NIST Standards-Related Authorizations

The Secretary of Commerce acting through the NIST Director serves as the President's principal adviser on standards policy pertaining to the Nation's technological competitiveness and innovation ability (15 USC §272 (b)).  The NIST Director is authorized by statute to take all actions necessary and appropriate to accomplish the functions of the Institute, including the following standards-related functions—

• to cooperate with other departments and agencies of the Federal Government, with industry, with State and local governments, with the governments of other nations and international organizations, and with private organizations in establishing standard practices, codes, specifications, and voluntary consensus standards,
• 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,
• to facilitate standards-related information sharing and cooperation between Federal agencies and to coordinate the use by Federal agencies of private sector standards, emphasizing where possible the use of standards developed by private, consensus organizations,
• to develop, maintain, and retain custody of the national standards of measurement, and provide the means and methods for making measurements consistent with those standards, and 
• to assure the compatibility of United States national measurement standards with those of other nations.

The National Technology Transfer and Advancement Act of 1995 (Public Law 104-113; hereinafter known as “the NTTAA”) codified pre-existing policies on the development and use of voluntary consensus standards in OMB Circular A-119, established additional reporting requirements for agencies, and authorized the Department of Commerce’s National Institute of Standards and Technology (NIST) to coordinate conformity assessment activities.

The policies of Circular A-119 are intended to encourage Federal agencies to benefit from the expertise of the private sector, promote Federal agency participation in standards bodies to support the creation of standards that are useable by Federal agencies, and minimize reliance on government-unique standards where an existing standard would meet the Federal government’s objective.

Specifically, the Circular directs agencies to use standards developed or adopted by voluntary consensus standards bodies rather than government-unique standards, except where inconsistent with applicable law or otherwise impractical.  The policies in the Circular are intended to facilitate agencies’ compliance with obligations under U.S. trade statutes and trade agreements. U.S. Federal law (19 U.S.C. § 2532 - Federal standards-related activities) specifically prohibits any U.S. Government agency from engaging in standards-related activities that create unnecessary obstacles to the foreign commerce of the United States

The OMB Circular A-119 states that the Secretary of Commerce:

1. coordinates and fosters executive branch implementation of the Circular and, as appropriate, provides administrative guidance to assist agencies in implementing the Circular, including guidance on identifying voluntary consensus standards bodies and voluntary consensus standards;
2. sponsors and supports the Interagency Council on Standards Policy (ICSP), chaired by NIST, which considers agency views and advises the Secretary and agency heads on the Circular;
3. reports to the Director of OMB concerning the implementation of the policy provisions of this Circular; and
4. issues guidance to the agencies to improve coordination on conformity assessment in accordance with Section 7 of the Circular.

The OMB Circular states that the role of the Agency Standards Executive is to promote the following goals in the context of agency participation in the work of standards bodies and in conformity assessment activities:

1. effective use of agency resources and participation in standards bodies,
2. the development of agency positions that are in the public interest and are coordinated across units,
3. the development of agency positions that are consistent with Administration policy,
4. the development of agency technical and policy positions that are clearly defined and coordinated with other Federal participants in a given standards activity, and
5. the development of agency policies on conformity assessment to implement the provisions of Section 7 of this Circular, consistent with 15 C.F.R. § 287.

The OMB Circular further states that the Agency Standards Executive functions include:

1. coordinating the agency’s participation in standards bodies, and
2. ensuring that agency rulemaking, procurement, and other programmatic activities are consistent with the Circular.

OMB Circular A-119 further states that an Agency Standards Executive, consistent with applicable law, should be a senior level official; have demonstrated knowledge of, and experience in, the areas of standards, standardization processes and procedures, and conformity assessment; be broadly engaged in the agency’s standards and conformity assessment related activities so as to ensure intra-agency coordination; and be broadly familiar with how the agency uses standards and conformity assessment in its mission and how it participates in activities of standards bodies and conformity assessment systems, including international systems of conformity assessment.

The OMB Circular does not specify any requirements for the Chair of the Interagency Council on Standards Policy. Specifically, it does not specify that the ICSP Chair should be the NIST Standards Executive, nor does it preclude the same individual being appointed to both positions.  The ICSP Chair typically has been the NIST Standards Executive. The NIST Director may decide to appoint the same or different individuals to these two positions.

(a) Sense of Congress

It is the sense of Congress that—

1. the principles of openness, transparency, due process, balance of interests, appeals, and consensus in the development of international standards are critical;
2. voluntary consensus standards, developed through an industry-led process, serve as the cornerstone of the United States standardization system and have become the basis of a sound national economy and the key to global market access;
3. strengthening the unique United States public-private partnerships approach to standards development is critical to United States economic competitiveness; and
4. the United States Government should ensure cooperation and coordination across Federal agencies to partner with and support private sector stakeholders to continue to shape international dialogues in regard to standards development for emerging technologies.

(b) International standards engagement

(1)  In general

The Director shall lead information exchange and coordination among Federal agencies and communication from Federal agencies to the private sector of the United States to ensure effective Federal engagement in the development and use of international technical standards.

(2)  Requirements 

To support private sector-led engagement and ensure effective Federal engagement in the development and use of international technical standards, the Director shall consider—

(A) the role and needs of the Federal Government with respect to international technical standards;

(B) organizations developing international technical standards of interest to the United States, United States representation and influence in these organizations, and key contributors for technical and leadership expertise in these organizations;

(C) support for persons with domain subject matter expertise, especially from small businesses located in the United States, to influence and engage in technical standards leadership positions, working groups and meetings;

(D) opportunities for partnerships for supporting international technical standards from across the Federal Government, Federally funded research and development centers, university-affiliated research centers, institutions of higher education, industry, industry associations, nonprofit organizations, and other key contributors;

(E) support for activities to encourage the adoption of technical standards developed in the United States to be adopted by international standards organizations; and

(F) other activities determined by the Director to be necessary to support United States participation in international standards development, economic competitiveness, and national security in the development and use of international technical standards.

(c)  Capacity building guidance

The Director shall support education and workforce development efforts to promote United States participation in international standards organizations. The Director shall—

(1) identify and create, as appropriate, technical standards education and training resources for interested businesses, industry associations, academia, nonprofit organizations, Federal agencies, and other relevant standards contributors, including activities targeted at integrating standards content into undergraduate and graduate curricula in science, engineering, business, public policy, and law;

(2) conduct outreach, including to private sector leaders, to support engagement by more United States stakeholders in international technical standards development; and

(3) other activities determined necessary by the Director to support increased engagement, influence, and leadership of United States organizations in the development of international technical standards.

(d) Capacity building pilot program

(1)  In general

The Director, in coordination with the Director of the National Science Foundation, and the heads of other relevant Federal agencies, as appropriate, shall establish or enter into cooperative agreements with appropriate nongovernmental organizations to establish a 5-year pilot program to award grants, on a merit-reviewed, competitive basis, to private sector entities, institutions of higher education, or nonprofit institutions based in the United States to support increased participation and leadership by small business and academic interests in international standards organizations.

(2)  Use of funds

Grants awarded to eligible entities under this subsection may be used to cover reasonable costs, up to a specified ceiling set by the Director, of activities to support increased engagement and leadership of eligible entity employees in international standards organizations, which may include costs associated with—

(A) travel;

(B) education and training;

(C) dues or fees related to participation in technical standards development activities; and

(D) other such costs that the Director determines may reasonably support participation of the eligible entity in international standards organizations.

(3)  Award criteria

The Director shall ensure that award decisions made under this subsection take into account the extent to which the eligible entity—

(A) employs full-time an individual or individuals who demonstrate deep technical standards expertise;

(B) employs full-time an individual or individuals who demonstrate knowledge with the processes of the standards development organization in which the eligible entity intends to engage using grant funds;

(C) proposes a feasible set of standard deliverables to be completed over the period of the grant;

(D) explains how the eligible entity will fund additional standards-related activities necessary to achieve the deliverables referred to in subparagraph (C) if the grant funds are insufficient to cover all costs of such activities;

(E) commits personnel with appropriate expertise to regularly engage in relevant international organizations responsible for developing technical standards over the period of the grant; and

(F) identifies a clearly defined current or anticipated market need or gap that would be addressed by their standards development proposal.

(4)  Eligibility

A small business concern (as such term is defined in section 632 of title 15 based in the United States, an institution of higher education, or a nonprofit institution (as such term is defined in section 3703 of title 15) shall be eligible to receive grants under this program.

1. Guidance on application and award process

The Director shall develop, and periodically update, guidance, including eligibility, applicant disclosure requirements, grant amount and duration, the merit review process, priority areas for standards development, and any additional requirements for how grants are awarded under this subsection.

2. Merit review process

The Director shall ensure that grants under this subsection are awarded based on a competitive, merit review process including the use of merit review panels that may include experts from both government, the private sector, and, as appropriate, academic, nonprofit, or other organizations as the Director determines appropriate.

3. Consultation

In carrying out the pilot program established under this subsection, the Director shall consult with other Federal agencies, private sector organizations, institutions of higher education, and nonprofit organizations to help inform the pilot program, including the guidance developed under paragraph (5).

(8)  Report to congress The Director shall brief Congress after the second year of the pilot program and each year following that includes the following:

(A) An assessment of the effectiveness of the pilot program for improving the participation of United States small businesses, United States institutions of higher education, or other nonprofit research institutions in international standards organizations, including—

(i)   the type of activities supported, including leadership roles;

(ii)  the international standards organizations participated in; and

(iii) the technical areas covered by the activities.

(B) If determined effective, a plan for permanent implementation of the pilot program.

§ 285.1 Purpose.

The purpose of this part is to set out procedures and general requirements under which the National Voluntary Laboratory Accreditation Program (NVLAP) operates as an unbiased third party to accredit both testing and calibration laboratories. Supplementary technical and administrative requirements are provided in supporting handbooks and documents as needed, depending on the criteria established for specific Laboratory Accreditation Programs (LAPs). 

§ 285.2 Confidentiality.

To the extent permitted by applicable laws, NVLAP will protect the confidentiality of all information obtained relating to the application, on-site assessment, proficiency testing, evaluation, and accreditation of laboratories. 

§ 285.3 Referencing NVLAP accreditation.

The term NVLAP (represented by the NVLAP logo) is a federally registered certification mark of the National Institute of Standards and Technology and the federal government, who retain exclusive rights to control the use thereof. Permission to use the term and/or logo is granted to NVLAP-accredited laboratories for the limited purposes of announcing their accredited status, and for use on reports that describe only testing and calibration within the scope of accreditation. NIST reserves the right to control the quality of the use of the term NVLAP and of the logo itself.

§ 285.4 Establishment of laboratory accreditation programs (LAPs) within NVLAP.

NVLAP establishes LAPs in response to legislative actions or to requests from private sector entities and government agencies. For legislatively mandated LAPs, NVLAP shall establish the LAP. For requests from private sector entities and government agencies, the Chief of NVLAP shall analyze each request, and, after consultation with interested parties through public workshops or other means to ensure open participation, shall establish the requested LAP, if the Chief of NVLAP determines there is need for the requested LAP. 

§ 285.5 Termination of a LAP.

(a) The Chief of NVLAP may terminate a LAP when he/she determines that a need no longer exists to accredit laboratories for the services covered under the scope of the LAP. In the event that the Chief of NVLAP proposes to terminate a LAP, a notice will be published in the Federal Register setting forth the basis for that determination. 

(b) When a LAP is terminated, NVLAP will no longer grant or renew accreditations following the effective date of termination. Accreditations previously granted shall remain effective until their expiration date unless terminated voluntarily by the laboratory or revoked by NVLAP. Technical expertise will be maintained by NVLAP while any accreditation remains effective. 

§ 285.6 Application for accreditation.

A laboratory may apply for accreditation in any of the established LAPs. The applicant laboratory shall provide a completed application to NVLAP, pay all required fees and agree to certain conditions as set forth in the NVLAP Application for Accreditation, and provide management system documentation to NVLAP (or a designated NVLAP assessor) prior to the assessment process. 

§ 285.7 Assessment.

(a) Frequency and scheduling. Before initial accreditation, during the first renewal year, and every two years thereafter, an on-site assessment of each laboratory is conducted to determine compliance with the NVLAP criteria. 

(b) Assessors. NVLAP shall select qualified assessors to evaluate all information collected from an applicant laboratory pursuant to § 285.6 of this part and to conduct the assessment on its behalf at the laboratory and any other sites where activities to be covered by the accreditation are performed. 

(c) Conduct of assessment. 

(1) Assessors use checklists provided by NVLAP so that each laboratory receives an assessment comparable to that received by others. 

(2) During the assessment, the assessor meets with management and laboratory personnel, examines the quality system, reviews staff information, examines equipment and facilities, observes demonstrations of testing or calibrations, and examines tests or calibration reports. 

(3) The assessor reviews laboratory records including resumes, job descriptions of key personnel, training, and competency evaluations for all staff members who routinely perform, or affect the quality of the testing or calibration for which accreditation is sought. The assessor need not be given information which violates individual privacy, such as salary, medical information, or performance reviews outside the scope of the accreditation program. The staff information may be kept in the laboratory's official personnel folders or separate folders that contain only the information that the NVLAP assessor needs to review. 

(4) At the conclusion of the assessment, the assessor conducts an exit briefing to discuss observations and any nonconformities with the authorized representative who signed the NVLAP application and other responsible laboratory staff. 

(d) Assessment report. At the exit briefing, the assessor submits a written report on the compliance of the laboratory with the accreditation requirements, together with the completed checklists, where appropriate. 

(e) Deficiency notification and resolution. 

(1) Laboratories are informed of nonconformities during the on-site assessment, and nonconformities are documented in the assessment report (see paragraph (d) of this section). 

(2) A laboratory shall, within thirty days of the date of the assessment report, provide documentation that the specified nonconformities have either been corrected and/or a plan of corrective actions as described in the NVLAP handbooks. 

(3) If substantial nonconformities have been cited, NVLAP may require an additional on-site assessment, at additional cost to the laboratory, prior to granting accreditation. All nonconformities and resolutions will be subject to thorough review and evaluation prior to an accreditation decision. 

(4) After the assessor submits their final report, NVLAP reviews the report and the laboratory's response to determine if the laboratory has met all of the on-site assessment requirements. 

§ 285.8 Proficiency testing.

(a) Proficiency testing requirements. Proficiency testing undertaken to meet the criteria for NVLAP accreditation shall be consistent with the provisions contained in NIST Handbook 150, NVLAP Procedures and General Requirements (incorporated by reference, see § 285.16), where applicable, including revisions from time to time. Laboratories must participate in proficiency testing as specified for each LAP in the NVLAP program handbooks. 

(b) Analysis and reporting. Proficiency testing results are analyzed by NVLAP and results of the analysis are made known to the participants. Any result not meeting the criteria specified in the NVLAP LAP program handbook is identified as a nonconformity. 

(c) Proficiency testing nonconformities. 

(1) Unsatisfactory participation in any proficiency testing program is a technical nonconformity which must be resolved in order to obtain initial accreditation or maintain accreditation. 

(2) Proficiency testing nonconformities are defined as, but not limited to, one or more of the following: 

(i) Failure to meet specified proficiency testing performance requirements prescribed by NVLAP; 

(ii) Failure to participate in a regularly scheduled “round” of proficiency testing for which the laboratory has received instructions and/or materials; 

(iii) Failure to submit laboratory control data as required; or 

(iv) Failure to produce acceptable test or calibration results when using NIST Standard Reference Materials or special artifacts whose properties are well-characterized and known to NIST/NVLAP. 

(3) NVLAP will notify the laboratory of proficiency testing nonconformities and actions to be taken to resolve the nonconformities. Denial or suspension of accreditation will result from failure to resolve nonconformities. 

§ 285.9 Granting accreditation.

(a) The Chief of NVLAP is responsible for all NVLAP accreditation actions, including granting, denying, renewing, suspending, and revoking any NVLAP accreditation. 

(b) Initial accreditation is granted when a laboratory has met all NVLAP requirements. One of four accreditation renewal dates (January 1, April 1, July 1, or October 1) is assigned to the laboratory and is usually retained as long as the laboratory remains in the program. Initial accreditation is granted for a period of one year; accreditation expires and is renewable on the assigned date. 

(c) Renewal dates may be reassigned to provide benefits to the laboratory and/or NVLAP. If a renewal date is changed, the laboratory will be notified in writing of the change and any related adjustment in fees. 

(d) When accreditation is granted, NVLAP shall provide to the laboratory a Certificate of Accreditation and a Scope of Accreditation, 

§ 285.10 Renewal of accreditation.

(a) An accredited laboratory must submit both its application for renewal and fees to NVLAP prior to expiration of the laboratory's current accreditation to avoid a lapse in accreditation. 

(b) On-site assessments of currently accredited laboratories are performed in accordance with the procedures in § 285.7. If nonconformities are found during the assessment of an accredited laboratory, the laboratory must follow the procedures set forth in § 285.7(e)(2) or face possible suspension or revocation of accreditation. 

§ 285.11 Changes to scope of accreditation.

A laboratory may request in writing changes to its Scope of Accreditation. If the laboratory requests additions to its Scope, it must meet all NVLAP criteria for the additional tests or calibrations, types of tests or calibrations, or standards. The need for an additional on-site assessment and/or proficiency testing will be determined on a case-by-case basis. 

§ 285.12 Monitoring visits.

(a) In addition to regularly scheduled assessments, monitoring visits may be conducted by NVLAP at any time during the accreditation period. They may occur for cause or on a random selection basis. While most monitoring visits will be scheduled in advance with the laboratory, NVLAP may conduct unannounced monitoring visits. 

(b) The scope of a monitoring visit may range from checking a few designated items to a complete review. The assessors may review nonconformity resolutions, verify reported changes in the laboratory's personnel, facilities or operations, or evaluate proficiency testing activities, when appropriate. 

§ 285.13 Denial, suspension, revocation, or termination of accreditation.

(a) A laboratory may at any time voluntarily terminate its participation and responsibilities as an accredited laboratory by advising NVLAP in writing of its desire to do so. 

(b) If NVLAP finds that an accredited laboratory does not meet all NVLAP requirements, has violated the terms of its accreditation, or does not continue to comply with the provisions of these procedures, NVLAP may suspend the laboratory's accreditation, or advise of NVLAP's intent to revoke accreditation. 

(1) If a laboratory's accreditation is suspended, NVLAP shall notify the laboratory of that action stating the reasons for and conditions of the suspension and specifying the action(s) the laboratory must take to have its accreditation reinstated. Conditions of suspension will include prohibiting the laboratory from using the NVLAP logo on its test or calibration reports, correspondence, or advertising during the suspension period in the area(s) affected by the suspension. 

(2) NVLAP will not require a suspended laboratory to return its Certificate and Scope of Accreditation, but the laboratory must refrain from using the NVLAP logo in the area(s) affected until such time as the problem(s) leading to the suspension has been resolved. When accreditation is reinstated, NVLAP will authorize the laboratory to resume testing or calibration activities in the previously suspended area(s) as an accredited laboratory. 

(c) If NVLAP proposes to deny or revoke accreditation of a laboratory, NVLAP shall inform the laboratory of the reasons for the proposed denial or revocation and the procedure for appealing such a decision. 

(1) The laboratory will have thirty days from the date of receipt of the proposed denial or revocation letter to appeal the decision to the Director of NIST. If the laboratory appeals the decision to the Director of NIST, the proposed denial or revocation will be stayed pending the outcome of the appeal. The proposed denial or revocation will become final through the issuance of a written decision to the laboratory in the event that the laboratory does not appeal the proposed denial or revocation within the thirty-day period. 

(2) If accreditation is revoked, the laboratory may be given the option of voluntarily terminating the accreditation. 

(3) A laboratory whose accreditation has been revoked must cease use of the NVLAP logo on any of its reports, correspondence, or advertising related to the area(s) affected by the revocation. If the revocation is total, NVLAP will instruct the laboratory to return its Certificate and Scope of Accreditation and to remove the NVLAP logo from all test or calibration reports, correspondence, or advertising. If the revocation affects only some, but not all of the items listed on a laboratory's Scope of Accreditation, NVLAP will issue a revised Scope that excludes the revoked area(s) in order that the laboratory might continue operations in accredited areas. 

(d) A laboratory whose accreditation has been voluntarily terminated, denied or revoked, may reapply and be accredited if the laboratory: 

(1) Completes the assessment and evaluation process; and 

(2) Meets the NVLAP conditions and criteria for accreditation. 

§ 285.14 Criteria for accreditation.

The requirements for laboratories to be recognized by the National Voluntary Laboratory Accreditation Program as competent to carry out tests and/or calibrations are contained in NIST Handbook 150, NVLAP Procedures and General Requirements (incorporated by reference, see § 285.16). 

§ 285.15 Obtaining documents.

(a) Application forms, NVLAP handbooks, and other NVLAP documents and information may be obtained by contacting the NVLAP, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 2140, Gaithersburg, Maryland 20899–2140; phone: 301–975–4016; fax: 301–926–2884; e-mail: nvlap [at] nist.gov (nvlap[at]nist[dot]gov). 

(b) Copies of all ISO/IEC documents are available for purchase from the American National Standards Institute's eStandards Store at http://webstore.ansi.org. You may inspect copies of all applicable ISO/IEC documents at the National Voluntary Laboratory Accreditation Program, National Institute of Standards and Technology, 100 Bureau Drive, Room B119, Gaithersburg, MD. For access to the NIST campus, please contact NVLAP by phone at 301–975–4016 or by email at NVLAP [at] nist.gov (NVLAP[at]nist[dot]gov) to obtain instructions for visitor registration. 

§ 285.16 Incorporation by reference.

Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at National Institute of Standards and Technology, National Voluntary Laboratory Accreditation Program (NVLAP), National Institute of Standards and Technology, 100 Bureau Drive, Room B119, Gaithersburg, MD and is available from the source(s) listed in the following paragraph(s). It is also available for inspection at the National Archives and Records Administration (NARA). For access to the NIST campus, please contact NVLAP by phone at 301–975–4016 or by email at NVLAP [at] nist.gov (NVLAP[at]nist[dot]gov) to obtain instructions for visitor registration. For information on the availability of this material at NARA, email fedreg.legal [at] nara.gov (fedreg[dot]legal[at]nara[dot]gov) or go to www.archives.gov/federal-register/cfr/ibr-locations.html. 

(a) National Institute of Standards and Technology (NIST), U.S. Department of Commerce, 100 Bureau Drive, Room B119, Gaithersburg, MD, 301–975–4016 NVLAP [at] nist.gov (NVLAP[at]nist[dot]gov), www.nist.gov/publications/. 

(1) NIST Handbook 150, National Voluntary Laboratory Accreditation Program Procedures (NVLAP) and General Requirements, authored by Dana S. Leaman and Bethany Hackett, 2020 Edition, August 2020, 2020 (NVLAP Procedures and General Requirements) https://nvlpubs.nist.gov/nistpubs/hb/2020/NIST.HB.150-2020.pdf; into §§ 285.8(a) and § 285.14. 

(2) [Reserved] 

(b) [Reserved]

§ 286.1 Purpose.

The purpose of this program is to enable U.S. industry to satisfy mandated foreign technical requirements using the results of U.S.-based conformity assessment programs that perform technical evaluations comparable in their rigor to practices in the receiving country. Under this program, the Department of Commerce, acting through the National Institute of Standards and Technology, evaluates U.S.-based conformity assessment bodies in order to be able to give assurances to a foreign government that qualifying bodies meet that government's requirements and can provide results that are acceptable to that government. The program is intended to provide a technically-based U.S. approval process for U.S. industry to gain foreign market access; the acceptability of conformity assessment results to the relevant foreign government will be a matter for agreement between the two governments. 

§ 286.2 Scope.

(a) For purposes of this program, conformity assessment consists of product sample testing, product certification, and quality system registration. Associated activities can be classified by level: 

(1) Conformity level: This level encompasses comparing a product, process, service, or system with a standard or specification. As appropriate, the evaluating body can be a testing laboratory, product certifier or certification body, or quality system registrar. 

(2) Accreditation level: This level encompasses the evaluation of a testing laboratory, a certification body, or a quality system registrar by an independent body—an accreditation body—based on requirements for the acceptance of these bodies, and the granting of accreditation to those which meet the established requirements. 

(3) Recognition level: This level encompasses the evaluation of an accreditation body based on requirements for its acceptance, and the recognition by the evaluating body of the accreditation body which satisfies the established requirements. 

(b) NIST operates the NVCASE program as follows: 

(1) Conformity level: Under this program NIST accepts requests for evaluations of U.S. bodies involved in activities related to conformity assessment. NIST does not perform conformity assessments as part of the program and therefore does not accept requests for such evaluations. 

(2) Accreditation level: NIST accepts requests for accreditation of conformity assessment bodies only when 

(i) directed by U.S. law;

(ii) requested by another U.S. government agency; or 

(iii) requested to respond to a specific U.S. industrial or technical need, relative to a mandatory foreign technical requirement, if it has been determined after public consultation that 

(A) there is no satisfactory accreditation alternative available and the private sector has declined to make acceptable accreditation available, and 

(B) there is evidence that significant public disadvantage would result from the absence of any alternative. 

(3) Recognition level: NIST accepts requests for recognition of bodies that accredit testing laboratories, certification bodies, and quality system registrars when 

(i) directed by U.S. law;

(ii) requested by another U.S. government agency; or 

(iii) requested to respond to a specific U.S. industrial or technical need relative to a mandatory foreign technical requirement if it has been determined after public consultation that 

(A) there is no suitable alternative available and 

(B) there is evidence that significant public disadvantage would result from the absence of any alternative. 

§ 286.3 Objective.

The objective of the program is to identify the activities of requesting U.S.-based conformity assessment bodies that have been evaluated as meeting requirements established for their acceptance by foreign governments. The evaluations may be provided by NIST or by bodies recognized by NIST for this purpose under the scope of this program. 

§ 286.4 Implementation.

The program is operated on a cost reimbursable basis. It is open for voluntary participation by any U.S.-based body that conducts activities related to conformity assessment falling within the program's scope. A common procedural approach is followed in responding to a request to participate. (See § 286.7 Evaluation process.) All evaluation activities rely on the use of generic program requirements based on standards and guides for the operation and acceptance of activities related to conformity assessment. Specific criteria for use in each evaluation are derived from the program requirements, as appropriate, for the mandated foreign technical requirements specified in the request to participate. A request involving a foreign technical requirement not previously addressed by NVCASE will result in an announcement of NIST's intent to develop evaluation criteria specific to the relevant requirements. NIST will contact all cognizant and interested federal agencies to coordinate appropriate actions and procedures. 

§ 286.5 Program requirements.

NIST provides and maintains documented generic requirements to be applied in evaluations related to accreditation and recognition within the scope of the program. Available documentation is provided on request to prospective program participants and other interested parties. Generic requirements are developed with public input and are based on guides for the acceptance of conformity assessment activities issued by such international organizations as the International Organization for Standardization and the International Electrotechnical Commission. NIST also provides and maintains documented criteria provided in response to requests for evaluations specific to mandated foreign technical requirements. Criteria are developed with public input derived from the application and interpretation of generic program requirements in relation to specified mandated requirements. Both documented generic requirements and specific criteria are developed and maintained with input from the public. 

§ 286.6 Public consultation.

NIST relies on substantial advice and technical assistance from all parties interested in program requirements and related specific criteria. Interested U.S. government agencies are routinely to be informed of prospective NVCASE actions, and advice is sought from those agencies on any actions of mutual interest. In preparing program documentation, input is also sought from workshops announced in the Federal Register and open tothe general public and other public means to identify appropriate standards and guides and to develop and maintain generic requirements, based on the identified standards and guides. Where relevant Federal advisory committees are available, their advice may also be sought. Similar procedures will be followed with respect to each request for evaluation which necessitates the development of criteria, derived from the generic requirements, specific to mandated foreign technical requirements. 

§ 286.7 Evaluation process.

(a) Each applicant requesting to be evaluated under NVCASE is expected to initiate the process and assume designated responsibilities as NIST proceeds with its evaluation: 

(1) Application. The applicant completes and submit a request to be evaluated. 

(2) Fee. The applicant submits a partial payment with the application and agrees to submit the remaining balance based on evaluation costs as a condition for satisfactory completion of the process. 

(3) Documentation. The applicant operates a system and procedures that meet the applicable generic requirements and specific criteria. Relevant documentation submitted with the application is reviewed by NIST. 

(4) On-site assessment. The applicant and NIST cooperate in the scheduling and conduct of all necessary on-site evaluations, including the resolution of any deficiencies cited. 

(5) Final review. The applicant provides any supplementary materials requested by NIST, then NIST completes the review and decides on appropriate action. 

(b) NIST may take one of the following actions with regard to an applicant: 

(1) Certificate. If an applicant fully demonstrates conformity with all program requirements and specific criteria, NIST issues a certificate documenting this finding. Each certificate is accompanied by a document describing the specific scope of the accreditation or recognition. 

(2) Denial. If an applicant cannot demonstrate conformity with all program requirements and specific criteria, NIST may deny award of the certificate. An applicant who has failed to complete the evaluation satisfactorily may reapply when prepared to demonstrate full conformance with program requirements. 

§ 286.8 Confidentiality of information.

All information collected relative to an applicant during an evaluation is maintained as confidential. Information is released only as required under the terms of the Freedom of Information Act or other legal requirement, subject to the rules of the Department of Commerce for such disclosure as found in 15 CFR part 4. 

§ 286.9 Maintaining recognized status.

Each program participant remaining in the program shall continuously meet all program requirements and cooperate with NIST in the conduct of all surveillance and reassessment activities. Participants shall reimburse NIST for expenses incurred for these purposes. 

§ 286.10 Appeal.

Any applicant or other affected party may appeal to the NIST Director any action taken under the program. When appropriate, the Director may seek an independent review by the Deputy Chief Counsel. 

§ 286.11 Listings.

(a) NIST maintains lists of all bodies holding current NIST program certificates, together with the assessment areas for which they are issued. 

(b) NIST also maintains lists of those qualified conformity assessment bodies that are currently accredited by bodies recognized by NIST, along with the activities of the assessment bodies within the scope of the NIST recognition program. 

(c) The lists are made available to the public through various media, e.g., printed directories, electronic bulletin boards, or other means to ensure accessibility by all potential users.

(d) With respect to the lists specified in paragraph (a) and (b) of this section, NIST may delist any body if it determines the action to be in the public interest. 

§ 286.12 Terminations.

(a) Voluntary termination. Any participant may voluntarily terminate participation at any time by written notification to NIST. 

(b) Involuntary termination. If a participant does not continue to meet all program requirements, or if NIST determines it to be necessary in the public interest, NIST may withdraw that participant's certificate. A body that has had its status as a certificate holder terminated may reapply when prepared to demonstrate full conformance with program requirements.

1. Recognition of Telecommunication Certification Bodies (47 CFR § 2.960) 

(a) The Commission may recognize Telecommunication Certification Bodies (TCBs) which have been designated according to requirements of paragraph (b) or (c) of this section to issue grants of certification as required under this part. Certification of equipment by a TCB shall be based on an application with all the information specified in this part. The TCB shall review the application to determine compliance with the Commission's requirements and shall issue a grant of equipment certification in accordance with § 2.911. 

(b) In the United States, TCBs shall be accredited and designated by the National Institute of Standards and Technology (NIST) under its National Voluntary Conformity Assessment Evaluation (NVCASE) program, or other recognized programs based on ISO/IEC 17065 (incorporated by reference, see § 2.910) to comply with the Commission's qualification criteria for TCBs. NIST may, in accordance with its procedures, allow other appropriately qualified accrediting bodies to accredit TCBs. TCBs shall comply with the requirements in § 2.962 of this part. 

(c) In accordance with the terms of an effective bilateral or multilateral mutual recognition agreement or arrangement (MRA) to which the United States is a party, bodies outside the United States shall be permitted to authorize equipment in lieu of the Commission. A body in an MRA partner economy may authorize equipment to U.S. requirements only if that economy permits bodies in the United States to authorize equipment to its requirements. The authority designating these telecommunication certification bodies shall meet the following criteria. 

(1) The organization accrediting the prospective telecommunication certification body shall be capable of meeting the requirements and conditions of ISO/IEC 17011 (incorporated by reference, see § 2.910). 

(2) The organization assessing the telecommunication certification body shall appoint a team of qualified experts to perform the assessment covering all of the elements within the scope of accreditation. For assessment of telecommunications equipment, the areas of expertise to be used during the assessment shall include, but not be limited to, electromagnetic compatibility and telecommunications equipment (wired and wireless).

1. Government-to-Government Mutual Recognition Agreements (MRAs)

Mutual Recognition Agreements are government-to-government agreements to facilitate trade of telecommunications equipment.  Parties that sign an MRA become MRA Partners.  MRAs establish procedures enabling the Parties to recognize each other’s competent conformity assessment bodies (CABs - such as testing laboratories or certification bodies) and to accept the conformity assessment results of those CABs for regulatory purposes.  MRAs may cover:

• Mutual recognition of testing laboratories and acceptance of test reports prepared by recognized testing laboratories (Phase I)
• Mutual recognition of certification bodies and acceptance of certifications prepared by the recognized certification bodies (Phase II)

The scope of telecommunications equipment covered is based on the regulatory requirements of each MRA Party.  The technical requirements and regulations of the importing Party always apply.

NIST serves as the U.S. Designating Authority for MRAs.  NIST is responsible for designating qualified U.S. CABs to our various MRA Partners. NIST receives, reviews and processes applications from CABs seeking recognition from our MRA Partners. The MRA Partner Regulatory Authorities formally recognize the CABs for their specific technical regulations/standards and/or certification requirements.  The recognized U.S. CABs can then help U.S. manufacturers with their testing and/or certification needs for specific economies.

NIST also provides technical assistance to the Office of the U.S. Trade Representative (USTR) and the Federal Communications Commission (FCC) in negotiating and implementing MRAs. The USTR leads the negotiations and signs the Agreements.  The FCC, as the U.S. Telecom Regulatory Authority, regulates telecommunication equipment placed on the market in the U.S. and formally recognizes domestic and MRA Partner CABs that meet FCC requirements.

Current agreements/arrangements include:

• U.S. – EU MRA   
• U.S. – EFTA MRA 
• U.S. – Israel MRA  
• U.S. – Japan MRA  
• U.S. – Mexico MRA
• U.S. - U.K. MRA
• APEC TEL MRA   

To formally implement the APEC TEL MRA, the U.S. signs binding exchange letters with the individual economies.  To date, exchange letters have been signed with Australia, Canada, Chinese Taipei, Hong Kong, Korea, Malaysia, New Zealand, Singapore, and Vietnam.  Please refer to the official USG signed bilateral exchange letters for the NIST role citation. 

§ 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. 

§ 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. 

§ 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. 

§ 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. 

§ 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.

1. Establishment

The Secretary of Commerce shall maintain within the Department of Commerce a standards information center.

1. Functions

The standards information center shall—

(1) serve as the central national collection facility for information relating to (A) standards, technical regulations, conformity assessment procedures, and standards-related activities, whether such standards, technical regulations, conformity assessment procedures, or activities are public or private, domestic or foreign, or international, regional, national, or local and (B) the membership and participation of Federal, State, or local government bodies or private bodies in the United States in international and regional standardizing bodies and conformity assessment systems, as well as in bilateral and multilateral arrangements concerning standards-related activities;

(2)  make available to the public at such reasonable fee as the Secretary shall prescribe, copies of information required to be collected under paragraph (1) other than information to which paragraph (3) applies;

(3)  use its best efforts to make available to the public, at such reasonable fees as the Secretary shall prescribe, copies of information required to be collected under paragraph (1) that is of private origin, on a cooperative basis with the private individual or entity, foreign or domestic, who holds the copyright on the information;

(4)  in case of such information that is of foreign origin, provide, at such reasonable fee as the Secretary shall prescribe, such translation services as may be necessary;

(5)  serve as the inquiry point for requests for information regarding standards-related activities, whether adopted or proposed, within the United States, except that in carrying out this paragraph, the Secretary of Commerce shall refer all inquiries regarding agricultural products to the technical office established under section 2542(a)(2) of this title within the Department of Agriculture; and

(6)  provide such other services as may be appropriate, including but not limited to, such services to the technical offices established under section 2542 of this title as may be requested by those offices in carrying out their functions.

(c)  Sanitary and phytosanitary measures

(1)  Public information 

The standards information center shall, in addition to the functions specified under subsection (b), make available to the public relevant documents, at such reasonable fees as the Secretary of Commerce may prescribe, and information regarding—

(A) any sanitary or phytosanitary measure of general application, including any inspection procedure or approval procedure proposed, adopted, or maintained by a Federal agency or agency of a State or local government;

(B) the procedures of a Federal agency or an agency of a State or local government for risk assessment and factors the agency considers in conducting the assessment;

(C) the determination of the levels of protection that a Federal agency or an agency of a State or local government considers appropriate; and

(D) the membership and participation of the Federal Government and State and local governments in international and regional sanitary and phytosanitary organizations and systems, and in bilateral and multilateral arrangements regarding sanitary and phytosanitary measures, and the provisions of those systems and arrangements.

(2)  Definitions

The definitions in section 2575b of this title apply for purposes of this subsection.

The standards information center maintained under section 2544 of this title shall, in addition to the functions specified therein, make available to the public relevant documents, at such reasonable fees as the Secretary of Commerce may prescribe, and information regarding—

1. the membership and participation of the Federal Government, State governments, and relevant nongovernmental bodies in the United States in international and regional standardizing bodies and conformity assessment systems, and in bilateral and multilateral arrangements regarding standards-related measures, and the provisions of those systems and arrangements;

(2) the location of notices of the type required under article 909 of the NAFTA, or where the information contained in such notice can be obtained; and

(3)  the Federal agency procedures for assessment of risk, and factors the agency considers in conducting the assessment and establishing the levels of protection that the agency considers appropriate.

Background:  The World Trade Organization (WTO) Agreement on Technical Barriers to Trade  (TBT Agreement) obliges all Parties  to maintain an Enquiry Point that is able to answer questions from interested parties and other WTO Members regarding technical regulations, standards developed by government bodies, and conformity assessment procedures, as well as provide relevant documents. The TBT Agreement also requires that WTO Members notify the WTO of certain proposed technical regulations and conformity assessment procedures so interested parties can become acquainted with them and have an opportunity to submit written comments prior to their finalization and entry into force. The enquiry point and notification authority for the United States is operated by the National Institute of Standards and Technology (NIST), an agency within the U.S. Department of Commerce.

The Enquiry Point:

• Facilitates public awareness of notifications made to and circulated by the TBT Committee via the WTO’s ePing SPS&TBT Platform, a free, web-based service accessible at https://epingalert.org/.  ePing is used to follow and search for notifications, to receive customized e-mail alerts when new notifications of interest are circulated, to enhance domestic communication and information sharing, and to locate and review Specific Trade Concerns (STCs) raised in the TBT Committee.  The e-mail alert service for U.S. stakeholders maintained and operated by NIST since 2005, Notify U.S., has reached its end of life.  Access to notifications stored there has been discontinued.  ePing is available to all stakeholders, provides complete notification details, and does not require registration unless the user wishes to receive e-mail alerts.  Requests for training on the use of ePing can be sent to usatbtep [at] nist.gov (usatbtep[at]nist[dot]gov). 
• Reviews notifications made by WTO Members to the TBT Committee, and when missing, requests the full-texts from the notifying WTO Member and makes them available via ePing. US stakeholders are encouraged to review notifications and the full-texts associated with them using ePing.  To request a full-text not provided by the WTO Member when a notification is made to the TBT Committee and circulated via ePing, please send a message to notifyus [at] nist.gov (notifyus[at]nist[dot]gov) and include the notification symbol associated with the missing text in the subject. 
• Circulates comments and other official communications from U.S. stakeholders on WTO Member notifications to the TBT Committee as well as WTO Member comments (and official communications) on notifications made by the United States to the TBT Committee. Comments from U.S. stakeholders are forwarded to the WTO Member national Inquiry Point and/or regulatory authority and U.S. trade agencies, WTO Member comments and communications are forwarded to the appropriate U.S. regulatory and trade agencies for consideration and response.  Prior to submitting comments, U.S. stakeholders are asked to review the Guidance on Comment Submissions by U.S. Stakeholders on Notifications by WTO Members to the TBT Committee.  
• Provides information on best practices for Inquiry Point operations to the global network of national WTO TBT Inquiry Points.  Further information about transparency and the TBT Agreement are available via the WTO’s transparency toolkit.

The Notification Authority:

Reviews the U.S. Federal Register  and U.S. state regulatory proceedings to identify activities concerning standards, technical regulations, and conformity assessment procedures which meet certain conditions in the TBT Agreement, including:

• Where there may be significant trade effects (e.g., a new labeling or packaging requirement is introduced, product requirements are introduced or changed); and
• Where the content is not in accordance with the content of relevant internationally-accepted standards and the relevant guides or recommendations issued by international standardizing bodies; or
• Where internationally-accepted standards, guides, or recommendations do not exist.

Notifies to the WTO technical regulations and conformity assessment procedures proposed at the federal level and at the state-level consistent with U.S. obligations under the TBT Agreement.

§ 10.0 General.

(a)  Introduction. The Department of Commerce (hereinafter referred to as the “Department”) recognizes the importance, the advantages, and the benefits of voluntary standards and standardization activities. Such standards may cover, but are not limited to, terms, classes, sizes (including quantities of packaged consumer commodities), dimensions, capacities, quality levels, performance criteria, inspection requirements, marking requirements, testing equipment, test procedures and installation procedures. Economic growth is promoted through: 

(1) Reduction of manufacturing costs, inventory costs, and distribution costs; 

(2) Better understanding among manufacturers, producers, or packagers (hereinafter referred to as producers), distributors, users, and consumers; and 

(3) Simplification of the purchase, installation, and use of the product being standardized. 

(b)  Requirements for Department of Commerce sponsorship. The Department may sponsor the development of a voluntary Product Standard if, upon receipt of a request, the Department determines that: 

(1) The proposed standard is likely to have substantial public impact; 

(2) The proposed standard reflects the broad interest of an industry group or an organization concerned with the manufacture, production, packaging, distribution, testing, consumption, or use of the product, or the interest of a Federal or State agency; 

(3) The proposed standard would not duplicate a standard published by, or actively being developed or revised by, a private standards-writing organization to such an extent that it would contain similar requirements and test methods for identical types of products, unless such duplication was deemed by the Department to be in the public interest; 

(4) Lack of government sponsorship would result in significant public disadvantage for legal reasons or reasons of domestic and international trade; 

(5) The proposed standard is not appropriate for development and maintenance by a private standards-writing organization; and 

(6) The proposed standard will be funded by a proponent organization or government agency to cover costs for administrative and technical support services provided by the Department. 

(c) Role of the Department. The Department assists in the establishment of a Voluntary Product Standard as follows: 

(1) Acts as an unbiased coordinator in the development of the standard; 

(2) Provides editorial assistance in the preparation of the standard; 

(3) Supplies such assistance and review as is required to assure the technical soundness of the standard; 

(4) Seeks satisfactory adjustment of valid points of disagreement; 

(5) Determines the compliance with the criteria established in these procedures for such voluntary standards; 

(6) Provides secretarial functions for each committee appointed by the Department under these procedures; 

(7) Publishes the standard as a public document; 

(8) Administers the funds for administrative and technical support services; and 

(9) Seeks listing for standards developed under these procedures as American National Standards through the American National Standards Institute, when deemed appropriate by the Department. 

(d) Role of producers, distributors, users, and consumers. Producers, distributors, users, consumers, and other interested groups may contribute to the development of a Voluntary Product Standard as follows: 

(1) Initiate and participate in the development of the standard; 

(2) Provide technical or other relevant counsel, as appropriate, relating to the standard; 

(3) Promote the use of, and support for, the standard; and 

(4) Assist in keeping the standard current with respect to advancing technology and marketing practices. 

(e) Role of the National Institute of Standards & Technology. The National Institute of Standards & Technology (NIST) administers these procedures for the Department. Any communications concerning these procedures (e.g., questions, clarifications, appeals) should be addressed to the Office of Product Standards Policy, National Institute of Standards & Technology, Gaithersburg, Maryland 20899. 

§ 10.1 Initiating development of a new standard.

(a) Any group or association of producers, distributors, users, or consumers, or a testing laboratory, or a State or Federal agency, may request the Department to initiate the development and publication of a Voluntary Product Standard under these procedures. Requests shall be in writing, signed by a representative of the group or agency, and forwarded to the Department. The initial request may be accompanied by a copy of a draft of the suggested standard. 

(b) The request shall include a commitment to provide sufficient funding to cover all costs associated with the development and maintenance of the proposed Voluntary Product Standard. 

(c) The Department may require additional information such as technical, marketing, or other appropriate data essential to discussion and development of the proposed standard, including, but not limited to, physical, mechanical, chemical, or performance characteristics, and production figures. 

(d) Upon receipt of an appropriate request and after a determination by the Department that the development of a Voluntary Product Standard is justified, the Department may initiate the development by requesting that a draft of the suggested standard be prepared by an appropriate committee, provided such a draft has not previously been submitted under paragraph (a) of this section. 

(e) The Department may initiate the development of a Voluntary Product Standard, if such action is deemed by the Department to be in the public interest, notwithstanding the absence of a request from an outside source. A voluntary standard initiated by the Department shall be processed in accordance with all requirements of these procedures and shall be developed in the same manner as a voluntary standard initiated by any group referred to in paragraph (a) of this section. 

(f) An agreement regarding funding procedures and receipt of a deposit estimated by the Department to be sufficient to cover the first year's costs shall occur prior to the initiation of any project. 

§ 10.2 Funding.

Groups who represent producers, distributors, consumers or users, or others that wish to act or continue to act as proponent organizations for the development or maintenance of a Voluntary Product Standard will be required to pay for administrative and technical support services provided by the National Institute of Standards & Technology and such other direct or indirect costs associated with the development or maintenance of that standard as may be deemed appropriate by the Department, including costs to the Department in connection with the operation of the Standard Review Committee and the Standing Committee. Funds may also be provided by a government agency at the request of a proponent organization or when acting on its own behalf for the development or maintenance of a Voluntary Product Standard. Proponents of standards that meet sponsorship criteria established in these procedures shall furnish an initial deposit of funds sufficient to cover the first year's services and other costs. Estimated annual costs will be based on an hourly rate for salary and overhead established by the Department for the National Institute of Standards & Technology's administrative and technical support services plus estimates of direct costs to provide funds for such items as the travel of consumer representatives unable to otherwise attend committee meetings, travel for Department staff, and printing costs. Project funds will be reviewed annually. Excess funds may be refunded or applied to the next accounting period. Should funds from deposits be inadequate during an accounting period, work on the project will continue only if funds are restored to a level estimated adequate to complete the 12-month period. 

§ 10.3 Development of a proposed standard.

(a) A proposed standard as submitted to the Department: 

(1) Shall be based on adequate technical information, or, in the case of size standards (including standards covering the quantities for packaged consumer commodities), on adequate marketing information, or both, as determined to be appropriate by the Department;

(2) Shall not be contrary to the public interest; 

(3) Shall be technically appropriate and such that conformance or nonconformance with the standard can be determined either during or after the manufacturing process by inspection or other procedures which may be utilized by either an individual or a testing facility competent in the particular field; 

(4) Shall follow the format prescribed by the National Institute of Standards & Technology. (Copies of the recommended format may be obtained from the Office of Product Standards Policy, National Institute of Standards & Technology, Gaithersburg, Maryland 20899.); 

(5) Shall include performance requirements if such are deemed by the Department to be technically sound, feasible, and practical, and the inclusion of such is deemed to be appropriate;

(6) May include dimensions, sizes, material specifications, product requirements, design stipulations, component requirements, test methods, testing equipment descriptions, and installation procedures. The appropriateness of the inclusion in a standard of any particular item listed in this subparagraph shall be determined by the Department; and 

(7) Shall be accompanied by rational statements pertaining to the requirements and test methods contained in the standard, if deemed necessary by the Department. 

(b) A proposed standard that is determined by the Department to meet the criteria set forth in paragraph (a) of this section may be subjected to further review by an appropriate individual, committee, organization, or agency (either government or nongovernment, but not associated with the proponent group). 

(c) A proposed standard may be circulated by the Department to appropriate producers, distributors, users, consumers, and other interested groups for consideration and comment as well as to others requesting the opportunity to comment. 

(d) The proponent group or appropriate committee which drafted the initial proposal under § 10.1(d) shall consider all comments and suggestions submitted by the reviewer designated under paragraph (b) of this section, and those received by the Department as a result of any circulation under paragraph (c) of this section, and may make such adjustments in the proposal as are technically sound and as are believed to cause the standard to be generally acceptable to producers, distributors, users, consumers, and other interested parties. The proposal will then be submitted to the Department for further processing. 

§ 10.4 Establishment of the Standard Review Committee.

(a) The Department shall establish and appoint the members of a Standard Review Committee within a reasonable time after receiving a proposed standard. The committee shall consist of qualified representatives of producers, distributors, and users or consumers of product for which a standard is sought or any other appropriate general interest groups such as State and Federal agencies. When requested by the Standard Review Committee, the Department shall appoint one voting member from among the representatives of the Federal agencies, other than the Department of Commerce. All other representatives of Federal agencies on the Standard Review Committees shall be advisory nonvoting members. (Alternates to committee members may be designated by the Department.) When deemed appropriate by the Department, project funds under § 10.2 may be made available to assure participation by consumer interests on the committee at required meetings. 

(b) A Standard Review Committee may remain in existence for a period necessary for the final development of the standard, or for 2 years, whichever is less. 

(c) The Department shall be responsible for the organization of the committee. Any formal operating procedures developed by the committee shall be subject to approval by the Department. The committee may conduct business either in a meeting or through correspondence, but only if a quorum participates. A quorum shall consist of two-thirds of all voting members of the committee. A majority of the voting members of the committee participating shall be required to approve any actions taken by the committee except for the action of recommending a standard to the Department, the requirements for which are contained in § 10.5(b). 

§ 10.5 Development of a recommended standard.

(a) The Standard Review Committee, with the guidance and assistance of the Department and, if appropriate, the reviewer designated under § 10.3(b), shall review a proposed standard promptly. If the committee finds that the proposal meets the requirements set forth in § 10.3(a), it may recommend to the Department that the proposal be circulated for acceptance under § 10.6. If, however, the committee finds that the proposal being reviewed does not meet the requirements set forth in § 10.3(a), the committee shall change the proposal, after consulting with the proponent group, so that these requirements are met, before recommending such proposal to the Department. 

(b) The recommendation of a standard by the Standard Review Committee shall be approved by at least three-quarters, or rejected by more than one-quarter, of all of the members of the committee eligible to vote. The voting on the recommendation of a standard shall be conducted by the Department if conducted by letter ballot. If such voting is accomplished at a meeting of the committee, the balloting shall be either by roll call or by signed written ballot conducted by the Department or the chairman of this committee. If conducted by the chairman, a report of the vote shall be made to the Department within 15 days. If the balloting at the meeting does not result in either approval by at least three-quarters of all members (or alternates) eligible to vote (whether present or not), or rejection by more than one-quarter of the members (or alternates) or the committee eligible to vote, the balloting shall be disregarded and the Department shall subsequently conduct a letter ballot of all members of the committee. 

(c) Any member of the committee casting a negative ballot shall have the right to support an objection by furnishing the chairman of the committee and the Department with a written statement setting forth the basis for the objection. The written statement of objection shall be filed within 15 days after the date of the meeting during which the voting on the standard was accomplished, or, in the case of a letter ballot, within the time limit established for the return of the ballot. 

(d) At the time a recommended standard is submitted to the Department, the Chairman of the Standard Review Committee shall furnish a written report in support of the committee's recommendation. Such report shall include a statement with respect to compliance with the requirements as established by these procedures, a discussion of the manner in which any objections were resolved, and a discussion of any unresolved objections together with the committee's reasons for rejecting such unresolved objections. 

§ 10.6 Procedures for acceptance of a recommended standard.

(a) Upon receipt from the Standard Review Committee of a recommended standard and report, the Department shall give appropriate public notice and distribute the recommended standard for acceptance unless: 

(1) Upon a showing by any member of the committee who has voted to oppose the recommended standard on the basis of an unresolved objection, the Department determines that if such objection were not resolved, the recommended standard: 

(i)  Would be contrary to the public interest, if published; 

(ii) Would be technically inadequate; or 

(iii) Would be inconsistent with law or established public policy; or 

(2) The Department determines that all criteria and procedures set forth herein have not been met satisfactorily or that there is a legal impediment to the recommended standard. 

(b) Distribution for acceptance or rejection for the purpose of determining general concurrence will be made to a list compiled by the Department, which, in the judgment of the Department, shall be representative of producers, distributors, and users and consumers. 

(c) Distribution for comment will be made to any party filing a written request with the Department, and to such other parties as the Department may deem appropriate, including testing laboratories and interested State and Federal agencies. 

(d) The Department shall analyze the recommended standard and the responses received under paragraphs (b) and (c) of this section. If such analysis indicates that the recommended standard is supported by a consensus, it shall be published as a Voluntary Product Standard by the Department: Provided, That all other requirements listed in these procedures have been satisfied. 

(e) The following definitions shall apply to the term used in this section: 

(1) “Consensus” means general concurrence and, in addition, no substantive objection deemed valid by the Department. 

(2) “General concurrence” means acceptance among those responding to the distribution made under paragraph (b) of this section in accordance with the conditions set forth in paragraph (f) of this section. 

(3) “Substantive objection” means a documented objection based on grounds that one or more of the criteria set forth in these procedures has not been satisfied. 

(4) “Average industry acceptance” means a percentage equal to the sum of the percentages of acceptance obtained from responses to distribution of the recommended standard in the producer segment, the distributor segment, and the user and consumer segment, divided by three. No consideration will be given to volume of production or volume of distribution in determining average industry acceptance. 

(5) “Producer segment” means those persons who manufacture or produce the product covered by the standard. 

(6) “Distributor segment” means those persons who distribute at wholesale or retail the product covered by the standard. 

(7) “User and consumer segment” means those persons who use or consume the product covered by the standard. 

(8) “Acceptance by volume of production” means the weighted percentage of acceptance of those responding to the distribution in the producer segment. The weighting of each response will be made in accordance with the volume of production represented by each respondent. 

(9) “Acceptance by volume of distribution” means the weighted percentage of acceptance of those responding to the distribution in the distributor segment. The weighting of each response will be made in accordance with the volume of distribution represented by each respondent. 

(f) A recommended standard shall be deemed to be supported by general concurrence whenever: 

(1) An analysis of the responses to the distribution under paragraph (b) of this section indicates: 

(i) An average industry acceptance of not less than 75 percent; 

(ii) Acceptance of not less than 70 percent by the producer segment, the distributor segment, and the user and consumer segment, each segment being considered separately; and 

(iii) Acceptance by volume of production and acceptance by volume of distribution of not less than 70 percent in each case: Provided, That the Department shall disregard acceptance by volume of production or acceptance by volume of distribution or both unless, in the judgment of the Department, accurate figures for the volume of production or distribution are reasonably available and an evaluation of either or both of such acceptances is deemed necessary by the Department; or 

(2) The Department determines that publication of the standard is appropriate under the procedures set forth in paragraph (g) of this section and, in addition, an analysis of the responses to the distribution under paragraph (b) of this section indicates: 

(i) An average industry acceptance of not less than 662⁄3 percent; 

(ii) Acceptance of not less than 60 percent by the producer segment, the distributor segment, and the user and consumer segment, each segment being considered separately; and 

(iii) Acceptance by volume of production and acceptance by volume of distribution of not less than 60 percent in each case: Provided, That the Department shall disregard acceptance by volume of production or acceptance by volume of distribution or both unless, in the judgment of the Department, accurate figures for the volume of production or distribution are reasonably available and an evaluation of either or both of such acceptances is deemed necessary by the Department. 

(g) A recommended standard which fails to achieve the acceptance requirements of paragraph (f)(1) of this section, but which satisfies the acceptance criteria of paragraph (f)(2) of this section, shall be returned to the Standard Review Committee for reconsideration. The committee, by the affirmative vote of not less than three-quarters of all members eligible to vote, may resubmit the recommended standard without change to the Department with a recommendation that the standard be published as a Voluntary Product Standard. The Department shall then conduct a public rulemaking hearing in accordance with the requirements of law as set forth in section 553 of Title 5, United States Code, to assist it in determining whether publication of the standard is in the public interest. If the Department determines that publication of the standard is in the public interest, the standard shall be published as a Voluntary Product Standard. 

§ 10.7 Procedure when a recommended standard is not supported by a consensus.

If the Department determines that a recommended standard is not supported by a consensus, the Department may: 

(a) Return the recommended standard to the Standard Review Committee for further action, with or without suggestions; 

(b) Terminate the development of the recommended standard under these procedures; or 

(c) Take such other action as it may deem necessary or appropriate under the circumstances. 

§ 10.8 Standing Committee.

(a) The Department shall establish and appoint the members of a Standing Committee prior to the publication of a standard. The committee may include members from the Standard Review Committee, and shall consist of qualified representatives of producers, distributors, and users or consumers of the product covered by the standard, and representatives of appropriate general interest groups such as municipal, State, and Federal agencies. When requested by the Standing Committee, the Department shall appoint one voting member from among the representatives of the Federal agencies, other than the Department of Commerce. When requested by the Standing Committee for PS 20–70, “American Softwood Lumber Standard,” the Department shall appoint two voting members from among the representatives of the Federal agencies, other than the Department of Commerce. All other representatives of Federal agencies shall be advisory nonvoting members of Standing Committees. (Alternates to committee members may be designated by the Department.) When deemed appropriate by the Department, project funds under § 10.2, may be made available to assure participation by consumer interests on the committee at required meetings. 

(b) Appointments to a Standing Committee may not exceed a term of 5 years. However, the committee may be reconstituted by the Department whenever appropriate, and members may be reappointed by the Department to succeeding terms. Appointments to the committee will be terminated upon the withdrawal of the standard. 

(c) The Department shall be responsible for the organization of the committee. Any formal operating procedures developed by the committee shall be subject to approval by the Department. The committee may conduct business either in a meeting or through correspondence, but only if a quorum participates. A quorum shall consist of two-thirds of all voting members of the committee. A majority of the voting members of the committee participating shall be required to approve any actions taken by the committee except for the approval of revisions of the standard which shall be governed by the provisions of § 10.5 (b), (c), and (d),

(d) The members of a Standing Committee should be knowledgeable about: 

(1) The product or products covered by the standard; 

(2) The standard itself; and 

(3) Industry and trade practices relating to the standard. 

(e) The committee shall: 

(1) Keep itself informed of any advancing technology that might affect the standard; 

(2) Provide the Department with interpretations of provisions of the standard upon request; 

(3) Make recommendations to the Department concerning the desirability or necessity of revising or amending the standard; 

(4) Receive and consider proposals to revise or amend the standard; and 

(5) Recommend to the Department the revision or amendment of a standard. 

§ 10.9 Publication of a standard.

A Voluntary Product Standard published by the department under these procedures shall be assigned an appropriate number for purposes of identification and reference. Public notice shall be given regarding the publication and identification of the standard. A voluntary standard by itself has no mandatory or legally binding effect. Any person may choose to use or not to use such a standard. Appropriate reference in contracts, codes, advertising, invoices, announcements, product labels, and the like may be made to a Voluntary Product Standard published under these procedures. Such reference shall be in accordance with such policies as the Department may establish, but no product may be advertised or represented in any manner which would imply or tend to imply approval or endorsement of that product by the Department or by the Federal Government. 

§ 10.10 Review of published standards.

(a) Each standard published under these or previous procedures shall be reviewed regularly to determine the feasibility of transferring sponsorship to a private standards-writing organization. While the Department encourages the development of standards to replace Voluntary Product Standards by private standards-writing organizations, withdrawal of a Voluntary Product Standard, which meets the requirements of § 10.0(b), shall not be considered until a replacement standard is published. 

(b) Each standard published under these or previous procedures shall be reviewed by the Department, with such assistance of the Standing Committee or others as may be deemed appropriate by the Department, within 5 years after initial issuance or last revision and at least every 5 years thereafter. The purpose of this review shall be to determine whether the standard has become obsolete, technically inadequate, no longer acceptable to or used by the industry, or inconsistent with law or established public policy. 

(c) If any of the above conditions is found to exist, the Department shall initiate action to amend, revise, or withdraw the standard in accordance with § 10.11 or § 10.13. If none is found to exist, the standard shall be kept in effect provided adequate funding is maintained. 

§ 10.11 Revision or amendment of a standard.

(a) A published standard shall be subject to revision or amendment when it is determined to be inadequate by its Standing Committee or by the Department of one or more of the following reasons or for any other appropriate reasons: 

(1) Any portion of the standard is obsolete, technically inadequate, or no longer generally acceptable to or used by the industry; 

(2) The standard or any part of it is inconsistent with law or established public policy; or 

(3) The standard or any part of it is being used to mislead users or consumers or is determined to be against the interest of users, consumers, or the public in general. 

(b) A revision of a standard shall be considered by the Department to include changes which are comprehensive in nature, which have a substantive effect on the standards, which change the level of performance or safety or the design characteristics of the product being standardized, or which cannot reasonably be injected into a standard without disturbing the general applicability of the standard. Each suggestion for revision shall be submitted by the Department to the Standing Committee for appropriate consideration. The Standing Committee shall serve the same functions in the revision of a standard as the Standard Review Committee serves in the development of a new standard. The processing of a revision of a standard shall be dependent upon the age of the standard as computed from its effective date and shall be accomplished as follows: 

(1) A proposed revision of a standard older than 5 years at the time such proposed revision is submitted to the Standing Committee by the Department shall be processed as a new standard under these procedures and, when approved for publication, the standard shall be republished and reidentified to indicate the year in which the revision became effective. The revised standard shall supersede the previously published standard. 

(2) A proposed revision of a standard less than 5 years at the time such proposed revision is submitted to the Standing Committee by the Department shall be processed as a new standard except that: 

(i) Distribution for acceptance or rejection shall be made to an appropriate list of producers, distributors, and users and consumers compiled by the Department; 

(ii) If the revision affects only one subsection of the requirement section and/or only one subsection of the test methods section, it may be circulated separately for determining consensus and subsequently published as an addendum to the standard with appropriate dissemination and public notice of the addendum; and 

(iii) If the revision does not change the level of performance or safety or the design characteristics of the product being standardized, the standard need not be reidentified. 

(c) An amendment to a standard shall be considered by the Department to be any non-editorial change which is not comprehensive in nature, which has no substantive effect on the standard, which does not change the level of performance or safety or the design characteristics of the product being standardized, and which reasonably can be injected into a standard without disturbing the general applicability of the standard. Each suggestion for amendment shall be submitted by the Department to the Standing Committee for appropriate consideration. An amendment to a standard recommended by not less than 90 percent of the members of the committee eligible to vote and found acceptable by the Department, shall be published as an addendum (until the standard is republished) and distributed to acceptors of record. Public notice of the amendment shall be given and copies of the amendment shall be distributed to those filing written requests. 

§ 10.12 Editorial changes.

The Department may, without prior notice, make such editorial or other minor changes as it deems necessary to reduce ambiguity or to improve clarity in any proposed, recommended, or published standard, or revision or amendment thereof. 

§ 10.13 Withdrawal of a published standard.

(a) Standards published under these and previous procedures may be withdrawn by the Director of the National Institute of Standards & Technology at any time. Such action will be taken if, after consultation with the Standing Committee as provided in paragraph (a)(1) of this section and after public notice, the Director determines that the standard is: Obsolete; technically inadequate; no longer generally acceptable to and used by the industry; inconsistent with law or established public policy; not in the public interest; or otherwise inappropriate; and revision or amendment is not feasible or would serve no useful purpose. Additionally, a standard may be withdrawn if it cannot be demonstrated that a particular standard has substantial public impact, that it does not duplicate a standard published by a private standards-writing organization, or that lack of government sponsorship would result in significant public disadvantage for legal reasons or for reasons of domestic and international trade. The Director may withdraw a standard if costs to maintain such a standard are not reimbursed by the proponent or other government agencies. 

(1) Before withdrawing a standard published under these procedures, the Director will review the relative advantages and disadvantages of amendment, revision, development of a new standard, or withdrawal with the members of the Standing Committee, if such committee was appointed or reappointed within the previous five years. 

(2) Public notice of intent to withdraw an existing standard published under these procedures shall be given and a 30-day period will be provided for the filing with the Director or written objections to the withdrawal. Such objections will be considered and analyzed by the Director before a determination is made to withdraw the standard. If the Director determines that a particular standard does not meet the criteria set out in § 10.0(b), the standard will be withdrawn. 

(b) The filing under paragraph (a) of this section of a request to retain a standard or standards shall operate to stay the withdrawal of such standard or standards until the Director's determination has been made. If the Director determines that the requested standard or standards shall be withdrawn, the stay will remain in effect, if an appeal is filed in accordance with the requirements of § 10.14, until the decision of the Director is announced in the Federal Register. If, however, no appeal is received, the Director shall announce withdrawal of the particular standard or standards. 

(c) Notice of the withdrawal action will be published in the Federal Register and such withdrawal will take effect 60 days from the date the withdrawal notice is published. 

§ 10.14 Appeals.

(a) Any person directly affected by a procedural action taken by NIST or the Standard Review Committee under §§ 10.5, 10.6 or 10.7 regarding the development of a standard, by NIST or the Standing Committee under § 10.10 regarding the review of a published standard, or under § 10.11 regarding the revision of a standard, or under § 10.13 regarding the withdrawal of a standard, may appeal such action. 

(b) Such appeal shall be filed in written form with the body taking the action complained of (NIST, the Standard Review Committee, or the Standing Committee) within 30 days after the date of announcement of the action. 

(c) If appeal is filed with the Standard Review Committee or the Standing Committee, the Committee shall attempt to resolve the appeal informally. If the appeal is filed with NIST, NIST with the consultation and advice of the Standard Review Committee or the Standing Committee, whichever is appropriate, shall attempt to resolve the appeal informally. 

(d) If the appeal is to the Standard Review Committee or the Standing Committee and the Committee is unable to resolve such an appeal informally, the Committee shall hold a hearing regarding the appeal. Announcement of the hearing shall be made to members of the Standard Review Committee or the Standing Committee and all the acceptors of record, when appropriate, as well as other known interests. Notice of the hearing shall be published in the Federal Register. The hearing will be an informal, nonadversary proceeding at which there will be no formal pleadings or adverse parties. Written statements will be furnished by witnesses prior to the hearing. A record of the hearing will be made. Copies of the written statements and the record of the hearing will be available at cost. 

(e) Those members of the Committee hearing the appeal will develop a recommendation to the Committee concerning the resolution of the appeal. NIST will review the recommendation and if found acceptable will subject it to a letter ballot of the Committee. Approval by three-fourths of the members of the Committee eligible to vote will constitute acceptance by the Committee and by NIST. Notice of the Committee decision will be published in the Federal Register. 

(f) If the appeal is to NIST and the attempt to resolve the appeal informally under paragraph (c) of this section is not successful, the Deputy Director of NIST will schedule a hearing with an appeals panel at an appropriate location. Announcement of the hearing shall be made to members of the Standard Review Committee or Standing Committee and all acceptors of record, when appropriate, as well as to other known interests. Notice of the hearing shall be published in the Federal Register. 

(g) The Deputy Director of NIST will name two other persons, who have not been directly involved in the matter in dispute and who will not be directly or materially affected by any decision made or to be made in the dispute, to sit on the panel with the Deputy Director, who will act as presiding officer. The presiding officer will have the right to exercise such authority as necessary to ensure the equitable and efficient conduct of the hearing and to maintain an orderly proceeding. 

(h) The hearing will be an informal, nonadversary proceeding at which there will be no formal pleadings or adverse parties. The hearing will be open to the public. Witnesses shall submit a written presentation for the record seven days prior to the hearing. A record will be made of the hearing. Copies of the written statements and the record of the hearing will be available at cost. 

(i) The appeals panel will make a recommendation to the Director of NIST. The Director's decision on the appeal will be announced within 60 days following the hearing and will be communicated to the complainant and other interested parties by letter. Notice of the Director's decision shall be published in the Federal Register. 

§ 10.15 Interpretations.

(a) An interpretation of a Voluntary Product Standard may be obtained through the submission of a written request. The request shall identify the specific section of the standard involved. 

(b) In the case of PS 20–70, the “American Softwood Lumber Standard,” interpretations shall be made by the American Lumber Standards Committee (ALSC) under the procedures developed by the ALSC and found acceptable to NIST. 

(c) In the case of the other Voluntary Product Standards, interpretations shall be made by the appropriate Standing Committees under procedures developed by those committees and found acceptable to NIST. 

§ 10.16 Effect of procedures.

Nothing contained in these procedures shall be deemed to apply to the development, publication, revision, amendment, or withdrawal of any standard which is not identified as a “Voluntary Product Standard” by the Department. The authority of the Department with respect to engineering standards activities generally, including the authority to publish appropriate recommendations not identified as “Voluntary Product Standards,” is not limited in any way by these procedures.

(a) Oversight and consultation

The Secretary concerned shall—

(3) carry out such functions as are required under subsections (b) and (c).

(B) Private international standards organization

(2) In general

(3) Inadequate representation

(4) Action by organization member

(5) Action by Secretary concerned 

(A) within the appropriate period referred to in paragraph (4), the organization member does not respond to the Secretary concerned with respect to the notification, or does respond but does not demonstrate to the Secretary concerned the requisite willingness and ability to represent adequately United States interests; or

(B) there is no organization member of the private international standards organization;

(c) Representation of United States interests by Federal agencies

With respect to any international standards organization before which the interests of the United States are represented by one or more Federal agencies that are officially recognized by that organization for such purpose, the Secretary concerned shall—

(1) encourage cooperation among interested Federal agencies with a view toward facilitating the development of a uniform position with respect to the technical activities with which the organization is concerned;

(2) encourage such Federal agencies to seek information from, and to cooperate with, the affected domestic interests when undertaking such representation; and

(3) not preempt the responsibilities of any Federal agency that has jurisdiction with respect to the activities undertaken by such organization, unless requested to do so by such agency.

No Federal agency may engage in any standards-related activity that creates unnecessary obstacles to the foreign commerce of the United States, including, but not limited to, standards-related activities that violate any of the following requirements:

(1) Nondiscriminatory treatment

Each Federal agency shall ensure, in applying standards-related activities with respect to any imported product, that such product is treated no less favorably than are like domestic or imported products, including, but not limited to, when applying tests or test methods, no less favorable treatment with respect to—

(A) the acceptance of the product for testing in comparable situations;

(B) the administration of the tests in comparable situations;

(C) the fees charged for tests;

(D) the release of test results to the exporter, importer, or agents;

(E) the siting of testing facilities and the selection of samples for testing; and

(F) the treatment of confidential information pertaining to the product.

(2)  Use of international standards

(A) In general

Except as provided in subparagraph (B)(ii), each Federal agency, in developing standards, shall take into consideration international standards and shall, if appropriate, base the standards on international standards.

(B) Application of requirement

For purposes of this paragraph, the following apply:

(i) International standards not appropriate

The reasons for which the basing of a standard on an international standard may not be appropriate include, but are not limited to, the following:

(I)     National security requirements.

(II)    The prevention of deceptive practices.

(III)  The protection of human health or safety, animal or plant life or health, or the environment.

(IV)  Fundamental climatic or other geographical factors.

(V)    Fundamental technological problems.

(ii)  Regional standards

In developing standards, a Federal agency may, but is not required to, take into consideration any international standard promulgated by an international standards organization the membership of which is described in section 2571(6)(A)(ii) [1] of this title.

(3)  Performance criteria

Each Federal agency shall, if appropriate, develop standards based on performance criteria, such as those relating to the intended use of a product and the level of performance that the product must achieve under defined conditions, rather than on design criteria, such as those relating to the physical form of the product or the types of material of which the product is made.

(4)  Access for foreign suppliers

Each Federal agency shall, with respect to any conformity assessment procedure used by it, permit access for obtaining an assessment of conformity and the mark of the system, if any, to foreign suppliers of a product on the same basis as access is permitted to suppliers of like products, whether of domestic or other foreign origin.

The NIST Quality Policy references 22 USC § 2656d - Responsibilities of Secretary of State, specifically for NIST’s participation in the International Committee for Weights and Measures (CIPM) Mutual Recognition Agreement (MRA):

(a)  Coordination and oversight over science and technology agreements between United States and foreign countries, etc.

(1) In order to implement the policies set forth in section 2656b of this title, the Secretary of State (hereafter in this section referred to as the “Secretary”) shall have primary responsibility for coordination and oversight with respect to all major science or science and technology agreements and activities between the United States and foreign countries, international organizations, or commissions of which the United States and one or more foreign countries are members.

(2) In coordinating and overseeing such agreements and activities, the Secretary shall consider (A) scientific merit; (B) equity of access as described in section 2656c(b) of this title; (C) possible commercial or trade linkages with the United States which may flow from the agreement or activity; (D) national security concerns; and (E) any other factors deemed appropriate.

(3) Prior to entering into negotiations on such an agreement or activity, the Secretary shall provide Federal agencies which have primary responsibility for, or substantial interest in, the subject matter of the agreement or activity, including those agencies responsible for—

(A) Federal technology management policies set forth by Public Law 96–517 and the Stevenson-Wydler Technology Innovation Act of 1980 [15 U.S.C. 3701 et seq.];

(B) national security policies;

(C) United States trade policies; and

(D) relevant Executive orders,

with an opportunity to review the proposed agreement or activity to ensure its consistency with such policies and Executive orders, and to ensure effective interagency coordination.