Guidance on Federal Conformity Assessment Activities, 60904-60907 [2020-18745]

Agencies

• DEPARTMENT OF COMMERCE
• National Institutes of Standards and Technology

[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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