[Federal Register: November 3, 1999 (Volume 64, Number 212)]

[Proposed Rules]

[Page 59691-59694]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr03no99-45]

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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

(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 managementand 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 foodindustry 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 thoseestablished 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 theextent 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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