, equal
employment opportunity, energy security, immigration
control, and consumer protection. The Office of
Management and Budget's (OMB) Office of Information and
Regulatory Affairs (OIRA) is responsible for overseeing
and coordinating the Federal Government's regulatory
policies.
The Regulatory Plan is published as part of the fall
edition of the Unified Agenda of Federal Regulatory and
Deregulatory Actions, and serves as a statement of the
Administration's regulatory and deregulatory policies
and priorities. The purpose of the Plan is to make the
regulatory process more accessible to the public and to
ensure that the planning and coordination necessary for
a well-functioning regulatory process occurs. The Plan
identifies regulatory priorities and contains
information about the most significant regulatory
actions that agencies expect to undertake in the coming
year. An accessible regulatory process enables citizen
centered service, which is a vital part of the
President's Management Agenda.
Federal Regulatory Policy
The Bush Administration supports Federal regulations
that are sensible and based on sound science,
economics, and the law. Accordingly, the Administration
is striving for a regulatory process that adopts new
rules when markets fail to serve the public interest,
simplifies and modifies existing rules to make them
more effective or less costly or less intrusive, and
rescinds outmoded rules whose benefits do not justify
their costs. In pursuing this agenda, OIRA has adopted
an approach based on the principles of regulatory
analysis and policy espoused in Executive Order 12866,
signed by President Clinton in 1993.
Effective regulatory policy is not uniformly pro-
regulation or anti-regulation. It begins with the
authority granted under the law. Within the discretion
available to the regulating agency by its statutory
authority, agencies apply a number of principles
articulated in Executive Order 12866, as well as other
applicable Executive orders, in order to design
regulations that achieve their ends in the most
efficient way. This means bringing to bear on the
policy problem sound economic principles, the highest
quality information, and the best possible science.
This is not always an easy task, as sometimes economic
and scientific information may point in very different
directions, and therefore designing regulations does
not mean just the rote application of quantified data
to reach policy decisions. In making regulatory
decisions, we expect agencies to consider not only
benefit and cost items that can be quantified and
expressed in monetary units, but also other attributes
and factors that cannot be integrated readily in a
benefit-cost framework, such as fairness and privacy.
However, effective regulation is the result
[[Page 72726]]
of the careful use of all available high-quality data,
and the application of broad principles established by
the President.
In pursuing this goal of establishing an effective,
results-oriented regulatory system, the Bush
Administration has increased the level of public
involvement and transparency in its review and
clearance of new and existing regulations.
For new rulemakings and programs, OIRA has enhanced the
transparency of OMB's regulatory review process. OIRA's
website now enables the public to find which rules are
formally under review at OMB and which rules have
recently been cleared or have been returned to agencies
for reconsideration. OIRA has also increased the amount
of information available on its website. In addition to
information on meetings and correspondence, OIRA makes
available communications from the OIRA Administrator to
agencies, including ``prompt letters,'' ``return
letters,'' and ``post clearance letters,'' as well as
the Administrator's memorandum to the President's
Management Council (September 20, 2001) on presidential
review of agency rulemaking by OIRA.
For existing rulemakings, OIRA has initiated a modest
series of calls for reform nominations in 2001, 2002,
and 2004. In the draft 2001 annual Report to Congress
on the Costs and Benefits of Federal Regulation, OMB
asked for suggestions from the public about specific
regulations that should be modified in order to
increase net benefits to the public. We received
suggestions regarding 71 regulations, 23 of which OMB
designated as high priorities. After a similar call for
reforms in the 2002 draft Report, OMB received
recommendations on 316 distinct rules, guidance
documents, and paperwork requirements from over 1,700
commenters. Many of the nominations involved rules and
guidance documents that were recently issued or already
under review by the agencies, or involved independent
agency rules or guidance documents. OMB determined that
the remaining 122 rules and 34 guidance documents were
not under active review, and referred them to the
agencies for their evaluation as possible reforms.
Finally, in the 2004 draft Report, OMB requested public
nominations of promising regulatory reforms relevant to
the manufacturing sector. In particular, commenters
were asked to suggest specific reforms to rules,
guidance documents, or paperwork requirements that
would improve manufacturing regulation by reducing
unnecessary costs, increasing effectiveness, enhancing
competitiveness, reducing uncertainty, and increasing
flexibility. In response to the solicitation, OMB
received 189 distinct reform nominations from 41
commenters. Of these, Federal agencies and OMB have
determined that 76 of the 189 nominations have
potential merit and justify further action. For further
information, all of these Reports are available on
OIRA's website at http://www.whitehouse.gov/omb/
inforeg/regpol.html.
The Bush Administration has also moved aggressively to
establish basic quality performance goals for all
information disseminated by Federal agencies, including
information disseminated in support of proposed and
final regulations. The Federal agencies issued
guidelines on October 1, 2002 under the Information
Quality Act to ensure the ``quality, objectivity,
utility, and integrity'' of all information
disseminated by Federal agencies. Under these
guidelines, Federal agencies are taking appropriate
steps to incorporate the information quality
performance standards into agency information
dissemination practices, and developing pre-
dissemination review procedures to substantiate the
quality of information before it is disseminated. Under
the agency information quality guidelines, ``affected
persons'' can request that the agencies correct
information if they believe that scientific, technical,
economic, statistical or other information disseminated
does not meet the agency and OMB standards. If the
requestor is dissatisfied with the initial
[[Page 72727]]
agency response to a correction request, an appeal
opportunity is provided by the agencies. With the
implementation of these guidelines, agencies are now
aware that ensuring the high quality of government
information disseminations is a high priority of the
Administration. Further information on OIRA's
activities implementing the Information Quality Act is
available on OIRA's website at http://
www.whitehouse.gov/omb/inforeg/infopoltech.html.
As part of its efforts to improve the quality,
objectivity, utility, and integrity of information
disseminated by the Federal agencies, on December 16,
2004, OMB issued a Final Information Quality Bulletin
for Peer Review. This Bulletin establishes government-
wide guidance aimed at enhancing the practice of peer
review of government science documents. The Bulletin
describes minimum standards for when peer review is
required and how intensive the peer review should be
for different information. The Bulletin requires the
most rigorous form of peer review for highly
influential scientific assessments. Further information
on peer review is available on OIRA's website at http:/
/www.whitehouse.gov/omb/memoranda/fy2005/m05-03.pdf.
In addition to increasing the level of public
involvement and transparency in its review of
regulations, the Bush Administration has sought to
enhance the role of analysis in the development of
effective regulations. On September 17, 2003, OMB
issued revised guidance to agencies on regulatory
analysis.\1\ Key features of the revised guidance
include more emphasis on cost-effectiveness, more
careful evaluation of qualitative and intangible
values, and a greater emphasis on considering the
uncertainty inherent in estimates of impact. OIRA was
very interested in updating the guidance in light of
these and other innovations now commonplace in the
research community. The 2006 Regulatory Plan continues
OIRA's effort to ensure coordination across Federal
agencies in pursuing analytically sound regulatory
policies.
The Administration's 2006 Regulatory Priorities
With regard to Federal regulation, the Bush
Administration's objective is quality, not quantity.
Those rules that are adopted promise to be more
effective, less intrusive, and more cost-effective in
achieving national objectives while demonstrating
greater durability in the face of political and legal
attack. The Regulatory Plan is integral to enhancing
the quality of Federal regulations, and OMB seeks to
ensure that the public is provided with the information
needed to understand and comment on the Federal
regulatory agenda. Accordingly, the 2006 Regulatory
Plan highlights the following themes:
Regulations that are particularly good
examples of the Administration's ``smart''
regulation agenda to streamline regulations
and reporting requirements, which is a key
part of the President's economic plan.
Regulations that are of particular
concern to small businesses.
------------
\1\ See Circular A-4, ``Regulatory Analysis,''
published as part of OMB's 2003 Report to Congress on
the Costs and Benefits of Federal Regulations. The
report is available on OMB's website at http://
www.whitehouse.gov/omb/inforeg/2003--cost-ben--final--
rpt.pdf
[[Page 72728]]
Regulations that respond to public
nominations submitted to OMB in 2001 or
2002.
Regulations that address 2004
nominations for promising regulatory
reforms in the manufacturing sector.
Conclusion
Smarter regulatory policies, created through public
participation, transparency, and cooperation across
Federal agencies, are a key Administration objective.
The following department and agency plans provide
further information on regulatory priorities. All
agencies' plans are a reflection of the
Administration's Federal Regulatory Policy objectives,
which aim at implementing an effective and results-
oriented regulatory system.
[[Page 72729]]
DEPARTMENT OF AGRICULTURE
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Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Procurement of Commodities for Foreign Donation 0560-AH40 Final Rule Stage
2 Animal Welfare; Regulations and Standards for Birds 0579-AC02 Proposed Rule
Stage
3 Importation of Plants for Planting; Establishing a New Category of Plants for Planting Not 0579-AC03 Proposed Rule
Authorized for Importation Pending Risk Assessment Stage
4 Revision of Fruits and Vegetables Import Regulations 0579-AB80 Final Rule Stage
5 Phytophthora Ramorum; Quarantine and Regulations 0579-AB82 Final Rule Stage
6 Special Nutrition Programs: Fluid Milk Substitutions 0584-AD58 Proposed Rule
Stage
7 Child and Adult Care Food Program: Improving Management and Program Integrity 0584-AC24 Final Rule Stage
8 FSP: Eligibility and Certification Provisions of the Farm Security and Rural Investment Act of 2002 0584-AD30 Final Rule Stage
9 Quality Control Provisions of Title IV of Public Law 107-171 0584-AD31 Final Rule Stage
10 Direct Certification of Children in Food Stamp Households and Certification of Homeless, Migrant 0584-AD60 Final Rule Stage
and Runaway Children for Free Meals in the NSLP, SBP, and SMP
11 Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): WIC Vendor Cost 0584-AD71 Final Rule Stage
Containment
12 Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC 0584-AD77 Final Rule Stage
Food Packages
13 Egg Products Inspection Regulations 0583-AC58 Proposed Rule
Stage
14 Performance Standards for the Production of Processed Meat and Poultry Products; Control of 0583-AC46 Final Rule Stage
Listeria Monocytogenes in Ready-to-Eat Meat and Poultry Products
15 Nutrition Labeling of Single-Ingredient Products and Ground or Chopped Meat and Poultry Products 0583-AC60 Final Rule Stage
16 Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the 0583-AC88 Final Rule Stage
Disposition of Non-Ambulatory Disabled Cattle
17 Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery Systems 0583-AD00 Final Rule Stage
18 Prohibition on the Use of Air-Injection Stunners for the Slaughter of Cattle 0583-AD03 Final Rule Stage
19 Availability of Lists of Retail Consignees During Meat or Poultry Product Recalls 0583-AD10 Final Rule Stage
20 Forest Service National Environmental Policy Act Procedures 0596-AC49 Proposed Rule
Stage
21 National Forest System Land Management Planning Categorical Exclusion (Final Directive, Forest 0596-AB86 Final Rule Stage
Service Handbook 1909.15, Chapter 30)
22 National Forest System Land Management Planning Directive (Final Directive, Forest Service Handbook 0596-AC57 Final Rule Stage
1909.12, Chapter 70-Wilderness Evaluation)
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DEPARTMENT OF COMMERCE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
23 Right Whale Ship Strike Reduction 0648-AS36 Final Rule Stage
24 Implement and Administer a Coupon Program for Digital-to-Analog Converter Boxes 0660-AA16 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF DEFENSE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
25 TRICARE Outpatient Prospective Payment System (OPPS) 0720-AB03 Final Rule Stage
26 TRICARE; Certain Survivors of Deceased Active Duty Members; and Adoption Intermediaries 0720-AB04 Final Rule Stage
27 Expand Eligibility of Selected Reserve Members Under the TRICARE Program 0720-AB05 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 72730]]
DEPARTMENT OF ENERGY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
28 Energy Conservation Standards for Residential Electric and Gas Ranges and Ovens and Microwave 1904-AB49 Prerule Stage
Ovens, Dishwashers, Dehumidifiers, and Commercial Clothes Washers
29 Energy Efficiency Standards for Commercial Refrigeration Equipment 1904-AB59 Prerule Stage
30 Energy Efficiency Standards for Residential Furnaces and Boilers 1904-AA78 Proposed Rule
Stage
31 Energy Efficiency Standards for Electric Distribution Transformers 1904-AB08 Final Rule Stage
32 Energy Efficiency Standards for Ceiling Fan Light Kits 1904-AB61 Final Rule Stage
33 Loan Guarantees for Projects That Employ Innovative Technologies 1901-AB21 Proposed Rule
Stage
34 Radiation Protection of the Public and the Environment 1901-AA38 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
35 Control of Communicable Diseases, Interstate and Foreign Quarantine 0920-AA12 Final Rule Stage
36 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics 0910-AC52 Proposed Rule
Stage
37 Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for 0910-AF11 Proposed Rule
Pregnancy and Lactation Labeling Stage
38 Expanded Access to Investigational Drugs for Treatment Use 0910-AF14 Proposed Rule
Stage
39 Label Requirement for Food That Has Been Refused Admission Into the United States 0910-AF61 Proposed Rule
Stage
40 Medical Device Reporting; Electronic Submission Requirements 0910-AF86 Proposed Rule
Stage
41 Electronic Registration and Listing for Devices 0910-AF88 Proposed Rule
Stage
42 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and 0910-AB88 Final Rule Stage
Dietary Supplements
43 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and 0910-AC41 Final Rule Stage
Response Act of 2002
44 Prospective Payment System for Long-Term Care Hospitals RY 2008: Annual Payment Rate Updates (CMS- 0938-AO30 Proposed Rule
1529-P) Stage
45 Standards for E-Prescribing Under Medicare Part D (CMS-0016-P) 0938-AO66 Proposed Rule
Stage
46 Changes to the Hospital Inpatient Prospective Payment Systems and FY 2008 Rates (CMS-1533-P) 0938-AO70 Proposed Rule
Stage
47 Revisions to the Medicare Advantage and Part D Prescription Drug Contract Confidentiality and 0938-AO78 Proposed Rule
Disclosure, Determinations, Appeals, and Intermediate Sanctions Processes (CMS-4124-P) Stage
48 Competitive Acquisition for Certain Durable Medical Equipment (DME), Prosthetics, Orthotics, and 0938-AN14 Final Rule Stage
Supplies (CMS-1270-F)
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
49 Minimum Standards for Driver's Licenses and Identification Cards Acceptable to Federal Agencies for 1601-AA37 Proposed Rule
Official Purposes Stage
50 United States Visitor and Immigrant Status Indicator Technology Program (US-VISIT), Enrollment of 1601-AA35 Final Rule Stage
Additional Aliens in US-VISIT
51 Chemical Security Anti-terrorism Standards 1601-AA41 Final Rule Stage
[[Page 72731]]
52 Special Immigrant and Nonimmigrant Religious Workers 1615-AA16 Proposed Rule
Stage
53 Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant Status 1615-AA60 Final Rule Stage
54 New Classification for Victims of Certain Criminal Activity; Eligibility for the U Nonimmigrant 1615-AA67 Final Rule Stage
Status
55 Removal of Standardized Request for Evidence Processing Timeframe 1615-AB13 Final Rule Stage
56 Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System (USCG- 1625-AA99 Proposed Rule
2005-21869) Stage
57 Passenger Manifest for Commercial Aircraft Arriving In and Departing From the United States; 1651-AA62 Final Rule Stage
Passengers and Crew Manifests for Commercial Vessels Departing From the United States
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
58 Permanent Foundations for Manufactured Housing (FR-5075) 2502-AI45 Proposed Rule
Stage
59 Capital Fund Program (FR-4880) 2577-AC50 Proposed Rule
Stage
60 Revisions to the Public Housing Assessment System (PHAS) (FR-5094) 2577-AC68 Proposed Rule
Stage
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DEPARTMENT OF THE INTERIOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
61 Valuation of Oil From Indian Leases 1010-AD00 Final Rule Stage
62 Placement of Excess Spoil 1029-AC04 Proposed Rule
Stage
63 Oil Shale Leasing and Operations 1004-AD90 Proposed Rule
Stage
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DEPARTMENT OF JUSTICE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
64 Nondiscrimination on the Basis of Disability in Public Accommodations and Commercial Facilities 1190-AA44 Proposed Rule
Stage
65 Nondiscrimination on the Basis of Disability in State and Local Government Services 1190-AA46 Proposed Rule
Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF LABOR
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
66 Family and Medical Leave Act of 1993; Conform to the Supreme Court's Ragsdale Decision 1215-AB35 Prerule Stage
67 Alternative Trade Adjustment Assistance Benefits; Amendment of Regulations 1205-AB40 Proposed Rule
Stage
[[Page 72732]]
68 Revision of the Department of Labor Regulations for Petitions and Determinations of Eligibility to 1205-AB44 Proposed Rule
Apply for Trade Adjustment Assistance for Workers Stage
69 Revision to the Department of Labor Benefit Regulations for Trade Adjustment Assistance for Workers 1205-AB32 Final Rule Stage
Under the Trade Act of 1974, as Amended
70 Labor Certification for the Permanent Employment of Aliens in the United States; Reducing the 1205-AB42 Final Rule Stage
Incentives and Opportunities for Fraud and Abuse and Enhancing Program Integrity
71 Amendment of Regulation Relating to Definition of Plan Assets--Participant Contributions 1210-AB02 Proposed Rule
Stage
72 Regulations Implementing the Health Care Access, Portability, and Renewability Provisions of the 1210-AA54 Final Rule Stage
Health Insurance Portability and Accountability Act of 1996
73 Prohibiting Discrimination Against Participants and Beneficiaries Based on Health Status 1210-AA77 Final Rule Stage
74 Section 404 Regulation--Default Investment Alternatives Under Participant Directed Individual 1210-AB10 Final Rule Stage
Account Plans
75 Personal Continuous Dust Monitors 1219-AB48 Prerule Stage
76 Sealing of Abandoned Areas 1219-AB52 Proposed Rule
Stage
77 Mine Rescue Teams 1219-AB53 Proposed Rule
Stage
78 Diesel Particulate Matter: Conversion Factor from Total Carbon to Elemental Carbon 1219-AB55 Proposed Rule
Stage
79 Asbestos Exposure Limit 1219-AB24 Final Rule Stage
80 Emergency Mine Evacuation 1219-AB46 Final Rule Stage
81 Criteria and Procedures for Proposed Assessment of Civil Penalties 1219-AB51 Final Rule Stage
82 Occupational Exposure to Crystalline Silica 1218-AB70 Prerule Stage
83 Hazard Communication 1218-AC20 Prerule Stage
84 Cranes and Derricks 1218-AC01 Proposed Rule
Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
85 Commuter Operations in Very Light Jets (VLJS) 2120-AI84 Proposed Rule
Stage
86 Aging Aircraft Program (Widespread Fatigue Damage) 2120-AI05 Final Rule Stage
87 Transport Airplane Fuel Tank Flammability Reduction 2120-AI23 Final Rule Stage
88 Medical Certification Requirements as Part of the Commercial Driver's License 2126-AA10 Proposed Rule
Stage
89 Unified Registration System 2126-AA22 Proposed Rule
Stage
90 National Registry of Certified Medical Examiners 2126-AA97 Proposed Rule
Stage
91 Roof Crush Resistance 2127-AG51 Final Rule Stage
92 Side Impact Protection Upgrade--FMVSS No. 214 2127-AJ10 Final Rule Stage
93 Reduced Stopping Distance Requirements for Truck Tractors 2127-AJ37 Final Rule Stage
94 Electronic Stability Control (ESC) 2127-AJ77 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
95 Implementation of a Revised Basel Capital Accord (Basel II) 1557-AC91 Proposed Rule
Stage
[[Page 72733]]
96 Risk-Based Capital Guidelines; Capital Adequacy Guidelines; Capital Maintenance: Domestic Capital 1557-AC95 Proposed Rule
Modifications (Basel IA) Stage
97 Implementation of a Revised Basel Capital Accord (Basel II) 1550-AB56 Proposed Rule
Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
98 Endocrine Disrupter Screening Program (EDSP); Implementing the Screening and Testing Phase 2070-AD61 Prerule Stage
99 Standards for the Management of Coal Combustion Wastes Generated by Commercial Electric Power 2050-AE81 Prerule Stage
Producers
100 Review of the National Ambient Air Quality Standards for Carbon Monoxide 2060-AI43 Proposed Rule
Stage
101 Control of Emissions From New Locomotives and New Marine Diesel Engines Less Than 30 Liters per 2060-AM06 Proposed Rule
Cylinder Stage
102 Control of Emissions From Nonroad Spark-Ignition Engines and Equipment 2060-AM34 Proposed Rule
Stage
103 Implementing Periodic Monitoring in Federal and State Operating Permit Programs 2060-AN00 Proposed Rule
Stage
104 Review of the National Ambient Air Quality Standards for Ozone 2060-AN24 Proposed Rule
Stage
105 Prevention of Significant Deterioration, Nonattainment New Source Review, and New Source 2060-AN28 Proposed Rule
Performance Standards: Emissions Test for Electric Generating Units Stage
106 Review of the National Ambient Air Quality Standards for Lead 2060-AN83 Proposed Rule
Stage
107 Test Rule; Testing of Certain High Production Volume (HPV) Chemicals 2070-AD16 Proposed Rule
Stage
108 Pesticides; Competency Standards for Occupational Users 2070-AJ20 Proposed Rule
Stage
109 Pesticides; Agricultural Worker Protection Standard Revisions 2070-AJ22 Proposed Rule
Stage
110 Pesticide Agricultural Container Recycling Program 2070-AJ29 Proposed Rule
Stage
111 Revisions to the Spill Prevention, Control, and Countermeasure (SPCC) Rule, 40 CFR Part 112 2050-AG16 Proposed Rule
Stage
112 Expanding the Comparable Fuels Exclusion under RCRA 2050-AG24 Proposed Rule
Stage
113 Definition of Solid Wastes Revisions 2050-AG31 Proposed Rule
Stage
114 NESHAP: Hazardous Organic NESHAP (HON) Residual Risk Standards 2060-AK14 Final Rule Stage
115 NESHAP: Halogenated Solvent Cleaning--Residual Risk Standards 2060-AK22 Final Rule Stage
116 Control of Hazardous Air Pollutants From Mobile Sources 2060-AK70 Final Rule Stage
117 Clean Air Fine Particle Implementation Rule 2060-AK74 Final Rule Stage
118 Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): 2060-AL75 Final Rule Stage
Debottlenecking, Aggregation and Project Netting
119 Fuel Economy Labeling of Motor Vehicles: Revisions to Improve Calculation of Fuel Economy Estimates 2060-AN14 Final Rule Stage
120 Amendment of the Standards for Radioactive Waste Disposal in Yucca Mountain, Nevada 2060-AN15 Final Rule Stage
121 Renewable Fuels Standard Rule 2060-AN76 Final Rule Stage
122 Final Rule for Implementation of the New Source Review (NSR) Program for PM2.5 2060-AN86 Final Rule Stage
123 Pesticides; Data Requirements for Conventional Chemicals 2070-AC12 Final Rule Stage
124 Lead-Based Paint Activities; Amendments for Renovation, Repair, and Painting 2070-AC83 Final Rule Stage
125 Pesticides; Data Requirements for Biochemical and Microbial Products 2070-AD51 Final Rule Stage
[[Page 72734]]
126 Notification of Chemical Exports under TSCA Section 12(b) 2070-AJ01 Final Rule Stage
127 Testing Agreement for Perfluorooctanoic Acid (PFOA) 2070-AJ06 Final Rule Stage
128 Hazardous Waste Manifest Revisions-Standards and Procedures for Electronic Manifests 2050-AG20 Final Rule Stage
129 Oil Pollution Prevention; Spill Prevention, Control, and Countermeasure (SPCC) Requirements-- 2050-AG23 Final Rule Stage
Amendments
130 National Pollutant Discharge Elimination System Permit Requirements for Peak Wet Weather Discharges 2040-AD87 Final Rule Stage
from Publicly Owned Treatment Work Treatment Plants Serving Sanitary Sewer Collection Systems
Policy
131 Concentrated Animal Feeding Operation Rule 2040-AE80 Final Rule Stage
132 Water Transfers Rule 2040-AE86 Final Rule Stage
133 Implementation Guidance for Mercury Water Quality Criteria 2040-AE87 Final Rule Stage
134 Toxics Release Inventory Reporting Burden Reduction Rule 2025-AA14 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
EQUAL EMPLOYMENT OPPORTUNITY COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
134A Coordination of Retired Health Benefits With Medicare and State Health Benefits 3046-AA72 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
NATIONAL ARCHIVES AND RECORDS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
135 Federal Records Management 3095-AB16 Proposed Rule
Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
SMALL BUSINESS ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
136 Small Business Lending Company and Lender Oversight Regulations 3245-AE14 Proposed Rule
Stage
137 Size for Purposes of Long Term Contracts; Small Business Size Regulations; 8(a) Business 3245-AF06 Final Rule Stage
Development/Small Disadvantaged Business Status Determinations
--------------------------------------------------------------------------------------------------------------------------------------------------------
SOCIAL SECURITY ADMINISTRATION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
138 Revised Medical Criteria for Evaluating Mental Disorders (886P) 0960-AF69 Proposed Rule
Stage
139 Additional Insured Status Requirements for Certain Alien Workers (2882P) 0960-AG22 Proposed Rule
Stage
140 Consultative Examination - Annual Onsite Review by DDSs (3338P) 0960-AG41 Proposed Rule
Stage
141 Revised Medical Criteria for Evaluating Impairments of the Digestive System (800F) 0960-AF28 Final Rule Stage
142 Revised Medical Criteria for Evaluating Immune System Disorders (804F) 0960-AF33 Final Rule Stage
143 Mandatory Exclusion of Health Care Providers and Representatives From Participating in Programs 0960-AF85 Final Rule Stage
Administered by SSA, Including Representative Payment (954F)
144 Amendments to the Ticket to Work and Self-Sufficiency Program (967F) 0960-AF89 Final Rule Stage
145 Age as a Factor in Evaluating Disability (3183F) 0960-AG29 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 72735]]
CONSUMER PRODUCT SAFETY COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
146 Flammability Standard for Upholstered Furniture 3041-AB35 Proposed Rule
Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
NATIONAL INDIAN GAMING COMMISSION
--------------------------------------------------------------------------------------------------------------------------------------------------------
Regulation
Sequence Title Identifier Rulemaking Stage
Number Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
147 Technical Amendments to the Minimum Internal Control Standards 3141-AA27 Final Rule Stage
148 Technical Standards for Gaming Machines and Gaming Systems 3141-AA29 Final Rule Stage
149 Game Classification Standards 3141-AA31 Final Rule Stage
--------------------------------------------------------------------------------------------------------------------------------------------------------
[FR Doc. 06-8765 Filed 12-08-06; 8:45 am]
BILLING CODE 6820-27-S
[[Page 72736]]
DEPARTMENT OF AGRICULTURE (USDA)
Statement of Regulatory Priorities
USDA's regulations cover a broad range of issues. Within the rulemaking
process is the department-wide effort to reduce burden on participants
and program administrators alike by focusing on improving program
outcomes, and particularly on achieving the performance measures
specified in the USDA and agency Strategic Plans. Significant focus is
being placed on efficiencies that can be achieved through eGov
activities, the migration to efficient electronic services and
capabilities, and the implementation of focused, efficient information
collections necessary to support effective program management.
Important areas of activity include the following:
USDA will continue regulatory work to protect the health and
value of U.S. agricultural and natural resources while
facilitating trade flows. This includes amending
regulations related to the importation of fruits and
vegetables, nursery products, and animals and animal
products, and continuing work related to regulation of
plant and animal biotechnologies. In addition, USDA will
propose specific standards for the humane handling, care,
treatment, and transportation of birds under the Animal
Welfare Act.
In the area of food safety, USDA will continue to develop
science-based regulations that improve the safety of meat,
poultry, and egg products in the least burdensome and most
cost-effective manner. In May 2006, an enhanced small
business outreach program was established. The agency will
collaborate in this initiative with other USDA agencies and
cooperating State partners. 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.
As changes are made for the nutrition assistance programs,
USDA will work to foster actions that will help improve
diets, and particularly to prevent and reduce overweight
and obesity. In 2007, FNS will continue to promote
nutritional knowledge and education while minimizing
participant and vender fraud.
USDA has a priority to improve access to natural resources of
Forest Service land by developing leases and expedited
reviews of permits. If accomplished, the use of oil or
natural gas could be used in accelerating the completion of
projects while maintaining the safety of public health,
environment and working to reduce dependence on foreign
oil.
USDA will continue to promote economic opportunities for
agriculture and rural communities through its Federal
Biobased Product Preferred Procurement Program (FB4P). The
Department will continue to designate groups of biobased
products to receive procurement preference from Federal
agencies and contractors. In addition, USDA intends to
publish rules establishing the Voluntary Labeling Program
for biobased products.
Reducing Paperwork Burden on Customers
USDA has made substantial progress in implementing the goal of the
Paperwork Reduction Act of 1995 to reduce the burden of information
collection on the public. To meet the requirements of the Government
Paperwork Elimination Act (GPEA) and the E-Government Act, agencies
across USDA are providing electronic alternatives to their
traditionally paper-based customer transactions. As a result, producers
increasingly have the option to electronically file forms and all other
documentation online. To facilitate the expansion of electronic
government, USDA implemented an electronic authentication capability
that allows customers to ``sign-on'' once and conduct business with all
USDA agencies. Supporting these efforts are ongoing analyses to
identify and eliminate redundant data collections and streamline
collection instructions. The end result of implementing these
initiatives is better service to our customers enabling them to choose
when and where to conduct business with USDA.
The Role of Regulations
The programs of USDA are diverse and far reaching, as are the
regulations that attend their delivery. Regulations codify how USDA
will conduct its business, including the specifics of access to, and
eligibility for, USDA programs. Regulations also specify the
responsibilities of State and local governments, private industry,
businesses, and individuals that are necessary to comply with their
provisions.
The diversity in purpose and outreach of USDA programs contributes
significantly to USDA being near the top of the list of departments
that produce the largest number of regulations annually. These
regulations range from nutrition standards for the school lunch
program, to natural resource and environmental measures governing
national forest usage and soil conservation, to emergency producer
assistance as a result of natural disasters, to regulations protecting
American agribusiness (the largest dollar value contributor to exports)
from the ravages of domestic or foreign plant or animal pestilence, and
they extend from farm to supermarket to ensure the safety, quality, and
availability of the Nation's food supply.
Many regulations function in a dynamic environment, which requires
their periodic modification. The factors determining various
entitlement, eligibility, and administrative criteria often change from
year to year. Therefore, many significant regulations must be revised
annually to reflect changes in economic and market benchmarks.
Almost all legislation that affects USDA programs has accompanying
regulatory needs, often with a significant impact. The Farm Security
and Rural Investment Act of 2002, Public Law 107-171; the Child
Nutrition and WIC Reauthorization Act of 2004, Public Law 108-265; and
the Agricultural Risk Protection Act of 2000, Public Law 106-224,
affect most agencies of USDA resulting in the modification, addition,
or deletion of many programs. These statutes set in motion rulemakings
that provide for improvements in market loss and conservation
assistance, crop and livestock disease and pest protection, marketing
enhancements, pollution control, research and development for biomass,
and refinements to the nutrition assistance programs to help ensure the
best practical outcomes for beneficiaries and the taxpayer.
Major Regulatory Priorities
This document represents summary information on prospective significant
regulations as called for in Executive Order 12866. The following
agencies are represented in this regulatory plan, along with a summary
of their mission and key regulatory priorities for 2007:
Food and Nutrition Service
Mission: FNS increases food security and reduces hunger in partnership
with cooperating organizations by providing
[[Page 72737]]
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'
2006 regulatory plan supports USDA's Strategic Goal 5, ``Improve the
Nation's Nutrition and Health,'' and its three related objectives:
Improve Access to Nutritious Food. This objective represents FNS'
efforts to improve nutrition by providing access to program benefits
(Food Stamps, WIC, and school meals) and distributing State
administrative funds to support program operations. To advance this
objective, FNS plans to finalize rules implementing provisions of the
Farm Security and Rural Investment Act of 2002 (P.L. 107-171) to
simplify program administration, support work, and improve access to
benefits in the Food Stamp Program. The Agency will also issue rules
implementing provisions of the Child Nutrition and WIC Reauthorization
Act of 2004 (P.L. 108-265) to ensure access to the Child Nutrition
Programs for low-income children receiving Food Stamps through direct
certification, and to establish automatic eligibility for homeless
children.
Promote Healthier Eating Habits and Lifestyles. This objective
represents FNS' efforts to improve nutrition knowledge and behavior
through nutrition education and breastfeeding promotion, and to ensure
that program benefits meet the appropriate nutrition standards to
effectively improve nutrition for program participants. In support of
this objective, FNS plans to propose a rule revising requirements that
allow schools to substitute nutritionally-equivalent non-dairy
beverages for fluid milk at the request of a recipient's parent. FNS
will also propose changes to improve food packages in the WIC program
to reflect current dietary guidance, based on recommendations made by
an Institute of Medicine expert panel.
Improve Nutrition Assistance Program Management and Customer Service.
This objective represents FNS' ongoing commitment to maximize the
accuracy of benefits issued, maximize the efficiency and effectiveness
of program operations, and minimize participant and vendor fraud. In
support of this objective, FNS plans to finalize rules in the Food
Stamp Program (FSP) to improve program operations and monitoring at the
State and institution levels. For example, the proposed Food Stamp
Program Disqualified Recipient Reporting and Computer Matching rule
would require State agencies at certification and periodically
thereafter to match persons in households applying for benefits against
several databases to ensure prisoners, deceased, and other disqualified
individuals are not receiving food stamp benefits. FNS will also
publish rules implementing several changes to the Food Stamp Quality
Control system, and related performance incentives for States, required
by P. L. 107-171, and propose rules to correct and clarify provisions
of the July 6, 2000, final regulation on recipient claims.
Food Safety and Inspection Service
Mission: The Food Safety and Inspection Service (FSIS) is responsible
for ensuring that meat, poultry, and egg products in 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, and egg products are
wholesome and not adulterated or misbranded. FSIS continues to review
its existing authorities and regulations to streamline excessively
prescriptive regulations, to revise or remove regulations that are
inconsistent with the Agency's hazard analysis and critical control
point regulations, and to ensure that it can address emerging food
safety challenges. FSIS' 2006 regulatory plan supports USDA's Strategic
Goal 5, ``Enhance Protection and Safety of the Nation's Agriculture and
Food Supply,'' and the related objective to reduce the incidence of
food borne illnesses related to meat, poultry, and egg products in the
U.S.
Following are some of the Agency's recent and planned initiatives:
Expand the Use of Performance Standards: In February 2001, FSIS
proposed a 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. The proposal also contained provisions addressing 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. The Agency is
evaluating the effectiveness of this interim rule, which in 2004 was
the subject of a regulatory reform nomination to OMB. FSIS has
carefully reviewed its economic analysis of the interim rule in
response to this recommendation and is planning to adjust provisions of
the rule to reduce the information collection burden on small
businesses. FSIS also is planning further action with respect to other
elements of the 2001 proposal, based on quantitative risk assessments
of target pathogens in processed products.
FSIS plans to propose amending the poultry products inspection
regulations by replacing, with a performance standard, the requirement
for ready-to-cook poultry products to be chilled to 40(deg) F or below
within certain time limits according to the weight of the dressed
carcasses. Under the performance standard, poultry establishments would
have to carry out slaughtering, dressing, and chilling operations in a
manner that ensures no significant growth of pathogens, as demonstrated
by control of the pathogens or indicator organisms. The existing time/
temperature chilling regulations would remain available for use by
establishments as a ``safe harbor'' for compliance with the new
standard.
Bovine Spongiform Encephalopathy (BSE): In January 2004, FSIS
published three interim final rules to prevent the agent of BSE from
entering the human food supply. FSIS took this action in response to
the confirmation of BSE in a cow in Washington State that had been
imported from Canada. In addition, FSIS issued a Federal Register
Notice in January 2004 that announced that the Agency would no longer
pass and apply the mark of inspection to carcasses and parts of cattle
selected for BSE testing by APHIS until the sample is determined to be
negative. FSIS has been evaluating the comments received in response to
the interim final rules to determine whether to implement additional
measures to prevent human exposure to the BSE agent.
Expand the Use of Hazard Analysis and Critical Control Point (HACCP)
Systems: FSIS also is planning to propose requirements for federally
inspected egg product plants to develop and implement HACCP systems and
sanitation standard operating procedures. The Agency will be proposing
pathogen reduction performance standards for egg products. Further, the
Agency will be proposing to remove requirements for FSIS approval of
egg-product plant drawings, specifications, and equipment before their
use, and to end the system for pre-marketing approval of labeling for
egg products.
[[Page 72738]]
Improve Consumer Information: FSIS has proposed requirements for the
nutrition labeling of ground or chopped meat and poultry products and
single-ingredient products. This proposed rule would require nutrition
labeling, on the label or at the point-of-purchase, for the major cuts
of single-ingredient, raw products and would require nutrition
information on the label of ground or chopped products. Completing this
rulemaking would respond to a regulatory reform recommendation made to
OMB in 2002.
FSIS proposed March 7, 2006, to amend the Federal meat and poultry
product regulations to provide that the Agency would make available to
individual consumers lists of the retail consignees of meat and poultry
products that a federally inspected meat or poultry products
establishment has voluntarily recalled. FSIS believes that this
information will be of value to consumers and the industry in
clarifying which products should be removed from commerce and form
consumers' possession because the products may be adulterated or
misbranded.
Small business implications: The great majority of businesses regulated
by FSIS are small businesses. With the possible exception of the
poultry chilling proposal, the regulations listed above substantially
affect small businesses. FSIS recognizes the difficulties faced by many
small and very small establishments in complying with necessary,
science-based food safety requirements and in assuming the associated
technical and financial burdens. FSIS attempts to reduce the burdens of
its regulations on small business by providing alternative dates of
compliance, furnishing detailed compliance guidance material, and
conducting outreach programs to small and very small establishments.
In May 2006, FSIS announced an enhanced small business outreach program
that will ensure critical training, access to food safety experts, and
information resources that are available in a form that is uniform,
easily comprehended, and consistent. The Agency will collaborate in
this initiative with other USDA Agencies and cooperating State
partners. For example, FSIS will make 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 will be meeting proactively 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 United
States 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, treatment, and
transportation of animals under the Animal Welfare Act.
Priorities: APHIS is continuing work that will result in a revision of
its regulations concerning the introduction of organisms and products
altered or produced through genetic engineering. This work consists of
two parts. The first is to amend the existing plant-related regulations
to reflect new consolidated authorities under the Plant Protection Act
and to address new technological trends. The second is to develop a
regulatory framework for transgenic animals. These regulatory changes
are needed to address risks to plant and animal health. APHIS also
plans to complete rulemaking to streamline the process for approving
new fruits and vegetables for importation, and to propose changes to
the regulations for importing nursery stock that will enhance our
ability to protect plant health. The Agency is also continuing to work
on amending its regulations concerning bovine spongiform encephalopathy
(BSE) to provide for the importation of certain animals and products
that present low risk.
With regard to animal welfare, APHIS plans to propose specific
standards for the humane handling, care, treatment, and transportation
of birds covered under the Animal Welfare Act.
APHIS' 2006 regulatory plan supports USDA's Strategic Goal 4, ``Enhance
Protection and Safety of the Nation's Agriculture and Food Supply, ''
and the related objective to reduce the number and severity of
agricultural pest and disease outbreaks.
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' priorities are to support Strategic Goal 2, ``Enhance
the Competitiveness and Sustainability of Rural and Farm Economies,''
by expanding domestic market opportunities for agricultural producers.
In response to concerns raised by Fruit and Vegetable industry members
that produce sellers may lose their status as trust creditors when
using electronic invoicing systems, the Agricultural Marketing Service
issued an advance notice of proposed rulemaking (ANPR) under the
Perishable Agricultural Commodities Act (PACA) soliciting comments from
the public, including buyers and sellers of fruits and vegetables. The
ANPR was published on January 30, 2006, and the comment period ended
March 16, 2006. The agency expects to proceed to rulemaking in the near
future. The PACA established a code of fair trading practices in the
marketing of fresh and frozen fruits and vegetables in interstate and
foreign commerce. The law imposes a statutory trust on the assets,
including inventory and receivables, of a licensee or firms operating
subject to the PACA. The PACA provides that PACA licensees may preserve
their trust rights by including specified language on billing or
invoicing statements. In 1997, the PACA regulations were amended to
state that electronic transmissions are considered ``ordinary and usual
billing and invoicing statements.'' A number of produce sellers have
voiced concerns that their PACA trust rights may not be preserved when
invoicing electronically. Additional concerns have been expressed that
notice to sellers using the alternate method of trust notice (i.e.,
separate trust notice letter) is not being accepted by some buyers who
require their suppliers to invoice electronically. Others in the
industry have expressed concern about being charged a fee by the buyer
to accept the notice to preserve their trust benefits if they send a
paper invoice or separate trust notice.
The Agricultural Marketing Service (AMS) administers the National
Organic Program (NOP) which is authorized by the Organic Food
Production Act of
[[Page 72739]]
1990 (7 U.S.C. 6510 et seq.). Under the NOP, AMS establishes national
standards for the production and handling of organically produced
agricultural products. Since the implementation of the NOP, some
members of the public have advocated for a more explicit regulatory
standard on the relationship between livestock, particularly dairy
animals, and grazing land. Appropriate access to pasture has been a
topic of discussion in the organic community for many years, including
by the National Organic Standards Board (NOSB). For these reasons, AMS
published an Advance Notice of Proposed Rulemaking (ANPR) on April 13,
2006, to give the public the opportunity to comment on key issues that
have been raised during previous rulemakings and National Organic
Standards Board deliberations regarding access to pasture and temporary
confinement based on an animal's stage of production. The comment
period closed on June 12. AMS intends to publish a proposed rule this
fall.
Farm Service Agency
Mission: The mission of the Farm Service Agency is to stabilize farm
income, help farmers conserve land and water resources, provide credit
to new or disadvantaged farmers and ranchers, and help farm operations
recover from the effects of disaster.
Priorities: FSA's Regulatory Plan supports USDA Strategic Goal 2,
``Enhance the Competitiveness and Sustainability of Rural and Farm
Economies,'' and Strategic Goal 6, ``Protect and Enhance the Nation's
Natural Resource Base and Environment.'' FSA's immediate priority is to
finish implementation of the disaster assistance programs required by
the 2006 Emergency Appropriations Act (Pub. L. 109-148), and the
Emergency Supplemental Appropriations Act for Defense, the Global War
on Terror, and Hurricane Recovery of 2006. The disaster programs
provide assistance to agricultural producers in areas that were
affected by the unusual number and severity of hurricanes in 2005.
A primary mission of FSA is to administer the commodity and
conservation programs provided by the Farm Security and Rural
Investment Act of 2002 (2002 Act). Generally, these programs are
authorized by the 2002 Act with respect to the 2002 through 2007 crop
years. Accordingly, FSA envisions no major changes in the last year of
the regulations used to administer these programs. However. the Agency
does expect major initiatives for a new Farm Bill to be proposed by
this Administration for the 2008 and subsequent crop years. FSA will
develop and issue the necessary regulations and make program funds
available to eligible clientele in as timely a manner as possible. As
these and future changes required by Administration initiatives and new
legislation are made, the Agency's focus will be to implement the
changes in such a way as to provide benefits while minimizing program
complexity and regulatory burden for program participants.
Opportunities will be taken to clarify, simplify, and reduce confusion
whenever possible. In addition, the Agency will continue to streamline
its farm loan programs operated under the Consolidated Farm and Rural
Development Act, as amended (Pub. L. 87-128).
The Agency plans to publish a final rule to adopt new procedures to be
used by the Commodity Credit Corporation (CCC) in the evaluation of
bids in connection with the procurement of commodities for foreign
donation under various food aid authorities. CCC is amending the
existing regulations to provide for the simultaneous review of
commodity and ocean freight offers when evaluating lowest-landed cost
options in connection with the procurement of commodities for foreign
donation. Under the revised bid process, CCC can better control
shipping costs, take advantage of efficiencies in load consolidation
and ensure a more competitive commodity procurement process. Program
savings should result from the ability to better position procured
commodities at domestic ports based on actual shipping cost
comparisons. Program savings are also expected as a result of greater
head-to-head competition for program freight among U.S.-flagged
carriers. These savings should allow for additional food aid quantities
to move to donation countries. This rule will enhance bidding
opportunities for potential vendors while allowing CCC to more
efficiently acquire commodities.
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.
Priorities: Forest Service's regulatory plan supports USDA Strategic
Goal 6, ``Protect and Enhance the Nation's Natural Resource Base and
Environment.'' The agency's priorities for fall 2006 include publishing
a proposed regulation to revise 36 CFR Part 220 regarding the agency's
implementation of the National Environmental Policy Act (NEPA). The
proposed regulation would move existing agency NEPA procedures required
by 40 CFR 1507.3 from the internal Forest Service Handbook 1909.15 to
the Code of Federal Regulations. Codifying agency NEPA procedures would
make it easier for the Forest Service to revise internal agency
guidance.
The agency plans to publish two final directives to Forest Service
Environmental Policy and Procedures Handbook 1909.15, chapter 30. The
existing agency NEPA procedures would be updated to allow the use of a
categorical exclusion when a land management plan is not making
decisions that will result in significant impacts on the human
environment and where no extraordinary circumstances exist that would
prohibit the use of the categorical exclusion. Notice of the proposed
categorical exclusion and request for comment was published January 5,
2005 (70 FR 3).
The second final directive to Forest Service Environmental Policy and
Procedures Handbook 1909.15, chapter 30 applies to issuance of Surface
Use Plans of Operation for exploration or development of an oil and gas
lease. The final directive will allow for expedited review of permits
to accelerate the completion of projects while maintaining safety,
public health and environmental protection. Notice of the proposed
directive and request for comment was published December 13, 2005 (70
FR 238).
Forest Service also plans to publish a final directive to Forest
Service National Forest System Land Management Planning Handbook
1909.12, chapter 70, regarding wilderness evaluation. The final
planning rule was published on January 5, 2005 (70 FR 1023), and an
interim directive to chapter 70 regarding wilderness evaluation was
published on March 23, 2005 (70 FR 14637). The final directive updates
guidance for the identification, inventory, evaluation, and
recommendation of areas within National Forest System lands that
satisfy the definition of wilderness
[[Page 72740]]
found in section 2(c) of the 1964 Wilderness Act.
Natural Resources Conservation Service
Mission: The Natural Resources Conservation Service (NRCS) mission is
to provide leadership in a partnership effort to help people conserve,
maintain, and improve our natural resources and environment.
Priorities: NRCS' priority for FY 2007 will be to make final
adjustments to rules related to the conservation provisions of the Farm
Security and Rural Investment Act of 2002 (the 2002 Farm Bill), in
response to public comments and experience gained from the
implementation of the programs. These clarifications and modifications
will ensure efficient and responsive delivery of conservation programs
to landowners and land users and help further the agency mission to
help people conserve, maintain, and improve our natural resources and
the environment. NRCS' 2006 regulatory plan supports USDA's Strategic
Goal 6, ``Protect and Enhance the Nation's Natural Resource Base and
Environment,'' and the related objectives to protect and conserve
natural resources that form the foundation for healthy lands.
NRCS remains committed to compliance with the Government Paperwork
Elimination Act and the Freedom to E-File Act, which require Government
agencies in general and NRCS in particular to provide the public the
option of submitting information or transacting business electronically
to the maximum extent possible. NRCS is designing its program forms to
allow the public to conduct business with NRCS electronically.
The NRCS plans to publish the following rules during FY 2007:
Interim Final Rule for the Environmental Quality Incentives Programs
(EQIP): This revision to the final rule is to: 1) consider public
comments about which resource concerns should be given national
priority in the implementation of EQIP in future years; 2) clarify the
cost-share rates (actual versus average cost); and 3) expansion of
conservation practice definitions with varying payment incentives for a
single conservation practice applied at different levels to achieve
additional environmental benefits.
The rulemaking for EQIP consists of making minor changes to existing
rules.
Final Rule for the Farmland and Ranchland Protection Program (FRPP):
This action will modify the FRPP final rule to clarify the amount of
construction and forested acres permitted on FRPP easements and
identify the procedure in which the United States would invoke its
contingent rights.
Interim Final Rule for the Confidentiality of Conservation Program
Information: If a producer believed that the proprietary information
about their land and the agricultural operation provided to NRCS for
participation in a conservation program would become ``public'' and
thus subject to disclosure requirements under the Freedom of
Information Act, the producer might not wish to participate in the
voluntary conservation programs. Therefore, NRCS action to promulgate a
rule is to ensure that NRCS or anyone acting on its behalf does not
unlawfully release protected information.
Final Rule for the Healthy Forest Reserve Program (HFRP): This action
implements HFRP -- a voluntary program to restore and enhance forest
ecosystems that promote the recovery of threatened and endangered
species, improve biodiversity, and enhance carbon sequestration. Land
can be enrolled through a 10-year cost-share agreement and an easement
contract.
_______________________________________________________________________
USDA--Farm Service Agency (FSA)
-----------
FINAL RULE STAGE
-----------
1. PROCUREMENT OF COMMODITIES FOR FOREIGN DONATION
Priority:
Other Significant
Legal Authority:
7 USC 1431; 7 USC 1721; 15 USC 714b
CFR Citation:
7 CFR 1496
Legal Deadline:
None
Abstract:
This rule proposes new procedures to be used by the Commodity Credit
Corporation (CCC) in the evaluation of bids in connection with the
procurement of commodities for donation overseas. This proposed rule
would enhance bidding opportunities for potential vendors while
allowing CCC to more efficiently acquire commodities. In general, CCC
proposes to amend the existing regulations to provide for the
simultaneous review of commodity and ocean freight offers when
evaluating lowest landed cost options in connection with the
procurement of commodities.
Statement of Need:
Under the revised bid process, CCC can better control shipping costs,
take advantage of efficiencies in load consolidation and ensure a more
competitive commodity procurement process. The ``two-step'' process was
designed at a time when donation commodities were shipped under ocean
carrier tariffs that could be readily identified. Despite the
irrelevance of published ocean tariffs and reliance on negotiated
shipping service contracts today, the current ``two-step'' procurement
process remains tied by regulation to the obsolete tariff system. 7 CFR
Part 1496.5 (b)(4) states as follows: ``Freight rates will be obtained
from published ocean tariffs to make cost comparisons between various
steamship companies and coastal ranges.''
Without the changes that are being made to 7 CFR Part 1496 under this
final rule, the Kansas City Commodity Office (KCCO) would be forced to
continue to operate the identified donation programs without reliable
rate information. The current collection process for non-binding rate
indications is exceedingly cumbersome and time-consuming. In addition,
the rate indications obtained are generally not representative of the
rates under which the procured products will be shipped. The ``two-
step'' process invites gaming and manipulation by participating ocean
carriers. These problems render the lowest-landed-cost criteria under
which the program operates nearly meaningless. Without the ability to
determine accurate freight rates, KCCO cannot effectively manage these
programs to maximize the quantity of food products donated under them.
Summary of Legal Basis:
15 U.S.C. 714b(h) provides that CCC may contract for the use, in
accordance with the usual customs of trade and commerce, of plants and
facilities for the physical handling, storage, processing, servicing,
and transportation of the agricultural commodities subject to its
control. The Commodity Credit Corporation may sell any commodity owned
or controlled by the Corporation at any price that the Secretary
determines will maximize returns to the Corporation, including
minimizing the handling and
[[Page 72741]]
transportation costs in making delivery of the commodity.
Alternatives:
CCC has the alternative of maintaining the current ``two-step'' process
used to procure and ship agricultural commodities.
Anticipated Cost and Benefits:
Program savings should result from the ability to better position
procured commodities at domestic ports based on actual shipping cost
comparisons. Program savings are also expected as a result of greater
head-to-head competition for program freight among U.S.-flagged
carriers. These savings should allow for additional food aid quantities
to move to donation countries. This rule will enhance bidding
opportunities for potential vendors while allowing CCC to more
efficiently acquire commodities.
Risks:
The magnitude of the savings or losses from lower expected freight
revenue will be driven by the behavior of carriers as they adjust to
the new process. Such costs are difficult to quantify given the
impossibility of predicting ocean carrier bidding behavior under the
``one-step'' system. Larger trends in program shipments and costs are
expected to continue when the ``one-step'' freight bidding process is
implemented. The existing trends reflect issues of port capacity and
facilities, shipping trade and vessel availability, and the more
general availability of container and inland freight equipment. The
opportunity to better consolidate loads should support the continuation
of these trends and, in doing so, lower freight costs for program
shipments.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 12/16/05 70 FR 74717
NPRM Comment Period End 01/17/06
NPRM Comment Period
Extended 01/23/06 71 FR 3442
Public Meeting 02/21/06
Second NPRM 04/07/06 71 FR 17767
Second NPRM Comment
Period End 05/08/06
Final Action 01/00/07
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Phillip Elder
Agricultural Economist
Department of Agriculture
Farm Service Agency
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 690-8104
Fax: 202 720-5233
Email: [email protected]
RIN: 0560-AH40
_______________________________________________________________________
USDA--Animal and Plant Health Inspection Service (APHIS)
-----------
PROPOSED RULE STAGE
-----------
2. ANIMAL WELFARE; REGULATIONS AND STANDARDS FOR BIRDS
Priority:
Other Significant
Legal Authority:
7 USC 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.
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:
To be determined.
Risks:
Not applicable.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 09/00/07
NPRM Comment Period End 11/00/07
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:
Jerry D. DePoyster
Senior Veterinary Medical Officer, Animal Care
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road, Unit 84
Riverdale, MD 20737-1234
Phone: 301 734-7586
RIN: 0579-AC02
_______________________________________________________________________
USDA--APHIS
3. IMPORTATION OF PLANTS FOR PLANTING; ESTABLISHING A NEW CATEGORY OF
PLANTS FOR PLANTING NOT AUTHORIZED FOR IMPORTATION PENDING RISK
ASSESSMENT (RULEMAKING RESULTING FROM A SECTION 610 REVIEW)
Priority:
Other Significant
[[Page 72742]]
Legal Authority:
7 USC 450; 7 USC 7701 to 7772; 7 USC 7781 to 7786; 21 USC 136 and 136a
CFR Citation:
7 CFR 319
Legal Deadline:
None
Abstract:
This action would establish a new category in the regulations governing
the importation of nursery stock, also known as plants for planting.
This category would list taxa of plants for planting whose importation
is not authorized pending risk assessment. In order to determine
whether to add a taxon of plants for planting to this category, we
would review scientific information other than a pest risk assessment;
the types of scientific information we would review would be listed in
the regulations. If scientific information other than a pest risk
assessment indicated that importation of the taxon of plants for
planting posed a potential risk, we would then publish an interim rule
adding the taxon to the proposed category and giving the public an
opportunity to comment on the change. We would allow foreign
governments to request that a pest risk assessment be conducted for a
taxon whose importation is not authorized pending risk evaluation.
After the pest risk assessment was completed, we would conduct
rulemaking to remove the taxon from the proposed category. We are also
proposing to expand the scope of the plants regulated in the plants for
planting regulations to include non-vascular plants. These changes
would allow us to react more quickly to evidence that a taxon of plants
for planting may pose a pest risk while ensuring that our actions are
based on scientific evidence.
Statement of Need:
APHIS typically relies on inspection at a Federal plant inspection
station or port of entry to mitigate the risks of pest introduction
associated with the importation of plants for planting. Importation of
plants for planting is further restricted or prohibited only if there
is specific evidence that such importation could introduce a quarantine
pest into the United States. Most of the taxa of plants for planting
currently being imported have not been thoroughly studied to determine
whether their importation presents a risk of introducing a quarantine
pest into the United States. The volume and the number of types of
plants for planting have increased dramatically in recent years, and
there are several problems associated with gathering data on what
plants for planting are being imported and on the risks such
importation presents. In addition, quarantine pests that enter the
United States via the importation of plants for planting pose a
particularly high risk of becoming established within the United
States. The current regulations need to be amended to better address
these risks.
Summary of Legal Basis:
The Secretary of Agriculture may prohibit or restrict the importation
or entry of any plant if the Secretary determines that the prohibition
or restriction is necessary to prevent the introduction into the United
States of a plant pest or noxious weed (7 U.S.C. 7712).
Alternatives:
APHIS has identified two alternatives to the approach we are
considering. The first is to maintain the status quo; this alternative
was rejected because, given our limited resources and the risks of pest
introduction posed by the rapid increase in the importation of plants
for planting, we do not believe that this approach would allow us to
address the potential risks posed by quarantine pests in a timely
manner. The second is to prohibit the importation of all nursery stock
pending risk evaluation, approval, and notice-and-comment rulemaking,
similar to APHIS's approach to regulating imported fruits and
vegetables; this approach was rejected because, in the absence of
additional resources for conducting risk evaluation and rulemaking,
this approach would lead to a major interruption in international trade
and would have significant economic effects on both U.S. importers and
U.S. consumers of plants for planting.
Anticipated Cost and Benefits:
In general, the costs associated with plant pests that are introduced
into the United States via imported nursery stock are expected to
increase in the absence of some action to revise the nursery stock
regulations to better address pest risks. Specific costs and benefits
will be determined.
Risks:
In the absence of some action to revise the nursery stock regulations
to allow us to better address pest risks, increased introductions of
plant pests via imported nursery stock are likely, causing extensive
damage to both agricultural and natural plant resources.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 02/00/07
NPRM Comment Period End 04/00/07
Regulatory Flexibility Analysis Required:
No
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:
Arnold T. Tschanz
Senior Import Specialist, Commodity Import Analysis & Operations, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road, Unit 141
Riverdale, MD 20737-1236
Phone: 301 734-5306
RIN: 0579-AC03
_______________________________________________________________________
USDA--APHIS
-----------
FINAL RULE STAGE
-----------
4. REVISION OF FRUITS AND VEGETABLES IMPORT REGULATIONS
Priority:
Other Significant
Legal Authority:
7 USC 450; 7 USC 7701 to 7772; 7 USC 7781 to 7786; 7 USC 8311; 21 USC
136 and 136a; 31 USC 9701
CFR Citation:
7 CFR 305; 7 CFR 319; 7 CFR 352
Legal Deadline:
None
Abstract:
This rule would revise and reorganize the regulations pertaining to the
importation of fruits and vegetables to consolidate requirements of
general applicability and eliminate redundant requirements, update
terms and remove outdated requirements and references, update the
regulations that apply to importations into territories under U.S.
[[Page 72743]]
administration, and make various editorial and nonsubstantive changes
to regulations to make them easier to use. The rule would also make
substantive changes to the regulations, including: (1) Establishing
criteria within the regulations that, if met, would allow us to approve
certain new fruits and vegetables for importation into the United
States and to acknowledge pest-free areas in foreign countries without
undertaking rulemaking; (2) doing away with the practice of listing
specific commodities that may be imported subject to certain types of
phytosanitary measures; and (3) providing for the issuance of special
use permits for fruits and vegetables. These changes are intended to
simplify and expedite our processes for approving certain new imports
and pest-free areas while continuing to allow for public participation
in the processes. If adopted, the rule would represent a significant
structural revision of the fruits and vegetables import regulations and
would establish a new process for approving certain new commodities for
importation into the United States. It would not, however, allow the
importation of any specific new fruits or vegetables, nor would it
alter the conditions for importing currently approved fruits or
vegetables except as specifically described in this document.
Statement of Need:
The volume of requests for new imports of fruits and vegetables has
risen sharply in recent years with expanding global trade. APHIS is
seeking an alternative process for certain new imports to expedite
their evaluation and, where applicable, their approval.
Summary of Legal Basis:
Under the Plant Protection Act of 2000, it is the responsibility of the
Secretary to facilitate . . . imports . . . in agricultural products
and other commodities that pose a risk of harboring plant pests or
noxious weeds in ways that will reduce, to the extent practicable, as
determined by the Secretary, the risk of dissemination of plant pests
or noxious weeds. This proposed rule, if adopted, would expedite the
process for approving certain new imports.
Alternatives:
One alternative to this proposed rule would be to simply continue under
APHIS' current process of authorizing the importation of fruits and
vegetables. In this case, we would continue to list all newly approved
fruits and vegetables in the regulations through notice-and-comment
rulemaking, as we have been doing since 1987. This approach is
unsatisfactory, because the number of requests we receive from foreign
exporters and domestic importers to amend the regulations has been
steadily increasing. Maintaining the current process will make it
difficult to keep pace with the volume of import requests. Therefore,
this alternative was rejected. We believe that the new approach would
enable us to be more responsive to the import requests of our trading
partners while maintaining the transparency of our decision-making
afforded by notice-and-comment rulemaking.
Prior to 1987, APHIS authorized the importation of a fruit or vegetable
by simply issuing a permit once the Agency was satisfied that the
relevant criteria in the regulations had been met. Another alternative
to this proposed rule would be to return to this method of authorizing
fruit and vegetable importations. This approach is unsatisfactory,
because it does not provide the opportunity for public analysis of and
comment on the science associated with such imports. Therefore, this
alternative was rejected. We believe that the new approach would enable
us to be more responsive to the import requests of our trading partners
while maintaining the transparency of our decisionmaking afforded by
notice-and-comment rulemaking.
Anticipated Cost and Benefits:
There would be no new costs associated with this rule. Benefits could
include more timely action on import requests, which could also lead to
reciprocal action by trading partners as they evaluate our export
requests.
Risks:
This action is administrative in nature and poses no direct specific
risks. If new import requests are evaluated using the system proposed
in this rule, each would be based on a unique risk analysis.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 04/27/06 71 FR 25010
NPRM Comment Period End 07/26/06
NPRM Comment Period
Reopened 08/01/06 71 FR 43385
NPRM Comment Period End 08/25/06
Final Rule 03/00/07
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:
Donna L. West
Senior Import Specialist, Commodity Import Analysis and Operations, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road, Unit 133
Riverdale, MD 20737-1231
Phone: 301 734-0627
RIN: 0579-AB80
_______________________________________________________________________
USDA--APHIS
5. PHYTOPHTHORA RAMORUM; QUARANTINE AND REGULATIONS
Priority:
Other Significant
Legal Authority:
7 USC 7701 to 7772; 7 USC 7781 to 7786; sec 301.75-15 also issued under
sec 204, title II, PL 106-113, 113 Stat 1501A-293; secs 301.75-15 and
301.75-16 also issued under sec 203, title II, PL 106-224, 114 Stat 400
(7 USC 1421 note)
CFR Citation:
7 CFR 301
Legal Deadline:
None
Abstract:
This action will amend the Phytophthora ramorum regulations to make the
regulations consistent with a Federal Order issued by APHIS in December
2004 that established restrictions on the interstate movement of
nursery stock from nurseries in nonquarantined counties in California,
Oregon, and Washington. This action will also update conditions for the
movement of regulated articles of nursery stock from quarantined areas,
as well as restrict the interstate movement of all other nursery stock
from nurseries in quarantined areas. We are also updating the list of
plants regulated because of P. ramorum and the list of areas that are
quarantined for P. ramorum and making other
[[Page 72744]]
miscellaneous revisions to the regulations. These actions are necessary
to prevent the spread of P. ramorum to noninfested areas of the United
States. We will continue to update the regulations through additional
rulemakings as new scientific information on this pathogen becomes
available.
Statement of Need:
Since 1995, oaks and tanoaks have been dying in the coastal counties of
California. Since then, other types of plants have been found to be
infected or associated with this disease, referred to as Sudden Oak
Death (SOD), ramorum leaf blight, ramorum dieback, or in Federal
regulations, as Phytophthora ramorum. P. ramorum was first seen in 1995
in Mill Valley (Marin County) on tanoak. Since that time, the disease
has been confirmed on various native hosts in 14 coastal California
counties (Marin, Santa Cruz, Sonoma, Napa, San Mateo, Monterey, Santa
Clara, Mendocino, Solano, Alameda, Contra Costa, Humboldt, Lake, and
San Francisco) and in Curry County, Oregon. The pathogen has been
confirmed to infect 39 host plant taxa, and there are over 30
additional taxa that are suspected to be hosts. In 2004, the pathogen
was detected in plants shipped interstate from nonquarantined areas in
California, Oregon, and Washington. Given the uncertainty associated
with the spread of the pathogen and its potential effects on eastern
oak forests, APHIS is taking action to define the extent of the
pathogen's distribution in the United States and limit its artificial
spread beyond infected areas through quarantine and a public education
program. Completing this action is integral to having a scientifically
sound quarantine as the foundation of our program.
Summary of Legal Basis:
The Plant Protection Act (7 U.S.C. 7701 to 7773) authorizes the
Secretary to prohibit or restrict the movement in interstate commerce
of any plant, plant product, or other article if the Secretary
determines that the prohibition or restriction is necessary to prevent
the dissemination of a plant pest within the United States.
Alternatives:
The two most significant alternatives APHIS considered were to (1)
eliminate the Federal quarantine for P. ramorum because of the
likelihood that the pathogen has already spread to other parts of the
United States via interstate trade in articles that may be infested,
and (2) quarantine the entire states of California, Oregon, and
Washington and prohibit the interstate movement of P. ramorum host
articles to protect against the interstate spread of the pathogen. We
rejected the first alternative because of insufficient evidence about
the presence of the pathogen in eastern U.S. nurseries or forests. The
lack of evidence of spread despite the significant amount of trade in
potentially infected material that has already occurred is the reason
we did not select the second alternative. Our preferred action balances
the need to protect eastern forests and nurseries with the goal of
imposing only those restrictions on trade that are necessary to prevent
the spread of the pathogen.
Anticipated Cost and Benefits:
The anticipated costs of this rulemaking mirror those of the Federal
Order of 2004. Specifically, nurseries in regulated and quarantined
areas will have to meet certain criteria prior to engaging in the
interstate trade of nursery stock. Depending on the location of the
nursery, the classification of nursery stock propagated within, and on
the classification of articles to be shipped, the nursery will have to
undergo annual inspection; and/or inspection, sampling, and testing of
individual shipments in order to receive certification for interstate
shipment. Currently, USDA covers the costs of annual inspection during
normal business hours; however, as with all government subsidized
programs, the budget allowable may differ from year to year. There are
other intangible costs of rulemaking, such as the potential for lost
revenue while holding plants during sampling and testing. Further,
there have been some negative stigma associated with nursery stock from
regulated areas of Oregon and Washington state as a result of the P.
ramorum rulemaking and restrictions on interstate movement, although it
is hard to quantify the effect of any perceived stigma.
Because knowledge of the P. ramorum pathogen and how it spreads is
still in its infancy, the benefits of proactively addressing the
situation in hopes of preventing widespread infestation far outweigh
any costs associated with the rulemaking. The total value of sales of
nursery stock reported in 2004 from operations with $100,000 or more in
sales in the United States was over $4.8 billion. California, Oregon,
and Washington alone account for about 25 percent of that total, with
sales of over $1.2 billion. With new hosts being consistently added to
the list, and our knowledge of the pathogen's pathways increasing, this
rulemaking is necessary, not only for protecting the nursery industry
in the Pacific northwest, but also for protecting the nursery industry
nationwide.
Risks:
This rulemaking addresses risks associated with the interstate movement
of articles that may spread P. ramorum to areas of the United States
where the disease is not known to exist.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 01/00/07
Interim Final Rule
Comment Period End 03/00/07
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Local, State
Additional Information:
Additional information about APHIS and its programs is available on the
Internet at http://www.aphis.usda.gov.
Agency Contact:
Jonathan Jones
National Phytophthora Ramorum Program Manager, Pest Detection and
Management Programs, PPQ
Department of Agriculture
Animal and Plant Health Inspection Service
4700 River Road, Unit 160
Riverdale, MD 20737
Phone: 301 734-8247
RIN: 0579-AB82
_______________________________________________________________________
USDA--Food and Nutrition Service (FNS)
-----------
PROPOSED RULE STAGE
-----------
6. SPECIAL NUTRITION PROGRAMS: FLUID MILK SUBSTITUTIONS
Priority:
Other Significant
Legal Authority:
PL 108-265, sec 102
CFR Citation:
7 CFR 210; 7 CFR 220
[[Page 72745]]
Legal Deadline:
None
Abstract:
Currently, by regulation, schools must make substitutions for fluid
milk for students with a disability when the request is authorized by a
licensed physician and may make substitutions for students with medical
or other dietary needs if requested by recognized medical authority.
These regulatory provisions were included in Public Law 108-265 which
amended the Richard B. Russell National School Lunch Act. Public Law
108-265 also amended the current law to allow schools to substitute
non-dairy beverages nutritionally equivalent (as established by the
Secretary) to fluid milk for medical or other special dietary needs at
the request of a parent/guardian. In response to Public Law 108-265,
the National School Lunch Program and School Breakfast Program
regulations will be revised to add these provisions. (04-016)
Statement of Need:
The changes made to the Richard B. Russell National School Lunch Act
concerning substitutions for fluid milk are intended to assist children
with an intolerance to or a cultural or other restriction concerning
the consumption of milk. This regulation allows schools to make
substitutions at the request of a parent or guardian, which assists
families that are unable to obtain a doctor's statement. However, the
Secretary must develop criteria to limit the substitutions for milk to
nutritionally equivalent beverages. The determination of nutritionally
equivalent beverages will require careful research and consultation.
Summary of Legal Basis:
These changes are being made in response to provisions in Public Law
108-265.
Alternatives:
USDA will be working with other Federal agencies to develop criteria
for nutritionally equivalent substitutes for fluid milk as well as
conducting research. USDA is issuing a proposed rule on this provision
in order to solicit public comments prior to any final decisionmaking.
Anticipated Cost and Benefits:
Schools may incur additional costs in obtaining and offering substitute
beverages. However, children who cannot consume milk will now have a
beverage nutritionally equivalent to milk.
Risks:
USDA must be diligent in making any determinations of nutritional
equivalency to milk.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 11/09/06 71 FR 65753
NPRM Comment Period End 01/08/07
Final Action 01/00/08
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
Local, State
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD58
_______________________________________________________________________
USDA--FNS
-----------
FINAL RULE STAGE
-----------
7. CHILD AND ADULT CARE FOOD PROGRAM: IMPROVING MANAGEMENT AND PROGRAM
INTEGRITY
Priority:
Other Significant
Legal Authority:
42 USC 1766; PL 103-448; PL 104-193; PL 105-336
CFR Citation:
7 CFR 226
Legal Deadline:
None
Abstract:
This rule amends the Child and Adult Care Food Program (CACFP)
regulations. The changes in this rule result from the findings of State
and Federal program reviews and from audits and investigations
conducted by the Office of Inspector General. This rule revises: State
agency criteria for approving and renewing institution applications;
program training and other operating requirements for child care
institutions and facilities; and State- and institution-level
monitoring requirements. This rule also includes changes that are
required by the Healthy Meals for Healthy Americans Act of 1994 (Pub.
L. 103-448), the Personal Responsibility and Work Opportunities
Reconciliation Act of 1996 (Pub. L. 104-193), and the William F.
Goodling Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336).
The changes are designed to improve program operations and monitoring
at the State and institution levels and, where possible, to streamline
and simplify program requirements for State agencies and institutions.
(95-024)
Statement of Need:
In recent years, State and Federal program reviews have found numerous
cases of mismanagement, abuse, and in some instances, fraud by child
care institutions and facilities in the CACFP. These reviews revealed
weaknesses in management controls over program operations and examples
of regulatory noncompliance by institutions, including failure to pay
facilities or failure to pay them in a timely manner; improper use of
program funds for non-program expenditures; and improper meal
reimbursements due to incorrect meal counts or to miscategorized or
incomplete income eligibility statements. In addition, audits and
investigations conducted by the Office of Inspector General (OIG) have
raised serious concerns regarding the adequacy of financial and
administrative controls in CACFP. Based on its findings, OIG
recommended changes to CACFP review requirements and management
controls.
Summary of Legal Basis:
Some of the changes proposed in the rule are discretionary changes
being made in response to deficiencies found in program reviews and OIG
audits. Other changes codify statutory changes made by the Healthy
Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal
Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub.
L. 104-193), and the William F. Goodling Child Nutrition
Reauthorization Act of 1998 (Pub. L. 105-336).
[[Page 72746]]
Alternatives:
In developing the proposal, the Agency considered various alternatives
to minimize burden on State agencies and institutions while ensuring
effective program operation. Key areas in which alternatives were
considered include State agency reviews of institutions and sponsoring
organization oversight of day care homes.
Anticipated Cost and Benefits:
This rule contains changes designed to improve management and financial
integrity in the CACFP. When implemented, these changes would affect
all entities in CACFP, from USDA to participating children and
children's households. These changes will primarily affect the
procedures used by State agencies in reviewing applications submitted
by, and monitoring the performance of, institutions which are
participating or wish to participate in the CACFP. Those changes which
would affect institutions and facilities will not, in the aggregate,
have a significant economic impact.
Data on CACFP integrity is limited, despite numerous OIG reports on
individual institutions and facilities that have been deficient in
CACFP management. While program reviews and OIG reports clearly
illustrate that there are weaknesses in parts of the program
regulations and that there have been weaknesses in oversight, neither
program reviews, OIG reports, nor any other data sources illustrate the
prevalence and magnitude of CACFP fraud and abuse. This lack of
information precludes USDA from estimating the amount of money lost due
to fraud and abuse or the reduction in fraud and abuse the changes in
this rule will realize.
Risks:
Continuing to operate the CACFP under existing provisions of the
regulations that do not sufficiently protect against fraud and abuse in
CACFP puts the program at significant risk. This rule includes changes
designed to strengthen current program regulations to reduce the risk
associated with the program.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 09/12/00 65 FR 55103
NPRM Comment Period End 12/11/00
Interim Final Rule 09/01/04 69 FR 53502
Interim Final Rule
Effective 10/01/04
Interim Final Rule
Comment Period End 09/01/05
Final Action 09/00/07
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.
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AC24
_______________________________________________________________________
USDA--FNS
8. FSP: ELIGIBILITY AND CERTIFICATION PROVISIONS OF THE FARM SECURITY
AND RURAL INVESTMENT ACT OF 2002
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 107-171, secs 4101 to 4109, 4114, 4115, and 4401
CFR Citation:
7 CFR 273
Legal Deadline:
None
Abstract:
This rulemaking will amend Food Stamp Program regulations to implement
11 provisions of the Farm Security and Rural Investment Act of 2002
that establish new eligibility and certification requirements for the
receipt of food stamps. (02-007)
Statement of Need:
The rule is needed to implement the food stamp certification and
eligibility provisions of Public Law 107-171, the Farm Security and
Rural Investment Act of 2002.
Summary of Legal Basis:
The legal basis for this rule is Public Law 107-171, the Farm Security
and Rural Investment Act of 2002.
Alternatives:
This final rule deals with changes required by Public Law 107-171, the
Farm Security and Rural Investment Act of 2002. The Department has
limited discretion in implementing provisions of that law. Most of the
provisions in this rule were effective October 1, 2002, and must be
implemented by State agencies prior to publication of this rule.
Anticipated Cost and Benefits:
The provisions of this rule simplify State administration of the Food
Stamp Program, increase eligibility for the program among certain
groups, increase access to the program among low-income families and
individuals, and increase benefit levels. The provisions of Public Law
107-171 implemented by this rule have a 5-year cost of approximately
$1.9 billion.
Risks:
The FSP provides nutrition assistance to millions of Americans
nationwide--working families, eligible non-citizens, and elderly and
disabled individuals. Many low-income families don't earn enough money
and many elderly and disabled individuals don't receive enough in
retirement or disability benefits to meet all of their expenses and
purchase healthy and nutritious meals. The FSP serves a vital role in
helping these families and individuals achieve and maintain self-
sufficiency and purchase a nutritious diet. This rule implements the
certification and eligibility provisions of Public Law 107-171, the
Farm Security and Rural Investment Act of 2002. It simplifies State
administration of the Food Stamp Program, increases eligibility for the
program among certain groups, increases access to the program among
low-income families and individuals, and increases benefit levels. The
provisions of this rule increase benefits by approximately $1.95
billion over 5 years. When fully effective in FY 2006, the provisions
of this rule will add approximately 415,000 new participants.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 04/16/04 69 FR 20724
[[Page 72747]]
NPRM Comment Period End 06/15/04
Final Action 12/00/06
Final Action Effective 02/00/07
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal, Local, State, Tribal
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD30
_______________________________________________________________________
USDA--FNS
9. QUALITY CONTROL PROVISIONS OF TITLE IV OF PUBLIC LAW 107-171
Priority:
Other Significant
Legal Authority:
7 USC 2011 to 2032; PL 107-171
CFR Citation:
7 CFR 273; 7 CFR 275
Legal Deadline:
None
Abstract:
This rule finalizes the Interim rule ``Non-Discretionary Quality
Control Provisions of Title IV of Public Law 107-171'' (published
October 16, 2003 at 68 FR 59519) and the Proposed rule ``Discretionary
Quality Control Provisions of Title IV of Public Law 107-171''
(published September 23, 2005 at 70 FR 55776).
The following quality control (QC) provisions required by Sections 4118
and 4119 of the Farm Security and Rural Investment Act of 2002 (Title
IV of Public Law 107-171) and contained in the Interim rule are
implemented by this final rule:
1) Timeframes for completing quality control reviews;
2) Timeframes for completing the arbitration process;
3) Timeframes for determining final error rates;
4) The threshold for potential sanctions and time period for sanctions;
5) The calculation of State error rates;
6) The formula for determining States' liability amounts;
7) Sanction notification and method of payment; and
8) Corrective action plans.
The following provisions required by Sections 4118 and 4119 and
additional policy and technical changes, and contained in the Proposed
rule, are implemented by this final rule:
Legislative changes based on or required by Sections 4118 and 4119
1) Eliminate enhanced funding;
2) Establish timeframes for completing individual quality control
reviews; and
3) Establish procedures for adjusting liability determinations
following appeal decisions.
Policy and technical changes
1) Require State agency QC reviewers to attempt to complete review when
a household refuses to cooperate;
2) Mandate FNS validation of negative sample for purposes of high
performance bonuses;
3) Revise procedures for conducting negative case reviews;
4) Revise time frames for household penalties for refusal to cooperate
with State and Federal QC reviews;
5) Revise procedures for QC reviews of demonstration and SSA processed
cases;
6) Eliminate requirement to report variances resulting from Federal
information exchange systems (FIX) errors;
7) Eliminate references to integrated QC; and
8) Update definitions section to remove out-dated definitions. (02-014)
Statement of Need:
The rule is needed to implement the food stamp quality control
provisions of Public Law 107-171, the Farm Security and Rural
Investment Act of 2002.
Summary of Legal Basis:
The legal basis for this rule is Public Law 107-171, the Farm Security
and Rural Investment Act of 2002.
Alternatives:
This rule deals with changes required by Public Law 107-171, the Farm
Security and Rural Investment Act of 2002. The Department has no
discretion in implementing the time frames for completing quality
control reviews, the arbitration process, and determining the final
error rates; the threshold for potential sanctions and the time period
for the sanctions; the calculation for State error rates; the formula
for determining liability amounts; the sanction notification; method of
payment for liabilities; corrective action planning, and the
elimination of enhanced funding. These provisions were effective for
the fiscal year 2003 quality control review period and must have been
implemented by FNS and State agencies during fiscal year 2003. This
rule also deals in part with discretionary changes to the quality
control system resulting from Public Law 107-171. The provision
addressing results of appeals is required to be regulated by Public Law
107-171. The remaining changes amend existing regulations and are
required to make technical changes resulting from these changes or to
update policy consistent with current requirements.
Anticipated Cost and Benefits:
The provisions of this rule are not anticipated to have any impact on
benefit levels or administrative costs.
Risks:
The FSP provides nutrition assistance to millions of Americans
nationwide. The quality control system measures the accuracy of States
providing food stamp benefits to the program recipients. This rule is
intended to implement the quality control provisions of Public Law 107-
701, the Farm Security and Rural Investment Act of 2002. It will
significantly revise the system for determining State agency
liabilities and sanctions for high payment error rates.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 10/16/03 68 FR 59519
Interim Final Rule
Effective 12/15/03
Interim Final Rule
Comment Period End 01/14/04
Final Action 01/00/07
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal, Local, State
[[Page 72748]]
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
Related RIN: Merged with 0584-AD37
RIN: 0584-AD31
_______________________________________________________________________
USDA--FNS
10. DIRECT CERTIFICATION OF CHILDREN IN FOOD STAMP HOUSEHOLDS AND
CERTIFICATION OF HOMELESS, MIGRANT AND RUNAWAY CHILDREN FOR FREE MEALS
IN THE NSLP, SBP, AND SMP
Priority:
Other Significant
Legal Authority:
PL 108-265, sec 104
CFR Citation:
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, will be 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 sec. 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 food stamps 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:
FNS will be working closely with State agencies to implement the
changes made by this regulation and will be developing extensive
guidance materials in conjunction with our cooperators.
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, food stamp offices, and
other agencies.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 02/00/07
Interim Final Rule
Comment Period End 02/00/08
Final Action 02/00/09
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Governmental Jurisdictions
Government Levels Affected:
Local, State
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
Related RIN: Merged with 0584-AD62
RIN: 0584-AD60
_______________________________________________________________________
USDA--FNS
11. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND
CHILDREN (WIC): WIC VENDOR COST CONTAINMENT
Priority:
Other Significant
Legal Authority:
42 USC 1786
CFR Citation:
7 CFR 246
Legal Deadline:
Final, Statutory, December 2005.
Abstract:
This final rule amends the WIC regulations to strengthen vendor cost
containment. The rule incorporates into program regulations new
legislative requirements that affect the selection, authorization, and
reimbursement of retail vendors. These requirements are contained in
the Child Nutrition and WIC Reauthorization Act of 2004 (Pub. L. 108-
265), which was enacted on June 30, 2004. The rule reflects the
statutory provisions that require WIC State agencies to implement a
vendor peer group system, competitive price selection criteria, and
allowable reimbursement levels in a manner that ensures that the WIC
Program pays authorized vendors competitive prices for supplemental
foods. It also requires State agencies to ensure that vendors that
derive more than 50 percent of their annual food sales revenue from WIC
food instruments do not result in higher food costs to the program than
do other vendors. The intent of these provisions is to maximize the
number of women, infants, and children served with available Federal
funding. (04-029)
Statement of Need:
This action is needed to implement the vendor cost containment
provisions of the Child Nutrition and WIC Reauthorization Act of 2004,
Public Law 108-265. The rule requires WIC State agencies to operate
vendor management systems that effectively contain food costs by
ensuring that prices paid for supplemental foods are competitive. The
rule also responds to data which indicate that WIC food expenditures
increasingly include payments to a type of vendor whose prices are not
governed by the market forces that affect most retail grocers. As a
result, the prices charged by these vendors tend to be higher than
those of other retail grocery stores participating in the program. To
ensure
[[Page 72749]]
that the program pays competitive prices, this rule codifies the new
statutory requirements for State agencies to use in evaluating vendor
applicants' prices during the vendor selection process and when paying
vendors for supplemental foods following authorization.
Summary of Legal Basis:
Section 203 of Public Law 108-265, Child Nutrition and WIC
Reauthorization Act of 2004.
Alternatives:
This rule implements the vendor peer group provisions of the Child
Nutrition and WIC Reauthorization Act of 2004, which FNS believes is an
effective means of controlling WIC food costs. While this Act mandates
that States establish peer groups, competitive price criteria, and
allowable reimbursement levels, and states that these requirements must
result in the outcome of paying above-50-percent vendors no more than
regular vendors, the rule does not specify particular criteria for peer
groups or acceptable methods of setting competitive price criteria and
allowable reimbursement levels. FNS considered mandating specific means
of developing peer groups, competitive price criteria, and allowable
reimbursement levels in order to ensure that the outcome of this
legislation was achieved.
However, given States' responsibility to manage WIC as a discretionary
grant program and the varying market conditions in each State, FNS
believes that States need flexibility to develop their own peer groups,
competitive price criteria, and allowable reimbursement levels. At the
October 2004 meeting the FNS convened to gain input for this rule,
States indicated that they needed the ability to design cost
containment practices that would be effective in their own markets and
would ensure participant access. In addition, there is little
information about the effectiveness of particular cost containment
practices in the variety of markets represented by the 89 WIC State
agencies. Mandating more specific means of developing peer groups,
competitive price criteria, and allowable reimbursement levels could
have unintended negative consequences for participant access, food
costs and administrative burden.
As States gain experience and the results of their vendor cost
containment practices become apparent, FNS may develop further
regulations and guidance to improve vendor cost containment. In the
interim, FNS believes that the current rule will substantially
accomplish the goal of the Act of containing food costs and ensuring
that above-50-percent vendors do not result in higher costs to the WIC
Program than regular vendors.
Anticipated Cost and Benefits:
Costs: This rule places new requirements on State agencies; therefore,
the cost implications of this rule relate primarily to administrative
burden for WIC State agencies. These cost implications are partially
dependent on the current practices of State agencies relative to the
requirements of the rule. Detailed information regarding the cost
implications of this rule is contained in the Regulatory Impact
Analysis developed by FNS to accompany this rulemaking.
Benefits: The WIC Program will benefit from the provisions of this rule
by reducing unnecessary food expenditures, thus increasing the
potential to serve more eligible women, infants, and children for the
same cost. This rule should have the effect of ensuring that payments
to vendors, particularly vendors that derive more than 50 percent of
their annual food sales revenue from WIC food instruments, reflect
competitive prices for WIC foods. The Regulatory Impact Analysis
prepared by FNS to accompany this rulemaking projects an estimated
monthly cost savings of over $6.25 million. (Details of this projection
can be found in the complete Regulatory Impact Analysis.)
Risks:
Because the vendor peer group provisions in the Child Nutrition and WIC
Reauthorization Act of 2004 and this rule provide for some flexibility
in implementation, and because there is a wide degree of variation in
food prices and current vendor cost containment practices across State
agencies, the impact of many of the provisions of this rule is
uncertain. Uncertainties include the administrative burden State
agencies will incur and the savings that can be realized nationally or
in any State agency. The major uncertainties for both administrative
burden and program savings are discussed in greater detail in the
Regulatory Impact Analysis.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 11/29/05 70 FR 71708
Interim Final Rule
Comment Period End 11/29/06
Interim Final Rule
Effective 12/29/05
Final Action 08/00/07
Final Action Effective 09/00/07
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
Federal, Local, State, Tribal
URL For More Information:
www.fns.usda.gov/wic
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD71
_______________________________________________________________________
USDA--FNS
12. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS AND
CHILDREN (WIC): REVISIONS IN THE WIC FOOD PACKAGES
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
42 USC 1786
CFR Citation:
7 CFR part 246
Legal Deadline:
Final, Statutory, November 2006, CN and WIC Reauthorization Act of 2004
requires issuance of final rule within 18 months of release of IOM
Report.
Abstract:
This proposed rule would revise regulations governing the WIC food
packages to change age specifications for assignment to infant feeding
packages; establish infant formula feeding or breastfeeding categories
for infants; revise the maximum monthly
[[Page 72750]]
allowances and minimum requirements for certain WIC foods; revise the
substitution rates for certain WIC foods and allow additional foods as
alternatives; add fruits and vegetables for WIC participants 6 months
of age and older and eliminate juice from infants' food packages; add
whole grains to food packages for children and women and baby food meat
for fully breastfed infants 6 through 11 months of age; revise the
purpose, content, and requirements for Food Package III; and address
general provisions that apply to all food packages. The revisions
reflect recommendations made by the Institute of Medicine in its
report, WIC Food Packages: Time for a Change, and certain other
administrative revisions deemed necessary by the Department. These
revisions would bring the WIC food packages in line with the 2005
Dietary Guidelines for Americans and current infant feeding practice
guidelines, better promote and support the establishment of successful
long-term breastfeeding, provide WIC participants with a wider variety
of food, provide WIC State agencies with greater flexibility in
prescribing food packages to accommodate participants with cultural
food preferences, and serve all participants with certain medical
provisions under one food package to facilitate efficient management of
medically fragile participants. (05-006)
Statement of Need:
The revisions proposed in this rulemaking reflect recommendations made
by the Institute of Medicine (IOM) in its report, WIC Food Packages:
Time for a Change, and certain administrative revisions deemed
necessary by the Department. The Child Nutrition and WIC
Reauthorization Act of 2004, enacted on June 30, 2004, requires the
Department to issue a final rule within 18 months (November 2006) of
receiving the IOM's report.
Summary of Legal Basis:
The Child Nutrition and WIC Reauthorization Act of 2004, enacted on
June 30, 2004, requires the Department to issue a final rule within 18
months of receiving the Institute of Medicine's report on revisions to
the WIC food packages. This report was published and released to the
public on April 27, 2005.
Alternatives:
FNS is in the process of developing a regulatory impact analysis that
will address a variety of alternatives that are considered in the
proposed rulemaking.
Anticipated Cost and Benefits:
The IOM was charged by FNS to develop recommendations that were cost-
neutral. The regulatory impact analysis will provide a more detailed
summary of specific costs/benefits associated with the proposed
revisions to the WIC Food Packages.
Risks:
The proposed rule has a 90-day comment period, during which interested
parties may submit comments on any and all provisions contained in the
rulemaking. Once the comment period has expired, all comments received
will be carefully considered in the development of the final rule.
Opportunities for training on and discussion of the revised WIC food
packages will be offered to State agencies and other entities as
necessary.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 08/07/06 71 FR 44784
NPRM Comment Period End 11/06/06
Interim Final Rule 09/00/07
Interim Final Rule
Effective 10/00/07
Interim Final Rule
Comment Period End 10/00/09
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
Local, State, Tribal
URL For More Information:
www.fns.usda.gov/wic
URL For Public Comments:
www.fns.usda.gov/wic
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 918
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: [email protected]
RIN: 0584-AD77
_______________________________________________________________________
USDA--Food Safety and Inspection Service (FSIS)
-----------
PROPOSED RULE STAGE
-----------
13. EGG PRODUCTS INSPECTION REGULATIONS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
Undetermined
Legal Authority:
21 USC 1031 to 1056
CFR Citation:
9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR
590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR 591; . . .
Legal Deadline:
None
Abstract:
The Food Safety and Inspection Service (FSIS) is proposing to require
egg products plants and establishments that pasteurize shell eggs to
develop and implement Hazard Analysis and Critical Control Points
(HACCP) systems and Sanitation Standard Operating Procedures (SOPs).
FSIS also is proposing pathogen reduction performance standards that
would be applicable to egg products and pasteurized shell eggs. FSIS is
proposing to amend the Federal egg products inspection regulations by
removing current requirements for prior approval by FSIS of egg
products plant drawings, specifications, and equipment prior to their
use in official plants. The Agency also plans to eliminate the prior
label approval system for egg products. This proposal will not
encompass shell egg packers. In the near future, FSIS will initiate
non-regulatory outreach efforts for shell egg packers that will provide
information intended to help them to safely process shell eggs intended
for human consumption or further processing.
The actions being proposed are part of FSIS' regulatory reform effort
to improve FSIS' egg products food safety regulations, better define
the roles of Government and the regulated industry, encourage
innovations that will improve food safety, remove unnecessary
regulatory burdens on inspected egg products plants, and
[[Page 72751]]
make the egg products regulations as consistent as possible with the
Agency's meat and poultry products regulations. FSIS is also taking
these actions in light of changing inspection priorities and findings
of Salmonella in pasteurized egg products.
Statement of Need:
The actions being proposed are part of FSIS' regulatory reform effort
to improve FSIS' shell egg and egg products food safety regulations,
better define the roles of Government and the regulated industry,
encourage innovations that will improve food safety, remove unnecessary
regulatory burdens on inspected egg products plants, and make the egg
products regulations as consistent as possible with the Agency's meat
and poultry products regulations. FSIS also is taking these actions in
light of changing inspection priorities and recent findings of
Salmonella in pasteurized egg products.
This proposal is directly related to FSIS' PR/HACCP initiative.
Summary of Legal Basis:
This proposed rule is authorized under the Egg Products Inspection Act
(21 U.S.C. 1031 to 1056). It is not the result of any specific mandate
by the Congress or a Federal court.
Alternatives:
A team of FSIS economists and food technologists is conducting a cost-
benefit analysis to evaluate the potential economic impacts of several
alternatives on the public, egg products industry, and FSIS. These
alternatives include: (1) Taking no regulatory action; (2) requiring
all inspected egg products plants to develop, adopt, and implement
written sanitation SOPs and HACCP plans; and (3) converting to a
lethality-based pathogen reduction performance standard many of the
current highly prescriptive egg products processing requirements. The
team will consider the effects of a uniform, across-the-board standard
for all egg products; a performance standard based on the relative risk
of different classes of egg products; and a performance standard based
on the relative risks to public health of different production
processes.
Anticipated Cost and Benefits:
FSIS is analyzing the potential costs of this proposed rulemaking to
industry, FSIS and other Federal agencies, State and local governments,
small entities, and foreign countries. The expected costs to industry
will depend on a number of factors. These costs include the required
lethality, or level of pathogen reduction, and the cost of HACCP plan
and sanitation SOP development, implementation, and associated employee
training. The pathogen reduction costs will depend on the amount of
reduction sought and on the classes of product, product formulations,
or processes.
Relative enforcement costs to FSIS and Food and Drug Administration may
change because the two agencies share responsibility for inspection and
oversight of the egg industry and a common farm-to-table approach for
shell egg and egg products food safety. Other Federal agencies and
local governments are not likely to be affected.
FSIS has cooperative agreements with four States and the Commonwealth
of Puerto Rico under which they provide inspection services to egg
processing plants under Federal jurisdiction. FSIS reimburses the
States for staffing costs and expenses for full-time State inspectors.
HACCP implementation may result in a reduction of staffing resource
requirements in the States and a corresponding reduction of the Federal
reimbursement. As a result, some States may decide to stop providing
inspection services and convert to Federal inspection of egg products
plants.
Egg and egg product inspection systems of foreign countries wishing to
export eggs and egg products to the U.S. must be equivalent to the U.S.
system. FSIS will consult with these countries, as needed, if and when
this proposal becomes effective.
This proposal is not likely to have a significant impact on small
entities. The entities that would be directly affected by this proposal
would be the approximately 75 federally inspected egg products plants,
most of which are small businesses, according to Small Business
Administration criteria. If necessary, FSIS will develop compliance
guides to assist these small firms in implementing the proposed
requirements.
Potential benefits associated with this rulemaking include:
Improvements in human health due to pathogen reduction; improved
utilization of FSIS inspection program resources; and cost savings
resulting from the flexibility of egg products plants in achieving a
lethality-based pathogen reduction performance standard. Once specific
alternatives are identified, economic analysis will identify the
quantitative and qualitative benefits associated with each alternative.
Human health benefits from this rulemaking are likely to be small
because of the low level of (chiefly post-processing) contamination of
pasteurized egg products. In light of recent scientific studies that
raise questions about the efficacy of current regulations, however, it
is likely that measurable reductions will be achieved in the risk of
foodborne illness.
Risks:
FSIS believes that this regulatory action may result in a further
reduction in the risks associated with egg products. The development of
a lethality-based pathogen reduction performance standard for egg
products, replacing command-and-control regulations, will remove
unnecessary regulatory obstacles to, and provide incentives for,
innovation to improve the safety of egg products.
To assess the potential risk-reduction impacts of this rulemaking on
the public, an intra-Agency group of scientific and technical experts
is conducting a risk management analysis. The group has been charged
with identifying the lethality requirement sufficient to ensure the
safety of egg products and the alternative methods for implementing the
requirement. FSIS has developed new risk assessments for SE in eggs and
for Salmonella spp. in liquid egg products to evaluate the risk
associated with the regulatory alternatives.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 09/00/07
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
Federal, State
Federalism:
Undetermined
[[Page 72752]]
Agency Contact:
Victoria Levine
Program Analyst, Regulations and Petitions Policy Staff
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-AC58
_______________________________________________________________________
USDA--FSIS
-----------
FINAL RULE STAGE
-----------
14. 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 USC 801.
Legal Authority:
21 USC 451 et seq; 21 USC 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
standards will include and be consistent with standards already in
place for certain ready-to-eat meat and poultry products.
Statement of Need:
The Food Safety and Inspection Service (FSIS) has proposed to amend the
Federal meat and poultry inspection regulations by establishing food
safety performance standards for all ready-to-eat and all partially
heat-treated meat and poultry products. The proposed performance
standards set forth both levels of pathogen reduction and limits on
pathogen growth that official meat and poultry establishments must
achieve during their operations in order to produce unadulterated
products but allow the use of customized, plant-specific processing
procedures. The proposed performance standards apply to ready-to-eat
meat and poultry products, categorized as follows: Dried products
(e.g., beef or poultry jerky); salt-cured products (e.g., country ham);
fermented products (e.g., salami and Lebanon bologna); cooked and
otherwise processed products (e.g., beef and chicken burritos, corned
beef, pastrami, poultry rolls, and turkey franks); and thermally
processed, commercially sterile products (e.g., canned spaghetti with
meat balls and canned corned beef hash).
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 will 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.
The proposal also contained provisions addressing Listeria
monocytogenes in RTE products. An Interim Final Rule on this subject
was published June 6, 2003 (68 FR 34208).
FSIS also has proposed to eliminate its regulations that require that
both ready-to-eat and not-ready-to-eat pork and products containing
pork be treated to destroy trichinae (Trichinella spiralis). These
requirements are inconsistent with HACCP, and some will be unnecessary
if FSIS makes final the proposed performance standards for ready-to-eat
meat and poultry products.
Summary of Legal Basis:
Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695) and the
Poultry Product Inspection Act (21 U.S.C. 451 to 470), FSIS issues
regulations governing the production of meat and poultry products
prepared for distribution in commerce. The regulations, along with FSIS
inspection programs, are designed to ensure that meat and poultry
products are safe, not adulterated, and properly marked, labeled, and
packaged.
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.
The main provisions of the proposed rule are: Lethality performance
standards for Salmonella and E. coli 0157: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:
None.
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 End 09/10/01
Interim Final Rule 06/06/03 68 FR 34208
Interim Final Rule
Effective 10/06/03
[[Page 72753]]
Interim Final Rule
Comment Period End 01/31/05
NPRM Comment Period
Reopened 03/24/05 70 FR 15017
NPRM Comment Period End 05/09/05
Affirmation of Interim
Final Rule 02/00/07
Final Action 06/00/07
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program, and Employee
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
15. NUTRITION LABELING OF SINGLE-INGREDIENT PRODUCTS AND GROUND OR
CHOPPED MEAT AND POULTRY PRODUCTS
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
21 USC 601 et seq; 21 USC 451 et seq
CFR Citation:
9 CFR 317; 9 CFR 381
Legal Deadline:
None
Abstract:
FSIS has proposed to amend the Federal meat and poultry products
inspection regulations to require nutrition labeling for the major cuts
of single-ingredient, raw meat and poultry products, either on their
label or at their point-of-purchase, unless an exemption applies. FSIS
also proposed to require nutrition information on the label of ground
or chopped meat and poultry products, unless an exemption applies. The
requirements for ground or chopped products will be consistent with
those for multi-ingredient products.
FSIS also proposed to amend the nutrition labeling regulations to
provide that when a ground or chopped product does not meet the
regulatory criteria to be labeled ``low fat,'' a lean percentage claim
may be included on the label or in labeling, as long as a statement of
the fat percentage also is displayed on the label or in labeling.
Statement of Need:
The Agency will require that nutrition information be provided for the
major cuts of single-ingredient, raw meat and poultry products, either
on their label or at their point-of-purchase, because during the most
recent surveys of retailers, the Agency did not find significant
participation in the voluntary nutrition labeling program for single-
ingredient, raw meat and poultry products. Without nutrition
information, FSIS has concluded that the major cuts of single-
ingredient, raw meat and poultry products would be misbranded.
Because consumers cannot easily estimate the level of fat in ground or
chopped meat and poultry products and because producers are able to
formulate precisely the fat content of ground or chopped products, FSIS
has concluded that ground or chopped meat and poultry products that do
not bear nutrition information on their labels would also be
misbranded.
Finally, FSIS will amend the nutrition labeling regulations to provide
that when a ground or chopped product does not meet the criteria to be
labeled ``low fat,'' a lean percentage claim may be included on the
product, as long as a statement of the fat percentage is also displayed
on the label or in labeling. FSIS will include these provisions in the
final nutrition labeling regulations because many consumers have become
accustomed to this labeling on ground beef products and because this
labeling provides a quick, simple, accurate means of comparing all
ground or chopped meat and poultry products.
Summary of Legal Basis:
This action is authorized under the Federal Meat Inspection Act (21
U.S.C. 601 to 695) and the Poultry Products Inspection Act (21 U.S.C.
451 to 470).
Alternatives:
No action; nutrition labels required on all single-ingredient, raw
products (major cuts and non-major cuts) and all ground or chopped
products; nutrition labels required on all major cuts of single-
ingredient, raw products (but not non-major cuts) and all ground or
chopped products; nutrition information at the point-of-purchase
required for all single-ingredient, raw products (major and non-major
cuts) and for all ground or chopped products.
Anticipated Cost and Benefits:
Costs will include the equipment for making labels, labor, and
materials used for labels for ground or chopped products. The cost of
providing nutrition labeling for the major cuts of single-ingredient,
raw meat and poultry products should not be significant, because retail
establishments would have the option of providing nutrition information
through point-of-purchase materials.
Benefits of the nutrition labeling rule would result from consumers
modifying their diets in response to new nutrition information
concerning ground or chopped products and the major cuts of single-
ingredient, raw products. Reductions in consumption of fat and
cholesterol are associated with reduced incidence of cancer and
coronary heart disease.
FSIS has concluded that the quantitative benefits will exceed the
quantitative costs of the rule.
Risks:
None.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 01/18/01 66 FR 4970
NPRM Comment Period End 04/18/01
Extension of Comment
Period 04/20/01 66 FR 20213
NPRM Comment Period End 07/17/01
Final Action 12/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
[[Page 72754]]
Agency Contact:
Robert Post Ph.D.
Director, Labeling and Consumer Protection Staff
Department of Agriculture
Food Safety and Inspection Service
1400 Independence Avenue SW
Washington, DC 20250
Phone: 202 205-0279
Email: [email protected]
RIN: 0583-AC60
_______________________________________________________________________
USDA--FSIS
16. PROHIBITION OF THE USE OF SPECIFIED RISK MATERIALS FOR HUMAN FOOD
AND REQUIREMENTS FOR THE DISPOSITION OF NON-AMBULATORY DISABLED CATTLE
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
21 USC 601 et seq
CFR Citation:
Not Yet Determined
Legal Deadline:
None
Abstract:
On January 12, 2004, the Food Safety and Inspection Service (FSIS)
issued an interim final rule to amend the Federal meat inspection
regulations to designate the brain, skull, eyes, trigeminal ganglia,
spinal cord, vertebral column (excluding the vertebrae of the tail, the
transverse processes of the thoracic and lumbar vertebrae, and the
wings of the sacrum), and dorsal root ganglia (DRG) of cattle 30 months
of age and older, and the tonsils and distal ileum of the small
intestine of all cattle, as ``specified risk materials'' (SRMs). The
Agency declared that SRMs are inedible and prohibited their use for
human food. In addition, as a result of the interim final rule, FSIS
now requires that all non-ambulatory disabled cattle presented for
slaughter be condemned. The Agency also requires that federally
inspected establishments that slaughter cattle and federally inspected
establishments that process the carcasses or parts of cattle develop,
implement, and maintain written procedures for the removal,
segregation, and disposition of SRMs. Establishments must incorporate
these procedures into their HACCP plans or in their Sanitation SOPs or
other prerequisite program. FSIS took this action in response to the
diagnosis on December 23, 2003, by the U.S. Department of Agriculture
of a positive case of bovine spongiform encephalopathy (BSE) in an
adult Holstein cow in the State of Washington. This action is intended
to minimize human exposure to materials that scientific studies have
demonstrated as containing the BSE agent in cattle infected with the
disease. Infectivity has never been demonstrated in the muscle tissue
of cattle experimentally or naturally infected with BSE at any stage of
the disease.
Statement of Need:
FSIS issued an interim final rule to amend the meat inspection
regulations to add provisions to prevent meat and meat products that
may contain the BSE agent from entering commerce.
BSE is a chronic, degenerative, neurological disorder of cattle.
Worldwide, there have been more than 185,000 cases since the disease
was first diagnosed in 1986 in Great Britain. Recent laboratory and
epidemiological research indicate that there is a causal association
between BSE and variant Creutzfeldt-Jakob Disease (vCJD), a slow
degenerative disease that affects the central nervous system of humans.
Both BSE and vCJD are always fatal.
USDA policy in regard to BSE has been to be proactive and preventive.
The regulations: (1) Prohibit certain materials that have been shown to
contain the BSE agent in BSE-infected cattle to be used for human food
or in the production of human food; (2) prescribe handling, storage,
and transportation requirements for such materials; (3) prohibit
slaughter procedures that may cause potentially infective tissues to
migrate to edible tissues; (4) prescribe requirements for the
slaughtering and processing of cattle whose materials are most likely
to contain the BSE agent if the animal is infected with BSE; and (5)
prescribe requirements for the sanitation or disposal of plant
equipment that may be contaminated with the BSE agent.
Summary of Legal Basis:
Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695), FSIS
issues regulations governing the production of meat and meat food
products. The regulations, along with FSIS inspection programs, are
designed to ensure that meat food products are safe, not adulterated,
and properly marked, labeled, and packaged.
Alternatives:
As an alternative to the interim final rule, FSIS considered taking no
action. FSIS rejected this option because, as previously mentioned,
USDA policy in regard to BSE has been to be proactive and preventive.
Anticipated Cost and Benefits:
This interim final rule could result in costs to the regulated
industry. FSIS expects to minimize the costs by targeting the
regulations to apply to those cattle whose materials are most likely to
contain the BSE agent if the animal is infected with BSE. Banning
certain materials, such as brain and spinal cord, for use as human food
may require additional staff and time to remove such materials.
Materials prohibited for use as human food could not be sold
domestically or exported. Companies may be required to find new ways to
handle and dispose of these materials, which would impose additional
costs. Prohibiting the use of bovine vertebral column as a source
material in AMRS could result in a decrease in product yield and may
require companies that use these systems to produce boneless beef and
beef products to find other uses for bovine vertebral column.
Establishments whose equipment may have been contaminated with the BSE
agent may have costs associated with sanitation or disposal of plant
equipment.
FSIS may incur costs to increase inspection and compliance activities
to ensure that the measures taken to prevent meat and meat food
products that may contain the BSE agent from entering commerce are
effective. Producers may receive lower prices from processors, and some
of their stock may be condemned outright. The price consumers pay for
meat may rise or fall depending on how the discovery of BSE in the U.S.
affects consumer demand for beef.
The main benefit of this proposed rule is the prevention of vCJD in the
United States. There have been over 100 definite and probable cases of
vCJD detected worldwide since the disease was first identified in 1986
in the United Kingdom. While vCJD is still considered a rare condition,
the extent or occurrence of a vCJD epidemic in the United Kingdom
cannot be determined because of the long incubation period (up to 25
years). Thus, the interim final rule could have widespread public
health benefits if it serves to prevent a vCJD epidemic from developing
in the U.S. Even if vCJD
[[Page 72755]]
remains a rare condition, this proposed rule will still have public
health benefits because of the severity of the symptoms associated with
vCJD and the fact that vCJD is always fatal.
This interim final rule may benefit the meat industry by helping to
restore confidence in the domestic meat supply. This may limit losses
to meat slaughter and processing operations in the long run.
Risks:
Although vCJD is a rare condition, the symptoms are severe, and it is
always fatal. This interim final rule is intended to reduce the risk of
humans developing vCJD in the U.S. in the event BSE is detected in
native cattle. The measures implemented by FSIS are intended to
minimize human exposure to materials from cattle that could potentially
contain the BSE agent. In April 1998, USDA entered into a cooperative
agreement with Harvard University's School of Public Health to conduct
a risk analysis to assess the potential pathways for entry into U.S.
cattle and the U.S. food supply, to evaluate existing regulations and
policies, and to identify any additional measures that could be taken
to protect human and animal health. FSIS used the findings of the risk
assessment to inform its decision to prohibit certain bovine materials
for human food.
Unlike bacterial and viral pathogens that may be found in or on meat
food products, the BSE agent cannot be destroyed by conventional
methods, such as cooking or irradiation. Also, although it is rare,
vCJD, the human disease associated with exposure to the BSE agent, is
generally more severe than the human illnesses associated with exposure
to bacterial and viral pathogens. Thus, additional measures to reduce
the risk of human exposure to the BSE agent are necessary to protect
public health.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 01/12/04 69 FR 1862
Interim Final Rule
Comment Period End 05/07/04
Interim Final Rule
Amendment 07/07/05 70 FR 53043
Interim Final Rule
Amendment Comment
Period End 10/07/05
Final Action 12/00/06
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program, and Employee
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-AC88
_______________________________________________________________________
USDA--FSIS
17. MEAT PRODUCED BY ADVANCED MEAT/BONE SEPARATION MACHINERY AND MEAT
RECOVERY SYSTEMS
Priority:
Other Significant
Legal Authority:
21 USC 601 to 695
CFR Citation:
9 CFR 301.2; 9 CFR 318.24 (Revision); 9 CFR 320.1
Legal Deadline:
None
Abstract:
On January 12, 2004, the Food Safety and Inspection Service (FSIS)
issued an interim final rule to amend the Federal meat inspection
regulations. The rule is designed, in part, to prevent human exposure
to the Bovine Spongiform Encephalopathy (BSE) agent by ensuring that
Advanced Meat/Bone Separation Machinery and Meat Recovery (AMR) systems
are not a means of introducing central nervous system (CNS)-type tissue
into product labeled as ``meat.'' Meat may be derived by mechanically
separating skeletal muscle tissue from the bones of livestock, other
than skulls or vertebral column bones of cattle 30 months of age and
older, using advances in mechanical meat/bone separation machinery;
i.e., AMR systems. The recovered meat product may not incorporate any
brain, trigeminal ganglia, spinal cord, or dorsal root ganglia tissues.
In addition, there must be no more than a non-significant incorporation
of bone solids or bone marrow as measured by the presence of calcium
and iron in excess of the requirements in the interim final rule. This
rule also requires that federally inspected establishments that process
cattle develop, implement, and maintain written procedures for the
removal, segregation, and disposition of specified risk materials
(SRMs), including non-complying products from beef AMR systems. These
procedures are required to be incorporated into an establishment's
HACCP plan, Sanitation Standard Operation Procedures, or other
prerequisite program. FSIS took this action in response to the
diagnosis on December 23, 2003, by the Department of Agriculture of a
positive case of BSE in an adult Holstein cow in the State of
Washington.
Statement of Need:
FSIS issued an interim final rule in part to prevent human exposure to
the BSE agent by ensuring that AMR systems are not a means of
introducing CNS-type tissue into product labeled as ``meat.'' In
addition to the measures related to BSE, FSIS is finalizing
restrictions related to bone solids and bone marrow for livestock
products. This rule sets out the criteria that FSIS will use to ensure
that AMR products can be represented as ``meat'' and, therefore, are
not adulterated or misbranded. Finally, the Agency is requiring that
federally inspected establishments that process the carcasses or parts
of cattle develop, implement, and maintain written procedures for the
removal, segregation, and disposition of specified risk materials
(SRMs), including noncomplying product from AMR systems processing
beef. A 2002 FSIS survey of establishments harvesting AMR product
derived from beef vertebrae or beef vertebrae mixed with other types of
beef bones indicated that 35 percent of the final AMRs product samples
tested positive for spinal cord or dorsal root ganglia.
Summary of Legal Basis:
This action is authorized under the Federal Meat Inspection Act (21
U.S.C. 601 to 695).
Alternatives:
No action.
Anticipated Cost and Benefits:
The interim final rule was determined to be not economically
significant, but significant. The benefit of enforcing the misbranding
provisions will ensure that the product does not contain materials
[[Page 72756]]
not consistent with boneless, comminuted meat.
Risks:
None
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 01/12/04 69 FR 1874
Interim Final Rule
Comment Period End 05/07/04
Final Action 09/00/07
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program, and Employee
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]
Related RIN: Duplicate of 0583-AC51
RIN: 0583-AD00
_______________________________________________________________________
USDA--FSIS
18. PROHIBITION ON THE USE OF AIR-INJECTION STUNNERS FOR THE SLAUGHTER
OF CATTLE
Priority:
Other Significant
Legal Authority:
Federal Meat Inspection Act, 21 USC 601(m), 621
CFR Citation:
9 CFR 313
Legal Deadline:
None
Abstract:
The Food Safety and Inspection Service (FSIS) is amending the Federal
meat inspection regulations to prohibit the use of penetrative captive
bolt stunning devices that deliberately inject air into the cranial
cavity of cattle. This rulemaking responds to the findings of a risk
assessment on bovine spongiform encephalopathy (BSE) conducted by the
Harvard Center for Risk Analysis (referred to as the Harvard study) and
is part of a series of actions that the USDA is taking to strengthen
its BSE prevention programs.
Statement of Need:
FSIS is taking this action to address the potential risk posed by
stunning devices that may force visible pieces of central nervous
system (CNS) tissue, known as macro-emboli, into the circulatory system
of stunned cattle. In cattle in the end stages of bovine spongiform
encephalopathy (BSE), CNS tissue contains the highest levels of the BSE
agent. Thus, because CNS macro-emboli can potentially become lodged in
edible tissues, this action is necessary to prevent potential human
exposure to the BSE agent.
Summary of Legal Basis:
FSIS' authority to prohibit the use of captive bolt stunning devices
that inject air into the cranium of cattle derives from the Federal
Meat Inspection Act (21 U.S.C. 601(m), 621).
Alternatives:
FSIS considered the alternative of establishing a performance standard
that stunning equipment would be required to meet to be used on cattle,
and the alternative of no rulemaking. Under the performance standard
option, the Agency would have developed a CNS tissue emboli performance
standard that stunners would be required to meet to be permitted to be
used on cattle. The benefits of this option are that it is more
consistent with FSIS regulatory policy than banning a specific
technology, and that it would prevent all methods of stunning that do
not comply with the performance standard from being used on cattle, not
just air-injection stunning. Thus, this option would prevent the need
to regulate individual pieces of equipment.
A potential problem with this option is that there are relatively few
studies on stunning methods and CNS tissue emboli. Thus, the Agency was
concerned that if it were to establish a CNS tissue emboli performance
standard for cattle stunning devices at this time, further studies
could reveal that the performance standard selected does not achieve
the result intended by the Agency. Therefore, FSIS decided to prohibit
the use of the stunning method that all available studies do conclude
result in CNS tissue macro-emboli, i.e., stunning that uses air-
injection.
FSIS rejected the option of no rulemaking because the Agency determined
that it does not address the potential risk of human exposure to the
BSE agent presented by air-injection stunning.
Anticipated Cost and Benefits:
There are likely no anticipated costs associated with this rule because
FSIS is not aware of any establishments that use air-injection stunning
on cattle. However, although the U.S. beef slaughter industry no longer
uses air-injection stunning devices, FSIS is taking this action to
prohibit any future use of these devices, to help facilitate exports of
U.S. products, and to ensure the safety of imported beef products into
the United States.
Risks:
None
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 01/12/04 69 FR 1885
Interim Final Rule
Comment Period End 05/07/04
Final Action 12/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Agency Contact:
Dr. Daniel L. Engeljohn
Deputy Assistant Administrator, Office of Policy, Program, and Employee
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-AD03
_______________________________________________________________________
USDA--FSIS
19. AVAILABILITY OF LISTS OF RETAIL CONSIGNEES DURING MEAT OR POULTRY
PRODUCT RECALLS
Priority:
Other Significant
Legal Authority:
5 USC 301, 552
[[Page 72757]]
CFR Citation:
9 CFR 390
Legal Deadline:
None
Abstract:
The Food Safety and Inspection Service (FSIS) has proposed to amend the
federal meat and poultry products inspection regulations to provide
that the Agency will make available to the public lists of the retail
consignees of meat and poultry products that have been voluntarily
recalled by a federally inspected meat or poultry products
establishment. FSIS has proposed this action because it believes that
making this information available will be of significant value to
consumers and the industry. It will clarify what products should be
removed from commerce and from consumers' possession because there is
reason to believe they are adulterated or misbranded.
Statement of Need:
The objective to be accomplished by this regulatory action is to
provide important information to consumers while ensuring the
appropriate flexibility for FSIS to protect proprietary information.
While FSIS does not have mandatory recall authority under the Federal
Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) or the Poultry
Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.), the Agency, to
protect the public health, does ask establishments to voluntarily
recall adulterated or misbranded meat and poultry products. FSIS
verifies that such recalls are conducted expeditiously and effectively.
In 2002, FSIS promulgated regulations defining the circumstances and
criteria under which it would share customer lists with States and
other Federal agencies in connection with voluntary meat and poultry
product recalls. In short, FSIS will disclose product distribution
lists that have been obtained during voluntary recalls to States and
other Federal government agencies to verify the removal of the recalled
product, provided that the State or Federal agency has provided: (1) A
written statement establishing its authority to protect confidential
distribution lists from public disclosure; and (2) a written commitment
not to disclose any information provided by FSIS without the written
permission of the submitter of the information or written confirmation
by FSIS that the information no longer has confidential status.
Currently, FSIS will not disclose distribution lists to the general
public or to States or other Federal government agencies that have not
provided to FSIS the written statement and commitment required by the
Agency's Freedom of Information and public information regulations.
Consumer activists and States have increasingly demanded the public
release of information on where recalled meat and poultry products have
been shipped. The States have requested this information be provided
without the limitations imposed by FSIS's regulations. Consumer groups
have claimed that the public needs this information to fully protect
itself. In response to these requests, FSIS is proposing to make
available to the public the names of likely retail consignees of
recalled meat and poultry products.
Summary of Legal Basis:
This proposed rule is authorized under 5 U.S.C. 301, Departmental
regulations, and 5 U.S.C. 552, Public information; agency rules,
opinions, orders, records, and proceedings. It is not the result of any
specific mandate by the Congress or a Federal court.
Alternatives:
FSIS has prepared a regulatory impact analysis to evaluate the
potential economic impacts of several alternatives on the public, the
meat and poultry industry, and FSIS. These alternatives include: (1)
Including local health departments as entities that could receive
recall distribution lists; (2) making available to the general public
recall distribution lists only in response to a Freedom of Information
request; and (3) making lists available to State agencies with
agreements with FSIS under 9 CFR 390.9.
Anticipated Cost and Benefits:
FSIS is analyzing the potential costs of this proposed rulemaking.
This proposed rule would provide information to consumers about meat
and poultry products sold at retail establishments that are believed to
be adulterated or misbranded and are therefore subject to being
recalled. The consumption of such products may cause food borne illness
and other adverse health consequences, including death. Providing
information of this sort that is more accessible and likely to be used
by the consumer will reduce the likelihood of food borne illnesses and
related consequences.
Risks:
FSIS believes that this regulatory action may result in a further
reduction in the risks associated with the consumption of meat and
poultry products.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 03/07/06 71 FR 11326
NPRM Comment Period End 06/11/06 71 FR 27211
Final Action 05/00/07
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Undetermined
Agency Contact:
Mr. Philip Derfler
Assistant Administrator, Office of Policy, Program, and Employee
Development
Department of Agriculture
Food Safety and Inspection Service
Room 350, Jamie L. Whitten Building
1400 Independence Avenue SW
Washington, DC 20250-3700
Phone: 202 720-2709
Fax: 202 720-2025
Email: [email protected]
RIN: 0583-AD10
_______________________________________________________________________
USDA--Forest Service (FS)
-----------
PROPOSED RULE STAGE
-----------
20. [bull] FOREST SERVICE NATIONAL ENVIRONMENTAL POLICY ACT PROCEDURES
Priority:
Other Significant
Legal Authority:
40 CFR 1507.3
CFR Citation:
36 CFR 220
Legal Deadline:
None
Abstract:
The Forest Service is proposing to move existing agency NEPA procedures
required by 40 CFR 1507.3 from Forest Service Handbook 1909.15 to the
CFR, add new procedures, and edit some existing procedures. Presently,
Forest Service procedures are combined with
[[Page 72758]]
agency guidance in FSH 1909.15 along with quotations from the Council
on Environmental Quality regulations. Having agency NEPA procedures in
regulations, separate from guidance, will make it easier for the Forest
Service to provide guidance through the agency directive system. Agency
internal processes will continue to reside in FSH 1909.15 with
references to both CEQ and Forest Service NEPA procedures.
Statement of Need:
The Forest Service is proposing to move existing agency NEPA
procedures, required by the Council on Environmental Quality (CEQ) and
codified at 40 CFR 1507.3, from the internal Forest Service
Environmental Policy and Procedures Handbook (FSH) 1909.15 to the Code
of Federal Regulations. New procedures would be added and existing
procedures would be revised where clarity is needed to incorporate CEQ
guidance and align agency NEPA procedures with agency decision
processes.
Presently, the Forest Service NEPA procedures are combined with agency
guidance in FSH 1909.15 along with quotations from the CEQ regulations.
This handbook contains general guidance such as how to select an
interdisciplinary team, thereby associating guidance with NEPA
procedures. Guidance and quotes from the CEQ regulations are important
to internal agency work, but bear little similarity to the agency
procedures contemplated in the CEQ regulations (40 CFR 1507.3(b)).
Changes to agency guidance in FSH 1909.15 currently involve
consultation with CEQ because the handbook does not differentiate
between NEPA guidance and ``procedures.'' This makes it more difficult
to update simple guidance.
Summary of Legal Basis:
The Council on Environmental Quality (CEQ) regulations (40 CFR 1507.3)
direct Federal agencies to develop NEPA procedures to supplement the
CEQ regulations. The CEQ regulations require agencies to provide for
public notice and comment and CEQ consultation when developing and
revising agency NEPA procedures.
Alternatives:
A possible alternative would be to have the CEQ revise its regulations
or seek legislative changes.
Anticipated Cost and Benefits:
Codifying agency NEPA procedures in regulation, separate from guidance,
would make it easier for the Forest Service to provide guidance through
the agency directive system. General guidance and internal processes
would reside in the FSH 1909.15 handbook with references to both CEQ
and Forest Service NEPA procedures set out in the CFR. This will make
future revisions to internal agency guidance more responsive to new
ideas and information. Having the agency NEPA procedures at the same
level as the CEQ regulations would also give them equal status in
court.
New procedures and revisions to existing procedures would further
define how the agency must comply with NEPA where the CEQ regulations
lack clarity, when additional CEQ guidance has been issued, or when
there are more efficient or applicable procedures appropriate to agency
decision making. With more flexibility in how NEPA documents are
prepared, the NEPA process is expected to be more efficient and
responsive to decision maker needs.
Risks:
More NEPA procedural requirements could be added which would add to the
present processes. Also, given that some of the proposed procedures
would allow more flexibility and options to comply with NEPA, the
results could be a more complex set of regulations for the field to
understand.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 12/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Andria D. Weeks
Regulatory Analyst
Department of Agriculture
Forest Service
ATTN: ORMS, D&R Branch
1400 Independence Avenue SW
Washington, DC 20250-0003
Phone: 202 205-3610
Fax: 202 260-6539
Email: [email protected]
RIN: 0596-AC49
_______________________________________________________________________
USDA--FS
-----------
FINAL RULE STAGE
-----------
21. NATIONAL FOREST SYSTEM LAND MANAGEMENT PLANNING CATEGORICAL
EXCLUSION (FINAL DIRECTIVE, FOREST SERVICE HANDBOOK 1909.15, CHAPTER
30)
Priority:
Other Significant
Legal Authority:
16 USC et seq; 5 USC 301
CFR Citation:
36 CFR 219, subpart A
Legal Deadline:
None
Abstract:
The Forest Service requested comment on a proposed revision to its
procedures for implementing the National Environmental Policy Act
(NEPA) and Council on Environmental Quality (CEQ) regulations. This
revision is being proposed at Forest Service Handbook 1909.15, chapter
30, which describes categorical exclusions, that is, categories of
actions that will not result in significant impacts on the human
environment and which are therefore exempt from requirements to prepare
further NEPA documentation absent extraordinary circumstances. The
proposal would add one such category of actions to the agency's NEPA
procedures for final approvals on proposals to develop, amend, or
revise land management plans that are comprised of five components,
which are desired conditions, objectives, guidelines, suitability of
areas, and special areas for a forest. This proposal was published in
conjunction with the final Forest Service planning regulations
published January 5, 2005.
Statement of Need:
On January 5, 2005, the Forest Service published a final rule in the
Federal Register (70 FR 1023) revising Title 36, Code of Federal
Regulations, Part 219, Subpart A, ``National Forest System Land
Management Planning.'' This final rule substantially changed the type
of decisions made in land management plans. These plans developed under
this regulation are aspirational, and do not result in significant
impacts on the human environment. Accordingly, existing agency NEPA
procedures need to be updated to allow the use of a
[[Page 72759]]
categorical exclusion when a land management plan is not making
decisions that will result in significant impacts on the human
environment and where no extraordinary circumstances exist that would
prohibit the use of the categorical exclusion.
Summary of Legal Basis:
The National Forest Management Act (NFMA) is the legal basis for
National Forest System Land Management Planning. It requires
``specifying procedures to insure that land management plans are
prepared in accordance with the National Environmental Policy Act
[NEPA] of 1969, including, but not limited to, direction on when and
for what plans an environmental impact statement required under section
102(2)(C) of that Act shall be prepared.'' Notice of the proposed
categorical exclusion and request for comment was published January 5,
2005 (70 FR 1062).
Alternatives:
The agency would continue using environmental impact statements or
environmental assessments for the development, amendment, or revision
of land management plans.
Anticipated Cost and Benefits:
A cost-benefit analysis was conducted to compare the costs and benefits
of implementing the final National Forest System Land Management
Planning regulation to the baseline, 1982 planning rule. This analysis
is posted at the Forest Service web site address (www.fs.fed.us/emc/
nfma/index2.html), along with other documents associated with the final
rule. A basic assumption of the cost-benefit analysis is that the
planning rule would be carried out using the planning categorical
exclusion.
Based on costs that can be quantified, implementation of the final rule
is expected to have an estimated annual average cost savings of $4.6
million when compared to the 1982 planning rule, and an estimated
annual average savings of $36.9 million when compared to estimates of
implementation of the 2000 planning rule. The final rule is expected to
be less costly than the 2000 planning rule; some of those saved costs
are expected to be shifted to monitoring and evaluation.
The appropriate use of a categorical exclusion to meet NEPA
requirements will be a substantial savings over the cost of an
environmental impact statement or environmental assessment.
Risks:
The directive will help strengthen the Forest Service's ability to
respond quickly and effectively to a variety of changing issues, such
as new scientific information, new listing of species, the effects of
wildfire, and unforeseen plan implementation activities. It will help
reduce the risk of a land management plan being outdated.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 12/06/02 67 FR 72770
NPRM Comment Period End 03/24/03
Final Rule 01/05/05 70 FR 1023
Proposed Directive 01/05/05 70 FR 1062
Comment Period End 03/07/05
Final Action 12/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Andria D. Weeks
Regulatory Analyst
Department of Agriculture
Forest Service
ATTN: ORMS, D&R Branch
1400 Independence Avenue SW
Washington, DC 20250-0003
Phone: 202 205-3610
Fax: 202 260-6539
Email: [email protected]
RIN: 0596-AB86
_______________________________________________________________________
USDA--FS
22. [bull] NATIONAL FOREST SYSTEM LAND MANAGEMENT PLANNING DIRECTIVE
(FINAL DIRECTIVE, FOREST SERVICE HANDBOOK 1909.12, CHAPTER 70-
WILDERNESS EVALUATION)
Priority:
Other Significant
Legal Authority:
36 CFR 219
CFR Citation:
None
Legal Deadline:
None
Abstract:
On March 23, 2005, the Forest Service published 12 interim directives
(70 FR 14637) to Forest Service Manual 1330 (New Management Strategies;
1900 (Planning; 1920 (Land and Resource Management Planning; and
1909.12 (Land and Resource Management Planning Handbook). These
directives provide the detailed direction to agency employees necessary
to implement the provisions of the final land and resource management
planning rule, which was published on January 5, 2005 (70 FR 1023). On
January 31, 2006 (71 FR 5124), all the chapters were finalized except
for FSH 1909.12, chapter 70-Wilderness Evaluation. Once finalized, this
chapter will provide guidance for the identification, inventory,
evaluation, and recommendation of areas within National Forest System
lands that satisfy the definition of wilderness found in section 2(c)
of the 1964 Wilderness Act.
Statement of Need:
On January 5, 2005, the Forest Service published a final rule in the
Federal Register (70 FR 1023) revising Title 36, Code of Federal
Regulations, Part 219, Subpart A, ``National Forest System Land
Management Planning.'' To meet the new requirements, this directive
updates guidance for the identification, inventory, evaluation, and
recommendation of areas within National Forest System lands that
satisfy the definition of wilderness found in section 2(c) of the 1964
Wilderness Act.
Summary of Legal Basis:
The Wilderness Act of 1964 requires identification of potential
wilderness areas. The National Forest Management Act of 1976 requires
``specifying guidelines for land management plans developed to achieve
the goals of the Program which -- (A) insure consideration of the
economic and environmental aspects of various systems of renewable
resource management, including the related systems of silviculture and
protection of forest resources, to provide for outdoor recreation
(including wilderness), range, timber, watershed, wildlife, and
fish;....''
The National Forest System Land Management Planning regulation requires
the development of planning directives to set forth the legal
authorities, objectives, policy, responsibilities, direction, and
overall guidance needed by Forest Service line officers, agency
employees, and others to use the rule. Notice of issuance of the
interim directive for Chapter 70 -- Wilderness Evaluation and a request
for
[[Page 72760]]
comment was published March 23, 2005 (70 FR 14637) along with 11 other
interim directives.
Alternatives:
As an alternative to publishing the final directive, the agency will
use the interim directive until it expires on September 23, 2006. The
interim directive could be extended for an additional 18 months beyond
September 23, 2006. If the interim directive is not issued in final,
before expiration, the agency would operate under the previous outdated
directive.
Anticipated Cost and Benefits:
A cost-benefit analysis was conducted to compare the costs and benefits
of implementing the final National Forest System Land Management
Planning regulation to the baseline, 1982 planning rule. This analysis
is posted on the Forest Service web site address (www.fs.fed.us/emc/
nfma/index2.html), along with other documents associated with the final
rule. A basic assumption of the cost-benefit analysis is that the
planning rule would be carried out using updated directives.
Based on costs that can be quantified, implementation of the final rule
is expected to have an estimated annual average cost savings of $4.6
million when compared to the 1982 planning rule, and an estimated
annual average savings of $36.9 million when compared to estimates of
implementation of the 2000 planning rule. The final rule is expected to
be less costly than the 2000 planning rule; some of those saved costs
are expected to be shifted to monitoring and evaluation.
Risks:
The interim directive expires on March 7, 2008. If it is not finalized,
the directive will not be coordinated with conceptual and terminology
changes made in the other 11 planning directives for implementation of
the 2005 National Forest System Land Management Planning regulation.
This lack of coordination would cause public and employee confusion,
delaying the agency's ability to respond quickly and effectively to
land management plan revision, changing issues, or unforeseen plan
implementation activities.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Directive 03/23/05 70 FR 14637
Comment Period End 06/21/05
Final Action 12/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Andria D. Weeks
Regulatory Analyst
Department of Agriculture
Forest Service
ATTN: ORMS, D&R Branch
1400 Independence Avenue SW
Washington, DC 20250-0003
Phone: 202 205-3610
Fax: 202 260-6539
Email: [email protected]
Related RIN: Related to 0596-AC02
RIN: 0596-AC57
BILLING CODE 3410-90-S
[[Page 72761]]
DEPARTMENT OF COMMERCE (DOC)
Statement of Regulatory and Deregulatory Priorities
Enhancing long-term economic growth is a central focus of the
President's policies and priorities. The mission of the Department of
Commerce is to promote job creation, economic growth, technological
competitiveness, sustainable development, and improved living standards
for all Americans by working in partnership with businesses,
universities, communities, and workers to:
Build for the future and promote U.S. economic competitiveness
in the global marketplace by strengthening and safeguarding
the Nation's economic infrastructure;
Keep America competitive with cutting-edge science and
technology and an unrivaled information base; and
Provide effective management and stewardship of our nation's
resources and assets to ensure sustainable economic
opportunities.
The DOC mission statement, containing our three strategic themes,
provides the vehicle for understanding the Department's aims, how they
interlock, and how they are to be implemented through our programs.
This statement was developed with the intent that it serve as both a
statement of departmental philosophy and as the guiding force behind
the Department's programs.
The importance that this mission statement and these strategic themes
have for the Nation is amplified by the vision they pursue for
America's communities, businesses, and families. Commerce is the
smallest Cabinet agency, yet our presence is felt, and our
contributions are found, in every State.
The DOC touches Americans, daily, in many ways--we make possible the
weather reports that all of us hear every morning; we facilitate the
technology that all of us use in the workplace and in the home each
day; we support the development, gathering, and transmitting of
information essential to competitive business; we make possible the
diversity of companies and goods found in America's (and the world's)
marketplace; and we support environmental and economic health for the
communities in which Americans live.
The DOC has a clear and powerful vision for itself, for its role in the
Federal Government, and for its roles supporting the American people,
now and in the future. We confront the intersection of trade promotion,
civilian technology, economic development, sustainable development, and
economic analysis, and we want to provide leadership in these areas for
the Nation.
We work to provide programs and services that serve our country's
businesses, communities, and families, as initiated and supported by
the President and the Congress. We are dedicated to making these
programs and services as effective as possible, while ensuring that
they are being delivered in the most cost-effective ways. We seek to
function in close concert with other agencies having complementary
responsibilities so that our collective impact can be most powerful. We
seek to meet the needs of our customers quickly and efficiently, with
programs, information, and services they require and deserve.
As a permanent part of the Federal Government, but serving an
Administration and Congress that can vary with election results, we
seek to serve the unchanging needs of the Nation, according to the
priorities of the President and the Congress. The President's
priorities for the Department range from issues concerning the economy
to the environment. For example, the President directs the Department
to promote electronic commerce activities; encourage open and free
trade; represent American business interests abroad; and assist small
businesses to expand and create jobs. We are able to address these
priorities effectively by functioning in accordance with the
legislation that undergirds our programs and by working closely with
the President and the committees in Congress, which have programmatic
and financial oversight for our programs.
The DOC also promotes and expedites American exports, helps nurture
business contacts abroad, protects U.S. firms from unfair foreign
competition, and makes how-to-export information accessible to small
and mid-sized companies throughout the Nation, thereby ensuring that
U.S. market opportunities span the globe.
The DOC encourages development in every community, clearing the way for
private-sector growth by building and rebuilding economically deprived
and distressed communities. We promote minority entrepreneurship to
establish businesses that frequently anchor neighborhoods and create
new job opportunities. We work with the private sector to enhance
competitive assets.
As the Nation looks to revitalize its industries and communities, the
DOC works as a partner with private entities to build America with an
eye on the future. Through technology, research and development, and
innovation, we are making sure America continues to prosper in the
short-term, while also helping industries prepare for long-term
success.
The DOC's considerable information capacities help businesses
understand clearly where our national and world economies are going and
take advantage of that knowledge by planning the road ahead. Armed with
the Department's economic and demographic statistics, businesses can
undertake the new ventures, investments, and expansions that make our
economy grow.
The DOC has instituted programs and policies that lead to cutting-edge,
competitive, and better paying jobs. We work every day to boost
exports, to deregulate business, to help smaller manufacturers battle
foreign competition, to advance the technologies critical to our future
prosperity, to invest in our communities, and to fuse economic and
environmental goals.
The DOC is American business' surest ally in job creation, serving as a
vital resource base, a tireless advocate, and its Cabinet-level voice.
The Regulatory Plan directly tracks these policy and program
priorities, only a few 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) and the
National Telecommunications and Information Administration (NTIA) plan
actions that are considered the ``most important'' significant
preregulatory or regulatory action for this Regulatory Plan year.
During the next year, NOAA plans to complete one action entitled
``Endangered Fish and Wildlife; Implement Speed Restrictions to Reduce
the Threat of Ship Collisions with North Atlantic Right Whales,'' and
NTIA plans to complete one action entitled ``Implement and Administer a
Coupon Program for Digital-to-Analog Converter Boxes. '' Further
information on these actions are provided below.
Though not principally a regulatory agency, the DOC has long been a
leader
[[Page 72762]]
in advocating and using market-oriented regulatory approaches in lieu
of traditional command-and-control regulations when such approaches
offer a better alternative. All regulations are designed and
implemented to maximize societal benefits while placing the smallest
possible burden on those being regulated.
The DOC is also refocusing on its regulatory mission by taking into
account, among other things, the President's regulatory principles. To
the extent permitted by law, all preregulatory and regulatory
activities and decisions adhere to the Administration's statement of
regulatory philosophy and principles, as set forth in section 1 of
Executive Order 12866. Moreover, we have made bold and dramatic
changes, never being satisfied with the status quo. We have emphasized,
initiated, and expanded programs that work in partnership with the
American people to secure the Nation's economic future. At the same
time we have downsized, cut regulations, closed offices, and eliminated
programs and jobs that are not part of our core mission. The bottom
line is that, after much thought and debate, we have made many hard
choices needed to make this Department ``state of the art.''
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
The 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 services vital to public safety and
to the Nation 's economy, such as weather 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 saving fisheries
and confronting short-term economic dislocation, while boosting long-
term economic growth. The Department is where business and
environmental interests 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
Services (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 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 Nation's 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 Administration is committed to an environmental strategy that
promotes sustainable economic development and rejects the false choice
between environmental goals and economic growth. The intent is to have
the Government's economic decisions guided by a comprehensive
understanding of the environment. 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 and other societal decisions can
be made.
In the environmental stewardship area, NOAA's goals include: rebuilding
U.S. fisheries by refocusing policies and fishery management planning
on increased scientific information; increasing the populations of
depleted, threatened, or endangered species of 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:
modernizing 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 Act Rulemakings
Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-
Stevens Act) rulemakings concern the conservation and management of
fishery resources in the U.S. 3-to-200-mile Exclusive Economic Zone
(EEZ). Among the several hundred rulemakings that NOAA plans to issue
in the Regulatory Plan year, 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. Once a rulemaking is triggered by an FMC, the Magnuson-Stevens
Act places stringent deadlines upon NMFS by which it must exercise its
rulemaking responsibilities.
While most of these rulemakings will be minor, involving only the
opening or closing of a fishery under an existing FMP, one action is of
particular significance and has been designated as one of the most
important regulatory actions undertaken by the Department. This rule is
entitled ``Endangered Fish and Wildlife; Implement Speed Restrictions
to Reduce the Threat of Ship Collisions with North Atlantic Right
Whales.'' In this rulemaking, NOAA plans to implement a strategy to
[[Page 72763]]
reduce the known mortalities to North Atlantic right whales as a result
of collisions with vessels, which account for more confirmed right
whale deaths than any other human-related activity. The strategy
addresses the lack of recovery of the endangered North Atlantic right
whale by reducing the likelihood and threat of ship strike mortalities
to the species. NOAA has developed a framework of proposed, new
operational measures for the shipping industry as an element of this
strategy, including consideration of routing and speed restrictions.
These operational measures would be limited to areas and times when
North Atlantic right whales and ships overlap to reduce the likelihood
of ship strikes to the extent practicable.
The Magnuson-Stevens Act, which is the primary legal authority for
Federal regulation to conserve and manage fishery resources,
establishes eight regional FMCs, responsible for preparing FMPs and FMP
amendments. NMFS issues regulations to implement FMPs and FMP
amendments. FMPs address a variety of fishery matters, including
depressed stocks, overfished stocks, gear conflicts, and foreign
fishing. One of the problems that FMPs may address is preventing
overcapitalization (preventing excess fishing capacity) of fisheries.
This may be resolved by limiting access to those dependent on the
fishery in the past and/or by allocating the resource through
individual transferable quotas, which can be sold on the open market to
other participants or those wishing access. Quotas set on sound
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.
The Magnuson-Stevens Act contains ten national standards against which
fishery management measures are judged. NMFS has supplemented the
standards with guidelines interpreting each standard, and has updated
and added to those guidelines. One of the national standards requires
that management measures, where practicable, minimize costs and avoid
unnecessary duplication. Under the guidelines, NMFS will not approve
management measures submitted by an FMC unless the fishery is in need
of management. Together, the standards and the guidelines correspond to
many of the Administration's principles of regulation as set forth in
section 1(b) of Executive Order 12866. One of the national standards
establishes a qualitative equivalent to the Executive Order's ``net
benefits'' requirement--one of the focuses of the Administration's
statement of regulatory philosophy as stated in section 1(a) of the
Executive Order.
Bureau of Industry and Security
The Bureau of Industry and Security (BIS) promotes U.S. national and
economic security and foreign policy interests by managing and
enforcing the Department's security-related trade and competitiveness
programs. BIS plays a key role in challenging issues involving national
security and nonproliferation, export growth, and high technology. The
Bureau's continuing major challenge is combating the proliferation of
weapons of mass destruction while furthering the growth of U.S.
exports, which are critical to maintaining our leadership in an
increasingly competitive global economy. BIS strives to be the leading
innovator in transforming U.S. strategic trade policy and programs to
adapt to the changing world.
Major Programs and Activities
The Export Administration Regulations (EAR) provide for export controls
on dual-use goods and technology (primarily commercial goods that have
potential military applications) not only to fight proliferation, but
also to pursue other national security, short supply, and foreign
policy goals (such as combating terrorism). Simplifying and updating
these controls in light of the end of the Cold War has been a major
accomplishment of BIS.
BIS is also responsible for:
Enforcing the export control and antiboycott provisions of the
Export Administration Act (EAA), as well as other statutes
such as the Fastener Quality Act. The EAA is enforced
through a variety of administrative, civil, and criminal
sanctions.
Analyzing and protecting the defense industrial and technology
base, pursuant to the Defense Production Act and other
laws. As the Defense Department increases its reliance on
dual-use high technology goods as part of its cost-cutting
efforts, ensuring that we remain competitive in those
sectors and subsectors is critical to our national
security.
Helping Ukraine, Kazakstan, Belarus, Russia, and other newly
emerging countries develop effective export control
systems. The effectiveness of U.S. export controls can be
severely undercut if ``rogue states'' or terrorists gain
access to sensitive goods and technology from other
supplier countries.
Working with former defense plants in the Newly Independent
States to help make a successful transition to profitable
and peaceful civilian endeavors. This involves helping
remove unnecessary obstacles to trade and investment and
identifying opportunities for joint ventures with U.S.
companies.
Assisting U.S. defense enterprises to meet the challenge of
the reduction in defense spending by converting to civilian
production and by developing export markets. This work
assists in maintaining our defense industrial base as well
as preserving jobs for U.S. workers.
National Telecommunications and Information Administration
The National Telecommunications and Information Administration (NTIA)
is the President's principal adviser on telecommunications and
information policy issues. The advent of the telecommunications and
information revolution is bringing dramatic growth and change to the
Nation's economic, social, and political life, and as a result, NTIA's
fundamental mission is to promote market-based policies which lower
prices to consumers and encourage innovation, while harnessing the
resources of the Federal Government to support spectrum-based
technologies which enhance efficiency and productivity.
[[Page 72764]]
Major Programs and Activities
NTIA's main role is to provide advice to the President on
telecommunications and information policy issues. In this role, NTIA
frequently works with other Executive Branch agencies to develop and
present the Administration's position on these issues. In addition to
representing the Executive Branch in both domestic and international
telecommunications and information policy activities, NTIA also:
Manages the Federal use of spectrum;
Performs cutting-edge telecommunications research and
engineering, including resolving technical
telecommunications issues for the Federal Government and
private sector; and
Administers infrastructure and public telecommunications
facilities grants.
During the next year, NTIA will be completing one action that rises to
the level of ``most important'' significant preregulatory or regulatory
action. This rule is entitled ``Implement and Administer a Coupon
Program for Digital-to-Analog Converter Boxes.'' In this action, NTIA
would implement a digital-to-analog converter box coupon program
pursuant to section 3005 of the Deficit Reduction Act of 2005 (the
``Act''). The Act, among other things, requires the Federal
Communications Commission (FCC) to require full-power television
stations to cease analog broadcasting by February 18, 2009. Recognizing
that consumers may wish to continue receiving broadcast programming
over the air using analog-only televisions not connected to cable or
satellite service, the Act authorizes NTIA to create an assistance
program to provide $40 coupons to consumers for use toward the purchase
of digital-to-analog converter boxes. Through this coupon program, NTIA
will facilitate public access to full-power broadcasting program over
the air using analog-only television sets. Without converter boxes,
consumers with analog-only television sets will be unable to view full-
power television broadcasts unless they purchase digital television
sets or subscribe to cable or satellite service.
_______________________________________________________________________
DOC--National Oceanic and Atmospheric Administration (NOAA)
-----------
FINAL RULE STAGE
-----------
23. RIGHT WHALE SHIP STRIKE REDUCTION
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
16 USC 1361
CFR Citation:
50 CFR 224
Legal Deadline:
None
Abstract:
These regulations would implement a strategy to reduce the known
mortalities to North Atlantic right whales as a result of collisions
with vessels, which account for more confirmed right whale deaths than
any other human-related activity. The strategy addresses the lack of
recovery of the endangered North Atlantic right whale by reducing the
likelihood and threat of ship strike mortalities to the species. The
National Marine Fisheries Service (NMFS) has developed a framework of
proposed, new operational measures for the shipping industry as an
element of this strategy, including consideration of routing and speed
restrictions. These operational measures would be limited to areas and
times when North Atlantic right whales and ships overlap to reduce the
likelihood of ship strikes to the extent practicable.
Statement of Need:
The National Oceanic and Atmospheric Administration (NOAA) proposes
regulations to implement speed restrictions on vessels 65 ft (19.8m) or
greater in overall length in certain locations and at certain times of
the year along the East Coast of the United States. These regulations
are needed as current efforts to reduce occurrence of North Atlantic
right whale deaths and serious injury from ship strikes have not been
sufficient to alter the trajectory of this species toward extinction.
The purpose of these proposed regulatory measures is to reduce the
likelihood of deaths and serious injuries to endangered North Atlantic
right whales that result from collisions with ships. These measures are
part of NMFS' Ship Strike Reduction Strategy to help recover the North
Atlantic right whale.
Summary of Legal Basis:
NOAA is proposing these regulations pursuant to its rulemaking
authority under Marine Mammal Protection Act (MMPA) section 112(a) (16
U.S.C. 1382(a)), and Endangered Species Act (ESA) section 11(f) (16
U.S.C. 1540(f)). These proposed regulations also are consistent with
the purpose of the ESA ``to provide a program for the conservation of
[. . .] endangered species'' and ``the policy of Congress that all
Federal departments and agencies shall seek to conserve endangered
species [. . .] and shall utilize their authorities in furtherance of
the purposes of [the ESA].'' 16 U.S.C. 1531(b),(c).
Alternatives:
NMFS identified five alternatives to the action being proposed.
Alternative 1 is No Action (Status Quo) in which NMFS would continue to
implement existing measures and programs, largely non-regulatory, to
reduce the likelihood of mortality from ship strikes. Alternative 2
includes all elements of Alternative 1 and involves use of Dynamically
Managed Areas (DMA), which consists of certain vessel speed
restrictions applying only when and where right whale sightings occur.
Alternative 3 is vessel speed restrictions in designated areas. It
includes all elements of Alternative 1 and implements large-scale speed
restrictions throughout the range of North Atlantic right whales.
Alternative 4 is the use of designated shipping routes. It includes all
the elements of Alternative 1 and relies on altering some current
vessel patterns to move vessels away from areas where whales are known
to congregate. Alternative 5 is a combination that includes all
elements of Alternatives 1 to 4. Alternative 6 (the preferred
alternative and the approach that is the subject of the proposed rule)
includes a combination of operational measures (routing measures and
speed restrictions). The principal difference between Alternatives 5
and 6 is that Alternative 6 does not include large-scale speed
restrictions (as identified in Alternative 3) but instead relies on
speed restrictions in much smaller Seasonally Managed Areas.
Anticipated Cost and Benefits:
Benefits
The benefits of reducing the risk of right whale mortality caused by
ship strikes are expected to be considerable.
[[Page 72765]]
Because ship strikes appear to be the leading anthropogenic cause of
right whale mortalities, adopting measures to reduce the incidences of
ship strikes will aid in the recovery of this highly endangered
species. However, monetary estimates of these benefits are currently
unavailable; therefore, the discussion of these benefits specific to
right whales is descriptive. The full range of values of right whale
recovery includes use values and nonuse values. Use values include
those values associated with whale watching trips, or other viewing
opportunities. Nonuse values include those values placed on knowing
that right whales remain for future generations (bequest value) and
values placed on knowing that right whales will continue to survive
(existence value). The proposed action would be highly beneficial to
the recovery of the right whale population as it also is designed to
address the various ship strike scenarios that might occur.
Estimated Direct Economic Impact
Shipping Industry:
Direct annual economic impact to commercial shipping is estimated at
$49.4 million at the 10 knot speed restriction. The following port
areas may expect the greatest impact: New York/New Jersey ($11.2
million), Hampton Roads, VA ($7.5 million), Savannah, GA ($5.3 million)
and Charleston, SC ($5.2 million).
Multi-port calls:
The speed restriction component of the proposed action leads to
additional impacts to vessels coming into at least two restricted
ports. The 2004 vessel arrival database indicates that the total number
of multi-port string restricted arrivals to be 5,147. The additional
direct economic impact of multi-port strings on the shipping industry
due to the 10 knot speed restriction in 2004 is estimated at $5.8
million.
Rerouting of Southbound Coastwise Shipping:
The proposed speed restrictions in the Mid-Atlantic region would be
implemented for a 30 nautical mile buffer zone radiating out from each
port area. Hence, the additional distance incurred by southbound
vessels would be 80 nautical miles (20 nautical miles per arrival and
departure at intermediate port calls). The 2003 vessel traffic database
indicated that 3,688 containerships and ro-ro cargo ships would have
traveled through speed restricted U.S. East Coast port areas ranging
from Baltimore through Port Canaveral had the restrictions been in
place. Assuming half of these calls were in the southbound direction
and that the typical vessel made calls at three U.S. East Coast ports
per service, there would be about 615 southbound vessels that are
likely to route outside of the seasonal speed restricted areas rather
than proceed through the restricted areas at a lower speed. Based on an
increase in routing of 80 nautical miles and an average operating speed
of 20 knots, the containership would have increased sailing time of 4
hours. Using an average hourly operating cost at sea of $1,000, the
estimated economic impact for each southbound vessel would be $4,000.
For 2003 and 2004, the additional economic impact for containerships
for coastwise shipping under Alternative 6 was estimated at $2.5
million.
Commercial fishing vessels:
Using 2003 data, the estimated impact at 10 knots on commercial fishing
vessels due to the proposed action is estimated to be $686,000 for the
Northeast Region and $348,000 for the Southeast Region. The combined
Northeast and Southeast regional economic impact of slightly more than
$1 million is approximately two-tenths of one percent of the U.S. East
Coast commercial fishery landings of $628.2 million in 2003.
Charter fishing vessels:
It is estimated that annual economic impact of a speed restriction of
10 knots for these vessels over 30 nautical miles for the proposed
action would be approximately $1.2 million. This calculation assumes 40
headboat vessels with 60 roundtrips per year and an hourly steaming
operating cost of $200.
Passenger ferries:
Under the proposed action, speed restrictions for Cape Cod Bay are
implemented from January 1 through May 15. As such, the fast ferry
service from Boston to Provincetown would remain in operation. Speed
restrictions for Block Island Sound would be from November 1 through
April 30. However, the speed restricted area for Block Island Sound
under the proposed action would not extend to the shoreline and hence
would not impact fast ferry operations. DMAs would also be implemented
under the proposed action. The estimated economic impact for fast ferry
service under the proposed action due to the presence of DMAs is $2.6
million. For regular ferries, the economic impact due to the proposed
action is estimated to be $3.0 million for 10 knots speed restrictions.
The combined impacts to the high-speed and regular-speed passenger
ferries bring the total estimated economic impacts to $5.6 million.
Whale watching vessels:
Under the proposed action, speed restrictions for Cape Cod Bay are
implemented from January 1 through May 15. Hence, the peak summer whale
watching season would not be affected for high-speed or regular speed
vessels. Similarly, the speed restrictions for the Off Race Point area
are proposed for March through April would not impact the whale
watching season. Accordingly, the economic impact due to DMAs under the
proposed action is an estimated $0.9 million.
Indirect Economic Impacts of Port Diversions
Under the proposed action, speed restrictions for both Off Race Point
area and the Great South Channel in the Northeast are in effect during
the month of April causing many ships to route around this large area
during that time. The diversion is assumed at 10 percent for
containerships and ro-ro cargo ships during the restricted period. For
port areas in Block Island Sound, two percent of containerships and ro-
ro cargo ships are assumed to divert to other port areas to avoid speed
restricted areas. For the affected Mid-Atlantic ports, 0.5 percent of
restricted period containership and ro-ro cargo ship vessel calls are
assumed to divert to other port areas.
Additional diversions away from the port area of Providence may also
occur under the proposed action. This port area has speed restrictions
in effect for 181 days as compared to 61 days for the port area of
Boston. Therefore, 15 percent of the containership and ro-ro cargo ship
restricted period calls at Providence are assumed to divert to the
nearby port area of Boston.
NMFS anticipates that the use of recommended routes into the
Southeastern Region ports of Brunswick and Fernandina are likely to
result in a diversion of two percent of containerships and ro-ro cargo
ships from these ports to Savannah. As a result of these diversions,
NMFS anticipates additional delays relative to Savannah. Finally, 30
percent of the restricted period cruise vessel calls at Jacksonville
are assumed to divert to Port Canaveral as that port is not affected by
speed restrictions or the use of recommended routes.
The indirect economic impact of port diversions is estimated to be
$49.7
[[Page 72766]]
million for the 10 knot speed restriction. The largest negative
indirect impacts are generated in the port areas of New York/New Jersey
($21.2 million), Jacksonville, FL ($15.5 million) and Hampton Roads, VA
($12.4 million). The following port areas are expected to experience a
positive indirect economic impact: Port Canaveral, FL ($2.2 million)
and Savannah, GA ($1.7 million).
Risks:
The risk associated with not pursuing the proposed rulemaking is
allowing the continued decline in the population of North Atlantic
right whales. The North Atlantic right whale is in danger of
extinction: some estimates have it on a trajectory of going extinct
within 200 years if serious injury and death from certain human
activities is not abated. NMFS conducts consultations under Section 7
of the Endangered Species Act (ESA) with other agencies with regard to
activities undertaken or permitted by those agencies that may adversely
affect North Atlantic right whales. NMFS routinely concludes that those
activities, and the cumulative effect of other pressures on the
population, will jeopardize the continued existence of the species in
all or part of its range. The proposed regulations are expected to
reduce or eliminate the threat of right whale deaths from collisions
with ships, and, as a result, provide relief from a key threat to the
species. NMFS is required under the ESA to take steps to recover the
species. By failing to take adequate steps, including those identified
in the rulemaking, NMFS would fail to meet its legal requirements under
the ESA.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
ANPRM 06/01/04 69 FR 30857
ANPRM Comment Period
Extended 07/09/04 69 FR 41446
ANPRM Comment Period
Extended 09/13/04 69 FR 55135
NPRM 06/26/06 71 FR 36299
NPRM Comment Period End 08/25/06
Comment Period Extended 08/14/06 71 FR 46440
Comment Period End 10/05/06
Final Action 12/00/06
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
Public Compliance Cost:
Initial Cost: $0
Yearly Recurring Cost: $116,000,000
Base Year for Dollar Estimates: 2005
URL For More Information:
www.nmfs.noaa.gov/pr/pr2
Agency Contact:
James H. Lecky
Director, Office of Protected Resources
Department of Commerce
National Oceanic and Atmospheric Administration
1315 East-West Highway
Silver Spring, MD 20910
Phone: 301 713-2332
Peter Robbins
Attorney Advisor
Department of Commerce
14th & Constitution Ave. NW.
Washington, DC 20230
Phone: 202 482-0846
Email: [email protected]
RIN: 0648-AS36
_______________________________________________________________________
DOC--National Telecommunications and Information Administration (NTIA)
-----------
FINAL RULE STAGE
-----------
24. [bull] IMPLEMENT AND ADMINISTER A COUPON PROGRAM FOR DIGITAL-TO-
ANALOG CONVERTER BOXES
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 109-171
CFR Citation:
47 CFR 301
Legal Deadline:
None
Abstract:
Pursuant to the Digital Television Transition and Public Safety Act of
2005 (the Act), the National Telecommunications and Information
Administration (NTIA) proposes to implement a digital-to-analog
converter box coupon program. The Act, among other things, requires the
Federal Communications Commission (FCC) to require full-power
television stations to cease analog broadcasting by February 18, 2009.
Recognizing that consumers may wish to continue receiving broadcast
programming over the air using analog-only televisions not connected to
cable or satellite service, the Act authorizes NTIA to create an
assistance program to provide $40 coupons to consumers for use toward
the purchase of digital-to-analog converter boxes. Without converter
boxes, consumers with analog-only television sets will be unable to
view full-power television broadcasts unless they purchase digital
television sets or subscribe to cable or satellite service.
Statement of Need:
This action is necessary to provide guidance for the digital-to-analog
converter box coupon program. Converter boxes are necessary for
consumers who wish to continue receiving full-power broadcast
programming over the air using analog-only television sets after
February 18, 2009--the date that the law requires full-power television
stations to cease analog broadcasting. With respect to consumers, this
action provides eligibility requirements, application procedures, and
guidance on the use, value, and restrictions of the coupons. This
action also provides specifications on eligible converter boxes that
will assist manufacturers in developing converter boxes. Finally, this
action provides guidance and sets for the rights and responsibilities
of retailers.
Summary of Legal Basis:
Section 3005 of the Deficit Reduction Act of 2005 directs NTIA to
implement and administer a program through which eligible U.S.
households may obtain a maximum of two coupons of $40 each to be
applied toward the purchase of a digital-to-analog converter box. See
title III of the Deficit Reduction Act of 2005, Pub. L. 109-171, 120
Stat. 4, 21 (Feb. 8, 2006).
Alternatives:
NTIA considered various ways to implement the program. NTIA proposed
that eligible households will be only those that receive over-the-air
broadcasts, and that coupons will be distributed on a first-come,
first-served basis. An alternative for which the agency sought public
comment through the proposed rule was whether other eligibility
factors, such as a means test, should be used. NTIA also considered
various formats for the actual coupon. In its proposed rule NTIA
proposed a paper coupon but requested comment on an electronic coupon
card. NTIA proposed options for addressing the expiration requirement.
In its proposed rule, NTIA proposed that the expiration date will be
three months after the
[[Page 72767]]
coupon's issuance date, which would be the date upon which the coupon
is placed in the U.S. mail. NTIA also requested comment on an
alternative to the definition of the issuance date, which would be the
date upon which a consumer receives a coupon. Finally, NTIA proposed to
require manufacturers to self-certify that the converter boxes meet the
standards outlined in the proposed rule. However, it requested comment
on whether there are existing industry or government organizations
engaged in activities that can help speed the development of testing/
certification processes within the allowed time frame of this program.
Anticipated Cost and Benefits:
The Act authorizes $1.5 billion to operate the coupon program. The Act,
however, is part of the Deficit Reduction Act of 2005 which the
Congressional Budget Office predicts will reduce direct spending by
about $39 billion over the 2006 to 2010 period and by about $99 billion
over the 2006 to 2015 period. The direct costs to eligible households
as a result of this rule is certainly less than if the coupon program
was not instituted. Estimates of the cost of the converter box range
between $50 and $70. Using the $40 coupon, consumers can then expect to
pay between $10 and $30 for each converter box purchased. Without the
coupons, consumers would have to pay the full retail price of the
converter box, or purchase a digital television.
This program, if implemented, imposes certain requirements if retailers
and manufacturers decide to participate in the coupon program. Besides
the time that it takes to submit a certification form to NTIA, there
will be actual costs associated with meeting compliance requirements.
These costs, however, are difficult to quantify because of many varying
factors. However, NTIA anticipates that the costs would be minimal
because retailers and manufacturers may already have the ability to
meet the requirements associated with participation in this program.
For example, retailers would have to ensure that employees are capable
of educating customers about the necessity for and installation of
converter boxes. The costs for this compliance would be calculated by
the number of hours it would take to train employees. The estimate
would depend on a number of factors such as the existing sales force's
expertise, number of employees, salary levels, type of converter box
that is certified, and consumer knowledge.
This program, if implemented, would also require retailers to have
systems in place that can be easily audited as well as systems that
have the ability to prevent fraud and abuse in the coupon program. We
assume that most businesses would have systems in place that can be
easily audited, and therefore, we do not anticipate that businesses
will have to assume a cost to purchase a new system for the coupon
program. Retailers must also have systems in place that have the
ability to prevent fraud and abuse in the coupon program. We assume
that most retailers are familiar with and accept coupons for
merchandise, and that they have in place systems to prevent fraud. The
nature of this coupon program, however, may require participating
retailers to assume additional costs associated with preventing fraud.
These costs cannot be estimated at this point in the rulemaking
process. There may be costs associated in complying with an audit.
These costs would most likely be calculated in terms of employee hourly
rates. The associated costs depend on the nature and extent of an
audit.
There are also costs associated with handling coupons, that is,
accepting the coupons, submitting the coupons for redemption, and
retaining hard copies of the coupons. Again, these associated costs
depend on a number of factors such as the particular systems that
retailers currently have in place, as well as which of these costs can
be absorbed within existing procedures that the retailer has in place.
Although there may be costs associated with accepting the coupons and
selling the converter boxes, the coupon program does not restrict the
retailer in pricing the converter box. Manufacturers and retailers may
consider these associated costs and establish the wholesale and retail
price of the converter boxes to recoup any associated costs. In fact,
the coupon program anticipates that there will be a co-pay element to
the purchase price. Thus, to the extent that a small retailer or
manufacturer incurs costs as a result of this program, those costs can
be recouped through the retail or wholesale price, which the retailer
and manufacturer are at liberty to choose.
Risks:
One risk is that the final rule will not be promulgated in time for the
manufacturers to build the converter boxes. The Act states that
consumers must be able to apply for coupons between January 1, 2008,
and March 31, 2009. The agency has been informed that the
specifications for the converter box, as directed in the final rule,
must be available at least one year in advance. To the extent that the
final rule is not issued by January 2007, converter boxes may not be
available when the statutory application period begins.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 07/25/06 71 FR 42067
Final Action 01/00/07
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Additional Information:
This action would establish the eligibility criteria, application
process, coupon value and use restrictions, and manufacturer and
retailer certification process. To implement this program, the Act
authorizes NTIA to use up to $990 million to fund the program,
including $100 million for program administration. NTIA is also
authorized to expend up to $1.5 billion for the program, including $160
million for administration, upon a 60-day notice and certification to
the Committee on Energy and Commerce of the House of Representatives
and the Committee on Commerce, Science, and Transportation of the
Senate that the $990 million is insufficient to fulfill coupon requests
for eligible U.S. households.
Agency Contact:
Milton Brown
Deputy Chief Counsel
Department of Commerce
National Telecommunications and Information Administration
14th & Pennsylvania Avenue, NW.
Washington, DC 20230
Phone: 202 482-1816
Fax: 202 501-8013
Email: [email protected]
RIN: 0660-AA16
BILLING CODE 3510-BW-S
[[Page 72768]]
DEPARTMENT OF DEFENSE (DOD)
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), 9
unified combatant commands, 17 Defense agencies, and 11 DoD field
activities. It has over 1,380,000 military personnel and 676,000
civilians assigned as of June 30, 2006, 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 the
Department of Defense, coupled with an innovative regulatory program,
presents a challenge to the management of the Defense regulatory
efforts under Executive Order 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 Executive Order 12866, there must be
coordination of proposed regulations among the regulating agencies and
the affected Defense 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 issues regulations
that have an affect on the public. These regulations, while small in
number compared to the regulating agencies, can be significant as
defined in Executive Order 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.
The regulatory program within DoD fully incorporates the provisions of
the President's priorities and objectives under Executive Order 12866.
Promulgating and implementing the regulatory program throughout DoD
presents a unique challenge to the management of our regulatory
efforts.
Coordination
Interagency
DoD annually receives regulatory plans from those agencies that
influence the operation of the Department through the issuance of
regulations. A system for coordinating the review process is in place,
regulations are reviewed, and comments are forwarded to the Office of
Management and Budget. The system is working in the Department, and the
feedback from the Defense components is most encouraging, since they
are able to see and comment on regulations from the other agencies
before they are required to comply with them. The coordination process
in DoD continues to work as outlined in Executive Order 12866.
Internal
Through regulatory program points of contact in the Department, we
have established a system that provides information from the
Administrator of the Office of Information and Regulatory Affairs
(OIRA) to the personnel responsible for the development and
implementation of DoD regulations. Conversely, the system can provide
feedback from DoD regulatory personnel to the Administrator, OIRA. DoD
continues to refine its internal procedures, and this ongoing effort to
improve coordination and communication practices is well received and
supported within the Department.
Overall Priorities
The Department of Defense 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 the Department while it must react 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, adheres to the general principles set forth
in Executive Order 12866 as amplified below.
Problem Identification
Congress typically passes legislation to authorize or require an
agency to issue regulations and often is quite specific about the
problem identified for correction. Therefore, DoD does not generally
initiate regulations as a part of its mission.
Conflicting Regulations
Since DoD seldom issues significant regulations, the probability of
developing conflicting regulations is low. Conversely, DoD is affected
to a great degree by the regulating agencies. From that perspective,
DoD is in a position to advise the regulatory agencies of conflicts
that appear to exist using the coordination processes that exist in the
DoD and other Federal agency regulatory programs. It is a priority in
the Department to communicate with other agencies and the affected
public to identify and proactively pursue regulatory problems that
occur as a result of conflicting regulations both within and outside
the Department.
Alternatives
DoD will identify feasible alternatives that will obtain the desired
regulatory objectives. Where possible, the Department encourages the
use of incentives to include financial, quality of life, and others to
achieve the desired regulatory results.
Risk Assessment
Assessing and managing risk is a high priority in the DoD regulatory
program. The Department is committed to risk prioritization and an
``anticipatory'' approach to regulatory planning, which focuses
attention on the identification of future risk. Predicting future
regulatory risk is exceedingly difficult due to rapid introduction of
new technologies, side effects of Government intervention, and changing
societal concerns. These difficulties can be mitigated to a manageable
degree through the incorporation of risk prioritization and
anticipatory regulatory planning into DoD's decisionmaking process,
which results in an improved regulatory process and increases the
customer's understanding of risk.
Cost-Effectiveness
One of the highest priority objectives of DoD is to obtain the desired
regulatory objective by the most cost-effective method available. This
may or may not be through the regulatory process. When a regulation is
required, DoD considers incentives for innovation to achieve desired
results, consistency in the application of the regulation,
predictability of the activity outcome (achieving the expected
results), and the costs for regulation development, enforcement, and
compliance. These will include costs to the public, Government, and
regulated entities, using the best available data or parametric
analysis methods, in the
[[Page 72769]]
cost-benefit analysis and the decisionmaking process.
Cost-Benefit
Conducting cost-benefit analyses on regulation alternatives is a
priority in the Department of Defense so as to ensure that the
potential benefits to society outweigh the costs. Evaluations of these
alternatives are done quantitatively or qualitatively or both,
depending on the nature of the problem being solved and the type of
information and data available on the subject. DoD is committed to
considering the most important alternative approaches to the problem
being solved and providing the reasoning for selecting the proposed
regulatory change over the other alternatives.
Information-Based Decisions
The Defense Department uses the latest technology to provide access to
the most current technical, scientific, and demographic information in
a timely manner through the worldwide communications capabilities that
are available on the Internet. Realizing that increased public
participation in the rulemaking process improves the quality and
acceptability of regulations, DoD is committed to exploring the use of
information technology (IT) in rule development and implementation. IT
provides the public with easier and more meaningful access to the
processing of regulations. Furthermore, the Department endeavors to
increase the use of automation in the Notice and Comment rulemaking
process in an effort to reduce time pressures and increase public
access in the regulatory process. Notable progress has been made in the
Defense acquisition regulations area toward achieving the
Administration's E-government initiative of making it simpler for
citizens to receive high-quality service from the Federal Government,
inform citizens, and allow access to the development of rules.
Performance-Based Regulations
Where appropriate, DoD is incorporating performance-based standards
that allow the regulated parties to achieve the regulatory objective in
the most cost-effective manner.
Outreach Initiatives
DoD endeavors to obtain the views of appropriate State, local, and
tribal officials and the public in implementing measures to enhance
public awareness and participation both in developing and implementing
regulatory efforts. Historically, this has included such activities as
receiving comments from the public, holding hearings, and conducting
focus groups. This reaching out to organizations and individuals that
are affected by or involved in a particular regulatory action remains a
significant regulatory priority of the Department and, we feel, results
in much better regulations.
The Department is actively engaged in addressing the requirements of
the Government Paperwork Elimination Act (GPEA) in implementing
electronic government and in achieving IT accessibility for individuals
with disabilities. This is consistent with the Administration's
strategy of advancing E-government as expressed in ``The President's
Management Agenda.'' The Department is actively participating in the
eRulemaking Initiative to implement a governmentwide docket management
system that will provide the framework for wider citizen input and
improve regulatory policies and outcomes by cultivating public
participation in Federal decisionmaking.
Coordination
DoD has enthusiastically embraced the coordination process between and
among other Federal agencies in the development of new and revised
regulations. Annually, DoD receives regulatory plans from key
regulatory agencies and has established a systematic approach to
providing the plans to the appropriate policy officials within the
Department. Feedback from the DoD components indicates that this
communication among the Federal agencies is a major step forward in
improving regulations and the regulatory process, as well as in
improving Government operations.
Minimize Burden
In the regulatory process, there are more complaints concerning burden
than anything else. In DoD, much of the burden is in the acquisition
area. Over the years, acquisition regulations have grown and become
burdensome principally because of legislative action. But, in
coordination with Congress, the Office of Federal Procurement Policy,
and the public, DoD is initiating significant reforms in acquisition so
as to effect major reductions in the regulatory burden on personnel in
Government and the private sector. DoD has implemented a multi-year
strategy for reducing the paperwork burden imposed on the public. This
plan shows that DoD has met and will exceed the goals set forth in the
Paperwork Reduction Act. It is the goal of the Department of Defense to
impose upon the public the smallest burden viable, as infrequently as
possible, and for no longer than absolutely necessary.
Plain Language
Ensuring that regulations are simple and easy to understand is a high
regulatory priority in the Department of Defense. All too often, the
regulations are complicated, difficult to understand, and subject to
misinterpretation, all of which can result in the costly process of
litigation. The objective in the development of regulations is to write
them in clear, concise language that is simple and easy to understand.
DoD recognizes that it has a responsibility for drafting clearly
written rules that are reader-oriented and easily understood. Rules
will be written for the customer using natural expressions and simple
words. Stilted jargon and complex construction will be avoided. Clearly
written rules will tell our customers what to do and how to do it. DoD
is committed to a more customer-oriented approach and uses plain
language rules thereby improving compliance and reducing litigation.
In summary, the rulemaking process in DoD should produce a rule that:
Addresses an identifiable problem, implements the law, incorporates the
President's policies defined in Executive Order 12866, is in the public
interest, is consistent with other rules and policies, is based on the
best information available, is rationally justified, is cost-effective,
can actually be implemented, is acceptable and enforceable, is easily
understood, and stays in effect only as long as is necessary. Moreover,
the proposed rule or the elimination of a rule should simply make
sense.
Rulemakings That Support the Administration's Regulation Agenda to
Streamline Regulations and Reporting Requirements
The Department will:
Consolidate all of the existing emergency procurement authorities into
Part 18 of the FAR and Part 218 of the DFARS;
Direct use of electronic subcontracting and reporting system for both
the summary and individual subcontract reporting, in conjunction with
and as part of the integration with FPDS;
Rewrite the rules on Government property to organize and streamline
management of Government property. Emphasize contractor accountability
while reducing contract clauses and
[[Page 72770]]
reporting requirements. Allow contractors to provide item unique
identification (IUID) data electronically in the IUID Registry for all
DoD personal property in possession of the contractor, rather than
annual reporting;
Simplify and clarify the coverage of multi-year acquisitions;
Provide simplified criteria for the release of supplies by the
contractor based on complexity and criticality;
Finalize the rewrite of FAR Part 27, Patents, Data and Copyrights, to
clarify, streamline, and update guidance and clauses on patents, data,
and copyrights. Transform the DFARS regulations on patents, data and
copyrights to clarify and simplify, dramatically reducing the amount of
regulatory text and the number of required clauses;
Implement DFARS transformation proposals relating to the Material
Inspection and Receiving Report, acquisition planning, transportation,
contract pricing and cost accounting standards, and protests, disputes,
and appeals; and
Delete obsolete restrictions on the acquisition of PAN Carbon Fiber.
Regulations of Particular Interest to Small Business
Of interest to small businesses are regulations to:
Permit subcontracts awarded to certain Alaska Native Corporations to
be counted toward a contractor's goal for subcontracting with Small
Business and Small Disadvantaged Business concerns and subcontracts to
Indian tribes to be counted toward a contractor's goal for
subcontracting with small business concerns, regardless of size, in
accordance with section 702 of Pub. L. 107-117, as amended by section
3003 of Pub. L. 107-206;
Amend the FAR to address changes in the Small Business Administration
regulations to implement changes in the HUBZone Program; and
Implement DFARS transformation proposals relating to small business
programs.
Suggestions From the Public for Reform--Status of DoD Items
Rulemaking Actions in Response to Public Nominations
The Army Corps of Engineers has not undertaken any rulemaking actions
in response to the public nominations submitted to the Office of
Management and Budget in 2001, 2002, or 2004. Those nominations were
discussed in Making Sense of Regulation: 2001 Report to Congress on the
Costs and Benefits of Regulations and Unfunded Mandates on State,
Local, and Tribal Entities, Stimulating Smarter Regulation: 2002 Report
to Congress on the Costs and Benefits of Regulations and Unfunded
Mandates on State, Local, and Tribal Entities, and Progress in
Regulatory Reform: 2004 Report to Congress on the Costs and Benefits of
Federal Regulations and Unfunded Mandates on State, Local, and Tribal
Entities.
Specific Priorities
For this regulatory plan, there are four specific DoD priorities, all
of which reflect the established regulatory 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 civil functions of the U.S. Army Corps of Engineers,
acquisition, installations and the environment, and health affairs.
U.S. Army Corps of Engineers, Directorate of Civil Works
Compensatory Mitigation in the Army Regulatory Program
Section 314 of the National Defense Authorization Act for Fiscal Year
2004 (Public Law 108-136) requires the Secretary of the Army, acting
through the Chief of Engineers, to issue regulations that establish
performance standards and criteria for the use of compensatory
mitigation for wetland functions lost as a result of activities
authorized by Department of the Army (DA) permits. The statute also
requires the regulation to contain provisions for the application of
equivalent standards and criteria to each type of compensatory
mitigation.
The proposed rule was published for public comment on March 28, 2006
(71 FR 15520). The comment period expired on June 30, 2006 (71 FR
29604). The proposed regulation was developed by considering concepts
in current Federal compensatory mitigation guidance documents, and
updating and modifying those concepts to improve compensatory
mitigation decisionmaking and processes. The proposed rule takes a
watershed approach to compensatory mitigation for permitted impacts to
wetlands, streams, and other aquatic resources. Although the statute
refers only to wetlands, the proposed rule is broader in scope, and
addresses compensatory mitigation requirements for impacts to other
aquatic resources, such as streams, in addition to wetlands. Comments
received in response to the proposed rule are being evaluated, and a
final rule will be prepared.
Army Regulatory Program's Compliance with the National Historic
Preservation Act
In 1990, the Army Corps of Engineers published as appendix C of 33 CFR
part 325, a rule that governs compliance with the National Historic
Preservation Act (NHPA) for the Army's Regulatory Program. Over the
years, there have been substantial changes in policy, and the NHPA was
amended in 1992, leading to the publication in December 2000 of new
implementing regulations at 36 CFR part 800, issued by the Advisory
Council on Historic Preservation. Those regulations were amended on
July 6, 2004. The Advisory Council on Historic Preservation's
regulations allow Federal agencies to utilize alternate procedures in
lieu of the regulations at 36 CFR part 800. To solicit public comment
on the appropriate mechanism for revising the Army Regulatory Program's
process for considering effects to historic properties resulting from
activities authorized by DA permits, the Army Corps of Engineers
published an Advance Notice of Proposed Rulemaking (ANPRM) to obtain
the views of interested parties. After reviewing the comments received
in response to the ANPRM, the Army Corps of Engineers held facilitated
stakeholder meetings to determine the best course of action for
revising its procedures to comply with the requirements of Section 106
of the National Historic Preservation Act. The Corps plans on holding
additional focus group meetings facilitated by our eight division
offices to gather input from federally recognized tribes on their
recommendations concerning how government-to-government consultation
could occur. Also, our division offices will solicit information on
topics that any new alternative procedure should address.
[[Page 72771]]
Defense Procurement and Acquisition
The Department continues its efforts to reengineer its acquisition
system to achieve its vision of an acquisition system that is
recognized as being the smartest, most efficient, most responsive buyer
of best value goods and services, which meet the warfighter's needs
from a globally competitive base. To achieve this vision, the
Department will focus in the acquisition regulations during this next
year on implementing and institutionalizing initiatives that may
include additional changes to existing and recently modified
regulations to ensure that we are achieving the outcomes we desire
(continuous process improvement).
The Department of Defense continuously reviews the Defense Federal
Acquisition Regulation Supplement (DFARS) and continues to lead
Government efforts to:
Improve the DFARS to enhance the efficiency and effectiveness
of the acquisition process, while allowing the acquisition
workforce flexibility to innovate. The DFARS contains only
requirements of law, DoD-wide policies, delegations of FAR
authorities, deviations from FAR requirements, and
policies/procedures that have a significant impact on
contractors, offerors, and/or the public.
Revise the uniform treatment of contractor personnel who are
authorized to accompany the U.S. Armed Forces deployed
outside the United States in contingency operations,
humanitarian or peacekeeping operations, other military
operations, or training exercises designated by the
combatant commander, to implement the new DoD Instruction,
and require training for contractor personnel who interact
with detainees. Implement the DoD Law of War Program,
requiring contractors to report violations.
Coordinate with the Department of State to finalize a FAR rule
to address uniform treatment of other contractor personnel
who are performing outside the United States in a theater
of operations during contingency operations; humanitarian
or peacekeeping operations; other military operations; or
military exercises designated by the combatant commander;
or at a diplomatic or consular mission, when designated by
the chief of mission.
Finalize the FAR rule that authorizes set-asides for awards
based on specific geographic areas under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, in
order to implement the Local Community Recovery Act of
2006.
Prohibit trafficking in persons by contractors, contractor
employees, and subcontractors.
Address contractor notification requirements associated with
deficient processes or defective parts related to aviation
critical safety items.
Phase in DFARS requirements for contractors to affix radio
frequency identification (RFID) tags to the exterior
packaging of items delivered under DoD contracts, adding
additional commodities and ship-to locations. This practice
will improve visibility of DoD assets in the supply chain,
increase the accuracy of shipment and receipt data, and
reduce the amount of time it takes to deliver material to
the warfighter.
Improve debt collection by evaluating existing FAR controls
and procedures for ensuring contract debts are identified
and recovered in a timely manner, properly accounted for in
each agencies' books and records, and properly coordinated
with the appropriate Government officials.
Defense Installations and the Environment
The Department is committed to reducing the total ownership costs of
the military infrastructure while providing the Nation with military
installations that efficiently support the warfighter in: Achieving
military dominance, ensuring superior living and working conditions,
and enhancing the safety of the force and the quality of the
environment. DoD has focused its regulatory priorities on explosives
safety, human health, and the environment. These regulations provide
means for the Department to provide information about restoration
activities at Federal facilities and to take public advice on the
restoration activities.
Restoration Advisory Boards
The requirement for the establishment of Restoration Advisory Board
(RABs) is grounded in Section 324(a) of Public Law 104-106, which
requires the Secretary of Defense to ``prescribe regulations regarding
the establishment, characteristics, composition, and funding of
restoration advisory boards.'' Section 324(a) also stated that DoD's
issuance of regulations shall not be a precondition to the
establishment of RABs (amended Title 10 Section 2705(d)(2)(B)). In
August 1996, the Department proposed and requested public comments on
regulations regarding the characteristics, composition, funding, and
establishment of RABs. These regulations were not finalized.
As a consequence of litigation in 2001, the Department substantially
revised the regulations and shared a draft rule with RAB community
members as part of the Department's outreach to affected members of the
public. On March 26, 2003, OMB reviewed the draft proposed rule and
agreed that it is not a ``significant regulatory action'' under EO
12866. The Department published the proposed rule in the Federal
Register on January 28, 2005. The proposed rule addressed scope,
characteristics, composition, funding, establishment, operation and
adjournment. The public comment period ended on March 29, 2005. The
Department received a total of 219 comments from 29 individuals and
organizations.
The Department published final regulations governing the establishment
and administration of Restoration Advisory Boards in the Federal
Register on May 12, 2006 (71 FR 27610-27621). Corrections were
published in the Federal Register on May 30, 2006 (71 FR 30719) and
July 28, 2006 (71 FR 42756-42757).
Munitions Response Site Prioritization Protocol
Section 2710(b)(1) of Title 10, United States Code, directed the
Secretary of Defense to develop a protocol for prioritizing response
actions for each defense site known or suspected to contain unexploded
ordnance, discarded military munitions, or munitions constituents.
Following required consultations with State and tribal representatives,
the Department published the proposed rule for public review and
comment on August 22, 2003. The Department reviewed comments received
during the public comment period, which ended on November 19, 2003, and
revised the rule accordingly. The most significant change pertained to
the module that evaluates health hazards associated with munitions
constituents and other chemical constituents. The Department published
the final rule in the Federal Register on October 5, 2005 (70 FR 58016-
58054).
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
[[Page 72772]]
medical treatment facilities. This network includes DoD's own military
treatment facilities supplemented by civilian healthcare 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 plans to submit the following rules:
Interim Final Rule concerning Certain Survivors of Deceased
Active Duty Members and Adoption Intermediaries: The rule
addresses two provisions of the National Defense
Authorization Act for Fiscal Year 2006 (NDAA-06), Pub. L.
109-163. Section 715 of the NDAA-06 extends the time frame
that certain dependents of Active Duty Service Members
(ADSM) who die while on active duty for more than 30 days
shall receive TRICARE medical benefits at active duty
dependent payment rates. Second, Section 592 modifies the
requirement for intermediaries who provide adoption
placements. The economic impact of this rule is estimated
to be less than $100 million. It is anticipated that the
final rule will be published by May 1, 2007.
Interim Final Rule on TRICARE Outpatient Prospective Payment
System (OPPS): The rule implements a prospective payment
system for hospital outpatient services similar to that
furnished to Medicare beneficiaries, as set forth in
section 1833(t) of the Social Security Act. The rule also
recognizes applicable statutory requirements and changes
arising from Medicare's continuing experience with its
system, including certain related provisions of the
Medicare Prescription Drug, Improvement, and Modernization
Act of 2003. While TRICARE intends to remain as true as
possible to Medicare's basic OPPS methodology (i.e.,
adoption and updating of the Medicare data elements used in
calculating the prospective payment amounts), there will be
some significant deviations required to accommodate the
uniqueness of the TRICARE program. These deviations have
been designed to accommodate existing TRICARE benefit
structure and claims processing procedures implemented
under the TRICARE Next Generation Contracts (T-NEX) while
at the same time eliminating any undue financial burden to
TRICARE Prime, Extra and Standard beneficiary populations.
The economic impact of this rule is estimated to be less
than $100 million. It is anticipated that the final rule
will be published by April 1, 2007. It is anticipated that
an interim final rule will be required to be promulgated in
order to implement a provision of the National Defense
Authorization Act for FY07 to expand the TRICARE Reserve
Select program to allow all members of the Selected Reserve
to purchase their health care through the Military Health
System at the same low cost, regardless of the member's
duty status. The economic impact of this rule is estimated
to be less than $100 million. It is anticipated that the
interim final rule will be published by June 1, 2007.
_______________________________________________________________________
DOD--Office of Assistant Secretary for Health Affairs (DODOASHA)
-----------
FINAL RULE STAGE
-----------
25. [bull] TRICARE OUTPATIENT PROSPECTIVE PAYMENT SYSTEM (OPPS)
Priority:
Other Significant
Legal Authority:
10 USC Ch 55; 5 USC 301; 10 USC 1079(j)(2)
CFR Citation:
32 CFR 199
Legal Deadline:
None
Abstract:
The interim final rule implements a prospective payment system for
hospital outpatient services similar to that furnished to Medicare
beneficiaries, as set forth in section 1833(t) of the Social Security
Act. The rule also recognizes applicable statutory requirements and
changes arising from Medicare's continuing experience with its system,
including certain related provisions of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003. While TRICARE intends to
remain as true as possible to Medicare's basic OPPS methodology (i.e.,
adoption and updating of the Medicare data elements used in calculating
the prospective payment amounts), there will be some significant
deviations required to accommodate the uniqueness of the TRICARE
program. These deviations have been designed to accommodate existing
TRICARE benefit structure and claims processing procedures implemented
under the TRICARE Next Generation Contracts (T-NEX) while at the same
time eliminating any undue financial burden to TRICARE Prime, Extra and
Standard beneficiary populations.
Statement of Need:
The interim final rule is necessary to meet the standing Congressional
mandate to adopt Medicare institutional payment methodologies whenever
practicable.
Summary of Legal Basis:
Congress established enabling legislation under section 707 of the
National Defense Authorization Act of Fiscal Year 2002 (NDAA-02), Pub.
L. 107-107 (December 28, 2001) changing the statutory authorization in
10 U.S.C. 1079(j)(2) that TRICARE payment methods for institutional
care be determined to the extent practicable, in accordance with the
same reimbursement rules used by Medicare.
Alternatives:
The interim final rule implements statutorily required provisions for
adoption and implementation of Medicare institutional reimbursement
systems which are consistent with well established Congressional
objectives. No other alternatives are applicable.
Anticipated Cost and Benefits:
It is projected that implementation of this rule will result in a
health care dollar savings of $50 to $70 million per year with an
estimated initial startup cost of $4 to $6 million and recurring
administrative costs of approximately $1 million per year.
Risks:
The interim final rule implements statutorily required provisions for
adoption and implementation of Medicare institutional reimbursement
systems which are consistent with well established Congressional
objectives. No risk to the public is applicable.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 12/00/06
Interim Final Rule
Comment Period End 02/00/07
Final Action 04/00/07
Final Action Effective 06/00/07
[[Page 72773]]
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
Agency Contact:
David E. Bennett
Department of Defense
Office of Assistant Secretary for Health Affairs
1200 Defense Pentagon
Washington, DC 20301
Phone: 303 676-3494
Email: [email protected]
RIN: 0720-AB03
_______________________________________________________________________
DOD--DODOASHA
26. [bull] TRICARE; CERTAIN SURVIVORS OF DECEASED ACTIVE DUTY MEMBERS;
AND ADOPTION INTERMEDIARIES
Priority:
Other Significant
Legal Authority:
10 USC Ch 55; 5 USC 301; PL 109-163
CFR Citation:
32 CFR 199
Legal Deadline:
Final, Statutory, October 7, 2001, Public Law 109-163.
Abstract:
The interim final addresses two provisions of the NDAA-FY06, Pub. L.
109-163. Section 715 of the NDAA-FY06 extends the time frame that
certain dependents of Active Duty Service Members (ADSM) who die while
on active duty for more than 30 days shall receive TRICARE medical
benefits at active duty dependent payment rates. Second, Section 592
modifies the requirement for intermediaries who provide adoption
placements.
Statement of Need:
This rule is necessary to comply with the statutory requirement.
Summary of Legal Basis:
This rule is required by the NDAA-FY06, Pub L 109-163.
Alternatives:
This rule is statutory. No other alternative is applicable.
Anticipated Cost and Benefits:
Estimated costs for FY07 (includes retroactive years to 2001). Health
care costs $533,000 and administrative costs of $774,000 (which
includes total startup costs of $300,000). The benefit of this rule is
that surviving children of ADSMs whose death occurs on or after October
7, 2001, will receive TRICARE benefits at the AD family member rate for
the duration of their TRICARE eligibility.
Risks:
This rule implements a statutory provision to extend the time frame
that surviving children of deceased ADSM whose death occurred on or
after October 7, 2001, can receive TRICARE at active duty family member
rates. Not implementing this statutory provision creates additional
out-of-pocket costs for surviving children.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 12/00/06
Interim Final Rule
Comment Period End 02/00/07
Interim Final Rule
Effective 10/07/01
Final Action 05/00/07
Final Action Effective 06/00/07
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal
Agency Contact:
Ann N. Fazzini
Department of Defense
Office of Assistant Secretary for Health Affairs
1200 Defense Pentagon
Washington, DC 20301
Phone: 303 676-3803
RIN: 0720-AB04
_______________________________________________________________________
DOD--DODOASHA
27. [bull] EXPAND ELIGIBILITY OF SELECTED RESERVE MEMBERS UNDER THE
TRICARE PROGRAM
Priority:
Other Significant
Legal Authority:
10 USC Ch 55; 5 USC 301
CFR Citation:
32 CFR 199
Legal Deadline:
Final, Statutory, October 1, 2007, NDAA for FY07.
Abstract:
The proposal would expand the recently enacted Reserve health care
benefit for Reservists (called TRICARE Reserve Select) to allow all
members of the Selected Reserve to purchase their health care through
the Military Health System at the same low cost, regardless of the
member's duty status. Only members who are eligible for the Federal
Health Benefits program would be excluded from this benefit.
Participating Reserve Component members would be required to pay a
monthly premium of 28 percent of the cost of care for the TRICARE
Reserve Select plan and would be subject to the same deductibles,
copayments and other non-premium payments applicable to dependents of
active duty members who selected the same TRICARE option.
Statement of Need:
The Department of Defense (DoD) interim final rule identifies a process
to comply with the Congressional mandate that all members of the
Selected Reserve may be able to purchase their health care through the
Military Health System, regardless of the member's duty status.
Summary of Legal Basis:
This regulation is proposed under the authorities the National Defense
Authorization Act for Fiscal Year 2007.
Alternatives:
The interim final rule complies with the Congressional mandate. No
other alternatives are applicable.
Anticipated Cost and Benefits:
It is estimated that implementing the rule equates to national
incremental costs totaling less than $100 million per year.
Benefits include: Access to health care for all Reservists, regardless
of the member's duty status; however, at this time, the effect on
readiness, recruitment, and retention are not known.
Risks:
The degree of risk to the public is low.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Interim Final Rule 06/00/07
[[Page 72774]]
Interim Final Rule
Comment Period End 08/00/07
Final Action 09/00/07
Final Action Effective 10/00/07
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
Federal
Agency Contact:
Jody Donehoo
Department of Defense
Office of Assistant Secretary for Health Affairs
Defense Pentagon
Washington, DC 20301
Phone: 703 681-0039
RIN: 0720-AB05
BILLING CODE 5001-06-S
[[Page 72775]]
DEPARTMENT OF EDUCATION (ED)
Statement of Regulatory and Deregulatory Priorities
General
We support States, local communities, institutions of higher education,
and others in improving education Nationwide. Our roles include
providing leadership and financial assistance for education to
agencies, institutions, and individuals in situations in which there is
a national interest; such as ensuring that all students reach grade
level standards in reading/language arts and mathematics; monitoring
and enforcing Federal civil rights laws in programs and activities that
receive Federal financial assistance; and supporting research,
evaluation, and dissemination of findings to improve the quality of
education.
We administer programs that touch nearly every American at one point in
their lives--nearly 54 million students attending 93,000 elementary and
secondary schools in approximately 15,000 public school districts and
almost 22 million postsecondary students.
We have forged effective partnerships with customers and others to
develop policies, regulations, guidance, technical assistance, and
approaches to compliance. We have a record of successful communication
and shared policy development with affected persons and groups,
including parents, students, and educators; State, local, and tribal
governments; neighborhood groups, schools, colleges, rehabilitation
service providers, professional associations, advocacy organizations,
businesses, and labor organizations.
In particular, we continue to seek greater and more useful customer
participation in our rulemaking activities through the use of
consensual rulemaking and new technology. If we determine that the
development of regulations is necessary, we seek customer participation
at all stages in the rulemaking process. We invite the public to submit
comments on all proposed regulations through the Internet or by regular
mail.
We are continuing our efforts to streamline information collections,
reduce burden on information providers involved in our programs, and
make information maintained by us easily available to the public.
Initiatives
Among our initiatives is bringing No Child Left Behind to the high
school level. The President has called evidence of poor performance by
America's high schools ``a warning and a call to action.'' The
Administration's response is a comprehensive proposal that builds on
the stronger accountability of No Child Left Behind to improve the
quality of secondary education and ensure that every student not only
graduates from high school, but, also, graduates prepared to enter
college or the workforce with the skills to succeed. This initiative
includes creation of several new programs and significant funding
increases for existing programs that can have a major impact on
secondary education. The actual appropriations will depend on
congressional action. The appropriations may, in turn, result in
additional regulatory activities by the Department.
No Child Left Behind
The No Child Left Behind Act of 2001, which reauthorized the Elementary
and Secondary Education Act of 1965, increases accountability for
States, school districts, and schools; provides greater choice for
parents and students, particularly those attending low-performing
schools; provides more flexibility for States and local educational
agencies in the use of Federal education dollars; and places a stronger
emphasis on using scientifically based research to guide instruction,
especially in reading for our youngest children.
Each State (including Puerto Rico and the District of Columbia) has
submitted an accountability plan, which the Department approved. Each
State has used its respective plan to hold schools and school districts
accountable since 2002-03 for the academic achievement of all their
students, including students in specific subgroups such as students
with disabilities and limited English proficient (LEP) students.
Beginning with the 2005-06 school year, each State assessed students in
each of grades 3 through 8 and high school and used those results for
school and district accountability.
With respect to students with disabilities and LEP students, in
particular, the Department has initiated regulatory actions to address
unique issues in the implementation of No Child Left Behind. Our
current regulations permit a State to: (1) develop alternate
achievement standards for students with the most significant cognitive
disabilities; and (2) include those students' proficient and advanced
scores in determinations of adequate yearly progress (AYP), subject to
a cap of one percent of the number of students in a school district or
State.
We are also working on developing final regulations that would provide
further flexibility by permitting a State to develop modified
achievement standards and assessments for some students with
disabilities who are not included in the regulations that apply to
students with the most significant cognitive disabilities.
Finally, we have published final regulations to permit a State to: (1)
exempt LEP students new to schools in the United States from one
administration of the State's reading/language arts assessment,
provided the student takes an English language proficiency assessment;
and (2) include, for up to two years, former LEP students in the LEP
subgroup when making determinations of AYP.
We are continuing to focus on helping States place a highly qualified
teacher in every classroom; identifying schools and districts in need
of improvement and making sure they are getting the assistance they
need to get back on track; expanding the opportunities for eligible
students to receive tutoring and other supplemental educational
services; and helping districts create capacity in order to make public
school choice available to all eligible students who wish to change
schools.
We have recently peer-reviewed evidence of each State's standards and
aligned assessment systems that implement No Child Left Behind's
requirements for annual testing in reading/language arts and
mathematics in grades 3 through 8 and once in high school. These new
reading/language arts and mathematics standards and assessments had to
be in place by the end of the 2005-06 school year.
Regulatory and Deregulatory Priorities for the Next Year
The Individuals with Disabilities Education Improvement Act of 2004
(Pub. L. 108-446) made substantial changes to the Individuals with
Disabilities Education Act (IDEA). In addition to recently published
final regulations designed to improve implementation of the education
of children with disabilities program (including preschool services)
under part B, we plan to issue in 2007 a notice of proposed rulemaking
that would address issues in part B that were not covered by those
final regulations. Also, in early 2007 we expect to issue proposed
regulations to implement changes to the part C program--the
[[Page 72776]]
early intervention program for infants and toddlers with disabilities.
On July 3, 2006, we published interim final regulations, with a request
for comments, and on November 1, 2006, we published final regulations
implementing the Academic Competitiveness Grant (ACG) and National
Science and Mathematics Access to Retain Talent Grant (National SMART
Grant) programs. These regulations and amendments to regulations
governing other higher education programs were needed to implement
provisions of the HEA, as amended by the Higher Education
Reconciliation Act of 2005 (HERA), enacted on February 8, 2006.
The regulations specify the eligibility requirements for a student to
apply for and receive an award under these programs. The regulations
also identify the roles of institutions of higher education, State
educational agencies, and local educational agencies in administering
the programs.
The interim final regulations are effective for the 2006-07 award year.
The final regulations, which amend the interim final regulations, are
effective for the 2007-08 award year.
In addition, we published on August 9, 2006, interim final regulations,
with a request for comments, and on November 1, 2006, we published
final regulations amending various regulations for Federal student aid
programs authorized under title IV of the HEA. These regulations
implement changes to the HEA resulting from the HERA and reflect
provisions of the HERA that affect students, borrowers, and program
participants.
On August 18, the Department announced in the Federal Register our
intent to conduct negotiated rulemaking under title IV of the Higher
Education Act. As we indicated when we announced the interim final
regulations on July 3, we intend to develop proposed regulations for
the new ACG and National SMART Grant programs for the third and
subsequent years of implementation of these programs (that is,
beginning July 1, 2008).
We also intend to consider the recommendations of the Secretary's
Commission on the Future of Higher Education. The Commission released
its report on September 19, 2006. To the extent possible within the
existing statutory framework of the HEA, the negotiated rulemaking
process could be used to address the recommendations of the Commission
for changes that could reduce regulatory burden; improve the
administration of the Department's programs authorized by title IV of
the HEA, including the Federal student aid programs; and improve the
quality of information on cost, price, and student outcomes available
to students and their families.
We expect that the negotiated rulemaking process will address other
regulatory issues, including issues raised by the public during the
regional hearings; issues resulting from changes made, other than those
relating to the ACG and National SMART Grant programs, by the HERA; and
items that have been identified by the Department as needed to improve
program administration and accountability.
Other Potential Regulatory Activities
Recent reauthorization of the Carl D. Perkins Vocational and Technical
Education Act of 1998 might result in regulatory activities by the
Department. The reauthorization made changes designed to improve the
State grant and other programs providing assistance under this statute
and to help States and local communities strengthen career and
technical education and improve educational opportunities for career
and technical education students. In working with Congress on the
reauthorization, the Administration has emphasized student achievement,
particularly the academic achievement of career and technical education
students, and increasing accountability and program quality.
Congress also is considering legislation to reauthorize the Adult
Education and Family Literacy Act (AEFLA) (title II of the Workforce
Investment Act of 1998)--including the National Institute for Literacy-
-and the Rehabilitation Act of 1973. The Administration is working with
Congress to ensure that any changes to these laws improve and
streamline the State grant and other programs providing assistance for
adult basic education under the AEFLA and for vocational rehabilitation
and independent living services for persons with disabilities under the
Rehabilitation Act of 1973, and that they provide greater
accountability in the administration of programs under both statutes.
During the coming year other regulations may be necessitated by
legislation or programmatic experience. In developing and promulgating
any additional regulations we will be guided by the following
Principles for Regulating:
Principles for Regulating
Our Principles for Regulating 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 any regulations or with
only limited regulations.
We will regulate only if regulating improves the quality and equality
of services to our customers, learners of all ages. We will regulate
only if absolutely necessary and then in the most flexible, most
equitable, and least burdensome way possible.
When regulating, we consider:
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 to be regulated are so diverse
that a uniform approach does more harm than good.
How to regulate:
Regulate no more than necessary.
Minimize burden and promote multiple approaches to meeting
statutory requirements.
Encourage federally funded activities to be integrated with
State and local reform activities.
Ensure that benefits justify costs of regulation.
Establish performance objectives rather than specify
compliance behavior.
Encourage flexibility so institutional forces and incentives
achieve desired results.
BILLING CODE 4000-01-S
[[Page 72777]]
DEPARTMENT OF ENERGY (DOE)
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;
Foster energy efficiency and conservation;
Provide responsible stewardship of the Nation's nuclear
weapons;
Clean up the Department's sites and facilities, which include
sites dating back to the Manhattan Project;
Lead in the physical sciences and advance the biological,
environmental and computational sciences; and
Provide premier instruments of science for the Nation's
research enterprise.
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 implement provisions of the
Energy Policy Act of 2005 (EPACT 2005). 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 Act of 2005, enacted on August 8, 2005, had a
significant impact on the Department's priorities for its rulemaking
activities related to energy efficiency standards, test procedures, and
determinations. EPACT 2005 not only added new products to those already
covered by the Energy Policy and Conservation Act (EPCA), but it also
affects ongoing rulemakings. On October 18, 2005, DOE published a
technical amendment to place in the Code of Federal Regulations the
energy conservation standards, and related definitions, that Congress
prescribed in EPACT 2005 for certain consumer products and commercial
and industrial equipment. In addition, on July 25, 2006, DOE published
a Notice of Proposed Rulemaking (NOPR) to provide for new Federal
energy efficiency and water conservation test procedures, and related
definitions, for certain consumer products and certain commercial and
industrial equipment under EPACT 2005. Consistent with EPACT 2005, the
Department intends to continue its work on adoption of amended energy
efficiency standards for residential furnaces and boilers and on new
standards for electric distribution transformers.
On January 31, 2006, the Department released a schedule for setting new
appliance efficiency standards that will save American consumers
billions of dollars in energy costs. The five-year plan outlines how
DOE will address the appliance standards rulemaking backlog and meet
the statutory requirements established in the EPCA and EPACT 2005. The
statutes require DOE to set appliance efficiency standards at levels
that achieve the maximum improvement in energy efficiency that is
technologically feasible and economically justified. Standards already
in place for residential products are expected to save consumers nearly
$93 billion by 2020, and to save enough energy to operate all U.S.
homes for approximately two years.
The five-year plan, which was developed considering the public comments
received on the appliance standards program, provides for the issuance
of one rulemaking for each of the 18 products in the backlog. The plan
also provides for setting appliance standards for products required
under EPACT 2005. The Department is aggressively implementing process
improvements to speed up the development and issuance of appliance
standards rules.
The overall plan for implementing the schedule is contained in the
Report to Congress under section 141 of EPACT 2005, which was released
January 31, 2006. The report and schedule is posted at: http://
www.eere.energy.gov/buildings/appliance--standards/2006--schedule--
setting.html. The report identifies all products for which DOE has
missed the deadlines established in EPCA (42 U.S.C. Sec. 6291 et
seq.). It also describes the reasons for such delays and the
Secretary's plan for expeditiously prescribing new or amended
standards. The first semi-annual update to the report was released
August 10, 2006. Information and timetables concerning these actions
can also be found in the Department's Regulatory Agenda, which appears
elsewhere in this issue of the Federal Register.
Nuclear Safety Regulations
The Department is committed to openness and public participation as it
addresses one of its greatest challenges--managing the environment,
health, and safety risks posed by its nuclear activities. A key element
in the management of these risks is to establish the Department's
expectations and requirements relative to nuclear safety and to hold
its contractors accountable for safety performance. The 1988 Price-
Anderson Amendments Act revisions to the Atomic Energy Act of 1954
(AEA) provide for the imposition of civil and criminal penalties for
violations of DOE nuclear safety requirements. As a result, new nuclear
safety requirements were initiated with the publication of four notices
of proposed rulemaking for review and comment in 1991. The Department's
nuclear safety procedural regulations (10 CFR part 820) were published
as a final rule in 1993. The Department's substantive nuclear safety
requirements (10 CFR parts 830 and 835) were finalized in 2001 and
1998, respectively. In February 2006, the Department issued a final
rule adding a new part, 10 CFR 851, Worker Safety and Health, that
established basic requirements to ensure workers are protected from
safety and health hazards at DOE facilities. The remaining action, 10
CFR part 834, Radiation Protection of the Public and the Environment,
is scheduled for completion in 2008.
Loan Guarantees
Title XVII of the Energy Policy Act of 2005 (42 U.S.C. 16511-16514)
authorizes the Secretary of Energy to issue loan guarantees for energy
related projects that ``avoid, reduce, or sequester air pollutants or
anthropogenic emissions of greenhouse gases; and employ new or
significantly improved technologies as compared to commercial
technologies in service in the United States at the time the guarantee
is issued.'' By reducing the financial risk of these innovative
technologies, DOE hopes to facilitate their advancement to market. DOE
believes that accelerated commercial use of new or improved
technologies will help to sustain economic growth, yield environmental
benefits, and produce a more stable and secure energy supply. DOE is
committed to openness and public participation as it develops rules and
criteria for loan guarantees and promptly will be taking action to
[[Page 72778]]
promulgate such rules. The Department intends to publish a notice of
proposed rulemaking in December 2006.
_______________________________________________________________________
DOE--Energy Efficiency and Renewable Energy (EE)
-----------
PRERULE STAGE
-----------
28. ENERGY CONSERVATION STANDARDS FOR RESIDENTIAL ELECTRIC AND GAS
RANGES AND OVENS AND MICROWAVE OVENS, DISHWASHERS, DEHUMIDIFIERS, AND
COMMERCIAL CLOTHES WASHERS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
Undetermined
Legal Authority:
42 USC 6295(g) to (h)(cc); 42 USC 6313(e)
CFR Citation:
10 CFR 430
Legal Deadline:
Final, Statutory, January 1, 1997.
Abstract:
The Department is committed to becoming current on all energy standards
rulemakings, including the current standards for residential electric
and gas ranges and ovens, microwave ovens, dishwashers, dehumidifiers,
and commercial clothes washers. The EPACT 2005 amendments to EPCA,
established initial energy efficiency standard level for commercial
clothes washers.
Statement of Need:
The Department may determine that separate rulemakings may be warranted
for some of these individual products or equipment.
Alternatives:
EPCA, as amended, requires DOE to conduct rulemaking to review
standards and to revise standards to achieve the maximum improvement in
energy efficiency that the Secretary determines is technically feasible
and economically justified. In making this determination, DOE conducts
a thorough analysis of alternative standard levels, including the
existing standard, based on criteria specified in the statute.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
ANPRM 08/00/07
NPRM 07/00/08
Final Action 03/00/09
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Local, State
Federalism:
Undetermined
Additional Information:
Merged dishwashers from RIN 1904-AA89 and added residential
dehumidifiers and commercial clothes washers.
Agency Contact:
Bryan Berringer, EE-2J
Office of Building Technologies Program
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-0371
Fax: 202 586-4617
Email: [email protected]
Related RIN: Merged with 1904-AA89
RIN: 1904-AB49
_______________________________________________________________________
DOE--EE
29. ENERGY EFFICIENCY STANDARDS FOR COMMERCIAL REFRIGERATION EQUIPMENT
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
42 USC 6313(c)
CFR Citation:
10 CFR 431
Legal Deadline:
Final, Statutory, January 1, 2009.
Abstract:
The EPACT 2005 amendments to EPCA require that standards be established
for ice cream freezers; self-contained commercial refrigerators,
freezers, and refrigerator-freezers without doors; and remote-
condensing commercial refrigerators, freezers, and refrigerator-
freezers.
Statement of Need:
EPCA, as amended, requires that DOE set energy efficiency standards
that are technologically feasible and economically justified.
Summary of Legal Basis:
The EPACT 2005 amendments to EPCA authorize DOE to establish energy
conservation standards for commercial refrigeration equipment.
Alternatives:
EPCA, as amended, requires DOE to conduct rulemaking to review
standards and to revise standards to achieve the maximum improvement in
energy efficiency that the Secretary determines is technically feasible
and economically justified. In making this determination, DOE conducts
a thorough analysis of alternative standard levels, based on criteria
specified by statute.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
ANPRM 07/00/07
NPRM 05/00/08
Final Action 01/01/09
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
None
Agency Contact:
Charles Llenza, EE-2J
Office of Building Technologies Program
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-2192
Email: [email protected]
RIN: 1904-AB59
_______________________________________________________________________
DOE--EE
-----------
PROPOSED RULE STAGE
-----------
30. ENERGY EFFICIENCY STANDARDS FOR RESIDENTIAL FURNACES AND BOILERS
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
42 USC 6295(f)
CFR Citation:
10 CFR 430
Legal Deadline:
Final, Statutory, January 1, 1994.
[[Page 72779]]
Abstract:
The Energy Policy and Conservation Act (EPCA), as amended, establishes
initial energy efficiency standard levels for most types of major
residential appliances and generally requires DOE to undertake two
subsequent rulemakings, at specified times, to determine whether the
extant standard for a covered product should be amended.
This is the initial review of the statutory standards for residential
furnaces and boilers.
Statement of Need:
Experience has shown that the choice of residential appliances and
commercial equipment being purchased by both builders and building
owners is generally based on the initial cost rather than on life-cycle
costs. Thus, the law requires minimum energy efficiency standards for
appliances to eliminate inefficient appliances and equipment from the
market.
Summary of Legal Basis:
EPCA establishes initial energy efficiency standard levels for most
types of major residential appliances and certain commercial equipment.
EPCA generally requires DOE to undertake rulemakings, at specified
times, to determine whether the standard for a covered product should
be made more stringent. EPACT 2005 amended EPCA to authorize the
Department to set standards for electricity used in furnaces to
circulate air through duct work. Section 135(c).
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 criteria specified by
statute.
Anticipated Cost and Benefits:
The specific costs and benefits for this rulemaking have not been
established because the final standard levels have not been determined.
Nevertheless, existing analysis from the Advance Notice of Proposed
Rulemaking for energy conservation standards for furnace and boilers
projects saving between 0.28 and 9.29 quadrillion BTUs of energy from
2012 to 2035, with a national financial impact on the consumer in terms
of national Net Present Value (NPV) ranging from $0.1 to $3.2 billion.
(69 FR 45420)
Risks:
At higher efficiency levels, consumers risk unintended condensation of
flue gases, whereas, without changes to the existing furnace and boiler
standards, energy use and energy costs for consumers will continue to
increase. Enhancing appliance energy efficiency also reduces
atmospheric emissions such as CO2 and NOx. Establishing standards that
are too stringent could result in excessive increases in the cost of
the product and possible reductions in product utility. It might also
place an undue burden on manufacturers that could result in loss of
jobs or other adverse economic impacts.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
ANPRM 09/08/93 58 FR 47326
ANPRM 07/29/04 69 FR 45419
ANPRM Comment Period End 11/10/04
NPRM 10/06/06 71 FR 59204
NPRM Comment Period End 01/15/07
Final Action 09/00/07
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Local, State
Agency Contact:
Mohammed Kahn EE-2J
Department of Energy
Energy Efficiency and Renewable Energy
Office of Building Technologies Program
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-7892
Email: [email protected]
RIN: 1904-AA78
_______________________________________________________________________
DOE--EE
-----------
FINAL RULE STAGE
-----------
31. ENERGY EFFICIENCY STANDARDS FOR ELECTRIC DISTRIBUTION TRANSFORMERS
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
42 USC 6317(a)(2)
CFR Citation:
10 CFR 431
Legal Deadline:
Final, Statutory, October 24, 1996.
Abstract:
Prior to enactment of EPACT 2005, the Energy Policy and Conservation
Act, as amended, (EPCA) did not establish energy efficiency standards
for electric distribution transformers. EPCA directed DOE to determine
whether standards for electric distribution transformers were
warranted. However, as a result of amendments adopted in EPACT 2005,
Public Law No. 109-58, section 135(c)(4), EPCA now contains standards
for low voltage dry-type electric distribution transformers, but not
other types of distribution transformers. This rulemaking will
determine whether it is appropriate to establish standards for these
other types of electric distribution transformers.
Statement of Need:
Experience has shown that the choice of residential appliances and
commercial equipment being purchased by both builders and building
owners is generally based on the initial cost rather than on life-cycle
cost. Thus, the law requires minimum energy efficiency standards for
appliances to eliminate inefficient appliances and equipment from the
market.
Summary of Legal Basis:
EPCA authorizes the Department to establish energy conservation
standards for various consumer products and commercial and industrial
equipment, including distribution transformers, if DOE determines that
energy conservation standards would be technologically feasible and
economically justified, and would result in significant energy savings.
Title III of EPCA sets forth a variety of provisions designed to
improve energy efficiency. Part C of title III, 42 U.S.C. 6311 to 6317,
establishes a program for ``Certain Industrial Equipment,'' similar to
the one for consumer products in part B, and includes distribution
transformers. Since EPACT 2005, Public Law No. 109-58, section 135(c),
establishes energy conservation standards for one group of
transformers, low-voltage, dry-type distribution transformers, that
category will no longer be covered by this rulemaking.
Alternatives:
The statute requires DOE to conduct rulemakings to review standards and
to
[[Page 72780]]
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 alternative standard levels,
including the existing standard, based on criteria specified by
statute.
Anticipated Cost and Benefits:
The specific costs and benefits for this rulemaking have not been
established because the final standard levels have not been determined.
Nevertheless, existing analysis from the Notice of Proposed Rulemaking,
71 FR 44356, for energy conservation standards for distribution
transformers projects savings of 2.4 quadrillion BTUs of energy from
2010 to 2038, with a national financial impact on the consumer in terms
of national Net Present Value (NPV) up to 2.5 billion dollars.
Risks:
At higher efficiency levels, the limited availability of some core
steels is an important issue. Other issues that pose some risks include
significant capital investment requirements, core processing equipment,
retooling, and R&D. Establishing standards that are too stringent could
result in excessive increases in the cost of the product, with possible
reductions in product utility (larger/bulkier/heavier transformers),
with additional pressure on some manufacturers to move production out
of the U.S. and a possible risk that some small manufacturers would
exit.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Determination Notice 10/22/97 62 FR 54809
ANPRM 07/29/04 69 FR 45375
ANPRM Comment Period End 11/09/04
NPRM 08/04/06 71 FR 44356
NPRM Comment Period End 10/13/06
Final Action 09/00/07
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
None
Agency Contact:
Antonio Bouza, EE-2J
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-4563
Fax: 202 586-4617
Email: [email protected]
RIN: 1904-AB08
_______________________________________________________________________
DOE--EE
32. ENERGY EFFICIENCY STANDARDS FOR CEILING FAN LIGHT KITS
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
42 USC 6295(ff)(4)
CFR Citation:
10 CFR 430
Legal Deadline:
Final, Statutory, January 1, 2007.
Abstract:
The EPACT 2005 amendments to EPCA require that DOE establish standards
for ceiling fan light kits (other than those with prescribed standards
in EPACT 2005) by January 1, 2007. If DOE does not meet this deadline,
EPACT 2005 specifies that the energy consumption levels in 42 U.S.C.
6295 (ff)(4)(C) go into effect for products manufactured after January
1, 2009.
Statement of Need:
EPCA, as amended, require DOE to set appliance efficiency standards at
technologically feasible and economically justified levels.
Summary of Legal Basis:
The EPACT 2005 amendments to EPCA authorize DOE to establish energy
conservation standards for ceiling fan light kits.
Alternatives:
The statute requires DOE to conduct rulemaking 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 alternative standard levels, including the
existing standard, based on criteria specified by statute. Pursuant to
EPACT 2005, if DOE does not complete the required rulemaking by January
1, 2007, energy efficiency levels specified in the statute go into
effect for covered products manufactured after January 1, 2009.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
Legislative Date for
Final Rule 01/00/07
Standards Effective Date
(for products
manufactured after
01/01/2009) 01/01/09
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
None
Additional Information:
DOE will not complete the required rulemaking by January 1, 2007. Thus,
the statutory standards specified in 42 U.S.C. 6295 (ff)(4)(C) will go
into effect for products manufactured after January 1, 2009.
Agency Contact:
Linda Graves, EE-2J
Office of Building Technologies Program
Department of Energy
Energy Efficiency and Renewable Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-1851
Email: [email protected]
RIN: 1904-AB61
_______________________________________________________________________
DOE--Departmental and Others (ENDEP)
-----------
PROPOSED RULE STAGE
-----------
33. [bull] LOAN GUARANTEES FOR PROJECTS THAT EMPLOY INNOVATIVE
TECHNOLOGIES
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
42 USC 16511; 42 USC 16514
CFR Citation:
Not Yet Determined
Legal Deadline:
None
Abstract:
Title XVII of the Energy Policy Act of 2005 authorizes the Secretary of
[[Page 72781]]
Energy, after consultation with the Secretary of the Treasury, to make
loan guarantees for projects that ``avoid, reduce, or sequester air
pollutants or anthropogenic emissions of greenhouse gases; and employ
new or significantly improved technologies as compared to commercial
technologies in service in the United States at the time the guarantee
is issued.'' Following publication of guidelines to govern an initial
solicitation of projects seeking Federal loan guarantees in August
2006, this proposed rulemaking will establish policies and procedures
applicable to all subsequent solicitations for project proposals. The
default and audit provisions of the proposed rulemaking, however, will
be applicable to all solicitations.
Statement of Need:
A principal purpose of the loan guarantee program is to encourage early
commercial use in the United States of new or significantly improved
technologies in energy projects. By facilitating the employment of such
technologies, we can meet the principal energy challenges of enhancing
energy security, repairing and modernizing our energy infrastructure,
promoting energy conservation, and increasing our energy supplies in
ways that protect and improve the environment.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 12/00/06
Final Action 10/00/07
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Warren Belmar
Deputy General Counsel for Energy Policy
Department of Energy
1000 Independence Avenue, SW.
Washington, DC 20585
Phone: 202 586-6758
Email: [email protected]
RIN: 1901-AB21
_______________________________________________________________________
DOE--ENDEP
-----------
FINAL RULE STAGE
-----------
34. RADIATION PROTECTION OF THE PUBLIC AND THE ENVIRONMENT
Priority:
Other Significant
Legal Authority:
42 USC 2201; 42 USC 7191
CFR Citation:
10 CFR 834
Legal Deadline:
None
Abstract:
This action would add a new 10 CFR 834 to DOE's regulations
establishing a body of rules setting forth the basic requirements for
ensuring radiation protection of the public and environment in
connection with DOE nuclear activities. These requirements stem from
the Department's ongoing effort to strengthen the protection of health,
safety, and the environment from the nuclear and chemical hazards posed
by these DOE activities. Major elements of the proposal include a dose
limitation system for protection of the public; requirements for
application optimization (As Low As is Reasonably Achievable, ALARA)
process; requirements for liquid discharges; reporting and monitoring
requirements; and residual radioactive material requirements.
Statement of Need:
The purpose of this rule is to ensure that the Department's obligation
to protect health and safety is fulfilled and to provide, if needed, a
basis for the imposition of civil and criminal penalties consistent
with the Price-Anderson Amendments Act of 1988. This action is
consistent with the Department's commitment to the issuance of nuclear
safety requirements using notice and comment rulemaking.
Summary of Legal Basis:
Under the Atomic Energy Act of 1954, as amended, the Department of
Energy has the authority to regulate activities at facilities under its
jurisdiction. The Department is committed to honoring its obligation to
ensure the health and safety of the public and workers affected by its
operations and the protection of the environs around its facilities.
Alternatives:
The Department could continue to impose nuclear safety requirements
through directives made applicable to DOE contractors through the terms
of their contracts.
Anticipated Cost and Benefits:
The incremental costs of the proposed rules should be minimal because
contractors are currently bound by comparable contractual obligations.
Full compliance by contractors with nuclear safety standards will
result in substantial societal benefits.
Risks:
This rulemaking should reduce the risk of nuclear safety problems by
clarifying safety requirements applicable to DOE contractors and
improving compliance.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 03/25/93 58 FR 16268
Second NPRM 08/31/95 60 FR 45381
Second NPRM Comment
Period End 10/02/95
Integrate New EPA
Guidance 12/00/06
Final Action 10/00/08
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
Federal
Additional Information:
The Environmental Protection Agency (EPA) is considering revising the
Federal Guidance for Radiation Protection of the Public. This
Presidential-level guidance would refine the radiation protection and
dose limitation framework for the public, and may include numerical
Radiation Protection Goals (i.e., dose limits). Because it is DOE's
preference to be consistent with Federal radiation protection policy,
the Department is adjusting the schedule for part 834 in anticipation
of revised Federal Guidance and will issue the rule following EPA
action on the guidance. This will allow DOE to be consistent with the
most current Presidential-level guidance upon its release.
[[Page 72782]]
Agency Contact:
Andrew Wallo III
Director, Office of Air, Water and Radiation Protection, Policy and
Guidance
Department of Energy
1000 Independence Avenue SW.
Washington, DC 20585
Phone: 202 586-4996
Fax: 202 586-3915
RIN: 1901-AA38
BILLING CODE 6450-01-S
[[Page 72783]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Statement of Regulatory Priorities
The Department of Health and Human Services (HHS) conducts a broad
range of programs mandated by Congress to protect and promote the
health and well-being of all Americans, focused especially on those
least able to help themselves. HHS responsibilities include: Medicare,
Medicaid, support for public health preparedness, biomedical research,
substance abuse and mental health treatment, assurance of safe and
effective drugs and other medical products, food safety, financial
assistance to low income families, Head Start, services to older
Americans, and direct health services delivery.
Since assuming the leadership of HHS, Secretary Michael O. Leavitt has
consistently sought to make transparent his approach to overseeing the
Department's programs, through his use of a 500-Day Plan and a recent
statement of his nine major priorities. The 500-Day Plan and the
statement of priorities are available for public review at http://
www.hhs.gov/secretaryspage.html. The regulatory actions noted below
reflect this policy framework.
Health Information Technology
The Secretary's strategy for promoting improvements in the Nation's
health sector stresses maximum use of electronic information
technology. The FY 2007 Regulatory Plan accordingly includes a notice
of proposed rulemaking to require that clinical study data be provided
to the Food and Drug Administration (FDA) in electronic format, using
standard data structures, terminology, and code sets. The change would
further increase the efficiency of the agency's review processes,
speeding up the availability of new therapies. Additionally, the Plan
includes: proposed actions to require medical-device firms to register
electronically with the FDA, as well as to report post-marketing
information to the agency electronically; and a proposal for the
adoption of final standards for the electronic transmission of basic
prescription-drug data.
Medicare Modernization
The Secretary's statement of priorities includes a focus on Medicare
modernization. The Regulatory Plan, accordingly, highlights:
a proposal to institute competitive bidding procedures to
improve the effectiveness of Medicare's current methodology
for setting payment amounts for durable medical equipment;
and
final rules for hospital inpatient services for fiscal year
2008 and for long-term-care hospital services for rate year
2008.
Medicare Part D
The Secretary believes that every senior must have access to affordable
prescription drugs, and that a reinforced regulatory framework for
implementing the Medicare prescription drug benefit can further connect
beneficiaries with the Part D program. The Plan accordingly includes a
proposal to clarify current provisions affecting Part D Prescription
Drug Plan sponsors and Medicare Advantage organizations, and the above-
cited proposal for the adoption of final standards for the electronic
transmission of basic prescription-drug data.
Disease Prevention
Also included among the Secretary's priorities is an emphasis on
disease prevention and the need for individual responsibility for
personal wellness. Three actions in the Plan reflect this concern:
a final rule establishing good manufacturing practices for the
dietary-supplement products favored by many Americans;
a proposal to modify prescription drug labeling so that health
care providers may better understand and communicate to
their patients the risks and benefits associated with the
use of prescribed medicines during pregnancy and lactation,
and
a proposal to amend existing regulations governing
investigational new drugs -- the rule would delineate new
avenues of access for patients to obtain investigational
drugs for treatment use.
Food Safety
The Secretary's 500-Day Plan also embraces the need to secure the
homeland. The Regulatory Plan thus includes:
a proposal to require owners or consignees to label imported
food that has previously been refused entry into the United
States. This action would prevent the introduction of
unsafe food and facilitate the examination of imported
food; and
a final rule completing the rulemaking process requiring that
the FDA be notified prior to the entry of imported food
into the United States.
_______________________________________________________________________
HHS--Centers for Disease Control and Prevention (CDC)
-----------
FINAL RULE STAGE
-----------
35. CONTROL OF COMMUNICABLE DISEASES, INTERSTATE AND FOREIGN QUARANTINE
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
Not Yet Determined
CFR Citation:
42 CFR 70; 42 CFR 71
Legal Deadline:
None
Abstract:
By statute, the Secretary of Health and Human Services has broad
authority to prevent introduction, transmission, and spread of
communicable diseases from foreign countries into the United States and
from one State or possession into another. Quarantine regulations are
divided into two parts: Part 71 dealing with foreign arrivals and part
70 dealing with interstate matters. The Secretary has delegated the
authority to prevent the introduction of diseases from foreign
countries to the Director, CDC. CDC maintains quarantine stations at
eight major airports with quarantine inspectors who respond to reports
of diseases from carriers. According to the statutory scheme, the
President determines through Executive order which diseases may subject
individuals to quarantine. The current disease list, which was last
updated in April 2005, includes cholera, diphtheria, tuberculosis,
plague, smallpox, yellow fever, viral hemorrhagic fevers, and Severe
Acute Respiratory Syndrome (SARS) and influenza caused by novel or
reemergent influenza virus that are causing, or have the potential to
cause, a pandemic.
Statement of Need:
The quarantine of persons believed to be infected with communicable
diseases is a long-term prevention measure that has been used
effectively to contain the spread of disease. As diseases evolve due to
natural
[[Page 72784]]
occurrences or man-made events, it is important to ensure that
prevention procedures reflect new threats and uniform ways to contain
them. Recent experiences with emerging infectious diseases such as West
Nile Virus, SARS, and monkeypox have illustrated the rapidity with
which disease may spread throughout the world, and the impact
communicable diseases, when left unchecked, may have on the global
economy. Stopping an outbreak -- whether it is naturally occurring or
intentionally caused -- requires the use of the most rapid and
effective public health tools available. One of those tools is
quarantine -- restricting the movement of persons exposed to infection
to prevent them from infecting others, including family members,
friends, and neighbors. Quarantine of exposed persons may be the best
initial way to prevent the uncontrolled spread of highly dangerous
biologic agents -- especially when combined with other health
strategies such as vaccination, prophylactic drug treatment, patient
isolation, and other appropriate infection control measures.
Summary of Legal Basis:
These regulations would be proposed under the authority of 25 U.S.C.
198, 231, 2001; 42 U.S.C. 243, 264 to 271. In addition, section 361(b)
of the Public Health Service Act (42 U.S.C. 264(b)) authorizes the
``apprehension, detention, or conditional release'' of persons to
prevent the introduction, transmission, and spread of specified
communicable diseases from foreign countries into the United States and
from one State or possession into another. Among other public health
powers, the lawful ability to inspect property, to medically examine
and monitor persons, and to detain or quarantine exists in current
regulations. Acknowledging the critical importance of protecting the
public's health, long-standing court decisions uphold the ability of
Congress and State legislatures to enact quarantine and other public
health laws, and to have them executed by public health officials.
Alternatives:
These regulations are necessary to ensure that HHS has the tools it
needs to respond to public health emergencies and disease threats. Any
less stringent alternatives would prevent the Department from the most
effective possible pursuit of this objective.
Anticipated Cost and Benefits:
The primary cost impact of the proposed rule would be the collection
and maintenance of crew and passenger manifest data by air and water
carriers that are likely to modify computer systems and collect
passenger information to come into compliance. The benefits of the rule
would be measured in terms of the number of deaths and illnesses
prevented by rapid intervention. When the costs and benefits of the
rule are considered over a 20-year period benefits clearly outweigh
costs.
Risks:
Failure to move forward with this rulemaking would hinder the Nation's
ability to use the most rapid and effective public health tools
available when responding to public health emergencies and disease
threats.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 11/30/05 70 FR 71892
Final Action 08/00/07
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Ram Koppaka M.D., Ph.D
Department of Health and Human Services
Centers for Disease Control and Prevention
MS-E-03
1600 Clifton Road
Atlanta, GA 30333
Phone: 404 498-2308
RIN: 0920-AA12
_______________________________________________________________________
HHS--Food and Drug Administration (FDA)
-----------
PROPOSED RULE STAGE
-----------
36. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS
AND BIOLOGICS
Priority:
Other Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
21 USC 355; 21 USC 371; 42 USC 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. The proposal would also require the
use of standardized data structure, terminology, and code sets
contained in current FDA guidance (the Study Data Tabulation Model
(SDTM) developed by the Clinical Data Interchange Standards Consortium)
to allow for more efficient and comprehensive data review.
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 require the submission of study data in a
standardized electronic format, and it provides that the specific
format will be announced in FDA guidance. 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.
[[Page 72785]]
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
(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 two-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 saving to industry would be small.
Anticipated Cost and Benefits:
Approximately 70 percent of study data for NDAs and ANDAs are already
submitted to FDA in electronic format consistent with our current
guidance on electronic submission of data. The other 30 percent is
either submitted on paper or in non-standardized electronic format. FDA
estimates that the costs to industry resulting from the proposal would
include some one-time costs 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 for industry,
including improved patient safety through faster, more efficient,
comprehensive, and accurate data review; enhanced communication among
sponsors and clinicians.
Risks:
None.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 03/00/07
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
Office of Regulatory Policy
5515 Security Lane, Suite 1101 (HFD-7)
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301-827-5562
Email: [email protected]
RIN: 0910-AC52
_______________________________________________________________________
HHS--FDA
37. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND
BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING
Priority:
Other Significant
Legal Authority:
21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21
USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21
USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264
CFR Citation:
21 CFR 201.56; 21 CFR 201.57; 21 CFR 201.80
Legal Deadline:
None
Abstract:
To amend the regulations governing the format and content of labeling
for human prescription drugs and biological products (21 CFR 201.56,
201.57, and 201.80).
Statement of Need:
Under FDA's current regulations, labeling concerning the use of
prescription drugs in pregnancy uses letter categories (A, B, C, D, X)
to characterize the risk to the fetus of using the drug during
pregnancy. Dissatisfaction with the category system has been expressed
by health care providers, medical organizations, experts in the study
of birth defects, women's health researchers, and women of childbearing
age. These stakeholders have expressed the view that the current
categories are confusing and overly simplistic and thus are not
adequate to communicate risks effectively. One of the deficiencies of
the category system is that drugs may be assigned to the same category
when the severity, incidence, and types of risk are quite different.
Stakeholders consulted through a public hearing, several focus groups,
and several advisory committees have recommended that FDA replace the
category system with a concise narrative summarizing a product's risks
to pregnant women and to women of childbearing age. It has also been
strongly recommended that pregnancy labeling address the situation
where a woman has taken drugs before she realizes she is pregnant. The
labeling that would be required under the proposed rule would be
responsive to the concerns discussed above, and others that have been
expressed by critics of the current category system.
Summary of Legal Basis:
FDA has broad authority under sections 201, 301, 501, 502, 503, 505,
and 701 of the Federal Food, Drug, and Cosmetic Act (the Act) (21
U.S.C. 321, 331, 351,352, 353, 355, and 371) and section 351 of the
Public Health Service Act (42 U.S.C. 262) to help ensure that
prescription drugs (including biological products that are regulated as
drugs) are safe and effective for their intended uses. A major part of
FDA's efforts concerning the safe and effective use of drug products
involves review, approval, and monitoring of drug labeling. Under
section 502(f)(1) of the Act, a drug is misbranded unless its labeling
bears ``adequate directions for use'' or it is exempted from this
requirement by regulation. Under section 201.100 (21 CFR 201.100), a
prescription drug is exempted from the requirement in section 502(f)(1)
of the Act only if, among other things, it contains the information
required and in the format specified by sections 201.56 and 201.57.
[[Page 72786]]
Under section 502(a) of the Act, a drug product is misbranded if its
labeling is false or misleading in any particular. Under section 505(d)
and 505(e) of the Act, FDA must refuse to approve an application or may
withdraw approval of an application if the labeling for the drug is
false or misleading in any particular. Section 201(n) of the Act
provides that in determining whether the labeling of a drug is
misleading, there shall be taken into account not only representations
or suggestions made in the labeling, but also the extent to which the
labeling fails to reveal facts that are material in light of such
representations or material with respect to consequences which may
result from use of the drug product under the conditions of use
prescribed in the labeling or under customary conditions of use.
These statutory provisions, combined with section 701(a) of the Act and
section 351 of the Public Health Service Act, clearly authorize FDA to
publish a proposed rule designed to help ensure that practitioners
prescribing drugs (including biological products) to pregnant women and
women of childbearing age would receive information essential to the
safe and effective use of these drugs.
Alternatives:
The alternatives to the proposal include not amending our existing
regulation governing the format and content of labeling for human
prescription drugs and biological products. This alternative is
inconsistent with widespread stakeholder dissatisfaction with the
pregnancy labeling provided pursuant to the current regulation.
Anticipated Cost and Benefits:
The proposed rule would impose one-time costs for firms to modify drug
product labeling. The extent of these modifications would depend on
whether a product's labeling is affected by the physician labeling
final rule (PLR) and on the scope of the implementation.
The revised format and the information provided in the labeling would
make it easier for health care providers to understand the risks and
benefits of drug use during pregnancy and lactation. A better
understanding of risks and benefits would help women and their
healthcare providers make informed decisions about whether or not to
use drugs during pregnancy and lactation. Labeling under the rule would
also provide information geared to women who took drugs before they
knew they were pregnant. Such information may often be reassuring to
women and their health care providers.
Risks:
None.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 03/00/07
Regulatory Flexibility Analysis Required:
Undetermined
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Christine F. Rogers
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
5515 Security Lane
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AF11
_______________________________________________________________________
HHS--FDA
38. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE
Priority:
Other Significant
Legal Authority:
21 USC 355; 21 USC 360bbb; 21 USC 371; 42 USC 262
CFR Citation:
21 CFR 312.42; 21 CFR 312.300; 21 CFR 312.305; 21 CFR 312.310; 21 CFR
312.315; 21 CFR 312.320
Legal Deadline:
None
Abstract:
To amend the regulations governing investigational new drugs to
describe the ways patients may obtain investigational drugs for
treatment use under expanded access programs. Such use of
investigational drugs would be available to: (1) Individual patients,
including in emergencies; (2) intermediate size patient populations;
and (3) larger populations under a treatment protocol or treatment IND.
Statement of Need:
The Food and Drug Administration Modernization Act of 1997
(Modernization Act) amended the Federal Food, Drug, and Cosmetic Act
(the Act) to include specific provisions concerning expanded access to
investigational drugs for treatment use. In particular, section 561(b)
of the Act permits any person, acting through a licensed physician, to
request access to an investigational drug to diagnose, monitor, or
treat a serious disease or condition provided that a number of
conditions are met. The proposed rule is needed to incorporate into
FDA's regulations this and other provisions of the Modernization Act
concerning access to investigational drugs.
In addition, by this proposed rule, the Agency seeks to increase
awareness and knowledge of expanded access programs and the procedures
for obtaining investigational drugs for treatment use. The proposed
rule would assist in achieving this goal by describing in detail the
criteria, submission requirements, and safeguards applicable to
different types of treatment uses.
Summary of Legal Basis:
FDA has the authority to impose requirements concerning the treatment
use of investigational drugs under various sections of the Act,
including sections 505(i), 561, and 701(a) (21 U.S.C. 355(i), 360bbb,
and 371(a)).
Section 505(i) of the Act directs the Secretary to promulgate
regulations exempting from the operation of the new drug approval
requirements drugs intended solely for investigational use by experts
qualified by scientific training and expertise to investigate the
safety and effectiveness of drugs. The proposed rule explains
procedures and criteria for obtaining FDA authorization for treatment
uses of investigational drugs.
The Modernization Act provides significant additional authority for
this proposed rule. Section 561(a) states that the Secretary may, under
appropriate conditions determined by the Secretary, authorize the
shipment of investigational drugs for the diagnosis, monitoring, or
treatment of a serious disease or condition in emergency situations.
Section 561(b) allows any person, acting through a physician licensed
in accordance with State law, to request from a manufacturer or
distributor an investigational drug for the diagnosis, monitoring, or
treatment of a serious disease or condition if certain conditions are
met. Section
[[Page 72787]]
561(c) closely tracks existing FDA's existing regulation at 21 CFR
312.34 providing for treatment use by large patient populations under a
treatment protocol or treatment IND if a number of conditions are met.
Section 701(a) provides the Secretary with the general authority to
promulgate regulations for the efficient enforcement of the Act. By
clarifying the criteria and procedures relating to treatment use of
investigational products, this proposed rule is expected to aid in the
efficient enforcement of the Act.
Alternatives:
One alternative to the proposed rule that FDA considered was not to
propose regulations implementing the expanded access provisions of the
Modernization Act. However, the Agency believes that implementing
regulations would further improve the availability of investigational
drugs for treatment use by providing clear direction to sponsors,
patients, and licensed physicians about the criteria for authorizing
treatment use and what information must be submitted to FDA.
Another alternative FDA considered was to propose a regulation
describing only individual patient and large scale expanded access
criteria. However, the Agency concluded that it would be preferable to
have a third category of expanded access for intermediate size patient
populations.
Anticipated Cost and Benefits:
FDA expects that the total one-time costs of the proposed rule will be
negligible. The Agency expects that the annual and annualized costs of
the proposed rule will range from a low of about $130,000 to $260,000
in the first year following publication of any final rule based on this
proposal, to a high of about $350,000 to $690,000 in the 4th and 5th
years. These estimates suggest that total annual and annualized costs
for the proposed rule would be between $1.4 million and $2.7 million
for the 5-year period following implementation of any final rule based
on this proposal. The Agency also expects that the estimated
incremental cost burdens associated with this proposed rule are likely
to be widely dispersed among affected entities.
The benefits of the proposed rule are expected to result from improved
patient access to investigational drugs generally and from treatment
use being made available for a broader variety of disease conditions
and treatment settings. In particular, the clarification of eligibility
criteria and submission requirements would enhance patient access by
easing the administrative burdens on individual physicians seeking
investigational drugs for their patients and on sponsors who make
investigational drugs available for treatment use.
Risks:
The agency foresees no risks associated with the proposed rule.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 12/00/06
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Organizations
Government Levels Affected:
None
Agency Contact:
Christine F. Rogers
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research
5515 Security Lane
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]
RIN: 0910-AF14
_______________________________________________________________________
HHS--FDA
39. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE
UNITED STATES
Priority:
Other Significant
Legal Authority:
15 USC 1453 to 1455 ; 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 371;
21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264
CFR Citation:
21 CFR 1.98
Legal Deadline:
None
Abstract:
The proposed rule would require owners or consignees to label imported
food that is refused entry into the United States. The label would
read, ''UNITED STATES: REFUSED ENTRY.'' The proposal would describe the
label's characteristics (such as its size) and processes for verifying
that the label has been affixed properly. We are taking this action to
prevent the introduction of unsafe food into the United States, to
facilitate the examination of imported food, and to implement section
308 of the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).
Statement of Need:
In 1998, the General Accounting Office issued a report titled, ``Food
Safety: Federal Efforts to Ensure the Safety of Imported Foods Are
Inconsistent and Unreliable.'' The report stated that some food
importers evade import controls and are able to introduce contaminated,
adulterated, or unsafe food into the United States even after FDA
refused to admit the food and the Customs Service ordered the food to
be reexported or destroyed.
Additionally, in 1998, the Senate Permanent Subcommittee on
Investigations conducted hearings on the safety of food imports. The
subcommittee heard testimony about reimporting refused foods through
another port (a practice known as ``port shopping''). On July 3, 1999,
then-President Clinton issued a memorandum to the Secretary of Health
and Human Services and the Secretary of the Treasury directing them, in
part, to take all actions available to ``prohibit the reimportation of
food that has been previously refused admission and has not been
brought into compliance with United States laws and regulations'' by
requiring the marking of shipping containers and/or papers of imported
food that is refused admission for safety reasons.
Consequently, on January 22, 2001, FDA and the Department of the
Treasury jointly issued a proposed rule (66 FR 6502) that would require
that imported food that has been refused admission for safety reasons
be marked as ``UNITED STATES: REFUSED ENTRY.'' The mark would make it
easier to detect previously refused food and reduce, if not eliminate,
``port shopping.'' However, on June 12, 2002, before FDA and Treasury
could prescribe a final rule, the Bioterrorism Act became law. Section
308(a) of the Bioterrorism Act created a new section 801(n) of the
Federal Food, Drug, and
[[Page 72788]]
Cosmetic Act (the act) to clarify FDA's authority to require the owner
or consignee of a food that had been refused admission into the United
States to ``affix to the container of the food a label that clearly and
conspicuously bears the statement: `UNITED STATES: REFUSED ENTRY'.''
Although section 308(c) of the Bioterrorism Act stated that ''nothing
in this section shall be construed to limit the authority of the
Secretary of Health and Human Services or the Secretary of the Treasury
to require the marking of refused articles of food under any other
provision of law,`` the new statutory provision differed from the
January 22, 2001, proposed rule and prompted FDA to withdraw the
proposal on August 21, 2002 (67 FR 54138).
The new proposal would describe the label requirements for imported
food that has been refused admission into the United States.
Summary of Legal Basis:
Section 801(a) of the act authorizes FDA to refuse to admit imported
food if the food has been manufactured, processed, or packed under
insanitary conditions, is forbidden or restricted in sale in the
country in which it was produced, or is adulterated or misbranded.
Additionally, as explained earlier, section 801(n) of the act gives FDA
express authority to require the owner or consignee of a food that had
been refused admission into the United States to ``affix to the
container of the food a label that clearly and conspicuously bears the
statement: `UNITED STATES: REFUSED ENTRY'.''
Sections 402 and 403 of the act describe when a food is adulterated or
misbranded respectively. Section 701(a) of the act authorizes FDA to
issue regulations for the efficient enforcement of the Act, while
section 701(b) of the act authorizes FDA and the Department of the
Treasury to jointly prescribe regulations for the efficient enforcement
of section 801 of the act.
The proposed rule is within FDA's authority at sections 402, 403, 701,
and 801 of the act. In general, unsafe food is often adulterated under
section 402 of the act, and may also be misbranded under section 403 of
the act if the food purports to meet a particular definition, standard
of identity, or standard of quality. Labeling refused foods will make
it easier for FDA to refuse to admit previously-refused, adulterated or
misbranded food imports into the United States.
Additionally, section 301 of the Public Health Service Act (PHS act)
authorizes FDA to ``render assistance'' to appropriate health
authorities in the conduct of or to promote coordination of research,
investigations, experiments, demonstrations, and studies relating to
the causes, diagnosis, treatment, control, and prevention of disease.
Section 361 of the PHS act authorizes FDA to issue regulations to
prevent the introduction, transmission, or spread of communicable
diseases into the United States. Affixing a label to refused food
products will help foreign health officials determine whether to take
regulatory action against a particular product. It would also alert
foreign officials to previously refused food and help prevent the
introduction, transmission, or spread of communicable diseases into the
United States by making it more difficult for unsafe food to reenter
the United States.
Alternatives:
FDA considered exempting small businesses from the rule, but, because
most importers and consignees would qualify as small businesses, this
would negate the rule's purpose.
The agency also considered ordering the destruction of all refused food
imports, but this would not be feasible because it would divert Federal
resources to supervising or otherwise ensuring that the refused food
imports are stored until they can be destroyed and that they are
destroyed.
FDA also rejected affixing the label on some, but not all, imported
food refused entry for safety reasons. While this alternative would be
less costly, it would also be less efficient because some refused food
imports would be able to reenter the United States and because a
previously-refused, but unlabeled, food would be difficult to detect
compared to a previously-refused and labeled food. This alternative
would also result in arguments as to the criteria to be applied and
whether a particular food should be labeled.
Anticipated Cost and Benefits:
Importers and consignees would bear the costs associated with affixing
the label to refused food imports. The rule's costs would, therefore,
consist of labor costs (to affix the mark) and equipment costs (the
label equipment used). FDA will estimate these costs in the proposed
rule.
The rule's principal benefit would be a reduction in the number of
illnesses and injuries caused by unsafe imported food. The Agency is
unable to quantify the amount of illegal importation of previously
refused foods, so it cannot accurately predict the value of reduced
illnesses and injury.
Risks:
There is a possible risk previously refused, unpackaged food (such as
loose grain in a railroad car) would be able to enter the United States
because the food itself cannot be labeled, although the proposed rule
would require the importer or consignee to affix a label on papers
accompanying the product.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 04/00/07
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Agency Contact:
Philip L. Chao
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Office of Policy and Planning (HF-23)
5600 Fishers Lane, Room 14C-17
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]
RIN: 0910-AF61
_______________________________________________________________________
HHS--FDA
40. [bull] MEDICAL DEVICE REPORTING; ELECTRONIC SUBMISSION REQUIREMENTS
Priority:
Other Significant
Legal Authority:
21 USC 352; 21 USC 360; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC
374
CFR Citation:
21 CFR 803
Legal Deadline:
None
Abstract:
The Food and Drug Administration (FDA) is proposing to amend its
[[Page 72789]]
postmarket medical device reporting regulations to require that reports
submitted to the agency by persons subject to mandatory reporting
requirements be transmitted electronically in a form 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 proposed rule would require user facilities and medical device
manufacturers and importers to send medical device adverse event
reports electronically 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 proposed
rule would require manufacturers, importers, and user facilities to
change their procedures to send reports of medical device adverse
events to FDA electronically instead of using a hard copy form.
Alternatives:
The alternatives to this rulemaking include not updating the medical
device reporting requirements and not requiring electronic submission
of this information. For over 20 years, medical device manufacturers,
importers, and user facilities have sent adverse event reports to FDA
on paper forms. Processing paper forms is a time consuming and
expensive process. FDA believes this rulemaking is the preferable
alternative.
Anticipated Cost and Benefits:
FDA estimates that over 80 percent of the adverse event reports it
receives come directly from the reporter's computer databases. Computer
applications are available that would take the information from the
corporate database and produce an electronic file that can be sent to
the FDA. Once reporters have developed the electronic reporting
capability, they would save significant mailing and adminstrative
processing costs. FDA is developing an electronic system for reporters
who do not have the capability to produce the required electronic file.
Risks:
None
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 03/00/07
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Myrna Hanna
Regulations Staff
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
HFZ-215
1350 Piccard Drive, PI50 RM150F
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]
RIN: 0910-AF86
_______________________________________________________________________
HHS--FDA
41. [bull] ELECTRONIC REGISTRATION AND LISTING FOR DEVICES
Priority:
Other Significant
Legal Authority:
PL 107-188, sec 321; 21 USC 360(p)
CFR Citation:
21 CFR 807
Legal Deadline:
None
Abstract:
FDA is proposing to amend the medical device establishment registration
and listing requirements under 21 CFR 807 to reflect the new
requirements in section 321 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 and 21 USC 360(p).
This proposed rule would require domestic and foreign device
establishments to submit registration and listing data electronically
via the Internet using FDA's Unified Registration and Listing System.
This proposed rule would convert the registration and listing process
to a paperless process. For those companies that do not have access to
the web, FDA would offer an avenue by which they can register, list,
and update information with a paper submission.
Statement of Need:
FDA is proposing to amend the medical device establishment registration
and listing requirements under 21 CFR part 807 to reflect the new
requirements in section 321 of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (BT Act) and Section
207 of the Medical Device User Fee and Modernization Act of 2002
(MDUFMA). This proposed rule would improve FDA's device establishment
and 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 903 of the Federal Food, Drug, and Cosmetic
Act.
Alternatives:
The alternatives to this rulemaking include not updating the
registration and listing regulations and not requiring the electronic
submission of registration and listing information. Because of the new
statutory requirements, and the advances in data collection and
transmission technology, FDA believes this rulemaking is the preferable
alternative to the paper system currently in place.
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 02/00/07
Regulatory Flexibility Analysis Required:
No
[[Page 72790]]
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Myrna Hanna
Regulations Staff
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
HFZ-215
1350 Piccard Drive, PI50 RM150F
Rockville, MD 20850
Phone: 240 276-2347
Fax: 240 276-2352
Email: [email protected]
RIN: 0910-AF88
_______________________________________________________________________
HHS--FDA
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FINAL RULE STAGE
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42. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS
Priority:
Economically Significant. Major under 5 USC 801.
Unfunded Mandates:
This action may affect the private sector under PL 104-4.
Legal Authority:
21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 371; 21 USC 374;
21 USC 381; 21 USC 393; 42 USC 264
CFR Citation:
21 CFR 111
Legal Deadline:
None
Abstract:
The Food and Drug Administration proposed in the Federal Register of
March 13, 2003 (68 FR 12158), current good manufacturing practice
(CGMP) regulations for dietary ingredients and dietary supplements. The
proposed rule was published to establish the minimum CGMPs necessary to
ensure that, if firms engage in activities related to manufacturing,
packaging, or holding dietary ingredients or dietary supplements, they
do so in a manner that will not adulterate and misbrand such dietary
ingredients or dietary supplements. FDA also proposed to require
manufacturers to evaluate the identity, purity, quality, strength, and
composition of their dietary ingredients and dietary supplements. The
proposed rule also responds to concerns that such regulations are
necessary to ensure that consumers are provided with dietary supplement
products which have not been adulterated as a result of manufacturing,
packing, or holding, e.g., which have the identity and provide the
quantity of dietary ingredients declared in labeling.
Statement of Need:
FDA intends to publish a final rule to establish CGMP for dietary
supplements and dietary ingredients for several reasons. First, FDA is
concerned that some firms may not be taking appropriate steps during
the manufacture of dietary supplements and dietary ingredients to
ensure that products are not adulterated as a result of manufacturing,
packing, or holding. There have been cases of misidentified ingredients
harming consumers using dietary supplements. FDA is also aware of
products that contain potentially harmful contaminants because of
apparently inadequate manufacturing controls and quality control
procedures. The Agency believes that a system of CGMPs is the most
effective and efficient way to ensure that these products will not be
adulterated during manufacturing, packing, or holding.
Summary of Legal Basis:
If CGMP regulations were adopted by FDA, failure to manufacture, pack,
or hold dietary supplements or dietary ingredients under CGMP
regulations would render the dietary supplement or dietary ingredients
adulterated under section 402(g) of the Act.
Alternatives:
The two principal alternatives to comprehensive CGMPs are end product
testing and Hazard Analysis Critical Control Points (HACCP). The Agency
asked whether different approaches may be better able to address the
needs of the broad spectrum of firms that conduct one or more distinct
operations, such as the manufacture of finished products, or solely the
distribution and sale of finished products at the wholesale or retail
level.
Anticipated Cost and Benefits:
The costs of the regulation will include the value of resources devoted
to increased sanitation, process monitoring and controls, testing, and
written records. The benefits of the proposed regulation are to improve
both product safety and quality. We estimate that the proposed
regulation will reduce the number of sporadic human illnesses and rare
catastrophic illnesses from contaminated products. The current quality
of these products is highly variable, and consumers lack information
about the potential hazards and variable quality of these products. The
product quality benefits occur because there will be fewer product
recalls and more uniform products will reduce consumer search for
preferred quality products. The proposed rule will have a significant
impact on a substantial number of small businesses, so it will be
significant under the Regulatory Flexibility Act. We anticipate that
small businesses will bear a proportionately larger cost than large
businesses.
Risks:
Any potential for consumers to be provided adulterated (e.g.,
contaminated with industrial chemicals, pesticides, microbial
pathogens, or dangerous misidentified ingredients or toxic components
of ingredients) products must be considered a very serious risk because
of the possibility that such contamination could be widespread,
affecting whole segments of the population, causing some severe long-
term effects and even loss of life. Dietary supplements are used by a
large segment of the American public. Moreover, they are often used by
segments of the population that are particularly vulnerable to
adulterated products, such as the elderly, young children, pregnant and
nursing women, and persons who may have serious illnesses or are taking
medications that may adversely interact with dietary supplements. FDA
has adopted or proposed manufacturing controls for a number of foods
and commodities that present potential health hazards to consumers if
not processed properly, including seafood, juice products, and fruits
and vegetables, and it is appropriate that FDA consider whether
manufacturing controls are necessary to assure consumers that dietary
supplements are not adulterated during the manufacturing, packing, or
holding process.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
ANPRM 02/06/97 62 FR 5700
ANPRM Comment Period End 06/06/97
[[Page 72791]]
NPRM 03/13/03 68 FR 12157
NPRM Comment Period End 08/11/03
Final Action 12/00/06
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Linda Kahl
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
HFS-024
College Park, MD 20740
Phone: 301 436-1209
Fax: 301 436-2964
Email: [email protected]
RIN: 0910-AB88
_______________________________________________________________________
HHS--FDA
43. PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND
BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002
Priority:
Other Significant
Legal Authority:
PL 107-188, sec 307
CFR Citation:
21 CFR 1.276 et seq
Legal Deadline:
Final, Statutory, December 12, 2003.
The Public Health Security and Bioterrorism Preparedness and Response
Act of 2002, section 307, directs the Secretary, through FDA, to issue
final regulations establishing prior notice requirements for all
imported food by December 12, 2003. If FDA fails to issue final
regulations by this date, the statute is self-executing on this date,
and requires FDA to receive prior notice of not less than eight hours,
nor more than five days until final regulations are issued.
Abstract:
This rulemaking is one of a number of actions being taken to improve
FDA's ability to respond to threats of bioterrorism. Section 801(m) of
the Federal Food, Drug, and Cosmetic Act (the act), which was added by
section 307 of the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (the Bioterrorism Act), requires notification
to FDA prior to the entry of imported food. The required prior notice
would provide the identity of the article of food; the manufacturer;
the shipper; the grower, if known at the time of notification; the
originating country; the shipping country; and the anticipated port of
entry. The regulation identifies the parties responsible for providing
the notice and explains the information that the prior notice is
required to contain, the method of submission of the notice, and the
minimum and maximum period of advance notice required. Section 307 also
states that if FDA does not receive prior notice or receives inadequate
prior notice, the imported food shall be refused admission and held at
the port of entry until proper notice is provided.
Section 307 authorizes the Secretary, through FDA, to promulgate final
regulations by December 12, 2003. FDA and the Bureau of Customs and
Border Protection (CBP) issued an interim final rule (IFR) on October
10, 2003 (68 FR 58974). The IFR originally provided a 75-day comment
period to ensure that those that comment on the IFR have the benefit of
our outreach and educational efforts and have the experience with the
systems, timeframes, and data elements. We reopened the comment period
for an additional 90 days in April through July 2004 to allow for
additional comment on the industry's experience with the prior notice
system, and comment on the Joint FDA-CBP Plan for Increasing
Integration and Assessing the Coordination of Prior Notice Timeframes.
The final rule currently is under development, and it will confirm or
amend the IFR, as appropriate. This final rule is not expected to have
a significant impact on a substantial number of small entities.
Statement of Need:
This final rule is needed to complete the rulemaking process to
implement section 307 of the Bioterrorism Act. The proposed rule was
published on February 3, 2003 (68 FR 5428) and the interim final rule
on October 10, 2003 (68 FR 58974).
Summary of Legal Basis:
Section 307 of the Bioterrorism Act amended the act by adding section
801(m), which authorizes the Secretary through FDA to establish by
regulation requirements for the notification to FDA prior to the entry
of imported food. In addition, section 307 of the Bioterrorism Act also
amends section 301 of the act by making the offering of a food for
import or the importing of a food without prior notification, as
required by the new regulations, a prohibited act.
Alternatives:
An alternative is to leave the IFR in place and not to issue a final
rule. However, we received numerous comments in response to the IFR
that require a response. Finalizing this rule will assist industry and
the public in better understanding and complying with the prior notice
requirements.
Anticipated Cost and Benefits:
The final rule will amend the interim final rule already in place. We
do not expect the changes from the interim final rule to be
economically significant.
This final rule will require that FDA be notified prior to the arrival
of the food.
Having prior notice of imported food will help deter deliberate and
accidental contamination of food shipments. Knowledge of when, where,
and how imported food will enter the United States will help mitigate
the effects of any potential food contamination issues.
Risks:
Regulations implementing legislation to protect the health of citizens
against bioterrorism and other public health threats would advance the
development, organization and enhancement of public health prevention
systems and tools. The magnitude of the risks addressed by such systems
and tools is at least as great as the other risk reduction efforts
within HHS' jurisdiction. These regulations will improve the FDA's
ability to address bioterrorism events and public-health threats
associated with imported food.
Timetable:
_______________________________________________________________________
Action Date FR Cite
_______________________________________________________________________
NPRM 02/03/03 68 FR 5428
Interim Final Rule 10/10/03 68 FR 58974
Interim Final Rule
Comment Period
Reopened 04/14/04 69 FR 19763
[[Page 72792]]
Interim Final Rule
Comment Period
Reopened End 07/13/04
Final Rule 05/00/07
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
Agency Contact:
May Nelson
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway
College Park, MD 20740
Phone: 301 436-1722
Fax: 301 436-2637
Email: [email protected]
RIN: 0910-AC41
_______________________________________________________________________
HHS--Centers for Medicare & Medicaid Services (CMS)
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PROPOSED RULE STAGE
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