NBS

PUBLICATIONS

NAT'L INST OF STANDARDS & TECH R.I.C.

A1 11 02772043

/Directory of federal government certlfl QC100 .U57 N0.739 1988 C.2 NBS-PUB-C 198

I

OF COMMERCE

Standards

NBS Special Publication 739

Directory of Federal Government

Certification Programs

Maureen Breitenberg, Editor

NBS NBS MBS NBS MBS MBS MBS MBS MBS I

iS NBS NBS NBS NBS NBS NBS NBS NBS NBS NB>

NBS NBS T BS NBS NBS NBS 1

IS NBS NBS NBS NBS NBS NBS NBS NBS NBS NB

MBS NBS NBS NBS NBS NBS NBS NBS NBS NBS 1

IS NBS NBS NBS NBS NBS NBS NBS NBS NBS NB

MBS NBS NBS NBS NBS NBS NBS NBS NBS NBS i

IS NBS NBS NBS NBS NBS NBS NBS NBS NBS NB

MBS NBS NBS NBS NBS NBS NBS NBS NBS NBS J

IS NBS NBS NBS NBS NBS NBS NBS NBS NBS NB

National Bureau ofStandards

IS NBS NBS NBS NBS NBS NBS NBS NBS NBS NB

MBS NBS NBS NBS NBS MBS NBS NBS NBS NBS j

S NBS NBS NBS NBS NBS NBS NBS NBS NB

S NBS NBS NBS NBS NBS NBS NBS NBS NB
m he National Bureau of Standards' was established by an act of Congress on March 3, 1901. The Bureau's overall

80al

s t0 strengthen and advance the nation's science and technology and facilitate their effective application for

public benefit. To this end, the Bureau conducts research to assure international competitiveness and leadership of U.S.

industry, science arid technology. NBS work involves development and transfer of measurements, standards and related

science and technology, in support of continually improving U.S. productivity, product quality and reliability, innovation

and underlying science and engineering. The Bureau's technical work is performed by the National Measurement

Laboratory, the National Engineering Laboratory, the Institute for Computer Sciences and Technology, and the Institute for Materials Science and Engineering.

The National Measurement Laboratory

Provides the national system of physical and chemical measurement;

coordinates the system with measurement systems of other nations and

furnishes essential services leading to accurate and uniform physical and

chemical measurement throughout the Nation's scientific community,

industry, and commerce; provides advisory and research services to other

Government agencies; conducts physical and chemical research; develops,

produces, and distributes Standard Reference Materials; provides

calibration services; and manages the National Standard Reference Data

System. The Laboratory consists of the following centers:

• Basic Standards2 • Radiation Research

• Chemical Physics

• Analytical Chemistry

The National Engineering Laboratory

Provides technology and technical services to the public and private sectors

to address national needs and to solve national problems; conducts research

in engineering and applied science in support of these efforts; builds and

maintains competence in the necessary disciplines required to carry out this research and technical service; develops engineering data and measurement

capabilities; provides engineering measurement traceability services;

develops test methods and proposes engineering standards and code

changes; develops and proposes new engineering practices; and develops

and improves mechanisms to transfer results of its research to the ultimate

user. The Laboratory consists of the following centers:

Applied Mathematics

Electronics and Electrical

Engineering2 Manufacturing Engineering

Building Technology

Fire Research

Chemical Engineering3

The Institute for Computer Sciences and Technology

Conducts research and provides scientific and technical services to aid

Federal agencies in the selection, acquisition, application, and use of

computer technology to improve effectiveness and economy in Government

operations in accordance with Public Law 89-306 (40 U.S.C. 759),

relevant Executive Orders, and other directives; carries out this mission by

managing the Federal Information Processing Standards Program,

developing Federal ADP standards guidelines, and managing Federal

participation in ADP voluntary standardization activities; provides scientific and technological advisory services and assistance to Federal agencies; and

provides the technical foundation for computer-related policies of the

Federal Government. The Institute consists of the following divisions:

Information Systems Engineering

Systems and Software

Technology

Computer Security

Systems and Network

Architecture

Advanced Computer Systems

The Institute for Materials Science and Engineering

Conducts research and provides measurements, data, standards, reference

materials, quantitative understanding and other technical information

fundamental to the processing, structure, properties and performance of

materials; addresses the scientific basis for new advanced materials

technologies; plans research around cross-cutting scientific themes such as nondestructive evaluation and phase diagram development; oversees Bureau-wide technical programs in nuclear reactor radiation research and

nondestructive evaluation; and broadly disseminates generic technical

information resulting from its programs. The Institute consists of the

following Divisions:

• Ceramics

• Fracture and Deformation3

• Polymers

• Metallurgy

• Reactor Radiation

'Headquarters and Laboratories at Gaithersburg, MD, unless otherwise noted; mailing address Gaithersburg, MD 20899. 'Some divisions within the center are located at Boulder, CO 80303.

'Located at Boulder, CO, with some elements at Gaithersburg, MD
NBS Special Publication 739

Directory of Federal Government

Certification Programs

Maureen Breitenberg, Editor

Office of Standards Code and Information

Office of the NBS Associate Director

for Industry and Standards

National Bureau of Standards

Gaithersburg, MD 20899

(Supersedes NBS Spec. Publ. 714)

April 1988

U.S. Department of Commerce

C. William Verity, Secretary

National Bureau of Standards

Ernest Ambler, Director

Research Information Center

National Bureau of Standards

Gaithersburg, Maryland 20899

GUslDO

i
Library of Congress

Catalog Card Number: 88-600511

National Bureau of Standards

Special Publication 739

(Supersedes NBS Spec. Publ. 714)

Nad. Bur. Stand. (U.S.),

Spec. Publ. 739

229 pages (April 1988)

CODEN: XNBSAV

U.S. Government Printing Office

Washington: 1988

For sale by the Superintendent

of Documents,

U.S. Government Printing Office,

Washington, DC 20402
F

This directory is the first revision of the National Bureau of Standards

(NBS) publication, NBS SP 714, Federal Government Certification Programs for

Products and Services , edited by Robert B. Toth and published in April 1986.

Additional federal certification programs have been identified and changes have

been made to reflect organizational or programmatic changes. This directory, a

joint effort of the U.S. Department of Agriculture (USDA) and NBS, is designed to

provide updated information on certification programs conducted by the federal

government for products and services.

Interest in certification arises from many sectors and may be motivated by

economic, procurement, safety, or other considerations. Certification has also

increased in significance due to its impact on free 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

certification programs and the details of such programs, as well as in finding a

contact point within the appropriate agency.

Dr. Stanley I.Warshaw

Associate Director for Industry and Standards

iii
ACKNOWLEDGMENTS

This directory is based on an earlier publication by Robert B. Toth, who was

responsible for much of the work in establishing the format of this publication

and its predecessor.

Special thanks are due to Carolyn Wilson and Audrey Talley at the U. S.

Department of Agriculture (USDA) , who oversaw the collection and review of

information on certification programs within USDA. I would also like to thank

the managers of federal certification programs who provided the information

contained in this directory, without which this publication would not have been

possible.

Maureen Breitenberg

Editor

iv
ABSTRACT

This directory, which represents a joint effort of the U.S. Department of

Agriculture (USDA) and the National Bureau of Standards (NBS) , is designed to

provide updated information on federal certification programs for products and

services. This directory is a revision of NBS SP 714, Federal Government

Certification Programs for Products and Services , edited by Robert B. Toth and

published in April 1986.

This directory is part of ongoing NBS/USDA efforts to establish and maintain

comprehensive databases on standards, regulations, 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 certification

programs.

Key Words: approved products; certification; grading; inspection; listing; premarket evaluation; qualification; qualified products; specifications; standards;

testing

V

CONTENTS

Page

Foreword iii

Acknowledgments iv

Abstract v

Introduction 1

ENTRIES

I. AGRICULTURAL PRODUCTS AND SERVICES 3

H. CONSUMER PRODUCTS AND SERVICES 71

III. CONSTRUCTION PRODUCTS AND SERVICES 87

IV. ELECTRONIC AND TELEOTMmCATIONS PRODUCTS AND SERVICES 95

V. GOVERNMENT PROCUREMENTS Ill

VI. TESTING, MEASUREMENT, AND IAB0RATORY SERVICES 119

VII. MEDICAL PRODUCTS AND SERVICES 137

VIII. MINING, DRILLING AND INDUSTRIAL EQUIPMENT 157

IX. TRANSPORTASTCN-RE1ATED PRODUCTS AND SERVICES 173

X. MISCELLANEOUS PRODUCTS AND SERVICES 219

Index by Product or Service Certified 229

Agency Index by Acronym 239

Department/Agency Index 241

Agency Index 243

Appendix I-Other NBS Documents of Possible Interest 245

Appendix II-Other USDA Documents of Possible Interest 249

Appendix Ill-Format Used for Each Entry 253

vi i

IMERDDUCPrCN

Background

In April 1986, the National Bureau of Standards (NBS) published a directory of

federal certification programs, NBS SP 714, Federal Government Certification

Programs for Products and Services , edited by Robert B. Toth. Since that time,

additional federal certification programs have been identified and some agencies

have undergone reorganizations or program changes. This directory, which

represents a joint effort of the U.S. Department of Agriculture (USDA) and the

National Bureau of Standards (NBS) , is designed to provide updated information on

certification programs which are conducted by the federal government for products

and services. It contains information on the date that programs were initiated;

the authority under which they are conducted; their aims, benefits and

requirements; availability of dcicumentation; and other related information.

Format

The entries in this directory are organized into ten sections: Section IAgricultural Products and Services; Section II - Consumer Products and Services;

Section III - Construction Products and Services; Section IV - Electronic and

Telecommunications Products and Services; Section V - Government Procurements,

Section VI - Testing, Measurement and Laboratory Services; Section VII - Medical

Products and Services; Section VIII - Mining, Drilling and Industrial Equipment;

Section IX - Transportation-Related Products and Services; and Section XMiscellaneous Products and Services. Indices are provided by product at the

beginning of each section, as well as references to related other sections of

possible interest. In addition, there is a cumulative product index at the end

of the entries, followed by indices by agency acronym, department and agency, and

by agency name alone. A description of the format used for each entry is

contained in Appendix III.

Directory Changes

U.S. Government agencies are encouraged to notify NBS of any changes in their

certification programs or of new programs. Such information should be sent to:

National Center for Standards and Certification

Information (NCSCI)

National Bureau of Standards

Administration Building, Room A629

Gaithersburg, MD 20899

(301) 975-4031

Other References

Additional NBS and USDA documents of possible interest are contained in

Appendices I and II.

1

SECTION I

AGRICULTURAL PRODUCTS AND SERVICES

3

SECTION I

AGRICOIOURAL PRODUCTS AND SERVICES

INDEX

REFERENCES IN THIS SECTION PAGE

ADDITIVES, COLOR 53

ANIMAL DISEASES 29

ANIMAL DRUGS 63

ANIMAL FEED 63

ANIMAL PRODUCTS 27, 35

MEAT 7, 35, 47, 49

ANIMALS FOR EXPORT 37

ANIMALS FOR IMPORT 29, 39

BEANS 43

BEEF 7, 47, 49

BINS, GRAIN 45

BIOLOGICAL PRODUCTS, ANIMAL 31

BIRDS, GAME 49

BIVALVES 57

BUFFALO SLAUGHTER 49

BUTTER 11

CHEESE 11

CIGARETTES 69

CIAMS 57

COTTON, RAW 9

DAIRY PRODUCTS 11

BUTTER 11

CHEESE 11

MILK PRODUCTS 11

DRUGS, VETERINARY 63

EGGS AND EGG PRODUCTS 19

ELEVATORS, GRAIN 45

EXPORTS 25, 27, 37

FEED 63

FISH 51

FOOD ADDITIVES 53

POOD FOR ANIMALS 63

FOOD FOR HUMANS 55

FOOD INSPECTION PERSONNEL 61

FORMULA, INFANT 59

FRUITS, FRESH 13

FRUITS, PROCESSED 15

FUNGICIDES 67

GAME BIRDS 49

GRAIN AND GRAIN PRODUCTS 43

GRAIN (INSPECTION AND WEIGHING) 45

HORSE MEAT 47

IMPORTS 23, 35, 39

INFANT FORMULA 59

INSPECTORS, FOOD 61

LABELING, FOOD 55

5
REFERENCES IN THIS SECTION CONTINUED PAGE

LAMB 7, 47, 49

LENTILS 43

LIVESTOCK FOR EXPORT 37

LIVESTOCK FOR IMPORT 29, 39

MEAT AND MEAT PRODUCTS 7, 35, 47, 49

MILK PRODUCTS 11, 35

MUSSELS 57

NAVAL STORES 17

NUTS 13

ORGANISMS 29

OYSTERS 57

PEAS 43

PESTICIDES 67

PET FOOD 49, 63

PLANTS AND PLANT PRODUCTS 23, 25

PORK 7, 47, 49

POULTRY AND POULTRY PRODUCTS 19, 35, 47, 49

POULTRY FOR EXPORT 37

POULTRY FOR IMPORT 35, 39

PULSES 43

RABBITS AND RABBIT PRODUCTS 19, 49

REINDEER SLAUGHTER 49

RICE 43

ROSIN 17

SEAFOOD 51, 57

SHELLFISH 51, 57

SQUAB 49

TOBACCO AND TOBACCO PRODUCTS 17, 69

TURPENTINE 17

VEAL 7, 47, 49

VECTORS 29

VEGETABLES, FRESH 13

BEANS 43

LENTILS 43

PEAS 43

VEGETABLES, PROCESSED 15

VETERINARY BIOLOGICAL PRODUCTS 31

VETERINARY DRUGS 63

WATER 65

REFERENCES IN OTHER SECTIONS

PARTS, MATERIALS AND EQUIPMENT FOR RURAL ELECTRIC & TELEPHONE SYSTEMS 99

EQUIPMENT AND MATERIALS USED IN THE WORKPLACE 171

LABORATORY ACCREDITATION FOR MEAT/POULTRY/FOOD PRODUCTS 125

LABORATORY CERTIFICATION FOR THE ANALYSIS OF WINES AND DISTILLED SPIRITS

FOR EXPORT 127

MEASUREMENT CALIBRATION SERVICES 129

SCALE TESTING AND CERTIFICATION-GRAIN 131

WEIGHING AND MEASURING DEVICES, COMMERCIAL 135

HAZARDOUS SUBSTANCES 227

VEHICLES, REFRIGERATED 215

6
Products or

Services

Meats, Prepared Meats, and Meat Products

(Beef, Lamb, Veal, Calf, and Pork)

Departanent/Agency U.S. Department of Agriculture

Agricultural Marketing Service

Livestock and Seed Division

Meat Grading and Certification

P. 0. Box 96456

Washington, D.C. 20090-6456

(202) 382-1246

FAX: (202) 447-7271

(USDA)

(AMS)

(MGC) Branch, Room 2638-S

Initiated

Compliance

Authority

Aim

Benefits

1946

Voluntary

Agricultural Marketing Act of 1946 (as amended)

To facilitate the marketing of livestock and meat.

Through uniform grade standards, the meat grading system

provides reliable identification of the value-determining

factors of meat and a common language to facilitate trading.

From producer to consumer, this system makes buying and

selling more efficient and meaningful. The certification

program assists large scale buyers by providing impartial

evaluation and certification that meat purchases meet their

contract specifications.

Agency Function The MGC Branch provides on-site grading and certification of

meats and meat products by the physical examination of

product characteristics during the production process prior

to the purchase.

Methodology

Testing

Inspection

Inspection by MGC Branch personnel.

Required tests are preformed in Government labs.

MGC Branch personnel.

Conformity

Identification

Approved USDA stamps and roller brands are applied in

compliance with applicable standards or specifications.

7
USDA. certification is withheld from products not conplying

with approved standards or specifications.

Continuous inspection on a voluntary basis.

None.

The agency develops and maintains its own USDA approved

standards and specifications for the various meat items.

beef; certification; grading; lamb; meat; meat products;

pork; veal

8
Products or

Services

Raw Cotton

Department/Agency U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Cotton Division, Rm. 2641-S

P. 0. Box 96456

Washington, D.C. 20090-6456

(202) 447-2145

FAX: (202) 472-9718

Initiated 1916

Compliance

Authority

Required for cotton delivered on Futures Contracts.

7 CFR Part 27 and U. S. Cotton Futures Act.

Aim To certify quality of cotton delivered on Futures Contracts

according to official U. S. Standards.

Benefits Orderly settlement of cotton Futures Contracts.

Agency Function Certifier.

Type of Program Cotton grading and certification.

Methodology Government agency classes (grades) cotton samples taken from

bales expected to be tendered on the futures market and

issues certificates certifying quality.

Testing

Inspection

Government labs.

Government.

Conformity

Identification

Grade certificates.

Availability of

Documentation

List of government cotton classing offices available from

above address.

9
Obligations of To order samples taken and transported to government

Manufacturer/Vendor classing offices.

Enforcement Decertification

.

Term One year from date of original certification.

Reciprocity Other federal agencies.

Standards, Codes The agency prepares all criteria documents,

or Regulations

Keywords certification; classing; cotton quality; grading

10
Products or

Services

Dairy Products

Department/Agency U.S. Department of Agriculture (USDA)

Agriailtural Marketing Service (AMS)

Dairy Division, Rm. 2750-S

P. 0. Box 96456

Washington, D.C. 20090-6456

(202) 382-9382

FAX: (202) 447-7271

Initiated 1925

Compliance

Authority

Voluntary

7 CFR Part 58 and the Agricultural Marketing Act of 1946 (as

amended)

Aim Orderly trade in processed dairy products and assurance of

consistent quality of such conmodities

Benefits Identification of qualified producers. Grading of selected

dairy products. Consistent nomenclature for buying and

selling processed dairy products.

Agency Function Certifier and program administrator.

Type of Program Pre-marketing evaluation.

Assessment prior to government purchase.

Methodology Government agency provides testing, inspection, audit and

site approval. State governments cooperate in some phases.

Testing Government labs.

Government accredited labs.

Inspection Government.

State government.

Conformity

Identification

List of approved dairy plants. Authorized grading marks

are applied on products for which grading standards are

established.

11
Availability List of approved dairy plants is updated quarterly and is

of Documentation available from the above address.

Obligations of Approved dairy plants must maintain quality control,

Manufacturer/Vendor

Enforcement Delisting.

Product recall.

Term Dairy plants are reinspected two to four times per year.

Reciprocity Other federal agencies.

State agencies.

Standards, Codes The agency prepares all criteria documents,

or Regulations

Keywords butter; cheese; dairy products; food quality; grading

12
Products or

Services

Fresh Fruits, Vegetables, Nuts, and Related Products

Department/Agency U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Fruits and Vegetables Division, Rm. 2077-S

P. 0. Box 96456

Washington, D.C. 20090-6456

(202) 447-6393

FAX: (202) 447-7271

Initiated

Compliance

Authority

Aim

1917

Voluntary

Agricultural Marketing Act of 1946 (as amended)

Orderly trade in fresh fruits and vegetables based on

standard nomenclature. Common basis for settling market

disputes over quality of products

Benefits Improve efficiency in buying and selling produce

based on official and standardized grading which is

consistent throughout the nation. Inspection certificates

are accepted in court as prima facie evidence of produce

condition at the time of inspection.

Agency Function

Type of Program

Certifier and program administrator.

Voluntary pre-marketing evaluation.

Voluntary post-marketing assessment.

Assessment prior to government purchase.

Methodology

Inspection

Federal or state inspection.

Federal government inspection.

Inspection by state government inspectors trained by USDA.

Conformity

Identification

Certificate of inspection.

13
Availability There are no lists of participating producers,

of Documentation

Obligations of Must have a financial interest in the product. Pay

Manufac±urer/Vendor assessed fee for service rendered.

Enforcement Although nearly all aspects of this program are voluntary, a

full range of enforcement options apply to shippers who

practice fraud.

Term Certification is done on a lot by lot basis.

Reciprocity USDA grade marking is recognized nation-wide and world-wide

in both private and public sectors.

Standards, Codes Grading criteria are established by AMS.

or Regulations

Keywords food quality; fruits; grading; nuts; vegetables

14
Products or

Services

Processed Fruits and Vegetables

Department/Agency U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Fruits and Vegetables Division, Rm. 0709-S

P. 0. Box 96456

Washington, D.C. 20090-6456

(202) 447-4693

FAX: (202) 447-7271

Initiated 1931

Compliance Voluntary, except for products covered by federal or state

marketing orders.

Authority 7 CFR Part 52 and the Agricultural Marketing Act of 1946 (as

amended)

.

Aim Provide an objective evaluation of quality and condition of

various processed food products and conditions under which

they are produced.

Benefits Provide a uniform basis for nation-wide trade in processed

fruits and vegetables.

Agency Function

Type of Program

Provide voluntary grading and inspection service.

Pre-market evaluation.

Post-market assessment.

Assessment prior to government purchase.

Methodology Government, testing, inspection, audit, site approval,

compliance with good manufacturing practices (GMPs)

.

Testing Government lab.

Manufacturer's lab under review by government inspectors.

State labs if state is cooperating in program.

Third party labs may be used by manufacturer for quality

control

.

15
Inspection Federal government inspection.

Inspection by cooperating state government inspectors.

Conformity

Identification

Authorized grade and/or inspection marks applied by

manufacturer. Government applied mark is restricted to

officially sampled lots.

Availability

of Documentation

List of processing plants under contract is published

annually and is available from the above address.

Obligations of Make product accessible for sampling. Produce product in

Manufacturer/Vendor accordance with the good manufacturing practices (GMPs) as

defined in the Food and Drug Administration's regulations.

Enforcement Since bulk of program is voluntary, means of enforcement is

withdrawal of labeling privilege or withdrawal of service.

When Marketing Orders are in effect, agency sponsoring the

order has authority for product recall or marketing ban.

Term Term is set by contract; activity may be renewed and/or

may provide for continuous inspection.

Reciprocity Certificates are recognized by other federal agencies for

procurement. Certificates of Sampling from states are

recognized by Agency under certain cooperative agreements.

Standards, Codes

or Regulations

Most acceptance criteria are based on requirements or

specifications developed by federal or state agencies;

however, sometimes buyer specifications are used.

Keywords agricultural marketing orders; food quality; fruits; good

manufacturing practices; grading; in-plant inspection;

processed foods; sanitation; vegetables

16
Products or

Services

Tobacco and Naval Stores

Department/Agency U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Tobacco Division, Rm. 502 Annex Building

300 12th Street, SW

P. O. Box 96456

Washington, D.C. 20090-6456

(202) 447-2567

FAX: (202) 447-2567

Initiated Tobacco - 1935

Naval Stores - 1923

Compliance Tobacco : Mandatory only for domestic tobacco sold on designated

auction markets and all imported tobacco, except cigar and

oriental, offered for importation into the U.S.

Naval Stores : Voluntary.

Authority The Tobacco Inspection Act.

The Dairy and Tobacco Adjustment Act.

The Naval Stores Act.

Aim Protection of producers and others against speculation,

manipulation, control and unreasonable price fluctuations.

Benefits Helps producers move commodities to consumers quickly,

fairly and efficiently.

Agency Function

Type of Program

Methodology

Certifier and program adnririistrator.

Pre-market evaluation.

Government grading in accordance with U.S. Official Standard

Grades and Specifications.

17
Testing Naval Stores : Government lab certifies results of manufacturer's lab.

Inspection Tobacco : Federal government inspection.

Naval Stores : Official inspectors.

Licensed inspectors.

Conformity

Identification

Tobacco : Government certificates.

Naval Stores : Government certificates and authorized mark by manufacturer.

Availability

of Documentation

Documentation is confidential.

Obligations of Proper lighting and adequate space.

Manufacturer/Vendor

Enforcement Tobacco : Reduction of sales opportunity or withdrawal of inspection.

Naval Stores : Withdrawal of inspection.

Term Continuous inspection.

Reciprocity Recognition of certification by other federal agencies and

international organizations.

Standards, Codes

or Regulations

7 CFR Part 29, Subpart C - Standards.

7 CFR Part 160, Regulations and Standards for Naval Stores.

ASTM Designation D 233, Sampling and Testing Turpentine.

Keywords agricultural marketing orders; food quality; good

manufacturing practices; inspection; naval stores; rosin;

sanitation; tobacco; turpentine

18
Products or Poultry, Shell Eggs, Egg Products, and Rabbits

Services

Department/Agency U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Poultry Division, Pom. 3938-S

P. O. Box 96456

Washington, D.C. 20090-6456

(202) 447-3271

Telex: 89-491

TWX: 710-822-9424 and 710-822-1104

FAX: (202) 447-9016

Initiated 1917

Compliance Mandatory for all products cited if service is rendered.

However, grading of poultry, shell eggs, and rabbits is not

mandatory and is provided only to plants requesting the

service.

Authority Laws:

Agricultural Marketing Act of 1946 (as amended) (60 Stat.

1087-1091; USC 1621-1627).

Egg Products Inspection Act (84 Stat. 1620-1635; 21 USC

1031-1056)

Regulations:

Poultry and rabbit grading - Regulations Governing the

Voluntary Grading of Poultry Products and Rabbit Products

and U. S. Classes, Standards, and Grades (7 CFR Part 70)

Voluntary egg products inspection - Regulations Governing

the Voluntary Inspection and Grading of Egg Products (7 CFR

Part 55)

Shell egg grading - Regulations Governing the Grading of

Shell Eggs and United States Standards, Grades, and Weight

Classes for Shell Eggs (7 CFR Part 56)

Mandatory egg products inspection - Regulations Governing

the Inspection of Eggs and Egg Products (7 CFR Part 59)

19
Aim Voluntary:

To develop and improve standards of quality, condition,

quantity, grade, and packaging, and recommend and

demonstrate such standards in order to encourage uniformity

and consistency in commercial practices and enhance the

orderly and efficient marketing of poultry and poultry

products.

Mandatory:

To assure that the health and welfare of consumers is

protected by adoption of measures for assuring that eggs and

egg products distributed to them and used in products

consumed by them are wholesome and labeled properly.

Benefits Third party evaluation.

Easier dispute settlement.

More accurate market price reporting.

More equitable competition.

Fewer rejections at destination.

Established buying guides (specifications)

.

Reduced illness.

upgraded product quality.

Agency Function Certifier and regulator.

Type of Program Pre-market evaluation.

Post-market evaluation.

Assessment prior to government purchase.

Specification development.

Inspection & grading.

Methodology Government:

Sampling.

Organoleptic laboratory testing.

Evaluation against standard.

Certification by third party certifiers.

Testing Government laboratories.

Approved state laboratories.

Third party laboratories.

Manufacturer's laboratories.

Inspection Federal government inspection.

Inspection by approved state agencies.

20
Cdnformity

Identification

Stamps (authorized marks)

Certificates

labeling.

Seals.

Availability

of Documentation

Single copies of regulations may be obtained from the

Agency. Multiple copies may be obtained from the

Superintendent of Documents, U.S. Government Printing

Office.

Obligations of

Manufacturer/Vendor

Operate in a sanitary manner.

Maintain volume records.

Comply with regulations.

Perform required laboratory tests.

Reimburse Government for cost of voluntary inspections and

gradings.

Provide access to products.

Provide access to equipment and facilities necessary for

accomplishing official duties.

Enforcement Product retention.

Product recall.

Withdrawal of service,

laboratory comparison samples.

Removal/withhold official identification.

Reinspection/regrading

Interruption of operations (mandatory only)

Judicial system.

Term Continuous mandatory inspection.

Continuous or intermittent voluntary inspection.

Reciprocity Use of licensed State employees.

Recognition of certification of ingredients by manufacturer.

Recognition of certification by approved government

laboratory.

Recognition of inspection stamp of "Agriculture Canada" for

egg products produced in specifically approved Canadian

plants,.

Standards, Codes

or Regulations

See "Authority."

Keywords contract acceptance; egg products; eggs; grading branch;

grading; poultry; rabbits; shell eggs;

21

Products or

Services

Plants and Unprocessed Plant Products for Export

Dqpartment/Agency U.S. Department of Agriculture

Animal and Plant Health Inspection Service (APHIS)

Plant Protection and Quarantine

National Program Planning Staff

Regulatory Services Staff, Federal Building

6505 Belcrest Road

Hyattsville, MD 20782

Telephone: (301) 436-8537

Telex: 89607 ADEHVIE

FAX: (301) 436-8794

Initiated 1913

Compliance Voluntary

Authority Department of Agriculture Organic Act of 1944, as amended.

7 CFR Part 353.

Aim To assist in foreign marketing of American agricultural

products.

Benefits Most foreign countries require that shipment of plants and

unprocessed or unmanufactured plant products be

accompanied by phytosanitary (plant health) certificates

certifying conformity with the receiving country's plant

quarantine import regulations. The certificates are

issued to exporters based upon physical inspection and

and the determination that the commodity is free from

insect pests, plant diseases, and other organisms

considered harmful by the receiving country.

Phytosanitary certificates are not issued to satisfy

letters of credit or other commercial contract terms and

are not certifications of grade or quality.

Agency Function Certifier and program administrator.

Type of Program Pre-export inspection.

Methodology Inspection by federal government and state government

cooperators.

23
'resting Testing in government labs and recognized state and

university labs.

Conformity

Identification

Federal Phytosanitary Certificate.

Availability

of Documentation

Information regarding foreign country plant quarantine

import requirements is maintained at above address and at

Agency offices at major points of entry into the United

States.

Obligations of the

Manufacturer/Vendor

Exporter must make written application for inspection and

make commodity available for physical inspection.

Applications for active growth field inspections must be

directed to the appropriate state plant regulatory agency

in advance of the planting season.

Enforcement Federal certification is withheld from commodities not

complying with the plant quarantine import requirements

of the foreign country.

Term Inspections normally not valid if conducted more than 14

days prior to commodity export.

Reciprocity Certification is recognized by foreign plant protection

services and by regional plant protection organizations.

Standards, Codes

or Regulations

Criteria for certification are established by each foreign

country.

Keywords export certification; export; phytosanitary; plant health;

plant quarantine; plant products; plant; re-export

24
Plants and Unprocessed Plant Products for Import

U.S. Department of Agriculture

Animal and Plant Health Inspection Service (APHIS)

Plant Protection and Quarantine

National Program Planning Staff

Regulatory Services Staff, Federal Building

6505 Belcrest Road

Hyattsville, MD 20782

Telephone: (301) 436-8645

Telex: 89607 ADEHVLE

FAX: (301) 436-8794

1912

Mandatory

Plant Quarantine Act of 1912, as amended.

Federal Plant Pest Act of 1957, as amended.

To assist in preventing the introduction and dissemination

of exotic plant pests and pathogens into and throughout

U.S. agriculture.

The permit system serves to notify prospective importers

of the entry status and special entry requirements for

their imports. This aids in preventing the arrival on

U.S. shores of plant material potentially infested with

exotic plant pests. The permit system also provides the

agency with a list of importers of plants and plant

products.

Reviews applications, issues permits, and provides

information on entry requirements and regulatory changes.

Pre-import evaluation of entry requirements.

Review of regulations and evaluation of pests associated

with product in country of origin.

None.

25
Conformity

Identification

Valid import permit number.

Availability

of Documentation

Lists of approved aaximodities and entry requirements

from each country available from above address.

Information on permit holders available only through the

freedom of information process.

Obligations of the

Manufacturer/Vendor

Importer must make written application for permit.

Term Permits issued for varying time periods ranging from 1 day

to 5 years, depending on the product.

Reciprocity Import permit is recognized by foreign plant protection

services and by state plant protection organizations.

Standards,

Codes, or

Regulations

Criteria for permits are established by the Acts and the

regulations promulgated therefrom.

Keywords import; permit; plant health; plant quarantine; plant

products; plant

26
Products or

Services

Animal By-products for Export

Department/Agency U.S. Department of Agriculture

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services

Program Planning and Development

Import-Export Emergency Planning Staff

Federal Building, Rm. 810

6505 Belcrest Road

Hyattsville, MD 20782

Telephone: (301) 436-8017

Telex: 89607 ADEHVIE

FAX: (301) 436-8794

Initiated

Cbnpliance

Authority

1946

Voluntary

Laws:

Agricultural Marketing Act of 1946, Sections 203 and 204,

Regulations

9 CFR Part 156.

Aim To assist U.S. exporters in complying with import

requirements of foreign countries.

Benefits Most foreign countries require shipments of certain

inedible animal by-products to be accompanied by

certificates indicating the class, quality, and condition

of the by-product and the U.S. status relative to certain

livestock diseases. The certificates are issued to

exporters based upon physical inspection, Department policy

regarding the absence of certain diseases in the U.S., and

endorsement of certain certifications made by state or

accredited veterinarians.

Agency Function

Type of Program

Methodology

Certifier and program administrator.

Pre-export inspection.

Inspection by federal government and/or state government

cooperators.

27
Testing None.

Conformity

Identification

USDA: export certificate, stamp endorsement, or letterhead

certification

.

Availability There are no lists of participating exporters. Copies of

of Documentation regulations may be obtained from the Agency.

Obligations of the In some cases, exporters must enter a cooperative

Manufacturer/Vendor agreement with Veterinary Services (VS) ; make written

application to the Deputy Administrator, VS; and make

product available for inspection.

Term No specific term; based on time limits set forth by

importing country.

Reciprocity None.

Standards,

Codes, or

Regulations

Criteria for certification are established by each foreign

country.

Keywords animal by-product; export; export certification; inedible

28
Products or

Services

Organisms and Vectors - Imported Livestock

Department/Agency U.S. Department of Agriculture

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services

Program Planning and Development

Import-Export Emergency Planning Staff

Federal Building, Rm. 810

6505 Belcrest Road

Hyattsville, MD 20782

Telephone: (301) 436-8017

Telex: 89607 ADEHVLE

FAX: (301) 436-8025

Initiated 1913

Compliance

Authority

Mandatory

Laws:

Virus-Serum-Toxin Act of 1913, as amended

(21 USC 111, 151-158) (7 USC 430)

.

Act of June 17, 1930 (Tariff Act Section 201)

(19 USC 1202) (46 Stat. 673)

.

Act of June 17, 1930 (Tariff Act-Section 306)

(19 USC 306) (46 Stat. 689)

.

Act of July 2, 1962 - P.L. 518 (21 USC 134)

(76 State 129)

.

Act Of May 6, 1970 - P.L. 91-239 (21 USC 135)

(84 Stat. 202)

.

Regulations:

9 CFR Chapter I, Subchapter D, Parts 92, 94, 97, and

122.

Aim To assist in preventing the introduction and dissemination

of exotic animal diseases into the U.S. livestock

population.

Benefits The permit system serves to notify importers about special

entry requirements and handling procedures for imports.

Uniform central control of imports.

29
Agency Function Review applications, issue permits, and provide

information on entry requirements and regulatory changes.

Type of Program Pre-import evaluation.

Methodology Review of applications and evaluation of the importer's

ability to handle the organisms or vectors in a safe

manner.

Testing None.

Inspection Government.

Conformity

Identification

Valid import permit and certificates.

Availability Copies of regulations may be obtained from the Agency,

of IDocumentation Information on permit holders available only through the

Freedom of Information process.

Obligations of the Comply with regulations and conditions of permits,

Manufac±urer/Vendor maintain records, provide access to facilities and records

for inspection.

Enforcement Revocation of permit, judicial system, refuse entry of

imports.

Term Permits are issued for 1 year.

Reciprocity None.

Standards,

Codes, or

Regulations

See "Authority."

Keywords import; organisms; permit; vectors

30
Products or

Services

Animal Biological Products

Department/Agency U.S. Department of Agriculture

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services

Rm. 320-E

Washington, D.C. 20250

Telephone: (202) 447-5193

Telex: 89607 Ans: ADEHVLE

FAX: (202) 472-5686

Initiated 1913

Compliance

Authority

Mandatory

Laws:

Virus-Serum-Toxin Act of 1913, as amended

(21 USC 151-159) (7 USC 430)

.

Regulations:

9 CFR Chapter I, Subchapter E, Parts 101-117

Aim To assure that animal biological products imported into or

prepared in the United States are pure, safe, potent, and

efficacious.

Benefits Uniform central control.

Prevention of the introduction and spread of animal

diseases

.

Avoidance of risk to public health and well-being.

Improved product quality.

Agency Function

Type of Program

Certifier and regulator.

Pre-license product evaluation.

Post-license product evaluation.

Specification development.

Inspection.

Export certification.

31
Methodology Government

Laboratory testing

Evaluation against standard

Inspection

Export certification.

Testing Manufacturer's laboratories.

Government laboratories.

Third party laboratories.

Inspection Government.

Conformity

Identification

Labeling and certificates.

Availability

of Documentation

Single copies of regulations may be obtained from the

Agency. Multiple copies may be ordered from the

Superintendent of Documents, U. S. Government Printing

Office.

Obligations of the

Manufacturer/Vendor

Comply with regulations.

Maintain detailed records.

Operate in a sanitary manner.

Perform manufacturing steps and tests in accordance with

requirements

.

Submit samples to government laboratory.

Provide access to facilities and records.

Enforcement Government release to market of each serial of each product.

Market suspension.

Reinspection.

Judicial system.

Term Continuous market release.

Periodic inspection of facilities and records.

Reciprocity None.

32
Standards, See "Authority."

Codes, or

Regulations

Keywords export certificates; licenses; standard requirements;

veterinary biological products

33

Products or Meat, Milk, and Poultry Products for Import

Services

Department/Agency U.S. Department of Agriculture

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services

Program Planning and Development

Import-Export Emergency Planning Staff

Federal Building, Rm. 810

6505 Belcrest Road

Hyattsville, MD 20782

Telephone: (301) 436-8017

Telex: 89607 ADEHVLE

FAX: (301) 436-8025

Initiated 1890

Compliance Mandatory

Authority Laws:

Act of August 30, 1890 (Animal Quarantine Acts; 21 USC 102

through 105) (26 Stat. 414)

.

Act of February 2, 1903 (21 USC 111) (32 Stat. 792).

Act of June 17, 1930 (Tariff Act Section 201)

(19 USC 1202) (46 Stat. 673)

.

Act of June 17, 1930 (Tariff Act-Section 306)

(19 USC 306) (46 Stat. 689)

.

Act of July 2, 1962 - P.L. 518 (21 USC 134)

(76 State 129)

.

Act of May 6, 1970 - P.L. 91-239 (21 USC 135)

(84 Stat. 202)

.

Regulations:

9 CFR Chapter I, Subchapter D, Parts 94, 95, and 96.

Aim To assure that imported animal products are properly

cooked and handled in a manner to prevent the entry and

dissemination of exotic animal diseases into the U.S.

livestock population.

35
Benefits The permit system serves to notify importers about special

entry requirements and handling procedures for imports.

Uniform central control of imports.

Agency Function Review applications, issue permits, and provide

information on entry requirements and regulatory changes.

Type of Program Pre-import evaluation.

Methodology Review of applications and evaluation of the importer's

ability to meet criteria for import.

Testing None.

Inspection Government.

Conformity

Identification

Valid import permit and certificates.

Availability Copies of regulations may be obtained from the Agency,

of Documentation Information on permit holders available only through the

Freedom of Information process.

Obligations of the Comply with regulations and conditions of permit.

Manufacturer/Vendor Maintain records and provide access to facilities and

records for inspection.

Enforcement Revocation of permit, judicial system, refuse entry of

imports.

Term Permits are issued for 1 month to 1 year.

Reciprocity None.

Standards,

Codes, or

Regulations

See "Authority."

Keywords animal product; import; meat; milk; permit

36
Products or

Services

Specified Animals for Export

Department/Agency U.S. Department of Agriculture

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services, Domestic Programs

Import-Export Operations Staff

Federal Building, Rm. 764

6505 Belcrest Road

Hyattsville, MD 20782

Telephone: (301) 436-8695

Telex: 89607 ADEHVLE

FAX: (301) 436-8025

Initiated 1884

Compliance

Authority

Mandatory

Laws:

Act Of May 29, 1884 (21 USC 112, 113, 120)

.

Act of May 29, 1884 (21 USC 114a)

.

Act of February 2, 1903 (21 USC 121).

Act of July 2, 1962 (21 USC 134, 134f)

.

Act of March 4, 1907 (21 USC 612, 613, 614, 618)

Regulations:

9 CFR Chapter I, Subchapter D, Part 91.

Aim To assure the exportation of healthy livestock and poultry

in a humane manner.

Benefits Provide a means for exporting healthy animals from the

United States which enhances the U.S.'s image and aids in

the balance of trade with foreign nations.

Agency Function

Type of Program

Inspection, certification and regulation.

Inspection and certification of health for livestock

exports.

37
Methodology Government:

Diagnostic testing

Inspection of documents and animals

Certification

Testing Government laboratories and government quarantine

personnel.

Inspection Government.

Conformity

Identification

Valid health certification matching individual animal

identification

.

Availability

of Documentation

Copies of regulations, specific health conditions, and

guidelines for approved export facilities available on

request from the above address.

Obligations of the The exporter must submit an international health

Manufac±urer/Vendor certificate issued by an accredited veterinarian to the

Department for endorsement. The enclosed health

certificate must accompany the animals to a port of

embarkation.

Enforcement The health certificates are not endorsed unless the

specific health requirements have been met. The importing

country is notified if the exporter chooses to export the

animals without USDA endorsement.

Term Health certificates are valid for 30 days.

Reciprocity None.

Standards,

Codes, or

Regulations

U.S. export requirements are based upon criteria developed

by experts in the field of preventative veterinary

medicine and accepted by the Department. The importing

country's health requirements are also enforced by the

Department.

Keywords animals; export; health certificate; inspection; livestock;

permit; poultry; quarantine; testing

38
Products or

Services

Specified Animals for Import

Deparbnent/Agency U.S. Department of Agriculture

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services, Domestic Programs

Import-Export Operations Staff

Federal Building, Rm. 764

6505 Belcrest Road

Hyattsville, MD 20782

Telephone: (301) 436-8590

Telex: 89607 ADEHVIE

FAX: (301) 436-8567

Initiated 1890

Compliance

Authority

Both mandatory and authorized to act.

Laws:

Act of August 30, 1890 (Animal Quarantine Acts; 21 USC 102

through 105) (26 Stat. 414)

Act of February 2, 1903 (21 USC 111) (32 Stat. 792).

Act of June 17, 1930 (Tariff Act-Section 201) (19 USC

1202) (46 Stat. 673)

Act of June 17, 1930 (Tariff Act-Section 306) (19 USC

306) (46 Stat. 689)

Act of July 2, 1962- P.L. 518 (21 USC 134)

(76 Stat. 129)

Act of May 6, 1970-P.L. 91-239 (21 USC 135)

(84 Stat. 202)

Regulations:

9 CFR Chapter I, Subchapter D, Parts 92, 94, 97, and

Subchapter G, Part 151.

Aim To prevent the introduction and dissemination of animal

diseases of foreign origin.

Benefits Allows the U.S. livestock and poultry industries access to

genetic materials to improve the national herd/flock and

increase its productivity.

39
Agency Function Provides an inspection and quarantine service, issues

permits for entry and certifies the health status of

animals and poultry released from quarantine.

Type of Program Pre-import evaluation of permit applications, inspection

of imported animals and re-evaluations of import

requirements on a continuing basis.

Methodology Government:

Diagnostic testing

Inspection of documents and animals

Certification

.

Testing Government laboratories and government quarantine

personnel.

Inspection Government.

Conformity

Identification

Valid health certification matching individual animal

identification

.

Availability

of Documentation

Copies of regulations, specific health conditions, and

guidelines for approved import facilities available on

request from the above address.

Obligations of the

Manufacturer/Vendor

The exporter must submit a written permit application,

provide a valid health certification for imports,

reimburse the Department for quarantine and special services

provided under cooperative agreements.

Enforcement Animals and poultry not meeting U.S. requirements for

entry are rejected and must be taken out of the country

or be destroyed at importer's expense. Violators of

Federal Import Laws are subject to legal action.

Term Permits are valid for periods from 2 weeks to 3 days.

In a very few cases, blanket permits for up to one year

are issued.

Reciprocity None.

40
Standards,

Oodes, or

Regulations

Keywords

Criteria based on norms developed by experts in the field

of preventative veterinary medicine and accepted by the

Department.

animals; entry; health certificate; import; inspection;

livestock; permit; poultry; quarantine; testing

41
I
Products or

Services

Rice, Beans, Whole and Split Peas, lentils, Processed

Grain Products, and Related Products

Department/Agency U.S. Department of Agriculture

Federal Grain Inspection Service (FGIS)

Field Management Division, Room 1641-S

P. 0. Box 96454

Washington, D.C. 20090-6454

Telephone: (202) 382-0262

Telex: 760 7351 ANS:FGIS UC.

FAX: (202) 447-4628

Initiated

Compliance

Authority

Aim

1916

Voluntary

Agricultural Marketing Act of 1946.

Orderly trade in rice, pulses, processed grain products,

and related products. Common basis for settling market

disputes over quality of products.

Benefits Improved efficiency in the buying and selling of rice and

pulses based on official and standardized grading and of

processed grain products and related products based on

user's specification. Inspections are uniform throughout

the nation. Inspection certificates are accepted in court

as prima facie evidence of product condition at time of

inspection.

Agency Function

Type of Program

Certifier, regulator, and program adndnistrator.

Pre-marketing evaluation.

Post-marketing assessment.

Assessment prior to government purchase.

Methodology

Testing

Accreditation of third party laboratories.

FGIS laboratory.

Government accredited laboratory.

Inspection FGIS, state government, or third party.

43
Conformity

Identification

Certificates of inspections.

Availability There are no lists of participating companies,

of Dxximentation

Obligations of the Must have financial interest in products and pay assessed

Manufacturer/Vendor fee.

Term Continuous or intermittent voluntary inspection on a lot

basis.

Reciprocity Certificates are required by federal agencies, state

agencies, private sector organizations, foreign

governments, and international organizations buying

and selling rice, pulses, processed grain products, and

related products.

Standards, Codes

or Regulations

U.S. Standards for Rough Rice, Brown Rice for Processing,

Milled Rice; United States Standards for Beans; United

States Standards for Whole Dry Peas, Split Peas, and

Lentils; and related handbooks. Acceptance criteria

for processed grain products and related products are

based on requirements or specifications developed by

federal and state agencies and/or PGIS inspection

handbooks. In some instances, buyer or seller

specification are used.

Keywords beans; good manufacturing practices; in-plant inspection;

lentils; peas; pulses; rice; sanitation

44
Products or

Services

Grain Inspection and Vfeighing

Department/Agency U.S. Department of Agriculture

Federal Grain Inspection Service (FGIS)

Field Management Division, Room 1641-S

P. 0. Box 96454

Washington, D.C. 20090-6454

Telephone: (202) 382-0262

Telex: 760 7351 ANS:FGIS UC.

FAX: (202) 447-4628

Initiated 1916 (inspection)

.

1976 (weights)

.

Compliance Mandatory for exports.

Voluntary for domestic products.

Authority U.S. Grain Standards Act, as amended.

Aim Provide for the establishment of Official United States

Standards for Grain, promote the uniform application of

the official standards by official inspection personnel,

provide for an official inspection systems for grain, and

to regulate the certification of the weight of grain

shipped in interstate and foreign commerce.

Benefits Facilitate the marketing and trading of grain in an

orderly and timely manner.

Agency Function

Type of Program

Certifier, regulator, and program administrator.

Pre-performance evaluation.

Post-performance assessment.

Assessment prior to government purchase.

Methodology Third party laboratory.

Testing FGIS laboratory.

Delegated state laboratory.

Designated local government agency laboratory.

45
Inspection PGIS, state government, or third party.

Conformity

Identification

Certification of inspection and/or weight.

Availability

of Documentation

List of official inspection and weighing agencies and

list of export elevators may be obtained from:

U.S. Department of Agriculture

Federal Grain Inspection Service (PGIS)

Compliance Division, Room 1647-S

P. 0. Box 96454

Washington, D.C. 20090-6454

Telephone: (202) 382-0262

Telex: 760 7351 ANS:FGIS UC.

FAX: (202) 447-4628

Obligations of the

Manufacturer/Vendor

Must submit application for inspection or weighing.

Term Continuous or intermittent, mandatory or voluntary

inspection and weighing services on a lot basis.

Reciprocity Certificates are recognized by federal agencies, state

agencies, private sector organizations, foreign

governments, and international organizations buying

and selling grain.

Standards, Codes

or Regulations

Keywords

U.S. Grain Standards Act, as amended, and the regulations

thereunder; Official United States Standards for Grain;

FGIS Inspection Handbooks; and FGIS Weighing Handbook.

grain elevators; grain scales; grain weights; grain bins;

load cells; loading plans; official grain standards

46
Products or

Services

Meat/Poultry Products

(Mandatory Inspection)

Department/Agency U.S. Department of Agriculture

Food Safety and Inspection Service (FSIS)

14th and Independence Ave. , SW

Washington, D.C. 20250

(202) 447-7025

Initiated

Compliance

Authority

1901 (Meat); 1958 (Poultry).

Mandatory

21 USC 601 et sea, (meat)

.

21 USC 451 et sea, (poultry)

.

Aim Assure that meat and poultry products moving in interstate

commerce for use as human food are safe, wholesome, and

accurately labeled.

Benefits The risk of adulterated or misbranded meat and poultry

products entering commerce has been minimized.

Agency Function Program adininistrator.

Type of Program Pre-marketing evaluation.

Methodology Government inspection.

Testing Government labs.

Government approved/accredited labs.

Manufacturer's labs.

State/local government labs.

Inspection Federal or state government.

Conformity

Identification

Government applied marks; pre-marketing label approval.

47
Availability

of Doomieintation

"Meat and Poultry Inspection Directory" published semiannually; for sale by the Superintendent of Documents,

U.S. Government Printing Office, Washington, D.C. 20402.

Obligations of the

Manufacturer/Vendor

Make application for inspection; meet requirements for

issuance of establishment number; operate under inspection

in conformance with Agency rules (9 CFR Parts 301-381)

.

Enforcement Condemnation of meat animals or birds before slaughter;

condemnation of carcasses or product; withdrawal of

inspection; criminal prosecution.

Term Continuous inspection for slaughtering plants, and the

frequency of inspection for processing plants to be

determined by the Secretary of Agriculture.

Reciprocity Inspection results recognized by:

Other federal agencies.

State agencies.

Private sector organizations.

Foreign government agencies.

International organizations.

Standards, Codes

or Regulations

9 CFR Parts 301-381; compatibility with FDA regulations

issued under authority of the Federal Food, Drug, and

Cosmetic Act.

Keywords adulterated product; humane slaughter; livestock; meat

inspection; misbranded product; poultry inspection

48
Products or

Services

Meat/Poultry Products

(Voluntary Inspection)

Deparl^nent/Agency U.S. Department of Agriculture

Food Safety and Inspection Service (FSIS)

14th and Independence Ave. , SW

Washington, D.C. 20250

(202) 447-7025

Initiated

Compliance

Authority

1958

Voluntary

7 USC 1622 (h)

.

Aim Provide identification service for meat or other federally

inspected products; food inspection service relating to

manufacture of a food article; reindeer slaughter

inspection service; certification of technical animal fats

for export; buffalo slaughter inspection service; rabbit

slaughter inspection service; certification of products

for dogs, cats, and other carnivores; and, migratory water

fowl, game bird, or squab slaughter inspection and/or

other poultry or poultry products.

Agency Function

Type of Program

Methodology

Testing

Certifier and program administrator

.

Pre-marketing evaluation.

Government inspection.

Government labs.

Government approved/acxrredited labs.

Inspection Federal or state government.

Conformity

Identification

Government applied mark.

Availability

of Documentation

"Meat and Poultry Inspection Directory" published semiannually; for sale by the Superintendent of Documents,

U.S. Government Printing Office, Washington, D.C. 20402.

49
Obligations of the

Manufactxirer/Vendor

Make application for inspection; meet requirements for

issuance of establishment number; operate under inspection

in conformance with Agency rules (9 CFR Parts 301-381)

.

Enforcement Condemnation of meat animals or birds;

condemnation of meat or poultry products; withdrawal of

inspection; criminal prosecution.

Term Indefinite term.

Reciprocity Inspection program recognized by:

Other federal agencies.

State agencies.

Private sector organizations.

Foreign government agencies.

International organizations.

Standards, Cedes

or Regulations

9 CFR Parts 350-362.

Keywords buffalo inspection; game birds; identification service;

meat inspection; pet food; poultry inspection; rabbit

inspection; reindeer inspection; squab

50
Products or

Services

Processed Fish and Shellfish

Department/Agency U.S. Department of Commerce

National Oceanic and Atmospheric Adnrinistration

National Marine Fisheries Service

Science and Technology

Office of Utilization Research

National Seafood Inspection Program

Room 814, Universal Building South

1825 Connecticut Ave. , NW

Washington, D.C. 20235

(201) 673-5374

Initiated 1958

Compliance

Authority

Voluntary

Agricultural Marketing Act of 1946 (as amended) , 50 CFR

Parts 260-266.

Aim Increase consumer confidence in products which bear

inspection marks and grade shields and provide technical

services to the participating industry.

Benefits Established quality control for seafood processing

operations has improved the wholesomeness of fishery

products. The quality and value of these products is

conmunicated to consumers through grading of major types

of seafood sold for human consumption. The program also

helps processors prepare processing specifications for

non-standard fishery products and provides mechanisms

for settling trade disputes.

Agency Function

Type of Program

Certifier and program administrator.

Pre-marketing evaluation of both processing plant and

processed products. Entire program is operated on a

fee-for-service basis.

Methodology Government inspection of plant and products, testing, and

certification.

51
Testing Testing in government labs, recognized state labs, and

Federally accredited private labs.

Inspection Inspection by licensed government agents and state agents

operating with a license agreement.

Conformity

Identification

Lists of approved suppliers and certified products.

Government applied mark.

Availability

of Docajmentation

Lists of Sanitary Inspected Fish Establishments (SIFE)

and seafood Packed under Federal Inspection (PUFI) or

which participate in grade marking. Lists of seafood

products covered by these services may be obtained from:

U.S. Department of Commerce, NCAA

National Marine Fisheries Service

National Seafood Inspection Laboratory

P. 0. Drawer 1207

Pascagoula, MS 39567-0112

(601) 762-4591

Obligations of the

Manufacturer/Vendor

Producers must comply with sanitary, quality control,

and inspection requirements in addition to providing

office, laundry and temporary lab space.

Enforcement Delisting.

Term Indefinite.

Reciprocity Certification is recognized by:

other federal and state agencies

private organizations,

foreign government agencies (inspection service

available for both import and export)

,

international organizations.

At present no reciprocity exists with similar agencies in

other countries.

Standards, Codes

or Regulations

Agency prepares all criteria documents including the

Fishery Products Inspection Manual.

Keywords fish quality; fish; fishery products; plant inspection;

PUFI; quality standards; sanitation; seafood specifications;

seafood; SIFE

52
Products or

Services

Color Additives

Department/Agency U.S. Department of Health and Human Services

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Physical Sciences

Division of Color Technology (HFF-430)

Colors Certification Branch

Room 4034, FOB 8

200 C Street, SW

Washington, D.C. 20204

(202) 245-1141

Initiated

Compliance

Authority

1977 (latest authority)

Mandatory

P.L. 94-295, 21 CFR Parts 70 through 82.

Aim To assure public health and safety in use and consumption

of foods, drugs, and cosmetics to which specified colors

have been added.

Benefits Color additive certification monitors conformance of

additives to existing requirements and identifies the need

for new limitations.

Agency Function Certifier.

Type of Program Pre-marketing evaluation.

Methodology

Testing

Inspection

Government testing.

Government labs.

Government.

Conformity

Identification

A list of approved colors and certified products.

53
Availability

of Documentation

Lists available from FDA.

Obligations of the

Manufac±urer/Vendor

Manufacturers must conform with Good Manufacturing

Practices (GMP) and report any known ill effects

associated with certified additives.

Enforcement Marketing ban

Product recall

Delisting.

Term Certification is provided on a batch basis.

Reciprocity Certification is recognized by other federal agencies,

state agencies, and private sector organization.

Standards, Codes

or Regulations

Agency prepares criteria for certification. Agency adepts

the test methods prepared by others such as the

Association of Official Analytic Chemists.

Keywords additives; adulteration; carcinogens; certification;

color additives; cosmetics; drugs; foods; misbranding

54
Products or

Services

Food for Humans

Department/Agency U.S. Department of Health and Human Services

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Compliance

Regulatory Guidance Division

Room 5001, FOB 8

200 C Street, SW

Washington, D.C. 20204

(201) 485-0187

Initiated 1938

Compliance

Authority

Aim

Mandatory

Food, Drug and Cosmetic Act of 1938, as amended.

To assure that foods are pure and wholesome, safe to

eat, and produced under sanitary conditions.

Benefits The appearance of adulterated and misbranded products in

the market has been iriinimized.

Agency Function Program administrator

.

Type of Program Pre-marketing evaluation.

Methodology

Testing

Government inspection.

Government labs

Manufacturers' labs

Third party labs

State/local labs

Inspection Government

State/local government

55
Conformity

Identification

Proper informative labeling; identification of processing

plant where such are specifically inspected, such as

shellfish packers.

Availability

of Documentation

FDA publicizes only firms known to be not complying with

required standards.

Obligations of the

Marnifactiirer/Vendor

Producers must advise FDA any time a violation of good

manufacturing practices occurs. Misbranded, adulterated

products should be destroyed, but may be seized by government agents.

Enforcement Marketing ban.

Product recall.

Term Continuous inspection.

Reciprocity Program is recognized by:

Other federal agencies.

State agencies.

Private sector organizations.

Standards, Codes

or Regulations

Agency prepares all criteria documents.

Keywords adulterated product; dietary foods; fill of container

standard; good manufacturing practices; infant formula;

misbranded product; nutrition labeling; sanitation; standard

of identity; standard of quality

56
Products or

Service

Fresh and Frozen Molluscan Bivalves

(Oysters, Clams, and Mussels)

Department/Agency U.S. Department of Health and Human Services

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Compliance

Shellfish Sanitation Branch (HFF-344)

Room 3092, FOB 8

200 C Street, SW

Washington, D.C. 20204

(201) 485-0149

Initiated 1925

Compliance

Authority

Voluntary/cooperative

Food, Drug and Cosmetic Act of 1938, (Sections 402, 403,

701(a)), as amended.

Public Health Service Act (Sections 301, 308, 311, 361),

as amended.

Aim To identify actual or potential sources of pollution that

may contaminate shellfish growing areas; prevent the

harvesting of shellfish from contaminated waters; and

maintain sanitary conditions during the handling and

processing of shellfish.

Benefits Shellfish products marketed in interstate commerce are

safe for human consumption.

Agency Function Administers program; evaluates state shellfish control

programs; and develops program guidelines and standards.

Type of Program Pre-marketing control of product through classification of

shellfish growing areas, prevention of illegal harvesting,

and inspection of harvesting and processing operations.

Methodology State shellfish agencies have the responsibility for

classifying growing waters and assuring industry maintains

adequate sanitary operating procedures. FDA evaluates

state programs to determine program compliance through

field visits and office file reviews.

57
58
Products or

Services

Infant Formula

Department/Agency U.S. Department of Health and Human Services

Food and Drug Adininistration (FDA)

Center for Food Safety and Applied Nutrition

Office of Compliance

Regulatory Guidance Division

Room 5001, FOB 8

200 C Street, SW

Washington, D.C. 20204

(201) 485-0187

Initiated 1980

Compliance

Authority

Mandatory

Infant Formula Act of 1980, 21 USC 412, 21 CFR Chapter 1,

Subchapters A and B.

Aim To establish minimum nutrition requirements for infant

formula.

Benefits Virtually all domestically produced infant formula now

complies with this rule.

Agency Function Program administrator

Type of Program Pre-marketing evaluation.

Methodology Manufacturer self-certification.

Compliance with Good Manufacturing Practices (GMP)

Testing Manufacturers lab.

Inspection Government.

59
Conformity

Identification

Lists of approved suppliers and certified products.

Availability

of Documerrtation

Lists available from FDAObligations of the Quarterly recertification by each producer. Prompt

Manufacturer/Vendor notification to FDA of any suspected batch non-compliance,

adulteration, or misbranding.

Enforcement Marketing ban.

Product recall by agency or producer.

Term Audit testing/inspection to assure conformance with

quality control requirements prescribed by agency.

Reciprocity FDA certification is recognized by other federal agencies,

states and private sector organizations.

Standards, Codes Technical requirements are specified in the Act.

or Regulations

Keywords adulteration; good manufacturing practices; infant formula;

misbranding; nutrition requirements; product recall; quality

control

60
Products or

Services

Food Inspection Personnel

Department/Agency U.S. Department of Health and Human Services

Food and Drug Administration (FDA)

State Training Branch (HFC-153)

5600 Fishers Lane

Rockville, MD 20857

(301) 443-5871

Initiated 1976

Compliance

Authority

Voluntary

Public Health Service Act, as amended.

Aim Achieve a high degree of uniformity throughout the nation

in the inspection of sanitation for the selling of food.

Benefits Program has provided uniform methods of training,

examination, and review of food inspection personnel.

Agency Function Certifier.

Type of Program Evaluation of individual's competence.

Methodology

Testing

Inspection

Government testing and audit.

Federal and state examination and training facilities.

Federal and state government.

Conformity

Identification

Lists of certified inspectors are kept by participating

state health departments.

Availability

of Documentation

List must be obtained at the state level.

Term Retesting every three years.

61
Reciprocity Recognition by other federal agencies, state agencies, and

private sector organizations.

Standards, Codes Agency prepares all criteria documents,

or Regulations

Keywords food inspection personnel; model ordinance; personnel

certification practices; retail sales; sanitation; standard

of quality; standard of identity; training

62
Products or

Services

Food and Drugs for Animals

Department/Agency U.S. Department of Health and Human Services

Food and Drug Administration (FDA)

Center for Veterinary Medicine

For new animal drugs:

Office of New Animal Drug Evaluation

5600 Fishers lane

Rockville, MD 20857

(301) 443-4313

For animal foods:

Office of Surveillance and Compliance

Animal Feeds Division

5600 Fishers Lane

Rockville, MD 20857

(301) 443-4438

Initiated 1938

Compliance

Authority

Mandatory

Food, Drug and Cosmetic Act, Title 21 USC, as amended by

P.L. 90-399.

Aim To assure that foods, feeds, additives and medicines

intended for animal use are safe and effective for

intended use.

Benefits Low-risk preparations with uniform quality and predictable

performance have been developed for animal use.

Agency Function For new animal drugs (NAD) : certifier.

For all other products: program administrator.

Type of Program

Methodology

Pre-marketing evaluation.

For NAD, government design approval, inspection, site

approval

.

For other products, manufacturer self-certification.

For all products, compliance with Good Manufacturing

Practices (GMP)

.

63
Testing

Inspection

Manufacturer's lab or third party lab.

Government.

Conformity

Identification

Lists of approved products and qualified producers are

maintained by FDA.

Availability

of Documentation

Lists are available from the Center.

Obligations of the

Manufac±urer/Vendor

For all products, manufacturers are required to register

establishments annually; maintain sanitary conditions,

provide adequate labeling; and comply with GMPs. For

NADs, substantial evidence to demonstrate safety and

effectiveness must be provided. Proof that residues

unsafe for human consumption are not left over specified

time periods is required for drugs or medicated feeds

intended for animals which are used as human food.

Enforcement Marketing ban and product recall.

Term No specific term; retesting is based on changes in product

characteristics or use. A major consideration is any

misbranding or adulteration.

Reciprocity Certifications are recognized widely in the U.S. Many

states require a "Guaranteed Analysis" for minimum

protein, fat, fiber, and moisture content. There is no

reciprocity among countries for these products.

Standards, Codes

or Regulations

Agency prepares regulatory requirements including the

GMPs, but draws some technical input from the National

Academy of Sciences.

Keywords additives; adulteration; animal drugs; animal feed; good

manufacturing practices; misbranding; pet food;

registration; veterinary medicine

64
Products or

Services

Drinking Water

Department/Agency Environmental Protection Agency (EPA)

Office of Drinking Water

Criteria and Standards Division

Science and Technology Branch

401 M Street, SW

Washington, D.C. 20460

(202) 382-3040

Initiated 1974

Compliance Mandatory.

Act requires states seeking primacy to implement a

certification program based on federal standards; otherwise

EPA will certify laboratories in remaining areas.

Authority Safe Drinking Water Act (42 USC 300) ; National Interim

Primary Drinking Water Regulations (40 CFR Parts 141 and

142).

Aim To broaden the base of testing facilities competent to

analyze drinking water in disciplines of chemistry,

microbiology, and radiochemistry.

Benefits Easier access to competent testing facilities for all

regulated and interested parties.

Agency Function Certifier (in nonprimary states, territories, and Indian

reservations)

.

Program administrator elsewhere.

Type of Program Pre-market evaluation.

(Act requires that data from a laboratory be acceptable

only after laboratory is certified; however, laboratory must

be in operation before it can be certified)

.

Methodology Government design of certification program testing,

inspection, audit, and site approval plus compliance with

Good laboratory Practice Regulations.

65
Testing Government labs.

State labs.

Inspection Government.

State labs.

Conformity

Identification

Certified labs are issued certificates identifying areas

of competency. Certifying authorities maintain lists of labs

which have been issued certificates.

Availability

of Documentation

Lists are available from certifying authorities and EPA

Regional Offices.

Obligations of Certified labs must complete periodic performance

Manufac±urer/Vendor evaluations satisfactorily, maintain competency in approved

methods, notify certifier of changes in staff or equipment

and submit to periodic on-site evaluations.

Enforcement Delisting.

Term Three years if certified by EPA or most states; some states

recertify more frequently.

Reciprocity Direct EPA certification is recognized by other federal

agencies and some states. States are expected to develop

procedures for recognizing certifications among themselves.

Standards, Codes,

or Regulations

EPA develops standards methods.

Agency recognizes methods prepared by others.

Keywords chemistry; drinking water; microbiology; on-site evaluation;

performance evaluation; pollution; quality assurance;

radicchemistry; water quality

66
Products or

Services

Certification of Private and Commercial Applicators of

Restricted Use Pesticides

Departinent/Agency Environmental Protection Agency (EPA)

Pesticide Applicator Certification and Training Program

Office of Pesticides and Toxic Substances

401 M Street, SW

Washington, D.C. 20460

(202) 475-9582

Initiated 1972

Compliance Mandatory. Act requires states to perform certification to

federal guidelines, but permits EPA to perform the function

if state is unable to do so.

Authority The Federal Fungicide, Insecticide, and Rodenticide Act

(FIFRA) P.L. 94140 and P.L. 95396.

40 CFR Part 171.1171.11; and various state laws and

regulations.

Aim To minimize misuse of pesticides by both private and

commercial applicators.

Benefits Greater awareness by regulated community of the hazards

associated with pesticide misuse.

Agency Function Certifier in Colorado and Nebraska; state facilities in all

other states and territories.

Type of Program Pre-market evaluation; applicator may not offer services for

hire until competency is demonstrated by examination or

attendance at an approved training program.

Methodology Government facilities in Colorado and Nebraska; state

facilities in all other states and territories.

Testing

Inspection

Personnel testing is conducted by the certifying agency.

Same basis as testing.

67
Conformity

Identification

Certifying states issue identification numbers to individual

certified applicators.

Availability

of Documentation

Each state maintains a controlled list of certified

applicators. Contacts in states are available from the

states or EPA. Lists of certified applicators in Colorado

and Nebraska are available from the EPA.

Obligations of

Manufacturer/Vendor

Certified applicators and/or their employees are obligated

to limit applications to those restricted pesticides for

which they have been certified.

Enforcement Delisting or limitation of certification by certifying

agency.

Term State certification terms vary from one to six years; the

term for federal certification is four years for private

applicators and three for commercial applicators.

Reciprocity Reciprocity among states is based on state agreements which

are on file with the EPA. No formal list of reciprocal

relations is available.

Standards, Codes, Certification standards are promulgated by the states and

Regulations must be as stringent as required by FIFRA.

Keywords chemicals; environmental hazards; fungicides; insecticides;

pesticides; registered chemicals; restricted use;

rodenticides

68
Products or

Services

The Testing of Cigarettes for "Tar, 11 Nicotine and Carbon

Monoxide (PROGRAM WAS MODIFIED IN 1987)

Department/Agency Federal Trade Commission

Bureau of Consumer Protection

Division of Advertising Practices

6th and Pennsylvania, NW

Washington, D.C. 20580

(202) 326-3150

Initiated

Compliance

Aim

1966

Voluntary

To inform the smoking public about the "tar," nicotine, and

carbon monoxide of cigarettes so that they can make an

informed choice in buying cigarettes.

Benefits See above.

Agency Function

Type of Program

Methodology

Program administrator.

Post-marketing assessment.

Cigarettes which used to be tested in a government owned

laboratory are now tested by the industry using a

government approved method. Results are reported to the FTC

for publication. A consultant to the FTC monitors the

testing.

Testing

Inspection

See above.

Advertisements are reviewed continually.

Conformity

Identification

A report on the test results are published in the

Federal Register and provided to Congress.

Availability

of Documentation

A copy of the report is available from the FTC.

69
Reciprocity There are no reciprocal agreements.

Keywords carbon monoxide; cigarettes; 00; nicotine; tar; tobacco

TFM

70
SECTION II

OGNSGMER FRDDDCES AND SERVICES

71

section ii

r products and services

INDEX

REFERENCES IN THIS SECTION PAGE

APPLIANCES, HOUSEHOLD 75, 77

CONSUMER PRODUCTS 81

FABRICS USED IN WEARING APPAREL AND INTERIOR FURNISHINGS 83

AMERICAN INDIAN, ESKIMO, AND ALEUT ENTERPRISES THAT MARKET INDIAN, ESKIMO,

OR ALEUT HANDICRAFTS 85

REFERENCES IN OTHER SECTIONS

SECTION I-AGRICULTURAL PRODUCTS AND SERVICES 3

SECTION VII-MEDICAL PRODUCTS AND SERVICES 137

ELECTRONIC PRODUCTS - RADIATION PROTECTION 107

ENGINES, MOTOR VEHICLE 191

HAZARDOUS HOUSEHOLD SUBSTANCES 227

MOTOR VEHICLE SAFETY 193

73
I
Products or

Services

Appliances

Department/Agency U.S. Department of Energy

Building Equipment Division

Office of Buildings and Community Systems

Office of Conservation and Renewable Energy

Deputy Assistant Secretary for Conservation

Mail Station CE-132

100 Independence Ave. , SW

Washington, D.C. 20585

(202) 586-9127

(202) 586-5100

Initiated Standards will be established and made effective as

follows:

January 1, 1987:

Dishwashers, Clothes Washers, Clothes Dryers

January 1, 1990:

Refrigerators, Refrigerator-Freezers, Freezers, Room Air

Conditioners, Water Heaters, Pool Heaters, Direct Heating

Equipment, Kitchen Ranges, Ovens

January 1, 1992:

Central Air Conditioners, Furnaces

Compliance Mandatory for all manufacturers and importers of the

11 types of covered products.

Authority Energy Policy Conservation Act (EPCA) as amended,

P.L. 94-163, 89 Stat. 917, 42 USC 6295.

Aim Reduce energy consumption through the use of more

efficient appliances.

Benefits By establishing technically feasible minimum energy

efficiency or maximum energy use levels of various

appliances covered (generally used in residential

applications) the consumer will save on utility bills

while reducing the need for utility companies to construct

additional facilities or consume larger quantities of

fuel.

75
Agency Function Administers a program to establish procedures to

evaluate the energy use of products, establish/revise

maximum use levels, and to analyze new products to

determine if the "Act" applies.

Type of Program

Methodology

Pre-marketing evaluation and post-marketing assessment.

Manufacturer's self-certification.

Testing Manufacturer's lab.

Third party labs.

Inspection Government.

Conformity

Identification

Policy/requirements not established at this time.

Availability Policy/requirements not esJ blished at this time,

of Documentation

Obligations of the Policy/requirements not established at this time.

Manufactiirer/Vendor

Enforcement Policy/requirements not established at this time.

Term Indefinite term.

Reciprocity National Appliance Energy Conservation Act (NAECA)

of 1987 (which amended the EPCA) preempts all state

legislation unless a waiver is granted by DOE or the state

complies with ecific requirements established in NAECA.

Standards, Codes

or Regulations

10 CFR Part 430.

Keywords appliances; central air conditioners; clothes dryers;

clothes washers; direct heating equipment; dishwashers;

energy efficiency; EPCA; freezers; furnaces; kitchen ranges

ovens; NAECA; pool heaters; refrigerator-freezers;

refrigerators; room air conditioners; water heaters

76
Products or

Services

Categories of Major Home Appliances

Departanent/Agency Federal Trade Commission

Bureau of Consumer Protection

Division of Enforcement

601 Pennsylvania Ave., NW

Washington, D.C. 20580

(202) 326-3035

Initiated 1980

Compliance

Authority

Mandatory for categories of covered appliance products.

The Energy Policy and Conservation Act (EPCA) P.L. 94-163,

89 Stat. 871 (1975) , as amended by the National Energy

Conservation Policy Act, P.L. No. 95-619, 92 Stat. 3258

(1978)

.

16 CFR Part 305 (Rule for Using Energy Costs and

Consumption Information Used in Labeling and Advertising

for Consumer Appliances Under the Energy Policy and

Conservation Act (Rule) )

.

Aim To encourage consumers to comparison shop for energy

efficient household appliances in order to reduce the amount

of energy they use in their homes.

Benefits The availability of energy consumption information should

enhance consumer demand for appliances that save energy. In

turn, competition should be generated among manufacturers to

meet this demand by producing more energy efficient

appliances. Consumers will be able to save money by

reducing their energy costs and can help to promote the

national goal of energy conservation.

Agency Function

Type of Program

Program administrator.

Pre-sale disclosure.

77
Methodology Following rulemaking proceedings as required by EPCA, the

FTC has adopted labeling rules for several appliance

categories. The appliance labels will give consumers the

estimated yearly energy cost or energy efficiency of

competing products before they buy an appliance. The labels

will also provide consumers with a range of estimated annual

energy costs for comparable appliances. Under the EPCA,

only appliances for which the DOE has prescribed final test

procedures can be covered by the FTC's Rule. Manufacturers

must base required label information on the results of tests

performed in accordance with the procedures prescribed by

DOE. Additionally, the FTC prescribed the required layout,

type size, setting, colors, paper stock and contents of the

appliance labels. FTC representatives are allowed to

observe any testing required by the Rule and to inspect the

results of the testing if requested.

Testing Commercial lab.

Manufacturer's lab.

Inspection Government.

Conformity

Identification

The Commission's Appliance Labeling Rule mandates a uniform

disclosure scheme (in the form of appliance labels) for

energy consumption information. All energy labels for each

category of covered appliance use the same size, colors and

typefaces with consistent positioning of headline, copy and

charts. Such uniformity in the disclosure format

facilitates immediate consumer recognition and readability.

Availability

of Documentation

The range of estimated annual energy costs for each covered

appliance is taken from the appropriate appendix to the Rule

in effect at the time the labels are affixed to the

products. The FTC publishes revised ranges annually in the

Federal Register, if appropriate, or a statement that

specific prior ranges are still applicable. Ranges are

changed if the upper or lower limit of the range changes by

15% or more.

78
Obligations of the

Manufacturer/Vendor

The Rule requires manufacturers to label covered appliances

with information indicating their estimated annual energy

costs and related information. Manufacturers base required

label information on tests they perform using procedures

prescribed by DOE. The Rule also contains specific

requirements concerning the duty of manufacturers to make

reports to the Commission, to maintain records and to have

substantiation for required disclosures or other

representations they make.

Term Indefinite term.

Reciprocity The Commission's Appliance Labeling Rule is recognized

by other federal agencies, state agencies, and private

sector organizations.

Standards, Codes

or Regulations

Standard test procedures are prescribed by the DOE.

Label format is prescribed by the FTC.

Keywords appliance labeling; energy efficiency rating; energy

conservation; estimated annual energy cost

79

Products or

Services

Consumer Products

(Personal use devices intended for household, school, or

recreational use)

Department/Agency Consumer Product Safety Commission (CPSC)

Office of the General Counsel

5401 Westbard Avenue, Room 200

Bethesda, MD 20207

(202) 492-6980

Initiated October 1972

Compliance

Authority

Mandatory

P.L. 92-573 as amended by P.L. 94-284, 95-319,

95-631, 96-373, 97-35.

Aim To reduce the number of consumer products which present

unreasonable risks.

Benefits Specific products covered by CPSC Standards are now

certified by manufacturers to conform with legal

requirements.

Agency Function Program a<±ninistrator

.

Type of Program Post-marketing assessment.

Methodology Manufacturer's self-certification.

Government audit.

Testing Manufacturer's lab.

Third party labs.

Inspection Government.

Conformity

Identification

Government authorized mark or label by manufacturer

or private brander.

81
Availability

of Documentation

Lists of manufacturers or private branders subject to

certification rules or banning orders can be obtained from

CPSC.

Obligations of

Manufacturer/Vendor

Manufacturers, private branders, and distributors shall

keep such records as the Commission directs to assist in

the enforcement of the Act, such as known non-conformance to

applicable standards or known defects which could present an

unreasonable risk of injury whether or not covered by a

standard.

Enforcement Marketing ban.

Product recall.

Term Periodic retesting in a testing program acceptable to the

CPSC is usually required.

Reciprocity None.

Standards, Codes,

or Regulations

Criteria for standards are cited in the Act; agency itself

prepares Consumer Product Safety Standards; Commission

recognizes the use of voluntary standards to reduce risks

of injury.

Keywords audit testing; banned products; consumer products; imminent

hazard; mandatory standards; product recall; product safety

82
Products or

Services

Fabrics Used in Wearing Apparel and Interior Furnishings

Department/Agency Consumer Product Safety Commission (CPSC)

Office of the General Counsel

5401 Westbard Avenue, Room 200

Bethesda, MD 20207

(202) 492-6980

Initiated June 1953

Compliance

Authority

Mandatory

P.L. 83-88.

Aim To reduce the risk of fire and injury or death related to

fire, in or on fabric articles.

Benefits Compliance with applicable standards and associated

labeling have reduced the covered risks.

Agency Function

Type of Program

Methodology

Program administrator.

Post-marketing assessment.

Manufacturer's self-certification.

Government audit inspection/testing.

Testing Government labs.

Government approved labs.

Third party labs.

Manufacturer's lab.

Inspection Government.

State/local government.

Third party.

Conformity

Identification

Authorized label by manufacturer.

83
Availability No list of certified suppliers or products is prepared,

of Documentation

Obligations of Manufacturer may comply with the Act by guaranteeing

Manufacturer/Vendor conformance with applicable standards based on test data.

Enforcement Product condemnation and destruction.

Term Periodic audit testing/inspection is required to maintain

certification.

Reciprocity Conformity is recognized by other federal agencies, state

governments, and private organizations.

Standards, Codes,

or Regulations

Criteria for standards are cited in the Act; agency itself

prepares Consumer Product Safety Standards; Commission

recognizes the use of voluntary standards to accomplish the

purpose of the Act.

Keywords apparel; bedding; fabrics; flammability; furnishings;

interior furnishings; product testing; voluntary standards;

wearing apparel

84
Products or

Services

American Indian, Eskimo, and Aleut Enterprises that Market

Indian, Eskimo, or Aleut Handicrafts

Department/Agency Indian Arts and Crafts Board

U.S. Department of the Interior

Room 4004, North Interior Building

Washington, D.C. 20240

(202) 343-2773

Initiated 1943

Compliance

Authority

Voluntary

P.L. 74-355; 25 CFR Part 308.

Aim To improve the competitiveness of genuine products which

are marketed in competition with imitations.

Benefits See above.

Agency Function Certifier and program administrator.

Type of Program Pre-marketing evaluation.

Methodology Government inspection and evaluation of product quality.

Inspection Products and facilities are inspected by the federal

government.

Conformity

Identification

Facilities are licensed to use the certification mark.

Products are marked.

Availability A free list of approved enterprises is available from the

of Documentation Board.

Obligations of The certification mark may be applied only to products

Manufacturer/Vendor that meet the Board's standards.

85
Enforcement Delisting as well as the imposition of criminal penalties

for the willful misuse of the mark.

Term Indefinite term with occasional re-inspection.

Reciprocity No reciprocal agreements.

Standards, Codes, Agency prepared standards/criteria,

or Regulations

Keywords Aleut; American Indian; crafts; Eskimo; handicrafts;

Indian; jewelry; native American artists; native American

craftsmen

86
SECTION III

OCNSDRDCTICN PRODUCES AND SERVICES

87

SECTION III

7I0N PRODUCTS AND SERVICES

INDEX

REFERENCES IN THIS SECTION PAGE

BUILDING PRODUCTS FOR CONSTRUCTION 91

MANUFACTURED HOUSING 93

REFERENCES IN OTHER SECTIONS

TOBACCO AND NAVAL STORES 17

EQUIPMENT AND MATERIALS USED IN THE WORKPLACE 171

HOUSEHOLD APPLIANCES 75, 77

SECTION VIII-MINING, DRILLING, AND INDUSTRIAL EQUIPMENT 157

89

Products or

Services

Building Products for Construction

Department/Agency U.S. Department of Housing and Urban Development

Federal Housing Administration

Manufactured Housing Construction and Regulatory Functions

Division, Room 6270

451 Seventh Street, SW

Washington, D.C. 20410-8000

(202) 755-5929

Initiated 1965

Compliance Voluntary

Authority 24 CFR Part 200.935.

Aim To prevent product failures and misrepresentations of

products. To expedite introduction of new or innovative

building materials. Alleviate safety hazards associated

with building materials, long term durability problems, and

misleading test results.

Benefits Better assurance that the building products arriving at the

job site comply with the designated standards.

Agency Function Program administrator.

Type of Program Ongoing validation of private certification of products

included under a HUD mortgage insurance program.

Methodology Third party certification.

Manufacturer's self-certification.

Testing Government accredited labs.

Third party validating labs.

Manufacturer's lab.

State/local government labs.

Agency accredited labs.

Inspection Third party.

91
Conformity

Identification

Authorized mark or label affixed by manufacturer or third

party validator. More than seventy third party validators

participate in the HUD Building Products Certification

program for building products including: solid

fuel type heaters, fireplace stoves, plastic bathtub units,

plastic shower receptors and stalls, plastic lavatories,

plastic water closet bowls and tanks, aluminum windows,

storm doors, sliding glass doors, storm windows, wood window

units, wood sliding patio doors, sealed insulating glass

units, carpet, carpet with attached cushion, PVC window

units, and lumber.

Availability

of Documentation

All documentation is published in the Federal Register,

24 CFR Part 200.

Obligations of the

Manufactxuner/Vendor

Manufacturers are obligated to cease marking products

which do not meet required standards.

Enforcement The principal means of enforcement is delisting of manufacturers. Laboratories whose quality control is inadequate

may be disapproved. Administrators may be suspended under

rules 24 CFR Part 200.935.

Term All parties may operate indefinitely in these programs.

Laboratories are subject to periodic reaccreditation.

Reciprocity Products in these programs enjoy a wide degree of reciprocal

recognition, including other federal agencies, state

agencies, private sector organizations, foreign governments,

and international organization. There are participating

organizations in Canada for certain building products.

Standards, Codes,

or Regulations

HUD adopts standards prepared by others, and prepares

criteria documents where necessary. Documents defining

acceptance are in 24 CFR Part 200.935.

Keywords acceptance criteria; adndnistrators; building products;

certification; construction; housing; mortgage insurance;

third party validation

92
Products or

Services

Manufactured Housing

Department/Agency U.S. Department of Housing and Urban Development

Federal Housing Administration

Manufactured Housing Construction Division, Rm. 6270

451 Seventh Street, SW

Washington, D.C. 20410-8000

(202) 755-6590

Initiated

Carpiiance

Authority

1976

Mandatory

National Manufactured Housing Construction and Safety

Standards Act, P.L. 93-382, 42 USC 5407; 24 CFR Part

3280.

Aim To reduce the number of personal injuries and deaths, cost

of insurance, and property damage resulting from

manufactured home accidents and to improve the quality and

durability of manufactured homes.

Benefits Uniform nation-wide certification program has accomplished

the stated purposes of the Act and improved interstate

commerce in manufactured housing.

Agency Function

Type of Program

Methodology

Program administrator.

Pre-emptive, mandatory, national regulation.

Third party certification of manufactured housing designs

and quality assurance manuals, and in-plant inspection to

assure compliance with standards.

Testing Third party labs.

Manufacturer's lab.

Inspection Third parties.

State government inspection agencies.

93
Ccnformity

Identification

Authorized label affixed by manufacturer.

Lists of approved third party agencies are issued by HUD.

Availability

of Documentation

Lists are maintained by HUD, HUD's Monitoring Agent, and

Approved State Administrative Agencies (SAA's)

.

Obligations of the

Manufacturer/Vendor

Manufacturers and dealers must keep accurate data by unit

serial number of each manufactured housing unit so that

purchasers can be notified if an imminent safety hazard

or serious defect is alleged.

Enforcement Marketing ban on unlabeled homes; notification and

correction of defective units; removal of approval of

third party inspection agencies for repeated inadequate

performance.

Term Indefinite term.

Reciprocity Other federal agencies.

State agencies.

Standards, Codes,

or Regulations

Agency references standards prepared by others and

incorporates requirements in the Federal Manufactured

Home Construction Safety Standards (24 CFR Part 3280)

.

Enforcement is in accordance with Procedural and

Enforcement Regulations (24 CFR Part 3282)

.

Keywords design approval; housing requirements; inspection;

manufactured housing; product safety

94
SECTION IV

ELfOBDNIC AND TELECOflO^CAlTGNS EKDDUCES AND SERVICES

95

SECTION IV

EIZETEDNIC AND TEUXXWMJNICATICNS ADDUCES AND SERVICES

INDEX

REFERENCES IN THIS SECTION PAGE

ELECTRIC AND TELEPHONE SYSTEMS, RURAL 99

ELECTRICAL AND ELECTRONIC DEVICES THAT GENERATE RADIO FREQUENCY ENERGY 101

ELECTRONIC FUND TRANSFER AUTHENTICATION DEVICES 105

ELECTRONIC PRODUCTS - RADIATION PROTECTION 107

INPUT/OUTPUT CHANNEL LEVEL INTERFACES FOR INFORMATION PROCESSING

EQUIPMENT 109

REFERENCES IN OTHER SECTIONS

AUTOMOTIVE DRIVING AIDS AND WHEELCHAIR LIFTS 151

BUILDING PRODUCTS FOR CONSTRUCTION 91

ELECTRICAL EQUIPMENT FOR MINES 167

EQUIPMENT AND MATERIALS USED IN THE WORKPLACE 171

MEDICAL DEVICES 149

MILITARY SYSTEMS, PARTS, MATERIALS AND COMPONENTS FOR 115

PARTS, MATERIALS, AND EQUIPMENT FOR GSA PROCUREMENT 117

SYSTEMS USING PRESENCE SENSING DEVICES FOR INITIATING MECHANICAL POWER

PRESSES (PSDI) 169

WHEELCHAIRS 153

SECTION IX-TRANSPORTATION-REIATED PRODUCTS AND SERVICES 173

97

SECTION IV

ELECTRONIC AND TEIEOCiMJNICATIONS PICJDUCTS AND SERVICES

INDEX

REFERENCES IN THIS SECTION PAGE

ELECTRIC AND TELEPHONE SYSTEMS, RURAL 99

ELECTRICAL AND ELECTRONIC DEVICES THAT GENERATE RADIO FREQUENCY ENERGY 101

ELECTRONIC FUND TRANSFER AUTHENTICATION DEVICES 105

ELECTRONIC PRODUCTS - RADIATION PROTECTION 107

INPUT/OUTPUT CHANNEL LEVEL INTERFACES FOR INFORMATION PROCESSING

EQUIPMENT 109

REFERENCES IN OTHER SECTIONS

AUTOMOTIVE DRIVING AIDS AND WHEELCHAIR LIFTS 151

BUILDING PRODUCTS FOR CONSTRUCTION 91

ELECTRICAL EQUIPMENT FOR MINES 167

EQUIPMENT AND MATERIALS USED IN THE WORKPLACE 171

MEDICAL DEVICES 149

MILITARY SYSTEMS, PARTS, MATERIALS AND COMPONENTS FOR 115

PARTS, MATERIALS, AND EQUIPMENT FOR GSA PROCUREMENT 117

SYSTEMS USING PRESENCE SENSING DEVICES FOR INITIATING MECHANICAL POWER

PRESSES (PSDI) 169

WHEELCHAIRS 153

SECTION IX-TRANSPORTATION-REIATED PRODUCTS AND SERVICES 173

97

Products or

Services

Parte, Materials and Equipment for Rural Electric and

Telephone Systems

Department/Agency U.S. Department of Agriculture

Rural Electrification Administration (REA)

14th and Independence Ave. , SW

Washington, D.C. 20250

Chairman, Technical Standards Committee "A" (Electric)

(202) 382-9080

Chairman, Technical Standards Committee "A" (Telephone)

(202) 382-8698

Initiated 1938

Compliance

Authority

Mandatory only for designated parties using REA loans.

7 CFR Part 1702.

Aim To minimize capital requirements and control the quality

of materials and equipment incorporated into rural

electric and telephone systems. The evaluation and

listing of material and equipment insures the availability

of suitable products at reasonable costs and, together

with REA standards for construction and installation,

provides an important element of loan security.

Agency Function Certifier.

Type of Program Electric and telephone systems receiving financing

administered by REA shall use materials and equipment

evaluated and listed by REA.

Methodology Government design review and testing.

Testing Government labs.

Manufacturers' labs.

99
Conformity

Identification

Approved manufacturers and suppliers for rural electric

systems are included in REA Bulletin 43-5, "List of

Materials Acceptable for Use on Systems of REA Electrification Borrowers." The 1986 issue contains over 185

categories of material and equipment from over 200

manufacturers

.

Approved manufacturers and suppliers for rural telephone

systems are listed in REA Bulletin 344-2, "List of

Materials Acceptable for USe on Telephone Systems of REA

Borrowers."

Availability

of Documentation

Bulletins 43-5 and 344-2 are available on a subscription

basis from the Superintendent of Documents, Government

Printing Office, Washington, D.C. 20402.

Enforcement Delisting.

Term Indefinite term. Bulletin 43-5 is published yearly and

supplements are issued quarterly. Bulletin 344-2 is

printed every two years followed by eleven supplements.

Standards, Codes

or Regulations

REA prepares product standards which define performance

and design requirements together with acceptance criteria.

Keywords acceptable materials; approved product lists; central office

equipment; components; distribution; electric systems;

electronic; microwave; private branch exchanges;

radio-telephone; telecommunications; telephone;

transmission;

100
Products or

Services

Electrical and Electronic Devices that

Generate Radio Frequency Energy

Department/Agency Federal Communications Commission (FCC)

Authorization and Standards Division

Columbia, MD 21045

(301) 725-1585

Initiated 1940 (Marine equipment was the earliest type approved)

Compliance Mandatory

Authority Federal Communications Act of 1934 as amended.

47 CFR Part 2, Subpart J.

Aim Reduce uncontrolled radio frequency interference first

observed in connection with medical diathermy equipment in

the 1940 's.

Benefits Broad decrease in spurious radio frequency energy in the

environment in spite of tremendous increases in the types

and quantity of devices in general use that have the

potential for creating radio frequency interference.

Agency Function

Type of Program

Certifier and program administrator.

Generally FCC procedures provide for pre-marketing

evaluation and/or post-marketing assessment.

Authorization procedures reflect the requirements of

particular categories of equipment which are summarized

here:

Type Approval

-Applies to some non-licensed devices.

-Testing of sample by FCC prior to issuance of grant is

mandated by FCC Rules.

-Grant of authorization is issued by FCC.

Type Acceptance

101
-Applies to some cxanpulsory installed marine

safety-of-life equipment, and to transmitting equipment

used in many of the radio services under a radio station

license issued by the FCC.

-Based on desk review and evaluation of written

application and test report submitted by applicant

-Testing of samples at FCC laboratory is not required by

FCC Rules, but FCC has authority to request samples for

testing either before or after issuance of grant.

-Grant of authorization is issued by FCC.

Certification

-Applies to non-licensed devices, mostly low power radio

frequency devices and, in addition, to certain categories

of receivers which tune in the band from 30 to 901 MHz

and 935 to 940 MHz, personal computers and peripherals,

citizen band receivers, and some other kinds of

industrial, scientific and medical equipment.

-Based on desk review and evaluation of written

application and test report submitted by applicant.

-Testing of samples at FCC laboratory is not required by

FCC Rules, but FCC has authority to request samples for

testing either before or after issuance of grant.

-Grant of authorization is issued by FCC.

Notification

-Applies to certain categories of receivers which tune in

the 30 to 901 MHz or 935 to 940 MHz bands (including

cordless telephone receivers) in addition to certain

licensed transmitters and associated devices employed

mostly in fixed point to point microwave and broadcast

services. The Commission will add equipment to this

category as it determines that additions are warranted.

-Manufacturer submits brief application for authorization

of device. Application is not required to include test

data.

-FCC may sample device or review the manufacturer's test

data before or after issuance of grant.

-Grant of authorization is issued by FCC.

102
Verification

-Applies to all computing devices except personal

computers, personal peripherals and exempt computing

devices (Section 15.801 (e)); also applies to FM

broadcast and television broadcast receivers, in

addition, certain categories of industrial, scientific

and medical devices and ship earth stations.

-Manufacturer tests device prior to marketing for

compliance with applicable FCC regulations and

retains test data.

-No filing with FCC is required. However, manufacturer's

test data may be required by FCC for subsequent review.

-FCC may sample devices, at its option

-No grant of authorization is issued by FCC.

Registration

-Applies to subscriber owned and common carrier owned

telephone devices interconnected to the public telephone

network. Objective of registration is to assure that

device will not cause "harm" (as defined in FCC Rules) to

telephone network. Radio frequency devices which connect

to the public telephone network may be subject to

registration as well as to one or more of the other

procedures.

-Based on desk review and evaluation of written

application and test report submitted by applicant.

Administrative review is done by FCC Laboratory. Other

aspects of application are handled by FCC Common Carrier

Bureau, including issuance of grant.

-Grant of authorization is issued by FCC.

-Subpart L or Part 2 and Part 68 of FCC Rules provides

further information on this procedure.

Program uses:

-Government lab for testing, inspection and audit,

-manufacturer and third party labs.

-Government recognition of private labs.

Testing may be performed by:

-FCC laboratory.

-Manufacturer's laboratory.

-Third party laboratory.

103
Inspection Agency accredits independent labs, but does not inspect

production facilities.

Conformity

Identification

Agency maintains lists of producers of approved products,

but lists are not published.

Producers are licensed to apply approval markings in

accord with regulations.

Availability Above lists must be requested from FCC through Freedom of

of Documentation Information procedures.

Obligations of the Maintain design of approved equipment.

Manufac±urer/Vendor requirements to users.

Explain maintenance

Enforcement Marketing ban.

Term Indefinite term.

Reciprocity None. Test data from counterpart agencies is taken into

consideration, but no reduction of test requirements is

provided.

Radio frequency devices must have the required form of

equipment authorization before being imported into the

United States and must be accompanied by a properly executed

copy of FCC Form 740.

There are some specified exceptions to this requirement

as given in Part 2 of the FCC Rules, Sections 2.806, 2.809,

2.811 and 2.813. Also, there are a few categories

of devices which are not subject to technical standards in

the FCC Rules. These devices must meet the applicable

standards before importation.

Standards,

Codes, or

Regulations

Criteria promulgated by FCC; private sector standards are

considered in preparing rules.

Keywords broadcast equipment; cable TV equipment; certification;

ccmmunications equipment; computer peripherals; computers;

medical electronics; radio frequency energy; transmitters;

TV equipment; type approval

104
Electronic Fund Transfer Authentication Devices

U.S. Department of the Treasury

Deputy Assistant Secretary for Departmental Information

Systems

1500 Pennsylvania Ave. , NW

Washington, D.C. 20220

(202) 566-5847

1984

Mandatory for all Government bureaus that receive or send

funds or securities electronically through the U.S.

Treasury.

Treasury Order 16-02.

To assure that equipment which authenticates electronic

fund transfers complies with designated standards to

minimize exploitation of Electronic Fund Transfer (EFT)

Systems.

It is a major milestone toward unifying the protection and

audit of the billions of dollars transferred electronically every day.

Program adniinistrator and certifier.

Evaluation for compliance with Treasury standard conducted

by the National Bureau of Standards (NBS) , Institute for

Computer Sciences and Technology (ICST)

.

Security evaluation guidance provided by the National

Security Agency (NSA)

.

Pre-marketing evaluation.

Assessment prior to government purchase.

Testing by NBS and NSA.

Testing by NBS and NSA.

Treasury.

105
Oonformity

Identification

A list of certified equipment and software is maintained

by the Department of the Treasury.

Availability

of Documentation

List and other technical documentation is available from

the Deputy Assistant Secretary for Departmental

Information Systems, Department of the Treasury.

Obligations of

Manufacturer/Vendor

To comply with criteria.

Enforcement Delisting.

Term Indefinite term.

Reciprocity No reciprocal agreements.

Standards, Codes,

or Regulations

Federal Information Processing Standard (FTPS) 46, FIPS

113, Federal Standard 1027, ANSI X9.9 and X 9.17.

Criteria documents are coordinated by Treasury.

Keywords authentication devices; communications security; computer

security; cryptolography; EFT; electronic fund transfer;

encryption standard; financial institutions; interface

requirements ; validation

106
Products or

Services

Electronic Products for Radiation Protection

Department/Agency U.S. Department of Health and Human Services

Food and Drug Administration (FDA)

Center for Devices and Radiological Health

Office of Compliance

Radiological Products Division

8757 Georgia Ave.

Silver Spring, MD 20910

(301) 427-7175

Initiated 1968

Compliance

Authority

Mandatory

Radiation Control for Health and Safety Act, 42 USC 2636;

21 CFR 1000-1050.

Aim To protect the public from unnecessary exposure to radiation

from electronic products.

Benefits Through enforcement, as well as product improvement and user

education, public exposure to ionizing and non-ionizing

radiation has been reduced significantly.

Agency Function Program administrator.

Type of Program Pre-marketing evaluation.

Methodology Manufacturer self certification.

Testing Manufacturer's lab.

Third party lab.

Government lab.

Inspection Government.

Conformity

Identification

Manufacturer applied label.

107
Availability

of Documentation

No lists are published or maintained in this program.

Obligations of the

Manufacturer/Vendor

Manufacturers must keep production and distribution records;

notify buyers of norK^onforming equipment and recall such

equipment for repair.

Enforcement Marketing ban.

Term Certification applies for the life of each distinctive

model.

Reciprocity No known reciprocity.

Standards, Codes

or Regulations

Agency sets criteria and publishes performance standards.

Keywords electronic radiation; lasers; mercury vapor lamps; microwave

ovens; product labeling; sunlamps; television receivers;

ultrasonic therapy equipment; x-ray equipment

108
Products or Input/Output Channel Level Interfaces for Information

Services Processing Equipment

Departanent/Agency U.S. Department of Commerce

National Bureau of Standards (NBS)

Institute for Computer Sciences and Technology

Advanced Systems Division

Technology Bldg. , Room A216

Gaithersburg, MD 20899

(301) 975-2904

Initiated

Compliance

1979

Mandatory for applicable information processing equipment

to be purchased by federal agencies.

Authority 15 CFR Part 200.

Aim To verify the ability of information processing equipment

from one manufacturer to function successfully with

equipment of other manufacturers.

Benefits Federal agencies are able to purchase information

processing equipment that has the necessary level of

compatibility. This enables systems to be assembled or

expanded more readily and with considerably less time for

troubleshooting. This program also enables all suppliers

to compete on an equitable basis.

Agency Function

Type of Program

Certifier and program administrator.

Verification of compliance prior to consideration for

purchase by the federal government.

Methodology NBS verification of compliance to specified standards by

review of documentation, or demonstrated use with verified

equipment.

Testing Any testing is ordinarily accomplished by the manufacturer

to fulfill requirements of the applicable standards or the

NBS Verification Checklist.

109
Inspection By purchasing agency.

Conformity

Identification

A verification certificate is issued for equipment having

no significant deviation from the applicable standard.

A Verification List of equipment conforming to standards

is published and maintained by NBS.

Availability

of Documentaticai

Verification List and Checklist are available from the

NBS. Applicable standards are available through the

National Technical Information Service, Springfield, VA

22161.

Obligations of the

Manufacturer/Vendor

Suppliers desiring a verification review must make a

request to NBS, identify the make and model, provide

required documentation, and reimburse the agency for cost

incurred.

Enforcement Delisting.

Term Indefinite.

Reciprocity Some states have used the Verification List in their

procurement process.

Standards, Codes

or Regulations

Federal Information Processing Standards Publications

(FTPS PUBs) 60-1, I/O Channel Interface; 61, Channel Level

Power Control Interface; 62, Operational Specifications

for Magnetic Tape Subsystems; 63, Operational

Specifications for Rotating Mass Storage Subsystems.

Keywords ADP; computer systems; data processing; I/O; verification

110
SECTION V

GOVERNMENT EROCUREMENTS

111

section v

GOVERNMENT PROCUREMENTS

INEEX

REFERENCES IN THIS SECTION PAGE

MILITARY SYSTEMS, PARTS, MATERIALS AND COMPONENTS FOR 115

PARTS, MATERIALS, AND EQUIPMENT FOR GSA PROCUREMENT 117

REFERENCES IN OTHER SECTIONS

BUILDING PRODUCTS FOR CONSTRUCTION 91

ELECTRIC AND TELEPHONE SYSTEMS, RURAL 99

EQUIPMENT AND MATERIALS USED IN THE WORKPLACE 171

INPUT/OUTPUT CHANNEL LEVEL INTERFACES FOR INFORMATION PROCESSING EQUIPMENT. 109

SECTION VI-TESTTNG, MEASUREMENT AND LABORATORY SERVICES 119

SECTION VII-MEDICAL PRODUCTS AND SERVICES 137

AUTOMOTIVE DRIVING AIDS AND WHEEL CHAIR LIFTS 151

WHEELCHAIRS 153

113

Products or

Services

Parts, Materials, and Equipment

Department/Agency General Services Administration (GSA)

Federal Supply Service (FSS)

Office of Quality and Contract Administration

Quality Assurance Division

Room 1122, Crystal Mall Bldg.4, Jefferson Davis Highway

Arlington, VA

Mailing Address: Washington, D.C. 20406

(703) 557-8515

Initiated

Compliance

1944

Mandatory for those products defined by Federal

Specifications which have been designated for the Qualified

Products List (QPL) certification program because

conformance demonstration at each procurement would

necessitate extensive testing.

Aim As a means of expediting contract awards and deliveries of

designated products, manufacturers are required to have

these products pre-tested to determine if the products

conform to all specified requirements. Subsequently,

assurance that proper quality is being maintained is

achieved by normal acceptance inspection of selected samples

of a shipment, rather than a detailed lot inspection.

Benefits The availability of products known to be qualified reduces

the cost and time to select products for inclusion in

equipment and systems that must perform reliably. Helps

control purchase lead times and increases the quality of

equipment using these products. The majority of these QPI/s

are for adhesives, paint, safety equipment, and security

office equipment - safes, vault doors, filing cabinets, and

padlocks.

Agency Function

Type of Program

Program administrator.

Pretesting prior to government purchase.

115
Testing Government or private laboratories, including the

manufacturer's lab, may be used if acceptable to the GSA and

the designated preparing activity,

accredited by GSA.

Labs are not formally

Inspection Follow-up inspection is not an integral part of this

program. Listing on a QPL does not waive requirements for

either in-process or other inspection by the manufacturer,

or inspection by the buyer.

Conformity

Identification

Listing on QPL's.

Availability

of Documentation

Federal QPL's and specifications are distributed by GSA

Business Service Centers.

Obligations of the

Manafac±urer/Vendor

Manufacturers and distributors must supply test samples,

ordinarily bear the cost of testing, maintain quality and

notify of design changes. Reference may be made to listing

of QPL's in advertising and related publicity, provided

there is no claim or implication of government preference

or endorsement, or that the product is the only one of its

type that has passed the prescribed tests.

Term Indefinite for most products; certain products may require

retesting at periodic intervals.

Reciprocity Federal and state agencies recognize and use federal QPL's.

There are no bilateral or multilateral arrangements with

other countries.

Standards, Codes,

or Regulations

Program is based on qualification requirements specified in

federal specifications.

Keywords government procurement; procurement; QPL; quality control;

testing

116
Parts, Materials and Components Used in Military Systems

U.S. Department of Defense

Director of Standardization and Data Management

The Pentagon, Room 2A-318

Washington, D.C. 20301

(202) 695-0121

1949

Mandatory for those products defined by procurement

specifications and having qualifications requirements.

Equipment supplied to the Department of Defense may not

contain products from other than qualified sources for those

commodities for which Qualified Products Lists (QPL's) have

been developed.

Federal Acquisition Regulations, General Provisions,

Part 9.

Defense Standardization Manual, DOD 4120, 3-M.

Defense Standardization Document SD-6.

Maintain a high level of quality for critical products

through pre-procurement evaluation of prospective vendors.

The QPL Program normalizes the selection of possible

vendors in several hundred critical technical commodities

which are sufficiently standardized to permit a stringent,

common, advanced assessment of supplier capability.

Program administrator

.

Pretesting prior to purchase by government or its

contractors.

Any type of laboratory acceptable to DOD sponsoring

activity may be used; labs are not formally accredited

by DOD.

117
Inspection Periodic follow-up inspection. Plant visits are part

of the overall management of the program. Listing on

a QPL does not waive the requirements for in-process

or other inspection by the manufacturer or receiving

inspection by the buyer.

Conformity

Identification

Listing on Qualified Product Lists (QPL's) . Authorized

designation (JAN Mark) may be applied by

manufacturer/distributor to qualified semiconductors,

microelectronic, and products with established reliability.

Availability

of Documentation

DOD specifications and QPL's are distributed by:

Naval Publications and Forms Center

5801 Taylor Avenue

Philadelphia, PA 19120

Obligations of the

Manufacturer/Vendor

Manufacturer/distributor must supply test samples,

ordinarily bear the cost of testing, maintain quality,

notify of design or process changes, and mark only

approved types. Advertising and publicity may refer to

listing on QPL's provided there is no claim or implication

of government preference or endorsement or that the product

is the only one of its type that has passed the prescribed

tests.

Enforcement

Term

Delisting.

Validated every two years; most critical components require

retesting at periodic intervals.

Reciprocity There is limited reciprocity with counterpart agencies in

Canada, Australia, and Ireland as well as specific

procedures for products complying with QPL's of NATO.

Standards, Codes

or Regulations

Program is based on qualification requirements specified

in Military Specifications.

Keywords government procurement; military; military specifications;

military systems; procurement; QPL; qualification; quality

control; testing

118
SECTION VI

TESTING, MEASUREMENT, AND IABORATGKY SERVICES

119

SECTION VI

TESTING, MEASUREMENT, AND IABORATORY SERVICES

INDEX

REFERENCES IN THIS SECTION PAGE

LABORATORY ACX3REDITATION 123

LABORATORY ACCREDITATION FOR MEAT/POUITRY/FOOD PRODUCTS 125

IABORATORY CERTIFICATION FOR THE ANALYSIS OF WINES AND DISTILLED SPIRITS

FOR EXPORT , 127

MEASUREMENT CALIBRATION SERVICES 129

SCALE TESTING AND CEKETFICATION-GRAIN 131

WEIGHING AND MEASURING DEVICES, COMMERCIAL 135

REFERENCES IN OTHER SECTIONS

ELECTRICAL AND ELECTRONIC DEVICES THAT GENERATE RADIO FREQUENCY ENERGY 101

ELECTRONIC PRODUCTS - RADIATION PROTECTION 107

EQUIPMENT AND MATERIALS USED IN THE WORKPIACE 171

SECTION VII-MEDICAL PRODUCTS AND SERVICES 137

INDEPENDENT IABORATORIES 141

INTERSTATE LICENSED IABORATORIES 141

IABORATORY TESTING PROCEDURES IN VA MEDICAL CENTERS 155

121

Products or

Services

Laboratory Accreditation

Department/Agency U.S. Department of Commerce

National Bureau of Standards (NBS)

National Voluntary Laboratory Accreditation Program (NVIAP)

Administration Bldg. , Room A531

Gaithersburg, MD 20899

(301) 975-4016

Initiated 1976

Compliance Voluntary

Authority Section 2, Stat. 1449 as amended (15 USC 272); Reorg. Plan

No. 3 of 1946, Part VI; 15 CFR Part 7.

Aim To accredit laboratories found competent to perform specific

tests or types of tests.

Benefits Provides a national recognition for competent laboratories;

helps regulatory and procurement agencies to identify

competent laboratories; fosters international acceptance of

test data produced in U.S. laboratories; provides laboratory

management with a quality assurance check of their

performance; and provides laboratories with guidance from

technical experts to aid in reaching a higher level of

performance.

Agency Function Accreditor.

Type of Program Laboratory accreditation.

Methodology Technical requirements, including test methods, standards

and the products or services to be covered, are established

for each laboratory accreditation program. Laboratories may

then request that their performance be assessed by NVIAP

against these requirements.

Testing Government.

Inspection Government.

123
Conformity

Identification

A certificate of accreditation is provided to the

laboratory. Directories of accredited laboratories are

published annually.

Availability

of Documentation

General requirements are set forth in 15 CFR Part 7.

Requirements for specific laboratory accreditation programs

are available from NVLAP.

Obligations of the Laboratories are obligated to maintain adequate quality

Manufacturer/Vendor control programs and to abide by the terms of its

accreditation

.

Enforcement Suspension or revocation of accreditation.

Term Certificates of Accreditation are valid for one year.

Reciprocity NBS accreditation of a laboratory is recognized by many

federal and state agencies, as well as some foreign

government bodies.

Standards, Codes

or Regulations

General requirements are set forth in 15 CFR Part 7.

Specific requirements for each laboratory accreditation

program are established by NBS in conjunction with technical

experts from the federal, state and local levels; academia;

and from industry.

Keywords accreditation; laboratories; NVLAP; quality control; test

methods; testing

124
125
Availability

of Documentation

The lists of USDA-FSIS accredited laboratories are

published in the "Meat and Poultry Inspection Directory."

Obligations of the

Manufact^iner/Vendor

Accredited laboratories must continue to operate under the

Accredited Laboratory Rules as documented under 9 CFR

Parts 318.21 and 381.153.

Enforcement Delisting.

Term Indefinite term.

Reciprocity Recognition of Accreditation by:

State agencies.

Private sector organizations.

Standards, Codes

or Regulations

9 CFR Parts 318.21 and 381.153.

Keywords accredited/laboratory coordinator; initial accreditation

sample check; laboratory accreditation; laboratory; meat

testing; official sample; ongoing accreditation check

sample; poultry testing; probation; split sample

126
Products or

Services

Certification of U.S. Laboratories for the Analysis of

Wines and Distilled Spirits for Export

Department/Agency U.S. Department of the Treasury

Bureau of Alcohol, Tobacco and Firearms

Office of Laboratory Services

1401 Research Boulevard

Rockville, MD 20850

(301) 294-0410

Telex: 710-822-9229 ATF HQ WSH

Initiated Distilled spirits beverages: 1969

Wines: 1973

Compliance Mandatory only for laboratories wishing to be certified by

the Bureau of Alcohol, Tobacco and Firearms.

Authority Internal Revenue Procedure 69-22 (Distilled Spirits)

.

ATF Procedure 86-3 (Wines)

.

Aim 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.

Benefits Enables U.S. industry to comply with foreign government

requirements.

Agency Function Program administrator and certifier.

Type of Program Pre-certification evaluation.

Methodology

Testing

Government review of applicant's qualifications.

ATF certifies laboratories qualified for the analysis of

wines and distilled spirits beverages.

Inspection Government inspection.

Conformity

Identification

A list of certified laboratories.

127
Availability

of Documentation

Obligations of

Manufacturer/Vendor

Enforcement

Term

Reciprocity

Standards, Codes,

or Regulations

Keywords

The list- of laboratories certified by ATF are available

and may obtained at the address indicated above.

Exporters of U.S. wines and distilled spirits beverages

obligated to use the services of laboratories certified

by ATF, but only if the importing country so requires.

Delisting.

Retesting after 4 years.

No reciprocal agreements.

Internal Revenue Procedure 69-22 (Distilled Spirits)

.

ATF Procedure 86-3 (Wines)

.

ATF prepares criteria documentation.

alcohol; ATF certified laboratory; beverages; chemical

analyses; distilled spirits; laboratory accreditation;

wines

128
Products or

Services

Measurement Calibration Services

Department/Agency U.S. Department of Commerce

National Bureau of Standards (NBS)

Office of Weights and Measures

Administration Bldg. , Room A617

Gaithersburg, MD 20899

(301) 975-4004

Initiated 1965

Compliance

Authority

Aim

Voluntary

NBS Organic Act (P.L. 81-619)

.

Provide certification of state measurement laboratories

capabilities to calibrate standards and equipment for

measuring mass, length, volume, temperature, and

frequency-based devices.

Benefits Provides basis for uniform requirements and consistent

results in metrological calibration and tolerance testing

among states.

Agency Function

Type of Program

Program administrator.

A joint on-going activity between federal and state

governments to: (1) maintain traceability to national

standards; and (2) evaluate, up-grade, and train

measurement technicians in official state weights and

measures laboratories.

Methodology Inspection and site approval of new laboratory facilities.

Installation and maintenance of measurement control

programs. Program requirements in NBS Handbook 143.

Technical standards in NBS Handbook 145.

Testing All services within this program are performed

by state laboratories accredited by NBS.

129
Inspection Government.

conformity

Identification

State laboratories receive certificates of accreditation and

are identified in a list, NBS SP 686. Instruments and

standards certified by state laboratories may be

identified by a state government-applied mark.

Availability

of Documentation

NBS SP 686, NBS Handbook 143, and NBS Handbook 145 are

available from NBS.

Obligations of the

Manufacturer/Vendor

State laboratories are obligated to participate in

external control programs based on geographical regions

which include controlled sample testing, round robin

experiments, and continuing education for technicians.

Enforcement NBS exercises influence over state laboratories through

provision of traceability to NBS standards, provision of

training and by sponsoring the Regional Measurement

Management Programs. State programs may ban the use of

uncalibrated measurement equipment in their regulatory

programs.

Term Indefinite term. NBS Certificates of Accreditation are

valid for up to 3 years.

Reciprocity NBS certification of a state laboratory carries

recognition within that state and among states and

recognition by federal government agencies and private

organizations

.

Standards, Codes

or Regulations

Criteria documents are developed by NBS.

Handbook 143 available from NBS.

See NBS

Keywords frequency; length; mass; measurement instruments; quality

control; state laboratories; temperature; volume

130
Products or

Services

Grain Scale Testing and Certification

Department/Agency U.S. Department of Agriculture

Federal Grain Inspection Service (FGIS)

Field Management Division, Room 1641-S

P. 0. Box 96454

Washington, D.C. 20090-6454

Telephone: (202) 382-0262

Telex: 760 7351 ANS:FGIS UC.

FAX: (202) 447-4628

Initiated 1976

Compliance

Authority

Aim

Mandatory only for official certification of grain weight.

U.S. Grain Standards Act, as amended.

Provide for the certification of grain weight and the

testing and certification of the weighing systems used for

official grain weighing and inspection. FGIS and delegated

states must test all grain scales at facilities

which have requested official weight certification.

FGIS conducts evaluations of automatic bulk weighing

systems and vehicle, railway track, and grain inspection

scales to determine compliance with FGIS regulations

and the applicable National Type Evaluation Program (NTEP)

type evaluation examination criteria and test procedures

as adopted by the National Conference on Weights and

Measures (NCWM) . Only those scales that have been

approved, and Class II, III, IIIL scales that have been

evaluated by FGIS or the National Bureau of Standards

(NBS) and approved under the NTEP may be used for

official weighing and inspection purposes.

Benefits Ensure the accuracy of weighing systems used to

officially weigh grain and provide uniformity in

the inspection and testing of weighing devices

used for that purpose.

Agency Function

Type of Program

Certifier, regulator, and program administrator.

Pre-performance evaluation.

Post-performance assessment.

Assessment prior to government purchase.

131
Methodology Government design approval, performance testing,

inspection, and site approval.

PGIS laboratory.

Government laboratory.

Manufacturer's laboratory.

State laboratory.

PGIS or state government.

NTEP Certificate of Conformance (CC)

.

PGIS CC.

PGIS Report of Test (ROT)

.

NBS ROT.

Government applied approval seal.

List of approved equipment may be obtained from:

U.S. Department of Agriculture

Federal Grain Inspection Service (PGIS)

Equipment Branch

Room 0623-South Building

P. 0. Box 96454

Washington, D.C. 20090-6454

Index of NTEP device evaluations and NTEP criteria and

test procedures may be obtained from :

NCWM/OWM

National Bureau of Standards

Administration Building Room A617

Gaithersburg, MD 20899

Obligations of the Must provide instruments under the CC exactly as specified

Manufacturer/Vendor and provide installation, maintenance, and operating

instructions consistent with the evaluation report.

Modifications affecting accuracy, reliability or integrity

must be approved by the PGIS Equipment Branch before

implementation

.

Term Continuous or intermittent, mandatory or voluntary

inspection on a scale.

Testing

Inspection

Conformity

Identification

Availability

of Documentation

132
Reciprocity Certificates are required by federal agencies, state

agencies, private sector organizations, foreign

governments, and international organizations buying

and selling grain.

Standards, Codes U.S. Grain Standards Act, as amended, and the regulations

or Regulations thereunder; FGIS Equipment Handbook; FGIS Weighing

Handbook; NBS Handbook 44; and NTEP device evaluation

criteria.

Keywords automatic bulkweighing systems; grain test; NTEP; railway

track; ROT; scale; state weights and measures officials

133

Products or

Services

Evaluation of Commercial Weighing and Measuring

Instruments

DepartaDent/Agency U.S. Department of Commerce

National Bureau of Standards (NBS)

Office of Weights and Measures

Administration Bldg. , Room A617

Gaithersburg, MD 20899

(301) 975-4004

Initiated 1984

Compliance

Authority

Voluntary

Resolution of the National Conference on Weights and

Measures (NCWM) and NBS Organic Act (P.L. 81-619)

.

Aim Provide an evaluation service for producers of specified

kinds of weighing and measuring instruments used in

commercial trade prior to acceptance for sale or use

within the U.S.

Benefits Provides a uniform means of evaluating the performance of

specific devices/systems for conformance to legal

requirements.

Agency Function

Type of Program

Methodology

Certifier and program administrator.

Pre-marketing evaluation.

NBS provides performance evaluation and testing either

directly or jointly with an NBS authorized laboratory.

Testing Government approved labs.

(Authorized laboratory indicated above is most likely to

be an authorized state measurement laboratory)

.

Inspection NBS or state government.

Conformity

Identification

Certificates of Conformance issued to manufacturer.

List of qualified manufacturers.

135
Availability

of Documentation

List published by NBS.

Obligations of the

Manufactxtrer/Vendor

Manufacturers must mark instruments marketed under the

Certificate of Conformance exactly as specified and

provide installation, maintenance, and operating

instructions consistent with the evaluation report.

Enforcement Delisting. States may require Certificate of Conformance

before allowing device to be marketed in the state.

Term Certificate is valid as long as the type and model of

instrument is produced consistent with the evaluation

report.

Reciprocity Other federal agencies and state agencies. This program is

the U.S. basis for recognition of approved measuring

instruments within an international system currently being

established.

Standards, Codes

or Regulations

Keywords

NCWM prepares acceptance criteria, taking advice from NBS,

device manufacturers and participating laboratories and

international organizations. The NCWM adopts these

criteria by consensus vote.

commercial measuring devices; legal metrology; measurement

instruments; production control; prototype; state

laboratories; type evaluation; weighing instruments

136
SECTICN VII

MEDICAL PRODUCTS AND SERVICES

137
I

I

I
section vn

MEDICAL PRODUCTS AND SERVICES

INDEX

REFERENCES IN THIS SECTION PAGE

AMBULATORY SURGICAL CENTERS (ASC) 141

AUTOMOTIVE DRIVING AIDS AND WHEELCHAIR LIFTS 151

DRUGS CONTAINING INSULIN 145

DRUGS FOR HUMAN USE 147

HEALTH CARE PROVIDERS AND SUPPLIERS 141

HOME HEALTH AGENCIES (HHA) 141

HOSPICES 141

HOSPITALS 141

INTERMEDIATE CARE FACILITIES (ICF) 141

INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED (ICF/MR) 141

1ABORATORY PROCEDURES, VA MEDICAL CENTERS 155

lABORATORIES, INDEPENDENT 141

lABORATORIES , INTERSTATE LICENSED 141

MEDICAL DEVICES 149

NURSING FACILITIES, SKIT TED (SNF) 141

PHYSICAL THERAPY, OUTPATIENT (OPT) 141

PHYSICAL THERAPISTS IN INDEPENDENT PRACTICE (PTIP) 141

REHABILITATION FACILITIES 141

RENAL DISEASE FACILITIES, END STAGE (ESRD) 141

RURAL HEALTH CLINICS (RHC) 141

SPEECH PATHOLOGY SERVICES, OUTPATIENT (OSP) 141

WHEELCHAIRS 153

X-RAY SERVICES, PORTABLE 141

REFERENCES IN OTHER SECTIONS

ELECTRICAL AND ELECTRONIC DEVICES THAT GENERATE RADIO FREQUENCY ENERGY 101

ELECTRONIC PRODUCTS - RADIATION PROTECTION 107

EQUIPMENT AND MATERIALS USED IN THE WORKPIACE 171

SECTION VI-TESTING, MEASUREMENT, AND lABORATORY SERVICES 119

LABORATORY ACCREDITATION 123

MEASUREMENT CALIBRATION SERVICES 129

VETERINARY FOODS AND DRUGS 63

139

Products or

Services

Health Care Providers and Suppliers: Hospitals,

Psychiatric Hospitals, Hospices, Skilled Nursing

Facilities (SNF) , Intermediate Care Facilities (ICF)

,

Intermediate Care Facilities for the Mentally Retarded

(ICF/MR) , Home Health Agencies (HHA) , Ambulatory Surgical

Centers (ASC) , Rural Health Clinics (RHC) , End Stage

Renal Disease Facilities (ESRD) , Outpatient Physical

Therapy or Speech Pathology Services (OPT/OSP) , Physical

Therapists in Independent Practice (PTIP) , Comprehensive

Outpatient Rehabilitation Facilities (CORF) , Independent

Laboratories, Interstate Licensed Laboratories, Portable

X-Ray Services.

Department/Agency U.S. Department of Health and Human Services (DHHS)

Health Care Financing Administration (HCFA)

Health Standards and Quality Bureau

Office of Survey and Certification

6325 Security Boulevard

Baltimore, MD 21207

(301) 934-5547 (FTS)

Initiated

Compliance

1966

Voluntary for Medicare Certification.

Mandatory licensure for laboratories performing work in

interstate commerce.

Authority Social Security Act, P.L. 92-603.

Clinical Laboratories Improvement Act of 1967 (CLIA)

,

P.L. 90-174.

42 CFR Part 416 (ASC) , Part 418 (Hospices) , Part 442

(ICF, ICF/MR) , Part 481 (RHC) , Part 482 (Hospitals) , Part

488 (CORF) , Part 405 (remaining facilities)

.

42 CFR Part 74 (Interstate (CLIA) licensed laboratories)

.

Aim To establish minimum health and safety standards which

must be met by providers and suppliers participating

in the Medicare and Medicaid programs.

Benefits Improved quality of health care for Medicare/Medicaid

beneficiaries

.

141
142
Standards, Codes Standards are specified in the Acts and in the Code of

or Regulations Federal Regulations.

Keywords ambulatory surgical centers; CL1A/interstate licensure;

health care facility; health care providers; home health

agencies; hospices; hospitals; intermediate care facilities;

laboratories; Medicare certification; physical therapy;

portable x-ray services; rehabilitation facilities; rural

health clinics; skilled nursing facilities; speech pathology

services

143

Products or

Services

Drugs Containing Insulin

Department/Agency U.S. Department of Health and Human Services

Food and Drug Administration (FDA)

Center for Drugs and Biologies

Office of Biologies Research and Review

5600 Fishers lane

Rockville, MD 20857

(301) 443-3490

Compliance

Authority

Voluntary

21 CFR Part 429.

Aim To provide insulin users with assurance of a uniform

quality drug.

Benefits Virtually all producers participate in this certification

program.

Agency Function Certifier.

Type of Program Pre-marketing evaluation.

Methodology Government inspection.

Compliance with Good Manufacturing Practices (GMP)

Testing Manufacturer's lab.

Government lab.

Inspection Government.

Conformity

Identification

Lists of qualified producers and certified products are

maintained by FDA.

Availability

of Documentation

Lists are available from FDA.

145
Obligations of the

Manufacturer/Vendor

Producers are required to keep production records for two

years after batch shipment.

Enforcement Marketing ban (under the requirement that any misbranded

drug is banned by law)

.

Term Certification is provided on a batch basis.

Reciprocity Certification is recognized by other federal agencies,

state agencies, and private sector organizations.

Standards, Codes

or Regulations

Agency prepares certification criteria. Agency adopts

test methods of the U.S. Pharmacopoeial Convention and

the National Formulary.

Keywords certification; color coding; drugs; insulin; labeling;

market ban; packaging

146
Products or

Services

Drugs for Human Use

Depaxtmer^t/Agericy U.S. Department of Health and Human Services

Food and Drug Administration (FDA)

Center for Drugs and Biologies

Office of Compliance

Regulatory Affairs Division

Legislative, Consumer and Professional Affairs Branch

Metro Park North

7520 Standish Place

Rockville, MD 20855

(301) 295-8012

Compliance

Authority

Mandatory

Food, Drug and Cosmetic Act of 1938 as amended,

Title 21 USC, 21 CFR Parts 200-212 and 300-315.

Aim To assure that drugs and antibiotics are both safe and

effective for intended use.

Benefits Virtually all covered products consumed in the U.S. are

made in registered establishments and produced under Good

Manufacturing Practices (GMP)

Agency Function

Type of Program

Methodology

Certifier.

Pre-marketing evaluation.

Government design approval, inspection, site approval and

compliance with GMP.

Testing Manufacturer's lab.

Third party lab.

Inspection Government.

Conformity

Identification

Lists of qualified producers and approved products are

maintained by FDA.

147
Availability

of Documentation

Official lists may be obtained from:

Drug Listing Branch (HFN-315)

Center for Drugs and Biologies

Food and Drug Administration (FDA)

7520 Standish Place

Rockville, MD 20855

(301) 295-8077

Obligations of the

Manufactiirer/Vendor

Producers are required to register establishments,

maintain sanitary conditions, provide substantial

clinical evidence of safety and effectiveness, prepare

adequate labeling and instructions for use, submit

advertising for approval, comply with GMP, use approved

packaging, and advise FDA of known adverse reactions.

Enforcement Marketing ban.

Product recall,

Term No specific term; retesting is based on changes in

product characteristics, composition, or intended use.

A major consideration is any misbranding or adulteration.

Reciprocity Certification is recognized widely in the U.S., but no

foreign reciprocity.

Standards, Codes

or Regulations

FDA prepares all standard requirements including GMP

Rules, except that specifications of official drug

components are prepared by private organizations, i.e.,

the U.S. Pharmacopeia, the Homeopathic Pharmacopeia, or

the National Formulary.

Keywords adulteration; antibiotics; drug registration; drugs; good

manufacturing practices; labeling; misbranding; packaging;

pre-market evaluation; recall; sanitation

148
Products or

Services

Medical Devices

DepartmeaTt/Agency U.S. Department of Health and Human Services

Food and Drug Administration (FDA)

Center for Devices and Radiological Health

Office of Device Evaluation

8757 Georgia Ave.

Silver Spring, MD 20910

(301) 427-7004

Initiated 1976

Compliance

Authority

Mandatory

Medical Device Amendments, P.L. 94-295 to Food, Drug and

Cosmetic Act, Title 21 USC.

Aim To assure that medical devices are both safe and

efficacious in their intended use.

Benefits For Class III devices, the program provides a more

thorough design review.

For Class I and II devices, the program provides clear

public expectations.

Agency Function For Class III devices, certifier.

For Classes I and II devices, program administrator.

Type of Program

Methodology

Pre-marketing evaluation.

For Class III, government design approval, audit

inspection, and site approval; manufacturers supply test

data.

For Classes I and II, manufacturer self-certification and

compliance with Good Manufacturing Practices (GMP)

Testing Manufacturer's lab or third party lab.

Audit testing may be done by labs under contract to

government.

149
Inspection Government.

Conformity

Identification

For Class III devices only, list of approved products is

maintained by FDA.. For Classes I and II, manufacturer

self-certification is evidenced through information

required in product labeling

Availability

of Documentation

Lists are available from the:

FDA. Devices Registration and Listing Branch

Product Surveillance Division

8757 Georgia Ave.

Silver Spring, MD 20910

(301) 427-7190

Obligations of the

Maniifac±urer/Vendor

Manufacturers of all classes of medical devices are

required to be registered and to collect data on patient/

practitioner experience and report any hazardous events or

noncompliances with Class III or Class II certification.

Enforcement Marketing ban, product recall, delisting are all

applicable to medical devices.

Term No specific term; retesting is based on changes in product

characteristics or use. A major consideration is any

misbranding or adulteration.

Reciprocity Certifications are recognized widely in the U.S., but no

foreign reciprocity.

Standards, Codes

or Regulations

Agency prepares requirements for Class III; standards for

Class II may be from private sector; FDA develops and

maintains GMP rules.

Keywords adulteration; good manufacturing practices; investigational

use; medical devices; medical device classification;

misbranding; pre-market notification; recall

150
Products or

Services

Automotive Driving Aids and Automatic Wheelchair Lifts

Department/Agency Veterans Administration

Prosthetic & Sensory Aids Service (121)

810 Vermont Ave. , NW

Washington, D.C. 20420

(202) 233-2011

Initiated Driving aids, March 27, 1975; wheelchair lifts,

May 10, 1978.

Compliance Mandatory only for purchases funded by the Veterans

Administration (VA)

Authority P.L. 91-666.

Aim To provide quality equipment and assure the safety of

veteran passengers and drivers as well as the general

public.

Benefits Since developing the Quality Products List for hand

controls and van lifts, manufacturers of these units have

been assisted by the VA in improving the quality of their

products. Establishment of standards has fostered

competition.

Agency Function Certification is made by the VA sponsored Automobile

Adaptive Equipment Committee.

Type of Program

Methodology

Assessment prior to government purchase.

Compliance is assured by government testing/inspection or

third party government approved certification, and

manufacturers' self-certification.

Testing Testing results are accepted from government laboratories,

government approved labs, third party labs and

manufacturers' labs.

Inspection Government.

151
Ccnformity

Identification

Listing in VA Circular 10-86-54.

Availability

of Documentation

The VA Compliance List, DM&S Circular 10-86-54,

dated April 24, 1986, lists certified suppliers of

wheelchair lift systems and hand controls.

Term Testing of new products is on-going. Listings are updated

annually.

Reciprocity Certification by other agencies is accepted when current

standards are applied.

Standards, Codes,

or Regulations

Federal Register . Vol. 40, No. 65 - April 3, 1975, defines

standards for driving aids.

Requirements for wheelchair lifts are specified in

Federal Register. Vol. 43, No. 96 - May 17, 1978.

Keywords adaptive equipment; automotive; driving aids; hand control;

handicapped aids; prosthetic aids; quality; safety;

wheelchair lifts

152
Self-Propelled and Motorized Wheelchairs

Veterans Administration

Prosthetic & Sensory Aids Service (121)

810 Vermont Ave. , NW

Washington, D.C. 20420

(202) 233-2011

Self-propelled wheelchairs , December 7, 1977; Motorized

wheelchairs, December 15, 1981

Mandatory only for purchases funded by the Veterans

Adrtiinistration (VA)

.

Title 38 USC 4101(c) (2)

.

Avoid hazardous conditions for disabled persons caused by

inferior products.

Product quality and safety has improved and competition

has increased. Federal Supply Schedule Contracts have

been established to enforce compliance.

Certification is made by the VA sponsored Prosthetic

Technology Equipment Committee.

Assessment prior to government purchase.

Compliance is assured by government testing/inspection or

third party government approved certification, and

manufacturers' self-certification.

Testing results are accepted from government laboratories,

government approved labs, third party labs and

manufacturers' labs.

Government.

153
Conformity

Identificatian

Self-propelled wheelchair suppliers and motorized wheelchair

suppliers are currently listed.

Availability The General Services Administration's (GSA) Federal

of Documentation Supply Schedule for wheelchairs provides particulars.

Term Testing of new products is on-going. Listings are updated

annually and GSA contracts are negotiated annually.

Reciprocity Certification by other agencies is accepted when current

standards are applied.

Standards, Codes,

or Regulations

Federal Register. Vol. 42, No. 239 - December 13, 1977,

defines standards for propelled wheelchairs.

Requirements for motorized wheelchairs are specified in

Federal Register. Vol. 46, No. 240 - December 15, 1981.

Keywords handicapped aids; prosthetic aids; quality; safety;

wheelchair

154
Products or

Services

Tests and Procedures Performed by Veterans Administration

Medical Center Laboratories

155
Indefinite term.

Recognition of certification by Joint Council of American

Hospitals.

College of American Pathologists Laboratory Accreditation

Program (CAPLAP)

.

clinical laboratories; laboratories; limited special

function laboratories; nuclear medicine; pathology

156
SECTION VIII

MINING, DRILLING, AND INDUSTRIAL EQOIIMENT

157

SECTION VIII

MINING, DRILLING, AND INDUSTRIAL EQUIPMENT

INDEX

REFERENCES IN THIS SECTION PAGE

COAL DUST SAMPLERS 161

DIESEL-POWERED EQUIPMENT FOR GASSY MINES 165

ELECTRICAL EQUIPMENT FOR MINES 167

EQUIPMENT AND MATERIALS USED IN THE WORKPLACE 171

RESPIRATORS AND OTHER BREATHING APPARATUS 161

SYSTEMS USING PRESENCE SENSING DEVICES FOR INITIATING MECHANICAL POWER

PRESSES (PSDI) 169

VALVES, SUBSURFACE AND SURFACE SAFETY FOR OIL AND GAS OPERATIONS 163

REFERENCES IN OTHER SECTIONS

ELECTRICAL AND ELECTRONIC DEVICES THAT GENERATE RADIO FREQUENCY ENERGY 101

ELECTRONIC PRODUCTS - RADIATION PROTECTION 107

HAZARDOUS SUBSTANCES 227

SECTION VI-TESTING, MEASUREMENT AND CALIBRATION SERVICES 119

SECTION VTI-MEDICAL PRODUCTS AND SERVICES 137

SECTION IX-TRANSPORTATION-REIATED PRODUCTS AND SERVICES 173

159

Respirators and Other Breathing Apparatus; Personal Coal

Dust Samplers

U.S. Department of Health and Human Services

National Institute for Occupational Safety and Health

Appalachian Laboratory for Occupational Safety and Health

Certification Branch

944 Chestnut Ridge Road

Morgantown, WV 26505-2888

(304) 291-4331

1972

Voluntary

30 CFR Part 11.

30 CFR Part 74.

To assure a minimum level of performance and quality for

respiratory protective devices in the marketplace and

provide an independent review of manufacturer's designs.

The certifying laboratory evaluates approximately 2000

samples of respiratory protective devices from a

population of 21 domestic manufacturers and five

importers. These evaluations combined with an extensive

defect notification program, including both users and

manufacturers, assures that nearly all potentially lifethreatening problems with respiratory protective equipment

are detected and corrected before equipment-related

injuries occur.

Certifier.

Pre-marketing evaluation and post-marketing assessment, in

the form of defect investigation.

Federal design approval and testing.

Government laboratory and manufacturers labs.

161
Inspection Federal agency representatives only.

Conformity

Identification

Approved product lists and government-approved labels

applied by the manufacturer.

Availability

of Documentation

Approved product lists are available to users at the above

address.

Obligations of the

Manufacturer/Vendor

Manufacturer must conduct pre-submittal tests; establish

a quality control plan for agency approval; notify agency

of possible or actual equipment or component defects;

participate in agency-sponsored investigations; and cease

labeling if approval is suspended.

Enforcement Delisting.

Product recall (voluntary by the manufacturer)

Notification to users.

Term Indefinite term.

Reciprocity Other federal agencies (e.g. the NRC)

.

State agencies.

Government of Canada and its counterpart agencies.

Standards, Codes

or Regulations

Agency prepares criteria documents. Agency adopts

standards prepared by others for quality plans and

respirator maintenance.

Keywords air samplers; breathing apparatus; coal mine dust; design

approval; face pieces; gas masks; mining equipment;

pesticides; respirators

162
Products or

Services

Surface and Subsurface Safety Valves for Oil and Gas

Operations

Department/Agency Minerals Management Service

Offshore Operations

Offshore Rules and Operations Division, Room 6A116

U.S. Department of the Interior

12203 Sunrise Valley Drive

Reston, VA 22091

(703) 648-7813

Initiated 1980

Compliance Mandatory

Authority 30 CFR Part 250.11.

Outer Continental Shelf (CCS) Orders.

Aim

Benefits

To prevent major oil spills that cause pollution.

Decreased pollution and accidents and improved consistency

of manufacturing and testing.

Agency Function Program administrator.

Type of Program Pre-marketing evaluation.

Methodology

Inspection

Third party inspection.

Federal inspection of drilling/production operations.

Valves subject to ASME-approved, third party inspection.

Conformity

Identification

Authorized mark or label by manufacturer.

Availability Available from ASME at 345 E. 47th Street, New York, NY

of Documentation 10017.

163
Obligations of

Manafactiirer/Vendor

Traceability.

Enforcement Delisting.

Term Three years.

Reciprocity No reciprocal agreements.

Standards, Codes,

or Regulations

ANSI/ASME - SPPE-1 , Quality Assurance and Certification of

Safety and Pollution Prevention Equipment Used in Offshore

Oil and Gas Operations.

ANSI/ASME - SPPE-2, Accreditation of Testing laboratories

for Safety and Pollution Prevention Equipment Used in

Offshore Oil and Gas Operations.

Keywords environmental protection; gas pollution; OCS; offshore

drilling; oil pollution; petroleum pollution; pollution

prevention; safety valves; valves

164
Products or

Services

Diesel-Powered Equipment for Gassy Mines

Department/Agency U.S. Department of Labor

Mine Safety and Health Administration (MSHA)

Approval and Certification Center

Box 251

Triadelphia, WV 26059

(304) 547-0400

Initiated 1977

Compliance Mandatory for certain areas of non-coal mines where

methane may be present.

Authority P.L. 91-173; 30 USC 957.

P.L. 95-164; 30 USC 961, 951; 30 CFR Part 36.

Aim To provide a uniform means for evaluating diesel-powered

equipment used in non-coal mines for mining and

transportation

.

Benefits Accidents and deaths related to diesel-powered mine

machinery have been minimized.

Agency Function Certifier.

Type of Program Pre-market evaluation.

Methodology Government design approval, testing, and inspection.

Testing Government labs or other labs under government monitoring.

Inspection Government.

Conformity

Identification

Agency designated and issued mark.

Availability Agency publishes lists of certified and approved

of Documentation equipment.

165
Obligations of the

Manufacturer/Vendor

Manufacturer must maintain production according to typeapproved drawings, including modifications to design

required for approval, and employ acceptable quality

control plan.

Enforcement Marketing ban; removal from mine use of rKDn-conforming

equipment; legal action.

Term Indefinite.

Reciprocity Other international, federal and state agencies, and

private organizations.

Standards, Codes

or Regulations

Agency prepares criteria documents.

Keywords diesel-powered equipment; dust collectors; electrical

components; exhaust gasses; flammable atmosphere; mining

machines; non-coal mines; safety; transporters; ventilators

166
Products or

Services

Electrical Equipment for Mines

Department/Agency U.S. Department of labor

Mine Safety and Health Administration (MSHA)

Approval and Certification Center

Box 251

Triadelphia, WV 26059

(304) 547-0400

Initiated 1977

Compliance

Authority

Mandatory

P.L. 95-164; 30 USC 961, 951; 30 CFR Part 18.

P.L. 91-173; 30 USC 957.

Aim To provide a uniform means for evaluating electrical

equipment used in gassy mines for mining, illuminating,

and measuring in order to reduce work place hazards.

Benefits Accidents and deaths related to electrically-powered mine

machinery have been minimized.

Agency Function Certifier.

Type of Program Pre-market evaluation.

Methodology

Testing

Inspection

Government design approval, testing, and inspection.

Government labs or other labs under government monitoring

Government.

Conformity

Identification

Agency designated and issued mark.

Availability Agency publishes lists of certified and approved

of Documentation equipment.

167
Obligations of the Manufacturer mist maintain production according to typeManufactxirer/Vendor approved drawings, including modifications to design

required for approval, and employ acceptable quality

control plan.

Enforcement Marketing ban; removal from mine use of ron-conformng

equipment; legal action.

Term Indefinite.

Reciprocity Other international, federal and state agencies, and

private organizations.

Standards, Codes

or Regulations

Agency prepares criteria documents.

Keywords battery powered equipment; coal mines; electrical equipment;

fans compressors; illumination; intrinsically-safe

equipment; mining equipment; pumps; safety; shuttle cars;

signalling devices

168
Products or

Services

Systems Using Presence Sensing Devices for Initiating

Mechanical Power Presses (PSDI)

Departanent/Agency U.S. Department of Labor

Occupational Safety and Health Administration (OSHA)

Directorate of Technical Support

Office of Variance Determination, Room N3656

200 Constitution Ave. , NW

Washington, D.C. 20210

(202) 523-7193

Initiated

Compliance

Authority

Final Rule to be issued in 1987.

Mandatory for employers planning to use such systems.

29 CFR Part 1910.217; 29 CFR Part 1910 —

General Industry; P.L. 91-596 —

Occupation Safety and Health Act of 1970.

Aim To provide protection for employees using presence

sensing devices for initiation of mechanical power

presses.

Benefits The overall press and control system safety are enhanced

by certification to ensure a higher degree of equipment

capability and reliability than was provided for in the

former standard.

Agency Function

Type of Program

Methodology

Program administrator.

Regulatory compliance.

OSHA recognizes third party certification program (s) to

validate certifications by manufacturer or employer.

Certifications include design, installation and annual

recertification

Testing

Inspection

Laboratory selected by recognized certification program.

Recognized third party certification program.

169
CJonformity

Identification

Mark or label authorized by recognized certification

program.

Availability Available from recognized certification program,

of Documentaticri manufacturer, or employer.

Obligations of the Cooperate with employers and recognized certification

Maniifac±urer/Vendor programs to develop, install and maintain safe devices for

presses.

Enforcement As required by OSHA Act; periodic inspection of employers

under OSHA inspection program; written report on

mechanical power presses also required.

Term Retesting after one year by recognized certification

program.

Reciprocity Recognition of certification by:

Other federal agencies

State agencies.

Standards, Codes

or Regulations

Recognized certification program adopts and uses standards

prepared by others.

Keywords industrial safety; light curtain; machine guarding;

mechanical power press; Presence Sensing Device Initiation

(PSDI) ; presses; safety distance

170
Products or

Services

Equipment and Materials Used in the Workplace

Department/Agency U.S. Department of Labor

Occupational Safety and Health Administration (OSHA)

Directorate of Safety Standards Programs

200 Constitution Ave. , NW

Washington, D.C. 20210

(202) 523-8061

Initiated 1971

Compliance

Authority

Aim

Mandatory

Occupational Safety and Health Act of 1970, PL 91-596.

29 CFR Part 1910 — Occupational Safety and Health Standards

for General Industry.

29 CFR Part 1915 — Occupational Safety and Health Standards

for Shipyard Employment.

29 CFR Part 1917-1918 — Occupational Safety and Health

Standards for Marine Terminals; Longshoring.

29 CFR Part 1926 — Construction Safety and Health

Standards.

29 CFR Part 1928 — Occupational Safety and Health Standards

for Agricultural Employment.

To provide protection to the nation's workers on their job

by reducing or eliminating the various hazards to which

workers may be exposed. Certain equipment because of its

nature or the types of hazards that may develop while in use

is required to be listed, labelled, or approved by third

party laboratories.

Benefits The certification program enables employers to install

equipment which has demonstrated compliance with applicable

standards and regulations. OSHA workplace inspections can

also be expedited when certified equipment is used.

Agency Function

Type of Program

Methodology

Program administrator.

Post-marketing assessment.

Third party certification.

171
Testing Third party test labs.

Accreditation of laboratories proposed in the Federal

Register Notice of March 6, 1984.

Inspection OSHA inspectors can inspect equipment in the workplace.

Obligations of the Comply with applicable standards.

Manufac±urer/Vendor

Enforcement Ban from the workplace.

Term Indefinite term.

Reciprocity Listing, labelling, or approval by foreign certification

agencies is recognized by OSHA so long as evaluation

criteria are equal to or more stringent than applicable OSHA

standards and regulations.

Standards, Codes

or Regulations

OSHA standards include extensions of federal standards

and federal and non-government standards incorporated by

reference. These include numerous standards of the American

National Standards Institute, the American Society of

Mechanical Engineers, the National Fire Protection

Association, Underwriters Laboratories , and others.

Keywords agriculture; construction; diving; electrical; equipment;

fire protection; hazardous materials; health; job safety;

machinery; material handling; medical services; personal

protective equipment; safety; tools; ventilation; welding

172
SECTICN IX

TRANSPCKEATICN-4JELATEI) PRODUCES AND SERVICES

173

section rx

TRANSPCSmmm-^ELATED PRODUCTS AND SERVICES

INDEX

REFERENCES IN THIS SECTION PAGE

AIR TRANSPORT

CIVILIAN AIRCRAFT, AIRCRAFT ENGINES, PROPELLERS, AND THEIR COMPONENTS

AND PARTS AS WELL AS RELATED PERSONNEL, SERVICES, AND FACILITIES 177

WEATHER OBSERVATION FOR AVIATION PURPOSES 181

MARINE TRANSPORT

MARITIME CARGO HANDLING EQUIPMENT 183

LIFESAVTNG, ENGINEERING, FIRE PROTECTION, AND POLLUTION PREVENTION

EQUIPMENT FOR RECREATIONAL BOATS AND COMMERCIAL VESSELS 185

SHIPBOARD NAVIGATIONAL AIDS 187

SHIPPING CONTAINERS 189

MOTOR VEHICLE TRANSPORT

AUTOMOTIVE AFTER PARTS 191

ENGINES, MOTOR VEHICLE, GASOLINE AND DIESEL 193

MOTOR VEHICLE SAFETY 195

RAILROAD TRANSPORT

RAILWAY TANK CARS 197

TRAINS, REAR END MARKING DEVICES FOR 199

TRANSPORT OF HAZARDOUS MATERIALS

CYLINDERS FOR TRANSPORTATION OF HAZARDOUS MATERIALS 201

PACKAGES AND CONTAINERS FOR RADIOACTIVE MATERIALS 203

PACKAGING OF HAZARDOUS MATERIALS FOR EXPORT 205

PACKAGING OF RADIOACTIVE MATERIALS FOR TRANSPORT 207

PIPELINES FOR HAZARDOUS FLUIDS 209

SPECIAL TANKS FOR TRANSPORT OF HAZARDOUS MATERIALS . 211

TANKS FOR TRANSPORT OF HAZARDOUS MATERIALS 213

REFRIGERATED TRANSPORT

REFRIGERATED VEHICLES AND REFRIGERATION UNITS 215

REFERENCES IN OTHER SECTIONS

AUTOMOTIVE DRIVING AIDS AND WHEELCHAIR LIFTS 151

ELECTRICAL AND ELECTRONIC DEVICES THAT GENERATE RADIO FREQUENCY ENERGY 101

EQUIPMENT AND MATERIALS USED IN THE WORKPLACE 171

HAZARDOUS SUBSTANCES 227

175

Products or

Services

Civilian Aircraft, Aircraft Engines, Propellers, and

their Components and Parts

In addition to these products, the comprehensive FAA system

provides for certification of pilots, flight instructors,

crew members, mechanics, parachute riggers, control tower

operators, dispatchers, air carriers in interstate or

overseas air transportation, air taxi operators,

agricultural aircraft operators, navigational facilities,

airports and heliports serving certificated air carriers,

repair stations, parachute lofts and schools for pilots and

mechanics. Certificates of designation and certificates of

authority are issued to aviation medical examiners,

examiners of pilots and technical personnel, designated

manufacturing inspection representatives.

Department/Agency U.S. Department of Transportation (DOT)

Federal Aviation Administration (FAA)

Office of the Associate Administrator for Aviation Standards

(AWS-1)

800 Independence Ave. , SW

Washington, D.C. 20591

(202) 267-3131

1926

Mandatory

Federal Aviation Act of 1958 (49 USC)

49 CFR Part 1-199.

To promote the development of civil aviation and to provide

for safe and efficient use of the airspace.

The FAA certification system has helped to produce one of

the safest and most efficient air transportation systems in

the world.

National Transportation Safety Board data demonstrate that

surface travel results in approximately 170 times more

fatalities than air travel, not only in total, but in rate

per passenger mile traveled.

Agency Function Program administrator and certifier.

Initiated

Compliance

Authority

Aim

Benefits

177
Type of Program Initial design assessment; initial product evaluation;

assessment of design, manufacturing, and quality control

practices; approval of maintenance periods; and monitoring

of all service discrepancy reports.

Methodology A Type Certificate is granted by the FAA after an applicant

has identified and demonstrated compliance with applicable

regulations. A Type Certificate is issued for a specific

make and model (type) of aircraft, engine, or propeller.

Special Conditions may be issued for novel or unusual design

features.

A Production Certificate is issued to holders of type

certificates upon demonstration that their quality control

system assures that products conform to the type

certificate.

An Airworthiness Certificate is granted for a specific

aircraft that meets the approved type design and is in

condition for safe operation. Airworthiness certificates

are also issued for engines that are exported.

Parts Manufacturer Approval (FMA) is required for the

manufacture of parts, materials, processes and equipment to

be installed on a type certificated product. This requires

demonstration of compliance with applicable regulations,

directives, and standards, and operation of an effective

quality control system.

Authorization to manufacture and designate products, in

accordance with FAA Technical Standard Orders (TSO's)

,

requires demonstration of compliance with performance and

quality control requirements specified in the respective

TSO's.

Testing Compliance with the applicable requirements is usually

accomplished by the applicant and the FAA will review,

witness and test as appropriate, prior to approval of the

design. Certain flight testing is performed by FAA

personnel. Test data for FMA and TSO's are submitted to the

FAA for review and approval. The FAA does not approve or

accredit test laboratories; however, a manufacturer must

possess, or have access to facilities that will enable it to

test and inspect products to the requisite levels.

Inspection Inspection is accomplished by FAA specialists and designated

representatives

.

178
CJcnformity

Identification

Airworthiness Certificates are issued for each approved

aircraft. Engines and propellers must list the Type

Certificate and Production Certificate numbers on their data

plates. Products conforming to RMA are marked "FAA-PMA".

Those manufactured in accordance with a TSO authorization

are marked with the applicable TSO number.

Availability

of Documentation

No lists of approved or qualified products or suppliers are

published for general distribution by FAA.

Obligations of the

Manufac±urer/Vendor

Each manufacturer or user of certified products, including

TSO items, shall report any accident, failure, malfunction,

or defect that could result in fire, engine failure, primary

structural defect, loss or more than one electrical or

hydraulic power generating system, and similar critical

occurrences. FAA personnel shall be provided access to

inspect any products manufactured under authorization, and

to inspect the manufacturing facilities, quality control

inspection and test, and technical data files.

Enforcement Various civil penalties are provided for under section 901

of the Federal Aviation Act of 1958. Under section 903, a

state or federal law enforcement officer, or an FAA safety

inspector may summarily seize an aircraft involved in a

violation. If it is determined that the public interest and

safety requires it, the FAA may issue an order amending,

suspending or revoking, all or in part of any Type

Certificate, Production Certificate, Airworthiness

Certificate or Air Carrier Operating Certificate or Air

Navigation Facility Certificate. Other enforcement options

include cease and desist orders, orders of denial and

injunctions.

Term Type Certificates and Production Certificates are effective

until surrendered, suspended, revoked, or a termination date

is otherwise established. Airworthiness Certificates are

effective as long as maintenance, and alterations are

performed in accordance with established regulations and

procedures, and the aircraft are registered in the U.S. A

PMA or TSO authorization is not transferable and is

effective until surrendered or withdrawn.

Reciprocity The International Civil Aviation Organization (ICAO) sets

general guidelines for airworthiness certification systems

in Annex 8 to the Chicago Convention. The Federal Aviation

Regulations implement ICAO guidelines in the U.S. The U.S.

Dept. of Defense and the Coast Guard require that certain of

their aircraft and equipment be FAA certified.

179
A Type Certificate may be issued for a product manufactured

in a foreign country with which the U.S. has a bilateral

agreement for acceptance of these products for export and

import if the country in which the product was manufactured

certifies that the product has been examined, tested, and

found to meet applicable FAA requirements and the manuals,

placards, and instrument markings are in English. Depending

on the design and any unique features, Special Conditions

may be identified for approval.

An Airworthiness Certificate is granted to imported aircraft

for which a Type Certificate has been issued if the country

in which the aircraft was manufactured certifies, and the

FAA finds, that the aircraft conforms to the type design and

is in condition for safe operation.

The FAA need not issue Production Certificates, PMA's, or

TSO authorizations if the manufacturing facilities are

located outside the U.S., unless there is no undue burden in

administering the applicable requirements of the Federal

Aviation Act of 1958.

Standards, Codes Applicable design, performance, and quality requirements are

or Regulations specified in 49 CFR Parts 1 to 199. Nongovernment standards

are primarily standards developed by the Society of

Automotive Engineers, Radio Technical Gsmmission for

Aeronautics, and the Aerospace Industries Association.

Keywords air taxi operators; aircraft repair; aircraft; airports;

airworthiness; aviation medical examiners; aviation;

avionics; control tower operators; dispatchers; engines;

flight crew; flight instructors; flight mechanics;

heliports; navigational facilities; parachute schools;

parachute riggers; pilots; PMA; production certificate;

propellers; safety; TSO; type certificate

180
Products or

Services

Weather Observation

Department/Agency U.S. Department of Commerce

National Oceanic and Atmospheric Administration

National Weather Service

8060 13th Street

Silver Spring, MD 20910

(301) 427-7792

Initiated 1983

Compliance

Authority

Mandatory

Organic Act of the National Weather Service, 15 USC 311.

Aim Codify the basis for training, examination, and

certification of human weather observers.

Benefits Assures consistent, minimum performance expectations for

manual weather observations used for the preparation of

forecasts and warnings and the support of aviation

operations.

Agency Function Certifier and program administrator.

Type of Program Pre-performance assessment.

Methodology Government testing, inspection, and audit.

Testing

Inspection

Government.

Government.

Conformity

Identification

Government-issued certificates and master list of

validated observers.

Availability Master List is maintained at the FAA Academy, Oklahoma

of Documentation City, OK.

181
Obligations of the Certificate holder is required to maintain skill level

Manufacturer/Vendor through experience (taking a miniinum number of observations throughout the year)

.

Enforcement Certificate suspension.

Term Audit testing keyed to individual performance, eyesight,

and current experience.

Reciprocity Other federal agencies.

State agencies.

Private organizations.

Canadian government agencies.

Standards, Codes

or Regulations

Agency prepares examination and performance criteria

and incorporates related criteria prepared by DOD, FAA,

and Canadian Atmospheric Environmental Service.

Keywords aviation weather; computer data entry; eyesight examination;

radar observation; radiosonde observation; vision standards;

weather observation

182
Products or

Services

Maritime Cargo Handling Equipment

Department/Agency U.S. Department of Labor

Occupational Safety and Health Administration (OSHA)

Directorate of Field Operations

Office of Construction & Maritime Compliance Assistance

Room N3108

200 Constitution Ave. , NW

Washington, D.C. 20210

(202) 523-8136

Initiated 1971

Compliance

Authority

Aim

Mandatory

29 CFR Part 1915-1919,

Assure that all covered equipment complies with regulatory

requirements. Most of the equipment is at marine

terminals and shipyards. Cargo gear on board U.S.

inspected vessels is under the jurisdiction of the U.S.

Coast Guard.

Benefits Safety of longshoremen, seamen, and dock workers has been

improved by this program which fulfills U.S.

responsibilities for International Tabor Organization

(IIO) Convention No. 32.

Agency Function

Type of Program

Methodology

Testing

Inspection

Program administrator.

Post-marketing assessment.

Third party certification.

Government accredited lab.

Third party.

Conformity

Identification

List of certified products made on OSHA official forms.

183
Availability

of Dtxxnnentation

Agency maintains a list of accredited inspectors. Such

firms are not required to publicize a list of their

clients.

Obligations of the

Manufacturer/Vendor

Cooperate with a specific third party certifier regarding

design, fabrication, and installation data and maintenance

requirements.

Enforcement Delisting or ban on usage.

Term Annual retesting.

Reciprocity Recognition of certification by:

Other federal agencies

State agencies.

Standards, Codes

or Regulations

Agency adepts standards prepared by others.

Keywords accreditation; cranes; derricks; marine equipment; materials

handling equipment; naval equipment; safe working loads;

wire rope

184
Products or

Services

Lifesaving, Engineering, Fire Protection, and Pollution

Prevention Equipment for Recreational Boats and Commercial

Vessels

Department/Agency U.S. Department of Transportation (DOT)

U.S. Coast Guard

Office of Marine Safety, Security and

Environmental Protection

2100 2nd Street, SW

Washington, D.C. 20593

Telex: 892427

For electrical, pneumatic, and hydraulic equipment:

Marine Technical and Hazardous Materials Division

Engineering Branch, G-MTH-2

Room 1218D

(202) 267-2206

For all other equipment:

Merchant Vessel Inspection and Documentation Division

Survival Systems Branch, G-MVI-3

Room 1404

(202) 267-1444

Initiated 1946

Compliance Mandatory for equipment required to be used on recreational

boats and commercial vessels.

Authority 33 CFR Part 159; 46 CFR Parts 2, 159-164.

Aim To approve equipment which meets minimum safety and

performance standards.

Benefits Approved equipment is intended to reduce the loss of life in

marine accidents, and to prevent oil and sewage pollution of

waterways by ships and boats.

Agency Function Program administrator and certifier.

Type of Program Pre-market evaluation, inspection, and testing.

185
Methodology Government design approval and audit testing and inspection.

Third party pre-approval testing and production testing and

inspection.

Manufacturer self-certification and/or production testing

and inspection on selected items.

Testing Coast Guard accredited laboratory.

Manufacturer inspection on selected items.

Inspection Coast Guard accredited laboratory.

Manufacturer inspection on selected items.

Conformity

Identification

List of approved/certified products and suppliers.

Items are marked with Coast Guard approval number.

Laboratory listing or classification marking required on

some items.

Availability Publication "Equipment Lists" (U.S. Coast Guard COMSTINST

of Documentation M16714.3A) available for sale through Government Printing

Office.

Obligations of the Manufacturer is required to produce approved item exactly

Manufacturer/Vendor as described in approved plans. Some record keeping

required.

Enforcement Delisting. Civil and criminal penalties are also available

in certain cases.

Term Five year term; renewal generally available on request.

Reciprocity None.

Standards, Codes

or Regulations

33 CFR Part 159.15 and 46 CFR Part 160-164 define applicable

requirements and criteria.

Keywords boats; commercial vessels; marine safety; marine equipment;

marine pollution prevention; recreational boats; ships

186
Products or

Services

Shipboard Navigational Aides

Department/Agency U.S. Department of Transportation (DOT)

U.S. Coast Guard

Office of Navigation, Room 1422

2100 2nd Street, SW

Washington, D.C. 20593

Telex: 892427

(202) 267-2267

Initiated January 1985

Compliance Mandatory

Authority 33 CFR Part 164; Port and Tanker Safety Act of 1978.

Aim To approve the standards of collision avoidance at sea.

Benefits Awareness and performance of observers is enhanced through

automatically acquired information.

Agency Function Program adniinistrator.

Type of Program Pre-market evaluation.

Methodology Manufacturer self-certification

Testing Manufacturer's laboratory.

Inspection Government.

Conformity

Identification

Authorized label by manufacturer.

Availability No lists of informing products are published,

of Documentation

187
Obligations of the Conformity obligations rest on the equipment user who

Manufactxirer/Vendor must perform and document tests specified in Coast Guard

regulations.

Enforcement Product recall (i.e. user would be required to replace

equipment not in compliance.)

Term Indefinite term.

Reciprocity Other Federal agencies.

Foreign government agencies.

International organizations.

Standards, Codes

or Regulations

Agency adopts standards prepared by the International

Maritime Organization and the U.S. Maritime Administration.

Keywords alarms; automatic radar plotting aids; bearing encoders;

boats; collision avoidance systems; depth sounding devices;

gyro compasses; loran receivers; marine safety; marine

equipment; ships; speed indicators; steering gear; vessels

188
Products or

Services

Shipping Containers

Department/Agency U.S. Department of Transportation (DOT)

U.S. Coast Guard

Office of Marine Safety, Security and

Environmental Protection

Merchant Vessel Inspection and Documentation Division

2100 2nd Street, SW

Washington, D.C. 20593

Telex: 892427

(202) 267-2978

Initiated 1977

Ccnpliance

Authority

Aim

Mandatory

International Safe Container Act.

To provide procedures to certify containers as conforming to

the International Convention for Safe Containers.

Benefits International transport of containers is safer.

Agency Function

Type of Program

Methodology

Program administrator and enforcement agency.

Container must be certified before it can be entered into

international traffic.

Third party certification.

Testing Manufacturer or owner and Certifying Authority witness tests

for container design type approval.

Conformity

Identification

Containers must display a safety approval plate from the

Certifying Authority in the country of registry.

Availability

of Documentation

List of approved manufacturers may be obtained from the

Certifying Authority in each signatory country. Coast Guard

can identifying Certifying Authorities.

189
Obligations of the Owner and lessees are responsible for maintaining each

Maniifac±urer/Vendor container in a safe condition.

Enforcement Detention of unsafe and noncomplying containers.

Term Individual containers and vehicles are subject to

re-inspection every 30 months.

Reciprocity Certification is recognized by foreign governments and

international organizations.

Standards, Codes

or Regulations

Standards are included in the International Convention

for Safe Containers, regulations in 49 CFR Part 450-453,

Keywords ACEP; Approved Continuous Examination; cargo container;

commercial vessels; container; CSC; design approval;

International Convention for Safe Containers; marine

equipment; ships

190
Products or

Services

Automotive After Parts

Department/Agency Environmental Protection Agency (EPA)

Manufacturers Operations Division

Technical Support Branch

401 M Street, SW

Washington, D.C. 20460

(202) 382-2487

Initiated 1980. Modification to current procedures are expected to be

proposed.

Compliance

Authority

Voluntary

Section 207 (a) of the Clean Air Act, 42 USC 7541;

40 CFR Part 85.

Aim To enable vehicle owners to identify replacement parts that

would not void the vehicle's emission warranty

Benefits Vehicle owners have benefited from the availability of parts

from competitive sources. Parts suppliers are able to

compete with original equipment and vehicle manufacturers

for aftermarket sales by being able to assure vehicle owners

that their products are in compliance with EPA standards and

the vehicle manufacturer's warranty for emission applies.

Agency Function

Type of Program

Methodology

Program administrator.

Self-certification by supplier.

Testing and certification by supplier after notifying EPA of

intent to certify.

Testing By supplier.

Conformity

Identification

The part or its packaging shall bear the statement

"Certified by (name of manufacturer or warranter) to EPA

Emission Standards."

191
Availability

of Dxxnnentation

Requirements are set forth in 40 CFR Part 85.

Obligations of

Manufac±urer/Vendor

Suppliers are required to establish and maintain records

of all certification tests as well as other information

related to the integrity of the parts and the certification

procedures.

Enforcement Decertification

.

Term Indefinite term.

Standards, Codes,

or Regulations

Test procedures and criteria for certification of catalytic

converters, positive crankcase ventilation valves, air

filters, spark plugs, distributors and other ignition and

carburetor components are specified in 40 CFR Part 85.

Keywords aftermarket; air pollution; automotive parts; environment

treatment; pollution control; replacement parts; vehicle

emissions; warranty

192
Motor Vehicle Engines, Gasoline and Diesel

Environmental Protection Agency (EPA)

Office of Mobile Sources

Certification Division

Certification Branch

2665 Plymouth Road

Ann Arbor, MI 48105

(313) 668-4280

1972

Mandatory for producers and distributors of motor vehicle

engines, automobiles, light duty trucks, and motorcycles.

The Clean Air Act as amended in 1977, 42 USC 1857.

To control emissions from motor vehicles and engines in the

interest of public health.

The atmospheric environment has become cleaner through

progressively more restrictive emissions of carbon monoxide,

hydrocarbons, oxides of nitrogen, and particulates from

internal combustion engines.

Both certifier and program administrator.

Pre-market evaluation; regulations provide for design

evaluation, pre-production testing, and production auditing.

Government design approval, testing, and audit in

conjunction with manufacturer self-certification.

Government lab.

Government accredited lab.

Manufacturer's labs.

Government.

Third party.

193
Conformity Authorized label by manufacturer.

Identification List of certified products.

Availability

of Documentation

Lists available from EPA.

Obligations of Manufacturer must qualify new engine designs, new emission

Maniifacturer/Vendor control system designs, and existing engine and emission

control system designs when emission regulations change.

Enforcement- Marketing ban.

Product recall.

Term Annual with audit testing.

Reciprocity Federal certification is recognized in all states except

California.

Standards, Codes,

or Regulations

EPA prepares all criteria documents; some test methods

prepared by others are referenced.

Keywords aftermarket; carbon monoxide; diesel engines; environmental

treatment; evaporative emissions replacement; exhaust

emissions; gasoline engines; hydrocarbons; light duty

trucks; motor vehicles; motorcycles; oxides of nitrogen;

pollution control; vehicles; warranty

194
Products or

Services

Motor Vehicle Safety

Departanent/Agency U.S. Department of Transportation (DOT)

National Highway Traffic Safety Administration (NHTSA)

Office of Vehicle Safety Compliance

400 Seventh Street, SW

Room 6113

Washington, D.C. 20590

(202) 366-2832

Initiated 1966

Cbnpliance

Authority

Mandatory

National Traffic and Motor Vehicle Safety Act of 1966 as

amended.

Aim To regulate design, construction, and performance of motor

vehicles to protect the public against unreasonable risk of

accidents.

Benefits Reduction of traffic accidents, and deaths and injuries

resulting from traffic accidents.

Agency Function Program administrator.

Type of Program Pre-market evaluation.

Methodology Government audit.

Manufacturer self-certification.

Testing Government laboratories.

Inspection Government.

Conformity

Identification

Authorized label by manufacturer.

195
Availability

of Documentation

Agency maintains list of vehicle and equipment manufacturers

who have undertaken product recalls for the purpose of

achieving compliance with Federal Motor Vehicle Safety

Standards.

Obligations of the

Manufacturer/Vendor

Manufacturers must inform the Agency, owners, purchasers,

and dealers of known defects and the plans to correct the

defect (s)

.

Enforcement Marketing ban.

Product recall.

Term Indefinite.

Reciprocity Other federal agencies and state agencies.

Private sector organizations may be paid contractors to the

agency for detection of defects or compliance research.

Standards, Codes

or Regulations

Agency prepares criteria documents.

Keywords automobiles; compliance; motor vehicle equipment; product

recall; safety; school buses; trucks; used vehicles

196
197
Availability of

Documentaticri

Certificates of construction are kept by Agency and AAR.

Cbligations of Manufacturer is obligated to use approved welders during

Manufacturer/Vendor construction.

Enforcement Delisting or product recall is defects can be repaired.

Term Certification is essentially indefinite.

Reciprocity Other federal agencies.

State agencies.

Private sector organizations.

Canadian government.

Standards, Codes

or Regulations

Agency adopts standards of other organizations and provides

integrating requirements.

Keywords certified welder; design approval; hazardous materials;

railroads; railway car couplers; welding

198
Products or

Services

Rear End Marking Devices for Passenger, Commuter and Freight

Trains

Department/Agency U.S. Department of Transportation (DOT)

Federal Railroad Administration (FRA)

Associate Administrator for Safety

Office of Safety Enforcement

400 7th St. , NW, Room 8326

Washington, D.C. 20590

(202) 366-9252

Initiated

Compliance

Authority

1978

Mandatory

Section 202, 84 Stat. 971, 45 USC 431 and 49 CFR Part

1.49 (n)

Aim To alleviate the potential for rear end collisions by

requiring use of marking devices which have characteristics

that assure visibility under adverse conditions encountered

in service.

Benefits Rear end collisions have decreased since implementation

of this certification program.

Agency Function

Type of Program

Program administrator and certifier.

Review of self-certification submitted by railways.

Review of test data submitted by device manufacturers or

railways.

Publication of Lists of Approved Rear End Marking Devices.

Methodology Testing to demonstrate compliance is accomplished by

manufacturers and railways in their labs or independent labs

that meet specified qualifications. Railways submit a

certificate signed by the chief operating officer that

devices used on the railway system have been tested and

comply with the FRA standard or are devices included in

FRA's list of approved devices.

199
Conformity

Identification

Inclusion on FRA's list of approved devices.

Availability of

Documentation

49 CFR Part 221, Appendix B.

Obligations of Produce devices that are the same as samples tested for

Manufacturer/Vendor the original approval.

Enforcement Civil penalties ranging from $250 to $2500 for each

violation. Each day of each violation constitutes a

separate offense.

Term Indefinite.

Reciprocity Recognition by state regulators as irdnimum requirements.

Standards, Codes Guidelines for Testing of ERA Rear End Marking Devices,

or Regulations

Keywords colorimetric; lights; photometric; railroads; railway car;

safety; strobe; transportation

200
Products or

Services

Cylinders for Transportation of Hazardous Materials

Department/Agency U.S. Department of Transportation (DOT)

Research and Special Programs Administration (RSPA)

Office of Hazardous Materials Transportation (DHM-1)

400 Seventh Street, SW

Room 8100A

Washington, D.C. 20590

(202) 366-0656

Initiated 1964

Compliance

Authority

Aim

Mandatory

49 CFR Part 178.36-178.68.

To provide a uniform testing program for cylinders made

from a variety of metals and used for many kinds of

hazardous materials.

Benefits Consistent safety and durability of cylinders for intended

use.

Agency Function Program administrator.

Type of Program Pre-market evaluation.

Methodology Third party certification or manufacturer self

certification

.

Testing Third party lab.

Manufacturer's lab.

Conformity

Identification

Authorized identity by manufacturer.

Availability

of Documentation

No central registry of manufacturers; all cylinders legal

for use are marked.

201
Obligations of the Manufacturers must maintain quality control. Vendors must

ManufacUirer/Vendor cycle inventory. Users must not use out-of-date cylinders.

Enforcement Product recall.

Term Fifteen year term; regulation has no specific provision for

retesting, but tanks in sound physical condition may be

tested and recertified.

Reciprocity Marked cylinders are accepted throughout the U.S.

Standards, Codes Agency has integrated product requirements based on industry

or Regulations test methods.

Keywords containers; cylinders; hazardous materials; hydrotest

;

quality control; safety; transportation

202
Products or

Services

Packages and Containers for Radioactive Material

Department/Agency Nuclear Regulatory Commission

Office of Nuclear Material Safety and Safeguards

Washington, D.C. 20555

(301) 427-4122

Initiated 1974

Compliance Mandatory

Authority 10 CFR Part 71.

Aim/Benefits Protection of public health and safety and the environment.

Agency Function Program administrator and certifier

Type of Program Review and assessment of package designs prior to

approval and grant of certificate of compliance.

Approximately 220 different designs have been certified.

Methodology Government design approval, inspection, and audit

inspection/testing

.

Testing

Inspection

Applic^t/Government

Applicant/ Government.

Conformity

Identification

Approved packages are assigned an identification number.

Availability

of Documentation

Part 71 Docket Files.

United States Nuclear Regulatory Commission

Public Document Room

Washington, D. C. 20555

(202) 634-3273

Obligations of Report defects or noncompliance

.

Manufactxirer/Vendor Report significant reduction of effectiveness during use.

203
Enforcement Order, denial, fine.

Term 5 year renewable.

Inspection prior to each use.

Reciprocity Recognition of certification by: - Department of Transportation (DOT)

.

- Foreign governments upon issuance of DOT Competent

Authority Certificate.

Standards, Codes,

or Regulations

U. S. Nuclear Regulatory Commission Regulatory Guides

(Division 7)

.

10 CFR Part 71 and 10 CFR Part 21.

Keywords environment; nuclear; packaging; radioactive material;

safety

204
Products or

Services

Packaging of Hazardous Materials for Export

Department/Agency U.S. Department of Transportation (DOT)

Research and Special Programs Administration (RSPA)

Office of Hazardous Materials Transportation

400 7th St. , NW, Room 8100A

Washington, D.C. 20590

(202) 366-0656

Initiated March 13, 1985

Compliance

Authority

Voluntary

49 USC 1804, 1805, 1808; 49 CFR Part 1.53; Appendix A to

Part 1.

Aim Designate third party testing agencies through which

shippers and container manufacturers may demonstrate

conformance of packaging designs with United Nations (U.N.)

standards.

Benefits To enhance the use of U.S. packaging in international

transportation and facilitate the ability of U.S. companies

to compete in export markets.

Agency Function Program administrator and National Competent Authority in

accordance with U.N. Recommendations.

Type of Program

Methodology

Pre-market evaluation.

Materials Transportation Bureau (MTB) designates third party

approval agencies to evaluate and issue approval

certificates for intermodal portable tanks and

certifications of conformance for other types of packaging.

Testing Testing by third party (manufacturers and shippers labs)

is permitted if acceptable to the approval agencies.

Inspection Subsequent inspection of packaging is not part of this

program.

205
Ccaiformity

Identification

Certificates are provided to shippers and/or manufacturers

by approval agencies.

Enforcement Designation of an approval agency to issue certification may

be withdrawn for failure to abide by requirements of the

program.

Term Indefinite.

Reciprocity Certification in accordance with U.N. Recommendations is

intended to avoid acceptance testing and packaging approval

in each country which might have such requirements.

Standards, Codes

or Regulations

Standards are set forth in the U.N. Recommendation

(Transport of Dangerous Goods) , and DOT requirements listed

in 49 CFR Part 171, Subchapter C.

Keywords containers; export; hazardous materials; National Competent

Authority; safety; transportation; United Nations

206
Products or

Services

Packaging of Radioactive Materials for Transport

Department/Agency U.S. Department of Transportation (DOT)

Research and Special Programs Administration (RSPA)

Office of Hazardous Materials Transportation

400 7th St. , NW, Room 8100A

Washington, D.C. 20590

(202) 366-0656

Initiated 1975

Compliance

Authority

Mandatory

49 USC 1803, 1808 as amended;

49 CFR Part 173.465-173.469.

Aim To provide packaging for radioactive materials which

maintains integrity under mild (Type A) or severe (Type B)

fault conditions.

Benefits Transport of radioactive materials is accomplished with

minimum radiation exposure to personnel.

Agency Function

Type of Program

Methodology

Certifier.

Pre-market evaluation.

Government design approval, inspection, and validation of

test data submitted by manufacturer based on own or third

party tests.

Testing Third party or manufacturer's lab.

Inspection Government or third party.

Conformity

Identification

Mark on packaging authorized by agency, known as Competent

Authority within International Atomic Energy Agency scheme.

207
Availability of

Documentation

Lists of approved manufacturers maintained in each country.

Packaging of certain radioactive materials requires

acceptance by Competent Authority in both shipping and

receiving countries.

Obligations of

Manufacturer/Vendor

Maintain specified quality control records; cooperate in

investigation of any package failures.

Enforcement Marketing ban.

Product recall.

Term Indefinite. Certification is based on prototype acceptance.

Reciprocity Type A packaging for domestic use accepted by other federal,

state, and private organizations.

Type B packaging for international use, subtype U

(unilateral) is accepted with mark from one country.

Subtype M (multilateral) requires mark from sending and

receiving countries and transit countries for certain

materials.

Standards, Codes

or Regulations

Agency establishes requirements and procedures.

Keywords fissile material; IAEA; package approval; packaging;

quality assurance; radioactive material; safety;

transportation

208
Products or

Services

Pipelines for Hazardous Fluids

Department/Agency U.S. Department of Transportation (DOT)

Research and Special Programs Administration (RSPA)

Office of Pipeline Safety

400 7th St. , NW, Roam 8417

Washington, D.C. 20590

(202) 366-4595

Initiated 1968

Compliance

Authority

Mandatory

49 USC 1803-1809 as amended.

Aim To provide a mechanism for regulating the installation and

maintenance of pipelines for the transportation of hazardous

materials.

Benefits Safety record of such pipelines in the U.S. meets

expectations.

Agency Function Program administrator.

Type of Program Pre-installation review with periodic testing of safety

equipment throughout the useful life of the pipeline.

Methodology Third party certification: welder and plastic pipe

assemblers.

Manufacturer self-certification: valves, pressure-limiting

services, and overall installation to specified standards.

Testing

Inspection

Third party or manufacturer's lab.

Third party.

Conformity

Identification

Lists of qualified welders/installers and approved

installations are published.

209
Availability of

Documentation

Certification of welders by the American Welding Society;

comparable program by the installing contractor may be

acceptable to DOT. List of approved pipelines kept by DOT.

Obligations of

Maraifactxirer/Vendor

Owner of pipeline is responsible for annual tests of

pressure-limiting devices and for reports on all accidents

related to the use of the pipeline. Accidents involving

deaths are investigated by the National Transportation

Safety Board.

Enforcement Delisting; individual welders or installers may be required

to undergo additional training; faulty valves or limiting

devices may have to be replaced; pipeline could be

decommissioned temporarily.

Term Pressure-limiting devices must be inspected on approximately

an annual basis, not to exceed a 17 month interval.

Reciprocity Approved pipelines are not regulated by any other federal or

state agency.

Standards, Codes Agency mainly adepts standards of other organizations,

or Regulations

Keywords certified welder; hazardous materials; pipelines;

pressure-limiting devices; qualified plastic pipe

assembler; safety; welding

210
Products or

Services

Special Tanks for Transport of Hazardous Materials

Department/Agency U.S. Department of Transportation (DOT)

Research and Special Programs Administration (RSPA)

Office of Hazardous Materials Transportation

400 7th St. , NW, Room 8100A

Washington, D.C. 20590

(202) 366-0656

Initiated 1964

Compliance Mandatory

Authority 49 CFR Part 178.270-272.

(Special category reauthorized by P.L. 93-633.)

Aim To provide a uniform means for assuring the reliability of

containers for shipping designated hazardous materials.

Benefits Materials are transported safely and efficiently and

personal injuries due to container failure are minimized.

Agency Function Program administrator.

Type of Program Pre-market evaluation.

Methodology Government design approval.

Third party certification.

Testing Third party or manufacturer's lab.

Inspection Third party.

Conformity

Identification

Authorized mark applied by manufacturer.

211
Availability of

Documentation

Agency maintains list of firms authorized to manufacture

such tanks.

Obligations of

Manufactairer/Vendor

Manufacturer must maintain integrity of design, quality

control, and cooperate in investigation of suspected faults.

Enforcement Delisting or product recall.

Term Retest; user/owner to arrange for documented visual

inspection at 2 1/2 year intervals; valves and pressure

relief devices must be retested at 2 1/2 year intervals; and

complete tank must be hydrotested every 5 years.

Reciprocity Other federal agencies.

State agencies

Private sector organizations.

Canadian government.

Standards, Codes

or Regulations

Agency integrates standards of other organizations into

the program.

Keywords hazardous materials; hydrotesting; pressure relief devices;

quality control; safety valves; tanks; transportation

212
Products or

Services

Tanks for Transport of Hazardous Materials

Departmer±/Agency U.S. Department of Transportation (DOT)

Research and Special Programs Adrninistration (RSPA)

Office of Hazardous Materials Transportation

400 7th St. , NW, Room 8100A

Washington, D.C. 20590

(202) 366-0656

Initiated 1964

Compliance

Authority

Mandatory

49 CFR Part 173.32-34, 49 USC 1803-1809.

Aim To provide safe and reliable containers for domestic

shipment of hazardous materials.

Benefits Certification minimizes the risk of leakage or rupture of

tanks and improper use of tanks for designated materials.

Agency Function Program administrator.

Type of Program Pre-market evaluation.

(Certain types of tanks in use at time regulation went into

effect which were made to specific standards of the

Association of American Railroads were approved.)

Methodology

Testing

Inspection

Manufacturer self-certification.

Third party or manufacturer's lab.

Periodic inspection is performed by owner.

Conformity

Identification

Certain tanks are identified by marking as specified in

the regulation.

213
Availability of

Documentation

Agency maintains list of manufacturers of certified tanks by

type.

Obligations of

Manufacturer/Vendor

Manufacturer must maintain design control and submit design

changes for approval.

Enforcement Marketing ban (also extends to distributors)

.

Term Retest; user/owner to arrange for documented visual

inspection at 2 1/2 year intervals; valves and pressure

relief devices must be retested at 2 1/2 year intervals; and

complete tank must be hydrotested every 5 years.

Reciprocity Other federal agencies.

State agencies.

Private sector organizations.

Canadian government.

Standards, Codes

or Regulations

Agency integrates standards of other organizations into

the program.

Keywords hazardous materials; hydrotesting; portable tanks; pressure

relief devices; quality control; safety valves;

transportation

214
Products or

Services

Refrigerated Vehicles and Refrigeration Units

Department/Agency U.S. Department of Agriculture

Office of Transportation

ATP Manager

Washington, D.C. 20250-4500

Telephone: (202) 653-6275

Telex: 89491

FAX: (202) 653-6327

Initiated 1986

Compliance Mandatory only for equipment transporting perishable

foodstuffs between countries in Europe, when the receiving

country is a contracting party to the Agreement on the

International Carriage of Perishable Foodstuffs Act and on

the Special Equipment To Be Used for Such Carriage (ATP) . Transport operations involving a movement of more than

150 km by sea are exempt. The Agreement does not apply to

carriage in the U.S. or any of its territories.

Authority 7 CFR Part 3300 and the International Carriage of

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

Aim The Agreement was developed by the Economic Commission

for Europe, of which the U.S. is a member, to improve the

conditions of preservation of perishable foodstuffs during

their carriage, particularly in international trade.

Benefits The objective of U.S. participation in the Agreement are

to protect and expand trade in perishable foodstuffs

transported in U.S. equipment to Europe and improve the

sale of U.S. made equipment.

Agency Function

Type of Program

Certifier and program administrator.

Inspection, testing and certification of equipment.

215
Methodology Manufacturer's guarantee that serially-produced equipment

conforms to the reference equipment which has been tested.

Agency approves test facilities, audits inspections and

testing, and provides ATP certificates.

Testing

Inspection

Agency approves and monitors test facilities.

Provides for self-inspection of equipment in service by

U.S. owners based on reference tests in approved test

facilities. Agency issues U.S. ATP certificates based on

statements and reports of the owners and the test

facilities.

Conformity

Identification

Approved equipment requires an authorized ATP certification

plate and distinguishing mark along with a manufacturers

plate.

Availability

of Documentation

Lists of approved test facilities and fees for

certificates can be obtained from the ATP Manager at the

above address. Copies of the Agreement, the Act, and the

Senate Report, and 7 CFR Part 3300 are also available.

Obligations of the

Manufacturer/Vendor

Approved test facilities must be open to the public,

maintain test records for three years, and permit the ATP

Manager to review records and observe tests. Owners of

equipment with U.S. ATP certificates have the

responsibility to maintain equipment in good repair.

Enforcement Delisting of test stations, laboratories, and

certificates.

Term Approval of test stations and laboratories is good for 5

years. Certificates for new equipment are good for 6

years. Renewal certificates are good for 6 years with a

test. Renewals or transfers with an inspection are good

for 3 years ininimum.

Reciprocity U.S. ATP certificates are recognized by the 21 countries

that are contracting parties to the Agreement under a

reciprocal arrangement.

216
Standards, Codes The Agreement and 7 CFR 3300 define all the acceptance

or Regulations criteria.

Keywords containers; food; frozen food; international agreement; rail

cars; refrigerated; refrigeration units; trailers;

transportation

217

SECTION X

MISCELLANEOUS PRODUCES AND SERVICES

219

SECTION X

MISCELLANEOUS PRODUCTS AND SERVICES

INDEX

REFERENCES IN THIS SECTION PAGE

AIR AND WATER TREATMENT FACILITIES 223

BREATH ALCOHOL TESTERS AND THEIR CALIBRATION UNITS 225

HAZARDOUS HOUSEHOLD SUBSTANCES 227

REFERENCES IN OTHER SECTIONS

DRINKING WATER 65

EQUIPMENT AND MATERIALS USED IN THE WORKPLACE 171

PESTICIDE APPLICATORS, PRIVATE AND COMMERCIAL 67

221

Products or

Services

Air and Water Treatment Facilities

(CHANGES IN THE TAX IAW HAVE ENDED THE NEED FOR THIS

CERTIFICATION)

Department/Agency Environmental Protection Agency (EPA)

Contact Appropriate Regional Administrator. Regional

Administrators located in Boston, MA; New York, NY;

Philadelphia, PA; Atlanta, GA; Chicago, IL; Dallas, TX;

Kansas City, KS; Denver, CO; San Francisco, CA; and

Seattle, WA.

Initiated 1976

Compliance

Authority

Voluntary

40 CFR Part 20.

Aim To identify facilities which reduce air or water pollution

for the purpose of qualifying for investment tax credit.

Benefits Increased investment by industries in pollution abatement

equipment and facilities.

Agency Function Certifier; some states also perform a parallel function for

local tax purposes.

Type of Program

Methodology

Tax incentive program.

Government design approval.

Testing No testing.

Inspection

Conformity

Identification

No inspection.

Lists of certified facilities maintained by state certifying

agencies and EPA Regional Offices.

Availability

of Documentation

Lists from states and EPA Regional Offices.

223
Obligations of Facilities must submit plans for review whenever

Manufacturer/Vendor modifications are made.

Enforcement Delisting.

Term Indefinite term.

Reciprocity No reciprocity.

Standards, Codes,

or Regulations

EPA defines acceptance criteria.

Keywords air quality; depreciation; investment tax credit; pollution

control; waste heat removal; waste water treatment; water

quality

224
Products or Breath Alcohol Testers and Their Calibration

Services

Department/Agency U.S. Department of Transportation (DOT)

National Highway Traffic Safety Administration (NHTSA)

Office of Alcohol and State Programs

Alcohol Programs Division, (NTS-21)

400 Seventh Street, SW

Room 5130

Washington, D.C. 20590

(202) 366-9581

1984

Voluntarily adopted by states and local jurisdictions.

Manufacturers voluntarily submit testers for evaluation and

listing.

23 USC 402 and 49 CFR Part 1.50.

Assist states and local communities by providing a

centralized qualification test program for breath-testing

devices designed to collect evidence in law enforcement

programs.

States have adopted the NHTSA model specification for

evidential breath testers and a calibration unit developed

by the National Bureau of Standards (NBS) . This

qualification program enables states and local jurisdictions

to buy equipment that has demonstrated compliance with these

model specifications. They avoid the cost of individual

tests and use equipment that is rugged and reliable and

bears the scrutiny of challenges in court cases.

Manufacturers benefit in not having to arrange for

individual tests in numerous jurisdictions.

Agency Function Certifier.

Type of Program Qualification testing.

Methodology Government testing.

Testing Testing is accomplished by the DOT Systems Center.

Initiated

Compliance

Authority

Aim

Benefits

225
Conformity

Identification

Qualified manufacturers are listed on a Conforming Products

List (CPL) .

Availability

of Documentation

Model specifications and CPL's are published in the Federal

Register; 49 FR 48854. Currently thirteen manufacturers of

breath measurement devices are listed. Four of these are

foreign suppliers.

Obligations of the

Manufacturer/Vendor

Manufacturers must submit a unit for testing.

Term Indefinite.

Standards, Codes

or Regulations

Acceptance criteria have been developed by NHTSA in

collaboration with NBS.

Keywords alcohol; analysis; blood alcohol; breath alcohol;

calibration; highway safety; law enforcement; legal

evidence; tester

226
Products or Hazardous Household Substances

Services (Chemicals which are toxic, corrosive, flammable

irritating, radioactive or pressure-generating, and devices

which are used with these chemicals and may injure intended

users.

)

Departinent/Agency Consumer Product Safety Commission (CPSC)

Office of the General Counsel

5401 Westbard Avenue, Room 200

Bethesda, MD 20207

(202) 492-6980

Initiated

Compliance

Authority

July 1960

Mandatory

P.L. 96-613 as amended by the Poison Prevention

Packaging Act, P.L. 91-601.

Aim To reduce the risk of injury to all intended users of

designated substances and devices.

Benefits Informative labeling is now in effect and selected products

have been banned.

Agency Function Program administrator.

Type of Program Pre-marketing evaluation.

Methodology Government approval of labeling information to be provided

with designated hazardous substances.

Testing Manufacturer's lab.

Government labs.

Inspection Government.

Conformity

Identification

Authorized mark or label by manufacturer.

227
Availability

of Documentation

Obligations of

Mamfac±urEr/Vendor

Enforoement

Term

Reciprocity

Standards, Codes,

or Regulations

Keywords

List of banned hazardous substances may be obtained from

CPSC.

Carriers must keep records of interstate shipment of

designated substances.

Marketing ban.

Product recall.

Indefinite term.

Approved labeling is recognized by other federal agencies,

state governments, and private organizations.

Criteria for designating substances as hazardous are

prepared by the Commission.

banned products; corrosive; flammability; hazardous

substances; irritant; misbranded substances; radioactivity;

toxicity

228
INDEX BY PRODUCT OR SERVICE CERTIFIED

PRODUCT PAGE

ACCREDITATION, LABORATORY 123

ACCREDTTATION, LABORATORY FOR ALCOHOL ANALYSIS 127

ACCREDITATION, LABORATORY FOR MEAT/POULTRY/POOD ANALYSIS 125

ACCREDITATION, LABORATORY, CLINICAL 140

ADDITIVE, COLOR 53

ADHESIVES 117

AFTERMARKET PARTS . . 191

AGRICULTURAL SAFETY 171

AIR CONDITIONERS , CENTRAL 75

AIR CONDITIONERS, ROOM 75

AIR SAMPLERS .161

AIR TAXI OPERATORS 177

AIR TREATMENT FACILITIES 223

AIRCRAFT 177

AIRCRAFT ENGINES 177

AIRCRAFT REPAIR 177

AIRPORTS 177

ALARMS, SHIP ..187

ALCOHOL ANALYSIS BY LABORATORIES 127

ALCOHOL TESTERS, BREATH 225

AMBULATORY SURGICAL CENTERS 141

ANIMAL BIOLOGICAL PRODUCTS 31

ANIMAL DISEASE 29

ANIMAL DRUGS 63

ANIMAL FEED 63

ANIMAL PRODUCTS 27, 37

ANIMALS FOR EXPORT 37

ANIMALS FOR IMPORT 39

ANTIBIOTICS 147

APPAREL, WEARING . 83

APPLIANCE LABELING 77

APPLIANCES 75

APPLICATORS OF PESTICIDE 67

AUTHENTICATION DEVICES, ELECTRONIC FUND TRANSFER 105

AUTOMOBILE EMISSIONS 191, 193

AUTOMOBILE ENGINES 193

AUTOMOBILE PARTS AND EQUIPMENT 191

AUTOMOBILE DRIVING AIDS 151

AUTOMOTIVE SAFETY 195

AVIATION 177

AVIATION WEATHER OBSERVERS 181

AVIONICS 177

BATHTUBS, PLASTIC 91

BATTERY POWERED MINING EQUIPMENT 167

BEANS 43

BEDDING 83

BEEF 7

BINS, GRAIN 45

229
PRODUCT PAGE

BIOLOGICAL PRODUCTS, ANIMAL 31

BIRDS, GAME 49

BIVALVES 57

BOATS, RECREATIONAL 185, 187

BREATH ALCOHOL TESTERS 225

BREATHING APPARATUS 161

BROADCAST EQUIPMENT 101

BUFFALO MEAT 49

BUILDING CONSTRUCTION SAFETY 171

BUILDING PRODUCTS 91

BUTTER 11

BUSSES, SCHOOL 195

BUTTER 11

CABINETS, FILING 117

CABLE TV EQUIPMENT 101

CALF 7

CALIBRATION, INSTRUMENT 129

CARGO CONTAINERS 189

CARGO HANDLING EQUIPMENT, MARITIME 183

CARPET 91

CHEESE 11

CHEMICALS, HAZARDOUS 227

CHEMICALS, PESTICIDES 67

CIGARETTES 69

CITIZEN BAND RADIOS 101

CLAMS 57

CLINICAL LABORATORIES 141

CLOTHES DRYERS 75

CLOTHES, FLAMMABIUTY OF 83

CLOTHES WASHERS 75

CLOTHING 83

COAL DUST SAMPLERS 161

COLLISION AVOIDANCE SYSTEMS 187

COLOR ADDITIVES 53

COMMUNICATIONS EQUIPMENT, RURAL TELEPHONE 99

COMMUNICATIONS SECURITY 105

COMPASSES, GYRO 187

COMPRESSORS, MINING 167

COMPUTER INTERFACES 105, 109

COMPUTER PERIPHERALS 101

(XMPUTERS 101

CONSTRUCTION PRODUCTS 91

CONSTRUCTION SAFETY 171

CONSUMER PRODUCTS 81

CONTAINERS FOR HAZARDOUS MATERIALS 201, 205, 211, 213

CONTAINERS FOR RADIOACTIVE MATERIALS 203, 207

CONTAINERS, SHIPPING 189, 205

CONTROL TOWER OPERATORS 177

COTTON, RAW 9

COUPLERS, RAILWAY TANK CARS 197

CRAFTS, INDIAN 85

CRANES 183

230
PRODUCT PAGE

CYLINDERS FOR HAZARDOUS MATERIALS 201

DAIRY PRODUCTS 11

DATA PROCESSING INTERFACES 105, 109

DEPTH INDICATORS, MARINE 187

DERRICKS 183

DEVICES, MEDICAL 149

DIESEL ENGINES, AUTOMOTIVE 193

DIESEL EQUIPMENT FOR MINING 165

DISHWASHERS 75

DISPATCHERS, AIRCRAFT 177

DIVING SAFETY 171

DOORS, PATIO, STORM AND SLIDING GLASS 91

DOORS, VAULT 117

DRILLING, OFFSHORE 163

DRINKING WATER 65

DRIVING AIDS, AUTOMOTIVE 151

DRUGS FOR ANIMALS 63

DRUGS FOR HUMANS 145, 147

DUST SAMPLERS 161

DRYERS, CLOTHES 75

EFT 105

EGGS AND EGG PRODUCTS 19

ELECTRICAL EQUIPMENT AND COMPONENTS 101

ELECTRICAL EQUIPMENT FOR MINING 167

ELECTRICAL SYSTEMS, RURAL 99

ELECTRONIC EQUIPMENT AND COMPONENTS 101

ELECTRONIC FUND TRANSFER AUTHENTICATION DEVICES 105

ELECTRONIC RADIATION 107

ELEVATORS, GRAIN 45

EMISSIONS, AUTO 191

ENGINES, AIRCRAFT 177

ENGINES, GASOLINE & DIESEL, AUTOMOTIVE 193

EXHAUST EMISSIONS 191

FABRICS 83

FACE PIECES 161

FANS FOR MINING 167

FEED, ANIMAL 63

FILING CABINETS 117

FILL OF CONTAINER 55

FIRE PROTECTION 171, 185

FIREPLACE, STOVES 91

FISH, PROCESSED 51

FISSILE MATERIAL PACKAGING 203, 207

FLAMMABILLTY OF FABRICS 83

FLIGHT CREW 177

FLIGHT INSTRUCTORS 177

FOOD 55

FOOD ANALYSIS, LABORATORY ACCREDITATION FOR 125

FOOD FOR ANIMALS 63

FOOD FOR INFANTS 55, 59

POOD INSPECTION PERSONNEL 61

FOOD, TRANSPORTATION OF PERISHABLE 215

231
PRODUCT PAGE

FORMULA, INFANT 55, 59

FREEZERS 75

FRUIT, FRESH 13

FRUIT, PROCESSED 15

FUNGICIDE APPLICATORS 67

FURNACES 75

FURNISHINGS 83

GAME BIRDS 49

GAS MASKS 161

GASOLINE ENGINES, AUTOMOTIVE 193

GLASS, SEALED INSUIATING 91

GOVERNMENT PROCUREMENT 109, 115, 117

GRAIN AND GRAIN PRODUCTS 43

GRAIN INSPECTION AND WEIGHING 45

GRAIN MEASURING SYSTEMS 131

GSA PROCUREMENT 117

GUARDING, MACHINE 169

HANDICAPPED DEVICES/AIDS 149, 151, 153

HANDICRAFTS, INDIAN 85

HAZARDOUS FLUIDS, PIPELINES FOR 209

HAZARDOUS MATERIALS, CONTAINERS & PACKAGING 201, 205, 211, 213

HAZARDOUS SUBSTANCES 227

HEALTH CARE FACILITY 141

HEALTH CARE PROVIDERS 141

HEALTH CLINICS, RURAL 141

HEATERS, POOL 75

HEATERS, SOLID FUEL TYPE 91

HEATERS, WATER 75

HEATING EQUIPMENT, DIRECT 75

HELIPORTS 177

HERBICIDES APPLICATORS 67

HOME HEALTH AGENCIES 141

HOSPICES 141

HOSPITAIS 141

HOUSEHOLD PRODUCTS 81

HOUSING, MANUFACTURED 93

ILLUMINATION, MINE 167

INDIAN HANDICRAFTS 85

INDUSTRIAL SAFETY 169

INFANT FORMULA 55, 59

INPUT/OUTPUT CHANNEL INTERFACES 105, 109

INSECTICIDE APPLICATORS 67

INSPECTORS, FOOD 61

INSTRUMENTS, MEASURING, CALIBRATION OF 129

INSUIATING GLASS, SEALED 91

INSULIN 145

INTERFACES, INFORMATION PROCESSING EQUIPMENT 105, 109

INTERMEDIATE CARE FACILITIES 141

JEWELRY, INDIAN 85

JOB SAFETY 171

LABELING, APPLIANCE 77

LABELING, POOD 55

232
PRODUCT PAGE

LABORATORIES, CLINICAL 155

LABORATORIES, CLINICAL INTERSTATE LICENSED 141

LABORATORIES, INDEPENDENT 141

LABORATORIES, NUCLEAR MEDICINE 155

LABORATORY ACCREDITATION 123

LABORATORY ACCREDLTATTON FOR ALCOHOL ANALYSLS 127

LABORATORY ACCREDITATION FOR MEAT/POULTRY/FOOD ANALYSIS 125

LAMB 7

LAMPS, MERCURY VAPOR 107

LAMPS, SUN 107

LASERS 107

LAVATORIES, PLASTIC 91

LENTILS 43

LLFE SAVING EQUIPMENT, MARINE 185

LEFTS, WHEELCHAIR 151

LLGHLTNG, MINE 167

LIGHTS, REAR END, RAILWAY TRAINS 199

LIVESTOCK 37, 39

LOAD CELLS, GRALN 45

LONGSHORING SAFETY 171, 183

LUMBER 91

MACHINERY SAFETY, PRESENCE SENSING DEVICES 169

MANUFACTURED HOUSING AND COMPONENTS 93

MARINE POLLUTION EQUIPMENT 163, 185

MARINE SAFETY EQUIPMENT 171, 185, 187

MARINE SHIPPING CONTAINERS 189, 205

MARINE TERMINAL SAFETY 171, 183

MARINE TRANSMITTER 101

MARITIME CARGO HANDLING EQULPMENT 183

MATERIALS HANDLING EQUIPMENT 183

MEASURING INSTRUMENT CALIBRATION 129

MEASURING INSTRUMENTS, COMMERCIAL 135

MEASURING SYSTEMS, GRAIN 131

MEAT . 7, 35, 47, 49

MECHANICAL GUARDING 169

MECHANICS, AIRCRAFT 177

MEDICAL DEVICES AND EQUIPMENT 149

MEDICAL LABORATORY TESTS 155

MEDICAL ELECTRONLCS 101

MEDICAL EXAMINERS, AVIATION 177

MEDICAL SERVICES 171

MEDICARE CERTIFICATION 141

MERCURY VAPOR LAMPS 107

MICROWAVE COMMUNICATIONS EQUIPMENT 99, 101

MICROWAVE OVENS 107

MILITARY COMPONENTS AND SYSTEMS 115

MILK 11, 35

MINING EQUIPMENT, DIESEL POWERED 165

MINING EQUIPMENT, ELECTRICAL 167

MINING EQUIPMENT, PROTECTIVE 161

MOTORCYCLES 193

MOTOR VEHICLE ENGINES 193

233
PRODUCT PAGE

MOTOR VEHICLES 195

MOTOR VEHICLES, USED 195

MOTORIZED WHKFT CHAIRS 153

MUSSELS 57

NATIVE AMERICAN HANDICRAFTS 85

NAVAL EQUIPMENT 171, 183, 185

NAVAL STORES 17

NAVIGATIONAL FACILITIES, AIR 177

NAVIGATIONAL AIDS, MARINE 187

NUCLEAR MEDICINE LABORATORIES 155

NUCLEAR PACKAGES AND CONTAINERS 203

NURSING FACILITIES 141

NUTS 13

NVLAP 123

OBSERVER, WEATHER 181

OFFSHORE DRILLING 163

ORGANISMS 29

OVENS 75

OYSTERS 57

PACKAGES FOR RADIOACTIVE MATERIALS 203, 207

PACKAGING FOR HAZARDOUS MATERIALS 201, 205

PADLOCKS 117

PAINTS 117

PARACHUTE RIGGERS 177

PARACHUTE SCHOOLS 177

PATHOLOGY TESTS 155

PEAS, WHOLE AND SPLIT 43

PERISHABLE POOD TRANSPORTATION 215

PESTICIDE APPLICATORS 67

PESTICIDES, RESPIRATORS FOR 161

PET FOOD 49, 63

PHYSICAL THERAPY 141

PILOTS 177

PIPE ASSEMBLERS, PLASTIC 209

PIPELINES 209

PLANTS AND UNPROCESSED PLANT PRODUCTS 23, 25

PLASTIC PIPE 209

POLLUTION CONTROL SAFETY VALVES 163

POLLUnON CONTROL BY AUTOMOBILES 191, 193

POLLUTION CONTROL BY SHIPS AND BOATS 185

POOL HEATERS 75

PORK 7

POULTRY AND POULTRY PRODUCTS 19, 35, 37, 39, 47, 49

POULTRY FOR EXPORT 37

POULTRY FOR IMPORT 39

PRESENCE SENSING DEVICE INITIATION (PSDI) 169

PRESSES, MECHANICAL POWER, PRESENCE SENSING DEVICES FOR 169

PRESSURE-LIMITING DEVICES 209

PRESSURE RELIEF DEVICES 211, 213

PROCUREMENT, GOVERNMENT 109, 115, 117

PROPELLERS 177

PROSTHETIC AIDS 149, 151, 153

234
PRODUCT PAGE

PULSES 43

PUMPS, MINING 167

QUALIFIED PRODUCTS LISTS 115, 117

RABBITS 19, 49

RADAR PLOTTING AIDS 187

RADIO FREQUENCY DEVICES 93

RADIO SERVICES 93

RADIO TELEPHONE, RURAL 99

RADIOACTIVE MATERIAL PACKAGES AND CONTAINERS 203, 207

RADIOACTIVE SUBSTANCES 207

RADIOS, CITIZEN BAND 101

RAILWAY CARS, REFRIGERATED 197

RAILWAY TANK CARS 197

RAILWAY TRAIN REAR END MARKING DEVICES 199

RANGES, KITCHEN 75

REAR END MARKING DEVICES FOR TRAINS 199

RECEIVERS, RADIO 101

RECEIVERS, TELEVISION 101, 107

RECREATIONAL BOATS 185

REFLECTORS, RAILWAY TRAINS 199

REFRIGERATED RAILWAY CARS 197

REFRIGERATED VEHICLES 215

REFRIGERATION UNITS 215

REFRIGERATOR-FREEZERS 75

REFRIGERATORS, HOUSEHOLD 75

REHABILITATION FACILITIES 141

REINDEER 49

RESPIRATORS 161

RICE 43

RODENTICIDE APPLICATORS 67

ROPE, WIRE 183

ROSIN 17

RURAL ELECTRIC AND TELEPHONE SYSTEMS 99

SAFES 117

SAFETY & RELIEF VALVES 163, 209, 211, 213

SAFETY EQUIPMENT 117, 161, 169, 171

SCALES 135

SCALES, GRAIN 45, 131

SCHOOL BUSES 195

SCHOOL PRODUCTS 81

SEAFOOD, FRESH AND FROZEN 57

SEAFOOD, PROCESSED 51

SELF-PROPELLED WHEELCHAIRS 153

SENSING DEVICE, PRESENCE 169

SHELLFISH, FRESH AND FROZEN 57

SHELLFISH, PROCESSED 51

SHIP SAFETY 185

SHIPBOARD NAVIGATION AIDES 187

SHIPPING CONTAINERS 189, 205

SHIPS, RECREATIONAL 185, 187

SHIPYARD SAFETY 171, 183

SHOWER RECEPTORS AND STALL, PLASTIC 91

235
PRODUCT PAGE

SHUTTLE CARS, MINING 167

SOUNDING DEVICES, MARINE DEPTH 187

SPEECH PATHOLDGY SERVICES 141

SPEED INDICATORS, MARINE 187

SPIRITS ANALYSIS, LABORATORY ACCREDITATION FOR 127

STEERING APPARATUS, MARINE 187

STOVES, FIREPLACE 91

SUNLAMPS 107

SURGICAL CENTERS, AMBULATORY 141

TANK CARS, RAILWAY 197

TANKS, PORTABLE FOR HAZARDOUS MATERLALS 205, 213

TANKS FOR HAZARDOUS MATERIALS 211, 213

TELEPHONE EQUIPMENT 101

TELEPHONE SYSTEMS, RURAL 99

TOBACCO AND TOBACCO PRODUCTS 17, 69

TOILETS, PLASTIC 91

TRAILERS, REFRIGERATED 215

TRANSMITTERS 101

TRANSPORTERS 165

TRUCKS 195

TURPENTINE 17

TV EQUIPMENT, CABLE 101

TV RECEIVERS 107

ULTRASONIC THERAPY EQUIPMENT 107

VALVES, SAFETY 163, 209, 211, 213

VAULT DOORS 117

VEAL 7

VECTORS 29

VEGETABLES, FRESH 13

VEGETABLES, PROCESSED 15

VEHICLE EMISSIONS 191

VEHICLES, NEW AND USED MOTOR 195

VENTTLATORS, MINE 165

VENTILATION 171

VESSELS, COMMERCIAL 185

VESSELS, NAVIGATIONAL AIDS FOR 187

VETERANS ADMINISTRATION MEDICAL CENTER 155

VETERINARY BIOLOGICAL PRODUCTS 31

VETERINARY MEDICINE 63

WASHING MACHINES, CLOTHES 75

WASTE WATER TREATMENT 223

WATER CLOSET BOWLS AND TANKS, PLASTIC 91

WATER, DRINKING 65

WATER HEATERS 75

WATER TREATMENT FACILITIES 223

WEARING APPAREL 83

WEATHER OBSERVATION 181

WEIGHING SYSTEMS, COMMERCIAL 135

WEIGHING, GRAIN 43

WELDERS, CERTIFIED 197, 209

WELDLNG 169

WHEELCHAIR LIFTS 151

236
PRODUCT PAGE

WHEELCHAIRS, MOTORIZED AND SELF-PROPELLED 153

WINDOWS 91

WINE ANALYSIS LABORATORY ACCREDITATION FOR 127

WIRE ROPE 183

WORKPLACE EQUIPMENT 171

X-RAY EQUIPMENT 107

X-RAY SERVICES, PORTABLE 141

YACHTS 185, 187

237

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.

ACRONYM PAGE

AMS/USDA 7, 9, 11, 13, 15, 17, 19

APHIS/USDA 23, 25, 27, 29, 31, 35, 37, 39

BATF/TREASURY 127

BIA/DOI 85

Coast Guard, DOT 185, 187, 189

Conservation and Renewable Energy/DOE 75

CPSC 81, 83, 227

Departmental Information Systems, TREASURY 105

DSPO/DOD 115

EPA 65, 67, 191, 193, 223

FAA/DOT 177

FCC 101

FDA/DHHS 53, 55, 57, 59, 61, 63, 107, 145, 147, 149

FGIS/USDA 43, 45, 131

FHA/HUD 91, 93

FRA/DOT 199

FSIS/USDA 47, 49, 125

FTC 69, 77

GSA 117

HCFA/DHHS 141

MMS/DOI 163

MSHA/DOI 165, 167

NBS/DOC 109, 123, 129, 135

NHTSA/DOT 195, 225

NIOSiyDHHS 161

NOAA/DOC 51, 181

NRC 203

OSHA/DOL 169, 171, 183

OT/USDA 215

REA/USDA 99

RSPA/DOT 197, 201, 205, 207, 209, 211, 213

VA 151, 153, 155

239

DEPARTMENT/AGENCY INDEX

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.

DEPARTMENT/INDEPENDENT AGENCY PAGE

DEPARTMENTS

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service 7, 9, 11, 13, 15, 17, 19

Animal and Plant Health Inspection Service 23, 25, 27, 29, 31, 35, 37, 39

Federal Grain Inspection Service 43, 45, 131

Food Safety and Inspection Service 47, 49, 125

Office of Transportation 215

Rural Electrification Administration 99

DEPARTMENT OF COMMERCE

National Bureau of Standards 109, 123, 129, 135

National Oceanic and Atmospheric Administration 51, 181

DEPARTMENT OF DEFENSE

Office of Standardization and Acquisition Support 115

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 53, 55, 57, 59, 61, 63, 107, 145, 147, 149

Health Care Financing Administration 141

National Institute of Occupational Safety and Health 161

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

Federal Housing Administration 91, 93

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs 85

Minerals Management Service 163

DEPARTMENT OF LABOR

Mine Safety and Health Administration 165, 167

Occupational Safety and Health Administration 169, 171, 183

DEPARTMENT OF TRANSPORTATION

Coast Guard 185, 187, 189

Federal Aviation Administration 177

Federal Railroad Administration 199

National Highway Traffic Safety Administration 195, 225

Research and Special Programs Administration 197, 201, 205, 207, 209,

211, 213

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco, and Firearms 127

Departmental Information Systems 105

241
I14DEPENDENT AGENCIES

CONSUMER PRODUCT SAFETY COMMISSION 81, 83, 227

ENVIRONMENTAL PROTECTION AGENCY 65, 67, 191, 193, 223

FEDERAL COMMUNICATIONS COMMISSION 101

FEDERAL TRADE COMMISSION 69, 77

GENERAL SERVICES ADMINISTRATION 117

NUCLEAR REGUIATORY COMMISSION 203

VETERANS ADMINISTRATION 151, 153, 155

242
AGENCY 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.

DEPARTMENTAL/INDEPENDENT AGENCY PAGE

Agricultural Marketing Service, USDA 7, 9, 11, 13, 15, 17, 19

Animal and Plant Health Inspection Service, USDA. 23, 25, 27, 29, 31, 35, 37, 39

Bureau of Alcohol, Tobacco, and Firearms, TREASURY 127

Bureau of Indian Affairs, DDI 85

Coast Guard, DOT 185, 187, 189

Conservation and Renewable Energy/DOE 75

Consumer Product Safety Oaranission 81, 83, 227

Conservation and Renewable Energy/DOE 75

Departmental Information Systems, TREASURY 105

Environmental Protection Agency 65, 67, 191, 193, 223

Federal Aviation Administration, DOT 177

Federal Communications Commission 101

Federal Grain Inspection Service, USDA 43, 45, 131

Federal Housing Administration, HUD 91, 93

Federal Railroad Administration, DOT 199

Federal Trade Commission 69, 77

Food and Drug Administration, DHHS...53, 55, 57, 59, 61, 63, 107, 145, 147, 149

Food Safety and Inspection Service, USDA 47, 49, 125

General Services Administration 117

Health Care Financing Administration, DHHS 141

Mine Safety and Health Administration, DOI 165, 167

Minerals Management Service, DOI 163

National Bureau of Standards, DOC 109, 123, 129, 135

National Highway Traffic Safety Administration, DOT 195, 225

National Institute of Occupational Safety and Health, DHHS 161

National Oceanic and Atmospheric Administration, DOC 51, 181

Nuclear Regulatory Commission 203

Occupational Safety and Health Administration, DOL 169, 171, 183

Office of Standardization and Acquisition Support, DOD 115

Office of Transportation, USDA 215

Research and Special Programs Adrninistration, DOT 197, 201, 205, 207, 209,

211, 213

Rural Electrification Administration, USDA 99

Veterans Administration 151, 153, 155

243

APPENDIX I

Information Available Fran

Office of Standards Code and Information (OSCI)

National Bureau of Standards

Administration Building, Room A629

Gaithersburg, MD 20899

(301) 975-4040

o Directory of International and Regional Organizations Conducting

Standards-Related Activities (NBS SP 649)

Directory contains information on 272 international and regional organizations

which conduct standardization, certification, laboratory accreditation, or other

standards-related activities. Volume 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.

o Standards Activities of Organizations in the United States (NBS SP 681)

The directory summarizes the standardization activities of more than 750

organizations in the United States, including federal and state agencies and

approximately 420 private sector groups that develop standards. It also contains

listings of state procurement offices, sources of standards documents and

information, a subject index and related listings that cover acronyms and

initials, defunct bodies and organizations with name changes.

o Private Sector Product Certification Programs in the United States (NBS SP 703)

This directory presents information from 109 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.

o Federal Government Certification Programs for Products and Services

(NBS SP 714)

This directory presents information on 61 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.

245
o KWIC Index (Computer Output Microform (COM) produced)

Hie KWIC Index contains the titles of more than 25,000 U.S. voluntary product and

engineering standards. A standard can be located by means of any significant or

key word in the title. Key words are arranged alphabetically. A standard with

five key words, for example, would therefore be listed in five different places.

To purchase microfiche copies of the 1987 revision of the Index, contact the

National Technical Information Service, 5285 Port Royal Road, Springfield, VA

22161; (703) 487-4600. Use order no. PB87-133377; cost $18.00.

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 NBS' 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.

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

Trade - "Standards Code"

This 2nd 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 Bureau of Standards, International Trade Administration)

;

Department of Agriculture and Department of State.

o Free Handout Material. Handouts are available on ADIS, NCSCI and GATT

activities, and standards-related information (such as government sources of

specifications and standards, use of the KWIC index, foreign and international

standards bodies, U.S. standards organizations, state purchasing offices) . A

NCSCI fact sheet and an ADIS publications list (bibliography) is also available.

246
In addition to general inquiry services, the following assistance is also

available:

o GATT Hotline. A telephone hotline provides current information received from

the GAIT 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 (TBI) notification number. The hotline number is (301) 975-

4041 (not toll-free) .

o Assistance to U.S. and Foreign Exporters. Current regulations and

certification information for the manufacture of products in the U.S. for export

are obtained from foreign countries. To aid foreign exporters, NCSCI provides

directory information to state offices prepared to respond to queries concerning

conditions to be met by goods for sale in their state, as well as standards and

certification information for export to the U.S.

247

APPENDIX II

Infannatlon Available Fran

Publications Office

U.S. Department of Agriculture

Foreign Agricultural Service (FAS)

14th & Independence Ave., S.W.

Room 5074-South Building

Washington, D.C. 20250-1000

(202) 447-7937

o Food and Agricultural Export Directory

This directory is published by the High Value Products Division, FAS for firms

engaged in exporting and marketing U.S. agricultural and food products. It

provides up-to-date listings and brief descriptions of federal and state

agencies, American embassy personnel abroad, trade associations, and related

other organizations that offer services and advice in exporting and marketing

U.S. agricultural and food products overseas.

o Agriculture' s Emissaries Overseas

This directory lists the names, addresses, telexes and telephone numbers and

descriptions of agricultural counselors and attaches overseas.

o U.S. Agricultural Trade Offices Overseas

This directory provides the names, addresses, telexes and telephone numbers and

descriptions of FAS agricultural trade offices overseas.

o The U.S. Farmer's Export Arm

This publication describes services of the Foreign Agricultural Service designed

to increase U.S. farm exports.

o Partners in Trade Promotion

This publication describes the market development cooperator program and lists

participants.

o How to Get Information on Agricultural Trade

This publication contains a check list and forms to order export publications

developed by the U.S. Department of Agriculture.

o FAS Reports

These are press releases announcing potential sales opportunities resulting from

the extension of Commodity Credit Corporation (CCC) or P.L. 480 credit to foreign

countries.

249
o Foreign Agriculture Magazine

This monthly magazine for U.S. business selling farm products overseas provides

tips on how best to break into exporting, descriptions of the markets with the

greatest sales potential, and export assistance available from the U.S.

Department of Agriculture. These articles are generally accompanied by tables

and graphs to let readers know at a glance what is going on overseas. Periodic

special issues - such as one devoted to the export of value-added items - provide

a more in-depth look at important segments of the overseas market. And every

month short wrap-ups of foreign buying trends, new competitors and products,

trade policy developments, and promotion activities going on around the world are

highlighted.

o Foreign Agricultural Trade of the United States

This is a bimonthly statistical and analytical review of the U.S. agricultural

trade.

o Foreign Agricultural Circulars

These periodic reports provide agricultural exporters with timely, reliable

information on the needs of foreign buyers, changing consumer preferences, and

the supply and demand situation in countries around the world. World

agricultural information and updates on special FAS export services for the food

and agricultural trade are highlighted in the circulars.

o Weekly Roundup of World Production and Trade

This report presents current news and statistics on various conmodities, and a

summary of recent developments in world production and trade. This report is

available at no cost within the United States.

o World Crop Production

This monthly report provides the U. S. Department of Agriculture's estimates on

the production of wheat, coarse grains, oilseeds, and cotton in major countries

and selected regions of the world.

o The World Agricultural Transportation Report

This is a monthly publication on key transportation issues and developments

related to agricultural exports.

o Ocean Liner Cargo Service Directory

A reference of ocean transportation services available to U.S. exporters,

o Export Handbook for U.S. Agricultural Exports , (No. #593)

This publication is provided by the U. S. Department of Agriculture, Office of

Transportation. It gives guidelines on shipping, export packing, and

transporting selected agricultural products.

250
o Export Product Review Program (EPR) . The ERR program is a fee-based service

which provides U. S. exporters and manufacturers of pre-packaged food products

with advance information on the general and product specific regulations on

product labeling, additive restrictions, ingredient requirements , and product

standards for their product in a targeted foreign country. The product

evaluation includes an in country review by local government officials to

determine whether the product can be admitted or if approval might be given if

certain changes were made. An indication of the product's marketability in the

country completes the evaluation. For more information, contact: Audrey Talley,

Export Product Review Program, HVPD/FAS, Room 4647-South, Washington, D. C.

20250-1000, Telephone: (202) 475-3408.

o Agricultural Information and Marketing Services (AIMS) . The AIMS program

functions as a liaison between American companies and foreign buyers to help

identify market opportunities and promote U.S. agricultural and food products

overseas. AIMS is a fee-based program offering the following services:

o Export Briefs

This weekly bulletin includes all trade leads processed by FAS each week.

These trade leads are processed as they are received from abroad and

disseminated through a direct mail service to interested U.S. suppliers. The

Export Briefs is targeted toward export agents, trade associations, and

companies interested in export opportunities for a wide variety of food and

agricultural products. The bulletin also highlights upcoming trade shows and

foreign trade developments.

An important feature of the Export Briefs bulletin is the USDA Technical

Office's section on foreign countries' proposed changes in agricultural

standards and regulations. Foreign countries who are signatories to the

General Agreement on Technical Barriers to Trade (GATT) (also known as the

Standards Code) are required to notify the GATT Secretariat of these changes

and allow time for comments from other signatories on possible impacts on

trade. Although the USDA Technical Office was established to inform and

collect comments from interested parties on changes in agricultural standards

by signatories to the Standards Code, this section in the Exports Briefs also

includes information on changes in the regulations and standards of nonsignatory countries. For more information on the USDA Technical Office,

contact: Carolyn Wilson, USDA Technical Office, Building 1072, BARC-East,

Beltsville, MD 20705, Telephone: (301) 344-2651

o Buyer Alert

This service goes a step beyond product introduction. It disseminates actual

sales announcements from U.S. suppliers to foreign exporters in the leading

value-added export markets for U.S. agricultural and food products.

251
o Contacts for U.S. Agricultural Products

This monthly newsletter for agricultural products assists American firms by

introducing their food and agricultural products to foreign markets.

Contacts are sent to FAS agricultural offices overseas for distribution to

prospective foreign buyers. The newsletter is translated into Japanese,

Spanish, French, Italian and Greek and mailed to thousands of buyers

worldwide. Product anroancements are included on a first-come, first-served

basis.

o International Marketing Profiles

The AIMS program offers two series of International Marketing Profile

reports - Product Marketing Profiles and Country Marketing Profiles. Both

reports draw from the world's major statistical reporting services to present

information and statistics on the trade of particular commodities and

specific countries.

To receive information on these or other AIMS services, contact: AIMS, FAS/HVPD,

Room 4647-South, Washington, D.C. 20250-1000, Telephone: (202) 475-3408.

252
APPENDIX III

Format Used for Each Entry

253
Testing Whether the agency or another specified party is responsible

for any tests conducted on the product/service.

Inspection Whether the agency or another specified party is responsible

for any inspections of the product/service.

Conformity

Identification

The method, if any, that the agency uses to identify that

the product/service has been certified.

Availability How information on lists of approved products/suppliers or

of Dccajmentation other documentation on the program can be obtained.

Enforcement The remedies (product recall, marketing ban, product

seizure, etc.) available to the agency in cases of

noncornpl iance with certification criteria.

Term The length of time the certification is valid.

Reciprocity Any recognition of the certification by other federal or

state agencies, private sector organizations, foreign

governments, or international organizations.

Standards, Codes,

or Regulations

The documents which define the acceptance criteria for

the certification.

Keywords Words describing key characteristics of the program.

254
U.S. DEPT. OF COMM.

DIDI mPDADUir n ATA

SHEET (See instructions)

1. PUBLICATION OR

REPORT NO.

NBS/SP-739

2. Performing Organ. Report No. 3. Publication Date

April 1988

4. TITLE AND SUBTITLE

Directory of Federal Government Certification Programs

5. AUTHOR(S)

Maureen Breitenberg, Editor

6. PERFORMING ORGANIZATION (If joint or other than NBS. see instructions)

NATIONAL BUREAU OF STANDARDS

U.S. DEPARTMENT OF COMMERCE

GAITHERSBURG, MD 20899

7. Contract/Grant No.

8. Type of Report & Period Covered

Final

9. SPONSORING ORGANIZATION NAME AND COMPLETE ADDRESS (Street, City. State, ZIP)

Same as in item 6 above.

10. SUPPLEMENTARY NOTES

Library of Congress Catalog Card Number: 88-600511

(Supersedes NBS Spec. Publ. 714)

| | Document describes a computer program; SF-185, FlPS Software Summary, is attached.

11. ABSTRACT (A 200-word or less factual summary of most si gnificant information. If document includes a significant

bibliography or literature survey, mention it here)

This directory, which represents a joint effort of the U.S. Department of

Agriculture (USDA) and the National Bureau of Standards (NBS), is designed to

provide updated information on federal certification programs for products and

services. This directory is a revision of NBS SP 714, Federal Government

Certification Programs for Products and Services, edited by Robert B. Toth and

published in April 1986.

This directory is part of ongoing NBS/USDA efforts to establish and maintain

comprehensive databases on standards, regulations, certification programs and

related information in accordance with the reguirements 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 certification

programs

.

12. KEY WORDS (Six to twelve entries; alphabetical order; capitalize only proper names; and separate key words by semicolons)

approved products; certification; grading; inspection; listing; pre-market

evaluation; qualification; qualified products; specifications; standards; testinlg

13. AVAILABILITY

|~X| Unlimited

| | For Official Distribution. Do Not Release to NTIS

[XI Order From Superintendent of Documents, U.S. Government Printing Office, Washington, D.C.

20402.

| 1 Order From National Technical Information Service (NTIS), Springfield, VA. 22161

14. NO. OF

PRINTED PAGES

229

15. Price

<p U.S. GOVERNMENT PRINTING OFFICE: 1988— 201-597 / 8251*0 USCOMM-DC 6043-PBO

Technical Publications

Periodical

Journal of Research—The Journal of Research of the National Bureau of Standards reports NBS research

and development in those disciplines of the physical and engineering sciences in which the Bureau 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 Bureau's

technical and scientific programs. Issued six times a year.

Nonperiodicals

Monographs—Major contributions to the technical literature on various subjects related to the Bureau'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 NBS, NBS 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 under a worldwide program coordinated by NBS 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 NBS by

the American Chemical Society (ACS) and the American Institute 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 Bureau on building materials,

components, systems, and whole structures. The series presents research results, test methods, and perfor- mance 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 treatment 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 NBS 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 re- quirements for products, and provide all concerned interests with a basis for common understanding of the

characteristics of the products. NBS administers this program as a supplement to the activities of the private

sector standardizing organizations.

Consumer Information Series—Practical information, based on NBS 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 NBS publications from: Superintendent of Documents, Government Printing Office,

Washington, DC 20402.

Order the following NBS publications—FfPS and NBSIR 's—from the National Technical Information Service, Springfield, VA 22161.

Federal Information Processing Standards Publications (FIPS PUB)—Publications in this series collectively

constitute the Federal Information Processing Standards Register. The Register serves as the official source of

information in the Federal Government regarding standards issued by NBS 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 1 1717 (38 FR 12315, dated May 11, 1973) and Part 6 of Title 15 CFR (Code of Federal

Regulations).

NBS Interagency Reports (NBSIR)—A special series of interim or final reports on work performed by NBS

for outside sponsors (both government and non-government). In general, initial distribution is handled by the

sponsor; public distribution is by the National Technical Information Service, Springfield, VA 22161, in paper

copy or microfiche form.
U.S. Department of Commerce

National Bureau of Standards

Gaithersburg. MD 20899

Official Business

Penalty for Private Use $300

Stimulating America s Progress 1913-1988