[Federal Register Volume 85, Number 26 (Friday, February 7, 2020)]
[Proposed Rules]
[Pages 7258-7262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01714]


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DEPARTMENT OF COMMERCE

National Institutes of Standards and Technology

15 CFR Part 287

[Docket No.: 191210-0104]
RIN 0693-AB65


Guidance on Federal Conformity Assessment Activities

AGENCY: National Institute of Standards and Technology (NIST), United 
States Department of Commerce.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The National Institute of Standards and Technology (NIST) 
requests 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.
    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: For Comments: Send comments on or before April 7, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number: 191210-0104, through the Federal e-Rulemaking Portal: 
http://www.regulations.gov (search using the docket number). Follow the 
online instructions for submitting comments. Identify the document by 
docket ID number and other identifying information (subject heading, 
Federal Register date and page number). See SUPPLEMENTARY INFORMATION 
for file formats and other information about electronic filing. All 
submissions, including attachments and other supporting materials, will 
become part of the public record and subject to public disclosure. NIST 
reserves the right to publish relevant comments publicly, unedited and 
in their entirety. Personal information, such as account numbers or 
Social Security numbers, or names of other individuals, should not be 
included. Do not submit confidential business information, or otherwise 
proprietary, sensitive or protected information. Comments that contain 
profanity, vulgarity, threats, or other inappropriate language or 
content will not be posted or considered.

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 burden 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

[[Page 7259]]

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 
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.
    The proposed revision to 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. This 
proposed revision to 15 CFR 287 represents NIST's most recent effort to 
provide Federal agencies with up-to-date tools for effective use of 
conformity assessment.
    In developing this revision to 15 CFR 287 the NIST Standards 
Coordination Office (SCO) leveraged the expertise and experience of the 
members of the Interagency Committee on Standards Policy (ICSP) and the 
ICSP Conformity Assessment Work Group (CAWG). NIST met with the ICSP 
and CAWG for input on the revision and received comments from eight 
agencies on an early draft version. NIST seeks public comment on this 
proposed revision; see Section IV. Request for Comment.

Summary of Significant Proposed Changes

    NIST is seeking public comments on the proposed changes. Brief 
explanations of significant proposed changes are included below. The 
full text of 15 CFR part 287 is available at https://www.govinfo.gov/content/pkg/CFR-2015-title15-vol1/pdf/CFR-2015-title15-vol1-part287.pdf. The proposed changes in full text appear at the end of 
this notice. A table showing each clause of 15 CFR 287 and the related 
changes can be found at https://www.nist.gov/document/15CFR287_NPRM_ChangesTable.pdf. Significant proposed changes are to:
    1. Revise sections throughout part 287 to clarify that agencies use 
conformity assessment in meeting agency programmatic needs in addition 
to the currently stated regulatory and procurement needs. Using 
conformity assessment for agency programmatic needs emphasizes the 
voluntary nature of many conformity assessment programs. This emphasis 
aligns with OMB Circular A-119.
    2. Revise throughout part 287 to reflect direction to agencies in 
the NTTAA and related guidance in OMB Circular A-119 regarding the use 
of and participation in the development of voluntary consensus 
standards related to conformity assessment topics. See OMB Circular A-
119 for a discussion of voluntary consensus standards.
    3. Revise the definition of conformity assessment (Sec.  287.2) by 
adding the term persons to the list of possible focus of conformity 
assessment. Some concepts discussed in the definition are removed; the 
reader is directed to NIST Special Publication 2000-01, ABCs of 
Conformity Assessment, found at https://doi.org/10.6028/NIST.SP.2000-01 
for these concepts.
    4. Remove the following terms because the they are no longer used 
in part 287: Accreditation, certification, inspection, recognition, 
registration, supplier's declaration of conformity, and testing (Sec.  
287.2).
    5. Add new responsibilities for NIST (Sec.  287.3) to (1) issue 
guidance, training material and other material that assist Federal 
agencies in understanding and applying conformity assessment; and (2) 
participate in the development of conformity assessment related 
standards. Both of these roles reflect NIST leadership and conformity 
assessment expertise.
    6. Remove the responsibility for NIST to collect and disseminate 
information on Federal, State and private sector conformity assessment 
activities in Sec.  287.3 (a-penultimate clause) and state conformity 
assessment practices (Sec.  287.3(c)). Information about Federal, State 
and private sector conformity assessment activities is electronically 
discoverable and available from many sources. NIST uses exemplar 
Federal conformity assessment programs and private sector activities as 
resource material on https://standards.gov.
    7. Extend the timeframe for NIST to review the effectiveness of 
part 287 from three to five years (Sec.  287.3).
    8. Add the responsibility for Federal agencies to develop and 
implement conformity assessment in a manner that meets objectives, 
reduces unnecessary burden on stakeholders, makes productive use of 
resources, and meets international trade obligations (Sec.  287.4).
    9. Remove the responsibility for Federal agencies to harmonize 
requirements for quality and environmental management systems for 
procurement and regulation purposes (Sec.  287.4(k)). This 
responsibility is no longer necessary due to the widespread adoption 
among agencies of the same voluntary consensus standards related to 
management systems resulting in reliance on the same requirements.
    10. Remove the examples of how an agency may implement a specific 
part of the guidance (Sec.  287.4). The examples in the current 
guidance served, in part, as tutorial in nature. The experience of 
Federal agencies in applying conformity assessment concepts makes 
examples unnecessary.
    11. Expand the Federal agency responsibility to consider using the 
activities and results of other conformity assessment programs to 
enhance the effectiveness of existing or proposed new programs. The 
current responsibility was scoped to enhancing the safety and efficacy 
of proposed requirements and measures (Sec.  287.4(c)).
    12. Remove the standards and conformity assessment related 
organizational names as examples (Sec.  287.4). The inclusion or 
exclusion of

[[Page 7260]]

names may be perceived as endorsement or criticism.
    13. Reflect that U.S. access to international markets is achievable 
through many mechanisms. The current language is specific to 
recognition agreements and infrastructure (Sec.  287.4(i),(l),(m)). The 
revised language recognizes that other mechanisms (not just 
recognition) can facilitate acceptance of standards and conformity 
assessment results to increase market access for U.S. products and 
services.
    14. Add additional guidance to Federal agencies for their 
selection, role, and responsibilities of the Agency Standards Executive 
(Sec.  287.5(n)). The expansion of guidance is consistent with the 
roles and responsibilities assigned to the Agency Standards Executive 
in the revision of OMB Circular A-119.
    15. Add new responsibilities for the Agency Standards Executive 
that (1) encourages the Agency Standards Executive's participation in 
the Interagency Committee on Standards Participation (ICSP) and (2) 
encourages the Executive to promote agency participation in ICSP 
working groups. These responsibilities reflect the value of ICSP 
participation and interaction with other ICSP members.
    16. Modify the responsibilities of the Agency Standards Executive 
by removing the three goals listed and adding specific responsibilities 
based on the goals (Sec.  287.5(a)). The three goals were transferred 
to the revision of OMB Circular A-119. The new resultant 
responsibilities in this part are to encourage effective use of 
conformity assessment and resources; assist the agency in developing 
policy positions and help resolve issues related to conformity 
assessment; and promote Federal agency participation in conformity 
assessment related standards development and coordination activities.
    17. Remove the responsibilities for the Agency Standards Executive 
to consult with NIST, as necessary, in the development and issuance of 
policies for meeting the guidance in this part (Sec.  287.5(d)) and 
coordinate with NIST in carrying out the responsibilities in this part 
(Sec.  287.5(c)). The removal reflects the evolution of the role of an 
Agency Standards Executive and lack of need, for the most part, for 
consultation. The ICSP is used as the mechanism for coordination among 
the Agency Standards Executives and NIST.

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. Request for Comments

    NIST is requesting comments about 15 CFR part 287. When submitting 
comments, remember to:
    1. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    2. The following file formats are encouraged: PDF, MS Word, txt.
    3. Please organize your comments by referencing the relevant 
section number in the proposed regulatory text.
    4. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    5. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    6. Explain your views as clearly as possible.
    7. All submissions, including attachments and other supporting 
materials, will become part of the public record and subject to public 
disclosure. NIST reserves the right to publish relevant comments 
publicly, unedited and in their entirety. Personal information, such as 
account numbers or Social Security numbers, or names of other 
individuals, should not be included. Do not submit confidential 
business information, or otherwise proprietary, sensitive or protected 
information. Comments that contain profanity, vulgarity, threats, or 
other inappropriate language will not be posted or considered.
    8. Make sure to submit your comments by the comment period deadline 
identified.

V. 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 proposed rule does not contain policies with Federalism 
implications as defined in Executive Order 13132.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) requires the preparation and 
availability for public comment of ``an initial regulatory flexibility 
analysis'' which will ``describe the impact of the proposed rule on 
small entities.'' (5 U.S.C. 603(a)). Section 605 of the RFA allows an 
agency to certify a rule, in lieu of preparing an analysis, if the 
proposed rulemaking is not expected to have a significant economic 
impact on a substantial number of small entities.
    The Chief Counsel for Regulation of the Department of Commerce 
certified to the Chief Counsel for Advocacy of the Small Business 
Administration (SBA) that this rulemaking, if adopted, would not have a 
significant economic impact on a substantial number of small entities. 
The factual basis for this determination is as follows: A description 
of this proposed rule, why it is being considered, and the objectives 
of this proposed rule are contained in the preamble. The statutory 
basis for this proposed rule is provided by 15 U.S.C. 272, which 
requires NIST to coordinate Federal, State, and local standards 
activities and conformity assessment activities with private sector 
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. To ensure effective coordination, the Secretary of Commerce 
must issue guidance to the agencies. The proposed rule would provide 
policy guidance on Federal agency use of conformity assessment 
activities. These provisions are solely intended to be used as guidance 
for agencies in their conformity assessment activities. It is not 
anticipated that external entities, including any small businesses, 
small organizations, or small governments, will experience significant 
or adverse economic impacts from this rule.
    The information provided above supports a determination that this 
proposed rule would not have a significant economic impact on a 
substantial number of small entities. Because this rulemaking, if 
implemented, is not expected to have a

[[Page 7261]]

significant economic impact on any small entities, an initial 
regulatory flexibility analysis is not required.

Paperwork Reduction Act

    This proposed 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 proposed rule will not significantly affect the quality of the 
human environment. Therefore, an environmental assessment or 
Environmental Impact Statement is not 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 proposes to revise 15 CFR part 287 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 Agency Standards Executives.

    Authority:  15 U.S.C. 272.


Sec.  287.1   Purpose and scope of this guidance.

    (a) 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 burden 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.
    (b) Using conformity assessment in a manner consistent with this 
guidance supports U.S. Government efforts to pursue conformity 
assessment activities in a manner that reduces unnecessary burden on 
international trade and increases market access for U.S. products and 
services.
    (c) This guidance applies to all agencies, which set policy for, 
manage, operate, or use conformity assessment. This guidance does not 
preempt the agencies' authority and responsibility to make 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, 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 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, 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 OMB Circular A-119 and the guidance in this part.
    Conformity assessment means any activity concerned with determining 
directly or indirectly that requirements 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 terminology is 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. The 
definitions included in NIST Special Publication 2000-01 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.
    NIST means the National Institute of Standards and Technology, an 
agency within the United States Department of Commerce.


Sec.  287.3   Responsibilities of the National Institute of Standards 
and Technology.

    (a) 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 the ICSP to address issues related to agency conformity 
assessment program development, use, and implementation; and provide 
resource support to the ICSP and its working groups related to 
conformity assessment issues, as needed.
    (c) Work with agencies through the ICSP 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 in the importance of 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 the issuance date of this part, 
the effectiveness of this guidance and recommend modifications to the 
Secretary as needed.


Sec.  287.4   Responsibilities of Federal agencies.

    Each agency should:

[[Page 7262]]

    (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 burden on stakeholders; makes productive use of Federal 
resources; and meets international trade agreements and obligations.
    (c) Provide a rationale for its use of specified conformity 
assessment in 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 conformity 
assessment related standards, guides and recommendations in their 
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 designed to improve coordination among 
governmental and private sector conformity assessment activities such 
as those to develop voluntary consensus conformity assessment related 
standards, guidelines and recommendations.
    (h) 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 market access 
for U.S. products and services.
    (i) 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 with 
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 conformity assessment related standards, recommendations 
and guidelines consistent with agency missions, authorities, 
priorities, and resources.
    (i) Establish an ongoing process for reviewing the agency's 
conformity assessment programs and use 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. 2020-01714 Filed 2-6-20; 8:45 am]
 BILLING CODE 3510-13-P