Guidance on Federal Conformity Assessment Activities
| Citation | 85 FR 60904 |
| Record Number | 2020-18745 |
| Published date | 29 September 2020 |
| Section | Rules and Regulations |
| Court | National Institutes Of Standards And Technology,National Institute Of Standards And Technology |
Federal Register, Volume 85 Issue 189 (Tuesday, September 29, 2020)
[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Rules and Regulations]
[Pages 60904-60907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18745]
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DEPARTMENT OF COMMERCE
National Institutes of Standards and Technology
15 CFR Part 287
[Docket No.: 200813-0217]
RIN 0693-AB65
Guidance on Federal Conformity Assessment Activities
AGENCY: National Institute of Standards and Technology (NIST), United
States Department of Commerce.
ACTION: Final rule.
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SUMMARY: The National Institute of Standards and Technology (NIST)
announces revisions to regulations updating guidance on Federal agency
use of conformity assessment that reflects advancement in conformity
assessment concepts, and the evolution in Federal agency strategies and
coordination in using and relying on conformity assessment. The
provisions are solely intended to be used as guidance for agencies in
their use and reliance on conformity assessment to meet agency
requirements and do not preempt the agency authority and responsibility
to make decisions authorized by statute or required in establishing
regulatory, procurement, or programmatic activities.
DATES: This rule is effective October 29, 2020.
FOR FURTHER INFORMATION CONTACT: Mr. Gordon Gillerman via email at
[email protected], or by phone at (301) 975-4000.
SUPPLEMENTARY INFORMATION:
I. Purpose of This Guidance
The guidance outlines Federal agencies' responsibilities for using
conformity assessment to meet respective agency requirements in an
efficient and cost-effective manner for the agency and its
stakeholders. To reduce unnecessary complexity and make productive use
of Federal resources, this guidance emphasizes that agencies should
consider coordinating conformity assessment activities with those of
other appropriate government agencies (Federal, State, and local) and
with those in the private sector. This guidance does not preempt agency
authority and responsibility to make decisions authorized by statute or
required in establishing regulatory, procurement, or program
activities. This guidance also does not preempt agency authority and
responsibility in determining or implementing procurement, regulatory,
or programmatic requirements.
II. Background
Section 12 of the National Technology Transfer and Advancement Act
(NTTAA) of 1995 directs NIST to ``coordinate technical standards
activities and conformity assessment activities of Federal, State, and
local governments with private sector technical standards activities
and conformity assessment activities, with the goal of eliminating
unnecessary duplication and complexity in the development and
promulgation of conformity assessment requirements and measures'' (15
U.S.C. 272(b)(13)). NIST originally issued the guidance found in 15 CFR
part 287 (this Guidance) on August 10, 2000, in response to Office of
Management and Budget (OMB) Circular A-119 (February 10, 1998)
directing the Secretary of Commerce to issue guidance to Federal
agencies to ensure effective coordination of Federal conformity
assessment activities (65 FR 48894). The January 2016 revision to OMB
Circular A-119 re-emphasizes NIST's role in issuing guidance to
agencies as well as Federal agencies responsibilities with respect to
conformity assessment. NIST is revising this guidance to reflect
progression in conformity assessment concepts and evolution in Federal
agency strategies and coordination in using and relying on conformity
assessment.
This guidance is one of several activities undertaken by the NIST
Standards Coordination Office to update its guidance, training, and
other artifacts that help agencies develop and use conformity
assessment. As a first activity, NIST provided significant input to the
conformity assessment related policies of OMB Circular A-119. NIST
released two NIST Special Publications (SPs) in September 2018. NIST SP
2000-01, ABCs of Conformity Assessment, serves as a primer for the
topic of conformity assessment, and NIST SP 2000-02, Conformity
Assessment Considerations for Federal Agencies, provides agencies with
a path to follow in considering the development, use or improvement of
conformity assessment to meet their requirements. The revisions to 15
CFR part 287 represent NIST's most recent effort to provide Federal
agencies with up-to-date tools for effective use of conformity
assessment.
Summary of Changes Between the Proposed Rule and Final Rule
On February 7, 2020, NIST published a notice of proposed rulemaking
(NPRM) in the Federal Register (85 FR 7258) requesting public comments
on proposed revisions to regulations updating policy guidance on
Federal agency use of conformity assessment that reflects advancement
in conformity assessment concepts, and the evolution in Federal agency
strategies and coordination in using and relying on conformity
assessment. Nine (9) entities submitted comments, including two (2)
accreditation bodies, one (1) conformity assessment body, two (2)
individuals, three (3) industry associations, and one (1) regional
government. The following is a summary and analysis of the comments
received during the public comment period, and NIST's responses
including the recommendations and issues considered in the development
of the CFR.
1. Comment: Commenters indicated that definitions should be updated
to include new terminology and definitions for state agency, local
agency, state standards executive, and local standards executive. In
addition, commenters indicated changes to the definition of conformity
assessment were necessary to ensure consistency between NIST conformity
assessment publications and this guidance.
Response: NIST agrees with the need for consistency of definitions
and has aligned the definitions in 15 CFR 287.2, Definitions, with
those in OMB Circular
[[Page 60905]]
A-119. NIST does not have the authority to define roles for a state
standards executive or a local standards executive. The definition of
NIST as an acronym has been removed from this guidance. During the
rulemaking process, NIST realized this definition was unnecessary and
that its removal does not result in substantive changes.
2. Comment: Commenters supported removal of examples (i.e.,
conformity assessment organizations by name and specific standards)
from the NPRM. Other comments were received that support continued
inclusion of examples.
Response: NIST reviewed the impact of the comments and has removed
the examples. While they may be valuable as a learning vehicle, the use
of examples may lead agencies to believe there are limited ways to
address specific needs. In addition, the inclusion of some examples,
(and exclusion of others) may be perceived as an endorsement or
criticism by NIST.
3. Comment: Commenters responded that they were concerned changes
reflected a reduction in NIST's role working with agencies and
indicated that a central coordination role should be included to guide,
collect, and disseminate Federal, State, and local conformity
assessment activities.
Response: The roles and responsibilities of Federal agencies,
including NIST, with respect to conformity assessment are stated in the
National Technology Transfer and Advancement Act (NTTAA) and OMB
Circular A-119. NIST does not interpret its statutory coordination role
under the NTTAA with respect to State and local agencies to include the
collection and dissemination of conformity assessment information from
State and local agencies, as the explicit purpose of the relevant
provision is limited to eliminating unnecessary duplication and
complexity in the development and promulgation of conformity assessment
requirements and measures.
4. Comment: Commenters responded that greater emphasis was placed
on the role of the Interagency Committee for Standards Policy (ICSP),
including coordination of conformity assessment activities through this
committee in the proposed revisions to the regulations than the
original CFR.
Response: NIST has clarified language in 15 CFR 287.3(c) regarding
the role of the ICSP by adding the phrase, ``and other means,'' so that
the new provision will indicate that NIST intends to ``work with
agencies through the ICSP and other means to coordinate Federal, State
and local conformity assessment activities with private sector
conformity assessment activities.'' NIST utilizes the ICSP to exchange
information, provide direction to Federal agencies, and provide
opportunities for coordination. The ICSP provides a conduit for sharing
conformity assessment information across agencies.
5. Comment: Commenters requested the use of Federal agency
viewpoints in the development of voluntary consensus standards related
to conformity assessment. In addition, commenters indicated that the
term ``voluntary consensus conformity assessment related standards'' is
not defined and may cause industry confusion.
Response: NIST has revised 15 CFR 287.4(g) to clarify the role of
agencies in development of voluntary consensus standards as well as
development of voluntary consensus standards related to conformity
assessment. In addition, NIST intends to revise the term ``voluntary
consensus conformity assessment related standard'' to ``voluntary
consensus standards related to conformity assessment.''
6. Comment: Commenters indicated that NIST should not extend the
review period of the effectiveness of this guidance from three to five
years. Commenters expressed the need for frequent review due to the
complex and dynamic nature of conformity assessment in addition to
transparency and openness.
Response: NIST has kept the proposed language and maintained the
five-year review of the effectiveness of the guidance consistent with
the review periodicity of OMB Circular A-119.
7. Comment: Commenters indicated a need for state and local
government conformity assessment coordination in addition to
coordination within the Federal Government in 15 CFR 287.3, NIST
Responsibilities, and 15 CFR 287.4, Federal Agency Responsibilities.
Response: NIST has retained the language as written in the CFR. The
proposed language is consistent with the statutory authority in NTTAA
as well as OMB Circular A-119. NIST does not have the authority to
expand the role of other Federal agencies regarding coordination of
state and local conformity assessment activities.
III. Applicability of This Guidance
This guidance applies to all agencies, which set policy for,
manage, operate, or use conformity assessment activities and results.
``Agency'' means any Executive Department, independent commission,
board, bureau, office, 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 insofar as they are 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 although
those branches may use this guidance to inform their own use of
conformity assessment.
IV. Classification
Executive Order 12866
This rulemaking is not a significant regulatory action under
Executive Order 12866.
Executive Order 13771
This rule is not subject to the requirements of Executive Order
13771, because its likely impact is de minimis.
Executive Order 13132
This rule does not contain policies with federalism implications as
defined in Executive Order 13132.
Regulatory Flexibility Act
The Chief Counsel for Regulation for the Department of Commerce
certified at the proposed rule stage to the Chief Counsel for Advocacy
of the Small Business Administration under the provisions of the
Regulatory Flexibility Act, 5 U.S.C. 605(b), that this rule, if
adopted, would not have a significant economic impact on a substantial
number of small business entities. No comments were received on this
certification, so no Final Regulatory Flexibility Analysis is required,
and none has been prepared.
Paperwork Reduction Act
This rule contains no new collection of information subject to the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
National Environmental Policy Act
This rule will not significantly affect the quality of the human
environment. Therefore, neither an environmental assessment nor an
Environmental Impact Statement is required to be prepared under the
National Environmental Policy Act of 1969.
List of Subjects in 15 CFR Part 287
Conformity assessment, Procurement, Trade agreements, Voluntary
standards.
0
For the reasons stated in the preamble, the National Institute of
Standards and Technology revises 15 CFR part 287 to read as follows:
[[Page 60906]]
PART 287--GUIDANCE ON FEDERAL CONFORMITY ASSESSMENT
Sec.
287.1 Purpose and scope of this part.
287.2 Definitions.
287.3 Responsibilities of the National Institute of Standards and
Technology.
287.4 Responsibilities of Federal agencies.
287.5 Responsibilities of Agency Standards Executives.
Authority: 15 U.S.C. 272.
Sec. 287.1 Purpose and scope of this part.
(a) This part outlines Federal agencies' responsibilities for using
conformity assessment to meet respective agency requirements in an
efficient and cost-effective manner for the agency and its
stakeholders. To reduce unnecessary complexity and make productive use
of Federal resources, this part emphasizes that agencies should
consider coordinating conformity assessment activities with those of
other appropriate government agencies (Federal, State, and local) and
with those in the private sector.
(b) Using conformity assessment in a manner consistent with this
part supports U.S. Government efforts to meet trade obligations and
demonstrate good regulatory practices, which reduces unnecessary
obstacles to international trade and improves market access for
products and services.
(c) This part applies to all agencies which set policy for, manage,
operate, or use conformity assessment. This part does not preempt the
agencies' authority and responsibility to make decisions authorized by
statute or required to meet regulatory, procurement, or 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 and technical resources (where statutes permit) in
establishing regulatory, procurement, and program requirements.
(d) Each agency retains broad discretion in its selection and use
of conformity assessment activities and may elect not to use or
recognize alternative conformity assessment approaches if the agency
deems the alternatives to be inappropriate, inadequate, or inconsistent
with statutory criteria or programmatic objectives and requirements.
Nothing contained in this part 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, procurement, or programmatic conformity assessment
actions.
Sec. 287.2 Definitions.
For the purposes of this part:
Agency means any Executive Department, independent commission,
board, bureau, office, 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 insofar as they are subject to separate statutory
requirements regarding policy setting, management, operation, and use
of conformity assessment. 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 Office of Management and Budget (OMB) Circular A-119
and the guidance in this part.
Conformity assessment is a demonstration, whether directly or
indirectly, that specified requirements relating to a product, process,
system, person, or body are fulfilled. Requirements for products,
services, systems, persons, and organizations are those defined by law
or regulation, by an agency in regulatory or procurement actions, or an
agency programmatic policy. 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 related terminology and concepts, including a discussion of
the value and benefits of conformity assessment, are contained in NIST
Special Publication 2000-01, ABCs of Conformity Assessment (2018) found
free of charge at: https://doi.org/10.6028/NIST.SP.2000-01 and NIST
Special Publication 2000-02, Conformity Assessment Considerations for
Federal Agencies, found at: https://doi.org/10.6028/NIST.SP.2000-02.
The definitions of conformity assessment related terminology included
in these documents are based on voluntary consensus standards. See OMB
Circular A-119 for a description of voluntary consensus standards and
recommendations for their development and use by Federal agencies.
Sec. 287.3 Responsibilities of the National Institute of Standards
and Technology.
(a) Coordinate issues related to agency conformity assessment
program development, use, and implementation and issue guidance,
training material, and other material to assist Federal agencies in
understanding and applying conformity assessment to meet their
requirements. Material is available at https://www.standards.gov.
(b) Chair the Interagency Committee on Standards Policy (ICSP);
encourage participation in the ICSP; as well as provide resource
support to the ICSP and its working groups related to conformity
assessment issues, as needed.
(c) Work with agencies through the ICSP and other means to
coordinate Federal, State, and local conformity assessment activities
with private sector conformity assessment activities.
(d) Participate in the development of voluntary consensus
standards, recommendations, and guidelines related to conformity
assessment to ensure that Federal viewpoints are represented.
(e) Increase awareness of the importance of public and private
sector conformity assessment through development and publication of
conformity assessment resources. Material is available at https://www.standards.gov.
(f) To the extent that resources are available and upon request by
a state government agency, work with that state agency to reduce
duplication and complexity in state conformity assessment activities.
(g) Review, within five years from October 29, 2020, the
effectiveness of the guidance in this part 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.
Agencies may rely on NIST Special Publication 2000-02 Conformity
Assessment Considerations for Federal Agencies found free of charge at
https://doi.org/10.6028/NIST.SP.2000-02.
(b) Develop and implement conformity assessment in a manner that
meets regulatory, procurement, and programmatic objectives; reduces
unnecessary complexity for stakeholders; makes productive use of
Federal resources; and meets international trade agreement obligations.
(c) Provide a rationale for its use of specified conformity
assessment in
[[Page 60907]]
rulemaking, procurement actions, and agency programs 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.
(d) Work with other Federal agencies to avoid unnecessary
duplication and complexity in Federal conformity assessment activities.
(e) Consider leveraging the activities and results of other
governmental agency and private sector programs in lieu of creating
government-unique programs or to enhance the effectiveness of proposed
new and existing conformity assessment.
(f) Give a preference for using voluntary consensus standards,
guides, and recommendations related to conformity assessment in agency
operations. Each agency retains responsibility for determining which,
if any, of these documents are relevant to its needs. See OMB Circular
A-119 for a description of voluntary consensus standards and
recommendations for their development and use by Federal agencies.
(g) Participate, as needed, representing agency and Federal
viewpoints, in efforts to develop voluntary consensus standards,
guideline, and recommendations related to conformity assessment.
(h) Participate, as needed, representing agency and Federal
viewpoints in efforts designed to improve coordination among
governmental and private sector conformity assessment activities.
(i) Work with NIST, other Federal agencies, ICSP members, and the
private sector to coordinate 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 trade of U.S.
products and services.
(j) Assign an Agency Standards Executive the responsibility for
coordinating agency-wide implementation of the guidance in this part
who is situated in the agency's organizational structure such that the
Agency Standards Executive is kept regularly apprised of the agency's
regulatory, procurement, and other mission-related activities, and has
sufficient authority within the agency to ensure implementation of the
guidance in this part.
Sec. 287.5 Responsibilities of Agency Standards Executives.
Each Agency Standards Executive should:
(a) Carry out the duties in OMB Circular A-119 related to
conformity assessment activities.
(b) Encourage effective use of agency conformity assessment related
resources.
(c) Provide ongoing assistance and policy guidance to the agency on
significant issues in conformity assessment.
(d) Contribute to the development and dissemination of:
(1) Internal agency policies related to conformity assessment
issues; and
(2) Agency positions on conformity assessment related issues that
are in the public interest.
(e) Work with other parts of the agency to develop and implement
improvements in agency conformity assessment activities.
(f) Participate in the Interagency Committee on Standards Policy
(ICSP) as the agency representative and member.
(g) Promote agency participation in ICSP working groups related to
conformity assessment issues, as needed.
(h) Encourage agency participation in efforts related to the
development of voluntary consensus standards, recommendations, and
guidelines related to conformity assessment consistent with agency
missions, authorities, priorities, and resources.
(i) Establish an ongoing process for reviewing the agency's
conformity assessment programs and identify areas where efficiencies
can be achieved through coordination within the agency and among other
agencies and private sector conformity assessment activities.
Kevin A. Kimball,
Chief of Staff.
[FR Doc. 2020-18745 Filed 9-28-20; 8:45 am]
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