NAT L INST. OF STAND & TECH R.I.C.

A 11 ID 3 MflDSVb

1 1 ^^P" United States Department of Commerce

I XI I^^P I National Institute of Standards and Technology

NIST Special Publication 808

Directory of Federal

Government Laboratory

AccreditationIDesignation Programs

Maureen Breitenberg, Editor

NIST Special Publication 808

Directory of Federal

Government Laboratory

Accreditation/Designation Programs

Office of Standards Code and Information

National Institute of Standards

and Technology

Gaithersburg, MD 20899

February 1991

U.S. Department of Commerce

Robert A. Mosbacher, Secretary

Maureen Breitenberg, Editor

National Institute of Standards and Technology

John W. Lyons, Director
National Institute of Standards U.S. Government Printing Office

and Technology Washington: 1991

Special Publication 808

Natl. Inst. Stand. Technol.

Spec. Publ. 808

105 pages (Feb. 1991)

CODEN: NSPUE2

For sale by the Superintendent

of Documents

U.S. Government Printing Office

Washington, DC 20402
FOREWORD

This directory is designed to provide updated information on

laboratory accreditation and similar types of programs conducted

by the federal government. These programs designate a set of

laboratories or other entities to conduct testing to assist

federal agencies in carrying out their responsibilities. The

programs include an assessment regarding the capability of the

laboratory to conduct the testing. The type and degree of such

assessments, however, vary greatly by program.

Laboratory accreditation and related efforts provide varying

degrees of assurance regarding the technical proficiency and

competence of a entity to assess a product's or service's

conformance to a set of prescribed standards. Many sectors of

the economy may be interested in laboratory accreditation and

related programs for a variety of economic, procurement, safety,

or other considerations. Mutual acceptance of laboratory test

results between countries can also serve as a basis for increased

opportunities for international trade.

Federal, state, and local government officials, manufacturers,

distributors, and others may find the information contained in

this directory of use in identifying pertinent federal laboratory

accreditation/designation programs and their details, as well as

in finding a contact point within the appropriate agency. It

should be noted that the entries in this directory are based

primarily on information provided by the federal agency and

reflect the agency's view of its activities. Parties interested

in this area may also wish to review NBS SP 739, Directory of

Federal Government Certification Programs , which contains

information on a number of closely related programs.

iii
ACKNOWLEDGMENTS

This directory is based on earlier publications in the field by

Charles W. Hyer, who was responsible for identifying many of the

programs included in this report. The United States General

Accounting Office Report, "GAO/RCED-89-102 , Laboratory

Accreditation: Requirements Vary Throughout the Federal

Government," was also very useful in preparing this directory.

Special thanks are due to Nancy Trahey, the National Voluntary

Laboratory Accreditation Program (NVLAP) , for her review of this

document and to all the program officials who provided the

information contained in this directory, without which this

publication would not have been possible.

Maureen Breitenberg

Editor

iv
ABSTRACT

This directory is designed to provide updated information on

federal government laboratory accreditation and similar type

programs conducted by the federal government. These programs

designate a set of laboratories or other entities to conduct

testing to assist federal agencies in carrying out their

responsibilities. The programs include an assessment regarding

the capability of the laboratory to conduct the testing. The

type and degree of such assessments, however, vary greatly by

program. It should be noted that the entries in this directory

are based primarily on information provided by the federal agency

and reflect the agency's view of its activities. Parties

interested in this area may also wish to review NBS SP 739,

Directory of Federal Government Certification Programs , which

contains information on a number of closely related programs.

This directory is part of ongoing NIST efforts to establish and

maintain comprehensive databases on standards, regulations,

laboratory accreditation and certification programs and related

information in accordance with the requirements of the Trade

Agreements Act of 1979. This material has been compiled to meet

the needs of government, industry, and the public for information

on U.S. Government laboratory accreditation and related programs.

Key Words: certification; grading; inspection; laboratory

accreditation; listing; mutual recognition schemes; proficiency

testing; qualified laboratories; standards; testing

v

CONTENTS

Page

Foreword iii

Acknowledgments iv

Abstract v

Introduction 1

Programs by Department/Agency 6

Appendix I Indices 71

Government National Accreditation Systems 72

Agency Index by Acronym 7 4

Department/Agency Index 7 5

Agency Index 7 7

Index by Field of Testing 78

Index by Product Tested 79

Appendix II Format Used for Each Entry 83

Appendix III — Other Programs of Possible Interest 85

Appendix IV List of Acronyms 93

Appendix V Other NIST Documents of Possible Interest 95

vii

INTRODUCTION

Background

Laboratory accreditation has taken on increased significance

worldwide as international recognition and acceptance of national

accreditation bodies have assumed greater importance in the

reduction of technical barriers to trade. Laboratory

accreditation provides varying degrees of assurance of the

technical proficiency and competence of a laboratory to assess a product's or service's conformance to a set of prescribed

standards. 1 The competence of laboratories which perform the

required testing within a certification or approval system is as

vital in securing acceptance of the results of that

certification/approval as is the adequacy of the standards on

which the certification is based. The effects of laboratory

accreditation, certification, and standardization activities are

intertwined and together can serve as a basis for increased or

diminished opportunities for international trade.

Purpose of this Directory

This directory is designed to provide information on federal

laboratory accreditation and similar type programs which

designate a set of laboratories or other entities to conduct

testing to assist federal agencies in carrying out their

responsibilities. The programs include an assessment regarding

the capability of the laboratory to conduct the testing. The

type and degree of such assessments, however, vary greatly by

program. It should be noted that the entries in this directory

are based primarily on information provided by the federal agency

and reflect the agency's view of its activities. Parties

interested in this area may also wish to review NBS SP 739,

Directory of Federal Government Certification Programs , which

contains information on a number of closely related programs.

These accreditation/designation programs are conducted by the

federal government for both products and services. The directory

contains descriptions of each program, information on the date

that the program was initiated, the authority under which the

program is conducted, the fields of testing being accredited or

designated, the products directly or indirectly affected by the

testing, program requirements, availability of related

publications, and other information.

1 Guide 2 of the International Organization for

Standardization notes that: "The term laboratory accreditation

may cover the recognition of both the technical competence and

the impartiality of a testing laboratory or only its technical

competence. Accreditation is normally awarded following

successful laboratory assessment and is followed by appropriate

surveillance.

1
Directory Format

The entries in this directory are organized by department or

independent commission/agency. Within each department, programs

are organized by departmental agency. There is a product index

in Appendix I, in addition to several organizational indices. A

description of the format used for each entry is contained in

Appendix II.

Programs included within this directory are based primarily on a listing of federal laboratory accreditation programs included in

a 1984 publication, Principal Aspects of U.S. Laboratory

Accreditation Systems , by Charles W. Hyer. A 1989 United States

General Accounting Office Report, RCED 89-102, Laboratory

Accreditation: Requirements Vary Throughout the Federal

Government , updated that listing and identified 20 active federal

laboratory accreditation programs. Thirty-one programs have been

included in this directory based on information provided by the

relevant department or agency.

Appendix III of the directory lists other federal agency programs

of possible interest. This section includes programs which are

very limited in the types and degree of assessment performed and

whose managers did not feel that the program qualified as an

accreditation program. This section also provides some

information on programs which are still under development.

Program Differences

Requirements for laboratory accreditation/designation programs

within the federal government vary greatly. Individual program

requirements may include a review of documentation on aspects of

an organization's structure; personnel; equipment and facilities;

equipment calibration and maintenance procedures; quality control

program; record keeping procedures; availability and use of

operational/quality manuals; content and quality of actual test

reports; testing conditions, methods and procedures; and/or

sample handling and selection procedures. Accreditation/

designation procedures may also include an on-site inspection of

the laboratory's equipment and facilities, or the use of a proficiency testing program. 2 While some programs, such as those

of the National Voluntary Laboratory Accreditation Program

(NVLAP) , are quite comprehensive, others involve only minimal

review of a laboratory's competence. In general, the

requirements of each program have been tailored to meet specific

agency needs; and, except for the Department of Commerce's NVLAP,

laboratory accreditation/designation is not the primary goal of

the program.

2 Laboratory proficiency testing is defined by ISO Guide 2

as: "Determination of laboratory testing performance by means of

interlaboratory test comparisons."

2
The reader should not assume that comparable programs, even those

which are conducted by the same department or agency, will

include the same types or number of assessment procedures or will

provide similar assurance regarding a laboratory's competency.

The following chart summarizes the number and types of assessment

criteria and procedures required by the federal government

laboratory accreditation type programs identified in this

directory:

NO. OF PROGRAMS WITH

REQUIREMENT REQUIREMENT

YES NO N/A

Submission of Appropriate Documentation 28 3

Independence (No Conflict-of-interest) 9 21 1

Financial Stability 7 23 1

On-site Inspection 26 5

Staff Qualifications Requirements 26 5

Adequate Q.A. System 23 8

Sample Control/Integrity Requirements 21 10

Recordkeeping Requirements 26 5

Test Report Content/Format Requirements 24 7

Available Operational Manuals/Instructions 21 10

Periodic Random Re-audit of Facilities 13 18

Periodic Scheduled Re-audit of Facilities 17 14

Participation in Proficiency Testing Program 18 13

Adequacy of Facilities & Equipment 28 3

Equipment Maintenance/Calibration Requirements 25 6

Other 6 25

All or most programs have equipment, facility, personnel, initial

on-site inspection, and recordkeeping requirements. There are,

however, considerable differences in requirements for laboratory

independence from any direct control by the manufacturer/producer

/user, the financial stability of the laboratory, for

participation in a proficiency testing program and for re-audit

requirements. In addition, some proqrams have other unique

requirements, such as that the test station be open for

public use, that the site of the test facility meet certain

requirements, that the facility has adequate security, or that

the laboratory has personnel available to testify in the event of

a legal proceeding.

Another difference between programs is that some accredit

laboratories in specific areas of testing (such as testing

textiles and apparel products) or for specific test methods,

while others accredit laboratories over a broader field of

testing.

3
Eligibility requirements for accreditation also vary among

programs. Some programs restrict applications to state

laboratories only. The Department of Agriculture (USDA) program

for inspecting grain for export restricts the number of approved

laboratories in a particular geographical area. Some

accreditation programs are restricted to laboratories operated by

the agency doing the accreditation, such as the Department of

Veterans Affairs (VA) program to accredit the laboratories of its

medical centers. This last type of program falls into a category

somewhere between laboratory accreditation and internal quality

assurance — since elements of both are present.

The terminology used also varies among programs with some

programs referring to a laboratory which meets the criteria

established within the program as "accredited," to others that

refer to the laboratory as "inspected," "accepted," "designated"

or even "nationally recognized." Even the same term, such as

"accredited," is used by different programs to mean very

different types of assessments and assessment procedures.

Different terms may also have different legal implications or may

reflect differences between various agencies' legal authority to

conduct specific programs. It is important that the reader be

aware of such differences when reviewing the entries in this

directory. The terminology used in individual entries, in some

cases, was modified to reflect the needs and preferences of the

agency

.

Multiple Accreditations

As noted in the recent GAO report, "many kinds of laboratories

and organizations perform testing to ensure compliance with

government requirements, including clinical laboratories that

test human tissue for disease; environmental laboratories that

test water for chemicals and bacteria; food laboratories that

test meat and poultry for moisture, fat, protein, and salt; and

commercial gauger laboratories that test petroleum products and

other merchandise for composition and/or characteristics."

Laboratories involved in multiple types of testing, in some

cases, may be accredited by more than one agency. Because the

government laboratory accreditation programs (except for the

NVLAP program) are narrowly focused — accrediting or designating

laboratories to test only a narrowly defined range of products or

services — it is unlikely that a laboratory would be accredited/

designated to perform the same type of testing by more than one

government agency.

4
The subject of overlapping accreditations was explored in the GAO

report, and only two programs (one operated by the Federal

Communications Commission and the NVLAP program) showed some

limited overlap.

Acceptance of Accreditation Program Results by Other Federal

Agencies

Some federal laboratory accreditation programs are accepted by

other agencies. Participation in the NVLAP program, for example,

is required by the Department of Housing & Urban Development

(HUD) , the Federal Communications Commission (FCC) , the Federal

Trade Commission, the Environmental Protection Agency (EPA) , the

Nuclear Regulatory Commission (NRC) , and parts of the Department

of Defense (DOD) . Reports on laboratories (that also test

pesticides and environmental contaminants) from the Food & Drug

Administration's (FDA's) toxicology laboratory monitoring program

are shared with the Environmental Protection Agency (EPA)

.

Again, because accreditation programs are usually narrowly

focused and limited to one agency's area of responsibility, the

results of laboratory assessments from these programs are usually

of only limited use to other federal agencies.

Directory Changes

Federal government agencies are encouraged to notify NIST of any

changes in their laboratory accreditation programs or of new

programs. Such information should be sent to:

Office of Standards Code & Information

National Institute of Standards & Technology

Administration Building, Room A629

Gaithersburg, MD 20899

(301) 975-4031

Other References

Additional NIST documents of possible interest are contained in

Appendix V.

5
Received: 10/90

Department/Agency: Department of Agriculture (USDA)

Animal & Plant Health Inspection Service (APHIS)

Veterinary Service (VS)

Science and Technology

Room 16308 SB

14th and Independence Avenue, SW

Washington, DC 20250

Phone:

FAX:

Program Title:

Date Established:

Description:

(202) 447-2081

(202) 475-4265

Accreditation of laboratory facilities for contagious equine

metritis (CEM)

.

April 1983.

To approve laboratories to conduct diagnostic procedures for

contagious equine metritis, a highly transmissible venereal

disease of horses.

Fields of Testing: Biological.

Products Tested:

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Equine-related products (specimens conducted from the

reproductive tract of horses)

.

See 9 CFR Part 92 and VS Memorandum 558.2, 5/18/81.

A list, is available from USDA/APHIS , Import-Export Animals

Staff, Room 764, 6505 Belcrest Road, Hyattsville, MD 20782.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection (includes complete audit of

capabilities)

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

x

X

X

X

X

X

X

X

X

X

Other Information: The criteria for accreditation are comparable to those

suggested in the American Society of Testing and Materials

(ASTM) E548, "Practice for Preparation of Criteria for Use in

the Evaluation of Testing and Inspection Bodies." They are

also similar to the EC requirements.

Accreditation

Terminology:

Uses the term, "approved," which is defined as the assurance

of a laboratory's competence to run approved tests and that

adequate space and equipment is available.

6
Cccpliance: Mandatory.

Authority: 9 CFR Part 92 and VS Memorandum 558.2, 5/18/81.

Fees: None.

Accreditation

Action Frequency: Good until revoked.

Assessors: On-site inspection done by APHIS field Veterinary Medical

Officers. Credentials reviewed by Head, General Bacteriology

Section.

Proficiency

Testing Program: Ongoing as required.

Appeal Procedure: Normal U.S. federal agency due process appeals mechanisms.

Publications: All standards and program notices and changes are published in

the Federal Register.

Logo: None.

No. of Labs: 23 laboratories as of March 1990.

Availability of

Accreditation: Open to all U.S. private and state government laboratories.

List/Directory of A list, "Contagious Equine Isolation Approved Laboratories, 11 Accredited Labs: is available from USDA/APHIS

.

Int'l Recognition/ No special arrangements. System is an importer assistance

Agreements: program.

Other Recognition: None.

7
Department/Agency:

Phone:

Program Title:

Received: 4/90

Department of Agriculture (USDA)

Federal Grain Inspection Service (FGIS)

Compliance Division

P.O. Box 96454

Washington, DC 20090-6454

(202) 447-8525

Grain and commodity inspection and weighing (including

equipment, scale and weight testing)

.

Date Established: 1977 (some aspects of the program were begun earlier)

.

Description: Approves federal and state governmental units and private

sector agencies to inspect and weigh grains and test equipment

and weights under the U.S. Grain Standards Act and approves

federal units to inspect and weigh commodities under the

Agricultural Marketing Act of 1946.

Fields of Testing: Biological, chemical, mechanical and metrology.

Products Tested: Grain, commodities, weighing and measurement equipment.

Standards/Test

Methods:

U.S. Grain Standards Act, as amended, and applicable

regulations; the official U.S. Standards for Grain; FGIS

Inspection Handbooks; FGIS Weighing Handbook; and

related instructions. List is available from FGIS.

Assessment

Criteria/

Procedures:

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

Other Information: The criteria for accreditation are comparable to those

suggested in the American Society of Testing and Materials

(ASTM) E548, "Practice for Preparation of Criteria for Use in

the Evaluation of Testing and Inspection Bodies."

x

x

x

x

xX

X

X

X

X

X

X

X

X

Accreditation

Terminology:

Uses the terms, "designated/delegated," which are defined as a person or agency which has adequate facilities and

qualifications for the performance of such official inspection

and weighing functions and meets other criteria.

8
Compliance: Mandatory for official inspection and weighing services under

the Act.

Authority: United States Grain Standards Act, as amended, 7 USC 71 et

seq. ; regulations are contained in 7 CFR Parts 800-810;

Agricultural Marketing Act, 7 USC 1621 et. seq. ; regulations

are contained in 7 CFR Part 68.

Fees: Fees are charged to the accredited agencies to cover FGIS

costs. Only fees that are approved by FGIS as being reasonable

and riorKiiscariminatory may be charged by an agency for official

service.

Accreditation

Action Frequency:

Ongoing for FGIS and certain state entities - others are

reissued every 3 years or more often if needed, provided

requirements are met.

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

:

FGIS personnel.

Randomly selected samples are monitored for accuracy.

Normal federal due process appeals exist for accredited

agencies. Appeals for weighing and measurement results may be

appealed to FGIS.

U.S. Grain Standards Act, as amended, and applicable

regulations; the official U.S. Standards for Grain; FGIS

Inspection Handbooks; FGIS Weighing Handbook; and

related instructions are available from FGIS.

logo:

No. of labs:

Availability of

Accreditation:

An "official mark" or "shield" prescribed by USDA/FGIS shall

be printed on all official inspection certificates.

107 laboratories as of 3/26/90.

Open to all U.S. private sector and state laboratories, though

each delegated/designated agency has an exclusive territory,

limiting the number of laboratories approved in a particular

area.

List/Directory of

Accredited Labs:

List of delegated/designated agencies and field offices is

available from FGIS.

Int'l Recognition/

Agreements: FGIS and certain delegated states inspect export grain.

Other Recognition: Program is recognized by FDA, ASCS/USDA, and APHIS/USDA and in

the scale testing area by NIST. There are mutual recognition

agreements in place with NIST and FDA.

9
Received: 3/90

Department/Agency: Department of Agriculture (USDA)

Food Safety & Inspection Service (FSIS)

Science & Technology, Chemistry Division

12th & C Streets, SW

Washington, DC 20250

Phone: 202-447-5850

FAX: 202-447-2257

Program Title: Accredited laboratory program.

Date Established: 1962.

Description: Accredits domestic nonfederal analytical chemistry

laboratories to analyze meat and poultry food products for

moisture, protein, fat and salt content, and/or certain

specific classes of chemical residues. Currently the specific

chemical residues are: chlorinated hydrocarbons,

polychlorinated piphenyls, sulfonamides, nitosamimes and

arsenic.

Fields of Testing: Chemical.

Products Tested: Meat and poultry food products only.

Standards/Test Requirements for accreditation are contained in 9 CFR Parts

Methods: 318 and 381.

Assessment Submission of Appropriate Documentation x

Criteria/ Independence (No Conflict-of-interest)

Procedures: Financial Stability

On-site Inspection x

Staff Qualifications Requirements x

Adequate Q.A. System x

Sample Control/Integrity Requirements x

Recordkeeping Requirements x

Test Report Content/Format Requirements x

Available Operational Manuals/Instructions x

Periodic Random Re-audit of Facilities x

Periodic Scheduled Re-audit of Facilities x

Participation in a Proficiency Testing Program x

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements x

Other

Other Information: The requirements are comparable to the guidelines suggested in

the American Society of Testing and Materials (ASTM) E548,

"Practice for Preparation of Criteria for Use in the

Evaluation of Testing and Inspection Bodies."

Accreditation Uses the term, "accredited," which means a nonfederal

Terndnology: analytical laboratory that has met the requirements for

accreditation . . . and may be used in lieu of an FSIS

laboratory for analyzing official regulatory samples.

10
Compliance: Voluntary.

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications:

logo:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Int'l Recognition/

Agreements:

9 CFR Parts 318 and 381.

No laboratory fees.

Accreditation is continuous. However, accreditation will be

withdrawn under 9 CFR Rules if the laboratory fails to meet

the requirements of the rules.

USDA/FSIS personnel who are fully trained and experienced

in laboratory review techniques.

A mandatory aspect of the program is the split sample

analytical capability review. Both as initial and continued,

the reference sample program constitutes the major

accreditation criteria method.

Normal U.S. federal agency due process appeals mechanisms.

Additional appeals procedures are spelled out in 52 FR 9202.

The Federal Register Notice of January 28, 1987.

None, though the accredited laboratory may say that it is

"USDA-FSIS accredited for XXX." (XXX must be a specific

statement)

Approximately 310 laboratories as of January 4, 1990.

Open to domestic private sector and state government

laboratories.

Meat and Poultry Inspection Directory.

Program is recognized by some foreign countries. There are

no mutual recognition arrangements with foreign governments,

though some foreign governments require the U.S. meat program

to offer such a program. Likewise the U.S. government would

like other governments to have similar programs.

Other Recognition: Program is recognized by all states.

11
Department/Agency

:

Department of Agriculture (USDA)

Office of Transportation (OT)

ATP Manager

P.O. Box 96575

Washington, DC 20090-96575

Received: 3/90

Phone:

FAX:

Program Title:

(202) 653-6310

(202) 653-6327

Agreement on the International Carriage of Perishable

Foodstuffs and on the Special Equipment to be Used

for Such Carriage (ATP)

.

Date Established: 1986.

Description: The ATP is an international agreement which sets standards for

the testing and uses of equipment which carries perishable

foodstuffs. The United States is a signatory to this

agreement; and, as such, certifies ATP test stations and

laboratories

.

Fields of Testing: Thermal.

Products Tested: Truck trailers, railcars, freight containers, refrigeration

units or other equipment used for the transport of perishable

foodstuffs.

Standards/Test The Agreement and 7 CFR Part 3300 define all the acceptance

Methods: criteria. A list may be obtained from the ATP Manager at the

above address.

Assessment Submission of Appropriate Documentation

Criteria/ Independence (No Conflict-of-interest)

Procedures: Financial Stability

On-site Inspection x

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements x

Test Report Content/Format Requirements x

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements

Other - test station must be open for public use

and costs of test must be reasonable. x

Other Information: The requirements for certification are similar to those

contained in the American Society of Testing and Materials

(ASTM) E548, "Practice for Preparation of Criteria for Use in

the Evaluation of Testing and Inspection Bodies," except that

there are no personnel qualifications requirements. The

requirements follow those of the ATP agreement, which is

negotiated among the contracting parties.

12
Accreditation

Terminology:

Uses the term, "approved," which means a facility which meets

the requirements of the Agreement and 7 CFR Part 3300.

Compliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications:

logo:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Mandatory for facilities wishing to issue ATP certificates.

7 CFR Part 3300 and the International Carriage of Perishable

Foodstuffs Act of 1982, P.L. 97-325.

Fees are set by and paid to testing station/laboratory.

Test stations must be reaccredited every 5 years.

ATP Manager.

None.

Normal U.S. federal agency due process appeals mechanisms,

Lists of approved test facilities and the text of the ATP

agreement is available from the ATP Manager at the above

address.

None for the test facility, an ATP Placard showing the

information obtained from the test procedure may be attached

to the certified equipment.

Two test facilities as of March 15, 1990.

Open to all U.S. federal, state and private sector

laboratories

.

A list is contained in "ATP Test Stations."

Int'l Recognition/ U.S. ATP certificates are recognized by other ATP signatories

Agreements: including Austria, Belgium, Czechoslovakia, Denmark, Finland,

France, F.R. of Germany, Hungary, Ireland, Italy, Luxembourg,

Morocco, Netherlands, Norway, Poland, Portugal, Spain, Sweden,

U.K., U.S., and Yugoslavia under a reciprocal arrangement.

13
Received: 3/90

Departmenty'Agency: Department of Commerce (DOC)

National Institute of Standards & Technology (NIST)

Office of Weights & Measures (OWM)

Bldg. 101, Room A

Gaithersburg, MD 20899

Phone: 301-975-4014

FAX: 301-963-2871

Telex: TRT 197674 NIST UT

Program Title: State laboratory program.

Date Established: 1967.

Description: Provides a system for certifying state weights and measures

laboratories by specific measurement areas. Authorizes state

laboratories to conduct initial evaluation of weighing and

measuring devices/systems under the National Type Evaluation

Program (NTEP) before their use in commerce.

Fields of Testing: Metrology (mass, volume, length, temperature (liquid

in-glass) )

.

Products Tested: Reference standards in the above areas, weighing and measuring

devices/systems

.

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

These are contained in NIST Handbooks 143 and 145,

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities and Equipment

Equipment Maintenance/Calibration Requirements

Other

xx

x

x

X

X

X

X

X

X

X

Other Information: Each state must have a trained metrologist and an adequate

laboratory facility and must demonstrate on a continuing basis

that it is capable of providing valid measurements in order to

be certified in a particular measurement area. The criteria

are comparable to the requirements of the American Society of

Testing and Materials (ASTM) E548, "Practice for Preparation

of Criteria for Use in the Evaluation of Testing and

Inspection Bodies." A quality assurance program is contained

in Handbook 143, Appendix D. Requirements are also comparable

14
Accreditation

Terminology:

Compliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

logo:

No. of labs:

Availability of

Accreditation:

to EN 45001, except that the assessors are NIST/OWM staff and

are not "appointed," except as "assigned." Subcontracting

sections are also not applicable.

Uses the term, "certified," which means the recognition that a a laboratory appears to have the capability to perform

reliable measurements in specific measurement areas and meets

the general and specific requirements described in NIST

Handbook 143.

Voluntary.

NIST Mission Statement.

None.

Normally every 3 years, but may be annually.

Office of Weights and Measures staff.

Measurement control (both internal and external) have been

established for mass calibration and the volume transfer

testing of glass standards. Internal measurement control

programs consist of repeated measurements on the same objects

over an extended period of time. In external measurement

control programs, standards external to the laboratory are

submitted to the laboratory for test. These standards are

usually calibrated by NIST to provide a reference value.

These programs are expected to be expanded into other areas. Round robin experiments are conducted to investigate the

agreement of state laboratories in other measurement areas.

Normal U.S. federal agency due process appeals mechanisms.

Requirements are contained in NIST Handbooks 143 and 145.

None.

51 laboratories as of March 28, 1990.

Open to all state government laboratories.

List/Directory of NIST SP 686 - State Weights and Measures Laboratories: Program

Accredited Labs: Description and Directory.

Int'l Recognition/

Agreements: None.

Other Recognition: Recognized by all states and the USDA/FGIS

.

15
Received: 6/90

Department/Agency: Department of Commerce (DOC)

National Institute of Standards & Technology (NIST)

National Voluntary Laboratory Accreditation Program (NVLAP)

Bldg. 411, Room A124

Gaithersburg, MD 20899

Phone:

FAX:

Program Title:

Date Established:

Description:

301-975-4016

301 975-3839

National Voluntary Laboratory Accreditation Program (NVLAP)

Formal procedures published February 25, 1976.

Accredits public and private testing laboratories based on

evaluation of their technical qualifications and competence

for conducting specific test methods in specified fields of

testing.

Fields of Testing: All fields for which a need has been demonstrated.

Products Tested:

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Current areas include: acoustical testing services; bulk and

airborne asbestos fiber analysis; carpet testing; thermal

insulation materials testing; construction testing services,

including concrete, cement, aggregates, road/paving

materials, admixtures, soil and rock, and geotextiles;

computer applications, including: GOSIP, POSIX and X.25;

solid fuel room heaters; personnel radiation dosimetry

processing; radiation dosimetry calibration; commercial

products testing including paint, paper, seals and sealants,

plastic, and plumbing fixtures; electromagnetic compatibility

and telecommunications testing according to FCC and Mil Std - 462 requirements.

The entire NVLAP procedure is based upon the premise that

accreditation will be to already published standards, which

are of importance to commerce, consumer well being, or the

public health and safety. A published list of requirements is

available from the above address.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

x

xX

X

X

X

X

X

X

X

X

X

16
Other Information

:

The requirements of the American Society of Testing and

Materials (ASTM) E548, "Practice for Preparation of Criteria

for Use in the Evaluation of Testing and Inspection Bodies,"

were patterned after the NVIAP procedures. NVLAP requirements

are also comparable to ISO Guides 25, 38, 54, and 55 and the

ISO 9000 Series standards.

Accreditation

Terminology:

Compliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications:

logo:

No. of labs:

Availability of

Accreditation:

Uses the term, "accredited," which means formal recognition

that a testing laboratory is competent to carry out specific

tests or types of tests.

Voluntary.

15 CFR Part 7.

Fees and charges to the laboratory participants cover the

costs of examining, accrediting, and auditing the laboratories

and are set by the agency.

Accreditation is reissued annually.

NVIAP uses technical experts recognized in a particular

field of testing, who are under contract to NVLAP.

A program policy is to employ proficiency testing and

reference sample procedures wherever practical and useful.

The laboratory has 30 days to appeal the suspension or

revocation of their accreditation. A hearing will be held

under 5 USC 556. Agency also employs other normal U.S.

federal agency due process appeals mechanisms.

Copies of 15 CFR, Part 7, the "NVIAP Directory of Accredited

laboratories," and "Program Handbooks" specific to each field

of testing are available from the above address.

Upon accreditation, the laboratory may use the "NVLAP" logo

under specified conditions.

Approximately 891 accredited laboratories as of March 1, 1990.

There are over 1100 laboratories involved in the program.

Open to all U.S. and foreign, private sector and government

laboratories

.

List/Directory of

Accredited labs: "Directory of NVLAP Accredited Laboratories."

17
Int'l Recognition/ NVLAP has Memoranda of Understanding (MOU's) , which provide

Agreements: for mutual recognition of accredited laboratories. Agreements

are in effect between the United States and the National

Association of Testing Laboratories (NATA) in Australia, the

Testing Laboratory Registration Council (TELARC) in New

Zealand, and the Standards Council of Canada (SCC)

,

Other Recognition: The NVLAP programs for accrediting carpet, asbestos, and

dosimetry laboratories are recognized by the Department of

Housing and Urban Development (HUD) , the Environmental

Protection Agency (EPA) , and the Nuclear Regulatory Commission

(NRC) respectively.

18
Department/Agency: Department of Defense (DOD)

Army Corps of Engineers (CE)

ATTN: DAEN-CECW-EG

Washington, DC 20314-1000

Received: 7/90

Rhone:

Program Title:

202-272-0207

CE district, project and commercial laboratories assurance

inspection program.

Date Established: 1966.

Description: The district engineer is responsible for assuring that

district, project and commercial laboratories performing

materials testing for the Corps of Engineers have the required

capability. Each district requests assurance inspections of

their testing laboratories by the division materials

laboratory. Division materials laboratories are inspected by

Cement and Concrete Reference Laboratory, NIST.

Fields of Testing: Mechanical and chemical.

Products Tested:

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

x

x

Other Information

Soil; aggregates; stone; sand, cement and cement based

products including: concrete, lime, gypsum, building

constructions (including foundations) , and water, air, and

components of the environment.

ASTM Standard E329; "Recommended Practice for Inspection and

Testing Agencies for Concrete, Steel, and Bituminous Materials

as Used in Construction," Engineer Manual 1110-2-1906 , Corps

of Engineers Waterways Experiment Station Handbook for

Concrete and Cement , or project specifications as applicable.

Submission of Appropriate Documentation x

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program x

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements x

Other

Human resources, physical resources, quality systems

requirements follow the American Society of Testing and

Materials (ASTM) E548, "Practice for Preparation of Criteria

for Use in the Evaluation of Testing and Inspection Bodies,"

and are then specifically amplified by the ASTM standard E329,

x

19
"Recommended Practice for Inspection and Testing Agencies for

Concrete, Steel, and Bituminous Materials as Used in

Construction.

Compliance:

Authority:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

:

logo:

No. of Labs:

Inspection of contracted, district or project laboratories is

required prior to testing and at least every 2 years

thereafter (Engineer Regulation 1110-1-261) . Laboratories for

testing concrete, steel, and bituminous materials are

inspected for compliance with ASTM E329 or project

specifications. Laboratories for testing soils and rock shall

be inspected for compliance with ASTM D3740 and applicable

tests in Engineer Manual 1110-2-1906 or tests required by

project specifications, Corps of Engineers Waterways

Experiment Station Handbook for Concrete and Cement .

Laboratories engaged in analysis of water, sediment or other

samples for chemical analysis are inspected to assure

capability using procedures described in Handbook for

Analytical Quality Control in Water and Wastewater

Laboratories , EPA 600/4-790919, March 1979; National Handbook

of Recommended Methods for Water Data Acquisition , USGS 1977;

"Guidelines for Establishing Test Procedures for Analysis of

Pollutants Under the Clean Water Act," 40 CFR Part 136,

Vol. 50, No 209; Test Methods for Evaluating Solid Wastes , EPA

SE-846, April 1984; Standard Methods for the Examination of

Water and Wastewater , 1985, APHA, AWWA, & WPCF, American

Public Health Association; Procedures of Sediment and Water

Samples . EPA/CE-81-1, 1981, Waterways Experiment Station;

Engineer Regulation 1110-1-263, "Chemical Data Quality

Management for Hazardous Waste Remedial Action."

Mandatory for testing to Corps of Engineers requirements.

Engineer Regulation No. 1110-1-261.

Every 2 years.

District laboratories will be inspected by qualified personnel

from the division laboratory; division laboratories will be

inspected by NIST Cement and Concrete Laboratory. (Engineer

Regulation No. 1110-1-8100.

Depends on the type of laboratory. See Other Information.

Normal U.S. federal agency due process appeals mechanisms.

See Other Information.

None.

Estimated at over 100 laboratories on a national basis,

however, an exact count would require a survey of each

district.

20
Availability of

Accreditation: Open to district, contracted and project laboratories.

List/Directory of

Accredited labs: None.

Int'l Recognition/

Agreements: None intended or expected.

Other Recognition: None.

21
Departaaent/Agency: Department of Defense (DOD)

Defense Electronics Supply Center (DESC)

Qualification Division (EQ)

1507 Wilmington Pike

Dayton, OH 45444

Received: 9/90

Phone:

FAX:

513-296-6271

513-296-8748

Date Established: 1962-assumed from ASESA program of 1940s.

Description: Determines that commercial laboratories are suitably

equipped to perform specific testing for manufacturers listed

on Qualified Product/Manufacturer Lists (QPL/QML)

.

Fields of Testing: Electrical, ionizing radiation, metrology, non-destructive,

optics and photometry.

Products Tested: Military devices and components.

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Other Information:

Accreditation

Terminology:

Military standards and specifications with appropriate federal

and commercial standards and test methods. See Legal

Authority.

Submission of Appropriate Documentation x

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection x

Staff Qualifications Requirements x

Adequate Q.A. System x

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions x

Periodic Random Re-audit of Facilities x

Periodic Scheduled Re-audit of Facilities x

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements x

Other

Emphasis is placed on the physical resources of the entity to

be approved. Human and organizational resources follow the

guidelines of the American Society of Testing and Materials

(ASTM) E548, "Practice for Preparation of Criteria for Use in

the Evaluation of Testing and Inspection Bodies."

Uses the term, "suitable," which means that the laboratories

are found to be suitably equipped and staffed for performing

qualification testing for manufacturers.

Compliance: Mandatory.

22
Authority:

Fees:

Acxireditaticn

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

:

logo:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Int'l Recognition/

Agreements:

Defense procurement approval requirements of Defense

Acquisition Regulation (DAR) and DOD Directive 4120. 3-M;

Qualification Information for Manufacturers, Qualification

Handbook for Established Reliability Specifications, and SD-6

Provisions Governing Qualifications.

None.

Accreditation is reissued every 2 years.

Qualified DESC-EQ engineers.

As required by standards or specifications.

Normal U.S. federal agency due process appeals mechanisms.

Qualified Product Lists (QPL's) ; DOD Standardization Manual

4120. 3-M; SD-6 Provisions Governing Qualifications and the

"List of Commercial Laboratories Suitable for Testing

Military Devices" are available.

None for laboratories. Most components will be marked with the

military P/N and "JAN" brand.

Approximately 111 laboratories as of September 17, 1990.

Open to all U.S. and foreign private sector laboratories.

"List of Commercial Laboratories Suitable for Testing

Military Devices."

Recognition agreements include NATO-STANAG 4093; U.S. -Canada,

U.S. -Ireland, and U.S. -Australia international standardization

agreements.

Other Recognition: None.

23
Received: 8/90

Department/Agency: Department of Defense (DOD)

Defense Logistics Agency (DIA)

Defense Personnel Support Center (DPSC)

2800 South 20th Street

Philadelphia, PA 19101

Phone: 215-737-3240

FAX: 215-737-3806

Telex:

Program Title: Qualified Laboratory List (QLL)

Date Established: 1961.

Description: Lists laboratories found to be capable of performing types of

specification tests for clothing, textiles, footwear, and

equipage-type items. DPSC is presently in the process of

revising the program to reduce the nonconformance rate for

suppliers' laboratory reports.

Fields of Testing: Chemical, electrical, non-destructive, optics and photometry,

thermal, and physical.

Products Tested: Textiles and equipages/apparel products.

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Principal standards are military, however, most textile and

chemical standards and specifications of voluntary and

governmental basis are referenced, i.e., American Society for

Testing and Materials (ASTM) , federal specifications, etc.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

x

x

Other Information: This program is applicable to the Laboratory Branch, Quality

Assurance Division and all testing laboratories and

contractors doing business on DPSC contracts. The QLL is

furnished to all firms on the DPSC Clothing and Textiles'

Bidders List to help contractors identify capable

laboratories. Human resources, physical resources, and quality

systems requirements are those essentially described in the

American Society of Testing and Materials (ASTM) E548,

"Practice for Preparation of Criteria for Use in the

24
Accreditaticn

Terminology:

Compliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications:

logo:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Int'l Recognition/

Agreements: None.

Other Recognition: None.

Evaluation of Testing and Inspection Bodies." Organizational

and records requirements are different. Initial detailed

dcicumentation affords the basis for conditional or tentative

approval.

Uses the term, "qualified," which means that the laboratories

are found to be capable of performing the types of

specification tests for which they are listed.

Voluntary for laboratory listing. Testing requirements,

however, are mandatory for supplier of product through

contractual requirements. Listing permits reduction in

government verification tests.

No specific citation.

None.

Review of activity reports and response to complaints and

other factors dictate frequency of laboratory review.

The agency maintains its own testing facility, and qualified

personnel of that laboratory constitute principal assessors.

Samples with known results obtained in the areas deemed

advisable as a reference sample procedure. Samples may also be

tested concurrently by the qualified laboratory and the DPSC.

Normal U.S. federal agency due process appeals mechanisms.

A list of qualified laboratories is available.

None.

Approximately 350 laboratories (as of June 30, 1989)

.

Open to all U.S. laboratories.

A "Qualified Laboratory List" is available.

25
Received: 11/90

Department/Agency: Environmental Protection Agency (EPA)

Office of Drinking Water, WH-550D

401 M Street, SW

Washington, DC 20460

Phone: 202-382-3022

FAX: 202-382-3762

Program Title: Drinking water

Date Established: 1977.

laboratory certification program.

Description: Provides for evaluation of laboratories which analyze public

drinking water supplies for compliance purposes. Primacy

states may certify local laboratories for testing drinking

water in compliance with the Safe Drinking Water Act of 1974,

as amended. Program covers EPA regional laboratories,

principal state laboratories, and local laboratories in

many states.

Fields of Testing: Biological, chemical, radiochemical.

Products Tested: Water.

Standards/Test EPA Drinking Water Regulations (40 CFR Parts 141, 142, and

Methods: 143) , standards and protocols referenced by the Agency.

Assessment

Criteria/

Procedures:

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

x

x

x

x

x

X

X

X

X

X

X

X

Other Information: Criteria for accreditation include such factors as personnel

training and experience, physical resources, analytical

capability, and quality control procedures. Documentation with

application and conferences held on a pre-evaluation basis are

used to explain what is expected by on-site review. On-site

review will be followed by evaluation, report, and

recommendations. Under this program, water system operators

and/or state inspectors periodically collect water samples as specified in the Drinking Water Regulations and have them

tested at a certified/approved laboratory. The frequency of

the required monitoring depends on the contaminant, the water

source (surface water or groundwater) , and, in some instances,

26
Accreditation

Terminology:

Compliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications:

lego:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited labs:

the size of the population served. Test results are reported

to the state for appropriate action. EPA has established time

frames and criteria for state enforcement actions.

Uses the terms, "approved," or "certified" which means that a laboratory has demonstrated to the EPA or the states that it

is capable of performing the analytical measurements required

in the drinking water program and obtaining accurate results.

Voluntary (but part of formal program)

.

Safe Drinking Water Act, as amended. Under section 1413 of

the amended act, a state has primary enforcement

responsibility for public water systems and certifies local

laboratories to test drinking water for compliance purposes.

No federal fees. States may charge fees for certifying local

laboratories.

Annual performance evaluations samples must be analyzed.

On-site evaluations are scheduled every 3 years, unless an

exception is granted by EPA.

Experienced laboratory personnel from EPA or the states.

Program requirements include satisfactory analysis of

performance evaluation samples.

Normal U.S. federal agency due process appeals mechanisms.

Laboratory certification manual, "Manual for the

Certification of Laboratories Analyzing Drinking Water," is

available from the above address.

None, though certified laboratories are issued certificates

identifying areas of competency.

Eventual number could reach 2500 laboratories.

Subject to state regulations.

The National Registry of Laboratories Certified to Test

for Drinking Water Parameters , is available from the

Association of State Drinking Water Administrators,

1911 North Fort Myer Drive, Arlington, VA 22209

Int'l Recognition/

Agreements: Program could have unofficial international participation.

Other Recognition: None.

27
Received: 8/90

Department/Agency: Environmental Protection Agency (EPA)

Office of Mobile Sources

Emission Control Technology Division

2565 Plymouth Road

Ann Arbor, MI 48105

Rione:

FAX:

Program Title:

Date Established:

313-668-4299

313-668-4368

Retrofit Device

1980.

Evaluation Program

Description: Recognizes independent laboratories as likely being capable of

performing preliminary screening tests on vehicles for

assessing the emission and fuel economy benefits of devices

(including fuel additives) . The preliminary testing is a

screening mechanism only and therefore not used in lieu of EPA

testing.

Fields of Testing: Chemical and mechanical.

Products Tested: Light duty on-highway transportation vehicles.

Standards/Test The evaluation and test protocols are provided for in 40

Methods: CFR Part 610, titled "Fuel Economy Retrofit Devices, Test

Procedures and Evaluation Criteria" and in the EPA document

"EPA Retrofit and Emission Control Device Evaluation Test

Policy," which may be obtained from the above address.

Assessment Submission of Appropriate Documentation x

Criteria/ Independence (No Conflict-of-interest) x

Procedures: Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements

Other

Other Information: The laboratory must have no financial interest in the outcome

of testing other than the fees charged for the actual

performance of the tests. The organization should be operating

independently of any manufacturer of motor vehicles, engines,

retrofit devices or fuel additives. Physical resources must be

similar or equivalent to facilities and equipment in the EPA

motor vehicle emissions laboratory.

28
Accreditation

Terminology:

Compliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

logo:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited labs: None.

Int'l Recognition/

Agreements: None

Other Recognition: None.

Uses the term, "recognized," which is defined as a test

facility operated independently of any motor vehicle, motor

vehicle engine, or retrofit device manufacturer and capable of

performing retrofit device evaluation tests.

Voluntary.

Section 511 of the Motor Vehicle Information and Cost Savings

Act, 15 USC 2011 et. seq.

None.

Test data is validated by correlation of test procedures,

ambient control and the accuracy and precision of the

measurement techniques and instrumentation

EPA professional qualified staff.

None.

Normal U.S. federal agency due process appeals mechanisms.

See 40 CFR Part 610, titled "Fuel Economy Retrofit Devices,

Test Procedures and Evaluation Criteria" and the EPA

document "EPA Retrofit and Emission Control Device Evaluation

Test Policy," which may be obtained from the above address.

None.

N/A.

Open to all U.S. laboratories.

29
Received: 8/90

Departinent/Agercy: Environmental Protection Agency (EPA)

Office of Air Quality Planning and Standards

Technical Support Division (MD-14)

Research Triangle Park, NC 27711

Phone: 919-541-1059

FAX: 919-541-5663

Program Title: Wood Stoves New Source Performance Standards Laboratory

Accreditation

Date Established: 1988.

Description: In order to comply with the new source performance standards

(Clean Air Act Section III) , wood stoves manufacturers must use

accredited laboratories to show (certify) that their stoves

meet the air emission limits. Test conditions are specified in

the Federal Register and laboratories undergo annual

performance proficiency tests. Stoves are subject to random

audits.

Fields of Testing: Chemical, mechanical, thermal, air emissions/operations

Products Tested: Residential wood heaters

Standards/Test A list is contained in 40 CFR Part 60, Subpart AAA and

Methods: Appendix A.

Assessment Submission of Appropriate Documentation x

Criteria/ Independence (No Conflict-of-interest) x

Procedures t Financial Stability x

On-site Inspection x

Staff Qualifications Requirements x

Adequate Q.A. System x

Sample Control/Integrity Requirements x

Recordkeeping Requirements x

Test Report Content/Format Requirements x

Available Operational Manuals/Instructions x

Periodic Random Re-audit of Facilities x

Periodic Scheduled Re-audit of Facilities x

Participation in a Proficiency Testing Program x

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements x

Other

Other Information: Requirements are essentially comparable to those contained in

the American Society of Testing and Materials (ASTM) E548,

"Practice for Preparation of Criteria for Use in the

Evaluation of Testing and Inspection Bodies." Program,

however, has additional requirements for specific emission

testing requirements.

Accreditation Uses the term, "accredited," which is defined as a test

Terminology: facility operated independently of any motor vehicle, motor

vehicle engine, or retrofit device manufacturer and capable of

performing retrofit device evaluation tests.

30
Compliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

Logo:

No. of Labs:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Int'l Recognition/

Agreements:

Mandatory

Clean Air Act Section III and 40 CFR Part 60, Subpart AAA and

Appendix A.

None.

Annual accreditation is required.

EPA Technical Support Division and Stationary Source

Compliance Division of the Office of Air Quality Planning and

Standards.

Proficiency testing is required annually.

Normal U.S. federal agency due process appeals mechanisms.

See 40 CFR Part 610, titled "Fuel Economy Retrofit Devices,

Test Procedures and Evaluation Criteria" and the EPA

document "EPA Retrofit and Emission Control Device Evaluation

Test Policy," which may be obtained from the above address.

Yes, for the stove.

Nine laboratories as of July 1990.

Open to all U.S. laboratories.

Yes, List of Accredited NSPS Woodstoves Laboratories is

available from above address.

None.

Other Recognition: Required throughout the United States.

31
Departmant/Agency: Federal Communications Commission (FCC)

Office of Engineering & Technology

Authorization & Evaluation Division

Chief, Equipment Authorization Branch

7435 Oakland Mills Road

Columbia, MD 21046

Received: 3/90

Khorte

;

301-725-1585

Program Title: Description of Measurement Facilities.

Date Established: 1975.

Description: Laboratories making measurements of devices that are included

in applications for FCC equipment (radio frequency emitting

devices) authorization provide a description of their

facilities. The limited descriptive information does not

require FCC approval and no inspections of the sites are

required. However, the FCC may reject measurement data from

facilities which file incomplete descriptions or show

deficiencies.

Fields of Testing: Electrical.

Products Tested: Radio frequency emitting devices.

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

As required by the device being tested. May employ FCC

and/or referenced voluntary consensus standards.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-listing of Facilities (every

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other Site qualification test data

3 years)

x

Other Information: Emphasis is placed on physical resources which constitute

principal FCC concerns; however, site situation and LISN

data is required.

Description filing reviewed for completeness and technical

capability of facility.

Accreditation

Terminology: No specific terminology used.

32
Compliance: Voluntary for testing facilities. Mandatory for applicants

for devices subject to certification and notification under 47

CFR Parts 15 and 18.

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

Logo:

No. of Labs:

Availability of

Accreditation:

list/Directory of

Accredited Labs:

Int'l Recognition/'

Agreements:

47 CFR Part 2.948, Description of Measurement Facilities.

None.

Information shall be kept current at all times. At least

every 3 years, the organization filing the data shall

advise that the data on file is current.

The professional staff of the FCC laboratory constitute

principal assessors.

Although no formal program exists, the retest of identical

units at FCC facility acts as a proficiency sample random

method.

Normal U.S. federal agency due process appeals mechanisms.

47 CFR 2.948 and OET Bulletin 55.

None.

Approximately 300 laboratories as of March 1990.

Open to all laboratories.

FCC maintains a list of parties who have filed the required

information.

None.

33
Received: 5/90

Departanent/Agency: Department of Health & Human Services (HHS)

Alcohol, Drug Abuse, & Mental Health Administration (ADAMHA)

National Institute on Drug Abuse

Division of Applied Research, Drug Testing Section

Room 9A-53

5600 Fishers Lane

Rockville, MD 20857

Phone:

FAX:

301-443-6014

301-443-2636

Program Title: National Laboratory Certification Program (NLCP)

.

Date Established: April 11, 1988.

Description: This program establishes appropriate standards and procedures

for periodic review of laboratories and criteria for

laboratory certification for urine drug testing for federal

agencies. The program certifies laboratories to perform

forensic urine drug testing. Methodology includes immunoassay

screen followed by a gas chromatography/mass spectrometry

confirmation. Cut-off levels established for marijuana

metabolites, cocaine metabolites, opiates, phencyclidine, and

amphetamines

.

Fields of Testing: Chemical, forensic toxicology.

Products Tested:

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Urine samples for drugs of abuse, specifically, marijuana,

cocaine, opiates, PCP and amphetamines

.

A list of standards/test methods for which laboratories may be

accredited may be obtained by requesting the Mandatory

Guidelines From NIDA.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Performance Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other Requirements - Security Requirements

- Availability of personnel to testify

x

x

x

x

x

x

x

x

x

x

xx

x

x

34
Other Informaticai: Requirements are in accordance with ASTM E 548, though the

program includes more detailed security and sample chain of

custody requirements in the accreditation procedures.

Procedures are comparable to DOD's drug testing program for

military personnel.

Accreditation

Tenninology:

Oompliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Uses the term, "certified, " meaning a laboratory which

meets the standards established in the Mandatory Guidelines

for Federal Workplace Drug Testing Programs.

Voluntary for laboratories not engaged in federal drug

testing. Mandatory for laboratories engaged in federal drug

testing programs.

Executive Order No. 125654 (9/15/86) ; P.L. 100-71, Title V,

Sec. 653; HHS Mandatory Guidelines (53 FR 11986), published

April 11, 1988; DOT 49 CFR Part 653; NRC 10 CFR Parts 2 & 26.

Fees are set by the contractor, Research Triangle Institute.

Twice a year.

NCLP staff.

Proficiency

Testing Program:

Appeal Procedure:

Publications

Procedures spelled out in 53 FR 11986, April 11, 1988.

Normal U.S. federal agency due process appeals mechanisms. In

addition, an appeal may be made to the Secretary HHS. Appeal

procedures are described in Mandatory Guidelines.

Executive Order 125654 and 53 FR 11986, April 11, 1988,

Mandatory Guidelines for Federal Workplace Drug Testing

Programs.

Logo:

No. of Labs:

Availability of

Accreditation:

None.

Approximately 48 laboratories as of 3/90.

Open to all domestic private, state and federal laboratories.

Also open to all foreign private and government laboratories.

List/Directory of

Accredited Labs:

Lht'l Recognition/

Agreements

Other

Recognition:

A list is published in the Federal Register every other month.

None.

Program is recognized by all federal agencies, DOT and NRC

regulated industries, and HCFA (CLIA 1988)

.

35
DepartanentyAgency: Department of Health & Human Services

Food & Drug Administration (FDA)

Bioresearch Program, (HFC-30)

Room 15A-03 Parklawn Bldg.

5600 Fishers lane

Rockville, MD 20857

(HHS)

Received: 3/90

Phone:

FAX:

301-443-2390

301-443-3496

Program Title: Toxicology laboratory monitoring program.

Date Established: June 21, 1979.

Description: Program seeks to assure the quality and integrity of the

safety data collected on drugs, food and feed additives, human

biological products and medical devices in order to support

regulatory decision making. FDA inspects nonclinical

laboratories to determine whether they are following good

laboratory practices (GLP)

.

Fields of Testing: Biological/toxicological

.

Products Tested: Human and animal drugs, food and feed additives, human

biological products and medical devices, electronic products

that emit radiation.

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Any and all appropriate rules and regulations of the FDA; and

in particular, those contained in 21 CFR Part 58.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection x

Staff Qualifications Requirements x

Adequate Q.A. System x

Sample Control/Integrity Requirements x

Recordkeeping Requirements x

Test Report Content/Format Requirements . x

Available Operational Manuals/Instructions x

Periodic Random Re-audit of Facilities x

Periodic Scheduled Re-audit of Facilities x

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements x

Other

Other Information: Laboratory documentation is reviewed and an on-site

examination is conducted to evaluate the laboratory's

capability. Requirements are comparable to those contained

in the American Society of Testing and Materials (ASTM) E548,

"Practice for Preparation of Criteria for Use in the

Evaluation of Testing and Inspection Bodies, 11 and European

Norm 45002.

36
Terminology:

Oonpliance:

Authority:

Fees:

Inspection

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

logo:

No. of labs:

Availability of

Coverage:

List/Directory of

Inspected labs:

No specific terminology used other than "complies with GLP

regulations." Laboratories not complying with GLP regulations

are referred to as "disqualified."

Mandatory for laboratories conducting tests on FDA. regulated

products.

21 CFR Part 58 (published in the Federal Register on December

22, 1978) , in accordance with the Federal Food, Drug and

Cosmetic Act and other applicable laws.

None.

A testing facility shall permit an authorized employee of the

Food and Drug Administration, at reasonable times and in a reasonable manner, to inspect the facility and to inspect (and

in the case of records also to copy) all records and specimens

which FDA requires the facility to maintain. Routine

inspections of domestic laboratories are made biennially.

Laboratories requiring data audit inspections are identified

by EPA and scheduled when necessary.

Qualified FDA field inspectors.

None currently employed.

Normal U.S. federal agency due process appeals mechanisms are

spelled out in regulations.

21 CFR Part 58 - Good Laboratory Practice for Nonclinical

Laboratory Studies, documents describing program and

procedures are available. Copies of individual inspection

reports may be obtained as a Freedom of Information request.

None.

Approximately 400 laboratories inspected as of March 6, 1990.

Open to all U.S. private sector, federal and state government

laboratories, as well as foreign private sector and government

laboratories

.

FDA maintains a list of toxicology laboratories that have

been inspected for compliance with the GLP's.

Int'l Recognition/ Agreements have been established with Canada, Switzerland,

Agreements: Germany, the Netherlands, France, Sweden, the U.K., Japan, and

Italy, and the Organization for Economic Cooperation and

Development (OECD)

.

Other Recognition: Cooperates with EPA, USDA, the Department of the Army,

and the CPSC.

37
Department/Agency: Department of Health & Human Services (HHS)

Food & Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Principal Milk Laboratory Evaluation Officer

Lab. OA Branch

10 West 35th Street

Chicago, IL 60616-3799

Received: 6/90

Phone: 312-353-1025

Program Title: Evaluation of milk laboratories.

Date Established: 1951.

Description: Evaluates and endorses laboratory sample collection

surveillance procedures to provide a national base for the

uniform collection and examination of milk.

Fields of Testing: Biological and chemical.

Products Tested: Milk and milk products.

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Test procedures are described in "Standard Methods for the

Examination of Dairy Products," and "Official Methods of

Analysis of the Association of Official Analytical Chemists,"

FDA Forms FDA 2400-2400j, criteria for accreditation defined

in "Evaluation of Milk Laboratories.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

x

xX

X

X

X

X

X

X

X

Other Information: Individual laboratories are accredited for specific test

procedures and official testing is done only at accredited

laboratories. Criteria include adequate physical resources and

qualified human resources determined by on-site evaluation,

and technical skills of analysts determined by proficiency

testing. Human and quality system requirements exceed the

suggested guidelines in the American Society of Testing and

Materials (ASTM) E548, "Practice for Preparation of Criteria

for Use in the Evaluation of Testing and Inspection Bodies."

On-site evaluation, including review of each analyst for all

procedures.

38
Accreditation

Terminology:

Ccsjpliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Uses the term, "accredited/' meaning a milk laboratory

certified as to performance of analyses by an appropriate

agency.

Voluntary for state, commercial and industry laboratories.

Established by FDA, the states and National Conference of

Interstate Milk Shippers (NCIMS) . NCIMS is an alliance of

federal USDA. and state regulatory agencies controlling the

interstate movement of grade A milk and milk products. The

program is voluntary for states.

Food, Drug and Cosmetic Act; Public Health Service Act;

memorandum of understanding between FDA and NCIMS.

None on federal level.

Triennial on-site evaluation by FDA and biennial on-site

review in state programs with at least annual split sample

analysis. Additional monitoring as required.

Experienced, trained laboratory personnel with qualifying

education.

Proficiency

Testing Program:

Appeal Procedure:

Publications:

logo:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Split sample analysis is a mandatory program requirement.

Normal U.S. federal agency due process appeals mechanisms.

"Evaluation of Milk Laboratories," "Recommendations of the

United States Public Health Service/Food and Drug

Administration;" "Sanitation Compliance and Enforcement

Ratings of Interstate Milk Shippers" (a quarterly listing of

all accredited laboratories) are available.

None.

681 laboratories as of April 1990.

Open to state, commercial and industry laboratories.

"Sanitation Compliance and Enforcement Ratings of Interstate

Milk Shippers" (a quarterly listing of all accredited

laboratories) is available from the above address.

Tnt'l Recognition/

Agreements:

Other

Recognition:

None.

States participating in the National Conference of

Interstate Milk Shippers (NCIMS)

.

39
Received: 5/90

Department/Agency: Department of Health & Human Services (HHS)

Health Care Financing Administration (HCFA)

Health Standards and Quality Bureau

2D3 Meadows East Bldg.

6325 Security Blvd.

Baltimore, MD 21207

Phone: 301-966-6801

FAX: 301-966-6730

Program Title: Clinical Laboratories Improvement Act of 1967 (CLIA '67) &

Medicare. Requirements under the CLIA '88 being developed.

Date Established: CLIA - 1969; Medicare - 1966. Requirements under CLIA '88 are

under development.

Description: CLIA is a licensure program required for laboratories in

interstate commerce. Laboratories seeking payment under

Medicare or Medicaid must also be certified for participation.

Fields of Testing: Biological, clinical.

Products Tested: Human specimens.

Standards/Test Laboratories are licensed or certified by specialty or

Methods: subspecialties

.

Assessment Submission of Appropriate Doojmentation

Criteria/ Independence (No Conflict-of-interest)

Procedures: Financial Stability

On-site Inspection x

Staff Qualifications Requirements x

Adequate Q.A. System x

Sample Control/Integrity Requirements x

Recordkeeping Requirements x

Test Report Content/Format Requirements x

Available Operational Manuals/Instructions x

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities x

Participation in a Proficiency Testing Program x

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements x

Other

Other Information: Requirements under Medicare and CLIA '67 are much more

specific the suggested guidelines offered in the American

Society of Testing and Materials (ASTM) E548, "Practice for

Preparation of Criteria for Use in the Evaluation of Testing

and Inspection Bodies."

HCFA now has the responsibility for implementing the CLIA '88

for the certification of all entities that test human

specimens. Proposed rules are being developed to establish

federal health and safety requirements for the certification

of laboratories under the CLIA '88. Among CLIA '88

requirements to be developed are standards for collection of

fees to cover all program costs of administering the CLIA

40
Accreditation

Terminology:

program as well as establishing the criteria to be used for

the recognition of laboratory accreditation and state

licensure programs. CLIA '88 expands HCFA's universe of

regulated laboratories from 12,000 laboratories to a potential

of 300,000 to 600,00 laboratories.

Uses the term, "approved clinical laboratory," meaning a laboratory licensed under the CLIA or approved under medicare

regulations. Also uses the term "licensed," meaning a laboratory approved under the CLIA to test specimens shipped

in interstate commerce.

Cccpliance:

Authority:

Voluntary for laboratories that serve as cooperating

participants. Mandatory for laboratories engaged in interstate

commerce or seeking reimbursement under medicare/medicaid.

Clinical Laboratories Improvement Act of 1967. Regulations may

be found under 42 CFR Part 74 Social Security Act, and

Medicare regulations under 42 CFR Subpart M.

Fees: None.

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications:

Logo:

No. of Labs:

Licenses are issued annually. Medicare approval letters are

sent to laboratories following each inspection to reflect

laboratory's certification status.

State survey agencies conduct inspections and HCFA regional

offices certify state agency findings.

On-site proficiency testing may be employed from

time-to-time. Requirements are contained in 42 CFR

405.1314(a) and 42 CFR Part 74.40-43.

Normal U.S. federal agency due process appeals mechanisms.

Clinical Laboratories Improvement Act of 1967. Regulations may

be found under 42 CFR Part 74 Social Security Act, and

Medicare regulations under 42 CFR Subpart M.

Department of Health and Human Services Logo.

Approximately 2871 laboratories licensed to test interstate

specimens as of 3/15/90 and 4811 laboratories approved for

medicare participation as of 12/30/89.

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Int'l Recognition/

Agreements:

Other

Recognition:

Open to all U.S. laboratories.

There is an alphabetic Listing of Medicare Approved

Independent Laboratories available from the above address.

Unofficial international participation is involved.

State licensure laws frequently reference federal laboratory

regulations and require compliance with federal standards.

New York State program has been recognized under CLIA '67.

41
Received: 6/90

Department/Agency: Department of Housing & Urban Development (HUD)

Federal Housing Administration (FHA)

Materials Engineer, Office of Architecture & Engineering

Materials Acceptance Division

Washington, DC 20410

Phone: 202-708-1029

Program Title: Technical suitability of building products program.

Date Established: 1964.

Description: Accredits third-party organizations which validate

manufacturers ' certifications that certain building materials

meet applicable requirements.

Fields of Testing: Mechanical and chemical.

Products Tested:

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Building products including: carpet, grade marking of lumber,

aluminum windows and doors, grade marking of plywood, pressure

treated lumber, wood flush doors, wood windows, wood sliding

patio doors, glued plywood flooring, textured plywood siding,

1-1/8" plywood flooring, particleboard stair treads, plastic

plumbing fixtures, insulating glass, and solid fuel burning

devices.

Applicable HUD Use of Materials bulletins and referenced

testing procedures, standards or specifications.

Submission of Appropriate Documentation x

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

x

x

Other Information: Human resources, physical resources, and quality systems

requirements essentially follow the guidelines of the American

Society of Testing and Materials (ASTM) E548, "Practice for

Preparation of Criteria for Use in the Evaluation of Testing

and Inspection Bodies."

Formal documentation is required of all laboratories.

Documentation consists of product test qualifications for

both personnel and facilities which is verified by on-site

reviews in all laboratories.

42
Accreditation

Terminology:

Compliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Accrediting

Authority:

Appeal Procedure:

an

Publications:

logo:

No. of labs:

Uses the term, "accepted," meaning an administrator

(organization) which is capable of conducting a certification

program through its organization, staff and facilities and

have a reputation for adhering to high ethical standards.

Voluntary,

programs.

Mandatory for manufacturers if involved in HUD

Int'l Recognition/

Agreements:

24 CFR Part 200, Administrator Qualifications and Procedures

for HUD Building Products Certification Programs, dated

September 20, 1979. Organizations acceptable to HUD are

authorized as administrators of the program. Adndnistrators

must accredit the laboratories they use. (Carpet

administrators must use the NIST NVIAP accredited

laboratories.)

Manufacturers laboratory fees for approval are included in the

participation charges of the administrator, fees may be

collected from commercial laboratories at the discretion of

the administrator.

Documentation must be kept current. Reviews are scheduled on a

1 or 2 year cycle with more frequent reviews possible if

deemed advisable by the administrator.

Administrator's staff or consultants.

None, however, appropriate round-robin procedures for

commercial may be employed by administrators.

Approved administrators.

A procedure is contained in each administrator's program and

additional appeal to HUD officials is possible.

The administrators must provide a directory of certified

products in which the names of both participating

manufacturers and approved laboratories appear.

The accredited laboratories do not employ a program logo. An

administrator's logo appears on certified products.

No exact count is available. There are approximately 30

administrators which accredit from one to 40 laboratories

each.

None currently.

43
Received: 6/90

Department/Agency: Department of Interior

Office of Surface Mining Reclamation & Enforcement (OSM)

Division of Technical Services

1951 Constitution Ave. , NW

Washington, DC 20240

Phone: 202-343-1507

FAX: 202-898-1291

Program Title: Small Operator Assistance Program (SOAP)

.

Date Established: 1979.

Description: Laboratories, qualified as part of the federal procurement

process, prepare a determination of probable hydrologic

consequences and a statement of results of test borings or

core samplings for eligible small coal operators, producing

less than 100,000 tons of coal annually. The information is

used for the operator's coal mine permit application.

Fields of Testing: Chemical, thermal, water quality, hydrology, overburden

testing.

Products Tested: Soil, rock, water.

Standards/Test

Methods:

There is no list of standards/test methods for which

laboratories are accredited. General requirements

may be found in 30 CFR 795.10.

Assessment

Criteria/

Procedures:

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

Other Information: NOTE: In the past, OSM qualified laboratories separate from

the procurement process. This practice ended in 1983 when

regulations for the SOAP were revised. Program uses some, but

not all of the criteria of the American Society

of Testing and Materials (ASTM) E548, "Practice for

Preparation of Criteria for Use in the Evaluation of Testing

and Inspection Bodies."

44
Acaneditation

Terminology:

Compliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications:

lego:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Int'l Recognition/

Agreements:

Other

Recognition:

Uses the term, "qualified," meaning a designated public

agency, private firm, institution, or analytical laboratory

which can prepare the required determination of probable

hydrologic consequences or statement of results of test

borings or core samplings.

Voluntary.

Sec. 507(c) of P.L. 95-87, 30 CFR Part 795.

N/A.

N/A.

Technical proposals are evaluated by professional staff.

No.

Normal U.S. federal agency due process appeals mechanisms.

30 CFR Part 795.

None.

One laboratory as of June 1990.

Program is open to all U.S. state, federal and private sector

laboratories

.

N/A.

None.

None.

45
Department/Agency: Department of Labor (DOL)

Mine Safety & Health Administration (MSHA)

Approval & Certification Center (A&CC)

RR1, Box 251

Industrial Park Road

Triadelphia, WV 26059

Phone: (304) -547-0400 FTS: 723-1501

Date Established: 1952 by the Federal Coal Mine Safety Act.

Description:

Received: 4/90

Accreditation of inspection/test laboratories as a function of

manufacturer quality control maintenance for component parts

made and assembled for MSHA approval or certification.

Fields of Testing: Electrical, mechanical.

Products Tested: Electrical machinery, equipment, supplies and appliances.

Standards/Test Standards, test methods, examinations and procedures are

Methods: contained in Title 30 of the CFR. There are also MSHA/A&CC

procedural requirements for products requiring approval

and certification.

Assessment

Criteria/

Procedures:

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other Periodic Product Audits

x

x

x

x

x

xx

Other Information: Since this program provides ongoing support for continued

compliance of products with certification and approval

requirements, it addresses primarily the organizational,

quality systems, and physical resources requirements such as those covered in the guidelines of the American Society of

Testing and Materials (ASTM) E548, "Practice for Preparation

of Criteria for Use in the Evaluation of Testing and

Inspection Bodies." A detailed quality characteristics

inspection and test application is required with detailed

inspection and test procedures, together with methods of test,

instrumentation, test equipment and referenced procedures

including sampling, plans. The application is verified through

product testing and on-site review as required.

46
Accreditation

Terminology: No specific terminology.

Compliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

logo:

No. of labs:

Availability of

Accreditation:

Voluntary approval and certification programs, with

inspection/test accreditation mandatory where they apply to

such products.

Title 30 of the CFR.

Fees are included in product approval and certification

charges.

Accreditation is a function of product monitoring and may be

reviewed by product changes and/or retest at MSHA, A&CC.

Inspection/test is essential during period of certification

and approval of products.

All assessments of inspection/test adequacy, in laboratory and

on-site are performed by the professional staff of the MSHA,

A&CC.

MSHA reserves the right to retest products or to witness

product testing at the test facility.

Normal U.S. federal agency due process appeals mechanisms.

Basic publication is Title 30 of the CFR with each part type

having its own instructions, application forms and

submission/testing/evaluation details. General material for

approval of mining products from review of analytical location

center and other circulars, lists of qualified/approved

products, manufacturers.

MSHA Logo for products, none for accredited inspection/test

facility.

Estimated at over 250 laboratories.

Open to all U.S. laboratories. MSHA will accept product

testing conducted outside the United States where such

acceptance is specifically required by international

agreement.

List/Directory of

Accredited Labs: None.

Int'l Recognition/ Since mine safety products are both exported and inported, the

Agreements: program has international recognition in this product area.

Other

Recognition: Generally accepted by state authorities.

47
Department/Agency: Department of Labor (COL)

Mine Safety & Health Administration (MSHA)

Approval & Certification Center (A&CC)

RR1, Box 251

Industrial Park Road

Triadelphia, WV 26059

Phone: (304) -547-0400 FTS: 723-1501

Date Established: 1976.

Received: 4/90

Program Title:

Description:

Testing and Evaluation of Illumination Systems.

Requires site evaluation to determine if light laboratory

meets the criteria as a simulated working place. Requirements

have been established for the laboratory and for the

measurement procedures. MSHA reserves the right to witness,

retest and is the approval issuer.

Fields of Testing: Electrical, mechanical.

Products Tested: Illumination equipment for mines.

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Standards, test methods, examinations and procedures are

contained in 30 CFR Part 75.1719. There are also MSHA/A&CC

procedural requirements for products requiring approval

and certification.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

- MSHA reserves the right to retest products

at its own facility

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

x

x

X

X

X

X

X

X

X

X

Other Information: This program addresses primarily equipment maintenance,

calibration, and testing procedures; quality control; and

physical resources requirements, such as those covered in the

guidelines of the American Society of Testing and Materials

(ASTM) E548, "Practice for Preparation of Criteria for Use in

the Evaluation of Testing and Inspection Bodies." MSHA

reserves the right to witness testing at the facility.

48
Accreditation

Terminology:

Carpiiance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

Logo:

No. of Labs:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Int'l Recognition/

Agreements:

Other

Recognition:

No specific terminology.

Voluntary for laboratories, except those wishing to test the

compliance of illumination products to MSHA requirements.

30 CFR 75 and 41 FR 14108, April 1, 1976.

Fees are assessed by MSHA based on costs involved.

Accreditation is a function of product monitoring and may be

reviewed by product changes and/or retest at MSHA, A&CC.

Inspection/test is essential during period of certification

and approval of products.

All assessments of inspection/test adequacy, in laboratory

and on-site are performed by the professional staff of the

MSHA, A&CC.

MSHA reserves the right to retest products or to witness

product testing at the test facility.

Normal U.S. federal agency due process appeals mechanisms.

"Handbook of Underground Coal Mine Illumination Requirements'1 30 CFR 75.1719, and 41 FR 14108, April 1, 1976.

Letter of acceptance and MSHA marking for products, none for

accredited facility.

Not available.

Open to all U.S. laboratories. MSHA will accept product

testing conducted outside the United States where such

acceptance is specifically required by international

agreement.

None.

Since mine safety products are both exported and imported, the

program has international recognition.

Generally accepted by state authorities.

49
Department/Agency

:

Department of Labor (DOL)

Mine Safety & Health Administration (MSHA)

Approval & Certification Center (A&CC)

RR1, Box 251

Industrial Park Road

Triadelphia, WV 26059

Phone: (304) -547-0400 FTS: 723-1501

Date Established: 1988.

Received: 4/90

Program Title:

Description:

Testing by Applicant or Third Party.

Requires testing of specific products at the manufacturer or

at a third-party laboratory. MSHA reserves the right to

witness tests, retest, and is the approval issuing authority.

Subparts will be issued by product line.

Fields of Testing: Electrical, mechanical.

Products Tested:

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Mining equipment, including brattice cloth, ventilation

tubing, battery assemblies, multiple shot blasting units.

Other products may be added in the future.

Standards, test methods, examinations and procedures are

contained in 30 CFR Part 7 or 53 FR 23486, June 22, 1988.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

- MSHA reserves the right to retest products

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

x

x

X

X

X

X

X

X

X

X

Other Information: This program addresses primarily equipment maintenance,

calibration, testing procedures, and quality control

requirements such as those covered in the guidelines of the

American Society of Testing and Materials (ASTM) E548,

"Practice for Preparation of Criteria for Use in

the Evaluation of Testing and Inspection Bodies." MSHA

reserves the right to witness testing at the facility.

Accreditation

Terminology: No specific terminology.

50
Ccupliance:

Authority:

Fees:

Voluntary for laboratories, except those wishing to test the

compliance of products listed above to MSHA requirements.

10 USC 957, 30 CFR 7.

Fees for product approval are determined by MSHA. No fees

specifically assessed to the test facility.

Accreditation Acceptance of test results is a part of the product approval

Action Frequency: process. Product approvals may be reviewed by and products

retested as required.

Assessors:

Proficiency

Testing Program:

All assessments of inspection/test adequacy, in laboratory

and on-site are performed by the professional staff of the

MSHA, A&CC.

MSHA reserves the right to retest products or to witness

product testing at the test facility.

Appeal Procedure: Normal U.S. federal agency due process appeals mechanisms.

Publications: 30 CFR 7; FR, June 22, 1988; and guidance.

logo:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited labs:

Letter of acceptance and MSHA marking for products, none for

test facility.

Not available.

Open to any laboratory chosen by the applicant for product

approval.

None.

Int'l Recognition/ Since mine safety products are both exported and imported, the

Agreements: program has international recognition.

Other

Recognition: Generally accepted by state authorities.

51
Received: 3/90

Department/Agency: Department of Labor (DDL)

Occupational Safety Health Administration (OSHA)

Office of Variance Determination

NRTL Program, Room 3653

200 Constitution Avenue, NW

Washington, DC 20210

Phone: 202-523-8131

EAX: 202-523-5046

Program Title: Nationally Recognized Testing Laboratories (NRTL) Program.

Date Established: June 13, 1988.

Description: The applicant for OSHA recognition as an NRTL shall have

administrative and technical capability to conduct product

testing activities and report on the results, to approve

products (product certification) , to inspect factory

production runs for product evaluation, and to conduct field

inspections to assure proper use of its identifying mark or

label on these products.

Fields of Testing: Electrical, fire protection.

Products Tested: Electrical and related products used in the workplace.

Standards/Test

Methods:

A list of standards/test methods for which laboratories

may be accredited is contained in 29 CFR Part 1910, OSHA

General Industry Standards.

Assessment Submission of Appropriate Documentation x

Criteria/ Independence (No Conflict-of-interest) x

Procedures: Financial Stability x

On-site Inspection x

Staff Qualifications Requirements x

Adequate Q.A. System x

Sample Control/Integrity Requirements x

Recordkeeping Requirements x

Test Report Content/Format Requirements x

Available Operational Manuals/Instructions x

Periodic Random Re-audit of Facilities x

Periodic Scheduled Re-audit of Facilities x

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements x

Other

Other Information: The requirements are compatible with those contained in

the American Society of Testing and Materials (ASTM) E548,

"Practice for Preparation of Criteria for Use in the

Evaluation of Testing and Inspection Bodies," and appropriate

international standards/guides. Laboratories, which are

accredited, however must also have a product approval

(certification) function.

52
Accreditation

Terminology:

Conpliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

logo:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited labs:

Uses the term, "nationally recognized, " meaning an

organization that is recognized by OSHA and tests for safety

and lists, labels, or accepts equipment or materials that meet

specific criteria.

Voluntary as to participation by the laboratory.

29 CFR Part 1910.7.

No laboratory fees are required.

Every 5 years.

Qualified OSHA and Mine Safety and Health Administration

(MSHA) staff.

None available.

Normal U.S. federal agency due process appeals mechanisms. In

addition each NRTL must have an acceptable appeals process.

OSHA standards and Federal Register notices.

Yes, there is a logo. In addition NRTL's must apply their own

mark to approved products.

Five laboratories as of March 6, 1990.

Open to all U.S. laboratories and to foreign private sector

laboratories meeting the criteria for application.

Int/1 Recognition/

Agreements:

Other

Recognition:

A list is available from the above address.

None.

The NRTL program is recognized by approved State Occupational

Safety and Health Plans.

53
Received: 6/90

Department/Agency: Department of Labor (DOL)

Occupational Safety & Health Administration (OSHA)

Blood Lead Program Director

P. 0. BOX 65200, Salt Lake City, UT 84165-0200

or

1781 S. 300 W, Salt Lake City, UT 84115

Phone:

Program Title:

Date Established:

Description:

(801) 524-4270

Blood Lead Program.

1979.

Evaluates proficiency testing data and approves laboratories

which meet OSHA accuracy requirements for blood lead analysis

under the OSHA lead standards.

Fields of Testing: Biological.

Products Tested: Blood for lead.

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Requirements for accreditation are available from the Blood

Lead Program Director, DOL - OSHA, P. O. Box 65200,

Salt Lake City, UT 84165-0200.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program x

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

Other Information: Requirements are based solely on the results of proficiency

testing.

Accreditation

Terminology:

Compliance:

Uses the term, "approved," meaning a laboratory that has

received a satisfactory grade in blood lead proficiency

testing in the prior 9 months.

Mandatory for laboratories wishing to supply data - lead

monitoring requirements of OSHA require test data be from an

OSHA approved laboratory.

Authority: OSHA Lead Standard, 29 CFR Part 1910.1025.

54
Fees:

Accreditation

Action Frequency:

Assessors:

Appeal Procedure:

Publications

None from OSHA, some proficiency testing programs do charge

fees.

Quarterly proficiency testing samples.

OSHA staff using proficiency test results from governmental

and private programs.

Normal U.S. federal agency due process procedures.

"OSHA List of Laboratories Approved for Blood Lead

Analysis," program information and instructions are available,

iAst/Directory of

Accredited Labs:

Logo:

No. of Labs:

Availability of

Accreditation:

Int'l Recognition/

Agreements:

Other

Recognition:

"OSHA List of Laboratories Approved for Blood Lead Analysis."

None.

Approximately 165 laboratories as of 5/90.

Open to all U.S. and foreign private sector and government

laboratories

.

None.

None

55
Received: 3/90

Departanent/Agericy: Department of Labor (DOL)

Occupational Safety & Health Administration (OSHA)

Office of Construction & Maritime Compliance Assistance

Rm. N-36010

200 Constitution Avenue, NW

Washington, DC 20210

Rhone:

FAX:

(202) 523-8131

(202) 523 9187

Program Title: Maritime Cargo Gear Accreditation and Certification Program.

Date Established: 1971.

Description: OSHA's cargo gear accreditation program is essentially one of

third-party providing impartial inspection of certain

maritime cargo gear handling devices specifically required to

be certified under OSHA's Maritime Safety and Health

Standards. The organization does not have to be a laboratory,

though it must be capable of conducting the required

testing. U.S. inspected vessels which fall under the

exclusive jurisdiction of the U.S. Coast Guard and foreign

flag vessels are excluded.

Fields of Testing: Mechanical, electrical and non-destructive.

Products Tested: Cranes, derricks, and other maritime material handling

devices.

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Other Information:

x

x

A list of standards/test methods for which laboratories may be

accredited is contained in 29 CFR Part 1919.

Submission of Appropriate Dcicumentation x

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection x

Staff Qualifications Requirements x

Adequate Q.A. System

Sample Control/Integrity Requirements x

Recordkeeping Requirements x

Test Report Content/Format Requirements x

Available Operational Manuals/Instructions x

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements x

Other - An accredited agency must perform at

least 1500 hours of vessel gear certification

work each year in order to maintain accredited

status. x

This program is not necessarily for laboratories. It is open

to third-party agencies with appropriate test equipment

traceable back to NIST and capable of conducting on-site

inspection of cranes, derricks, and other material handling

56
Accreditation

Terminology:

Compliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

logo:

No. of Entities:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Int'l Recognition/

Agreements:

Other

Recognition:

devices in the maritime industry. Requirements are compatible

with those of the International Labor Organization Convention

No. 32.

Uses the term, "accredited, 11 meaning an applicant for

accreditation which is staffed by individuals technically

qualified to conduct the inspections and examinations.

Mandatory.

29 CFR Parts 1912, 1917, 1918, and 1919.

None.

Accreditation is reissued every 1 to 3 years dependent

upon demonstrated experience/expertise.

OSHA Office of Maritime Compliance Assistance staff.

None.

Normal U.S. federal agency due process appeals mechanisms.

Application kit with full program information, the Federal

Register for notification purposes and a list of accredited

agencies are available.

None.

134 laboratories as of March 5, 1990.

Open to all qualified organizations or individuals in the

maritime industry. These do not have to be laboratories.

A list entitled "Certification Agencies Accredited by the

Occupational Safety and Health Adininistration Under Title 29,

Chapter XVII Part 1919 is available from the above address.

Accreditation is recognized by the International Labor

Organization (ILO)

.

Accreditation is recognized by the Coast Guard, and various

states.

57
Received: 4/90

Department/Agency: Department of Transportation (DOT)

United States Coast Guard

Chief, Merchant Vessel Inspection Division

(G-MVI-3)

2100 Second Street, SW

Washington, DC 29593-0001

202-426-1444

202-267-1069

892427

Program Title: Lifesaving, Engineering, Fire Protection, and Pollution

Prevention Equipment for Recreational Boats and Commercial

Vessels. 4

Date Established: 1960.

Description: Accredited laboratories test equipment to standards identified

by the Coast Guard. Equipment is then either certified by the

laboratory, or approved by the Coast Guard after review of the

laboratory test report.

Fields of Testing: Biological, chemical, electrical, mechanical, optics and

photometry, thermal.

Products Tested: Marine safety survival, fire protection and pollution

prevention equipment.

Standards/Test

Methods: List is available from the above address.

Assessment Submission of Appropriate Documentation x

Criteria/ Independence (No Conflict-of-interest) x

Procedures: Financial Stability x

On-site Inspection x

Staff Qualifications Requirements x

Adequate Q.A. System x

Sample ODntrol/Integrity Requirements

Recordkeeping Requirements x

Test Report Content/Format Requirements x

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements x

Other

Other Information: The accreditation requirements generally follow the guidelines

suggested in the American Society of Testing and Materials

(ASTM) E548, "Practice for Preparation of Criteria for Use in

the Evaluation of Testing and Inspection Bodies; 11 however,

ASTM E548 is very general and not sufficient as a standard for

evaluation.

Phone:

FAX:

Telex:

58
Accreditation

Terminology:

Compliance:

Authority:

Fees:

Aocreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications:

Logo:

NO. of labs:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Uses the term, "listed," meaning an independent laboratory

that has been found acceptable under an applicable subpart

of the provisions of 46 CFR 159.010-11.

Mandatory to obtain certification or approval.

46 CFR Part 159.010.

None.

Accreditation is valid until withdrawn.

U.S. Coast Guard engineers.

None is currently employed.

Normal U.S. federal agency due process appeals mechanisms.

46 CFR Part 159.010.

None.

59 laboratories as of March 30, 1990.

Open to all U.S. and state government laboratories, private

sector laboratories, foreign government and private sector

laboratories.

None published, but a List of Coast Guard Accepted Independent

Laboratories and Inspection Agencies List is available upon

request.

Int'l Recognition/

Agreements:

Other

Recognition:

None.

None.

59
Department/Agency:

Received: 4/90

Department of Transportation (DOT)

United States Coast Guard

Marine Technical & Hazardous Materials Division

Chief, Engineering Branch

(G—MTH-2)

2100 Second Street, SW

Washington, DC 29593-0001

Phone:

FAX:

202-267-2206

202-267-0025

Program Title: Approval of equipment for use in hazardous areas aboard

commercial vessels.

Date Established: 1960.

Description: The U.S. Coast Guard requires electrical equipment in

hazardous areas on U.S. Coast Guard certified vessels to be

"listed" by an independent testing laboratory recognized by

the Commandant.

Fields of Testing: Electrical, mechanical, non-destructive.

Products Tested: Electrical enclosures, wiring and cabling.

Standards/Test

Methods:

Assessment

Criteria/

Procedures: x

Laboratories are accredited to Articles 500-503 of the

National Electrical Code (NEC) and NFPA No. 496.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

Other Information: The accreditation requirements generally follow the guidelines

suggested in the American Society of Testing and Materials

(ASTM) E548, "Practice for Preparation of Criteria for Use in

the Evaluation of Testing and Inspection Bodies;" however,

ASTM E548 is very general and not sufficient as a standard for

evaluation.

Accreditation

Terminology:

Uses the term, "listed," meaning an independent laboratory

that has been found acceptable under an applicable subpart

of the provisions of 46 CFR 159.010-11.

60
Ccnpliance: Mandatory.

Authority: 46 CFR Part 159.010.

Fees: None.

Accreditation

Action Frequency: Accreditation is valid until withdrawn.

Assessors: U.S. Coast Guard engineers.

Proficiency

Testing Program: None is currently employed.

Appeal Procedure: Normal U.S. federal agency due process appeals mechanisms.

Publications: 46 CFR Part 159.010.

logo: None, though USCG requires product marking by test lab.

No. of labs: Four laboratories as of March 30, 1990.

Availability of Open to all U.S. laboratories, foreign government and foreign

Accreditation: private sector laboratories.

List/Directory of

Accredited labs: None published, but a list is available upon request.

Int'l Recognition/

Agreements: None.

Other

Recognition: None.

61
Received: 9/90

Department of Transportation (DOT)

United States Coast Guard

Merchant Vessel Inspection and Documentation Division

2100 Second Street, SW

Washington, DC 29593-0001

Ebcne:

FAX:

Telex:

202-267-2978

202-267-1069

892427 Coast Guard - WSH

Program Title: Delegated approval authorities for safety approval of cargo

containers.

Date Established: May 22, 1978.

To delegate to qualified persons or organizations the

authority to approve, on behalf of the Coast Guard, cargo

containers used in international transport in accordance with

the International Convention for Safe Containers (CSC)

.

Fields of Testing: Mechanical.

Products Tested: Cargo containers.

Standards/Test

Methods:

Assessment

Criteria/

Procedures^

International convention for safe containers (CSC) formed at

Geneva, December, 1972, and ratified by the United States on

January 3, 1978, as implemented by 49 CFR Part 450-453.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

Otter Informtioni: The accreditation requirements generally follow the guidelines

suggested in the American Society of Testing and Materials

(ASTM) E548, "Practice for Preparation of Criteria for Use in

the Evaluation of Testing and Inspection Bodies." More

emphasis is placed on the individual or agency as to

organization resources such as independence from manufacturer

influence and financial independence. A detailed application

is required. An on-site inspection may be conducted. Initial

and follow-up and on-site visits are random in nature and

dependent on report review information. Records of approvals

issued and backup information must be kept for 15 years and

62
Accreditation

Terminology:

Ccnpliance:

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

:

lego:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Int'l Recognition/

Agreements:

Other

Recognition:

become property of the Coast Guard if approval is withdrawn or

otherwise terminated. Requirements are also comparable to

those contained in the International Convention for

Safe Containers (CSC) dated 12/72 and ratified by the U.S.

1/3/78.

Uses the term, "delegated," meaning delegate of the

Commandant of the Coast Guard authorized to approve

containers.

Voluntary for delegation agencies; mandatory as to the product

(cargo containers)

.

For purposes of the international convention for safe

containers regulations contained in 49 CFR Part 450-453.

The program is without fee to the accredited delegated

approval authority. Each authority "shall establish and make

available to the public a schedule of fees for the approval of

services performed under these regulations, the fees must not

be disproportional to the costs (including transportation

expense, if any) actually incurred."

Accreditation is valid until withdrawn.

Representatives of U.S. Coast Guard.

None is currently employed.

In addition to normal federal due process, detailed appeals

are spelled out in the 49 CFR Part 450-453 regulations.

Regulations are contained in the Federal Register , 20 April

1978, revised 2 June 1980; and list of delegated approval

authorities.

Identification code assigned by Chief, Merchant Vessel

Inspection Division, U.S. Coast Guard, to the approval

authority.

13 laboratories as December 1, 1989.

Open to all U.S. laboratories; and foreign private sector

laboratories if their own government is not a signatory to the

(CSC).

A list entitled, "United States Authorities for the

International Convention for Safe Containers," is available.

Inherent in the scope of program based upon a ratified U.S.

foreign convention.

None.

63
Received; 3/90

Department/Agency: Department of Treasury

United States Customs Service

Office of Laboratories & Scientific Services

Room 7113

1301 Constitution Ave. , NW

Washington, DC 20229

Phone: 202-566-5853

FAX: 202-343-0345

Program Title: Petroleum gaugers and commercial laboratory program.

Date Established: 1973

Description: Accredits commercial laboratories to test petroleum, petroleum

products, and organic chemicals in bulk and liquid form

for customs purposes.

Fields of Testing: Chemical.

Products Tested: Petroleum, petroleum products, bulk/liquid organic

chemicals.

Standards/Test List of requirements for accreditation is available from the

Methods: above address. The Office of Laboratories and Scientific

Services uses standards based on methods found in the

American Society for Testing and Materials (ASTM)

publications, and the American Petroleum Institute (API)

standards.

Assessment Submission of Appropriate Documentation x

Criteria/ Independence (No Conflict-of-interest) x

Procedures: Financial Stability x

On-site Inspection x

Staff Qualifications Requirements x

Adequate Q.A. System x

Sample Control/Integrity Requirements x

Recordkeeping Requirements x

Test Report Content/Format Requirements x

Available Operational Manuals/Instructions x

Periodic Random Re-audit of Facilities x

Periodic Scheduled Re-audit of Facilities x

Participation in a Proficiency Testing Program x

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements x

Other - A bond is required as well as the successful

completion of a background investigation

Other Information: Requirements are comparable to those contained in ASTM E548,

"Practice for Preparation of Criteria for Use in the

Evaluation of Testing and Inspection Bodies," and those

contained in relevant ISO documents.

Accreditation Uses the term, "accredited," meaning that a positive

Terminology: determination has been made that the applicant is competent,

independent, and reputable.

64
Compliance: Mandatory if results of measurements and analyses are used

for customs purposes.

Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

:

logo:

No. of labs:

Availability of

Accreditation:

list/Directory of

Accredited Labs:

Int'l Recognition/

Agreements:

Other

Recognition:

19 CFR Part 151.13.

None.

Because gauger services are ongoing, monitoring by

appropriate local Customs staff is essentially continuing.

Accreditation is not reissued.

Office of Laboratories and Scientific Services personnel.

A random sampling program is conducted. Samples are submitted

to Customs field laboratories for confirmatory analysis.

Normal U.S. federal agency due process appeals mechanisms.

An accredited laboratory may also appeal a decision to the

Commissioner of Customs.

19 CFR Part 151.13. A list of requirements for accreditation

is also available from the above address.

None.

30 laboratories as of 3/1/90.

Available to all U.S. laboratories.

Lists of accredited laboratories are published in the Federal

Register and the Customs Bulletin.

None. Commercial laboratories are accredited by the U.S.

Customs Service to provide analytical data unique to U.S.

Customs requirements.

None. Commercial laboratories are accredited by the U.S.

Customs Service to provide analytical data unique to U.S.

Customs requirements.

65
Received: 11/90

Department/Agency: Department of the Treasury

Bureau of Alcohol, Tobacco and Firearms (ATF)

Office of Laboratory Services, Room 253

1401 Research Boulevard

Rockville, MD 20850

Phone:

FAX:

Program Title:

(301) 294-0410

(301) 443-4419

Certification of U.S. laboratories for the analysis of

wines and distilled spirits for export.

Date Established: Distilled spirits beverages: 1969. Wines: 1973,

Description: ATF certifies laboratories qualified for the analysis of

wines and distilled spirits beverages to meet the requirements

of certain countries which require that U.S. wines and/or

distilled spirits beverages exported to those countries be

accompanied by a chemical analysis performed by a laboratory

certified by ATF.

Fields of Testing: Chemical.

Products Tested: Distilled spirits beverages, wines.

Standards/Test

Methods:

Assessment

Criteria/

Procedures:

Internal Revenue Procedure 69-22 (Distilled Spirits)

ATF Procedure 86-3 (Wines)

.

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other -

Other Information: Laboratories are required to send copies of school

transcripts and other pertinent information on their

personnel.

Accreditation

Terminology:

Compliance:

Uses the term "certified."

Mandatory only for laboratories wishing to be certified by

the Bureau of Alcohol, Tobacco and Firearms.

66
Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

logo:

No. of Labs:

Availability of

Accreditation:

List/Directory of

Accredited Labs:

Int'l Recognition/

Agreements:

Internal Revenue Procedure 69-22 (Distilled Spirits)

.

ATF Procedure 86-3 (Wines)

.

None.

Retesting after 2 years.

Uses ATF personnel.

None.

Normal U.S. federal agency due process appeals mechanisms.

Internal Revenue Procedure 69-22 (Distilled Spirits)

.

ATF Procedure 86-3 (Wines)

.

None.

Thirty.

Open to all U.S. laboratories.

A list of certified laboratories is available from the

above address.

As established by individual countries

Other Recognition: None.

67
Received: 3/90

Department/Agency: Department of Veterans Affairs (VA)

Veterans Health Services & Research Administration (VHS&RA)

Pathology Service (113)

810 Vermont Ave. , NW

Room 933

Washington, DC 20420

Phone:

FAX:

Program Title:

(202)

(202)

233-7469

233-4756

College of American Pathologists (CAP) Inspection and

Accreditation Program and related quality control programs.

Date Established: 1970.

Description: A centralized contract through the VA Marketing Center is

established annually to provide quality control, inspection,

and accreditation of clinical laboratories, special function

laboratories and nuclear medicine laboratories numbering 408

in the VA system. This contract is monitored by the

Pathology Service, VA. A quality control program has also

been established through the American Society of Clinical

Pathologists (known as CheckPath) to help assess physicians'

diagnostic skills. All full time physicians in the VA system

will be enrolled. The VA also monitors its histopathology

program through the Armed Forces Institute of Pathologists.

Fields of Testing: Clinical, chemical, nuclear, biological.

Products Tested: Clinical samples.

Standards/Test College of American Pathologists Laboratory Accreditation

Methods: Program (CAPLAP) standards and test methods.

Assessment Submission of Appropriate Documentation x

Criteria/ Independence (No Conflict-of-interest) n/a

Procedures: Financial Stability n/a

On-site Inspection x

Staff Qualifications Requirements x

Adequate Q.A. System x

Sample Control/Integrity Requirements x

Recordkeeping Requirements x

Test Report Content/Format Requirements x

Available Operational Manuals/Instructions x

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities x

Participation in a Proficiency Testing Program x

Adequacy of Facilities & Equipment x

Equipment Maintenance/Calibration Requirements x

Other

Accreditation

Terminology: Uses the term "accredited," as defined by the CAP.

Compliance: Mandatory for all VA facilities covered by the program.

68
Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications:

lego:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited labs:

Int'l Recognition/

Agreements:

N/A.

Fees are negotiated between CAP and the VA.

Accreditation is reissued every 2 years with a selfinspection required in the interim year.

A group of physicians and technologists assembled by CAP.

They are from both the government and private sector.

Participation in proficiency testing is required.

Deficiencies are cited. A time frame is provided for

correction. If deficiencies are corrected, then accreditation

is granted.

None, though documentation is maintained by Pathology Service,

local VA laboratories, and at CAP.

Authorized certificate issued by CAP.

There are 408 VA laboratories covered by this program as of

3/1/90.

This program is open to VA laboratories only, though CAP

provides accreditation for all laboratories.

A list is available from the College of American Pathologists,

325 Waukegan Rd. , Northfield, IL, Phone: (708) 446-8800.

No special agreements other than ones that CAP may have.

Other Recognition: The CAP program is recognized by many organizations.

69

APPENDIX I - INDICES

INDEX PAGE

GOVERNMENT NATIONAL ACCREDITATION SYSTEMS 72

AGENCY INDEX BY ACRONYM 74

DEPARTMENT/AGENCY INDEX 75

AGENCY INDEX 77

INDEX BY FIELD OF TESTING 78

INDEX BY PRODUCT TESTED 79

71
GOVERNMENT NATIONAL ACCREDITATION SYSTEMS

Department of Agriculture (USDA) , Animal & Plant Health Inspection Service

(APHIS) , Veterinary Service (VS) , Science and Technology, Accreditation of

laboratory facilities for contagious equine metritis (GEM)

.

Department of Agriculture (USDA) , Federal Grain Inspection Service (FGIS)

,

Compliance Division, Grain and commodity inspection and weighing (including

equipment, scale and weight testing)

.

Department of Agriculture (USDA) , Food Safety & Inspection Service (FSIS)

,

Science & Technology, Chemistry Division, Accredited laboratory program.

Department of Agriculture (USDA) , Office of Transportation (OT) , ATP Manager,

Agreement on the International Carriage of Perishable Foodstuffs and on the

Special Equipment to be Used for Such Carriage (ATP)

.

Department of Commerce (DOC) , National Institute of Standards & Technology

(NIST) , Office of Weights & Measures (OWM) , State laboratory program.

Department of Commerce (DOC) , National Institute of Standards & Technology

(NIST) , National Voluntary Laboratory Accreditation Program (NVLAP)

.

Department of Defense (DOD) , Army Corps of Engineers (CE) , CE district, project

and commercial laboratories assurance inspection program.

Department of Defense (DOD) , Defense Electronics Supply Center (DESC)

,

Qualification Division (EQ) , Qualified Produce/Manufacturer Lists (QPL/QML) •

Department of Defense (DOD) , Defense Logistics Agency (DIA) , Defense Personnel

Support Center (DPSC) , Qualified Laboratory List (QLL)

.

Environmental Protection Agency (EPA) , Office of Drinking Water, Monitoring &

Exposure Section, Drinking water laboratory certification program.

Environmental Protection Agency (EPA) , Office of Mobile Sources,

Emission Control Technology Division, Retrofit Device Evaluation Program.

Environmental Protection Agency (EPA) , Office of Air Quality Planning and

Standards, Technical Support Division, Wood Stoves New Source Performance

Standards Laboratory Accreditation.

Federal Communications Commission (FCC) , Office of Engineering & Technology,

Authorization & Evaluation Division, Equipment Authorization Branch, Description

of Measurement Facilities.

Department of Health & Human Services (HHS) , Alcohol, Drug Abuse, & Mental Health

Acmiinistration (ADAMHA) , National Institute on Drug Abuse, Division of Applied

Research, Drug Testing Section, National Laboratory Certification Program (NLCP)

.

Department of Health & Human Services (HHS) , Food Drug Administration (FDA)

,

Bioresearch Program, Toxicology laboratory monitoring program.

Department of Health & Human Services (HHS) , Food & Drug Administration (FDA)

,

Center for Food Safety and Applied Nutrition, Lab. QA Branch, Evaluation of milk

laboratories

.

72
Department of Health & Human Services (HHS) , Health Care Financing Administration

(HCFA) , Clinical Laboratories Improvement Act.

Department of Housing & Urban Development (HUD) , Office of Architecture &

Engineering, Materials Acceptance Division, Technical suitability of building

products program.

Department of Interior (DDI) , Office of Surface Mining Reclamation & Enforcement

(OSM) , Division of Technical Services, Small Operator Assistance Program (SOAP)

Department of Labor (DDL) , Mine Safety & Health Administration (MSHA)

,

Approval & Certification Center (A&CC) , Accreditation of laboratories for MSHA

approval or certification.

Department of Labor (DDL) , Mine Safety & Health Administration (MSHA)

,

Approval & Certification Center (A&CC) , Testing and Evaluation of Illumination

Systems.

Department of Labor (DDL) , Mine Safety & Health Administration (MSHA)

,

Approval & Certification Center (A&CC) , Testing by Applicant or Third Party.

Department of Labor (DDL) , Occupational Safety Health Administration (OSHA)

Office of Variance Determination, Nationally Recognized Testing Laboratories

(NRTL) Program.

Department of Labor (DDL) , Occupational Safety & Health Administration (OSHA)

,

Blood Lead Program.

Department of Labor (DDL) , Occupational Safety & Health Administration (OSHA)

,

Office of Construction & Maritime Compliance Assistance, Maritime Cargo Gear

Accreditation and Certification Program.

Department of Transportation (DOT) , United States Coast Guard, Merchant Vessel

Inspection Division, Lifesaving, Engineering, Fire Protection, and Pollution

Prevention Equipment for Recreational Boats and Commercial Vessels.

Department of Transportation (DOT) , United States Coast Guard, Marine Technical &

Hazardous Materials Division, Engineering Branch, Approval of equipment for use

in hazardous areas aboard commercial vessels.

Department of Transportation (DOT) , United States Coast Guard, Merchant Vessel

Inspection and Documentation Division, Delegated approval authorities for safety

approval of cargo containers.

Department of Treasury, United States Customs Service, Office of Laboratories &

Scientific Services, Petroleum gaugers and commercial laboratory program.

Department of Treasury, Bureau of Alcohol, Tobacco and Firearms, Office of

Laboratory Services, Certification of U.S. Laboratories for the Analysis of

Wines and Distilled Spirits for Export.

Department of Veterans Affairs (VA) , Veterans Health Services & Research

Administration (VHS&RA) , Pathology Service, College of American Pathologists

(CAP) Inspection and Accreditation Program and related quality control programs.

73
AGENCY INDEX BY ACRONYM

This index may be used by readers to learn what certification programs a

particular agency operates when only the agency's acronym or other limited

designation is known. Agencies are listed alphabetically by acronym/designation.

PAGE

ADAMHA/HHS 34

APHIS/USDA 6

ATF/TREASURY 66

CE/DOD 19

DESC/DOD 22

DLA/DOD 24

EPA 26, 28, 30

FCC 32

FDA/HHS 36, 38

PGIS/USDA 8

FHA/HUD 42

FSIS/USDA 10

HCFA/HHS 40

MSHA/DOL 46, 48, 50

NIST/DOC 14, 16

OSHA/DOL 52, 54, 56

OSM/DOI 44

OT/USDA 12

USCG/DOT 58, 60, 62

USCS/TREASURY 64

VHS&PA/VA 68

74
EEPARTMENT/AGENCY INEEX

This index may be used by readers to learn what certification programs a

particular department and/or departmental agency operates when both the

department and agency's names are known. Departments are listed alphabetically,

followed by a listing of independent federal agencies.

DFPARTMENIS/Pn%IJENDENT AGENCY PAGE

DEPARTMENT OF AGRICULTURE

Animal & Plant Health Inspection Service (APHIS) 6

Federal Grain Inspection Service (FGIS) 8

Food Safety & Inspection Service (FSIS) 10

Office of Transportation (OT) 12

DEPARTMENT OF COMMERCE

National Institute of Standards & Technology (NIST)

Office of Weights & Measures (OWM) 14

National Voluntary Laboratory Accreditation Program (NVLAP) 16

DEPARTMENT OF DEFENSE

Army Corps of Engineers (CE) 19

Defense Electronics Supply Center (DESC) — 22

Defense Logistics Agency (DIA) 24

ENVIRONMENTAL PROTECTION AGENCY

Office of Drinking Water 26

Office of Mobile Sources 28

Office of Air Quality Planning and Standards 30

FEDERAL COMMJNICATTONS COMMISSION

Office of Engineering & Technology 32

DEPARTMENT OF HEALTH & HUMAN SERVICES

Alcohol, Drug Abuse, & Mental Health Administration (ADAMHA) 34

Food Drug Administration (FDA)

Bioresearch Program 36

Center for Food Safety and Applied Nutrition 38

Health Care Financing Administration (HCFA) 40

DEPARTMENT OF HOUSING & URBAN DEVELOPMENT

Federal Housing Adniinistration (FHA)

Office of Architecture & Engineering 42

DEPARTMENT OF INTERIOR

Office of Surface Mining Reclamation & Enforcement (OSM) 44

75
DEPARTMENT OF IABCR

Mine Safety & Health Administration (MSHA)

Approval & Certification Center (A&CC) 46, 48, 50

Occupational Safety Health Administration (OSHA)

Office of Variance Determination 52

Blood Lead Program 54

Office of Construction & Maritime Compliance Assistance . 56

DEPARTMENT OF TRANSPORTATION

United States Coast Guard

Merchant Vessel Inspection Division 58

Marine Technical & Hazardous Materials Division 60

Merchant Vessel Inspection and Documentation Division 62

DEPARTMENT OF TREASURY

United States Customs Service 64

Bureau of Alcohol, Tobacco and Firearms 66

DEPARTMENT OF VETERANS AFFAIRS

Veterans Health Services & Research Administration (VHS&RA) .... 68

76
AGIUCY INDEX

This index may be used by readers to learn what certification programs a particular agency operates when only the agency's name is known. Agency names

are listed alphabetically.

DEPARTMENIAL/IM3fclPfcflD£NT AGENCY PAGR

Alcohol, Drug Abuse, & Mental Health Administration (HHS) 34

Animal & Plant Health Inspection Service (USDA) 6

Army Corps of Engineers (DOD) 19

Bureau of Alcohol, Tobacco and Firearms (TREASURY) 66

Defense Electronics Supply Center (DOD) 22

Defense logistics Agency (DOD) 24

Federal Grain Inspection Service (USDA) 8

Federal Housing Administration (HUD) 42

Food Drug Administration (HHS) 36, 38

Food Safety & Inspection Service (USDA) 10

Health Care Financing Administration (HSS) 40

Mine Safety & Health Administration (DOL) 46, 48, 50

National Institute of Standards & Technology (DOC) 14, 16

Occupational Safety Health Administration (DOL) 52, 54, 56

Office of Air Quality Planning and Standards (EPA) 30

Office of Drinking Water (EPA) 26

Office of Engineering & Technology (FCC) 32

Office of Mobile Sources (EPA) 28

Office of Surface Mining Reclamation & Enforcement (DOI) 44

Office of Transportation (USDA) 12

United States Coast Guard (DOT) 58, 60, 62

United States Customs Service (TREAS) 64

Veterans Health Services & Research Administration (VA) 68

77
INDEX BY KlKin OF TESTING

Air emissions —•— NIST/DOC* , Office of Air Quality Planning and Standards

/EPA

Biological APHIS/USDA, FSIS/USDA, NIST/DOC (2)*, Office of

Drinking Water/EPA, FDA/HHS (2), HCFA/HHS, OSHA/DOL,

USOG/DOT, VHS&PA/VA

Chemical — FSIS/USDA (2), NIST/DOC*, CE/DOD, DIA/DOD, Office of

Drinking Water/EPA, Office of Mobile Sources/EPA, Office

of Air Quality Planning and Standards/EPA, ADAMHA/HHS,

FDA/HHS, FHA/HUD, OSM/DOI, USOG/DOT, USCS/TREASURY,

ATF/TREASURY , VHS&PA/VA

Clinical - ——— HCFA/HHS, VHS&PA/VA, NIST/DOC*

Electrical NIST/DOC*, DESC/DOD, DLA/DOD, FCC, MSHA/DOL (3) , OSHA/DOL (2), USOG/DOT (2)

Fire Protection — OSHA/DOL, NIST/DOC*

Hydrology OSM/DOI, NIST/DOC*

Ionizing Radiation DESC/DOD, NIST/DOC*, Office of Drinking Water/EPA

Mechanical FSIS/USDA, NIST/DOC*, CE/DOD, Office of Mobile Sources/

EPA, Office of Air Quality Planning and Standards/EPA,

FHA/HUD, MSHA/DOL (3) , OSHA/DOL, USOG/DOT (3)

Metrology — - FSIS/USDA, NIST/DOC (2)*, DESC/DOD

Non-destructive • DESC/DOD, DIA/DOD, NIST/DOC*, OSHA/DOL, USOG/DOT

Nuclear — VHS&PA/VA, NIST/DOC*

Optics and photometry - DESC/DOD, DIA/DOD, NIST/DOC*, USOG/DOT

Overburden Testing OSM/DOI, NIST/DOC*

Physical DIA/DOD, NIST/DOC*

Thermal OT/USDA, DIA/DOD, NIST/DOC*, Office of Air Quality

Planning and Standards/EPA, OSM/DOI, USOG/DOT

Toxicological ADAMHA/HHS, FDA/HHS, NIST/DOC*

Water Quality — OSM/DOI, NIST/DOC*

*The National Institute of Standards and Technology (NIST) , National Voluntary

laboratory Accreditation Program (NVLAP) is authorized to be involved in all

fields of testing for which a need is demonstrated.

78
INDEX BY ERDCUCT

BIODDGICAT/rT.TTJTrATVMEDICAL PRODUCTS

biological products, human 34, 36, 40, 54, 68

blood for lead 54

clinical samples 34, 36, 40, 54, 68

drugs, human and animal 36

equine-related products 6

human biological products 34, 36, 40, 54, 68

human specimens 34, 40, 54, 68

medical devices 36

specimens 34, 40, 54, 68

urine specimens 34, 40, 68

EUIIDIMS/aaiSTOJCITON PRODUCTS

acoustical testing services 16

admixtures 16, 19

aggregates 16, 19

asbestos fiber 16

building products & constructions 16, 19, 42

carpet 16, 42

cement, aggregates, & cement based products (3) 16, 19

commercial products 16

concrete (2) 16, 19

construction products 16, 19, 42

doors 42

flooring, glued plywood 42

foundations 19

geotextiles 16

glass, insulating 42

gypsum 19

insulation materials, thermal 16

lumber 42

lumber, pressure treated 42

paint 16

particleboard 42

plastic 16

plumbing fixtures 16, 42

plywood 42

road/Paving materials 16, 19

sand 16, 19

seals and sealants 16

siding, textured plywood 42

stair treads 42

windows 42

ETECTRICAT/FT FTTODNIC PRODUCTS

battery assemblies 50

computer applications 16

dosimetry, personnel radiation 16

electrical and related products used in the workplace . . 52

79
electrical cables (in hazardous areas) 60

electrical enclosures (in hazardous areas) 60

electrical equipment and supplies (mining) 46

electrical machinery (mining) 46

electrical wiring (in hazardous areas) 60

electromagnetic compatibility 16, 32

electronic products that emit radiation 16, 32, 36

illumination equipment for mines 48

radiation dosimetry 16

radio frequency emitting devices 16, 32

telecommunications 16, 32

ENVTRONMENEAL PRODUCTS

air 19

asbestos fiber 16

marine pollution prevention equipment 58

petroleum and petroleum products 64

pollution prevention equipment, marine 58

rock 16, 19, 44

sand 16, 19

soil 16, 19, 44

stone 16, 19, 44

water 19, 26, 44

FOOD AND AGRICULTURAL PRODUCTS

alcoholic beverages 66

asmmodities for weight 8

equine-related products 6

equipment for the transport of perishable foodstuffs ...12

feed additives 36

food additives 36

grain 8

lime 19

meat food products 10

milk & milk products 38

poultry food products 10

veterinary drugs 36

MINING PRODUCTS

battery assemblies 50

electrical equipment and supplies 46

equipment, inining 50

geotextiles 16

illumination equipment for mines 48

machinery, electrical 46

rock 16, 19, 44

soil 16, 19, 44

80
MISC. CONSUMER PRODUCTS

alcoholic beverages 66

apparel products 24

carpet 16, 42

commodities for weight 8

equipages/apparel products 24

heaters, residential solid fuel 16, 30, 42

textiles 24

TRANSPORTATION RELATED PRODUCTS

admixtures 16, 19

aggregates 16, 19

cargo containers 62

cement, aggregates, & cement based products 16, 19

concrete 16, 19

containers, cargo . 62

containers, freight 12

cranes 56

derricks 56

electrical and related products used in the workplace . . 52

equipment for the transport of perishable foodstuffs 12

fire protection equipment, marine 58

marine pollution prevention equipment 58

marine safety equipment 58

maritime material handling devices 56

material handling devices, maritime 56

pollution prevention equipment, marine 58

railcars 12

refrigeration units 12

road/paving materials 16, 19

rock 16, 19, 44

safety equipment, marine 58

sand 16, 19

soil 16, 19, 44

stone 16, 19, 44

trailers, truck 12

truck trailers 12

vehicles, light duty on-highway transportation 28

workplace products, electrical and other 52

81
WEIGHING AND MEASUREMENT PRODUCTS

commodities for weight 8

dosimetry, personnel radiation ...16

length reference standards 14

mass reference standards 14

measurement equipment/systems 8, 14

radiation dosimetry 16

temperature (liquid in-glass) reference standards 14

volume reference standards 14

weighing equipment/systems 8, 14

MISC. EKODUCIS

chemicals, organic 64

geotextiles 16

military devices and components 22

organic chemicals 64

petroleum and petroleum products 64

82
APPENDIX II

FORMAT USED FOR EACH EWB2Y

Received:

Department/Agency: The responsible office/agency/department , as well as their

address, telephone, telex, and fax numbers if available.

Program Title: Designation identifying the program or part of the program

responsible for laboratory accreditation.

Date Established: The date the program was begun.

Description: Brief description of the scope and intent of the program.

Fields of Testing: The fields of testing covered by the program, including:

acoustic/vibration measurement, biological, chemical,

electrical, ionizing radiation, mechanical, metrology,

non-destructive, optics and photometry, thermal, and other

fields as indicated by the agency.

Products Tested: The products/services which laboratories are accredited to

test.

Standards/Test

Methods:

The documents employed by the accrediting agency to define

the terms of accreditation.

Assessment The criteria/procedures used by the program to ensure the

Criteria/ competence of a laboratory to conduct a test or set of tests.

Procedures: including:

Submission of Appropriate Documentation

Independence (No Conflict-of-interest)

Financial Stability

On-site Inspection

Staff Qualifications Requirements

Adequate Q.A. System

Sample Control/Integrity Requirements

Recordkeeping Requirements

Test Report Content/Format Requirements

Available Operational Manuals/Instructions

Periodic Random Re-audit of Facilities

Periodic Scheduled Re-audit of Facilities

Participation in a Proficiency Testing Program

Adequacy of Facilities & Equipment

Equipment Maintenance/Calibration Requirements

Other

Other Information: Any other relevant information on the criteria/procedures used

in the program.

Accreditation

Terminology:

Compliance:

Term(s) used by the accrediting authority to refer to a laboratory which has met the accreditation criteria.

Whether the program is mandatory, voluntary, or mandatory

only under specified circumstances.

83
Authority:

Fees:

Accreditation

Action Frequency:

Assessors:

Proficiency

Testing Program:

Appeal Procedure:

Publications

:

Logo:

No. of labs:

Availability of

Accreditation:

List/Directory of

Accredited labs:

Xnt'l Recognition/

Agreements:

The public laws, sections in the Code of Federal Regulations

or in the Federal Register which authorize the agency to

conduct the program.

The fees paid by a laboratory to participate in the

accreditation program.

The length of time the accreditation is valid.

Who conducts the assessment and their qualifications.

Methods (if any) used to check laboratory performance using

interlaboratory testing.

Appeals prtx^ss/procedures used by the program.

Available information on accredited laboratories or

other documentation on the program.

Any agency authorized use of a logo or other mark by

accredited laboratories.

The number of laboratories accredited as of a specified date.

Whether the program is open to U.S. private sector,

federal, state government, and/or foreign laboratories.

Available directories/lists of approved laboratories.

Any recognition of the accreditation by foreign governments

or international organizations or agreements between the

United States and other country (s) on mutual recognition of

accredited laboratories or test results from accredited

laboratories.

Other Recognition: Any recognition of the accreditation by other federal or

state agencies, or private sector organizations.

84
APPENDIX m ~ OTHER PRPGRAtC OF POSSIBLE INTEREST

Parties interested in this area may wish to review NBS SP 739, Directory of

Federal Government Certification Programs , which contains information on a number

of closely related programs. In addition, the following information is provided

on current and proposed federal programs which also in designate laboratories in

some manner. The agencies, however, do not consider the programs to be

operational laboratory accreditation/designation programs.

Agricultural Marketing Service, USDA, Accreditation of laboratories and

certification of laboratory analysts for AMS - UNDER DEVELOPMENT.

Rural Electrification Administration, USDA, Requirements for the inspection of

treated wood products by independent third-party inspection agencies.

National Institute of Standards and Technology, Law Enforcement Standards

Laboratory (LESL) , DOC, TAPIC contracts.

Office of Atmospheric & Indoor Air Programs, EPA, Survey of Indoor Air

Assessment/Mitigation Firms.

Federal Supply Service, GSA, A new program is being established by GSA for

Federal Supply Service Schedule 71-111 M - Acoustical/Speech Privacy

Partitions

.

Food and Drug Administration, DHHS, National Shellfish Sanitation Program (NSSP)

Federal Housing Administration, HUD, Recognition of laboratories accredited by

the National Voluntary Laboratory Accreditation Program (NVLAP) and the

American Association for Laboratory Accreditation (A2LA)

.

Mine Safety & Health Administration, DDL, Mine-Wide Monitoring Systems Program.

Mine Safety & Health Administration, DDL, Diesel Test Program.

Federal Aviation Administration, DOT, Airport lighting equipment manufacturers

entered into an aviation equipment certification program with an independent

testing laboratory that was selected and is paid for by the manufacturers.

Federal Aviation Administration, DOT, Recognition of the use of a third-party

accreditation program by holders of FAA Production Approval Certification (PC)

,

Parts Manufacturer Approval (PMA) , Technical Standards Order Authorization (TSOA)

or Approved Production Inspection System (APIS) under certain conditions.

National Highway Traffic Safety Administration, DOT, Contracts with laboratories

capable of conducting vehicle safety related testing.

Prosthetic & Sensory Aids Service, VA, Certification of equipment is made by the

VA sponsored Automobile Adaptive Equipment or Prosthetic Technology Equipment

Committees. Test results used include those from approved laboratories.

85
Department/Agency:

Program Title:

Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Commodities Scientific Support Division

P.O. Box 96456

Room 3521 South Building

Washington, DC 20090-6456

(CSSD)

Accreditation of laboratories and certification of laboratory

analysts for AMS - UNDER DEVELOPMENT.

Date Established: Several programs currently under development.

Description: While AMS does not currently have any laboratory accreditation

programs, AMS has received requests from the dairy industry

regarding the accreditation of laboratories to perform testing

of dairy products. A program to accredit laboratories to test

for salmonella in dried and liquid egg products is also under

consideration. CSSD has been assigned responsibility for the

accreditation of laboratories and certification of laboratory

analysts for AMS. CSSD also works with various other food

commodity industries and will, at their request, consider

laboratory accreditation programs in other areas.

In addition, under a 1990 farm bill, USDA may be required to

establish a accreditation program in conjunction with FDA to

accredit laboratories that test foods for pesticide residues.

Products Tested: Dairy products, egg products, food commodities, food products

for pesticide residues.

Department/Agency: Department of Commerce (DOC)

National Institute of Standards and Technology (NIST)

Law Enforcement Standards Laboratory (LESL)

Building 224, B116

Gaithersburg, MD 20899

Ehone: (301) 975-2757

FAX: (301) 975-7434

Program Title: TAPIC contracts.

Description: Under an NLJ contract, the Aspen Systems Corporation has

operated a limited equipment testing program through the

Technology Assessment Program Information Center (TAPIC)

.

Where LESL and the National Institute of Justice (NLJ) , U.S.

Department of Justice sponsor the testing of specific items of

law enforcement equipment, LESL assists in the preparation of

the request for proposal from testing laboratories and the

evaluation of the resulting bids to tentatively select two

independent laboratories for each item of equipment to be

tested. Following the award of the two contracts, LESL,

TAPIC, and members of the National Voluntary Laboratory

Accreditation Program (NVLAP) visit the laboratories for an

on-site facility investigation and witness the complete

86
testing of one item of equipment. When the inspection team is

satisfied that the laboratory personnel are proficient in

testing to the LESL-developed standards, that all test

equipment is properly calibrated, maintained and operated, and

that all appropriate test records are maintained, the TAPIC

classifies the laboratory as a certified laboratory for that

item of equipment.

Products Tested: Law enforcement equipment.

Department/Agency: Department of Agriculture (USDA)

Rural Electrification Administration (REA)

Electric Staff Division

Room 1272 S. Agriculture Bldg.

Independence Ave. bet. 12th & 14th Sts. , SW

Washington, DC 20250

Phone:

Description:

(202) 382-9086

REA maintains requirements for the inspection of treated wood

products by independent third-party inspection agencies, but

no longer maintains a list of approved agencies. Each

electric cooperative is responsible for assuring that the

agencies they use have the qualifications and experience

required by REA.

Products Tested: Forestry products.

Department/Agency: Environmental Protection Agency (EPA)

Assistant Aditiinistrator for Air and Radiation

Office of Atmospheric & Indoor Air Programs

Indoor Air Division (AMR-445)

West Tower of Waterside Mall, W-735

401 M Street, SW

Washington, DC 20460

Phone:

FAX:

Program Title:

Description:

202-475-8470

202-382-7991

Survey of Indoor Air Assessment/Mitigation Firms.

Surveys firms which assess the quality of air inside

buildings and conduct mitigation services.

Fields of Testing: Chemical, microbiological, climatic conditions.

Products Tested: Air.

Other Information: Information is reported by the firm. No evaluation of that

information is conducted.

Compliance: Voluntary.

87
Authority: Title IV, Superfund Amendments and Reauthorization Act.

Fees:

Appeal Procedure:

Publications

:

logo:

List/Directory of

Accredited Labs:

Department/Agency:

N/A.

N/A.

EPA publishes a "Survey of Indoor Air Quality Diagnostic and

Mitigation Firms," which is a list of firms which have

responded to the survey.

None.

"Survey of Indoor Air Quality Diagnostic and Mitigation

Firms."

Phone:

FAX:

Description:

General Services Administration (GSA)

Federal Supply Service (FSS)

Furniture Commodity Center (FCNE)

Bldg. 4, Crystal Mall

Arlington, VA 22202

703-557-8473

703-557-0032

A new program is being established by GSA for Federal Supply

Service Schedule 71-111 M - Acoustical/Speech Privacy

Partitions. Under this program, all contractors will be

required to enter into an agreement with a GSA accepted

laboratory or certifying body before a contract will be

awarded.

Products Tested: Acoustical/Speech Privacy Partitions

Standards/Test

Methods:

Compliance:

Fees:

Publications

:

logo:

Federal specifications and all referenced standards and test

methods applicable.

Voluntary for certification bodies/laboratories; mandatory for

manufacturers trying to meet procurement requirements of the

FSS.

None by FSS.

Specific federal specifications in which requirements are

described as well as federal procurement regulations are

available.

The listing/label of the accepted laboratory/certification

body

88
Department/Agency: Department of Health and Human Services

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

(HFF-232)

200 C Street, SW

Washington, D.C. 20204

Phone:

Program Title:

Description:

(202) 245-1221 or 245-1231

National Shellfish Sanitation Program (NSSP)

A 2-month pilot program conducted jointly by FDA and NOAA will

begin October 1, 1990. Plans for this voluntary program may

be obtained from the National Seafood Inspection Laboratory,

P.O. Drawer 1207 Pascagoula, MS 39567. FDA contact is: John

Kvenber, or George Hoskin (HFF-400) , Center for Food Safety

and Applied Nutrition (HFF-232) , FDA, 200 C Street, SW,

Washington, DC 20204 (202) 245-1221 or 245-1231. Under the

old program, FDA evaluated state and local laboratories used

for the examination of sea water and shellfish. The

laboratories are only evaluated for compliance with American

Public Health Association (APHA) procedures for the

examination of sea water and shellfish, not approved or

certified.

Products Tested: Shellfish.

Standards/Test

Methods:

Publications

:

National Shellfish Sanitation Program (NSSP) criteria and Good

Manufacturing Practice Regulations, American Public Health

Association (APHA) Procedures.

FDA publishes monthly the "Interstate Certified Shellfish

Shippers List" (ICSSL) containing the names and certification

numbers of state certified shellfish firms.

Departanent/Agency: Department of Housing and Urban Development (HUD)

Office Manufactured Housing and Regulatory Functions

Room 6270

451 Seventh Street, SW

Washington, DC 20410 -8000

Description: Program recognizes laboratories accredited by the National

Voluntary Laboratory Accreditation Program (NVLAP) and the

American Association for Laboratory Accreditation

(A2IA) .

Products Tested: Building construction products and components.

89
Departme^/Agency: Department of Labor (DOL)

Mine Safety & Health Administration (MSHA)

Approval & Certification Center (A&CC)

RR1, Box 251

Industrial Park Road

Triadelphia, WV 26059

Phone

:

(304) -547-0400 FTS: 723-1501

Date Established: 1981.

Program Title:

Description:

Products Tested:

Mine-Wide Monitoring Systems Program.

MSHA accepts data from laboratories on intrinsic safety of

barriers and sensors. MSHA reserves the right to retest.

Barriers and sensors.

Department/Agency: Department of Labor (DOL)

Mine Safety & Health Adniinistration (MSHA)

Approval & Certification Center (A&CC)

RR1, Box 25^.

Industrial Park Road

Triadelphia, WV 26059

Phone:

Program Title:

Description:

(304) -547-0400 FTS: 723-1501

Diesel Test Program.

MSHA allows for the testing of diesel engines for emissions at

an outside laboratory. MSHA witnesses all tests and is the

approval authority.

Products Tested: Diesel engines.

Department/Agency: Department of Transportation (DOT)

Federal Aviation Administration (FAA)

Office of Airports

Engineering and Specifications Division

800 Independence Avenue, SW

Washington, DC 20591

Phone

:

Description:

202-267-3053

As of 1/1/90, airport lighting equipment manufacturers entered

into a certification program with an independent testing

laboratory selected and paid for by the manufacturers. The

FAA continues to publish a list of approved equipment based on the findings of that laboratory.

Products Tested: Airport lighting

90
Department/Agency: Department of Transportation (DOT)

Federal Aviation Administration

Aircraft Certification Service, AIR-1, Room 300W

800 Independence Ave., SW

Washington, DC 20591

Phone: 703-267-8235

Description: The FAA recognizes the use of a third-party accreditation

program by a holder of a FAA Production Approval Certification

(PC) , Parts Manufacturer Approval (PMA) , Technical Standards

Order Authorization (TSOA) or Approved Production Inspection

System (APIS) under certain conditions. An action notice

(A8120.8) dated June 4, 1990 defines conditions under which

such use is acceptable. Manufacturers/suppliers must notify

the cognizant FAA Manufacturing Inspection District or

Satellite Office in writing prior to the use of the thirdparty accreditation program. Implementation of a third-party

accreditation program is subject to FAA review and approval.

Aircraft, aircraft parts and related products. Use of thirdparty accreditation programs is most common in areas such as nondestructive inspection sources, fasteners, and microcircuit

suppliers.

Department/Agency: Department of Transportation (DOT)

National Highway Traffic Safety Administration (NHTSA)

Office of Vehicle Safety Compliance

Crashworthiness Branch

400 7th Street, SW

Washington, DC 20590

Products Tested:

Description: Contracts with laboratories interested and capable of

conducting vehicle safety related testing. Laboratories

conduct testing to test procedures supplied as part of the

contract. Standards for instrumentation and laboratory

conduct are also part of the supplied test procedure. A list

of the contract laboratories is available from the above

address.

Products Tested: Motor vehicles.

Department/Agency

Phone:

Date Established:

Department of Veterans Affairs (VA)

Prosthetic & Sensory Aids Service

810 Vermont Ave. , NW

Washington, DC 20420

(202) 233-2011

Driving aids, March 27, 1975; wheelchair lifts, May 10, 1978,

self-propelled wheelchairs, December 7, 1977; motorized

wheelchairs, December 15, 1981.

91
Description:

Products Tested:

Compliance:

Authority:

Publications:

Other

Recognition:

Certification of equipment is made by the VA sponsored

Automobile Adaptive Equipment or Prosthetic Technology

Equipment Committees. Test results used include those from

approved laboratories.

Automotive driving aids and automatic wheelchair lifts. Selfpropelled wheelchairs, motorized wheelchairs.

Mandatory only for purchases funded by the VA.

Title 38 USC 4101(c)(2), P.L. 91-666.

VA Circular 10-86-54, lists certified suppliers of

wheelchair lift systems and hand controls, the General

Services Administration's (GSA) Federal Supply Schedule for

wheelchairs provides particulars for those products.

General Services Administration.

92
APPENDIX TV - T.TOT QF ACRCNYM5

A&CC Approval and Certification Center, MSHA

ACSC Agricultural Stabilization and Conservation Service, USDA

AMS Agricultural Marketing Service, USDA.

APHIS Animal and Plant Health Inspection Service, USDA.

ATF Bureau of Alcohol, Tobacco, and Firearms, Dept. of Treasury

CAP College of American Pathologists

CAPLAP College of American Pathologists Laboratory Accreditation Program

CE Army Corps of Engineers, DOD

CEM contagious equine metritis

CFR Code of Federal Regulations

CLIA -Clinical Laboratories Improvement Act

CPSC——Consumer Product Safety Commission

CS United States Customs Service, Dept. of Treasury

DESC Defense Electronics Supply Center, DOD

DHHS Department of Health and Human Services

DIA Defense Logistics Agency/ DOD

DOC Department of Commerce

DOD Department of Defense

DOT Department of the Interior

DOL Department of Labor

DOT Department of Transportation

DPSC Defense Personnel Support Center, DOD

EPA Environmental Protection Agency

FAA Federal Aviation Administration, DOT

FCC Federal Communications Commission

FDA Food and Drug Administration, DHHS

FGIS Federal Grain Inspection Service, USDA

FHA-- Federal Housing Administration, HUD

FMVSS Federal Motor Vehicle Safety Standards

FPA Federal Railroad Administration, DOT

FSIS Food Safety and Inspection Service, USDA

FSS Federal Supply Service, GSA

FTC Federal Trade Commission

GAO United States General Accounting Office

GSA General Services Administration

HCFA Health Care Financing Administration, DHHS

HUD- Department of Housing and Urban Development

MMS Minerals Management Service, DDI

MSHA Mine Safety and Health Administration, DOI

NBS National Bureau of Standards, now called NIST

NHTSA National Highway Traffic Safety Administration, DOT

NIOSH National Institute of Occupational Safety and Health, DHHS

NIST National Institute of Standards and Technology, DOC

NOAA National Oceanic and Atmospheric Administration, DOC

NPIP National Poultry Improvement Plan

NRC Nuclear Regulatory Commission

NVLAP National Voluntary Laboratory Accreditation Program, NIST/DOC

OSHA -Occupational Safety and Health Administration, DOL

OT Office of Transportation, USDA

Q.A. -Quality Assurance

REA Rural Electrification Administration, USDA

93
RSPA——-Research and Special Programs Administration, DOT

SOAP -Small Operator Assistance Program

USDA-——United States Department of Agriculture

USGS' -United States Coast Guard, DOT

VA——Department of Veterans Affairs

VHS&RA—Veterans Health Services and Research Administration

VS- Veterinary Service, USDA

94
APFBTOEX V

INFORMATION AND KJBIJCATTONS

AVAHABL£ FRCM

Office of Standards Code and Information (OSCI)

Office of Standards Services

National Institute of Standards and Technology

Administration Building, Room A629

Gaithersburg, MD 20899

(301) 975-4029

o The ABC's of Standards-Related Activities in the United States (NBSTR 87-3576)

This report provides an introduction to voluntary standardization, product

certification and laboratory accreditation for a reader who is not fully familiar

with these topics. It highlights some of the more important aspects of these

fields; furnishes the reader with both historical and current information on

these topics; describes the importance and impact of the development and use of

standards; and serves as background for using available documents and services.

Order as PB 87-224309 from NTIS.

o The ABC'S of Certification Activities in the United States (NBSTR 88-3821)

This report, a sequel to NBSTR 87-3576, The ABC/ S of Standards-Related

Activities in the United States , provides a further introduction to certification

for a reader who is not entirely familiar with this topic. It highlights some of

the more important aspects of this field, furnishes the reader with information

necessary to make informed purchases, and serves as background for using

available documents and services.

Order as PB 88-239793 from NTIS.

o Directory of International and Regional Organizations Conducting

Standards-Related Activities (NIST SP 767)

This directory contains information on 338 international and regional

organizations which conduct standardization, certification, laboratory

accreditation, or other standards-related activities. It describes their work in

these areas, as well as the scope of each organization, national affiliations of

members, U.S. participants, restrictions on membership, and the availability of

any standards in English.

Order as SN 003-003-02937-8 from GPO.

o Standards Activities of Organizations in the United States (NBS SP 806)

The directory summarizes the standardization activities of more than 750

organizations in the United States, both federal and private sector, that develop

standards, work with others to develop and use standards, regularly comment on

draft standards, or which provide information on and distribute standards. It

contains listings of sources of standards documents and information, a subject

index and related listings that cover acronyms and initials, defunct bodies and

organizations with name changes.

Order from GPO or NTIS. Copies can also be purchased from Global Engineering

Documents, 2805 McGaw Ave. , P.O. Box 19539, Irvine, CA 92714; (714) 261-1455.

95
o Directory of Private Sector Product Certification Programs (NIST SP 774)

This directory presents information from 132 private sector organizations in

the United States which engage in product certification activities. Entries

describe the type and purpose of each organization, the nature of the activity,

product certified, standards used, certification requirements, availability and

cost of services, and other relevant details.

Order as SN 003-003-02984-0 from GPO.

o Directory of Federal Government Certification Programs (NBS SP 739)

This directory presents information on U.S. Government certification programs

for products and services. Entries describe the scope and nature of each

certification program, testing and inspection practices, standards used, methods

of identification and enforcement, reciprocal recognition or acceptance of

certification, and other relevant details.

Order as SN 003-003-02852-5 from GPO.

o Barriers Encountered by U.S. Exporters of Telecommunications Equipment (NBSIR

87-3641)

This report addresses the perceived institution of unreasonable technical trade

barriers by major European trading partners to the export of telecom products and

systems by U.S. companies. The GAIT technical office, which has responsibilities

to assist U.S. exporters to take advantage of trade opportunities, informally

contacted over a period of six months, telecom companies and agencies to assess

the extent of unreasonableness in foreign national standards, regulations,

testing and certification requirements, and accreditation procedures.

Order as PB 88-153630 from NTTS.

o A Review of U.S. Participation in International Standards Activities (NBSIR 88-

3698)

This report describes the role of international standards, their increasingly

significant importance in world trade, and the extent of past and current U.S.

participation in the two major international standardization bodies - ISO and

IEC. The degree of U.S. participation covers the 20 year period 1966-1986. A

coarse analysis of data indicates some correlation between U.S. participation and

recent export performance for several major product categories.

Order as PB 88-164165 from NTTS.

o An Update of U.S. Participation in International Standards Activities (NISTIR

89-4124)

This report presents updated information on the current level of U.S.

participation in ISO and IEC (reference: NBSIR 88-3698)

.

Order as PB 89-228282/AS from NTTS.

o A Summary of the New European Community Approach to Standards Development

(NBSIR 88-3793-1)

This paper summarizes European Community (EC) plans to aggressively pursue its

goal of achieving an "internal market" by 1992 and the standards-related

implications of such a program on U.S. exporters.

Order as PB 88-229489/AS from NTTS.

96
o Trade Implications of Processes and Production Methods (PPMs) (NISTTR 90-4265)

This report discusses processes and production methods (or PPM's) and their

relationship to trade, the GATT Agreement on Technical Barriers to Trade, and

traditional product standards used in international commerce. The report

provides background information on PPM's, a suggested definition, and the

possible extension of their application from the agricultural sector to

industrial products.

Order as PB 90-205485 from NTTS.

o Directory of European Regional Standards-Related Organizations (NIST SP 795)

This publication contains information on European regional organizations which

are involved in standardization, certification, laboratory accreditation, or

other related activities. The directory describes their work in these areas, as well as other information of interest.

Order as SN 003-003-03038-4 from GPO.

[SEE IAST PAGE FOR NTTS AND GPO CONTACTS]

The following documents are available upon request from the OSCI office,

o tbt news

This newsletter provides information on government programs and available

services established in support of the GATT Agreement on Technical Barriers to

Trade (Standards Code) . tbt news reports on the latest notifications of proposed

foreign regulations; bilateral consultations with major U.S. trade partners;

programs of interest to U.S. exporters; and availability of standards and

certification information. Subscription is free upon request.

o Technical Barriers to Trade

This booklet explains the basic rules of the international Agreement on

Technical Barriers to Trade negotiated during the Tokyo Round of the Multilateral

Trade Negotiations (MTN) , and describes Title IV of the U.S. Trade Agreements Act

of 1979 which implements the United States' obligations under the Agreement. The

Agreement, popularly known as the Standards Code, was designed to eliminate the

use of standards and certification systems as barriers to trade. The booklet

describes the functions of the Departments of Commerce and Agriculture, the

Office of the U.S. Trade Representative, and the State Department in carrying out

the U.S.'s responsibilities.

o "GATT Standards Code Activities"

This brochure gives a brief description of NIST's activities in support of the

Standards Code. These activities include operating the U.S. GATT inquiry point

for information on standards and certification systems; notifying the GATT

Secretariat of proposed U.S. regulations; assisting U.S. industry with

trade-related standards problems; responding to inquiries on foreign and U.S.

proposed regulations; and preparing reports on the Standard Code.

97
o GATT Standards Code Activities of the National Institute of Standards and

Technology

This annual report describes the GATT Standards Code activities conducted by

the Office of Standards Code and Information for each calendar year. NIST

responsibilities include operating the GATT inquiry point, notifying the GATT

Secretariat of proposed U.S. Federal government regulations which may affect

trade, assisting U.S. industry with standards-related trade problems, and

responding to inquiries about proposed foreign and U.S. regulations.

o Report to the United States Congress on the Agreement on Technical Barriers to

Trade - "Standards Code"

This triennial report describes the programs and activities established to

implement the Standards Code in the United States by the four responsible U.S.

government agencies: Office of the U.S. Trade Representative; Department of

Commerce (National Institute of Standards and Technology, International Trade

Administration) ; Department of Agriculture and Department of State.

o Free handout material on office activities and standards-related information

such as: government sources of specifications and standards; foreign standards

bodies; U.S. standards organizations; and a brochure on the National Center for

Standards and Certification Information (NCSCI)

.

In addition to general inquiry services, the following assistance is also

available:

o EC Hotline

This hotline reports on draft standards of the European Committee on

Standardization (CEN) , the European Committee for Electrotechnical

Standardization (CENELEC) , and the European Telecommunications Standards

Institute (ETSI) . It also provides information on selected EC directives. The

recorded message is updated weekly and gives the document number, product, and

closing date for comments. The hotline number is (301) 921-4164 (not toll-free) .

o GATT Hotline

A telephone hotline provides current information received from the GATT

Secretariat in Geneva, Switzerland, on proposed foreign regulations which may

significantly affect trade. The recorded message is updated weekly and gives the

product, country, closing date for comments (if any) and Technical Barriers to

Trade (TBT) notification number. The hotline number is (301) 975-4041 (not

toll-free) .

o NCSCI provides assistance to U.S. and foreign exporters in obtaining current

standards, regulations and certification information for the manufacture of

products. To aid foreign exporters, NCSCI also provides directory information of

state offices prepared to respond to queries concerning conditions to be met by

goods for sale in their state.

98
Publication Ordering Information

NITS - National Technical Information Service

5285 Port Royal Road

Springfield, VA 22161

(703) 487-4650

GFO - Superintendent of Documents

U.S. Government Printing Office

Washington, DC 20402

(202) 783-3238

99

NIST-114A U.S. DEPARTMENT OF COMMERCE 1. PUBLICATION OR REPORT NUMBER

(REV. 3-89) NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY NIST/SP-808

2. PERFORMING ORGANIZATION REPORT NUMBER BIBLIOGRAPHIC DATA SHEET 3. PUBLICATION DATE February 1991

4. TITLE AND SUBTITLE Directory of Federal Government Laboratory Accreditation/Designation Programs

5. AUTHOR(S)

Maureen Breitenberg, Editor

6. PERFORMING ORGANIZATION (IF JOINT OR OTHER THAN NIST, SEE INSTRUCTIONS)

U.S. DEPARTMENT OF COMMERCE

NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

GAITHERSBURG, MO 20899

7. CONTRACT/GRANT NUMBER

8. TYPE OF REPORT AND PERIOD COVERED Final

9. SPONSORING ORGANIZATION NAME AND COMPLETE ADDRESS (STREET, CITY, STATE, ZIP) National Voluntary Laboratory Accreditation Program (NVLAP)

Technology Services

National Institute of Standards and Technology

Gaithersburg, MD

10. SUPPLEMENTARY NOTES

J

DOCUMENT DESCRIBES A COMPUTER PROGRAM; SF-185, FIPS SOFTWARE SUMMARY, IS ATTACHED.

11. ABSTRACT (A 200-WORD OR LESS FACTUAL SUMMARY OF MOST SIGNIFICANT INFORMATION. IF DOCUMENT INCLUDES A SIGNIFICANT BIBLIOGRAPHY OR

LITERATURE SURVEY, MENTION IT HERE.) This directory is designed to provide updated information on federal government laboratory

accreditation and similar type programs conducted by the federal government. These programs

designate a set of laboratories or other entities to conduct testing to assist federal

agencies in carrying out their responsibilities. The programs generally include some assessment regarding the capability of the lab to conduct the testing. The type and degree

of such assessments, however, vary greatly by program. It should be noted that the entries

in this directory are based primarily on information provided by the federal agency and

reflect the agency's view of its activities. Parties interested in this area may also wish

to review NBS SP 739, Directory of Federal Government Certification Programs , which contains

information on a number of closely related programs.

This directory is part of ongoing NIST efforts to establish and maintain comprehensive

databases on standards, regulations, laboratory accreditation and certification programs

and related information in accordance with the requirements of the Trade Agreements Act

of 1979. This material has been compiled to meet the needs of government, industry, and

the public for information on U.S. Government laboratory accreditation and related programs.

12. KEYWORDS (6 TO 12 ENTRIES; ALPHABETICAL ORDER; CAPITALIZE ONLY PROPER NAMES; AND SEPARATE KEY WORDS BY SEMICOLONS)

certification; grading; inspection; laboratory accreditation; listing; mutual recognition

schemes; proficiency testing; qualified laboratories; standards; testing

13. AVAILABILITY UNLIMITED FOR OFFICIAL DISTRIBUTION. DO NOT RELEASE TO NATIONAL TECHNICAL INFORMATION SERVICE (NTIS). X

X ORDER FROM SUPERINTENDENT OF DOCUMENTS, U.S. GOVERNMENT PRINTING OFFICE, WASHINGTON, DC 20402. ORDER FROM NATIONAL TECHNICAL INFORMATION SERVICE (NTIS), SPRINGFIELD, VA 22161.

14. NUMBER OF PRINTED PAGES 105

15. PRICE

ELECTRONIC FORM

nU.S. GOVERNMENT PRINTING OFFICE: 1 9 9 1- 28 1. 6 1 ^270 6

It
.
1 Ak3 4 Technical Publications

Periodical

Journal of Research of the National Institute of Standards and Technology—Reports NIST research

and development in those disciplines of the physical and engineering sciences in which the Institute

is active. These include physics, chemistry, engineering, mathematics, and computer sciences.

Papers cover a broad range of subjects, with major emphasis on measurement methodology and

the basic technology underlying standardization. Also included from time to time are survey articles on topics closely related to the Institute's technical and scientific programs. Issued six times a year.

Nonperiodicals

Monographs—Major contributions to the technical literature on various subjects related to the

Institute's scientific and technical activities. Handbooks—Recommended codes of engineering and industrial practice (including safety codes) developed in cooperation with interested industries, professional organizations, and regulatory bodies.

Special Publications—Include proceedings of conferences sponsored by NIST, NIST annual reports,

and other special publications appropriate to this grouping such as wall charts, pocket cards, and

bibliographies.

Applied Mathematics Series—Mathematical tables, manuals, and studies of special interest to physicists, engineers, chemists, biologists, mathematicians, computer programmers, and others engaged in scientific and technical work.

National Standard Reference Data Series—Provides quantitative data on the physical and chemical

properties of materials, compiled from the world's literature and critically evaluated. Developed un- der a worldwide program coordinated by NIST under the authority of the National Standard Data

Act (Public Law 90-396). NOTE: The Journal of Physical and Chemical Reference Data (JPCRD)

is published quarterly for NIST by the American Chemical Society (ACS) and the American Insti- tute of Physics (AIP). Subscriptions, reprints, and supplements are available from ACS, 1155 Sixteenth St., NW., Washington, DC 20056.

Building Science Series—Disseminates technical information developed at the Institute on building

materials, components, systems, and whole structures. The series presents research results, test methods, and performance criteria related to the structural and environmental functions and the

durability and safety characteristics of building elements and systems.

Technical Notes—Studies or reports which are complete in themselves but restrictive in their treat- ment of a subject. Analogous to monographs but not so comprehensive in scope or definitive in treatment of the subject area. Often serve as a vehicle for final reports of work performed at NIST

under the sponsorship of other government agencies.

Voluntary Product Standards—Developed under procedures published by the Department of Commerce in Part 10, Title 15, of the Code of Federal Regulations. The standards establish nationally

recognized requirements for products, and provide all concerned interests with a basis for common

understanding of the characteristics of the products. NIST administers this program as a supplement

to the activities of the private sector standardizing organizations.

Consumer Information Series—Practical information, based on NIST research and experience, covering areas of interest to the consumer. Easily understandable language and illustrations provide useful background knowledge for shopping in today's technological marketplace.

Order the above NISTpublications from: Superintendent of Documents, Government Printing Office,

Washington, DC 20402.

Order the following NISTpublications—FIPS and NISTIRs—from the National Technical Information

Service, Springfield, VA 22161.

Federal Information Processing Standards Publications (FIPS PUB)—Publications in this series col- lectively constitute the Federal Information Processing Standards Register. The Register serves as the official source of information in the Federal Government regarding standards issued by NIST

pursuant to the Federal Property and Administrative Services Act of 1949 as amended, Public Law

89-306 (79 Stat. 1127), and as implemented by Executive Order 11717 (38 FR 12315, dated May 11, 1973) and Part 6 of Title 15 CFR (Code of Federal Regulations).

NIST Interagency Reports (NISTIR)—A special series of interim or final reports on work performed

by NIST for outside sponsors (both government and non-government). In general, initial distribu- tion is handled by the sponsor; public distribution is by the National Technical Information Service,

Springfield, VA 22161, in paper copy or microfiche form.