AlllDb bT[]T3M

9

roceedings of

NIST

orkshop o

onformity

ssessment for a

anging

vernment

a ry J o Di Be r n ardo , Editor
rhe National Institute of Standards and Technology was established in 1988 by Congress to "assist industry in the development of technology . . . needed to improve product quality, to modernize manufacturing processes,

to ensure product reliability . . . and to facilitate rapid commercialization ... of products based on new scientific discoveries." NIST, originally founded as the National Bureau of Standards in 1901, works to strengthen U.S. industry's

competitiveness; advance science and engineering; and improve public health, safety, and the environment. One

of the agency's basic functions is to develop, maintain, and retain custody of the national standards of

measurement, and provide the means and methods for comparing standards used in science, engineering,

manufacturing, commerce, industry, and education with the standards adopted or recognized by the Federal

Government.

As an agency of the U.S. Commerce Department's Technology Administration, NIST conducts basic and

applied research in the physical sciences and engineering, and develops measurement techniques, test methods, standards, and related services. The Institute does generic and precompetitive work on new and

advanced technologies. NIST's research facilities are located at Gaithersburg, MD 20899, and at Boulder, CO 80303.

Major technical operating units and their principal activities are listed below. For more information visit the NIST

Website at http://www.nist.gov, or contact the Publications and Program Inquiries Desk, 301-975-3058.

Office of the Director

• National Quality Program

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Chemical Science and Technology

Laboratory

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2

• Analytical Chemistry

Physics Laboratory

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Manufacturing Engineering

Laboratory

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Laboratory

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• Statistical Engineering

'At Boulder, CO 80303.

2 Some elements at Boulder, CO.
NIST Special Publication 986

Proceedings of the NIST

Conformity Assessment for a Changing Government

Workshop

Mary Jo DiBernardo, Editor

Standards Services Division

Technology Services

National Institute of Standards and Technology

Gaithersburg, MD 20899-0001

May 2003

U.S. Department of Commerce

Donald L. Evans, Secretary

Technology Administration

Phillip J. Bond, Under Secretary for Technology

National Institute of Standards and Technology

Arden L. Bement, Jr., Director
Certain commercial entities, equipment, or materials may be identified in this document in order to describe an experimental procedure or concept adequately. Such identification is not intended to imply

recommendation or endorsement by the National Institute of Standards and Technology, nor is it intended

to imply that the entities, materials, or equipment are necessarily the best available for the purpose.

National Institute of Standards and Technology Special Publication 986

Natl. Inst. Stand. Technol. Spec. Publ. 986, 126 pages (May 2003)

CODEN: NSPUE2

U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON: 2003

For sale by the Superintendent of Documents, U.S. Government Printing Office

Internet: bookstore.gpo.gov —Phone: (202) 512-1800 —Fax: (202)512-2250

Mail Stop SSOP, Washington, DC 20402-0001
Abstract:

The National Institute of Standards and Technology (NIST) sponsored

the NIST Conformity Assessment for a Changing Government

Workshop on December 3, 2001. The National Technology Transfer

and Advancement Act (NTTAA) of 1995 instructs NIST to work with

other Federal agencies and with private sector organizations to coordinate

testing, certification, inspection, laboratory accreditation, and other

conformity assessment activities in the United States with the goal or reducing duplication and complexity. This publication is a compilation

of speeches and presentations from multiple speakers on various

conformity assessment-related topics including laboratory accreditation,

testing, third party certification, supplier's declaration of conformity,

and quality management and registration systems.

Key Words:

Accreditation, Calibration, Certification, Conformity Assessment,

ISO 9000, ISO 1 4000, Interagency Committee on Standards Policy, ICSP,

Laboratory Accreditation, NACLA, NTTAA, National Technology

Transfer and Advancement Act, Quality Management and Registration

Systems, Suppliers Declaration of Conformity, Standards, Testing,

Third Party Product Certification.

iii

Table of Contents

Foreword: Conformity Assessment for a Changing Government 1 Opening Remarks 3 Karen Brown

Acting Director

National Institute of Standards and Technology (NIST)

Opening Remarks 5 Richard Kayser

Director, Technology Services , NIST

Part One — National Technology Transfer and Advancement Act (NTTAA) of 1995 7 Overview of the NTTAA 9

The National Technology Transfer and Advancement Act and Conformity Assessment 11 Belinda Collins Associate Director, Technology Services, NIST

Federal Agency Obligations Under OMB Circular A-l 19 and Benefits of the NTTAA 13 Kevin Mclntyre

Standards Specialist, NIST

Conformity Assessment Guidance Training 17 Guidance on Federal Conformity Assessment Activities 19

Maureen Breitenberg

Senior Economist, NIST

Part Two —Public and Private Sector Cooperation in Support of Regulation 25

Private Sector Testing and Certification in Support of Federal Agency Needs 27

Meeting Safety and Quality Needs Through Third Party Conformity Assessment 29

Gordon Gillerman

Manager, Government Affairs Underwriters Laboratories

Testing and Certification Programs for Federal/State Agencies 31 Joseph Hazeltine

Senior Director, Eastern Test Operations

Wyle Laboratories

Public/Private Partnerships: Factors for Success in Conformity Assessment 34

Gordon Bellen Vice President of Federal Programs

NSF International

Testing, Calibration, and Certification 39

NCSLI Perspective 41 Georgia Harris

Manager, State Laboratory Program

Office of Weights and Measures, NIST

Conformity Assessment Options Federal Communications Commission 43

William Hurst

Electronics Engineer, Office of Engineering and Technology

Federal Communications Commission

v
Model Building Codes Status and Support Infrastructure 46

Si Farvardin

Program Manager

National Evaluation Service, Inc. Suppliers Declaration of Conformity: Pros, Cons, and Enforcement 49

Use of a Supplier's Declaration of Conformity for Product Certification. , 51 Timothy Jeffries Director, Administrative Council for Terminal Attachments and Technology Development

Alliance for Telecommunications Industry Solutions

Suppliers Declaration 53

Eric Stone

Director, Legal Division, Office of Compliance

Consumer Product Safety Commission

Supplier's Declaration of Conformity and the Motor Vehicle Safety Act 55

Rebeccea MacPherson

Attorney Advisor

National Highway Traffic Safety Administration

Department of Transportation

Registration 57

NASA Headquarters (HQ) ISO 9001 Registration Overview 59

Scott Holliday

Director, ISO 9001 Program Office

National Aeronautics and Space Administration

Envirnmental Management Systems (EMS): Paving the Way for Wider Acceptance 60

John Bridges

Environmental Compliance Coordinator

U.S. Postal Service

Mary McKiel 63

Director, EPA Standards Program

Environmental Protection Agency

(Presentation Materials Not Available)

Part Three — National Cooperation for Laboratory Accreditation (NACLA) 65

What is NACLA and What Can It Do For Your Agency? 66

National Cooperation for Laboratory Accreditation (NACLA) — Purpose 67

Donald Heirman

President

NACLA

NIST-NACLA MOU 70

Mary Saunders

Director, Office of Standards Services

N1ST

Use of Commercial Calibration Laboratories in the DOE Nuclear Weapons Complex 72

Richard Pettit Manager, Primary Standards Laboratories

Sandia National Laboratory

vi
Closing Remarks 75

Belinda Collins

Deputy Director, Technology Services, NIST

Appendices 79

t. Biographies 81

II. Final Participants List 91

HI. Public Law 104-113 101 W. OMB Circular A- 1 1 9 (Text Only) Ill V. Conformity Assessment Guidance Document 1 29

On December 3, 2001, the following people served as panel moderators: 1) James Walters, Director, International Standards, Air-Conditioning and Refrigeration Institute; 2) Mary Saunders, NIST; 3) Roberta Breden, Director,

Technical Regulatory Affairs, Telecommunications Industry Association; 4) Joseph Dunbeck, Chief Executive

Officer, Registrar Accreditation Board; 5) Belinda Collins, NIST.

vii
I i
Conformity Assessment for a Changing Government

December 3, 2001

Foreword

Eliminating unnecessary duplication of effort and

improving operational efficiency are aims of any

organization, private or public. These aims motivated passage of the National Technology Transfer and

Advancement Act (NTTAA) of 1995, which instructs the National Institute of Standards and Technology

(NIST) to work with other Federal agencies and with

private sector organizations to coordinate testing,

certification, inspection, laboratory accreditation, and

other conformity assessment activities in the United

States with the goal of reducing duplication and

complexity.

Several agencies and their customers realize the benefits that derive from streamlining, coordination,

and faster approval times, all of which result in cost savings and opportunities to redirect organizational

resources. For some agencies, these benefits are the products of partnerships with private sector organizations and other Federal and state agencies with

corresponding interests. For others, newly realized advantages stem from internal adjustments motivated by

the NTTAA.

December 3, 2001, was a day of instructive, thoughtprovoking presentations and discussions on how various Federal agencies are successfully following the letter and the spirit of the Act. Agency representatives

described the processes that they use to evaluate conformity assessment alternatives and prospective

partners, and to ensure a good fit with their missions,

regulatory responsibilities, and procurement activities. This workshop was organized by NIST in accordance

with the NTTAA mandate. With the similar goal of

eliminating unnecessary duplication in conformity

assessment processes, the Office of Management and

Budget (OMB) Circular A-l 19 directs the Secretary of

Commerce to issue guidance to Federal agencies

to ensure effective coordination of their conformity

assessment activities. NIST, with the assistance of the

Interagency Committee on Standards Policy, published

guidance on Federal conformity assessment activities in the Federal Register on August 10, 2000 (Volume 65,

Number 155).

As explained in the NIST guidance document, each

Federal agency is responsible for coordinating its conformity assessment activities with those of other

relevant government agencies and with those of the

private sector to make more efficient use of Federal

resources. This guidance applies to all agencies that set policy for, manage, operate, or use conformity assess- ment activities and results, both domestic and inter- national. It does not apply to activities carried out pursuant to treaties. At the workshop, standards executives, managers and

staff members of regulatory agencies, and procurement

personnel reviewed various options for trimming "red

tape" by using private sector conformity assessment programs or other cooperative approaches. A general

overview of the NTTAA was presented, and the NIST

guidance to Federal Agencies on Conformity Assess- ment was discussed. Panel discussions dealt with topics

ranging from private sector programs in support of

Federal agencies to testing, calibration, and certification, suppliers' declarations of conformity, and registration. Participants heard the insights of top-level govern- ment officials from the Consumer Product Safety

Commission, Environmental Protection Agency,

Federal Communications Commission, NASA, NIST,

the National Highway Traffic Safety Administration,

Sandia National Laboratory, and the U.S. Postal Service. They were also briefed about the National Cooperation

for Laboratory Accreditation (NACLA), a nonprofit

corporation established to coordinate laboratory accreditation activities within the United States and to serve as the U.S. link to the worldwide lab accreditation system.

This report presents the viewgraphs used by speakers.

1

Opening Remarks

Karen Brown

Acting Director, NIST .

Good morning and welcome to NIST. It's good to see such a great turnout for this workshop. We're looking forward to an instructive, thoughtprovoking day. Both government and private sector

representatives will discuss how federal agencies are implementing the National Technology Transfer and

Advancement Act, which calls for reducing complexity

and duplication in conformity assessment activities. Before we get into the details of the program today, let me say a few words about NIST.

Our mission is to develop and promote measurement,

standards, and technology to enhance productivity,

facilitate trade, and improve the quality of life. We provide a variety of services to our customers

ranging from calibrations, standard reference materials,

and standard reference data to measurement quality assurance programs and laboratory accreditation

services. These NIST services are essential to the nation's measurement infrastructure. In turn, that infrastructure

is critical to the effective operation of conformity

assessment programs in both the government and the

private sector. Accurate measurements made on the factory floor mean less rework and less waste. Customers can rely on

the results of tests performed in accredited laboratories,

whose measurements are traceable to NIST, where

required. All of this contributes to improving quality and

increasing production efficiency, and to increasing

regulators' confidence in the performance of regulated

industries. Eliminating unnecessary duplication of effort and

improving operational efficiency are important to any

organization, private or public. These aims motivated passage of the National Technology Transfer and

Advancement Act, or NTTAA, five years ago. Under the Act, NIST is responsible for facilitating federal agency use of and participation in private

voluntary standards. We also coordinate conformity

assessment activities of Federal, state and local agencies

with private sector activities. What better way to facilitate sharing of information

than to bring together standards executives, managers

and staff members of federal agencies with private

sector experts to talk about different approaches to conformity assessment activities? We have an opportunity here today to look at various options for trimming "red tape" and reducing costs through greater governmental use of private sector conformity assessment programs, along with other cooperative approaches.

At a time of tight budgets and increasing demands on

resources, we are all looking at ways to leverage our

limited resources to provide better service to our

customers. At NIST, we are engaged in a strategic

planning effort intended to focus on those areas where

NIST programs over the next several years can have the

greatest impact.

Other federal agencies face similar challenges.

Regulatory agencies need to allocate their resources

effectively so that they can carry out their mandates

from Congress to protect consumer safety, health, and

the environment. Procurement personnel in all agencies

need to apply cost-effective procedures; they also need

to have confidence in the quality of the products and

services that they purchase.

Several agencies and their customers have already

realized the benefits of streamlining and coordination of

conformity assessment activities: faster approval times,

cost savings and opportunities to redirect organizational resources. We'll hear from representatives of some of these agencies today, and also from managers of private sector programs that support agency regulatory and

procurement activities. This workshop is an important step in sharing infor- mation across the federal government on leveraging

limited resources to carry out statutory responsibilities.

We are very glad to have you all here with us to participate in this workshop.

Now I'd like to turn the floor over to Dr. Richard

Kayser, Director of Technology Services. Rich will tell you a little more about how NIST is working with other

federal agencies to carry out the NTTAA. He will also

give you an overview of what you can expect during the workshop today.

Again, welcome.

3
B
Opening Remarks

Richard F. Kayser

Director, Technology Services, NIST

As Karen mentioned, the NTTAA directs NIST, and I quote, "to coordinate Federal, State, and local technical standards activities and conformity assessment activities 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."

"Eliminating unnecessary duplication and complexity" sounds good, and it would enable Federal agencies

to make more productive use of their resources, but how

far should Federal agencies go and what specifically

should they do to achieve this goal?

Well, as many of you may know, one of the sections of the NTTAA codified the policies of OMB Circular

A-119: Federal Participation in the Development and

Use of Voluntary Consensus Standards and in Conformity Assessment Activities. Moreover, the most recent

version of the Circular, issued in February 1998,

directed NIST to issue guidance to Federal agencies

outlining their responsibilities for evaluating, on an ongoing basis, the efficacy and efficiency of their conformity assessment activities. NIST issued its Guidance on Federal Conformity Assessment Activities in August of 2000. Copies of the Law, the Circular and the Guidance document are included in your workshop

materials.

You'll be hearing more about the NTTAA, OMB

Circular A-119, and the Guidance shortly, so I won't go

into detail. Suffice it to say that during 2002, NIST will be working with Federal agencies on government-wide

coordination efforts in conformity assessment. We'll

share information with each other and look for ways to reduce duplication and increase effectiveness of the conformity assessment activities carried out by, or on behalf

of, Federal agencies. We will do this through the existing

Interagency Committee on Standards Policy, which

NIST chairs, and through meetings such as this. In 2003, we will be reviewing the effectiveness of our Guidance on Federal Conformity Assessment Activities and recommending modifications to the Secretary of

Commerce, as needed. We value your input to this process. The first portion of today's workshop will focus on

implementation and benefits of the NTTAA, including

the Conformity Assessment Guidance. Following a

break, we'll hear from the first of five panels, where

speakers will provide practical examples of private- sector testing and certification programs that support

Federal agency needs.

I'd now like to introduce our first speaker, Dr. Belinda Collins, Acting Deputy Director of

Technology Services. Belinda will speak about the Law and OMB Circular, focusing on the role of the Interagency Committee on Standards Policy, which she

chairs.

5

PART ONE

NATIONAL TECHNOLOGY TRANSFER

AND ADVANCEMENT ACT

(NTTAA) OF 1995

Overview of the NTTAA

9

I!

The National Technology Transfer

and Advancement Act and

Conformity Assessment

Belinda L. Collins, Ph.D. Deputy Director Technology Services, NIST

National Technology Transfer and

Advancement Act (NTTAA)

Directs Federal Agencies to use consensus

technical standards developed by voluntary consensus standards bodies — if agencies do not use these standards, must explain

to OMB why they chose not to Encourages participation in voluntary consensus

standards bodies when compatible with missions, authorities, etc. Directs NIST to coordinate Federal standards and conformity assessment activities with those

of the private sector

SLIDE 1 SLIDE 2 IfH

NIST Role Under the NTTAA

Provide Annual Reports to Congress through

OMB to track progress on NTTAA and

implementation of OMB Circular A-1 1

Chair the Interagency Committee on Standards

Policy (ICSP); provide secretariat — Ensure effective participation in and use of standards — Meets at least 3 times a year; subcommittees more

frequently — Improve coordination in conformity assessment to "eliminate unnecessary duplication and complexity in the development and promulgation of conformity assessment requirements and measures"

NTTAA Accomplishments

Annual Reports on Federal Activities ANSI/NIST MOU

NTTAA Website — Conformity Assessment Network and Website — NIST SP 739: Directory of Federal Government

Certification and Related Programs Conformity Assessment Guidance (Federal Register - Aug 2000) — Agencies to ensure effective coordination of conformity assessment activities to eliminate unnecessary

duplication and complexity — http//www.ts.nist.gov/ca

SLIDE 3 SLIDE 4

What is Conformity Assessment?

Conformity assessment is any activity that helps ensure that products, services, or systems have

required, consistent characteristics. Conformity assessment activities include: —Sampling and testing —Inspection

—Certification (products, services and personnel)

—Management system registration (ISO 9000/14000)

Accreditation verifies competence of conformity assessment activities

Product Certification in the United States

Largely a private sector activity to meet

regulatory, industry and customer needs Government agencies play a variety of roles: -Direct certification (FDA, USDA)

—Recognition of private sector third party

certification (OSHA)

—Recognition of manufacturer declaration of conformity (FCC; DOT)

—Recognition of laboratory accreditation bodies (NIST)

SLIDE 5 SLIDE 6

U
Federal Government Programs

There are about 28 Federal conformity assessment programs in various agencies:

—Department of Agriculture: food safety, grain

inspection, etc. —EPA: drinking water, vehicle emissions, etc. — NIST: laboratory accreditation required by

FCC, HUD, DOE, EPA, NRC, etc.

U.S Laboratory Accreditation

Historically, a mix of programs — No formal recognition between/among programs — Overlapping and redundant assessments National Cooperation for Laboratory

Accreditation created in 1998 under NTTAA — NIST MOU with NACLA recognizes process for recognizing competent laboratory accreditation bodies - supports Trade Agreements — DOT chairs recognition committee Mutual Recognition Arrangement (MRA) among

3 U.S. bodies provides framework for recognizing technical competence

• Stakeholder members or ILAC

SLIDE 7 SLIDE 8

1

Desired NTTAA Outcomes

Increased Federal use of standards; greater

coordination with private sector Improved participation in relevant standards and

conformity assessment activities Web access to standards referenced in regulations Coordination of Federal conformity assessment

activities to reduce duplication Improved linkage with state activities

Planned NTTAA Activities for 2002

Workshops and Training — NTTAA Workshop - Oct 1

— Conformity Assessment Workshop - Dec 3 — How to participate in standards - for NIST/DOC staff Federal Level — Impart understanding, improve compliance for all member agencies — Coordinate activities in conformity assessment,

including support for NACLA

Outreach to states — Evaluate needs, effort, Use California as test case

SLIDE 9 SLIDE 10

12
Federal Agency Obligations under

OMB Circular A-1 19

and

Benefits of The NTTAA

Kevin Mclntyre Senior Standards Specialist

Office of Standards Services. NIST

Commerce/NIST's Role

Coordinate federal implementation of the

Circular and provide administrative guidance

Chair the ICSP; serve as secretariat Report to OMB on implementation of the

Circular Establish procedures for developing participant directories Issue Conformity Assessment guidance

SLIDE 1 SLIDE 2

I!

Responsibilities ofAgency Heads

• Implement policies of the Circular

• Ensure agency compliance

• Appoint a Standards Executive to serve on the ICSP

• Transmit information to NIST for the annual

report to OMB

Responsibilities of Standards Executives

Promote effective use of agency resources and participation Promote development of appropriate agency

positions on standards that — Are clearly defined — Do not conflict with each other — Are in the public interest — Are consistent with administration policy

SLIDE 3 SLIDE 4

I!

Responsibilities of Standards Executives

(cont.)

Assure agency participation consistent with agency mission, authority, goals, and budget

Assure that agency participants understand and accurately represent agency positions Coordinate multi-agency committee

participation Assure that necessary internal policies are in place for managing standards use and

participation

Responsibilities of Standards Executives

(cont.)

Cooperate with DOC/NIST in implementing the

Circular, including participant database

Prepare agency input to OMB report Develop processes for ongoing review and

update of agency standards use

Develop processes to ensure that participation

is properly reviewed (legal, budgetary) for compliance with applicable law

SLIDE 5 SLIDE 6

13
General Agency Requirements

Use voluntary consensus standards (VCS) in

lieu of government-unique standards except where inconsistent with law or otherwise

impractical

Participate in standards bodies where

appropriate to agency mission Report on use of government-unique

standards

Report on participation in the development and

use of voluntary consensus standards

Participation in Standards Bodies

Agencies must:

• Consult with voluntary consensus bodies, both domestic and international

• Participate in standards development when — In the public Interest — Compatible with agency mission, authority, priorities, budget resources

SLIDE 7 SLIDE 8

Agency Support of VCS Activities

Must not be contingent on the outcome of the

activity Can be no greater than that of other

participants except when — In the direct and predominant interest of the government — Development or revision is otherwise unlikely Forms of Support — Participation of agency personnel — Joint planning with SDOs to identify needed standards — Drect financial, administrative, technical

Limitations on Agency Participation

Agencies must not: • Get involved in internal management issues

• Dominate standards activities • Exert undue influence

Participation must be in compliance with all applicable federal laws

SLIDE 9 SLIDE 10

Annual Reporting Requirements

List of government-unique standards used in

lieu of voluntary standards Number of bodies in which agency participates Number of agency participants Number of voluntary standards used

Identification of voluntary standards substituted

for government-unique standards

Evaluation of the effectiveness of the Circular

Successful Implementation Strategies

Several presented at ANSI World Standards Week workshop — Defense — Energy -NASA — NRC

-NIST

Presentations available on-line — NTTAA WebSite: MDJAs-risLQaj-AsMdccsVIOMtaattaiLlKm — ANSI Online: mp-./Mnm.af!siom

SLIDE 1

SLIDE 12

14
Results ofNTTAA Efforts Thus Far

Greater use of voluntary consensus standards

Federal agency activity levels increasing Greater knowledge of standards More focused participation in specific, relevant standards activities Greater involvement with SDOs

Mounting anecdotal evidence of positive outcomes

Number of Voluntary Standards Used by

Federal Agencies

SLIDE 13 SLIDE 14

Voluntary Standards Bodies in Which

Agencies Participate

Agency Employees Participating on SDO

Committees

3500 A

3000 /

2500 /

2000 /

1500 /

1000 /

500 /

ft A

SLIDE 15 SLIDE 16

OMB Circular: Goals for Government Use

of Voluntary Consensus Standards

Eliminate costs of developing in-house standards Decrease the cost of goods procured

Minimize burden of complying with agency

regulation Provide incentives/opportunities to establish standards that serve national needs

Encourage long-term growth for US

enterprises Promote efficiency and economic competition

Further policy of reliance upon the private sector

Significant Procurement Cost Savings

Case studies - DoD

• Aircraft batteries — Total reported savings $4547 million — Total investment $9 3 million • Mechanically attached pipe fittings — Total 10-year savings - over $58 million — Investment during the same period - $750,000

SLIDE 17 SLIDE 18

15
II

Additional Benefits

• Decreased in-house costs — Attention shifted from regulatory process to technical issues — Reduced time spent in preparation of regulations — Agencies can focus more on mission oriented activities • Improved communications with standards

developing organizations — Process of replacing government-unique standards — Strategic alliances with SDOs

• DOT/ITS with AASHTO, ASTM, IEEE, fTE, SAE

SLIDE 19

16
Conformity Assessment Guidance

Training

17

GUIDANCE ON FEDERAL

CA ACTIVITIES

MAUREEN BREITENBERG

OSS/NIST

NIST

SLIDE 1

MYTH I - ITS NIST's PROBLEM

MYTH: OUR AGENCY DOESN'T HAVE TO DO

ANYTHING - ONLY NIST DOES.

REALITY: EACH FEDERAL AGENCY MUST EVALUATE

EFFICACY AND EFFICIENCY OF THEIR CA ACTIVITIES TO REDUCE UNNECESSARY DUPLICATION AND COMPLEXITY.

NIST STANDS READY TO HELP, BUT EACH AGENCY IS RESPONSIBLE FOR COORDINATING ITS CA ACTIVITIES WITH THOSE OF OTHER GOV'T AGENCIES/ PRIVATE SECTOR TO MAKE MORE PRODUCTIVE USE OF LIMITED

FED. RESOURCES AVAILABLE FOR CA ACTIVITIES.

SLIDE 3 WTO OBLIGATIONS

WTO AGREEMENT:

- REQUIRES EQUAL TREATMENT FOR

DOMESTIC PRODUCTS AND PRODUCTS FROM

SIGNATORY COUNTRIES.

- ENCOURAGES GOVERNMENTS TO PERMIT

EQUAL PARTICIPATION FOR DOMESTIC CA

BODIES AND CA BODIES LOCATED IN TERRITORIES OF OTHER MEMBERS.

SLIDE 5

OBLIGATIONS UNDER NTTAA

SECTION 12 OF NTTAA AUTHORIZED NIST TO

COORDINATE FEDERAL, STATE AND LOCAL

CONFORMITY ASSESSMENT (CA) ACTIVITIES

WITH PRIVATE SECTOR CONFORMITY

ASSESSMENT ACTIVITIES.

GOAL OF NTTAA IS ELIMINATION OF

UNNECESSARY DUPLICATION AND COMPLEXITY

IN DEVELOPMENT/PROMULGATION OF

CONFORMITY ASSESSMENT REQUIREMENTS

AND MEASURES.

SLIDE 2

MYTH 2- MY AGENCY ONLY NEEDS

TO COMPLY WITH NTTAA

m MYTH: ALL MY AGENCY HAS TO DO IS COMPLY WITH NTTAA AND WE HAVE

FULFILLED OUR CA OBLIGATIONS.

REALITY:AGENCIES HAVE MANY DOMESTIC/INT'L.

OBLIGATIONS AFFECTING CONFORMITY

ASSESSMENT - NTTAA IS ONLY ONE OF THEM.

EXAMPLE: VARIOUS RULEMAKING REQUIREMENTS

AFFECT ALL REGULATORY ACTIVITIES, INCLUDING

CA PROCEDURES AND REQUIREMENTS.

EXAMPLE: U.S. IS SIGNATORY TO INTERNATIONAL

TRADE AGREEMENTS (WTO AGREEMENT, NAFTA,

ETC.)

SLIDE 4

MYTH 3 - IT'S A RULE

m MYTH: GUIDANCE IS A RULE SINCE IT'S IN THE CFR. WE HAVE TO FOLLOW

EVERYTHING IN IT.

REALITY: THE GUIDANCE IS GUIDANCE. IT'S NOT A RULE. OMB CIRCULAR A-119 DIRECTED

DOC SECRETARY TO ISSUE GUIDANCE TO

AGENCIES TO ENSURE EFFECTIVE

COORDINATION OF FEDERAL CA ACTIVITIES. GUIDANCE PUBLISHED IN 15 CFR PART 287 TO

MAKE IT EASIER TO FIND. PROVISIONS OF 15 CFR PART 287 ARE INTENDED

TO BE USED AS GUIDANCE -- IT'S NOT A RULE!

SLIDE 6

19
MYTH 4 - APPLICABILITY

m MYTH: NTTAA/GUIDANCE DOESN'T APPLY TO

OUR AGENCY.

REALITY: IT APPLIES TO ALL AGENCIES, WHICH SET POLICY FOR, MANAGE, OPERATE, OR USE CA ACTIVITIES AND RESULTS, BOTH DOMESTIC AND INTERNATIONAL, EXCEPT FOR ACTIVITIES CARRIED OUT PURSUANT TO

TREATIES.

"AGENCY" MEANS ANY EXEC. BRANCH DEPT., INDEPENDENT COMMISSION, BOARD, BUREAU, OFFICE, AGENCY, GOVT-OWNED OR CONTROLLED CORPORATION,

OR OTHER ESTABLISHMENT OF THE FED. GOV'T. DOES NOT INCLUDE LEGISLATIVE OR JUDICIAL BRANCHES.

SLIDE 7

AGENCIES RETAIN BROAD DISCRETION IN SELECTION/ USE OF REGULATORY/PROCUREMENT CA PRACTICES.

AGENCIES MAY ELECT NOT TO USE ALTERNATIVE CA

PRACTICES IF AGENCY DEEMS THEM INAPPROPRIATE,

INADEQUATE, OR INCONSISTENT WITH STATUTORY

CRITERIA OR PROGRAMMATIC OBJECTIVES AND

REQUIREMENTS.

GUIDANCE DOES NOT GIVE ANY PARTY ANY CLAIM OR

CAUSE OF ACTION AGAINST ANY FED. GOVT AGENCY

EACH AGENCY RESPONSIBLE FOR REPRESENTATION OF

ITS VIEWS ON CA IN MATTERS UNDER ITS JURISDICTION.

EACH AGENCY IS PRIMARY POINT OF CONTACT FOR INFO. ON ITS REGULATORY/ PROCUREMENT CA ACTIONS.

SLIDE 9

MYTH 7: USE OF THIRD

PARTIES IS REQUIRED

m MYTH: AGENCIES MUST VSE PRIVATE SECTOR

CA PROGRAMS IN THEIR ACTIVITIES.

REALITY: REDUCTION IN DUPLICATION AND

COMPLEXITY MAY BE ACHIEVED BY

- RELYING ON PRIVATE SECTOR CONFORMITY

ASSESSMENT PROGRAMS AND ACTIVITIES;

- RELYING ON OTHER GOVERNMENTAL ACTIVITIES;

- RELYING ON SUPPLIER'S DECLARATION

OF CONFORMITY; OR

- BY ENCOURAGING PRIVATE SECTOR TO RELY ON

GOVERNMENTAL ACTIVITIES.

SLIDE 1

MYTH 5 - PREEMPTION

MYTH: NIST WILL TAKE OVER AGENCY'S CA

RESPONSIBILITIES.

REALITY: GUIDANCE DOES NOT PREEMPT AGENCIES' AUTHORITY/ RESPONSIBILITY TO MAKE REGULATORY OR

PROCUREMENT DECISIONS AUTHORIZED BY STATUTE OR

REQUIRED TO MEET PROGRAMMATIC OBJECTIVES AND

REQUIREMENTS.

DECISION-MAKING ACTIVITIES INCLUDE:

- DETERMINING LEVEL OF ACCEPTABLE REGULATORY OR PROCUREMENT

RISK; - SETTING LEVEL OF PROTECTION;

- BALANCING RISK, COST AND AVAILABILITY OF TECHNOLOGY (WHERE

STATUTES PERMIT) IN ESTABLISHING REGULATORY AND PROCUREMENT

OBJECTIVES; AND

- DETERMINING/IMPLEMENTING PROCUREMENT OR REGULATORY

REQUIREMENTS NECESSARY TO MEET PROGRAMMATIC OR REGULATORY

OBJECTIVES

SLIDE 8 MYTH 6 - NIST IS TAKING

OVER ANSI's ROLE

MYTH: NIST WILL COORDINATE PRIVATE

SECTOR CA ACTIVITIES.

REALITY: NIST HAS RESPONSIBILITY FOR

HELPING TO COORDINATE ACTIVITIES OF

PUBLIC SECTOR.

NIST WILL WORK WITH ANSI AND PRIVATE

SECTOR AS APPROPRIATE.

GUIDANCE REAFFIRMS ANSI'S ROLE IN COORDINATION OF PRIVATE SECTOR

STANDARDS ACTIVITIES AS SPELLED OUT IN MOU BETWEEN NIST AND ANSI.

SLIDE 10

AGENCIES SHOULD CONSIDER

ALTERNATIVE APPROACHES IN

RULEMAKING/PROCUREMENT

HOWEVER, AGENCY IS

RESPONSIBLE FOR FINAL

DETERMINATION OF WHICH

APPROACH(ES) BEST MEET AGENCY

OBJECTIVES.

SLIDE 12

20
MYTH 8 - WE HAVE TO USE

GUIDANCE'S DEFINITIONS

MYTH: OUR AGENCY HAS TO USE THE

GUIDANCE'S TERMS AND DEFINITIONS IN ITS PROGRAMS.

REALITY: IT WOULD BE NICE, BUT

TERMS AND DEFINITIONS WERE ONLY

INCLUDED TO HELP READERS UNDERSTAND

GUIDANCE BECAUSE AGENCIES DO NOT USE

CONSISTENT TERMINOLOGY.

DEFINITIONS BASED ON ISO/IEC GUIDE 2. MODIFIED TO ADDRESS UNIQUE NATURE OF

FEDERAL GOVERNMENT CA ACTIVITIES.

SLIDE 13

DEFINITIONS -CA

i Conformity assessment means any activity concerned with determining directly or indirectly that requirements are fulfilled. Requirements for products,

services, systems, and organizations are those

defined by law or regulation or by an agency in a procurement action.

i Conformity assessment includes: sampling and

testing; inspection; supplier's declaration of

conformity, certification; and quality and

environmental management system assessment and

registration. It also includes accreditation and

recognition.

SLIDE 15

MYTH 10 » AGENCIES

CAN'T SAY NO

MYTH: GUIDANCE REQUIRES THAT AGENCIES

UNDERTAKE ALL COORDINATION ACTIVITIES

EVEN WHERE COSTS INVOLVED ARE LIKELY

TO EXCEED BENEFITS.

REALITY: WHILE COORDINATION IS OFTEN BENEFICIAL AND SHOULD ALWAYS BE CONSIDERED, AGENCIES ARE

RESPONSIBLE FOR FINAL DECISION AS TO APPROPRIATE LEVEL OF COORDINATION AND COMMITMENT OF

RESOURCES.

SLIDE 17

MYTH 9 - SUPPLIER'S

DECLARATION ISN'T INCLUDED

MYTH: SUPPLIER'S DECLARATION IS NOT

RECOGNIZED IN GUIDANCE.

REALITY: GUIDANCE RECOGNIZES 1ST, 2ND AND 3RD PARTY CA ACTIVITIES AND PROCEDURES IN DEFINITION OFCA.

GUIDANCE DOES NOT SUGGEST ANY ONE

METHOD/ACTIVITY IS PREFERABLE.

EACH AGENCY MUST SELECT CA ACTIVITIES AND

PROCEDURES, WHICH BEST MEET LEGISLATIVE MANDATES AND PROGRAMMATIC OBJECTIVES IN MOST

COST-EFFECTIVE AND EFFICIENT MANNER.

SLIDE 14

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 activities may be conducted

by the supplier (first party) or by the buyer [second

party) either directly or by another party on the

supplier's or buyer's behalf, or by a body not under the

control or influence of either the buyer or the seller

[third party).

SLIDE 16 MYTH 11 - MANDATORY

REPORTING

MYTH : REPORTING IS MANDATORY.

REALITY: MANDATORY AGENCY REPORTING

REQUIREMENTS REGARDING CA ACTIVITIES

WAS NOT SPECIFIED IN NTTAA. CA REPORTING

FOR ALL AGENCIES IS VOLUNTARY.

• HOWEVER, IT IS AN OPPORTUNITY TO TAKE

CREDIT FOR WHAT AGENCY IS DOING.

• VOLUNTARY REPORT TO NIST ON AGENCY CA

ACTIVITIES IS TO BE INCLUDED IN ANNUAL

REPORT ON AGENCY'S IMPLEMENTATION OF

OMB CIRCULAR A- 119.

SLIDE 18

21
MYTH 12- ONLY ONE STDS.

EXECUTIVE ALLOWED

m MYTH: UNDER NO CIRCUMSTANCES CAN

THERE BE MORE THAN ONE STDS EXECUTIVE.

REALITY: OMB A-l 19 INDICATES MORE THAN ONE STDS. EXECUTIVE WAS NOT CONTEMPLATED.

NIST/OMB BELIEVE ONE STDS. EXECUTIVE FOR STDS. AND CA FACILITATES BETTER COORDINATION AND

COMMUNICATION.

HOWEVER. OMB AND NIST RECOGNIZE IT MAY BE NECESSARY TO ASSIGN ADDITIONAL STAFF TO CARRY

OUT CA RESPONSIBILITIES. AGENCY MUST ENSURE RESPONSIBILITIES ARE COORDINATED AND EFFECTIVELY CONDUCTED!

SLIDE 19

AGENCY RESPONSIBILITIES

IMPLEMENT POLICIES IN NTTAA/

GUIDANCE.

PROVIDE RATIONALE FOR USE OF CA

PROCEDURES AND PROCESSES IN

RULEMAKING/ PROCUREMENT TO

EXTENT FEASIBLE.

WHEN NOTICE/COMMENT RULEMAKING

REQUIRED, PROVIDE OPPORTUNITY FOR

PUBLIC COMMENT ON AGENCY'S CA

DECISION.

SLIDE 21

USE RELEVANT CA GUIDES/

RECOMMENDATIONS PUBLISHED BY

DOMESTIC/INTERNATIONAL STDS.

BODIES AS APPROPRIATE, [i.e., ISO, IEC,

ITU, OECD, WHO, AND CODEX

ALIMENTARIUS COMMISSION.]

EACH AGENCY IS RESPONSIBLE FOR

DETERMINING WHICH, IF ANY,

DOCUMENTS ARE RELEVANT TO ITS

NEEDS.

NCSC1 CAN HELP IDENTIFY PERTINENT

STANDARDS/GUIDES

SLIDE 23

NIST RESPONSIBILITIES

• WCRK WITH AGENCIES THROUGH (ICSP) TO COORDINATE

FEDERAL, STATE, AND LOCAL CA ACTIVITIES WITH

PRIVATE SECTOR CA ACTIVITIES. CHMR ICSP AND ASSIST ICSP IN DEVELOPING

POLICIES/GUIDANCE ON CA ISSUES. CO-LECT/DISSEMINATE INFO. ON FEDERAL, STATE AND

PRIVATE SECTOR CA ACTIVITIES. INCREASE PUBLIC AWARENESS OF IMPORTANCE OF CA

ANO NATURE/EXTENT OF NAT L AND INTX CA

ACTIVITIES. ENCOURAGE ICSP PARTICIPATION BY ALL AGENCIES AND ENSURE AGENCY VIEWS ARE CONSIDERED. TO EXTENT RESOURCES ARE AVAILABLE, DEVELOP

INK). ON STATE CA PRACTICES; AND, UPON REQUEST BY

STATE AGENCY, WORK WITH AGENCY TO REDUCE

DUPLICATION/COMPLEXITY IN STATE CA ACTIVITIES. REVIEW GUIDANCE WITHIN THREE YEARS OF ISSUANCE.

SLIDE 20

USE RESULTS OF OTHER GOV'T AGENCY AND

PRIVATE SECTOR ORGANIZATIONS IN CA

ACTIVITIES TO ENHANCE SAFETY/EFFICACY OF

PROPOSED NEW CA REQUIREMENTS/MEASURES.

EXAMPLE: COLLECT/ REVIEW INFORMATION ON

SIMILAR ACTIVITIES CONDUCTED BY OTHER

FEDERAL/STATE AGENCIES/PRIVATE SECTOR

BODIES TO DETERMINE IF RESULTS CAN BE USED

TO IMPROVE EFFECTIVENESS OF PROPOSED FED. AGENCY CA ACTIVITY.

SLIDE 22

IDENTIFY APPROPRIATE PRIVATE SECTOR CA

PRACTICES /PROGRAMS AND CONSIDER USING

RESULTS IN EXISTING REGULATORY/

PROCUREMENT ACTIONS.

EXAMPLE: AGENCY COULD USE RESULTS OF

PRIVATE SECTOR/OTHER GOV'T. AGENCY CA

ACTrVTITES TO SCHEDULE PROCUREMENT

AUDITS MORE EFFECTIVELY. COULD ALLOW

AGENCDES TO REDUCE NO./EXTENT OF AUDITS

AT COMPANIES PERFORMING WELL AND

UNDER REV IEW BY THIRD PARTY/ANOTHER

AGENCY AND CONCENTRATE EFFORTS ON

COMPANIES WHICH HAVE PROBLEMS

CONFORMING TO CONTRACT

SPECIFICATIONS.

SLIDE 24

22
uEXAMPLE: FEDERAL COMMUNICATIONS

COMMISSION'S (FCC)

TELECOMMUNICATION CERTIFICATION

BODY (TCB) PROGRAM AND FCC's

REPLACMENT OF PREMARKETING

APPROVAL REQUIREMENTS FOR CERTAIN

TYPES OF EQUIPMENT WITH SUPPLIERS

DECLARATION OF CONFORMITY,

PROVIDED TEST RESULTS SUPPORTING

DECLARATION ARE FROM ACCREDITED

TESTING LAB.

SLIDE 25

WORK WITH OTHER AGENCIES TO AVOID

UNNECESSARY DUPLICATION AND COMPLEXITY IN FED. CA ACTIVITIES.

EXAMPLES:

- PARTICIPATE IN ANOTHER AGENCY'S CA

ACTIVITIES BY CONDUCTING JOINT PROCUREMENT

AUDITS/ INSPECTIONS OF SUPPLIERS WHICH SELL TO BOTH.

- SHARE CA INFORMATION WITH OTHER AGENCIES.

- USE CA INFO. PROVIDED BY OTHER AGENCIES TO

IMPROVE EFFECTIVENESS/EFFICIENCY IN CA

ACTIVITIES.

- CA INFORMATION MAY INCLUDE: CA PROCEDURES/

RESULTS, TECHNICAL DATA ON OPERATION OF CA

PROGRAMS, PROCESSING METHODS/REQUIREMENTS

FOR APPLICATIONS, FEES, FACILITY SITE DATA,

COMPLAINT REVIEW PROCEDURES, AND

CONFIDENTIALITY PROCEDURES.

SLIDE 27

WORK WITH OTHER ICSP MEMBERS, NIST, AND

PRIVATE SECTOR AS NECESSARY/APPROPRIATE TO

ESTABLISH CRITERIA FOR DEVELOPMENT/

IMPLEMENTATION OF GOV'T RECOGNITION

SYSTEMS TO MEET GOV'T RECOGNITION

REQUIREMENTS IMPOSED BY OTHER

NATIONS/REGIONAL GROUPS TO FACILITATE INT'L MARKET ACCESS FOR U.S. PRODUCTS.

ASSIGN AGENCY STDS EXECUTIVE RESPONSIBILITY

FOR COORDINATING IMPLEMENTATION OF

GUIDANCE.

SLIDE 29

CONSIDER USING RESULTS OF OTHER

AGENCIES' CA PROCEDURES.

EXAMPLE: AGENCY COULD USE RESULTS OF

ANOTHER AGENCY'S INSPECTION/AUDIT OF

SUPPLDZR TO ELIMINATE/REDUCE SCOPE OF

ITS INSPECTION/AUDIT OF THAT SUPPLffiR.

PARTICIPATE IN EFFORTS DESIGNED TO

IMPROVE COORDINATION AMONG GOV'T. AND

PRIVATE SECTOR CA ACTIVITIES.

EXAMPLES: NATIONAL COOPERATION FOR

LABORATORY ACCREDITATION (NACLA)

ORGANIZATION, NATIONAL ENVIRONMENTAL

LABORATORY ACCREDITATION CONFERENCE

(NELAC), ), ISO/CASCO, ANSI'S CA ACTIVITIES),

AND ICSP WGs DEALING WITH CA ISSUES.

SLIDE 26

ENCOURAGE DOMESTIC/INT'L RECOGNITION OF

U.S. CA RESULTS, INCLUDING PROVIDING

SUPPORT FOR INT'L NEGOTIATIONS AND ANY

RESULTING ACTIVITIES/REQUIREMENTS

RESULTING FROM THOSE NEGOTIATIONS AND

HELPING U.S. INDUSTRY IN PURSUE

AGREEMENTS WITH FOREIGN NAT'L/ INT'L PRIVATE SECTOR ORGANIZATIONS.

PARTICIPATE IN DEVELOPMENT OF PRIVATE

SECTOR CA STDS. TO ENSURE FEDERAL

VIEWPOINTS ARE REPRESENTED.

WORK WITH OTHER AGENCIES TO HARMONIZE

FEDERAL REQUIREMENTS FOR QUALITY/

ENVIRONMENTAL MGT. SYSTEMS FOR USE IN PROCUREMENT/REGULATION

SLIDE 28

RESPONSIBILITIES OF AGENCY

STANDARDS EXECUTIVE

CARRIES OUT DUTIES IN OMB CIRCULAR A-119 RELATED TO STDS. PROMOTES THE FOLLOWING GOALS:

- EFFECTIVE USE OF AGENCY CA RELATED

RESOURCES AND PARTICIPATION IN CA

ACTIVITIES OF AGENCY INTEREST.

- DEVELOPMENT/DISSEMINATION OF AGENCY

TECHNICAL AND POLICY POSITIONS.

- DEVELOPMENT OF AGENCY POSITIONS ON CA

RELATED ISSUES THAT ARE IN PUBLIC

INTEREST.

SLIDE 30

23
OTHER DUTIES

ENSURE AGENCY PARTICIPATION IN CA ACTIVITIES IS CONSISTENT WITH AGENCY MISSIONS, AUTHORITIES,

PRIORITIES, AND BUDGET. COOPERATE WITH NIST IN CARRYING OUT AGENCY

RESPONSIBILITIES UNDER GUIDANCE. CONSULT WITH NIST, AS NECESSARY, IN DEVELOPMENT/ISSUANCE OF INTERNAL AGENCY

IMPLEMENTATION PROCEDURES AND GUIDANCE.

ESTABLISH ONGOING PROCESS FOR REVIEWING AGENCY'S EXISTING CA ACTIVITIES AND IDENTIFYING AREAS WHERE EFFICIENCIES ARE POSSIBLE. WORK WITH OTHER PARTS OF AGENCY TO DEVELOP/ IMPLEMENT IMPROVEMENTS IN AGENCY CA ACTIVITIES.

SLIDE 31

HELPFUL INFORMATION

NIST HAS CONFORMITY ASSESSMENT

WEBSITE AT:

HTTP://TS.NIST.GOV/CA

SLIDE 33

REPORT TO NIST, ON A

VOLUNTARY BASIS, ON AGENCY

CA ACTIVITIES FOR INCLUSION

IN ANNUAL REPORT TO OMB ON

AGENCY'S IMPLEMENTATION OF

OMB CIRCULAR A-1 19

SLIDE 32

NCSCI CONTACTINFORMATION

NATIONAL CENTER FOR STANDARDS AND

CERTIFICATION INFORMATION (NCSCI)

NIST

100 BUREAU DRIVE, MS 2150 GAITHERSBURG, MD 20899-2150

PHONE: 301-975-4040 FAX: 301-926-1559 E-MAIL: NCSCI@NIST.GOV

SLIDE 34

24
PART TWO

PUBLIC AND PRIVATE SECTOR

COOPERATION IN SUPPORT

OF REGULATION

25

Private Sector Testing and

Certification in Support of

Federal Agency Needs

27

DELIVERINC%

9ULLIflONS >r

MPPTINJfS Mtc i irMo oftrc QAPFTVi t ana anrl OlvJUMLI IAI ITV1 T NEEDS THROUGH THIRD PARTY

CONFORMITY ASSESSMENT

Presented by:

Gordon Gillerman

Manager - Governmental Services

^

Underwriters Laboratories

SLIDE 1

DELIVERING*

SOLUTIONS <> Meeting these needs simultaneously *

requires third parties Conformity

Assessment Programs to: operate with integrity

excel technically

maintain objectivity

be responsive

be efficient be accredited - when needed

What are the needs of:

DELIVERING # mmrsmr&yf'B , SOLUTIONS #

Acceptance Interests - Confidence that a

product or system meets requirements

(Regulatory and Non-Regulatory)

Manufacturers/Service ProvidersEffective/Efficient Conformity Assessment

conducted locally and accepted without

further evaluation

SLIDE 2

DELIVERING*

SOLUTIONS »

If the third party does not meet the confidence

needs of the Acceptance Interests - the

demand for the third party's services is not

driven.

If the third party does not meet the needs of the

Suppliers - other third parties are sought to provide conformity assessment services.

SLIDE 3 SLIDE 4

DELIVERING * SOL0IONSp

TYPICAL CONFORMITY ASSESSMENT

PROGRAMS to ADDRESS THESE

NEEDS

• Testing

• Product Certification

• Quality System Registration

• Inspection

Testing

DELIVERING%

SOLUTIONS #

Conduct specified tests Deliver test results and methods

SLIDE 5 SLIDE 6

29
DELIVERING*

Product Certification5M^ite5/

Investigation

• Construction and Marking Review

• Testing Conducted

• Results Compared to Requirements

• Compliance or Non-Compliance Determined

Surveillance

•Unannounced, Frequent Product Inspections •Witnessing of Production Tests •Countercheck Testing •Market Sampling

DELIVERING^*

SOLUTIONS &*

Quality Management System

Registration

Pre-assessment (procedure review)

Assessment (on site implementation)

Audit (verify continued implementation and

identify potential improvements)

SLIDE 7 SLIDE 8

DELIVERING*

SOLUTIONS

Commercial Testing and

Inspection

Purpose is to Determine if Products meet

Purchaser's/Procurement Specifications

• Useful if a full quality system is not in place or does not cover key aspects of product

• or if confidence needs of purchaser demand

product specification inspection in addition to quality management systems

UL Governmental

accreditation:

DELIVERING*

Federal Government

Defense Logistics Agency US EPA FCC

DoL OSHA

FDA

A^mfn^tra^orPfijSA

National Institute of Justice

United States Coast Guard US Department of _

Agriculture Forest Service

Slate and Local Government

State of Arizona

State of California

State of Colorado

State of Florida

State of Iowa

State of Indiana

City of Los Angeles

State of Massachusetts

State of Maryland

State of Maine

State of Michigan

State of Minnesota

State of Missouri

State of Montana

State of North Carolina

State of Nebraska

State of New Hampshire

SOLUTIONS ?

State of New York

State of Ohio

State of Oregon

State of Pennsylvania, Department of Environmental

Protection

Slate of South Carolina

State of Tennessee

State of Texas

State of Virginia

State of Washington

State of Wisconsin

SLIDE 9 SLIDE 10

FDA Accredited

Persons Program

First Tier Review of Medical Device Manufacturer's Reports for Market Clearance Not Testing, Certification, Registration or Inspection

Recommend Determination of Substantial Equivalence (or Not) to Legally Marketed Device

Accreditation covers - Eligible Devices, Personnel

Qualifications, Conflict of Interest and Procedures

FDA Trains, Assesses and Audits for Continued

Compliance

We Conduct Internal Audits (not required)

delivering*

solutionTj'

Resources to Facilitate High Integrity 5'6*^ *

Effective, Efficient Conformity

Assessment Programs

Conformity assessment program

infrastructure and procedures

Engineering and technical Laboratory facilities Experienced inspectors.assessors/auditors

stationed in the field

SLIDE 1

SLIDE 12

30
wyle

Testing and Certification

Programs for

Federal/State Agencies

Joseph Hazeltine

Agenda

Overview of Activities

Details on Specific Programs

Certification Process

Auditing/ Enforcement

Fees

Marks Used

Conclusions/ Recommendations

Contact Information

SLIDE 1 SLIDE 2

Wyle - Huntsville, AL Facility

• Founded 1962

• >200 people

• 125 acre secure site

• 220.000 ft2 Facilities

• >40 chambers up to 30x18'x18'

• Wide range of electrical power loads plus

fault/surge conditions

• All other utilities including

natural gas. telecom &

computer networks

• Highly-integrated & self- sufficient

• On-site engineeri ng & fab

• Wide-ranging foreign compliance capability

Overview of Wyle

Certification Activities

OSHA CAB for Safety (Low Voltage Directive) OSHA Nationally Recognized Testing Laboratory (NRTL) NIST CAB for EMC (EMC Directive) DOT Performance Oriented Packaging (POP)

Verizon Independent Testing Laboratory (ITL) NASED Independent Testing Authority (ITA)

FCC Listed Sites US Navy Shock Testing

DoD Qualification Testing

SLIDE 3 SLIDE 4

OSHA NRTL Program

Started in 1989 Focus is workplace safety 18 NRTLstodate

~ 800 Standards covered

Certification by standard ANSI/ UL/NFPA/ASTM

Reciprocity ? Now permitted to

participate in some

standard revisions and

development

SLIDE 5

31
NIST CAB for EMC

Focus is wor1<place and

household compatibility

Started in 1999 via EU MRA

Many CABs to date

Certification by directives European Norm Standards

Reciprocity ? Some participation in standard revisions and

development

DOT POP

Focus is safety in container

transporting hazardous goods

Started in 1984

Approx. 30 POP testing

facilities UN Orange Book/ 49CFR/ICAO/IATA/IMDG

Standards

Reciprocity Administered by DOT

Research & Special Programs Administration (RSPA)

SLIDE 6 SLIDE 7

Verizon ITL

Focus is workplace safety

Started in 2001 5ITLstodate

Certification by vendor

Bellcore/ Verizon No Reciprocity Not permitted to participate in standard

revisions and/or development

NASED ITA

Focus is electronic voting machines safety, reliability &

performance

Started in 1994

3 ITAs to-date FEC Guidelines Standard in revision process

Issue NASED Control mark

Includes Configuration Management

SLIDE 8 SLIDE 9

FCC Listed Facility

Focus is workplace and home

safety and EMC

Started in 1975 Hundreds of laboratories listed by FCC to date

Certification by equipment

category 47CFR series and ANSI

Standards

Permitted to participate in standard revisions and

development

DoD Testing

(Including US Navy Shock)

Focus is military equipment

operability & safety Wyle started in 1949 Thousands of facilities Thousands of DoD

Standards Navy Shock to Mit-Std 901

(Qualification based on

machine size) Participation is available in

all standard revisions and

development

DCMA Witnesses some

testing

SLIDE 10 SLIDE 1

32
Certification Process

Certification Process

OSHA NRTL Audit + Proposal

OSHA CAB (Safety) Proposal

NIST CAB (EMC) Proposal

DOT POP Site Visit Verizon ITL Proposal

NASED ITA Audit + Proposal

FCC Proposal

US NAVY Proposal

DoD DCMA

SLIDE 12

Certification Program Fees

Certification Fees

OSHA NRTL Cost of Audit

OSHA CAB (Safety) None

NIST CAB (EMC) None

DOT POP Audit Fees

Verizon ITL Annual Fee+ audits

NASED ITA Initial Audit

FCC None

US NAVY None

DoD None

Certification Program

Enforcement Activities

Certification Auditing/Enforcement

HQUA ^JorlM MDTI INK 1 L Annual Audit OSHA CAB (Safety) Accreditation NIST CAB (EMC) Accreditation DOT POP Bi-annual Audit

Verizon ITL Quarterly Audits

NASED ITA Quarterly Meetings

FCC Accreditation + 3 yr Review

US NAVY DCMA

DoD DCMA

SLIDE 13

Certification Marks

Certification Marks

OSHA NRTL NRTL Mark

OSHA CAB (Safety) CE Mark

NIST CAB (EMC) CE Mark

DOT POP POP Mark

Verizon ITL NRTL Mark

NASED ITA NASED Mark

FCC FCC Mark

US NAVY None

DoD None

SLIDE 14 SLIDE 15

Conclusion/Recommendations

Must obtain reciprocity in international programs

Involvement in standards development must be available

to all participating organizations Cost of accreditations are growing- has become a barrier to entry in some markets

Industry needs a common accreditation scheme with a common set of guidelines

Need to have training available and forums where

problems can be shared and resolved

Contacts

NRTL/FCC-Jim Dearman, ext. 218

jdearman@hnt.wylelabs.com Telecom-Don Smith, ext. 221 desmith@hnt.wylelabs.com DoD-Bob Porter, ext. 545

rporter2@hnt.wylelabs.com

Div. Dir. -Joe Hazeltine, ext. 390

hazeltin@hnt.wylelabs.com GM-Keith Wilson, ext. 227

kwilson@hnt.wylelabs.com

PO Box 077777

7800 Highway 20

Huntsvilie, AL 35807

Phone: (256) 837-4411

Fax: (256) 721-0144

www.wylelabs.com

SLIDE 16 SLIDE 17

33
Public/Private Partnerships: Factors

for Success in Conformity

Assessment

Gordon Bellen

NSF International

NIST Conformity Assessment Workshop

December 3, 2001

SLIDE 1

Verification of Claims

• Self certification.

• Third party conformity assessment (CA).

• Government regulation/oversight.

SLIDE 3

CA Continuum

• Photographic film - low risk, consumer

verification.

• Food safety - high risk, consumer can't

verify, government oversight.

• Airport security?

SLIDE 5

Today's Discussion

• Case Studies of third party conformity

assessment(CA) programs at NSF.

• Review of four factors influencing success.

SLIDE 2

Conformity Assessment Decision

Factors

• Risk severity - societal risk in the absence

of verification.

• Response of market - confidence in

verification.

• Reliability of verification - is the market

properly informed.

• Resources - is the verification cost

effective.

SLIDE 4

NSF Third Party Case Studies

Success

- Drinking Water Additives - Retail Food Service Equipment - Bottled Water - Environmental Technology Verification

• Less success - Shelf Stable Foods - Food Processing Equipment - Seafood Inspections

SLIDE 6

34
Success- Drinking Water

Additives

• Chemicals and materials in contact with

drinking water.

• Ingredient review.

• Product testing in water.

• Toxicology evaluation.

• Follow-up services.

SLIDE 7

Success - Retail Food Service

Equipment

• Commercial restaurant and institutional

food preparation and storage.

• Design and construction.

• Food contact material content.

• Some performance.

• Follow-up services.

SLIDE 9

Success - Bottled Water

• FDA plus IB WA requirements.

• Sanitary inspection.

• Source water testing.

• Product water testing.

• Containers and closures.

SLIDE 1

1

Drinking Water Additives, cont.

• EPA advisory program.

• No EPA funding.

• Industry ambivalence.

• Strong State support.

• Strong utility support.

• Cost savings in reduced redundant reviews.

SLIDE 8

Retail Food Service Equipment,

cont.

• FDA support.

• Strong local health department support.

• Strong industry support.

• Cost savings in reduced reviews.

SLIDE 10

Bottled Water, cont.

• Industry driven.

• Regulatory awareness.

• Service in over 60 countries.

• Two levels of service.

• Industry risk management.

SLIDE 12

35
ETV, cont.

• EPA support - improve commercialization

and use through verification of

performance.

• EPA funding reduced over time.

• Semi-finalist - Harvard/Ford Foundation

innovations in government.

• Move towards CA program.

Success - Environmental

Technology Verification (ETV)

• Drinking water treatment technologies -

arsenic, Cryptosporidium.

• Source water protection technologies -

decentralized waste, infrastructure, ballast water.

• Wet weather flows - storm water treatment.

• One time verification.

SLIDE 13

Less Success - Shelf Stable

Foods

• Pies, pastries, etc.

• Product chemistry - water activity, pH.

• Microbiological challenge.

• Follow-up services.

SLIDE 15

Less Success - Food Processing

Equipment

• Meat and poultry processing.

• Design and construction.

• Cleanable.

• Follow-up services.

• Replacing USDA program.

SLIDE 17

SLIDE 14

Shelf Stable Foods, cont.

• Initial FDA support.

• NSF standard produced.

• State support.

• Industry resistance.

• No agreement on risk/reward issues.

SLIDE 16

Food Processing Equipment,

cont.

• Initial USDA support.

• NSF/international standard produced.

• USDA now competing.

SLIDE 18

36
Seafood Inspection

Non regulatory program.

Issues similar to food processing.

SLIDE 19

Conclusion

• Better collaboration between third parties,

government and industry needed.

• Education on standards and conformity

assessment needed in government.

• Analyze the four "Rs": Risk, Response,

Reliability and Resources.

SLIDE 20

37

Testing, Calibration, and

Certification

39

NCSLI Perspective

Conformity Assessment Workshop

December 3, 2001

Georgia L. Harris NCSLI V.P. Publications (NIST, Office of Weights & Measures)

SLIDE 1

Policy

• NCSLI International Position Statement

published April 2001 NCSLI Newsletter - clarifies terminology related to Laboratory

Accreditation, Registration. Certification, and

Third Party - focus on accreditation and competence

SLIDE 3

Participation

• Representation on NACLA Board

• Sponsorship of NACLA (Patron Member)

• Stakeholder member in ILAC

• Annual meetings with NMI management

(NIST, CENAM. NRC)

SLIDE 5

NCSLI Involvement

• WHY^

• Primary focus: Laboratory Accreditation

- Policy on Laboratory Accreditation, Registration, and

Certification - Standards Writing & Adoption & Resources - Participation with NACLA, ILAC, NMIs (incl. NIST)

- Collaboration

• Secondary focus: Certification for product

evaluation (barriers to trade)

SLIDE 2

I Standards Writing and Adoption

& Resources

• ANSI/NCSLI Z 540. Standards Writing

Committee

• U.S. National Standards:

• Publications & Training

SLIDE 4

Collaboration

• Requested NIST establish a laboratory accreditation program for

"calibration laboratories"

- in NYLAP

• Includes government representatives on wntirffi committees to encourage adoption of standards when published - Adoption ofZ 540-1-1994 in NYLAP & OWM laboratory criteria at NIST

- Adoption ofZ 540-1-1994 by DOD, DOE. etc for calibration laboratories - E.g^ DOE adoption ofISO/TEC 17025 - FAA contacted Airline Industry Committee - regarding Z 540-1

appplicability to FAA regulations

SLIDE 6

41
Collaboration

• Met with Jim Turner, House Majority Counsel to Committee on Science, Commerce, Technology

July 27,2001

- laboratory accreditation issues; lack of uniformity in acceptance of accreditation by Federal agencies,

effectiveness of NCSLI in representing interests of members

- possible proposal to OMB

SLIDE 7

Suggestions

• Government agencies should recognize

competence of laboratories accredited to international quality standards - versus additional audits and requirements - compare ISO/IEC 17025 and NRC 10 CFR 50, find out

if there are gaps, then address the gaps by 17025

updates - environmental, chemical, biological

• Collaboration among Federal & accredited labs to provide traceable calibration services

s

SLIDE 8

42
Conformity Assessment Options

Federal Communications

Commission

Wimam S. Hurst

Office Engineering and Technology

December 3, 2001

3Detxrrtxx2001 Federal CommLnicalions Commission

Equipment Authorization Program

7t The FCC currently has three equipment approval programs

^Verification •^Declaration of Conformity (DoC)

^Certification

7i The product approval requirement is specified in the rule part under which equipment operates

7i All three programs involve the use of the private sector to varying degrees

3 December 2001 Federal Communications Commission Slide

SLIDE 1 SLIDE 2

Equipment Authorization Program

The type of approval

is specified in the rules

for the particular type of device

Certification (Approved by FCC

or TC8)

| Declaration of Conformity

; 'Self-approval using

I an accredited lab)

Verification (Seif-approva3)

Federal Conrnuri icati ons Ccmmissoi

FCC Authorization Requirements

Verification DoC Certification Most ISM equipment Cable Sys Term. Device Cable Sys Term Device TV & FM receivers PC's & peripherals PC's & peripherals 2

Ait other digital devices Most receivers Most receivers

Pt-to-Pt Microwave TV interface Devices TV Interface Oevices Broadcast transmitters Consumer ISM eqmt. Consumer ISM eqmt. Aux. Broadcast Xmtrs Telephone Equipment 1 Telephone Equipment 2 INMARSAT equipment Most transmitters 406 MHz ELT Scanning Receivers CATV Relay Xmtrs

(11 TTE does f«jt require the use of an accredited iah.

(21 A 7CB may certify this equipment

3 December 2001 Federal Communications Commission

SLIDE 3 SLIDE 4

Why Use the Private Sector?

7i Speed at which technology is changing and shorter product life cycles require faster product approvals

7! The private sector has the technical expertise and

ability to certify equipment.

7t Increase the resources performing conformity assessment

71 Efficiencies in designing and approving product in the same geographic location

7> Reduce uncertainty and delay in obtaining

certification

.5 December 2007 Federal Commtjlicatjons Commission

Objectives

7S To meet the Commission's Mission:

"The FCC's mission is to encourage competition in communications and to promote and support access for every American to existing and advanced

telecommunications services."

7! ET Docket 98-68 provided for:

-i- Private Certification Bodies known as Telecommunication

Certification Bodies (TCBs); and ^ Permit the certification of equipment by private organizations outside of the United States through Mutual

Recognition Agreements (MRAs)

3 Decerrtxx 2001 Federal Corrmunicaljons Commission

SLIDE 5 SLIDE 6

43
What is a TCB?

7! A Telecommunication Certification Body is a

Certification Body that has been accredited to ISO/IEC Guide 65 by a recognized Accrediting

Organization and designated by the FCC to approve

equipment subject to certification.

71 A TCB is not a test laboratory, nor should it function

in that capacity.

7! As a TCB, it has certain rights and responsibilities.

75 Foreign entities may become a TCB in accordance

with the terms of a govemment-to-government

Mutual Recognition Agreement/Arrangement.

3 December 2001 Federal Communications Commission Slide?

SLIDE 7

TCB Scope of Responsibility

7t A TCB (see § 2.962 (e) and Public Notice, DA 99- 1640)

si' Is empowered to certify products in accordance

with the FCC rules

-I- Must provide fair and equitable treatment

4^ Must accept test data from any source, subject to subcontracting clause in ISO Guide 65 and shall not unnecessarily repeat tests 4>May assess fees for processing applications

4- May rescind grant within 30 days

3 December 2001 Federal Communications Commission Slide 9

SLIDE 9

TCB Implementation

71 TCB Training Course - December 1999

71 Accreditation and designation of TCBs - January

- May 2000

7i Designation of first group of TCBs - June 2000

7i European Union designates first foreign TCBs - January 2001

7i Total of 30 operational TCBs in the United States and Europe - October 2001

3 December 2001 Federal Communications Commiss*on Slide 11

SLIDE 1

New Rules for TCBs

7f FCC GEN Docket 98-68

7! Establishes procedures for designating a Telecommunications Certification Body (TCB)

4» Manufacturers have the option to choose a TCB

or the FCC to obtain approval of a product subject

to certification 4'NIST identified as the accrediting organization

Authority for US Conformity Assessment Bodies (CABs)

4/ A TCB must be accredited to ISO Guides 25 & 65

3 DecBrrtyef 2001 Federal Communications Commission Sided

SLIDE 8

TCB Limitations

7! A TCB cannot (see §2.962(e)(5))

4/ Waive the rules sPTake enforcement actions (refer to FCC)

4-Certify a unique product for which there are no

Rules

4- Revoke a grant after 30 days

^Authorize transfer of control of a grantee

All TCB actions are subject to FCC review

3 December 2001 Federal Communications Commission State 10

SLIDE 10

Application Filing Trends

7i Since June 2000, the TCBs have granted over 2300 certifications

?l The number of applications granted by TCBs

have been steadily increasing since June of last year.

71 One year since the program started the number

of grants issued by TCBs exceeds the number of grants issued by the FCC.

7i TCBs are granting approximately 75% of the

total number of grants issued.

3 December 2001 Federal Communications Commission Skde 12

SLIDE 12

44
TCB vs FCC Grants

't

' f w

-TCB *g —FCC Aiq|

3Dec8vrt*r2C0T Federal CornmLfiiCBtions Commisstori

Thank You

WiiliamS. Hurst

f-'ederai Communications Commission

Office of Engineering and Technology

Tel: {202} 418-7266 Fax:(202)413-1944

svhurst@foo.gov

3 December 2001 Federal Communications Commssio

SLIDE 13 SLIDE 14

45
Model Building Codes

Status and Support

Infrastructure

NIST Workshop on Conformity

Assessment for a Changing

Government

December 3, 2001

Si Farvardin, Program Manager

Goal

A better understanding of the

International Code Council's

model building codes and

efforts of the National

Evaluation Service related to

conformity assessment of

innovative building products

with respect to those codes

SLIDE 1 SLIDE 2

U.S. Situation

Codes and Standards

• Numerous voluntary and public sector standards

developers

• Three developers of model codes

- developed a single and coordinated family of model

building codes - are consolidating as the International Code Council

• Federal, state, and local government adoption

and implementation of voluntary sector standards and model codes

• Increased national uniformity through adoption

of the ICC International Codes

SBCCI

INTERNATIONAL CODE COUNCIL ICC Formation

December 1994

SLIDE 3 SLIDE 4

Development of Codes and

Standards

ICC code development process

-Any person, corporation or entity can participate - Regulatory-based consensus - Predictable agenda, no surprises

-Two cycles every three years -Two hearings per cycle

Proposed revisions to the procee - Full consensus-based voting Full Consolidation - January 2003

Support Infrastructure for

the ICC Codes

• Education and Training

• Certification Programs for Personnel

• Plan Review

• Code Interpretations

• Automated Products

• Technical Handbooks

SLIDE 5 SLIDE 6

46
Determining Compliance with

the ICC Codes

Specific prescriptive provisions - simple plan

review and construction inspection

Specific provisions that rely on reference standards

and other criteria not easily field verified - testing

and certification by third parties

Few if any specific provisions - verification of equivalency with other materials and methods

already accepted through EVALUATION and

ASSESSMENT A

The Need for Technology

Evaluation and Assessment

• Adopted codes and standards criteria tend to lag behind new technology development and deployment

• It is difficult to easily determine if new technologies meet minimum building code requirements; especially if they are not mentioned in the code - Each code official would need to expend time and

resources to determine how they were going to evaluate code compliance on the basis of equivalent

performance - Each code official would then need to conduct an

independent assessment based on the evaluation method they developed

Nahonal Evaluation Strvtct, Inc.

SLIDE 7 SLIDE 8

The Key to Technology Evaluation

and Assessment

Alternative Materials, Design and Methods of Construction (Chapter 1 of the model building

codes) - The code is not intended to prevent anything not

specifically prescribed by the code when such

alternative has been approved by the code official - The code official can approve an alternative when it is found what is proposed is equivalent to that prescribed by the code A National Evaluation Service, Inc.

The Purpose of Technology

Evaluation and Assessment

Provide a defensible basis for code

compliance and safety assurance Save time and money for the technology

proponent and users of the technology

Make the code official's job easier

Facilitate technology acceptance and

associated benefits

Improve uniformity of code interpretation

and application

National Evaluation Service, Inc. A

SLIDE 9 SLIDE 10

National Evaluation Reports

Provide basis for compliance with the

International Codes and 3 Model Codes

-2000 International Building Code - 1999 Standard Building Code - 1 997 Uniform Building Code - 1999 BOCA National Building Code

Relationship to the ICC: - Cooperative relationship and co-locat - ICC Logo appears on all new reports

National Evaluation Reports

NES evaluation reports provide: - Identification of the technology - Scope of evaluation

-Technology description and relevant

installation details - Information on labeling - List of testing and other documentation - Conditions of acceptance and use

National Evaluation Service, Inc. A

SLIDE 1

SLIDE 12

47
The Evaluation Process

Addresses evaluation and assessment in a way that would satisfy the majority of code

official's "approval" authority

• Eliminates time and effort associated with

each state or local agency designing an

evaluation method and then performing the

evaluation

• A benchmark for all parties to rely on and

upon which uniformity can be realized

National Evaluation Service, Inc. A

SLIDE 13

CONTACTING the ICC

or the NES

International Code Council

National Evaluation Service

5203 Leesburg Pike, Suite 600

Falls Church, VA 22041

703-931-4533 (ICC)

703-931-2187 (NES)

www.intlcode.org

www.nateval.org

INTERNATIONAL CODE COUNCIL

What Does this Mean for

Federal Agencies?

Savings in manpower and money

Codes exist upon which Federal construction requirements can be based

A support infrastructure for those codes exists that readily applies to and can be used by Federal agencies

Evaluation and assessment of new building

technology is ongoing and available

to Federal agencies

National Evaluation Service, Inc.

SLIDE 14

SLIDE 15

48
Suppliers Declaration of Conformity:

Pros, Cons, and Enforcement

49

Use of a Supplier's Declaration of

Conformityfor Product Certification

Presenter. Tim Jeffries Director, Administrative Council for Terminal Attachments (ACTA) &

Technology Development

Alliance for Telecommunications Industry Solutions

SLIDE 1

Argumentsfor SDoC

&Reduce complexity & cost

s> Faster time to market

£Manufacturers have a vested interest £ Marketability of brand name

SInternal technical expertise, facilities, & test equipment

£ Internationally recognized (iso/iec Guide 22) £ Precedence set with product verification

SLIDE 3

SDoC Enforcement

5Accountability is essential

& Identify party responsible

& Ensure traceability

B Detailed evidence of compliance

6Mechanisms and procedures

B Proactive (Audits, product monitoring)

& Reactive (Industry & public complaints) a& Enforcement of compliance

S Must be ready to act

SLIDE 5

Supplier's Declaration ofConformity

& Supplier's Declaration of Conformity

(SDoC) contmue to be debated

5 Varying options among:

& Regulators

fi5 Providers of Service & Manufacturers 2> Pros & Cons are transposable

6 Enforcement is critical

SLIDE 2

Arguments against SDoC

& Competitive disadvantage

5> Increase product testing

«> Manufacturers have a vested interest «> Loss of neutrality ^ Lack of accountability ^Poorly-equipped

^Incorrect interpretation of criteria & Prone to abuse

SLIDE 4

SDoC in Part 68

£> Responsible Party must be located in the

USA

Responsible Party must:

S> Submit a copy to ACTA

S1 Include a copy in package

S1 Post on website => SDoC must include:

e> Identification of Responsible Party

r? Statement of compliance

& Date & place ofissue &Signature, name, and function of declarer

SLIDE 6

51
ACTA & Part 68 Information

Internet: www. part68.org

Email:

ACTA@atis.org

ACTA

c/o ATIS

1200 G Street, N.W., Suite 500

Washington, DC 20005

Phone: +1.202.628.6380

SLIDE 7
Supplier's Declaration of

Conformity

Consumer Product Safety

Commission

By

Eric Stone

SLIDE 1

Common Elements

• Authority to set standards

• Preference for performance

requirements

• Rigorous cost-benefit analysis

• Deferral to voluntary standards

where they adequately address

the risk of injury.

SLIDE 3

CPSA

• CPSA adds a Certification

provision (15 U.SX. § 2063)

• Manufacturer issues certificate

- must accompany product

- based on a reasonable test program

- include name of manufacturer or

private labeler on certificate

- date and place of manufacture

• Commission may require tests

SLIDE 5

CPSC Authority

• Rulemaking authority under

- Consumer Product Safety Act (CPSA)

- Federal Hazardous Substances Act (FHSA)

- Flammable Fabrics Act (FFA)

- Poison Prevention Packaging Act

SLIDE 2

Common Enforcement

Schemes

• Import surveillance

- Seizure or denial of entry

- U.S. Customs penalties

• Seizure (U.S. District Court)

• Injunction (U.S. District Court)

• Civil penalties for "knowing"

violations

• Criminal penalties

SLIDE 4

Example: Child Resistant

Cigarette Lighters

16 CFR Part 1210

• Child testing in U.S.

* Submit report 30 days before

import including

- Child test results

- Lighter specifications

- Where lighters manufactured

- Prototype of product

SLIDE 6

53
Lighters Continued

• Must maintain testing records

- child resistance

- production

- keep for 3 years

• Make available within limited

time

- CR tests in U.S.—48 hours

- Production tests w/in 7 days

SLIDE 7

Clothing Standard

• Must be issued by U.S. firm

• Must keep records for 3 years

• Must produce records upon

demand or assumption made that

the guaranty is false

• Criminal penalties for false

guaranty as well as penalties for

any violations of standards.

SLIDE 9

Flammable Fabrics Act

15 U.S.C. § 1197

• Guaranty Provisions

- continuing guaranty on fife - guaranty for product

• Protect customers

• Backed by reasonable and

representative tests

• Example: clothing fiammabiiity

standard (16 CFR 1610}

SLIDE 8

54
Supplier's Declaration of Conformity

and the Motor Vehicle Safety Act

Conformity Assessment for a Changing

Government

Rebecca B. MacPherson. Esq. National Highway Traffic Safety Administration (NHTSA)

Decembers, 2001

SLIDE 1

Prohibition on Manufacturing, Selling, and

Importing Noncomplying Motor Vehicles

and Equipment (49 TJ.S.C. 30112)

An individual (including commercial businesses) may not - manufacture for sale, - sell, - introduce or deliver for introduction in interstate commerce,

- or import into the United States, any motor vehicle (including trailers) or motor vehicle equipment manufactured on or after the date an applicable FMVSS takes effect unless the vehicle or equipment

complies with the standard and is certified as complying

with the standard.

SLIDE 3

Certification Requirements (cont)

• All manufacturer certifications must be based on a good faith belief that the certification is not false or misleading in any material respect. This good faith requirement for self-certification forces manufacturers to satisfy themselves that their vehicles comply with all applicable safety standards

prior to first retail sale.

• If a vehicle complies with all applicable FMVSS in effect on the date of manufacture, a certification label may be applied to the vehicle.

• All vehicles must have a certification label that is permanently affixed to the vehicle.

SLIDE 5

Federal Motor Vehicle Safety Act

(49 U.S.C. 30101, etseq.)

• Regulation of motor vehicles is effected through

compliance with Federal Motor Vehicle Safety Standards (FMVSS)

• FMVSS must be practicable, objective, and meet

the need for motor vehicle safety;

• Regulations creating or amending a FMVSS are subject to extensive public notice and comment

procedures under the Administrative Procedure

Act.

SLIDE 2

Certification Requirements

(49 U.S.C. 30115; 49 CFR 567)

• U.S. employs a system of manufacturer self- certification.

• U.S. Government does not conduct testing for manufacturers or certify that a vehicle or piece of motor vehicle equipment meets all applicable

FMVSS.

• Either a vehicle manufacturer or a registered

importer can certify that a vehicle complies with

all applicable FMVSS.

SLIDE 4

Manufacturer Reporting Requirements

(49 CFR 573)

• Noncompliance information report - Must be submitted to NHTSA within 5 working days of either an agency or manufacturer determination that there is a non-compliance.

• Quarterly reports - Must be submitted to NHTSA on a

quarterly basis for six consecutive quarters beginning with

the quarter when the recall campaign was initiated

• Lists of purchasers, owners, lessors and lessees - Must be

maintained by the manufacturer in a form suitable for inspection by NHTSA.

• Notices, bulletins, and other communications - must be

submitted to NHTSA.

SLIDE 6

55
Manufacturer Notification Requirements

(49 CFR577)

• When a manufacturer determines a vehicle fails to conform to an applicable safety standard, it must

provide notification in the time and manner

required by 49 CFR 577.7.

• Manufacturer may not include a disclaimer in the

notification letter.

• If, based on the quarterly reports, NHTSA

determines a follow-up notification is necessary, it may order the manufacturer to send a follow-up

letter.

SLIDE 7

Ways to Remedy a Noncompliance

• Manufacturer of a noncomplying vehicle must remedy the noncompliance at no cost to the vehicle owner unless the

vehicle was purchased at least 10 years before the agency

determines there is a non-compliance or the manufacturer

notified NHTSA that the vehicle is noncompliant.

• The manufacturer may remedy the noncompliance by

repairing the vehicle, replacing the vehicle with an

identical or reasonably equivalent vehicle, or by refunding

the purchase price, minus a reasonable allowance for depreciation.

SLIDE 9

Vehicle Recalls

• All noncomplying motor vehicles or motor vehicle equipment must be recalled.

• A recall consists of two parts, notification of the noncompliance to the vehicle owner and a remedy

of the defect or noncompliance.

• Majority of recalls are based on a determination by the manufacturer that a vehicle or piece of equipment does not comply with an applicable

FMVSS.

SLIDE 8

Enforcement

(49 U.S.C. 30165; 49 CFR 578)

• Civil penalties for failure to comply or failure to attach a certification label to a vehicle that requires such a label may be assessed for up to $5,000 per violation, with a maximum penalty for a related series of violations of $15 million.

• NHTSA may decrease the amount of penalty after considering the size of the affected business and

the gravity of the violation.

SLIDE 10

56
Registration

57

(?&<W Program Offfce :,

NASA Headquarters (HQ)

ISO 9001 Registration Overview

Scott M. Holliday Director ISO 9001 Program Office (Code Jl) NASA HQ

Background - Key Milestones

November 1996 - NASA Administrator directs all NASA Centers AND HQ to be certified to ISO 9001 NLT 9/30/99 October 1997 - NASA HQ senior management decides to register the work of NASA's Strategic Enterprises (SE) to ISO 9001, but

all efforts flounder until May 1998; involves 5 offices May 1998 - ISO 9001 Program Office established to lead the dayto-day effort required to achieve and maintain registration - Plan is developed utilizing a core staff, and matrixed team of SE

representatives and key "functional" staff - Plan calls for May. 1999 registration of SE scope May 1999 - NASA HQ SE's are successfully registered to ISO

9001 June 1 999 - NASA HQ senior management decides to broaden

the scope of registration to all HQ offices (23 total) May 2000 - All offices at NASA HQ are successfully registered

SLIDE 1 SLIDE 2

Why ISO 9001?

Administrator decision, i.e., top-down direction "Say what you do, do what you say and prove it" was

appealing and promised much needed discipline and

accountability Expansion of NASA international partnerships, especially with Space Station - registration viewed as a tool to improve our performance and build customer and

stakeholder confidence Widely accepted in industry

Fully deploy recent strategic and program/project management initiatives Establish one Quality Management System (QMS) for HQ

parts of key Agency processes

Provide a measure of continuity and stability to HQ

employees after downsizing from - 2,500 to 950.

100 Stt0i Program Office :• Benefits

1st question is always "what did you save?" Answer - can't tell because: 1) after downsizing from 2,500 to 950 our focus was not

to cut costs, therefore didnt focus on it; 2) no baseline, i.e., we

don't account for costs by process, and don't measure cost of processes now, but know we're more effective and efficient Reengineering - impossible to implement a QMS that conforms to ISO 9001 without undertaking some to great amount of reengineering; all key processes are much "better" than previously Reduced rework • minimize variability of quality of products and

services through consistency and better understanding of processes

Better control of and understanding of documentation and records

results in better products and services and traceability Improved communication and understanding of organizational goals at all levels, and how employees fit in - focused training Enhanced discipline in taking corrective action by addressing root causes and verifying effectiveness vice putting bandaids on symptoms

SLIDE 3 SLIDE 4

%4 6//! ISO vm Program Office Lessons learned

Was it worth it? ABSOLUTELY

Would we do it again? Not sure. In many cases, especially for a

federal agency HQ, this is a dramatic change to the modus

operandi requiring a serious commitment by top management

(as opposed to trying to check the box), and lots of hard work. Dont focus so much on what needs to be done that you lose

sight of the fact that the hardest part is not doing "the work," it's managing the change. See the big picture or risk suboptimizing Determine early on your reasons for doing, set measurable

goals, take baseline measurements, and monitor

Plan well - ambitious but achievable milestones keeping in mind:

- being too ambitious can result in cutting some corners, - the work fits the time, and - "idle hands are the devil's workshop," i.e., it grves the "saboteurs' more

time to plan and execute their strategy

SLIDE 5

59
SLIDE 1 SLIDE 2

EMS and Operational Success

Environmental impacts are expected, which forms the fj need for an EMS. Contributions from an EMS framework can provide a standard for excellence, which;

Drives continual environmental improve Reduces environmental impacts based

requirements

Provides a business and

» right t

1 'Aim

SLIDE 3 SLIDE 4

EMS Opportunities

* Reduction in training needs

Eliminate redundant inspections

Consistency in operations a Cost savings!
fflVICt Adopt an Integrated Approach

f ORG. GOALS I

SLIDE 6

Framework incorporation at all lei

Strategic Planning^

Transportation

c -u \ Social Program N"" BP1 Responsibility Costs Response Metrics .

OellvW Bottom line

Reductions /Shared Services: Supply Chains: Enterprise Logistics: Customer Services:

•EH&Sf-uocllon -Product ami Rfek Manasemcot -Fuel Utlliratjofl Costs [ -Staffing Complement

Integrated Plans -Materials Manauemertt : • PannersMp Aateemetrts - Enn4nr*d Prodoaferfty

• Comro6daled Training -National Contracts Vehicle Sp^cu Complement • Standardised Goals

• Piofessiottal Expertise : Strategic Leverane -emission Impacts • Financial Metrics, not SP

• ReduceVSrorkersComp/miuries •Imranet/E-Transactlons -Network ProrSmg -Strategic Plans

-Prioritize Performance -Integrated Performance • Improve Performance ' Establish Performance

Opportunities

SLIDE 7

61
Lessons Learned

Environmental Management System - Key processes are linked and

measurable i , : TM „.« — Participation is critical

j to success — Shared responsibility j — Reduction in waste

streams, disposal costs and labor — Working towards a common goat

Managing our EMS through Stewardshi

MilHIll

* Contributions - Key processes are linked and

measurable

ftocyclabla/ Reusable P«l«mn.?K - Participation Is critical to success r/ w *%Jg - S200.000 COSt R^MWKiaiK ^ Pf*f?f| - S200.000 cost avoidance

- LOG to CESQG : - 43 noncompliam r after EMS

SLIDE 8 SLIDE 9

Summa

By continuing to build on our successes and

plan for the future, we will realize a "triple" bottom line that benefits:

SLIDE 10

62
Mary McKiel

Director, EPA Standards Program

Environmental Protection Agency

(Presentation Material Not Available)

63

PART THREE

NATIONAL COOPERATION FOR

LABORATORY ACCREDITATION

(NACLA)

65
What is NACLA and What Can It Do

For Your Agency?

66
to tar iaftcwrtwy NACLA Organization

National Cooperation for Laboratory

Accreditation (NACLA)

What is NACLA and what can it do for your Agency

Don Heirman

President

December 3, 2001

for Labamofy NACLA purpose

Purpose of NACLA Recognition

•Offers recognition to laboratory accreditation bodies (ABs)

•Recognition creates mechanism for establishing confidence in equivalency of the operation

of laboratory accreditation programs

•Following successful completion of evaluation procedure, ABs invited to sign Mutual

Recognition Arrangement

•Laboratories accredited by signatory ABs

considered to have demonstrated

equivalent competence

N1ST Wtxfctiop

SLIDE 1 SLIDE 2

figs* IACLA/NIST MOU

NACLA signs MOU in July 2000 which

gave NACLA responsibility to recognize

Accrediting Bodies

far itbarvsor} NACLA Operation

NACLA:

- Coordinates and recognizes laboratory

accreditation activities in the US

- Planning to apply for national coordinating body in International Laboratory Accreditation Cooperation (I LAC) to represent US positions on ILAC accreditation matters.

- Monitoring and emulating where applicable similar procedures for recognition used by ILAC,

European Cooperation for Accreditation (EA), and Inter-American Accreditation Cooperation (IAAC), etc.

- Is NOT another accrediting body

SLIDE 3 SLIDE 4

to NACLA Process

• NACLA recognizes competent accreditors by

the following:

-Recognition based on international

quality standards (Guide 58 and

Standard 17025 (Guide 25)

- Mutual recognition arrangement among NACLA-recognized

accrediting bodies which leads to:

- Enhanced specifier choice

- Government recognition where needed

motet NACLA-Govcrnment

•NACLA interfaces with regulators and

government agencies:

-Government agencies requested to agree on harmonizing common

accrediting requirements and

practices

-May require special procedures, but

the goal is to apply them consistently

SLIDE 5 SLIDE 6

67
NIST Use of NACLA

•NACLA News-

•In October 2000, NIST designated 23

accredited testing labs to participate in the operational phase of the EMC sectoral annex of the US-EL MRA

•NIST established the competence of both A2LA and NVLAP (who accredited the 23

labs) on the basis of their NACLA

recognition and thus designated these labs which they accredited •Subsequent NIST designations have been made on the same basis

NIST Worktop

Mg|§§ | NI3TUs€ofiMACl.n.

•NACLA News-2000 •NIST is also relying on NACLA recognition

as basis for designating test labs for Phase

I of the APEC Telecommunication

Equipment MRA

•Burden on NIST staff to verify technical competence of testing Taiwanese,

Singapore, and Canadian testing labs designated by NIST has been significantly reduced by the NACLA recognition process!

SLIDE 7 SLIDE 8

i

: \>T NACLA citings

•NACLA News

•NIST published in August 2000 the final Guidance on Federal Conformity

Assessment Activities in the Federal

Register

•Section 287.4 (Responsibilities of Federal

Agencies) directs agencies to identify

appropriate private sector CA practices. •Section 287.4g directs agencies to participate

in efforts to improve government and

private sector CA activities and makes

specific reference to NACLA.

fen l*fcksmofy NACLA This Year

NACLA 2001 activity:

* Bilateral agreement signed with Standards Council of Canada

* North American Calibration Committee MOU formed with Mexico, Canada and US

(NACLA)

* Stakeholder member of International Laboratory Accreditation Cooperation

(ILAC) -recognition follows that oflLAC

* Participating in ILAC Laboratory Liaison Committee

* Considering formal linkage with the Inter- America Accreditation Cooperation

NIST Wvtefrop

SLIDE 9 SLIDE 10

NACLA ABAction

NACLA 2001 activity:

* Presently 8 Accrediting Bodies

"m ijuciue * Department of Energy requires

NACLA recognition of ABs used

for DOE calibration labs which

are accredited

|ACU\ NACLA Business Han

TJiough much has been accomplished, there are immediate concerns:

Meet client needs

Grow the membership

• Obtain financial independence as a 501(c)(6) not-for-profit organization

SLIDE 1

SLIDE 12

68
NK&+ ACLi NACLA-Summary

In summary, NIST-recognition will help achieve NACLA (and its customer's) goals:

* worldwide (as well as specific sector) recognition of accreditations

4 one test/calibration done once accepted

worldwide and sectorily

VISIT OUR WEBSITE: www.nacla.net

SLIDE 13
NIST-NACLA MOU

Mary Saunders

Director

Office of Standards Services

Workshop on Conformity Assessment for a Changing Government December 3, 2001

Outline

NIST-NACLA Approach

Purpose

NIST's Mandate NACLA Responsibilities NIST Responsibilities

Progress to Date Summary

SLIDE 1 SLIDE 2

NIST-NACLA Approach

Work together to develop and maintain a system in the U.S. that will

* recognize laboratory accreditation bodies to accredit

testing and calibration laboratories to meet the procurement and other requirements of the public and private sectors

* promote the use of such accreditation bodies

* recognize laboratory accreditation bodies to accredit

testing and calibration laboratories to carry out

specific activities under govemment-to-government

trade agreements

Purpose

Eliminate unnecessary duplication and

complexity in laboratory accreditation requirements

Support govemment-to-government trade agreements

Improve communications within and between

the public and private sectors on laboratory

accreditation requirements and practices

SLIDE 3 SLIDE 4

NIST's Mandate

NIST's mandate under the National Technology

Transfer and Advancement Act (NTTAA) of 1995 and OMB Circular A-1 19 is to

• coordinate Federal, State, and local conformity assessment activities with those of the

private-sector to eliminate unnecessary

duplication and complexity in the development and promulgation of conformity assessment

requirements and measures

* rely on the private sector as much as possible

NACLA Responsibilities

Recognize laboratory accreditation bodies as

being generally competent

Encourage the private sector to specify the use NACLA-recognized laboratory accreditation bodies Encourage laboratory accreditation bodies to seek NACLA recognition Assess the competence of laboratory

accreditation bodies to accredit laboratories to meet the specific technical requirements of selected trade agreements

SLIDE 5 SLIDE 6

70
NIST Responsibilities

Verify conformance of NACLA recognition of

laboratory accreditation bodies to the MOU

Encourage government at all levels to use NACLA-recognized accreditation bodies, taking

into account agency-unique requirements

Encourage laboratory accreditation bodies to seek NACLA recognition

Designate testing and calibration laboratories accredited by NACLA-recognized accreditation bodies as Conformity Assessment Bodies

under selected trade agreements

Progress to Date

NIST has designated two NACLA-recognized

accreditation bodies as competent to accredit

testing laboratories to EU and APEC economy

standards and regulatory requirements - supporting trade agreements

NIST designations based on these

accreditations: - 28 CABS under US-EU EMC sectoral annex - 11 CABs under US-EU telecom sectoral annex - APEC: Canada-20, Chinese Taipei-75, Singapore-6

SLIDE 7 SLIDE 8

I

Progress to Date

* The Interagency Committee on Standards

Policy has formed a working group on

conformity assessment - to advise ICSP on effective means of coordinating agency laboratory accreditation activities with those

of the private sector - recommend practical ways to eliminate unnecessary

duplication and complexity in development and

promulgation of laboratory accreditation requirements at the federal level - Use of the NACLA recognition process is a primary focus

Summary

The NIST-NACLA MOU will — help eliminate unnecessary duplication and

complexity in laboratory accreditation requirements in the U.S. - help NIST meet its obligations under the NTTAA

and OMB Circular A-119 - help NIST meet its obligations as a designating

authority under selected trade agreements — all while relying on the private sector to the maximum extent possible

The MOU has the full support of NIST management

SLIDE 9 SLIDE 10

71
Use of Commercial Calibration Labs. In

the DOE Nuclear Weapons Complex

Richard B. Pettit Primary Standards Laboratory Sandia National Laboratories Albuquerque, New Mexico

Conformity Assessmentfor a Changing Government December 3, 2001

SrOOfam Utoracrt cw»ea trr Sand* CtnxmJIon aLocktiWd Wa-tfl Cortwry.

OUTLINE

1. Describe Current Review/Approval Process

2. Requirements for Using Accredited Commercial

Calibration Labs.

3. Develop Confidence in NACLA

4. Benefits

Sanfc Mai

ttbwata»

SLIDE 1 SLIDE 2

DOE/AL Nuclear Weapons Complex

• Eight Laboratories Throughout the U.S.

• Primary Standards Laboratory (Sandia) - Ensure all facilities follow same calibration program standard - Certify Reference Standards

- Develop Needed Measurement Techniques

Quality Standard: ANSI/NCSL Z540-1 1994

- Transition to new ISO/IEC 17025 1999

Current DOE Review and

Approval Process

• Identify DOE Technical Requirements

•Complete Technical Survey by Metrology Staff

• Include Proficiency Testing

• Approve for Specific Scope

• Periodically Report all Approved Calibration Labs, to Sandia

• DOE Process Essentially Identical to Accreditation Process ®

SLIDE 3 SLIDE 4

New DOE Approval Process

•Identify DOE Technical Requirements

' If Commercial Lab. is Accredited, Accept Without

Oversight IF: - Accreditation Body is Recognized by NACLA

- Scope of Accreditation Covers Tech. Requirements Reserve Right for Technical Survey IF: - Calibrations are State-of-the-Art; or - Support Critical DOE Requirement

' If all Technical Requirements NOT Covered:

- Limit Technical Survey to only those areas

I Sods

Ubntoriss

SLIDE 5

72
Participating DOE Laboratories

SLIDE 6

Confidence in NACLA

• Participate in Process

- Member of NACLA Board of Directors - Team Member during NACLA Assessment of

Accreditation Body

- Member of NACLA Working Committees

• Proficiency Test

• Quality Committee - Seven DOE Labs. Members of NACLA

- Become NACLA Team Member as "Observer" m

Santa

teborri IdhnrsturiK

Benefits of New Process

• DOE Technical Survey Time/Cost

- 2-3 Days of Technical Staff Time

- $5-1 OK Each Survey

- Currently 40 Commercial Calibration Labs. 'Commercial Calibration Labs. Reduce External Surveys

'Accreditation Recognized Internationally

> Uniformity of Quality & Technical Requirements

SLIDE 7 SLIDE

73

Closing Remarks

75

ClosingRemarks

Belinda Collins

Deputy Director, Technology Services, *NIST

It is now my pleasure to conclude today's meeting.

During the first seven sessions, we heard an in-depth

review of the National Technology Transfer and

Advancement Act and what it means for Federal

Agencies. We also learned about the Conformity Assessment Guidance that NIST issued in 2000, as well

as some opportunities for Federal Agencies to collaborate more on conformity assessment requirements. The

results of these efforts will enable us to meet the NTTAA responsibilities assigned to Federal Agencies;

namely, to reduce redundancy and duplication while

ensuring conformance to a standard or regulation.

The four panel sessions gave us a flavor of the complexity of the U.S. conformity assessment system

and how it got that way. We heard about the wide variety

of approaches used by the government, used by the

private sector for itself, and used by the private sector to support the government, in many combinations.

Throughout the discussions, speakers stressed the importance of having confidence in the process, that the

results must be believable, and that a system should be in place to ensure that results will be reliable from one

time to the next. We heard quite a bit about certification of both

products and systems. We also received a very good

introduction to what we have called self-certification— since that's the term that the U.S. Congress uses. We

learned about the power of recall, and about the under- pinnings for the whole process of manufacturer's self declaration of conformity (SDOC), or "self-certification." We also received excellent information about

testing and inspection, and descriptions of good case

studies on the federal use of both quality management

systems and environmental management systems.

Speakers provided excellent examples that showed how

the government could actually save money and improve

its processes at the same time. The last session summarized activities in the field of

laboratory accreditation. The speakers emphasized that working together to build and maintain a national

infrastructure, such as that provided by the National

Cooperation for Laboratory Accreditation (NACLA),

will result in the saving of time and money for a Federal Agency, and reduce the burdens of redundant evaluations on laboratories.

Many of the speakers offered specific recommendations, such as the need to coordinate Federal conformity

assessment activities; the importance of reciprocity and

acceptance of certifications, accreditations, and even

data at times; the need for common accreditation schemes; the importance of training; and the need for better collaboration among third parties, government,

and industry. The various talks about NACLA were a good example of how that process might work. Speakers

also stressed the importance of education regarding

standards and conformity assessment for Government

agencies and for their collaborators in the private sector. They also reiterated the need for government to recognize the competence of laboratories accredited to international standards and the need for continued cooperation. All the talks provided a very good flavor of the NTTAA and the importance of using consensus

standards developed by the private sector. Time and

time again, speakers mentioned the importance of using

the international standards for laboratory accreditation,

quality system management, and environmental system

management. These exemplify the use of private sector standards, as urged by the NTTAA, to support confor- mity assessment processes. Today's discussions referred to the possibility of

using new building technology through agreements on

conformity assessment. We were challenged by the fascinating discussion of some of the pros and cons of

SDOC, and the importance of voluntary industry

efforts to meet Federal requirements for conformity

assessment.

I actually noted so many ideas that I could continue

listing them for another hour, but I won't bore you with

any more. NIST was challenged to return to these topics

later, and review the lessons we learned to define opportunities for the ICSP to coordinate Federal efforts in conformity assessment. As a result of today's session, we now have a really good idea of the complexity of the system. One challenge is to reduce this complexity by

starting to share more information, then look for opportunities to collaborate at the Federal level, and perhaps

with the state and local level. Meeting the challenges for collaboration will be a major ICSP activity during 2002.

I encourage all of you, Federal agencies in particular, to consider ideas from the private sector as well.

77
ClosingRemarks

Belinda Collins

(continued)

Mary Saunders mentioned the subcommittee on

conformity assessment of the ICSP, which she chairs. I'd like to drum up membership in that while I have the microphone. Only by active participation from, and

cooperation by, Federal agencies can we ensure that the processes for conformity assessment are as effective as they can be to meet the needs of the United States. In summary, I thank all the speakers who gave their valuable time to come and talk to us today. I'd also like to thank the audience for staying to the bitter end.

Finally, I want to acknowledge and thank one

particular person, Mary Jo DiBernardo, who played a major role in organizing the agenda, identifying and

scheduling speakers, and then making sure that they

understood the purpose of the program and submitted

their talks on time. I'd also like to recognize Mary

Saunders, Kevin Mclntyre, Walter Light, and all the other OSS staff who worked so hard to make this workshop a success. Thank you all very much.

78
Appendices

79

I. BIOGRAPHIES

GORDON E. BELLEN

Mr. Bellen is Vice President of Federal Programs at NSF International. In his current position he is responsible

for government relations at the federal level and management of several Government sponsored environmental

technology projects.

Mr. Bellen is a lifetime honorary member of the American Chemical Society's (ACS) Division of Environmental

Chemistry. He Chaired the Division for two years (94-95) and has received its Distinguished Service Award. He also was chosen to Chair the Society's Committee on Environmental Improvement (91-93). Mr. Bellen was also Chair of

the Environmental Labeling Delegation for the ISO 14000 series of standards. Mr. Bellen has a B.S. in Chemistry and M.S. in Water Resources Science from the University of Michigan. He is an Adjunct Faculty Member at the University of Michigan School of Public Health. Mr. Bellen is a retired Army officer with 23 years of service in Army aviation including active duty and the National Guard.

ROBERTA E. BREDEN

Roberta Breden is Director, Technical Regulatory Affairs, for the Telecommunications Industry Association (TIA).

She is responsible for the Fiber Optics and User Premises Equipment Divisions, and coordinates the activities of these Divisions and their Sections in matters of regulatory and technical issues of concern to Association members. In

addition, she is the Association's lead for conformity assessment issues. Ms. Breden also represents the Association in many international regulatory, standards, and consumer issues. She

participates on the American National Standards Institute Executive Standards Council, Consumer Interest Council,

and the Board Committee on Conformity Assessment. At the end of 2000, she was appointed as a member of the United States National Committee/International Electrotechnical Commission (USNC/IEC) Council after its internal reorganization that year. Ms. Breden is also a member of the International Electrotechnical Commission (IEC) Sector Board 4 and participates the IEC World Wide System for Certification and Testing of Electrical Equipment (IECEE).

She has participated as a member of the International Organization for Standardization Consumer Policy Committee

(ISO COPOLCO) Working Group on a joint agreement between ISO and IEC on consumer participation in voluntary

industry standards development.

On the constantly changing regulatory front, Ms. Breden was one of the telecommunications industry representatives working with the FCC on the streamlining and eventual privatization of the Part 68 consumer premises

equipment (CPE) registration process and the regulatory transition of terminal attachment in the United States. She now represents TIA as one of the sponsors of the recently formed Administrative Council for Terminal Attachments

(ACTA), the organization created to adopt technical criteria and to act as the clearing-house, publishing technical

criteria for terminal equipment developed by ANSI-accredited standards development organizations; and to establish and maintain a registration database of equipment approved as compliant with the technical criteria. Ms. Breden reports directly to Grant Seiffert, TIA's Vice President, External Affairs and Global Policy. Before

joining TIA in 1994, Ms. Breden was a Systems Engineer and Task Leader with Titan Systems for tasks in support

of the Federal Emergency Management Agency. She was actively involved in analyzing a variety of wireless telecommunications products and systems. From 1972 to 1992, Ms. Breden held various positions, both technical and

administrative, with the United States Marine Corps. She retired in 1992 as a Captain, with prior enlisted experience.

Ms. Breden holds a Bachelor of Science degree in Electrical Engineering from Purdue University and a Master of

Science in Systems Management from the University of Southern California.

MAUREEN BREITENBERG

Ms. Breitenberg is a senior economist with NIST and holds a B.S. in Mathematics and an M.B.A. in operations research from the University of Maryland. Her prior employment experience includes positions with the General

Accounting Office and the Food and Drug Administration and the Indian Health Service within the Department of

Health and Human Services (HHS).

81
She is currently responsible for providing technical advice and assistance on standards, conformity assessment and

other trade-related matters to other government agencies, foreign government bodies, and private industry. She is the author of a number of reports on subjects related to standardization and conformity assessment. Her publications

include two widely distributed reports on the ISO 9000 Standards Series; primers on U.S. standardization, certi- fication, conformity assessment, and laboratory accreditation activities; and directories of European regional and

international/regional standards related organizations, U.S. private sector and government certification programs, and

federal government laboratory accreditation/designation programs. Ms. Breitenberg is a winner of the Department of Commerce Bronze Medal and Vice President Gore's National

Performance Review award.

JOHN H. BRIDGES III

John H. Bridges III is an Environmental Compliance Coordinator for the U.S. Postal Service and has responsibility

for furthering postal manager's efforts to achieve environmental excellence as an integral part of overall business

excellence. In addition, he has recently assumed responsibility for corporate positioning of USPS Environmental

Management System efforts. He joined the Postal Service in 1996, after retiring from the U.S Marine Corps. Over

the past 25 years, he has held professional and leadership positions in environmental, health and safety (EHS)

planning, operational integration, and sustainable development. John served for three years on the President's Council on Sustainable Development, Environmental Management Task Force, as well as the American Society for Testing

and Materials (ASTM) E-50 Committee on Environmental Assessments. Most recently, Mr. Bridges was appointed

to the American Society of Safety Engineers (ASSE) Z490 Committee developing Standard Guidelines for Safety,

Health, and Environmental Training. Mr. Bridges serves on the Chairman's Advisory Group for the U.S. Technical Advisory Group of ISO 14000, as well as a technical advisor on ISO 14001 for Environmental Management Systems. He holds a BS in Occupational

Safety, is a graduate of the Marine Corps Command and Staff College and the Corporate Environmental Leadership

Program from Yale University. In 1999, he received the Environmental Manager of the Year Award, by the National

Association for Environmental Management and the Outstanding Service Award 2000 from the National Registry of

Environmental Professionals. Most recently, his EMS facilitation was recognized as one of the 2001 White House

Closing the Circle Awards winners.

KAREN H. BROWN

Karen H. Brown is the National Institute of Standards and Technology's Acting Director and Deputy Director. As

a non-regulatory agency of the U.S. Department of Commerce's Technology Administration, NIST's mission is to strengthen the U.S. economy and improve the quality of life by working with industry to develop and apply

technology, measurements, and standards through a portfolio of four major programs: the NIST Laboratories, the Baldrige National Quality Program, the Manufacturing Extension Partnership, and the Advanced Technology

Program. Brown oversees an $800M annual operating budget and 3,300 on-site staff complemented by 2,000

manufacturing and business specialists serving smaller manufacturers around the country. Brown came to NIST as deputy director in January 1999. Previously she was a Distinguished Engineer at IBM Microelectronics in Hopewell

Junction, N.Y. Brown also served (on assignment from IBM) as director of lithography for SEMATECH from

1994-1998. Brown's 22-year career at IBM concentrated on solving problems in semiconductor lithography and

microelectronics. She has a proven track record in management, having successfully met the challenges of moving

ideas from the laboratory into manufacturing. Brown also has a keen awareness of the impact of national and

international standards on U.S. industry and the economy, having held a variety of standards leadership positions in Semiconductor Equipment and Materials International and helping to bring a semiconductor fabrication line on-board

in France. A native of Schenectady, N.Y., Brown holds a B.A. in chemistry and in history, and a Ph.D. in chemistry from the University of Rochester.

82
BELINDA L. COLLINS

Belinda L. Collins is the Acting Deputy Director of the NIST Technology Services, which provides U.S. industry,

government, and the public with measurements, standards, and knowledge resources and services from NIST that promote innovation, increase competitiveness, and facilitate trade. It also provides policy support for standards and

conformity assessment activities for Federal agencies. Dr. Collins chairs the federal Interagency Committee on

Standards Policy (ICSP), serves on the ANSI Board of Directors, representing the NIST Director, and is the immediate past chair of the International Laboratory Accreditation Cooperation (ILAC) and a past chair of the National Cooperation for Laboratory Accreditation (NACLA).

Dr. Collins received her M.A. and Ph.D. in experimental psychology (visual psychophysics) from the University

of Virginia, and her B.A. in experimental psychology from Mary Washington College. While at NIST, she has served

in several different positions, including research psychologist, Leader of the Lighting Group, Program Analyst in the Office of the NIST Director, Director of the Office of Standards Services, and now Acting Deputy Director,

Technology Services. Dr. Collins has authored numerous technical publications and has been active in both domestic

and international standardization, chairing several different technical committees.

Dr. Collins is a Fellow of the Illumination Engineering Society of North America (IESNA) and served as its Vice

President for Education (1995-1997). Dr. Collins received the NIST Bronze Medal in 1984, a Meritorious Service

Award from the American National Standards Institute, along with a Public Service Award from ACIL in 1997, the NACLA Lifetime Achievement award and the NIST Edward Bennett Rosa Award in 2000, and the Department of

Commerce Silver Medal in 2001.

JOSEPH R. DUNBECK

loseph R. Dunbeck is the first Chief Executive Officer of the Registrar Accreditation Board (RAB) in Milwaukee,

WI. As CEO, Dunbeck directs the not-for-profit organization's ISO 9000 quality management systems and ISO 14000

environmental management systems programs for auditors, course providers, and registrars.

RAB, through a joint agreement with ANSI, manages the National Accreditation Program for accrediting registrars

and course providers for Quality Management Systems (QMS) and Environmental Management Systems (EMS).

RAB directly operates the QMS and EMS auditor certification program.

Before joining RAB in 1995, Dunbeck served as president of EKCO Housewares, Inc., Ingrid Housewares, Inc., and Bruning Paint Company. He began his career in sales and marketing positions for Kaiser Aluminum & Chemical

Corporation, Maremont Corporation, and Cragar Industries. Dunbeck holds a B. A. degree in economics from Lawrence University in Appleton, WI and an M.B.A. in marketing from Northwestern University in Evanston, IL.

SI FARVARDIN

Mr. Farvardin is Program Manager for the National Evaluation Service, Inc. He holds a Bachelor of Science Degree

in Civil Engineering from the University of Louisville, and an Engineering Intern Certification (EIT). He has over

16 years of experience in building codes and standards, building inspections, design review, and materials and

methods in building construction. His current technical work involves managing National Evaluation Service review

and approval of emerging building technologies/products for industry manufactures. He manages the multi-year

contract with the United States Department of Housing and Urban Development (HUD) for their Technical Suitability of Products Program (TSPP) as well. In the past, he served as a local building official in Anne Arundel County,

Maryland, and Fairfax County, Virginia, as well as Project Engineer for the National Conference of States on Building

Codes and Standards.

83
GORDON GILLERMAN

Mr. Gillerman works with government agencies and trade associations on domestic and global safety, conformity

assessment and trade issues in Underwriters Laboratories' Washington, DC Office. His experience includes: interfaces with elected officials, government agencies such as USTR, DOC, OSHA, FDA,

FCC and CPSC, as well as trade associations concerning issues related to health, safety, protection of property,

conformity assessment and trade. Mr. Gillerman's technical expertise includes medical equipment, information technology equipment and power

supplies. He has certified products to U.S., Canadian, European and other international standards and is an FDA

510(k) third party reviewer. He is a member of the IEC 62A, WG 18 for fire and thermal hazards in electromedical

equipment and a central reviewer for IEC 60601 CB Scheme reports. He is also an expert on EU Directives for Medical Devices, Safety of Low Voltage Equipment, Machinery, and EMC.

He has conducted presentations on safety, conformity assessment and trade issues for domestic and foreign

government and industry groups and has developed and conducted two-day open and in-house seminars on

harmonized safety standards for electromedical equipment, IEC 60601 and information technology including

telecommunications equipment. These seminars continue to be the primary source of training for regulatory

compliance in both industries and their regulators.

He holds a BSEET from Bradley University in Illinois.

GEORGIA HARRIS

Georgia Harris is a Physical Scientist with the NIST Office of Weights and Measures (OWM). As manager of the OWM Laboratory Metrology Program, Georgia is responsible for the NIST recognition of the State weights and

measures laboratories and the ongoing training and evaluation of metrologists in 55 laboratories. She coordinates numerous activities, such as round robins, regional measurement assurance groups, and the development and updating

of technical handbooks with cooperative and voluntary efforts of State and industry metrologists through NIST

working groups. She has been active in NCSL functions since 1985 when she first attended a Twin Cities section meeting (St. Paul,

MN). She has given presentations at both local and national meetings. She served as the Section Coordinator for the Twin Cities Section of NCSL in 1988 and 1989. Since 1991, she has functioned as liaison to the NCSL Board of

Directors for the National Conference on Weights and Measures. She was a VP on the NCSL Board of Directors for

the Eastern Division and the Measurement Science and Technology from 1994 through 1997. In 2001, she returned

to the Board of Directors for NCSLI as the VP for Publications. She has spoken at numerous NCSL sectional and

national meetings.

JOSEPH HAZELTINE

Joseph Hazeltine, PE, is a Senior Division Director at Wyle Laboratories Huntsville, Alabama test facility. He has

been with Wyle Laboratories for over 20 years after serving in the U.S. Navy's Nuclear Submarine Force. Mr. Hazeltine has extensive testing experience and is in charge of all conformity assessment activities in the laboratory. Mr. Hazeltine graduated from Marquette University with a BSEE degree and Florida Institute of

Technology with a MBA degree. He is a registered professional engineer and a member of many professional and

engineering organizations.

84
DONALD N. HEIRMAN

Donald Heirman is President of Don HEIRMAN Consultants, a training and educational EMC consultation corporation. Previously he was with Bell Laboratories for over 30 years in many EMC roles including Manager of Lucent Technologies (Bell Labs) Global Product Compliance Laboratory where he was in charge of the Corporation's

major EMC and regulatory test facility. He chairs, or is a principal contributor to, national and international EMC

standards organizations including ANSI ASC C63 and the International Special Committee on Radio Interference (CISPR) that develop new emission and immunity instrumentation specifications and measurement techniques. Mr. Heirman is a Fellow of the IEEE, a member of its EMC Society Board of Directors (and its Vice President for Standards), chairs the Society's Electromagnetic Compatibility Measurement Committee, and has authored and

presented internationally numerous papers, tutorials, and seminars/workshops on EMC subjects. He is also the chair of the IEEE Standards Association Standards Board and is President of the National Cooperation for Laboratory

Accreditation (NACLA). He chairs the American National Standards Institute Accredited Standards Committee C63,

Subcommittee One on EMC Techniques and Developments, which prepares guidelines or standards for EMC

measurements, test site qualifications, antenna calibrations, automated measurements, and emission and immunity

limit setting. Mr. Heirman is a technical expert for CISPR Subcommittees A (Radio Interference Measurements and

Statistical Techniques) and I (Information Technology, Multimedia, and Receiver Equipment). He is also the Subcommittee A chairman and chairman of its Working Group 1 responsible for CISPR 16 Part 1 on EMC

measurement instrumentation. He is also group manager for electromagnetics for the U.S. National Committee

Executive Committee (now called the Technical Management Committee) for the IEC (International Electrotechnical Commission) responsible for facilitating the CISPR and TC77 (immunity) U.S. participation and Chair of its Coordinating Committee on EMC. Mr. Heirman is also an adjunct professor/senior research scientist at the University

of Oklahoma and is the Associate Director for Wireless EMC at the University's Center for the Study of Wireless

EMC. He is a retired Commander in the U.S. Navy Reserves and he is listed in multiple Who's Who publications.

SCOTT HOLLIDAY

Scott has worked for the National Aeronautics and Space Administration (NASA) Headquarters in Washington, DC

since November 1991. He is currently the Director of the ISO 9001 Program Office. Over the past 3 years Scott led

the day-to-day implementation of a Quality Management System (QMS) that conforms to the ISO 9001 quality standard at NASA Headquarters, to include third party certification of Headquarters compliance. Headquarters was

initially certified to the ISO 9001 standard for Strategic Enterprise Management in May 1999. The certification was

then expanded to all Headquarters offices in May 2000. For his efforts Scott was awarded the Aero-Space

Technology Enterprise Award and NASA Headquarters Exceptional Performance Award. In October 2000, Scott's

role was expanded to provide NASA-wide functional leadership for ISO 9001-based QMS's.

In his previous position with NASA Headquarters, Scott worked as a senior engineer responsible for leading

NASA-wide facilities maintenance and management efforts. Major functions included leading NASA-wide

benchmarking efforts, leading the NASA-wide conversion to Reliability Centered Maintenance; leading the effort to convert cost reimbursement, level of effort facilities maintenance contracts to fixed price performance based

contracts; and providing strategic insight as a member of NASA's Strategic Management Working Group, responsible

for coordinating all NASA-wide strategic management efforts. For his efforts, Scott received NASA's Outstanding

Leadership Medal in June 1998, the Office of Safety and Mission Assurance's NASA-wide QASAR Award in October 1997, and two NASA Group Achievement Awards for the NASA Strategic Management Handbook and

National Facilities Study in 1997 and 1994 respectively. Scott also accepted one of the Association for Facilities Engineering's highest awards for international Facilities Management Excellence (FAME) in October 1997 for his

efforts as leader of the NASA-wide Corporate Maintenance Leadership Team.

85
Scott began his career in 1983 with the Navy in Philadelphia providing consulting services related to Public Works

management to Navy bases in a 24 state area. His duties also included teaching various adult education classes. From

1989 until joining NASA in 1991 , Scott worked for Naval Facilities Engineering Command (NAVFAC) Headquarters

in Alexandria, VA where he was the Navy-wide Program Manager for Facility Support Contracts and facilities operations and maintenance outsourcing. His duties also included teaching advanced contract management. He

was promoted to the Industrial Engineering Branch Head at NAVFAC Headquarters in May 1990 where he was

responsible for Navy-wide facilities maintenance and management policy and programs.

Scott received a Bachelor of Science in Industrial and Management Systems Engineering from Pennsylvania

State University in 1983. He currently resides in Lorton, Virginia with his wife Elizabeth and 2 daughters, Michaela

and Caitlin.

WILLIAM S. HURST

William (Bill) Hurst is an Electrical Engineer for the Policy and Rules Division, Office of Engineering and

Technology of the Federal Communications Commission, where he represents the FCC on national and international committees. He is responsible for the FCC's implementation of Mutual Recognition Agreements (MRAs) and

coordinates with other government agencies and groups concerned with equipment authorization policy and rules. Mr. Hurst spent 25 years in the private sector where he managed a telecommunications, EMC and product safety

testing laboratory and certification body. He has authored and presented numerous papers and has actively

participated in many industry organizations with regards to telecommunications, laboratory accreditation, EMC

standards, and equipment authorization. Mr. Hurst has been involved in Mutual Recognition Agreement (MRA) negotiations between the United

States Government and the European Union, Asian Pacific Economic Cooperation (APEC) and the Inter-American

Telecommunication Commission (CITEL).

TIM JEFFRIES

Mr. Tim Jeffries is the Director of the Administrative Council of Terminal Attachments, or ACTA, the newly

formed industry council for FCC Part 68 certification, and Technology Development for the Alliance for Telecommunications Industry Solution (ATIS).

As the director of ACTA, Tim's primary responsibility is to carry out the directives of the Council, including the management of its activities and oversight of all Secretariat duties. Tim also provides ongoing support, guidance, and

advice to the Council in the development, implementation, and achievement of its strategic objectives.

Tim jointed ATIS ' management staff after serving the Cellular Telecommunications & Internet Association (CTIA)

as its Director of Certification Programs. At CTIA, Tim was responsible for all aspects of the wireless industry's

product certification program; including its redesign to streamline the industry's product testing and approval

processes. The Alliance for Telecommunications Industry Solutions (ATIS) is a member company organization that is the leader for standards and operating procedures for the telecommunications industry. More than 1 ,500 experts from over 400 telecommunications companies participate in ATIS' 19 committees, forums, and Incubator Solutions programs.

RICHARD F. KAYSER

Dr. Kayser received a Sc.B. in physical chemistry from Brown University in June 1973 and a Ph.D. in physical

chemistry from Rice University in May 1976. He moved to the National Bureau of Standards (now the National

Institute of Standards and Technology) in May 1976 as a National Science Foundation Postdoctoral Fellow and joined

the Thermophysics Division as a permanent staff member one year later. Over the next ten years, Dr. Kayser performed research on a wide variety of theoretical and experimental topics,

ranging from phase transitions to wetting phenomena. During that time, he published approximately 40 papers in the peer-reviewed archival literature.

86
Dr. Kayser became Chief of the Thermophysics Division in May 1989 and Chief of the Physical and Chemical

Properties Division in May 1996. In these positions, he was responsible for NIST's programs on the thermophysical

and thermochemical properties of gases, liquids, and solids; the rates and mechanisms of chemical reactions in the gas and liquid phases; process separations and low-temperature refrigeration, heat transfer, and flow; and pressure, vacuum, and low-flow-rate measurements and standards, including the U.S. national standards in those areas. Dr. Kayser assumed the position of Director of Technology Services in August 1999. Among its activities, Technology Services supports the NIST Measurement and Standards Laboratories in the provision of calibrations,

Standard Reference Materials, and Standard Reference Data; promotes accuracy and uniformity throughout the States

in weights and measures; conducts the National Voluntary Laboratory Accreditation Program; and facilitates trade by promoting the efficient development and use of U.S. standards and technology and by reducing technical barriers

to trade.

REBECCA B. MACPHERSON

A graduate of Tulane University School of Law, Ms. MacPherson has worked at the National Highway Traffic Safety Administration (NHTSA) as a rulemaking attorney for five years. She had previously worked as a litigation

attorney for the U.S. Maritime Administration. During her tenure at NHTSA, Ms. MacPherson has worked on

regulations addressing a variety of safety-related issues. These projects include a new, comprehensive regulation on advanced air bags, regulations creating exemptions

from the statutory prohibition against making mandated motor vehicle safety equipment inoperative, and certification of vehicles manufactured in two or more stages. Ms. MacPherson has also worked in the international sphere, assisting

in the development of a U.N. agreement on the development of global technical regulations and representing NHTSA

before governmental and private entities from Korea, Japan, China, and Mexico.

KEVIN L. MCIIS TYRE

Mr. Mclntyre is a Senior Standards Specialist in NIST's Office of Standards Services. He is responsible for furthering NIST's progress in implementing Public Law 104-113, the National Technology Transfer and Advancement Act of 1995. Mr. Mclntyre also serves as Secretary to the Interagency Committee on Standards Policy. Prior to joining NIST in 1993, Mr. Mclntyre worked in private industry in several capacities including manufacturing engineering, engineering management and new business development. While at NIST, Mr. Mclntyre worked

in the Manufacturing Extension Partnership Program, serving as a Regional Account Manager and Group Leader

before joining the Office of Standards Services in June 2000. Mr. Mclntyre holds a B.Sc. in Mechanical Engineering

from the University of Maryland and an MBA from George Washington University. In 1996, Mr. Mclntyre was

awarded the Department of Commerce Bronze Medal Award for Superior Federal Service.

MARY C. MCKIEL

Dr. McKiel began her Federal career in 1976 as an analytical chemist at the National Archives and Records Service

(now an independent Administration). There, she developed chemical methods for restoring and preserving textual and non-textual materials. As a member of the U.S. Group to ISO Technical Committee (6) on Paper, she participated

in developing international standards for archival quality paper. From 1982 to 1993, Mary served in several capacities at the Federal Supply Service of the General Services

Administration: Chief of Engineering and Standards Policy, Director of Quality Standards, and Director of

Environmental Planning. At GSA, among other achievements Mary instituted and managed quality control and

assurance programs for the Service, and developed and published GSA's first "green" catalog. She earned several Outstanding Service awards and medals while at GSA.

87
In 1993, she joined the Environmental Protection Agency in the Office of Prevention, Pesticides and Toxic

Substances. With the approval of EPA's Administrator, she initiated and managed the EPA's first cross-office program for voluntary standards. As Director of the EPA Standards Network, she coordinated Agency use of

non-government standards and managed EPA's participation in the U.S. Technical Advisory Group (TAG) for the development of the ISO 14000 standards for Environmental Management. She was elected Vice Chair of the U.S. TAG and continues to serve in that capacity.

In 1998, Mary was appointed by to the position of EPA Standards Executive. As such, her role is Agency-wide

in responsibility and includes implementing the National Technology Transfer and Advancement Act and OMB

Circular A-119 throughout EPA. She heads up the Agency's Standards Program and represents the Agency on the Interagency Committee for Standards Policy. Mary represents EPA standards policies in national, regional and

international standards-related fora, the International Organization for Standardization (ISO), the Pacific Area

Standards Congress (PASC) and the South American Congress for Norms and Technical Standards (COPANT). She

has earned the 1998 EPA Administrator's Silver Medal for Excellence in Service, as well as Silver and Bronze

Agency medals from 1996 to the present.

Mary currently serves as a Vice Chair on the Board of Directors of the American National Standards Institute (ANSI) and is immediate past Chair of ANSI's Government Member Council. She has served on the Board of

Directors for the International Policy Institute in Washington and represented the U.S. in international environmental

discussions involving standards through the United Nations Environmental Program (UNEP) and the United Nations

Committee on Trade and Development (UNCTAD) as well as in the Organization for Economic Cooperation and

Development (OECD).

Mary has numerous publications on standards and standards in regulations and regularly makes national and

international presentations on standards-related topics.

RICHARD (DICK) B. PETTIT

After gaining his Ph.D. in Applied Physics from Cornell University in 1971, Dick joined Sandia National

Laboratories as a Member of the Technical Staff. Initial assignments involved developing optical measurement

techniques and optical coatings for solar collectors, including black chrome solar absorbers, light-weight flexible mirror materials, and antireflection coatings for glazings. Since 1986 he has been a manager in the Sandia Primary

Standards Laboratory overseeing electrical metrology in AC, DC, and Microwave disciplines. Dr. Pettit's expertise includes:

• Metrology management systems and quality operations

• Calibration uncertainties

• Optical properties of solar absorbers, mirrors, and glazings

• Ellipsometry and multilayer thin film optical properties

• Thermal radiative properties of metals and coatings

• Transmission Electron Microscopy

• Enhanced superconductivity of thin films He was a recipient of the Department of Energy (DOE) Solar Thermal Program Award in Technical Excellence

in 1982; and he has been an American Society for Quality (ASQ) Certified Quality Engineer since 1992. Among

several professional societies and various honors, Dick serves as Vice President of Measurement Science and

Technology for NCSL International (NCSLI); and he was the DOE representative to the National Cooperation for Laboratory Accreditation (NACLA). He is also a member of the American Association for the Advancement of

Science (AAAS) and the American Physical Society (APS).

Dick has been involved with the NCSLI for the past 1 3 years; he was Chairman of the Intrinsic/Derived Standards

Committee for over 8 years and led the development of the recently published "Catalogue of Intrinsic/Derived

88
Standards." He has organized several topical sessions and presented material on metrology issues at the annual NCSLI

Symposium and Workshop, and he was the Technical Program Chair for the 2001 NCSLI Conference.

Dick's outside interests include bicycling, camping, gardening, and traveling. He and his wife, Ellen, have been

involved with hosting and assisting foreign exchange students over the past 10 years.

MARY H. SAUNDERS

Mary H. Saunders is the Director of NIST's Office of Standards Services, which provides policy support

for standards and conformity assessment activities for federal agencies. OSS administers programs in Laboratory

Accreditation, Technical Standards Activities, Global Standards and Information, as well as the implementation of

the National Technology Transfer and Advancement Act of 1995. Ms. Saunders joined NIST in July 1993, having served for four years as Director of the Internal Market Staff of

the Commerce Department's Office of European Community Affairs, where she developed a program to track developments in Europe in the areas of product safety standards, testing and certification and accreditation requirements, and ISO 9000 registration and accreditation. While at NIST, she has served in several different positions, including Chief of the Global Standards and Information Program and Program Analyst in the Office of

the NIST Director. Ms. Saunders received the NIST Bronze Medal in 1995 and the Department of Commerce Silver Medal in 1999. She continues to be active in both domestic and international standardization.

ERIC L. STONE

Mr. Stone is Director of the Legal Division of the Office of Compliance at the Consumer Product Safety

Commission. Since 1977, Mr. Stone has served as a trial attorney at the Commission litigating administrative and

federal court cases. Mr. Stone also wrote the Commission's reporting regulations under section 15 of the Consumer

Product Safety Act and the Child Safety Protection Act. Mr. Stone graduated from the Washington College of Law (American University), Washington, D.C. in 1976 and

received his BA from Franklin & Marshall College, Lancaster, PA in 1974. Mr. Stone has taught courses in consumer

law, product liability, and government regulation at the University of Maryland and has authored several articles and

a book about the Commission's laws. (Consumer Product Safety Primer: An Industry Guide to the Regulatory System

with Samuel Goldblatt, LRP Publications (1998))

JAMES K. WALTERS

Jim Walters is the Director, International Standards, at the Air-Conditioning and Refrigeration Institute (ARI),

Arlington, Va. ARI is a trade association whose members manufacture about 90% of the central air-conditioning and

refrigeration equipment sold in North America and account for about 80% of $6 billion in exports per year. ARI

administers the Secretariat of several ISO committees.

Prior to joining ARI's staff in April 1999, Jim was Director and General Manager of a petroleum industry on-line information service in New York, which he sold to an international on-line information company.

Jim's trade association and business experience includes managing an engineering standards and certification department and a $20 million for-profit products and services group at the American Petroleum Institute. Jim's

background also includes government relations specializing in international trade issues. He is currently the Vice

Chair of the Low Frequency Emissions Industry Coalition. Jim was educated at the George Washington University, University of Virginia and the Stanford University

Graduate School of Business.

Jim is a member of the Boards of Directors of the Standards Engineering Society and The Center for Global

Standards Analysis, and is a member of ASTM, The American Society of Association Executives, several committees

of the American National Standards Institute, and the Industry Advisory Committee of the Elliott School of

International Affairs of the George Washington University. He is formerly Secretary of ASTM Committee D-2.

89

II. Final Participants List

Sherryl Acey

Entela, Inc 3033 Madison Ave., SE

Grand Rapids, MI 49548 USA

Telephone: 616/248-9608

Fax: 616/247-7527

Email: sacey@entela.com

David Alderman

NIST

100 Bureau Drive

Mail Stop 2140

Gaithersburg, MD 20899-2140 USA

Telephone: 301/975-4019

Fax: 301/926-2884

Email: david.alderman@nist.gov

Jim Allen FHWA

400 Seventh Street, SW

Room 3416

Washington, DC 20590 USA

Telephone: 202/366-2211

Fax: 202/493-2027

Email: jim.allen@fhwa.dot.gov

Mel Altman

U.S. Food & Drug Administration

2094 Gaither Road

HFZ-80

Rockville, MD 20851 USA

Telephone: 301/594-4766

Fax: 301/827-0193

Email: mra@cdrh.fda.gov

Janet Anquez

U.S. Food & Drug Administration

5600 Fishers Lane

Rockville, MD 20857 USA

Telephone: 301/827-0037

Fax: 301/480-0814

Email: CAnquez@oc.fda.gov

David Baker

U.S. Air Force Metrology & Calibration Program

813 Irving-Wick Drive

Heath, OH 43056 USA

Telephone: 740/788-5000

Fax: 740/788-5020

Email: david.baker@afmetcal.af.mil

Gordon Bellen NSF International 789 Dixboro Road

Ann Arbor, MI 48105 USA

Telephone: 734/769-8010

Fax: 734/827-7181

Email: bellen@nsf.org

Reg Blake

BSI America, Inc. 12110 Sunset Hills Road

Suite 140

Reston, VA 20190 USA

Telephone: 703/464-1908

Fax: 703/437-9001

Email: reg.blake@bsiamericas.com

Roberta Breden

Telecommunications Industry Association

2500 Wilson Blvd.

Suite 300

Arlington, VA 22201 USA

Telephone: 703/907-7705

Fax: 703/907-7727

Email: rbreden@tia.eia.org

Maureen Breitenberg

NIST

100 Bureau Drive

Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-4031

Fax: 301/963-2871

Email: maureen.breitenberg@nist.gov

91
Carroll Brickenkamp

NIST

100 Bureau Drive

Mail Stop 2140

Gaithersburg, MD 20899-2140 USA

Telephone: 301/975-4291

Fax: 301/926-2884

Email: carroll.brickenkamp@nist.gov

John Bridges

U.S. Postal Service

475 L'Enfant Plaza, SW

Room 1P830

Washington, DC 20260 USA

Telephone: 202/268-5595

Fax: 202/268-6016

Email: jbridge4@email.usps.gov

Milton Bush

The M Companies

3942 N. Upland Street Arlington, VA 22207 USA

Telephone: 703/533-9539

Fax: 703/533-1612

Email: themcos@aol.com

Gum Ho Choe

NIST

100 Bureau Drive

Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-2929

Fax: 301/963-2871

Email: choe@nist.gov

Alan Clune

AFMETCAL

813 Irving Wick Drive

Heath, OH 43056 USA

Telephone: 740/788-5051

Fax: 740/788-5021

Email: alan.clune@afmetcal.af.mil

Belinda Collins

NIST

100 Bureau Drive

Mail Stop 2000

Gaithersburg, MD 20899-2000 USA

Telephone: 301/975-6455

Fax: 301/975-2183

Email: belinda.collins@nist.gov

Dave Conover

National Evaluation Services, Inc. 5203 Leesburg Pike

Suite 600

Falls Church, VA 22041 USA

Telephone: 703/931-2187

Email: DConover@nateval.org

Stephen Cook

NIST

100 Bureau Drive

MS 2350

Gaithersburg, MD 20899-2350 USA

Telephone: 301/975-4003

Fax: 301/926-0647

Email: steven.cook@nist.gov

Ronald Cressman

U.S. Air Force

18 ALSAB Drive

Pataskala, OH 43062 USA

Telephone: 740/788-5030

Fax: 740/788-5036

Email: ron.cressman@afmetcal.af.mil

Zubin Dastoor

Air-Conditioning & Refrigeration Institute 4301 N. Fairfax Drive

Suite 425

Arlington, VA 22203 USA

Telephone: 703/524-8800

Fax: 703/524-9011

Email: zdastoor@ari.org

92
Tom Davis

NIST

100 Bureau Drive

Mail Stop 2140

Gaithersburg, MD 20899-2140 USA

Telephone: 301/975-6499

Fax: 301/926-2884

Email: thomas.davis@nist.gov

Christine DeVaux

NIST

100 Bureau Drive

Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-4679

Fax: 301/963-2871

Email: christine.devaux@nist.gov

Mary Jo DiBernardo

NIST

100 Bureau Drive

Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-5503

Fax: 301/963-2871

Email: maryjo.dibernardo@nist.gov

Andrew Dilworth

DOC/ITA/MAC/TCC

14th & Constitution Ave. HCHB Room 3043

Washington, DC 20230 USA

Telephone: 202/482-8212

Fax: 202/501-0674

Email: andrew_dilworth@ita.doc.gov

Steve Doty

NIST

100 Bureau Drive

Mail Stop 2140

Gaithersburg, MD 20899-2140 USA

Telephone: 301/975-4857

Fax: 301/926-2884

Email: stephen.doty@nist.gov

Joseph Dunbeck

Registrar Accreditation Board

600 N. Plankinton Ave.

Suite 300

Milwaukee, WI 53203 USA

Telephone: 414/272-3937

Fax: 414/765-8661

Email: jdunbeck@rabnet.com

Catherine Ecalard

Food & Drug Administration

5600 Fishers Lane

Rockville, MD 20857 USA

Telephone: 301/827-6615

Fax: 301/480-0814

Email: cecalard@oc.fda.gov

Si Farvardin

National Evaluation Service, Inc. 5203 Leesburg Pike

Suite 600

Falls Church, VA 22041 USA

Telephone: 703/931-2187

Fax: 703/931-6505

Email: sfarvardin@nateval.org

Reinaldo Figueiredo

ANSI

1819 L Street Washington, DC 20036 USA

Telephone: 202/331-3611

Email: reinoldobf@aol.com

Mike Foran

U.S. Air Force Metrology & Calibration Program

813 Irving-Wick Drive

Heath, OH 43056 USA

Telephone: 740/788-5060

Email: Michael .Foran@ afmetcal .af.mil

93
Leonard Frier MET Laboratories

914 W. Patapsco Ave. Baltimore, MD 21230 USA

Telephone: 410/354-3300

Fax: 410/354-3313

Email: lfrier@metlabs.com

Brian Gilda U.S. Coast Guard

2100 Second Street, SW

G-MSE-4

Washington, DC 20593 USA

Telephone: 202/267-0147

Fax: 202/267-1069

Email: bgilda@comdt.uscg.mil

Gordon Gillerman

Underwriters Laboratories

1850 M Street, NW

Suite 1000

Washington, DC 20036 USA

Telephone: 202/296-7840

Fax: 202/872-1576

Email: gillermang@aol.com

Cecil Gittens

Eastman Kodak Co. 24 Woodside Drive

Rochester, NY 14624 USA

Telephone: 716/726-2290

Email: cecil.gittens@kodak.com

Allen Groh

Ericsson

740 E. Campbell Rd.

Richardson, TX 75081 USA

Telephone: 972/583-0902

Fax: 972/583-1809

Email: allen.groh@ericsson.com

Fred Grunder

American Industrial Hygiene Assoc. 2700 Prosperity Ave.

Suite 250

Fairfax, VA 22031 USA

Telephone: 703/849-8888

Fax: 703/207-8558

Email: fgrunder@aiha.org

Sandra Hale

NIST

100 Bureau Drive

MS 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-3609

Email: sandra.hale@nist.gov

Denise Hanchulak

AAMVA

4301 Wilson Blvd.

Suite 400

Arlington, VA 22203 USA

Telephone: 703/908-5767

Fax: 703/908-2868

Email: dhanchulak@aamva.org

Jeanne Hankins

U.S. EPA

MD-75A

Res. Triangle Pk., NC 2771 1 USA

Telephone: 919/541-1120

Fax: 919/541-4261

Email: hankins.jeanne@epa.gov

Georgia Harris

NIST

100 Bureau Drive

MS 2350

Gaithersburg, MD 20899-2350 USA

Telephone: 301/975-4014

Email: g.harris@nist.gov

94
Joseph Hazeltine

Wyle Laboratories, Inc. 7800 Highway 20 West

Huntsville, AL 35806 USA

Telephone: 256/837-441

1

Fax: 256/721-0144

Email: hazeltin@wylelabs.com

Donald Heirman

Lucent Technologies

143 Jumping Brook Road

Lincroft, NJ 07738 USA

Telephone: 732/741-7723

Fax: 732/530-5695

Email: d.heirman@worldnet.att.net

Scott Holliday

NASA HQ

300 E Street, SW

Code JJ, Rm. 7N80

Washington, DC 20546 USA

Telephone: 202/358-1096

Fax: 202/358-3944

Email: sholida@hq.nasa.gov

Jeffrey Horlick

NIST

100 Bureau Drive

Mail Stop 2140

Gaithersburg, MD 20899-2140 USA

Telephone: 301/975-4020

Fax: 301/926-2884

Email: jeffrey.horlick@nist.gov

Susan Hoyler

Telecommunications Industry Assoc. 2500 Wilson Blvd.

Arlington, VA 22201 USA

Telephone: 703/907-7704

Fax: 703/907-7728

Email: shoyler@tia.eia.org

William Hurst

Federal Communications Commission

445 12th Street, SW

Room 7-C257

Washington, DC 20554 USA

Telephone: 202/418-7266

Fax: 202/418-1944

Email: whurst@fcc.gov

Mary Hyer

The Marley Organization, Inc. 412 Main Street Suite 3

Ridgefield, CT 06877 USA

Telephone: 203/438-3801

Fax: 203/438-3801

Email: CHyer@TMOinc.com

Tim Jeffries ATIS

1200 G Street, NW

Suite 500

Washington, DC 20005 USA

Telephone: 202/662-8669

Email: tjeffries@atis.org

Edward Kantor

U.S. EPA

P.O. Box 93478

Las Vegas, NV 89193 USA

Telephone: 702/798-2690

Fax: 702/798-2261

Email: kantor.edward@epa.gov

Rich Kayser

NIST

100 Bureau Drive

Mail Stop 2000

Gaithersburg, MD 20899-2000 USA

Telephone: 301/975-4500

Fax: 301/975-2183

Email: richard.kayser@nist.gov

95
Larry Knab

NIST

100 Bureau Drive

Mail Stop 2140

Gaithersburg, MD 20899-2140 USA

Telephone: 301/975-6712

Fax: 301/926-2884

Email: lawrence.knab@nist.gov

Diane Lay

NIST

100 Bureau Drive

Mail Stop 2160

Gaithersburg, MD 20899-2160 USA

Telephone: 301/975-5634

Fax: 301/926-1559

Email: diane.lay@nist.gov

Walter Leight

NIST

100 Bureau Drive

Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-4000

Fax: 301/963-2871

Email: walter.leight@nist.gov

Alvin Logan

FAA

800 Independence Ave., SW

AAS-100, Rm 61B

Washington, DC 20591 USA

Telephone: 202/267-8743

Fax: 202/267-5383

Email: alvin.logan@faa.gov

Carmina Londono

NIST

100 Bureau Drive

Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-2573

Email: carmina.londono@nist.gov

Emiliano Lopez

U.S. DOT

10 S. Howard

Baltimore, MD 21201 USA

Telephone: 410/215-8130

Email: emiliano.lopez@fhwa.dot.gov

John Lucas

Food & Drug Administration

5600 Fishers Lane

Rockville, MD 20857 USA

Telephone: 301/827-0917

Fax: 301/480-0814

Email: jlucas@oc.fda.gov

Rebecca MacPherson

National Highway Traffic Safety Administration

400 Seventh St., SW

Room 5219

Washington, DC 20003 USA

Telephone: 202/366-2992

Fax: 202/366-3820

Email: rebecca.macpherson@nhtsa.dot.gov

Ileana Martinez

NIST

100 Bureau Drive

Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-2766

Fax: 301/963-2871

Email: ileana.martinez@nist.gov

Kevin Mclntyre

NIST

100 Bureau Drive

Mail Stop 2150

Gaithersburg, MD 20899-2150 USA

Telephone: 301/975-4907

Fax: 301/975-5414

Email: kevin.mcintyre@nist.gov

96
Mary McKiel

U.S. EPA

1200 Pennsylvania Ave., NW

MC 7101, Ariel Rios Bldg.

Washington, DC 20460 USA

Telephone: 202/260-3584

Fax: 202/260-6906

Email: mckiel.mary@epa.gov

Mike Moore

NIST

100 Bureau Drive

Mail Stop 2150

Gaithersburg, MD 20899-2150 USA

Telephone: 301/975-2007

Fax: 301/975-5414

Email: mike.moore@nist.gov

Sherrey Nicolas

OSHA

200 Constitution Ave., NW

N3655

Washington, DC 20210 USA

Telephone: 202/693-2110

Fax: 202/693-1644

Email: sherrey.nicolas@osha.gov

Joseph O'Neil

NACLA

P.O. Box 4045

Gaithersburg, MD 20885 USA

Telephone: 301/975-6472

Fax: 301/963-2871

Email: secretariat@nacla.net

Kevin Oditt U.S. Coast Guard

2100 Second Street, SW

G-MSE-4

Washington, DC 20593 USA

Telephone: 202/267-0169

Fax: 202/267-1069

Email: koditt@comdt.uscg.mil

Manny Olds

U.S. Government Printing Office

732 North Capitol Street, NW

Washington, DC 20401 USA

Telephone: 202/512-0767

Fax: 202/512-1314

Email: rbaker@gpo.gov

JoAnne Overman

NIST

100 Bureau Drive

Mail Stop 2160

Gaithersburg, MD 20899-2160 USA

Telephone: 301/975-4037

Fax: 301/926-1559

Email: joanne.overman@nist.gov

Libby Parker NIST

100 Bureau Drive

Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-3089

Fax: 301/963-2871

Email: libby.parker@nist.gov

Bernard Pasquet

OSHA

200 Constitution Ave., NW

N3655

Washington, DC 20210 USA

Telephone: 202/693-2110

Fax: 202/693-1644

Email: bernard.pasquet@osha.gov

Richard Pettit Sandia National Laboratories

Mail Stop 0665

Albuquerque, NM 87185 USA

Telephone: 505/844-6242

Fax: 505/844-4372

Email: rbpetti@sandia.gov

97
Jerry Pittenger

Battelle 505 King Avenue Columbus, OH 43201 USA

Telephone: 614/424-5189

Fax: 614/458-5189

Email: pittengj@battelle.org

CP. (Chuck) Ramani

ICBO Evaluation Services, Inc. 5360 Workman Mill Road

Whittier, CA 90601 USA

Telephone: 562/699-0541

Fax: 562/692-2845

Email: ramani@icbo.org

Douglas Read

SAE International 1300 I Street, NW

Washington, DC 20005 USA

Telephone: 202/962-8691

Fax: 202/962-8692

Email: douglasr@sae.org

Hazel Richmond

NIST

100 Bureau Drive

Mail Stop 2140

Gaithersburg, MD 20899-2140 USA

Telephone: 301/975-3024

Fax: 301/926-2884

Email: hazel.richmond@nist.gov

Anita Ricketts IEEE

445 Hoes Lane

Piscataway, NJ 08854 USA

Telephone: 732/562-3847

Fax: 732/562-1571

Email: a.ricketts@ieee.org

Ann Rollins

Information Technology Industry Council

1250 Eye Street, NW

Suite 200

Washington, DC 20005 USA

Telephone: 202/626-5735

Email: arollins@itc.org

Nathan Root

AAMVAnet

4301 Wilson Blvd.

Suite 400

Arlington, VA 22203 USA

Telephone: 703/908-5843

Fax: 703/908-2868

James Rountree NIST

100 Bureau Drive

Mail Stop 2160

Gaithersburg, MD 20899-2160 USA

Telephone: 301/975-4035

Fax: 301/975-1559

Email: james.rountree@nist.gov

Sid Sanders

Timco Engineering, Inc. 849 N.W State Road 45

Newberry, FL 32669 USA

Telephone: 352/472-5500

Fax: 352/472-2030

Email: info@timcoengr.com

Mary Saunders

NIST

100 Bureau Drive

Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-2396

Fax: 301/963-2871

Email: mary.saunders@nist.gov

98
Michael Schagrin

U.S. DOT

400 7th Street, SW

Room 3416

Washington, DC 20590 USA

Telephone: 202/366-2180

Fax: 202/493-2027

Email: mike.schagrin@fhwa.dot.gov

Andy Schoka

Mitretek Systems

600 Maryland Ave., SW

Suite 755

Washington, DC 20024 USA

Telephone: 202/488-5702

Email: schoka@mitretek.org

Jane Schweiker

Schweiker & Associates

4853 Cordell Avenue

Suite 1515

Bethesda, MD 20814 USA

Telephone: 301/656-9599

Email: jschweiker@erols.com

Dennis Smith

Tyco Electronics

P.O. Box 3608

Harrisburg, PA 17105 USA

Telephone: 717/810-4667

Fax: 717/810-3400

Email: desmith@tycoelectronics.com

Joan Sterling

ITS

1233 S Street, NW

Suite A

Washington, DC 20009 USA

Telephone: 202/265-3378

Fax: 202/265-0687

Email: js@etlsemko.com

Eric Stone

U.S. Consumer Product Safety Commission

4340 East West Highway

Room 613 E

Bethesda, MD 20207 USA

Telephone: 301/504-0626

Fax: 301/504-0359

Email: estone@cpsc.gov

Diane Thompson

Thompson Consulting

7028 Roslyn Avenue Derwood, MD 20855 USA

Telephone: 240/632-2660

Email: dianet2001@msn.com

Ambler Thompson

NIST

100 Bureau Drive

Mail Stop 2150

Gaithersburg, MD 20899-2150 USA

Telephone: 301/975-5414

Email: ambler@nist.gov

James Thurston

Information Technology Industry Council

1250 Eye Street, NW

Suite 200

Washington, DC 20005 USA

Telephone: 202/626-5721

Fax: 202/638-4922

Email: jthurston@itic.org

Ellen Trager

NIST

100 Bureau Drive

Mail Stop 2160

Gaithersburg, MD 20899-2160 USA

Telephone: 301/975-4038

Fax: 301/926-1559

Email: ellen.trager@nist.gov

99
Brenda Umberger

NIST

100 Bureau Drive, Mail Stop 2160

Gaithersburg, MD 20899-2160 USA

Telephone: 301/975-4036

Fax: 301/926-1559

Email: brenda.umberger@nist.gov

George Willingmyre

GTW Associates

1012 Parrs Ridge Drive

Spencerville, MD 20868 USA

Telephone: 301/421-4138

Fax: 301/421-0977

Email: gtw@gtwassociates.com

Peter Unger

A2LA

5301 Buckeystown Pike, Suite 350

Frederick, MD 21704 USA

Telephone: 301/644-3212

Fax: 301/662-2974

Email: punger@a21a.org

James Walters

Air-Conditioning & Refridgeration Institute 4301 N. Fairfax Drive, Suite 425

Arlington, VA 22203 USA

Telephone: 703/524-8800

Jeris White

Mitretek Systems

600 Maryland Avenue

Washington, DC 20024 USA

Telephone: 202/488-5712

Fax: 202/863-2988

Email: jeris.white@mitretek.org

Vanda White

NIST

100 Bureau Drive, Mail Stop 2140

Gaithersburg, MD 20899-2140 USA

Telephone: 301/975-3592

Fax: 301/926-2884

Email: vanda.white@nist.gov

Trudie Williams

U.S. DoD

8725 John J. Kingman Road, Suite 4235

Fort Belvoir, VA 22060 USA

Telephone: 703/767-6875

Fax: 703/767-6876

Email: trudie_williams@hq.dla.mil

Kathleen Winn

Kathleen Winn & Associates

213 A Street, NE

Washington, DC 20002 USA

Telephone: 202/547-3363

Fax: 202/544-6144

Email: kjayewinn@aol.com

Leanne Wright

Standards Council of Canada

270 Albert Street Ottawa, ON KIP 6N7 CANADA

Telephone: 613/238-3222

Fax: 613/569-7808

Email: lwright@scc.ca

Grant Zammit

U.S. DOT

61 Forsyth Street, Suite 17T26

Atlanta, GA 30303 USA

Telephone: 404/562-3575

Fax: 404/562-3700

Email: grant.zammit@fhwa.dot.gov

Eldar Zulfugarzade

NIST

100 Bureau Drive

Mail Stop 2100

Gaithersburg, MD 20899-2100 USA

Telephone: 301/975-4412

Fax: 301/963-2871

Email: eldar.zulfugarzade@nist.gov

100
III. Public Law 104-113

PUBLIC LAW 104-113—MAR. 7, 1996 110 STAT. 775

Public Law 104-113

104th Congress

An Act

To amend the Stevenson-Wydler Technology Innovation Act of 1980 with respect

to Inventions made under cooperative research and development agreements, and for other purposes. Be it enacted by the Senate and House of Representatives of

the United States ofAmerica in Congress assembled,

SECTION I. SHORT TITLE. This Act may be cited as the "National Technology Transfer

and Advancement Act of 1995". SEC. 2. FINDINGS.

The Congress finds the following:

(1) Bringing technology and industrial innovation to the

marketplace is central to the economic, environmental, and

social well-being of the people of the United States.

(2) The Federal Government can help United States busi- ness to speed the development of new products and processes by entering into cooperative research and development agree- ments which make available the assistance of Federal laboratories to the private sector, but the commercialization of tech- nology and industrial innovation in the United States depends

upon actions by business.

(3) The commercialization of technology and industrial

innovation in the United States will be enhanced if companies,

in return for reasonable compensation to the Federal Government, can more easily obtain exclusive licenses to inventions

which develop as a result of cooperative research with scientists employed by Federal laboratories. SEC. 3. USE OF FEDERAL TECHNOLOGY.

Subparagraph (B) of section 11(e)(7) of the Stevenson-Wydler

Technology Innovation Act of 1980 (15 U.S.C. 3710(e)(7)(B)) is amended to read as follows:

"(B) A transfer shall be made by any Federal agency under

subparagraph (A), for any fiscal year, only if the amount so transferred by that agency (as determined under such subparagraph)

would exceed $10,000.". SEC. 4. TITLE TO INTELLECTUAL PROPERTY ARISING FROM COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENTS.

Subsection (b) of section 12 of the Stevenson-Wydler Technology

Innovation Act of 1980 (15 U.S.C. 3710a(b)) is amended to read

as follows:

"(b) Enumerated Authority.—(1) Under an agreement entered

into pursuant to subsection (a)(1), the laboratory may grant, or

Mar. 7. 1996

[H.R 2196]

National Technology

Transfer and Advancement Act

of 1995. 15 USC 3701

note. 15 USC 3701

note.

101
110 STAT. 776 PUBLIC LAW 104-113—MAR. 7, 1996

agree to grant in advance, to a collaborating party patent licenses or assignments, or options thereto, in any invention made in whole

or in part by a laboratory employee under the agreement, for reasonable compensation when appropriate. The laboratory shall ensure, through such agreement, that the collaborating party has

the option to choose an exclusive license for a pre-negotiated field of use for any such invention under the agreement or, if there

is more than one collaborating party, that the collaborating parties are offered the option to hold licensing rights that collectively

encompass the rights that would be held under such an exclusive

license by one party. In consideration for the Government's contribution under the agreement, grants under this paragraph shall be

subject to the following explicit conditions:

"(A) A nonexclusive, nontransferable, irrevocable, paid-up

license from the collaborating party to the laboratory to practice

the invention or have the invention practiced throughout the

Confidential world by or on behalf of the Government. In the exercise

information. 0f such license, the Government shall not publicly disclose

trade secrets or commercial or financial information that is privileged or confidential within the meaning of section

552(b)(4) of title 5, United States Code, or which would be

considered as such if it had been obtained from a non-Federal

party.

'(B) If a laboratory assigns title or grants an exclusive

license to such an invention, the Government shall retain the

right—

"(i) to require the collaborating party to grant to a

responsible applicant a nonexclusive, partially exclusive, or exclusive license to use the invention in the applicant's

licensed field of use, on terms that are reasonable under

the circumstances; or

"(ii) if the collaborating party fails to grant such a

license, to grant the license itself. "(C) The Government may exercise its right retained under

subparagraph (B) only in exceptional circumstances and only

if the Government determines that

"(i) the action is necessary to meet health or safety

needs that are not reasonably satisfied by the collaborating

party;

'(ii) the action is necessary to meet requirements for public use specified by Federal regulations, and such

requirements are not reasonably satisfied by the collaborating party; or

"(iii) the collaborating party has failed to comply with an agreement containing provisions described in subsection

(c)(4)(B). This determination is subject to administrative appeal and

judicial review under section 203(2) of title 35, United States

Code.

"(2) Under agreements entered into pursuant to subsection

(a)(1), the laboratory shall ensure that a collaborating party may

retain title to any invention made solely by its employee in exchange

for normally granting the Government a nonexclusive,

nontransferable, irrevocable, paid-up license to practice the invention or have the invention practiced throughout the world by or on behalf of the Government for research or other Government

purposes.

102
PUBLIC LAW 104-113—MAR. 7, 1996 110 STAT. 777

"(3) Under an agreement entered into pursuant to subsection

(a)(1), a laboratory may

"(A) accept, retain, and use funds, personnel, services, and

property from a collaborating party and provide personnel,

services, and property to a collaborating party;

"(B) use funds received from a collaborating party in accord- ance with subparagraph (A) to hire personnel to carry out

the agreement who will not be subject to full-time-equivalent

restrictions of the agency;

"(C) to the extent consistent with any applicable agency

requirements or standards of conduct, permit an employee or former employee of the laboratory to participate in an effort to commercialize an invention made by the employee or former

employee while in the employment or service of the Government; and

"(D) waive, subject to reservation by the Government of a nonexclusive, irrevocable, paid-up license to practice the

invention or have the invention practiced throughout the world

by or on behalf of the Government, in advance, in whole or

in part, any right of ownership which the Federal Government

may have to any subject invention made under the agreement

by a collaborating party or employee of a collaborating party.

"(4) A collaborating party in an exclusive license in any invention made under an agreement entered into pursuant to subsection

(a)(1) shall have the right of enforcement under chapter 29 of

title 35, United States Code.

"(5) A Government-owned, contractor-operated laboratory that

enters into a cooperative research and development agreement

pursuant to subsection (a)(1) may use or obligate royalties or other

income accruing to the laboratory under such agreement with

respect to any invention only

"(A) for payments to inventors;

"(B) for purposes described in clauses (i), (ii), (iii), and

(iv) of section 14(a)(1)(B); and

"(C) for scientific research and development consistent with

the research and development missions and objectives of the

laboratory.".

SEC. 5. DISTRIBUTION OF INCOME FROM INTELLECTUAL PROPERTY Royalties

RECEIVED BY FEDERAL LABORATORIES.

Section 14 of the Stevenson-Wydler Technology Innovation Act

of 1980 (15 U.S.C. 3710c) is amended—

(1) by amending subsection (a)(1) to read as follows:

or other payments received by a Federal agency from the licensing

and assignment of inventions under agreements entered into by

Federal laboratories under section 12, and from the licensing of inventions of Federal laboratories under section 207 of title 35,

United States Code, or under any other provision of law, shall be retained by the laboratory which produced the invention and

shall be disposed of as follows:

"(A)(i) The head of the agency or laboratory, or such individual's designee, shall pay each year the first $2,000, and thereafter at least 15 percent, of the royalties or other payments

to the inventor or coinventors.

"(ii) An agency or laboratory may provide appropriate

incentives, from royalties, or other payments, to laboratory

"(1) Except as provided

103
110 STAT. 778 PUBLIC LAW 104-113—MAR. 7, 1996

employees who are not an inventor of such inventions but

who substantially increased the technical value of such inventions.

"(iii) The agency or laboratory shall retain the royalties

and other payments received from an invention until the agency

or laboratory makes payments to employees of a laboratory

under clause (i) or (ii)

"(B) The balance of the royalties or other payments shall

be transferred by the agency to its laboratories, with the majority share of the royalties or other payments from any invention

going to the laboratory where the invention occurred. The royalties or other payments so transferred to any laboratory may

be used or obligated by that laboratory during the fiscal year

in which they are received or during the succeeding fiscal year

"(i) to reward scientific, engineering, and technical

employees of the laboratory, including developers of sensitive or classified technology, regardless of whether the

technology has commercial applications;

"(ii) to further scientific exchange among the laboratories of the agency;

"(iii) for education and training of employees consistent

with the research and development missions and objectives

of the agency or laboratory, and for other activities that

increase the potential for transfer of the technology of

the laboratories of the agency;

"(iv) for payment of expenses incidental to the administration and licensing of intellectual property by the agency

or laboratory with respect to inventions made at that lab- oratory, including the fees or other costs for the services

of other agencies, persons, or organizations for intellectual

property management and licensing services; or

"(v) for scientific research and development consistent

with the research and development missions and objectives

of the laboratory.

"(C) All royalties or other payments retained by the agency

or laboratory after payments have been made pursuant to subparagraphs (A) and (B) that is unobligated and unexpended

at the end of the second fiscal year succeeding the fiscal year

in which the royalties and other payments were received shall

be paid into the Treasury.";

(A) by inserting "or other payments" after "royalties";

and

(B) by striking "for the purposes described in clauses

(i) through (iv) of paragraph (1)(B) during that fiscal year

or the succeeding fiscal year" and inserting in lieu thereof

"under paragraph (1)(B)";

(3) in subsection (a)(3), by striking "$100,000" both places

it appears and inserting "$150,000";

(4) in subsection (a)(4)

(A) by striking "income" each place it appears and

inserting in lieu thereof "payments";

(B) by striking "the payment of royalties to inventors"

in the first sentence thereof and inserting in lieu thereof

"payments to inventors";

104
PUBLIC LAW 104-1 13—MAR. 7, 1996 110 STAT. 779

(C) by striking "clause (i) of paragraph (1)(B)" and

inserting in lieu thereof "clause (iv) of paragraph (1)(B)"; (D) by striking "payment of the royalties," in the second

sentence thereof and inserting in lieu thereof "offsetting

the payments to inventors,"; and

(E) by striking "clauses (i) through (iv) of; and

(5) by amending paragraph (1) of subsection (b) to read

as follows:

"(1) by a contractor, grantee, or participant, or an employee

of a contractor, grantee, or participant, in an agreement or other arrangement with the agency, or". SEC. 6. EMPLOYEE ACTIVITIES.

Section 15(a) of the Stevenson-Wydler Technology Innovation

Act of 1980 (15 U.S.C. 3710d(a)) is amended—

(1) by striking "the right of ownership to an invention

under this Act" and inserting in lieu thereof "ownership of or the right of ownership to an invention made by a Federal

employee '; and

(2) by inserting "obtain or" after "the Government, to". SEC. 7. AMENDMENT TO BAYH-DOLE ACT.

Section 210(e) of title 35, United States Code, is amended

by striking ", as amended by the Federal Technology Transfer

Act of 1986.". SEC. 8. NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY ACT

AMENDMENTS.

The National Institute of Standards and Technology Act (15

U.S.C. 271 et seq.) is amended

(1) in section 10(a)—

(A) by striking "nine" and inserting in lieu thereof

"15"; and

(B) by striking "five" and inserting in lieu thereof "10";

(2) in section 15

(A) by striking "Pay Act of 1945; and" and inserting

in lieu thereof "Pay Act of 1945;"; and

(B) by inserting "; and (h) the provision of transportation services for employees of the Institute between the

facilities of the Institute and nearby public transportation,

notwithstanding section 1344 of title 31, United States

Code" after "interests of the Government"; and

(3) in section 19

(A) by inserting ", subject to the availability of appropriations, ' after "post-doctoral fellowship program"; and

(B) by striking "nor more than forty" and inserting

in lieu thereof "nor more than 60". SEC. 9. RESEARCH EQUIPMENT.

Section 1 1 (i) of the Stevenson-Wydler Technology Innovation

Act of 1980 (15 U.S.C. 3710(i)) is amended by inserting "loan,

lease, or" before "give".

SEC. 10. PERSONNEL. 15 USC 275 note. The personnel management demonstration project established

under section 10 of the National Bureau of Standards Authorization

Act for Fiscal Year 1987 (15 U.S.C. 275 note) is extended indefinitely.

15 USC 278.

15 USC 278e.

15 USC 278g-2.

105
110 STAT. 780 PUBLIC LAW 104-113—MAR. 7. 1996

SEC. 11. FASTENER QUALITY ACT AMENDMENTS.

(a) Section 2 Amendments—Section 2 of the Fastener Quality

Act (15 U.S.C. 5401) is amended—

(1) by striking subsection (a)(4), and redesignating paragraphs (5) through (9) as paragraphs (4) through (8), respectively;

(2) in subsection (a)(7), as so redesignated by paragraph

(1) of this subsection, by striking "by lot number"; and

(3) in subsection (b), by striking "used in critical applications" and inserting in lieu thereof "in commerce".

(b) Section 3 Amendments.—Section 3 of the Fastener Quality

Act (15 U.S.C. 5402) is amended—

(1) in paragraph (1)(B) by striking "having a minimum

tensile strength of 150,000 pounds per square inch";

(2) in paragraph (2), by inserting "consensus" after "or any other";

(3) in paragraph (5)

(A) by inserting "or" after "standard or specification,"

in subparagraph (B); (B) by striking "or" at the end of subparagraph (C); (C) by striking subparagraph (D); and

(D) by inserting "or produced in accordance with ASTM

F 432" after "307 Grade A";

(4) in paragraph (6) by striking "other person" and inserting

in lieu thereof "government agency";

(5) in paragraph (8) by striking "Standard" and inserting

in lieu thereof "Standards";

(6) by striking paragraph (11) and redesignating paragraphs (12) through (15) as paragraphs (11) through (14), respectively;

(7) in paragraph (13), as so redesignated by paragraph

(6) of this subsection, by striking ", a government agency"

and all that follows through "markings of any fastener" and

inserting in lieu thereof "or a government agency"; and

(8) in paragraph (14), as so redesignated by paragraph

(6) of this subsection, by inserting "for the purpose of achieving a uniform hardness" after "quenching and tempering".

(c) Section 4 Repeal.—Section 4 of the Fastener Quality Act

(15 U.S.C. 5403) is repealed.

(d) Section 5 Amendments.—Section 5 of the Fastener Quality

Act (15 U.S.C. 5404) is amended—

(1) in subsection (a)(1)(B) and (2)(A)(i) by striking "subsections (b) and (c)" and inserting in lieu thereof "subsections

(b), (c), and (d)";

(2) in subsection (c)(2) by striking "or, where applicable"

and all that follows through "section 7(c)(1)";

(3) in subsection (c)(3) by striking ", such as the chemical,

dimensional, physical, mechanical, and any other";

(4) in subsection (c)(4) by inserting "except as provided

in subsection (d)," before "state whether"; and

(5) by adding at the end the following new subsection:

"(d) Alternative Procedure for Chemical Characteristics.—Notwithstanding the requirements of subsections (b) and

(c), a manufacturer shall be deemed to have demonstrated, for purposes of subsection (a)(1), that the chemical characteristics of a lot conform to the standards and specifications to which the

106
PUBLIC LAW 104-113—MAR. 7, 1996 110 STAT. 781

manufacturer represents such lot has been manufactured if the

following requirements are met:

"(1) The coil or heat number of metal from which such

lot was fabricated has been inspected and tested with respect

to its chemical characteristics by a laboratory accredited in accordance with the procedures and conditions specified by

the Secretary under section 6. "(2) Such laboratory has provided to the manufacturer, Reports, either directly or through the metal manufacturer, a written Regulations,

inspection and testing report, which shall be in a form pre- scribed by the Secretary by regulation, listing the chemical

characteristics of such coil or heat number.

"(3) The report described in paragraph (2) indicates that

the chemical characteristics of such coil or heat number conform

to those required by the standards and specifications to which

the manufacturer represents such lot has been manufactured.

"(4) The manufacturer demonstrates that such lot has been

fabricated from the coil or heat number of metal to which

the report described in paragraphs (2) and (3) relates. In prescribing the form of report required by subsection (c), the

Secretary shall provide for an alternative to the statement required

by subsection (c)(4), insofar as such statement pertains to chemical

characteristics, for cases in which a manufacturer elects to use

the procedure permitted by this subsection.".

(e) Section 6 Amendment.—Section 6(a)(1) of the Fastener

Quality Act (15 U.S.C. 5405(a)(1)) is amended by striking "Within

180 days after the date of enactment of this Act, the" and inserting

in lieu thereof 'The".

(f) Section 7 Amendments.—Section 7 of the Fastener Quality

Act (15 U.S.C. 5406) is amended—

(1) by amending subsection (a) to read as follows:

"(a) Domestically Produced Fasteners.—It shall be unlawful

for a manufacturer to sell any shipment of fasteners covered by

this Act which are manufactured in the United States unless the

fasteners

"(1) have been manufactured according to the requirements

of the applicable standards and specifications and have been

inspected and tested by a laboratory accredited in accordance

with the procedures and conditions specified by the Secretary

under section 6; and

"(2) an original laboratory testing report described in sec- tion 5(c) and a manufacturer's certificate of conformance are on file with the manufacturer, or under such custody as may

be prescribed by the Secretary, and available for inspection.'

;

(2) in subsection (c)(2) by inserting "to the same" after

"in the same manner and";

(3) in subsection (d)(1) by striking "certificate" and inserting

in lieu thereof "test report"; and

(4) by striking subsections (e), (f), and (g) and inserting

in lieu thereof the following:

"(e) Commingling.—It shall be unlawful for any manufacturer,

importer, or private label distributor to commingle like fasteners

from different lots in the same container, except that such manufacturer, importer, or private label distributor may commingle like fasteners of the same type, grade, and dimension from not more

than two tested and certified lots in the same container during

repackaging and plating operations. Any container which contains

107
110 STAT. 782 PUBLIC LAW 104-113—MAR. 7, 1996

fasteners from two lots shall be conspicuously marked with the

lot identification numbers of both lots.

"(f) Subsequent Purchaser.—If a person who purchases fas- teners for any purpose so requests either prior to the sale or

at the time of sale, the seller shall conspicuously mark the container

of the fasteners with the lot number from which such fasteners were taken.".

(g) Section 9 Amendment.—Section 9 of the Fastener Quality

Act (15 U.S.C. 5408) is amended by adding at the end the following new subsection:

"(d) Enforcement.—The Secretary may designate officers or employees of the Department of Commerce to conduct investigations

pursuant to this Act. In conducting such investigations, those offi- cers or employees may, to the extent necessary or appropriate

to the enforcement of this Act, exercise such authorities as are

conferred upon them by other laws of the United States, subject

to policies and procedures approved by the Attorney General.".

(h) Section 10 Amendments.—Section 10 of the Fastener Quality Act (15 U.S.C. 5409) is amended—

(1) in subsections (a) and (b), by striking "10 years" and

(2) in subsection (b), by striking "any subsequent" and

inserting in lieu thereof "the subsequent".

(i) Section 13 Amendment.—Section 13 of the Fastener Quality

Act (15 U.S.C. 5412) is amended by striking "within 180 days

after the date of enactment of this Act".

(j) Section 14 Repeal.—Section 14 of the Fastener Quality

Act (15 U.S.C. 5413) is repealed. SEC. 12. STANDARDS CONFORMITY.

(a) Use of Standards.—Section 2(b) of the National Institute

of Standards and Technology Act (15 U.S.C. 272(b)) is amended

(1) in paragraph (2), by striking ", including comparing

standards" and all that follows through "Federal Government'

(2) by redesignating paragraphs (3) through (11) as paragraphs (4) through (12), respectively; and

(3) by inserting after paragraph (2) the following new paragraph:

"(3) to compare standards used in scientific investigations,

engineering, manufacturing, commerce, industry, and educational institutions with the standards adopted or recognized

by the Federal Government and to coordinate the use by Federal agencies of private sector standards, emphasizing where

possible the use of standards developed by private, consensus

organizations;".

(b) Conformity Assessment Activities.—Section 2(b) of the

National Institute of Standards and Technology Act (15 U.S.C.

272(b)) is amended

(1) by striking "and" at the end of paragraph (11), as

so redesignated by subsection (a)(2) of this section;

(2) by striking the period at the end of paragraph (12), as so redesignated by subsection (a)(2) of this section, and

inserting in lieu thereof "; and"; and

(3) by adding at the end the following new paragraph:

"(13) to coordinate Federal, State, and local technical standards activities and conformity assessment activities, with pri- vate sector technical standards activities and conformity assess108
PUBLIC LAW 104-113—MAR. 7, 1996 110 STAT. 783

ment activities, with the goal of eliminating unnecessary

duplication and complexity in the development and promulgation of conformity assessment requirements and measures.".

(c) Transmittal of Plan to Congress.—The National 1 5 use 272 note. Institute of Standards and Technology shall, within 90 days after the date of enactment of this Act, transmit to the Congress a plan for implementing the amendments made by this section.

(d) Utilization of Consensus Technical Standards by Fed- 15 use 272 note. eral Agencies; Reports.—

(1) In general.—Except as provided in paragraph (3) of

this subsection, all Federal agencies and departments shall use technical standards that are developed or adopted by vol- untary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.

(2) Consultation; participation.—In carrying out para- graph (1) of this subsection, Federal agencies and departments

shall consult with voluntary, private sector, consensus standards bodies and shall, when such participation is in the public

interest and is compatible with agency and departmental missions, authorities, priorities, and budget resources, participate

with such bodies in the development of technical standards.

(3) EXCEPTION.—If compliance with paragraph (1) of this subsection is inconsistent with applicable law or otherwise

impractical, a Federal agency or department may elect to use

technical standards that are not developed or adopted by vol- untary consensus standards bodies if the head of each such

agency or department transmits to the Office of Management

and Budget an explanation of the reasons for using such standards. Each year, beginning with fiscal year 1997, the Office

of Management and Budget shall transmit to Congress and

its committees a report summarizing all explanations received

in the preceding year under this paragraph.

(4) Definition of technical standards.—As used in this

subsection, the term "technical standards" means performancebased or design-specific technical specifications and related

management systems practices.

SEC. 13. SENSE OF CONGRESS.

It is the sense of the Congress that the Malcolm Baldrige

National Quality Award program offers substantial benefits to

109
110 STAT. 784 PUBLIC LAW 104-113—MAR. 7. 1996

United States industry, and that all funds appropriated for such

program should be spent in support of the goals of the program.

Approved March 7, 1996.

LEGISLATIVE HISTORY—H.R. 2196: HOUSE REPORTS: No. 104-390 (Comm. on Science). CONGRESSIONAL RECORD:

Vol. 141 (1995): Dec. 12, considered and passed House.

Vol. 142 (1996): Feb. 7, considered and passed Senate, amended.

Feb. 27, House concurred in Senate amendments.

o

110
IV. OMB Circular A-119 (Text Only)

OMB Home

February 10, 1998

CIRCULAR NO. A-119

Revised

MEMORANDUM FOR HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES

SUBJECT:

Federal Participation in the Development and Use of Voluntary Consensus

Standards and in Conformity Assessment Activities

Revised OMB CircularA- 1 19 establishes policies on Federal use and development of

voluntary consensus standards and on conformity assessment activities. Pub. L. 104-113,

the "National Technology Transfer and Advancement Act of 1995," codified existing

policies in A-119, established reporting requirements, and authorized the National

Institute of Standards and Technology to coordinate conformity assessment activities of

the agencies. OMB is issuing this revision of the Circular in order to make the

terminology of the Circular consistent with the National Technology Transfer and

Advancement Act of 1995, to issue guidance to the agencies on making their reports to OMB, to direct the Secretary of Commerce to issue policy guidance for conformity

assessment, and to make changes for clarity.

Franklin D. Raines

Circular No. A-119

Revised

(Accompanying Federal Register Materials - 2/10/98)

TO THE HEADS OF EXECUTIVE DEPARTMENTS AND ESTABLISHMENTS

ill
SUBJECT: Federal Participation in the Development and Use of Voluntary Consensus

Standards and in Conformity Assessment Activities

TABLE OF CONTENTS

BACKGROUND

1

What Is The Purpose Of This Circular?

2. What Are The Goals Of The Government Using Voluntary Consensus Standards?

DEFINITIONS OF STANDARDS

3. What Is A Standard?

4. What Are Voluntary, Consensus Standards?

a. Definition of voluntary, consensus standard.

(1) Definition of voluntary, consensus standards body.

b. Other types of standards.

(1) Non-consensus standards, industry standards, company standards, or de facto standards.

(2) Government-unique standards.

(3) Standards mandated by law.

POLICY

5. Who Does This Policy Apply To?

6. What Is The Policy For Federal Use Of Standards?

a. When must my agency use voluntary consensus standards?

(1) Definition of "Use."

(2) Definition of "Impractical."

b. What must my agency do when such use is determined by my agency to be

inconsistent with applicable law or otherwise impractical?

c. How does this policy affect my agency's regulatory authorities and

responsibilities?

d. How does this policy affect my agency's procurement authority?

e. What are the goals of agency use of voluntary consensus standards?

f. What considerations should my agency make when it is considering using a standard?

g. Does this policy establish a preference between consensus and non-consensus

standards that are developed in the private sector?

h. Does this policy establish a preference between domestic and international

voluntary consensus standards?

i. Should my agency give preference to performance standards?

j. How should my agency reference voluntary consensus standards?

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k. What if no voluntary consensus standard exists?

1. How may my agency identify voluntary consensus standards?

7. What Is The Policy For Federal Participation In Voluntary Consensus Standards

Bodies?

a. What are the purposes of agency participation?

b. What are the general principles that apply to agency support?

c. What forms of support may my agency provide?

d. Must agency participants be authorized?

e. Does agency participation indicate endorsement of any decisions reached by

voluntary consensus standards bodies?

f. Do agency representatives participate equally with other members?

g. Are there any limitations on participation by agency representatives?

h. Are there any limits on the number of federal participants in voluntary consensus standards bodies?

i. Is there anything else agency representatives should know?

j. What if a voluntary consensus standards body is likely to develop an acceptable,

needed standard in a timely fashion?

8. What Is The Policy On Conformity Assessment?

MANAGEMENT AND REPORTING OF STANDARDS USE

9. What Is My Agency Required To Report?

10. How Does My Agency Manage And Report On Its Development and Use Of

Standards?

11. What Are The Procedures For Reporting My Agency's Use Of Standards In Regulations?

12. What Are The Procedures For Reporting My Agency's Use Of Standards In Procurements?

a. How does my agency report the use of standards in procurements on a

categorical basis?

b. How does my agency report the use of standards in procurements on a

transaction basis?

AGENCY RESPONSIBILITIES

13. What Are The Responsibilities Of The Secretary Of Commerce?

14. What Are The Responsibilities Of The Heads Of Agencies?

15. What Are The Responsibilities Of Agency Standards Executives?

SUPPLEMENTARY INFORMATION

16. When Will This Circular Be Reviewed?

17. What Is The Legal Effect Of This Circular?

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18. Do You Have Further Questions?

BACKGROUND

1. What Is The Purpose Of This Circular?

This Circular establishes policies to improve the internal management of the Executive

Branch. Consistent with Section 12(d) of P.L. 104-113, the "National Technology

Transfer and Advancement Act of 1995" (hereinafter "the Act"), this Circular directs

agencies to use voluntary consensus standards in lieu of government-unique standards

except where inconsistent with law or otherwise impractical. It also provides guidance for

agencies participating in voluntary consensus standards bodies and describes procedures

for satisfying the reporting requirements in the Act. The policies in this Circular are intended to reduce to a minimum the reliance by agencies on government-unique

standards. These policies do not create the bases for discrimination in agency

procurement or regulatory activities among standards developed in the private sector,

whether or not they are developed by voluntary consensus standards bodies. Consistent

with Section 12(b) of the Act, this Circular directs the Secretary of Commerce to issue

guidance to the agencies in order to coordinate conformity assessment activities. This

Circular replaces OMB Circular No. A-119, dated October 20, 1993.

2. What Are The Goals Of The Government In Using Voluntary Consensus

Standards?

Many voluntary consensus standards are appropriate or adaptable for the Government's

purposes. The use of such standards, whenever practicable and appropriate, is intended to achieve the following goals:

a. Eliminate the cost to the Government of developing its own standards and decrease the

cost of goods procured and the burden of complying with agency regulation.

b. Provide incentives and opportunities to establish standards that serve national needs.

c. Encourage long-term growth for U.S. enterprises andpromote efficiency and economic

competition through harmonization of standards.

d. Further the policy of reliance upon the private sector to supply Government needs for

goods and services.

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WHAT DEFINITIONS OF STANDARDS

3. What Is A Standard?

a. The term "standard," or "technical standard" as cited in the Act, includes all of the

following:

(1) Common and repeated use of rules, conditions,guidelines or characteristics for

products or related processes and production methods, and related management systems

practices.

(2) The definition of terms; classification of components; delineation of procedures;

specification of dimensions, materials, performance, designs, or operations; measurement

of quality and quantity in describing materials, processes, products, systems, services, or

practices; test methods and sampling procedures; or descriptions of fit and measurements

of size or strength.

b. The term "standard" does not include the following:

(1) Professional standards of personal conduct.

(2) Institutional codes of ethics.

c. "Performance standard" is a standard as defined above that states requirements in terms

of required results with criteria for verifying compliance but without stating the methods

for achieving required results. A performance standard may define the functional

requirements for the item, operational requirements, and/or interface and

interchangeability characteristics. A performance standard may be viewed in

juxtaposition to a prescriptive standard which may specify design requirements, such as materials to be used, how a requirement is to be achieved, or how an item is to be

fabricated or constructed.

d. "Non-government standard" is a standard as defined above that is in the form of a standardization document developed by a private sector association, organization or

technical society which plans, develops, establishes or coordinates standards,

specifications, handbooks, or related documents.

4. What Are Voluntary, Consensus Standards?

a. For purposes of this policy, "voluntary consensus standards" are standards developed

or adopted by voluntary consensus standards bodies, both domestic and international.

These standards include provisions requiring that owners of relevant intellectual property

have agreed to make that intellectual property available on a non-discriminatory, royaltyfree or reasonable royalty basis to all interested parties. For purposes of this Circular,

"technical standards that are developed or adopted by voluntary consensus standard

bodies" is an equivalent term.

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(1) "Voluntary consensus standards bodies" are domestic or international organizations

which plan, develop, establish, or coordinate voluntary consensus standards using agreedupon procedures. For purposes of this Circular, "voluntary, private sector, consensus

standards bodies," as cited in Act, is an equivalent term. The Act and the Circular

encourage the participation of federal representatives in these bodies to increase the

likelihood that the standards they develop will meet both public and private sector needs.

A voluntary consensus standards body is defined by the following attributes:

(i) Openness.

(ii) Balance of interest.

(iii) Due process.

(vi) An appeals process.

(v) Consensus, which is defined as general agreement, but not necessarily unanimity, and

includes a process for attempting to resolve objections by interested parties, as long as all comments have been fairly considered, each objector is advised of the disposition of his or her objection(s) and the reasons why, and the consensus body members are given an

opportunity to change their votes after reviewing the comments.

b. Other types of standards, which are distinct from voluntary consensus standards, are the

following:

(1) "Non-consensus standards," "Industry standards," "Company standards," or "de facto

standards," which are developed in the private sector but not in the full consensus

process.

(2) "Government-unique standards," which are developed by the government for its own

uses.

(3) Standards mandated by law, such as those contained in the United States

Pharmacopeia and the National Formulary, as referenced in 21 U.S.C. 351.

POLICY

5. Who Does This Policy Apply To?

This Circular applies to all agencies and agency employees who use standards and

participate in voluntary consensus standards activities, domestic and international, except

for activities carried out pursuant to treaties. "Agency" means any executive 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

insofar as they are subject to separate statutory requirements regarding the use of

voluntary consensus standards. It does not include the legislative or judicial branches of

the Federal Government.

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6. What Is The Policy For Federal Use Of Standards?

All federal agencies must use voluntary consensus standards in lieu of governmentunique standards in their procurement and regulatory activities, except where inconsistent

with law or otherwise impractical. In these circumstances, your agency must submit a

report describing the reason(s) for its use of government-unique standards in lieu of

voluntary consensus standards to the Office of Management and Budget (OMB) through

the National Institute of Standards and Technology (NIST).

a. When must my agency use voluntary consensus standards?

Your agency must use voluntary consensus standards, both domestic and international, in

its regulatory and procurement activities in lieu of government-unique standards, unless use of such standards would be inconsistent with applicable law or otherwise impractical.

In all cases, your agency has the discretion to decline to use existing voluntary consensus

standards if your agency determines that such standards are inconsistent with applicable

law or otherwise impractical.

(1) "Use" means incorporation of a standard in whole, in part, or by reference for

procurement purposes, and the inclusion of a standard in whole, in part, or by reference

in regulation(s).

(2) "Impractical" includes circumstances in which such use would fail to serve the

agency's program needs; would be infeasible; would be inadequate, ineffectual,

inefficient, or inconsistent with agency mission; or would impose more burdens, or would

be less useful, than the use of another standard.

b. What must my agency do when such use is determined by my agency to be

inconsistent with applicable law or otherwise impractical?

The head of your agency must transmit to the Office of Management and Budget (OMB),

through the National Institute of Standards and Technology (NIST), an explanation of the

reason(s) for using government-unique standards in lieu of voluntary consensus

standards. For more information on reporting, see section 9.

c. How does this policy affect my agency's regulatory authorities and

responsibilities?

This policy does not preempt or restrict agencies' authorities and responsibilities to make

regulatory decisions authorized by statute. Such regulatory authorities and responsibilities

include determining the level of acceptable risk; setting the level of protection; and

balancing risk, cost, and availability of technology in establishing regulatory standards.

However, to determine whether established regulatory limits or targets have been met,

agencies should use voluntary consensus standards for test methods, sampling procedures,

or protocols.

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d. How does this policy affect my agency's procurement authority?

This policy does not preempt or restrict agencies' authorities and responsibilities to identify the capabilities that they need to obtain through procurements. Rather, this policy

limits an agency's authority to pursue an identified capability through reliance on a government-unique standard when a voluntary consensus standard exists (see Section 6a).

e. What are the goals of agency use of voluntary consensus standards?

Agencies should recognize the positive contribution of standards development and related

activities. When properly conducted, standards development can increase productivity

and efficiency in Government and industry, expand opportunities for international trade, conserve resources, improve health and safety, and protect the environment.

f. What considerations should my agency make when it is considering using a standard?

When considering using a standard, your agency should take full account of the effect of

using the standard on the economy, and of applicable federal laws and policies, including

laws and regulations relating to antitrust, national security, small business, product safety,

environment, metrication, technology development, and conflicts of interest. Your

agency should also recognize that use of standards, if improperly conducted, can suppress

free and fair competition; impede innovation and technical progress; exclude safer or less

expensive products; or otherwise adversely affect trade, commerce, health, or safety. If your agency is proposing to incorporate a standard into a proposed or final rulemaking,

your agency must comply with the "Principles of Regulation" (enumerated in Section 1(b))

and with the other analytical requirements of Executive Order 12866, "Regulatory

Planning and Review."

g. Does this policy establish a preference between consensus and non-consensus

standards that are developed in the private sector?

This policy does not establish a preference among standards developed in the private

sector. Specifically, agencies that promulgate regulations referencing non-consensus

standards developed in the private sector are not required to report on these actions, and

agencies that procure products or services based on non-consensus standards are not

required to report on such procurements. For example, this policy allows agencies to select a non-consensus standard developed in the private sector as a means of establishing

testing methods in a regulation and to choose among commercial-off-the-shelf products,

regardless of whether the underlying standards are developed by voluntary consensus

standards bodies or not.

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h. Does this policy establish a preference between domestic and international

voluntary consensus standards?

This policy does not establish a preference between domestic and international voluntary consensus standards. However, in the interests of promoting trade and implementing the

provisions of international treaty agreements, your agency should consider international

standards in procurement and regulatory applications.

i. Should my agency give preference to performance standards?

In using voluntary consensus standards, your agency should give preference to performance standards when such standards may reasonably be used in lieu of

prescriptive standards.

j. How should my agency reference voluntary consensus standards?

Your agency should reference voluntary consensus standards, along with sources of

availability, in appropriate publications, regulatory orders, and related internal

documents. In regulations, the reference must include the date of issuance. For all other

uses, your agency must determine the most appropriate form of reference, which may

exclude the date of issuance as long as users are elsewhere directed to the latest issue. If a voluntary standard is used and published in an agency document, your agency must

observe and protect the rights of the copyright holder and any other similar obligations.

k. What if no voluntary consensus standard exists?

In cases where no voluntary consensus standards exist, an agency may use governmentunique standards (in addition to other standards, see Section 6g) and is not required to file a report on its use of government-unique standards. As explained above (see Section 6a), an agency may use government-unique standards in lieu of voluntary consensus standards

if the use of such standards would be inconsistent with applicable law or otherwise

impractical; in such cases, the agency must file a report under Section 9a regarding its use

of government-unique standards.

1. How may my agency identify voluntary consensus standards?

Your agency may identify voluntary consensus standards through databases of standards

maintained by the National Institute of Standards and Technology (NIST), or by other

organizations including voluntary consensus standards bodies, other federal agencies, or standards publishing companies.

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7. What Is The Policy For Federal Participation In Voluntary Consensus Standards

Bodies?

Agencies must consult with voluntary consensus standards bodies, both domestic and

international, and must participate with such bodies in the development of voluntary consensus standards when consultation and participation is in the public interest and is compatible with their missions, authorities, priorities, and budget resources.

a. What are the purposes of agency participation?

Agency representatives should participate in voluntary consensus standards activities in

order to accomplish the following purposes:

(1) Eliminate the necessity for development or maintenance of separate Governmentunique standards.

(2) Further such national goals and objectives as increased use of the metric system of

measurement; use of environmentally sound and energy efficient materials, products,

systems, services, or practices; and improvement of public health and safety.

b. What are the general principles that apply to agency support?

Agency support provided to a voluntary consensus standards activity must be limited to that which clearly furthers agency and departmental missions, authorities, priorities, and

is consistent with budget resources. Agency support must not be contingent upon the

outcome of the standards activity. Normally, the total amount of federal support should

be no greater than that of other participants in that activity, except when it is in the direct

and predominant interest of the Government to develop or revise a standard, and its timely development or revision appears unlikely in the absence of such support.

c. What forms of support may my agency provide?

The form of agency support, may include the following:

(1) Direct financial support; e.g., grants, memberships, and contracts.

(2) Administrative support; e.g., travel costs, hosting of meetings, and secretarial

functions.

(3) Technical support; e.g., cooperative testing for standards evaluation and participation

of agency personnel in the activities of voluntary consensus standards bodies.

(4) Joint planning with voluntary consensus standards bodies to promote the

identification and development of needed standards.

(5) Participation of agency personnel.

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d. Must agency participants be authorized?

Agency employees who, at Government expense, participate in standards activities of

voluntary consensus standards bodies on behalf of the agency must do so as specifically

authorized agency representatives. Agency support for, and participation by agency

personnel in, voluntary consensus standards bodies must be in compliance with

applicable laws and regulations. For example, agency support is subject to legal and

budgetary authority and availability of funds. Similarly, participation by agency

employees (whether or not on behalf of the agency) in the activities of voluntary consensus standards bodies is subject to the laws and regulations that apply to participation by federal employees in the activities of outside organizations. While we

anticipate that participation in a committee that is developing a standard would generally

not raise significant issues, participation as an officer, director, or trustee of an

organization would raise more significant issues. An agency should involve its agency

ethics officer, as appropriate, before authorizing support for or participation in a voluntary consensus standards body.

e. Does agency participation indicate endorsement of any decisions reached by

voluntary consensus standards bodies?

Agency participation in voluntary consensus standards bodies does not necessarily

connote agency agreement with, or endorsement of, decisions reached by such

organizations.

f. Do agency representatives participate equally with other members?

Agency representatives serving as members of voluntary consensus standards bodies

should participate actively and on an equal basis with other members, consistent with the

procedures of those bodies, particularly in matters such as establishing priorities,

developing procedures for preparing, reviewing, and approving standards, and developing

or adopting new standards. Active participation includes full involvement in discussions

and technical debates, registering of opinions and, if selected, serving as chairpersons or

in other official capacities. Agency representatives may vote, in accordance with the

procedures of the voluntary consensus standards body, at each stage of the standards

development process unless prohibited from doing so by law or their agencies.

g. Are there any limitations on participation by agency representatives?

In order to maintain the independence of voluntary consensus standards bodies, agency

representatives must refrain from involvement in the internal management of such

organizations (e.g., selection of salaried officers and employees, establishment of staff

salaries, and administrative policies). Agency representatives must not dominate such

bodies, and in any case are bound by voluntary consensus standards bodies' rules and

procedures, including those regarding domination of proceedings by any individual.

Regardless, such agency employees must avoid the practice or the appearance of undue

influence relating to their agency representation and activities in voluntary consensus

standards bodies.

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h. Are there any limits on the number of federal participants in voluntary consensus standards bodies?

The number of individual agency participants in a given voluntary standards activity

should be kept to the minimum required for effective representation of the various

program, technical, or other concerns of federal agencies.

i. Is there anything else agency representatives should know?

This Circular does not provide guidance concerning the internal operating procedures that

may be applicable to voluntary consensus standards bodies because of their relationships

to agencies under this Circular. Agencies should, however, carefully consider what laws

or rules may apply in a particular instance because of these relationships. For example,

these relationships may involve the Federal Advisory Committee Act, as amended

(5 U.S.C. App. I), or a provision of an authorizing statute for a particular agency.

j. What if a voluntary consensus standards body is likely to develop an acceptable,

needed standard in a timely fashion?

If a voluntary consensus standards body is in the process of developing or adopting a voluntary consensus standard that would likely be lawful and practical for an agency to use, and would likely be developed or adopted on a timely basis, an agency should not be

developing its own government-unique standard and instead should be participating in

the activities of the voluntary consensus standards body.

8. What Is The Policy On Conformity Assessment?

Section 12(b) of the Act requires NIST to coordinate Federal, State, and local standards

activities and conformity assessment activities with private sector 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 ensure effective coordination, the Secretary of Commerce

must issue guidance to the agencies.

MANAGEMENT AND REPORTING OF STANDARDS USE

9. What Is My Agency Required to Report?

a. As required by the Act, your agency must report to NIST, no later than December 3

of each year, the decisions by your agency in the previous fiscal year to use governmentunique standards in lieu of voluntary consensus standards. If no voluntary consensus

standard exists, your agency does not need to report its use of government-unique

standards. (In addition, an agency is not required to report on its use of other standards.

See Section 6g.) Your agency must include an explanation of the reason(s) why use of

such voluntary consensus standard would be inconsistent with applicable law or otherwise impractical, as described in Sections llb(2), 12a(3), and 12b(2) of this

Circular. Your agency must report in accordance with format instructions issued by NIST.

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b. Your agency must report to NIST, no later than December 31 of each year, information on the nature and extent of agency participation in the development and use of voluntary consensus standards from the previous fiscal year. Your agency must report in

accordance with format instructions issued by NIST. Such reporting must include the

following:

(1) The number of voluntary consensus standards bodies in which there is agency

participation, as well as the number of agency employees participating.

(2) The number of voluntary consensus standards the agency has used since the last report, based on the procedures set forth in sections 1 1 and 12 of this Circular.

(3) Identification of voluntary consensus standards that have been substituted for

government-unique standards as a result of an agency review under section 15b(7) of this

Circular.

(4) An evaluation of the effectiveness of this policy and recommendations for any

changes.

c. No later than the following January 3 1

, NIST must transmit to OMB a summary report

of the information received.

10. How Does My Agency Manage And Report Its Development and Use Of

Standards?

Your agency must establish a process to identify, manage, and review your agency's

development and use of standards. At minimum, your agency must have the ability to

(1) report to OMB through NIST on the agency's use of government-unique standards in

lieu of voluntary consensus standards, along with an explanation of the reasons for such

non-usage, as described in section 9a, and (2) report on your agency's participation in the

development and use of voluntary consensus standards, as described in section 9b. This

policy establishes two ways, category based reporting and transaction based reporting, for

agencies to manage and report their use of standards. Your agency must report all uses of

standards in one or both ways.

11. What Are The Procedures For Reporting My Agency's Use Of Standards In

Regulations?

Your agency should use transaction based reporting if your agency issues regulations that use or reference standards. If your agency is issuing or revising a regulation that contains

a standard, your agency must follow these procedures:

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a. Publish a request for comment within the preamble of a Notice of Proposed

Rulemaking (NPRM) or Interim Final Rule (IFR). Such request must provide the

appropriate information, as follows:

(1) When your agency is proposing to use a voluntary consensus standard, provide a statement which identifies such standard.

(2) When your agency is proposing to use a government-unique standard in lieu of a voluntary consensus standard, provide a statement which identifies such standards and

provides a preliminary explanation for the proposed use of a government-unique standard

in lieu of a voluntary consensus standard.

(3) When your agency is proposing to use a government-unique standard, and no

voluntary consensus standard has been identified, a statement to that effect and an

invitation to identify any such standard and to explain why such standard should be used.

b. Publish a discussion in the preamble of a Final Rulemaking that restates the statement

in the NPRM or IFR, acknowledges and summarizes any comments received and

responds to them, and explains the agency's final decision. This discussion must provide

the appropriate information, as follows:

(1) When a voluntary consensus standard is being used, provide a statement that

identifies such standard and any alternative voluntary consensus standards which have

been identified.

(2) When a government-unique standard is being used in lieu of a voluntary consensus

standard, provide a statement that identifies the standards and explains why using the

voluntary consensus standard would be inconsistent with applicable law or otherwise

impractical. Such explanation must be transmitted in accordance with the requirements of

Section 9a.

(3) When a government-unique standard is being used, and no voluntary consensus

standard has been identified, provide a statement to that effect.

12. What Are The Procedures For Reporting My Agency's Use Of Standards In

Procurements?

To identify, manage, and review the standards used in your agency's procurements, your

agency must either report on a categorical basis or on a transaction basis.

a. How does my agency report the use of standards in procurements on a categorical

basis?

Your agency must report on a category basis when your agency identifies, manages, and

reviews the use of standards by group or category. Category based reporting is especially

useful when your agency either conducts large procurements or large numbers of

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procurements using government-unique standards, or is involved in long-term

procurement contracts which require replacement parts based on government-unique

standards. To report use of government-unique standards on a categorical basis, your

agency must:

( 1

) Maintain a centralized standards management system that identifies how your agency

uses both government-unique and voluntary consensus standards.

(2) Systematically review your agency's use of government-unique standards for

conversion to voluntary consensus standards.

(3) Maintain records on the groups or categories in which your agency uses governmentunique standards in lieu of voluntary consensus standards, including an explanation of the reasons for such use, which must be transmitted according to Section 9a.

(4) Enable potential offerors to suggest voluntary consensus standards that can replace

government-unique standards.

b. How does my agency report the use of standards in procurements on a transaction

basis?

Your agency should report on a transaction basis when your agency identifies, manages,

and reviews the use of standards on a transaction basis rather than a category basis.

Transaction based reporting is especially useful when your agency conducts procurement

mostly through commercial products and services, but is occasionally involved in a procurement involving government-unique standards. To report use of governmentunique standards on a transaction basis, your agency must follow the following

procedures:

(1) In each solicitation which references government-unique standards, the solicitation

must:

(1) Identify such standards.

(ii) Provide potential offerors an opportunity to suggest alternative voluntary consensus

standards that meet the agency's requirements.

(2) If such suggestions are made and the agency decides to use government-unique

standards in lieu of voluntary consensus standards, the agency must explain in its report

to OMB as described in Section 9a why using such voluntary consensus standards is inconsistent with applicable law or otherwise impractical.

c. For those solicitations that are for commercial-off-the-shelf products (COTS), or for

products or services that rely on voluntary consensus standards or non-consensus

standards developed in the private sector, or for products that otherwise do not rely on

government-unique standards, the requirements in this section do not apply.

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AGENCY RESPONSIBILITIES

13. What Are The Responsibilities Of The Secretary Of Commerce?

The Secretary of Commerce:

a. Coordinates and fosters executive branch implementation of this Circular and, as appropriate, provides administrative guidance to assist agencies in implementing this

Circular including guidance on identifying voluntary consensus standards bodies and

voluntary consensus standards.

b. Sponsors and supports the Interagency Committee on Standards Policy (ICSP), chaired

by the National Institute of Standards and Technology, which considers agency views

and advises the Secretary and agency heads on the Circular.

c. Reports to the Director of OMB concerning the implementation of the policy

provisions of this Circular.

d. Establishes procedures for agencies to use when developing directories described in

Section 15b(5) and establish procedures to make these directories available to the public.

e. Issues guidance to the agencies to improve coordination on conformity assessment in

accordance with section 8.

14. What Are The Responsibilities Of The Heads Of Agencies?

The Heads of Agencies:

a. Implement the policies of this Circular in accordance with procedures described.

b. Ensure agency compliance with the policies of the Circular.

c. In the case of an agency with significant interest in the use of standards, designate a

senior level official as the Standards Executive who will be responsible for the agency's

implementation of this Circular and who will represent the agency on the ICSP.

d. Transmit the annual report prepared by the Agency Standards Executive as described

in Sections 9 and 15b(6).

15. What Are The Responsibilities Of Agency Standards Executives?

An Agency Standards Executive:

a. Promotes the following goals:

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(1) Effective use of agency resources and participation.

(2) The development of agency positions that are in the public interest and that do not

conflict with each other.

(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

known in advance to all federal participants on a given committee.

b. Coordinates his or her agency's participation in voluntary consensus standards bodies

by:

(1) Establishing procedures to ensure that agency representatives who participate in

voluntary consensus standards bodies will, to the extent possible, ascertain the views of

the agency on matters of paramount interest and will, at a minimum, express views that are not inconsistent or in conflict with established agency views.

(2) To the extent possible, ensuring that the agency's participation in voluntary consensus

standards bodies is consistent with agency missions, authorities, priorities, and budget

resources.

(3) Ensuring, when two or more agencies participate in a given voluntary consensus

standards activity, that they coordinate their views on matters of paramount importance

so as to present, whenever feasible, a single, unified position and, where not feasible, a mutual recognition of differences.

(4) Cooperating with the Secretary in carrying out his or her responsibilities under this

Circular.

(5) Consulting with the Secretary, as necessary, in the development and issuance of

internal agency procedures and guidance implementing this Circular, including the

development and implementation of an agency-wide directory identifying agency

employees participating in voluntary consensus standards bodies and the identification of

voluntary consensus standards bodies.

(6) Preparing, as described in Section 9, a report on uses of government-unique standards

in lieu of voluntary consensus standards and a report on the status of agency standards

policy activities.

(7) Establishing a process for ongoing review of the agency's use of standards for

purposes of updating such use.

(8) Coordinating with appropriate agency offices (e.g., budget and legal offices) to ensure

that effective processes exist for the review of proposed agency support for, and

participation in, voluntary consensus standards bodies, so that agency support and

participation will comply with applicable laws and regulations.

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SUPPLEMENTARY INFORMATION

16. When Will This Circular Be Reviewed?

This Circular will be reviewed for effectiveness by the OMB three years from the date of

issuance.

17. What Is The Legal Effect Of This Circular?

Authority for this Circular is based on 31 U.S.C. 1111, which gives OMB broad authority

to establish policies for the improved management of the Executive Branch. This Circular

is intended to implement Section 12(d) of P.L. 104-1 13 and to establish policies that will

improve the internal management of the Executive Branch. This Circular is not intended

to create delay in the administrative process, provide new grounds for judicial review, or

create new rights or benefits, substantive or procedural, enforceable at law or equity by a

party against the United States, its agencies or instrumentalities, or its officers or employees.

18. Do You Have Further Questions?

For information concerning this Circular, contact the Office of Management and Budget,

Office of Information and Regulatory Affairs: Telephone 202/395-3785.

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V. Conformity Assessment Guidance Document

48894 Federal Register /Vol. 65, No. 155 /Thursday, August 10, 2000/Rules and Regulations

good cause exists for making some

SIAPs effective in less than 30 days.

Conclusion

The FAA has determined that this regulation only involves an established body of technical regulations for which

frequent and routine amendments are necessary to keep them operationally

current. It, therefore—(1) is not a

"significant regulatory action" under

Executive Order 12866; (2) is not a "significant rule" under DOT

Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated

impact is so minimal. For the same

reason, the FAA certifies that this amendment will not have a significant

economic impact on a substantial number of small entities under the

criteria of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

Air Traffic Control, Airports,

Navigation (Air). Issued in Washington, DC on August 4, 2000.

L. Nicholas Lacey,

Director, Flight Standards Service. Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me, part 97 of the Federal Aviation Regulations (14 CFR

part 97) is amended by establishing,

amending, suspending, or revoking Standard Instrument Approach

Procedures, effective at 0901 UTC on

the dates specified, as follows: PART 97—STANDARD INSTRUMENT

APPROACH PROCEDURES

1. The authority citation for part 97 is revised to read as follows:

Authority: 49 U.S.C. 106(g). 40103, 40113,

40120, 44701: and 14 CFR 11.49(b)(2).

2. Part 97 is amended to read as

follows:

§§97.23, 97.25, 97.27, 97.29, 97.31, 97.33, and 97.35 [Amended]

By amending: § 97.23 VOR, VOR7

DME, VOR or TACAN, and VOR/DME

or TACAN; § 97.25 LOC, LOC/DME,

LDA, LDA/DME, SDF, SDF/DME;

§ 97.27 NDB, NDB/DME; § 97.29 ILS. ILS/DME, ISMLS, MLS, MLS/DME,

MLS/RNAV; §97.31 RADAR SIAPs;

§ 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, identified as follows:

* * * Effective October 5, 2000

Walnut Ridge, AR, Walnut Ridge Regional, VOR-A. Amdt 16 Walnut Ridge, AR, Walnut Ridge Regional,

VOR/DME RWY 22, Amtd 13

Walnut Ridge, AR, Walnut Ridge Regional,

LOC RWY 18, Amdt 3 Walnut Ridge, AR, Walnut Ridge Regional,

NDB RWY 18, Amdt 4

Jacksonville, FL, Cecil Field , VOR RWY 9R, Orig

Alton/St. Louis, IL, St. Louis Regional, NDB

OR GPS RWY 29, Amdt 10B

Carbondale/Murphysboro, IL, Southern

Illinois. NDB OR GPS RWY 18L, Amdt 12C

Champaign-Urbana, IL, University of Illinois- Willard, NDB OR GPS RWY 32L, Amdt

10B

Danville, IL, Vermilion County, VOR/DME

OR GPS RWY 3, Amdt 11B

Effingham, IL, Effingham County Memorial,

LOC RWY 29, Amdt IB

Galesburg, IL, Galesburg Muni, VOR OR GPS RWY 21, Amdt 6B Macomb. IL, Macomb Muni, NDB OR CPS RWY 27, Amdt 2D

Pekin, XL. Pekin Muni. VOR/DME RNAV OR

GPS RWY 9, Amdt 5A

Peoria, IL, Greater Peoria Regional, NDB OR

GPS RWY 31, Amdt 14A

South Bend, IN, South Bend Regional, VOR

OR GPS RWY 18. Amdt 7B

South Bend, IN, South Bend Regional, NDB

OR GPS RWY 27L, Amdt 28C

Hays, KS. Hays Regional. RNAV RWY 34, Orig

Frenchville, ME, Northern Aroostock

Regional, NDB RWY 32, Amdt 6

Frenchville, ME, Northern Aroostock

Regional, RNAV RWY 14, Orig

Frenchville, ME, Northern Aroostock

Regional, RNAV RWY 32, Orig

College Park, MD, College Park, RNAV RWY

15. Orig

College Park, MD, College Park. VOR/DME

RNAV RWY 15. Amdt 3 Gaithersburg, MD, Montgomery County

Airpark, VOR RWY 14, Amdt 3 Gaithersburg, MD, Montgomery County

Airpark, NDB RWY 14, Amdt 1 Gaithersburg, MD, Montgomery County

Airpark, RNAV RWY 14, Orig

Gaithersburg, MD, Montgomery County

Airpark, VOR/DME RNAV RWY 14, Amdt

4, CANCELLED

Stevensville, MD, Bay Bridge, VOR/DME

RWY 29. Amdt 1 Stevensville, MD, Bay Bridge, RNAV RWY

11. Orig

Stevensville, MD, Bay Bridge, GPS RWY 11, Orig, CANCELLED

Stevensville, MD, Bay Bridge, RNAV RWY

29, Orig

Westminster, MD, Carroll County Reg/Jack B. Poage Field, VOR-A, Amdt 1 Westminster, MD, Carroll County Reg/Jack B. Poage Field, VOR RWY 34, Amdt 4 Westminster, MD, Carroll County Reg/Jack B. Poage Field, RNAV RWY 16. Orig Westminster, MD, Carroll County Reg/Jack B. Poage Field, RNAV RWY 34, Orig Westminster, MD, Clearview Airpark. VORA, Amdt 4 Westminster, MD, Clearview Airpark, RNAV

RWY 14, Orig

Chillicothe, OH. Ross County, VOR RWY 23. Amdt 3B

Columbus, OH, Bolton Field, NDB OR GPS

RWY 4, Amdt 6B

Columbus, OH, Rickenbacker Intl, NDB OR

GPS RWY 23L. Orig-A

Findlay, OH, Findlay, GPS RWY 18, Amdt

1A

Fremont, OH, Sandusky County Regional, GPS RWY 6, Orig-A

Fremont, OH, Sandusky County Regional,

GPS RWY 24, Orig-A

Lancaster, OH, Fairfield County, LOC RWY

28, Amdt 1A

Lancaster, OH, Fairfield County, NDB OR

GPS RWY 28. Amdt 8A

Lancaster, OH, Fairfield County, VOR/DME

RNAV OR GPS RWY 10, Amdt 10A

Lima, OH, Lima Allen County, VOR OR GPS RWY 27, Amdt 14B

Marion. OH, Marion Muni, GPS RWY 24, Orig-A Mount Vernon, OH, Knox County, VOR/DME

RNAV OR GPS RWY 28, Amdt 2B

Springfield, OH, Springfield-Beckley Muni,

NDB OR GPS RWY 24. Amdt 16A

Wapakoneta, OH. Neil Armstrong, LOC RWY

26, Amdt 3C

Wapakoneta, OH, Neil Armstrong, VOR/DME

RNAV OR GPS RWY 26, Amdt 5C

Springfield, TN, Springfield-Robertson County, LOC RWY 4. Orig

Springfield, TN, Springfield-Robertson County, NDB RWY 4. Orig

Corsicana, TX, C. David Campbell Field- Corsicana Muni, VOR/DME-A, Amdt 1 Corsicana, TX, C. David Campbell Field- Corsicana Muni, VOR/DME-B, Amdt 1 Corsicana, TX, C. David Campbell Field- Corsicana Muni, NDB RWY 14, Amdt 4

Corsicana, TX, C. David Campbell Field- Corsicana Muni, NDB RWY 32, Amdt 3 Corsicana, TX, C. David Campbell Field- Corsicana Muni. RNAV RWY 14, Orig

Corsicana, TX, C. David Campbell Field- Corsicana Muni, RNAV RWY 32, Orig

Charlotte Amalie. VI, Cyril E King, GPS RWY

10, Orig, CANCELLED

Charlotte Amalie, VI, Cyril E King, RNAV

RWY 10, Orig [FR Doc. 00-20275 Filed 8-9-00; 8:45 am]

BILLING CODE 4910-13-M

DEPARTMENT OF COMMERCE

National Institute of Standards and

Technology

15 CFR Part 287

[Docket No. 981222315-0219-02]

RIN 0693-AB49 Guidance on Federal Conformity Assessment Activities AGENCY: National Institute of Standards and Technology (NIST), Commerce.

ACTION: Final policy guidance. SUMMARY: This document contains final policy guidance on Federal agency use

of conformity assessment activities. The

provisions are solely intended to be

used as guidance for agencies in their conformity assessment activities and do

not preempt the agencies' authority and

responsibility to make regulatory

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Federal Register / Vol. 65, No. 155 /Thursday, August 10, 2000/Rules and Regulations 48895

procurement decisions authorized by

statute or required to meet

programmatic objectives and

requirements. DATES: This guidance becomes effective August 10, 2000. FOR FURTHER INFORMATION CONTACT: Dr. Belinda Collins, Director, Office of Standards Services, National Institute of Standards and Technology, Building

820, MS 2100, Room 282, Gaithersburg,

MD 20899. Phone: (301) 975-4000. SUPPLEMENTARY INFORMATION: Background

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.

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.

History of the Guidance

In February 1996, The National Technology Transfer and Advancement

Act (NTAA) of 1995 was enacted by

Congress. Section 12 of the Act directed NIST to coordinate conformity

assessment activities of Federal, state and local entities with private sector technical standards activities and

conformity assessment activities with

the goal of eliminating any unnecessary

duplication of conformity assessment

activities. The Office of Management

and Budget (OMB) Circular A-119,

revised February 19, 1998 directed the

Secretary of Commerce to issue guidance to the agencies to ensure

effective coordination of Federal

conformity assessment activities. The

Director of the National Institute of Standards and Technology (NIST),

United States Department of Commerce,

published proposed guidance in the Federal Register on Federal conformity

assessment activities on November 3, 1999 (64 FR 59691 (1999)). Closing date

for comments was January 18, 2000. Summary of Public Comments Received

by the Agency in Response to the November 3, 1999 Request for Public Comments, and the Agency's Response

to the Comments

NIST received comments from nine

commentors, including: one national standards coordinating and conformity

assessment accreditation body, one

government agency, one international company, one laboratory accreditation body, one certification body, one

consulting organization, and three trade

associations in response to its request. In addition, in September 1999, the U.S. General Accounting Office (GAO)

published a report, entitled "GAO/

GGD-99-1 70—Certification Requirements: New Guidance Should

Encourage Transparency in Agency

Decisionmaking," which contained a recommendation for including a section

in the guidance on the issue of transparency in agency certification decisionmaking. The 51 comments as well as the GAO recommendation were

considered in finalizing the guidance.

The following summarizes the comments received and the agency's response to the comments.

General Comments

One national standards coordinating

and conformity assessment

accreditation body commented that the guidance should task only NIST with

substantive objectives and identify the approach and procedures for accomplishing them. Response: In OMB Circular A-119,

OMB stated that "(t)o ensure effective coordination, the Secretary of Commerce must issue guidance to the

agencies." This guidance is a response

to that mandate. The suggested

approach would not be consistent with

OMB's mandate. One laboratory accreditation body

commented the proposed rule should be withdrawn and that the guidance be

issued as an annex to OMB Circular A—

119.Response: This document is intended

to serve as guidance for Federal agencies

in implementing their responsibilities

under the NTTAA, and is not a rule. The guidance was issued at the

direction of OMB, which chose not to include conformity assessment in OMB

Circular A-119. This comment has been

forwarded to OMB for consideration during the next revision of the Circular. One government agency commented

that while the examples in the guidance were helpful in describing how the guidance may be implemented, they should remain examples in the final version of the guidance.

Response: NIST agrees with this comment. One government agency commented

that Federal regulatory programs that engage in conformity assessment must

apply a high degree of scrutiny to ensure that requirements are met.

Therefore, it may be very difficult to rely on the work of private sector organizations, which understandably

perform their activities for other motives

and perhaps to a lesser degree of

scrutiny. The guidance should present

the option that private sector organizations rely on the conformity assessment activities of a Federal

agency. This option would also promote

the objectives under the proposed

Section 287.1. Response: Elimination of unnecessary

duplication and complexity in conformity assessment activities can be accomplished by relying on private

sector conformity assessment programs and activities. However, reduction in duplication and complexity can also be accomplished by Federal agency

reliance on other governmental

conformity assessment activities, by

reliance on supplier's declaration of conformity, or by encouraging the

private sector to rely on governmental

activities. The NTTAA does not indicate

a preference for any specific approach.

The determination of which approach

best meets agency objectives is the

responsibility of the agency. Comments on Section 287.1 One national standards coordinating

and conformity assessment

accreditation body commented that Section 287.1 should provide more

information on the evaluation procedures to be used to evaluate the

efficacy and efficiency of Federal conformity assessment activities. Response: The variety of conformity assessment activities conducted by

different Federal agencies precludes

development of specific evaluation techniques that would apply to all agencies. Guidance on how to measure

certain aspects of performance

(regulatory burden, cost-benefit issues,

etc.,) is available from the Office of Management and Budget (OMB) and

from other sources within the Federal government, but this guidance must

usually be tailored to reflect the type of

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48896 Federal Register/ Vol. 65, No. 155 /Thursday, August 10, 2000 /Rules and Regulations

activities a given agency undertakes. NIST believes that evaluations of only one aspect of program performance can

be misleading. Evaluations of program

performance/effectiveness should

consider all programmatic aspects, including an agency's legislative

mandates, program objectives and

resource availability. One laboratory accreditation body

commented that the second and third sentences of Section 287.1 should be

replaced by: "Each agency should seek ways in which it can use existing

conformity assessment activities of the

private sector instead of creating or maintaining their own activities." Response: The purpose and scope, as currently written in Section 287.1, best

reflects the intent stated in the Act, which is to eliminate "unnecessary

duplication and complexity in the development and promulgation of conformity assessment requirements

and measures." This can be

accomplished in a number of ways. Using the results of private sector conformity assessment activities is only one method. One laboratory accreditation body

commented that the last sentence of Section 287.1 should be revised to cite the role of the U.S. Trade Representative

(USTR) in overseeing the implementation of the U.S. trade

obligations including commitments

under the World Trade Organization

(WTO) Agreement on Technical Barriers

to Trade (TBT). Response: The guidance is not intended to address U.S. obligations or the USTR's role in implementing the WTO Agreement or in other trade agreements. This guidance addresses

only matters covered in the NTTAA.

The Federal government's obligations under the World Trade Organization

Agreement and other trade agreements

are addressed elsewhere. One consulting organization

commented that NIST should state its position on who is responsible for accreditation in the United States. Response: Accreditation activities can

be conducted by either the public and/

or the private sector. The appropriate

sector to be assigned responsibility for accreditation should be determined on a case-by-case basis. The need for accreditation also needs to be

determined on a case-by-case basis. There is no one-size-fits-all solution to

this issue. One certification body commented

that the Interagency Committee on

Standards Policy (ICSP) should be opened to regular participation and

attendance by private sector standards developers and organizations providing

conformity assessment services to

facilitate cooperation and confidence

between the government and private

sector conformity assessment

organizations.

Response: The ICSP has invited a number of standards developers and

conformity assessment organizations to present information and viewpoints on

topics of interest to the ICSP. However,

the ICSP is an interagency committee. Membership is restricted to the Federal departments and agencies listed in its charter. One certification body commented

that the promotion of accreditation and/

or recognition organizations that have

not demonstrated added value to the marketplace should be discouraged.

Response: NIST agrees with this comment. Agencies are responsible for meeting programmatic objectives in a cost-effective manner. However, it is the

responsibility of each agency to determine which approach best meets

its needs. One certification body commented

that no single mechanism can meet the needs of all suppliers or acceptance

authorities around the globe. New

mechanisms that facilitate trade, provide regulatory confidence and

protect public safety should be

considered as they are developed and

proven effective to meet the needs of supplier and acceptance authorities. Response: NIST agrees with this comment. However, it remains the

responsibility of each agency to determine which mechanisms are appropriate for application within its programs. One trade association commented that the following objectives should be

included in the proposed guidance:

• Eliminate the cost to government of conducting (developing) its own

conformity assessment activities and

thereby decrease the cost of goods

procured and the burden of complying

with agency regulation;

• Provide incentives and

opportunities (to whom) to establish conformity assessment programs that serve national needs;

• Encourage long term growth of U.S. enterprises and promote efficiency and

economic competition through

harmonization of conformity assessment

activities; and

• Further the policy of reliance upon

the private sector to supply the government need for goods and services. Response: While the statements listed above are a partial list of potential

benefits from implementation of the guidance, the objective of the guidance was clearly and succinctly defined in the NTAAA—to eliminate "unnecessary

duplication and complexity in the development and promulgation of conformity assessment requirements

and measures." Comments on Section 287.2 One national standards coordinating

and conformity assessment

accreditation body commented that the

definition of recognition is too narrow

in section 287.2 and is inconsistent with

the way it is used in the example in section 287.4. Response: While the definition for the term "recognition" in Section 287.2 is appropriate; the term has been changed

in the example.

One national standards coordinating

and conformity assessment

accreditation body and one trade association commented that the

definitions in the International Organization for Standardization/

International Electrotechnical Commission (ISO/EEC) Guide 2 should

be cited without modification. Response: The definitions in section 287.2 were based on ISO/IEC Guide 2, but the definitions have been modified

to better address the nature of Federal government conformity assessment

activities. Definitions were considered

necessary because agencies do not use

consistent terminology in their regulatory and procurement conformity assessment programs. This inconsistent use of terminology could create

potential confusion for agencies reading

the guidance. NIST decided to define only those terms which were considered

to be necessary to understand the guidance.

One laboratory accreditation body

commented that the World Trade

Organization (WTO) Agreement on

Technical Barriers to Trade (TBT)

definition of conformity assessment

should be referenced and "mandatory

administrative procedures" should not be excluded from the definition. Response: ISO/IEC Guide definitions have been used in accordance with the NTTAA's requirements that preference be given to the use of voluntary consensus standards. There is also no

evidence in the Act or legislative history

that Congress intended to include mandatory administrative procedures.

The Occupational Safety and Health Administration (OSHA) commented that some of the key definitions in the notice do not correctly depict the Occupational

Safety and Health Administration's (OSHA's) National Recognized Testing

Laboratory (NRTL) Program. OSHA

recognizes a testing/certification body

under the NRTL Program, not an

accreditation body. In addition, the agency commented that OSHA's

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Federal Register/ Vol. 65, No. 155 /Thursday, August 10. 2000 /Rules and Regulations 48897

recognition does not mean that an

organization is "competent" in testing

or in certification to the extent that "competent" means adept, proficient or

a similar term. To obtain recognition, an

organization must demonstrate that it meets the requirements in 29 CFR

1910.7, but this regulation does not include requirements for proficiency or other criteria to judge "competence."

Response: NIST agrees that agencies

do not use standardized terminology in

their conformity assessment activities. In defining key terms, NIST intended to

let the reader know what is meant by

that term within the context of the

guidance. NIST recognizes that the same

term may be used by different agencies

to mean very different types of

activities. A footnote will be added to the definition for "accreditation" to accommodate OSHA's activities. OSHA also commented that the

definition of conformity assessment

describes requirements as being

applicable to "products, services, and

systems," but not to "organizations"

and requested that the word

"organizations" be added. Response: The word "organizations" has been added. One international company, one

laboratory accreditation body, and one

trade association commented that the guidance should identify supplier's

declaration as an appropriate option for agencies to consider in their conformity

assessment policies, taking into account

the appropriate balance of risks and

benefits of first party (supplier), second

party, and third party conformity

assessment for specific products and

services. The same trade association recommended that NIST amend the

definition in the proposed Section 287.2

as follows: In the definition of conformity assessment, add "suppliers

declaration of conformity" after "inspection" and add a definition for "supplier's declaration of conformity."

Response: The guidance now includes

reference to first, second and third party conformity assessment activities and

procedures. The definition of conformity assessment has been

amended to include "supplier's

declaration of conformity." A definition

of "supplier's declaration of conformity" has also been included. However, the guidance does not intend

to suggest that any one method or

activity is preferable. It is the

responsibility of each agency to select the conformity assessment activities and

procedures, which will best meet its legislative mandates and programmatic

objectives in the most cost-effective and

efficient manner.

Comments on Section 287.3 One national standards coordinating

and conformity assessment

accreditation body commented that NIST should be charged in section 287.3 with ensuring that other agencies are aware of their obligation to adopt

policies needed to accomplish the purpose of this guidance.

Response: While NIST is charged with

coordinating conformity assessment

activities, agencies remain responsible

for their own conformity assessment

activities, including the adoption of any

policies that agencies feel are needed to operate in accordance with their statutory mandates. NIST is available and willing to assist agencies in carrying out this responsibility and to provide

guidance as needed. One national standards coordinating

and conformity assessment

accreditation body and one trade

association commented that some

attention should be given in section 287.3 to NIST's obligations beyond the Federal level, especially to its obligations at the state level. Response: NIST partially agrees with

this comment. The language in the Act

is unclear as to what Congress intended

NIST to do with regard to state conformity assessment activities. However, in the Congressional House

Record of 2/27/96 for The National Technology Transfer and Advancement

Act (NTTAA), Representative Morel la stated that: "Section 12 Standards

Conformity. Restates existing authorities

for the National Institute of Standards and Technology (NIST) activities in standards and conformity assessment. Requires NIST to coordinate among

Federal agencies, survey existing state and Federal practices, and report back

to Congress on recommendations for improvements in these activities." NIST

is undertaking studies of existing state conformity assessment practices, subject

to resource limitations. NIST also plans

to undertake additional activities with

the states as resources become available. Any activities undertaken by NIST will be conducted in a manner that respects

state sovereignty issues. NIST has added

the following statement to the guidance: "To the extent that resources are

available, NIST will develop

information on existing state conformity

assessment practices; and, upon request

by a state government agency, will work

with that agency to reduce duplication

and complexity in state conformity

assessment activities." One laboratory accreditation body

commented that a new clause should be

added to section 287.3 so that NIST

would also "encourage government

participation and use of private sector, conformity assessment activities to the maximum extent practical."

Response: NIST disagrees. NIST is obligated to assist other Federal

agencies in reducing duplication and

complexity in their conformity assessment activities. The use of private

sector conformity assessment activities

is only one of a number of methods that can be used by an agency to accomplish

this goal. It remains the responsibility of

the agency to determine which method

is most appropriate for its specific

applications.

Comments on Section 287.4 One national standards coordinating

and conformity assessment

accreditation body commented that the example in section 287.4, which uses

the term "recognition," does not support the use of the qualifier "mutual." Response: The agency agrees with this comment. The qualifier "mutual" has been removed and the term

"recognition" has been replaced.

One national standards coordinating

and conformity assessment

accreditation body and one laboratory

accreditation body commented that a

list of references, containing the documents of the organizations cited in section 287.4 should be inserted in this section or that NIST should provide a

list of specific conformity assessment

guides and standards, perhaps as a separate document.

Response: NIST believes that a better solution is to address an agency's need

for a list of applicable standards on a case-by-case basis. NIST's National Center for Standards and Certification Information (NCSCI) assists agencies to identify possible conformity assessment

standards/guides, which may be of

interest for a specific application. The

organizations listed in the guidance are examples, and are not intended to represent a comprehensive list of organizations that develop standards and guidance in the conformity assessment area. A specific list could

omit standards of potential interest to agencies in conformity assessment

related areas or from other organizations not included as examples. In addition,

such a list would rapidly become

outdated as ISO guides and standards in the conformity assessment area are

revised, reissued, or removed. Lastly, standards that appear on such a list might be presumed by some to have a

"special blessing" by NIST, which

could create misunderstanding.

Agencies can contact NCSCI for a list of standards in their area of interest.

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48898 Federal Register/ Vol. 65, No. 155 /Thursday, August 10, 2000/Rules and Regulations

One national standards coordinating

and conformity assessment

accreditation body commented that section 287.4 should be rewritten to address the policies and procedures that should be adopted by agencies through

the mechanism of the Interagency

Committee on Standards Policy (ICSP). The development of a policy on

conformity assessment might be

stipulated that would address the roles of supplier's declaration, third parties, and accreditors. Response: As noted in section

287.3(a), NIST will assist "the ICSP in developing policies and guidance on

conformity assessment issues." Agency

Standards Executives serving on the ICSP are responsible for determining

which policies and procedures the ICSP

should develop, which might be useful

for consideration within their agencies.

However, the individual agency is responsible for the final selection and

implementation of the policies and

procedures needed by die agency to implement the goals of the NTTAA.

One national standards coordinating

and conformity assessment

accreditation body commented that the ICSP Agency Standards Executives'

suitability for serving as change agents with respect to the conformity

assessment activities of the Federal government should be reconsidered. Response: The selection of the ICSP Agency Standards Executives is the

responsibility of the Agency, as noted in section 287.4(n). The agency is responsible for selecting an individual who is capable of carrying out the guidance in OMB Circular A-119 as well as the guidance in this document.

If needed, the Agency is free to assign additional personnel to assist the Agency Standards Executive in carrying

out these responsibilities.

One international company

commented that the examples listed in section 287.4(g) are limited to laboratory

issues and organizations that are close

to the Federal process. It would be

appropriate to list some other

organizations such as the American

National Standards Institute (ANSI) or the International Organization for Standardization's (ISO) Committee on

Conformity Assessment (CASCO) to indicate the broader direction that is intended. Response: The examples cited have been included in the guidance.

One international company

commented that organizations, such as the American National Standards

Institute (ANSI) or the International Organization for Standardization's (ISO) Committee on Conformity Assessment (CASCO) be listed in section 287.4(j) to

indicate the broader direction that is intended. Response: Section 287.4(j) does not

list examples. Participation in the development of any private sector conformity assessment standards

(consistent with the mission and

objectives of the agency) would be

included in this section. ANSI does not develop standards, so it would not be

included in this section. ISO is a private

sector organization, which develops

conformity assessment standards, so

participation in ISO CASCO is included

in this section. One laboratory accreditation body

commented that in section 287.4(c), agencies need to consider ways to use

not only conformity assessment results of others (both domestic and foreign), but the conformity assessment activities themselves as a replacement for their own activities. Response: This comment addresses

matters beyond the scope of this guidance. Regulatory and procurement

obligations of Federal agencies have

been authorized by Congress, and such

activities/systems cannot be replaced by

private sector activities/systems without

congressional approval or legislative change.

One laboratory accreditation body

commented that the examples in sections 287.4(e) and (h) are weak as they only suggest an agency might

supplement (not replace) its own

activities with outside conformity

assessment activities mainly

administered by other government

agencies.

Response: In section 287.4(e), NIST

will include the example of the Federal Communications Commission's FCC

Telecommunications Certification Body

(TCB) program, which allows

designated private entities to issue telecommunications equipment

approvals for specified regulatory

requirements in essentially the same manner as the FCC. FCC has also replaced requirements for premarketing

approval with supplier's declaration of conformity for certain types of equipment.

One laboratory accreditation body

commented that in section 287.4(f), it is not clear why "mutual recognition" is necessary or desirable between agencies

when one-way recognition may also be

appropriate.

Response: This section has been

reworded. One laboratory accreditation body

commented that section 287.4(g) should

delete any reference to the National Environmental Laboratory Accreditation Conference (NELAC) because NELAC

specifically prohibits private sector

laboratory accreditation bodies from

being part of NELAC by suggesting that accreditation is an inherent government

function. This is contrary to the intent

of the NTTAA, which encourages use of

private sector conformity assessment

activities. Response: The purpose of the NTTAA

is to eliminate unnecessary duplication

and complexity in conformity assessment activities. While this can be done by relying on private sector conformity assessment programs and

activities, it can also be accomplished

by relying on other governmental

activities, by relying on a supplier's declaration of conformity, or by

encouraging the private sector to rely on

governmental activities. While agencies should consider alternative approaches

in their rulemaking and procurement

activities, the determination of which

approach best meets agency objectives is the responsibility of the agency. One laboratory accreditation body and

one trade association commented that sections 287.4(i) should cite the USTR's

role in trade policy. The same trade association commented that sections

287.4(j) should also cite the USTR's

role. Response: While NIST recognizes the important role that the USTR has in developing trade related policies, as well as the responsibilities placed on

Federal agencies as a result of trade agreements, such as the WTO

Agreement, these roles and

responsibilities are defined in other

legislation and related documents. This

guidance addresses only matters covered in the NTTAA.

One laboratory accreditation body

commented that there is no need for separate government recognition

systems if equivalent systems exist in the private sector that provide

equivalent recognition. Government

recognition systems would add cost without adding value and would create unnecessary duplication and

complexity, the opposite intent of the NTTAA.

Response: In trade agreements, the need for government recognition of conformity assessment bodies is determined not only by the U.S. Government, but also by the other

countries signatory to such an

agreement. Since some governments do

not deem the use of private sector systems to be adequate proof of competence in the absence of governmental recognition, such

recognition becomes a requirement under the terms of the specific

agreement. For domestic regulatory and

procurement issues, it is the

responsibility of each Federal agency to

133
Federal Register / Vol. 65, No. 155 /Thursday, August 10, 2000 /Rules and Regulations 48899

determine whether use of a private

sector system can adequately address all of its programmatic objectives and any

relevant legislative mandates in a costeffective manner. One trade association commented that while the reference to the National Cooperation for Laboratory

Accreditation (NACLA) and the National Environmental Laboratory

Accreditation Conference (NELAC) in section 287.4(g) begins to address the

issue of duplication of accreditations for testing programs, the proposed guidance

should also provide direction related to other forms of conformity assessment, such as certification and registration.

Response: The organizations listed in section 287.4(g) are intended to serve only as examples of activities in which

agencies should consider participation.

The activities of ANSI have been added

to the list of examples to better illustrate the broad range of activities where

Federal participation is encouraged.

One trade association commented that the wording in section 287.4(c) should

strongly encourage the use of private

sector conformity assessment programs

in lieu of the development of government programs. The same trade

association commented that Section

287.4(e) include a requirement that NIST provide a centralized coordinating

function in the determination of acceptable private sector conformity

assessment practices. To allocate the

responsibility to each agency only

continues the duplication of

accreditation and approval processes. NIST should advocate the use of private

sector accreditation bodies that comply

with national and international criteria as the tool to be used for determination

of acceptance. The same trade

association also commented that in section 287.4(f), mutual recognition of

private sector procedures should be recommended for all agencies.

Response: The purpose of the NTTAA

is to eliminate unnecessary duplication

and complexity in conformity

assessment activities. While this can be done by relying on private sector conformity assessment programs and

activities, it can also be accomplished

by relying on other governmental

activities, by relying on a supplier's declaration of conformity, or by

encouraging the private sector to rely on

governmental activities. While agencies should consider alternative approaches

in their rulemaking and procurement

activities, the determination of which

approach best meets agency objectives is the responsibility of the agency. One trade association commented that

in section 287.4(j), agencies should be encouraged to participate in the

development of private sector conformity assessment procedures and

programs as well as the development of

standards. RESPONSE: NIST partially agrees with this comment. The

responsibility for participation in conformity assessment programs and

activities, as distinct from standards development, is covered in section

287.4(g). The examples in this section

will be expanded to include

participation in ANSI's conformity

assessment related activities to better

illustrate the intention of this section. GAO Recommendation: GAO

recommended that the guidance include

a section that "specifically addresses the transparency of agencies' certification decisionmaking." GAO recommended

that the guidance "should encourage

agencies to publicly explain why

particular certification decisions were made or how certification decisions in the future will be made."

Response: A new item has been added

to section 287.4 of the guidance to address this issue. Comments on Section 287.5 One national standards coordinating

and conformity assessment

accreditation body commented that section 287.5 places responsibility for both standards and conformity

assessment with one representative from

each agency and noted that a significant

majority of persons with major

responsibilities for standards have no

responsibility or knowledge of conformity assessment. Response: NIST partially disagrees

with this comment. The Office of Management and Budget (OMB) A-119

indicates that more than one Standards

Executive was not contemplated by

OMB. That is, the Circular speaks of "a"

Standards Executive (14(c)) and "the" Standards Executive (14(d)), etc. NIST

and OMB believe that having only one

Standards Executive would facilitate better coordination and communication

for both standards and their related conformity assessment activities. However, both also recognize that because responsibility for an agency's

conformity assessment activities may

cut across organizational boundaries, it may be necessary to assign additional agency personnel to carry out these new

responsibilities. The agency must

ensure that these responsibilities are coordinated and should carefully define each staff member's responsibilities to ensure that the duties defined under

this guidance and under OMB Circular A-119 are effectively carried out. One laboratory accreditation body

commented that section 287.5 should

contain reporting requirements for the

annual agency reports to NIST and

OMB, including whether each agency

gave consideration to the use of relevant

private sector, conformity assessment

activities and the reason for not using

them—similar to agencies' reporting

under OMB Circular A-119. NIST itself should be required to make similar

reports justifying it own conformity assessment activities. Response: Mandatory agency

reporting requirements regarding

conformity assessment activities were

not specified in the NTTAA. Conformity

assessment reporting requirements for

all agencies, including NIST, remain

voluntary.

One government agency commented

that the guidance states that each agency

"should coordinate its * * * activities"

to make "more productive use of * *

* limited Federal resources * * *." However, the "responsibilities" under

the proposed Section 2987.5 and the

actual coordination could demand

resources that may more than offset any

gains expected from the coordination. Response: The guidance does not recommend that agencies undertake

activities where the costs involved are

likely to exceed the benefits realized. While coordination is often beneficial and should always be considered, the agencies themselves are responsible for the final decision as to the appropriate

level of coordination and commitment

of resources to the agency's conformity assessment activities. One trade association commented that

a new responsibility should be added to

this section— "To use private sector conformity assessment program results

in all agency assessment programs."

Response: The goal of the guidance,

which is spelled out in the NTTAA, can

be accomplished in a number of ways.

It is the responsibility of each agency to determine which option or set of procedures is most appropriate for its application.

Purpose of This Guidance

This guidance outlines Federal

agencies' responsibility for evaluation

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 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

134
48900 Federal Register/ Vol. 65, No. 155 /Thursday, August 10, 2000/RuIes and Regulations

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: August 4, 2000. Karen H. Brown,

Deputy Director. For the reasons set forth in the preamble, Part 287 is 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: Sec. 12, Pub. L. 104-113, 110

Stat. 782 (15 U.S.C. 272).

§ 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 pursuing 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 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. Nothing

contained herein 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

and procurement conformity assessment

actions. §287.2 Definitions. 1 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.2 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

commission 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,

' Definitions of accreditation, certification, conformity assessment, inspection, supplier's declaration of conformity, registration and testing are based on the International Organization for Standardization (ISO)/Intemational

Electrotechnical Commission (1EC), 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.

2 For some agencies, accreditation may mean that a body or person meets requirements defined in a

specific section(s) of the CFR. The referenced

section(s) may include only limited requirements

for demonstration of technical competency.

135
Federal Register/ Vol. 65, No. 155 /Thursday, August 10, 2000/Rules and Regulations 48901

services, systems, and organizations are those defined by law or regulation or by

an agency in a procurement action. Conformity assessment includes: sampling and testing; inspection;

supplier's declaration of conformity;

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. Conformity

assessment activities may be conducted

by the supplier (first party) or by the buyer (second party) either directly or by another party on the supplier's or buyer's behalf, or by a body not under

the control or influence of either the buyer or the seller (third party). Inspection is defines ad 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.

Supplier's declaration of conformity means a procedure by which a supplier

gives written assurance that a product,

process, service or organization conforms 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).

§ 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) To the extent that resources are

available, develop information on state conformity assessment practices; and,

upon request by a state government

agency, work with that state agency to reduce duplication and complexity in

state conformity assessment activities.

(d) Review within three years from August 10, 2000, the effectiveness of the

final guidance 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.

(b) Provide a rationale for its use of

specified conformity assessment

procedures and processes in rulemaking

and procurement actions to the extent

feasible. Further, when notice and

comment rulemaking is otherwise

required, each agency should provide

the opportunity for public comment on

the rationale for the agency's conformity

assessment decision.

(c) Use the results of other governmental agency and private sector organization conformity assessment

activities to enhance the safety and

efficacy of proposed new conformity

assessment requirements and measures. An example of this would be to collect and review information on similar

activities conducted by other Federal,

state and international organizations

and agencies and private sector organizations to determine if the results of these activities can be used to improve the effectiveness of a proposed

Federal agency conformity assessment

activity.

(d) Use relevant guides or standards

for conformity assessment practices

published by domestic and international standardizing bodies as appropriate in meeting regulatory and procurement

objectives. Guides and standards for sampling, testing, inspection,

certification, quality and environmental

management systems, management

system registration and accreditation are issued by organizations which include, but are not limited to, the American

National Standards Institute, the

International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the

International Telecommunications

Union (ITU) and the Organization for Economic Cooperation and

Development (OECD), the World Health

Organization (WHO), and the Codex

Alimentarius Commission. Each agency

retains responsibility for determining

which, if any, of these documents are relevant to its needs.

(e) Identify appropriate private sector conformity assessment practices and

programs and consider the results of such practices and/or programs as appropriate in existing regulatory and

procurement actions. Responsibility for the determination of appropriateness

rests with each agency. Examples: an agency could use the results of private

sector or other governmental conformity assessment activities to schedule procurement type audits more

effectively. This could allow agencies to reduce the number and extent of audits conducted at companies which are performing in accordance with contract

specifications and which are under

review by a third party or another agency and to concentrate agency audit

efforts on companies which have shown

problems in conforming to contract

specifications. Another example is the Federal Communications Commission's

(FCC) Telecommunication Certification Body (TCB) program, which allows

designated private entities to issue telecommunications equipment

approvals for specified regulatory

requirements. In addition, under Part

15, FCC premarketing approval

requirements for certain types of equipment have been replaced with

suppliers declaration of conformity to the regulations, provided test results supporting the declaration are obtained from an accredited testing lab.

(f) Consider using the results of other

agencies' conformity assessment

procedures. Example: An agency could

use the results of another agency's

inspection/audit of a supplier to eliminate or reduce the scope of its own

inspection/audit of that supplier.

136
48902 Federal Register/ Vol. 65, No. 155 /Thursday, August 10, 2000 /Rules and Regulations

(g) 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 (NELAC), the

International Organizations for Standardization's (ISO) Committee on

Conformity Assessment (CASCO),

conformity assessment related activities of the American National Standards

Institute (ANSI), and ICSP working

groups dealing with conformity assessment issues.

(h) Work with other agencies to avoid unnecessary duplication and

complexity in Federal conformity

assessment activities. Examples: An

agency can participate in another

agency's conformity assessment

activities by conducting joint

procurement audits/inspections of suppliers that sell to both agencies. An

agency can share conformity assessment

information with other agencies. An

agency can use conformity assessment

information provided by other agencies

to the extent appropriate to improve the

effectiveness and efficiency in its own

conformity assessment activities. Conformity assessment information may

include: Conformity assessment

procedures and results, technical data on the operation of conformity assessment programs, processing

methods and requirements for applications, fees, facility site data, complaint review procedures, and

confidentiality procedures.

(i) Encourage domestic and

international recognition of U.S. conformity assessment results by

supporting the work of the U.S. Government in international trade and

related negotiations with foreign countries and U.S. industry in pursuing

agreements with foreign national and

international private sector organizations and any resulting

activities/requirements resulting from

those negotiations/agreements.

(j) Participate in the development of

private sector conformity assessment

standards to ensure that Federal viewpoints are represented.

(k) Work with other agencies to harmonize Federal requirements for quality and environmental management

systems for use in procurement and

regulation, including provisions which

will allow the use of one quality or environmental management system per

supplier facility in the Federal procurement process and the sharing

and usage of audit results and related information as appropriate.

(1) 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.

(m) Work with other ICSP members,

NIST, and the private sector as necessary and appropriate to establish

criteria for the development and

implementation of governmental

recognition systems to meet government

recognition requirements imposed by

other nations and regional groups to support the efforts of the U.S. Government to facilitate international market access for U.S. products.

(n) Assign an Agency Standard

Executive responsibility for coordinating the agency-wide

implementation of the guidance in this

part.

§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 A119. (FR Doc. 00-20262 Filed 8-9-00; 8:45 am]

BILLING CODE 3510-13-M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 310, and 344

[Docket No. 77N-334S]

RIN 091O-AA01

Topical Otic Drug Products for Overthe-Counter Human Use; Products for Drying Water-Clogged Ears; Amendment of Monograph; Lift of

Partial Stay of Effective Date

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; lift of partial stay of

effective date. SUMMARY: The Food and Drug

Administration (FDA) is issuing a final rule amending the monograph for over- the-counter (OTC) topical otic drug

products (the regulation that establishes conditions under which these drug

products are generally recognized as

safe and effective and not misbranded).

The amendment adds conditions for marketing topical otic drug products for drying water-clogged ears and includes

labeling in the new OTC drug format. The agency is amending its final regulations for OTC drug labeling

requirements to include the new

flammability warning for topical otic drug products for drying water-clogged

ears. The agency is also lifting a partial stay of the effective date of certain provisions of the regulations for topical

otic drug products for the drying of water clogged ears. This final rule is part of the ongoing review of OTC drug

products conducted by FDA.

DATES:

Effective Date: This rule is effective May 17, 2002. The stay of § 310.545

(a)(15)(ii) for topical otic drug products

for the drying of water-clogged ears that published at 60 FR 42436 on August 16, 1995, and effective June 22, 1995, is lifted effective September 11, 2000. Compliance Date: The compliance

date for products with annual sales less that $25,000 is May 17, 2003. The

compliance date for all other OTC drug

products is May 17, 2002. FOR FURTHER INFORMATION CONTACT:

Gerald M. Rachanow, Center for Drug

Evaluation and Research (HFD—560), Food and Drug Administration, 5600

137



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