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Title 15Subtitle BChapter IISubchapter J → Part 287


Title 15: Commerce and Foreign Trade


PART 287—GUIDANCE ON FEDERAL CONFORMITY ASSESSMENT


Contents
§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.

Source: 85 FR 60905, Sept. 29, 2020, unless otherwise noted.

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§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.

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§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.

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§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.

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§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 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.

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§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.

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