United States Department of Commerce

Technology Administration

National Institute of Standards and Technology

NIST Special Publication 739

1998 Edition

Directory of Federal Government

Certification and Related

Programs

Maureen Breitenberg, Editor
rhc National Institute of Standards and Technology was established in 1988 by Congress to "assist industry in the development of technology . . . needed to improve product quality, to modernize manufacturing processes,

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'At Boulder, CO 80303.

2 Some elements at Boulder, CO.
NIST Special Publication 739

1998 Edition

Directory of Federal Government

Certification and Related

Programs

Maureen Breitenberg, Editor

Office of Standards Services

Technology Services

National Institute of Standards and Technology

Gaithersburg, MD 20899-0001

(Supersedes NIST Special Publication 739, April 1988)

December 1 998

U.S. Department of Commerce

William M. Daley, Secretary

Technology Administration

Gary R. Bachula, Acting Under Secretary for Technology

National Institute of Standards and Technology

Raymond G. Kammer, Director
National Institute of Standards

and Technology

Special Publication 739

1998 Edition

(Supersedes NIST Special

Publication 739, April 1988)

Natl. Inst. Stand. Technol.

Spec. Publ. 739

1998 Ed.

496 pages (Dec. 1998)

CODEN: NSPUE2

U.S. Government Printing Office

Washington: 1998

For sale by the Superintendent of Documents

U.S. Government Printing Office

Washington, DC 20402
FOREWORD

This directory is the third edition of the National Institute of Standards and

Technology (NIST) directory of federal government procurement and regulatory

programs which may affect products and services in the marketplace. Prior

editions include: NBS SP 714, Federal Government Certification Programs for

Products and Services , published in April 1986: and NBS SP - 739, Directory of

Federal Government Certification Programs , published in April 1988. Since the

last edition, additional federal programs have been identified and changes

have been made in previously listed entries to reflect organizational or programmatic changes. The scope of this directory has also been expanded to

include both certification and other types of federal programs which impact on the marketplace. We have not attempted to include programs operated by the

U.S. government to accredit or assess laboratories unless they are an integral

part of a products or service regulatory or procurement program. Laboratory

accreditation programs are included in a separate publication, NIST SP 808

Directory of Federal Government Laboratory Accreditation/Designation Programs.

Federal, state, and local government officials, manufacturers, distributors,

foreign governments, researchers, and others may find the information

contained in this directory useful in identifying pertinent federal

product/service programs and in finding the appropriate agency contact points.

iii
ACKNOWLEDGMENTS

Special thanks and credit are due to the managers of federal programs who

provided the information contained in this directory, without which this

publication would not have been possible. I would also like to thank the

Senior Standards Executives on the Interagency Committee on Standards Policy

(ICSP) who also reviewed their agency's information.

Maureen Breitenberg

Editor
ABSTRACT

This directory is the third edition of the National Institute of Standards and

Technology (NIST) directory of federal government procurement and regulatory

conformity assessment programs which may affect products and services in the

marketplace. Prior editions include: NBS SP 714, Federal Government

Certification Programs for Products and Services , published in April 1986: and

NBS SP - 739, Directory of Federal Government Certification Programs , published in April 1988. Since the last edition, additional federal programs

have been identified and changes have been made in previously listed entries

to reflect organizational or programmatic changes. The scope of this

directory has also been expanded to include conformity assessment and other

types of federal programs which impact on the marketplace. We have not

attempted to include programs operated by the U.S. government to accredit or assess laboratories unless they are an integral part of a product or service

regulatory or procurement program. Laboratory accreditation programs are included in a separate publication, NIST SP 808 Directory of Federal

Government Laboratory Accreditation /Designation Programs.

Federal conformity assessment procedures are a means of providing assurance

that the products and services regulated or procured by federal agencies have

the required characteristics and/or perform in a specified manner. The

methods used by federal agencies to assure conformance can be very different

from those traditionally employed by the private sector and by third party

certifiers. Agency conformity assessment procedures may include: sampling and

testing, inspection, and/or certification by the agency or other specified

organization; licensing; product listing; the submission to an agency of

manufacturing, operational, and related data for review; manufacturer selfdeclaration of conformity to agency requirements; mandatory labeling and

advertising requirements; establishment of national requirements which are adopted/enforced at state and local government levels; issuance of regulatory

guidelines; pre-marketing approval requirements; post-marketing monitoring

requirements; and the conduct of environmental impact assessments.

Interest in such programs arises from many different sectors and may be

motivated by economic, procurement, safety, environmental or other

considerations. Such programs have also increased in significance due to

growing awareness of their impact on trade and the increasing obligations

placed on federal agencies to consider the impact of their regulatory and

procurement actions on the U.S. as well as the international marketplace.

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

comprehensive databases on standards, regulations, conformity assessment

programs and related information. This material has been compiled to meet the

needs of government, industry, and the public for information on U.S.

Government procurement and regulatory programs which affect products and

services in the marketplace certification and related programs.

Key Words: advertising; certification; grading; inspection; labeling;

licensing; listing; marketplace monitoring; permits; procurement; product

approval; regulation; specifications; standards; testing

v

CONTENTS

Page

Foreword iii

Acknowledgments iv

Abstract v

Introduction 1

ENTRIES BY DEPARTMENT/ INDEPENDENT AGENCY

DEPARTMENT OF AGRICULTURE (USDA) 3

USDA Index 62

DEPARTMENT OF COMMERCE (DOC) 64

DOC Index 91

DEPARTMENT OF DEFENSE (DOD) 93

DOD Index 100

DEPARTMENT OF ENERGY (DOE) 101

DOE Index 109

DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS) 110

DHHS Index 172

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HUD) 175

HUD Index 182

DEPARTMENT OF THE INTERIOR (DOD 183

DOI Index 188

DEPARTMENT OF JUSTICE (DOJ) 189

DOJ Index 192

DEPARTMENT OF LABOR (DOD 193

DOL Index 205

DEPARTMENT OF TRANSPORTATION (DOT) 207

DOT Index 282

vii
DEPARTMENT OF THE TREASURY (TREASURY) 286

TREASURY Index 299

DEPARTMENT OF VETERANS AFFAIRS (VA) 300

VA Index 307

INDEPENDENT AGENCIES

CONSUMER PRODUCT SAFETY COMMISSION (CPSC) 308

CPSC Index 315

ENVIRONMENTAL PROTECTION AGENCY (EPA) 316

EPA Index 385

FEDERAL COMMUNICATIONS COMMISSION (FCC) 389

FCC Index 403

FEDERAL TRADE COMMISSION (FTC) 404

FTC Index 438

GENERAL SERVICES ADMINISTRATION (GSA) 440

GSA Index 447

NUCLEAR REGULATORY COMMISSION (NRC) 448

NRC Index 456

APPENDIX I INDEX OF PROGRAM BY PRODUCT/SERVICE 457

APPENDIX II INFORMATION AVAILABLE FROM THE OFFICE OF STANDARDS SERVICES. 474

APPENDIX III FORMAT USED FOR EACH ENTRY 481

APPENDIX IV LIST OF ACRONYMS AND ABBREVIATIONS 483

viii
Background

INTRODUCTION

To ensure that the vast array of foreign and domestic products and services in

the U.S. marketplace meet certain minimum standards of health, safety, and

performance and that information about such products and services is accurate

and available to allow buyers and others to make informed choices, federal

agencies have established a number of voluntary and mandatory methods and

requirements. Such methods and requirements are designed to provide assurance

that the products, services, and systems that agencies regulate or purchase

consistently conform to manufacturers' claims and comply with other

appropriate regulatory and procurement requirements.

In April 1988. the National Institute of Standards and Technology (NIST)

published its second edition of a directory of such federal programs -- NBS SP

739, Federal Government Certification Programs. Since that time, new federal

programs have been identified and changes have been made in previously listed

entries to reflect organizational or programmatic changes. The scope of this

directory has also been expanded to include additional types of federal

programs which impact on the marketplace, which may also be of interest to the

reader.

Federal conformity assessment procedures are a means of providing assurance

that the products, services, or systems regulated or procured by federal

agencies have the required characteristics. The methods used by federal

agencies to assure conformance can be very different from those traditionally

employed by the private sector and by third party certifiers. Agency

conformity assessment procedures may include: sampling and testing,

inspection, and/or certification by the agency or other specified

organization; licensing; product listing; the submission to an agency of

manufacturing, operational, and related data for review; manufacturer selfdeclaration of conformity to agency requirements; mandatory labeling and

advertising requirements; establishment of national requirements which are adopted/enforced at state and local government levels; issuance of regulatory

guidelines; pre-marketing approval requirements; post-marketing monitoring

requirements; and the conduct of environmental impact assessments.

Interest in such programs arises from many different sectors and may be

motivated by economic, procurement, safety, or other considerations. Such

programs have also increased in significance due to growing awareness of their

impact on trade and the increasing obligations placed on federal agencies to

consider the impact of their regulatory and procurement actions on the U.S. as well as the international marketplace.

This directory does not include programs operated by the U.S. government to

accredit or assess laboratories, though such programs may be mentioned if they

are in integral part of a product or services conformity assessment program.

1
Information on laboratory accreditation and related assessment programs is

included in a separate publication, NIST SP 808 Directory of Federal

Government Laboratory Accreditation/Designation Programs.

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

comprehensive databases on standards, regulations, certification programs and

related information. This material has been compiled to meet the needs of

government, industry, and the public for information on U.S. Government

procurement and regulatory programs which affect product and services in the

marketplace certification and related programs.

Format

The entries in this directory are organized alphabetically by Department

followed by Independent Commissions/Agencies. In addition, there is a cumulative index of programs by product/service, an index of acronyms, and a list of additional NIST publications of possible interest.

Directory Changes

U.S. Government agencies are encouraged to notify NIST of any new programs or modifications to existing programs. Such information should be sent to:

National Institute of Standards and Technology

Building 820, Room 282

Gaithersburg, MD 20899

Phone: (301) 975-4031

Fax: (301) 963-2871

e-mail : maureen.breitenberg@nist.gov

We intend to include the information in this publication on the NIST website

at the following URL address:

http://ts.nist/gsp

We also intend to update the information on the website as changes are received.

2
DEPARTMENT OF AGR1CULTURI
Products or Services

Department /Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Enforcement

MEATS. PREPARED HEATS, I (Beef, Lamb, Veal. Calf

Received 12/97

and

[AT

Pork)

U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Livestock and Seed Division

Meat Grading and Certification (MGC) Branch, Room 2628-S

P.O. Box 96456, Stop 0248

Washington, DC 20090-6456

Phone: (202) 720-1113

FAX: (202) 690-4119

e-mail: barry l_carpenter@usda .gov

URL address: n~ttp:/ /www. ams.usda.gov/

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 valuedetermining actors 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 assists large scale

buyers by providing impartial evaluation and

certification that meat purchases meet their contract

specifications

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. Also does

supplier capability audits for suppliers of red meat

products to the Bureau of Prisons and supplier

assessments for ham suppliers for school lunch program.

Required tests are preformed in Government labs.

MGC Branch personnel

Approved USDA stamps and roller brands are applied in

compliance with applicable standards or specifications.

USDA certification is withheld from products not

complying with approved standards or specifications.

Term Continuous inspection on a voluntary basis.

4
Reciprocity None.

Standards, Codes The agency develops and maintains its own USDA approved

or Regulations standards and specifications for the various meat items.

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

pork; veal

5
Products or

Services

Department/Agency

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Enforcement

Received 12/97

U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Livestock and Seed Division (LS)

Seed Regulatory and Testing Branch

Room 209, Bldg. 306, BARC-East

Beltsville, MD 20705-2325

Phone: (301) 504-9237

FAX: (301) 504-5454

e-mail: James P_Triplitt@usda.gov

URL address: n~ttp://www.ams. usda.gov/lsg/ls-sd. htm

Mandatory compliance with seed labeling requirements.

Voluntary testing services also available for such

factors as genetic purity, germination, weeds, chaff,

and moisture.

Agricultural Marketing Act of 1946 (as amended).

Federal Seed Act (FSA).

To help promote uniformity among State laws and fair

competition within the seed trade.

Helps ensure that the labeling information and related

advertisements pertaining to seed are truthful and

facilitates international marketing of seed.

Agency serves as program administrator, regulator, and

certifier (in some cases). Provides regulatory followup testing and voluntary seed testing services.

State seed control officials routinely inspect and

sample seed. Branch personnel used for regulatory

follow-up testing following receipt of a complaint of

mislabeling and for voluntary testing services.

See Testing.

Federal Seed Analysis Certificate.

Regulatory action can be taken against shippers of

mislabeled seed ranging from letters of warning to

monetary penalties.

Term None. Requirements apply to each shipment

6
Reciprocity

Standards, Codes

or Regulations

Many importing countries require a Federal Seed Analysis

Certificate. The testing section is accredited by the

International Seed Testing Association (ISTA).

The agency develops and maintains its own USDA approved

standards and specifications for the seed.

Keywords agricultural seed; seed; vegetable seed

7
Products or

Services

Department/Agency

PLANT VMIETJE!

Received 12/97

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Enforcement

U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Science and Technology

Plant Variety Protection (PVP) Office

National Agricultural Library Bldg., Room 500

Beltsvi lie. MD 20705

Phone: (301) 504-5518

FAX: (301) 504-5291

e-mail : Marsha_A_Stanton@usda.gov

URL address: http://www.ams.usda.gov/science/pvp.htm

1970.

Voluntary.

Agricultural Marketing Act of 1946 (as amended).

The PVP Act.

To issue USDA plant variety certificates.

Provides legal protection (similar to patents) to

developers of new varieties of plants which are sexually

produced by seed or are tuber propagated.

Agency issues a Certificate of Protection to an owner of

a variety after examination shows that it is new. distinct from other varieties, and genetically uniform

and stable through successive generations.

Proof of the distinctness, uniformity, and stability of new variety lies with the owner. The PVP Office uses the information submitted and databases it maintains for

crops and other sources to determine which, if any,

varieties are indistinguishable from the new one. The

PVP does not perform tests to confirm distinctness of

variety. That responsibility rests with the applicant.

See Testing.

Certificates of Protection.

Owners of a protected variety may bring civil action

against persons infringing on his/her rights. USDA does

not take legal action.

8
Twenty years for most crops; 25 years for tees, shrubs,

and vines.

Member of the International Union for the Protection of

New Varieties of Plants (UPOV).

plants; plant varieties; certification
Products or

Services

Department/Agency

RAM GOTTOf

Received 11/97

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Cotton Programs, Rm. 2641 -S

Washington, DC 20250

Phone: (202) 720-3193

e-mail: Mary_E_Atienza@usda .gov

URL address: http://www.ams.usda.gov/

1916.

Mandatory for cotton delivered on Futures Contracts.

May also be mandatory for government financed exports

and for the Commodity Credit Corporation (CCC) sales

program. Voluntary grading services are also provided

on a fee basis.

7 CFR Part 27.

U.S. Cotton Futures Act.

To certify quality of cotton delivered on Futures

Contracts according to official U.S. Standards.

Orderly settlement of cotton Futures Contracts.

Government agency classes (grades) cotton samples taken

from bales expected to be tendered on the futures market

and issues certificates certifying quality.

Government labs.

Government.

Grade certificates.

List of government cotton classing offices available

from above address.

To order samples taken and transported to government

classing offices.

Decertification.

One year from date of original certification.

Other federal agencies.

10
Standards, Codes The agency prepares all criteria documents.

or Regulations

Keywords certification; classing; cotton quality; grad

11
Products or

Services

Department /Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Received 12/97

DAIRY PRODUCTS, PLANTS AND EQUIPMENT

(Including Cheese, Nonfat Dry Milk, Dry Whey, Dry

Buttermilk and Dried and Condensed Milk. Butter)

U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Dairy Programs

P.O. Box 96456

Washington, DC 20090-6456

Phone: (202) 720-4392

FAX: (202) 690-3410

e-mail: Richard_M_McKee@usda.gov

URL address: http://www.ams.usda.gov/

1925.

Voluntary. However, all dairy product offered for sale

to the federal government under the dairy price support

program or sanctioned under such programs as the Dairy

Export Incentive Program (DEIP) are inspected by AMS

graders

7 CFR Part 58.

The Agricultural Marketing Act of 1946 (as amended).

To assist the dairy industry in marketing high-quality

dairy products by providing buyers and sellers with an impartial appraisal of product quality and to provide

the consumer confidence in buying.

Provides buyers and sellers with an impartial appraisal

of product quality; stimulates manufacturers to produce

uniformly high quality, stable products; assures the

quality of dairy products so consumers can buy with

confidence.

Government provides: (1) plant inspections and equipment

reviews; (2) inspection and grading; (3) dairy product

grades and quality approval; and (4) resident grading

and quality control for approved plants with a USDAapproved laboratory.

Testing

Inspection

Conformity

Identification

Government

Government

labs.

accredited abs.

Government.

State government.

List of approved dairy plants/equipment. Authorized

grading marks are applied on products for which grading

standards are established.

12
Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes or Regulations

List of approved dairy plants and accepted equipment is

available from the above mailing address or at URL

address.

Approved dairy plants must maintain quality control in

plants and comply with grading requirements.

Del i sting.

Product recal 1

Dairy plants are reinspected at least twice a year.

Other federal agencies.

State agencies.

The agency prepares all criteria documents and grading

standards. May use standards prepared by the 3-A

Sanitary Standards Committees for dairy equipment.

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

13
Products or

Services

Department/Agency

FRESH FRUITS. VEGETABLES . IUTS. AND

Received 2/98

RELATED PRODUCTS

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Inspection

Conformity

Identification

Availability

of Documentation

U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Fruit and Vegetable Programs

Fresh Product Branch, Room 2049-South

P.O. Box 96456

Washington, DC 20090-6456

Phone: (202) 720-5870

FAX: (202) 720-0393

e-mail: Robert_C_Keeney@usda.gov

URL address: http://www.ams.usda.gov/

1917.

Voluntary, except for commodities that are regulated for

quality by a marketing order or marketing agreement, or that are subject to import or export requirements.

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.

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.

Federal or state inspection usually conducted at the

shipping point as produce is being packed for shipment

to market. May also be graded at destination to

determine current grade.

Federal government inspection.

Inspection by state government inspectors trained by

USDA.

Certificate of inspection.

There are no lists of participating producers.

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

Manufacturer/Vendor assessed fee for service rendered.

14
Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Although nearly all aspects of this program are voluntary, a full range of enforcement options apply to

shippers who practice fraud.

Certification is done on a lot by lot basis.

USDA grade marking is recognized nationwide and

worldwide in both private and public sectors.

Grading criteria are established by AMS.

Keywords food quality; fruits; grading; nuts; vegetables

15
Products or

Services

Department /Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

PROCESSED (Canned, Frozen. Dehydrated

FRUITS AND VEGETABLES

Received 1/98

or Fresh-Cut)

U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Fruit and Vegetable Programs

Processed Products Branch

P.O. Box 96456

Washington, DC 20090-6456

Phone: (202) 720-4693

FAX: (202) 690-1527

e-mail: james r_rodeheaver@usda .gov

URL address: Http:/ /www. ams.usda.gov/

1931.

Voluntary, except for products covered by federal or state marketing orders.

7 CFR Part 52.

The Agricultural Marketing Act of 1946 (as amended).

Provide an objective evaluation of quality and condition

of various processed food products and conditions under

which they are produced.

Can check overall production quality and provide an impartial evaluation of the final product's quality.

Agency provides voluntary grading and inspection

service. Services can include: inspection of processing

plants for compliance with government or buyer

sanitation requirements; checking warehouse lots for

condition of food containers and wholesomeness of

product: case stamping to provide lot identity: and

check loading to verify identity and quantity.

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

Federal government inspection.

Inspection by cooperating state government inspectors.

Authorized grade and/or inspection marks applied by

manufacturer. Government applied mark is restricted

officially sampled lots.

to

lb
Availability List of processing plants under contract is published

of Documentation annually and is available from the above address.

Obligations of the Make product accessible for sampling. Produce product

Manufacturer/Vendor in accordance with the good manufacturing practices

(GMPs) as defined in the Food and Drug Administration's

regulations

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

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

may provide for continuous inspection.

Certificates are recognized by other federal agencies

for procurement. Certificates of Sampling from states

are recognized by Agency under certain cooperative

agreements

Most acceptance criteria are based on requirements or specifications developed by federal or state agencies;

however, sometimes buyer specifications are used.

agricultural marketing orders; food quality; fruits;

good manufacturing practices; grading; in-plant

inspection; processed foods; sanitation; vegetables;

third party auditing; food safety systems; food quality

systems; food wholesomeness

17
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Received 11/97

U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Tobacco Programs

P.O. Box 96456

Washington, DC 20090-6456

Phone: (202) 205-0567

FAX: (202) 205-0235

URL address: http://www.ams.usda.gov/tob/

Tobacco - 1935.

Naval Stores - 1923.

Tobacco : Mandatory only for domestic tobacco sold on designated

auction markets and all imported tobacco, except cigar

and oriental, offered for importation into the United

States

Naval Stores : Voluntary.

The Tobacco Inspection Act.

The Dairy and Tobacco Adjustment Act.

The Naval Stores Act.

To facilitate the orderly marketing of unmanufactured

tobacco.

Helps producers move commodities to consumers quickly,

fairly and efficiently.

Government grading in accordance with U.S. Official

Standard Grades and Specifications.

Naval Stores:

Government lab certifies results of manufacturer's lab

Tobacco : Federal government inspection.

Naval Stores : Official inspectors.

Licensed inspectors.

18
Conformity

Identification

Tobacco : Government certificates.

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes or Regulations

Keywords

Naval Stores : Government certificates and authorized mark by

manufacturer.

Documentation is confidential.

Proper lighting and adequate space

Tobacco : Reduction of sales opportunity or withdrawal of

inspection.

Naval Stores : Withdrawal of inspection.

Continuous inspection.

Recognition of certification by other federal agencies

and international organizations.

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

agricultural marketing orders: food quality; good

manufacturing practices; inspection; naval stores;

rosin; sanitation; tobacco; turpentine

19
Products or

Services

Department /Agency

Initiated

Compliance

Authority

Pigeons

(Chickens

, SHELL E6

Turkeys Ducks

ABBITS

Received 12/97

Geese, Guineas, and

U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Poultry Division. Rm. 3932-S

P.O. Box 96456

Washington. DC 20090-6456

Phone: (202) 720-4476

Telex: 89-491

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

FAX: (202) 720-5631

e-mail : D_Michael_Holbrook@usda.gov

URL address: http://www.ams.usda.gov/

1917.

Voluntary.

Laws

Agricultural Marketing Act of 1946 (as amended) (60

Stat. 1087-1091; U.S.C. 1621-1627).

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

U.S.C. 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).

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 shell egg product inspection - Regulations

Governing the Inspection of Eggs and Egg Products (7 CFR

Part 59).

Aim 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 shell

eggs, poultry and poultry products.

Through the Shell Egg Surveillance program, fair

competition in the movement and sale of consumer eggs in

commerce is enhanced by inspecting shell eggs and

assuring they do not contain excess restricted eggs.

Additionally, surveillance inspections ensure that

restricted eggs generated from processing operations are properly labeled and handled accordingly.

20
Benefits

Methodology

Testing

Benefits include: third party evaluation; easier dispute

settlement; more accurate market price reporting; more

equitable competition; fewer rejections at destination;

established buying guides (specifications); reduced

illness; and upgraded product quality.

Testing/inspection/grading is conducted by AMS or federally licensed state graders and authorization given

to use grade marks as appropriate.

Conducted in Government laboratories or in approved

state laboratories.

Inspect i on/Grading

Conformity

Identification

Conducted by Federal government inspectors/graders or Federally licensed state graders.

Stamps (authorized marks).

Certificates.

Labeling.

Seals

Availability

of Documentation

Single copies of regulations

Agency. Multiple copies may

Superintendent of Documents,

Office.

may be obtained from the

be obtained from the

U.S. Government Printing

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes or Regulations

Keywords

To operate in a sanitary manner; maintain volume

records; comply with regulations; perform required

laboratory tests, when applicable; reimburse Government

for cost of voluntary inspections and gradings; provide

access to products; and provide access to equipment and

facilities necessary for accomplishing official duties.

Product retention or recall; withdrawal of service;

laboratory comparison samples; removal /withhold official

identification; reinspection/regrading; judicial system.

Continuous or intermittent voluntary inspection.

Use of licensed State employees.

Recognition of certification of ingredients by

manufacturer.

Recognition of certification by approved government

laboratory.

See Authority.

contract acceptance; eggs; grading branch; grading

poultry; rabbits; shell eggs

21
Products or

Services

Department/Agency

REFRIGERATED VEHICLE

Received 2/98

AID REFRIGERATION UNITS

U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

Transportation and Marketing Division (TMD)

ATP Manager

Room 1217 South Building

Washington, DC 20250

Phone: (202) 690-1319

FAX: (202) 690-1340

e-mail: brianm_mcgregor@usda.gov

URL address: fittp:/ /www. ams.usda.gov/tmd/

Initiated

Compliance

Authority

Aim

Benefits

1986.

Mandatory only for

foodstuffs between

receiving country

Agreement on the I Foodstuffs Act and

for Such Carriage

a movement of more Agreement does not

States or any of i

equipment transporting perishable

countries in Europe, when the

is a contracting party to the

nternational Carriage of Perishable

on the Special Equipment To Be Used

(ATP). Transport operations involving

than 150 km by sea are exempt. The

apply to carriage in the United

ts territories.

7 CFR Part 3300.

The International Carriage of Perishable Foodstuffs Act

of 1982. P.L. 97-325.

The ATP was developed by the U.N. Economic Commission

for Europe, of which the United States is a member, to

improve the conditions of preservation of perishable

foodstuffs during their carriage, particularly in

international trade.

The objective of U.S. participation in the ATP 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.

Methodology Requires 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 Agency approves and monitors test facilities.

22
Inspection 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

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Approved equipment requires an authorized ATP

certification plate and distinguishing mark along with a manufacturers plate.

Lists of approved test facilities and fees for

certificates can be obtained from the ATP Manager at the

above address. Copies of the ATP, the Act, the Senate

Report, and 7 CFR Part 3300 are also available.

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.

Delisting of test stations, laboratories, and

certificates

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 minimum.

U.S. ATP certificates are recognized by the 28 countries

that are contracting parties to the Agreement under a reciprocal arrangement.

The Agreement and 7 CFR 3300 define all the acceptance

criteria

containers; food; frozen food; international agreement;

rail cars; refrigerated; refrigeration units; trailers;

transportation

23
Products or Services

Department /Agency

ORSAIIC mm FOOD PRODUCT!

Received 4/98

Initiated

Compliance

Authority

Aim

Benefits

Methodology

U.S. Department of Agriculture (USDA)

Agricultural Marketing Service (AMS)

National Organic Program (NOP)

Room 2510 South Building

P.O. Box 96456

Washington, DC 20090-6456

Phone: (202) 720-3252

FAX: (202) 690-3924

URL address: http://www.ams.usda.gov.nop

Proposed Rule issued 12/16/97 in the Federal Register

(62 FR 65849). Comment period extended until 4/30/98.

On May 8, 1998, the Secretary indicated that fundamental

revisions to the proposed rule were expected based on the 200 000 comments received on the proposed rule.

Mandatory upon issuance of the final Rule.

Organic Foods Production Act (OFPA) of 1990; 7 U.S.C.

6501 et seq.

To establish national standards governing the marketing

of certain agricultural products as organically

produced. The Act also requires the USDA to establish

an organic certification program for producers and

handlers of agricultural products that are produced

using organic methods.

The NOP is intended to bring stability and credibility

to a rapidly expanding market. When the final Rule is

implemented, a wider variety of organically produced

products, especially meat and poultry, will be available

for domestic consumption through a greater number of

markets; organic producers will have easier access to

foreign markets, particularly the European Union; consumers will be assured that products labeled as organic have been produced using consistent practices;

assurance will be provided by USDA that products

organically grown in other countries and sold in the

United States were produced using equivalent standards

and similar oversight standards; and the USDA seal will

be available for use on organically grown products to

indicate they have been produced under regulated

standards and certified by an agency that has been

accredited by the USDA.

This program would establish national standards for the

organic production and handling of agricultural

24
Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes or Regulations

Keywords

products, which would include a National List of

synthetic substances approved for use in the production

and handling of agriculturally produced products. It

would also establish an accreditation program for farm,

wild crop harvesting, and handling operations that want

to be certified as meeting the program's requirements.

The program would also include labeling requirements for

organic products and products containing organic

ingredients, and enforcement provisions. The proposed

rule provides for the approval of State organic programs

and for the importation into the United States of

organic agricultural products from foreign programs

determined to have requirements at least equivalent to

those of the NOP.

Approved state programs and private organizations.

Approved state programs and private organizations.

A USDA seal will be available for use on organically

grown products to indicate they have been produced under

regulated standards and certified by an agency that has

been accredited by USDA.

State Programs: Public access to certification documents

and laboratory analyses that pertain to certification.

Private Organizations: Public access to non-confidential

business information as permitted by the producer and

approved by the Secretary.

Producers and handlers are obligated to produce to

national standards and to label their products

accordingly.

Product retention; product recall; withdrawal of

certification status; product relabelling; or judicial

systems

Certifying agents must be reaccredited every 5 years.

Accredited certifying agents would be authorized to

certify operations that meet the requirements of the

NOP. Any operations certified by accredited certifying

agents would enjoy full equivalency.

Proposed Rule issued December 16, 1997, 7 CFR Part 205

National Organic Program.

accreditation; crops; food; labeling; livestock

food; organic produce; packaging; produce

organic

25
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Conformity

Identification

Received 12/97

PLANTS AID UNPROCESSED PLAIT PRODUCTS FOR 1HP0RT

U.S. Department of Agriculture (USDA)

Animal and Plant Health Inspection Service (APHIS)

Plant Protection and Quarantines Services

Biological Assessments and Taxonomic Support (BATS)

4700 River Road, Unit 133

Riverdale. MD 20737-1236

Phone: (301) 734-5055

Telex: 89607 ADEHVLE

FAX: (301) 734-8700

Automated document FAX: (301) 734-4327

URL address: http://www.aphis.usda.gov/ppq/bats/permits

1912.

Mandatory. Requirements dependant on product and

country of origin.

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, including

arthropods, snails, and plant 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

Agency reviews applications, issues permits, and

provides information on entry requirements and

regulatory changes. Also conducts pre-import evaluation

against entry requirements. Reviews regulations and

evaluates pests associated with product in country of

origin.

Plant and plant materials must usually be accompanied by

a phytosanitary certificate issued by an official of the

exporting country

Valid import permit number.

26
Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Lists of approved commodities and entry requirements

from each country available from above address.

Information on permit holders available only through the

freedom of information process.

Importer must make written application for permit.

Permits issued for varying time periods ranging from 1 day to 5 years, depending on the product.

Import permit is recognized by foreign plant protection

services and by state plant protection organizations.

Criteria for permits are established by the Acts and the

regulations promulgated therefrom.

import; permit; plant health; plant quarantine; plant

products; plant

27
Products or

Services

ESSE!

Received 12/97

m EXPORT

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

Animal and Plant Health Inspection Service (APHIS)

Plant Protection and Quarantines Services

Biological Assessments and Taxonomic Support (BATS)

4700 River Road, Unit 133

Riverdale, MD 20737-1236

Phone: (301) 734-5055

Telex: 89607 ADEHVLE

FAX: (301) 734-8700

Automated document FAX: (301)

URL address: http: //www. aphis

734-4327

usda.gov/ppq/bats/permits/

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Conformity

Identification

1913.

Voluntary in U.S.; but often mandatory for exporting to

a foreign country.

Department of Agriculture Organic Act of 1944, as amended.

7 CFR Part 353.

To assist in foreign marketing of American agricultural

products

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

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.

Inspection is conducted by federal government and state

government cooperators, who issue phytosanitary (plant

health) certificates certifying conformity with the

receiving country's plant quarantine import regulations.

Testing in government

university labs.

abs and recognized state and

Federal Phytosanitary Certificate.

28
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

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

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.

Federal certification is withheld from commodities not

complying with the plant quarantine import requirements

of the foreign country.

Inspections normally not valid if conducted more than 14

days prior to commodity export.

Certification is recognized by foreign plant protection

services and by regional plant protection organizations.

Criteria for certification are established by each

foreign country.

export certification; export; phytosanitary ; plant

health; plant quarantine; plant products; plant; re- export

29
Products or Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

1AL B' iODUGTS FOR EXPORT

Received 12/97

U.S. Department of Agriculture (USDA)

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services

National Center for Import-Export Product Program (NCIE)

4700 River Road, Unit 40

Riverdale. MD 20737-1231

Phone: (301) 734-3277

FAX: (301) 734-8226

Telex: 89607 ADEHVLE

URL address: http://www.aphis.usda.gov/ncie

1946.

Voluntary in U.S.

a foreign country.

but often mandatory for exporting to

Laws: Agricultural Marketing Act of 1946. Sections 203

and 204.

Regulations: 9 CFR Part 156.

To assist U.S. exporters in complying with import

requirements of foreign countries.

Most foreign countries require shipments of certain

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

United States, and endorsement of certain certifications

made by state or accredited veterinarians.

Inspection is conducted by federal government and/or

state government cooperators.

None.

USDA: export certificate,

letterhead certification.

stamp endorsement, or

There are no lists of participating exporters,

of regulations may be obtained from the Agency

Copies

In some cases, exporters must enter a cooperative

agreement with Veterinary Services (VS); make written

application to the Deputy Administrator. VS; and make

product available for inspection.

30
Term

Reciprocity

Standards, Codes

or Regulations

Keywords

No specific term; based on importing country.

None.

Criteria for certification

foreign country.

animal by-product; export;

time limits set forth by

are established by each

export certification

31
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Received 12/97

U.S. Department of Agriculture (USDA)

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services

National Center for Import-Export Animals Program (NCIE)

4700 River Road, Unit 39

Riverdale, MD 20737-1231

Phone: (301) 734-8364

Telex: 89607 ADEHVLE

FAX: (301) 734-6402

Automated document FAX: (301) 734-4952

URL address: http://www.aphis.usda.gov/ncie

1913.

Mandatory.

Laws

Virus-Serum-Toxin Act of 1913, as amended

(21 U.S.C. Ill, 151-158) (7 U.S.C. 430).

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

(19 U.S.C. 1202) (46 Stat. 673).

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

(19 U.S.C. 306) (46 Stat. 689).

Act of July 2. 1962 - P.L. 518 (21 U.S.C. 134)

(76 State 129).

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

(84 Stat. 202).

Regulations:

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

122.

To assist in preventing the introduction and

dissemination of exotic animal diseases into the U.S.

livestock population.

The permit system serves to notify importers about

special entry requirements and handling procedures for

imports. Uniform central control of imports.

Agency reviews applications; monitors international

livestock and poultry disease data; and provides

information on entry requirements and regulatory

changes. Agency evaluates the importer's ability to

handle the disease agents, organisms or vectors in a safe manner. Also issues permits and provides

information on entry requirements and regulatory

changes.

32
Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Livestock and poultry must be accompanied by a health

certificate issued by an official of the exporting

country. Livestock and poultry must meet test

requirements for specific disease agents.

Government.

Valid import permit and health certificates.

Copies of regulations may be obtained from the Agency.

Information on permit holders available only through the

Freedom of Information process.

Comply with regulations and conditions of permits,

maintain records, provide access to facilities and

records for inspection.

Revocation of permit, judicial system, refuse entry of

imports.

Permits are issued for 1 year.

None.

See Authority.

import; organisms; permit; vectors; disease; livestock

33
Products or

Services

Department/Agency

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Received 6/98

IMPORTED BI01G31CAI PRODUCTS

(Livestock or Avian-Origin Products and By-products;

Products Exposed to Animal or Avian Material; CellDerived Material; and Microorganisms)

U.S. Department of Agriculture (USDA)

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services

National Center for Import-Export Product Program (NCIE)

4700 River Road, Unit 40

Riverdale, MD 20737-1231

Phone: (301) 734-7830

Telex: 89607 ADEHVLE

FAX: (301) 734-8226

Automated document FAX: (301) 734-4952

URL address: http://www.aphis.usda.gov/ncie

Mandatory.

9 CFR Parts 92, 94, 95, and 122.

To assure that animal biological products imported are

safe.

To prevent the introduction and spread of animal

diseases; to avoid risk to public health and well-being;

and to improve product quality.

Importation requires an import permit from USDA and

compliance with USDA regulations.

Safety testing or irradiation of some products.

Government.

Permits, certificates.

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.

Comply with regulations. Maintain detailed records.

Complete permit application

Government non-release of product; market suspension;

reinspection; judicial system.

Term Annual with one year renewal

34
Reciprocity None.

Keywords animal -derived materials ; biological products; materials

of animal origin; materials of avian origin;

microorganism; vector;

35
Products or

Services

Department IAgency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

VETERINARY BIOLOGIC

Received 1/98

U.S. Department of Agriculture (USDA)

Animal and Plant Health Inspection Service (APHIS)

Services

Veterinary Biologies

Road

MD 20737-1231

734-8245

ADEHVLE

Veterinary

Center for

4700 River

Riverdale,

Phone: (301)

Telex: 89607

FAX: (301) 734-8910

e-mai 1 : despeseth@aphi s . usda . gov

URL address: http://www.aphis.usda.gov/

1913.

Mandatory.

Laws

Virus-Serum-Toxin Act of 1913, as amended

(21 U.S.C. 151-159) (7 U.S.C. 430).

Regulations:

9 CFR Chapter I. Subchapter E Parts 101-199

To ensure that biologies are free of disease producing

agents, especially foreign animal diseases; to develop

appropriate standards and procedures for product

release; to issue licenses and permits; to monitor and

inspect products and facilities; and to control field

tests and release of veterinary products.

To assure that veterinary biologies imported into or prepared in the United States are pure, safe, potent,

and efficacious.

Veterinary biologies must be registered/licensed.

Permits are required to import veterinary products.

Pre-licensing/ registration inspection/testing is

conducted as well as batch/serial check

inspection/testing and post release compliance

inspection/testing as appropriate.

Government.

Government.

Labeling, licensing/registration and permits.

36
Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

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.

Comply with regulations; maintain detailed records;

complete permit application.

Government non-release of product; market suspension;

reinspection; or judicial system.

Continuous market release.

None.

See Authority.

Keywords biologies; veterinary biologies; serums

37
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Received 12/97

HEAT, MILK. AID POULTRY PRODUCTS FOR IMPORT

U.S. Department of Agriculture (USDA)

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services

National Center for Import-Export Product Program (NCIE)

4700 River Road, Unit 40

Riverdale, MD 20737-1231

Phone: (301) 734-3277

Telex: 89607 ADEHVLE

FAX: (301) 734-8226

URL address: http://www.aphis.usda.gov/ncie

1890.

Mandatory.

Laws

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

U.S.C.

102 through 105) (26 Stat. 414).

Act of February 2, 1903 (21 U.S.C. Ill) (32 Stat. 792).

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

(19 U.S.C. 1202) (46 Stat. 673).

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

(19 U.S.C. 306) (46 Stat. 689).

Act of July 2, 1962 - P.L. 518 (21 U.S.C. 134)

(76 State 129).

Act of May 6. 1970 - P.L. 91-239 (21 U.S.C. 135)

(84 Stat. 202).

Regulations

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

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.

The permit system serves to notify importers about

special entry requirements and handling procedures for

imports. Uniform central control of imports.

Agency reviews applications and evaluates importer's

ability to meet criteria for import. Also issues

permits and provides information on entry requirements

and regulatory changes.

Testing None

38
Inspection

Conformity

Identification

Government.

Valid import permit and certificates.

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes or Regulations

Keywords

Copies of regulations may be obtained from the Agency.

Information on permit holders available only through th

Freedom of Information process.

Comply with regulations and conditions of permit.

Maintain records and provide access to facilities and

records for inspection.

Revocation of permit, judicial system, refuse entry of

imports

Permits are issued for 1 month to 1 year.

None.

See Authority.

animal product; import; meat; milk; permit

39
Products or Services

Department/Agency

SPECIFIED

Received 12/97

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

U.S. Department of Agriculture (USDA)

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services

National Center for Import-Export Animals Program (NCIE)

4700 River Road. Unit 39

Riverdale, MD 20737-1231

Phone: (301) 734-8364

Telex: 89607 ADEHVLE

FAX: (301) 734-6402

Automated document FAX: (301) 734-4952

URL address: http://www.aphis.usda.gov/ncie

1884.

Mandatory.

Laws:

Act of May 29, 1884 (21 U.S.C. 112. 113. 120).

Act of May 29. 1884 (21 U.S.C. 114a).

Act of February 2. 1903 (21 U.S.C. 121).

Act of July 2. 1962 (21 U.S.C. 134. 134f).

Act of March 4. 1907 (21 U.S.C. 612. 613. 614. 618).

Regulations

9 CFR Chapter I. Subchapter D. Part 91.

To assure the exportation of healthy livestock and

poultry in a humane manner.

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 conducts inspections and issues certifications of

health for livestock exports. Government conducts:

diagnostic testing; inspection of documents and animals;

and issues certification.

Government and government-approved laboratories and

government quarantine personnel.

Government.

Conformity

Identification

Valid health certification matching individual animal

identification.

40
Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Copies of regulations, specific health conditions, and

guidelines for approved export facilities available on request from the above address. See also web URL

http : //www . aphi s . usda . gov/export/

The exporter must submit an international health

certificate issued by an accredited veterinarian to the

Department for endorsement. The enclosed health

certificate must accompany the animals to an approved

port of embarkation.

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.

Health certificates are valid for 30 days.

None.

U.S. export requirements are based upon criteria

developed by experts in the field of preventive

veterinary medicine and accepted by the Department

importing country's health requirements are also

enforced by the Department.

animals; export; health certificate; inspection;

livestock; permit; poultry; quarantine; testing

The

41
Products or

Services

Department/Agency

SPECIFIED ANIMALS FOf

Received 12/97

Initiated

Compliance

Authority

Aim

Benefits

Methodology

U.S. Department of Agriculture (USDA)

Animal and Plant Health Inspection Service (APHIS)

Veterinary Services, Domestic Programs

National Center for Import-Export Animals Program (NCIE)

4700 River Road, Unit 39

Riverdale. MD 20737-1231

Phone: (301) 734-8364

Telex: 89607 ADEHVLE

FAX: (301) 734-6402

Automated document FAX: (301) 734-4952

URL address: http://www.aphis.usda.gov/ncie

1890.

Both mandatory and authorized to act.

Laws:

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

U.S.C.

102 through 105) (26 Stat. 414).

Act of February 2, 1903 (21 U.S.C. Ill) (32 Stat. 792).

Act of June 17, 1930 (Tariff Act-Section 201) (19 U.S.C.

1202) (46 Stat. 673).

Act of June 17, 1930 (Tariff Act-Section 306) (19 U.S.C.

306) (46 Stat. 689).

Act of July 2, 1962-P.L. 518 (21 U.S.C. 134)

(76 Stat. 129).

Act of May 6. 1970-P.L. 91-239 (21 U.S.C. 135)

(84 Stat. 202).

Parts 92, 94, 97. and

Regulations

9 CFR Chapter I, Subchapter D

Subchapter G, Part 151.

To prevent the introduction and dissemination of animal

diseases of foreign origin.

Allows the U.S. livestock and poultry industries access

to genetic materials to improve the national herd/flock

and increase its productivity.

Agency provides an inspection and quarantine service,

issues permits for entry and certifies the health status

of animals and poultry released from quarantine. Agency

conducts pre-import evaluation of permit applications,

42
Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

inspection of imported animals and re-evaluations of

import requirements on a continuing basis. Government

conducts diagnostic testing; inspects documents and

animals; and issues certification.

Government laboratories and government quarantine

personnel

Government.

Valid health certification matching individual animal

identification.

Copies of regulations, specific health conditions, and

guidelines for approved import facilities available on request from the above address.

The importer 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.

Animals and poultry not meeting U.S. requirements for

entry are refused entry 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

Reciprocity

Standards, Codes

or Regulations

Keywords

Permits are valid for periods from 2 weeks to 90 days

(avian only)

None.

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

43
Products or

Services

Department/Agency

SCRAPIE FLOCKS (Goats. Sheep, and

Received 11/97

Moufflon)

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

U.S. Department of Agriculture (USDA)

Animal and Plant Health Inspection Service (APHIS)

National Animal Health Programs Staff

4700 River Road, Unit 43

Riverdale. MD 20737-1231

Phone: (301) 734-6954

FAX: (301) 734-7964

e-mail: braab@aphis.usda gov

URL address: http://www.aphis.usda.gov/

1992, though still under development.

Voluntary.

9 CFR 79.3.

To prevent the introduction and dissemination of

scrapie, a fatal degenerative disease affecting the

central nervous system of sheep, goats, and moufflon.

Protection of flocks from scrapie and enhancement of

animal marketability.

This is a cooperative effort among producers, allied

industry representatives, accredited veterinarians,

state animal health officials, and APHIS. Agency

monitors flocks using established program standards over

a period of greater than 5 years and identifies flocks

that are free of scrapie.

N/A.

See Obligations of the Manufacturer/Vendor.

Certification.

Copies of regulations, specific health conditions, and

guidelines for approved import facilities available on request from above address.

Regularly inspect flocks; complete documentation; submit

tissue samples from suspected infected animals for

testing.

Removal from program.

Program is conducted for 5 or more years.

44
Reciprocity None.

Standards, Codes or Regulations Criteria based on norms developed by experts in the

field.

Keywords flocks; goats; moufflin; scrapie; sheep

45
Products or

Services

Department/Agency

JHEAT, BARLEY Af :ertificates

Received 12/97

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Reciprocity

Keywords

U.S. Department of Agriculture (USDA)

Farm Service Agency (FSA)

Kansas City Commodity Office (KCCO)

P.O. Box 419205

Kansas City, MO 64141-6205

Phone: (816) 926-6497

FAX: (816) 926-6511

URL address: http://wwwaix.fsa.usda.gov.kcco/kcco.htm

1995.

Mandatory for wheat and barley imported from

countries/instrumentalities requiring end use certificates

North American Free Trade Agreement (NAFTA).

To conduct a program which meets requirements imposed by

NAFTA.

Allows the monitoring of the disposition of foreign

wheat imported into the United States.

FSA issues end use certificates requiring the "identity

preserved" storage of wheat/barley that enters the

United States from countries/instrumentalities which

also require end use certificates.

N/A.

N/A.

End use certificates.

None.

barley; end use certificates; grain; wheat

46
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Reciprocity

Standards, Codes

or Regulations

Received 12/97

U.S. Department of Agriculture (USDA)

Farm Service Agency (FSA)

Kansas City Commodity Office (KCCO)

P.O. Box 419205

Kansas City, MO 64141-6205

Phone: (816) 926-6497

FAX: (816) 926-6511

URL address: http://wwwaix.fsa.usda.gov.kcco/kcco.htm

1939.

Mandatory.

Commodity Credit Corporation (CCC) Uniform Storage

Agreements.

The United States Warehouse Act (USWA).

To ensure the integrity of agricultural commodities

stored in approved/licensed facilities and that

facilities meet established approval standards.

To improve the quality and safety of the U.S. food

supply.

FSA performs warehouse examination to ensure that

warehouse storing agricultural commodities meet

established standards.

N/A.

FSA examiners.

End use certificates.

None.

7 CFR 736 for USWA Warehouses.

7 CFR 1421 for CCC Uniform Storage Agreements.

Keywords warehouses

47
Products or

Services

Department /Agency

Received 12/97

(Mandatory Inspection)

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

U.S. Department of Agriculture (USDA)

Food Safety and Inspection Service (FSIS)

Food Safety Education and Communications Staff

Room 1175 - South Building

1400 Independence Ave., SW

Washington. DC 20250

Phone: (202) 720-7943

FAX: (202) 720-1843

Meat and Poultry Hotline: 1-800-535-4555 or in the DC area (202) 720-3333

URL address: http://www.usda.gov/fsis

1907 (Meat).

1958 (Poultry).

Mandatory.

21 U.S.C. 601 et sea. (meat).

21 U.S.C. 451 et sec;, (poultry).

Assure that meat and poultry products moving in

interstate commerce for use as human food are safe,

wholesome, and accurately labeled.

The risk of adulterated or misbranded meat and poultry

products entering commerce has been minimized.

Government conducts meat/poultry inspections.

Uses government labs, government approved/accredited

labs, manufacturer's labs, and State/local government

labs as appropriate.

Conducted by federal or state government.

Government applied marks; pre-marketing label approval.

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

U.S. Government Printing Office, Washington, DC 20402.

Make application for inspection; meet requirements for

issuance of establishment number; operate under

inspection in conformance with Agency rules (9 CFR Parts

301-381).

48
Enforcement

Term

Reciprocity

Standards. Codes

or Regulations

Condemnation of meat animals or birds before slaughter;

condemnation of carcasses or product; withdrawal of

inspection; criminal prosecution.

Continuous inspection for slaughtering plants, and the

frequency of inspection for processing plants to be

determined by the Secretary of Agriculture.

Inspection results recognized by:

Other federal agencies.

State agencies.

Private sector organizations.

Foreign government agencies.

International organizations.

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

49
Products or Services

Department /Agency

Received 12/97

MEAT/ POULTRY PRODUCTS

(Voluntary Inspection)

Initiated

Compliance

Authority

Aim

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

U.S. Department of Agriculture (USDA)

U.S. Food Safety and Inspection Service (FSIS)

Food Safety Education and Communications Staff

Room 1175 - South Building

1400 Independence Ave., SW

Washington, DC 20250

Phone: (202) 720-7943

FAX: (202) 720-1843

Meat and Poultry Hotline: 1-800-535-4555 or in the DC area (202) 720-3333

URL address: http://www.usda.gov/fsis

1958.

Voluntary.

7 U.S.C. 1622(h).

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.

Government conducts inspections.

Uses government labs or government approved/accredited

labs

Conducted by federal or state government.

Government applied mark.

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

U.S. Government Printing Office, Washington, DC 20402.

Make application for inspection; meet requirements for

issuance of establishment number; operate under

inspection in conformance with Agency rules (9 CFR Parts

301-381).

50
Enforcement

Term

Reciprocity

Standards, Codes or Regulations

Keywords

Condemnation of meat animals or birds; condemnation of

meat or poultry products; withdrawal of inspection;

criminal prosecution.

Indefinite term.

Inspection program recognized by:

Other federal agencies.

State agencies.

Private sector organizations.

Foreign government agencies.

International organizations.

9 CFR Parts 350-362.

buffalo inspection; game birds; identification service

meat inspection; pet food; poultry inspection; rabbit

inspection; reindeer inspection; squab

51
Products or

Services

Department/Agency

HEAT/POULTRY/FOOD PRODUCTS

(Accreditation of laboratories)

Received 12/97

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

U.S. Department of Agriculture (USDA)

U.S. Food Safety and Inspection Service (FSIS)

Food Safety Education and Communications Staff

Room 1175 - South Building

1400 Independence Ave. , SW

Washington, DC 20250

Phone: (202) 720-7943

FAX: (202) 720-1843

Meat and Poultry Hotline: 1-800-535-4555 or in the DC area (202) 720-3333

URL address: http://www.usda.gov/fsis

1962, Final Rule 9 CFR Parts 318 and 381. 1/20/87.

Voluntary.

9 CFR Parts 318 and 381.

This program allows the acceptance of official sample

results from accredited laboratories which service the

meat and poultry food industry and provides faster

service than can be provided by FSIS laboratories.

Provides faster analytical service to the meat and

poultry food industry. This allows for a better

inspection program.

Government issues accreditation based on on-site

laboratory review; results of proficiency sample testing

and ongoing split sample testing that serve as a continuing check on the laboratory's analytical

capabi 1 ity

Government accredited labs.

Government.

Government applied mark.

The lists of USDA-FSIS accredited laboratories are published in the "Meat and Poultry Inspection

Directory.

Accredited laboratories must continue to operate under

the Accredited Laboratory Rules as documented under 9

CFR Parts 318.21 and 381.153.

52
Enforcement

Term

Reciprocity

Standards, Codes or Regulations

Keywords

Del isting.

Indefinite term.

Recognition of Accreditation by:

State agencies.

Private sector organizations.

9 CFR Parts 318.21 and 381.153.

accredited/laboratory coordinator; initial accreditation

sample check; laboratory accreditation; laboratory; meat

testing; official sample; ongoing accreditation check

sample; poultry testing; probation; split sample

53
Products or Services

Department/Agency

RICE. BEAIS, WHOLE AND

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Term

mn CTJ m

Received 11/97

SPLIT PEAS, LENTILS, PROCESSED

ATED PRODUCTS

U.S. Department of Agriculture (USDA)

Grain Inspection, Packers and Stockyards Administration

(GIPSA)

Federal Grain Inspection Service (FGIS)

Filed Management Division, Regulatory Branch

Stop 3630

Washington, DC 20250-3630

Phone: (202) 720-0228

FAX: (202) 720-1015

e-mail: jgiler@fgisdc.usda.gov

URL address: http://www.usda. gov. gipsa/

1946.

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.

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.

Representative sample is obtained by official personnel

and tested in a third party laboratory.

FGIS laboratory.

FGIS, state government.

Certificates of inspections.

There are no lists of participating companies

Must have financial interest in products and pay

assessed fee.

Continuous or intermittent voluntary inspection on a lot

basis

54
Reciprocity

Standards. Codes

or Regulations

Keywords

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.

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 FGIS

inspection handbooks. In some instances, buyer or seller specification are used.

beans; good manufacturing practices; in-plant

inspection; lentils; peas; pulses; rice; sanitation

55
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Received 2/98

U.S. Department of Agriculture (USDA)

Grain Inspection, Packers and Stockyards Administration

(GIPSA)

Federal Grain Inspection Service (FGIS)

Office of the Administrator

Stop 3601

Washington, DC 20250-3604

Phone: (202) 720-5091

FAX: (202) 205-9237

Telex: 760 7351 ANS:FGIS UC.

e-mail : mbegley@fgisdc.usda.gov

URL address: http: //www. usda.gov. gipsa/

1916 (inspection) - P.L. 64-190.

1976 (weights) - P.L. 94-582.

Mandatory inspection and weighing requirements for

exports and intercompany barge grain received at export

locations. Official aflatoxin testing of exported corn

is also mandatory unless contract stipulates that

testing is not required. Mandatory inspection

requirements do not apply to grain which: (1) is not

sold or described by grade; (2) is shipped by truck or train to Canada or Mexico; is shipped by exporter

shipping less than 15 000 metric tons of grain abroad

annually; for grain sold as seed; and for train

transshipped through the U.S. in a bonded identity

preserved fashion.

Voluntary inspection and weighing services for domestic

products. Also offers pesticide residue testing for

corn, wheat, soybeans, and barley.

U.S. Grain Standards Act, as amended, P.L. 100-518, 7

U.S.C. 71-87.

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 gram,

and to regulate the certification of the weight of grain

shipped in interstate and foreign commerce.

Facilitate the marketing and trading of grain in

orderly and timely manner.

an

Representative : and tested in a ample is obtained by official personnel

third party laboratory.

56
Testing Uses FGIS laboratory, delegated state laboratory, or designated state or private sector laboratory.

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Term

Reciprocity

Standards, Codes or Regulations

Conducted by FGIS, state government, or private sector

agency.

Certificates of weight and of grade/quality.

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 (FGIS)

Office of the Administrator

Stop 3601

Washington, DC 20250-3604

Phone: (202) 720-5091

Telex: 760 7351 ANS:FGIS UC.

FAX: (202) 205-9237

e-mai 1 : mbegl ey@fgi sdc . usda . gov

Must submit application for inspection and/or weighing,

Continuous or intermittent, mandatory or voluntary

inspection and weighing services on a lot basis.

Certificates are recognized by federal agencies, state

agencies, private sector organizations, foreign

governments, and international organizations buying and

selling grain.

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

regulations thereunder; Official United States Standards

for Grain; FGIS Inspection Handbooks; and FGIS Weighing

Handbook.

Keywords grain elevators; grain scales; grain weights; grain

bins; load cells; loading plans; official grain

standards

57
Products or

Services

Received 12/97

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

Grain Inspection, Packers and Stockyards Administration

(GIPSA)

Federal Grain Inspection Service (FGIS)

Weighing and Equipment Branch (WEB)

STOP 3631. Rm. 1640-S

1400 Independence Ave.. SW

Washington. DC 20250-3631

Phone: (202) 720-0262

Telex: 760 7351 ANS:FGIS UC.

FAX: (202) 720-1015

e-mail: richard.pforr@usda.gov

URL address: http://www.usda.gov.gipsa/

Initiated 1976.

Compliance Mandatory only for official certification of grain

weight.

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

Aim 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. 1 1 1 L scales that have been

evaluated by FGIS or the National Institute of Standards

and Technology (NIST) 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.

Methodology Government conducts design approval . performance

testing, inspection, and site approval.

53
Testing Official personnel or delegated state agencies

Inspection Official personnel or delegated state agencies.

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Term

Reciprocity

Standards, Codes or Regulations

Keywords

NTEP Certificate of Conformance (CO.

FGIS CC.

FGIS Report of Test (ROT).

NIST ROT.

Government applied approval seal.

List of approved equipment may be obtained from:

U.S. Department of Agriculture (USDA)

Grain Inspection, Packers and Stockyards Administration

STOP 3631

1400 Independence Ave., SW

Washington, DC 20250-3631

Index of NTEP device evaluations and NTEP criteria and

test procedures may be obtained from :

NCWM/OWM

National Institute of Standards and Technology

Building 820, Room 232

Gaithersburg, MD 20899

Must provide instruments under the CC exactly as specified and provide installation, maintenance, and

operating instructions consistent with the evaluation

report. Modifications affecting accuracy, reliability

or integrity must be approved by the FGIS Equipment

Branch before implementation.

Continuous or intermittent, mandatory or voluntary

inspection on a scale.

Certificates are required by federal agencies, state

agencies, private sector organizations, foreign

governments, and international organizations buying and

selling grain.

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

regulations thereunder; FGIS Equipment Handbook; FGIS

Weighing Handbook; NIST Handbook 44; and NTEP device

evaluation criteria.

automatic bulkweighing systems; grain test; NTEP;

railway track; ROT; scale; state weights and measures

officials

59
Products or

Services

Department /Agency

Initiated

Compliance

Authority

Aim

Methodology

Testing

PARTS . MATERIAL!

TELECOMMUNICATK

1 EQUIPMENT

SYSTEMS

Received 12/97

FOR RURAL ELECTRIC AND

U.S. Department of Agriculture (USDA)

Rural Utilities Service (RUS)

14th and Independence Ave., SW, Mail Stop 1500

Washington. DC 20250-1500

URL address: http://www.usda.gov/rus/

Assistant Administrator-Electric Program

Mail Stop 1560

e-mai 1 : bstockto@rus . usda . gov

Phone: (202) 720-9545

Assistant Administrator-Telecommunications Program

Mail Stop 1590

e-mail: rpeters@rus.usda.gov

Phone: (202) 720-9554

1938.

Required for designated parties using RUS loans.

Rural Electrification Act of 1936 (7 U.S.C. 901).

7 CFR Part 1700.

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 RUS standards for construction and

installation, provides an important element of loan

security.

Electric and telephone systems receiving financing

administered by RUS should use materials and equipment

evaluated and accepted by RUS.

Government labs.

Manufacturers' labs.

Conformity

Identification

Accepted products for rural electric systems are included in RUS Informational Publication 202-1 "List

Materials Acceptable for Use on Systems of RUS

Electrification Borrowers." Accepted products rural

telephone systems are listed in RUS Informational

Publication 344-2 "List of Materials Acceptable for

Use on Telecommunications Systems of RUS Borrowers."

of

60
Availability

of Documentation

Enforcement

Term

Standards, Codes

or Regulations

Keywords

Informational Publications are available on a subscription basis from the Superintendent of Documents

Government Printing Office, Washington, DC 20402.

Information on acceptable telecommunications/electric

materials is also available on the RUS website as http : //www. usda . gov/rus/home/home . htm.

Acceptance voiding.

Indefinite term.

RUS prepares product standards which define performance

and design requirements together with acceptance

criteria

acceptable materials; central office equipment;

components; distribution; electric systems; electronic;

microwave; radio-telephone; telecommunications;

telephone; transmission

61
Product Page

agricultural seed 6

animal products 38

animal by-products 30

animal -derived materials 34

animals 40. 42

automatic bulkweighing systems 58

barley 46

beans 54

beef 4

biological products 34, 36

birds, game 50

buffalo 50

butter 12

cheese 12

classing 10

containers 22

cotton quality 10

crops 24

dairy products 12

eggs 20

electric systems 60

export certification 28, 30, 40

flocks 44

food quality/safety 4. 12, 14, 16, 18

food, frozen 22

frozen food 22

fruits 14, 16

goats 44

good manufacturing practices 16, 18, 54

grading 4, 10, 12, 14. 16, 20

grain standards 56

grain scales 56

grain elevators 56

grain weights 56

grain test 58

grain bins 56

grain 46. 56, 58

lamb 4

lentils 54

laboratory accreditation 52

livestock 24. 32, 40, 42. 44, 48

materials of avian origin 34

materials of animal origin 34

meat products 1 meat 4. 38. 48, 50. 52

microwave 60

62
milk 38

moufflin 44

naval stores 18

NTEP 58

nuts 14

organic food 24

organic produce 24

peas 54

pet food 50

plant health 26. 28

plant products 26, 28

plant varieties 8

plants 8, 26. 28

pork 1 poultry 20. 40. 42. 48. 50. 52

processed foods 16

produce, organic 24

pulses 54

rabbits 20. 50

radio-telephone 60

rail cars 22

railway track 58

refrigeration units 22

reindeer 50

rice 54

rosin 18

scale 58

scrapie 44

seed 6

sheep 44

shell eggs 20

squab 50

telecommunications 60

telephone 60

tobacco 18

trai lers 22

transportation, food 22

turpentine 18

veal 1 vegetable seed 6

vegetables 14, 16

veterinary biologies 36

warehouses 47

weighing systems 56, 58

wheat 46

63
DAD" T OF CO!

64
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Enforcement

Term

Received 11/97

U.S. Department of Commerce

International Trade Administration (ITA)

Trade Fair Certification

HCHB Room 2118

14th and Constitution Ave.. NW

Washington, DC 20230

Phone: (202) 482-0584

FAX: (202) 482-0872 or (202) 482-0115

E-mail: WCorfitz@doc.gov

URL address: http://www.ita.doc.gov.uscs/uscstfc

1983.

Voluntary.

Mutual Educational and Cultural Exchange Act of 1961

(MECEA). 22 U.S.C. 2455(f). See also Federal Register,

Vol. 58, No. 82, Friday, April 30, 1993.

To promote U.S. firms' export promotion efforts.

Provides Commerce Department endorsement and support for

private sector recruited and organized foreign trade

shows. U.S. pavilions are frequently used in certified

trade fairs to create enhanced visibility for U.S.

firms, particularly new-to-export and new-to-market

firms. Exhibitors in certified trade fairs also receive

the support of the Commercial Service from U.S.

Embassies or consulates. Certification provides a means

for the exporter to verify that a particular trade fair

will be a good promotional medium.

Commerce employees review applications and evaluates the

information contained in them against the criteria

listed in the Federal Register notice referenced above.

N/A.

See Methodology.

A list of certified trade fairs is available.

Decertification.

Trade fairs are certified

must be certified.

on an annual basis, each fair

65
Reciprocity

Keywords

N/A.

exports; trade; trade fairs

66
Products or

Services

fasteier:

Received 6/98

Department/Agency U.S. Department of Commerce (DOC)

National Institute of Standards and Technology (NIST)

Office of Standards Services (OSS)

Bldg. 820, Room 282

Gaithersburg. MD 20899

URL address: http://www.nist.gov/fqa

The amended Act and recently issued final regulations

are available via the Internet at the current address:

http://www.nist.gov/fqa

Questions concerning the Act and regulations should be

directed to the following individuals:

A. Dr. Subhas Malghan, FQA Program Manager, Technology

Services, National Institute of Standards and

Technology, Building 820, Room 311, Gaithersburg, MD

20899, telephone number (301) 975-5120, FAX: (301) 975-

5414, E-mail: ma lghan@ni st.gov (for general questions

and for questions pertaining to Subpart A of the

regulations)

B. David Alderman. Deputy Chief, National Voluntary

Laboratory Accreditation Program, NIST. (301) 975-4016,

FAX: (301) 926-2884, (for questions pertaining to

laboratory accreditation in Subpart C of the

regulations)

C. Robert L. Gladhill, Global Standards Policy Program,

NIST, (301) 975-4273. FAX: (301) 975-5414 (for questions

pertaining to the approval of bodies which accredit

laboratories under Subparts B, D, E, and F of the

regulations)

D. Kirt Flashner, Special Assistant to the Assistant

Secretary for Export Enforcement, (202) 482-2252 (for

questions pertaining to enforcement of the Act and

regulations under Subpart G of the regulations); and

E. Ari Leifman, Trademark Legal Administrator. Patent

and Trademark Office, (703) 308-8910 Ext. 55 (for

questions pertaining to the recordal of manufacturers'

insignia under Subpart H of the regulations).

Initiated Final regulations were published April 14, 1998 in the

Federal Register. Implementation date for final

regulations was extended to July 26, 1998.

67
Compliance Mandatory.

Authority

Aim

Fastener Quality Act (P.L. 101-592)

P.L. 104-113.

as amended under

Benefits

Methodology

Testing

To protect public safety, deter introduction of

nonconforming fasteners into commerce, and to provide

users with increased assurance that fasteners meet

stated specifications.

Increase likelihood that certain fasteners sold in

interstate commerce conform to the specifications to

which they are represented.

The Act requires that certain fasteners sold in commerce

conform to the specifications to which they are represented to be manufacturers; provides for

accreditation of laboratories engaged in fasteners

testing; and requires the inspection, testing and

certification (in accordance with standardized test

methods) of fasteners used in critical applications.

Mandatory testing is required for fasteners falling

within the scope of the Act in accredited laboratories.

Fasteners which fail be conform to the applicable

standard(s) cannot be sold. Agency serves as program

administrator, laboratory accreditor, recognition/

approval authority for other laboratory accreditation

programs. Agency has also defined the procedures by

which fastener manufacturers can use qualified Quality

Assurance Systems/Statistical Process Control (QAS/SPC)

to meet some of the requirements of the Act.

Testing conducted at laboratories accredited by NIST

under the National Voluntary Laboratory Accreditation

Program (NVLAP) or by laboratories accredited by a laboratory accreditation body recognized/approved by

NIST. Qualified QAS/SPC manufacturing facilities can also be used to meet some of the requirements of the

Act.

Conformity A test certificate is issued by the accredited

Identification laboratory, which must be made available to buyers under

terms and conditions outlined in the Act. Fasteners

must be marked with a symbol or designation which

identifies the manufacturer.

Availability Fastener Quality Act and 15 CFR Part 280.

of Documentation A final Rule was published in the Federal Register on April 14. 1998.

NIST Handbook 150 - NVLAP Procedures and General

Requirements and the NVLAP Handbook for Fastener

Testing.

68
Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Enforcement mechanisms as specified in the Fastener

Quality Act, including the imposition of civil and

criminal penalties. Enforcement is the responsibility

of the Bureau of Export Administration within the

Department of Commerce.

Accreditation terms are specified in the implementing

regulations. Test reports are valid as long as the

products are not significantly altered.

None, though efforts are underway in this area.

Program relies on private sector voluntary fastener

standards.

accredited laboratory; fasteners; laboratory

accreditation; quality management system; statistical

process control

69
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Received 6/98

1ENT ACTIVITIES

U.S. Department of Commerce (DOC)

National Institute of Standards and Technology (NIST)

Office of Standards Services (OSS)

National Voluntary Conformity Assessment Systems

Evaluation (NVCASE) Program

Bldg. 820. Room 282

Gaithersburg, MD 20899

Phone: (301) 975-4273

FAX: (301) 975-5414

E-mail: robert.gladhill@nist.gov

URL address: http://ts.nist.gov/ts/210/218/218.htm

Final regulations were published in the Federal Register

on April 22. 1994.

Voluntary.

15 CFR Part 286.

NVCASE recognition provides other governments with a basis for having confidence that qualifying U.S.

conformity assessment bodies are competent and

facilitates the acceptance of U.S. products in foreign

regulated markets based on U.S. conformity assessment

results

See Aim.

Program is offered on a fee-for-service basis and

includes activities related to laboratory testing,

product certification, and quality system registration.

After NVCASE evaluation, NIST provides recognition to

qualified U.S. organizations that effectively

demonstrate conformance with established criteria.

NVCASE does not unilaterally establish program areas. Operational areas are established only after a formal

request from a conformity assessment body and

concurrence of need from the affected industry sector.

If another U.S. government agency has domestic

regulatory responsibility for a sector, that agency will

be consulted prior to any program action by NIST.

NVCASE recognition may be sought by a body that

accredits other bodies, (i.e., an accreditor of

laboratories, certifiers or registrars). If acceptable

accreditation is not available elsewhere, a body may be

accredited directly by NVCASE to perform a function.

70
Conformity

Identification

Availability

of Documentation

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

In the NVCASE evaluation process, an applicant provides

NIST with sufficient information to allow thorough

assessment. The applicant's management system is

thoroughly reviewed based on established internationally

accepted criteria, such as ISO/IEC 9000 series. The

criteria for technical operation are based on internationally accepted criteria such as ISO/IEC Guide

25 for laboratories and ISO/IEC Guide 58 for their

accreditors, ISO/IEC Guide 61 for accreditors of

registrars, and ISO/IEC Guide 62 for registrars.

Each participant must undergo an initial on-site

assessment by peer assessors prior to obtaining

recognition. All elements of non-conformance must be

resolved before recognition will be granted. Once

recognized, follow-up assessments are conducted on a regular two-year cycle, with periodic surveillance

visits both announced and unannounced. NVCASE

recognition is effective until either voluntary or involuntary termination.

NVCASE maintains listings of all recognized bodies,

including the name, address, pertinent contacts and the

scope of recognition. NVCASE also maintains listings of

qualified bodies which have been accredited or otherwise

approved by a NVCASE recognized accreditor (only within

the scope and period of recognition of the accreditor),

indicating they are traceable to NIST via the NVCASE

recognized body. All listings are freely disseminated

to the public through various media.

NVCASE maintains listings of all recognized bodies.

Recognized bodies receive a Certificate of Recognition.

See CFR reference and URL address listed above.

Recognition may be terminated if a participant does not

continue to meet all program requirements.

NVCASE recognition is effective until either voluntary

or involuntary termination.

See Methodology.

See Methodology.

MRA; mutual recognition agreement; NVCASE; recognition;

trade

71
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Received 11/97

COMPUTER SOFTWARE (Including Computer Graphics; Computer

Security; Operating Systems Languages- POSIX;

Programming Languages - C, COBOL 85, FORTRAN 77) - NOTE:

THESE PROGRAMS (EXCEPT FOR COMPUTER SECURITY) ARE

SCHEDULED TO BE TERMINATED BY 10/1/98. (See page 52976

in the Federal Register dated 10/10/97 for further

information on termination schedule.)

U.S. Department of Commerce (DOC)

National Institute of Standards and Technology (NIST)

Information Technology Laboratory (ITL)

Software Diagnostics and Conformance Testing Division

Conformance Testing Group

Bldg. 820, Room 562

Gaithersburg, MD 20899

Phone: (301) 975-3353

FAX: (301) 590-0932

URL address: http://www.itl.nist.gov/div897/stg/ctg.htm

Varies.

Usually voluntary; may be required by agencies in order

to be offered to federal government, otherwise

voluntary.

Federal Information Resource Management Requirements

(FIRMR) Parts 201.13 and 201.39.

To ensure that computer software used by the federal

government and others conform, insofar as is possible,

to applicable Federal Information Processing Standards

(FIPS) and other relevant standards.

Benefits

Methodology

Testing

Reduces software costs to the government; acts as a marketing tool for private industry; assists government

agencies in assessing programming and database language

implementations for conformance to programming language

standards; promotes open systems environments which will

reduce software costs; and increases portability and

interoperability.

Develops conformance testing scenarios, testing

procedures, and test suites. Also conducts software

operational testing services, though this service is

being phased out. Validates that an operating system

has successfully passed the relevant Conformance Test

Suite prior to consideration for purchase by federal

agencies

NIST or NIST recognized testing laboratories.

72
Inspection NIST or NIST recognized testing laboratories

Conformity

Identification

Availability

of Documentation

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

A certificate is issued by NIST. A directory of

approved products is also available from NIST at the

address listed above or on the NIST website.

See Conformity Identification.

Would not receive a certificate unless test results

demonstrated conformance.

Certificate is valid for one year, but may be extended

on a year-to-year basis under certain predefined

circumstances.

International organizations which have entered into

reciprocal agreements with NIST.

Federal Information Processing Standards Publications

(FIPS PUBs), and other relevant private sector software

standards

COBOL; computer graphics; computer security; computer

software; conformance testing; FORTRAN; programming

language validations; software validation; POSIX

73
Products or

Services

Department/Agency

iTANDARD/CERTI F 1 ED REFERENCE MATERIAL!

Received 2/98

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Conformity

Identification

Availability

of Documentation

U.S. Department of Commerce (DOC)

National Institute of Standards and Technology (NIST)

Office of Measurement Services

Standard Reference Materials Program

Bldg. 202. Room 204

Gaithersburg, MD 20899

Phone: (301) 975-6776

FAX: (301) 948-3730

Telex: TRT 197674NIST UT

e-mail: srminfo@nist.gov

URL address: http://ts.nist.gov/srm

Varies by material

Voluntary.

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

To provide certified/standard reference materials which

have been certified for the chemical compositions,

chemical properties, or physical properties to aid in

the control of production processes.

Provides a basis for developing accurate methods of

analysis; for calibration of measurement systems: and

for assuring the long term adequacy and integrity of

measurement quality assurance programs.

Requires testing prior to sale using a previously

validated reference method; two or more independent,

reliable measurement methods; or a network of

cooperating laboratories, technically competent and

thoroughly knowledgeable with the material being tested.

Government testing or testing by a network of

cooperating, technically competent laboratories.

A unique numerical identifier is assigned to every

standard/certified reference material. Materials are accompanied by a certificate of their conformity to

specified characteristics/properties

Standards Reference Materials Catalog and price lists are available from the above address.

Term Indefinite.

74
Reciprocity Materials are recognized and used by other federal and

state agencies, private sector organizations, foreign

governments, and international organizations.

Standards, Codes Chemical composition, chemical properties, or physical

or Regulations properties are specified for each material.

Keywords analysis; calibration; certified reference materials;

measurement; quality assurance; quality control;

reference materials; standard reference materials

75
Products or

Services

Department/Agency

iTAIDARD REFERENCE DATA

Received 11/97

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Conformity

Identification

Availability

of Documentation

Term

Reciprocity

Standards, Codes or Regulations

U.S. Department of Commerce (DOC)

National Institute of Standards and Technology (NIST)

Office of Measurement Services

Standard Reference Data Program

Bldg. 820, Room 113

Gaithersburg. MD 20899

Phone: (301) 975-2200

FAX: (301) 926-0416

e-mai 1 : srdata@nist.gov

URL address: http://www.nist.gov/srd

Varies by material

Voluntary.

Standard Reference Data Act, P.L. 90-396.

To provide well documented numeric data to scientists

and engineers for use in technical problem solving,

research, and development.

See Aim.

Recommended values are based on data that have been

extracted from the world's literature, assessed for

reliability, and then evaluated for preferred values.

Agency serves as certifier, program administrator, and

sales agent/distributor.

Data is evaluated by scientists at NIST and elsewhere.

Listed in NIST Standard Reference Database.

See NIST Standard Reference Database

Indefinite.

Data is recognized and used by other federal and state

agencies, private sector organizations, foreign

governments, and international organizations.

N/A.

Keywords data; numeric data; reference data; standard reference

data

76
Products or

Services

Department/Agency

Ml

Received 2/98

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

U.S. Department of Commerce (DOC)

National Institute of Standards and Technology (NIST)

Office of Weights and Measures (OWM)

Bldg. 820, Room 232

Gaithersburg, MD 20899

Phone: (301) 975-4014

FAX: (301) 926-0647

e-mail: Georgia.Harris@nist.gov

URL SP 791 address:

http : / /ts . ni st . gov/ts/htdocs/230/235/791txt94 . htm

URL Office address:

http : //www. ni st . gov/owm

1965.

Voluntary.

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

Provide recognition of state measurement laboratories

capabilities to calibrate standards and equipment for

measuring mass, length, volume, temperature, and

frequency-based devices.

Provides basis for uniform requirements and consistent

results in metrological calibration and tolerance

testing among states.

This is an 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. Requires inspection and site

approval of new laboratory facilities and installation

and maintenance of measurement control programs.

Program requirements in NIST Handbook 143. Technical

standards in NIST Handbook 145.

All services within this program are performed by state

laboratories recognized by NIST.

Government.

State laboratories receive certificates of measurement

traceability are identified in a list, NIST SP 791.

Instruments and standards certified by state

laboratories may be identified by a state

government-applied mark.

77
Availability NIST SP 791 is available on the NIST website. NIST

of Documentation Handbook 143 is available from NIST. NIST Handbook 145

is out-of-print, but is available from OWM for training

purposes

Obligations of the State laboratories are obligated to participate in

Manufacturer/Vendor regional measurement assurance programs, which include

controlled sample testing, round robin experiments, and

continuing education for technicians.

Enforcement

Term

Reciprocity

Standards, Codes or Regulations

Keywords

NIST exercises influence over state laboratories through

provision of traceability to NIST standards, provision

of training and by sponsoring the Regional Measurement

Assurance Programs. State programs may ban the use of

uncalibrated measurement equipment in their regulatory

programs

NIST Certificates of Measurement Traceability are valid

for one to two years.

NIST certification of a state laboratory carries

recognition within that state and among states and

recognition by federal government agencies and private

organizations

Criteria documents are developed by NIST and adopt

national or international standards. NIST Handbook 143,

available from NIST, adopts ANSI/NCSL Z540-1-1994. as adopted by NVLAP Handbook 150.

frequency; length; mass; measurement instruments;

quality control; state laboratories; temperature; volume

78
Products or Services

Department/Agency

CALIBRATION AND RELATED MEASUREMENT

Received

IRVICES

11/97

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Conformity

Identification

Availability

of Documentation

Term

Reciprocity

Standards, Codes

or Regulations

U.S. Department of Commerce (DOC)

National Institute of Standards and Technology (NIST)

Office of Measurement Services

Calibration Program

Bldg. 820, Room 232

Gaithersburg, MD 20899

Phone: (301) 975-2005

FAX: (301) 869-3548

e-mail: calibrations@nist.gov

URL address: http://ts.nist.gov/calibrations

1901.

Voluntary.

NIST Organic Act (P.L. 100-418).

To provide measurement services, including: the

calibration of standards or instruments, and the conduct

of certain interlaboratory measurement assurance

programs

Provides a basis for developing accurate methods of

analysis; for calibration of measurement systems; and

for assuring the long term adequacy and integrity of

measurement quality assurance programs.

Calibration/verification of accuracy of standards/test

instruments and related measurement services are provided by NIST upon request.

NIST calibration.

Certificate issued by NIST.

Calibration Services Users Guide is available from the

above address.

Varies by service.

Measurement services are recognized; used; and, in some

cases, required by other federal and state agencies,

private sector organizations, foreign governments, and

international organizations.

Specifications and tolerances are for each type of

service.

79
Keywords calibration; measurement; measurement service; quality

assurance; quality control

80
Products or Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Received 11/97

COMMERCIAL WE1GH1IG AID MEASUREMENT DEVICES (Scales,

Automatic Weighing Systems, Belt Conveyor Scales, Mass

Flow Meters, Taximeters, Test Load Cells, Railroad Track

Scales)

U.S. Department of Commerce (DOC)

National Institute of Standards and Technology (NIST)

Office of Weights and Measures (OWM)

National Type Evaluation Program (NTEP)

Bldg. 820, Room 232

Gaithersburg, MD 20899

Phone: (301) 975-2196

FAX: (301) 926-0647

e-mail: Tina.Butcher@nist.gov

URL address: http://www.nist.gov/owm

1984, though a number of state and federal programs

existed prior to this time.

Mandatory in a number of states.

Resolution of the National Conference on Weights and

Measures (NCWM).

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

The National Type Evaluation Program provides 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

United States.

Provides a uniform means of evaluating the performance

of specific devices/systems for conformance to legal

requirements.

Requirements for commercial weighing and measuring

devices are stated in NIST Handbook 44, which is

established through the National Conference on Weights

and Measures (NCWM), whose membership is comprised of

weights and measures officials and others. Because

requirements are stated in general terms and apply to a wide range of devices, a set of interpretations has been

developed which are the type evaluation criteria.

Testing is performed by laboratories authorized by OWM

to perform type evaluations.

Government approved labs. (Authorized laboratory

indicated above is most likely to be an authorized state

measurement laboratory).

81
Inspection NIST, USDA's Grain Packers and Stockyards Administration

(GIPSA) or state government.

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Certificates of Conformance issued to manufacturer

List of qualified devices.

NIST Handbook 44 is available from NIST.

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.

Delisting. States and the USDA's Food Safety and

Inspection Service (FSIS) may require a Certificate of

Conformance before allowing device to be marketed in the

state or in federally-inspected meat and poultry plants.

Certificate is valid as long as the type and model of

instrument is produced consistent with the evaluation

report.

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.

NCWM prepares acceptance criteria, taking advice from

NIST, 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

82
Products or Services

Department/Agency

m FISH AND SEAF

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Received 12/97

U.S. Department of Commerce (DOC)

National Oceanic and Atmospheric Administration (NOAA)

National Marine Fisheries Service (NMFS)

Seafood Inspection Program

1315 East West Hwy.

Silver Spring, MD 20910

Phone: (301) 713-2355 or 1-800-422-2750

FAX: (301) 713-1081

e-mail: Kim.Young@noaa.gov

URL address: http://seafood.ssp.nmfs.gov/iss/issue.html

1958. The voluntary Hazard Analysis Critical

Point (HACCP) Program was introduced in 1992.

Control

Voluntary, though effective 12/18/97 U.S. importers will

have new requirements for foreign-produced product

specifications, process controls (HACCP - Hazard

Analysis Critical Control Point), training, and sanitary

practices. It will be the U.S. importers'

responsibility to verify that these requirements have

been met. The services offered by the Seafood

Inspection Program can help meet these obligations.

Agricultural Marketing Act of 1946 (as amended).

50 CFR Parts 260-266.

Increase consumer confidence in products which bear

inspection marks and grade shields and provide technical

services to the participating industry.

Established quality control (HACCP requirements) for

vessels and seafood processing operations has improved

the wholesomeness of fishery products. The quality and

value of these products is communicated 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 conducts a voluntary seafood inspection program

on a fee-for-service basis. Program involves vessel and

plant sanitation, product inspection, grading,

certification, label review, and laboratory analysis.

Testing in government labs, recognized state labs

Federally accredited private labs.

and

83
Inspection Inspection by licensed government agents and

agents operating with a license agreement.

state

Availability

of Documentation

Conformity Lists of approved suppliers and graded/certified

Identification products. Government applied "U.S. Grade A" mark, "lot

inspected" mark, the "PUFI" (Processed Under Federal

Inspection) and HACCP marks, and the "retail mark" for

seafood retailers and restaurants.

Lists of Sanitary Inspected Fish Establishments (SIFE)

and seafood Processed 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, NOAA

National Marine Fisheries Service

National Seafood Inspection Laboratory

P.O. Drawer 1207

Pascagoula, MS 39567-0112

(601) 762-4591

HACCP regulations for seafood are published by the U.S.

Food and Drug Administration.

Obligations of the Producers/suppliers must comply with sanitary, quality

Manufacturer/Vendor control, and inspection requirements.

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Delisting and removal of authority to use marks.

Indefinite.

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.

Agency prepares all criteria documents including the

Fishery Products Inspection Manual. HACCP regulations

for seafood are published by the U.S. Food and Drug

Administration.

fish quality; fish; fishery products; HACCP; plant

inspection; PUFI; quality standards; sanitation; seafood

specifications; seafood; SIFE

84
Products or

Services

Department/Agency

UU¥ TRANSMITTERS AID RELATED EQl

Received 2/98

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

U.S. Department of Commerce (DOC)

National Oceanic and Atmospheric Administration (NOAA)

National Environmental Satellite, Data, and Information

Service (NESDIS)

Direct Services Division

E/SP3, Stop 9909

4700 Silver Hill Road

Washington, DC 20233-3309

Phone: (301) 457-5681

FAX: (301) 457-5620

URL address: http: //140 . 90 . 207 . 25 : 8080/noaasi s .html

Mandatory.

15 U.S.C. 3.3, 49 U.S.C. 1483.

Regulations on the administration and operation of a Geostationary Orbiting Environmental Satellite Data

Collection System (GOES-DCS) is codified at 15 CFR, Part

911.

The NOAA GOES Data Collection System utilizes geostationary satellites to collect environmental data from

remote locations. Standards on UHF transmitters and

related equipment are established and equipment

certified.

Ensures system integrity of the NOAA GOES Data

Collection System.

Manufacturers submit plans for in-plant testing of Data

Collection Platform Radio Sets. If the plans are

approved, a NOAA representative visits the

manufacturer's testing facility and witnesses the tests.

If a representative unit meets all of the established

standards a type certificate is issued to the

manufacturer.

Government witnessed at manufacturer's facility.

Government witnessed at manufacturer's facility.

A type certificate is issued to approved sets.

List of certified manufacturers and model numbers

obtainable from: Chief, Direct Services Division, E/SP3,

Stop 9909, 4700 Silver Hill Road. NOAA/NESDIS,

Washington, DC 20233-9909.

85
Enforcement Notification to both manufacturer and user community

that a specific manufacturer's equipment is not

certified for use on GOES DCS.

Term

Standards, Codes

or Regulations

Keywords

No expiration date.

Four standards for self -timed,

international and interrogated

Radio Sets are available from:

Services Division. E/SP3. Stop

Road, NOAA/NESDIS. Washington,

random reporting.

Data Collection Platform

DCS Manager, Direct

9909. 4700 Silver Hill

DC 20233-9909.

satellites; environment; electronic equipment; data

processing; aerospace

86
Products or Services

Department/Agency

WEKWER OBSERVERS/STATION

Received 7/98

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

U.S. Department of Commerce (DOC)

National Oceanic and Atmospheric Administration (NOAA)

National Weather Service (NWS)

Surface Weather Observing Program

1325 East West Highway

Silver Spring, MD 20910

Phone: (301) 713-1792

FAX: (301) 713-0959

URL address: Under development.

1928.

Mandatory.

Organic Act of the National Weather Service, 15 U.S.C.

311.

Codify the basis for training, examination and

certification of all surface aviation weather observers

in all 50 states, territories and Micronesia.

Assures consistent, minimum performance expectations for

manual weather observations used for the preparation of

forecasts and warnings and the support of aviation

operations

Observers are certified by examination and experience

for acceptable vision, adequate training, and

demonstrated ability to take and record accurate and

timely weather observations. Stations are approved

based on use of appropriate instrumentation,

installation of automated sensors, maintenance programs,

and certification of observers.

Government.

Government.

Government-issued certificates and master list of

validated observers and a list of observatories.

Each NWS regional headquarters maintains a master list

of certified observers within their

region

Certificate holder is required to maintain skill level

through experience (taking a minimum number of

observations throughout the year).

87
Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Certificate cancellation.

Audit testing keyed to individual performance, eyesight,

and current experience.

Data is used by other federal agencies, State agencies,

and private organizations.

NWS prepares examination questions and performance

criteria. Standards for observing, determining, and

reporting weather information are included in the series

of Federal Meteorological Handbooks, Federal Standard

for Siting Meteorological Sensors, and operational

directives from the NWS.

Keywords aviation weather; eyesight examination; vision

standards; weather observation; weather station

88
Products or Services

Department/Agency

flER Received 12/97

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

U.S. Department of Commerce (DOC)

National Oceanic and Atmospheric Administration (NOAA)

National Environmental Satellite, Data and Information

Service (NESDIS)

National Climatic Data Center (NCDC)

Climate Services Branch (E/CC31)

151 Patton Ave. . Room 120

Asheville, NC 28801-5001

Phone: (704) 271-4800

FAX: (704) 271-4876

e-mai 1 : orders@ncdc . noaa . gov

URL address: http://www.noaa.gov/

Voluntary service.

Federal Records Act of 1950.

Certifies weather records and data for litigation.

Certified records are more readily accepted in legal

proceedings

NCDC is the collection center and the custodian of all

U.S. weather records and is the largest climatic center

in the world. NCDC uses this information to certify

copies of archived weather records and publications for

1 itigation.

N/A.

N/A.

Certification document.

Data and information services are described in the NOAA

Environmental Services Data Directory (N0AADIR), the

NOAA National Environmental Data Referral Service

(NEDRED), and the NOAA Product Information Catalog

(PIC).

Pay appropriate fees.

Term Indefinite

89
Reciprocity Accepted within the U.S. legal system and by other U.S.

and state government agencies.

Keywords certified record; cl imatological data; weather; weather

data; weather records

90
WC INDEX

Product Page

accreditation 70

calibration 74. 77, 79

certified reference materials 74

COBOL 72

computer security 72

computer software 72

computer graphics 72

conformity assessment recognition 70

data, weather 85, 87, 89

data, environmental 85, 87

data 76

electronic equipment 85

fasteners 67

fish 83

fishery products 83

food quality/safety 83

FORTRAN 72

HACCP 83

laboratories, state 77

laboratory accreditation 67, 70

measurement instruments 77, 79, 81

mutual recognition agreement 70

NTEP 81

numeric data 76

POSIX 72

programming language validations 72

PUFI 83

railroad track scales 81

recognition, conformity assessment 40, 70

reference data 76

reference materials 74

satel 1 ites 85

scales, railroad track 81

seafood 83

shellfish 83

SiFE 83

software validation 72

standard reference data 76

standard reference materials 74

traceability 74, 77, 79

trade fairs 65

trade 65, 70

transmitters. UHF 85

91
weather station 87

weather data 85, 87, 89

weather observers 87

weighing systems 77, 79, 81

92
U.S. DEPARTMENT OF DEFEN

93
Products or

Services

Department /Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

QUAL1F1EI

IK

Received 6/98

CT LISTS

AfTURERS :qmls)

U.S. Department of Defense (DOD)

Defense Logistics Agency, DLSC-LM

Defense Standardization Program Office

DOD Executive Agency for Standardization

8725 John J. Kingman Road, Suite 2533

Fort Bel voir, VA 22060-6221

767-6888

767-6876

ireland@hq.dla.mil

Phone: (703)

FAX: (703)

e-mai 1 : judy

1949.

Mandatory for those products defined by procurement

specifications and having qualification 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' products.

The Qualification 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.

Conducts pretesting and vendor facility evaluation 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.

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.

94
Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

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

designation (J or JAN Mark) may be applied by the

manufacturer/distributor to qualified semiconductors,

microelectronic, and products with established

reliability.

DOD specifications and QPL's are distributed by:

DOD Single Stock Point

Standardization Document Order Desk

700 Robbins Ave. , Building 4D

Philadelphia, PA 19111-5094

Maintain a quality management program. 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

Reciprocity

Standards, Codes or Regulations

Keywords

Del isting.

Validated every two years; most critical components

require retesting at periodic intervals.

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.

Program is based on qualification requirements specified

in Military Specifications.

government procurement; military; military

specifications; military systems; procurement;

qualification; quality control ; testing

QPL;

95
Products or

Services

Department/Agency

Compliance

Authority

Not Received

ARHY CONTRACTORS/SUPPLIERS

CONTRACTOR PERFORMANCE CERTIFICATION PRQSRMfl (CP)2

U.S. Department of Defense (DOD)

U.S Department of the Army

U.S. Army Material Command

Public Affairs Office

6001 Eisenhower Ave.

Alexandria. VA 22333

Phone: (703) 617-4723

FAX: (703) 617-8010

URL address: http://wwvj.amc.army.mil

Voluntary supplier recognition program open to any

contractor what has pursued or made plans to pursue

contracts with the Army Material Command's (AMC) Major

Subordinate Commands (MSCs).

Federal Acquisition Regulations, General Provisions.

Part 9.

Defense Standardization Manual. DOD 4120. 3-M.

Defense Standardization Document SD-6.

Aim

Benefits

Methodology

To use an established methodology and set of measures to

appraise contractor's development, production, and

maintenance facilities to identify those contractors

with a commitment to quality, customer satisfaction, and

improved products and processes.

Cuts government and contractors administrative costs

while increasing levels of contractor quality and

performance.

Involves the determination of eligibility for one of

three types of certifications: (1) production

certification; (2) design and development certification;

and (3) production, design and development

certification. Contractor commits to a multi -phase

assessment process. Contractor submits information on facilities, organizational structure, and past

performance. A initial and final assessment is

conducted by an assessment team (composed of individuals

from the MSCs and the contractor) using 28 defined

criteria and a series of additional assessment audits

requested by the contractor to verify that suggested

actions have been implemented. When all criteria have

been met and related concerns addressed by the

contractor, a memorandum of agreement is issued

detailing the scope and responsibilities of the

contractor's (CP)2 status. The contractor then provides

periodic reports on its management and program and

96
government may conduct additional assessment as needed

to determine continued compliance with criteria.

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes or Regulations

Keywords

See Methodology.

See Methodology.

See Methodology.

AMC-P 715-6 Contractor Performance Certification Program

(CP)2 and Contractor Performance Certification Program

(pamphlet), published by the U.S. Army Material Command.

See Methodology.

Removal of (CP)2 recognition.

See Methodology.

None.

Program is based on qualification requirements specified

in Military Specifications or other relevant standards.

Army; (CP)2; government procurement; military; military

specifications; military systems; procurement;

qualification; quality control; testing

97
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Enforcement

Standards, Codes

or Regulations

Keywords

Received 12/97

JSE III DOB'S DEFENSE MESSAGE SYSTEM (DMS)

(Electronic Messaging System Products)

U.S. Department of Defense (DOD)

Assistant Secretary of Defense (Command, Control,

Communications and Intelligence)

Defense Information Systems Agency (DISA)

C4 and Intelligence Program Integration Directorate

(D24)

Skyline 5

5111 Leesburg Pike

Falls Church, VA 22041-3205

Phone: (703) 681-0753

FAX: (703) 681-0343

e-mai 1 : dms@ncr.disa .mi 1 URL address: http://www.disa.mil/D2/dms

1997.

Mandatory for e-mail products sold to DoD.

Federal Acquisition Regulations.

Provide secure, accountable, reliable writer-to-reader

messaging for the warfighter at reduced cost.

See Aim.

Pretesting is required prior to purchase by DOD or the

Services

Testing by Joint Interoperability Test Command, DISA.

See Testing.

Certified products can be sold as "DMS-Compliant.

DISA also maintains a Certified Compliant Products List

(CCPL).

See URL address listed above.

Delisting

Uses X.400 and X.500.

Defense Message System; DMS; electronic communications

government procurement; messaging systems; military

specifications; military systems; procurement; QPL;

qualification; testing; command and control; e-mail

98
Products or

Services

Department/Agency

Received 6/98

WAL AUTOMATED TELECOMMUNICATION SYSTEMS ASHORE AND

Compliance

Authority

Aim

Benefits

Methodology

Testing

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Reciprocity

Standards, Codes or Regulations

Keywords

U.S. Department of Defense (DOD)

Defense Information Systems Agency (DISA)

Joint Interoperability Test Command (JITC)

7700 Redman Avenue

Clinton, MD 20725

Phone: (301) 394-0441

FAX: (301) 394-0285

e-mail: carmanyt@ncr.disa.mil

Mandatory for products supplied to the U.S. Navy.

Federal Acquisition Regulations.

Maintain a high level of quality for critical products

through pre-procurement evaluation of prospective

vendors' products.

To ensure compatibility of naval automated

telecommunication systems ashore and afloat.

Testing is conducted by the government at the Joint

Interoperability Test Command.

See above.

DOD specifications are distributed by:

DOD Single Stock Point

Standardization Document Order Desk

700 Robbins Ave., Building 4D

Philadelphia, PA 19111-5094

Suppliers are obligated to meet qualification

requirements specified in Military Specifications.

None, though meeting qualifications requirements is

required for suppliers of naval automated

telecommunication systems ashore and afloat.

None.

Program is based on qualification requirements specified

in Military Specifications.

government procurement; military; military

specifications; naval systems; procurement;

telecommunications equipment

99
DO© MM!

Product Page

(CP)2 96

communications procurement 98, 99

DMS 98

e-mail 98

electronic equipment procurement 98, 99

military procurement 94, 96, 98, 99

procurement, government 94, 96. 98, 99

QMLs 94

QPLs 94

telecommunications procurement 98, 99

100
y.So PEMIEiT ©F E1E«

101
Products or

Services

Department/Agency

Initiated

ITIAL

le bb

Received 7/98

JSUHER APPLIANCES . LIGHTING DEVICES.

rrs. aid commercial equipment

U.S. Department of Energy (DOE)

Energy Efficiency and Renewable Energy

Office of Codes and Standards

1000 Independence Avenue. SW

Washington, DC 20585-0121

Phone: (202) -586-9127

FAX: (202) -586-4617

E-mail : michael .mccabe@ee.doe.gov

URL address: http://www.eren.doe.gov/

bui 1 di ngs/codes_standards/i ndex . htm

Standards were effective for residential consumer

products; lighting devices; plumbing products; and

commercial equipment as follows:

Effective Date Product/Equipment

January 1. 1988 Dishwashers, Clothes Dryers, Clothes

Washers

January 1. 1990 Refrigerators. Refrigerator-Freezers,

Freezers, Room AC, Water Heaters, Pool

Heaters, Direct Heating Equipment,

Fluorescent Lamp Ballasts (with some exceptions), Kitchen Ranges and Ovens

September I, 1990 Mobile Home Furnaces

January 1, 1992 Central AC (Split System), Furnaces,

Boi lers

January 1, 1993 Central AC (Single Package)

January 1, 1994 Faucets, Showerheads, Water Closets,

Urinals. Small Commercial Packaged

AC and Heating Equipment. Packaged

Terminal AC and Packaged Terminal

HP. Warm Air Furnace and Packaged

Boilers, Storage Water Heaters,

Instantaneous Water Heaters, and

Unfired Storage Tanks

May 1, 1994 General Service Fluorescent Lamps

(8-foot)

January 1, 1995 Large Commercial Package AC and

Heating Equipment, Incandescent

Reflector Lamps. General Service

Fluorescent Lamps (4-foot and

2- foot)

November 24. 1997 Electric Motors (1 hp - 200 hp)

Compliance Mandatory for all manufacturers and importers of covered

products/equipment.

102
Authority The Energy Policy Act (EPAct), P.L. 102-486.

The National Appliance Energy Conservation Act (NAECA),

P.L. 100-12.

The National Energy Conservation Policy Act, P.L. 95-

619.

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

163.

Aim Reduce energy consumption through the use of more efficient residential consumer appliances, lighting

devices, plumbing products, and commercial equipment.

Benefits The establishment of technically feasible minimum energy

efficiency (or maximum energy use) levels for various

residential consumer appliances, lighting devices,

plumbing products, and commercial equipment will save the taxpayer money on utility bills, reduce the need for

utility companies to construct additional power plants,

and provide significant benefits to the environment by

reducing the discharge of COx, NOx and SOx pollutants.

Methodology Administer a program to establish test procedures to

evaluate the energy use of residential consumer

appliances, lighting devices, plumbing products, and

commercial equipment (if needed), conduct analyses to

determine cost/benefit of new or amended energy

efficiency standard levels, monitor manufacturer/private

labeler compliance via self-certification, conduct

enforcement activities as required by law.

Testing Uses manufacturer's lab and third party labs.

Inspection Government

Conformity See FTC entry.

Identification

Availability 10 CFR Part 430, 10 CFR Part 431 (currently under

of Documentation development)

Obligations of the Self-certifi cation and labeling.

Manufacturer/ Vendor

Enforcement Any person who knowingly violates energy efficiency

standards provisions shall be subject to a civil penalty

of $100 per violation. Some violations are subject to a $100 penalty per day.

103
Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Indefinite term.

The Energy Policy Act (EPAct). P.L. 102-486 and the

National Appliance Energy Conservation Act (NAECA), P.L.

100-12, which amend the Energy Policy and Conservation

Act (EPCA). P.L. 94-163, preempt corresponding state

regulation/program unless a waiver is granted by the DOE

or the state regulation/program is exempt under specific

EPAct or NAECA provisions.

10 CFR Part 430. 10 CFR Part 431 (currently under

development)

appliances; boilers; central air conditioners; clothes

dryers; clothes washers; codes; commercial package air

conditioning and heating equipment; consumer products;

direct heating equipment; dishwashers; electric motors;

energy efficiency; EPACT; EPCA; faucets; showerheads;

water closets; urinals; fluorescent lamp ballasts;

furnaces; general service fluorescent lamps;

incandescent reflector lamps; kitchen ranges and ovens;

lighting; mobile home furnaces; NAECA; packaged terminal

air conditioners and packaged terminal heat pumps; pool

heaters; refrigerators; refrigerator-freezers; freezers; room air conditioners; standards; storage water heaters;

instantaneous water heaters; unfired storage tanks; warm

air furnace and packaged boilers; water heaters

104
Products or

Services

Received 12/97

MAJOR APPLIANCES . HEATING AND COOLING

EQUIPMENT/SYSTEMS. RESIDENTIAL LIGHTING FIXTURES, OFF]

EQUIPMENT. NEW HOMES - ENERGY STAR PRC

Department/Agency U.S. Department of Energy (DOE)

Office of Building Equipment

Energy Star Program

1000 Independence Ave., SW

Washington, DC 20585

Phone: (202) 586-9127 or 1-800-doe-erec

FAX: (202) 586-1628

e-mail: info@energystar.gov

URL address: http://www.energystar.gov

NOTE: This program is conducted jointly with the U.S.

Environmental Protection Agency (EPA). See also EPA

Energy Star entry.

Initiated Program began with computers in 1993. Other products

have been added to the program since that time.

Compliance

Authority

Voluntary.

Energy Policy Conservation Act (EPCA) as amended

P.L. 94-163, 89 Stat. 917, 42 U.S.C. 6295.

Aim Reduce energy consumption through voluntary/industry

government programs to promote efficient appliance.

Benefits Helps consumers identify and buy products that use less

energy, and raises awareness about environmental and

economic benefits of energy efficient products.

Methodology The federal government defines minimum standards for

energy consumption for many consumer products such as major appliances. In order for one of these products to

receive an Energy Star rating, it must exceed the

minimum federal standard by a certain amount, which

varies from product to product. For other products

where there are no minimum energy use standards (such as office equipment), products which qualify for the Energy

Star label have special features which enable them to

use less energy than similar products.

105
Testing Independent third party

Inspection

Conformity

Identification

Independent third party,

Energy Star label

Availability

of Documentation

See URL address listed above,

Obligations of the See Methodology.

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Revocation of license to use the Energy Star label

Indefinite term.

None, though program is recognized by many states,

utility companies and retailers who cooperate in

promoting the program.

Standards, Codes The federal government defines minimum standards for

or Regulations energy consumption for many consumer products such as major appliances. In order for one of these products to

receive an Energy Star rating, it must exceed the

minimum federal standard by a certain amount, which

varies from product to product. For other products

where there are no minimum energy use standards (such as office equipment), products which qualify for the Energy

Star label have special features which enable them to use less energy than similar products.

Keywords appliances; dishwashers; energy star; clothes washers;

office equipment, heating and cooling equipment/systems;

refrigerators; residential lighting fixtures; room air

conditioners; new homes

106
Products or

Services

HIGH ENERGY PARTICULATE

Received 1/98

[PA) FILTERS

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

U.S. Department of Energy (DOE)

Assistant Secretary for Defense Programs

DP-2

Room 4A-028 Forestal Building

Washington. DC 20585

Phone: (202) 586-2181

FAX: (202) 586-1628

e-mail: victor.reis@dp.doe.gov

URL address: http://www.dp.doe.gov/Public/default.htm

1960.

Recommended for the Dept. of Energy (DOE).

The Atomic Energy Act of 1954.

Energy Reorganization Act of 1974.

Department of Energy (DOE) Reorganization Act of 1977.

To improve and ensure the safety of nuclear facilities

This program ensures that the filters used in DOE

facilities have demonstrated compliance with DOE

standards.

Methodology High Efficiency Particulate Air (HEPA) filters must be

approved prior to use in DOE facilities. Quality

assurance/specification inspection and performance

testing is conducted prior to installation in DOE

faci 1 ities

Testing Testing is conducted by DOE contractor test facilities

Inspection Inspection is conducted by DOE contractor test

facilities.

Conformity Certification label on the inspected/tested filters.

Identification

107
Availability

of Documentation

Documentation is maintained on all tested filters.

General results of testing are presented at Air Cleaning

Conferences.

Enforcement Noncompliant filters are returned to the manufacturer

for replacement. Continued failure of products would

result in a ban and/or cancellation of contract.

Term

Reciprocity

Indefinite.

Inspection and testing of non-DOE private and other

agency filters are conducted on a cost recovery basis at

DOE Filter Test Facilities as capacities permit.

Standards, Codes

or Regulations

Department of Energy Standards:

F 3-42, Operating Policy of DOE Filter Test Program,

which is being replaced by DOE-STD-3022-97 , DOE HEPA

Filter Test Program.

F 3-43. Quality Assurance Testing of HEPA Filters

F 3-44, DOE Filter Test Facilities Quality Program Plan

DOE-STD- 3020-97, Specifications for HEPA Filters Used

by DOE Contractors

Keywords HEPA filters; nuclear energy

108
ME IMBEK

Product Page

air conditioners/systems 102, 105

appliances 102, 105

boilers 102

clothes dryers 102

clothes washers 102, 105

dishwashers 102, 105

electric motors 102

energy efficiency 102, 105

filters 107

fluorescent lamps 102

freezers 102

furnaces 102. 105

heating equipment /systems 102, 105

HEPA filters 107

homes, new 105

incandescent lamps 102

lamps 102, 105

lighting 102. 105

mobile home furnaces 102

nuclear energy 107

office equipment 105 ovens 102

plumbing products 102

pool heaters 102

ranges 102

refrigerators 102, 105

water heaters 102

109
lE^MTMEW ©F MBOTnl m OMM SERVXC

no
Products or Services

RESPIRATORS AID

DUST SAMPLERS

Received 4/98

PERSONAL I

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

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

Center for Disease Control and Prevention (CDC)

National Institute for Occupational Safety and Health

(NIOSH)

Appalachian Laboratory for Occupational Safety & Health

Certification and Quality Assurance Branch

Division of Respiratory Disease Studies

1095 Willowdale Road

Morgantown, WV 26505-2888

Phone: (304) 285-5907

For listings of certified respirators, call: 1-800-35-

NIOSH

URL address: http://www.cdc.gov/niosh/homepage.html

1972. Latest modification in 1995 (Note that this

change was the first in a series of modules which will

be published to upgrade respirator approval standards.

Voluntary.

30 CFR Part 74; 42 CFR Part 84.

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

life-threatening problems with respiratory protective

equipment are detected and corrected before

equipment-related injuries occur.

Federal design approval /testing and certification is

requi red.

Government laboratory and manufacturers labs.

Ill
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 website or by calling the number listed above.

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

Reciprocity

Indefinite term.

Certain mine emergency devices are certified jointly

with the Mine Safety and Health Administration (MSHA)

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

112
Received 5/98

Products or Services

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

Center for Disease Control and Prevention (CDC)

National Institute for Occupational Safety and Health

(NIOSH)

Hazard Evaluation and Technical Assistance Branch

4676 Columbia Pkwy. , R-9

Cincinnati, OH 45226

Phone: (513) 851-4382

FAX: (513) 841-4488

URL address: http://www.cdc.gov/niosh/hhepage.html

Compliance

Authority

Voluntary.

For Private Sector Workplaces: Section 20(a)(6) of the

Occupational Safety and Health Act (P.L. 91-596):

Section 501(a) of the Federal Mine Safety Act of 1977;

42 CFR 85.

For Federal Workplaces: Section 19 of the Occupational

Safety and Health Act; E.O. 12196 dated February 26,

1980; 29 CFR 1960.

In Other Governmental Agency Work

the Occupational Safety and Healt

places: Section 18 of

h Act (29 U.S.C. 667).

Aim To evaluate new or unique types of hazards or common workplace hazards which are not well understood.

Benefits Provides a mechanism to obtain a scientific and

professional evaluation of potential hazards on the

workplace.

Methodology NIOSH conducts, in response to requests, assessments of

whether there is a health hazard to employees caused by

exposure to hazardous materials (chemical or biological

contaminants) in the workplace. NIOSH also evaluates

other potentially hazardous working conditions, such as exposures to heat, noise, radiation, or musculoskeletal

stresses. In some cases, requests are referred to a state agency or other resources as appropriate.

Testing Testing is conducted by NIOSH as appropriate,

113
Inspection Inspections are conducted by NIOSH personnel as appropriate.

Conformity

Identification

Reports of determination, findings, and recommendations

are published.

Availability

of Documentation

Additional information is available at the URL address

listed above or by contacting NIOSH.

Obligations of the N/A.

Manufacturer/ Vendor

Enforcement While NIOSH has no authority to enforce the adoption of

recommendations in the report, most employers attempt to

address any problems identified in the HHE report.

Term

Reciprocity

N/A.

Recognized by OSHA, other federal and state agencies as being an authoritative source of information.

Standards, Codes

or Regulations See Authority.

Keywords contaminant; hazard; health hazard; workplace

114
Products or Service

Department /Agency

^EllFM (Oysters

Received 9/98

Clams, Mussels, and

Seal lops)

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

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Seafood

Division of Programs and Enforcement Policy

200 C St. , SW

Washington, DC 20204

Phone: (202) 418-3150

FAX: (202) 418-3196

E-mai 1 : seafood@bangate . fda . gov

URL address: http://vm.cfsan.fda.gov/seafoodl.html or http : //www. fda . gov/opacom/morechoi ces/

sma 1 1 busi ness/bl ubook . htm

Initiated 1925.

Compliance Voluntary/Cooperative. Mandatory coverage under the

Domestic Fish and Fishery Products Inspection Program

only when the appropriate state authority cannot or will

not provide appropriate coverage under the terms of the

National Shellfish Sanitation Program (NSSP).

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

Public Health Service Act, as amended.

Fair Packaging and Labeling Act.

Aim The NSSP is the federal /state cooperative program

recognized by FDA and the Interstate Shellfish

Sanitation Conference (ISSC) for the sanitary control of

Shellfish produced and sold for human consumption. The

purpose of the NSSP is to promote and improve the

sanitation of shellfish (oysters, clams, mussels and

scallops) moving in interstate commerce through

federal /state cooperation and uniformity of State

shellfish programs. Participants in the NSSP include

agencies from shellfish producing states, FDA, and the

shellfish industry. Under international agreements with

FDA, foreign governments also participate in the NSSP.

Other components of the NSSP include: program

guidelines; state growing area classification and dealer

certification programs; and FDA evaluation of state

program elements.

115
Benefits The NSSP was designed to prevent illness associated with

the consumption of shellfish (oysters, clams, mussels,

and scallops - scallops are excluded when the final

product is shucked adductor muscle only.) consumption.

Methodology Each shellfish shipping state adopts adequate laws and

regulations for sanitary control of the shellfish

industry, completes sanitary surveys of growing areas,

delineates and patrols restricted areas, inspects

shellfish plants, and conducts such additional

inspections, laboratory investigations and control

measures as are necessary to insure that shellfish

reaching the consumer have been grown, harvested and

processed in a sanitary manner. The FDA conducts an annual review of each state shellfish control program,

"including the inspection of a representative number of

shellfish processing plants. On the basis of the

information obtained, the FDA determines the degree of

conformity the state control program has with the NSSP.

The shellfish industry cooperates by obtaining shellfish

from safe sources, by providing plants which meet the

agreed upon sanitary standards, by maintaining sanitary

operating conditions, by placing the proper certificate

number on each package of shellfish, and by keeping and

making available to the control authorities, records

which show the origin and disposition of all shellfish.

Testing

Inspection

Testing is performed by state and local laboratories

Inspection is performed by the State Shellfish

Sanitation Control Authority (SSCA).

Conformity

Identification

The states annually issue number certificates to

shellfish dealers who comply with the agreed-upon

sanitary standards, and forward copies of the interstate

certificates to the FDA. For the information of health

authorities and others concerned, the FDA publishes a monthly list of all shellfish shippers certified by

states that maintained "satisfactory" control program.

Availability Persons interested in received information and

of Documentation publications about the NSSP, contact:

Program and Enforcement Branch (HFS-417)

Division of Programs and Enforcement Policy

Office of Seafood

FDA

116
200 C St. , SW

Washington, DC 20204

Phone: (202) 418-3177

Persons interested in technical assistance about the

NSSP, contact:

Shellfish Safety Team (HFS-628)

Division of Cooperative Programs

Office of Field Programs

FDA

200 C St. , SW

Washington, DC 20204

Phone: (202) 205-5461

Persons interested in receiving the ICSSL, Interstate

Shellfish Dealer's Certificate Form FD 3038, contact:

Division of Cooperative Programs (HFS-625)

Office of Field Programs

FDA

200 C St. , SW

Washington, DC 20204

Phone: (202) 205-8137

Persons interested in receiving information about the

ISSC, contact:

ISSC

115 Atrium Way, Suite 117

Columbia. SC 29223-6382

(803) 788-7559

Obligations of the Shellfish plants certified by the SSCA are required

Manufacturer/Vendor to place then' certification number on each container or package of shellfish shipped. The number indicates that

the shipper is under state inspection, and that it meets

the applicable state requirements, it also serves the

important purpose of identifying and tracing shipments

found to be contaminated or involved in disease

outbreaks. Shippers are requried to keep records

showing the origin and disposition of all shellfish

handled to make these records available tot he control

authorities

Enforcement FDA removes noncompliant firms, as identified by the

states, from the ICSSL.

Term Indefinite; The "INTERSTATE CERTIFIED SHELLFISH SHIPPERS

LIST" (ISSN 0364-7048) is published monthly for

117
information and use by food control officials, the

seafood industry and other interested persons.

Reciprocity The shippers listed have been certified by regulatory

authorities in the U.S., Canada, Chile, the Republic of

Korea, Mexico and New Zealand under the uniform

sanitation requirements of the national shellfish

program. Control measures of the states are evaluated

by the FDA. Canadian, Chilean, Korean, Mexican, and New

Zealand shippers are included under the terms of the

shellfish sanitation agreements with the governments of

these countries.

Standards, Codes The National Shellfish Sanitation Program - Guide for

or Regulations the Control of Molluscan Shellfish, which consist of a Model Ordinance, supported guidance documents,

recommended forms, and other related materials

associated with the Program.

Keywords clams; Interstate Certified Shellfish Shippers List;

Interstate Shellfish Sanitation Conference; ISSC;

mussels; National Shellfish Sanitation Program; NSSP;

oysters; scallops; seafood; shellfish

118
Received 9/98

Products or FISH AND FISHERY PRODUCTS, including RAH MDllUSCAN

Service SHELLFISH (that is not inspected under a cooperative

agreement with the Interstate Shellfish Sanitation

Conference (ISSC); or when the appropriate state

authority cannot or will not provide appropriate

coverage under the terms of the National Shellfish

Sanitation Program (NSSP))

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

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Seafood

Division of Programs and Enforcement Policy

200 C St. , SW

Washington, DC 20204

Phone: (202) 418-3150

FAX: (202) 418-3196

E-mail: seafood@bangate.fda.gov

URL address: http://vm.cfsan.fda.gov/seafoodl.html or

http: //www. fda . gov/opacom/morechoices/

smal 1 busi ness/bl ubook . htm

Initiated

Compliance

Authority

1906

Mandatory.

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

Public Health Service Act, as amended.

Fair Packaging and Labeling Act.

Aim The FDA currently operates oversight compliance programs

for domestic fish and fishery products and import

seafood products under which responsibility for the

product's safety, wholesomeness , identity and economic

integrity rests with the processor or importer.

Benefits The programs are designed to ensure that seafood

products are prepared, packed, and held under sanitary

conditions; that they are safe, clean, wholesome, and

that their labeling is honest and informative.

Methodology FDA conducts both mandatory surveillance and enforcement

inspection of domestic seafood harvesters, growers,

wholesalers, warehouses, carriers and processors under

119
the authority of the FD&C Act. The frequency of

inspection is at the agency's discretion, and firms are required to submit to these inspections which are backed

by federal statutes containing both criminal and civil

penalties. Most FDA in-plant inspection consider

product safety, plant/food hygiene and economic fraud

issues, while other inspections address subsets of these

compliance concerns. In addition, FDA has the authority

to detain or temporarily hold food being imported into

the U.S., while it determines if the product is

misbranded or adulterated. The FDA receives notice of

every seafood entry, and at its option, conducts wharf

examinations, collects and analyzes samples, and where

appropriate, detains individual shipments or invokes

"Automatic Detention," requiring private or source country analysis of every shipment of product when

recurring problems are found, before the product is

allowed entry.

Testing Samples may be taken during FDA inspections in

accordance with the agency's annual compliance programs

and operational plans or because of concerns raised

during individual inspections. The FDA has laboratories

around the country to analyze samples taken by its

investigators. These analyses are for a vast array of

defects, including chemical contaminants, decomposition,

net weight, radionuclides, various microbial pathogens,

food and color additives, drugs, pesticides, filth and

marine toxins such as Paralytic Shellfish Poison (PSP)

and domoic acid.

Inspection FDA conducts both mandatory surveillance and enforcement

inspections of domestic seafood harvesters, growers,

wholesalers, warehouses, carriers and processors under

the authority of the FD&C Act. The frequency of

inspection is at the agency's discretion, and firms are required to submit to these inspections which are backed

by federal statutes containing both criminal and civil

penalties

Conformity Inspection reports. In addition, FDA has historically

Identification issued a number of different types of certificates.

e.g.. Certificates of Free Sale, Certificate of Export.

Certificates to Foreign Governments, and most recently

European Union (EU) Health Certificates for Fishery

Products. FDA's long term goal is to work towards the

reduction or elimination of export certificates by

finding other means to assure other countries of the

acceptability of FDA regulated products.

120
Availability FDA/Center for Food Safety and Applied Nutrition

of Documentation Office of Seafood

Division of Programs and Enforcement Policy (HFS-415)

200 C St. , SW

Washington, DC 20204

Phone: (202) 418-3150

Obligations of the Seafood processors and importers must comply with

Manufacturer/Vendor regulations promulgated under the Food, Drug and

Cosmetic Act of 1938, as amended; the Public Health

Service Act, and the Fair Packaging and Labeling Act.

Recent significant additions to these regulations

require that seafood processors (both domestic and

foreign) implement a preventative system of food safety

controls known as Hazard Analysis Critical Control Point

(HACCP) and that seafood importers have and implement

written verification procedures to verify that their

foreign suppliers have implemented this system.

Enforcement If a company if found violating any of the laws that FDA

enforces, FDA can encourage the firm to voluntarily

correct the problem or to recall a faulty product from

the market. A recall is generally the fastest and most

effective way to protect the public from an unsafe

product. When a company can't or won't correct a public

health problem with one of its products voluntarily. FDA

has legal sanctions it can bring to bear. The agency

can go to court to force a company to stop selling a product and to have items already produced seized and

destroyed. When warranted, criminal penalties--

including prison sentences--are sought against

manufacturers and distributors.

Term Indefinite.

Reciprocity The agency has a variety of agreements with foreign

governments. An agreement can be formal or informal,

depending on the substance of the agreement. Agreements

with foreign governments include Memoranda of

Understanding, Memoranda of Agreement, Notes Verbal e, Exchange of Letters, Memoranda of Cooperation, and

Mutual Recognition Agreements. These agreements

include, but are not limited to, information exchange,

mutual recognition of inspection reports, and product

certification.

121
tandards. Codes

or Regulations

The FDA's regulations are printed in 21 CFR. In

addition, FDA and other government agencies publish new regulations and proposals in the Federal register

throughout the year. One book in particular. 21 CFR

100-169, contains general regulations for food labeling,

food standards, and current good manufacturing practice

for food, in addition, this book contains seafood HACCP

regulations and regulations for low-acid canned foods

and acidified foods.

Keywords clams; fish; fishery products; HACCP; moilusks; mussels

oysters; seafood; shellfish

122
Products or

Service

Received 9/98

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

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Seafood

Division of Programs and Enforcement Policy

200 C St. , SW

Washington, DC 20204

Phone: (202) 418-3150

FAX: (202) 418-3196

E-mai 1 : seafood@bangate . fda . gov

URL address: http://vm.cfsan.fda.gov/seafoodl.html or

http: //www. fda .gov/opacom/morechoices/

smal 1 busi ness/bl ubook . htm

Initiated

Compliance

Authority

1937.

Voluntary/Cooperative. The self-imposed Salmon Control

Plan requirements are over and above mandatory Federal

requirements.

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

Public Health Service Act. as amended.

Fair Packaging and Labeling Act.

Aim The Salmon Control Plan; a voluntary cooperative program

among the industry, FDA and the National Food Processors

Association (NFPA); was established to enhance the

safety and wholesomeness of salmon products. The Plan

has resulted in industry compliance with new regulations

years before their effective date, and has provided a cooperative format for industry and government to cut

red tape and resolve domestic and international issues

of mutual concern.

Benefits

Methodology

Improved consumer protection, at little or no additional

cost to the public.

The Salmon Control Plan requires processors to comply

with laws and regulations enforced by the FDA and the

Sanitation and Operational Requirements and Guidelines

of the Plan. In addition, processors must submit

123
representative samples of canned salmon for sensory

examination by the NFPA. The FDA monitors individual

packer's compliance with the terms of the Plan through

plant inspections, investigations, sample collection and

analysis, labeling warehouse inspections, examination of

audit samples and review of information from the packers

and the NFPA.

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Testing is performed by FDA and the NFPA.

Inspection of food processing operations and the

container integrity operations of participating packers

are conducted by the FDA and NFPA.

A current list of each participating processing facility

is maintained by the NFPA.

Information concerning the Salmon Control Plan:

NFPA

1600 South Jackson Street

Seattle, WA 98144

Phone: (206) 323-3540

Fax: (206) 323-3543

Obligations of the In order to secure the benefits of the Plan, each

Manufacturer/Vendor participating packer must provide the NFPA with a signed

statement, on forms to be provided by the Association,

of the intention to comply with the Plan and its terms

and conditions. All lots of salmon packed by

participating packers are subject to the requirements of

the Plan. All records as required by the Food. Drug and

Cosmetic Act must be made available during inspections

to representatives of the FDA and the NFPA.

Enforcement If a processing facility is found to be or to have been

operating in such a manner or with such equipment as to

raise serious question concerning the production of a safe and wholesome product, or if there are substantial

deviations from the Sanitation and Operation

Requirements or Container Integrity Program which are a part of this Plan, or if the container integrity

operations are found to be operating in such a manner or with such equipment as to raise a serious question

concerning the safety of the food, the packer and/or

processing facility may be subject to penalties which

may include suspension from participation in the Plan.

124
Term Indefinite.

Reciprocity N/A.

Standards, Codes The Salmon Control Plan. The FDA's regulations a or Regulations printed in 21 CFR.

Keywords canned salmon; salmon; fish; NFPA; National Food

Processors Association

125
Products or

Services

Received 7/98

COLOR ADDITIVE!

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

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Cosmetics and Colors

Programs and Enforcement Policy Division

Colors Certification Branch

Room 4034, FOB 8

200 C Street. SW

Washington. DC 20204

Phone: (202) 205-5725

FAX: (202) 205-4098

URL address: http://www.fda.gov/opacom/morechoices/

smal 1 busi ness/bl ubook . htm

Initiated

Compliance

Authority

Program began 1938. Latest authority-1977.

Mandatory.

P.L. 94-295.

21 CFR Parts 70-82.

Food & Drug Administration Modernization Act of 1997

(FDAMA).

Aim

Benefits

To assure public health and safety in use and

consumption of foods, drugs, cosmetics, and medical

devices to which specified colors have been added.

Color additive certification monitors conformance of

additives to existing requirements and identifies the

need for new limitations.

Methodology

Testing

Government testing is required.

Color additives must be tested and certified in

government labs.

Inspection Government

126
Conformity

Identification

A list of approved colors and certified products.

Availability

of Documentation

Lists available from FDA.

Obligations of the Manufacturers must conform with Good Manufacturing

Manufacturer/Vendor Practices (GMP) and report any known ill effects

associated with certified additives.

Enforcement

Term

Marketing ban; product recall; delisting.

Certification is provided on a batch basis. No

expiration date for certification.

Reciprocity Certification is recognized by other federal agencies,

state agencies, and private sector organization.

Standards, Codes

or Regulations

Agency prepares criteria for certification. Agency

adopts 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

127
Products or

Services

Received 8/98

COSMETICS (See Also Color Additive Entry)

(Note: Recent Reductions in the Office of Cosmetics and

Colors have resulted in programmatic changes)

Department /Agency

Initiated

Compliance

Authority

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

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Cosmetics and Colors

Cosmetics Program

200 C Street. SW

Washington, DC 20204

Phone: 1-800-270-8869

URL address: http://www.fda.gov/opacom/morechoices/

small business/bl ubook.htm or http://www.cfsan.fda.gov

Program began in 1938. Latest authority-1977

Mandatory.

Federal Food, Drug and Cosmetic Act as amended.

Fair Packaging and Labeling Act.

21 CFR Parts 700-740.

Aim To assure public health and safety in use and

consumption of cosmetics.

Benefits

Methodology

See Aim.

FDA does not require, though it encourages, cosmetic

manufacturers and marketers test their products for

safety. However, if the safety of a cosmetic is not

adequately substantiated, the product may be considered

misbranded and may be subject to regulatory action

unless the label bears the following statement:

"Warning-The safety of this product has not been

determined. With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may,

on his own responsibility, use essentially any raw

material as a cosmetic ingredient and market the product

without prior FDA approval. Although FDA does not

require cosmetic firms to register their establishment

or formulas with FDA or make available safety data or other information for a product marketed in the United

States, manufacturers or distributors may submit this

128
information voluntarily. (Note that due to recent resource reductions, the Cosmetics Voluntary

Registration Program has been suspended in its

entirety.) Cosmetics distributed in the United States

do have to comply with labeling and ingredient

declaration regulations published by FDA, and bear

appropriate warnings. Liquid oral hygiene products and

all cosmetic vaginal products must also be packaged in

tamper-resistant packages when sold at retail. Note:

that cosmetics that are intended to treat or prevent

disease, or affect the structure or functions of the

human body are considered to be both drugs and cosmetics

and are also subject to FDA's requirements for drugs.

Testing Manufacturer or government as necessary.

Inspection Government.

Conformity N/A.

Identification

Availability

of Documentation

See 21 CFR Parts 700-740 and information at URL

addresses listed above. Due to recent resource

reductions, FDA will not be able to respond to technical

inquiries concerning ingredient usage, product

formulation or safety substantiations. Consumers

experiencing an adverse reaction from a cosmetic should

call their nearest FDA office (listed under the U.S.

Government section in the white pages) or call the

Cosmetic Adverse Reaction Monitor (CARM) coordinator at

202-205-4706.

Obligations of the See Methodology

Manufacturer/ Vendor

Enforcement

Term

Marketing ban; product recall; delisting

N/A.

Reciprocity N/A.

Standards, Codes

or Regulations

See CFR citations listed above.

Keywords color additives; cosmetics; drugs; labeling; packaging

129
Products or

Services

Received 6/98

(Includes Food Contact Articles)

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

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Premarket Approval

200 C Street. SW

Washington, DC 20204

Phone: (202) 418-3100

FAX: (202) 418-3131

URL address: http://www.fda.gov/opacom/morechoices/

smal 1 busi ness/bl ubook . htm

Initiated

Compliance

Authority

1958.

Mandatory.

Federal Food. Drug, and Cosmetic Act (FFD&CA), as amended.

Food & Drug Administration Modernization Act of 1997

(FDAMA).

21 CFR Parts 1-199.

Aim To assure public health and safety in use and

consumption of food additives.

Benefits

Methodology

See Aim.

Premarket approval is required for some additives. If

FDA concludes from the evidence submitted to it that the

additive will be safe, a regulation permitting its use

will be issued. The regulations may specify the amount

of the substance which may be present in or on the

foods, the foods in which it is permitted, the manner of

use, and any special labeling required.

Testing Certain additives must be tested in accordance with

recognized scientific procedures and the results

submitted to FDA for evaluation.

Inspection Government.

130
Conformity

Identification

A list of approved additives

Availability

of Documentation

Lists available from FDA.

Obligations of the Substances added to food must be approved as safe,

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Marketing ban; product recall; delisting.

Approval is good till revoked.

Approval is recognized by other federal agencies, state

agencies, and private sector organization.

See applicable CFR references.

Keywords food; food additives; packaging

131
Products or

Services

Received 7/98

plant OS. BEVERAGE!

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

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Plant and Dairy Food and Beverages (HFS-300)

Room 4827, FOB 8

200 C Street. SW

Washington, DC 20204

Phone: (202) 205-4064

FAX: (202) 205-4422

For low acid canned foods (LACF), contact:

FDA LACF Coordinator

HFS-618

200 C Street, SW

Washington, DC 20204

URL address: http://www.fda.gov/opacom/morechoices/

smal lbusiness/bl ubook . htm

Initiated

Compliance

Authority

Aim

1938

Mandatory.

Federal Food, Drug and Cosmetic (FFD&C) Act of 1938, as amended.

Food & Drug Administration Modernization Act of 1997

(FDAMA).

Tea Importation Act.

The Import Milk Act (21 U.S.C. 141-149).

Requirements for foods are contained in Title 21 of the

CFR.

See 21 CFR 108, 113, and 114 for low-acid canned food

and acidified food regulations.

To assure that foods are pure and wholesome, safe to

eat, properly labeled, and produced under sanitary

conditions

132
Benefits The appearance of adulterated, insanitary, unsafe,

mislabeled and misbranded products in the market has

been minimized.

Methodology FDA enforces pesticide residue tolerances set by the

Environmental Protection Agency (EPA). Food additives

must be determined to be safe by FDA, before they may be

used in a food, or become part of a food as a result of

processing, packaging, transporting, or holding the food

(See Food Additives entry. A food is illegal

(adulterated) if it bears or contains an added poisonous

or deleterious (harmful) substance which may render it

injurious to health. A food is illegal if it bears or contains a naturally occurring poisonous or deleterious

substance which ordinarily renders it injurious to

health. A food is illegal if it has been prepared,

packed or held under insanitary conditions whereby it

may have been rendered injurious to health. Food

containers must be free from any poisonous or deleterious substances which may cause the contents to

be injurious to health and must not be so made, formed

or filled as to be misleading. A food is illegal if any

part of it is filthy, putrid, decomposed or otherwise

"unfit." Damage or inferiority in food must not be

concealed in any manner. A food is also illegal if it

is the product of a diseased animal or one that has dies

otherwise than by slaughter. Special regulations apply

to low acid canned foods and acidified foods. Milk

safety is assured through the Federal -State Milk

Sanitation Program administered by FDA though the

Interstate Milk Shippers (IMS) Agreements, under which

Grade A milk producers are required to pass inspection

and be rated by cooperating state agencies.

Testing

Inspection

Uses government labs, manufacturers' labs, third party

labs, and state/local government labs as appropriate.

Conducted by federal or state/local government

employees.

Conformity

Identification

Proper informative labeling; identification of

processing plants which are specifically inspected

as Grade A milk producers.

such

Availability

of Documentation

See appropriate CFR sections.

LACF requirements are available from: FDA. Industry

Activities Staff (HFS-565). 200 C Street. SE,

133
Washington, DC 20204. The IMS list is published by FDA

and revised quarterly and is available from the office

listed above.

Obligations of the

Manufacturer/ Vendor

Enforcement

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. Producers of LACFs must be

registered. Grade A milk producers must be inspected

and rated by the appropriate state agency.

Marketing ban; product recall.

Term

Reciprocity

Continuous inspection.

Program is recognized by:

Other federal agencies.

State agencies.

Private sector organizations

Standards. Codes

or Regulations

Agency prepares all criteria documents

Keywords adulterated product; beverages; bottled water; butter;

canned foods; cheese; coffee; cooking wines; dairy

products; fill of container; food standards; fruits;

fruit juices; good manufacturing practices; herbs; lowacid canned foods; LACF; margarine; mayonnaise; milk;

misbranded product; nutrition labeling; nuts; oils

(edible); olives; salad dressings; sanitation; spices;

tea; vegetables; wine beverages with less than 7%

alcoholic content

134
Products or

Services

FOOD LABELING

Received 5/98

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

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Food Labeling

Programs and Enforcement Policy Division

Room 1832, FOB 8

200 C Street, SW

Washington, DC 20204

Phone: (202) 205-4561

FAX: (202) 205-4594

URL address: http://www.fda.gov/opacom/morechoices/

smal 1 busi ness/bl ubook . htm

Initiated

Compliance

Authority

1938

Mandatory.

Federal Food, Drug and Cosmetic (FFD&C) Act of 1938, as amended.

Food & Drug Administration Modernization Act of 1997

(FDAMA).

The Nutrition Labeling and Education Act of 1990 (NLEA)

21 CFR 101.9).

Fair Packaging and Labeling Act, as amended, 21 CFR

403(f), 101.

Aim To ensure that food labels do not contain false or misleading information or fail to reveal material facts

To also ensure that nutritional information is provided

on the label for almost all packaged consumer food

products.

Benefits Label information is conspicuously displayed and in

terms that the ordinary consumer is likely to read,

understand and be able to use.

Methodology

Testing

Government inspection is required.

Uses government labs, manufacturers' labs, third party

labs, and state/local government labs as appropriate.

135
Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Conducted by federal or state/local government

employees

Proper informative labeling; identification of

processing plant where such are specifically inspected,

such as shellfish packers.

FDA publicizes only firms known to be not complying with

required standards.

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.

Marketing ban; product recall.

Continuous inspection.

Program is recognized by:

Other federal agencies.

State agencies.

Private sector organizations.

Agency prepares all criteria documents.

adulterated product; dietary foods; fill of container

standard; good manufacturing practices; infant formula;

misbranded product; nutrition labeling; sanitation;

standard of identity; standard of quality

136
Products or

Services

MEAT AND POULTRY

Received 7/98

Department/Agency In general these products handled by the Food Safety and

Inspection Services, U.S. Department of Agriculture,

under the Meat Inspection Act and the Poultry Products

Inspection Act. However, all foods are subject to the

requirements of the Federal Food Drug and Cosmetic Act

to the extent that the provisions of the Meat and

Poultry Products Inspection Acts do not apply. Wild

game and gelatin, however, are subject to the

requirements of the Federal Food Drug, and Cosmetic Act

and its regulations.

137
Products or Services

Department/Agency

1IFAIT FORMULA AID SPECIAL

Special Dietary Use)

Received 8/98

I (Foods for

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

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Office of Special Nutritionals

Room 2804, FOB 8

200 C Street, SW

Washington, DC 20204

Phone: (202) 205-4168

FAX: (202) 205-5295

URL address: http://www.fda.gov/opacom/morechoices/

smal lbusiness/blubook .htm

Initiated

Compliance

Authority

Aim

Benefits

Methodology

1980.

Mandatory.

Infant Formula Act of 1980, 21 U.S.C. 412.

Food & Drug Administration Modernization Act of 1997

(FDAMA).

21 CFR 411 and 412.

Fair Packaging and Labeling Act (15 U.S.C. 1451-1461).

To establish minimum nutrition requirements for infant

formulas and special nutritionals.

Virtually all domestically produced infant formula and

special nutritionals now comply with this Rule.

Agency requires manufacturer of infant formulas to

comply with Good Manufacturing Practices (GMP), and

requirements for nutrient quantity, nutrient quality

control, recordkeeping, and for reporting and recall of

infant formulas which pose a potential hazard to health.

Foods for special dietary use must bear appropriate

label information. When foods for special dietary use

are labeled with claims of disease prevention,

138
treatment, mitigation, cure or diagnosis, they must

comply with the drug provisions of the FFD&CA, unless

the health claim is a health claim authorized by

legislation.

Testing Manufacturers lab.

Inspection Government.

Conformity

Identification

Lists of approved suppliers and certified products for

formulas. Labeling information.

Availability

of Documentation

Lists available from FDA.

Obligations of the See Methodology.

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Marketing ban; product recall by agency or producer.

Audit testing/inspection to assure conformance with

quality control requirements prescribed by agency.

FDA approval /certification is recognized by other

federal agencies, states and private sector

organizations

Technical requirements are specified in the relevant

Acts and appropriate section of the CFR.

adulteration; good manufacturing practices; infant

formula; misbranding; nutrition requirements;

nutritionals; product recall; quality control; foods fo

special dietary use

139
Products or

Services

Received 6/98

FOOD INSPECTION

(LIKELY TO BE REPLACED BY SYSTEM ENDORSED BY FDA OF

THIRD PARTY TESTING. CERTIFICATION AND LISTING BY A

NATIONALLY ACCREDITED ORGANIZATION)

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

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Retail Food Protection Branch (HFS-627)

200 C Street, SW

Rm. 1042 MES

Washington. DC 20204

Phone: (202) 205-8140

FAX: (202) 205-5560

URL address: http://www.fda.gov/opacom/morechoices/

smal lbusiness/bl ubook.htm

Initiated

Compliance

Authority

Aim

1976.

Voluntary.

Public Health Service Act, as amended.

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.

Also provides model food protection laws and uniform

standards

Methodology

Testing

Requires evaluation of individual's competence,

government testing and audit.

Federal and state examination and training facilities.

Inspection

Conformity

Identification

Federal and state government.

Lists of certified inspectors are kept by participating

state health departments.

140
Availability

of Documentation

List must be obtained at the state level

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Retesting every three years.

Recognition by other federal agencies, state agencies,

and private sector organizations.

Agency prepares all criteria documents.

food inspection personnel; milk safety; model ordinance;

personnel certification practices; retail food;

shellfish sanitation; sanitation; standard of quality;

standard of identity; training

141
Products or Services

Received 6/98

INTERSTATE CARRIERS (For Food and Environmental

Sanitation) (CURRENTLY INACTIVE)

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

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition

Division of Cooperative Programs (HFS-625)

Room 1042 MES

200 C Street, SW

Washington. DC 20204

Phone: (202) 205-8137

FAX: (202) 205-5560

URL address: http://www.fda.gov/opacom/morechoices/

smal lbusiness/bl ubook.htm

Compliance

Authority

Aim

Mandatory.

21 CFR 1240 and 1250.

To assure sanitary food practices on interstate

carriers.

Benefits

Methodology

See Aim.

Establishes specific requirements for equipment and

operations for handling food, water, and waste both on conveyances (aircraft, buses, railroads, and vessels)

and other located elsewhere, i.e., support facilities

such as caterers and commissaries, watering points and

waste servicing areas. The regulations also specify

requirements for reviewing plans and inspection

construction of equipment, conveyances and support

facilities. Carriers are required to use only equipment

and support facilities that have been approved by the

Agency.

Testing See Methodology.

Inspection

Conformity

Identification

See Methodology.

Lists of approved equipment and support facilities are maintained by the Agency. (Listing has been curtailed.)

142
Availability

of Documentation

List is available from the Agency. (Listing has been

curtailed.

)

Reciprocity Recognition by other federal agencies, state agencies

and private sector organizations.

Standards, Codes or RegulationsAgency prepares all criteria documents.

Keywords aircraft; buses; carriers; railroads; sanitation;

vessels

143
Received 8/98

Products or ANIMAL PRODUCTS -- FOOD (Animal Feeds and Pet Foods),

Services FOOD ADDITIVES. DRUGS AID MEDICAL DEVICES

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

Food and Drug Administration (FDA)

Center for Veterinary Medicine (CVM)

Office of Surveillance and Compliance

Rm. E4-81 MPN2

7500 Standish Place

Rockville, MD 20855

Phone: (301) 827-6647

FAX: (301) 594-4512

URL address: http://www.fda.gov/opacom/morechoices/

smal 1 busi ness/bl ubook . htm

1938.

Mandatory.

Federal Food, Drug and Cosmetic Act, Title 21 U.S.C., as amended.

Food & Drug Administration Modernization Act of 1997

(FDAMA).

Fair Packaging and Labeling Act (15 U.S.C. 1451-1461).

To assure that foods, feeds, additives, medical devices

and medicines intended for animal use are safe and

effective for intended use. Such products are also

evaluated for safety effects on meat, milk, eggs.

Low-risk preparations with uniform quality and

predictable performance have been developed for animal

use.

Methodology For new animal drugs (NAD), FDA requires government

design approval, inspection and site approval.

Manufacturers of animal drugs are required to register

with FDA annually and manufacturers of certain medicated

feeds are required to hold a medicated feed license and

register annually. For all products, FDA requires

compliance with Good Manufacturing Practices (GMP). Pet

food must comply with provisions of the Fair Packaging

and Labeling Act. Animal cosmetics (grooming aids) are

not regulated unless a therapeutic claim is made.

Initiated

Compliance

Authority

Aim

Benefits

144
Animal feed must also comply with state laws requiring

label statement of "Guaranteed Analysis" for minimum

fiber content, and, in

content. Some state

bear a nutritional

additives are illegal

prior approval

protein and fat content, maximum

some instances, maximum moisture

laws also require that pet foods

adequacy statement. Animal food

unless they are the subject of a (sanction) or a regulation for their safe use. Food

additive regulations are based on data submitted in the

form of a food additive petition. Animal medical

devices and diagnostic aids are subject to the general

provisions of the Act in regard to misbranding and

adulteration and may be prescribed and dispensed only by

a licensed veterinarian. A warning label is required.

Testing Manufacturer's lab or third party lab

Inspection Government

Conformity

Identification

Lists of approved products and qualified producers are maintained by FDA.

Availability

of Documentation

Lists are available from the Center for Veterinary

Medicine or at the following URL address:

http://www.fda.gov.cvm. Information on state feed/pet

food laws is available from individual states or from

the Official Publication of the Association of American

Feed Control Officials. Inc., P.O. Box 478, 104 East

McConnell St., Oxford, IN 47971.

Obligations of the

Manufacturer/ Vendor

For all drug and device 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. Only additives approved by the FDA may

be used. See also Methodology.

Enforcement Marketing ban; product recall.

145
Term No specific term; retesting is based on changes in

product characteristics or use. A major consideration

is any misbranding or adulteration.

Reciprocity Approvals/certifications are recognized widely in the

United States. 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 and an advisory committee.

Keywords additives; adulteration; animal drugs; animal feed;

animal medical devices; good manufacturing practices

licensing; misbranding; pet food; registration;

veterinary medicine

146
Products or Services

Received 6/98

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

Food and Drug Administration (FDA)

Center for Drug Evaluation and Research (CDER)

Office of Compliance

Metro Park North, ROOM 254

7520 Standish Place

Rockville, MD 20855

Phone: (301) 594-0054

URL address: http://www.fda.gov/opacom/morechoices/

smal 1 busi ness/bl ubook . htm

Compliance

Authority

Mandatory.

Food & Drug Administration Modernization Act of 1997

(FDAMA).

Federal Food, Drug and Cosmetic Act of 1938 as amended

Title 21 U.S.C.

Fair Packaging and Labeling Act (15 U.S.C. 1451-1461).

21 CFR Parts 200-212 and 300-315.

Aim To ensure that human drugs are safe and effective for

their intended use.

Benefits Virtually all covered products consumed in the United

States are made in registered establishments and

produced under Good Manufacturing Practices (GMP).

Methodology Government conducts design approvals, inspections, and

site approvals. FDA requires compliance with Current

Good Manufacturing Practices (GMP), including:

adequately equipped manufacturing facilities, adequately

trained personnel, stringent control over the

manufacturing processes, reliable and secure computerized operations, and appropriate finished

product examination and testing (See 21 CFR 210 and

211). FDA also regulates drug labeling, including all

written, printed, or graphic material on the immediate

container, and outer carton or wrapper of the package,

other matter accompanying the product, and the

advertisement of prescription drugs. Advertising of

nonprescription drugs is regulated by the Federal Trade

147
Commission. FDA also regulates drug containers and

packaging. For regulatory purposes, FDA has divided

drugs into several major categories, each subject to

particular requirements: New Drugs, Investigational

Drugs, Antibiotics, and Insulin. FDA also categorizes

drugs by dispensing requirements- -prescription and

nonprescription (over-the-counter or OTC) drugs. Each

category is subject to specific regulatory requirements.

Persons involved in the investigation, control or manufacture of drug products are required to report

adverse drug experiences. All establishments, unless

exempted by law, are required to be registered and all

drugs marketed in the U.S. are required to be listed

with the FDA. FDA also has sales restrictions on prescription drugs. Wholesale prescription drug

distributors are required to be licensed by the

appropriate state and meet minimum federally prescribed

standards, including recordkeeping requirements.

Exported new drugs for human or animal use are subject

to special statutory provisions. Exported drugs are also subject to the Drug Export Amendments Act of 1986.

Exported drugs must also meet GMP and labeling

requirements.

Testing Uses manufacturer's lab, third party labs, or government

labs

Inspection Government

Conformity

Identification

Lists of qualified producers and approved products are maintained by FDA.

Availability Additional information may be obtained at the following

of Documentation URL address: http://www.fda.gov.cder

Information may also be obtained by calling

The Drug Information Branch (General Inquiries):

301-827-4573;

Fax-on-Demand System: 1-800-342-2722; or the

Freedom of Information Staff: 301-827-4583.

CDER also publishes the Orange Book Showing Approved

Drug Products with Therapeutic Equivalence Evaluations.

For information on the book, contact the Office of

Information Technology, Division of Management and

Services at 301-827-5467.

148
Obligations of the Producers are required to register establishments,

Manufacturer/Vendor 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.

Administrative and Marketing ban - refusal to file NDA, clinical hold,

Enforcement Actions nonapproval , detention of imported drugs, issuance of

untitled letters or warning letters, seizure of

products, product recall actions, injunction, and

prosecution.

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 United States,

but no foreign reciprocity.

Standards, Codes FDA prepares all standard requirements including GMP

or Regulations Rules, except that FDA recognizes specifications for

drugs and components prepared by some private

organizations, i.e., the U.S. Pharmacopeia (USP), the

Homeopathic Pharmacopeia, or the National Formulary

(NF).

Keywords adulteration; antibiotics; drug registration; drugs;

good manufacturing practices; labeling; misbranding;

packaging; pre-market evaluation; recall; sanitation

149
Products or Services

Received 6/98

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

Food and Drug Administration (FDA)

Center for Biologies Evaluation and Research (CBER)

Office of Compliance and Biological Quality

HFM-600 WOCI

1401 Rockvi lie Pike

Rockville, MD 20852

Phone: (301) 827-6190

FAX: (301) 594-1944

URL address: http://www.fda.gov/opacom/morechoices/

smal Ibusiness/blubook.htm

Compliance

Authority

Mandatory.

Food, Drug and Cosmetic Act of 1938, as amended

(21 U.S.C.).

Food & Drug Administration Modernization Act of 1997

(FDAMA).

Public Health Service Act (42 U.S.C.).

Fair Packaging and Labeling Act (15 U.S.C. 1451-1461)

21 CFR 201. 211, 600-680, 1270.

Aim To assure that biologies are both safe and effective for

intended use.

Benefits

Methodology

Since most biological products are derived from living

organisms, they are by nature potentially dangerous if

improperly prepared or tested. Close surveillance of

biologies production, batch testing, and research helps ensure the quality, safety and efficacy of the products.

Government conducts inspections and issues biologies

licenses. A valid U.S. biologies license must be in

effect for all biological products shipped in interstate

commerce in the United States. Manufacturers must

comply with appropriate federal standards in

manufacturing the products being marketed. FDA requires

compliance with GMP, including adequately equipped

manufacturing facilities, adequately trained personnel,

stringent control over the manufacturing processes,

reliable and secure computerized operations, appropriate

150
finished product examination and testing, and

investigation of manufacturing deviations. Prior to the

release of each lot of certain licensed products,

specified materials must be submitted to and cleared by

FDA. FDA regulates labeling for prescription drug and

biologies products, including immediate container and

outer carton or wrapper of the package, and all other

written, printed or graphic materials that accompany the

product. FDA also regulates the advertisement of

prescription drugs and biologic products. All

establishments that manufacture biological products for

commercial distribution in the United States, including

blood banks, are required to be registered and all

biologies marketed in the U.S. are required to be listed

with the FDA, unless exempted by law. For a specified

fee. FDA may issue export certificates for licensed or unlicensed biological products upon receipt of a requires, if the facility meets the requirements for

certification.

Testing Uses manufacturer, third party, or government labs

Inspection Government.

Conformity

Identification

Lists of qualified manufacturers and approved products

are maintained by FDA and are available on the CBER

website at: http://www.fda.cber/establish.htm

Availability

of Documentation

See information at URL address listed above as well as CFR references.

Obligations of the Manufacturers are required to register establishments,

Manufacturer/Vendor and list products; maintain sanitary conditions; provide

substantial clinical evidence of safety/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, manufacturing errors and accidents, and

changes to the approved manufacturing process or labeling. Manufacturers of certain licensed products,

including antitoxins, bacterial and viral vaccines, and

skin tests, are required to obtain and use standard

preparations supplied by CBER for potency tests.

Denial of license application; license suspension or revocation; injunction, seizure; prosecution; product

recall; civil monetary penalties.

Enforcement

151
Term No specific term for U.S. licenses, although licenses

may be withdrawn under circumstances defined in the

regulations. Registration and listing must be updated

annual ly

Reciprocity Approval is recognized in the U.S.. but no foreign

reciprocity.

Standards, Codes

or Regulations

FDA prepares all standard requirements including GMP

regulations

Keywords antitoxin; biological products; blood banks; blood

products; good manufacturing practices; labeling;

packaging; vaccine

152
Received 6/98

Products or ELECTRONIC PRODUCTS FOR RADIATION CONTROL

Services (Includes Products or Equipment Capable of Emitting

Ionizing or Non-ionizing Radiation, or Sonic.

Infrasonic, or Ultrasonic Waves) fWfHDSRAPHY SERVICE

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

Food and Drug Administration (FDA)

Center for Devices and Radiological Health (CDRH)

Office of Health and Industry Programs

For Electronic Products : 1. Div. of Small Mfrs. Assistance (DSMA) (HFZ-220)

1350 Piccard Drive

Rockville, MD 20850

Phone: (800) 638-2041, or (301) 443-6597

FAX: (301) 443-8818

e-mail: dsmo@cdrh.fda.gov

Facts-On-Demand (F-0-D): 800-899-0381 or (303) -827-0111

Request a DSMA Facts Index or enter the 3 or 4 digit

number of the document requested.

2. Electronic Products Branch, Office of Compliance

Rm. 244 OAK

5600 Fishers Lane

Rockville, MD 20857

Phone: (301) 594-4654

FAX: (301) 594-4610

URL address: http://www.fda.gov/cdrh/index/html OR

URL address: http://www.fda.gov/opacom/morechoices/

smal Ibusiness/blubook .htm

For Mammography Services:

Division of Mammography Quality and Radiation Programs

5600 Fishers Lane

Rockville, MD 20857

Phone: (301) 443-0806

FAX: (301) 443-8818

e-mail: jfs@cdrh.fda.gov

Initiated 1968.

Compliance Mandatory.

Authority Electronic Products : Radiation Control for Health and

153
Safety Act. 42 U.S.C. 2636; 21 CFR 1000-1050; Fair

Packaging and Labeling Act (15 U.S.C. 1451-1461).

Mammography Services : Mammography Quality Standards Act

of 1992 (MQSA); 42 U.S.C. 263b.

Aim Protect public from unnecessary exposure to radiation

from electronic products and establish national uniform

quality/safety standards for mammography facilities.

Benefits Enforcement, product improvement, and user education has

reduced significantly public exposure to ionizing and

non-ionizing radiation. Enforcement has also ensured

patients of adequate quality mammography with minimal

risk no matter where they go for the examination.

Methodology Electronic Products : Establishes performance standards

when deemed necessary. Requires manufacturer's selfcertification to standards and a label to that effect

affixed on the product. Certification is based on a test described in a performance standard and implemented

in a certification and testing program (which is

reviewed by FDA). Products currently covered by

performance standards include: television receivers,

demonstration-type cold-cathode gas discharge tubes,

microwave ovens, diagnostic x-ray equipment, cabinet x- ray equipment, laser products, ultrasonic therapy

equipment, mercury vapor lamps, and sunlamps.

Mammography Services : Facilities must be certified by

FDA to lawfully provide mammography services. To become

certified, facilities must first be accredited by an FDA-approved accreditation body. To become accredited,

facilities must meet FDA-established quality standards,

including personnel qualifications, equipment

specifications, facility quality assurance program, and

reporting and record keeping requirements. To retain

their certification, facilities must also pass annual

inspections during which they demonstrate that they

continue to meet the quality standards.

Testing Electronic Products : Manufacturer's or third party lab.

Mammography Services : Facility medical physicist/quality

control technologist; accreditation body; FDA.

Inspection Government

Conformity

Identification

Electronic Products : Manufacturer applied label.

Mammography Services : FDA provided certificate in

position clearly visible to patients.

154
Availability

of Documentation

Electronic Products : No lists are available.

Mammography Services : Facility certification status may

be obtained from the National Cancer Institute's Cancer

Information Service at 1-800-4-CANCER or FDA. FDA also

produces an annual list of mammography facilities for

which "adverse events" have been reported by the MQSA or State radiation control programs.

Obligations of the

Manufacturer/ Vendor

Electronic Products : Manufacturers must keep production

and distribution records: notify buyers of nonconforming

equipment/recalls.

Mammography Services : Facilities must post certificate

in a visible location; maintain and make available

during inspection, records showing that they meet

quality standards; correct non-compliances found during

inspections; and become re-accredited every 3 years.

Facilities must also pay an annual inspection fee to cover cost of inspections.

Enforcement Electronic Products : Marketing ban; product recalls; and

manufacturers may be required to repair, replace, or refund the cost of the nonconforming product.

Mammography Services : Non-compliance with quality

standards must be corrected on a time schedule related

to its seriousness. The more severe sanctions of

directed plans of correction, civil money penalties,

injunctions, and suspension or revocation of

certificates are available for use if necessary.

Term Electronic Products : Certification applies for the life

of each distinctive model.

Mammography Services : Accreditation and certification

must be renewed every 3 years.

Reciprocity

Standards, Codes

or Regulations

No known reciprocity.

Electronic Products : Agency sets criteria and publishes

performance standards.

Mammography Services : Agency publishes quality standards

for facilities and requirements for accreditation body.

Keywords cold-cathode discharge tubes; electronic radiation;

lasers; mercury vapor lamps; mammography; microwave

ovens; product labeling; sunlamps; television receivers;

ultrasonic therapy equipment; x-ray equipment

155
Products or

Services

MEDICAL DEVICE:

Received 6/98

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

Food and Drug Administration (FDA)

Center for Devices and Radiological Health (CDRH)

Office of Health and Industry Programs

Division of Small Manufacturers Assistance (DSMA)

(HFZ-220)

1350 Piccard Drive

Rock vi lie. MD 208507

Phone: (800) 638-2041 or (301) 443-6597

FAX: (301) 443-8818

e-mail: dsmo@cdrh.fda.gov

Facts-On-Demand (F-O-D): 800-899-0381 or (303) -827-0111

Request a DSMA Facts Index or enter the 3 or 4 digit

number of the document requested.

OR

Office of Compliance. Rm. 244 OAK

5600 Fishers Lane

Rockville. MD 20857

Phone: (301) 594-4692

FAX: (301) 594-4610

URL address: http://www.fda.gov/cdrh/index/html OR

URL address: http://www.fda.gov/opacom/morechoices/

smal 1 busi ness/bl ubook . htm

Initiated 1976.

Compliance Mandatory.

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

Cosmetic Act. Title 21 U.S.C.

Fair Packaging and Labeling Act (15 U.S.C. 1451-1461).

21 CFR Part 807 E for premarket approval requirements.

21 CFR 860. 862 through 892 for device classification

requirements.

Aim To assure that medical devices are both safe and

effective for their intended use.

156
Benefits For Class III devices, the program provides a more thorough design and performance review.

For Class I and II devices, the program provides clear

public health safeguards.

Methodology Class III devices require premarket approval (PMA) to

demonstrate safety and effectiveness before they can be

marketed unless FDA determines otherwise. Premarket

approval may include: design approval, audit inspection

and site approval; review of manufacturer's test data.

They are also subject to general controls.

For Class II devices, are subject to general controls

plus special controls, which may include: performance

standards, postmarket surveillance, patient registries,

guidelines, recommendations and other appropriate

actions. In the case of life supporting or life

sustaining devices, special controls shall be

identified, if any, that are necessary to provide

adequate assurance of the safety and efficacy of such

devices and describe how these special control provide

such assurance.

For Classes I devices, manufacturers are subject to

general controls applicable to all device manufacturers

which include: registration of manufacturers; medical

device listing; recordkeeping requirements; labeling

requirements; and compliance with Good Manufacturing

Practices (GMP).

Unless exempted by regulation, all manufacturers are required to give FDA 90 days notice before they intend

to introduce a device on the market by submitting a premarket notification. During the 90 day period, FDA

will determine whether the device is or is not

equivalent to a pre-amendment device. A device may not

be marketed until the firm receives a notice from the

Agency that their device is substantially equivalent to

a device that does not require premarket approval (PMA)

Testing Manufacturer's lab or third party lab.

Audit testing may be done by labs under contract to

government.

Inspection Government.

157
Conformity For Class III devices only, list of approved products

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

self-certification is evidenced through information

required in product labeling

Availability Lists are available from the CDRH website at:

of Documentation http://www.fda.cdrh

Program areas provide access to Premarket Approval

Applications (releasable PMAs) and Premarket

Notifications (releasable 510(k)s).

Obligations of the Manufacturers of all classes of medical devices are Manufacturer/Vendor required to be registered and to collect data on patient/ practitioner experience and report any

hazardous events or noncompliance with Class III or Class II certification.

Enforcement Marketing ban, product recall, and civil penalties 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 United

States, 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;

recal

158
Products or

Services

Received 5/98

ALL ENTITIES DTP ORATORY TESTIi

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

Health Care Financing Administration (HCFA)

Center for Medicaid and State Operations

Family and Children's Health Program Group

Division of Outcomes and Improvement

7500 Security Boulevard

Baltimore, MD 21244-1850

Phone: (410) 786-3531

FAX: (410) 786-3517

E-Mail: (As of March 26, 1998, the URL address is:

http : / /www . hcfa . gov/medi care/hsqb/cl i a . htm

This URL should become

http://www.hcfa.gov/clia/clial.htm on or about April 1, 1998)

Initiated

Compliance

September 1992

Mandatory CLIA certification for all laboratories.

Laboratory is defined as any facility that performs

laboratory testing on specimens derived from the human

body for the purpose of providing information for the

diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

Authority P.L. 100-578. Section 353 of the PHS Act. Clinical

Laboratories Improvement Amendments of 1988 (CLIA)

CFR Part 493.

42

Aim To establish minimum requirements (health and safety

standards) which must be met by providers and suppliers

of laboratory services. The CLIA regulations are based

on the complexity of the test to set minimum

requirements that are related to the performance of

laboratory testing.

Benefits Intended to improve the performance and quality

(accuracy, reliability, and timeliness) of laboratory

testing/services regardless of where performed.

159
Methodology Agency is charged with the implementation, enforcement,

and monitoring of the CLIA program, including approval

of accreditation programs. State exemption applications,

and proficiency testing programs. Laboratories must

register and pay the appropriate fee(s). The laboratory

is surveyed before the certificate is issued. Upon

determining compliance, HCFA issues the appropriate

certificate(s) . Laboratories that perform only waived

and/or Provider Performed Microscopy (PPM)

tests/procedures, apply directly for the Certificate of

Waiver or Certificate of PPM. Laboratories holding

either of these types of certificates are not subject to

routine inspections. Additionally, laboratories have

the opportunity to choose an approved accreditation

organization to fulfill compliance with CLIA.

Testing Based on the complexity of the testing performed. CLIA

specifies regulations for Quality Control (QC), Patient

Test Management (PTM), Personnel. Proficiency Testing

(PT), Quality Assurance (QA), and Inspections to assure quality laboratory testing. Laboratories performing

either moderate and/or high complexity testing are inspected/surveyed every 2 years. The Centers for

Disease Control and Prevention (CDC) has responsibility

for test categorization.

Conformity

Identification

A unique 10 digit CLIA number is assigned to the

laboratory upon registering for the CLIA program. The

laboratory retains this number for its entire CLIA

history. The appropriate CLIA certificate is issued to

the laboratory for the types of testing the laboratory

performs. Additionally, CLIA certified laboratories

that voluntarily receive Medicare/Medicaid

reimbursement, are subject to certain payment and

coverage requirements.

Availability of

Documentation

A list of certified laboratories may be available upon

request. Relevant information about the CLIA

requirements and the scope of the program is available

at the above website.

Enforcement Medicare decertification/termination or revocation of

CLIA certificates if laboratories fail to comply with

program requirements.

Term CLIA certificates for laboratories are effective for a two-year period.

160
Reciprocity Approved Laboratory Accreditation and State Licensure

Programs. Some laboratories are accredited by the Joint

Commission on Accreditation of Healthcare Organizations

(JACHO), American Osteopathic Association (AOA),

American Society for Histocompatibility and

Immunogenetics (ASHI), American Association for Blood

Banks (AABB), Commission of Laboratory Accreditation

(COLA), College of American Pathologists (CAP). Certain

laboratories are licensed under a State's CLIA-exempt

licensure program such as New York State, Washington

State and Oregon.

Standards. Codes Standards are specified in the Acts and in the Code of

or Regulations Federal Regulations.

Keywords CLIA; health care facility; health care providers;

hospitals; laboratories; laboratory testing; medical

tests; Medicare certification
Received 5/98

Products or TOE RHC BEIEF1T MAS ENACTED INTO LAM ON DECEMBER 13.

Services 1977 IN TOE RURAL HEALTH CLINIC SERVICES ACT OF 1977

(RHCSA). PUBLIC LAW 95=210. MEDICARE AID MEDICAID COVER

PRIMARY AND EMERGENCY SERVICES FURNISHED BY RHCS LOCATED

IN RURAL MEDICALLY UNDERSERVED COMMUNITIES BY PHYSICIANS

AND NON~PHYSICIAI MEDICAL PRACTITIONERS , INCLUDING

PHYSICIAN ASSISTANTS (PAS). NURSE PRACTITIONERS (NPS).

AND CERTIFIED NURSE MIDWIVES (CNMS).

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

Health Care Financing Administration (HCFA)

Center for Medicaid and State Operations

Family and Children's Health Program Group

Division of Outcomes and Improvement

7500 Security Blvd.

Baltimore. MD 21244-1850

Phone: (410) 786-3531

FAX: (410) 786-3517

Initiated The RHC benefit was enacted into law on December 13,

1977 in the

Rural Health Clinic Services Act of 1977 (RHCSA) , Public

Law 95-210.

Compliance Voluntary for Medicare/Medicaid certification. Medicare

and Medicaid cover primary and emergency services

furnished by RHCs located in rural medically underserved

communities by physicians and non-physician medical

practitioners, including physician assistants (PAs), nurse practitioners (NPs), and certified nurse midwives

(CNMs).

Authority The RHC benefit was enacted into law on December 13,

1977 in the

Rural Health Clinic Services Act of 1977 (RHCSA), Public

Law 95-210. Refer to 42 CFR Part 491.

Social Security Act - Sections 1861(aa), 1832(a),

1833(f). 1842(b). 1905(a), 1910(a)

Aim The intent of the rural health clinic program is to

increase the availability of primary medical care and

services to residents of rural areas that have a shortage of health care professionals.

162
Benefits Increased access to primary health care services in

rural, medically underserved and low-income communities.

Methodology The Agency is charged with the implementation and

enforcement of the rural health clinic program. The

Rural Health Clinic Services Act uses two strategies to

increase access to primary care for rural communities at

risk of being medically underserved: 1) offering

enhanced financial incentives (cost-based reimbursement)

to improve physician recruitment and retention, and 2)

mandating the employment of non-physician medical

practitioners as a condition of cost-based

reimbursement.

Testing Specific laboratory tests must be available in order for

a facility to meet the requirements for a rural health

clinic.

Inspection The Agency has authority to perform oversight in

processing the requests of new applicants requesting

participation in the Medicare and Medicaid program as rural health clinics. The Agency also has authority to

conduct investigations and resurvey existing clinics.

Conformity

Identification

A Medicare identification number is given to the

supplier when it is determined that federal health and

safety requirements have been met.

Availability

of Documentation

A list of certified suppliers may be obtained by calling

the Health Care Administration at the above referenced

number. Information may be obtained more formally

through formal channels (Freedom of Information) within

HCFA and/or the State survey agency (our agent for

conducting surveys)

Enforcement Failure to comply with all health and safety

requirements may result in being terminated from

participation in the Medicare/Medicaid programs.

Term The certification of a rural health clinic continues

until the RHC is voluntarily or involuntarily terminated

from participation in the Medicare/Medicaid programs.

Standards, Codes

or Regulations

Standards are specified in the Acts and in the Code of

Federal Regulations.

163
Keywords health care facility; health care providers; home health

agencies; hospitals; Medicare certification; rural

health clinics

164
Products or Services

Received 5/98

JRGICAL CENTERS (ASCS)

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

Health Care Financing Administration (HCFA)

Family and Children's Health Program Group

Center For Medicaid and State Operations

Division of Outcomes and Improvement

7500 Security Boulevard

Baltimore, Maryland 21244-1850

Phone: (410) 786-3531

FAX: (410) 786-3517

Initiated

Compliance

Authority

Fully integrated into the health care system since 1982.

Mandatory certification for all Ambulatory Surgical

Centers (ASCs) that voluntarily participate with the

Medicare program. Must meet Conditions for Coverage.

ASC is defined as a distinct entity that operates

exclusively for the purpose of providing surgical

services to patients not requiring hospitalization.

Social Security Act:

Section 1832(a) (2) (F) (I)

Section 1833(1) (1) (A)

Section 1833( I ) (2) (A) and (3).

42 CFR Part 416.

Aim To establish minimum health and safety standards which

must be met by providers and suppliers participating in

the Medicare and Medicaid programs.

Benefits

Methodology

To improve quality of health care for Medicare/Medicaid

beneficiaries

The Agency charged with the implementation and

enforcement of ASC. After enrolling with HCFA for

participation in the Medicare program, HCFA, through

agreements with State survey agencies, surveys ASC to

determine compliance with the Conditions for Coverage.

If the Conditions for Coverage are met, HCFA issues a provider agreement to the ASC. The Conditions for

Coverage of ASC services are found in regulations at 42

CFR Part 416.

165
Inspection See Methodology.

Conformity

Identification

An identification number is given to the supplier (ASC)

when it is determined that Federal requirements are met

Availability

of Documentation

HCFA Homepage address:

<<www.hcfa.gov/stats/pufiles.htm>>; when this area of

the homepage opens, scroll down to the section headed

"Payment Rates: Non-Institutional Providers" and then go

to the public use file entitled "ASC base eligibility

file."

Enforcement Medicare termination if ASCs fail to comply with program

requi rements

Reciprocity ASCs accredited by the Joint Commission on Accreditation

of Healthcare Organizations (JACHO) or the Accreditation

Association for Ambulatory Health Centers (AAAHC).

Standards, Codes

or Regulations

Standards are specified in the Acts and in the Code of

Federal Regulations.

Keywords ambulatory surgical centers; health care facility;

health care providers; hospitals; Medicare certification

166
Received 5/98

Products or CRITICAL ACCESS HOSPITALS

Services

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

Health Care Financing Administration (HCFA)

Family and Children's Health Program Group

Center for Medicaid and State Operations

Division of Outcomes and Improvement

7500 Security Boulevard

Baltimore, MD 21244-1850

Phone: (410) 786-3531

FAX: (410) 786-3517

URL address: To be determined

Initiated August 4, 1997

Compliance Voluntary for Medicare/Medicaid Certification

Authority 42 CFR Part 485 (Critical Access Hospitals)

Aim To establish minimum health and safety standards which

must be met by rural hospital providers participating in

the program. To allow rural hospital providers the

opportunity to continue to provide services within their

community by downsizing the hospital services offered

and networking with other area providers.

Benefits Improved quality of health care for Medicare/Medicaid

beneficiaries in rural communities. Continued services

within rural communities, decrease in duplication of

services within the community while maintaining health

care services for rural beneficiaries.

Methodology The agency is charged with the implementation and

enforcement of the Critical Access Hospital program. A

State develops a rural health care plan which designates

hospitals as critical access hospitals and submits the

plan to the regional office. The regional office

reviews and ultimately approves the plan when it meets

all the required criteria. The State survey agency is

directed to survey the hospital for compliance with the

Conditions of Participation for Critical Access

Hospitals. When it has been determined the hospital

meets the requirements, the regional office designates

the hospital as a critical access hospital.

167
Testing

Inspection

Conformity

Identification

Availability

of Documentation

Non-appl icable.

An initial survey to determine compliance with the

Conditions of Participation is completed by the State

agency in which the hospital is located. The critical access hospital is selected on a random basis to be

resurveyed by the State agency to ensure continued

compliance with the Federal requirements. Reports of

these surveys are provided to the regional office.

A Medicare provider number is given to the facility when

it is determined the Federal requirements are met.

A list of certified facilities is available at each

state agency, regional office or at the central office

location.

Enforcement Medicare decertification/termination per 42 CFR 488 and

42 CFR 489.

Term

Reciprocity

Standards, Codes

or Regulations

Medicare certification remains valid as long as the

provider continues to meet the Federal requirements and

provide services to Medicare beneficiaries.

Non-appl icable

Standards are specified in the Acts and in the Code of

Federal Regulations.

Keywords health care facility; health care providers; hospitals

Medicare certification

168
Products or Services

Received 5/98

:y aid certification activities for

!ME/f€DICAID PARTICIPATING HOSPITALS

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

Health Care Financing Administration (HCFA)

Center for Medicaid and State Operations (CMSO)

Family and Children's Health Program Group (FCHPG)

Division of Outcomes and Improvement (DOI)

7500 Security Blvd.

Baltimore. MD 21244-1850

Phone: (410) 786-3531

FAX: (410) 786-3517

Initiated

Compliance

Authority

1966

Voluntary for Medicare/Medicaid Certification.

Section 1861(e) of the Social Security Act (SSA)

(Definition of Hospital Provider of Services).

Section 1864 of the SSA (Use of State Agencies to

determine Compliance by Providers with Conditions of

Participation)

Section 1865 of the SSA (Effect of Accreditation).

42 CFR Part 482 (Hospital Conditions of Participation)

42 CFR Part 488 (Survey, Certification and Enforcement

Procedures)

Aim To establish minimum health and safety standards which

must be met by providers and suppliers participating in

the Medicare and Medicaid programs as defined above.

Benefits Intended to improve the quality of health care and

assurance of a safe environment for Medicare/Medicaid

beneficiaries.

Methodology The Agency is charged with implementation and

enforcement of the Medicare/Medicaid hospital Conditions

of Participation. After enrolling with HCFA for

participation in the Medicare programs, HCFA, through

agreements with State survey agencies, surveys hospitals

to determine compliance with the conditions of

participation. If the conditions of participation are

met, HCFA issues a provider agreement to the hospital.

Nonaccredited hospitals are subject to periodic Medicare

169
recerti f i cation surveys by the State survey agencies.

Hospitals accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or the

American Osteopathic Association (AOA) are deemed by the

Medicare statute to participate in the program. These

hospitals are not survey agencies. Accredited hospitals

are only subject to HCFA surveys if there is a complaint

investigation or the hospital is selected by HCFA for a sample validation survey.

Testing Not applicable.

Inspection See Methodology

Conformity

Identification

A identification number is given to the provider when it

is determined that Federal requirements are met.

Availability

of Documentation

A list of Medicare certified hospitals maybe obtained by

calling the agency at the telephone number listed above.

Enforcement Medicare decertification/termination if the hospital

fails to meet program requirements.

Term Continued participation until voluntary or involuntary

termination.

Reciprocity Hospitals accredited by the JCAHO or the AOA are deemed

by the Medicare statute to participate in the program.

Based on the complexity of the testing performed, CLIA

specifies regulations for quality control, quality

assurance, patient test management, personnel,

inspections and proficiency testing to assure accurate

and reliable laboratory testing. CDC has responsibility

for test categorization.

Inspection See Methodology and Testing.

Conformity

Identification

An identification number is given to the

provider/supplier when it is determined that federal

requirements are met, or a certificate is given for

laboratories

Availability

of Documentation

A list of accredited laboratories is available at the

above web site as is other relevant information on CLIA

requi rements

170
Obligations of the Laboratories must obtain certification, pay applicable

Manufacturer/Vendor fees and comply with regulations regarding proficiency

testing, personnel, inspections, patient test

management, quality control and quality assurance.

Enforcement Medicare decertification/termination or revocation of

CLIA certificates if laboratories fail to comply with

program requirements.

Term CLIA certificates

two-year period.

for laboratories are effective for a

Reciprocity Hospitals accredited by the Joint Commission on Accreditation of Healthcare Organizations (JACHO) or American Osteopathic Association (AOA) are deemed to

meet the Federal Medicare requirements.

the

Standards. Codes or Regulations

Standards are specified in the Acts and in the Code of

Federal Regulations.

Keywords ambulatory surgical centers; CLIA; health care facility

health care providers; home health agencies; hospices;

hospitals; intermediate care facilities; Medicare

certification; physical therapy; portable x-ray

services; rehabilitation facilities; rural health

clinics; skilled nursing facilities; speech pathology

services

171
Product Page

additives 126. 130. 144

ai rcraft 142

animal feed 144

antibiotics, human 147

antitoxin 150

beverages 132

biologies, veterinary 144

biologies, human 150

blood banks 150

blood products 150

bottled water 132

breathing apparatus 111

buses 142

butter 132

canned foods, low-acid 132

cheese 132

coffee-- 132

color additives 126

cosmetics, animal 144

cosmetics 126, 128

dairy products 132

dietary foods 135. 138

drugs, human 147

drugs, veterinary 144

drugs 126, 128

electronic products (radiation protection) 153

feed, animal 144

fish 115. 119. 123, 140

food additives--- ---126, 130, 144

food inspection personnel 140

foods (general) 135, 140

foods, canned 132

formula, infant 135. 138

172
fruits/juices 132

game, wild 137

gas masks 111

gelatin 137

good manufacturing practices-132. 135. 138, 144, 147, 152, 156

HACCP 115, 119, 132

health clinics, rural 162, 169

health care facilities 159, 162, 165, 167, 169

health care provider 159, 162. 165, 167, 169

herbs 132

hospices 169

hospitals 159. 162. 165, 167, 169

inspection personnel, food 140

laboratory testing 159, 162, 169

lamps, mercury vapor 153

lasers 153

mammography 153

margarine 132

mayonnaise 132

meat 137

medical devices, human 156

medical testing 159, 162

medical devices, veterinary 144

Medicare certification 162, 165, 167

microwave ovens 153

milk 132. 320

mining equipment 111

NSSP 115. 119

nutritionals , special 135, 138

nuts 132

oils (edible) 132

olives 132

pesticide equipment 111

pet food 144

physical therapy 169

poultry 137

radiation protection 153

radiation emitting equipment 153

rai 1 roads 142

receivers, television 153

rehabilitation services 169

respirators 111

173
salad dressings 132

seafood 115. 119. 140

shellfish 115. 119. 140

salmon, canned 123

speech pathology 169

spices 132

sunlamps 153

surgical centers, ambulatory 165. 169

tea- 132

television receivers 153

transportation, food 142

tubes, cold-cathode discharge 153

ultrasonic therapy equipment 153

vaccine 150

vegetables 132

vessels 142

veterinary drugs 144

veterinary biologies 144

veterinary medical devices 144

water, bottled 132

wine beverages (less than 1% alcohol) 132

wines, cooking 132

workplace safety 111. 113

x-rays 153, 169

174
iEWRTOEIT ©F DUMN6 $M Ml iEWELOMEIT

175
Received 7/98

Products or

Services

Department/Agency

(See Also EPA Entry for Lead Paint)

U.S. Department of Housing and Urban Development (HUD)

Office of Lead Hazard Control

Planning and Standards Division

451 Seventh Street, SW

Washington. DC 20410

National Lead Information Clearinghouse: 1-800-424-LEAD

Phone: (202) 755-1785

FAX: (202) 708-1000

URL address: http://www.hud.gov/lea/leadhelp.html

Initiated

Compliance

Authority

1997

Mandatory.

Residential Lead-Based Paint Hazard Reduction Act of

1992 (title X of HUD Act of 1992), 42 U.S.C. 4852d; 24

CFR Part 35.

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

To address the problems of lead-based paint poisoning.

Identification and reduction of lead-based hazards.

Lead-based paint hazard disclosure requirements upon

purchase and sale of most housing built before 1978.

Sellers and landlords have to disclose known information

on lead-based paint hazards and lead based paint before

leases take effect.

Optional, by buyer/renter or seller/lessor.

Optional, by buyer/renter or seller/lessor.

Disclosure statements.

Availability

of Documentation

See Authority. Also see website for further

information.

176
Enforcement Civil penalties (42 U.S.C. 4852d(b)).

Reciprocity Other federal and state agencies.

Keywords lead-based paint; lead hazard; housing; paint; real

estate leasing; real estate transactions

177
Products or

Services

Received 4/98

Department/Agency U.S. Department of Housing and Urban Development (HUD)

Federal Housing Administration (FHA)

Office of Housing

Office of Consumer and Regulatory Affairs

Manufactured Housing and Standards Division

HSCM Room 9152

451 Seventh Street, SW

Washington. DC 20410

Phone: (202) 708-6409

FAX: (202) 708-4213

e-mail : marion_f._connell@hud.gov

URL address: http://www.hud.gov/fcs.html

Initiated

Compliance

Authority

Aim

1965

Voluntary

24 CFR Part 200.935.

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.

Methodology Agency requires ongoing validation of private sector

certifications of products included under a HUD mortgage

insurance program. Uses third party certifications and

manufacturer ' s sel f -certi fi cati on

Testing Uses government accredited labs, third party validating

labs, manufacturers' labs, or state/local government

labs as appropriate.

Inspection Third party

178
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

Manufacturer/ 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 in 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; administrators; building products;

certification; construction; housing; mortgage

insurance; third party validation

179
Products or

Services

Received 4/98

Department /Agency U.S. Department of Housing and Urban Development (HUD)

Federal Housing Administration (FHA)

Office of Housing

Office of Consumer and Regulatory Affairs

Manufactured Housing and Standards Division

HSCM Room 9152

451 Seventh Street, SW

Washington. DC 20410-8000

Hotline for complaints: 1-800-927-2891

Phone: (202) 708-6409

FAX: (202) 708-4213

e-mai 1 : mhs@hud.gov

URL address: http://www.hud.gov/fha/sfh/mhssht3.html

Initiated

Compliance

Authority

1976.

Mandatory.

National Manufactured Housing Construction and Safety

Standards Act, P.L. 93-382, 42 U.S.C. 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 nationwide certification program has

accomplished the stated purposes of the Act and improved

interstate commerce in manufactured housing.

Methodology Agency requires third party certification of

manufactured housing designs and quality assurance

manuals, and in-plant inspection to assure compliance

with standards.

Testing Use third party labs or manufacturer's lab.

180
Inspection Conducted by third parties or state government

inspection agencies.

Conformity

Identification

Authorized red 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 (SAAs).

Obligations of the

Manufacturer/ Vendor

Enforcement

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. Manufacturers must

certify/label that the home section is built in

accordance with HUD's construction and safety standards.

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

181
urn mm

Product Page

paint 176

lead paint 176

housing 176, 178, 180

housing, manufactured 180

manufactured housing 180

building products 176, 178

construction 178

182
ILLS. DEMMEIT ©F WE 3OTfM«

183
Products or

Services

Received 4/98

ID ALEUT ENTERPRISES THAT

\FTS

Department/Agency U.S. Department of the Interior (DOI)

Indian Arts and Crafts Board

1849 "C" Street. NW. MS 4004-M1B

Washington, DC 20240

Phone: (202) 208-3773

Initiated 1943

Compliance

Authority

Voluntary.

P.L. 74-355.

25 CFR Part 308

Aim

Benefits

To improve the competitiveness of genuine products which

are marketed in competition with imitations.

See above.

Methodology

Inspection

Conformity

Identification

Agency requires government inspection and evaluation of

product quality.

Products and facilities are inspected by the federal

government.

Facilities are licensed to use the certification mark.

Products are marked.

Availability A free list of approved enterprises is available from

of Documentation the Board.

Obligations of the The certification mark may be applied only to products

Manufacturer/Vendor that meet the Board's standards.

Enforcement Delisting as well as the imposition of criminal

penalties for the willful misuse of the mark.

Term Indefinite term with occasional re-inspection

184
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

185
Products or

Services 1PERAT10MS AID TRAINING FOR

ES

TALLER:

Received 3/98

d

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

U.S. Department of the Interior (DOI)

Minerals Management Service (MMS)

Engineering and Safety Branch

PAB Rm. 3327A

381 El don Street

Herndon, VA 22070-4817

Phone: (703) 787-1610

FAX: (703) 787-1575

e-mail: bill_cooke@mms.gov

1980.

Mandatory.

30 CFR Part 250.126, Quality assurance and performance

of safety and pollution prevention equipment.

To prevent major oil spills that cause pollution and to

improve safety.

Decreased pollution and accidents and improved

consistency of manufacturing and testing.

Agency requires manufacturer self -certification of

quality of materials; establishment of training course

requirements for installation and maintenance

requirements; and user reporting to Minerals Management

Service.

Inspection

Conformity

Identification

Federal inspection of drilling/production operations.

Valves subject to ASME-approval ; third party inspection

Certified by manufacturer.

Availability

of Documentation

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

10017. Available from API at 1220 L Street. NW.

Washington, DC 20005; Attention: Publications and

Distribution Section; Phone: (202) 682-8375.

186
Obligations of the

Manufacturer/ Vendor

Ensure installers take approved training and certify

that product meets ASME/ANSI or API standards.

Enforcement Warning; prohibition of use

Term On-going.

Reciprocity No reciprocal agreements.

Standards, Codes

or Regulations

ANSI/ASME - SPPE-1-1988, addenda a, b. c, and d. Quality

Assurance and Certification of Safety and Pollution

Prevention Equipment Used in Offshore Oil and Gas

Operations

.

API Specs. Ql. 14A (Technical specification for SSSV's)

14D (Technical specification for SSV's and USV's).

API RP 14B (Installation, inspection, maintenance,

testing, removal, redress, field repair and

documentation for an SSSV.)

API RP 14H (Installation, inspection, maintenance,

testing, removal, redress, field repair and

documentation for an SSV or USV.)

Keywords environmental protection; gas pollution; OCS; offshore

drilling; oil pollution; petroleum pollution; pollution

prevention; safety valves; valves

187
Ml INDEX

Product Page

American Indian jewelry/crafts 184

crafts, Native American -- 184

drilling equipment 186

Eskimo jewelry/crafts 184

gas production equipment 186

Indian jewelry/crafts - -184

jewelry/crafts, Native American 184

Native American jewelry/crafts 184

oil production equipment--- 186

pollution prevention equipment-- - 186

valves, surface and subsurface safety 186

188
y o S, IE1FMU1EMT ©F jySTlO

189
Products or

Services

Received 4/98

UM ENFORCEMENT EQUIPMENT (Including: Police Body Armor

Hand-Held Personal /Portable Transceivers, Handcuffs,

Riot and Crash Helmets, Narcotic Test Kits, Batteries

for Hand-Held Transceivers, 12-Gauge Shotguns. 9mm and

45 Caliber Auto-Loading Pistols, 38 and 357 Caliber

Revolvers, Vehicle Tracking Devices, Body-Worn

Transmitters, and Police Vehicles)

Department /Agency U.S. Department of Justice (DOJ)

National Institute of Justice (NIJ)

SEVEN

810 Seventh Street, NW

Washington. DC 20531

Phone: (202) 306-2942

FAX: (202) 307-6394

Compliance Voluntarily adopted by states and local jurisdictions.

Manufacturers voluntarily submit devices for evaluation

and listing.

Authority Title 1. Section (402)b of the Omnibus Crime Control and

Safe Streets Act of 1968. P.L. 90-351.

42 U.S.C. 3701. Justice System Improvement Act of 1979

P.L. 96-157.

Aim To assist state and local law enforcement agencies in

selecting equipment that is suitable for their needs.

Benefits Test results reported by the National Law Enforcement

and Corrections Technology Center (NLECTC) in a consumer

information report series can assist state and local law

enforcement agencies in selecting equipment suitable for

their needs. In addition, certain manufacturers use the

NIJ standards as the benchmark for product design and

certify compliance to the NIJ standards in their

equipment specifications.

Methodology NIJ awarded a cooperative agreement to Aspen Systems

Corporation to operate a limited equipment testing

program through NLECTC, which in turn contracts with

independent testing laboratories to conduct tests of

equipment in accordance with NIJ standards. Requires

190
independent laboratory qualification testing and

production unit testing in accordance with appropriate

NIJ standard.

Testing Under an NIJ cooperative agreement Aspen Systems

Corporation operates a testing program through NLECTC.

NLECTC contracts with independent testing laboratories

to conduct tests of equipment in accordance with NIJ

standards. Manufacturers may have their equipment

tested to the NIJ standard by an approved testing

laboratory.

Conformity

Identification

Manufacturers may represent their products as complying

with the appropriate NIJ standard. Complying equipment

is listed in an NIJ consumer products list. Test

results are published by NLECTC in a consumer

information report series.

Availability

of Documentation

Copies of the consumer information report series are available from NLECTC, 2277 Research Blvd., Rockville,

MD 20850; Phone 1 -800 -24-TAPIC or (301) 519-5060; Fax:

(301) 519-5212. The Office of Law Enforcement Standards

(OLES) in NIST provides a complete list of standards

upon request.

Obligation of the

Manufacturer/ Vendor

Manufacturers must demonstrate compliance with the

standard by successfully passing testing in accordance

with the standards.

Term Indefinite

Reciprocity Results are recognized by many state and local law

enforcement agencies.

Standards, Codes Uses standards developed by OLES, NIST, which are or Regulations subjected to extensive technical and editorial review

within NIST, as well as by other government agencies,

manufacturers, users, and independent experts, and are given a final review and promulgated by NIJ.

Keywords batteries; body armor; handcuffs; handguns; helmets; law

enforcement equipment; narcotic test kits; performance

standards; police vehicles; shotguns; surveillance

equipment; transceivers

191
m IIS

Product Page

batteries 190

body armor, police 190

guns 190

handcuffs 190

handguns 190

helmets, crash 190

law enforcement equipment 190

narcotic test kits 190

police equipment 190

shotguns 190

surveillance equipment 190

transceivers 190

transmitters 190

vehicle tracking devices 190

vehicles, police 190

weapons 190

192

Products or

Services

DIESEL -POWERED EQU1PI

Received 6/98

4INES

Department /Agency

Initiated

Compliance

U.S. Department of Labor (DOL)

Mine Safety and Health Administration (MSHA)

Directorate of Technical Support

Approval and Certification Center

RR #1, Box 251, Industrial Park Rd.

Triadelphia. WV 26059

Phone: (304) 547-2029

FAX: (304) 547-2044

e-mail: lusiksj@msha.gov

URL address: http://www.msha.gov/S&HINFO/DIESEL.HTM

1996,

Mandatory for diesel -powered equipment in underground

coal mines where methane may be present; mandatory for

all diesel engines in underground coal mines after

11/99.

Authority P.L. 91-173; 30 U.S.C. 957.

P.L. 95-164; 30 U.S.C. 961. 951.

30 CFR Parts 7 and 36. Mandatory health and safety

standards are contained in Sections 70 and 75.

Aim To provide a uniform means for evaluating diesel engines

and diesel -powered equipment used in underground coal

mines

Benefits

Methodology

Testing

Inspection

Accidents and deaths related to diesel -powered mine

machinery have been minimized. Miner exposure to toxic

gas emissions has been held to acceptable levels.

Government conducts design approval, testing, and

inspection.

Government labs or other labs under government

monitoring.

Government.

194
Conformity

Identification

Diesel engines approved under Part 7 will display an approval plate on the engine indicating its approval

status and the minimum ventilating air quantity for that

engine. Part 36 equipment which is equipped with a power package approved under Part 7 will have three

approval plates: one on the engine indicating that it

has been approved under subpart E of Part 7; one on the

power package indicating that it has been approved under

subpart F of Part 7; and one on the machine (which will

generally be located in the operator's compartment)

indicating that the equipment has been approved as a fully assembled machine under Part 36.

Availability

of Documentation

Agency publishes lists of certified and approved

equipment. Additional information on the requirements

is available at the URL address listed above.

Obligations of the

Manufacturer/ Vendor

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

required for approval

.

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

equipment; legal action.

Term Indefinite,

Standards, Codes or RegulationsAgency prepares criteria documents. Equipment

approval requirements are spelled out in the CFR.

Keywords engines; diesel -powered equipment; dust collectors;

electrical components; exhaust gasses; flammable

atmosphere; locomotives; mining machines; coal mines

safety; ventilation

195
Products or

Services

Received 6/98

ELECTRICAL EQUIPMENT FOR NINE

Department/Agency

Initiated

Compliance

Authority

U.S. Department of Labor (DOL)

Mine Safety and Health Administration (MSHA)

Approval and Certification Center

Directorate of Technical Support

RR #1, Box 251. Industrial Park Rd.

Triadelphia. WV 26059

Phone: (304) 547-2029

FAX: (304) 547-2044

e-mail: luziksj@msha.gov

URL address: http://www.msha.gov/REGSINFO/SAFETY.HTM

1969

Mandatory for gassy areas of underground mines.

P.L. 95-164; 30 U.S.C. 961. 951.

P.L. 91-173: 30 U.S.C. 957.

30 CFR Parts 7. 18. 19. 20. 22. 23. 24. 26. 27. 28. 29.

Mandatory safety standards re contained in Parts 57 and

75.

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

To provide a uniform means for evaluating electrical

equipment used in gassy mines for mining, illuminating

communicating and measuring in order to reduce work

place hazards.

Accidents and deaths related to electrically-powered

mine machinery have been minimized.

Government conducts design approval, testing, and

inspection.

Government labs or other labs under government

monitoring.

Government.

Agency designated approval marking on product

type and location varies with product design.

Size,

196
Availability Agency publishes lists of certified and approved

of Documentation equi pment

.

Obligations of the Manufacturer must maintain production according to typeManufacturer/Vendor approved drawings, including modifications to design

required for approval, and employ acceptable quality

control plan.

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

equipment; legal action.

Term Indefinite.

Standards, Codes

or Regulations

Agency prepares criteria documents. Safety standards

and equipment approval requirements are spelled out in

the CFR. More information on the requirements is

available at the URL address listed above.

Keywords battery powered equipment; carbon monoxide monitors;

coal mines; compressors; continuous mining machines;

electric cables; electric cap lamps; electric motors;

electrical equipment; explosion-proof enclosures; fans

illumination; intrinsically-safe equipment; lamps;

longwalls; mining equipment; methane monitors; pumps;

roof bolsters; safety; shearers; shuttle cars;

signalling devices; telephones

197
Products or

Services

Received 6/98

SYSTEMS USING PRESENCE SENSING DEVICES FOR INITIATING

MECWHICAL POWER PRESSES (PSD!) (PROGRAM NOT CURRENTLY

ACTIVE)

Department /Agency U.S. Department of Labor (DOL)

Occupational Safety and Health Administration (OSHA)

Directorate of Technical Support

Office of Variance Determination, Room N3653

200 Constitution Ave. , NW

Washington, DC 20210

Phone: (202) 219-7056

FAX: (202) 219-7068

e-mail : jennifer.silk@osha-no.osha.gov

URL address: http://www.osha.gov

Initiated Final Rule issued in the Federal Register at 53 FR 8322

March 14, 1988.

Compliance

Authority

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.

Methodology OSHA recognizes third party certification program(s) to

validate certifications by manufacturer or employer.

Certifications include design, installation and annual

recertifi cation.

Testing

Inspection

Laboratory selected by recognized certification program.

Recognized third party certification program.

198
Conformity

Identification

Mark or label authorized by recognized certification

program.

Availability

of Documentation

Available from recognized certification program,

manufacturer, or employer.

Obligations of the Cooperate with employers and recognized certification

Manufacturer/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

199
Products or

Services

Received 6/98

EQUIPHEIT AND MATERIALS USED IN THE WORKPLACE

Department/Agency U.S. Department of Labor (DOL)

Occupational Safety and Health Administration (OSHA)

Directorate of Technical Support

NRTL Program, Room 3653

200 Constitution Ave. , NW

Washington. DC 20210

Phone: (202) 219-7056

FAX: (202) 219-7068

e-mail: jennifer.silk@osha-no.osha.gov or bernard . pasquet@osha -no . osha . gov

URL address:

http : //www . osha - si c . gov/SLTC/NRTL/i ndex . html

Initiated Federal Register Notices dated April 12, 1988 pages

12102-12125 and supplemental requirements in notice

dated March 9, 1995, pages 12980-12985.

Compliance

Authority

Mandatory.

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

29 CFR Part 1910 -- Occupational Safety and Health

Standards for General Industry, Section 1910.7.

Aim 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 accredited by OSHA.

Benefits The accreditation or recognition program enables

employers to install equipment which has demonstrated,

compliance with applicable product test standards. OSHA

workplace inspections can also be expedited when

certified equipment is used.

Methodology Requires third party certification bodies to meet the

strict criteria and requirements of competency and

independence in 29 CFR 1910.7, including applicable

international guides. Initial recognition is granted

after the applicant completes a process that include:

200
submission of a complete application; an on-site

assessment; resolution by the applicant of deficiencies

found during the assessment; publication of a preliminary notice in the Federal Register (FR)

announcing the application for recognition, the proposed

scope of recognition, the findings by OSHA, and any

conditions of the recognition; a 60-day comment period;

and then absent compelling reasons to the contrary,

publication of a final FR notice to formally recognize

the applicant as an NRTL.

Testing Third party test/certification labs.

Inspection

Conformity

Identification

OSHA inspectors can inspect equipment in the workplace.

Mark or label authorized by recognized NRTLs.

Obligations of the

Manufacturer/ Vendor

Comply with applicable standards. NRTLs must use appropriate product safety standards in testing

products; test only products within their approved scope

of recognition; and comply with other applicable

requirements.

Enforcement Citation of employer for using uncertified equipment.

Term Initial recognition is valid for 5 years.

Reciprocity Listing, labelling, or approval by foreign certification

agencies is accepted by OSHA if the organization in

question is recognized by OSHA as an NRTL. Eligibility

for recognition of foreign organizations as NRTLs

depends in part on whether the foreign countries are

open to U.S. certifiers.

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,

international standards and guides, and others. OSHA

standards are different from the product test standards

used by the NRTL in certifying products.

201
Keywords electrical; equipment; fire protection; hazardous

materials; job safety; product safety certification

safety.

202
Products or Services

tITIME CARGO LIFTING AID WD11NS

Received 5/98

EQUIPMENT

Department/Agency U.S. Department of Labor (DOL)

Occupational Safety and Health Administration (OSHA)

Directorate of Safety Standards Programs

Office of Maritime Safety Standards

Room N3609

200 Constitution Ave. , NW

Washington, DC 20210

Phone: (202) 219-7234

URL address: http://www.oshaslc.gov/OshStd data/1919. htm

Initiated

Compliance

Authority

1971

Mandatory.

29 CFR Parts 1915-1919.

International Labour Organisation Convention 152.

Longshore and Harbor Workers' Compensation Act.

Occupational Safety and Health Act.

Aim To provide procedures and standards governing

accreditation of persons by OSHA for the purpose of

certifying vessels' cargo gear and shore-based handling

devices. Assure that all covered equipment complies

with regulatory requirements. Most of the equipment is

at marine terminals, shipyards and foreign flag vessels

Cargo gear on board U.S. inspected vessels is under the

jurisdiction of the U.S. Coast Guard.

Benefits

Methodology

Safety of longshoremen, seamen, and dock workers has

been improved by this program which fulfills U.S.

responsibilities for International Labour Organisation

(IL0) Convention No. 152.

Agency approves independent third party certification

agencies and enforces compliance with OSHA maritime

regulations

.

Testing Government on-site audit program.

203
Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Third party.

List of certified products on OSHA official forms.

Agency maintains a list of accredited certification

agencies and surveyors. Such firms are not required to

publicize a list of their clients.

Cooperate with a specific third party certifier

regarding design, fabrication, and installation data and

maintenance requirements.

Removal of accreditation.

One to three years based on quality of certification

activities

Recognition of certification by:

Other federal agencies

State agencies.

Foreign countries.

Agency adopts standards prepared by others.

accreditation; cranes; deficiencies; derricks; marine

equipment; materials handling equipment; naval

equipment; safe working loads; signatory authority;

surveyor; wire rope

204
ML IMEK

Product Page

accreditation 200

battery powered equipment for mining 196

carbon monoxide monitors for mining 196

carbon monoxide monitors for mining 196

coal mine equipment 194, 196

compressors for mining 196 cranes 203

derricks 203

diesel -powered equipment for underground coal mines 194

electric motors for mining 196

electric cables 196

electrical equipment, workplace 200

electrical equipment for mines 196

engine, diesel 194

equipment, battery-powered 196

equipment, diesel -powered 194

equipment, marine 203

fans, electric for mining 196

lamps, mining 196

lifting equipment, maritime 203

light curtain 198

locomotives 194

longwal Is 196

machine guarding 198

marine equipment 203

materials handling equipment 203

methane monitors for mining 196

mining equipment 194, 196

naval equipment 203

power presses 198

presses, presence sensing device for 198

pumps, mining 196

roof bolsters for mines 196

205
rope, wire 203

shuttle cars 196

signalling devices for mining 196

telephones for mining 196

workplace safety 194. 196. 198. 200. 203

206
. iEFMTMEW ©F TWEWTATIi

207
Received 6/98

Products or

Services

Department /Agency

Initiated

Compliance

Authority

["ELLIGENT

(Involves the Use of Telecommunications, Computer

Sensors and Robotics, and Electronic Technologies to

Obtain and Provide Information About the Performance of

Highways, Roads, Transit, and Rail.)

U.S. Department of Transportation (DOT)

Intelligent Transportation Systems Joint Program Office

Room 3422

400 7th Street. SW

Washington, DC 20590

Phone: (202) 366-9536

FAX: (202) 366-3302

URL address: http://www.its.dot.gov/transil.htm

1994

Voluntary, though information obtained through the

program could be used to establish mandatory

requirements.

The Intermodal Surface Transportation Efficiency Act

(ISTEA) of 1991.

Aim

Benefits

Methodology

Testing

To research, develop, test and evaluate advanced

electronic systems that could improve the operational

safety and efficiency of existing surface transportation

infrastructure -- even in the face of increasing traffic

demand and usage.

Has promoted the development of intelligent

transportation technologies and has facilitated the

testing of their "real world" potential outside the

laboratory to address concerns about traffic congestion,

traffic safety, and air quality.

To operate a public/private initiative to research,

develop, test, and evaluate advanced electronic

transportation systems for local or nationwide

implementation.

Primarily private sector labs, though federal/state labs

may be used if appropriate.

208
Inspection Federal and state government agencies and private sector

bodies.

Conformity

Identification

Reciprocity

Keywords

The only identification would be reports on the results

of testing for specific technologies.

This program involves several agencies within DoT. as well as state agencies and the private sector.

computer sensors; electronic technologies; highways;

intelligent vehicle-highway system; roads; robotics;

telecommunications; transit

209
Received 6/98

LIFESAVING. ENGINEERING EQUIPMENT. ELECTRICAL EQUIPMENT.

FIRE PROTECTION. AID POLLUTION. PREVENTION EQUIPMENT FOR

RECREATIONAL BOATS AND COMMERCIAL VESSELS

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

U.S. Coast Guard (USCG)

Marine Safety and Environmental Protection

Office of Design and Engineering Standards (G-MSE)

Room 1218

400 Seventh Street. SW

Washington, DC 20593

Phone: (202) 267-2997

FAX: (202) 267-4816

URL address: See below.

For electrical equipment, engineering equipment, and

pollution prevention equipment:

Office of Design and Engineering Standards

Systems Engineering Division (G-MSF-3)

Room 1300

Phone: (202) 267-2206

FAX: (202) 267-4816

URL address: See below.

For all other equipment:

Office Design and Engineering Standards

Lifesaving and Fire Safety Standards Division

Room 1308

Phone: (202) 267-1444

FAX: (202) 267-1069

e-mail: rmarkle@comdt.uscg.mil

URL address: http://www.uscg.mil/hq/g-m/index.htm

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.

Products or

Services

210
Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

To approve equipment which meets minimum safety and

performance standards.

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.

Government or third party conducts design approval,

audit testing and inspection for some equipment.

Third party pre-approval testing and production testing

and inspection may be required for some products.

Manufacturer self-certification and/or production

testing and inspection may also be allowed for selected

items

.

Coast Guard accredited laboratory.

Manufacturer inspection on selected items.

Coast Guard accredited laboratory.

Manufacturer inspection on selected items.

List of approved/certified products and suppliers.

Items are marked with Coast Guard approval number.

Laboratory listing or classification marking required on some items.

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

COMSTINST M16714.3E) available for sale through

Government Printing Office. Future website availability

of this document is planned.

Manufacturer is required to produce approved item

exactly as described in approved plans. Some

recordkeeping required.

Delisting. Civil and criminal penalties are also

available in certain cases.

Five year term; renewal generally available on request.

None, but in negotiation with the European Union.

211
Standards, Codes 33 CFR Part 159.15 and 46 CFR Parts 160-164 define

or Regulations applicable requirements and criteria.

Keywords boats; commercial vessels; marine safety; marine

equipment; marine pollution prevention; recreational

boats; ships

212
Products or

Services

Received 8/98

HAR1T11H1E COURSE!

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

U.S. Coast Guard (USCG)

National Maritime Center (NMC-4B)

4200 Wilson Blvd. , Room 510

Arlington, VA 22203-1804

Phone: (703) 235-0018

FAX: (703) 235-1063

URL address: http://www.uscg.mil/hq/g-m/gmhome.htm

e-mail: To contact a particular person, use his first

initial followed by last name (with no spaces )@BALLST0N . uscg . mi 1

Initiated

Compliance

Authority

Courses were first approved for education mandated by

regulation such as radar observer, fire-fighting, and

first aid. Courses were then approved for formal

training instead of required sea service for both

renewal and raise in grade of license or an endorsement

and to substitute for a Coast Guard examination.

Mandatory

voluntary.

where required by regulations; otherwise

46 CFR Parts 1 to 40, Subpart C - Training Schools with

Approved Courses.

The International Convention on Standards of Training

Certification and Watchkeeping for Seafarers 1978, as amended in 1995 (STCW Code).

Aim

Benefits

Methodology

To approve merchant marine courses.

To ensure the integrity of Coast Guard approved courses

Coast Guard Regional Examination Centers (RECs) have

oversight responsibility for the approval of maritime

training courses. Training organizations seeking

approval must submit course packages to the NMC.

Packages receive a preliminary review, the proposed

training facility is inspected, and instructor

qualifications are reviewed; and a recommendation

regarding approval is made. The National Maritime

Center then makes a final decision on course approval.

Site approval are done at the local (RECs).

213
Testing

Inspection

N/A.

Inspections are conducted at the REC level. Course

content and instructor approvals are reviewed by the

NIC.

Conformity

Identification

Obligations of the

Manufacturer/ Vendor

Enforcement

Reciprocity

Standards, Codes

or Regulations

List of approved courses is available via the Internet

at the URL listed above. Certificates of approval,

along with an approval letter citing the regulatory

requirement the course meets, are issued to approved

course providers.

To comply with applicable regulations and the terms of course approval

Coast Guard may direct certificate holder to correct

deficiencies, suspend course approval, direct the

surrender of the certificate of approval, and/or direct

the holder to cease claiming the course is Coast Guard

approved.

None

See 46 CFR Part 10

Keywords marine safety; maritime courses; maritime training

214
Products or

Services

Received 6/98

LICENSING OF MARITIHE OFFICE!

Department/Agency

Compliance

Authority

Aim

Benefits

U.S. Department of Transportation (DOT)

U.S. Coast Guard (USCG)

National Maritime Center (NMC)

Marine Personnel Division

4200 Wilson Blvd.

Arlington, VA 22203-1804

Phone: (703) 235-0018

FAX: (703) 235-1062

URL address: http://www.uscg.mil/hq/g-m/gmhome.htm

Mandatory where required by regulation.

46 CFR Part 10.

To license qualified maritime officers and seamen.

To ensure that all vessels are adequately manned with a minimum number of qualified crewmen to safely operate

the vessel

.

Testing By the Coast Guard or by an approved Coast Guard

training course provider.

Conformity

Identification

Licenses are issued by the Coast Guard

Obligations of the To comply with applicable regulations and the terms of

Manufacturer/Vendor the license and pay the appropriate licensing fees.

Enforcement Coast Guards may suspend or revoke license

Term

Reciprocity

Licenses/documents are valid for 5 years; course

approvals for 2 years and renewals for 5 years.

None.

Standards, Codes

or Regulations

46 CFR Part 10.

215
Keywords marine licensing; marine safety; maritime courses;

maritime officers; maritime seamen; maritime training

216
Products or Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Not Received

U.S. Department of Transportation (DOT)

U.S. Coast Guard (USCG)

Marine Safety and Environmental Protection

Field Activities

Office of Vessel Traffic Management (G-MOV)

400 Seventh Street, SW

Washington, DC 20590

Phone: (202) 267-0407

FAX: (202) 267-4826

January 1985.

Mandatory.

33 CFR Part 164.

Port and Tanker Safety Act of 1978.

To approve the standards of collision avoidance at sea

Awareness and performance of observers is enhanced

through automatically acquired information.

Requires manufacturer's self -certification.

Manufacturer's laboratory.

Government.

Authorized label by manufacturer.

No lists of conforming products are published

217
Obligations of the Conformity obligations rest on the equipment user who

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

regulations

Enforcement

Term

Reciprocity

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

equipment not in compliance).

Indefinite term.

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; satellite receivers; ships; speed

indicators; steering gear; vessels

218
Products or Services

Received 6/98

VESSEL!

Department/Agency

Compliance

Authority

U.S. Department of Transportation (DOT)

U.S. Coast Guard (USCG)

Marine Safety Center

400 Seventh Street, SW

Washington, DC 20590-0001

Phone: (202) 366-6480

FAX: (202) 366-3877

URL address: http://www.uscg.mil/hq/msc

Mandatory for certain vessels where required by statute.

Titles 33. 46 and 49 of the CFR.

International Convention for the Safety of Life at Sea

(SOLAS), 1974 as amended.

International Load Line Convention. 1966.

International Convention for the Prevention of Pollution

from Ships, 1973 as modified by the Protocol of 1978.

Aim To review and approve plans for vessels being built or converted to ensure compliance with applicable

regulations, construction standards, and specifications

for the service and route(s) specified.

Benefits To permit the safe operation of vessels without

endangering life, property, or the environment.

Methodology

Testing

Inspection

Coast Guard conducts complete inspection of vessels

covered by statute prior to certification. The

procedures used in the inspections are provided

primarily by regulations and instructions, but in some cases are specified in the statutes or treaties. The

procedures and requirements vary by type of vessel and

depend on such factors as trade, route, length, tonnage

or number of passengers. All inspections include

verification that the vessel has been constructed and

equipped in accordance with approved plans.

Government or an organization recognized by the USCG.

Government or an organization recognized by the USCG.

219
Conformity

Identification

Certificates of Inspection (COD are issued by the Coast

Guard.

Availability

of Documentation

See information on inspection of vessels for

certification listed at: http://www.uscg.mil/hq/gm/nmc/pubs/msm/v2/c6 . htm

Obligations of the File and application for inspection. Satisfactory

Manufacturer/Vendor completion of an inspection for certification.

Continued maintenance of the vessel in a safe operating

condition. Operation in accordance with the terms

stated in the COI.

Enforcement Vessels may be detained and/or COI revoked and civil

penalties man also be assessed.

Term Permanent COIs as well as temporary COIs may be issued

(pending the issuance of a permanent COI). Periods of

validity for COIs vary by vessel type and generally

range from 1 to 5 years. Retention of the COI depends

upon the continued maintenance of the vessel in safe

operating condition.

Reciprocity Other Federal agencies.

Foreign government agencies

International organizations

Standards, Codes

or Regulations

Standards are generally established by the U.S. Coast

Guard, but may also be established by statute or through

international conventions and treaties to which the U.S.

is signatory.

Keywords boats: maritime safety; ships; vessels

220
Products or

Services

Received 6/98

SHIPPING COITAltJER!

Department/Agency

Initiated

Compliance

Authority

Aim

U.S. Department of Transportation (DOT)

U.S. Coast Guard (USCG)

Office of Marine Safety and Environmental Protection

Office of Compliance

Ports and Facilities Compliance Division (G-MOC-3)

2100 Second Street, SW

Washington, DC 20593-0001

Phone: (202) 267-0499

FAX: (202) 267-0506

e-mail: rproctor@comdt.uscg.mil

1977.

Mandatory.

International Safe Container Act.

To provide procedures to certify containers as conforming to the International Convention for Safe

Containers

.

Benefits

Methodology

Testing

Conformity

Identification

Availability

of Documentation

International transport of containers is safer.

Container must be certified by a third party before it can be entered into international traffic. Agency

enforces requirements.

Manufacturer or owner and Approval Authority witness

tests for container design type approval.

Containers must display a Safety Approval Plate from the

Approval Authority in the country of registry.

List of approved manufacturers may be obtained from the

Approval Authorities in each signatory country. Coast

Guard can identify Approval Authorities within the

United States.

221
Obligations of the Owner and lessees are responsible for maintaining each

Manufacturer/Vendor container in a safe condition.

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Detention of unsafe and noncomplying containers.

Individual containers used in international transport of

cargo are subject to re-inspection every 30 months.

Certification is recognized by foreign governments and

international organizations.

Standards are included in the International Convention

for Safe Containers, regulations in 49 CFR Parts 450-

453.

Keywords ACEP; Approved Continuous Examination Program; cargo

container; commercial vessels; container; CSC; design

approval; International Convention for Safe Containers;

marine equipment; ships

222
Products or

Services

CIVILIAN AIRCRAFT, AIRCRAFT ENGINE!

THEIR COMPONENTS AND PARTS

Received 6/98

OPELLERS. AND

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, 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 ENGINEERING REPRESENTATIVES,

DESIGNATED AIRWORTHINESS REPRESENTATIVES, ORGANIZATIONAL

DESIGNATED AIRWORTHINESS REPRESENTATIVES, and

MANUFACTURING INSPECTION REPRESENTATIVES, DESIGNATED

ALTERATION STATIONS, and DELEGATION OPTION

AUTHORIZATIONS.

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

Federal Aviation Administration (FAA)

Assoc. Administrator for Regulation and Certification

Aircraft Certification Service

800 Independence Ave., SW, Room 800E

Washington, DC 20591

Phone: (202) 267-8235

FAX: (202) 267-5364

e-mail: tom.mcsweeny@faa.dot.gov

For information on Air Carrier security requirements,

contact:

the Associate Administrator for Civil Aviation Security

Office of Civil Aviation Security Operations

Room 319

800 Independence Ave., SW

Washington, DC 20591

Phone: (202) 267-7261

FAX: (202) 267-8496

e-mai 1 : bruce . butterworth@faa . dot . gov

URL address: http:cas.faa.gov/esp.htm

Initiated 1926.

223
Compliance

Authority

Aim

Benefits

Mandatory.

Federal Aviation Act of 1958 as recodified in 1994 (49

U.S.C.).

14 CFR Parts 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.

Methodology Conducts 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

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,

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 Approved Production Inspection System (APIS) is

issued to holders of type certificates that are more

than 6 months old that wish to manufacture a complete

product or parts without benefit of a Production

Certificate.

An Airworthiness Certificate is granted for a specific

aircraft that meets the approved type design and is in

condition for safe operation. Export certificates of

airworthiness are also issued for aircraft, aircraft,

engines, and propellers that are exported.

224
Parts Manufacturer Approval (PMA) 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

under an effective quality control system.

A Technical Standard Order Authorization (TSOA) is a design and production approval to manufacture and

identify products, in accordance with FAA Technical

Standard Orders (TSOs). It requires demonstration of

compliance with performance and quality control

requirements specified in the respective TSOs.

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 PMAs and TSOs 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

required levels.

Inspection Inspection is accomplished by FAA specialists and

designated representatives.

Conformity

Identification

Airworthiness Certificates are issued for each approved

aircraft. Aircraft, aircraft engines and propellers

must list the Type Certificate and Production

Certificate numbers on their data plates. Products

conforming to PMA are marked "FAA-PMA". Those

manufactured in accordance with a TSO authorization are marked with the applicable TSO number.

Availability No lists of approved or qualified products or suppliers

of Documentation are published for general distribution by FAA.

Obligations of the Each manufacturer or user of certified products,

Manufacturer/Vendor 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

225
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

1155(a). 46301, 46302. 46303. 46304 and 1153 of the

former Federal Aviation Act of 1958 as recodified in

1994. Under sections 1155. 46305 and 46304. 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 United States. 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 United States. The U.S. Dept. of Defense and the

Coast Guard require that certain of their aircraft and

equipment be FAA certified.

A Type Certificate may be issued for a product

manufactured in a foreign country with which the United

States has a bilateral airworthiness 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

226
An Airworthiness Certificate is granted to imported

aircraft for which a U.S. Type Certificate has been

issued, and 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, APISs

PMAs, or TSOAs if the manufacturing facilities are located outside the United States, unless there is no undue burden found in administering the applicable

requirements of the former Federal Aviation Act of 1958

as recodified in 1994.

Applicable design, performance, and quality requirements

are specified in 14 CFR Parts 1-199. Nongovernment

standards, accepted by the FAA, are primarily standards

developed by the Society of Automotive Engineers, Radio

Technical Commission 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

Standards, Codes

or Regulations

227
Products or

Services

Received 7/98

JD RELATED FACILITIES AID

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

Federal Aviation Administration (FAA)

Assoc. Administrator for Airports

Office of Airport Safety and Standards

800 Independence Ave., SW, Room 600E

Washington, DC 20591

Phone: (202) 267-3053

FAX: (202) 267-5383

e-mail: dave.bennett@faa.dot.gov

URL address: http:www.faa.gov/arp/arpmiss.htm

For information on Airport Security requirements,

contact:

the Associate Administrator for Civil Aviation Security

Office of Civil Aviation Security Operations

Room 319

800 Independence Ave., SW

Washington, DC 20591

Phone: (202) 267-7261

FAX: (202) 267-8496

e-mail : bruce.butterworth@faa.dot.gov

URL address: http:cas.faa.gov/esp.htm

Compliance

Authority

Aim

Mandatory.

Federal Aviation Act of 1958 (49 U.S.C.).

FAA Regulations Parts 139, 150 and 161.

National Environmental Policy Act of 1969.

Airport and Airway Improvement Act

Aviation Safety and Noise Abatement Act.

To promote the development of and integrated system of

airports and improve safety in the national airport

system.

Benefits The FAA airport certification system has helped to

produce some of the safest and most efficient airports

in the world.

228
Methodology Operates an Airport Safety and Certification Program.

Develops FAA standards and criteria for: airport design

construction, operation and maintenance, environmental

impact, noise levels, safety, and data collection and

reporting requirements. Controls the conveyance and

lease of federal land and surplus property for airport

purposes. Conducts programs to monitor the safe

operation of airports. Collects and maintains data on the nation's airports. FAA also operates an Airport

Lighting Equipment Certification Program and inspects

and approved airport lighting equipment as well as friction measurement equipment.

Testing Compliance with the applicable requirements is usually

accomplished by the applicant and the FAA will review,

witness and tests as appropriate, prior to approval.

Inspection Inspection is accomplished by FAA specialists and

designated representatives.

Conformity

Identification

Certificates are issued to approved airports

Availability

of Documentation

A list of approved facilities which constitute the

National Plan of Integrated Airport System (NPIAS) is

available from the office listed above.

Enforcement Various civil penalties are provided for under section

901 of the Federal Aviation Act of 1958. The FAA may

also modify or revoke the operating authority granted to

airports. Other enforcement options include cease and

desist orders, orders of denial and injunctions.

Standards. Codes or Regulations

Applicable design, performance, and quality requirements

are specified in 14 CFR Parts 150 and 161.

Nongovernment standards, used by the FAA where

appropriate.

Keywords airport buildings; airport capacity; airport lighting;

airport safety; airports; aviation; heliports; navaids;

pavement; runways; transportation safety

229
Products or

Services

Received 6/98

COMMERCIAL VEHICLES (Size/Weight Limits and Safety

Requirements for Buses and Trucks)

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

Federal Highway Administration (FHWA)

Associate Administrator for Motor Carriers

Office of Motor Carrier Information Analysis

Room 3103

400 7th Street. SW

Washington. DC 20590

Phone: (202) 366-1790

FAX: (202) 366-7298

Initiated

Compliance

Authority

1956, expanded in 1982 and 1991

Mandatory.

Authority to establish certain federal size limits for

commercial motor vehicles operating on the National

Highway System, and on routes offering reasonable access

to and from most highways, is provided in 49 U.S.C. App.

2311, 2312, and 2316. Authority to establish weight

limits that states must apply to vehicles operating on the interstate system and to penalize states that fail

to adopt these limits, is provided by 23 U.S.C. 127. See

also the Motor Carrier Safety Act of 1997, the Federal

Motor Carrier Safety Regulations (FMCSRs), and Hazardous

Materials Transportation Uniform Safety Act of 1990

(HMTUSA 90).

Vehicle size and weight regulations and state

certification requirements are codified in 23 CFR 657

658. These include regulation of truck lengths and

widths on the National Highway System (published in

Appendix A to Part 658) which consists of the

interstates and other designated federal -aid primary

highways.

HMTUSA 90 establishes requirements for registration,

routing, and safety permits for certain types of

hazardous materials and training of haxmat employees.

Aim To maintain highway and bridge conditions and improve

highway safety and national uniformity.

230
Benefits This program assures that commercial vehicles will not

exceed size and weight limits established by FHWA or violate FHWA safety requirements, and controls the

transportation of some hazardous materials via motor

carriers

.

Methodology States, which are determined to be competent by FHWA,

agree to adopt and to assume responsibility for

enforcement of the Federal Motor Carrier Safety

Regulations (FMCSRs) (CFR Parts 390-399). State

assessment is required prior to and during vehicle

operations. State and FHWA investigators review the

safety records of individual motor carriers to assess their compliance and safety performance. The results

are used to assign safety ratings and are incorporated

along with other safety data in SafeStat to reassess carrier safety status. Inspection/vehicle weighing is

also conducted by state agencies in accordance with

standards

.

Testing Testing (vehicle weighing) is conducted by state

agencies

.

Inspection Inspection is conducted by state agencies

Conformity

Identification

Annual State Certification.

Availability

of Documentation

FHWA regulations are available from the Government

Printing Office and several private organizations.

Enforcement Each state must enforce the federal size and weight

requirements on their interstate highways. They must

enforce the federal size requirements on their National

Highway System highways. States are required to certify

annually that they are enforcing their size and weight

laws on all of their federal -aid highways. States whose

enforcement efforts on federal -aid highways are inadequate may lose 10-percent of their federal -aid

highway funds. Motor carriers who violate size, weight

or safety requirements can be fined or have their

licenses suspended or revoked.

Term Annual

231
Reciprocity

Standards, Codes or Regulations

Keywords

State laws must provide for maximum reciprocity for

inspection conducted pursuant to the North American

Uniform Driver/Vehicle Inspection Standards.

Standards and requirements can be found in 23 U.S.C.

and 658.

bus; commercial motor vehicles; hazardous materials;

motor carriers; truck; vehicle size; vehicle weight

232
Products or Services

SIGNS, PAVEMENT HARC

OPEN TO THE PUBLIC

Received 7/98

IGS AID TRAFFIC SIGNALS ON ROM

Department/Agency

Initiated

U.S. Department of Transportation (DOT)

Federal Highway Administration (FHWA)

Office of Highway Safety (HHS-10)

400 7th Street. SW, Room 3414

Washington, DC 20590

Phone: (202) 366-2192

URL address:

http: //www. ohs/fhwa .dot .gov/devices/i ndex.html

Original edition of the Manual of Uniform Traffic

Control Devices (MUTCD) was published in 1936. FHWA has

administered the MUTCD since 1971.

Compliance Under authority granted by legislation in 1966, the

Secretary of Transportation decreed that traffic control

devices on all roads in each State shall be in

substantial conformance with the MUTCD.

Authority

Aim

23 U.S.C. 109(d) and 23 CFR Parts 655.601-603.

To improve highway safety and national uniformity of

traffic control devices.

Benefits

Methodology

Testing

Inspection

See Aim.

The FHWA is responsible for developing standards for the

design, application and proper placement of traffic

control devices. The FHWA is also responsible for

publishing the Manual on Uniform Traffic Control Devices

(MUTCD), which contains the national standards and

guidance for traffic control devices used on all roads

open to the public as well as the Standard Highway Signs

Book. The responsibility for the selection,

installation, operation and maintenance of traffic

control devices is that of the individual State and

local highway agencies.

Responsibility rests with the state and local highway

agencies

.

Responsibility rests with the state and local highway

233
agencies

Conformity

Identification None.

Availability

of Documentation

Copies of the Manual on Uniform Traffic

Control Devices (MUTCD) as well as the Standard Highway

Signs Book are available from the Government Printing

Office (GPO).

Enforcement Responsibility rests with the state and local highway

agencies

Term N/A.

Reciprocity Recognized throughout the United States

Standards, Codes

or Regulations

Standards are contained in the Manual on Uniform Traffic

Control Devices (MUTCD) as well as the Standard Highway

Signs Book.

Keywords traffic signs; traffic signals; pavement markings;

traffic control devices

234
COMMERCIAL DRIVER LICENSE CCDL)

Received 7/98

U.S. Department of Transportation (DOT)

Federal Highway Administration (FHWA)

Associate Administrator for Motor Carriers

Office of Motor Carrier Research and Standards

Room 3107

400 7th Street, SW

Washington, DC 20590

Phone: (202) 366-1790

FAX: (202) 366-8842

e-mail: aamotorcarriers.fhwa@fhwa.dot.com or mcregis@fhwa .dot .gov

1992.

CDL program implementation is mandatory for each State

to avoid a reduction in highway funding. States are required to test and issue CDLs to all drivers of

commercial motor vehicles prior to April 1, 1992. This

is mandatory for drivers of commercial motor vehicles

having a gross vehicle weight rating over 26 000 lbs.,

designed to carry 16 or more persons including the

driver, or is of any size and requires placarding for

hazardous materials.

Authority to regulate the qualifications and maximum

hours of service of employees, the licensing standards

for commercial drivers, and safety of operations and

equipment is specified in 49 U.S.C. 31136, 31301 et

seq., and 31502, and 49 CFR 1.48. Requirements are codified in 49 CFR Part 383. The CDL regulations apply

without distinction to inter- and intrastate

transportation.

To improve the highway safety.

This program assures that commercial drivers have

demonstrated competence in accordance with FHWA

standards

.

235
Methodology Standardize testing and licensing procedures by state

agencies in accordance with standards prior to

licensing.

Testing

Conformity

Identification

Availability

of Documentation

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Testing is conducted by state agencies.

Issuance of a standardized commercial driver's license

(CDL).

Commercial Drivers 's License (CDL) standards are codified in 49 CFR Part 383. FHWA regulations are available from the Government Printing Office and

several private organizations.

CDL provisions include a prohibition on multiple

licenses; testing and licensing procedures which states

and drivers must follow; employer responsibilities;

mandatory driver disqualifications for alcohol, drug,

and other serious traffic violations and felonies; and a nationwide pointer system for driver identification.

Office of Motor Carriers reviews state compliance with

the CDL program.

Ongoing.

State laws must provide for maximum reciprocity for

inspection conducted pursuant to the North American

Uniform Driver/Vehicle Inspection Standards.

Commercial Drivers's License (CDL) standards are codified in 49 CFR Part 383.

commercial motor vehicles; motor carrier; commercial

drivers license; hazardous materials; bus; truck; driver

qualifications; state compliance

236
Products or

Services

Received 6/98

DESIGN CRITERIA FOR BR]

PAVEMENT

DOES, TUNNELS. HIGHWAY!

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

Federal Highway Administration (FHWA)

Associate Administrator for Program Development

Office of Engineering, Room 3212C

400 7th Street, SW

Washington, DC 20590

Phone: (202) 366-4853

FAX: (202) 366-3043

URL address: http://www.fhwa.dot.gov

Compliance Mandatory for highways which are part of the National

Highway System; otherwise voluntary, though states may

mandate usage for other types of roads. Projects (other

than highway projects on the National Highway System)

shall be designed, constructed, and maintained in

accordance with State laws; regulations; directives; and

safety, design and construction standards.

Authority Title 23 U.S.C. 109

23 CFR 625.

Aim To provide technical assistance for quality design,

construction, rehabilitation, maintenance, and operation

of the Nation's highways and bridges.

Benefits Improvement in the quality of the Nation's highways and

bridges.

Methodology Title 23 U.S.C. 109 provides that design standards for

projects on the National Highway System (NHS) must be

approved by DOT in cooperation with State highway

departments and used on the NHS.

Testing Generally performed by State laboratories or by the

suppl iers

.

Inspection Generally performed by state inspectors

Conformity

Identification

N/A.

237
Avai lability

of Documentation

Contact FHWA at the address listed above.

Enforcement

Term

Withholding of federal funds

N/A.

Reciprocity

Standards, Codes

or Regulations

Keywords

Program is recognized nationwide.

Uses FHWA and appropriate private sector standards

bridges; construction; highways; pavement; roads;

tunnels

238
Products or

Services

Not Received

RAILROAD TRA1IS AND EQUIPMENT

See Also FRA entries for Rear End Marking Devices and

Safety Glazing of Windows)

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

Federal Railroad Administration (FRA)

Associate Administrator for Safety

Office of Safety Enforcement

Motive Power and Equipment Staff

RRS 12, Mail Stop 25

400 7th St. . SW

Washington, DC 20590

Phone: (202) 632-3338

FAX: (202) 632-3875

URL address: http://www.fra.dot.gov/safety/mpc/mpc.htm

Initiated FRA has been responsible for this area since its

creation in 1966.

Compliance

Authority

Mandatory.

49 U.S.C. 20101, 20103.

49 CFR Part 1.49).

Aim To ensure a safe, efficient and effective passenger and

freight railroad network.

Benefits

Methodology

See Aim.

FRA staff inspect approximately 1.2 million freight cars and over 20 000 locomotives. Railroads must also

conduct a program of operational tests and inspection

under 49 CFR Part 217. Tests and operation monitoring

checks must be documented and available for FRA review

and conduct required crew training. Since 9/94, FRA

also has been developing passenger equipment and safety

standards on a priority basis.

Testing Testing is conducted by railroad owners and by FRA/state

inspectors

.

239
Inspection Inspections are conducted by railroad owners and by

FRA/state inspectors.

Obligations of the Passenger train railroads must develop safety plans

Manufacturer/Vendor addressing safety concerns associated with passenger

occupancy rates, operating rules, adverse operating

conditions, short-term technology enhancements, crew

management, highway-rail crossings, and information on emergency exits. Railroad owners must conduct the

required crew training, tests and operational

monitoring; document the results of such activities;

provide monthly reports to FRA including

accident/incident information; and comply with all othe

relevant FRA regulations.

Enforcement Violations are subject to a civil penalty of up to

$25,000 and criminal penalties of not more than 5 years

FRA may also seek injunctive relief to enforce these

regulations

Reciprocity

Keywords

Recognition by state regulators and other federal

agencies.

locomotives; railroads; railway car; safety;

transportation

240
Products or

Services

Received 7/98

m

Department/Agency

Initiated

U.S. Department of Transportation (DOT)

Federal Railroad Administration (FRA)

Associate Administrator for Safety

Office of Safety Enforcement

Signal and Train Control Division

Mail Stop 25

400 7th St. . SW

Washington, DC 20590

Phone: (202) 632-3353

FAX: (202) 632-3875

URL address: http://www.fra.dot.gov

FRA has been responsible for this area since its

creation in 1966.

Compliance

Authority

Mandatory.

49 U.S.C. 20101, 20103.

49 CFR Part 1.49).

Aim To ensure a safe, efficient and effective passenger and

freight railroad network.

Benefits

Methodology

Testing

Inspection

Availability

of Documentation

See Aim.

Inspects 87 000 miles of signal and control systems.

Testing is conducted by railroad owners and by FRA/state

inspectors.

Inspections are conducted by railroad owners and by

FRA/state inspectors.

See information at URL address listed above or contact

the Signal and Train Control Division at the address

listed above.

241
Enforcement Violations are subject to a civil penalty of up to

$25,000 and criminal penalties of not more than 5 years

FRA may also seek injunctive relief to enforce these

regulations

Reciprocity

Keywords

Recognition by state regulators and other federal

agencies

control devices; locomotives; railroads; safety devices

signaling devices; transportation

242
Products or

Services

REM END MARI

FREIGHT TRAli

Not Received

DEVICES FOR PASSEI6ER 0 COMMUTER AND

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

Federal Railroad Administration (FRA)

Associate Administrator for Safety

Office of Safety Enforcement

Motive Power and Equipment Staff

RRS 12. Mail Stop 25

400 7th St. , SW

Washington, DC 20590

Phone: (202) 632-3338

FAX: (202) 632-3875

URL address: http://www.fra.dot.gov/safety/mpc/mpc.htm

Initiated

Compliance

Authority

1978.

Mandatory.

Section 202, 84 Stat. 971, 45 U.S.C. 431

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

Methodology

Conformity

Identification

Rear end collisions have decreased since implementation

of this certification program.

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.

Inclusion on FRA's list of approved devices.

243
Availability 49 CFR Part 221. Appendix B. of Documentation

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

Manufacturer/Vendor the original approval.

Enforcement Civil penalties ranging from $1000 to $7500 for each

violation. Each day of each violation constitutes a separate offense.

Term Indefinite.

Reciprocity Recognition by state regulators as minimum requirements.

Standards, Codes

or Regulations

Guidelines for Testing of FRA Rear End Marking Devices

Keywords colorimetric; lights; photometric; railroads; railway

car; safety; strobe; transportation

244
Products or

Services

Not Received

ES. FASSEI6I

IB

Department/Agency

Initiated

Compliance

Authority

U.S. Department of Transportation (DOT)

Federal Railroad Administration (FRA)

Associate Administrator for Safety

Office of Safety Enforcement

Motive Power and Equipment Staff

RRS 12, Mail Stop 25

400 7th St., SW

Washington, DC 20590

Phone: (202) 632-3338

FAX: (202) 632-3875

URL address: http://www.fra.dot.gov/safety/mpc/mpc.htm

1979.

Mandatory.

45 U.S.C. 431 and 438, as amended; P.L. 100-342.

49 CFR Part 1.49(m), 49 CFR Part 223.

Aim

Benefits

Methodology

Conformity

Identification

To protects railroad employees and passengers from

injury as the result of objects striking the windows of

locomotives, cabooses, and passenger cars.

Injuries from projectiles and broken glass have

decreased since implementation of this certification

program.

Testing to demonstrate compliance is accomplished by

manufacturers in their labs or independent labs that

meet specified qualifications. Each individual unit of

glazing material is permanently marked to indicate

certification. Agency enforces compliance with

regulatory requirements.

Each unit of glazing must be permanently marked and each

equipped vehicle must be so stencilled.

245
Availability 49 CFR Part 223, Appendix A. of Documentation

Obligations of the Produce glazing that is the same as samples tested for

Manufacturer/Vendor the original approval.

Enforcement Civil penalties ranging from $500 to $5000 for each

violation. Each day of each violation constitutes a separate offense.

Term Indefinite

Reciprocity Recognition by state regulators as minimum requirements

Standards, Codes

or Regulations

FRA's Certification of Glazing Materials.

Keywords certified glazing; ballistic impact; FRA Type I; FRA

Type II; glazing; large object impact; target material;

window glazing

246
Products or

Services

Received 7/98

Department/Agency

Initiated

U.S. Department of Transportation (DOT)

Federal Railroad Administration (FRA)

Associate Administrator for Safety

Office of Safety Enforcement

Track Standards Division. RRS-15

Mail Stop 25

400 7th St. . SW

Washington, DC 20590

Phone: (202) 493-6243

FAX: (202) 493-6230

URL address: http://www.fra.dot.gov

FRA has been responsible for this area since its

creation in 1966.

Compliance

Authority

Mandatory.

49 U.S.C. 20101, 20103

49 CFR Part 1.49).

Aim To ensure a safe, efficient and effective passenger and

freight railroad network.

Benefits

Methodology

See Aim.

Through spot observations, FRA regional track inspectors

evaluate the effectiveness of railroad track inspectors

in their determination of compliance with the track

safety regulations for some 200 000 miles of railroad

track. Inspections must be documented and these records

available for FRA review.

Testing

Inspection

Testing is conducted by railroad owners and by FRA/state

inspectors as required.

Inspections are conducted by railroad owners and by

FRA/state inspectors.

247
Obligations of the

Manufacturer/ Vendor

Railroads conduct the required inspections and document

the results and comply with all other relevant FRA

regulations.

Enforcement Violations are subject to a civil penalty of up to

$22,000 and criminal penalties of not more than 2 years

FRA may also seek injunctive relief to enforce these

regulations

Reciprocity Recognition by state regulators and other federal

agencies.

Keywords locomotives; railroads; railway car; safety; track

transportation

248
Products or

Services

VTERIAIS B

Received 5/98

RAIL

Department/Agency

Compliance

Authority

U.S. Department of Transportation (DOT)

Federal Railroad Administration (FRA)

Associate Administrator for Safety

Office of Safety Assurance and Compliance

Hazardous Materials Division

RRS 12 Mail Stop 25

400 7th St. , SW

Washington, DC 20590

Phone: (202) 632-3348

FAX: (202) 632-3875

URL address: http://www. fra.dot.gov/safety/mpc/mpc. htm

Mandatory.

49 U.S.C. 20101 et seq. and 49 U.S.C. 5101 et seq.

49 CFR Part 1.49).

Aim To enforce federal railroad safety laws, including laws

pertaining to the transportation of hazardous materials

by railroad.

Benefits

Methodology

See Aim.

All tank car facilities must establish a Quality

Assurance Program (QAP) to help prevent and detect non- conformities during the manufacturing, repair, or inspection and test process. The QAP must ensure that

the finished product conforms to the requirements of the

applicable specification and regulations of the FRA.

The FRA also imposes identification and marking

requirements of rail cars, freight containers, transport

vehicles, portable tanks, and tank cars containing

certain hazardous materials.

Testing

Inspection

Testing conducted by railroad owners and by FRA/state

inspectors

.

Inspections conducted by railroad owners and FRA/state

inspectors.

249
Conformity

Identification

Appropriate identification and marking requirements of

railcars, freight containers, transport vehicles,

portable tanks, and tank cars containing certain

lazardous materials.

Availability

of Documentation

See CFR reference and information at URL address listed

above.

Obligations of the

Manufacturer/ Vendor

See Methodology.

Enforcement Violations are subject to a civil penalty of up to

$27,500 and criminal penalties of up to 5 years. FRA

may also seek injunctive relief to enforce these

regulations.

Reciprocity

Keywords

Recognition by state regulators and other federal

agencies

freight containers; hazardous materials; portable tanks;

railcar; railroads; safety; tank car; transport vehicles

250
Received 7/98

Products or BUSES AID TMISIT VANS

Services

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

Federal Transit Administration (FTA)

Office of Grants Management (for grant requirements)

400 Seventh Street, SW. Room 9315

Washington, DC 20590

Phone: (202) 366-4020

FAX: (202) 366-7951

e-mail: walkerh@tgm.dot.gov

or U.S. Department of Transportation (DOT)

Federal Transit Administration (FTA) TRI -20

Office of Technology (for testing determinations)

400 Seventh Street, SW

Washington, DC 20590

Phone: (202) 366-8063

FAX; (202) 366-3765

or Altoona Bus Testing Center (test facility issues)

6th Avenue and 45th Street,

Altoona, PA 16602

Phone: (814) 863-1889

or Office of Chief Counsel, Room 9316 (for legal issues)

FTA

400 Seventh Street, SW

Washington, DC 20590

Phone: (202) 366-1936 (for legal issues)

FAX: (202) 366-3809 (for legal issues)

e-mail: durkeed@tcc.dot.gov (for legal issues)

URL address:

http://www.fta.goV/library/policy/circ9300/9300ch3/html#

clig

Initiated 1989.

Compliance Mandatory for purchase of new model buses with federal

funds

.

251
Authority 49 U.S.C. 1601. et seq.. 1608(h). section 317. Surface

Transportation and Uniform Relocation Assistance Act of

1987.

49 CFR 665.

Aim To require that one model of any new bus purchased with

federal transit funds after September 30, 1989 be tested

at a facility established by the Secretary in Altoona,

PA.

Benefits To provide transit agencies with test data before

purchase of a vehicle, identifying how each bus model

performs under 7 different tests.

Methodology Any new model bus, as well as models with significant

changes, must be test at the FTA-sponsored test facility

in Altoona, PA. before federal funds may be expended to

purchase them. This bus testing requirement applies to

modified vans used in transit service as well as buses.

The requirement also applies to new bus models using

alternative fuels such as methanol, ethanol . and

compressed natural gas. FTA does not require a manufacturer to test its model before bidding; however,

a grant applicant must certify that the model will have

been tested prior to final acceptance of the first

vehicle. A "new model bus" is one not used in mass transportation service in the United States before

October 1, 1988, or one used in such service but which,

after 9/30/88 is being produced with a major change in

configuration or components. Partial testing is allowed

for vehicle models that previously have been fully

tested but are being produced with significant changes.

Vehicles are tested for maintainability, reliability,

safety, performance, structural integrity, fuel economy,

and noise. FTA and the manufacturer together pay the

bus testing fees. Bus testing is not required for

unmodified mass-produced vans.

Testing

Inspection

Test facility in Altoona, PA, and test track at Penn

State, University at State College. PA.

State inspector or other entity under government

contract.

Conformity

Identification

None.

252
Availability

of Documentation

Program requirements are contained in 49 CFR 665.

Facility maintains list of final test reports on buses

See also Chapter III of Grant Application Instructions

at URL address listed above.

Obligations of the Manufacturers provide facility with a sample bus for

Manufacturer/Vendor testing.

Enforcement Federal transit funds can only be used to purchase new

model buses tested at facility.

Term Indefinite,

Reciprocity None

Standards, Codes or Regulations

Facility prepares testing criteria using private sector

and other federal standards as appropriate, subject to

governmental approval

.

Keywords buses; mass transportation; motor vehicles; school

buses; vans; vehicles

253
Products or

Services

Received 6/98

MOTOR VEHICLE SAFETY AID FUEL ECOIOi

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

National Highway Traffic Safety Administration (NHTSA)

Office of Vehicle Safety Compliance

400 Seventh Street, SW

Room 6111

Washington, DC 20590

Phone: (202) 366-5291

FAX: (202) 366-1024

DOT Auto Safety Hotline: 1-800-424-9393

URL address: http://www.nhtsa.dot.gov/hotline

Initiated

Compliance

Authority

Aim

1966.

Mandatory,

49 U.S.C. Chapter 301 - Motor Vehicle Safety.

To administer programs to ensure compliance with federal

laws, standards and regulations pertinent to vehicle

safety, fuel economy, and damageability.

Benefits

Methodology

Reduction of traffic accidents, and deaths and injuries

resulting from traffic accidents: improved fuel economy

and pollution reduction.

Agency evaluates new and imported motor vehicle safety

to determine compliance to Federal Motor Vehicle Safety

Standards (FMVSS). Agency develops an annual compliance

test program which include an average of 30 of the 43

testable FMVSSs and randomly selects test samples from

the marketplace and test them to the minimum performance

requirements of the applicable standard. In addition

vehicle new car inspections are conducted at new car dealerships and testing laboratories to visually verify

compliance to the 11 non testable FMVSSs. If a test

failure occurs, an investigation is conducted which

could ultimately lead to an owner notification and

remedy campaign along with a civil penalty. Also

requires manufacturer's self-certification. NHTSA uses the information obtained from the Auto Safety Hotline as one data source to determine is a safety-related defect

exists in a motor vehicle or related equipment.

254
Testing NHTSA Contractor laboratories as well as manufacturers

Government engineers also analyze reported safety

related problems.

Inspection Government or contractors as well as manufacturers

Conformity

Identification

Authorized certification label by manufacturer or registered importer.

Availability

of Documentation

Agency maintains list of vehicle and equipment

manufacturers who have undertaken product recalls for

the purpose of achieving compliance with FMVSS, or to

correct safety related defects. The agency also

maintains a list of vehicles that are acceptable for

importation. This information can also be accessed at

the URL address listed above.

Obligations of the

Manufacturer/ Vendor

Manufacturers must inform the Agency, owners,

purchasers, and dealers of known defects and

noncompliance to FMVSS and the plans to correct the

defect(s)

.

Enforcement Civil penalties; 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; safety defects; school buses

trucks; used vehicles

255
Products or

Services

Department/Agency

Received 7/98

LOW SPEED VEHICLES (LSVs) (4-Wheeled Vehicles with Top

Speeds of 20-25 Miles Per Hour)

U.S. Department of Transportation (DOT)

National Highway Traffic Safety Administration (NHTSA)

Office of Crash Avoidance Standards

400 Seventh Street. SW

Room 5307

Washington, DC 20590

Phone: (202) 366-4931

FAX: (202) 366-4329

URL address:

http: //www. nhtsa .dot .gov/cars/rules/rul ings/lsv/lsv. html

Initiated

Compliance

Authority

1998.

Mandatory.

49 U.S.C. Chapter 301

49 CFR Part 571.

- Motor Vehicle Safety

Aim To ensure that low-s

streets, roads, and

minimum motor vehicl

vehicle safety. To

vehicles of the need

Federal Motor Vehicl

ensuring the safety

a new standard for s

peed vehicles operated on the public

highways are equipped with the

e equipment appropriate for motor

relieve manufacturers of such

to comply with the full range of

e Safety Standards (FMVSSs). while

of LSVs by requiring compliance with

uch vehicles.

Benefits Eliminates a barrier to the manufacture and sale of a segment of the sub-25 mph vehicle group. Ensures the

safety of LSVs by requiring safety equipment on LSVs

consistent with their characteristics and operating

environment.

Methodology Agency evaluates new and imported LSV safety to

determine compliance to FMVSS 500. Agency develops an annual compliance test program and randomly selects test

samples from the marketplace and tests them to the

minimum performance requirements of the applicable

standard. If a test failure occurs, an investigation is

conducted which could ultimately lead to an owner

256
notification and remedy campaign along with a civil

penalty. Also requires manufacturer's selfcertification.

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards. Codes

or Regulations

Keywords

NHTSA Contractor laboratories as well as manufacturers

Government engineers also analyze reported safety

related problems.

Government or contractors as well as manufacturers.

Authorized certification label by manufacturer or registered importer.

See Federal Motor Vehicle Safety Standard No. 500 (49

CFR 571.500).

Manufacturers must inform the Agency, owners,

purchasers, and dealers of known defects and

noncompliance to FMVSS and the plans to correct the

defect(s)

.

Civil penalties; product recall.

Indefinite.

Other federal agencies and state agencies. Private

sector organizations may be paid contractors to the

agency for detection of defects or compliance research

Federal Motor Vehicle Safety Standard No. 500 (49 CFR

571.500).

4-wheeled vehicles; low speed vehicles; LSVs; electric

cars; golf cars

257
Products or

Services

Received 6/98

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

National Highway Traffic Safety Administration (NHTSA)

Office of Vehicle Safety Compliance

Uniform Tire Quality Grading Facility

SATX

P.O. Box 1671

San Angel o, TX 76902

Phone: (915) 655-0546

FAX: (915) 655-0548

URL address: http://www.nhtsa.dot/cars/testing/tirerate/

Compliance

Authority

Mandatory.

National Traffic and Motor Vehicle Safety Act of 1966 as amended.

Aim To provide information about the relative performance of

tires in the areas of treadwear, traction, and

temperature resistance and other information by

permanently molding such information into the tires

sidewalls, indelibly stamped on a label or labels

affixed to the tire tread surface, and be made available

in consumer brochures.

Benefits The information aids sales people and consumers in the

evaluation, selection and sale of tires and repairers

and retreaders in their repair.

Methodology The Uniform Tire Quality Grading System (UTQGS) is a tire information system designed to help buyers make

relative comparisons among tires. UTQGS is not a guarantee that a tire will last for a prescribed number

of miles, but UTQGS traction grades and temperature

resistance grades certainly relate to safety and offer

the consumers an indicator of relative safety on wet

roads an resistance to blow outs under hot summertime

driving conditions. Agency requires manufacturer to

grade and label tires prior to marketing. Also requires

manufacturer self-certification supplemented by

government audits as needed.

258
Testing Random testing by independent laboratories under

government contract.

Inspection Manufacturer's facilities

Conformity

Identification

Availability

of Documentation

Grades are molded into the sidewalls and also are on paper labels affixed to the tread.

Federal Motor Vehicle Safety Standards (FMVSS) No. 109

No. 117; and No. 119; and the Uniform Tire Quality

Grading Standards (UTQG 575.104) are included in the

CFR. Information on specific tires is permanently

molded into the tires sidewalls or indelibly stamped on

a label or labels affixed to the tire tread surface.

Uniform Tire Quality Grading Reports are also available

Obligations of the

Manufacturer/ Vendor

Manufacturers must inform the Agency, owners,

purchasers, and dealers of known defects and

noncompliance to FMVSS or UTQGS and the plans to correct

the defect (s)

.

Enforcement Civil penalties; product recall

Term Indefinite -- for the life of the tire,

Reciprocity Program is recognized nationwide,

Standards, Codes

or Regulations

Federal Motor Vehicle Safety Standards (FMVSS) No. 109

(49 CFR 571.109); No. 117 (49 CFR 571.117); and No. 119

(49 CFR 571.119); and the Uniform Tire Quality Grading

Standards (49 CFR 575.104).

Keywords automobiles; motor vehicle equipment; FMVSS; grading;

retreads; temperature resistance; tires; traction;

treadwear; trucks; vehicles

259
Products or

Services

Received 6/98

SPEED NEASUR1I6 DEVICES (Radar. Automated Speed

Measurement Devices and Laser Speed Measurement Devices)

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

National Highway Traffic Safety Administration (NHTSA)

Office of Traffic Injury Control Programs

Traffic Law Enforcement Division (NTS-13)

400 Seventh Street, SW

Washington, DC 20590

Phone: (202) 366-4295

FAX: (202) 366-7721

URL address:

http : / /www . nhtsa . dot . gov/peopl e/i n jury/enforce/

Initiated

Compliance

1983.

Voluntary adoption of performance specifications by

states and local jurisdictions.

Authority 23 U.S.C. 402.

49 CFR Part 1.50.

Aim To assist state and local law enforcement agencies in

selecting speed measuring devices that are appropriate

for their speed enforcement programs.

Benefits Test results published by NLECTC in a consumer

information report series can assist state and local

enforcement agencies in selecting speed measuring

devices. The report will also provide information to

courts and the public regarding device compliance with

published performance specifications. The report will

enable state and local jurisdictions to determine

specifications compliance and performance reliability

while avoiding the cost associated individually testing

devices. Manufacturers also benefit by not having to

arrange for individual device testing for each of the numerous jurisdictions.

Methodology Performance specification compliance testing by an independent laboratory is required.

260
Testing In 1983. the International Association of Chiefs of

Police (IACP) began testing radar speed measuring

devices in the same manner as the NIJ/NLECTC equipment

testing program and issued a consumer report on the

results of those tests. In 1991, testing began on photo-radar devices. In 1992, work began on lidar

devices which includes development of performance

specifications and publishing consumer reports.

Conformity

Identification

Test results are published by the IACP

in a consumer information report series

Availability

of Documentation

Copies of the consumer information report series are available to the public though:

International Association of Chief of Police

515 North Washington Street

Alexandria, VA 22314-2357

Fax request for information to the IACP, Attn: Speed

Measuring Device Program Manager, 703-836-4543.

NHTSA, 400 Seventh Street, SW, NTS- 13. Washington, DC

20590. Fax request for information to NHTSA. Attn:

Speed Measuring Device Program manager. 202-366-7721.

This information is also available on the web at:

http://www.theiacp.org or http://www.nhtsa.dot.gov

Obligations of the

Manufacturer/ Vendor

Manufacturers must submit devices for testing

Term

Reciprocity

Indefinite.

Results are recognized and adopted by most state and

local law enforcement agencies.

Standards, Codes

or Regulations

The Office of Law Enforcement (0LES) developed

specifications are published by NHTSA as recommended

model minimum speed measuring device specifications.

Radar and lidar performance specifications are available. Photo-radar performance specifications are being developed.

Keywords performance specifications;

speed measuring devices

lidar; photo-radar; radar;

261
Products or

Services

Received 6/98

TESTE!

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

National Highway Traffic Safety Administration (NHTSA)

Office of Traffic Injury Control Programs

Impaired Driving Division

400 Seventh Street. SW, Room 5118

Washington. DC 20590

Phone: (202) 366-9588

FAX: (202) 366-2766

URL address: http://www.nhtsa.dot.gov

Initiated

Compliance

1984,

Voluntarily adopted by states and local jurisdictions.

Manufacturers voluntarily submit testers for evaluation

and listing.

Authority 23 U.S.C. 402.

49 CFR Part 1.50

Aim Assist states and local communities by providing a centralized qualification test program for breathtesting devices designed to collect evidence in law

enforcement programs. Also provides lists of devices

that must be used for the DOT workplace alcohol testing

program.

Benefits States have adopted the NHTSA model specification for

evidential breath testers. This 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.

Methodology

Testing

Testing by government is required.

Testing is accomplished at the DOT Volpe National

Transportation Systems Center in Cambridge, MA.

262
Conformity

Identification

Qualified manufacturers are listed on a Conforming

Products List (CPL).

Availability Model specifications and CPL's are published in the

of Documentation Federal Register. Currently there are six active

manufacturers of evidential breath measurement devices.

Qblig@ti©m @f tlhm Manufacturers must submit units for testing.

Manufacturer/ Vendor

Term Indefinite.

Keywords alcohol; analysis; blood alcohol; breath alcohol;

calibration; highway safety; law enforcement; legal

evidence; tester

263
Products or

Services

Received 6/98

TORT

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

U.S. Department of Transportation (DOT)

Research and Special Programs Administration (RSPA)

Assoc. Administrator for Hazardous Materials Safety

Office of Hazardous Materials Technology

400 7th St. , NW, Room 8436

Washington, DC 20590

Phone: (202) 366-4512

FAX: (202) 366-3753

The Hazardous Materials Information Center can be

reached at: 1-800-467-4922 or 202-366-4488

e-mail : james.jones@rspa.dot.gov

URL address: http://www.hazmat.dot.gov

March 13. 1985.

Voluntary.

49 U.S.C. 1804. 1805, 1808.

49 CFR Parts 100-178.

49 CFR 107 (regarding designation of approval and

certification agencies)

Designate third party testing agencies through which

shippers and container manufacturers may demonstrate

conformance of packaging designs with United Nations

(U.N.) standards. May also recognize manufacturer selfcertification by manufacturers with a history of

producing safe packages.

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 serves as program administrator and National

Competent Authority in accordance with U.N.

Recommendations. Office of Hazardous Materials

Technology designates third party approval agencies to

evaluate and issue approval certificates for intermodal

portable tanks and certifications of conformance for

other types of packaging.

264
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.

Conformity

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

Reciprocity

Indefinite.

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; shipping containers;

transportation; United Nations

265
Products or Services

Received 6/98

\im OF RADIOACTIVE MATERIALS FOR TRAISP0R1

Department/Agency

Initiated

Compliance

Authority

U.S. Department of Transportation (DOT)

Research and Special Programs Administration (RSPA)

Assoc. Administrator for Hazardous Materials Safety

Office of Hazardous Materials Technology

400 7th St. , NW. Room 8430

Washington, DC 20590

Phone: (202) 366-4545

FAX: (202) 366-3753

The Hazardous Materials Information Center can be

reached at: 1-800-467-4922 or 202-366-4488

e-mail : richard.boyle@rspa.dot.gov

URL address: http://www.dot.gov

1975.

Mandatory.

49 U.S.C. 1803, 1808 as amended.

49 CFR Part 173.465-173.469.

49 CFR 107 (regarding designation of approval and

certification agencies)

Aim

Benefits

Methodology

To provide packaging for radioactive materials which

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

B) conditions.

Transport of radioactive materials is accomplished with

minimum radiation exposure to personnel.

Government serves as the Competent Authority and issue

certificates for the international movement of

radioactive materials. Also recommends disposition of

all certification requests under the provisions of the

International Civil Aviation Organization (ICA0) and the

International Maritime Organization (IM0). Government

conducts design approval, inspection, and validation of

test data submitted by manufacturer based on agency or third party tests. Also imposes mandatory labeling and

reporting requirements.

266
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.

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 the

Manufacturer/ Vendor

Maintain specified quality control records; cooperate in

investigation of any package failures.

Enforcement

Term

Marketing ban; product recall

Indefinite,

acceptance.

Certification is based on prototype

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

267
Received 6/98

Products or

Services

Department/Agency

Initiated

Compliance

Authority

WO TAIKS

^UFACTUREi ASSEMBLER!

/EHICLE

AID REPAIRER!

U.S. Department of Transportation (DOT)

Research and Special Programs Administration (RSPA)

Assoc. Administrator for Hazardous Materials Safety

Office of Hazardous Materials Technology

400 7th St. , SW. Room 8436

Washington, DC 20590

Phone: (202) 366-4512

FAX: (202) 366-3753

The Hazardous Materials Information Center can be

reached at: 1-800-467-4922 or 202-366-4488

e-mail : james.jones@rspa.dot.gov

URL address: http://www.hazmat.dot.gov

1964

Mandatory.

49 U.S.C. 1804, 1805

49 CFR 107.501-504

1808

Aim To ensure that persons engaged in the manufacture,

assembly, inspection and testing, certification, or repair of cargo tanks or cargo tank motor vehicles are familiar and comply with requirements set forth in part

180 E.

Benefits

Methodology

See AIM.

Agency requires registration all person/organizations

engaged in the activities listed above. Manufacturers

of special /cargo tanks and cargo tank motor vehicles

must also obtain an ASME Certificate of Authorization

for the use of the ASME "U" stamp. Repairs, which are

not verified to the ASME Code must obtain a National

Board or ASME Certificate of Authorization.

Testing

Inspection

By ASME or ASME designated bodies

By ASME or ASME designated bodies

268
Conformity

Identification

Registration certificates and identification numbers are provided.

Enforcement Withdrawal of registration,

Obligations of the See Methodology.

Manufacturer/ Vendor

Term

Reciprocity

Standards, Codes or Regulations

Keywords

Registration is for a maximum of 6 years.

Other federal agencies.

State agencies

Private sector organizations.

Canadian government.

Uses agency, ASME and other private sector/international

standards.

cargo tanks; cargo tank motor vehicles; hazardous

materials; hydrotesting; pressure relief devices; safety

valves; tanks; transportation

269
Products or

Services

Received 6/98

Department/Agency

Compliance

Authority

U.S. Department of Transportation (DOT)

Research and Special Programs Administration (RSPA)

Assoc. Administrator for Hazardous Materials Safety

Office of Hazardous Materials Technology

400 7th St. , SW, Room 8108

Washington, DC 20590

Phone: (202) 366-4109

FAX: (202) 366-7435

The Hazardous Materials Information Center can be

reached at: 1-800-467-4922 or 202-366-4488

e-mail : david.donaldson@rspa.dot.gov

URL address: http://www.hazmat.dot.gov

Mandatory.

49 U.S.C. 1804, 1805,

49 CFR 107.601-620

1808

A 7/73 To ensure that persons engaged in the transport of

hazardous materials in foreign, interstate, and

intrastate commerce register with RSPA and comply with

applicable safety requirements.

Benefits See AIM.

Methodology Agency requires registration all person/organizations

engaged in the transport activities listed above.

Testing N/A.

Inspection By RSPA inspectors

Conformity

Identification

Certificate of Registration

Enforcement Withdrawal of registration

Obligations of the Pay appropriate fees, comply with recordkeeping

Manufacturer/Vendor requi rements

270
Term

Reciprocity

Standards, Codes

or Regulations

Annual registration is required

Other federal agencies.

State agencies

Private sector organizations.

Canadian government.

Uses agency and other private sector/international

standards

.

Keywords hazardous materials; transportation services

271
Products or

Services

Not Received

P1PEL1IES FOR HAZARDOUS FLUID!

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

Research and Special Programs Administration (RSPA)

Assoc. Administrator for Pipeline Safety

Office of Pipeline Safety Regulatory Programs

400 7th St. . SW. Room 2335

Washington, DC 20590

Phone: (202) 366-4565

FAX: (202) 366-2106

e-mail : ri chard. huriaux@rspa . dot. gov

URL address: http://ops.dot.gov

Initiated

Compliance

Authority

1968.

Mandatory.

49 U.S.C. 1803-1809 as amended.

Oil Pollution Act of 1990.

49 CFR 190-199.

Aim

Benefits

Methodology

To ensure the safe transportation of natural gas,

petroleum, and other hazardous materials by pipeline.

Ensure the safe, reliable, and environmentally sound

operation of the nation's pipeline transportation

system.

Agency develops regulations to ensure safety in design,

construction, testing operation, maintenance, and

emergency response of pipeline facilities. Agency

requires pre-instal 1 at ion review with periodic testing

of safety equipment throughout the useful life of the

pipeline. Third party certification of welder and

plastic assemblers is also required. Manufacturer's

self-certification is required for: valves, pressurelimiting services, and overall installation to specified

standards. Agency conducts routine inspections of

pipelines and works with pipeline operators to implement

Dest practices and achieve improvements. States also

inspect natural gas and hazardous liquid pipelines.

272
Testing Third party or manufacturer's lab

Inspection Agency, state agency or third party

Conformity

Identification

Availability

of Documentation

Lists of qualified welders/installers and approved

installations are published.

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 the

Manufacturer/ 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

Reciprocity

Standards, Codes or Regulations

Pressure-limiting devices must be inspected on approximately an annual basis, not to exceed a 17 month

interval

.

Approved pipelines are not regulated by any other

federal or state agency.

Agency mainly adopts standards of other organizations.

Keywords certified welder; hazardous materials; pipelines;

pressure-limiting devices; qualified plastic pipe

assembler; safety; welding

273
Products or Services

SPECIAL TAIfCS FOR

Received 6/98

IDOUS MATERIALS

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

Research and Special Programs Administration (RSPA)

Assoc. Administrator for Hazardous Materials Safety

Office of Hazardous Materials Technology

400 7th St. , SW. Room 8436

Washington, DC 20590

Phone: (202) 366-4512

FAX: (202) 366-3753

The Hazardous Materials Information Center can be

reached at: 1-800-467-4922 or 202-366-4488

e-mai 1 : james . jones@rspa . dot . gov

URL address: http://www.hazmat.dot.gov

Initiated

Compliance

Authority

1964.

Mandatory

49 CFR Parts 178.270-272.

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

Aim lo 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.

Methodology Requires government design approval and third party

certification.

Testing Third party or manufacturer's lab.

Inspection Third party.

Conformity

Identification

Authorized mark applied by manufacturer.

274
Availability Agency maintains list of firms authorized to manufacture

of Documentation such tanks.

Obligations of the Manufacturer must maintain integrity of design, quality

Manufacturer/Vendor control, and cooperate in investigation of suspected

faults

.

Enforcement

Term

Delisting or product recall.

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

Keywords

Agency integrates standards of other organizations into

the program.

hazardous materials; hydrotesting; pressure relief

devices; quality control; safety valves; tanks;

transportation

275
Products or

Services

Received 6/98

TAIKS FOR TMISPQRT OF HAZARDOUS MATERIALS

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

Research and Special Programs Administration (RSPA)

Assoc. Administrator for Hazardous Materials Safety

Office of Hazardous Materials Technology

400 7th St. . SW. Room 8436

Washington. DC 20590

Phone: (202) 366-4512

FAX: (202) 366-3753

The Hazardous Materials Information Center can be

reached at: 1-800-467-4922 or 202-366-4488

e-mai 1 : james . jones@rspa .dot .gov

URL address: http://www.hazmat.dot.gov

Initiated

Compliance

Authority

1964.

Mandatory.

49 CFR Part 173.32-34.

49 U.S.C. 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

Methodology

Testing

Inspection

Agency requires manufacturer's self-certification

Uses 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.

Availability

of Documentation

Agency maintains list of manufacturers of certified

tanks by type.

276
Obligations of the Manufacturer must maintain design control and submit

Manufacturer/Vendor design changes for approval

.

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Marketing ban (also extends to distributors).

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.

Other federal agencies.

State agencies.

Private sector organizations.

Canadian government.

Agency integrates standards of other organizations into

the program.

hazardous materials; hydrotesting; portable tanks;

pressure relief devices; quality control; safety valves

transportation

277
Products or

Services

CYLINDERS FOR TRANSPORTATION OF

Received 7/98

MATER

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

Research and Special Programs Administration (RSPA)

Associate Administrator for Hazardous Materials Safety

Office of Hazardous Material Standards

400 7th St. , SW, Room 8102

Washington, DC 20590

Phone: (202) 366-8553

FAX: (202) 366-3012

The Hazardous Materials Information Center can be

reached at: 1-800-467-4922 or 202-366-4488

e-mail : edward.mazzullo@rspa.dot.gov

URL address: http://www.hazmat.dot.gov

Initiated

Compliance

Authority

Aim

First cylinder regulations adopted 1911

Mandatory.

49 CFR Part 178 subpart C.

To develop standards for the manufacture and use of

cylinders for transport of hazardous materials in commerce.

Benefits Consistent safety and durability of cylinders for

intended use.

Methodology Requires third party certification (independent

inspection) or manufacturer's self-certification

Testing Uses third party or manufacturer's lab

Conformity

Identification

Authorized identity by manufacturer

Availability

of Documentation

No central registry of manufacturers; all cylinders

legal for use are marked.

278
Obligations of the Manufacturers must maintain quality control. Users must

Manufacturer/Vendor not use nonconforming cylinders for transport of

hazardous materials in commerce.

Enforcement

Term

Compliance orders or civil penalties.

Cylinders in sound physical condition that are authorized for reuse may be requalified and recertified

Reciprocity Marked cylinders are accepted throughout the United

States. Canada, and internationally.

Standards, Codes

or Regulations

Agency develops standards and adopts industry standards

by reference in regulations.

Keywords containers; cylinders; hazardous materials; hydrotest

quality control; safety; transportation

279
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

RAILWAY TAff

pressurized

Received 7/98

CMS (Includes Pressurized, NonMulti-Unit, and Cryogenic Types)

U.S. Department of Transportation (DOT)

Research and Special Programs Administration (RSPA)

Assoc. Administrator for Hazardous Materials Safety

Office of Hazardous Materials Standards

400 7th St. , SW, Room 8102

Washington, DC 20590

Phone: (202) 366-8553

FAX: (202) 366-3012

e-mail : edward.mazzullo@rspa.dot.gov

1965 (Couplers subject to approval after 1977).

Mandatory.

49 CFR 179.100-400.

To provide safe and reliable tank cars for transport of

hazardous materials.

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Certification minimizes the risk of leakage or rupture

of tanks, inadequacy of couplers and the improper use of

tanks for designated materials.

Requires third party certification; Association of

American Railroads (AAR) provides design approval of

couplers which is accepted by DOT under this regulation.

Third party acceptable to the AAR and to the Bureau of

Explosives

Third party acceptable to the AAR and to the Bureau of

Explosives

Direct marking on tanks.

Certificates of construction issued by Agency.

280
Availability Certificates of construction are kept by Agency and AAR.

of Documentation

Obligations of the Manufacturer is obligated to use approved welders during

Manufacturer/Vendor const ructi on

.

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Delisting or product recall if defects can be repaired.

Certification is essentially indefinite.

Other federal agencies.

State agencies.

Private sector organizations.

Canadian government.

Agency adopts standards of other organizations and

provides integrating requirements.

certified welder; design approval; hazardous materials;

railroads; railway car couplers; welding

281
TOT iwm

Product Page

agricultural aircraft operators 223

air taxi operators 223

aircraft repair stations 223

aircraft, civilian 223

airports 228

alarms, marine 217

alcohol testers, breath 262

automobiles 254, 258

aviation 223, 228

avionics 223

blood alcohol 262

boats 210, 217, 219

breath alcohol testers 262

bridge 237

buses 230, 235, 251, 254

cabooses 245

cargo containers 221

cargo tank motor vehicles 268

cars, electric 256

carts, golf 256

collision avoidance systems 217

compasses, gyro 217

computer sensors 208

construction 237

containers, freight for railroads 249

containers, shipping 221, 264

containers 278

control devices, railroad 241

control tower operators 223

cylinders for hazardous materials 278

dispatchers, aircraft 223

driver's license, commercial 235

electrical equipment, marine 210, 217

282
electronic technologies 208

engineering equipment, marine 210, 217

engines, aircraft 223

fire protection equipment, marine 210

fissile material 266

flight instructors 223

flight crew 223

golf carts 256

hazardous materials for export 264

hazardous materials, transport by rail 249

hazardous material tanks 274, 276

hazardous materials (radioactive) 266

hazardous materials 230, 235. 268

hazardous materials transport 270, 272, 274, 276, 278, 280

heliports 228

highways 208, 237

intelligent vehicle-highway system 208

laser speed measuring devices 260

law enforcement equipment 260, 262

lidar 260

lifesaving equipment 210

lighting, airport 228

locomotives 239, 241. 245, 247

marine equipment 210, 217, 221

marine safety 210, 213, 215, 217, 219, 221

maritime training 213, 215

maritime officer licensing 215

marking devices, railroad 243

mechanics, aircraft 223

medical examiners, aviation 223

motor carriers 230, 235

navigational aids, aviation 228

navigational aids, shipboard 217

parachute riggers 223

pavement markings 233

pavement 237

photo-radar 260

pilots, aircraft 223

pipe assembler, plastic 272

pipelines 272

police equipment 260, 262

pollution prevention equipment, marine 210

283
pressure limiting/release devices 268. 272, 274, 276

propellers, aircraft 223

radar plotting aids 217

radar ---260

radioactive materials for transport 266

railroad signals -241

railroads 239. 241, 243, 245, 247, 249, 280

railway tank cars 280

railway car couplers 280

railway equipment 239, 241, 243

railway cars 239. 243. 245. 247. 249, 280

receivers, loran 217

receivers, satellite 217

roads 208

robotics 208

runways, aircraft -228

safety devices, railroad --241, 243

satellite receivers 217

schools for pilots and mechanics 223

shipping containers 221

ships 210, 217, 219, 221

signals, railroad 241

signs, road 233

speed indicators, marine 217

speed measuring devices, vehicle 260

steering gear, marine 217

tank cars 249. 280

tanks, for hazardous materials 274, 276

tanks, portable 249. 276

tanks, cargo 268

telecommunications 208

tires, motor vehicle 258

track, railroad 247

traffic signals ---233

traffic signs 233

traffic control devices 233. 260

transit vans 251

transit 208

transportation systems, intelligent 208

trucks 230. 235. 254. 258

tunnels 237

valves, safety 268. 274. 276

284
vans 251

vehicle equipment, motor 254, 258

vehicle fuel economy 254

vehicle driver, commercial 235

vehicles, commercial 230, 251

vehicles, cargo tank motor 268

vehicles, low speed 256

vessels 210, 217. 219. 221

welder, certified 272. 280

windows, safety glazing for railway cars 245

285
DEPARTMENT OF THE TREASURY

286
Products or

Services

ELECTRONIC FUND TRANSFER AUTHENTICATE

Received 2/98

I DEVICES

Department/Agency U.S. Department of the Treasury

Deputy Assistant Secretary for Information Systems

and Chief Information Officer

1500 Pennsylvania Ave., NW

Room 2464

Washington, DC 20220

Phone: (202) 622-1200

FAX: (202) 622-2224

e-mail : jim.flyzik@cio.treas .gov

Initiated

Compliance

1984,

Mandatory for all Government bureaus that receive or send funds or securities electronically through the

United States.

Authority Treasury Directive 16-02 on automated information

systems security and risk management establishes the

policy with respect to ensuring adequate security for

automated information systems, applications, and

facilities

.

Aim To assure that equipment which authenticates electronic

fund transfers complies with designated standards to

minimize exploitation of Electronic Fund Transfer (EFT)

Systems

.

Benefits It is a major milestone toward unifying the protection

and audit of the billions of dollars transferred

electronically every day.

Methodology Agency requires validation of compliance with Treasury

standard by the Systems and Network Architecture

Division, Information Technology Laboratory (ITL),

National Institute of Standards and Technology (NIST).

Security evaluation guidance provided by the National

Security Agency (NSA).

Testing

Inspection

Testing by NIST and NSA.

Treasury.

287
Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

A list of certified equipment and software is maintained

by the Department of the Treasury.

List and other technical documentation is available from

the Deputy Assistant Secretary for Information Systems,

Department of the Treasury.

To comply with criteria.

Del i sting.

Indefinite term.

No reciprocal agreements.

Federal Information Processing Standards (FIPS) 46-1,

74. 81. 113. 140-1. 161. and 171, and ANSI X3.105 and

X9.9. Criteria documents are coordinated by Treasury.

authentication devices; communications security;

computer security; cryptographic; EFT; electronic fund

transfer; encryption standard; financial institutions;

interface requirements; validation

288
Products or

Services

Received 2/98

ALCOHOLIC BEVERAGES

(Certificates of Label Approval - COLA) (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 (BATF)

For Labeling and Content Requirements:

Product Compliance Branch

Labeling Section

650 Massachusetts Ave., NW

Washington, DC 20226

Phone: (202) 927-8140

FAX: (202) 927-8605

Or for laboratory certification information

Import Export Branch

Phone: (202) 927-8110

URL address: http://www.atf.treas.gov

Initiated Distilled spirits beverages: 1969

Wines: 1973.

Compliance Mandatory for label approval. Only mandatory for

laboratories wishing to be approved by ATF for export

testing.

Authority Federal Alcohol Administration Act.

Internal Revenue Procedure 69-22 (Distilled Spirits).

ATF Procedure 86-2 (Wines).

Aim To determine whether any products currently on the

market pose a health risk to consumers and to ensure

alcohol beverage labels do not contain misleading

information and adhere to regulatory mandates.

Benefits Suppression of label fraud and other unlawful practices

in the alcohol beverage marketplace.

289
Methodology Government reviews proposed labeling for false or misleading claims. Also enforces the Government Health

Warning Statement. Issues Certificates of Label

Approval (COLA). Approves laboratories for export

testing.

Testing ATF National Laboratory Center (or other laboratories

qualified by ATF for export testing) for the analysis of

wines and distilled spirits beverages.

Inspection Government inspection

Conformity

Identification

A list of approved laboratories for export testing or COLAs.

Availability

of Documentation

The list of laboratories certified by ATF for export

testing is available and may obtained at the mailing or URL address listed above. Other documentation

describing the regulatory requirements for alcoholic

beverages is also available on the website or from ATF.

Obligations of the

Manufacturer/ Vendor

Exporters of U.S. wines and distilled spirits beverages

obligated to use the services of laboratories certified

by ATF if the importing country so requires.

Domestic/foreign bottlers and producers, domestic

wholesalers and importers are obligated to obtain COLAs

for their products.

Enforcement Delisting of laboratories. Seizure

other legal action (as appropriate)

alcoholic beverages.

prosecution, or for noncompliant

Term Termination date on COLAs is the expiration date, are retested after 4 years.Labs

Reciprocity No reciprocal agreements

Standards, Codes

or Regulations

Internal Revenue Procedure 69-22 (Distilled Spirits)

ATF Procedure 86-2 (Wines). ATF prepares criteria

documentation.

Keywords alcohol; ATF certified laboratory; beverages; chemical

analyses; distilled spirits; laboratory accreditation;

wines

290
Received 12/97

TOBACCO PRODUCTS . ALCOHOLIC BEVERAGE PRODUCTS.

INDUSTRIAL ALCOHOL (See Also Requirements of the Food

and Drug Administration and the U.S. Department of

Agriculture.

)

Department/Agency U.S. Department of the Treasury

Bureau of Alcohol, Tobacco and Firearms (BATF)

National Revenue Center

6525 Federal Office Building

550 Main Street

Cincinnati , OH 45202-3263

Phone: 1-800-398-2282

(513) 684-3334

FAX: (513) 684-3168

URL address: http://www.atf.treas.gov

Products or

Services

Compliance Mandatory for manufacturers of tobacco products and

operators of export warehouses, and certain users and

manufacturers of alcohol and alcohol products.

Authority United States Code, Code of Federal Regulations

Aim To qualify applicants for permits to manufacture tobacco

or operate tobacco export warehouses or produce and use alcohol, tobacco and alcoholic beverages. To collect

Federal alcohol, tobacco and firearms/ammunition excise

taxes

.

Benefits

Methodology

Testing

Inspection

Conformity

Identification

To protect the consumer and reduce the deficit.

Verify an applicant's qualifications information, check

security of premises, and ensure tax compliance. Agency

issues licenses and conducts inspections.

N/A.

Government inspection by field inspectors

Licensing.

291
Availability

of Documentation

Contact BATF at the address listed above or

see URL address listed above for license application

information.

Obligations of the

Manufacturer/ Vendor

File an application and necessary documents with ATF;

comply with applicable laws and specific recordkeeping

regulations.

Reciprocity

Keywords

None.

alcohol excise tax; tobacco excise tax; firearms excise

tax; ammunition excise tax; federal licensing; tobacco;

tobacco products; warehouses

292
Products or

Services

Received 12/97

FIREARMS AND FIREARMS MAIUFACTURERS. IMPORTER . AID

DEALERS

Department/Agency U.S. Department of the Treasury

Bureau of Alcohol, Tobacco and Firearms (BATF)

Firearms and Explosives Licensing Center

2600 Century Pkwy, NE, Room 400

Atlanta, GA 30345-3104

Phone: (404) 679-5097

FAX: (404) 679-5078 or 5079

e-mail : LMVannett@atfhq.atf.treas.gov

URL address:

http : //www . atf . treas . gov/about/prog/fi re . htm

Compliance Mandatory for every manufacturer

fi rearms. importer, or dealer in

Authority

Methodology

The Gun Control Act of 1968: P.L. 90-618.

Agency issues licenses and conducts compliance

inspections of licensees. Requires marking of firearms

in accordance with 27 CFR 178.92 and 179.104. Also

operates a unique comparison system known as the

Integrated Ballistic Identification System (IBIS) which

allows the digitalization and automatic sorting of

bullets and shell casing marking to assist in tracking

illegal firearms trafficking and usage in shooting

incidents.

Inspection Government inspectors

Conformity

Identification

Licenses

Availability

of Documentation

Regulatory requirements are available from ATF.

Obligations of the To comply with applicable laws and specific

Manufacturer/Vendor recordkeeping regulations.

Enforcement Enforcement alternatives range from revocation of

license to criminal prosecution.

293
Reciprocity None.

Standards, Codes Federal licensing standards are contained in 27 CFR 178

or Regulations

Keywords ammunition; firearms; guns; weapons

294
Received 12/97

Products or EXPLOSIVES

Services

Department/Agency U.S. Department of the Treasury

Bureau of Alcohol, Tobacco and Firearms (BATF)

Firearms and Explosives Licensing Center

2600 Century Pkwy, NE. Room 400

Atlanta, GA 30345-3104

Phone: (404) 679-5097

FAX: (404) 679-5078 or 5079

e-mail : LMVannett@atfhq.atf.treas.gov

URL address:

http : //www. atf . treas . gov/about/prog/expl /htm

Initiated 1970.

Compliance All manufacturers, importers and dealers are required to

obtain a federal license from ATF to conduct business,

and certain users of explosives are required to obtain a federal permit.

Authority

Aim

Organized Crime Control Act of 1970.

To avert accidents and to keep explosives from the hands

of those who are prohibited from possessing them.

Benefits See Aim.

Methodology ATF maintains a regular program of on-site inspections

to ensure that explosives are stored in approved

facilities, which are secure from theft and located at

prescribed distances from inhabited buildings, railways

and roads. Agency issues licenses/permits to compliant

bodies.

Testing N/A.

Inspection Government inspection of products, sites and records

Conformity

Identification

Licenses/permits are required to import, manufacture

and deal in explosive materials.

295
Availability Regulatory requirements are available from ATF at the

of Documentation address or from the URL address listed above.

Obligations of the To obtain the necessary permits and licenses and abide

Manufacturer/Vendor by all restrictions on the manufacture, distribution,

sale and usage of explosive materials, including

inventory control and recordkeeping.

Enforcement Enforcement options range from license removal

criminal prosecution.

to

Term Original

Renewals

permits/'

period.

licenses/permits are valid for one year.

are valid for 3 years. However, some limited

icenses are only valid for a shorter time

Reciprocity None

Standards, Codes

or Regulations

Storage requirements are established by ATF in 27 CFR

Part 55, Subpart K - Storage.

Keywords blasting agents, detonators; explosives; fireworks

296
Products or

Services

Received 12/97

COMMERCIAL SAUSERS (Organizations and Individuals Who

Measure, Gauge or Sample Merchandise)

COMMERCIAL LABORATORIES (Organizations and Individuals

Who Analyze Merchandise, i.e., Determine its Composition

and/or Characteristics Through Laboratory Analysis)

Department/Agency U.S. Department of the Treasury

U.S. Customs Service

Laboratories and Scientific Services

Mail Stop 5.5-B

1300 Pennsylvania Ave., NW

Washington, DC 20229

Phone: (202) 927-1060

FAX: (202) 927-2060

e-mail : LAB-HQ@LABHQX31.customs.sprint.com

URL address:

http : / /www . customs . treas . gov/about/1 abs/ 1 abi ndex . htm

Initiated

Compliance

1970.

Mandatory only for gaugers/laboratories wishing to be

approved by the U.S. Customs Service for testing for

customs purposes. Current testing areas include:

petroleum and petroleum products, organic chemicals in

bulk and liquid form and animal and vegetable oils.

However, Customs will accredit gaugers/laboratories for

any commodity that requires a laboratory analysis for

Customs purposes.

Authority

Aim

19 CFR 151.13.

To provide measurement and analytical results that can

be used by Customs for entry and admissibility purposes

Benefits

Methodology

See Aim.

Agency conducts technical evaluations of each site to be

approved as well as reviews the technical qualifications

of those doing the gauging or lab analyses.

Testing Testing is done by Customs or by Customs accredited

gaugers/laboratories

.

297
Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Standards, Codes or Regulations

Keywords

Government inspectors.

A list of accredited gaugers/laboratories

The list of accredited gaugers/laboratories is

available at the URL address listed above.

N/A.

Laboratories/gangers failing to meet requirements are removed from the approved list.

See Part 151.13 of the Customs regulations.

animal oils; gaugers; laboratory accreditation;

laboratories; organic chemicals; petroleum products;

testing; vegetable oils

298
Product Page

alcohol 289, 291

ammunition 293

authentication devices 287

beer 289, 291

beverages, alcoholic 289, 291

blasting agents 295

chemicals, organic 297

computer security 287

detonators 295

EFT 287

electronic fund transfer authentication devices 287

explosives 295

financial institutions 287

firearms 291. 293

fireworks 295

gaugers, commercial 297

guns 291, 293

laboratory accreditation 289, 297

oils, animal 297

oils, vegetable 297

organic chemicals 297

petroleum products 297

spirits, distilled 289, 291

telecommunications 287

tobacco products 291

warehouses 291

weapons 291, 293

wine 289, 291

299
. iE^MTOEMT OF VOBWMS AFFAIR

300
Products or

Services

Received 11/97

AUTONDTIVE DRIVING AIDS AND AUTOMATIC WEELCHAIR LIFTS

Department/Agency U.S. Department of Veterans Affairs (VA)

Veterans Health Administration (VHA)

Prosthetic & Sensory Aids Strategic Healthcare Group

810 Vermont Ave. . NW

Washington, DC 20420

Phone: (202) 273-8515

FAX: (202) 273-9110

URL address: http://www.va.gov

Initiated March 27, 1975 (driving aids).

May 10, 1978 (wheelchair lifts).

Compliance

Authority

Mandatory only for purchases funded by VA.

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 VA in improving the quality of

their products,

competition

Establishment of standards has fostered

Methodology Certification is made by VA sponsored Automobile

Adaptive Equipment Committee. Compliance is assured by

government testing/inspection or third party government

approved certification (SAE), and manufacturers' selfcertification.

Testing Testing results are accepted from government

laboratories, government approved labs, third party labs

and manufacturers' labs.

Inspection Government.

Conformity

Identification

Listing in VHA Directive 97-034.

301
Availability

of Documentation

The VA Compliance List, VHA Directive 97-034,

dated July 9, 1997, 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

302
Products or

Services

Received 11/97

SELF-PROPELLED AND MOTORIZED UHEELCHAII

Department/Agency U.S. Department of Veterans Affairs (VA)

Veterans Health Administration (VHA)

Prosthetic & Sensory Aids Strategic Healthcare Group

(113)

810 Vermont Ave. , NW

Washington, DC 20420

Phone: (202) 273-8515

FAX: (202) 273-9110

URL address: http://www.va.gov

Initiated December 7, 1977 (self-propelled wheelchairs)

December 15, 1981 (motorized wheelchairs).

Compliance

Authority

Aim

Mandatory only for purchases funded by VA.

Title 38 U.S.C. 4101(c)(2).

Avoid hazardous conditions for disabled persons caused

by inferior products.

Benefits

Methodology

Product quality and safety has improved and competition

has increased. Federal Supply Schedule Contracts have

been established to enforce compliance.

Certification is made by VA sponsored Prosthetic

Technology Equipment Committee. Compliance is assured

by government testing/inspection or third party

government approved certification (RESNA/ANSI) , and

manufacturers ' self-certifi cation.

Testing Testing results are accepted from government

laboratories, government approved labs, third party labs

and manufacturers' labs.

Inspection

Conformity

Identification

Government.

Self-propelled wheelchair suppliers and motorized

wheelchair suppliers are currently listed.

303
Availability

of Documentation

The General Services Administration's (GSA) Federal

Supply Schedule for wheelchairs provides particulars

Term Testing of new products is on-going. Listings are updated annually and GSA contracts are negotiated

annual ly

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

304
Products or

Services

TESTS Al PERFORMED BY THE

CEITEP

Received 12/97

DEPT. OF

MIES

Department/Agency

Initiated

Compliance

Aim

Benefits

U.S. Department of Veterans Affairs (VA)

Veterans Health Administration (VHA)

Pathology And Laboratory Medicine Service

Samuel S. Stratton VAMC

113 Holland Ave.

Albany, NY 12208

Phone: (518) 462-3311 x2292

FAX: (518) 462-1258

URL address: http://www.va.gov

1970.

Mandatory.

Standardization and uniformity in laboratory test

performance throughout 204 clinical laboratories, 63

nuclear medicine laboratories, 944 special purpose

ancillary testing laboratories of the VA system.

Improved quality of care for patients. Peer-review

process provides cross-educational benefits for all

laboratories.

Methodology Requires third party certification by the College of

American Pathologists (CAP) and Joint Commission on Accreditation of Healthcare Organizations.

Inspection

Conformity

Identification

Availability

of Documentation

Third party.

Authorized certificate issued by third party

of American Pathologists.

College

Maintained by Pathology and Laboratory Medicine local

laboratories, and at CAP.

Enforcement

Term

Conducted by Pathology Service. VHS&R/VA Central Office,

Indefinite term.

305
Reciprocity Recognition of certification by Joint Council of

American Hospitals.

Standards, Codes

or Regulations

College of American Pathologists Laboratory

Accreditation Program (CAP/LAP).

Keywords clinical laboratories; laboratories; limited special

function laboratories; electron microscopy; pathology

306
m 1WER

Product Page

adaptive equipment 301

automotive driving aids 301

driving aids 301

handicapped aids 301, 303

health care facilities 305

hospitals 305

laboratories, clinical 305

medical testing 305

prosthetic aids 301, 303

wheelchair lifts 301

wheelchairs 303

307
308
Products or

Services

Received 12/97

CONSUMER PRODUCTS

(Approximately 15 000 Consumer Products Intended for

Household, School, or Recreational Use -- Excludes Some

Types of Products Covered by Other Agencies, such as Cars, Trucks, Motorcycles, Drugs and Cosmetics, Alcohol,

Tobacco and Firearms.

)

Department/Agency Consumer Product Safety Commission (CPSC)

Office of the General Counsel

4330 East-West Highway

Bethesda, MD 20814-4408

Phone: (301) 504-0980 (General Counsel)

Phone: 1-800-638-2772 (Consumer Hotline-to obtain

product safety information, report unsafe products, and

obtain other agency information)

FAX: (301) 504-0403

e-mail: info@cpsc.gov

URL address: http://www.cpsc.gov

Initiated

Compliance

Authority

1972.

Mandatory.

Consumer Product Safety Act (CPSA).

The Poison Prevention Packaging Act (PPPA)

The Refrigerator Safety Act (RSA).

Aim

Benefits

Methodology

Testing

Inspection

To protect consumers from hazardous products.

Specific products covered by CPSC Standards are declared

by manufacturers to conform with legal requirements.

Agency relies on manufacturer's declaration of

compliance, but also conducts government surveillance

and follow up on reports of products that may not be in

compliance with federal standards or are otherwise

potentially hazardous.

May use government lab, manufacturer's lab, or third

party labs in assessing compliance.

Government.

309
Conformity

Identification

Government authorized mark or label by manufacturer

or private brander for some products. No marking

required for other products.

Availability

of Documentation

Lists of products subject to CPSC regulations/recalls

as well as other business and consumer-related

publications can be obtained from CPSC.

Obligations of the

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 nonconformance

to applicable standards or known defects which could

present substantial risk of injury whether or not

covered by a standard. Manufacturers, importers,

distributors, and retailers are required to report

potentially hazardous products to CPSC.

Enforcement Obtain correction of violations and recall of hazardous

products from the marketplace or consumers' hands,

primarily by working cooperatively with industry, but

through litigation when necessary. Civil and criminal

fines and imprisonment for not more than one year can be

imposed against firms and individuals. Other remedies,

such as injunctions, product recalls and seizures are also available.

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

310
Products or

Services

Department/Agency

Received 12/97

FABRICS (Used in Wearing Apparel and Interior

Furnishings)

Consumer Product Safety Commission (CPSC)

Office of the General Counsel

4330 East-West Highway

Bethesda, MD 20814-4408

Phone: (301) 504-0980 (General Counsel)

Phone: 1-800-638-2772 (Consumer Hotline-to obtain

product safety information, report unsafe products, and

obtain other agency information)

FAX: (301) 504-0403

e-mail: info@cpsc.gov

URL address: http://www.cpsc.gov

Initiated

Compliance

Authority

Aim

1953

Mandatory.

Flammable Fabrics Act, 16 U.S.C. 1191 et seq

To reduce the risk of fire and injury or death related

to fire, in or on fabric articles.

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Compliance with applicable standards and associated

labeling have reduced the covered risks.

Agency relies on manufacturer's declaration of

compliance, but also conducts government surveillance

and follow up on reports of products that may not be in

compliance with federal standards or are otherwise

potentially hazardous.

May use government lab, manufacturer's lab. or third

party labs in assessing compliance.

Government.

State/local government.

Third party.

Authorized label by manufacturer.

311
Avail ability No list of certified suppliers or products is prepared.

of Documentation

Obligations of the

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 nonconformance

to applicable standards or known defects which could

present substantial risk of injury whether or not

covered by a standard. Manufacturers, importers,

distributors, and retailers are required to report

potentially hazardous products to CPSC. Manufacturer

may comply with the Act by guaranteeing conformance with

applicable standards based on test data.

Enforcement Marketing ban; product seizure; injunction

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 flammability standards and regulations;

Commission recognizes the use of voluntary standards to

accomplish the purpose of the Act.

Keywords apparel; bedding; carpets; children's sleepwear;

fabrics; flammability; furnishings; interior

furnishings; product testing; voluntary standards

wearing apparel

312
Products or

Services

Received 12/97

ARTICLES

(Chemicals which are Toxic, Corrosive, Flammable

Irritating or Pressure-Generating, and Which May Injure

Intended Users; Toys with Mechanical, Electrical and

Thermal Hazards.)

Department/Agency Consumer Product Safety Commission (CPSC)

Office of the General Counsel

4330 East-West Highway

Bethesda. MD 20814-4408

Phone: (301) 504-0980 (General Counsel)

Phone: 1-800-638-2772 (Consumer Hotline-to obtain

product safety information, report unsafe products, and

obtain other agency information)

FAX: (301) 504-0403

e-mail: info@cpsc.gov

URL address: http://www.cpsc.gov

Initiated

Compliance

Authority

Aim

1960.

Mandatory.

Federal Hazardous Substances Act, 15 U.S.C. 1261 et seq

To reduce the risk of injury to all intended users of

designated substances and articles.

Benefits Informative labeling is now in effect and selected

products have been or will be banned if they don't meet

certain standards.

Methodology Agency audits of labeling information to be provided

with designated hazardous substances.

Testing May use government lab, manufacturer's lab, or third

party labs in assessing compliance.

Inspection

Conformity

Identification

Government.

Authorized mark or label by manufacturer.

313
Availability List of regulations may be obtained from

of Documentation CPSC.

Obligations of the

Manufacturer/ Vendor

Keep such records as the Commission directs to assist in

the enforcement of the Act, such as known nonconformance

to applicable standards or known defects which could

present an unreasonable risk of injury whether or not

covered by a standard. Carriers must keep records of

interstate shipment of designated substances.

Enforcement Marketing ban; product recall.

Term Indefinite term.

Reciprocity Approved labeling is recognized by other federal

agencies, state governments, and private organizations

Standards, Codes or RegulationsCriteria for designating substances as hazardous are prepared by the Commission. Commission recognized use of voluntary standards to accomplish purposes of the

Act.

Keywords banned products; corrosive; flammability; hazardous

substances; irritant; misbranded substances; strong

sensitizer; toxicity; toys; children's products;

mechanical hazards; electrical hazards; thermal hazards

314
(TO IMBEK

Product Page

apparel 311

bedding 311

carpets 311

children's products 311, 313

consumer products 309

corrosive materials 313

electrical hazards 313

fabrics 311

flammable products 313

furnishings (fabric for) 311

hazardous substances 313

hazards, electrical, chemical, thermal, mechanical 313

mechanical hazards 313

sleepwear, children's 311

thermal hazards 313

toxic substances 313

toys 313

wearing apparel 311

315
316
Products or

Services

Not Received

Department/Agency

Initiated

Compliance

Authority

Environmental Protection Agency (EPA)

Office of Mobile Sources

Testing Services Division

Fuels and Technical Analysis Group

2565 Plymouth Road

Ann Arbor, MI 48105

Phone: (313) 668-4583

FAX: (313) 668-4440

URL address:

http : //www. epa . gov/OMSWWW/fuel s . htm#consumer

1970.

Mandatory. Products may not be introduced into commerce

until they have been registered by the Agency.

Section 211(a) and (b) of the Clean Air Act, 42 U.S.C.

7545.

40 CFR Part 79.

Aim To identify fuels and additive which warrant regulation

in order to protect the public health and welfare from

exposure to evaporative emissions and products of

combustion, and to prevent damage to automotive emission

controls

.

Benefits

Methodology

Reduced public exposure to harmful automotive emissions

Agency reviews information on composition and emissions

prior to the introduction into commerce of a fuel or additive. Manufacturers must provide detailed

information on the composition of their fuels and

additives, and available data on emissions. The Agency

reviews for: (1) compliance with Agency restrictions on compositions; and (2) emissions performance.

Testing Not specified, but required test data must be submitted

317
Inspection No scheduled inspections. Agency has authority to

conduct audits of the manufacturers to determine if

submitted data are accurate.

Conformity A registration letter is issued to the manufacturer.

Identification Agency's Fuel and Fuel Additive Registration Database

will have a record of its registration.

Availability A list of registered products is available to the public

of Documentation on request. Product composition is typically claimed as confidential

Enforcement Any party which introduces into commerce an unregistered

fuel or fuel additive is subject to a penalty of up to

$25,000 per day. In addition, EPA can: (1) take an informal action, such as a notice of violation or warning letter; (2) issue a field citation for minor

violations; (3) issue a formal administrative response,

such as an administrative penalty order; (4) initiate a civil judicial response; (5) initiate a criminal

judicial response; or (6) list a company so that it will

not receive federal contracts. For additional

information on enforcement, See Environmental

Enforcement: a Citizens Guide.

Term There is no term limit on registration.

Reciprocity None. See: http://www.ccar-greenlink.org for state

contacts.

Standards, Codes

or Regulations

Requirements are set forth in 40 CFR Parts 79 and 80.

Keywords automobile emissions; fuel additives; fuels; gasoline:

pollution control; reformulated gasoline; vehicle

emissions

318
Products or

Services

ENVIRONMENTALLY PREFERABLE PR

IENT

Received 8/98

I GOVERNMENT

Department/Agency

Initiated

Environmental Protection Agency (EPA)

Office of Pollution Prevention and Toxics

Pollution Prevention Division

Environmentally Preferable Purchasing Program

401 M Street, SW (Mail Code 7409)

Washington, DC 20460

Phone: (202) 260-3296

FAX: (202) 260-0178

Fax-on-Demand: (202) 401-0527

e-mail: goidel.eunsook@epa.gov

URL address: http://www.epa.gov/opptintr/epp

September 28, 1995, EPA issued a proposed Guidance on the Acquisition of Environmentally Preferable Products

and Services. Further development/expansion of that

guidance and the conduct of various pilot programs is

currently underway.

Compliance Compliance with Executive Order 12873 is required for

all federal agencies.

Authority Executive Order (E.0.) 12873, Federal Acquisition,

Recycling, and Waste Prevention. The Order directs EPA

to develop guidance to help federal agencies incorporate

environmental preferability into their purchasing

procedures.

Aim To promote the federal government's use of products and

services that pose reduced impact to human health and

the environment.

Benefits Guidance provided by EPA helps federal agencies begin

the process of identifying and purchasing

environmentally preferable products and services.

Methodology EPA has provided proposed guidance to federal agencies

and has implemented a pilot project approach to evaluate

the use of non-governmental entities in assisting

government agencies to implement Section 503 of E.0.

12873. (See Federal Register dated September 29, 1995,

Vol. 60, No. 189 or obtain from Fax-on-Demand and

319
indicate document #8001

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

By federal agencies, manufacturers or third parties at

the procurement agency's discretion.

By federal agencies, manufacturers or third parties at

the procurement agency's discretion.

EPA maintains a list of products which have been

certified by the manufacturer as being in compliance

with EPA guidance.

See URL address listed above or contact the EPP Program

at the address listed above.

Compliance with E.O. is the responsibility of each

federal agency. EPA does not enforce federal agency

compliance. The Federal Trade Commission is responsible

for environmental claims and has issued Guides for the

Use of Environmental Marketing Claims which govern

environmental claims made by anyone, including

manufacturers or environmental testing/certification

programs

N/A.

Guidance is recognized by all other federal agencies.

None with foreign governments.

Private sector or governmental standards as appropriate.

environmental preferability; government procurement;

government purchasing; recycling; waste prevention

320
Products or

Services

Received 12/97

E AFTERMARKET PARTS

Department/Agency Environmental Protection Agency (EPA)

Office of Air and Radiation

Office of Mobile Sources

Vehicle Programs and Compliance Division

Vehicle Compliance Programs Group (6405J)

401 M Street. SW

Washington, DC 20460

Phone: (202) 564-9328

FAX: (202) 565-2057

URL address: http://www.epa.gov/docs/OMSWWW.omshome.htm

Initiated 1980

1989

Program regulations were amended on August 8,

Compliance

Authority

Voluntary.

Section 207 (a) of the Clean Air Act. 42 U.S.C. 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.

Methodology Testing and certification is conducted by supplier after

notifying EPA of intent to certify.

Testing By supplier,

Conformity

Identification

The part or its packaging shall bear the statement

"Certified to EPA Standards."

321
Availability Requirements are set forth in 40 CFR Part 85, Subpart V

of Documentation

Obligations of the Suppliers are required to establish and maintain records

Manufacturer/Vendor of all certification tests as well as other information

related to the integrity of the parts and the

certification procedures.

Enforcement Decertification. In addition, EPA can: (1) take an informal action, such as a notice of violation or warning letter; (2) issue a field citation for minor

violations; (3) issue a formal administrative response,

such as an administrative penalty order; (4) initiate a civil judicial response; (5) initiate a criminal

judicial response; or (6) list a company so that it wil

not receive federal contracts. For additional

information on enforcement, See Environmental

Enforcement: a Citizens Guide.

Term Indefinite term.

Reciprocity None. See:

contacts

http://www.ccar-greenlink.org for state

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

322
Products or

Services

Department/Agency

»TOR VEH1CL

ENSUES. GA"

Received 7/98

(Automobile and Light Truck)

ME AID DIESEL

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Conformity

Identification

Environmental Protection Agency (EPA)

Office of Air and Radiation

Office of Mobile Sources

Vehicle Programs and Compliance Division

Vehicle Programs Group

2000 Traverwood Drive

Ann Arbor, MI 48105

Phone: (734) 214-4281

FAX: (734) 214-4869

URL address: http://www.epa.gov/OMSWWW/ld-hwy.htm

1972

Mandatory for manufacturers and distributors of motor

vehicle engines, automobiles, light duty trucks, and

motorcycles

.

The Clean Air Act as amended in 1990, 42 U.S.C. 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.

Government conducts design approval, testing, and audits

in conjunction with manufacturer's self-certification.

Uses government labs, government accredited lab, and

manufacturer's labs.

Inspection is conducted by government employees by third

parties.

Authorized label by manufacturer.

List of certified products.

323
Availability Lists available from EPA.

of Documentation

Obligations of the Manufacturer must qualify new engine designs, new Manufacturer/Vendor emission control system designs, and existing engine and

emission control system designs when emission

regulations change.

Enforcement EPA can: (1) take an informal action, such as a notice

of violation or warning letter; (2) issue a field

citation for minor violations; (3) issue a formal

administrative response, such as an administrative

penalty order; (4) initiate a civil judicial response;

(5) initiate a criminal judicial response; or (6) list

company so that it will not receive federal contracts.

For additional information on enforcement, See

Environmental Enforcement: a Citizens Guide.

Term Annual with audit testing.

Reciprocity Federal certification is recognized in all states except

California. See: http://www.ccar-greenlink.org for

state contacts and Clean Air Act Section 177: States.

Standards, Codes EPA prepares all criteria documents; some test methods or Regulations 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

324
Products or

Services

Received 8/98

BUSES AND DIESEL TRUCK!

Department/Agency

Initiated

Compliance

Environmental Protection Agency (EPA)

Office of Air and Radiation

Office of Mobile Sources (OMS)

Engine Programs and Compliance Division

Engine Compliance Programs Group

401 M Street, SW (6403J)

Washington, DC 20460

Phone: (202) 564-9287

FAX: (202) 565-2057

URL address: http://www.epa.gov/OMSWWW/hd-hwy.htm

1994,

Mandatory for manufacturers of heavy duty engines for

trucks and buses.

Authority The Clean Air Act of 1990.

40 CFR Part 86

Aim To control emissions from heavy duty trucks and buses in

the interest of public health.

Benefits The atmospheric environment has become cleaner through

progressively more restrictive emissions of carbon

monoxide, hydrocarbons, oxides of nitrogen, and

particulates from internal combustion engines.

Methodology Model year 1994 heavy duty diesel trucks and buses have

to be built to reduce particulate releases. Model year

1998 heavy duty diesel truck and buses have to be built

to reduce emissions of oxides of nitrogen. Government

conducts design approval, testing, and audits in

conjunction with manufacturer's self-certification.

Testing

Inspection

Uses government labs, government accredited lab, and

manufacturer's labs.

Inspection is conducted by government employees

325
Conformity Authorized label by manufacturer

Identification List of certified products.

Availability

of Documentation

See URL address or contact the address listed above.

Obligations of the Manufacturer must qualify new engine designs, new Manufacturer/Vendor emission control system designs, and existing engine and

emission control system designs when emission

regulations change.

Enforcement OMS can: (1) take an informal action, such as a notice

of violation or warning letter; (2) issue a formal

administrative response, such as an penalty order; (3) initiate a civil

or (4) initiate a criminal judicial

additional information on enforcement, See Environmental

Enforcement: a Citizens Guide.

administrative

judicial response;

response. For

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Annual with audit testing.

Federal certification is recognized in all states except

California and states which have adopted California

Standards under the Clean Air Act Section 177. See:

http://www.ccar-greenlink.org for state contacts.

EPA prepares all criteria documents; some test methods

prepared by others are referenced.

buses; carbon monoxide; diesel engines; environmental

treatment; evaporative emissions replacement; exhaust

emissions; gasoline engines; hydrocarbons; trucks; motor

vehicles; pollution control; vehicles; warranty

326
Products or

Services

LOW EMISSION VEHICLE

Received 7/98

Final Rulemaking

Department/Agency

Initiated

Compliance

Authority

Environmental Protection Agency (EPA)

Office of Air and Radiation

Office of Mobile Sources

National Low Emission Vehicle (NLEV) Program

2000 Traverwood Drive

Ann Arbor, MI 48105

Phone: (734) 214-4380

FAX: (734) 214-4869

URL address: http://www.epa.gov/OMSWWW/lev-nlev.html

Begins n Northeast in model year 1999. Begins

nationwide in model year 2001.

Voluntary.

The Clean Air Act of 1990.

40 CFR Parts 85 and 86.

Aim

Benefits

To encourage manufacturers to develop and consumers to

buy low emission vehicles.

The atmospheric environment has become cleaner through

progressively more restrictive emissions of carbon

monoxide, hydrocarbons, oxides of nitrogen, and

particulates from internal combustion engines.

Methodology

Testing

Government inspection.

EPA. Manufacturers do testing as well and provide test

data to EPA.

Inspection EPA,

Conformity

Identification

Availability

of Documentation

List of certified products.

Lists will be available from EPA.

327
Enforcement Removal from program; withdrawal of certification.

Term

Reciprocity

Standards, Codes

or Regulations

Annual on a model year basis.

Federal certification is recognized by other federal and

state agencies. See: http://www.ccar-greenlink.org for

state contacts.

EPA prepares all criteria documents; some test methods

prepared by others are referenced.

Keywords low emissions vehicles; light trucks; automobiles

328
Products or

Services

Received 8/98

NOIROAD (Off-Road or Off-Highway) ENSUES (Lawn and

Garden Equipment, Construction Equipment, Locomotives

Marine, Aviation, etc.

)

Department/Agency Environmental Protection Agency (EPA)

Office of Air and Radiation

Office of Mobile Sources (OMS)

Engine Programs and Compliance Division

Engine Compliance Programs Group

401 M Street. SW (6403J)

Washington, DC 20460

Phone: (202) 564-9287

FAX: (202) 565-2057

URL address: http://www.epa.gov/OMSWWW/nonroad.htm

Initiated

Compliance

Authority

1996. (Different years for industry/engine type.)

Mandatory for manufacturers of nonroad vehicles.

The Clean Air Act of 1990.

40 CFR Part 89-92.

Aim To control emissions from nonroad engines which lead to

air pollution in the interest of public health.

Benefits The atmospheric environment has become cleaner through

progressively more restrictive emissions of carbon

monoxide, hydrocarbons, oxides of nitrogen, and

particulates from internal combustion engines.

Methodology Certified nonroad engines are required to be used after

the effective date of the applicable regulations for

specific types of engines.

Testing

Inspection

Uses government labs

manufacturer's labs.

government accredited lab, and

Inspection is conducted by government employees and by

the manufacturers themselves in certain instances.

Conformity

Identification

Authorized label by manufacturer.

List of certified products.

329
Availability See URL address or contact the address listed above.

of Documentation

Obligations of the Manufacturer must qualify new engine designs, new Manufacturer/Vendor emission control system designs, and existing engine and

emission control system designs when emission

regulations change.

Enforcement OMS can: (1) take an informal action, such as a notice

of violation or warning letter; (2) issue a formal

administrative response, such as an administrative

penalty order; (3) initiate a civil judicial response;

or (4) initiate a criminal judicial response. For

additional information on enforcement, See Environmental

Enforcement: a Citizens Guide.

Reciprocity Federal certification is recognized in all states except

California and states which have adopted California

standards under the Clean Air Act Section 177. See:

http://www.ccar-greenlink.org for state contacts.

Standards, Codes EPA prepares all criteria documents; some test methods

or Regulations prepared by others are referenced.

Keywords diesel engines; exhaust emissions; gasoline engines;

nonroad vehicles; off-road vehicle; off-highway

vehicles; outdoor power equipment; recreational

vehicles; farm and construction equipment; boats;

locomotives; pollution control

330
Products or

Services

Not Received

VEHICLE 1HSPECT10I AID HAINTENAICE PROGJ

Department/Agency Environmental Protection Agency (EPA)

Office of Mobile Sources

Regional and State Programs Division

2565 Plymouth Road

Ann Arbor, MI 48105

Phone: (313) 668-4438

FAX: (313) 668-47906

URL address: http://www.epa.gov/0MSWWW/14-insp.htm

Compliance EPA established requirements which are mandated by many

states.

Authority

Aim

1990 Clean Air Act, as amended.

To check whether the emission control system on a vehicle is working correctly to ensure that vehicles

stay clean in actual customer use through periodic

vehicle checks and required repairs for vehicles that

fail the test.

Benefits Though motor vehicle manufacturers have been required to

meet increasingly stringent vehicle pollution standards,

poorly maintained or malfunctioning emission controls

often cause emissions from a vehicle to increase -- sometimes dramatically. Effective inspection and

maintenance programs can identify problem vehicles and assure their repair.

Methodology

Testing

Inspection

Agency establishes requirements for implementation at

the state level. States design and operate inspection

and maintenance programs in accordance with national

policy set by EPA.

States or state recognized facilities

States or state recognized facilities

Conformity

Identification

Varies by state,

331
Availability

of Documentation

Enforcement

Term

Reciprocity

Documentation on effective inspection and maintenance

programs is available from EPA. Fact Sheet OMS-14

"Clean Cars for Clean Air: Inspection and Maintenance

Programs" is available on the web at

http : / /www . epa . gov/OMSWWW/ 14- i nsp . htm

Enforcement is at the state level.

Varies by state.

None. See: http://www.ccar-greenlink.org for state

contacts.

Standards, Codes

or Regulations

Keywords

These are contained in EPA-AA-RSPD-IM-96-2 "Acceleration

Simulation Mode Test Procedures, Emission Standards,

Quality Control Requirements, and Equipment

Specifications: Technical Guidance."

vehicles; emission standards; vehicles emissions

testing/inspection

332
Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Not Received

EQUIPHEIT AID OPERATORS WHICH SERVICE MOTOR VEHICLE

AIR CONDITIONERS (MVACS)

Environmental Protection Agency (EPA)

Office of Mobile Sources

Vehicle Programs and Compliance Division

2565 Plymouth Road

Ann Arbor, MI 48105

Phone: (313) 668-4471

FAX: (313) 668-4869

1992.

Mandatory.

P.L. 101-549; Clean Air Act Amendments of 1990, Section

609.

40 CFR Part 82.

To maximize the recapture and recycling of refrigerant

during the servicing of motor vehicle air conditioners.

The protect the stratospheric ozone and allow for a smooth transition away from ozone depleting substances.

Operators must be certified under an approved 609

program prior to offering services. EPA restricts the

sale of small containers of Class I and Class II substances appropriate for use in motor vehicle air

conditioners to certified personnel. Recovery and/or

recycling equipment must be approved by EPA and must

meet the requirements of the Society of Automotive

Engineers (SAE) standards for approval. Recovery-only

equipment must meet SAE Standard J-2209. Reclaimers

must also be EPA approved.

Personnel testing is conducted by private industry

programs approved by EPA.

EPA performs inspections.

333
Conformity

Identification

Certifying programs issue identification numbers to

individual certified technicians. Certificates for such

technicians are generally found framed on the wall of

the shop or on wallet-sized cards carried by

technicians. Each technician must have his own certification. EPA approved equipment must have a label

indicating UL, ARI or EPA approval.

Availability

of Documentation

EPA maintains a list of technician certification

programs and approved equipment.

Enforcement The Clean Air Act authorizes fines of up to $25,000 per

day of violation. In addition, EPA can: (1) take an informal action, such as a notice of violation or warning letter; (2) issue a field citation for minor

violations; (3) issue a formal administrative response,

such as an administrative penalty order; (4) initiate a civil judicial response; (5) initiate a criminal

judicial response; or (6) list a company so that it will

not receive federal contracts. For additional

information on enforcement. See Environmental

Enforcement: a Citizens Guide.

Term

Reciprocity

Recertification not required.

None. See: http://www.ccar-greenlink.org for state

contacts

Standards, Codes

or Regulations

Keywords

40 CFR Part 82, Subpart B (published in the Federal

Register July 14, 1992).

air conditioner; CFCs; chemicals; environmental hazards

motor vehicles; Class I or II substances; restricted

use; vehicles

334
Products or

Services

Received 6/98

) STORAGE TANKS COST'S) AID ASSOCIATED

PIPING (Which Hold Petroleum Products or Certain

Chemicals)

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

Environmental Protection Agency (EPA)

Office of Solid Waste and Emergency Response (OSWER)

Office of Underground Storage Tanks (OUST)

401 M Street, SW (Mail Code 5403G)

Washington, DC 20460

Phone: (703) 603-9900

RCRA Hotline: 1-800-424-9346

FAX: (703) 603-9163

URL address: http://www.epa.gov/swerustl/index.htm

Final rule issued in 1988.

Mandatory.

Resource Conservation and Recovery Act (RCRA).

See also 40 CFR Parts 280 and 281.

Individual state and territorial programs are codified

in 40 CFR 282.50-105.

To prevent underground storage tanks from leaking

petroleum or other hazardous substances into the

surrounding environment.

Protects human health, safety, and the environment.

Facilities with USTs must meet federal requirements

specified in the CFR references listed above.

Tanks should comply with testing requirements contained

in the CFR references listed above.

Inspection requirements are specified in the CFR

references listed above.

Conformity

Identification

None

335
Availability

of Documentation

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

See URL address or contact EPA at the above address for

additional information.

See 40 CFR 281 Subparts A-F. States with approved

programs are responsible for enforcement.

N/A.

None.

See 40 CFR Parts 280 and 281.

underground storage tanks; USTs; hazardous substances

storage; petroleum; storage tanks

336
Products or

Services

Received 3/98

HASTE COMBUSTION FACIL1T1I

Department/Agency

Initiated

Environmental Protection Agency (EPA)

Office of Solid Waste and Emergency Response (OSWER)

Office of Solid Waste

401 M Street, SW

Washington, DC 20460

Phone: (703) 412-9810

RCRA Hotline: 1-800-424-9346

URL address:

http : //www. epa . gov/epaoswer/hazwaste/combust . htm

1981 for incinerators.

1991 for boilers and industrial furnaces.

Compliance

Authority

Mandatory.

Resource Conservation and Recovery Act (RCRA), 40 CFR

260-270. Individual state and territorial programs are also codified.

Aim To reduce the amount of hazardous waste generated in

this country and to improve the safety and reliability

of hazardous waste combustion in incinerators and

boilers and industrial furnaces (BIFs).

Benefits

Methodology

Testing

Inspection

See Aim.

To work with states to co-regulate hazardous waste

burning facilities. Agency serves as certifier where

there is no approved state program.

Testing is likely to be required by EPA or state

employees or organizations recognized by responsible

agencies. Testing requirements and frequency may vary

by state, though they must be consistent with (at least

as stringent as) federal requirements.

EPA or state employees or organizations recognized by

responsible agencies. See also Testing.

337
Conformity

Identification

Permits issued by EPA or the appropriate state agencies.

Availability

of Documentation

See URL address or contact EPA at the above address for

additional information.

Enforcement States with approved programs are responsible for

enforcement. In addition, EPA can: (1) take an informal

action, such as a notice of violation or warning letter;

(2) issue a field citation for minor violations; (3)

issue a formal administrative response, such as an administrative penalty order; (4) initiate a civil

judicial response; (5) initiate a criminal judicial

response; or (6) list a company so that it will not

receive federal contracts. For additional information

on enforcement,

Citizens Guide.

See Environmental Enforcement: a

Term Unknown. May vary by state.

Reciprocity None.

Standards, Codes

or Regulations

40 CFR Part 264 Subpart 0 (Incinerators).

40 CFR Part 266 Subpart H (Boilers and industrial

furnaces)

Keywords boilers; combustion; furnaces; hazardous waste;

incinerators; industrial furnaces

338
Received 3/98

Products or WASTE TREATMENT. STORAGE AND DISPOSAL FACILITIES:

Services ALSO SOLID WASTE FROM: WASTEWATER TREATMENT PLANTS.

WATER SUPPLY TREATMENT PLANTS. AIR POLLUTION CONTROL

FACILITY. INDUSTRIAL. COMMERCIAL. MINING AND

AGRICULTURAL OPERATIONS AND FROM COMMUNITY ACTIVITIES

(See Also EPA Entries for Specific Industrial Sectors)

Department/Agency Environmental Protection Agency (EPA)

Office of Solid Waste and Emergency Response (OSWER)

Office of Solid Waste

401 M Street, SW

Washington, DC 20460

Phone: (703) 412-9810

RCRA Hotline: 1-800-424-9346

e-mail : rcra-docket@epamail .epa.gov

URL address: http://www.epa.gov/osw

Initiated

Compliance

Authority

Aim

Benefits

Methodology

1976.

Mandatory.

Resource Conservation and Recovery Act (RCRA).

40 CFR 258-270.

Information on hazardous waste injection wells is

contained in 40

CFR 144-148.

Individual state and territorial programs may also have

codified

requirements.

To reduce the amount of waste generated in this country

and to improve the safety, efficacy, and reliability of

waste treatment, storage and disposal facilities.

Protection of human health and the environment from the

hazards associated with solid waste.

To work with states to co-regulate waste treatment,

storage and disposal. Such activities are controlled by

state and federal requirements. Agency serves as certifier where there is no approved state program.

339
Testing Testing, where required, is conducted by EPA. state

employees or organizations recognized by responsible

agencies. Testing requirements and frequency may vary

by state, though they must be consistent with (at least

as stringent as) federal requirements.

Inspection EPA or state employees or organizations recognized by

responsible agencies. See also Testing.

Conformity

Identification

Permits issued by EPA or the appropriate state agencies

Availability

of Documentation

See URL address or contact EPA at the above address for

additional information.

Enforcement States with approved programs are responsible for

enforcement. In addition, EPA can: (1) take an informal

action, such as a notice of violation or warning letter;

(2) issue a field citation for minor violations; (3)

issue a formal administrative response, such as an administrative penalty order; (4) initiate a civil

judicial response; (5) initiate a criminal

response; or (6) list a company so that it

receive federal contracts. For additional

judicial

will not

information

on enforcement,

Citizens Guide.

See Environmental Enforcement: a

Term Unknown. May vary by state

Reciprocity None

Standards, Codes

or Regulations

See 40 CFR Parts 258-270.

Keywords hazardous waste injection wells; lead; solid waste;

waste treatment facilities; waste storage facilities

waste disposal facilities

340
Products or

Services

Received 3/98

IAT GEIERATE/TRANSP0RT/T1EAT/ST0RE OR

DISPOSE OF HAZARDOUS WASTE (See Also EPA Entries for

Specific Industrial Sectors)

Department/Agency Environmental Protection Agency (EPA)

Office of Solid Waste and Emergency Response (OSWER)

Office of Solid Waste

401 M Street, SW

Washington, DC 20460

Phone: (703) 412-9810

RCRA Hotline: 1-800-424-9346

e-mail : rcra-docket@epamail .epa.gov

URL address: http://www.epa.gov/osw

Initiated

Compliance

Authority

1976,

Mandatory.

Resource Conservation and Recovery Act (RCRA), 40 CFR

260-270. Individual state and territorial programs may

also have codified requirements.

Aim To reduce the amount of hazardous waste generated in

this country and to improve the safety, efficacy, and

reliability of hazardous waste generating, treatment,

storage and disposal facilities.

Benefits Protection of human health and the environment from the

hazards associated with hazardous waste.

Methodology To work with states to co-regulate hazardous waste

generation, treatment, storage and disposal. Such

activities are controlled by state and federal

requirements. Handlers of hazardous waste must meet

certain regulatory requirements. Generators and

transporters must have government issued identification

numbers, and comply with other regulations regarding the

handling of hazardous waste. Treatment, storage and

disposal facilities must meet even more stringent

requirements, and must have a permit to operate. Agency

serves as certifier where there is no approved state

program.

341
Testing Testing, where required, is conducted by EPA, state

employees or organizations recognized by responsible

agencies. Testing requirements and frequency may vary

by state, though they must be consistent with (at least

as stringent as) federal requirements.

Inspection EPA or state employees or organizations recognized by

responsible agencies. See also Testing.

Conformity

Identification

Permits issued by EPA or the appropriate state agencies

Availability

of Documentation

See URL address or contact EPA at the above address for

additional information.

Enforcement States with approved programs are responsible for

enforcement. In addition, EPA can: (1) take an informal

action, such as a notice of violation or warning letter;

(2) issue a field citation for minor violations; (3)

issue a formal administrative response, such as an administrative penalty order; (4) initiate a civil

judicial response; (5) initiate a criminal

response; or (6) list a company so that it

receive federal contracts. For additional

judicial

will not

information

on enforcement.

Citizens Guide.

See Environmental Enforcement: a

Term Varies by state

Reciprocity None

Standards, Codes

or Regulations

See 40 CFR 260-270.

Keywords hazardous waste injection wells; hazardous waste;

hazardous waste treatment facilities; hazardous waste

storage facilities; hazardous waste disposal facilities

342
Products or

Services

Received 12/97

NEW RESIDENTIAL MOOD HEATER!

Department/Agency

Initiated

Compliance

Authority

U.S. Environmental Protection Agency (EPA)

Office of Compliance

Manufacturing, Energy & Transportation Division (2223-A)

Wood Heater Program

401 M Street, SW

Washington, DC 20460

Phone: (202) 564-7021

FAX: (202) 564-0039

URL address: http://es/epa.gov/oeca/metd/stoves/html

1987

Mandatory.

Section 111 of the Clean Air Act.

Standards of Performance for New Stationary Sources; New

Residential Wood Heaters (40 CFR Part 60).

Aim To require all new residential wood heaters to reduce

emissions of particulate matter (PM) to levels

achievable by the best demonstrated system of continuous

emission reduction.

Benefits Lower emissions of PM, increased wood heater efficiency

by reduced wood consumption and a reduction in the

creosote deposition in chimneys lessening the chance of

chimney fires.

Methodology An EPA accredited laboratory must conduct emissions

testing for certification and submit the results to

EPA certifies a representative model line. EPA has

field inspectors throughout the country who inspect

manufacturing and retail sites regularly to ensure

compliance. Random compliance audit and selective

enforcement audit programs are conducted.

EPA,

343
Testing EPA accredited, third party laboratories are responsible

for conducting certification testing. For further

information, contact: Emission Monitoring and Analysis

Division SCGB (MD 19), U.S. EPA, Research Triangle Park,

NC 27711, Att: Wood Heater Accreditation, Triangle

Park, NC 27711, Att: Wood Heater Laboratory

Accreditation.

Inspection See Testing.

Conformity

Identification

A model line which has been approved by EPA is granted a certificate which is good for 5 (five) years. The

manufacturer must attach a permanent label and a temporary label to each unit. The permanent label must

have the serial number, month and year of manufacturer,

and model name or number.

Availability

of Documentation

Certified stove lists, brochures, and other information

can be obtained from the Federal Programs Section of the

Stationary Source Compliance Division.

Enforcement Revocation of certification. I take an informal action, such a or warning letter; (2) issue a violations; (3) issue a formal

such as an administrative penal

civil judicial response; (5) in

judicial response; or (6) list

not receive federal contracts,

information on enforcement, See

Enforcement: a Citizens Guide.

n addition, EPA can: (1)

s a notice of violation

field citation for minor

administrative response,

ty order; (4) initiate a itiate a criminal

a company so that it will

For additional

Environmental

Term A certificate is valid for 5 (five) years

Reciprocity None.

Standards, Codes See 40 CFR Part 60.

or Regulations

Keywords wood heater; wood stove; emissions

344
Received 6/98

Products or

Services

Department/Agency

Initiated

Compliance

(Laboratory Certification Criteria)

Environmental Protection Agency (EPA)

Office of Ground Water and Drinking Water

Drinking Water Standards Division

401 M Street, SW

Washington, DC 20460

Phone: (202) 260-7575

Safe Drinking Water Hotline: 1-800-426-4794

FAX: (202) 260-3762

URL address: http://www7epa.gov/0GWDW/

1974.

Mandatory. Laboratories performing drinking water

analysis to demonstrate compliance with regulations must

be certified as capable of delivering acceptable

performance.

States seeking to operate a drinking water regulatory

program must implement a laboratory certification

program based on federal standards; otherwise EPA's

Regional Offices will certify laboratories in the State

Authority Safe Drinking Water Act (42 U.S.C. 300), as amended,

National Primary Drinking Water Regulations (40 CFR

Parts 141 and 142).

Aim To provide scientifically sound criteria for the

evaluation of drinking water laboratories and associated

method performance in the disciplines of chemistry,

microbiology, and radiochemistry

.

Benefits Ensures high quality analytical information in support

of Agency's drinking water and public health objectives

Methodology Government design of certification program with

primarily state oversight. Key elements include

recordkeeping, inspection, audit, and performance

evaluation samples. Act requires that data from a laboratory be acceptable only after laboratory is

certified; however, laboratory must be in operation

345
before it can be certified. Agency serves as certifier

in cases where there is no approved state program.

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

Obligations of the

Manufacturer/ Vendor

Lists are available from state certifying authorities

and EPA Regional Offices.

Certified labs must complete periodic performance

evaluations satisfactorily, maintain competency in

approved methods, notify certifier of changes in staff

or equipment and submit to periodic on-site evaluations

Enforcement Delisting. In addition, EPA can: (1) take an informal

action, such as a notice of violation or warning letter:

(2) issue a field citation for minor violations; (3)

issue a formal administrative response, such as an administrative penalty order; (4) initiate a civil

judicial response; (5) initiate a criminal judicial

response; or (6) list a company so that it will not

receive federal contracts. For additional information

on enforcement.

Citizens Guide.

See Environmental Enforcement: a

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

states recertify more frequently.

Reciprocity States are expected to develop procedures for

recognizing certifications among themselves.

Standards, Codes

or Regulations

EPA develops methods and QA/QC criteria

Keywords chemistry; drinking water; microbiology; on-site

evaluation; performance evaluation; pollution; quality

assurance; radiochemistry; water quality

346
Products or

Services

Received 6/98

OPERATORS OF DRINKING WATER SYSTEMS

Department/Agency Environmental Protection Agency (EPA)

Office of Ground Water and Drinking Water (OGWDW)

Implementation and Assistance Division (4606)

401 M Street, SW

Washington, DC 20460

Phone: (202) 260-7575

Safe Drinking Water Hotline: 1-800-426-4794

FAX: (202) 260-3762

e-mail: nayl or. rick@epamail .epa.gov or URL address: http://www7epa.gov/0GWDW/

Initiated

Compliance

Under development.

Mandatory. Operators of all drinking water systems will

be required to obtain state certification.

Authority Safe Drinking Water Act (42 U.S.C. 300), as amended.

National Primary Drinking Water Regulations (40 CFR

Parts 141 and 142).

Aim To set minimum operator certification standards to be

used by the states in their certification programs.

Drinking Water operator competency is critical for the

protection of public health and the maintenance of safe,

optimal, and reliable operations of water treatment and

distribution facilities.

Benefits Minimum Federal guidelines ensure that operators have

the operational skills, knowledge, experience,

education, and training required to operate a water

system.

Methodology Agency develops recommended state operator certification

guidelines and issues guidelines specifying minimum

standards for certification and recertification of the

operators of community and nontransient , noncommunity

public water systems. States are required to implement

the minimum guidelines or an equivalent state program to

avoid a reduction in its drinking water state revolving

fund allocation.

347
Testing State agencies or their designees

Inspection State agencies or their designees

Conformity

Identification

Availability

of Documentation

Operators will be issued certification certificates by

the appropriate state authority.

Lists of certifying agencies and criteria should be

available from EPA when the program is operational.

Obligations of the Must apply for certification and meet the required

Manufacturer/Vendor certification criteria.

Enforcement Delisting. In addition, EPA can: (1) take an informal

action, such as a notice of violation or warning letter

(2) issue a field citation for minor violations; (3)

issue a formal administrative response, such as an administrative penalty order; (4) initiate a civil

judicial response; (5) initiate a criminal judicial

response; or (6) list a company so that it will not

receive federal contracts. For additional information

on enforcement, See Environmental Enforcement: a Citizens Guide.

Term

Reciprocity

Standards, Codes

or Regulations

May vary by State.

State program requirements must be "substantially

equivalent" to federal guidelines published by EPA.

EPA will develop federal guidelines.

Keywords drinking water; water systems; water system operators

operator competency; water quality

348
Received 3/98

Products or

Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

CERTIFIGA'

OF RESTRICTED

WE Ai

PESTICIDE

ID COMMERCIAL

Environmental Protection Agency (EPA)

Office of Pesticide Programs

Certification and Worker Protection Branch

401 M Street, SW

Crystal Mall 2

Washington, DC 20460-0001

Phone: (703) 305-7666

URL address: http://www.epa.gov/pesticides

1972.

Mandatory.

The Federal Insecticide, Fungicide, and Rodenticide Act

(FIFRA - P.L. 94149 and P.L. 95396.

40 CFR Part 171.

Various state laws and regulations.

Food Quality Protection Act of 1996.

To ensure that pesticides posing relatively high risk, or which are difficult to use, are used only by or under

the direct supervision of competent, certified persons.

Reduced risk to human health and the environment while

maintaining necessary tools with which to control

agricultural, public health, and other pest species.

Agency oversees state programs to certify applicators

and serves as certifier of applicators in Colorado and

Nebraska. Applicator may not apply restricted use pesticides until competency is demonstrated and

certification is received. Uses government facilities

in Colorado and Nebraska; state facilities in all other

states and territories.

Testing Testing is conducted by the certifying agency for

commercial applicators; in some cases, states test

private applicators as well.

Inspection Same basis as testing.

349
Conformity

Identification

Certifying states issue identification numbers to

individual certified applicators.

Availability Each state maintains a controlled list of certified

of Documentation 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 the Certified applicators and/or their employees are Manufacturer/Vendor obligated to limit applications to those restricted

pesticides registered for uses for which they have been

certified.

Enforcement Delisting or limitation of certification by certifying

agency; fines under FIFRA and governing laws of many

states. In addition, EPA can: (1) take an informal

action, such as a notice of violation or warning letter;

(2) issue a field citation for minor violations; (3)

issue a formal administrative response, such as an administrative penalty order; (4) initiate a civil

judicial response; (5) initiate a criminal judicial

response; or (6) list a company so that it will not

receive federal contracts. For additional information

on enforcement, See Environmental Enforcement: a Citizens Guide.

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

No formal list of reciprocal relations is available.

Standards, Codes

or Regulations

Minimum Certification Standards are found at 40 CFR Part

171. Certification standards also are promulgated by

the states and must be as stringent as, or more stringent than those required at 40 CFR Part 171.

Keywords chemicals; environmental hazards; fungicides;

insecticides; pesticides; registered chemicals;

restricted use; rodenticides ; termiticides

350
Products or

Services

Received 7/98

IRAL I0TECT10N

Department/Agency

Initiated

Environmental Protection Agency (EPA)

Office of Pesticide Programs

Worker Protection Program

401 M Street, SW

Washington, DC 20460-0001

Phone: (703) 305-7666

FAX: (703) 305-6920

URL address: http://www.epa.gov/pesticides

Initiated August 21

38151.

1992. See 57 Federal Register

Compliance

Authority

Aim

Benefits

Methodology

Mandatory.

The Federal Insecticide, Fungicide, and Rodenticide Act

FIFRA - P.L. 94149 and P.L. 95396.

Various state laws and regulations.

Food Quality Protection Act of 1996.

To reduce the risk of pesticide poisonings and injuries

among agricultural workers who are exposed to pesticide

residues and to reduce the risk of pesticide poisoning

and injuries among pesticide handlers who may face more hazardous levels of exposure.

See Aim.

EPA has established the Worker Protection Standard (WPS)

and oversees state programs designed to ensure worker

safety. EPA implements several programs to protect

workers from risks posed by pesticides in partnership

with state agencies. The WPS contains requirements for

pesticide safety training, notification of pesticide

applications, use of personal protective equipment,

restricted entry intervals following pesticide

applications, decontamination supplies, and emergency

medical assistance.

Testing

Inspection

Is associated with certification and training and

administered by state employees or their designees

Primarily by state employees or their designees.

351
Conformity Certification issues by the states.

Identification

Availability The Worker Protection Standard is available on the EPA

of Documentation website at the URL address listed above.

Obligations of the Training is required for all worker and handlers. In

Manufacturer/Vendor addition, employers must comply with WPS requirements.

Enforcement Enforcement is primarily at the state level, though EPA

can: (1) take an informal action, such as a notice of

violation or warning letter; (2) issue a field citation

for minor violations; (3) issue a formal administrative

response, such as an administrative penalty order; (4)

initiate a civil judicial response; (5) initiate a criminal judicial response; or (6) list a company so that it will not receive federal contracts. For

additional information on enforcement. See Environmental

Enforcement: a Citizens Guide.

Term Ongoing requirements, though term for certifications

varies by state.

Reciprocity Requirements are enforced at the state level, though

states may impose additional requirements.

Standards, Codes

or Regulations

See Worker Protection Standard.

Keywords agricultural workers; pesticides; farm workers; forestry

workers; nursery workers; greenhouse workers; pesticide

handlers worker protection

352
Products or

Services

Received 3/98

Department/Agency

Initiated

Compliance

Authority

Environmental Protection Agency (EPA)

Office of Pesticide Programs

Antimicrobial Division (Mail Code 7510W)

401 M Street, SW

Washington, DC 20460-0001

Ombudsperson: Phone: (703) 308-6212

FAX: (703) 308-4687

URL address: http://www.epa.gov/pesticides

1970.

Mandatory.

The Federal Insecticide, Fungicide, and Rodenticide Act

(FIFRA).

Food Quality Protection Act of 1996.

Aim To ensure that pesticides do not pose an unreasonable

risk or to health and the environment.

Benefits

Methodology

Reduced risk to human health and the environment while

maintaining necessary tools with which to control

agricultural, public health, and other pest species.

Applicants submit an application to EPA with required

information on the chemical composition of the

pesticide; labeling and packaging for the pesticide.

EPA reviews the documentation submitted by the

manufacturer and registers the pesticide if appropriate,

Testing Testing must be performed by the manufacturer and the

required test data/information submitted to EPA for

review. Any changes must be notified in accordance with

regulations

.

Conformity

Identification

Registration.

Availability

of Documentation

See CFR references listed above as well as information

at the above URL address.

353
Obligations of the Must submit an application from a responsible official

Manufacturer/Vendor in the company to EPA containing the required

information, certifications, and test data.

Enforcement See FIFRA section 12 and 14. In addition, EPA can: (1)

take an informal action, such as a notice of violation

or warning letter; (2) issue a field citation for minor

violations; (3) issue a formal administrative response,

such as an administrative penalty order; (4) initiate a civil judicial response; (5) initiate a criminal

judicial response; or (6) list a company so that it will

not receive federal contracts. EPA is also able to

immediately suspend registrations in an emergency. For

additional information on enforcement. See Environmental

Enforcement: a Citizens Guide.

Term Good till cancelled, though EPA is attempting to

initiate a 15 year review cycle for all registrations

Reciprocity EPA's requirements are recognized and enforced by the

states, which may also impose additional requirements,

Standards, Codes

or Regulations

See CFR references listed above.

Keywords antimicrobial products: chemicals; environmental

hazards; fungicides; insecticides; packaging;

pesticides; registered chemicals; rodenticides;

termiticides

354
Products or

Services

Received 4/98

PESTICIDE!

Department/Agency Environmental Protection Agency (EPA)

Office of Pesticide Programs

Registration Division (Mail Code: 7505C)

401 M Street. SW

Washington, DC 20460-0001

For general questions on registration, contact:

Registration Division Ombudsperson

Phone: (703) 305-5446

FAX: (703) -305-6920

For pesticide information, contact:

National Pesticide Telecommunications Network

(NPTN): 1-800-858-7378

For Biopesticides and Pollution Prevention information

contact:

For Biopesticides and Pollution Prevention Division

(Mail Code: 7501W)

Phone: (703) 308-8098

FAX: (703) 308-8712

For Antimicrobial information: See prior entry.

NPTN E-Mail: nptn@ace.orst.edu

URL address: http://www.epa.gov/pesticides/chemreg.htm

or (NPTN) http://ace.orst.edu/info/nptn

Initiated

Compliance

Authority

1970.

Mandatory.

The Federal Insecticide. Fungicide, and Rodenticide Act

(FIFRA) as amended by the Food Quality Protection Act of

1996 (FQPA). (7 U.S.C. 136, et seq.)

Federal Food. Drug and Cosmetic Act as amended by the

FQPA.

;

Aim To ensure that pesticides do not pose an unreasonable

risk or to health and the environment.

Benefits Reduced risk to human health and the environment while

maintaining necessary tools with which to control

agricultural, public health, and other pest species.

355
Methodology Applicants submit an application to EPA with required

information on the chemical composition of the

pesticide; labeling and packaging for the pesticide.

EPA reviews the documentation submitted by the

manufacturer and registers the pesticide if appropriate.

EPA also maintains the Pesticide Product Information

System (PPIS). which contains information on all

pesticide products registered in the United States.

Testing Testing must be performed by the manufacturer and the

required test data/information submitted to EPA for

review. Any changes must be notified in accordance with

regulations

Conformity Registration/ registration number. Registered product

Identification information is also contained in the PPIS.

Availability See references listed above as well as information at

of Documentation the above URL addresses. A updated edition of "General

Information on Applying for Registration of Pesticides

in the United States" is expected to be available in the

Spring of 1998. The new edition will incorporate

regulatory changes resulting from the passage of the

Food Quality Act of 1996.

Obligations of the Must submit an application from a responsible official

Manufacturer/Vendor in the company to EPA containing the required

information, certifications, and test data.

Enforcement See FIFRA section 12 and 14. In addition. EPA can: (1)

take an informal action, such as a notice of violation

or warning letter; (2) issue a field citation for minor

violations; (3) issue a formal administrative response,

such as an administrative penalty order; (4) initiate a civil judicial response; (5) initiate a criminal

judicial response; or (6) list a company so that it will

not receive federal contracts. EPA is also able to

immediately suspend registrations in an emergency. For

additional information on enforcement, See Environmental

Enforcement: a Citizens Guide.

Term Good till cancelled, though EPA is attempting to

initiate a 15 year review cycle for all registrations.

Reciprocity EPA's requirements are recognized and enforced by the

states, which may also impose additional requirements.

356
Standards, Codes See references listed above. or Regulations

Keywords chemicals; cockroach sprays/baits; defoliants;

desiccants; disinfectants; environmental hazards; flea

sprays; fungicides; fumigants; growth regulators; insect

repellant; insecticides; miticides; molluscicides;

nematicides; ovicides; packaging; pesticides; pet

collars; registered chemicals; rodenticides ; swimming

pool chemicals; termiticides ; tick sprays; weed killers

357
Products or

Services

Received 3/98

PESTICIDE PACKAGING

Department/Agency

Initiated

Compliance

Authority

Environmental Protection Agency (EPA)

Office of Pesticide Programs

Registration Division

Technical Review Branch (7505-W)

401 M Street. SW, Room

Crystal Mall 2

Washington. DC 20460-0001

Phone: (703) 305-5447

URL address: http://www.epa.gov/pesticides

1970.

Mandatory.

The Federal Insecticide. Fungicide, and Rodenticide Act

(FIFRA) section 25(c)(3) requires EPA's child resistant

packaging (CRP) standards to be consistent with those

established under the Poison Prevention Packaging Act of

1970 (PPPA). EPA's regulations at 40 CFR 157.32

reference the Consumer Product Safety Commission (CPSC)

packaging standards and testing procedures for CRP (16

CFR 1700.15(b) and 1700.20.

Aim

Benefits

Methodology

Testing

Inspection

To ensure that pesticides packaging resists entry by

most young children and must not be difficult for most

adults to open and properly resecure.

Reduced risk of poisoning or other injury to young

chi Idren.

Agency adopts and enforces CPSC's CRP standards.

Applicants submit an application to EPA to obtain a CRP

certification for their packaging based on selfcertification by the manufacturers that the product as packaged meets CRP requirements.

Must be conducted by manufacturer in accordance with

testing requirements established by CPSC.

Same as testing.

358
Conformity

Identification

Registration.

Availability

of Documentation

See CFR references listed above as well as the above URL

address.

Obligations of the Must submit an application form with a CRP certification

Manufacturer/Vendor from a responsible official in the company to EPA and

conduct the required testing.

Enforcement See FIFRA section 12 and 14. In addition, EPA can: (1)

take an informal action, such as a notice of violation

or warning letter; (2) issue a field citation for minor

violations; (3) issue a formal administrative response,

such as an administrative penalty order; (4) initiate a civil judicial response; (5) initiate a criminal

judicial response; or (6) list a company so that it will

not receive federal contracts. For additional

information on enforcement, See Environmental

Enforcement: a Citizens Guide.

Term

Reciprocity

Packaging is approved until changes are made in the CPSC

requirements. Then packaging must be modified and

reapproved based on those changes.

EPA's requirements are recognized and enforced by the

states, which may also impose additional requirements.

Standards, Codes

or Regulations

Keywords

See CFR references listed above

chemicals; child resistant packaging; CRP; environmental

hazards; fungicides; insecticides; packaging;

pesticides; registered chemicals; rodenticides

359
Products or Services

Received 4/98

1E1IT, MITIGATION. TRAINII

Department/Agency Environmental Protection Agency (EPA)

Office of Radiation and Indoor Air

Indoor Environments Division

National Radon Proficiency Program (RPP)

Radon Proficiency Program Information Service (RIS)

401 M Street, SW

Washington, DC 20460

Phone: 1-800-962-4684 or (334) 270-3414

FAX: (334) 270-3471 or (334) 270-4354

National Safety Council's Radon Hotline: 1-800-55-RADON

e-mail: maill0554@pop.net or poppell .sam@epamail .epa.gov

URL address: http://www.epa.gov/radonpro/

Initiated

Compliance

Authority

February 1986

Voluntary.

Title III of TSCA. Section 305(a) (2) of the Indoor

Radon Abatement Act (IRAA) of 1988.

Aim To assess the proficiency of individuals and

organizations providing radon in indoor air measurement

services and individuals that offer radon mitigation

(remediation) services.

Benefits Allows consumers to purchase radon services from EPAlisted individuals and organizations providing consumers

with some assurance of their competency.

Methodology

Testing

Agency approves state implementation plans (SIPS).

Applicants must meet a number of programmatic

requirements, e.g., submission of an application,

adherence to sound QA/QC practices, passing a device

performance test for analytical services, etc. In order

to remain listed participants must also meet

requirements on a continual basis.

Passing of a device performance test is required for

analytical services listing.

360
Inspection None.

Conformity EPA maintains a list of qualified participants which

Identification appear in the Proficiency Listings. Also issues photo

ID cards showing the individual's/organization's status

for some service categories.

Availability Additional information is available from the URL address

of Documentation listed above, or from the above

address

.

Obligations of the See Methodology. Requirements vary based on service

Manufacturer/ Vendor category

.

Enforcement Removal from Listings. In addition, EPA can: (1) take

an informal action, such as a notice of violation or warning letter; (2) issue a field citation for minor

violations; (3) issue a formal administrative response,

such as an administrative penalty order; (4) initiate a civil judicial response; (5) initiate a criminal

judicial response; or (6) list a company so that it will

not receive federal contracts. For additional

information on enforcement, See Environmental

Enforcement: a Citizens Guide.

Term

Reciprocity

Standards, Codes

or Regulations

One year.

None, though other federal and state agencies use these

listings in their communications and consumer

publications.

See RPP Handbook for requirements, EPA 402-R-95-013,

July 1996.

Keywords radon; air pollution; radon mitigation services; radon

measurement services

361
Products or

Services

Received 6/98

NEW ENVIRONMENTAL TECHIOIQS]

Department/Agency

Initiated

Compliance

Authority

Aim

Environmental Protection Agency (EPA)

Office of Research and Development

National Risk Management Research Laboratory

Environmental Technology Verification Program (ETV)

401 M Street. SW

Washington, DC 20460

Phone: (202) 564-3211

FAX: (202) 565-0075

URL address: http: //www.epa .gov/etv

1996.

Voluntary.

President's Environmental Technology Strategy:

Congressional Appropriation.

The Environmental Technology Verification Program (ETV)

verifies the performance of innovative technical

solutions to problems that threaten human health or the

environment.

Benefits Helps to accelerate the entrance of new environmental

technologies into the domestic and international

marketplace by providing technology buyers, innovation

developers, consulting engineers, states, and EPA

regions with high quality data on the performance of new technologies

Methodology EPA competitively selects partner organizations to

design, manage, test, report and quality assure the

evaluation of environmental technologies in all media.

Operational, test and report protocols are developed by

Stakeholder Groups that consist of representative

members of groups that are expected to use the data

produced (e.g., state and federal regulators, consulting

engineers, permitters. technology users/purchasers, and

technology vendors.

)

362
Testing Verification is conducted under protocols and test plans

by partner organization or by others operating under the

oversight of partner organizations. Quality is assured

through the implementation of a program-wide ANSI E4

Quality Management Plan operated under EPA oversight.

Test reports and verification statements are independently peer reviewed and signed by EPA officials

and their partners.

Inspection ETV does not conduct operational inspections (See

Testing)

.

Conformity

Identification

Test reports and the ETV mark.

Enforcement

Term

Reciprocity

Voluntary program.

Ongoing.

None, though this information is accepted by other state

and federal government agencies.

Standards, Codes

or Regulations

Based on test protocols developed by EPA in conjunction

with all interested stakeholders.

Keywords air pollution control technologies; drinking water

technologies; indoor air products; pollution prevention

research and waste treatment technology; wet weather

flow control systems; source water protection

technologies; climate change technologies; metal

finishing technologies; environmental technologies;

advanced monitoring systems; field monitoring systems.

363
Products or

Services

INNOVATIVE TECHNOLOGY DEMONSTRATION AND EVALUATIOI

Received 6/98

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Environmental Protection Agency (EPA)

Office of Research and Development

Superfund Innovative Technology Evaluation (SITE)

Program

National Risk Management Research Laboratory

26 West Martin Luther King Drive

Phone: (513) 569-7697

FAX: (513) 569-7620

URL address: http://www.epa.gov/ORD/SITE

1986.

Voluntary.

Comprehensive Environmental Response, Compensation and

Liability Act (1980), as amended by the Superfund

Amendments and Reauthorization Act (1986), and other

congressional mandates.

The goal of the SITE Program is to evaluate

demonstrations of innovative or alternative technologies

to provide performance, cost, and applicability

information for cleanup decision making.

Assists in the development and use of innovative

treatment and monitoring and measurement technologies.

Provides environmental decision makers with data on new,

viable treatment technologies. Assists in the

introduction of new environmental technologies into the

commercial marketplace.

Technologies are field tested on hazardous waste

materials. Engineering and cost data are gathered on the innovative technology so that potential users can assess the applicability of the technology to a particular site.

Technology evaluations are performed with SITE Program

oversight. Testing protocols are developed by EPA using

Agency quality assurance protocols with input from all

technology developers and other stakeholders.

364
Inspection The SITE Program is responsible for assurance of the

quality of the final product(s) of the demonstration.

Conformity

Identification

Final reports

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

This program is conducted on a voluntary basis

N/A.

None, though this information is accepted by other state

and federal government agencies.

Based on test protocols established by the SITE Program.

soil treatment technologies; hazardous waste site

cleanup; groundwater treatment technologies;

environmental remediation technologies; innovative

treatment technologies; measuring and monitoring

technologies.

365
Products or

Services

Received 1/98

LABELING FOR HOUSEHOLD PRODUCTS (Indoor Insecticides

Outdoor House and Garden Pesticides, Household Hard

Surface Cleaners)

Department/Agency Environmental Protection Agency (EPA)

Address to send comments:

Office of Pollution Prevention and Toxics

Document Control Officer (7407)

Attention: AR-139. Consumer Labeling Initiative

401 M Street, SW

Washington, DC 20460

Address to obtain additional information:

Mary F. Domini ak

Office of Pollution Prevention and Toxics

Chemical Control Division (7405)

401 M Street, SW

Washington, DC 20460

Phone: (202) 260-7768

FAX: (202) 260-1096

e-mail : consumer. label @epamail .epa.gov

URL address: http://www.epa.gov/opptintr/labeling

Initiated

Compliance

Aim

1996

Voluntary

To foster pollution prevention, empower consumer choice

and improve understanding by presenting clear,

consistent, and useful health, environmental, and safe

use information on household consumer product labels.

Benefits Label information is easier for consumers to find

and understand.

read

Methodology Joint project with industry to collect and use consumer

research data to make label information more

understandable and useful.

Testing N/A.

366
Inspection N/A.

Conformity

Identification

None

Availability

of Documentation

See URL address for additional information or contact

EPA at the address listed above.

Obligations of the Participants agree to make voluntary label changes on Manufacturer/Vendor household products in an effort to improve labels.

Enforcement Voluntary programs. Participants may withdraw from the

program.

Term N/A.

Reciprocity EPA has been cooperating with the Consumer Product

Safety Commission, the Federal Trade Commission, the

Food and Drug Administration and other state agencies in

this effort.

Standards, Codes or Regulations

Changes are being made based primarily on the results of

research efforts rather than standards. Initial

research findings were published in the "Consumer

Labeling Initiative Phase I Report" dated 9/30/96.

Additional research is planned.

Keywords consumer products; insecticides; labeling; pesticides;

household cleaners

367
Products or

Services

Received 6/98

IT: TVs; VCRs; HEATHS,

G EQUIPMENT/ SYSTEMS;

; EXIT SIGNS:

TAR PROGRAM

Department/Agency U.S. Environmental Protection Agency (EPA)

Atmospheric Pollution Prevention Division

Mail Code (6202J)

401 M Street, SW

Washington, DC 20460

Phone: (202) 564-9019 or 1-888-STAR-YES (1-888-782-7937)

FAX: (202) 565-2134

e-mail: fanara.andrew@epa.gov

URL address: http: //www. energystar.gov

NOTE: This program is conducted jointly with the U.S.

Department of Energy (DOE). See also DOE Energy Star

entry.

Initiated 1992 for personal computers; 1993 for printers: 1994 for

fax machines and combination printer/fax machines and

retrofit power management equipment; 1995 for new homes

and photocopiers; 1997 for scanners and multi -function

devices; 1998 for TVs and VCRs.

Compliance

Authority

Aim

Benefits

Voluntary.

Clean Air Act; Pollution Prevention Act of 1990;

Framework Convention on Climate Change; Global Climatic

Protection Act of 1987; Climate Change R&D Act of 1990.

Reduce energy consumption through the voluntary

development of more energy-efficient appliances.

Helps consumers buy products that use less energy and

raises awareness about environmental and economic

benefits of energy efficient products.

Methodology The EPA and the DOE work together to promote the use of

energy-efficient equipment by awarding the Energy Star

label to products that save energy. The agencies set

energy-efficient criteria for specific consumer and

commercial products. These criteria exceed the minimum

national efficiency standards, where such standards

368
exist. Manufacturers or retailers volunteer to place

the Energy Star label on those models that meet or exceed the criteria set by EPA and DOE.

Testing Participant or independent third party agree to perform

tests, as necessary, to determine which products comply.

Inspection N/A.

Conformity

Identification

Energy Star label

Availability

of Documentation

See information listed at the above URL address

Obligations of the

Manufacturer/ Vendor

See Methodology.

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Revocation of right to use the Energy Star label.

Indefinite term.

None, though program is recognized by many states,

utility companies and retailers who cooperate in

promoting the program.

In order for a product to be labeled as Energy Star

compliant, that product must meet standards as set forth

by the Energy Star program. Product specifications vary

from product to product.

Energy Star; office equipment; personal computers;

printers; fax machines; photocopiers; scanners; multifunction devices; appliances; dishwashers; clothes

dryers; refrigerators; heating, ventilating, and air

conditioning equipment/systems; room air conditioners;

residential light fixtures; transformers; new homes;

exit signs; TVs; VCRs

369
Products or

Services

ENERGY STAR BUILDINC

Received 8/98

LIGHTS PARTO

FIRMS WITH ENERGY EFFICIENT LIGHTING

Department/Agency U.S. Environmental Protection Agency (EPA)

Manager, Energy Star Buildings and Green Lights

Partnership

Atmospheric Pollution Prevention Division

401 M Street. SW (6202J)

Washington, DC 20460

Phone: (202) 775-6650 or 1-888-star-yes

FAX: (202) 564-2083

Fax-back system: (202) 564-8659

URL address: http://www.epa.gov/buildings

Initiated

Compliance

Authority

1991

Voluntary.

Energy Policy Conservation Act (EPCA) as amended

P.L. 94-163. 89 Stat. 917, 42 U.S.C. 6295.

Aim To promote strategic energy management through

investment in profit-based, energy-efficient building

upgrades.

Benefits Creates a cleaner environment by reducing pollutants

released into the environment and reduces energy costs

Methodology Participants sign a Memorandum of Understanding (MOU)

with EPA in which participants agree to survey their

facilities and upgrade square footage that can be

upgraded profitably without compromising workspace

quality or comfort. Participants also agree to appoint

an implementation manager to oversee their progress in

the program and report at least annually to EPA on their

upgrade progress.

Testing N/A.

Inspection

Conformity

Identification

N/A.

Green Lights and ENERGY STAR Buildings program logos

370
Availability See information at the above URL address.

of Documentation

Obligations of the See Methodology.

Manufacturer/ Vendor

Enforcement Revocation of right to use the program logo or withdrawal from program.

Term

Reciprocity

Participants have 7 years to complete their requirements

for upgrade.

None, though program is recognized by many states,

utility companies and retailers who cooperate in

promoting the program.

Standards, Codes

or Regulations

EPA provides a range of participant support programs

which include: technical manuals, software analysis and

planning tools, and related publications.

Keywords building; energy efficiency; green lights; lighting

371
Products or

Services

Received 3/98

TOXIC AIR POLLUTANTS (Pollutants Known or Suspected to

Cause Serious Health Problems. See Also Industry

Specific EPA Programs. Includes Consumer Products

containing CFCs and Related Chemicals Identified in the

1990 Clean Air Act)

Department /Agency U.S. Environmental Protection Agency

Office of Air Quality Planning and Standards (MD-6205J)

401 M Street, SW

Washington, DC 20460

Stratospheric Ozone Information Hotline: 1-800-296-1996

or (202) 775-6677

Phone: (202) 564-9101

FAX: (202) 565-2096

URL address: http: //www/epa .gov/ttn/uatw/basi cfac.html

http : //www. epa . gov/oaqps/peg_caa/pegcaa07 . html

http : //www . epa . gov/docs/ozone/ i ndex . html

Initiated

Compliance

Authority

Varies by toxic pollutant and source.

Mandatory.

Clean Air Act as amended in 1990. Section 112 lists 188

toxic air pollutants to be regulated by EPA.

Aim

Benefits

Methodology

To reduce the risk to human health and the environment

by establishing and enforcing requirements designed to

reduce the level of toxic emissions.

Reduction in the potential release of toxic pollutants.

In general, compliance is assessed during inspections by

EPA or and EPA designee. Requirements placed on the source of the pollutant include: emission limits;

implementation of ongoing monitoring and work practice

standards: recordkeeping; initial testing; and periodic

reporting. Permits may be required for larger potential sources of air pollutants. EPA also approves state

implementation plans (SIPS).

As of May 1993, consumer products containing CFCs and

related chemicals identified in the 1990 Clean Air Act

as most damaging to the ozone layer are required to bear

a warning label. All products containing less

372
r

destructive ozone destroying chemicals (HCFCs)

identified in the Act must bear a warning label by 2015

unless otherwise accelerated by the Administrator. In

addition EPA is authorized to issue regulations for

product categories, starting with the worst polluters.

Labeling, repackaging, chemical formula changes, fees or other procedures may be used to reduce VOC releases.

Testing EPA, EPA designee, or regulated party depending on toxant and source.

Inspection EPA or and EPA designee.

Conformity

Identification

Permits issued by the states or EPA will be required.

The permit must contain information on which pollutants

are being released, how much may be released, and what

kinds of steps the source's owners or operator are taking to reduce pollution, including plans to monitor

the pollution. Consumer products containing ozone destroying chemicals other than HCFCs will bear a warning label

.

Availability

of Documentation

See information at the above URL address

fact sheets are available at

http : //www . epa . gov/chemfact

.

In addition

Obligations of the

Manufacturer/ Vendor

See Methodology.

Enforcement EPA can: (1) take an informal action, such as a notice

of violation or warning letter; (2) issue a field

citation for minor violations; (3) issue a formal

administrative response, such as an administrative

penalty order; (4) initiate a civil judicial response;

(5) initiate a criminal judicial response; or (6) list a company so that it will not receive federal contracts.

Under the 1990 Clean Air Act, EPA was also given

authority to fine companies for violating the Act. For

additional information on enforcement. See Environmental

Enforcement: a Citizens Guide.

Term

Reciprocity

Usually not applicable. Monitoring is ongoing.

None. EPA's requirements are the minimum applicable

requirements. Some states may have stricter

requirements in place.

373
Keywords air pollutants; carburetor sprays; choke sprays;

consumer products; foam plastic products; hair sprays

HCFCs; lead; paints; pollutants; toxic substances

374
Products or Services

Department/Agency

Initiated

Compliance

Authority

Not Received

(See Also HUD Entry for Lead Paint Disclosure)

U.S. Environmental Protection Agency

Office of Pollution Prevention and Toxics (OPPT)

National Program Chemical Division

Lead, Heavy Metals, and Inorganics Branch Programs

401 M Street, SW

Washington, DC 20460

Phone: (202) 260-1878

FAX: (202) 260-0018

National Lead Information Clearinghouse: 1-800-424- 1 ead

URL address: http://www7epa.gov/opptintr/lead/

1996.

Mandatory.

Section 1018 (LBP Disclosure Rule) of Title IV of the

Toxic Substances Control Act (TSCA). Also TSCA Section

402/404 for federal training and certification programs

authority. The Residential Lead-Based Paint Hazard Act

of 1992.

Aim

Benefits

To ensure family health by reducing lead exposure.

Reduction of lead exposure, which is considered by EPA

to be a major public health treat. Lead poisoning in

young children can produce permanent damage to the brain

and may cause reductions in intelligence and behavioral

problems. It also can have deleterious health impacts

on pregnant women and interfere with the formation of

red blood cells.

Methodology Disclosure of known information on lead-based paint

and/or lead-based paint hazards is required before the

sale or lease of housing built before 1978. Sellers

must permit the purchasers a 10-day period in which to

conduct an inspection or risk assessment for the

presence of lead-based paint and/or lead based paint

hazards. Sales contract must also include a lead

Warning Statement, signed by the purchaser or lessor.

Training and certification standards for contractors

providing lead hazard evaluation and abatement services

are still under development.

375
Testing This Rule does not require any testing or removal of

lead-based paint by sellers or landlords.

Inspection Inspectors are selected by the purchaser.

Conformity

Identification

Disclosure is required.

Availability

of Documentation

Contact the National Lead Information Center at the

phone number listed above or review the information at

the above URL address.

Obligations of the

Manufacturer/ Vendor

See Methodology.

Enforcement EPA can: (1) take an informal action, such

of violation or warning letter; (2) issue

citation for minor violations; (3) issue a administrative response, such as an admini

penalty order; (4) initiate a civil judici

(5) initiate a criminal judicial response;

company so that it will not receive federa

Under the 1990 Clean Air Act, EPA was also

authority to fine companies for violating

additional information on enforcement, See

Enforcement: a Citizens Guide.

as a notice

a field

formal

strative

al response;

or (6) list a

1 contracts.

given

the Act. For

Environmental

Term

Reciprocity

Not applicable.

None. EPA's requirements are the minimum applicable

requirements. Some states may have stricter

requirements in place.

Standards, Codes

or Regulations

TSCA Section 403 directs EPA to establish criteria for

identifying lead-based paint hazards. EPA is currently

in the process of establishing such standards.

Keywords disclosure; housing; lead; paints; toxic substances

376
Products or

Services

Not Received

CT CLEANING MACHINES

(Degreasers - Generally Used to Dry Materials and Remove

Soils, such as Grease, Wax and Oil from Metal Parts,

Circuit Boards, Sheet Metal, Assemblies, and Other

Materials) AID FROM DRY CLEANING MACHINES

Department/Agency U.S. Environmental Protection Agency

Office of Air Quality Planning and Standards

Emission Standards Division

Research Triangle, NC 27711

Phone: (919) 541-5572

FAX: (919) 541-2464

URL address: http://www7epa.gov/ttn/uatw/basi cfac.html

Initiated 1993 (dry cleaning machines) and 1995 (solvent cleaning

machines)

.

Compliance

Authority

Mandatory.

Clean Air Act as amended in 1990. Section 112 lists 188

toxic air pollutants to be regulated by EPA.

Aim To set standards requiring owners and operators of batch

cold cleaning machines and dry cleaning machines to

implement procedures designed to control the release of

halogenated solvents and percs. Regulations require the

use good housekeeping practices and efficient, wellcontrolled cleaning machines.

Benefits Reduction in the potential release of halogenated

solvents or perc.

Methodology All owners and operators of solvent cleaning machines

and all dry cleaners who use perc in both transfer and

dry-to-dry machines must implement specific process

control procedures and worker practices. All new and some existing dry cleaning machines must be equipped

with at least a refrigerated condenser used as a perc

vapor recovery system. Compliance is assessed during

inspections by EPA or and EPA designee. Recordkeeping

requirements are also imposed by the EPA. Agency also

approves State Implementation Plans (SIPS).

Testing EPA or and EPA designee may, during the course of an inspection, request a solvent machine operator to pass a

377
written test. Refrigerated condensers and carbon

adsorbers used for control equipment must also be

tested.

Inspection

Enforcement

Term

Reciprocity

Keywords

EPA or and EPA designee.

EPA can: (1) take an informal action, such as a notice

of violation or warning letter; (2) issue a field

citation for minor violations; (3) issue a formal

administrative response, such as an administrative

penalty order; (4) initiate a civil judicial response;

(5) initiate a criminal judicial response; or (6) list

company so that it will not receive federal contracts.

For additional information on enforcement, See

Environmental Enforcement: a Citizens Guide.

N/A.

None. EPA's requirements are the minimum applicable

requirements. Some states may have stricter

requirements in place.

halogenated solvent; cleaning machines; degreasers;

solvent cleaning machines; dry cleaning machines

378
Products or

Services

:r enu

If? TAMI

Received 12/97

ILECTR0PLAT1IG AMD

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Methodology

Testing

Inspection

U.S. Environmental Protection Agency

Office of Air Quality Planning and Standards

Emission Standards Division (ESD)

Organic Chemical Group (OCG) (MD-13)

Research Triangle Park, NC 27711

Phone: (919) 541-5420

FAX: (919) 541-2464

URL address: http: //www/epa .gov/ttn/uatw/basicfac. html

1995,

Mandatory.

Clean Air Act as amended in 1990. Section 112 lists 188

toxic air pollutants to be regulated by EPA.

To set standards requiring owners and operators of

electroplating and anodizing tanks to implement

procedures designed to control the release of chromium.

Regulations require the use good housekeeping practices

and efficient, wel 1 -control led electroplating

operations

.

Reduction in the potential release of chromium.

All owners and operators of chromium electroplating and

anodizing tanks must implement specific process control

procedures and worker practices. Compliance is assessed

during inspections by EPA or and EPA designee. The

regulation requires: emission limits; implementation of

ongoing monitoring and work practice standards:

recordkeeping: initial testing; and periodic reporting.

Agency also approves state implementation plans (SIPS).

Performed by the plater or anodizer and monitored by the

EPA or its designee.

EPA or and EPA designee.

379
Enforcement EPA can: (1) take an informal action, such as a notice

of violation or warning letter; (2) issue a field

citation for minor violations; (3) issue a formal

administrative response, such as an administrative

penalty order; (4) initiate a civil judicial response;

(5) initiate a criminal judicial response; or (6) list

company so that it will not receive federal contracts.

For additional information on enforcement. See

Environmental Enforcement: a Citizens Guide.

Term

Reciprocity

N/A. Ongoing monitoring is required.

None. EPA's requirements are the minimum applicable

requirements. Some states may have stricter

requirements in place.

Keywords anodizing; electroplating; tanks; anodizing tanks;

electroplating tanks; chromium; plating

380
Products or

Services

Not Received

ASBESTOS M1TI6ATI0I SERVICES AID

Department/Agency

Initiated

Compliance

Authority

Environmental Protection Agency (EPA)

Office of Air Quality Planning and Standards (MD-13)

Office of Air Quality Planning and Standards

Emission Standards Division (ESD)

Research Triangle, NC 27711

Phone: (919) 541-5572

FAX: (919) 541-2464

URL address: http://www/epa.gov/iaq/asbestos.htm

1973.

Mandatory

Clean Air Act as amended in 1990. Section 112 lists 188

toxic air pollutants to be regulated by EPA.

National Emissions Standard for Hazardous Air Pollutants

(NESHAP) for asbestos as revised in 1990.

Aim To control asbestos emissions from various mitigation

sources.

Benefits Reduction in the environmental and health risks

associated with asbestos emissions.

Methodology

Testing

Standards, Codes

or Regulations

Keywords

Agency approves state implementation plans (SIPS).

A list of EPA approved laboratories is available from:

NIST, NVLAP, Bldg. 820. Room 282, Gaithersburg . MD

20899 or by calling (301) 975-4042.

National Emissions Standard for Hazardous Air

Pollutants (NESHAP) for asbestos as revised in 1990.

air pollutants; asbestos: emissions; mitigation;

pollutants; toxics

381
Products or Services

Pece" /ed Vti ril

Initiated

Compliance

Authority

Aim

U.S. Environmental Protection Agency

Office of Air Quality Planning and Standards

Emission Standards Division (ESD)

Organic Chemical Group (OCG) (MD-13)

Research Triangle Park, NC 27711

Phone: (919) 541-5616

FAX: (919) 541-2464

URL address: http://www/epa.gov/oar/oaqps/

1995.

Mandatory.

Clean Air Act as amended in 1990.

To reduce the risk to human health and the environment

by establishing and enforcing requirements designed to

reduce acid rain.

Benefits

Methodology

Reduction in acid rain.

Phase I of the acid rain reduction program went into

effect in 1995. Big coal burning boilers in 100 power

plants in 21 Midwest, Appalachian, Southeastern and

Northeastern states reduced releases of sulfur dioxide.

In 2000, Phase II of the acid rain program goes into

effect, further reducing sulfur dioxide releases from

coal burning plants and covering other smaller

polluters. Reductions in Sulfur dio/ide releases will

be obtained though a program of emission (release)

allowances. EPA issued allowances to power plants

covered by the acid rain program; each allowance is

worth one ton of sulfur dioxide pollution released from

the smokestack. To obtain reductions, allowances are

set below 1980 levels of releases. Plants may only

release as much as they have allowances to cover. If a plant expects to release more sulfur dioxide than it has

allowances, it has to get more allowances, perhaps by

buying them from another power plant that has reduced

its sulfur dioxide releases below its number of

allowances and therefore has allowances to sell or trade. Allowances can also be bought and sold by

382
"middlemen," such as brokers. Stiff penalties will be

imposed for plants which release more pollutants than

their allowances cover. The acid rain program provides

bonus allowances to power plants for (among other

things) installing clean coal technology, using

renewable energy sources, or encouraging energy

conservation by customers so that less power needs to be

produced. All power plants have to install continuous

emission monitoring systems (CEMS) to track how much

sulfur dioxide and nitrogen oxides the plant is

emitting. A power plant's program for meeting its

sulfur dioxide and nitrogen oxide limit will appear on the plant's permit, which will be filed with the state

or EPA. EPA will also require power plants to reduce

their nitrogen oxide releases.

Testing See Methodology.

Inspection

Conformity

Identification

See Methodology.

See Methodology.

Availability Additional information is available from the appropriate

of Documentation state authority or from EPA.

Obligations of the See Methodology.

Manufacturer/ Vendor

Enforcement EPA can: (1) take an informal action, such as a notice

of violation or warning letter; (2) issue a field

citation for minor violations; (3) issue a formal

administrative response, such as an administrative

penalty order; (4) initiate a civil judicial response;

(5) initiate a criminal judicial response; or (6) list a company so that it will not receive federal contracts.

Under the 1990 Clean Air Act. EPA was also given

authority to fine companies for violating the Act. For

additional information on enforcement, See Environmental

Enforcement: a Citizens Guide.

Term Usually not applicable. Monitoring is ongoing.

Reciprocity None. EPA's requirements are the minimum applicable

requirements. Some states may have stricter

requirements in place.

383
Standards. Codes Standards are established by EPA in conjunction with the

or Regulations states.

Keywords acid rain; boilers; power plants; toxic substances; air

pollutants; pollutants; sulfur dioxide

384
EPA IMMX

Product Page

agricultural worker safety 351

air conditioners, motor vehicle 333

air pollutants 372

air conditioners/systems 368

anodizing tanks 380

antimicrobial products (pesticides) 353

appliances 368

asbestos mitigation services 381

automobile engines 323

automobile emissions 317, 321, 323, 327

automobiles, low emission 327

automotive parts 321

automotive cleaning sprays 372

aviation vehicle engines, off-road 329

boat engines 329

boilers for hazardous waste 337

boilers, coal burning 382

buildings, office 370

buses 325

carburetor sprays 372

CFCs 333, 372

child resistant packaging (pesticides) 358

choke sprays 372

cleaner labeling (household hard surface) 366

cleaning machines, toxic air emissions 377

clothes dryers 368

computers, personal 368

construction vehicle engines, off-road 329

consumer product labeling 366

consumer products 372

defoliants 355

degreasers 377

diesel engines 323, 325, 329

385
diesel trucks 325

dishwashers 368

drinking water systems, operators of 347

dry cleaning machines, toxic air emissions 377

electroplating, chromium 380

emissions, vehicle testing/inspection 331

emissions, nonroad vehicle engine 329

energy efficiency 368, 370

engines, off-road vehicle 329

environmental technologies, new 362, 364

environmental preferabi 1 ity for government procurement 319

exit signs 368

foam plastic products 372

fuel additives 317

fuels, motor vehicle 317

fungicide applicators 349

fungicides 353. 355, 358

furnaces, industrial for hazardous waste 337

gasoline engines 323. 325. 329

gasol ine 317

green labeling 319

green lights 370

hair sprays 372

hazardous waste facilities 339, 341

hazardous substances storage 335

hazardous waste combustion facilities 337

heaters, wood 343

heating appliances/systems 368

homes, new 368

housing, new 368

housing (lead) 376

incinerators for hazardous waste 337

insect repel lants 355

insecticide applicators 349

insecticides 353, 355, 358

laboratory accreditation 345

lamps 368

lead 372, 375

lighting, energy efficient 370

lighting systems 368, 370

locomotive engines 329

marine vehicle engines, off-road 329

386
motorcycle engines 323

office equipment/buildings 368, 370

outdoor power equipment engines 329

packaging, pesticide 358

paints 372, 375

pesticide safety for workers 351

pesticide labeling 366

pesticide applicators 349

pesticides 353, 355, 358

petroleum underground storage tanks 335

plating 380

pollution control /monitoring/remediation systems, new-362, 364

pool chemicals, swimming 355

power plants 382

procurement, government 319

radon 360

recreational vehicle engines 329

refrigerators 368

rodenticides 353. 355, 358

solid waste disposal 339

solvents 377

storage tanks, underground 335

stoves, wood 343

tanks, underground storage 335

tanks, electroplating 380

televisions 368

termiticide applicators 349

termiticides 353, 355, 358

toxic substances, air 372, 375, 376, 377, 380, 381, 382

transformers 368

truck engines 323

trucks, light low emission 327

trucks, diesel 325

USTs 335

VCRs 368

vehicle engines, off-road 329

vehicle emissions 317, 321, 323, 325, 327

vehicle inspection programs 331

vehicle engines 323, 329

vehicle, motor fuels 317

vehicle emissions testing/inspection 331

vehicle air conditioners 333

387
vehicles, low emission 327

vehicles, off-road 329

waste disposal, hazardous 341

waste storage and disposal facilities 339

waste treatment facilities, solid 339

waste treatment facilities, hazardous 341

water, drinking 345

water system operators 347

weed killers --- 355

wells, injection (hazardous waste) - --339, 341

wood heaters 343

wood stoves 343

workplace safety (pesticides) 351

388
I FEiE^L CMU1IOTWS CWfflSSIWil

389
Products or

Services

Received 7/98

ELECTRICAL AID ELECTRONIC DEVICES/EQUIPMENT THAT

GENERATE RADIO FREQUEICY EIERGY

Department/Agency Federal Communications Commission (FCC)

Office of Engineering and Technology (OET)

Equipment Authorization Division

7435 Oakland Mills Road

Columbia, MD 21046

Phone: (301) 725-1585

FAX: (301) 344-2050

URL address: http://www.fcc.gov/oet

Initiated

Compliance

Authority

Radio frequency electromagnetic fields requirements

questions should be addressed to:

FCC

Office of Engineering and Technology

2000 M Street. NW. Suite 480. MS 1300

Washington. DC 20554

Phone: (202) 418-7506

FAX: (202) 418-1944

URL address: http: //www/ fcc.gov/oet/rfsafety/

1940 (Marine equipment was the earliest type approved)

The FCC has recently made major changes in their

regulatory requirements and more changes are anticipated.

Mandatory.

Federal Communications Act of 1934 as amended.

National Environmental Policy Act of 1969.

Telecommunications Act of 1996: P.L. 104-104. 110 Stat

56.

47 CFR Parts 1 and 2.

Aim To reduce uncontrolled radio frequency interference

first observed in connection with medical diathermy

equipment in the 1940' s and to prevent harmful

interference to authorized radio communications. The

FCC has recently adopted streamlining actions to (1)

simplify the existing equipment authorization process,

390
(2) move to a system of electronic filing of equipment

authorization applications, and (3) deregulate and relax

equipment authorization requirements for a wide number

of types of equipment that have demonstrated a good

record of compliance.

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.

Equipment authorization ensures that radio transmitters

and other equipment meet standards to minimize their

potential to cause interference to radio services. The

equipment authorization process is based on a written

application and test results submitted by the

manufacturer or other responsible party. FCC acts on applications for three types of equipment authorization

procedures: Certification, where applications are sent

to the FCC; and Declaration of Conformity and

Verification, which are based on manufacturer selfauthorizations. FCC evaluates new products submitted

for equipment authorization, determines interference

risk, and decides how rules apply. FCC also designs

test procedures for equipment subject to FCC regulations

in cooperation with industry.

Procedures used reflect the requirements of particular

categories of equipment which are summarized here:

Certification

-Applies to some compulsory installed marine

safety-of-life equipment, 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 960 MHz, personal computers and

peripherals, citizen band receivers, and some other

kinds of industrial, scientific and medical equipment.

-Manufacturers submit a written application for review

and approval by the FCC, which includes a description of

the product and a test report showing compliance with

applicable FCC technical requirements.

391
-approval is 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.

Verification

-Applies to non-consumer devices, including business

computers; computing devices except personal computers,

personal peripherals and exempt computing devices

(Section 15.103); FM broadcast and television broadcast

receivers; and ship earth stations. May also apply to

transmitters used in certain licensed services under

Parts 5. 73. 74. 78. 80. 87 and 101.

-Manufacturer submits brief application for

authorization of device. Application is not required to

include test data, though manufacturer must test product

to determine compliance with applicable technical

requirements. Manufacturer need not issue a Declaration

of Conformity (DoC) or use an accredited laboratory.

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

data

-No grant of authorization is issued by FCC.

Declaration of Conformity (DoC)

-Applies to personal computer equipment and peripherals;

television interface devices (including video cassette

recorders (VCRs); cable system terminal devices (CSTDs)

and other types of television receivers); industrial,

scientific and medical equipment (ISM); and radio

receivers (except scanning receivers). May also apply

to transmitters used in certain licensed services under

Parts 5, 73, 74, 78, 80. 87 and 101.

392
-Requires manufacturer to test the equipment for

compliance with applicable FCC requirements and to issue

a Declaration of Conformity (DoC). Testing must be done

in an accredited laboratory. ISM equipment may be

tested in laboratories currently accredited to conduct

Part 15 testing until a laboratory accreditation program

is established for ISM equipment. No testing is

required for product assembled from authorized modular

components.

-Devices must be labeled with the FCC logo (for Part 15

and 18 equipment) as a demonstration of compliance with

FCC requirements. Manufacturers must also include a short compliance statement to ensure the continued

interference-free operation of the device by the user.

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

data

.

-No grant of authorization is issued by FCC.

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Depending upon the type of approval sought, testing may

be performed by:

-FCC laboratory.

-Manufacturer's laboratory.

-Third party laboratory.

FCC recognizes laboratories accredited by NIST's NVLAP

program and by A2LA as well as laboratories accredited

by foreign national accreditors who are parties to

mutual recognition agreements with NVLAP or A2LA.

Agency does not inspect production facilities.

FCC logo is required for some products. Agency

maintains lists of producers of approved products.

The list of approved equipment may be

purchased from:

Public Record Duplication

International Transcription Services

Suite 140

2100 M Street, NW

Washington. DC 20037

Phone: (202) 857-3800

393
Obligations of the Maintain design of approved equipment. Explain

Manufacturer/Vendor maintenance requirements to users. Submit FCC sample

requests with 14 days. After July 1999, manufacturers

will be required to file applications electronically.

Certain applicants for use of FCC regulated transmitters

are required to routinely perform an environmental

evaluation with respect to determining compliance with

FCC RF electromagnetic exposure limits.

Marketing ban.

Indefinite term.

See Testing.

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 Criteria promulgated by FCC; private sector standards or Regulations are considered in preparing rules.

Keywords broadcast equipment; cable TV equipment; certification;

communications equipment; computer peripherals;

computers; medical electronics; radio frequency energy;

transmitters; TV equipment; type approval; digital

television; advanced television

Enforcement

Term

Reciprocity

394
Products or Services

Received 2/98

TELE I AND RADIO BROADCAST!

Department/Agency Federal Communications Commission (FCC)

Mass Media Bureau

1919 M Street, NW. Room 314

Washington, DC 20554

Phone: (202) 418-2600

FAX: (202) 418-2828

E-mail: mmbinfo@fcc.gov

URL address: http://www7fcc.gov/bureaus/html

Radio frequency electromagnetic fields requirements

questions should be addressed to:

FCC

Office of Engineering and Technology

2000 M Street, NW, Suite 480, MS 1300

Washington, DC 20554

Phone: (202) 418-2464

URL address: http: //www/fcc.gov/oet/rfsafety/

Compliance Mandatory,

Authority Federal Communications Act of 1934 as amended.

Telecommunications Act of 1996; P.L. 104-104, 110 Stat

56.

47 CFR Part 2, Subpart J.

Testing N/A,

Obligations of the Certain applicants for use of FCC regulated transmitters

Manufacturer/Vendor are required to routinely perform an environmental

evaluation with respect to determining compliance with

FCC RF electromagnetic exposure limits.

Term Indefinite term.

Reciprocity

Standards, Codes

or Regulations

None.

Criteria promulgated by FCC; private sector standards

are considered in preparing rules.

395
broadcasts; radio; radio stations; TV- television

television networks; televisions stations

396
Not Received

WIRELESS SERVICES (Includes: 229 MHz Radio Service.

Air-Ground Radiotelephone Service; Amateur Radio

Service; Aviation and Marine Services; Basic Exchange

Telephone Radio Service; Cellular Radiotelephone

Service; Commercial Operators; Interactive Video and

Data Service; Microwave Services; Offshore

Radiotelephone Service; Paging Services; Personal

Communications Services (PCS); Personal Radio Service;

Private Radio Service; Private Land Mobile Radio

Services; Public Safety Radio Services; Rural Radio

Telephone Service; Specialized Mobile Radio Service;

Wireless Communication Service (WCS)

Department/Agency Federal Communications Commission (FCC)

Wireless Telecommunications Bureau

1919 M Street, NW

Washington, DC 20554

Phone: (202) 418-0600 or National Call Center: 1-888-225-5322

FAX: (202) 418-2644

e-mail : callctr@nightwind.fcc.gov

or dphythyon@fcc.gov

URL address: http: //www/ fcc.gov/wtb

Radio frequency electromagnetic fields requirements

questions

should be addressed to:

FCC

Office of Engineering and Technology

2000 M Street, NW. Suite 480, MS 1300

Washington, DC 20554

Phone: (202) 418-7506

FAX: (202) 418-1944

URL address: http://www.fcc.gov/oet

Compliance Mandatory.

Authority Federal Communications Act of 1934 as amended.

National Environmental Policy Act of 1969.

Telecommunications Act of 1996; P.L. 104-104. 110 Stat.

56.

Products or

Services

397
Communications Assistance for Law Enforcement Act

(CALEA) of 1994.

47 CFR Parts 17, 22, Subpart J.

Aim To establish policies and requirements for all domestic

wireless telecommunications equipment/services (except

those involving satellite communications or broadcasting) in order to foster competition among

different services; promote universal service, public

safety, and service to individuals with disabilities;

maximize efficient use of the spectrum; and facilitate

innovative service and product offerings.

Benefits See Aim

Methodology Requires registration of antenna structures. (See WTB

Fact Sheet #15). Has established a Universal Licensing

System (ULS) for processing of applications for Part 22

paging licenses. Has established national wireless

tower siting policies in accordance with the

Telecommunications Act of 1996. Responsible for CALEA'j

requirements for telecommunications carriers to modify

their equipment, facilities, and services by 10/98 to ensure that they are able to comply with authorized

electronic surveillance.

Conformity

Identification

License for some products/services

Availability

of Documentation

See URL address listed above or contact offices listed

above for additional information.

Obligations of the Certain applicants for use of FCC regulated transmitters

Manufacturer/Vendor are required to routinely perform an environmental evaluation with respect to determining

compliance with FCC RF electromagnetic exposure limits.

Term Indefinite term.

Reciprocity None

Standards, Codes

or Regulations

Keywords

Criteria promulgated by FCC; private sector standards

are considered in preparing rules.

wireless services; private radio; cellular phones;

personal services; communications service; pagers

398
Products or

Services

Received 6/98

HIE TELEVISION AID RELATED SERVICE!

Department/Agency Federal Communications Commission (FCC)

Cable Services Bureau

1919 M Street. NW

Washington, DC 20554

Phone: (202) 418-7200

FAX: (202) 418-1198

URL address:

http : //www/fcc . gov/Bureaus/Cabl e/WWW/cab . html

Radio frequency electromagnetic fields requirements

questions should be addressed to:

FCC/OET

2000 M Street. NW, Suite 480, MS 1300

Washington, DC 20554

Phone: (202) 418-7506

FAX: (202) 418-1944

URL address: http://www.fcc.gov/oet

Initiated Rules for cable television were first established in

1965.

Compliance

Authority

Aim

Mandatory.

Federal Communications Act of 1934 as amended.

Cable Communications Policy Act of 1984 (1984 Cable

Act).

Telecommunications Act of 1996; P.L. 104-104. 110 Stat.

56.

Cable Television Consumer Protection and Competition Act

of 1992.

47 CFR Part 2, Subpart J.

To provide a single point-of-contact for cable and other

video distribution related issues before the FCC. The

Bureau is responsible for establishing policy and rules

regarding cable television and video distribution

services and enforcing those rules.

399
Benefits Promotes the availability to the public of cable

television and other video distribution services;

promotes competition in the video marketplace; ensures

growth and development in the video industry; and ensures reasonable rates for consumers in areas that do

not have competition to cable service.

Methodology Cable system operators must register cable systems with

the FCC and provide the FCC with the required

information. The FCC issues a public notice setting

forth the details of each registration statement as it

is received. The FCC has also established policies

regarding franchising requirements and fees, subscriber

signal quality standards, maximum sign leakage

requirements; and guidelines for customer service.

Unauthorized reception of cable services and

unauthorized cable carriage of broadcast stations are prohibited. Other requirements for cable television can

be found at the URL address listed above or in the CFR

reference.

There are also a variety of state and local laws for

cable television. State and local authorities may

select a cable franchisee and regulate in any areas that

the FCC does not preempt.

Conformity

Identification

Cable systems must be registered with the FCC.

Availability

of Documentation

See URL address listed above. Additional information

may also be obtained from the Cable Services Bureau at

the address listed above.

Obligations of the Certain applicants for use of FCC regulated transmitters

Manufacturer/Vendor are required to routinely perform an environmental

evaluation with respect to determining compliance with

FCC RF electromagnetic exposure limits.

Term Indefinite term.

Reciprocity None.

Standards, Codes

or Regulations

Criteria promulgated by FCC; private sector standards

are considered in preparing rules.

Keywords cable TV; cable television

400
Products or

Services

ITEf 110. TELECOMMUNICATE

Received 3/98

> AND SATELLITE

Department/Agency

Initiated

Compliance

Authority

Federal Communications Commission (FCC)

International Bureau

2000 M Street. NW

Washington, DC 20554

Phone: (202) 418-0420

FAX: (202) 418-2818

e-mail: ibinfo@fcc.gov

URL address: http: / /www/ fee. gov/ ib

Radio frequency electromagnetic fields requirements

questions should be addressed to:

FCC/OET

2000 M Street. NW. Suite 480. MS 1300

Washington. DC 20554

Phone: (202) 418-7506

FAX: (202) 418-1944

URL address: http://www.fcc.gov/oet

N/A.

Mandatory.

Federal Communications Act of 1934 as amended.

Telecommunications Act of 1996; P.L. 104-104. 110 Stat

56. 47 CFR Part 2. Subpart J. and Parts 23. 25. 64 and

65.

Aim

Benefits

To develop policy rules, procedures and standards for

licensing and regulation of satellite and earth stations

facilities, both domestic and international under Part

25; and the international fixed public radio program

under Part 23: and international telecommunications

facilities, services, and operators under relevant

portions of Parts 63 and 65.

Promotion of a high quality, reliable, globally

interconnected and interoperable international

infrastructure.

401
Methodology

Testing

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Processes license applications and special requests

under Part 25 for all space station and earth station

facilities, Part 23 for international fixed public radio

facilities, and under Parts 63 and 65 for international

telecommunications facilities and services.

N/A.

N/A.

Licenses

See 47 CFR Part 2, Subpart J, and Parts 23, 25. 63 and

65 as well as information on the website listed above.

Comply with the terms and conditions of their

authorizations/1 i censes.

Pursues enforcement action in conjunction with other

bureaus and offices.

Indefinite term.

The U.S. is a signatory to a number of different

agreements in this area.

Criteria promulgated by FCC; private sector standards

are considered in preparing rules.

earth stations; international radiocommuni cations;

Recognized Private Operating Agency; satellite

communications; satellites; telecommunications

402
FCC 1WMJ

Product Page

amateur radio service 397

broadcast equipment 390

broadcasts, TV and radio 395

cable television 390, 399

cable TV equipment 390

cellular radiotelephone service 397

communication services, wireless 397

communications, satellite 401

communications equipment 390

computers and related equipment 390

earth stations 401

electronics, medical 390

medical electronics 390

offshore radiotelephone service 397

pagers 397

radio frequency energy 390

radio communications, international 401

radio service, wireless 397

radio stations 395

radio broadcasts 395

radio-telephone service 397

receivers 390

satellite communications 401

telecommunications , international 401

telephone service, wireless 397

telephones and related equipment 390

television, cable 390, 399

television, satellite 401

television broadcasts 395

television networks 395

television equipment 390

television, digital /advanced 390

transmitters 390

TV 390, 395, 399

wireless communications services 397

403
E

in:,; I TWfiE COM:

404
Products or

Services

Received 6/98

CIGARETTES (Testing for "Tar," Nicotine and Carbon

Monoxide)

Department/Agency Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Advertising Practices

6th and Pennsylvania, NW

Washington, DC 20580

Phone: (202) 326-3090

FAX: (202) 326-3259

Initiated

Compliance

Aim

1966. Program was modified in 1987.

Voluntary.

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

and carbon monoxide machine smoking yields of

cigarettes.

Benefits

Methodology

See above.

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

Conformity

Identification

Availability

of Documentation

See above.

Advertisements are reviewed continually.

A report on the test results are published in the

Federal Register and provided to Congress.

A copy of the report is available from the FTC.

Reciprocity

Keywords

There are no reciprocal agreements.

carbon monoxide; cigarettes; CO; nicotine; tar; tobacco;

TPM

405
Products or

Services

Received 6/98

ADVERTISING

Department/Agency Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Advertising Practices

6th and Pennsylvania, NW

Washington, DC 20580

Phone: (202) 326-3090

FAX: (202) 326-3259

URL address: http://www.ftc.gov/ftc/consumer.htm

Authority The Federal Trade Commission Act.

Federal Cigarette Labeling and Advertising Act.

Comprehensive Smokeless Tobacco Health Education Act

Fair Credit Reporting Act.

Telephone Disclosure and Dispute Resolution Act.

Compliance

Aim

Mandatory.

To ensure that advertising is truthful and non deceptive; that advertisers have evidence to back up

their claims; and that advertisements are not unfair.

Note that additional laws/requirements apply to ads for

specialized products like consumer leases, credit, 900

telephone numbers, products sold through mail order or telephone sales, household appliances; automobiles;

funeral services, and tobacco. In addition, each state

has consumer protection laws that govern ads running in

that state.

Benefits

Methodology

See above.

The FTC looks at ads from the point of view of the

"reasonable consumer." The FTC looks at both "express"

and "implied" claims. The FTC also looks at what the ad

does not say -- that is, if the failure to include

information leaves the consumer with a misimpression

about the product. The FTC also looks at whether the

claim would be "material" -- that is, important to a consumer's decision to buy or use the product. Finally,

the FTC looks at whether the advertiser has sufficient

evidence to support the claims in the ad. The law

requires that advertisers have proof before the ad runs. The FTC pays closest attention to ads that make claims

406
about health or safety and claims that consumers would

have trouble evaluating for themselves. Although the

FTC has jurisdiction over ads for most products and

services, other government agencies also have authority

to investigate advertising by food and drug companies,

airlines, banks, insurance companies, telephone and

cable companies, and companies that sell securities and

commodities

.

Testing Not usually applicable.

Inspection Advertisements are reviewed continually.

Conformity N/A.

Identification

Availability See URL site for additional information.

of Documentation

Obligations of the

Manufacturer/ Vendor

Companies need to ensure that ads are not false or deceptive and that they have objective evidence that

supports their claims.

Enforcement Among the remedies that the FTC or the courts can impose

are: cease and desist orders, civil penalties, consumer

redress, and other monetary remedies, corrective

advertising, disclosures, and other informational

remedies, bans and bonds.

Term N/A.

Reciprocity There are no reciprocal agreements.

Keywords ads; advertising; advertisements; commercials;

endorsements; labels; product claims; testimonials

407
Received 6/98

Products or

Services

Department /Agency

RESIDENTIAL GONSUf E APPLIANCES. LIGHTING DEVICE!

AID COMMERCIAL EQUIPMENT

(See Also Department of Energy)

Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Enforcement

601 Pennsylvania Ave., NW

Washington, DC 20580

Phone: (202) 326-2996

FAX: (202) 326-3259

e-mai 1 : jmi 1 ls@ftc.gov

URL address: http://www.ftc.gov/ftc/consumer.htm

Initiated

Compliance

1980.

Mandatory for categories of covered products and

systems

Appliance manufacturers are required to label covered

appliances with information indicating their estimated

annual energy consumption or efficiency ratings and

related information. Manufacturers base required label

information on tests they perform using procedures

prescribed by DOE. There are also specific requirements

concerning the duty of appliance manufacturers to make

reports to the Commission, to maintain records and to

have substantiation for required disclosures or other

representations they make.

Manufacturers of fluorescent lamp ballasts must disclose

an encircled "E" on ballasts, luminaries containing

them, and packaging to signify compliance with DOE

minimum efficiency standards.

Manufacturers of showerheads, faucets, toilets, and

urinals must disclose, on the products, packaging and

labeling, the water usage of their products in gallons

and liters per flush, per minute, or per cycle.

Manufacturers of certain incandescent and fluorescent

bulbs must disclose, on packaging, the light output in

lumens, energy used in watts, voltage, average life, and

number of bulbs.

408
Manufacturers of certain tube-type fluorescent bulbs

must disclose on packages an encircled letter "E" to

show the bulb meets Federal minimum efficiency

standards. The manufacturers of these products are required to make reports to the Commission, to maintain

records and to have substantiation for the required

disclosures and for some of the other representations

they make.

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).

The National Appliance Energy Conservation Act, P.L.

100-12, 101 Stat. 103 (1987).

The National Appliance Energy Conservation Amendments of

1988, P.L. 100-357, 102 Stat. 671 (1988).

The Energy Policy Act of 1992, P.L. 102-486, 106 Stat.

2776 (1992).

16 CFR Part 305 (Rule Concerning Disclosures Regarding

Energy Consumption and Water Use of Certain Home

Appliances and Other Products Required Under the Energy

Policy and Conservation Act ("Appliance Labeling

Rule")).

To encourage consumers to comparison shop for energy

efficient household appliances, fluorescent lamp

ballasts, pool heaters, lighting products, and plumbing

products in order to reduce the amount of energy and/or

water they use in their homes.

The availability of energy consumption or efficiency

information should enhance consumer demand for products

that save energy. In turn, competition should be

generated among manufacturers to meet this demand by

producing more energy efficient products. Consumers

will be able to save money by reducing their energy

costs and can help to promote the national goal of

energy conservation.

Following rulemaking proceedings as required by EPCA,

the FTC has adopted labeling rules for several product

categories. The appliance (and pool heater) labels give consumers the estimated yearly energy consumption or energy efficiency of competing products before they buy

an appliance. Appliance labels also provide consumers

with a range of estimated annual energy consumption or

409
efficiencies for comparable appliances. The FTC

prescribed the required layout, type size, setting,

colors, paper stock, and contents of the appliance

labels. Under the EPCA, only appliances for which the

Department of Energy 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. FTC representatives are allowed to observe any appliance testing required by the

Rule and to inspect the results of the testing, if they

so request. The Rule's requirements for other covered

products vary. Manufacturers of fluorescent lamp

ballasts must disclose an encircled "E" on ballasts,

luminaries containing them, and packaging. The "E"

signifies compliance with DOE minimum efficiency

standards. Manufacturers of showerheads, faucets,

toilets, and urinals must disclose, on the products,

packaging and labeling, the water usage of their

products in terms of gallons and liters per flush, per

minute, or per cycle. Manufacturers of certain

incandescent and fluorescent bulbs must disclose, on packaging, the light output in lumens, energy used in

watts, voltage, average life, and number of bulbs.

Manufacturers of certain tube-type fluorescent bulbs

must disclose on packages an encircled letter "E" and a statement that the "E" logo means the bulb meets Federal

minimum efficiency standards.

Testing Commercial lab.

Manufacturer's lab.

Inspection Government.

Conformity The FTC's Appliance Labeling Rule mandates a disclosure

Identification scheme (in the form of labels for appliances and other

marking requirements for certain other products) for

energy consumption, energy efficiency, or water

consumption. All appliance energy labels for each

category of covered appliance use the same size, colors

and typefaces with consistent positioning of headline,

copy and charts. All disclosures for the other products

covered by the Rule must provide identical information

in a prescribed format for all such products. Such

uniformity in the disclosure format facilitates

immediate consumer recognition and readability.

410
Avail ability The ranges of estimated annual energy consumption or of Documentation efficiency ratings for each covered appliance product 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. Ranges do not appear in the

disclosures required for covered products other than

appliances and pool heaters.

The Appliance Labeling Rule is published in the CFR.

See the URL site for additional information.

Enforcement The FTC can sue violators of the Appliance Labeling Rule

in Federal court. The court can impose civil penalties

of up to $11,000 for each violation and can issue an order prohibiting further violations, and other relief,

such as redress, if appropriate.

Term Indefinite term.

Reciprocity The FTC's Appliance Labeling Rule is recognized by other

federal agencies, state agencies, and private sector

organizations

.

Standards, Codes

or Regulations

Keywords

Standard test procedures are prescribed by the DOE.

See 10 CFR Part 430, 10 CFR Part 431 (currently under

development). Label format is prescribed by the FTC.

appliance labeling; energy efficiency rating; energy

conservation; estimated annual energy cost; appliances;

boilers; central air conditioners; clothes dryers;

clothes washers; codes; commercial package air

conditioning and heating equipment; consumer products;

direct heating equipment; dishwashers; electric motors;

energy efficiency; EPACT; EPCA; faucets; showerheads

;

water closets; urinals; fluorescent lamp ballasts;

furnaces; general service fluorescent lamps;

incandescent reflector lamps; kitchen ranges and ovens;

lighting; mobile home furnaces; NAECA; packaged terminal

air conditioners and packaged terminal heat pumps; pool

heaters; refrigerators; refrigerator-freezers; freezers; room air conditioners; standards; storage water heaters;

instantaneous water heaters; unfired storage tanks; warm

air furnace and packaged boilers; water heaters

411
Products or

Services

lOISUMER GOODS OR SEff WE AND PURCHASED Al

1ACE OF BUSINESS OF

Received 6/98

5 COSTING $25 OR MORE

A PLACE OTHER THAN TOE PERHANEf

THE SELLER

Department/Agency Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Enforcement

6th and Pennsylvania Avenue, NW

Washington. DC 20580

Phone: (202) 326-4357

FAX: (202) 326-2012

URL address: http://www.ftc.gov/ftc/consumer.htm

Initiated

Compliance

Effective June 7, 1974.

Mandatory for sellers who sell products or services

(costing $25 or more) at the buyer's residence or at

temporary business locations (e.g. at facilities rented

on a temporary or short-term basis, such as hotel or motel rooms, convention centers, fairgrounds and

restaurants, or sales at the buyer's workplace or in

dormitory lounges).

These sellers are required to furnish the buyer with a fully completed copy of the contract or receipt in the

same language as that was principally used in the sales

presentation. The contract must contain a verbatim

disclosure of the buyer's right to cancel the

transaction at any time prior to midnight of the third

business day after the sale. Sellers are also required

to furnish two copies of a Notice of Cancellation, which

sets forth in detail the buyer's cancellation rights.

Authority Rule Concerning Cooling-Off Period for Sales Made at

Homes or at Certain Other Locations. 16 CFR Part 429

("Cooling-Off Rule")

Federal Trade Commission Act, 15 U.S.C. § 41, et seq

Aim To provide consumers with an opportunity to review their

decision to purchase goods or services (where such

purchases are made at the consumer's residence or at

temporary business locations) and decide whether to

cancel the transaction and receive a full refund of all

payments.

412
Benefits See above

Methodology FTC staff monitors and investigates consumer complaints

involving the merchant's failure to inform consumers of

their cancellation rights or failure to honor valid

cancellations.

Testing

Inspection

Conformity

Identification

N/A.

Government

N/A.

Availability of

Documentation

The FTC publishes the Cooling-Off Rule in the Code of

Federal Regulations. See URL side for additional

information.

Enforcement The FTC can sue violators of the Cooling-Off Rule in

Federal Court. The court can impose civil penalties of

up to $11,000 for each violation and can issue an order

prohibiting further violations, and other relief, such

redress if appropriate.

Term N/A.

Reciprocity N/A.

Standards. Codes 16 CFR Part 455.

of Regulations

Keywords used car; used vehicles; used car dealers

413
Product or

Services

Received 6/98

TEXT!LI ID CERTAIN PIECE G

Department/Agency Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Enforcement

6th & Pennsylvania Ave., NW

Washington, DC 20580

Phone: (202) 326-3034

FAX: (202) 326-2558

URL address: http://www.ftc.gov/ftc/consumer.htm

Initiated

Compliance

Effective 1972, Amended Effective 1984 and 1997

Mandatory. Manufacturers and importers of textile

wearing apparel and certain piece goods must provide

proper care instructions with the products at the point

of sale.

Authority Trade Regulation Rule for Textile Wearing Apparel and

Certain Piece Goods, 16 CFR Part 423 ("Care Labeling

Rule").

Federal Trade Commission Act, 15 U.S.C. § 41, et seq.

Aim The aim of the Care Labeling Rule is to provide

appropriate care instructions for textile wearing

apparel and textile products sold by the piece from

bolts or rolls for the purpose of making home-sewn

textile wearing apparel.

Benefits The availability of care instructions for wearing

apparel and certain piece goods helps consumers make

informed purchasing decisions and promotes fair

competition.

Methodology FTC staff monitors complaints about products and may

conduct investigations, including testing, to ensure

accurate labeling.

Testing

Inspection

See above

Government.

414
Conformity

Identification

Availability

of Documentation

Enforcement

Term

Reciprocity

Standards, Codes or Regulations

Keywords

Laboratory analysis may be conducted.

Complaints are reviewed.

The FTC publishes the Care Labeling Rule in the Code of

Federal Regulations. See the URL site for additional

information

The FTC can sue violators of the Care Labeling Rule in

Federal court. The court can impose civil penalties of

up to $11,000 for each violation and can issue an order

prohibiting further violations, and other relief, such

as redress, if appropriate.

N/A.

N/A.

The Care Labeling Rule is located at 16 CFR Part 423.

care labeling; textiles, clothing; apparel; piece goods;

fabric; washing; dry cleaning

415
Products or

Services

Oh

Received 6/98

iGEO CONSUMER C«f»D!TlES (Excluding

Meat or Meat Products, Poultry or Poultry Products.

Tobacco or Tobacco Products, and Alcoholic Beverages)

Department/Agency Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Enforcement

6th and Pennsylvania, NW

Washington, DC 20580

Phone: (202) 326-4357

FAX: (202) 326-2012

e-mail: consumerline@ftc.gov

URL address: http://www.ftc.gov/ftc/consumer.htm

Initiated

Compliance

Authority

1966,

Mandatory.

Fair Packaging and Labeling Act, 15 U.S.C. § 1451, et

seq.

Rules Under the Fair Packaging and Labeling Act, 16 CFR

Parts 500, 501. 502, and 503.

Aim To enable consumers to obtain accurate information as to

quantity and identity of packaged commodities to

facilitate value comparisons by requiring disclosure of

such information on the packages. To promote fair

competition by ensuring that all consumer commodities

are labeled properly.

Benefits

Methodology

See above

The quantity disclosures must be made using both the

metric and "traditional" inch/pound systems of

measurement. The accuracy of quantity and identity

disclosures is tested by state, county, and municipal

weights and measures agencies.

Testing

Inspection

See above

See above

416
Conformity

Identification

N/A.

Availability

of Documentation

The FTC publishes the Fair Packaging Rules in the

CFR. Copies of the Fair Packaging and Labeling Act are available upon request.

Enforcement The FTC can bring administrative cases for cease and

desist orders and can go to federal court for

injunctions against mislabeling of consumer commodities

The Food and Drug Administration has enforcement

authority under the Act with respect to foods, drugs,

devices or cosmetics, as defined in the Federal Food,

Drug and Cosmetic Act, 21 U.S.C. § 371.

Term The required disclosures must remain on the packages of

consumer commodities until purchased by the retail consumer.

Reciprocity N/A.

Standards, Codes, 16 CFR Parts 500, 501, 502 and 503. or Regulations

Keywords consumer commodity; packaged goods; quantity disclosure

identity disclosure; net contents; labeling

417
Products or

Services

Received 6/98

mmputer,

>E ORDER!

AND FAX

:d by mail, telep

Department/Agency Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Enforcement

6th and Pennsylvania, NW

Washington, DC 20580

Phone: (202) 326-4357

FAX: (202) 326-2012

e-mail: consumerline@ftc.gov

URL address: http://www.ftc.gov/ftc/consumer.htm

Initiated Originally effective February 2

Amended effective March 1, 1994,

1976.

Compliance Mandatory for sellers of merchandise ordered by mail,

telephone, computer, and fax machine.

If a seller cannot ship ordered merchandise to the buyer

within the time represented in the advertisement

soliciting the sale, or within 30 day if no time is

represented, the seller must promptly provide the buyer

with the option to either cancel the order and receive a prompt refund or to agree to the delayed shipment. If

the seller fails timely to obtain the buyer's agreement

to delayed shipment, the seller must promptly make a full refund to the buyer.

Authority

Aim

Mail or Telephone Order Merchandise Rule, 16 CFR Part

435 ("Mail or Telephone Order Rule").

Federal Trade Commission Act, 15 U.S.C. § 41, et seq.

To give consumers the right to have mail or telephone

order merchandise shipped within a certain period of

time, and if there is a shipment delay, to provide

consumers with a right to agree to a delayed shipment or receive a prompt refund.

Benefits

Methodology

See above.

FTC staff monitors and investigates consumer complaints

involving the merchant's failure to timely and

appropriately obtain the consumer's consent to delay or

418
make correct and timely refunds. The FTC continues to

educate industry members by giving speeches and through

distribution of a business guide to industry members.

The FTC also educates consumers through distribution of consumer pamphlets regarding the Mail or Telephone Order

Rule.

Testing

Inspection

Conformity

Identification

N/A.

Government.

N/A.

Availability

of Documentation

The FTC publishes the Mail or Telephone Order Rule in

the CFR. See URL site for additional information

Enforcement The FTC can sue violators of the Mail or Telephone Order

Rule in Federal court. The court can impose civil

penalties of up to $11,000 for each violation and can issue an order prohibiting further violations, and other

relief, such as redress, if appropriate.

Term N/A.

Reciprocity N/A.

Standards, Codes

or Regulations

16 CFR Part 435

Keywords mail order sales; telephone sales; computer sales;

facsimile sales; catalog sales

419
Products or

Services

Received 6/98

TELEPHONE

TELEPHONE

PER-CALL ERVICE

ES

Department/Agency Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Marketing Practices

6th and Pennsylvania, NW

Washington, DC 20580

Phone: (202) FTC-HELP

FAX: (202) 326-2012

URL address: http://www.ftc.gov

Initiated The 900 Number Rule was promulgated in 1993 pursuant to

the Telephone Disclosure and Dispute Resolution Act of

1992 (TDDRA).

Compliance

Authority

All entities in the advertising, provision, billing and

collection of pay-per-call services and telephone-billed

purchases must comply with the Rule's requirements.

Telephone Disclosure and Dispute Resolution Act of 1992

(TDDRA), 15 U.S.C. § 5701 et. seq.

Federal Trade Commission Act, 15 U.S.C. § 41, et seq.

900 Number Rule. 16 CFR Part 308.

Aim

Benefits

Abuses in the 900 number industry prompted Congress to

pass legislation requiring the FTC and the FCC to

promulgate rules to regulate the advertising, provision

of. and billing and collection of pay-per-call services

and the billing and collection of telephone-billed

purchases

Enactment of the Rule has significantly reduced problems

with 9000 numbers, but certain problems have migrated to

other dialing patterns and telephone billing methods.

Methodology The FTC reviews complaints and information received from

consumers and other sources to determine whether a particular company's practices violated the Rule's

requirements. If the Commission has reason to believe a company's practices are not in compliance, or are otherwise deceptive or unfair, the Commission may bring

an enforcement action against that company.

420
Testing

Inspection

N/A.

The FTC monitors advertising for pay--per-call

as well as reviews consumer complaints about a or the industry's practices.

services,

company's

Conformity

Identification

N/A.

Availability

of Documentation

A copy of the Rule, educational materials, and

information about FTC enforcement actions can be

obtained from the FTC's Consumer Response Center, at the

telephone number listed above, or from the agency's

website.

Enforcement Among remedies available, the agency can seek civil

penalties, in the amount of $11,000 for each violation

of the Rule. The FTC also has the authority to seek cease and desist orders, consumer redress, other

monetary remedies, as well as injunctive relief,

including bans on engaging in particular activities or bonding requirements.

Term

Reciprocity

N/A.

The TDDRA authorizes state attorneys general to bring

actions for violations of the Rule.

Standards, Codes

or Regulations

The text of the Rule and TDDRA can be found at the sites

listed above. The Statement of Basis and Purpose to the

Rule provides additional explanation regarding the Rule

and can be found at 58 Federal Register 42364 (August 9,

1993).

Keywords pay-per-call service; 900 number; provider; service

bureau; billing entity; telephone-billed purchase

421
Received 6/98

Products or TELEMARKETING (Selling Products or Services Via the

Services Telephone)

Department/Agency Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Marketing Practices

6th and Pennsylvania, NW

Washington, DC 20580

Phone: (202) FTC-HELP

FAX: (202) 326-2012

URL address: http://www.ftc.gov

The Telemarketing Sales Rule was promulgated in 1995,

pursuant to the Telemarketing Consumer Fraud and Abuse

Prevention Act.

Compliance is mandatory for all entities whose

activities are covered by the Telemarketing Rule. The

Rule contains a number of exemptions. Businesses

engaged in telemarketing should review the text of the

Rule to determine whether it applies to them.

Telemarketing Sales Rule, 15 CFR Part 310.

Telemarketing Consumer Fraud and Abuse Prevention Act.

(Telemarketing Act) 15 U.S.C. §§ 6101-6108.

Federal Trade Commission Act, 15 U.S.C. § 41, et seq.

The Telemarketing Sales Rule was promulgated in 1995.

The purpose of the Rule is to prevent deceptive

telemarketing practices and to ensure that consumers

receive truthful and complete information about products

and services marketed to them via the telephone.

See Aim.

Methodology The FTC reviews complaints and information received from

consumers and other sources to determine whether a particular company's telemarketing practices are in

compliance with provisions of the Telemarketing Sales

Rule. If the Commission has reason to believe a company's telemarketing practices are not in compliance

with the Rule, or are otherwise deceptive or unfair, the

Commission may bring an enforcement action as described

below.

Initiated

Compliance

Authority

Aim

Benefits

422
Testing N/A.

Inspection The FTC monitors telemarketing practices. However, the

FTC does not routinely inspect businesses engaged in

telemarketing or the products or services they sell. In connection with particular FTC investigations or enforcement actions, businesses may be obligated to

produce records, testify about their telemarketing

practices, or provide FTC representatives with access to

the business premises.

Conformity N/A.

Identification

Availability

of Documentation

Enforcement

A copy of the Telemarketing Sales Rule, can be obtained

by calling the telephone number listed above.

Educational materials about telemarketing and

information about FTC enforcement actions involving

telemarketing are also available from the FTC's website.

Among the remedies available, the agency can seek civil

penalties in the amount of $11,000 for each violation of

the Rule. The FTC also has the authority to seek cease

and desist orders, consumer redress, other monetary

remedies, as well as injunctive relief, including bans

on engaging in particular activities or bonding

requirements

.

Term

Reciprocity

N/A.

The Telemarketing and Consumer Fraud and Abuse Act

authorizes state attorneys general to bring actions for

violations of the Rule.

Standards, Codes

or Regulations

The Telemarketing Sales Rule and the Telemarketing Act

can be found at the citations listed above. At the time

the Commission issued the Telemarketing Sales Rule, it

also issued a Statement of Basis and Purpose in support

of the Rule. The Statement of Basis and Purpose

provides additional explanation regarding the Rule and can be found at 60 Federal Register 43842 (August 23,

1995).

Keywords telemarketing; telemarketers; consumer protection

423
Products or

Services

LIQUID AUTOMOTIVE FUEL

Received 6/98

Department/Agency Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Enforcement

601 Pennsylvania Ave., NW

Washington, DC 20580

Phone: (202) 326-2996

FAX: (202) 326-3259

e-mail: nblickman@ftc.gov

URL address: http://www.ftc.gov/ftc/consumer.htm

Initiated 1979

Compliance Mandatory for refiners, importers, producers,

distributors, and retailers of automotive fuel

exception of diesel fuel.

with the

Authority The Petroleum Marketing Practices Act, ("PMPA"), P.L.

No. 95-297, 92 Stat. 322 (1978), as amended by the

Energy Policy Act of 1992, P.L. No. 102-486. 106 Stat.

2776 (1992).

16 CFR Part 306 (Automotive Fuel Ratings, Certification

and Posting Rule ("Fuel Rating Rule").

Aim To give fuel purchasers the information they need to

choose the correct type or grade of fuel for their

vehicles.

Benefits Consumers need to know, as accurately as possible, both

the fuel rating requirements of their individual cars

and the fuel ratings of the fuels they purchase at the

dispenser. With this information, motorists

simultaneously can conserve energy, save money, reduce

air pollution, and protect their cars against possible

engine damage.

Methodology Following directives in the PMPA, the Fuel Rating Rule

requires sellers of liquid automotive fuels, including

alternative liquid automotive fuels, to determine,

certify, post on fuel dispensers, and keep records of

the automotive fuel rating appropriate for each fuel.

The fuel rating for gasoline is the octane rating. For

an alternative liquid automotive fuel, it is the

424
commonly- used name of the fuel along with a disclosure

of the amount, expressed as a minimum percentage by

volume, of the principal component of the fuel. The

Fuel Rating Rule prescribes the required layout, type

size, setting, colors and contents of the gasoline and

liquid alternative fuel dispenser labels. Automotive

fuel ratings must be determined and certified in

accordance with specific provisions in the Fuel Rating

Rule. Records of any fuel rating determinations and

records on which fuel rating certifications are based

must be available for inspection by FTC staff.

Testing Commercial lab.

Fuel seller's lab.

Inspection Government.

Inspections may be conducted by

state, county, and municipal

weights and measures agencies, as well as the FTC.

Conformity The Commission's Fuel Rating Rule mandates a disclosure

Identification scheme (in the form of dispenser labels) for posting on

fuel dispensers the octane rating of gasoline, and the common name and minimum percentage of the principal

component of liquid alternative fuels intended for sale

to consumers. Dispenser labels for each fuel type

covered by the Rule use the same size, colors and

typefaces with consistent positioning of contents. Such

uniformity in the disclosure format facilitates consumer

confidence, recognition and readability. Gasoline

labels are to be printed in black ink on a yellow

background. Alternative fuel labels must be printed in

black ink on an orange background.

Availability The FTC publishes the Fuel Rating Rule, including sample

of Documentation labels, in the CFR. See the URL site for more

information.

Enforcement The FTC can sue violators of the Fuel Rating Rule in

Federal court. The court can impose civil penalties of

up to $11,000 for each violation and can issue an order

prohibiting further violations, and other relief, such

as redress, if appropriate. State and local agencies

may also investigate violators of the Fuel Rating Rule.

Term Indefinite term until sellers transfer automotive fuel

with a lower automotive fuel rating.

425
Reciprocity The Commission's Fuel Rating Rule is recognized by other

federal agencies, state agencies, and private sector

organizations.

Standards. Codes

or Regulations

Standard test procedures are prescribed by the PMPA.

Label format is prescribed by the FTC.

Keywords alternative fuels; energy conservation; gasoline;

label ing

426
Products or Services

Received 6/98

NON-LIQUID ALTERNATIVE FUELS AID

ALTERNATIVE-FUELED VEHICLES ("A

Department/Agency

Initiated

Compliance

Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Enforcement

601 Pennsylvania Ave., NW

Washington, DC 20580

Phone: (202) 326-2996

FAX: (202) 326-3259

e-mail: nblickman@ftc.gov

URL address: http://www.ftc.gov/ftc/consumer.htm

1995

Mandatory for refiners, importers, producers,

distributors, and retailers of vehicle fuels,

manufacturers of electric vehicle fuel dispensing

systems, manufacturers and dealers of new AFVs, dealers

of used AFVs, and certain conversion companies.

Authority The Energy Policy Act of 1992

Stat. 2776 (1992).

P.L. No. 102-486, 106

Labeling Requirements for Alternative Fuels and

Alternative Fueled Vehicles, 16 CFR Part 309 ("Rule").

Aim To give fuel purchasers the information they need to

choose the correct type or grade of fuel for their

vehicles. To provide information to potential

purchasers of alternative fueled vehicles to help them

compare vehicles.

Benefits Consumers need to know, as accurately as possible, both

the fuel rating requirements of their individual cars

and the fuel ratings of the fuels they purchase at the

dispenser. With this information, motorists

simultaneously can conserve energy, save money, reduce

air pollution, and protect their cars against possible

engine damage. In addition, with the information made

available by the Rule concerning AFVs, consumers can determine the costs and benefits of purchasing

alternative fuels and AFVs.

427
Methodology Under the Rule, retail non-liquid alternative fuel

dispensers must display a label near the selling price

of the fuel disclosing the commonly -used name of the

fuel. The label for gaseous fuels also must disclose

the fuel's principal component, and could disclose other

components, with all components expressed as minimum

percentages. For electric vehicle fuel dispensers, the

label must disclose the kilowatt capacity, voltage,

current (either AC or DC), amperage, and type of charge

(either conductive or inductive).

For AFVs, the Rule requires that AFV manufacturers affix

to AFVs, and AFV dealers maintain, standard labels

consisting of three parts. The labels are to be placed

conspicuously on any visible surface on the AFV. The

first part of these labels must contain the estimated

cruising range and any Environmental Protection Agency

emissions standard. The second part of the AFV label

must list and explain factors consumers should consider

in purchasing an AFV; and the third part directs

consumers to additional sources of information from the

Departments of Energy and Transportation.

Additionally, the Rule imposes substantiation,

recordkeeping, and in some instances, certification

requirements on importers, producers, refiners, and

distributors of gaseous alternative fuels; manufacturers

and distributors of electric vehicle fuel dispensers;

retailers of non-liquid alternative fuels; and AFV

manufacturers.

Testing Commercial lab.

Fuel seller's or vehicle manufacturer's lab.

Government lab.

Inspection Government.

Conformity The FTC's Rule mandates disclosure schemes

Identification (in the form of fuel dispenser and AFV labels) for

posting on fuel dispensers the fuel rating of gaseous

alternative fuels, and for posting on covered AFVs

specific data and other descriptive disclosures.

Dispenser and AFV labels for each fuel type or AFV

covered by the Rule use the same size, colors and

typefaces with consistent positioning of contents. Such

uniformity in the disclosure formats facilitate consumer

confidence, recognition and readability. Alternative

fuel labels must be printed in black ink on an orange

428
Availability

of Documentation

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

background. AFV labels must be printed in black ink on sky blue paper.

The FTC publishes the Rule, including sample labels,

in the CFR. See the URL site for additional

information.

The Secretary of Energy may hold hearings, take

testimony, and require by subpoena, the attendance and

testimony of witnesses and the production of books,

papers, correspondence, memorandums, contracts,

agreements, or other records.

Indefinite term. In the case of fuel sellers, however,

the term is indefinite until they transfer vehicle fuel

with a lower fuel rating.

The FTC's Rule is recognized by other federal agencies,

state agencies, and private sector organizations.

Standard test procedures or methods, and label format

are prescribed by the FTC.

alternative fuels; alternative fueled vehicle; energy

conservation; labeling

429
Received 6/98

Product or FUR. MOOL AID TEXTILE PRODUCTS

Services

Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Enforcement

6th & Pennsylvania Ave., NW

Washington. DC 20580

Phone: (202) 326-3034

FAX: (202) 326-2558

URL address: http://www.ftc.gov/ftc/consumer.htm

Wool Products Labeling Act. effective 1941.

Fur Products Labeling Act, effective 1952.

Textile Fiber Products Identification Act, effective

1960.

Compliance Mandatory: Textile, wool and fur

products must be labeled with

either the business name of some party distributing the goods or a Registered Identification Number

("RN number") obtained from the

FTC; country of origin; and

fiber/fur/textile content.

Voluntary: Continuing guaranties

filed with the FTC are voluntary.

Authority Textile Fiber Products Identification Act, 15 U.S.C.

§ 70.

Wool Products Labeling Act, 15 U.S.C.§ 68.

Fur Products Labeling Act, 15 U.S.C. § 69.

Federal Trade Commission Act, 15 U.S.C. § 41 et seq.

Rules and Regulations under the Textile Fiber Products

Identification Act, 16 CFR Part 303.

Rules and Regulations under the Wool Products Labeling

Act, 16 CFR Part 300.

Rules and Regulations under the Fur Products Labeling

Act, 16 CFR Part 301.

Department/Agency

Initiated

430
Aim The aim of these laws and regulations is to provide

truthful, meaningful information that may be used in the

purchasing decision process by distributors and consumers. A continuing guaranty filed with the FTC is

a promise that the goods are properly labeled.

Benefits

Methodology

See above.

FTC staff monitors complaints about products and may

conduct investigations, including testing of content, to ensure accurate labeling or advertising.

Testing See above,

Inspection FTC staff may inspect textile, wool, and fur products

Conformity

Identification

Laboratory analysis of content may be conducted

Availability

of Documentation

Holders of RN numbers may be identified through the RN

Lookup Service which is available on the Internet at

http://www.ftc.gov/bcp/rn/rn.htm", or by calling the

FTC.

The Los Angeles Regional Office of the FTC maintains

continuing guaranty files and may disclose whether a company has filed a continuing guaranty with the

Commission.

the

The FTC publishes the Rules and Regulations in the CFR.

Copies of the Acts are available upon request.

Enforcement Enforcement actions may be brought by the FTC under the

various Acts.

Term RN numbers and continuing guaranties filed with the FTC

remain in effect unless revoked by the Commission.

Reciprocity

Standards. Codes

or Regulations

N/A.

The Wool, Fur, and Textile Acts are located at

15 U.S.C. §§ 68, 69, and 70, respectively. The

regulations are located at 16 CFR Parts 300, 301, and

303, respectively.

431
Keywords RN number; continuing guaranty; textile; wool

apparel; clothing; fabric; labeling; advertis

432
Products or

Services

Received 6/98

HOME

Department/Agency Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Enforcement

601 Pennsylvania Ave., NW

Washington, DC 20580

Phone: (202) 326-4357

FAX: (202) 326-2012

e-mail: consumerl ine@ftc.gov

URL address: http://www.ftc.gov/ftc/consumer.htm

Initiated

Compliance

1980.

Mandatory for manufacturers and other sellers of home

insulation products.

Manufacturers or sellers of thermal insulation products

for use in residential structures must disclose specific

information about the thermal performance of the

insulation at the point of sale (on product labels,

manufacturers' fact sheets, and receipts or contracts to

purchasers from professional installers and new home

sellers), and in advertising and other promotional

materials that contain certain claims. Thermal

performance is described by the product's R-value, which

varies among insulation types and forms and among

specific products of the same type and form.

Authority Labeling and Advertising of Home Insulation, 16 CFR Part

460 ("R-value Rule")

Federal Trade Commission Act, 15 U.S.C. § 41 et seq.

Aim To provide consumers with an opportunity to compare

relative insulating efficiencies ("R-values") , to make

cost-effective purchase, and to consider the main

variables limiting insulation effectiveness and

realization of claimed energy savings.

Benefits The availability of verified R-value information based

on uniform standards should enhance consumer demand for

insulation products that save energy. In turn,

competition should be generated among manufacturers to

meet this demand by producing more energy efficient

433
insulation products. Consumers will be able to save money by reducing the costs of heating and cooling their

homes, which will help to promote the national goal of

energy conservation.

Methodology Following rulemaking proceedings under the Federal Trade

Commission Act. the FTC has adopted testing and

disclosure rules for manufacturers and other sellers of

home insulation products. The required point-of-sale

(label, manufacturers' fact sheets) and advertising

disclosures give consumers R-value ratings and related

information they can use in making cost-effective

purchasing decisions. Manufacturers must use specified

test procedures to determine the R- values of their

products, and must disclose R-values and related

information on product labels and fact sheets, and in

advertisements that contain certain claims. FTC

representatives may review a manufacturer's or other

seller's test records, labels, fact sheets, advertising,

or other materials to determine whether the manufacturer

or other seller is in compliance with the R-value Rule's

requirements.

Testing Manufacturers are responsible for testing their products

in their own labs or in commercial labs of their choice.

Inspection No inspections are required. Government may inspect or have products tested to confirm manufacturers' test

results or thermal performance claims.

Conformity

Identification

The FTC's R-value Rule mandates a disclosure scheme for

energy efficiency (R-value), based on standardized test

procedures. All disclosures for insulation products

covered by the Rule must provide identical information

in a prescribed format. Such uniformity in the

disclosure format facilitates immediate consumer

recognition and readability. The FTC does not require

the certification of home insulation products or suppl iers

Availability

of Documentation

The FTC publishes the R-value Rule in the CFR.

See the URL site for additional information.

Enforcement The FTC can sue violators of the R-value Rule in Federal

court. The court can impose civil penalties of up to

$11,000 per violation, and can issue an order

prohibiting further violations, and other relief, such

as redress, if appropriate.

434
Term

Reciprocity

Standards, Codes or Regulations

Indefinite term.

The Commission's R- value Rule is recognized by other

federal agencies, state agencies, and private sector

organizations

.

16 CFR Part 460.

Keywords advertising; energy conservation; insulation; labeling

trade practices

435
Products or

Services GPTIOI PLAN:

Received 6/98

RCHANDISE SOLD BY PRENOTIFICATIQI NEGATIVE

Department/Agency Federal Trade Commission (FTC)

Bureau of Consumer Protection

Division of Enforcement

6th & Pennsylvania Ave., NW

Washington, DC 20580

Phone: (202) 326-4357

FAX: (202) 326-2012

e-mail: consumerline@ftc.gov

URL address: http://www.ftc.gov/ftc/consumer.htm

Initiated

Compliance

1973

Mandatory. Operators of prenotification negative option

plans must disclose the material terms of the membership

in ads that contain a device consumers can use to

subscribe.

Authority Use of Negative Option Plans by Sellers in Commerce

CFR Part 425 (the "Rule").

Federal Trade Commission Act, 15 U.S.C. 41, et seq.

16

Aim

Benefits

Methodology

To ensure that consumers are not misled about the terms

of prenotification negative option plans before they

subscribe, the Rule requires sellers to disclose the

material terms of the plans in ads that contain a means consumers can use to subscribe. The Rule also imposes

certain duties on operators of prenotification negative

option plans to protect consumers from potentially

unfair or deceptive practices once they have subscribed,

See above.

FTC staff monitors ads that contain a means that

consumers can use to subscribe to prenotification

negative option plans to determine whether the ads

disclose the material terms of membership, including

disclosures specifically set forth in the Rule. FTC

staff also monitors consumer complaints to determine

whether operators of prenotification negative option

plans are complying with Rule requirements.

436
Testing N/A.

Inspection Advertisements are reviewed continually,

Conformity

Identification

N/A.

Availability

of Documentation

The FTC publishes the Rule in the CFR.

See the URL site for additional information

Enforcement The FTC may bring enforcement actions administratively

or in federal court against companies or individuals who

violate the Rule. In some cases, the FTC may seek civil

penalties, as well as consumer redress and other

remedies.

Term N/A.

Reciprocity N/A.

Standards, Codes

or Regulations

16 CFR Part 425

Keywords goods; merchandise; advertising; prenotifi cation

negative option plan

437
FTC IMBE1

Product Page

advertisements 406

advertising 406. 436

air conditioners/systems 408

apparel 414, 430

appliances 408

automobile, used, purchase of 412

automobiles, alternative fueled 427

automotive fuels (liquid) 424

boilers 408

building materials 433

car dealers, used 412

care labeling, textile 414

catalog sales 418

cigarette testing 405

clothes washers 408

clothes dryers 408

clothing 414, 430

commercials 406

computer sales 418

construction 433

consumer commodities, packaged 416

consumer purchases away from home 412

diesel 424

dishwashers 408

dry cleaning instructions 414

electric motors 408

energy efficiency 408

fabrics 430

fax orders 418

fluorescent lamps 408

freezers 408

fuels, alternative 424, 427

fuels, non-liquid 427

fuels, liquid automotive 424

fur 430

438
furnaces 408

furnishings, textiles 414

gasoline 424

heating equipment /systems 408

incandescent lamps 408

insulation, home 433

internet sales 418

labels (general) 406, 416

lamps 408

lighting 408

mail orders 418

mobile home furnaces 408

motors, electric 408

nicotine 405

ovens 408

packaged goods 416

plumbing products 408

pool heaters 408

product claims 406

purchases, telephone-billed 420

purchases, telephone sales 422

purchases by mail, phone and fax 418

purchases by prenotifi cation negative option plan 436

purchases, consumer (away from home) 412

ranges 408

refrigerators 408

subscription purchases 436

swimming pool heaters 408

telemarketing 422

telephone orders 418

telephone sales 422

telephone pay-per-call service 420

telephone-billed purchase 420

testimonials 406

textiles 414, 430

tobacco testing 405

vehicles, used, purchase of 412

vehicles, alternative fueled 427

washing instructions 414

water heaters 408

wearing apparel 414

wool 430

439
RVICES ADMINISTRATION

440
Received 8/98

Products or PARTS, MATERIALS, AND EQUIPMENT

Services (Qualified Products Listing (QPL) Program)

Department/Agency General Services Administration (GSA)

Federal Supply Service (FSS)

Mail Code: 3FNE-C0

CM4, Room 403

Washington, DC 20406

Phone: (703) 305-6338

FAX: (703) 308-3658

URL address: http://www.fss.gsa.gov

Initiated 1949.

Compliance Mandatory for those products defined by Federal

Specifications which have been designated for the

Qualified Products List (QPL) 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 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 QPLs are for security office

equipment - safes, vault doors, filing cabinets, and

padlocks

.

Methodology Testing prior to government purchase.

Testing Government or private laboratories, including the

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

and the designated preparing activity. Labs are not

formally accredited by GSA.

441
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 QPLs

Availability of

Documentation

Federal QPLs and specifications are distributed by

GSA Business Service Centers.

Obligations of Manufacturers and distributors must supply test

Manufacturer/Vendor samples, ordinarily bear the cost of testing, maintain

quality and notify of design changes. Reference may be

made to listing of QPLs 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

QPLs. 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

442
Not Received

Products or PARTS . MATERIALS . AID EQUIPMENT FOR GOVERNMENT PURCHASE

Services (Federal Supply Schedule Listing Program)

Department/Agency General Services Administration (GSA)

Federal Supply Service (FSS)

Mail Code: 3FNE-C0

CM4. Room 403

Washington, DC 20406

Phone: (703) 305-6338

FAX: (703) 308-3658

URL address: http://www.fss.gsa.gov

Initiated 1949.

Compliance Currently mandatory for covered products and

procurements. However, the FSS is converting to

nonmandatory sources of supply. This includes all

multiple and single award schedules.

Aim To expedite government procurements. Allows agencies

purchase products from commercial firms at volume

discount pricing for given period of time.

to

Benefits Reduces cost and time in the government procurement

process

.

Methodology The Federal Supply Schedule Program mirrors commercial

buying practices. The Multiple Award Schedules (MAS) cover contracts awarded to contractors supplying

comparable commercial supplies and services a varying

prices. Single Award Schedules (SAS) cover contract

made with one supplier for a specific product at a stated price for delivery to a geographic areas defined

in the schedule.

Conformity

Identification

Federal Supply Schedules are available from: GSA,

Centralized Mailing List Services, 4900 Hemphill St.,

P.O. Box 6477. Fort Worth, TX 76115 Phone: (817) 334-

5215; Fax: (817) 334-5227.

Availability

of Documentation

Federal Supply Schedules and specifications are distributed by GSA Business Service Centers.

443
Obligations of the To comply with the terms of the contract.

Manufacturer/ Vendor

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Contract period.

Federal and state agencies recognize and use Federal

Supply Schedules. There are no bilateral or multilateral arrangements with other countries.

Program is based on commercial standards where

available.

federal supply schedule; government procurement;

procurement; quality control ; testing

444
Received 1/98

Products or FEDERAL AUTOMOBILES AND TRUCKS

Services

Department/Agency General Services Administration (GSA)

Federal Supply Service (FSS)

GSA Automotive Center (FCAE)

Mailing Address:

1941 Jefferson Davis Hwy.

Arlington, VA 22202-4502

Phone: (703) 308-4190

FAX: (703) 305-3034

URL address: http://www.fss.gsa.gov

Compliance

Authority

Mandatory for procuring federal agencies/offices.

Federal Property Management Regulation (FPMR) No. 101-

26.501 regarding the Purchase of New Motor Vehicles.

FPMR No. 101-38.13, Acquisition of Fuel Efficient Motor

Vehicles.

Aim To achieve a practical degree of standardization in the

Federal automotive fleet, yet be responsive to the wide

range of vehicles required to meet the needs of the

various agencies.

Benefits Allows the procurement of commercial, nontactical

vehicles which are capable of meeting

performance/functional requirements equal to or better

than vehicles purchased by the private sector.

Methodology Quality assurance operations performed by the contractor

are subject to Government verification at unscheduled

intervals. Verification will consist of observation of

the operations to determine that practices, methods, and

procedures of the contractor's inspection are being

properly applied. Failure of the contractor to promptly

correct product deficiencies discovered shall be cause

for suspension of acceptance until correction has been

made or until conformation of product to specification

criteria has been demonstrated. The products provided

must meet all of the FMVSS, conform to the producer's

own drawings, specifications, standards, quality assurance practices, and government standards and be the

445
same product offered for sale in the commercial market.

The Government reserves the right to require proof of

such conformance.

Conformity

Identification

GSA lists representative vehicles meeting federal

vehicle standards in their respective documents, which

are available from the office listed above.

Availability

of Documentation

Federal Motor Vehicle Safety Standards are available

from the National Highway Transportation Safety

Administration (NHTSA). 400 7th Street, SW, Washington

DC 20590.

Obligations of the

Manufacturer/ Vendor

See Methodology.

Term Annual

Reciprocity Federal agencies recognize and use federal vehicle

standards in their procurements. There are no bilateral

or multilateral arrangements with other countries.

Standards, Codes

or Regulations

Program is based on federal vehicle standards developed

by GSA and based on classification characteristics and

specifications from the American Automobile

Manufacturers Association (AAMA), the EPA and DOE's fuel

economy information.

Keywords government procurement; procurement; QPL; vehicles

automobiles; testing

446
GSA MM!

Product Page

automobiles, government procurement of 445

federal supply schedule 443

FMVSS 445

government procurement 441, 443, 445

procurement, government 441, 443, 445

QPL 441. 445

trucks, government procurement of ---445

vehicles, government procurement of 445

447
448
Products or

Services

Received 6/98

NUCLEAR POWER PLANTS. NUCLEAR FUEL CYCLE FACILITIES ANI

NONPOWER TEST AND RESEARCH REACTORS (Regulation of the

Civilian Use of By-Product, Source and Special Nuclear

Material

)

Department/Agency

Initiated

Compliance

Authority

Aim

Nuclear Regulatory Commission (NRC)

Office of Nuclear material Safety and Safeguards

Two White Flint North Building

Washington, DC 20555 (Mailing Address)

Phone: (301) 415-2741

Fax: (301) 415-3431

e-mai 1 : jxl@nrc.gov

URL address: http://www.nrc.gov/NMSS/nrc.htm

or Office of Nuclear Reactor Regulation

OWFN 5-E7

11545 Rockville Pike

Rockville, MD 20552

NRC, Washington, DC 20555 (Mailing Address)

Phone: (301) 415-1270

Fax: (301) 415-8333

e-mail : bmm@nrc.gov

URL address- http://www.nrc.gov/OPA/finder.htm

1954 with the Atomic Energy Act, as amended.

Mandatory.

Atomic Energy Act, as amended.

Protection of public health and safety, promote common

defense and security, and protect the environment

through effective and efficient regulations.

Benefits

Methodology

See Aim.

NRC develops regulations and guidance documents for

programs and activities it regulates, reviews

applications and issues licenses for regulated

activities, and conducts periodic inspections to ensure compliance and overall safe implementation of programs.

449
Inspection

Availability

of Documentation

Enforcement

Standards, Codes

or Regulations

Keywords

NRC conducts routine planned inspections and conducts

inspections in response to events and operational concerns

NRC maintains a public docket room in Washington, DC and

local public document rooms at selected locations

throughout the U.S. in the vicinity of key licensees.

NRC may issue Notices of Violation, impose civil

penalties and issue Orders. All violations are subject

to civil enforcement action and may also be subject to

criminal prosecution.

10 CFR 1.

construction; design; design; environment; nuclear

facility; nuclear fuel cycle; fuel fabrication facility;

gaseous diffusion plant; nuclear safety

450
Products or

Services

Department/Agency

Received 6/98

Initiated

Compliance

Authority

Aim

RADIOACTIVE M

ACADEMIC USES.

CONTAINERS

€1

RADIOACTIVE MATERIAL PACKAGING AND

Nuclear Regulatory Commission (NRC)

Office of Nuclear Material Safety and Safeguards

Two White Flint North

Washington, DC 20555-0001 (Mailing Address)

Phone: (301) 415-7800

FAX: (301) 415-5369

e-mail : opa@nrc.gov

URL address: http://www.nrc.gov/NMSS/nrc.htm

1974

Mandatory.

Atomic Energy Act of 1954, as amended.

Energy Reorganization Act of 1974, as amended.

Uranium Mill Tailings Radiation Control Act of 1978.

Nuclear Non-Prol iteration Act of 1978.

Low-Level Radioactive Waste Policy Act of 1980, as amended.

West Valley Demonstration Act of 1980.

Nuclear Waste Policy Act of 1982, as amended.

Diplomatic Security and Anti -Terrorism Act of 1986.

Solar, Wind, Waste and Geothermal Power Production

Incentives Act of 1990.

Energy Policy Act of 1992.

10 CFR 1.

To ensure adequate protection of public health and

safety, the common defense and security, and the

environment in the use of nuclear material in the United

States.

Benefits

Methodology

See Aim.

Responsible for the public health and safety licensing,

inspection, and environmental review for all activities

regulated by the NRC, except operating power and all

non-power reactors and for the safeguards technical

451
review of all licensing activities, including

export/import of special nuclear materials, but

excluding reactors. Develops and implements NRC policy

for the regulation of activities involving safety,

quality, approval, and inspection of the use and

handling of byproduct or special nuclear materials, such

as uranium recovery activities fuel fabrication and fuel

development; medical industrial, academic, and

commercial uses of radioactive isotopes; safeguards

activities; transportation of nuclear materials,

including certification of transport containers; spent

fuel storage; safe management and disposal of low-level

and high-level radioactive waste; and management of

related decommissioning.

Most organizations or individuals intending to possess,

use. or transfer byproduct or special nuclear materials

must also be licensed and inspected by NRC or an NRC

Agreement State. Such materials include: new and spent

nuclear fuel; medical radiation therapy and diagnostic

tests using a radiopharmaceutical; consumer products,

such as smoke detectors, "exit" signs, static

eliminations devices and luminous watch dials, wood

flooring treated with gamma radiation to resist

abrasion, and certain gemstones such as blue topaz;

industrial radiography; and other commercial and

industrial uses of radioactive materials, such as testing devices, and gauges. States also have

regulatory jurisdiction over certain radioactive

substances that occur naturally (primarily radium) or are produced by machines called particle accelerators.

Testing NRC, State government, or Applicant

Inspection NRC or Agreement State.

Conformity

Identification

Approved products are assigned an identification number

Approved users are issued licenses.

Availability NRC documents may be requested from the NRC, for single

of Documentation copies, or through the Government Printing Office.

Additional information may also be available from the

agency or for viewing at the NRC Public Document Room.

452
Obligations of the Report defects or noncompliance. Report significant

Manufacturer/Vendor reduction of effectiveness of packaging/containers

during use. To conform to regulatory requirements and

abide by conditions and limitations of licensing and

registration.

Enforcement NRC may issue Notices of Violation, impose civil

penalties and issue Orders. All violations are subject

to civil enforcement action and may also be subject to

criminal prosecution.

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

Five (5) year (renewable) for certificate holders.

Recognition of certification by:

- State agencies (Agreement States and Licensing

States

.

- U.S. Department of Transportation (DOT).

- Foreign governments upon issuance of DOT Competent

Authority Certificate.

U.S. Nuclear Regulatory Commission Regulatory Guides

(NUREG). 10 CFR 1 Parts 1-199.

ANSI, ISO. or other industry and consensus standards.

brachytherapy; byproduct material; consumer products;

containers; device; diagnostic tests using

radiopharmaceuticals; environment; "exit" signs; fuel

fabrication; gamma irradiator; gauges; industrial

radiography; luminous watch dials; medical radiation

therapy; new nuclear fuel; nuclear; nuclear fuel;

nuclear safety; packaging; radioactive material;

radiation treated gemstones; sealed source; smoke

detectors; special nuclear; spent nuclear fuel; static

elimination devices; teletherapy; testing devices;

transportation; well logging; wood flooring treated with

gamma radiation

453
Products or

Services

Received 6/98

HE

Department/Agency Nuclear Regulatory Commission (NRC)

Office of Nuclear Material Safety and Safeguards

11545 Rockvi lie Pike

Rockville. MD 20852

Compliance

Authority

Aim

NRC, Washington. DC 20555-0001 (Mailing Address)

Phone: (301) 415-7800

FAX: (301) 415-5369

e-mai 1 : opa@nrc.gov

URL address: http://www.nrc.gov

Mandatory.

Energy Reorganization Act of 1974, as amended.

Uranium Mill Tailings Radiation Control Act of 1978.

Nuclear Non-Prol iteration Act of 1978.

Low-Level Radioactive Waste Policy Act of 1980. as amended.

West Valley Demonstration Act of 1980.

Nuclear Waste Policy Act of 1982. as amended.

Energy Policy Act of 1992.

10 CFR 1.

To protect public health and safety and the environment

through the licensing and monitoring of nuclear waste

facilities.

Benefits

Methodology

See Aim.

NRC licenses the siting, design, construction, operation

and closure of low-level radioactive waste disposal

sites under NRC jurisdiction and the construction,

operation and closure of the geologic repository for

high-level radioactive waste. NRC also regulates the

siting, operation, decontamination, decommissioning, and

reclamation of uranium mills, and uranium mill tailings

disposal facilities at both active and inactive mill

sites. NRC also inspects all licensed interim storage

facilities and related vendor activities.

454
Testing NRC or applicant

Inspection

Conformity

Identification

Availability

of Documentation

Obligations of the

Manufacturer/ Vendor

Enforcement

Term

Reciprocity

Standards, Codes

or Regulations

Keywords

NRC Inspectors.

NRC maintains a list of licensed facilities and

certificate holders.

See URL address listed above for further information.

Additional information is also available from the

offices listed above.

To conform to regulatory requirements and abide by

conditions for licensing or certification.

NRC may issue Notices of Violation, impose civil

penalties and issue Orders. All violations are subject

to civil enforcement action and may also be subject to

criminal prosecution.

Not determined for repository. Twenty (20) year

renewable for independent spent fuel storage

installations, licenses and certificates of compliance.

N/A.

10 CFR Parts 40, 60, 61, 72.

nuclear waste; nuclear waste facility; nuclear safety;

waste disposal; waste management; uranium mill tailings;

uranium mills; uranium mill tailings disposal

facilities; spent fuel storage; spent fuel cask;

independent spent fuel installations; interim spent fuel

storage; monitored retrievable storage

455
mrc mm

Product Page

brachytherapy 451

diagnostic tests using radiopharmaceuticals 451

exit signs 451

flooring treated with gamma radiation 451

fuel fabrication, nuclear 451

fuel fabrication facility 449

gamma irradiator 451

gaseous diffusion plant 449

gemstones, radiation treated 451

medical radiation radiotherapy 451

nuclear waste storage 454

nuclear fuel, spent 451

nuclear waste facility 454

nuclear waste 454

nuclear power plants 449

nuclear facility 449, 454

nuclear fuel 451

nuclear safety 449, 451, 454

nuclear fuel cycle facilities 449

packaging, radioactive material 451

radioactive material 451

radiography 451

radiopharmaceuticals, diagnostic tests using 451

radiotherapy, medical radiation 451

reactors, nonpower test and research 449

signs, exit 451

spent fuel storage 454

static elimination devices 451

teletherapy 451

uranium mills 454

waste facility, nuclear 454

waste, nuclear 454

well logging 451

wood flooring treated with gamma radiation 451

456
APPENDIX ! INDEX OF PROGRAM BY PRODUCT/SERVICE

PRODUCT PAGE

accreditation 70. 200

adaptive equipment 301

additives 126, 130, 144

advertisements 406

advertising 406, 436

agricultural aircraft operators 223

agricultural seed 6

agricultural worker safety 351

air conditioners/systems 102, 105, 368. 408

air conditioners, motor vehicle 333

air pollutants 372

air taxi operators 223

aircraft, civilian 223

aircraft repair stations 223

aircraft 142, 223

airports 228

alarms, marine 217

alcohol testers, breath 262

alcohol 289. 291

amateur radio service 397

American Indian jewelry/crafts 184

ammunition 293

animal by-products 30

animal feed 144

animal products 38

animal -derived materials 34

animals 40. 42

anodizing tanks 380

antibiotics, human 147

antimicrobial products (pesticides) 353

antitoxin 150

apparel 311, 414, 430

appliances 102, 105, 368. 408

asbestos mitigation services 381

authentication devices 287

automatic bulkweighing systems 58

457
automobile emissions 317, 321. 323, 327

automobile engines 323

automobile, used, purchase of 412

automobiles, alternative fueled 427

automobiles, government procurement of 445

automobiles, low emission 327

automobiles 254, 258, 317. 321. 323. 327, 412. 427

automotive cleaning sprays 372

automotive driving aids 301

automotive fuels (liquid) 432

automotive parts 321

aviation vehicle engines, off-road 329

aviation 142. 223. 228, 329

barley 46

batteries 190

battery powered equipment for mining 196

beans 54

bedding 311

beef 4

beer 289, 291

beverages, alcoholic 289. 291

beverages 132. 289. 291

biological products 34, 36

biologies, human 150

biologies, veterinary 144

birds, game 50

blasting agents 295

blood alcohol 262

blood banks 150

blood products 150

boat engines 329

boats 210. 217. 219, 329

body armor, police 190

boilers, coal burning 382

boilers for hazardous waste 337

boilers 102, 337, 382, 408

bottled water 132

brachytherapy 451

breath alcohol testers 262

breathing apparatus 111

bridges 237

broadcast equipment 390

458
broadcasts, TV and radio 395

buffalo 50

building products 176. 178, 433

buses 142, 230, 235. 251, 254, 325

butter 12. 132

cable television 390, 399

cable TV equipment 390

cabooses 245

calibration 74, 77, 79

canned foods, low-acid 132 car dealers, used 412

carbon monoxide monitors for mining 196

carburetor sprays 372

care labeling, textile 414

cargo containers 221

cargo tank motor vehicles 268

carpets 311

cars, electric 256

carts, golf 256

catalog sales 418

cellular radiotelephone service 397

certified reference materials 74

CFCs 333, 372

cheese 12, 132

chemicals, organic 297

child resistant packaging (pesticides) 358

children's products 311. 313

choke sprays 372

cigarette testing 405

classing 10

cleaner labeling (household hard surface) 366

cleaning machines, toxic air emissions 377

clothes dryers 102. 368. 408

clothes washers 102. 105. 408

clothing 414. 430

coal mine equipment 194, 196

COBOL 72

coffee 132

collision avoidance systems 217

color additives 126

commercials 406

communication services, wireless 397

459
communications equipment 390, 401

communications procurement 98. 99

communications, satellite 401

compasses, gyro 217

compressors for mining 196

computer graphics 72

computer sales 418

computer security 72. 287

computer sensors 208

computer software 72

computers and related equipment 72. 208. 287, 368. 390

computers, personal 368

conformity assessment recognition 70

construction vehicle engines, off-road 329

construction 178. 237. 433

consumer commodities, packaged 416

consumer product labeling 366

consumer products 309, 366. 372. 416

consumer purchases away from home 412

containers, freight for railroads 249

containers, shipping 221, 264

containers 22, 221, 249, 264, 278

control devices, railroad 241

control tower operators 223

corrosive materials 313

cosmetics, animal 144

cosmetics 126, 128

cotton quality 10

(CP)2 96

crafts, Native American 184 cranes 203

crops 24

cylinders for hazardous materials 278

dairy products 12, 132

data, environmental 85, 87, 89

data, weather 85, 87, 89

data 76

defol iants 355

degreasers 377

derricks 203

detonators 295

diagnostic tests using radiopharmaceuticals 451

460
diesel engines 323, 325, 329

diesel -powered equipment for underground coal mines 194

diesel trucks 325

diesel 424

dietary foods 135. 138

dishwashers 102, 105. 368, 408

dispatchers, aircraft 223

DMS 98

drilling equipment 186

drinking water systems, operators of 346

driver's license, commercial 235

driving aids 301

drugs, human 147

drugs, veterinary 144

drugs 126. 128, 144, 147

dry cleaning instructions 414

dry cleaning machines, toxic air emissions 377

e-mail 98

earth stations 401

EFT 287

eggs 20

electric cables 196

electric motors for mining 196

electric motors 102, 196, 408

electric systems 60

electrical equipment for mines 196

electrical equipment, marine 210, 217

electrical equipment, workplace 200

electrical hazards 313

electronic equipment procurement 98, 99

electronic equipment 85. 98. 99. 153. 208, 287, 400

electronic fund transfer authentication devices 287

electronic products (radiation protection) 153

electronic technologies 208

electronics, medical 390

electroplating, chromium 380

emissions, nonroad vehicle engine 329

emissions, vehicle testing/inspection 331

energy efficiency 102, 105, 368. 370. 408

engineering equipment, marine 210, 217

engines, aircraft 223

engines, diesel 194

461
engines, off-road vehicle 329

environmental preferability for government procurement 319

environmental technologies, new 362, 364

equipment, battery-powered 196

equipment, diesel -powered 194

equipment, marine 203

Eskimo jewelry/crafts 184

exit signs 368, 451

explosives 295

export certification 28, 30, 40

fabrics 311. 414, 430

fans, electric for mining 196

fasteners 67

fax orders 418

federal supply schedule 443

feed, animal 50, 144

filters 107

financial institutions 287

fire protection equipment, marine 210

firearms 190. 291, 293

fi reworks 295

fish 83, 115, 119. 123. 140

fissile material 266

flammable products 313

flight crew 223

flight instructors 223

flocks 44

flooring treated with gamma radiation 451

fluorescent lamps 102. 408

FMVSS 445

foam plastic products 372

food additives 126. 130. 144

food, frozen 22

food inspection personnel 140

foods (general) 22, 132, 135, 140

foods, canned 132

formula, infant 135, 138

FORTRAN 72

freezers 102, 408

frozen food 22

fruits 14, 16, 132

fuel additives 317

462
fuel fabrication facility 449

fuel fabrication, nuclear 451

fuels, alternative 424, 427

fuels, liquid automotive 424

fuels, motor vehicle 317, 424, 427

fuels, non-liquid 427

fungicide applicators 349

fungicides 353, 355, 358

fur 430

furnaces, industrial for hazardous waste 337

furnaces 102, 105, 337, 408

furnishings, textiles 311, 414

game, wild 137

gamma irradiator 451

gas masks 111

gas production equipment 186

gaseous diffusion plant 449

gasoline engines 323, 325, 329

gasoline 317, 424

gaugers, commercial 297

gelatin 137

gemstones, radiation treated 451

goats 44

golf carts 256

good manufacturing practices-16, 18, 54, 132, 135, 138, 144, 147, 152, 156

government procurement (see procurement) 441, 443, 445

grading 4, 10, 12, 14, 16, 20

grain bins 56

grain elevators 56

grain scales 56

grain standards 56

grain test 58

grain weights 56

grain 46. 56, 58

green labeling 319, 370

green lights 370

g uns 190, 291. 293

HACCP 83. 115. 119. 132

hair sprays 372

handcuffs 190

handicapped aids 301, 303

hazardous material tanks 274, 276

463
hazardous materials transport-249. 270. 272, 274, 276, 278. 280

hazardous materials for export 264

hazardous materials (radioactive) 266

hazardous materials/substances 230, 235, 266, 268, 313

hazardous substances storage 335

hazardous waste facilities 337, 339. 341

hazards, electrical, chemical, thermal, mechanical 313

health care facilities 159, 162, 165. 167. 169. 305

health care provider 159, 162, 165. 167. 169

health clinics, rural 162, 169

heaters, wood 343

heating equipment/systems 102, 105, 368. 408

heliports 228

helmets, crash 190

HEPA filters 107

herbs 132

highways 208, 237

hospices 169

hospitals 159, 162, 165. 167, 169. 305

housing (lead in) 376

housing, manufactured 180

housing 105, 176, 178, 180. 368, 376

incandescent lamps 102, 408

incinerators for hazardous waste 337

Indian jewelry/crafts 184

insect repel lants 355

insecticide applicators 349

insecticides 353, 355, 358

inspection personnel, food 140

insulation, home 433

intelligent vehicle-highway system 208

internet sales 418

jewelry/crafts, Native American 184

labels (general) 406, 416

laboratories, clinical 305

laboratories, state 77

laboratory accreditation 52, 67, 70, 289. 197. 345

laboratory testing 159. 162. 169

lamb 4

lamps, mercury vapor 153

lamps, mining 196

lamps 102, 105, 196. 368. 408

464
aser speed measuring devices 260 asers 153, 260 aw enforcement equipment 190, 260, 262

ead paint 176

ead 372. 375

entils 54

idar 260

ifesaving equipment 210

ifting equipment, maritime 203

ight curtain 198

ighting, airport 228

ighting 102, 105, 228, 368, 370, 408

ivestock 24, 32, 40, 42. 44, 48

ocomotive engines 329

ocomotives 194, 239, 241, 245. 247

ongwal Is 196

machine guarding 198

mail orders 418

mammography 153

manufactured housing 180

margarine 132

marine equipment 203, 210. 217. 221. 329

marine safety 210, 213, 215, 217. 219. 221

marine vehicle engines, off-road 329

maritime officer licensing 215

maritime training 213, 215

marking devices, railroad 243

materials handling equipment 203

materials of avian origin 34

materials of animal origin 34

mayonnaise 132

measurement instruments 77, 79, 81

meat/meat products 1, 4, 38. 48. 50, 52, 137

mechanical hazards 313

mechanics, aircraft 223

medical devices, veterinary 144

medical devices, human 156

medical electronics 390

medical examiners, aviation 223

medical radiation radiotherapy 451

medical testing 159, 162, 305

Medicare certification 162, 165, 167

465
methane monitors for mining 196

microwave ovens 153

microwave 60

military procurement 94, 96, 98, 99

milk 38, 132, 320

mining equipment 111. 194, 196

mobile home furnaces 102, 408

motor carriers 230, 235

motorcycle engines 323

motors, electric 408

mouffl in 44

mutual recognition agreement 70

narcotic test kits 190

Native American jewelry/crafts 184

naval equipment 203

naval stores 18

navigational aids, shipboard 217

navigational aids, aviation 228

nicotine 405

NSSP 115. 119

NTEP 58, 81

nuclear energy 107

nuclear facility 449, 454

nuclear fuel cycle facilities 449

nuclear fuel, spent 451

nuclear fuel 451

nuclear power plants 449

nuclear safety 449, 451, 454

nuclear waste storage 454

nuclear waste facility 454

nuclear waste 454

numeric data 76

nutritionals , special 135, 138

nuts 14, 132

office equipment/buildings 105, 368, 370

offshore radiotelephone service 397

oil production equipment 186

oils (edible) 132

oils, animal 297

oils, vegetable 297

ol ives 132

organic chemicals 297

466
organic food 24

outdoor power equipment engines 329 ovens 102, 408

packaged goods 416

packaging, pesticide 358

packaging, radioactive material 451

pagers 397

paint 176, 372, 375

parachute riggers 223

pavement markings 233

pavement 237

peas 54

pesticide applicators 349

pesticide equipment 111

pesticide labeling 366

pesticide safety for workers 351

pesticides 353, 355, 358

pet food 50, 144

petroleum products 297

petroleum underground storage tanks 335

photo-radar 260

physical therapy 169

pilots, aircraft 223

pipe assembler, plastic 272

pipelines 272

plant products 26, 28

plants 8, 26, 28

plating 380

plumbing products 102, 408

police equipment 190, 260, 262

pollution control /monitoring/remediation systems, new-362, 364

pollution prevention equipment 186, 210

pool chemicals, swimming 355

pool heaters 102, 408

pork 1 POSIX 72

poultry 20, 40, 42. 48, 50. 52, 137

power plants 382

power presses 198

presses, presence sensing device for 198

pressure limiting/release devices 268, 272, 274. 276

processed foods 16

467
procurement, government 94, 96, 98, 99. 319. 441. 443, 445

produce, organic 24

product claims 406

programming language validations 72

propellers, aircraft 223

prosthetic aids 301. 303

PUFI 83

pulses 54

pumps, mining 196

purchases by mail, phone and fax 418

purchases by prenotification negative option plan 436

purchases, consumer (away from home) 412

purchases, telephone sales 422

purchases, telephone-billed 420

QMLs 94

QPLs 94, 441. 445

rabbits 20, 50

radar plotting aids 217

radar 260

radiation emitting equipment 153

radiation protection 153

radio broadcasts 395

radio communications, international 401

radio frequency energy 390

radio service, wireless 397

radio stations 395

radio-telephones 60

radio-telephone service 397

radioactive material 451

radioactive materials for transport 266

radiography 451

radiopharmaceuticals, diagnostic tests using 451

radiotherapy, medical radiation 451

radon 360

railroad signals 241

railroad track scales 81

railroads 22, 58, 142, 239. 241, 243, 245, 247, 249, 280

railway car couplers 280

railway cars 22. 239, 243. 245. 247. 249, 280

railway equipment 239, 241. 243

railway tank cars 280

railway track 58

468
ranges 102, 408

reactors, nonpower test and research 449

receivers, loran 217

receivers, satellite 217

receivers, television 153

receivers 153. 217. 390

recognition, conformity assessment 40, 70

recreational vehicle engines 329

reference data 76

reference materials 74

refrigeration units 22

refrigerators 102, 105, 368, 408

rehabilitation services 169

reindeer 50

respirators 111

rice 54

roads 208

robotics 208

rodenticides 353, 355, 358

roof bolsters for mines 196

rope, wire 203

rosin 18

runways, aircraft 228

safety devices, railroad 241, 243

salad dressings 132

salmon, canned 123

satellite communications 401

satellite receivers 217

satellites 85, 217. 401

scale 58. 81

scales, railroad track 81

schools for pilots and mechanics 223

scrapie 44

seafood 83, 115. 119. 140

seed 6

sheep 44

shell eggs 20

shellfish 83. 115. 119. 140

shipping containers 221

ships 210. 217. 219. 221

shotguns 190

shuttle cars 196

469
SIFE 83

signalling devices for mining 196

signals, railroad 241

signs, exit 451

signs, road 233

sleepwear, children's 311

software validation 72

solid waste disposal 339

solvents 377

speech pathology 169

speed indicators, marine 217

speed measuring devices, vehicle 260

spent fuel storage 454

spices 132

spirits, distilled 289, 291

squab 50

standard reference data 76

standard reference materials 74

static elimination devices 451

steering gear, marine 217

storage tanks, underground 335

stoves, wood 343

subscription purchases 436

sunlamps 153

surgical centers, ambulatory 165, 169

surveillance equipment 190

swimming pool heaters 102, 408

tank cars 249, 280

tanks, cargo 268

tanks, electroplating 380

tanks, for hazardous materials 274, 276

tanks, portable 249, 276

tanks, underground storage 335

tea 132

telecommunications , international 401

telecommunications procurement 98, 99

telecommunications 60. 208, 287, 401

telemarketing 422

telephone orders 418

telephone pay-per-call service 420

telephone sales 422

telephone service, wireless 397

470
telephone-billed purchase 420

telephones and related equipment 390

telephones for mining 196

telephones 60. 196. 390

teletherapy 451

television broadcasts 395

television, cable 390. 399

television, digital/advanced 390

television equipment 390

television networks 395

television receivers 153

television, satellite 401

television 153, 390. 395. 399, 401

termiticide applicators 349

termiticides 353, 355, 358

testimonials 406

textiles 414, 430

thermal hazards 313

tires, motor vehicle 258

tobacco testing 405

tobacco 18, 291

toxic substances, air 372, 375, 376, 377, 380, 381, 382

toxic substances 313

toys 313

traceability 74, 77, 79

track, railroad 247

trade fairs 65

trade 65, 70

traffic control devices 233, 260

traffic signals 233

traffic signs 233

trailers 22

transceivers 190

transformers 368

transit vans 251

transit 208

transmitters 85, 190, 390

transportation, food 22. 142

transportation systems, intelligent 208

truck engines 323

trucks, diesel 325

trucks, government procurement of 445

471
trucks, light low emission 327

trucks 230, 235, 254, 258, 323, 325. 327

tubes, cold-cathode discharge 153

tunnels 237

turpentine 18

TV 153. 390. 395. 399. 401

ultrasonic therapy equipment 153

uranium mills 454

USTs 335

vaccine 150

valves, safety 186. 268, 274, 276

valves, surface and subsurface safety 186 vans 251

VCRs 368

veal 1 vegetable seed 6

vegetables 14, 16, 132

vehicle air conditioners 333

vehicle driver, commercial 235

vehicle emissions testing/inspection 331

vehicle emissions 317. 321. 323, 325. 327, 331

vehicle engines, off-road 329

vehicle engines 323, 329

vehicle equipment, motor 254, 258, 333

vehicle fuel economy 254

vehicle inspection programs 331

vehicle, motor fuels 317

vehicle tracking devices 190

vehicles, alternative fueled 427

vehicles, cargo tank motor 268

vehicles, commercial 230, 251

vehicles, government procurement of 445

vehicles, low speed 256

vehicles, low emission 327

vehicles, off-road 329

vehicles, police 190

vehicles, used, purchase of 412

vessels 142, 210, 217, 219, 221

veterinary biologies 36, 144

veterinary drugs 144

veterinary medical devices 144

warehouses 47, 291

472
washing instructions 414

waste disposal, hazardous 341

waste facility, nuclear 454

waste, nuclear 454

waste storage and disposal facilities 339

waste treatment facilities, hazardous 341

waste treatment facilities, solid 339

water, bottled 132

water, drinking 345

water heaters 102, 408

water system operators 347

weapons 190, 291, 293

weather data 85, 87, 89

weather observers 87

weather station 87

weed killers 355

weighing systems 56, 58. 77, 79, 81

welder, certified 272, 280

well logging 451

wells, injection (hazardous waste) 339, 341

wheat 46

wheelchair lifts 301

wheelchairs 303

windows, safety glazing for railway cars 245

wine beverages (less than 7% alcohol) 132

w1ne 132, 289, 291

wines, cooking 132

wireless communications services 397

wood flooring treated with gamma radiation 451

wood stoves 343

wool 430

workplace safety (pesticides) 351

workplace safety 111. 113, 194, 196, 198, 200, 203, 351

x-rays 153. 169

473
APFE»IX II

INFORMATION AVAILABLE FROM

Office of Standards Services

National Institute of Standards and Technology

Gaithersburg, Maryland 20899

(See last page for ordering information)

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

This report is an introduction to voluntary standardization, product

certification and laboratory accreditation for readers not fully familiar with

these topics. It stresses some of the more important aspects of these fields;

furnishes the reader with both historical and current information on these

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

standards; and serves as background for using available documents and

services.

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The ABC's of Certification Activities in the United States (NBSIR 88-3821)

This report, a sequel to NBSIR 87-3576, The ABC'S of Standards -Related

Activities in the United States, provides an introduction to certification for

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The ABC's of the U.S. Conformity Assessment System (NISTIR 6014)

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Directory of U.S. Private Sector Product Certification Programs (NIST SP 903)

This directory presents information from 178 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, a pictorial representation of the organization's mark (if

available), products certified, standards used, certification requirements,

any accreditation or recognition by a U.S. or foreign private sector or

474
government agency, availability of services, methods of cost

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Profiles of National Standards -Related Activities (NIST SP 912).

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Laboratory Accreditation Activities in the United States (NISTIR 4576)

This report, a companion to NBSIR 87-3576 The ABC'S of Standards -Related

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Activities in the United States, is designed to provide information on laboratory accreditation to readers who are new to this field. It discusses

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The National Technology Transfer and Advancement Act (P.L. 104-113) gives NIST

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sector. Congress required NIST to submit a plan for implementing the

coordination activities. Specific activities in strategic standards

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voluntary standards, and conformity assessment procedures are

475
described. Responsibilities of governments, standards developers, and private

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Examination of Laboratory Accreditation Programs in the United States and the

Potential Role for a National Laboratory Accreditation System (NIST GCR 97-

714)

This report presents an initial study of existing U.S. laboratory

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Proceedings of the Open Forum on Laboratory Accreditation at the National

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476
Questions and Answers on Quality, the ISO 9000 Standard Series, Quality System

Registration, and Related Issues (NISTIR 4721)

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the standards. It attempts to answer some of the most commonly asked questions

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More Questions and Answers on the ISO 9000 Standard Series and Related Issues

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Survey on the Implementation of ISO/IEC Guide 25 by National Laboratory

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ISO/IEC Guide 25, General Requirements for the Competence of Calibration and

Testing Laboratories, has been used by many laboratory accreditation programs

worldwide to establish accreditation requirements designed to promote

confidence in the calibrations and testing results of laboratories. National

delegations to the International Laboratory Accreditation Conference (ILAC)

were surveyed to collect information on the implementation and supplementation

of the requirements of ISO/IEC Guide 25 within the context of their countries'

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Directory of International and Regional Organizations Conducting StandardsRelated Activities (NIST SP 767)

This directory contains information on 338 international and regional

organizations which conduct standardization, certification, laboratory

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

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

affiliations of members, U.S. participants, restrictions on membership, and

477
the availability of any standards in English.

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Standards Activities of Organizations in the United States (NIST SP 806, 1996

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which include some type of assessment regarding laboratory capability,

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assist state and local government agencies in carrying out their

478
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479
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480
FORMAT USED FOR EACH ENTRY

DATE INFORMATION

APPROVED BY THE AGENCY

Products or

Services

The products/services covered by this program.

Department/Agency The responsible office/agency/department, as well as their address, telephone, telex, fax and e-mail numbers

and URL address, if available.

Initiated

Compliance

The date the program was initiated.

Whether the program is mandatory, voluntary, or mandatory only under specified circumstances.

Authority The public laws, sections in the Code of Federal

Regulations (CFR) or in the Federal Register which

authorize the agency to conduct the program.

Aim The problems or conditions which prompted the program's

establishment and how the program will or has remedied

them.

Benefits Information on the benefits (decreased accident rate,

improved product quality/safety, improved competition

etc. ) of the program.

Methodology The methodology used by the program to ensure compliance

with certification criteria, such as government

inspection, third party testing, compliance with Good

Manufacturing Practices, etc.

Testing

Inspection

Conformity

Identification

Whether the agency or another specified party is

responsible for any tests conducted on the

product/service.

Whether the agency or another specified party is

responsible for any inspections of the product/service

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

that the product/service has been certified.

481
Availability How information on lists of approved products/suppliers

of Documentation or other documentation on the program can be obtained.

Obligations of the Requirements for testing, inspection, labeling,

Manufacturer/Vendor documentation, submission, notification, etc.. placed on the manufacturer by the agency.

Enforcement The remedies (product recall, marketing ban, product

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

noncompliance with certification criteria.

Term

Reciprocity

The length of time the certification is valid.

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.

482
APPEIDIX IV

LIST OF ACRONYMS AND ABBREVIATIONS

AAHC ACCREDITATION ASSOCIATION FOR AMBULATORY HEALTH CENTERS

AABB AMERICAN ASSOCIATION FOR BLOOD BANKS

AAMA AMERICAN AUTOMOBILE MANUFACTURERS ASSOCIATION

AAR ASSOCIATION OF AMERICAN RAILROADS

AFVS ALTERNATIVE-FUELED VEHICLES

AGA AMERICAN GAS ASSOCIATION

AHAM ASSOCIATION OF HOME APPLIANCE MANUFACTURERS

AMC ARMY MATERIAL COMMAND, DOD

AMS AGRICULTURAL MARKETING SERVICE, USDA

ANSI AMERICAN NATIONAL STANDARDS INSTITUTE

AOA AMERICAN OSTEOPATHIC ASSOCIATION

APHA AMERICAN PUBLIC HEALTH ASSOCIATION

APHIS ANIMAL AND PLANT HEALTH INSPECTION SERVICE, USDA

APIS FAA APPROVED PRODUCTION INSPECTION SYSTEM

ARI AIR-CONDITIONING AND REFRIGERATION INSTITUTE

ASC AMBULATORY SURGICAL CENTER

ASHI AMERICAN SOCIETY FOR HISTOCOMPATIBILITY AND IMMUNOGENETICS

ASME AMERICAN SOCIETY OF MECHANICAL ENGINEERS

ASQ AMERICAN SOCIETY FOR QUALITY

ASTM AMERICAN SOCIETY FOR TESTING AND MATERIALS

BATF BUREAU OF ALCOHOL, TOBACCO AND FIREARMS

BIA BUREAU OF INDIAN AFFAIRS, DOI

BIFS BOILERS AND INDUSTRIAL FURNACES

BOCA BUILDING OFFICIALS AND CODE ADMINISTRATORS INTERNATIONAL

CAC CODEX ALIMENTARIUS COMMISSION

CALEA COMMUNICATIONS ASSISTANCE FOR LAW ENFORCEMENT ACT OF 1994

CAP COLLEGE OF AMERICAN PATHOLOGISTS

CASCO ISO COUNCIL COMMITTEE ON CONFORMITY ASSESSMENT

CBER CENTER FOR BIOLOGICS EVALUATION AND RESEARCH, FDA

CC NTEP OR FGIS CERTIFICATE OF CONFORMANCE

CCC COMMODITY CREDIT CORPORATION

CCPL CERTIFIED COMPLIANT PRODUCTS LIST MAINTAINED BY DISA

CDC CENTER FOR DISEASE CONTROL AND PREVENTION, DHHS

CDER CENTER FOR DRUG EVALUATION AND RESEARCH, FDA

CDL COMMERCIAL DRIVER LICENSE

CDRH CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FDA

CEMS CONTINUOUS EMISSION MONITORING SYSTEMS

CFR CODE OF FEDERAL REGULATIONS

483
CFSAN CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FDA

CLIA CLINICAL LABORATORIES IMPROVEMENT AMENDMENTS OF 1988

CNM CERTIFIED NURSE MIDWIFE

COI CERTIFICATE OF INSPECTION

COLA BATF CERTIFICATES OF LABEL APPROVAL

COLA COMMISSION OF LABORATORY ACCREDITATION

CORF COMPREHENSIVE OUTPATIENT REHABILITATION FACILITIES

(CP)2 ARMY CONTRACTORS/SUPPLIERS CONTRACTOR PERFORMANCE CERTIFICATION

PROGRAM, AMC ARMY MATERIAL COMMAND. DOD

CPL NHTSA CONFORMING PRODUCTS LIST

CPSA CONSUMER PRODUCT SAFETY ACT

CPSC CONSUMER PRODUCT SAFETY COMMISSION

CRP CHILD RESISTANT PACKAGING

CSTDS CABLE SYSTEM TERMINAL DEVICES

CVM CENTER FOR VETERINARY MEDICINE, FDA

DEIP DAIRY EXPORT INCENTIVE PROGRAM

DESC DEFENSE ELECTRONICS SUPPLY CENTER, DOD

DFARS DOD FEDERAL ACQUISITION REGULATION SUPPLEMENT

DHHS U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (DHHS)

DISA DEFENSE INFORMATION SYSTEMS AGENCY

DLA DEFENSE LOGISTICS AGENCY, U.S. DEPT. OF DEFENSE

DMS DEFENSE MESSAGE SYSTEM

DOA U. S. DEPARTMENT OF ENERGY

DOC DECLARATION OF CONFORMITY

DOC U.S. DEPARTMENT OF COMMERCE

DOD U.S. DEPARTMENT OF DEFENSE

DOE U.S. DEPARTMENT OF ENERGY

DOI U.S. DEPARTMENT OF THE INTERIOR

DOJ U.S. DEPARTMENT OF JUSTICE

DOL U.S. DEPARTMENT OF LABOR

DOT U.S. DEPARTMENT OF TRANSPORTATION

DSMA DIVISION OF SMALL MANUFACTURERS ASSISTANCE, CDRH/FDA

E.O. EXECUTIVE ORDER

EFT ELECTRONIC FUND TRANSFER (SYSTEMS)

EIA ELECTRONIC INDUSTRIES ASSOCIATION

EPA ENVIRONMENTAL PROTECTION AGENCY

EPAct ENERGY POLICY ACT

EPCA ENERGY POLICY AND CONSERVATION ACT

ESRD END STAGE RENAL DISEASE

ETV ENVIRONMENTAL TECHNOLOGY VERIFICATION PROGRAM, EPA

FAA FEDERAL AVIATION ADMINISTRATION, DOT

FAO/WHO FOOD AND AGRICULTURAL ORGANIZATION/WORLD HEALTH ORGANIZATION

484
FAR FEDERAL ACQUISITION REGULATIONS

FCAE GSA AUTOMOTIVE CENTER

FCC FEDERAL COMMUNICATIONS COMMISSION

FDA FOOD AND DRUG ADMINISTRATION, DHHS

FDAMA FOOD & DRUG ADMINISTRATION MODERNIZATION ACT OF 1997

FFD&CA FEDERAL FOOD, DRUG AND COSMETIC ACT

FGIS FEDERAL GRAIN INSPECTION SERVICE, GIPSA/USDA

FHA FEDERAL HOUSING ADMINISTRATION, HUD

FHWA FEDERAL HIGHWAY ADMINISTRATION, DOT

FIFRA FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT

FIPS FEDERAL INFORMATION PROCESSING STANDARDS

FIRMR FEDERAL INFORMATION RESOURCE MANAGEMENT REQUIREMENTS

FMCSRS FEDERAL MOTOR CARRIER SAFETY REGULATIONS

FMVSS FEDERAL MOTOR VEHICLE SAFETY STANDARDS

FPMR FEDERAL PROPERTY MANAGEMENT REGULATION

FQHCS FEDERALLY QUALIFIED HEALTH CENTERS

FQPA FOOD QUALITY PROTECTION ACT OF 1996

FR FEDERAL REGISTER

FRA FEDERAL RAILROAD ADMINISTRATION, DOT

FSA FEDERAL SEED ACT

FSA FARM SERVICE AGENCY, USDA

FSIS FOOD SAFETY AND INSPECTION SERVICE, USDA

FSS FEDERAL SUPPLY SERVICE, GSA

FTA FEDERAL TRANSIT ADMINISTRATION, DOT

FTC FEDERAL TRADE COMMISSION

GIPSA GRAIN INSPECTION. PACKERS AND STOCKYARDS ADMINISTRATION, USDA

GMP GOOD MANUFACTURING PRACTICE GUIDELINES (FDA)

GOES-DCS GEOSTATIONARY ORBITING ENVIRONMENTAL SATELLITE DATA COLLECTION

SYSTEM

GPO GOVERNMENT PRINTING OFFICE

GSA GENERAL SERVICES ADMINISTRATION

HACCP HAZARD ANALYSIS CRITICAL CONTROL POINT

HCFA HEALTH CARE FINANCING ADMINISTRATION, DHHS

HEPA HIGH ENERGY PARTICULATE AIR (FILTERS)

HMTUSA HAZARDOUS MATERIALS TRANSPORTATION UNIFORM SAFETY ACT OF 1990

HUD U.S. DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

IACP INTERNATIONAL ASSOCIATION OF CHIEFS OF POLICE

IBIS INTEGRATED BALLISTIC IDENTIFICATION SYSTEM

ICAO INTERNATIONAL CIVIL AVIATION ORGANIZATION

ICBO INTERNATIONAL CONFERENCE OF BUILDING OFFICIALS

ICSP INTERAGENCY COMMITTEE ON STANDARDS POLICY

ICSSL INTERSTATE CERTIFIED SHELLFISH SHIPPERS LIST

485
ILO INTERNATIONAL LABOUR ORGANISATION

I MO INTERNATIONAL MARITIME ORGANIZATION

IRAA INDOOR RADON ABATEMENT ACT OF 1988.

ISM INDUSTRIAL, SCIENTIFIC AND MEDICAL EQUIPMENT

ISO INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

ISTA INTERNATIONAL SEED TESTING ASSOCIATION

ITA INTERNATIONAL TRADE ADMINISTRATION, DOC

ITL INFORMATION TECHNOLOGY LABORATORY, NIST

ITU INTERNATIONAL TELECOMMUNICATIONS UNION. UNITED NATIONS

JACHO JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS

JITC JOINT INTEROPERABILITY TEST COMMAND, DISA, DOD

LACF LOW ACID CANNED FOOD PROGRAM

LAP LABORATORY ACCREDITATION PROGRAM

LBP LEAD BASED PAINT

LSVS LOW SPEED VEHICLES

MAS GSA MULTIPLE AWARD SCHEDULES

MECEA MUTUAL EDUCATIONAL AND CULTURAL EXCHANGE ACT OF 1961

MMS MINERALS MANAGEMENT SERVICE, DOI

MOU MEMORANDUM OF UNDERSTANDING

MQSA MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992

MRA MUTUAL RECOGNITION AGREEMENT

MSCS AMC'S MAJOR SUBORDINATE COMMANDS

MSHA MINE SAFETY AND HEALTH ADMINISTRATION, DOL

MUTCD MANUAL OF UNIFORM TRAFFIC CONTROL DEVICES

MVACS MOTOR VEHICLE AIR CONDITIONERS

NAD NEW ANIMAL DRUG

NAECA NATIONAL APPLIANCE ENERGY CONSERVATION ACT

NAFTA NORTH AMERICAN FREE TRADE AGREEMENT

NATO NORTH ATLANTIC TREATY ORGANIZATION

NCIE NATIONAL CENTER FOR IMPORT-EXPORT ANIMALS PROGRAM

NCSCI NATIONAL CENTER FOR STANDARDS & CERTIFICATION INFORMATION, NIST

NCWM NATIONAL CONFERENCE ON WEIGHTS AND MEASURES

NECPA NATIONAL ENERGY CONSERVATION POLICY ACT

NEDRED NOAA NATIONAL ENVIRONMENTAL DATA REFERRAL SERVICE

NESDIS NATIONAL ENVIRONMENTAL SATELLITE. DATA, & INFORMATION SERVICE

NESHAP NATIONAL EMISSIONS STANDARD FOR HAZARDOUS AIR POLLUTANTS

NF NATIONAL FORMULARY

NF NURSING FACILITIES

NHS NATIONAL HIGHWAY SYSTEM

NHTSA NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION. DOT

NIJ NATIONAL INSTITUTE OF JUSTICE. DOJ

NIOSH NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH, CDC/DHHS

486
NIST NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DOC

NLECTC NATIONAL LAW ENFORCEMENT AND CORRECTIONS TECHNOLOGY CENTER

NLEV NATIONAL LOW EMISSION VEHICLE PROGRAM

NMC NATIONAL MARITIME CENTER, USCG

NMFS NATIONAL MARINE FISHERIES SERVICE, NOAA/DOC

NOAA NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DOC

NOAADIR NOAA ENVIRONMENTAL SERVICES DATA DIRECTORY

NOP NATIONAL ORGANIC PROGRAM

NP NURSE PRACTITIONER

NPIAS NATIONAL PLAN OF INTEGRATED AIRPORT SYSTEM

NPTN NATIONAL PESTICIDE TELECOMMUNICATIONS NETWORK

NRC NUCLEAR REGULATORY COMMISSION

NRTL NATIONALLY RECOGNIZED TESTING LABORATORIES PROGRAM. OSHA

NSA NATIONAL SECURITY AGENCY

NSSP NATIONAL SHELLFISH SANITATION PROGRAM

NTEP NATIONAL TYPE EVALUATION PROGRAM

NUREG U.S. NUCLEAR REGULATORY COMMISSION REGULATORY GUIDES

NVCASE NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEMS EVALUATION

PROGRAM

NVLAP NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM, NIST

NWS NATIONAL WEATHER SERVICE, NOAA/DOC

OET OFFICE OF ENGINEERING AND TECHNOLOGY, FCC

OFPA ORGANIC FOODS PRODUCTION ACT OF 1990

OGWDW OFFICE OF GROUND WATER AND DRINKING WATER, EPA

OIML INTERNATIONAL ORGANIZATION FOR LEGAL METROLOGY

OLES OFFICE OF LAW ENFORCEMENT STANDARDS

OPPT OFFICE OF POLLUTION PREVENTION AND TOXICS, EPA

OSHA OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DOL

OSS OFFICE OF STANDARDS SERVICES, NIST

OSWER OFFICE OF SOLID WASTE AND EMERGENCY RESPONSE, EPA

OTC OVER-THE-COUNTER

OUST OFFICE OF UNDERGROUND STORAGE TANKS, EPA

OWM OFFICE OF WEIGHTS AND MEASURES, NIST/DOC

P.L. PUBLIC LAW

PA PHYSICIAN ASSISTANT

PCS PERSONAL COMMUNICATIONS SERVICES

PCTS POSIX CONFORMANCE TEST SUITE

PIC NOAA PRODUCT INFORMATION CATALOG

PM PARTICULATE MATTER

PMA PREMARKET APPROVAL

PMA FAA PARTS MANUFACTURER APPROVAL

PMPA PETROLEUM MARKETING PRACTICES ACT

487
nnc t v POblX nnnTA ni r ppnmhi urn nnrn att mp p\/p~rr~k>i t mtt nr a r*r~ PORTABLE COMPUTER OPERATING SYSTEM INTERFACE

n n t c PPIb p n a nrrTTnnr n r/^ pu ipt t MPAny atthm \/ c*~tt~ ka EPA PESTICIDE PRODUCT INFORMATION SYSTEM

PPM nnnwTnrn npnpp\nMPr\ MTrnnrrAn\/ PROVIDER PERFORMED MICROSCOPY

nnn a PrPA Tijr nmcnM nnn/rnTTnM nAr^APTiip apt IHL PUIbON PRtVENIION PACKAGING ACT

nc n T PbUl nnrcrMrr o p m c t mp* nn/Trrr rnn tmtttattmp kappmamt/~*ai PREbENCE bENblNG DEVICES FOR INITIATING MECHANICAL POWER PRESSES

DT PROr ICILNCY 1 Lb 1 INb

DTM r 1 m nATTTMT TCCT MAMA/TMCMT PAI1LNI ILbl MANAGLMLNI

PUr 1 PROCESSED UNDER FEDERAL INSPECTION

n\/n rVP PLANT VARIETY PROTECTION

n a OA QUALITY ASSURANCE

HAD L)AP QUALITY ASSURANCE PROGRAM

a a c / c nr QAb/bPC QUALITY ASSURANCE SYSTEMS/STATISTICAL PROCESS CONTROL

QC QUALITY CONTROL

(JML QUALIFIED MANUFACTURERS LISTS

nm

(JPL QUALIFIED PRODUCT LIST

nm a KLKA RESOURCE CONSERVATION AND RECOVERY ACT

RECS COAST GUARD REGIONAL EXAMINATION CENTERS

RHC RURAL HEALTH CLINICS

HI IPC A RHCSA RURAL HEALTH CLINIC SERVICES ACT OF 1977

RIS EPA'S RADON PROFICIENCY PROGRAM INFORMATION SERVICE

DAT RU

NIST OR FGIS REPORT OF TEST

RPP EPA'S NATIONAL RADON PROFICIENCY PROGRAM

n c a RbA THE REFRIGERATOR SAFETY ACT

n c n a RSPA RESEARCH AND SPECIAL PROGRAMS ADMINISTRATION, DOT

RUS RURAL UTILITIES SERVICE

C A A C bAAb APPROVED STATE ADMINISTRATIVE AGENCIES

CAT SAE SOCIETY OF AUTOMOTIVE ENGINEERS

C AC bAb GSA SINGLE AWARD SCHEDULES

C Dm T SOUTHERN BUILDING CODE CONGRESS INTERNATIONAL

c t rr blr L SANITARY INSPECTED FISH ESTABLISHMENTS

c t nc blPb STATE IMPLEMENTATION PLANS

P T TP SITE SUPERFUND INNOVATIVE TECHNOLOGY EVALUATION PROGRAM, EPA

CMP SNF SKILLED NURSING FACILITIES

fur

SNF SKILLED NURSING FACILITIES

SRMS STANDARD REFERENCE MATERIALS

SSA SOCIAL SECURITY ACT

SSSVS SURFACE AND SUBSURFACE SAFETY VALVES

SSV SURFACE SAFETY VALVES

STCE INTERNATIONAL CONVENTION ON STANDARDS OF TRAINING CERTIFICATION &

WATCHKEEPING FOR SEAFARERS

TAPIC TECHNOLOGY ASSESSMENT PROGRAM INFORMATION CENTER

TDDRA TELEPHONE DISCLOSURE AND DISPUTE RESOLUTION ACT OF 1992

488
TSCA TOXIC SUBSTANCES CONTROL ACT

TSOA FAA TECHNICAL STANDARD ORDER AUTHORIZATION

TSOS FAA TECHNICAL STANDARD ORDERS

U.N. UNITED NATIONS

U.S.C. U.S. CODE

UL UNDERWRITERS LABORATORIES. INC.

ULS FCC'S UNIVERSAL LICENSING SYSTEM

UPOV INTERNATIONAL UNION FOR THE PROTECTION OF NEW VARIETIES OF PLANTS

USCG U.S. COAST GUARD, DOT

USDA U.S. DEPARTMENT OF AGRICULTURE

USGS U.S. COAST GUARD, DOT

USP U.S. PHARMACOPEIA

USTS UNDERGROUND STORAGE TANKS

USV UNDERGROUND SAFETY VALVES

USWA UNITED STATES WAREHOUSE ACT

UTQG UNIFORM TIRE QUALITY GRADING STANDARDS

VA U.S. DEPARTMENT OF VETERANS AFFAIRS

VCRS VIDEO CASSETTE RECORDERS

VHA VETERANS HEALTH ADMINISTRATION, VA

VPL VALIDATED PRODUCTS LIST

VS VETERINARY SERVICES, APHIS/USDA

WCS WIRELESS COMMUNICATION SERVICE

WPS EPA WORKER PROTECTION STANDARD

WTB WIRELESS TELECOMMUNICATIONS BUREAU, FCC

WTO WORLD TRADE ORGANIZATION

*U.S. GOVERNMENT PRINTING OFFICE: 1998 - 454-531 / 93233

489



Technical Publications

Periodical

Journal of Research of the National Institute of Standards and Technology—Reports NIST research and development in those disciplines of the physical and engineering sciences in which the Institute is active. These include physics, chemistry, engineering, mathematics, and computer sciences. Papers cover a broad range of subjects, with major emphasis on measurement methodology and the basic technology

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

Nonperiodicals

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

Institute's scientific and technical activities. Handbooks—Recommended codes of engineering and industrial practice (including safety codes) devel- oped in cooperation with interested industries, professional organizations, and regulatory bodies. Special Publications—Include proceedings of conferences sponsored by NIST, NIST annual reports, and

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

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 NIST under the authority of the National Standard Data Act (Public

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

bimonthly for NIST 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 Institute on building

materials, components, systems, and whole structures. The series presents research results, test methods, and

performance criteria related to the structural and environmental functions and the durability and safety

characteristics of building elements and systems.

Technical Notes—Studies or reports which are complete in themselves but restrictive in their 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 NIST under the sponsorship of

other government agencies.

Voluntary Product Standards—Developed under procedures published by the Department of Commerce

in Part 10, Title 15, of the Code of Federal Regulations. The standards establish nationally recognized

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

the characteristics of the products. NIST administers this program in support of the efforts of private-sector

standardizing organizations.

Order the following NIST publications—FIPS and NISTIRs—from the National Technical Information

Service, Springfield, VA 22161.

Federal Information Processing Standards Publications (FEPS 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 NIST pursuant to the Federal Property and Administrative Services Act of 1949 as amended, Public Law 89-306 (79 Stat. 1127), and as implemented by Executive Order 11717 (38 FR 12315, dated May 11, 1973) and Part 6 of

Title 15 CFR (Code of Federal Regulations).

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

NIST for outside sponsors (both government and nongovernment). 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.