[Federal Register Volume 65, Number 155 (Thursday, August 10, 2000)]
[Rules and Regulations]
[Pages 48894-48902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20262]
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DEPARTMENT OF COMMERCE
National Institute of Standards and Technology
15 CFR Part 287
[Docket No. 981222315-0219-02]
RIN 0693-AB49
Guidance on Federal Conformity Assessment Activities
AGENCY: National Institute of Standards and Technology (NIST),
Commerce.
ACTION: Final policy guidance.
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SUMMARY: This document contains final policy guidance on Federal agency
use of conformity assessment activities. The provisions are solely
intended to be used as guidance for agencies in their conformity
assessment activities and do not preempt the agencies' authority and
responsibility to make regulatory
[[Page 48895]]
procurement decisions authorized by statute or required to meet
programmatic objectives and requirements.
DATES: This guidance becomes effective August 10, 2000.
FOR FURTHER INFORMATION CONTACT: Dr. Belinda Collins, Director, Office
of Standards Services, National Institute of Standards and Technology,
Building 820, MS 2100, Room 282, Gaithersburg, MD 20899. Phone: (301)
975-4000.
SUPPLEMENTARY INFORMATION:
Background
This guidance outlines Federal agencies' responsibility for
evaluating the efficacy and efficiency of their conformity assessment
activities. Each agency is responsible for coordinating its conformity
assessment activities with those of other appropriate government
agencies and with those of the private sector to make more productive
use of the increasingly limited Federal resources available for the
conduct of conformity assessment activities and to reduce unnecessary
duplication.
This guidance applies to all agencies, which set policy for,
manage, operate, or use conformity assessment activities and results,
both domestic and international, except for activities carried out
pursuant to treaties. ``Agency'' means any Executive Branch Department,
independent commission, board, bureau, office, agency, government-owned
or controlled corporation, or other establishment of the Federal
government. It also includes any regulatory commission or board, except
for independent regulatory commissions subject to separate statutory
requirements regarding policy setting, management, operation, and use
of conformity assessment activities. It does not include the
legislative or judicial branches of the Federal government.
History of the Guidance
In February 1996, The National Technology Transfer and Advancement
Act (NTAA) of 1995 was enacted by Congress. Section 12 of the Act
directed NIST to coordinate conformity assessment activities of
Federal, state and local entities with private sector technical
standards activities and conformity assessment activities with the goal
of eliminating any unnecessary duplication of conformity assessment
activities. The Office of Management and Budget (OMB) Circular A-119,
revised February 19, 1998 directed the Secretary of Commerce to issue
guidance to the agencies to ensure effective coordination of Federal
conformity assessment activities. The Director of the National
Institute of Standards and Technology (NIST), United States Department
of Commerce, published proposed guidance in the Federal Register on
Federal conformity assessment activities on November 3, 1999 (64 FR
59691 (1999)). Closing date for comments was January 18, 2000.
Summary of Public Comments Received by the Agency in Response to
the November 3, 1999 Request for Public Comments, and the Agency's
Response to the Comments
NIST received comments from nine commentors, including: one
national standards coordinating and conformity assessment accreditation
body, one government agency, one international company, one laboratory
accreditation body, one certification body, one consulting
organization, and three trade associations in response to its request.
In addition, in September 1999, the U.S. General Accounting Office
(GAO) published a report, entitled ``GAO/GGD-99-170--Certification
Requirements: New Guidance Should Encourage Transparency in Agency
Decisionmaking,'' which contained a recommendation for including a
section in the guidance on the issue of transparency in agency
certification decisionmaking. The 51 comments as well as the GAO
recommendation were considered in finalizing the guidance. The
following summarizes the comments received and the agency's response to
the comments.
General Comments
One national standards coordinating and conformity assessment
accreditation body commented that the guidance should task only NIST
with substantive objectives and identify the approach and procedures
for accomplishing them.
Response: In OMB Circular A-119, OMB stated that ``(t)o ensure
effective coordination, the Secretary of Commerce must issue guidance
to the agencies.'' This guidance is a response to that mandate. The
suggested approach would not be consistent with OMB's mandate.
One laboratory accreditation body commented the proposed rule
should be withdrawn and that the guidance be issued as an annex to OMB
Circular A-119.
Response: This document is intended to serve as guidance for
Federal agencies in implementing their responsibilities under the
NTTAA, and is not a rule. The guidance was issued at the direction of
OMB, which chose not to include conformity assessment in OMB Circular
A-119. This comment has been forwarded to OMB for consideration during
the next revision of the Circular.
One government agency commented that while the examples in the
guidance were helpful in describing how the guidance may be
implemented, they should remain examples in the final version of the
guidance.
Response: NIST agrees with this comment.
One government agency commented that Federal regulatory programs
that engage in conformity assessment must apply a high degree of
scrutiny to ensure that requirements are met. Therefore, it may be very
difficult to rely on the work of private sector organizations, which
understandably perform their activities for other motives and perhaps
to a lesser degree of scrutiny. The guidance should present the option
that private sector organizations rely on the conformity assessment
activities of a Federal agency. This option would also promote the
objectives under the proposed Section 287.1.
Response: Elimination of unnecessary duplication and complexity in
conformity assessment activities can be accomplished by relying on
private sector conformity assessment programs and activities. However,
reduction in duplication and complexity can also be accomplished by
Federal agency reliance on other governmental conformity assessment
activities, by reliance on supplier's declaration of conformity, or by
encouraging the private sector to rely on governmental activities. The
NTTAA does not indicate a preference for any specific approach. The
determination of which approach best meets agency objectives is the
responsibility of the agency.
Comments on Section 287.1
One national standards coordinating and conformity assessment
accreditation body commented that Section 287.1 should provide more
information on the evaluation procedures to be used to evaluate the
efficacy and efficiency of Federal conformity assessment activities.
Response: The variety of conformity assessment activities conducted
by different Federal agencies precludes development of specific
evaluation techniques that would apply to all agencies. Guidance on how
to measure certain aspects of performance (regulatory burden, cost-
benefit issues, etc.,) is available from the Office of Management and
Budget (OMB) and from other sources within the Federal government, but
this guidance must usually be tailored to reflect the type of
[[Page 48896]]
activities a given agency undertakes. NIST believes that evaluations of
only one aspect of program performance can be misleading. Evaluations
of program performance/effectiveness should consider all programmatic
aspects, including an agency's legislative mandates, program objectives
and resource availability.
One laboratory accreditation body commented that the second and
third sentences of Section 287.1 should be replaced by: ``Each agency
should seek ways in which it can use existing conformity assessment
activities of the private sector instead of creating or maintaining
their own activities.''
Response: The purpose and scope, as currently written in Section
287.1, best reflects the intent stated in the Act, which is to
eliminate ``unnecessary duplication and complexity in the development
and promulgation of conformity assessment requirements and measures.''
This can be accomplished in a number of ways. Using the results of
private sector conformity assessment activities is only one method.
One laboratory accreditation body commented that the last sentence
of Section 287.1 should be revised to cite the role of the U.S. Trade
Representative (USTR) in overseeing the implementation of the U.S.
trade obligations including commitments under the World Trade
Organization (WTO) Agreement on Technical Barriers to Trade (TBT).
Response: The guidance is not intended to address U.S. obligations
or the USTR's role in implementing the WTO Agreement or in other trade
agreements. This guidance addresses only matters covered in the NTTAA.
The Federal government's obligations under the World Trade Organization
Agreement and other trade agreements are addressed elsewhere.
One consulting organization commented that NIST should state its
position on who is responsible for accreditation in the United States.
Response: Accreditation activities can be conducted by either the
public and/or the private sector. The appropriate sector to be assigned
responsibility for accreditation should be determined on a case-by-case
basis. The need for accreditation also needs to be determined on a
case-by-case basis. There is no one-size-fits-all solution to this
issue.
One certification body commented that the Interagency Committee on
Standards Policy (ICSP) should be opened to regular participation and
attendance by private sector standards developers and organizations
providing conformity assessment services to facilitate cooperation and
confidence between the government and private sector conformity
assessment organizations.
Response: The ICSP has invited a number of standards developers and
conformity assessment organizations to present information and
viewpoints on topics of interest to the ICSP. However, the ICSP is an
interagency committee. Membership is restricted to the Federal
departments and agencies listed in its charter.
One certification body commented that the promotion of
accreditation and/or recognition organizations that have not
demonstrated added value to the marketplace should be discouraged.
Response: NIST agrees with this comment. Agencies are responsible
for meeting programmatic objectives in a cost-effective manner.
However, it is the responsibility of each agency to determine which
approach best meets its needs.
One certification body commented that no single mechanism can meet
the needs of all suppliers or acceptance authorities around the globe.
New mechanisms that facilitate trade, provide regulatory confidence and
protect public safety should be considered as they are developed and
proven effective to meet the needs of supplier and acceptance
authorities.
Response: NIST agrees with this comment. However, it remains the
responsibility of each agency to determine which mechanisms are
appropriate for application within its programs.
One trade association commented that the following objectives
should be included in the proposed guidance:
Eliminate the cost to government of conducting
(developing) its own conformity assessment activities and thereby
decrease the cost of goods procured and the burden of complying with
agency regulation;
Provide incentives and opportunities (to whom) to
establish conformity assessment programs that serve national needs;
Encourage long term growth of U.S. enterprises and promote
efficiency and economic competition through harmonization of conformity
assessment activities; and
Further the policy of reliance upon the private sector to
supply the government need for goods and services.
Response: While the statements listed above are a partial list of
potential benefits from implementation of the guidance, the objective
of the guidance was clearly and succinctly defined in the NTAAA--to
eliminate ``unnecessary duplication and complexity in the development
and promulgation of conformity assessment requirements and measures.''
Comments on Section 287.2
One national standards coordinating and conformity assessment
accreditation body commented that the definition of recognition is too
narrow in section 287.2 and is inconsistent with the way it is used in
the example in section 287.4.
Response: While the definition for the term ``recognition'' in
Section 287.2 is appropriate; the term has been changed in the example.
One national standards coordinating and conformity assessment
accreditation body and one trade association commented that the
definitions in the International Organization for Standardization/
International Electrotechnical Commission (ISO/IEC) Guide 2 should be
cited without modification.
Response: The definitions in section 287.2 were based on ISO/IEC
Guide 2, but the definitions have been modified to better address the
nature of Federal government conformity assessment activities.
Definitions were considered necessary because agencies do not use
consistent terminology in their regulatory and procurement conformity
assessment programs. This inconsistent use of terminology could create
potential confusion for agencies reading the guidance. NIST decided to
define only those terms which were considered to be necessary to
understand the guidance.
One laboratory accreditation body commented that the World Trade
Organization (WTO) Agreement on Technical Barriers to Trade (TBT)
definition of conformity assessment should be referenced and
``mandatory administrative procedures'' should not be excluded from the
definition.
Response: ISO/IEC Guide definitions have been used in accordance
with the NTTAA's requirements that preference be given to the use of
voluntary consensus standards. There is also no evidence in the Act or
legislative history that Congress intended to include mandatory
administrative procedures.
The Occupational Safety and Health Administration (OSHA) commented
that some of the key definitions in the notice do not correctly depict
the Occupational Safety and Health Administration's (OSHA's) National
Recognized Testing Laboratory (NRTL) Program. OSHA recognizes a
testing/certification body under the NRTL Program, not an accreditation
body. In addition, the agency commented that OSHA's
[[Page 48897]]
recognition does not mean that an organization is ``competent'' in
testing or in certification to the extent that ``competent'' means
adept, proficient or a similar term. To obtain recognition, an
organization must demonstrate that it meets the requirements in 29 CFR
1910.7, but this regulation does not include requirements for
proficiency or other criteria to judge ``competence.''
Response: NIST agrees that agencies do not use standardized
terminology in their conformity assessment activities. In defining key
terms, NIST intended to let the reader know what is meant by that term
within the context of the guidance. NIST recognizes that the same term
may be used by different agencies to mean very different types of
activities. A footnote will be added to the definition for
``accreditation'' to accommodate OSHA's activities.
OSHA also commented that the definition of conformity assessment
describes requirements as being applicable to ``products, services, and
systems,'' but not to ``organizations'' and requested that the word
``organizations'' be added.
Response: The word ``organizations'' has been added.
One international company, one laboratory accreditation body, and
one trade association commented that the guidance should identify
supplier's declaration as an appropriate option for agencies to
consider in their conformity assessment policies, taking into account
the appropriate balance of risks and benefits of first party
(supplier), second party, and third party conformity assessment for
specific products and services. The same trade association recommended
that NIST amend the definition in the proposed Section 287.2 as
follows: In the definition of conformity assessment, add ``suppliers
declaration of conformity'' after ``inspection'' and add a definition
for ``supplier's declaration of conformity.''
Response: The guidance now includes reference to first, second and
third party conformity assessment activities and procedures. The
definition of conformity assessment has been amended to include
``supplier's declaration of conformity.'' A definition of ``supplier's
declaration of conformity'' has also been included. However, the
guidance does not intend to suggest that any one method or activity is
preferable. It is the responsibility of each agency to select the
conformity assessment activities and procedures, which will best meet
its legislative mandates and programmatic objectives in the most cost-
effective and efficient manner.
Comments on Section 287.3
One national standards coordinating and conformity assessment
accreditation body commented that NIST should be charged in section
287.3 with ensuring that other agencies are aware of their obligation
to adopt policies needed to accomplish the purpose of this guidance.
Response: While NIST is charged with coordinating conformity
assessment activities, agencies remain responsible for their own
conformity assessment activities, including the adoption of any
policies that agencies feel are needed to operate in accordance with
their statutory mandates. NIST is available and willing to assist
agencies in carrying out this responsibility and to provide guidance as
needed.
One national standards coordinating and conformity assessment
accreditation body and one trade association commented that some
attention should be given in section 287.3 to NIST's obligations beyond
the Federal level, especially to its obligations at the state level.
Response: NIST partially agrees with this comment. The language in
the Act is unclear as to what Congress intended NIST to do with regard
to state conformity assessment activities. However, in the
Congressional House Record of 2/27/96 for The National Technology
Transfer and Advancement Act (NTTAA), Representative Morella stated
that: ``Section 12 Standards Conformity. Restates existing authorities
for the National Institute of Standards and Technology (NIST)
activities in standards and conformity assessment. Requires NIST to
coordinate among Federal agencies, survey existing state and Federal
practices, and report back to Congress on recommendations for
improvements in these activities.'' NIST is undertaking studies of
existing state conformity assessment practices, subject to resource
limitations. NIST also plans to undertake additional activities with
the states as resources become available. Any activities undertaken by
NIST will be conducted in a manner that respects state sovereignty
issues. NIST has added the following statement to the guidance: ``To
the extent that resources are available, NIST will develop information
on existing state conformity assessment practices; and, upon request by
a state government agency, will work with that agency to reduce
duplication and complexity in state conformity assessment activities.''
One laboratory accreditation body commented that a new clause
should be added to section 287.3 so that NIST would also ``encourage
government participation and use of private sector, conformity
assessment activities to the maximum extent practical.''
Response: NIST disagrees. NIST is obligated to assist other Federal
agencies in reducing duplication and complexity in their conformity
assessment activities. The use of private sector conformity assessment
activities is only one of a number of methods that can be used by an
agency to accomplish this goal. It remains the responsibility of the
agency to determine which method is most appropriate for its specific
applications.
Comments on Section 287.4
One national standards coordinating and conformity assessment
accreditation body commented that the example in section 287.4, which
uses the term ``recognition,'' does not support the use of the
qualifier ``mutual.''
Response: The agency agrees with this comment. The qualifier
``mutual'' has been removed and the term ``recognition'' has been
replaced.
One national standards coordinating and conformity assessment
accreditation body and one laboratory accreditation body commented that
a list of references, containing the documents of the organizations
cited in section 287.4 should be inserted in this section or that NIST
should provide a list of specific conformity assessment guides and
standards, perhaps as a separate document.
Response: NIST believes that a better solution is to address an
agency's need for a list of applicable standards on a case-by-case
basis. NIST's National Center for Standards and Certification
Information (NCSCI) assists agencies to identify possible conformity
assessment standards/guides, which may be of interest for a specific
application. The organizations listed in the guidance are examples, and
are not intended to represent a comprehensive list of organizations
that develop standards and guidance in the conformity assessment area.
A specific list could omit standards of potential interest to agencies
in conformity assessment related areas or from other organizations not
included as examples. In addition, such a list would rapidly become
outdated as ISO guides and standards in the conformity assessment area
are revised, reissued, or removed. Lastly, standards that appear on
such a list might be presumed by some to have a ``special blessing'' by
NIST, which could create misunderstanding. Agencies can contact NCSCI
for a list of standards in their area of interest.
[[Page 48898]]
One national standards coordinating and conformity assessment
accreditation body commented that section 287.4 should be rewritten to
address the policies and procedures that should be adopted by agencies
through the mechanism of the Interagency Committee on Standards Policy
(ICSP). The development of a policy on conformity assessment might be
stipulated that would address the roles of supplier's declaration,
third parties, and accreditors.
Response: As noted in section 287.3(a), NIST will assist ``the ICSP
in developing policies and guidance on conformity assessment issues.''
Agency Standards Executives serving on the ICSP are responsible for
determining which policies and procedures the ICSP should develop,
which might be useful for consideration within their agencies. However,
the individual agency is responsible for the final selection and
implementation of the policies and procedures needed by the agency to
implement the goals of the NTTAA.
One national standards coordinating and conformity assessment
accreditation body commented that the ICSP Agency Standards Executives'
suitability for serving as change agents with respect to the conformity
assessment activities of the Federal government should be reconsidered.
Response: The selection of the ICSP Agency Standards Executives is
the responsibility of the Agency, as noted in section 287.4(n). The
agency is responsible for selecting an individual who is capable of
carrying out the guidance in OMB Circular A-119 as well as the guidance
in this document. If needed, the Agency is free to assign additional
personnel to assist the Agency Standards Executive in carrying out
these responsibilities.
One international company commented that the examples listed in
section 287.4(g) are limited to laboratory issues and organizations
that are close to the Federal process. It would be appropriate to list
some other organizations such as the American National Standards
Institute (ANSI) or the International Organization for
Standardization's (ISO) Committee on Conformity Assessment (CASCO) to
indicate the broader direction that is intended.
Response: The examples cited have been included in the guidance.
One international company commented that organizations, such as the
American National Standards Institute (ANSI) or the International
Organization for Standardization's (ISO) Committee on Conformity
Assessment (CASCO) be listed in section 287.4(j) to indicate the
broader direction that is intended.
Response: Section 287.4(j) does not list examples. Participation in
the development of any private sector conformity assessment standards
(consistent with the mission and objectives of the agency) would be
included in this section. ANSI does not develop standards, so it would
not be included in this section. ISO is a private sector organization,
which develops conformity assessment standards, so participation in ISO
CASCO is included in this section.
One laboratory accreditation body commented that in section
287.4(c), agencies need to consider ways to use not only conformity
assessment results of others (both domestic and foreign), but the
conformity assessment activities themselves as a replacement for their
own activities.
Response: This comment addresses matters beyond the scope of this
guidance. Regulatory and procurement obligations of Federal agencies
have been authorized by Congress, and such activities/systems cannot be
replaced by private sector activities/systems without congressional
approval or legislative change.
One laboratory accreditation body commented that the examples in
sections 287.4(e) and (h) are weak as they only suggest an agency might
supplement (not replace) its own activities with outside conformity
assessment activities mainly administered by other government agencies.
Response: In section 287.4(e), NIST will include the example of the
Federal Communications Commission's FCC Telecommunications
Certification Body (TCB) program, which allows designated private
entities to issue telecommunications equipment approvals for specified
regulatory requirements in essentially the same manner as the FCC. FCC
has also replaced requirements for premarketing approval with
supplier's declaration of conformity for certain types of equipment.
One laboratory accreditation body commented that in section
287.4(f), it is not clear why ``mutual recognition'' is necessary or
desirable between agencies when one-way recognition may also be
appropriate.
Response: This section has been reworded.
One laboratory accreditation body commented that section 287.4(g)
should delete any reference to the National Environmental Laboratory
Accreditation Conference (NELAC) because NELAC specifically prohibits
private sector laboratory accreditation bodies from being part of NELAC
by suggesting that accreditation is an inherent government function.
This is contrary to the intent of the NTTAA, which encourages use of
private sector conformity assessment activities.
Response: The purpose of the NTTAA is to eliminate unnecessary
duplication and complexity in conformity assessment activities. While
this can be done by relying on private sector conformity assessment
programs and activities, it can also be accomplished by relying on
other governmental activities, by relying on a supplier's declaration
of conformity, or by encouraging the private sector to rely on
governmental activities. While agencies should consider alternative
approaches in their rulemaking and procurement activities, the
determination of which approach best meets agency objectives is the
responsibility of the agency.
One laboratory accreditation body and one trade association
commented that sections 287.4(i) should cite the USTR's role in trade
policy. The same trade association commented that sections 287.4(j)
should also cite the USTR's role.
Response: While NIST recognizes the important role that the USTR
has in developing trade related policies, as well as the
responsibilities placed on Federal agencies as a result of trade
agreements, such as the WTO Agreement, these roles and responsibilities
are defined in other legislation and related documents. This guidance
addresses only matters covered in the NTTAA.
One laboratory accreditation body commented that there is no need
for separate government recognition systems if equivalent systems exist
in the private sector that provide equivalent recognition. Government
recognition systems would add cost without adding value and would
create unnecessary duplication and complexity, the opposite intent of
the NTTAA.
Response: In trade agreements, the need for government recognition
of conformity assessment bodies is determined not only by the U.S.
Government, but also by the other countries signatory to such an
agreement. Since some governments do not deem the use of private sector
systems to be adequate proof of competence in the absence of
governmental recognition, such recognition becomes a requirement under
the terms of the specific agreement. For domestic regulatory and
procurement issues, it is the responsibility of each Federal agency to
[[Page 48899]]
determine whether use of a private sector system can adequately address
all of its programmatic objectives and any relevant legislative
mandates in a cost-effective manner.
One trade association commented that while the reference to the
National Cooperation for Laboratory Accreditation (NACLA) and the
National Environmental Laboratory Accreditation Conference (NELAC) in
section 287.4(g) begins to address the issue of duplication of
accreditations for testing programs, the proposed guidance should also
provide direction related to other forms of conformity assessment, such
as certification and registration.
Response: The organizations listed in section 287.4(g) are intended
to serve only as examples of activities in which agencies should
consider participation. The activities of ANSI have been added to the
list of examples to better illustrate the broad range of activities
where Federal participation is encouraged.
One trade association commented that the wording in section
287.4(c) should strongly encourage the use of private sector conformity
assessment programs in lieu of the development of government programs.
The same trade association commented that Section 287.4(e) include a
requirement that NIST provide a centralized coordinating function in
the determination of acceptable private sector conformity assessment
practices. To allocate the responsibility to each agency only continues
the duplication of accreditation and approval processes. NIST should
advocate the use of private sector accreditation bodies that comply
with national and international criteria as the tool to be used for
determination of acceptance. The same trade association also commented
that in section 287.4(f), mutual recognition of private sector
procedures should be recommended for all agencies.
Response: The purpose of the NTTAA is to eliminate unnecessary
duplication and complexity in conformity assessment activities. While
this can be done by relying on private sector conformity assessment
programs and activities, it can also be accomplished by relying on
other governmental activities, by relying on a supplier's declaration
of conformity, or by encouraging the private sector to rely on
governmental activities. While agencies should consider alternative
approaches in their rulemaking and procurement activities, the
determination of which approach best meets agency objectives is the
responsibility of the agency.
One trade association commented that in section 287.4(j), agencies
should be encouraged to participate in the development of private
sector conformity assessment procedures and programs as well as the
development of standards. RESPONSE: NIST partially agrees with this
comment. The responsibility for participation in conformity assessment
programs and activities, as distinct from standards development, is
covered in section 287.4(g). The examples in this section will be
expanded to include participation in ANSI's conformity assessment
related activities to better illustrate the intention of this section.
GAO Recommendation: GAO recommended that the guidance include a
section that ``specifically addresses the transparency of agencies'
certification decisionmaking.'' GAO recommended that the guidance
``should encourage agencies to publicly explain why particular
certification decisions were made or how certification decisions in the
future will be made.''
Response: A new item has been added to section 287.4 of the
guidance to address this issue.
Comments on Section 287.5
One national standards coordinating and conformity assessment
accreditation body commented that section 287.5 places responsibility
for both standards and conformity assessment with one representative
from each agency and noted that a significant majority of persons with
major responsibilities for standards have no responsibility or
knowledge of conformity assessment.
Response: NIST partially disagrees with this comment. The Office of
Management and Budget (OMB) A-119 indicates that more than one
Standards Executive was not contemplated by OMB. That is, the Circular
speaks of ``a'' Standards Executive (14(c)) and ``the'' Standards
Executive (14(d)), etc. NIST and OMB believe that having only one
Standards Executive would facilitate better coordination and
communication for both standards and their related conformity
assessment activities. However, both also recognize that because
responsibility for an agency's conformity assessment activities may cut
across organizational boundaries, it may be necessary to assign
additional agency personnel to carry out these new responsibilities.
The agency must ensure that these responsibilities are coordinated and
should carefully define each staff member's responsibilities to ensure
that the duties defined under this guidance and under OMB Circular A-
119 are effectively carried out.
One laboratory accreditation body commented that section 287.5
should contain reporting requirements for the annual agency reports to
NIST and OMB, including whether each agency gave consideration to the
use of relevant private sector, conformity assessment activities and
the reason for not using them--similar to agencies' reporting under OMB
Circular A-119. NIST itself should be required to make similar reports
justifying it own conformity assessment activities.
Response: Mandatory agency reporting requirements regarding
conformity assessment activities were not specified in the NTTAA.
Conformity assessment reporting requirements for all agencies,
including NIST, remain voluntary.
One government agency commented that the guidance states that each
agency ``should coordinate its * * * activities'' to make ``more
productive use of * * * limited Federal resources * * *.'' However, the
``responsibilities'' under the proposed Section 2987.5 and the actual
coordination could demand resources that may more than offset any gains
expected from the coordination.
Response: The guidance does not recommend that agencies undertake
activities where the costs involved are likely to exceed the benefits
realized. While coordination is often beneficial and should always be
considered, the agencies themselves are responsible for the final
decision as to the appropriate level of coordination and commitment of
resources to the agency's conformity assessment activities.
One trade association commented that a new responsibility should be
added to this section-- ``To use private sector conformity assessment
program results in all agency assessment programs.''
Response: The goal of the guidance, which is spelled out in the
NTTAA, can be accomplished in a number of ways. It is the
responsibility of each agency to determine which option or set of
procedures is most appropriate for its application.
Purpose of This Guidance
This guidance outlines Federal agencies' responsibility for
evaluation the efficacy and efficiency of their conformity assessment
activities. Each agency is responsible for coordinating its conformity
assessment activities with those of other appropriate government
agencies and with those of private sector to make more productive use
of the increasingly limited Federal resources available for the conduct
of conformity assessment activities and to reduce unnecessary
duplication.
Applicability of This Guidance
This guidance applies to all agencies, which set policy for,
manage, operate, or
[[Page 48900]]
use conformity assessment activities and results, both domestic and
international, except for activities carried out pursuant to treaties.
``Agency'' means any Executive Branch Department, independent
commission, board, bureau, office, agency, government-owned or
controlled corporation, or other establishment of the Federal
government. It also includes any regulatory commission or board, except
for independent regulatory commissions subject to separate statutory
requirements regarding policy setting, management, operation, and use
of conformity assessment activities. It does not include the
legislative or judicial branches of the Federal government.
Rulemaking Requirements
Under 5 U.S.C. 553(b)(A), this guidance is not subject to the
notice and comment requirements of the Administrative Procedure Act.
Furthermore, pursuant to 5 U.S.C. 553(d)(2), this guidance is not
subject to the delayed effective date requirement of the Act. The
Director has chosen to publish this document for comment only to obtain
input from persons who may be affected by the guidance.
PRA Clearance
This policy statement does not contain a collection of information
for purposes of the Paperwork Reduction Act.
Executive Order 12866
It has been determined that this action is significant for purposes
of Executive Order 12866.
Regulatory Flexibility Act
This action is exempt from the analytical requirements of the
Regulatory Flexibility Act because notice and comment are not required
for this action by section 553 of the Administrative Procedure Act or
any other law.
List of Subjects in 15 CFR Part 287
Conformity assessment, Procurement, Reporting and recordkeeping
requirements.
Dated: August 4, 2000.
Karen H. Brown,
Deputy Director.
For the reasons set forth in the preamble, Part 287 is added to
subchapter J of chapter II in Title 15 of the Code of Federal
Regulations (CFR) to read as follows:
PART 287--GUIDANCE ON FEDERAL CONFORMITY ASSESSMENT
Sec.
287.1 Purpose and scope of this guidance.
287.2 Definitions.
287.3 Responsibilities of the National Institute of Standards and
Technology.
287.4 Responsibilities of Federal agencies.
287.5 Responsibilities of an Agency Standards Executive.
Authority: Sec. 12, Pub. L. 104-113, 110 Stat. 782 (15 U.S.C.
272).
Sec. 287.1 Purpose and scope of this guidance.
(a) This part provides guidance for each Federal agency to use in
evaluating the efficacy and efficiency of its conformity assessment
activities. Each agency should coordinate its conformity assessment
activities with those of other appropriate government agencies and with
those of the private sector to reduce unnecessary duplication. This
guidance is intended to help Federal agencies improve the management
and coordination of their own conformity assessment activities with
respect to other government entities and the private sector. This will
help ensure more productive use of the increasingly limited Federal
resources available to conduct conformity assessment activities. This
will also support the role of the U.S. Government in pursuing
international trade and other related negotiations and agreements with
foreign countries and U.S. industry in pursuing agreements with foreign
national and international private sector organizations.
(b) This guidance applies to all agencies, which set policy for,
manage, operate, or use conformity assessment activities and results,
both domestic and international, except for activities carried out
pursuant to treaties.
(c) This guidance does not preempt the agencies' authority and
responsibility to make regulatory or procurement decisions authorized
by statute or required to meet programmatic objectives and
requirements. These decision-making activities include: determining the
level of acceptable regulatory or procurement risk; setting the level
of protection; balancing risk, cost and availability of technology
(where statutes permit) in establishing regulatory and procurement
objectives; and determining or implementing procurement or regulatory
requirements necessary to meet programmatic or regulatory objectives.
Each agency retains broad discretion in its selection and use of
regulatory and procurement conformity assessment practices and may
elect not to use or recognize alternative conformity assessment
practices if the agency deems them to be inappropriate, inadequate, or
inconsistent with statutory criteria or programmatic objectives and
requirements. Nothing contained herein shall give any party any claim
or cause of action against the Federal government or any agency
thereof. Each agency remains responsible for representation of the
agency's views on conformity assessment in matters under its
jurisdiction. Each agency also remains the primary point of contact for
information on the agency's regulatory and procurement conformity
assessment actions.
Sec. 287.2 Definitions.\1\
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\1\ Definitions of accreditation, certification, conformity
assessment, inspection, supplier's declaration of conformity,
registration and testing are based on the International Organization
for Standardization (ISO)/International Electrotechnical Commission
(IEC), Guide 2 (1996). In certain industrial sectors, it is
recognized that organizations other than ISO or IEC may issue
definitions relevant to conformity assessment, such as the Codex
Alimentarius Commission with respect to the food industry sector.
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Accreditation means a procedure used to provide formal notice that
a body or person is competent to carry out specific tasks. These tasks
include: sampling and testing; inspection; certification; and
registration.\2\
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\2\ For some agencies, accreditation may mean that a body or
person meets requirements defined in a specific section(s) of the
CFR. The referenced section(s) may include only limited requirements
for demonstration of technical competency.
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Agency means any Executive Branch Department, independent
commission, board, bureau, office, agency, government-owned or
controlled corporation, or other establishment of the Federal
government. It also includes any regulatory commission or board, except
for independent regulatory commission subject to separate statutory
requirements regarding policy setting, management, operation, and use
of conformity assessment activities. It does not include the
legislative or judicial branches of the Federal government.
Agency Standards Executive means an official designated by an
agency as its representative on the Interagency Committee for Standards
Policy (ICSP) and delegated the responsibility for agency
implementation of OMB Circular A-119 and the guidance in this part.
Certification means a procedure used to provide written assurance
that a product, process, service, or person's qualifications conforms
to specified requirements.
Conformity assessment means any activity concerned with determining
directly or indirectly that requirements are fulfilled. Requirements
for products,
[[Page 48901]]
services, systems, and organizations are those defined by law or
regulation or by an agency in a procurement action. Conformity
assessment includes: sampling and testing; inspection; supplier's
declaration of conformity; certification; and quality and environmental
management system assessment and registration. It also includes
accreditation and recognition. Conformity assessment does not include
mandatory administrative procedures (such as registration notification)
for granting permission for a good or service to be produced, marketed,
or used for a stated purpose or under stated conditions. Conformity
assessment activities may be conducted by the supplier (first party) or
by the buyer (second party) either directly or by another party on the
supplier's or buyer's behalf, or by a body not under the control or
influence of either the buyer or the seller (third party).
Inspection is defines ad the evaluation by observation and judgment
accompanied as appropriate by measurement, testing or gauging of the
conformity of a product, process or service to specified requirements.
NIST means the National Institute of Standards and Technology, an
agency within the United States Department of Commerce.
Recognition means a procedure used to provide formal notice that an
accreditation body is competent to carry out specific tasks. These
tasks include: the accreditation of testing laboratories and
inspection, certification, and registration bodies. A governmental
recognition system is a set of one or more procedures used by a Federal
agency to provide recognition.
Registration means a procedure used to give written assurance that
a system conforms to specified requirements. Such systems include those
established for the management of product, process or service quality
and environmental performance.
Sampling means the selection of one or more specimens of a product,
process, or service for the purpose of evaluating the conformity of the
product, process or service to specified requirements.
Supplier's declaration of conformity means a procedure by which a
supplier gives written assurance that a product, process, service or
organization conforms to specified requirements.
Testing means the action of carrying out one or more technical
operations (tests) that determine one or more characteristics or
performance of a given product, material, equipment, organism, person's
qualifications, physical phenomenon, process, or service according to a
specified technical procedure (test method).
Sec. 287.3 Responsibilities of the National Institute of Standards and
Technology.
(a) Work with agencies through the Interagency Committee on
Standards Policy (ICSP) to coordinate Federal, state and local
conformity assessment activities with private sector conformity
assessment activities. NIST chairs the ICSP; assists the ICSP in
developing and publishing policies and guidance on conformity
assessment related issues; collects and disseminates information on
Federal, state and private sector conformity assessment activities; and
increases public awareness of the importance of conformity assessment
and nature and extent of national and international conformity
assessment activities.
(b) Encourage participation in the ICSP by all affected agencies
and ensure that all agency views on conformity assessment are
considered.
(c) To the extent that resources are available, develop information
on state conformity assessment practices; and, upon request by a state
government agency, work with that state agency to reduce duplication
and complexity in state conformity assessment activities.
(d) Review within three years from August 10, 2000, the
effectiveness of the final guidance and recommend modifications to the
Secretary as needed.
Sec. 287.4 Responsibilities of Federal agencies.
Each agency should:
(a) Implement the policies contained in the guidance in this part.
(b) Provide a rationale for its use of specified conformity
assessment procedures and processes in rulemaking and procurement
actions to the extent feasible. Further, when notice and comment
rulemaking is otherwise required, each agency should provide the
opportunity for public comment on the rationale for the agency's
conformity assessment decision.
(c) Use the results of other governmental agency and private sector
organization conformity assessment activities to enhance the safety and
efficacy of proposed new conformity assessment requirements and
measures. An example of this would be to collect and review information
on similar activities conducted by other Federal, state and
international organizations and agencies and private sector
organizations to determine if the results of these activities can be
used to improve the effectiveness of a proposed Federal agency
conformity assessment activity.
(d) Use relevant guides or standards for conformity assessment
practices published by domestic and international standardizing bodies
as appropriate in meeting regulatory and procurement objectives. Guides
and standards for sampling, testing, inspection, certification, quality
and environmental management systems, management system registration
and accreditation are issued by organizations which include, but are
not limited to, the American National Standards Institute, the
International Organization for Standardization (ISO), the International
Electrotechnical Commission (IEC), the International Telecommunications
Union (ITU) and the Organization for Economic Cooperation and
Development (OECD), the World Health Organization (WHO), and the Codex
Alimentarius Commission. Each agency retains responsibility for
determining which, if any, of these documents are relevant to its
needs.
(e) Identify appropriate private sector conformity assessment
practices and programs and consider the results of such practices and/
or programs as appropriate in existing regulatory and procurement
actions. Responsibility for the determination of appropriateness rests
with each agency. Examples: an agency could use the results of private
sector or other governmental conformity assessment activities to
schedule procurement type audits more effectively. This could allow
agencies to reduce the number and extent of audits conducted at
companies which are performing in accordance with contract
specifications and which are under review by a third party or another
agency and to concentrate agency audit efforts on companies which have
shown problems in conforming to contract specifications. Another
example is the Federal Communications Commission's (FCC)
Telecommunication Certification Body (TCB) program, which allows
designated private entities to issue telecommunications equipment
approvals for specified regulatory requirements. In addition, under
Part 15, FCC premarketing approval requirements for certain types of
equipment have been replaced with suppliers declaration of conformity
to the regulations, provided test results supporting the declaration
are obtained from an accredited testing lab.
(f) Consider using the results of other agencies' conformity
assessment procedures. Example: An agency could use the results of
another agency's inspection/audit of a supplier to eliminate or reduce
the scope of its own inspection/audit of that supplier.
[[Page 48902]]
(g) Participate in efforts designed to improve coordination among
governmental and private sector conformity assessment activities. These
efforts include, but are not limited to, the National Cooperation for
Laboratory Accreditation (NACLA) organization, the National
Environmental Laboratory Accreditation (NELAC), the International
Organizations for Standardization's (ISO) Committee on Conformity
Assessment (CASCO), conformity assessment related activities of the
American National Standards Institute (ANSI), and ICSP working groups
dealing with conformity assessment issues.
(h) Work with other agencies to avoid unnecessary duplication and
complexity in Federal conformity assessment activities. Examples: An
agency can participate in another agency's conformity assessment
activities by conducting joint procurement audits/inspections of
suppliers that sell to both agencies. An agency can share conformity
assessment information with other agencies. An agency can use
conformity assessment information provided by other agencies to the
extent appropriate to improve the effectiveness and efficiency in its
own conformity assessment activities. Conformity assessment information
may include: Conformity assessment procedures and results, technical
data on the operation of conformity assessment programs, processing
methods and requirements for applications, fees, facility site data,
complaint review procedures, and confidentiality procedures.
(i) Encourage domestic and international recognition of U.S.
conformity assessment results by supporting the work of the U.S.
Government in international trade and related negotiations with foreign
countries and U.S. industry in pursuing agreements with foreign
national and international private sector organizations and any
resulting activities/requirements resulting from those negotiations/
agreements.
(j) Participate in the development of private sector conformity
assessment standards to ensure that Federal viewpoints are represented.
(k) Work with other agencies to harmonize Federal requirements for
quality and environmental management systems for use in procurement and
regulation, including provisions which will allow the use of one
quality or environmental management system per supplier facility in the
Federal procurement process and the sharing and usage of audit results
and related information as appropriate.
(l) Work with other ICSP members, NIST, and the private sector to
develop national infrastructures for coordinating and harmonizing U.S.
conformity assessment needs, practices and requirements in support of
the efforts of the U.S. Government and U.S. industry to increase
international market access for U.S. products.
(m) Work with other ICSP members, NIST, and the private sector as
necessary and appropriate to establish criteria for the development and
implementation of governmental recognition systems to meet government
recognition requirements imposed by other nations and regional groups
to support the efforts of the U.S. Government to facilitate
international market access for U.S. products.
(n) Assign an Agency Standard Executive responsibility for
coordinating the agency-wide implementation of the guidance in this
part.
Sec. 287.5 Responsibilities of an Agency Standards Executive.
In addition to carrying out the duties described in OMB Circular A-
119 related to standards activities, an Agency Standards Executive
should:
(a) Promote the following goals:
(1) Effective use of agency conformity assessment related resources
and participation in conformity assessment related activities of agency
interest.
(2) Development and dissemination of agency technical and policy
positions.
(3) Development of agency positions on conformity assessment
related issues that are in the public interest.
(b) Ensure that agency participation in conformity assessment
related activities is consistent with agency missions, authorities,
priorities, and budget.
(c) Cooperate with NIST in carrying out agency responsibilities
under the guidance in this part.
(d) Consult with NIST, as necessary, in the development and
issuance of internal agency procedures and guidance implementing the
policies in this part.
(e) Establish an ongoing process for reviewing his/her agency's
existing conformity assessment activities and identifying areas where
efficiencies can be achieved through coordination with other agency and
private sector conformity assessment activities.
(f) Work with other parts of his/her agency to develop and
implement improvements in agency conformity assessment related
activities.
(g) Report to NIST, on a voluntary basis, on agency conformity
assessment activities for inclusion in the annual report to the Office
of Management and Budget (OMB) on the agency's implementation of OMB
Circular A-119.
[FR Doc. 00-20262 Filed 8-9-00; 8:45 am]
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