[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Proposed Rules]
[Pages 59691-59694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28496]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

15 CFR Part 287

[Docket No. 981222315-8315-01]
RIN 0693-AB49


Proposed Guidance on Federal Conformity Assessment Activities

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

ACTION: Proposed policy guidance; request for comments.

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SUMMARY: The Director of the National Institute of Standards and 
Technology (NIST), United States Department of Commerce, requests 
comments on the proposed addition of guidance on Federal conformity 
assessment activities. In February 1996, The National Technology 
Transfer and Advancement Act of 1995 was enacted by Congress. Section 
12 of the Act changed the policies contained in the existing Office of 
Management and Budget (OMB) Circular A-119 into law, created additional 
reporting requirements, and directed NIST to coordinate conformity 
assessment activities of Federal, state and local entities thus 
eliminating any unnecessary duplication of conformity assessment 
activities. OMB Circular A-119, revised February 19, 1998, recognized 
the conformity assessment requirements and obligations defined in the 
Act and the role of the Department of Commerce in this area. The 
Circular directed the Secretary of Commerce to issue guidance to the 
agencies to ensure effective coordination of Federal conformity 
assessment activities. This document contains that guidance.
    The Director of NIST has decided to include this guidance for 
conformity assessment activities in the Code of Federal Regulations 
(CFR). Inclusion in the CFR will make it easier for federal, state and 
local entities to find the guidance necessary for effective 
coordination of conformity assessment activities. The provisions are 
solely intended to be used as guidance for agencies in their conformity 
assessment activities.


[[Page 59692]]


DATES: Comments must be received no later than January 18, 2000.

ADDRESSES: All comments concerning this proposed guidance should be 
addressed to: Dr. Belinda Collins, Director, Office of Standards 
Services, National Institute of Standards and Technology, Building 820, 
Room 282, Gaithersburg, MD 20899.

FOR FURTHER INFORMATION CONTACT: Dr. Belinda L. Collins, Office of 
Standards Services, NIST, 301-975-4000, facsimile: 301-963-2871 or 
Maureen A. Breitenberg, Global Standards Program, NIST, 301-975-4031, 
facsimile: 301-963-2871.

SUPPLEMENTARY INFORMATION:

Background

    Section 12 of the National Technology Transfer and Advancement Act 
of 1995, (Public Law 104-113 or ``the Act'') enacted by Congress in 
February 1996 established the policies of the existing Office of 
Management and Budget (OMB) Circular A-119 into law. The Act also 
directed the National Institute of Standards and Technology NIST) to 
coordinate conformity assessment activities of Federal, state and local 
entities thus eliminating unnecessary duplication of conformity 
assessment activities. OMB Circular A-119, which was revised and 
reissued on February 19, 1998, recognized the conformity assessment 
requirements and obligations defined in the Act and the role of the 
Department of Commerce in this area.
    Conformity assessment is defined in the International Organization 
for Standardization (ISO)/International Electrotechnical Commission 
(IEC) Guide 2 (1996), as: ``any activity concerned with determining 
directly or indirectly that relevant requirements are fulfilled.'' 
Conformity assessment includes: sampling and testing; inspection; 
certification; and quality and environmental management system 
assessment and registration. It also includes accreditation and 
recognition.
    The Act states and OMB Circular A-119 reiterates that NIST is to 
``coordinate Federal, State and local * * * conformity assessment 
activities, with private sector * * * conformity assessment activities. 
* * *'' This guidance is designed to improve the internal management of 
the Executive Branch with regard to its conformity assessment 
activities.

Purpose of This Guidance

    This guidance outlines Federal agencies' responsibility for 
evaluating the efficacy and efficiency of their conformity assessment 
activities. Each agency is responsible for coordinating its conformity 
assessment activities with those of other appropriate government 
agencies and with those of the private sector to make more productive 
use of the increasingly limited Federal resources available for the 
conduct of conformity assessment activities and to reduce unnecessary 
duplication.

Applicability of This Guidance

    This guidance applies to all agencies, which set policy for, 
manage, operate, or use conformity assessment activities and results, 
both domestic and international, except for activities carried out 
pursuant to treaties. ``Agency'' means any Executive Branch Department, 
independent commission, board, bureau, office, agency, 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 subject to separate statutory 
requirements regarding policy setting, management, operation, and use 
of conformity assessment activities. It does not include the 
legislative or judicial branches of the Federal government.

Rulemaking Requirements

    Under 5 U.S.C. 553(b)(A), this guidance is not subject to the 
notice and comment requirements of the Administrative Procedure Act. 
Furthermore, pursuant to 5 U.S.C. 553(d)(2), this guidance is not 
subject to the delayed effective date requirement of the Act. The 
Director has chosen to publish this document for comment only to obtain 
input from persons who may be affected by the guidance.

PRA Clearance

    This policy statement does not contain a collection of information 
for purposes of the Paperwork Reduction Act.

Executive Order 12866

    It has been determined that this action is significant for purposes 
of Executive Order 12866.

Regulatory Flexibility Act

    This action is exempt from the analytical requirements of the 
Regulatory Flexibility Act because notice and comment are not required 
for this action by section 553 of the Administrative Procedure Act or 
any other law.

List of Subjects in 15 CFR Part 287

    Conformity assessment, Procurement, Reporting and recordkeeping 
requirements.

    Dated: October 22, 1999.
Karen H. Brown,
Deputy Director.

    For the reasons set forth in the preamble, it is proposed that Part 
287 be added to subchapter J of chapter II in Title 15 of the Code of 
Federal Regulations (CFR) to read as follows:

PART 287--GUIDANCE ON FEDERAL CONFORMITY ASSESSMENT

Sec.
287.1  Purpose and scope of this guidance.
287.2  Definitions.
287.3  Responsibilities of the National Institute of Standards and 
Technology.
287.4  Responsibilities of Federal agencies.
287.5  Responsibilities of an Agency Standards Executive.

    Authority: 15 U.S.C. et seq. Pub. L. 104-113, section 12.


Sec. 287.1  Purpose and scope of this guidance.

    (a) This part provides guidance for each Federal agency to use in 
evaluating the efficacy and efficiency of its conformity assessment 
activities. Each agency should coordinate its conformity assessment 
activities with those of other appropriate government agencies and with 
those of the private sector to reduce unnecessary duplication. This 
guidance is intended to help Federal agencies improve the management 
and coordination of their own conformity assessment activities with 
respect to other government entities and the private sector. This will 
help ensure more productive use of the increasingly limited Federal 
resources available to conduct conformity assessment activities. This 
will also support the role of the U.S. Government in pursuing 
international trade and other related negotiations and agreements with 
foreign countries and U.S. industry in pursing agreements with foreign 
national and international private sector organizations.
    (b) This guidance applies to all agencies, which set policy for, 
manage, operate, or use conformity assessment activities and results, 
both domestic and international, except for activities carried out 
pursuant to treaties.
    (c) This guidance does not preempt the agencies' authority and 
responsibility to make regulatory or procurement decisions authorized 
by statute or required to meet programmatic objectives and 
requirements. These decision-making activities include: determining the 
level

[[Page 59693]]

of acceptable regulatory or procurement risk; setting the level of 
protection; balancing risk, cost and availability of technology (where 
statutes permit) in establishing regulatory and procurement objectives; 
and determining or implementing procurement or regulatory requirements 
necessary to meet programmatic or regulatory objectives. Each agency 
retains broad discretion in its selection and use of regulatory and 
procurement conformity assessment practices and may elect not to use or 
recognize alternative conformity assessment practices if the agency 
deems them to be inappropriate, inadequate, or inconsistent with 
statutory criteria or programmatic objectives and requirements. 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 and procurement conformity assessment actions.


Sec. 287.2  Definitions \1\.
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    \1\ Definitions of accreditation, certification, conformity 
assessment, inspection, registration and testing are based on the 
International Organization for Standardization (ISO)/International 
Electrotechnical Commission (IEC), Guide 2 (1996). In certain 
industrial sectors, it is recognized that organizations other than 
ISO or IEC may issue definitions relevant to conformity assessment, 
such as the Codex Alimentarius Commission with respect to the food 
industry sector.
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    Accreditation means a procedure used to provide formal notice that 
a body or person is competent to carry out specific tasks. These tasks 
include: sampling and testing; inspection; certification; and 
registration.
    Agency means any Executive Branch Department, independent 
commission, board, bureau, office, agency, 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 subject to separate statutory 
requirements regarding policy setting, management, operation, and use 
of conformity assessment activities. It does not include the 
legislative or judicial branches of the Federal government.
    Agency Standards Executive means an official designated by an 
agency as its representative on the Interagency Committee for Standards 
Policy (ICSP) and delegated the responsibility for agency 
implementation of OMB Circular A-119 and the guidance in this part.
    Certification means a procedure used to provide written assurance 
that a product, process, service, or person's qualifications conforms 
to specified requirements.
    Conformity assessment means any activity concerned with determining 
directly or indirectly that requirements are fulfilled. Requirements 
for products, services, and systems are those defined by law or 
regulation or by an agency in a procurement action. Conformity 
assessment includes: sampling and testing; inspection; certification; 
and quality and environmental management system assessment and 
registration. It also includes accreditation and recognition. 
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.
    Inspection is defined as the evaluation by observation and judgment 
accompanied as appropriate by measurement, testing or gauging of the 
conformity of a product, process or service to specified requirements.
    NIST means the National Institute of Standards and Technology, an 
agency within the United States Department of Commerce.
    Recognition means a procedure used to provide formal notice that an 
accreditation body is competent to carry out specific tasks. These 
tasks include: the accreditation of testing laboratories and 
inspection, certification, and registration bodies. A governmental 
recognition system is a set of one or more procedures used by a Federal 
agency to provide recognition.
    Registration means a procedure used to give written assurance that 
a system conforms to specified requirements. Such systems include those 
established for the management of product, process or service quality 
and environmental performance.
    Sampling means the selection of one or more specimens of a product, 
process, or service for the purpose of evaluating the conformity of the 
product, process or service to specified requirements.
    Testing means the action of carrying out one or more technical 
operations (tests) that determine one or more characteristics or 
performance of a given product, material, equipment, organism, person's 
qualifications, physical phenomenon, process, or service according to a 
specified technical procedure (test method).


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

    (a) Work with agencies through the Interagency Committee on 
Standards Policy (ICSP) to coordinate Federal, state and local 
conformity assessment activities with private sector conformity 
assessment activities. NIST chairs the ICSP; assists the ICSP in 
developing and publishing policies and guidance on conformity 
assessment related issues; collects and disseminates information on 
Federal, state and private sector conformity assessment activities; and 
increases public awareness of the importance of conformity assessment 
and nature and extent of national and international conformity 
assessment activities.
    (b) Encourage participation in the ICSP by all affected agencies 
and ensure that all agency views on conformity assessment are 
considered.
    (c) Review within three years from [EFFECTIVE DATE OF THE FINAL 
GUIDANCE] the effectiveness of the final guidance and recommend 
modifications to the Secretary as needed.


Sec. 287.4  Responsibilities of Federal agencies.

    Each agency should:
    (a) Implement the policies contained in the guidance in this part.
    (b) Use the results of other governmental agency and private sector 
organization conformity assessment activities to enhance the safety and 
efficacy of proposed new conformity assessment requirements and 
measures. An example of this would be to collect and review information 
on similar activities conducted by other Federal, state and 
international organizations and agencies and private sector 
organizations to determine if the results of these activities can be 
used to improve the effectiveness of a proposed Federal agency 
conformity assessment activity.
    (c) Use relevant guides or standards for conformity assessment 
practices published by domestic and international standardizing bodies 
as appropriate in meeting regulatory and procurement objectives. Guides 
and standards for sampling, testing, inspection, certification, quality 
and environmental management systems, management system registration 
and accreditation are issued by organizations which include, but are 
not limited to, the American National Standards Institute, the 
International Organization for Standardization (ISO), the International 
Electrotechnical Commission (IEC), the International Telecommunications 
Union (ITU) and the Organization for Economic Cooperation and 
Development (OECD), the World Health Organization (WHO), and the Codex 
Alimentarius Commission. Each agency retains responsibility for 
determining

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which, if any, of these documents are relevant to its needs.
    (d) Identify appropriate private sector conformity assessment 
practices and programs and consider using the results of such practices 
and/or programs as appropriate in existing regulatory and procurement 
actions. Responsibility for the determination of appropriateness rests 
with each agency. Example: An agency could use the results of private 
sector or other governmental conformity assessment activities to 
schedule procurement type audits more effectively. This could allow 
agencies to reduce the number and extent of audits conducted at 
companies which are performing in accordance with contract 
specifications and which are under review by a third party or another 
agency and to concentrate agency audit efforts on companies which have 
shown problems in conforming to contract specifications.
    (e) Consider mutual recognition of the results of other agencies' 
conformity assessment procedures. Example: An agency could use the 
results of another agency's inspection/audit of a supplier to eliminate 
or reduce the scope of its own inspection/audit of that supplier.
    (f) Participate in efforts designed to improve coordination among 
governmental and private sector conformity assessment activities. These 
efforts include, but are not limited to, the National Cooperation for 
Laboratory Accreditation (NACLA) organization, the National 
Environmental Laboratory Accreditation Conference (NELAC), and ICSP 
working groups dealing with conformity assessment issues.
    (g) Work with other agencies to avoid unnecessary duplication and 
complexity in federal conformity assessment activities. Examples: An 
agency can participate in another agency's conformity assessment 
activities by conducting joint procurement audits/inspections of 
suppliers that sell to both agencies. An agency can share conformity 
assessment information with other agencies. An agency can use 
conformity assessment information provided by other agencies to the 
extent appropriate to improve the effectiveness and efficiency in its 
own conformity assessment activities. Conformity assessment information 
may include: conformity assessment procedures and results, technical 
data on the operation of conformity assessment programs, processing 
methods and requirements for applications, fees, facility site data, 
complaint review procedures, and confidentiality procedures.
    (h) Encourage domestic and international recognition of U.S. 
conformity assessment results by supporting the work of the U.S. 
Government in international trade and related negotiations with foreign 
countries and U.S. industry in pursuing agreements with foreign 
national and international private sector organizations and any 
resulting activities/requirements resulting from those negotiations/
agreements.
    (i) Participate in the development of private sector conformity 
assessment standards to ensure that Federal viewpoints are represented.
    (j) Work with other agencies to harmonize Federal requirements for 
quality and environmental management systems for use in procurement and 
regulation, including provisions which will allow the use of one 
quality or environmental management system per supplier facility in the 
Federal procurement process and the sharing and usage of audit results 
and related information as appropriate.
    (k) Work with other ICSP members, NIST, and the private sector to 
develop national infrastructures for coordinating and harmonizing U.S. 
conformity assessment needs, practices and requirements in support of 
the efforts of the U.S. Government and U.S. industry to increase 
international market access for U.S. products.
    (l) Work with other ICSP members, NIST, and the private sector as 
necessary and appropriate to establish criteria for the development and 
implementation of governmental recognition systems to meet government 
recognition requirements imposed by other nations and regional groups 
to support the efforts of the U.S. Government to facilitate 
international market access for U.S. products.
    (m) Assign an Agency Standard Executive responsibility for 
coordinating the agency-wide implementation of the guidance in this 
part.


Sec. 287.5  Responsibilities of an Agency Standards Executive.

    In addition to carrying out the duties described in OMB Circular A-
119 related to standards activities, an Agency Standards Executive 
should:
    (a) Promote the following goals:
    (1) Effective use of agency conformity assessment related resources 
and participation in conformity assessment related activities of agency 
interest.
    (2) Development and dissemination of agency technical and policy 
positions.
    (3) Development of agency positions on conformity assessment 
related issues that are in the public interest.
    (b) Ensure that agency participation in conformity assessment 
related activities is consistent with agency missions, authorities, 
priorities, and budget.
    (c) Cooperate with NIST in carrying out agency responsibilities 
under the guidance in this part.
    (d) Consult with NIST, as necessary, in the development and 
issuance of internal agency procedures and guidance implementing the 
policies in this part.
    (e) Establish an ongoing process for reviewing his/her agency's 
existing conformity assessment activities and identifying areas where 
efficiencies can be achieved through coordination with other agency and 
private sector conformity assessment activities.
    (f) Work with other parts of his/her agency to develop and 
implement improvements in agency conformity assessment related 
activities.
    (g) Report to NIST, on a voluntary basis, on agency conformity 
assessment activities for inclusion in the annual report to the Office 
of Management and Budget (OMB) on the agency's implementation of OMB 
Circular A-119.

[FR Doc. 99-28496 Filed 11-2-99; 8:45 am]
BILLING CODE 3510-13-M