[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]
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