§ 287.4 - Responsibilities of Federal agencies.

§ 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

procedures and processes

in rulemaking

and

, 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.

(

c) Use the results of other governmental agency and private sector organization conformity assessment activities to enhance the safety and efficacy of proposed new conformity assessment requirements and measures. An example of this would be to collect and review information on similar activities conducted by other Federal, state and international organizations and agencies and private sector organizations to determine if the results of these activities can be used to improve the effectiveness of a proposed Federal agency conformity assessment activity.

(d) Use relevant guides or standards for conformity assessment practices published by domestic and international standardizing bodies as appropriate in meeting regulatory and procurement objectives. Guides and standards for sampling, testing, inspection, certification, quality and environmental management systems, management system registration and accreditation are issued by organizations which include, but are not limited to, the American National Standards Institute, the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the International Telecommunications Union (ITU) and the Organization for Economic Cooperation and Development (OECD), the World Health Organization (WHO), and the Codex Alimentarius Commissiond) 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.

(e) Identify appropriate private sector conformity assessment practices and programs and consider the results of such practices and/or programs as appropriate in existing regulatory and procurement actions. Responsibility for the determination of appropriateness rests with each agency. Examples: an agency could use the results of private sector or other governmental conformity assessment activities to schedule procurement type audits more effectively. This could allow agencies to reduce the number and extent of audits conducted at companies which are performing in accordance with contract specifications and which are under review by a third party or another agency and to concentrate agency audit efforts on companies which have shown problems in conforming to contract specifications. Another example is the Federal Communications Commission's (FCC) Telecommunication Certification Body (TCB) program, which allows designated private entities to issue telecommunications equipment approvals for specified regulatory requirements. In addition, under Part 15, FCC premarketing approval requirements for certain types of equipment have been replaced with suppliers declaration of conformity to the regulations, provided test results supporting the declaration are obtained from an accredited testing lab.

(f) Consider using the results of other agencies' conformity assessment procedures. Example: An agency could use the results of another agency's inspection/audit of a supplier to eliminate or reduce the scope of its own inspection/audit of that supplier.

(g) Participate

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.

These efforts include, but are not limited to, the National Cooperation for Laboratory Accreditation (NACLA) organization, the National Environmental Laboratory Accreditation (NELAC), the International Organizations for Standardization's (ISO) Committee on Conformity Assessment (CASCO), conformity assessment related activities of the American National Standards Institute (ANSI), and ICSP working groups dealing with conformity assessment issues.

(h) Work with other agencies to avoid unnecessary duplication and complexity in Federal conformity assessment activities. Examples: An agency can participate in another agency's conformity assessment activities by conducting joint procurement audits/inspections of suppliers that sell to both agencies. An agency can share conformity assessment information with other agencies. An agency can use conformity assessment information provided by other agencies to the extent appropriate to improve the effectiveness and efficiency in its own conformity assessment activities. Conformity assessment information may include: Conformity assessment procedures and results, technical data on the operation of conformity assessment programs, processing methods and requirements for applications, fees, facility site data, complaint review procedures, and confidentiality procedures.

(i) Encourage domestic and international recognition of U.S. conformity assessment results by supporting the work of the U.S. Government in international trade and related negotiations with foreign countries and U.S. industry in pursuing agreements with foreign national and international private sector organizations and any resulting activities/requirements resulting from those negotiations/agreements.

(j) Participate in the development of private sector conformity assessment standards to ensure that Federal viewpoints are represented.

(k) Work with other agencies to harmonize Federal requirements for quality and environmental management systems for use in procurement and regulation, including provisions which will allow the use of one quality or environmental management system per supplier facility in the Federal procurement process and the sharing and usage of audit results and related information as appropriate.

(l) Work with other ICSP members, NIST, and the private sector to develop national infrastructures for coordinating and harmonizing

(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

market access for

trade of U.S. products

.

(m) Work with other ICSP members, NIST, and the private sector as necessary and appropriate to establish criteria for the development and implementation of governmental recognition systems to meet government recognition requirements imposed by other nations and regional groups to support the efforts of the U.S. Government to facilitate international market access for U.S. products.

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and services.

(j) Assign an Agency

Standard

Standards Executive the responsibility for coordinating

the

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.