Guidance on Federal Conformity Assessment Activities
| Published date | 07 February 2020 |
| Citation | 85 FR 7258 |
| Record Number | 2020-01714 |
| Section | Proposed rules |
| Court | National Institutes Of Standards And Technology |
Federal Register, Volume 85 Issue 26 (Friday, February 7, 2020)
[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
