Products and Services - NIST

U.S. DEPARTMENT OF COMMERCENational Bureau of Standards

NBS Special Publication 714

Federal GovernmentCertification Programs for

Products and Services

Robert B. Toth, Editor

NBS NBS NBS NBS NBS NBS MBS^ NBSiS NBS NBS NBS NBS NBS NBS NBS NBS NBSNBS NBS NBS NBS NBS NBS NBS NBS NBS AiS NBS NBS NBS NBS NBS NBS NBS NBS NBSNBS NBS NBS NBS NBS NBS NBS NBSNBS AtS NBS NBS NBS NBS NBS NBS NBS NBS NBSNBS NBS NBS NBS NBS NBS NBS NBS NBSiS NBS NBS NBS NBS NBS NBS NBS NBS NBSNBS NBS NBS NBS NBS NBS^NBS NBS AiS NBS NBS NBS NBS NBS NBS NBS NBS NBSNBS NBS NBS National Bureau ofStandards

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100

TM he National Bureau of Standards' was established by an act of Congress on March 3, 1901. TheM Bureau's overall goal is to strengthen and advance the nation's science and technology and facilitate

their effective application for public benefit. To this end, the Bureau conducts research and provides: (1) a

basis for the nation's physical measurement system, (2) scientific and technological services for industry andgovernment, (3) a technical basis for equity in trade, and (4) technical services to promote public safety.

The Bureau's technical work is performed by the National Measurement Laboratory, the National

Engineering Laboratory, the Institute for Computer Sciences and Technology, and the Institute for Materials

Science and Engineering

.

The National Measurement Laboratory

Provides the national system of physical and chemical measurement;

coordinates the system with measurement systems of other nations andfurnishes essential services leading to accurate and uniform physical andchemical measurement throughout the Nation's scientific community, in-

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

Government agencies; conducts physical and chemical research; develops,

produces, and distributes Standard Reference Materials; and provides

calibration services. The Laboratory consists of the following centers:

• Basic Standards^• Radiation Research• Chemical Physics

• Analytical Chemistry

The National Engineering Laboratory

Provides technology and technical services to the public and private sectors to

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

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

tains competence in the necessary disciplines required to carry out this

research and technical service; develops engineering data and measurementcapabilities; provides engineering measurement traceability services; develops

test methods and proposes engineering standards and code changes; develops

and proposes new engineering practices; and develops and improves

mechanisms to transfer results of its research to the ultimate user. TheLaboratory consists of the following centers:

Applied Mathematics

Electronics and Electrical

Engineering'

Manufacturing Engineering

Building TechnologyFire Research

Chemical Engineering"

The Institute for Computer Sciences and Technology

Conducts research and provides scientific and technical services to aid

Federal agencies in the selection, acquisition, application, and use of com-puter technology to improve effectiveness and economy in Governmentoperations in accordance with Public Law 89-306 (40 U.S.C. 759), relevant

Executive Orders, and other directives; carries out this mission by managingthe Federal Information Processing Standards Program, developing Federal

ADP standards guidelines, and managing Federal participation in ADPvoluntary standardization activities; provides scientific and technological ad-

visory' services and assistance to Federal agencies; and provides the technical

foundation for computer-related policies of the Federal Government. The In-

stitute consists of the following centers:

Programming Science andTechnologyComputer Systems

Engineering

The Institute for Materials Science and Engineering

Conducts research and provides measurements, data, standards, reference

materials, quantitative understanding and other technical information funda-

mental to the processing, structure, properties and performance of materials;

addresses the scientific basis for new advanced materials technologies; plans

research around cross-country scientific themes such as nondestructive

evaluation and phase diagram development; oversees Bureau-wide technical

programs in nuclear reactor radiation research and nondestructive evalua-

tion; and broadly disseminates generic technical information resulting from

its programs. The Institute consists of the following Divisions:

CeramicsFracture and Deformation

PolymersMetallurgy

Reactor Radiation

'Hcadquariers and l aboratories ai Gailhersburg, MD, unless otherwise noted; mailing address

Gailhcrsburg. MD 20899.

'Some divisions within the center are located at Boulder, C O 80.10.V

'Located at Boulder, CO, with some elements at (iaithersburg. Ml)

NBS Special Publication 714

Federal GovernmentCertification Programs forProducts and Services

Prepared for:

Office of Product Standards Policy

National Bureau of Standards

Gaithersburg, MD 20899


R. B. Toth Associates

Issued April 1986

U.S. Department of CommerceMalcolm Baldrige, Secretary


Ernest Ambler, Director

Library of Congress U.S. Government Printing Office

Catalog Card Number: 86-600516 Washington: 1986


Special Publication 714

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

Spec. Publ. 714

157 pages (Apr. 1986)

CODEN: XNBSAV

For sale by the Superintendent

of Documents,

U.S. Government Printing Office,

Washington, DC 20402

Foreword

This volume is the second of three listings of certificationprograms in the United States. NBS Special Publication 703, publishedin August 19 85, provided information on private sector programs; thecurrent work is devoted to Federal government programs; and a compila-tion of state programs is under way. These databases will combineto furnish a comprehensive source of information to respond to theneeds of a vast and broad array of public and private sector organi-zations .

Interest in product certification stems from any of a numberof economic, procurement, health and safety, equity, or otherconsiderations. Federal agencies, manufacturers, distributors,state government officials, and others may find this directory tobe of value for identifying pertinent programs, the nature of thecertification activities, program requirements, standards used,and other relevant information.

Dr. Stanley I. Warshaw, DirectorOffice of Product Standards Policy

iii

Acknowledgements

This directory could not have been compiled without thecontributions and cooperation of many key people responsible forstandardization and certification programs at Governmentagencies. They deserve the thanks of those who worked on thisproject and all who use the directory. Walter Leight, NBS Officeof Product Standards Policy, provided guidance and direction andMaureen Breitenberg contributed her expertise and experience.Norman V^. Lemley, U.S. Coast Guard, was most generous inproviding information on the Government's earliest certificationprogram.

Special thanks are due the staff of R. B. Toth Associateswho acquired and organized this volume for publication.

Robert B. TothEditor

iv

Abstract

This directory presents information on 61 U.S. Governmentcertification programs for products and services. Entriesdescribe the scope and nature of each certification program,testing and inspection practices, standards used, methods ofidentification and enforcement, reciprocal recognition oracceptance of certification, and other relevant details.

This directory is part of an ongoing NBS effort to establishand maintain a comprehensive database on standards, regulations,certification programs and related information. This materialhas been compiled to meet the needs of government, industry, andthe public for information on U.S. Government certificationprograms in accordance with the requirements of the U.S. TradeAgreements Act of 1979.

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

V

CONTENTS

Page

Foreword ill

Acknowledgements iv

Abstract v

Introduction 1

Alphabetic Listing of Government Departments and Agencies... 9

Index By Product or Service Certified 141

vi

Introduction

Classifying Certification Programs

The public has traditionally looked to government to provideprotection and prevent hazardous conditions. In many areas the U.S.

Federal Government accomplishes this through laws that establishregulations and standards. In some instances, users need assurancethat products or services comply with the regulations or standards.This need usually arises because only sophisticated or expensiveassessments - design analysis and/or testing - can provide each userwith the necessary level of assurance that a product or service willnot harm the user nor the public at large. The process of assessment,then marking or listing the product or service so as to indicatecompliance, is generally termed certification.

Federal Government certification programs can be classified intothree general categories:

1. Certification of products or services which directly affectthe health or safety of the user or the public;

2. Programs to avoid extensive product testing to demonstrateconformance at each procurement;

3. Programs to provide a uniform basis for trade by objectiveevaluation of the quality and condition of products

.

Of the 61 Federal Government certification programs described inthis directory, many include elements of more than one category. Aslisted on the following page, 19 can be classified as Category 2 or 3

programs; the remaining 42 Category 1 programs directly affect healthand safety.

Nearly all Category 1 certification programs are mandatory.Affected products cannot be sold or used, except for carefullyrestricted experimental purposes, until they have been judged safe.In some cases, such as drugs and medical devices, products must notonly be harmless, but they must also be effective. Except for eggs andtobacco. Category 3 programs are voluntary. Producers and distrib-utors participate in these certification programs because theirproducts have wider customer acceptance or can command better priceswhen marked "choice" or "Grade A".

Nearly all Category 2 programs are basically voluntary in thatproducers or distributors can sell their products in the open marketwithout Government certification. However, if these products are to be

1

Category 2 Certification Programs

Avoiding Repetitive Extensive Conformance Deroonstration

Department of Defense- Qualified Products Lists

General Services Administration- Qualified Products Lists

Rural Electrification Administration- Approved Products Lists

Department of Commerce- Measuring Instruments- Input/Output Channel Interfaces

Environmental Protection Agency- Automotive Aftermarket Parts

Department of Housing and Urban Development- Building Products

Department of Transportation- Breath Alcohol Testers

Department of the Treasury- Electronic Fund Transfer Authentication Devices

Veterans Administration- Self Propelled and Motorized Wheelchairs

Category 3 Certification Programs

Uniform Grading of Quality and Conditions

Department of Agriculture- Eggs and Dairy Products- Fresh and Processed Fruits and Vegetables- Poultry and Meats- Turpentine and Rosin- Tobacco

Department of Commerce- Processed Fish and Shellfish

bought by Government agencies or with funds provided or guaranteed bythe Government, certification is mandatory. The largest program ofthis type is operated by the Department of Defense. Its QualifiedProducts Lists (QPL's) are used throughout the world not only by U.S.

and foreign military agencies, but many commercial organizations suchas aircraft and electronic equipment manufacturers and their customers.Of the more than 38,000 military specifications and standards, fewerthan 1300 (3.4%) require qualification testing and establishment of aQPL.

2

The Department of Defense has strict criteria for its QPL's. Oneor more of the following must apply:

(a) Tests to determine compliance with the specification exceed30 days (720 hours)

.

(b) Quality conformance inspection requires special equipment notcommonly available.

(c) The products are emergency life saving equipment or arecritical to life survival.

General Services Administration has a similar program, with 80 QPL's(1.3%) among its 6000 Federal specifications/ standards, and productdescriptions

.

While the private sector often uses these QPL's merely as buyer'sguides, for a variety of reasons (including product liability) manybuyers will purchase products only from sources that have demonstratedtheir military specification requirements and being listed on thepertinent QPL. Small businesses have found this technique to beparticularly cost-effective to gain entry into a market.

Certification for Safety and Health

Category 1 certification programs are the most visible andpervasive. With few exceptions, nearly every certification program inthis category has been mandated by Congress in reaction to majordisasters or to protect the public from unhealthy or hazardousconditions that could not be controlled adequately by traditionalmarket factors. The oldest Federal certification program illustratesthe relationship between legislation and certification.

In the early nineteenth century steamboats were a major, easilyobserved indicator of America's growing industrial and commercialstrength. However, boiler explosions were common occurrences and tookmany lives. These disasters made a real impression on the public sincethey occurred not on the high seas, or in remote areas, but on heavilytrafficked rivers and harbors, often near cities and towns. Harrowingdescriptions by spectators and survivors spread throughout the country.Congress was reluctant to act because it would be "...adverse to fetteror discourage the ingenuity and skill for which the artists of thiscountry are so distinguished...." In many circles, including Congress,it was felt that the prudent businessman would see to it that hisequipment was properly designed and operated because of the tremendousloss he would incur should there be an accident. Nevertheless, boilerexplosions continued at a disastrous rate. In 1832 alone, fourteenpercent of this country's steam vessels were destroyed by suchoccurrences, and over one thousand people were killed. Between 1830

3

and 1838, Presidents Jackson and Van Buren periodically requestedCongress to take action.

In the Spring of 1838 explosions on three steamboats killed morethan a thousand. That year Congress enacted legislation which requiredperiodic regulatory inspection and certification of ship boilers andmachinery. Subsequent legislation in 1852 and 1871 provided a systemof requirements including establishment of maximum permitted steampressure, instituting hydrostatic overpressure testing, and extendinginspection from boiler fabricators to also include boiler materialssuppliers. Certification was a basic element of this system.

While steamboat boiler explosions fell off markedly, boilerscontinued to explode ashore with considerable frequency, but theeffects were usually confined to factory sites. The general public wasnot affected directly as in the case of steamboats, so public clamorfor legislation was not raised until 1907, when a catastrophic boilerexplosion in a shoe factory in Brockton, Mass. led to legislation bythe Commonwealth of Massachusetts. This was the first legal code forsteam boiler construction by a state and other states soon followedsuit. The American Society of Mechanical Engineers then undertookdevelopment of its Boiler Code, which was first published in 1914.This Code has since been adopted by most states, and in 1969 selectedsections were adopted by the Coast Guard for application on steamboats.Self-certification by equipment manufacturers and governmentcertification either by a government agency or a designated third-partyinspection agency, are basic elements of boiler safety assurance onland and sea.

The most comprehensive Federal certification program is unique inthat it was not established as a result of public clamor but at theinstigation of the industry that would be regulated. Immediately afterWorld War I, the nascent aircraft manufacturing industry recognizedthat the public would more likely have sufficient confidence to flyregularly if their airplanes had been tested and certified safe forflying by the Federal Government. A certification program was proposedby industry that included assessment and certification of the detaileddesign; certification of the production process with special emphasison quality assurance; and an airworthiness certificate for eachaircraft, engine and propeller produced by the certified facility. Thefirst aircraft was certified in 1926. Interestingly, in these earlyyears, the Government delegated certification of airworthiness forproduction aircraft to Underwriters Laboratories.

The rigorous testing and subsequent certification by the U.S.

Government resulted in a level of assurance and confidence which becamerecognized throughout the world. This product certification programcontributed in no small measure to the sales of American aircraft. Thepreeminent position earned by American aircraft manufacturers in theworld market continues to this day. Since those days, the aircraftcerti f i oat i - program has encompassed nearly every critical aspect of

4

aviation. In addition to certification of aviation products, theFederal Aviation Administration certifies pilots and mechanics, theirinstructors, and their schools, the airlines, airports, repairfacilities, and many other elements. This comprehensive approach hasbeen adopted by most countries that manufacture or operate aircraft.

The U.S. Department of Transportation is responsible for thewidest range of Federal certification programs. These programs alsoprobably have the largest actual or potential monetary impact. Inaddition to certifying ships, recreational boats, and aircraft, theDepartment of Transportation has certification programs for automo-biles, all types of containers for shipping hazardous materials, aswell as pipelines.

Food and Drug Administration (FDA) no doubt has responsibility forprotecting the greatest number of lives. Its certification programsinclude not only foods and drugs for human consumption, but also thosefor animals with special attention to those elements that affect thefood chain. Medical devices of all kinds require FDA certification.Unlike the FAA, which implements its comprehensive certificationprogram on the basis of a single, all-inclusive law, FDA is reponsiblefor enforcing a variety of individual programs defined by Congress in ahalf dozen laws.

Interrelationships and International Developments

The specialized responsibilities of Federal agencies and themandates of Congress may confuse those who are not familiar withFederal certification programs. An importer of television sets, forexample, requires not only Federal Communications Commissioncertification, but FDA certification that viewers' eyes will not beexposed to harmful radiation from the cathode ray tube. A wholesalerof seafood products needs to be aware of grading programs of theDepartment of Commerce's National Marine Fisheries Service, the specialrequirements of FDA's Shellfish Sanitation Branch, and the generalrequirements for sanitation, labelling and plant identification set byFDA's Bureau of Foods. This directory is intended to assist inidentifying pertinent and related certification programs.

Most Federal certification programs have in the past beenestablished to meet domestic needs. Recently, however, the U.S. hasoriginated certification programs in response to internationalinitiatives. International organizations established by treaties towhich the United States is signatory set product standards andregulations to alleviate specific problems, usually affecting safety orhealth, encountered in international trade. Certification is a commontechnique to assure compliance. The establishment of a U.S. Governmentcertification program enables U.S. companies to comply and continue toengage in international trade.

5

hs a result of the International Convention for Safe Containers,the U.S. Coast Guard has been designated this nation's CertifyingAuthority. A certification program has been established complying withrequirements of the Convention for design approval, testing andcertification, including affixing a safety approval plate to eachcontainer. Without this plate, a container cannot be entered intointernational traffic. If the container is refrigerated, or if it is arefrigerated trailer, another certification program applies. TheUnited Nations Economic Commission for Europe has set requirements fortransporting perishable food which include design approval, testing,inspection and certification. To enable U.S. exporters to continue touse U.S. -made refrigerated containers and vehicles, the Department ofAgriculture's Office of Transportation has been designated the U.S.certifying authority and has established a certification program inaccordance with United Nations criteria. The U.S. Department of Laborcertifies maritime cargo handling equipment as complying with theInternational Labor Organization Convention for cranes, derricks, wirerope and other equipment used to load and unload ships. Standards andcertification requirements set by the United Nations for packinghazardous materials resulted in the of Department of Transportation'sMaterials Transportation Bureau being designated the "NationalCompetent Authority" to evaluate and issue approval and conformancecertificates for a wide variety of tanks and other types of packaging.

Few (if any) new Federal Certification programs are expected inthe foreseeable future except those mandated by internationalrequirements. In these cases, the Federal Government probably willparticipate only at the urging of industrial sectors which would beadversely affected if the certification process were not available tothem.

Certification and the National Bureau of Standards

The U.S. Trade Agreements Act of 1979 implemented U.S. acceptanceof the Agreement on Technical Barriers to Trade (also known as the"Standards Code") of the General Agreement on Tariffs and Trade (GATT).The Act assigned to the Department of Commerce responsibility tomaintain an information center for standards and standards-relatedsubjects, such as certification. The National Bureau of StandardsOffice of Product Standards Policy carries out this departmentalresponsibility through its National Center for Standards andCertification Information (NCSCI), which maintains a reference collectionconsisting of data on 240,000 standards, specifications, and relatedmaterials. NCSCI exchanges standards information with similar nationalcenters in other countries and responds to requests for informationfrom governmental and private sector organizations, as well asindividuals. Besides specifications and standards, NCSCI seeks,maintains, and disseminates information on certification programs andactivities as they relate to the application and use of specificationsand standards.

6

In the area of certification, the Office of Product Standards Policyaims to improve the accessibility, understanding, and acceptability ofcertification programs. Specific objectives include help forinterested parties in acquiring information on certification activitiesand facilitating the acceptance of U.S. based certification data byboth domestic and foreign jurisdictions.

This directory is the result of one phase of the efforts initiatedby NBS's Office of Product Standards Policy to accomplish itscertification-related objectives. It is a companion volume to NBS SP703 which lists private sector certification programs, and a thirdvolume on state programs, currently under development. It will aid inrecognizing the diversity and therefore the complexity of U.S.

certification activities, and will serve as a useful reference forfinding out about specific programs orperated by U.S. Governmentagencies

.

Organization of the Directory

Sixty-one certification programs are arranged in alphabetic orderby department or agency name and, where there is more than onecertification program, in alphabetic order by name of the product orservice. The index provides the quickest route to identify responsibleagencies. Numerous synonyms and cross-references are provided. Eachentry includes a block of keywords. These synopsize the scope of eachcertification program and, as such, assist the directory user to findpertinent information. These keywords provide the capability forsimple computer search at some time in the future, and for that reasonare separated by semicolons - the convention that is utilized in mostsearch software.

Considerable effort was made to be comprehensive. More than 100U.S. Government organizations were invited to provide information anddocumentation relevant to their certification programs. Informationfor the entries was voluntarily provided by the respondents. OtherFederal organizations concerned with certification activities that arenot included in this directory are invited to send pertinentinformation to:

National Center for Standards and CertificationInformation (NCSCI)

Office of Product Standards PolicyNational Bureau of StandardsAdministration Building, Room A629Gaithersburg, MD 20899

U.S. Government agencies are also encouraged to keep NBS informedof changes in name or address, or in the nature of their programs. Inaddition to this directory, NCSCI maintains a publicly accessiblereference collection of current materials on U.S. Governmentcertification programs.

7

other NCSCI Documents of Possible Interest

In addition to this directory, NCSCI has published three relateddirectories

:

- NBS SP 649 Directory of International and RegionalOrganizations Conducting Standards-Related Activities /

April, 1983,

- NBS SP 681 Standards Activities of Organizations in the UnitedStates , August 1984, and

- NBS SP 703 Private Sector Product Certification Programs in theUnited States , August, 1985.

A new microfiche revision of

- NBS SP 329 Index of U.S. Voluntary Engineering Standards ,

May, 1975

lists U.S. Voluntary Standards by key words in the titles.

NCSCI is also preparing a directory of State certificationprograms. Further information on these publications and activities canbe obtained from NCSCI at the address listed above.

8

ALPHABETIC LISTING OF GOVERNMENT DEPARTMENTS AND AGENCIES

Products orServices

Dairy Products

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection

ConformityIdentification

U.S. Department of AgricultureAgricultural Plarketing ServiceDairy Division, Room 2750-SWashington, D.C. 20250(202) 382-9382

1925

Voluntary

CFR Title 7 Part 58 and AgriculturalMarketing Act of 1946

Orderly trade in processed dairy products andassurance of consistent quality of suchcommodities

Identification of qualified producers.Grading of selected dairy products.Consistent nomenclature for buying andselling processed dairy products.

Certifier and program administrator

Pre-marketing evaluationAssessment prior to government purchase

Government agency provides testing,inspection, audit, and site approval.State governments cooperate in some phases.

Government labsGovernment accredited labs

GovernmentState government

List of approved dairy plants.Authorized grading marks are applied on productsfor which grading standards are established.

9 I

Availabilityof Documentation

Obligations ofManufacturer/Vendor

Enforcement

Terra

Reciprocity

Standards, Codes^or Regulations

Keywords

List of approved dairy plants isupdated quarterly; available from aboveaddress

.

Approved dairy plants must maintainquality control.

DelistingProduct recall

Dairy plants are reinspected two to four timesper year.

Other Federal agenciesState agencies

Agency prepares all criteria documents

grading; dairy products; butter; cheese; foodquality;

10

Products orServices

Fresh Fruits, Vegetables, Nuts, andRelated Products

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Inspection




U.S. Department of AgricultureAgricultural Marketing ServiceFruits and Vegetables Division, Room 2056-SWashington, D.C. 20250(202) 447-5697

1917

Voluntary

Agricultural Marketing Act of 1946

Orderly trade in fresh fruits andvegetables based on standard nomenclature.Common basis for settling market disputesover quality of products.

Improve efficiency in buying and sellingproduce based on official and standardizedgrading which is consistent throughout thenation. Inspection certificates are acceptedin court as prima facie evidence of producecondition at the time of inspection.

Both certifier and program administrator

Voluntary premarketing evaluationVoluntary post marketing assessmentAssessment prior to government purchase

Third party certification

Federal Government inspectionInspection by State government inspectorstrained by the USDA

Certificate of Inspection

There are no lists of participatingproducers.

Must have a financial interest in theproduct. Pay assessed fee for servicerendered.

11

Enforcement

Term

Standards, Codes,or Regulations

Although nearly all aspects of thisprogram are voluntary, a full range ofenforcement options apply to shipperswho practice fraud.

Certification made on lot by lot basis.

Grading criteria are established byAgricultural Marketing Service.USDA grade marking is recognizednation-wide and world-wide in both privateand public sectors.

Keywords grading; fruits; vegetable; nuts; foodguality

;

12

Products orServices

Meats, Prepared Meats, and Meat Products(beef, lamb, veal, calf, and pork)

Department Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Methodology

Testing

U.S. Department of AgricultureAgricultural Marketing ServiceLivestock Seed DivisionMeat Grading and Certification Branch, Room 2638-SWashington, DC 20250(202) 382-1246Telex: 89491

1946

Voluntary

Agricultural Marketing Act of 1946(as amended).

To facilitate the marketing of livestock andmeat.

In FY 1982, the Meat Grading and Certification(MGC) Branch graded an estimated 11.9 billionpounds of beef, 271.5 million pounds of lamb,and 38.3 million pounds of veal and calf. Thisrepresents approximately 53 percent of thecoramercial beef slaughter or two-thirds of thesteers and heifers slaughtered under Federalinspection. These figures also represent 76percent of the commercial lamb slaughter and 10percent of the commercial veal and calfslaughter. Additionally, the MGC Branchcertified approximately 2.0 billion pounds ofmeat and meat products in FY 1982 for buyerssuch as Department of Defense, LivestockIndustry Promotion Corporation, and the FederalSchool Lunch Program.

The MGC Branch provides onsite certificationof meats and meat products by the physical «

examination of product characteristics duringthe production process prior to the purchase.

Inspection by MGC Branch personnel.

Reguired tests are performed in Governmentlaboratories.

13

Inspection MGC Branch personnel


Enforcement

Term

Reciprocity


Approved U.S. Department of Agriculture (USDA)stamps and roller brands are applied in compliancwith applicable standards or specifications.

USDA certification is withheld from productsnot complying with approved standards or speci-f icat ions

.

Continuous inspection on a voluntary basis

None

The agency develops and maintains its ownUSDA approved standards and specificationsfor the various meat items.

Keywords meat; meat products; grading;

14

Products or Parts, Materials and Equipment for RuralServices Electric and Telephone Systems

Department/Agency U.S. Department of AgricultureRural Electrification Administration (REA)14th and Independence Avenue, NW.Washington, DC 20250(202) 382-9082, Electric(202) 382-8663, Telephone

Initiated About 1938

Authority 7 CFR 1701

Aim To minimize capital requirements andcontrol the quality of materials and equip-ment incorporated into rural electric andtelephone systems. The evaluation and listingof material and equipment insures the availa-bility of suitable products at reasonable costsand, toqether with REA standards for con-struction and installation, provides animportant element of loan security.

Benefits The standardization and product eval-uation program yields many economies in theconstruction, operation, and maintenance ofrural electric and telephone systems thusassuring dependable service at affordablerates

.

Agency Function

Type of Program

Certifier

Electric and telephone systems receivingfinancing administered by REA shall use materialsand eguipment evaluated and listed by REA.

Methodology

Testing

Government design review and testing

Government labManufacturers' labs

Conformity Approved manufacturers and suppliers forIdentification rural electric systems are included in

REA Bulletin 43-5, "List of Materials Accept-able for Use on Systems of REA Electrifi-cation Borrowers". The 1985 issue containsover 185 categories of material and eguipmentfrom over 200 manufacturers.

15

Availability ofDocumentation

Approved manufacturers and suppliers forrural telephone systems are listed in REABulletin 344-2, "List of Materials Acceptablefor Use on Telephone Systems of REA Borrowers",

Bulletin 43-5 and 344-2 are available on asubscription basis from the Superintendentof Documents, Government Printing Office,Washington, DC 20402

Enforcement

Term


Delisting

Indefinite; Bulletin 43-5 is publishedyearly and supplements are issued guarterly.Bulletin 344-2 is printed on a two-year basisfollowed by eleven supplements.

REA prepares product standards which defineperformance and design reguirements togetherwith acceptance criteria.

Keywords approved products lists; acceptablematerials; components; electric systems;distribution; transmission; telephone; elec-tronic; microwave; telecommunications; radio-telephone; central office eguipment; privatebranch exchanges;

16

Products or Poultry, Shell Eggs, Egg Products, andServices Rabbits

Department/Agency U.S. Department of AgricultureAgricultural Marketing ServicePoultry DivisionGrading Branch, Room 3938-SWashington, DC 20250(202) 447-3271 Telex: 89-491TWX; 710-822-9424 and 710-822-1104

Initiated 1917

Compliance Mandatory for all products cited ifservice is rendered. However, gradingof poultry, shell eggs, and rabbits isnot mandatory and is provided only toplants requesting the service.

Authority Laws:

Agricultural MarketingAct 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 - RegulationsGoverning the Voluntary Grading of PoultryProducts and Rabbit Products and U.S. Classes,Standards, and Grades (7 CFR Part 70)

Voluntary egg products inspection -

Regulations Governing the VoluntaryInspection and Grading of Egg Products(7 CFR Part 55)

Shell egg grading - Regulations Govern-ing the Grading of Shell Eggs and UnitedStates Standards, Grades, and WeightClasses for Shell Eggs (7 CFR Part 56)

Mandatory egg products inspection -

Regulations Governing the Inspection ofEggs and Egg Products (7 CFR Part 59)

17

Aim Voluntary:To develop and improve standards ofquality, condition, quantity, grade, andpackaging, and recommend and demonstratesuch standards in order to encourageuniformity and consistency in commercialpractices and enhance the orderly andefficient marketing of poultry andpoultry products.

Mandatory:

To assure that the health and welfare ofconsumers is protected by adoption ofmeasures for assuring that eggs and eggproducts distributed to them and used inproducts consumed by them are wholesomeand labeled properly.

Benefits Third party evaluationEasier dispute settlementMore accurate market price reportingMore equitable competitionFewer rejections at destinationEstablished buying guides (specifica-tions )

Reduced illnessUpgraded product quality

Agency Function Certifier and regulator

Type of Program Pre-market evaluationPost-market evaluationAssessment prior to Government purchaseSpecification developmentInspectionGrading

Methodology GovernmentSampl ingOrganoleptic laboratory testingEvaluation against standardInspectionAudits

Certification by third party certifiers

18

Testing

Inspection




Enforcement

Term

Government laboratoriesApproved State laboratoriesThird party laboratoriesManufacturer's laboratories

GovernmentApproved State government agencies

Stamps (authorized marks)CertificatesLabelingSeals

Single copies of regulations may beobtained from the Agency. Multiplecopies may be obtained from theSuperintendent of Documents, U.S. Govern-ment Printing Office.

Operate in sanitary mannerMaintain volume recordsComply with regulationsPerform reguired laboratory testsReimburse Government for cost ofvoluntary inspections and gradingsProvide access to productsProvide access to eguipment and facili-ties necessary for accomplishingofficial duties.

Product retentionProduct recallWithdrawal of serviceLaboratory comparison samplesRemoval/withhold official identifi-cationReinspect ion/regradingInterruption of operations (mandatoryonly

)

Judicial system

Continuous mandatory inspectionContinuous or intermittent voluntaryinspection

19

Reciprocity Use of licensed State employeesRecognition of certification of ingre-dients by manufacturerRecognition of certification by appro-ved Government laboratoryRecognition of certification ofingredients by other Government agenciesRecognition of inspection stamp of"Agriculture Canada" for egg productsproduced in specifically approvedCanadian plants


See "Authority"

Keywords contract acceptance; egg products;grading; grading branch; poultry;grading; grading branch; poultry;rabbits; shell; eggs; USDA;

20

ProductsServices

or Processed Fruits and Vegetables

Department/Agency U.S. Department of AgricultureAgricultural Marketing ServiceFruit and Vegetable DivisionProcessed Products Branch, Room 0709-SWashington, D.C. 20250(202) 447-4693

Initiated 1931

Compliance Voluntary except for products coveredby Federal or State marketing orders.

Authority CFR Title 7 Part 52 and AgriculturalMarketing Act of 1946

Aim Provide an objective evaluation ofguality and condition of variousprocessed food products and conditionsunder which they are produced.

Benefits Provide a uniform basis for nation-widetrade in processed fruits and vegetables.As of 1984, over 300 plants participatedwith more than 10.5 million tons ofcommodities in 150 categories subject toinspection.

Agency Function Certifier

Type of Program

Methodology

Testing

Pre-market ing evaluationPost-marketing assessmentAssessment prior to Government procurement

Government, testing, inspection, audit,site approval, compliance with goodmanufacturing practices.

Government's labManufacturer's lab used under view ofGovernment inspectionState labs if state is cooperatingin programThird party labs may be used bymanufacturer for guality control

21

Inspection


Availability ofDocumentat ion

Obligations ofManufacturer

Enforcement

Term

Reciprocity


Keywords

Inspection by Government personnel,or cooperating State representatives.

Authorized grade and/or inspectionmarks applied by manufacturer. Govern-ment applied mark is restricted toofficially sampled lots.

List of processing plants undercontract is published annually;available from the above address.

Manufacturer must submit to plantinspection and provision of samples atreguest of agency.

Since bulk of program is voluntary,means of enforcement is withdrawal oflabelling privilege or withdrawal ofservice

.

When Marketing Orders are in effect,agency sponsoring the order, hasauthority for product recall ormarketing ban.

Term is set by contract; activity maybe renewed and/or may provide forcontinuous inspection.

Certificates are recognized by otherFederal agencies for procurement.Certificates of Sampling from Statesare recognized by Agency under certaincooperative agreements.

Most acceptance criteria are based onreguirements or specificationsdeveloped by Federal or Stateagencies; however, sometimes buyerspecifications are used.

fruits; vegetables; processed foods;in-plant Inspection; sanitation; goodmanufacturing prachices; agriculturalmarketing orders; food guality;

22

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection



Refrigerated Vehicles

U.S. Department of AgricultureOffice of Transportation1405 Auditor's Building14th Street and Constitution Avenue, NW.Washington, DC 20250(202) 447-3963

Being established

Mandatory for manufacturers of refrigeratedcontainers intended to be used in Europe.

International Carriage of Foodstuffs Act of1982.

The program is responsive to an inter-national agreement on the transport ofperishable food which aims to promote publichealth and consumer values by assuring thattransport equipment is initially capable ofperforming in a safe and effective manner.

Technical requirements are based on trans-port refrigeration practices in countrieswhich have successful records in commercialtransport of perishable food.

Certifier

Pre-market evaluation

Government design approval, testing, in-spection.

Government labGovernment accredited lab

Government

Lists of approved suppliers and certifiedproductsAn internationally-recognized mark may beinstituted at some time in the future.

Lists available from Office of Trans-portation, the Department of Agriculture

23


Enforcement

Term

Reciprocity


Keywords

Subiect a sample container to specified tests

Del is ting

Indefinite

Recognition by foreign government agenciesand international organizations(For the present, U.S. participation will belimited to certification for U.S. export-ers )

.

U.S Department of Agriculture adopts testreguirements agreed to in the internationalprogram sponsored by the United Nations EconomicCommission for Europe.

refrigerated trucks; refrigerated railcars; perishable foodstuffs; internationalagreement; frozen food;

24

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Tobacco, and Naval Stores

U.S. Department of AgricultureAgricultural Marketing ServiceTobacco DivisionRoom 502 Annex Building300 12th Street, SW.Washington, DC 20250(202) 447-2567

Tobacco - 1935Naval Stores - 1923

Tobacco:

Mandatory only for domestic tobaccosold on designated auction markets andall imported tobacco, except cigar andoriental, offered for importation intothe United States.

Naval Stores:

Voluntary

The Tobacco Inspection ActThe Dairy and Tobacco Adjustment ActThe Naval Stores Act

Protection of producers and othersagainst speculation, manipulation,control and unreasonable price fluctua-tions.

Helps producers move commodities toconsumers guickly, fairly and effi-ciently.


Pre-market ing evaluation

Government grading in accordance withU.S. Official Standard Grades andSpecifications

.

25

Testing

Inspection

Naval Stores:Government lab certifies results ofmanufacturer's lab.

Tobacco:

Government

Naval Stores:Licensed company inspectorsFederal accepted appointees




Enforcement*

Term

Reciprocity


Tobacco:

Government certificates

Naval Stores:

Government certificates and authorizedmark by manufacturer

Documentation is confidential.

Proper lighting and adequate space

Tobacco:

Reduction of sales opportunity orwithdrawal of inspection.

Naval Stores:

Withdrawal of inspection.

Continuous inspection

Recognition of certification by otherFederal agencies and internationalorganizations,

7 CFR Part 29, Subpart C - Standards7 CFR Part 160, Regulations andStandards for Naval StoresAmerican Society for Testing andMaterials, Designation D 233, Samplingand Testing Turpentine

Keywords tobacco; naval stores; turpentine; rosin

26

Products orServices

Evaluation of Measuring Instruments

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection


U.S. Department of CommerceNational Bureau of Standards (NBS)Office of Weights and MeasuresGaithersburg, MD 20899(301) 921-2401

1984

Voluntary

Resolution of the National Conference onWeights and Measures (NCWM) and NBSOrganic Act (PL 81-619)

Provide an evaluation service for produc-ers of specified kinds of measuringinstruments used in commercial tradeprior to acceptance for sale or usewithin the U.S.

Provides a uniform means of recognizingthe measurement quality of specificmodels of measuring instrument and theability of their producers to manufactureinstruments of consistent quality.



NBS provides design approval, testing,inspection, auditing, and site approvaleither directly or jointly with an authorizedlaboratory.

Government approved laboratory(Authorized laboratory indicated above ismost likely to be a certified Statemeasurement laboratory).

State government

Certificates of conformance issued tomanufacturer.List of qualified manufacturers


List published by NBS.


Enforcement

Term

Reciprocity

Standards, Codesor Regulations

Keywords

Manufacturer must mark instrumentsmarketed under the Certificate ofConformance exactly as specified andprovide installation, maintenance, andoperating instructions consistent withthe evaluation report.

Delisting. States may require Certifi-cate of Conformance before allowingdevice to be marketed in the State.

Certificate is valid as long as the typeand model of instrument is producedconsistent with the evaluation report.

Other Federal agencies and State agen-cies. This program is the U.S. basis forrecognition of approved measuring instru-ments within an international systemcurrently being established.

NBS prepares acceptance criteria, takingadvice from NCWM, device manufacturersand participating laboratories and inter-national organizations. The NCWM adoptsthese criteria by consensus vote.

commercial measuring devices; measurementinstruments; state laboratories; legalmetrology; type evaluation; prototype;production control;

28

Products orServices

Input/Output Channel Level Interfaces forInformation Processing Equipment

Department Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Methodology

Type of Program

Testing

Inspection


U.S. Department of CommerceNational Bureau of Standards (NBS)Institute for Computer Sciences andTechnology

System Components DivisionGaithersburg, MD 20899(301) 921-3723

1979

Mandatory for applicable information processingequipment to be purchased by Federal agencies.

Title 15, CFR Part 200

To verify the ability of information processingequipment from one manufacturer to functionsuccessfully with equipment of other manufac-turers.

Federal agencies are able to purchaseinformation processing equipment that has thenecessary level of compatibility. This enablessystems to be assembled or expanded more-readily and with considerably less time fortroubleshooting. This program also enables allsuppliers to compete on an equitable basis.


NBS verification of compliance to specifiedstandards by review of documentation, ordemonstrated use with verified equipment.

Verification of compliance prior to consider-ation for purchase by Government.

Any testing is ordinarily accomplished bythe manufacturer to fulfill requirements of theapplicable standards or the NBS VerificationChecklist.

By purchasing agency

A verification certificate is issued for equip-ment having no significant deviations from theapplicable standard.

A Verification List of equipment conforming tostandards is published and maintained by NBS.

29



Enforcement

Term

Reciprocity

Standards, Codes,Regulations

Keywords

Verification List and Checklist, are availablefrom the agency. Applicable standards areavailable through the National Technicalinformation Service, Springfield VA, 22161.

Suppliers desiring a verification review mustmake a reguest to NBS , identify the make andmodel, provide reguired documentation, andreimburse the agency for costs incurred.

Delisting

Indef ini te

Some States have used the Verification Listin their procurement process.

Federal Information Processing StandardsPublications (PIPS PUBs ) 60-1, I/O ChannelInterface; 61 Channel level Power ControlInterfacel 62, Operational Specifications forMagnetic Tape Subsystems; 63, OperationalSpecifications for Rotating Mass Storage Sub-systems .

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

30

Products orServices

Measurement Calibration Services

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

U.S. Department of CommerceNational Bureau of Standards (NBS)Office of Weights and MeasuresGaithersburg, MD 20899(301) 921-2401

1965

Voluntary

PL 81-619 (NBS Organic Act).

Provide certification of state measurementlaboratory capabilities to calibrate standardsand equipment for measuring mass, length,volume, temperature, and frequency-baseddevices.

Provides basis for consistent results incalibration and tolerance testing amongStates and between States and NBS.Provides measurement equivalency inregulation of interstate commerce.

Program administrator

A joint on-going activity betweenFederal and State Governments toevaluate, up-grade, and train measurementtechnicians in official State weights andmeasures laboratories.

Government inspection and site approval.Installation and maintenance of measure-ment control programs. Program Require-ments in NBS Handbook 143.

All delivery of services within thisprogram is performed by state laborato-ries accredited by a Federal agency.

Inspection Government

31



States receive certificates of accredita-tion and are identified in a list, NBS SP686.Instruments and standards certified by Statelaboratories may be identified by a government-applied mark.

NBS SP686 is available from NBS.


State laboratories are obligated toparticipate in external control pro-grams based on geographical regionswhich include controlled sample testing,round-robin experiments, and continuingeducation for technicians.

Enforcement

Term

Reciprocity


Keywords

NBS exercises influence over Statelaboratories through provision of trace-ability to NBS standards, provision oftraining and by sponsoring the RegionalMeasurement Management Programs. Stateprograms may ban the use of uncalibratedmeasurement eguipment in their regulatoryprograms

.

Indefinite term. Certificates of accred-itation are valid for up to 3 years.

NBS certification of a State laboratorycarries recognition within that State andamong the states and by private organizations.

Criteria documents are developed by NBS.See NBS Handbook 143 available from NBS.

measurement instruments; mass; length;state laboratories; volume; gualitycontrol; temperature; freguency;

32

Products orServices

Processed Fish and Shellfish

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection

U.S. Department of CommerceNational Oceanic

and Atmospheric AdministrationNational Marine Fisheries ServiceNational Seafood Inspection ProgramWashington, DC 20235(202) 634-7058

1958

Voluntary

Agricultural Marketing Act of 1946 (asamended) 50 CFR Parts 260-266

Increase consumer confidence in productswhich bear inspection marks and grade shieldsand provide technical services to the partici-pating industry.

Established quality control for seafoodprocessing operations has improved thewholesomeness of fishery products. Theguality and value of these products is commu-nicated to consumers through the grading ofmajor types of seafood sold for human consump-tion. The program also helps processorsprepare processing specifications for non-standard fishery products and providesmechanisms for settling trade disputes.


Pre-market ing evaluation of both processingplant and processed products. Entire programis operated on a fee-for-service basis.

Government inspection of plant and product,testing, and certification.

Testing in government labs, recognized statelabs, and accredited private labs.

Inspection by licensed government agents andstate agents operating with a license agreement

33




Enforcement

Term

Reciprocity

Standards, Codes,or regulations

Keywords

Lists of approved suppliers and certifiedproductsGovernment applied mark

Lists of Sanitary Inspected Fish Establish-ments (SIFE) and seafood Packed Under FederalInspection (PUFI) or which participate ingrade marking. Lists of seafood productscovered by these services. Lists may beobtained from:

U.S. Department of Commerce, NOAANational Marine Fisheries ServiceNational Seafood Inspection LaboratoryP.O. Drawer 1207Pascagoula, MS 39567-0112(601) 762-4591

Producers must comply with sanitary, gualitycontrol, and inspection requirements in addi-tion to providing office, laundry, and tempo-rary lab space.

Del is ting

Indefinite term

Certification is recognized by:other Federal and State agencies,private organizations,foreign government agencies (inspectionservice available for both import andexport )

,

international organizations.At present no reciprocity exists with similaragencies in any other country.

Agency prepares all criteria documents includ-ing the Fishery Products Inspection Manual.

fish; fishery products; seafood; gualitystandards; fish quality; seafood specifica-tions; plant inspection; sanitation; SIFE;PUFI;

34

Products orServices

Weather Observation

Department/Agency

Initiated

Compliance

Authority

Aim

Agency Function

Type of Program

Methodology

Testing

Inspection



U.S. Department of CommerceNational Oceanic

and Atmospheric AdministrationNational Weather ServiceBasic Observations Branch8060 13th Street, NW.Silver Spring, MD 20910(301) 427-7792

May 1983

Mandatory

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

Codify the basis for training, examination,and certification of human weather observers.

Benefits Assures consistent, minimum performanceexpectations for manual weather observationsused for the preparation of forecasts andwarnings and the support of aviation operations.


Pre-performance assessment

Government testing, inspection, and audit

Government

Government

Government-issued certificates and masterlist of validated observers

Master List is maintained at the FAAAcademy, Oklahoma City, OK.

35


Enforcement

Term

Reciprocity


Certificate holder is required to main-tain experience and participate inannual training.

Certificate suspension

Audit testing keyed to individual performance,eyesight, and current experience.

Other Federal agenciesState agenciesPrivate organizationsCanadian government agencies

Agency prepares examination andperformance criteria and incorporatesrelated criteria prepared by DOD, FAA,and Canadian Atmospheric EnvironmentalService,

Keywords weather observation; eyesight examination;vision standards; Snellen test;laeger test; radar observation; aviationweather; radiosonde observation; computerdata entry; self-study; personnel;

36

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection



Obligationsof Manufacturer/Vendor

Consumer Products(personal use devices Intended forhousehold, school, or recreational use)

Consumer Product Safety Commission (CPSC)Office of the General Counsel1111 18th Street, NW.Washington, DC 20207(202) 492-6980

October 1972

Mandatory

Public Law 92-573 as amended by PL 94-284,95-319, 95-631-, 96373, 97-35

Reduce the number of consumer products whichpresent unreasonable risks.

Specific products covered by CPSC Standardsare now certified by manufacturers to con-form with legal requirements.


Post-marketing assessment

Manufacturer ' s self -cert if icat ionGovernment audit

Manufacturer's labThird-party labs

Government

Government authorized mark or label by manu-facturer or private brander

Lists of manufacturers or private branderssubject to certification rules or banningorders can be obtained from CPSC.

Manufacturers, private branders, and distribu-tors shall keep such records as the Commis-sion directs to assist in the enforcement ofthe Act, such as known non-conformance toapplicable standards or known defects whichcould present an unreasonable risk of injurywhether or not covered by a standard.

37

Enforcement Marketing banProduct recall

Term Periodic retesting in a testing programacceptable to the Commission is usuallyreguired.

Reciprocity None


Keywords

Criteria for standards are cited in the Act;agency itself prepares Consumer ProductSafety Standards; Commission recognizes theuse of voluntary standards to reduce risksof injury.

consumer products; audit testing; mandatorystandards; product recall; banned products;imminent hazard;

38

Products orServices

Fabrics Used in Wearing Apparel and InteriorFurnishings

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency/Funct ion

Type of Program

Methodology

Testing

Inspection





June 1953

Mandatory

Public Law 83-88 as amended

Reduce risk of fire and injury or deathrelated to fire, in or on fabric articles.

Compliance with applicable standards andassociated labelling have reduced thecovered risks.



Manufacturer ' s self-cert if icat ionGovernment audit inspection/testing

Government labsGovernment approved labsThird-party labsManufacturers' labs

GovernmentState/local governmentThird party

Authorized label by manufacturer

No list of certified suppliers or productsis prepared.

Manufacturer may comply with the Act byguaranteeing conformance with applicablestandards based on test data.

39

Enforcement

Term

Reciprocity


Keywords

Product condemnation and destruction

Periodic audit test inq/inspection isrequired to maintain certification.

Conformity is recognized by other Federalagencies, State governments, and privateorganizations.

Criteria for standards are cited in the Act;Commission recognizes the use of voluntarystandards to accomplish the purpose of theAct

.

fabrics; wearing apparel; interior furnish-ings; voluntary standards; f lammability

;

product testing;

40

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




Hazardous Substances(chemicals which are toxic, corrosive, flam-mable, irrating, radioactive or pressure-generating, and devices including thesechemicals, or which may injure intendedusers

)


July 1960

Mandatory

Public Law 86-613 as amended by the PoisonPrevention Packaging Act P.L. 91-601

Reduce risk of injury to all intended usersof designated substances and devices.

Informative labelling is now in effect andselected products have been banned.



Government approval of labelling informationto be provided with designated hazardous substances

Manufacturers' labsGovernment labs

Government


List of banned hazardous substances may beobtained from CPSC.

Carriers must keep records of interstateshipment of designated hazardous substances

41


Term

Reciprocity


Keywords

Indefinite term

Approved labelling is recognized by otherFederal agencies, State governments, andprivate organizations.

Criteria for designating substances ashazardous are prepared by CPSC.

hazardous substances; f lammability ; corrosi-ve; toxicity; irritant; radioactivity;banned products; misbranded substances;

42

Products orServices

Parts, Materials and Components Usedin Military Systems

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Methodology

Testing

U.S. Department of DefenseDirector of Standardization

and Acquisition SupportThe Pentagon, Room 2A-318Washington, DC 20301

1949

Mandatory for those products defined byspecifications having qualification require-ments. Equipment supplied to the Departmentof Defense may not contain products from otherthan qualified sources for those commoditiesfor which Qualified Products Lists (QPL's)have been developed.

Federal Acquisition Regulations, GeneralProvisions, Part 9;Defense Standardization Manual, DOD 4120, 3-M7Defense Standardization Document SD-6.

Maintain a high level of quality for criticalproducts through pre-procurement evaluationof prospective vendors.

The QPL Program normalizes the selection ofpossible vendors in several hundred criticaltechnical commodities which are sufficientlystandardized to permit a stringent, common,advance assessment of supplier capability.At the end of 1984 1300 QPL's existed listingmore than 3000 manufacturers. Approximately50 percent of these are U.S. small businessmanufacturers

.


Pretesting prior to purchase by Government orits contractors.

Any type of laboratory acceptable to DODsponsoring activity may be used; labs are notformally accredited by DOD.

43

I

Inspection




Enforcement

Term

Periodic follow-up inspection. Plant visitsare part of the overall management of theprogram. Listing on a QPL does not waivereguirements for either in-process or otherinspection by the manufacturer, or receivinginspection by the buyer.

Listing on Qualified Products Lists (QPL's)Authorized designation (JAN Mark) appliedby manufacturer/distributor to gualifiedsemiconductors, microelectronic, andestablished reliability products.

DOD specifications and QPLs are distributedby:

Naval Publications and Forms Center5801 Tabor AvenuePhiladelphia, PA 19120

Manufacturer/distributor must supply testsamples, ordinarily bear the cost of testing,maintain guality, notify of design or processchanges, and mark only approved types. Ad-vertising and publicity may refer to listingon QPL's provided there is no claim or impli-cation of Government preference or endorsementor that the product is the only one of itstype that has passed the prescribed tests.

Delisting

Indefinite for most products; most criticalcomponents reguire retesting at periodicintervals.

Reciprocity

Standards, Codesor Regulations

Keywords

There is limited reciprocity with counterpartagencies in Canada, Australia, and Ireland aswell as specific procedures for productscomplying with QPL's of NATO. Ministries of Defensej

Program is based on gualif ication reguirementsspecified in Military Specifications.

guality control; procurement; gualif ication;testing; military; QPL;

44

Products orServices

A^ir and Water Treatment Facilities

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




Enforcement

Term

Environmental Protection A.gency (EPA)Office of Air Quality Programs, and

Office of Water Quality Programs401 M Street, SW.Washington, DC 20460(202) 382-5575, Air(202) 382-5400, Water

1976

Voluntary

40 CFR 20

Identify facilities which reduce air orwater pollution for the purpose of qualifyingfor investment tax credit.

Increased investment by industries inpollution abatement equipment and facilities.

Certifier; some .States also perform a parallelfunction for local tax purposes.

Tax incentive program

Government design approval

No testing

No inspection

Lists of certified facilities maintainedby State certifying agencies and EPA.

Lists available from States and EPA.

Facilities must submit plans for reviewwhenever modifications are made.

Delisting

Indefinite

45

Reciprocity No reciprocity

Standards, Codes, EPA defines acceptance criteria.

Keywords air quality; water quality; pollutioncontrol; waste water treatment; waste heatremoval; investment tax credit; depreciation;pollution control;

46

Products orServices

?\utomotive termarket Parts

Department/Agency

Initiated

Compliance

Author ity

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing



Obligation ofManufacturer/Vendor

Environmental Protection Agency (EPA)Manufacturers Operations Division (EN-340F)401 M Street, SW.Washington, DC 20460(202) 382-2515

1980 (Modifications to current proceduresare expected to be proposed in late 1985)

Voluntary

Section 207 (a) of the Clean Air Act, 42U.S.C. 7541; 40 CFR Part 85

To enable vehicle owners to identifyreplacement parts that would not void thevehicle's emission warranty.

Vehicle owners have benefited from theavailability of parts from competitivesources. Parts suppliers are able to competwith original equipment and vehicle manufac-turers for aftermarket sales by being able tassure vehicle owners that their products arin compliance with EPA standards and thevehicle manufacturer's warranty for emis-sions applies.


Self-certification by supplier

Testing and self-certification by supplierafter notifying EPA of intent to certify.

By supplier

The part or its packaging shall bear thestatement "Certified by (name of manufac-turer or warranter) to EPA Emission Standard

Requirements are set forth in 40 CFR Part 85

Suppliers are required to establish andmaintain records containing descriptions andresults of all certification tests as well

47

as other information related to the integrityof the parts and the certification procedures.

Enforcement

Terra


Keywords

Decertification

Indefinite term

Test procedures and criteria for certifi-cation of catalytic converters, positivecrankcase ventilation valves, air filters,spark plugs, distributors and other ignitionand carburetor components are specified in40 CFR Part 85.

automotive parts; vehicle emissions; airpollution; replacement; aftermarket; warranty;environment;

48

Products orServices

Department Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection

Drinking Water

Environmental Protection Agency (EPA)Office of Drinking Water (WH550)401 M Street, SW.Washington, DC 20460(202) 382-3040

1974

MandatoryAct requires States seeking primacy to implementa certification program based on federal stand-ards; otherwise EPA will certify laboratories inremaining areas.

Safe Drinking Water Act (42 USC 300)National Interim Primary Drinking WaterRegulations (40 CFR 141 and 142)

Broaden the base of testing facilitiescompetent to analyze drinking water in disci-plines of chemistry, microbiology, and radio-chemistry.

Easier access to competent testing facilitiesfor all regulated and interested parties.

Certifier (in nonprimacy states, territories,and Indian reservations)Program administrator elsewhere.

Premarket evaluation(Act requires that data from a laboratory beacceptable only after laboratory is certified?however, laboratory must be in operation beforeit can be certified).

Government design of certification programtesting, inspection, audit, and site approvalplus compliance with Good Laboratory PracticeRegulations

.

Government labsState labs

GovernmentState government

49

Conformity Certified labs are issued certificatesidentifying areas of competency. Certifyingauthorities maintain lest of labs which havebeen issued certificates.



Enforcement

Term

Reciprocity


Keywords

Lists are available from certifyingauthorities and EPA Regional Office.

Certified labs must complete periodicperformance evaluations satisfactorily,maintain competency in approved method,notify certifier of changes in staff or equip-ment and submit to periodic onsite evaluations.

Delisting

Three years if certified by EPA or mostStates; some States recertify more frequently.

Direct EPA certification is recognized byother Federal agencies and some States. Stateson expected to develop procedures for recognizingcertifications among themselves.

EPA develops standard methods.Agency recognizes methods prepared by others.

drinking water; chemistry; microbiology;radiochemistry ; quality assurance; performanceevaluation; onsite evaluation;

50

Products orServices

Agency Function

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection



Motor Vehicle Engines, Gasoline and Diesel

Environmental Protection Agency (EPA)Office of Mobile Sources2 565 Plymouth RoadAnn Arbor, MI 48105(313) 668-4200

1972

Mandatory for producers and distributorsmotor vehicle engines, automobiles, light dutytrucks, and motorcycles.

Clean Air Act as amended in 1977, 42 USC 1857

To control emissions from motor vehicles andengines in the interest of public health.

The atmospheric environment has become cleanerthough progressively more restrictive emissionsof carbon monoxide, hydrocarbons, oxides ofnitrogen, and particulates from internalcombustion engines.

Both certifier and program administrator

Premarket evaluation; regulations providefor design evaluation, pre-production testing,and production auditing.

Governmental design approval, testing, andaudit in conjunction with manu-^acturer self-certification.

Government labGovernment accredited labsManufacturers' labs

GovernmentThird party

Authorized label by manufacturerList of certified products

Lists available from EP^

51


Enforcement

Term

Reciprocity

Standards, Codesof Regulations

Keywords

Manufacturer must qualify new enginedesigns, new emission control systemdesigns, and existing engine and emissioncontrol system designs when emissionregulations change.

Marketing banProduct recall

Annual with audit testing

Federal certification is recognized in allStates except California.

EPA prepares all criteria documents; sometest methods prepared by others are referenced.

motor vehicles; light duty trucks; motor-cycles; exhaust emissions; hydrocarbons; oxidesof nitrogen; carbon monoxide; diesel engines;evaporative emissions;

52

Products orServices

Private and Commercial Applicators ofRestricted Use Pesticides

Department/Agency Environmental Protection Agency (EPA)Office of Pesticide Programs401 M Street, SW.Washington, DC 20460(703) 557-7096

Initiated 1972

Compliance MandatoryAct requires States to per-^orm certificationto Federal guidelines, but permits EPA toperform the function if State is unable todo so.

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Federal Fungicide, Insecticide, andRodenticide Act (FIFRA) PL 94140 and PL 9539640 CFR 171. 11 71.11; and various State laws andregulations

To minimize misuse of pesticides by bothprivate and commercial applicators.

Greater awareness by regulated community ofhazards associated with pesticide misuse.

Certifier in Colorado and Nebraska program.Administrator in all other States andterritories in which the local program isapproved

.

Premarket evaluationApplicator may not offer services for hireuntil competency is demonstrated by exam-ination or attendance at an approved trainingprogram.

Government facilities in Colorado andNebraska; State facilities in all other Statesand territories.

Testing

Inspection


Personnel testing is conducted by thecertifying agency.

Same basis as testing

Certifying States issue identificationnumbers to individual certified applicators

53



Each State maintains a controlled list ofcertified applicators. Contacts in Statesare available from EPA. Lists of certifiedapplicators in Colorado and Nebraska areavailable directly from EPA.

Certified applicators and/or their employeesare obligated to limit applications to thoserestricted pesticides for which they have beencertified.

Enforcement

Term

Reciprocity

Delisting or limitation of certification bycertifying agency.

State certification terms vary from one tosix years; the term for Federal certificationis four years for private applicators and threeyears for commercial applicators.

Reciprocity among States is based on Stateagreements which are on file with EPA. Noformal list of reciprocal relations is avail-able.


Keywords

Certifications standards are promulgated byStates and must be as stringent as requiredby FIFRA.

pesticides, fungicides, rodent icides

;

insecticides; registered chemicals; restricteduse; environmental hazards; personnel;

54

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Electrical and Electronic Devices thatGenerate Radio Frequency Energy

Federal Communications Commission (FCC)Authorization and Standards DivisionColumbia, MD 21045(301) 725-1585

1940 (Marine equipment was the earliesttype approved).

Mandatory

Federal Communications Act of 1934 asamended CFR 47 Part 2, Subpart J

Reduce uncontrolled radio frequencyinterference first observed in connectionwith medical diathermy equipment in the1940 's.

Broad decrease in spurious radiofrequency energy in the environment inspite of tremendous increase in the typesand quantity of devices in general usethat have the potential for creatingradio frequency interference.


Generally FCC procedures provide forpre-marketing evaluation and/or post-marketing assessment. Authorizationprocedures reflect the requirements ofparticular categories of equipment whichare summarized here:

Type Approval

-Applies to some compulsory installedmarine safety-of-life equipment, and tosome nonlicensed devices, includingcertain industrial, scientific, andmedical devices.

-Testing of sample by FCC prior toissuance of grant is mandated by FCCRules

.

55

-Grant of authorization is issued by t^CC.

Type Acceptance

-Applies to transmitting equipment usedunder a radio station license issued bythe FCC in many of the radio services.

-Based on desk review and evaluation ofwritten application and test reportsubmitted by applicant.

-Testing of samples at FCC Laboratory isnot required by FCC Rules, but FCC hasauthority to request samples for testingeither before or after issuance ofgrant

.

-Grant of authorization is issued by FCC.

Certification

-Applies to nonlicensed devices, mostlylow power radio frequency devices and,in addition, to certain categories ofreceivers which tune anywhere in theband 30 to 890 MHz, personal computersand peripherals, citizen band receivers,and some other kinds of industrial,scientific and medical equipment.

-Based on desk review and evaluation ofwritte application and test reportsubmitted by applicant.

-Testing of samples at FCC Laboratory isnot required by FCC Rules, but FCC hasauthority to request samples for testingeither before or after issuance ofgrant

.


Notification

-A newly established procedure. (Reportand Order - Docket No. 82-242 - releasedJanuary 21 , 1983 .

)

56

-Applicability to particular categoriesof equipment has been established in theReport and Order - Docket No. 83-10,released Jan. 26, 1984.

-Manufacturer submits brief applicationfor authorization of device. Applica-tion is not required to include testdata.

-FCC may sample device or review themanufacturer's test data at its option,before or after issuance of grant.


Verification

-Applies to all computing devices exceptpersonal computers, personal peripheralsand exempt computing devices (Section15.801(e)); also applies to FM broad-cast and television broadcast receivers.

-Manufacturer tests device prior tomarketing, for compliance with applica-ble FCC regulations, and retains testdata.

-No filing with FCC is required.However, manufacturer's test data may berequired by FCC for subsequent review.

-FCC may sample device, at its option.

-No grant of authorization is issued byFCC.

Registration

-Applies to subscriber owned and commoncarrier owned telephone devices inter-connected to the public telephonenetwork. Objective of registration isto assure that device will not cause"harm" (as defined in FCC Rules) totelephone network. Radio frequencydevices which connect to the public

57

Methodology

telephone network may be subject toregistration as well as to one or moreof the other procedures.

-Based on desk review and evaluation ofwritten application and test reportsubmitted by applicant. Administrativereview is done by FCC Laboratory. Otheraspects of application are handled byFCC Common Carrier Bureau, includingissuance of grant.


-Subpart L of Part 2, and Part 68 of FCCRules provides further information onthis procedure.

Program uses:- Government lab for testing, in-

spection, auditmanufacturer and third party labs- Government recognition of private

labs

.

Testing

Inspection




Testing may be performed by:- FCC labmanufacturer ' s labthird-party lab.

Agency accredits independent labs, butdoes not inspect production facilities.

Agency maintains lists of producers ofapproved products, but lists are notpublished

.

Producers are licensed to apply approvalmarkings in accord with regulations.

Above lists must be requested from FCCthrough Freedom of Information procedures

Maintain design of approved equipment.State maintenance requirements to users.

Enforcement Marketing ban and product recall

58

Term Indefinite term

Reciprocity None. Test data from counterpart agenciesis taken into consideration but no

Standards , Codes

,

or Regulations

Keywords

reduction of test requirements isprovided.

Radio frequency devices must have therequired form of equipment authorizationbefore being imported into the UnitedStates and must be accompanied by aproperly executed copy of FCC Form 740.

There are s

this requirthe FCC rul2.811 and 2

categoriessubject toFCC rules,applicable

ome specified exceptions toement as given in Part 2 ofes, Sections 2.806, 2.809,.813. Also, there are a fewof devices which are nottechnical standards in theThese devices must meet thestandards before importation,

Criteria promulgated by FCC; privatesector standards are considered inpreparing rules.

transmitters? cable TV equipment; broadcastequipment; computer peripherals; medicalelectronics, radio frequency energy; communi-cations equipment; type approval; computers;certification;

59

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Parts, Materials, and Equipment

General Services Administration (GSA)Office of Federal Supply ServicesCommodity Management Division (FCM)Washington, DC 20406(703) 557-1001

1944

Mandatory for those products defined byFederal Specifications which have been design-ated for the Qualified Products List (QPL)certification program because conformancedemonstration at each procurement wouldnecessitate extensive testing.

Armed Services Property Regulations of 1944Federal Property Management Regulations,(FPMR) 101-29

As a means of expediting contract awards anddeliveries of designated products, manufactur-ers are required to have these products pre-tested to determine if the products conform toall specified requirements. Subsequently,assurance that proper quality is being main-tained is achieved by normal acceptanceinspection of selected samples of a shipment,rather than a detailed inspection of each lot.

The availability of products known to bequalified reduces the costs and time to selectproducts for inclusion in equipment and sys-tems that must perform reliably. Readyavailability of qualified products reducespurchase lead times and increases quality Olthe equipment using these products.At the end of 1984, approximately 80 FederalQualified Products Lists (QPL's) existed list-ing more than 450 manufacturers. The majorityof these QPL's are for adhesives, paint,safety equipment, and security office equip-ment - safes, vault doors, filing cabinets,and padlocks.


Pretesting prior to Government purchase

61

Testing

Inspection


Government or private laboratories, includingthe manufacturer's lab, may be used if accept-able to General Services Administration (GSA)and the designated preparing activity. Labsare not formally accredited by GSA.

Follow-up inspection is not an integral partof this program. Listing on a QPL does notwaive reguirements for either in-process orother inspection by the manufacturer, orinspection by the buyer.

Listing on Qualified Products Lists (QPL's)



Federal QPL's and specifications are distrib-uted by:

General Services AdministrationSpecification Unit (WFSIS)7th and D Streets, SW.Washington, DC 20406

Manufacturers and distributors must supplytest samples, ordinarily bear the cost oftesting, maintain guality and notify ofdesign changes. Reference may be made tolisting on QPL's in advertising and publicityprovided there is no claim or implication ofGovernment preference or endorsement, or thatthe product is the only one of its type thathas passed the prescribed tests.

Enforcement

Term

Delisting

Indefinite for most products; certain prod-ucts may reguire retesting at periodic inter-vals.

Reciprocity Federal and State agencies recognize and useFederal QPL's. There are no bilateral ormultilateral arrangements with other coun-tries .

Standards, Codes, Program is based on gual if icat ion reguirementsor Regulations specified in Federal specifications.

Keywords guality control; procurement; testing; Fed-eral; QPL;

62

Products orServices

Color Additives

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




Enforcement

U.S. Department of Health and Human ServicesFood and Drug Administration (FDA)Center for Food Safety and NutritionDivision of Color Technology (HFF-430)200 C Street, SW.Washington, DC 20204(202) 245-1141

1977 (latest authority)

Mandatory

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

To assure public health and safety in use andconsumption of foods, drugs, and cosmetics towhich specified colors have been added.

As an ongoing program, color additive certi-fication monitors conformance of additives toexisting reguirements and identifies need fornew limitations.

Certifier


Government testing

Government labs

Government

List of approved colors and certifiedproducts

Lists available from FDA.

Manufacturers must conform with Good Manufac-turing Practices (GMP) and report any knownill effects associated with certified addi-tives.

Marketing banProduct recal

1

Delisting

63

Term

Reciprocity

Certification is provided on a batch basis.

Certification is recognized by other Federalagencies, State agencies, and private sectororganizations.

Standards, Codes, Agency prepares criteria for certification,or Regulations Agency adopts test methods prepared by others

such as the Association of Official AnalyticChemists

.

Keywords color additives; foods; drugs; cosmetics;certification; adulteration; misbranding;carcinogens

;

64

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




Electronic Products

U.S. Department of Health and Human ServicesFood and Drug Administration (FDA)

Center for Devices and Radiological Health5600 Fishers LaneRockville, MD 20857(301) 443-4690

1968

Mandatory

Radiation Control for Health and Safety Act42 use 2636; 21 CFR 1000-1050

To protect the public from unnecessary expo-sure to radiation from electronic products.

Through enforcement, as well as productimprovement and user education, publicexposure to ionizing and nonionizingradiation has been reduced significantly.



Manufacturer self-certification

Manufacturer's labThird party labGovernment lab

Government

Manufacturer applied label

No lists are published or maintained in thisprogram.

Manufacturer must keep production and distri-bution records; notify buyers of nonconform-ing eguipment and recall such equipment forrepair.

65

Enforcement

Term

Reciprocity


Keywords

Marketing ban

Certification applies for the life of eachdistinctive model.

No effective reciprocity

Agency sets criteria and publishes performancestandards.

electronic radiation; microwave ovens; lasers;sunlamps; ultrasonic therapy equipment; x-rayequipment; mercury vapor lamps; televisionreceivers; product labelling;

66

Products orServices

Drugs Containing Insulin

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




Enforcement

U.S. Department of Health and Human ServicesFood and Drug Administration (FDA)Center for Drugs and Biologies5600 Fishers LaneRockville, MD 20857(301) 443-1016

1969

Voluntary

21 CFR Part 429

Provide insulin users with assurance of auniform guality drug.

Virtually all producers participate in thiscertification program.

Certifier


Compliance with Good Manufacturing PracticesGovernment inspection

Government labManufacturer's lab

Government

Lists of gualified suppliers and certifiedproducts


Producer must keep production records for twoyears after batch shipment.

Marketing ban (under the reguirement that anymisbranded drug is banned by law).

67

Term

Reciprocity


Keywords

Certification is provided on a batch basis.

Certification recognized by other Federalagencies, State agencies, and private sectororganizations.

Agency prepares certification criteria.Agency adopts test methods of theUnited States Pharmacope ial Convention and theNational Formulary.

insulin; packaging; labelling; color coding;distribution; records;

68

Products orServices

Drugs for Human Use

Department/Aqency

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




U.S. Department of Health and Human ServicesFood and Drug Administration (FDA)Center for Drugs and Biologies5600 Fishers LaneRockville, MD 20857(301) 443-1016

Mandatory

Food, Drug, and Cosmetic Act, Title 21 USC21 CFR Parts 200-212 and 300-315

To assure that drugs and antibiotics are bothsafe and effective for intended use.

Virtually all covered products consumed in theU.S. are made in registered establishments andproduced under Good Manufacturing Practices(GMP).

Certifier


Government design approval, inspection, siteapproval and compliance with GMP.

Manufacturer's labThird party lab

Government

Lists of gualified producers and approvedproducts are maintained by FDA.

Official lists may be obtained from the DrugListing Branch (HFN-315) of the FDA.

Producers are reguired to register establish-ments, maintain sanitary conditions, providesubstantial clinical evidence of safety andeffectiveness, prepare adequate labelling andinstructions for use, submit advertising forapproval, comply with Good ManufacturingPractices, use approved packaging, and adviseFDA of known adverse reactions.

Enforcement Marketing ban and product recall

69

Term

Reciprocity


Keywords

No specific term; retesting is based onchanges in product characteristics, composi-tion, or intended use. A major considerationis any misbrading or adulteration.

Certification is recognized widely in U.S.but no foreign reciprocity.

FDA prepares all standard requirementsincluding GMP rules, except that specifica-tions of official drug components are preparedby private organizations, i.e., U.S. Pharmaco-peia, Homeopathic Pharmacopeia, or NationalFormulary.

drugs; antibiotics; registration; labelling;good manufacturing practices; sanitation;misbranding; adulteration; recall; packaging;premarket evaluation;

70

Products orServices

Department/Agency

Initiated

Con5)liance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection



Food and Drugs ^or Animals

U.S. Department of Health and Human 'lervicesFood and Drug Administration (FDA)Center for Veterinary Medicine (HFV-1)Roclcville, MD 20857(301) 443-3450

1938

Mandatory

Food, Drug, and Cosmetic Act, Title 21 USC,as amended by P.L. 90-399

To assure that foods, Feeds, additives andmedicines intended for animal use are safe andeffective for intended use.

Low-risk preparations with uniform quality andpredictable performance have been developedfor animal use.

For new animal drugs (NAD): certifierFor all other products: program administrator


For NAD, Government design approval,inspection, site approval.For other products, manufacturer self-certification .

For all products, compliance with GoodManufacturing Practices (GMP)

.

Manufacturer's labThird-party lab

Government

Lists of approved products and qualifiedproducers are maintained by FDA.

Official lists may be obtained from the FDACenter for Veterinary Medicine.

71


Enforcement

Term

Reciprocity

Standards, Codes

r

or Regulations

Keywords

For all products, producers are required toregister establishments annually, maintainsanitary conditions, provide adeguate label-ling, and comply with Good ManufacturingPractices, For NDA substantial evidence todemonstrate safety and effectiveness mustbe provided. Proof that residues unsafe forhuman consumption are not left over specifiedtime periods is reguired for drugs or medi-cated feeds intended for animals which areused as human food.

Marketing ban and product recall

No specific term; testing is based on changesin product characteristics composition orintended use. A major consideration is anymisbranding or adulteration.

Certification recognized widely in the U.S.Many states require a "Guaranteed Analysis"for minimum protein, fat, fiber, and moisturecontent. There is no reciprocity among coun-tries for these products.

FDA prepares the regulatory requirementsincluding the GMP, but draws some technicalinput from the National Academy of Sciences.

animal feed; pet food; food additives;veterinary medicines; animal drugs; mis-branding; adulteration; good manufacturingpractices; registration;

72

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




Food for Humans

U.S. Department of Health and Human ServicesFood and Drug Administration (FDA)Bureau of Foods5600 Fishers LaneRockville, MD 20857(301) 443-1544

1938

Mandatory

Food, Drug and Cosmetic Act of 1938, asamended

Assure that foods are pure and wholesome,safe to eat, and produced under sanitaryconditions

.

The appearance of adulterated and misbrandedproducts in the market has been minimized.



Government inspection

Government labsManufacturers' labsThird party labsState/local government labs

GovernmentState/local government

Proper informative labelling; identificationof processing plant where such are specif-ically inspected, such as shellfish packers.

FDA publicizes only firms known to be notcomplying with reguired standards.

Producers must advise FDA any time a violationof good manufacturing practices occurs. Mis-branded adulterated products should be de-stroyed, but may be seized by governmentagents

.

73

Enforcement

Term

Reciprocity


Keywords


Continuous inspection

Other Federal agenciesState agenciesPrivate sector organizations

Agency prepares all criteria document.

adulterated product; misbranded product?dietary foods; infant foods; nutritionlabelling; good manufacturing practices;standard of guality; sanitation; standard ofidentity; fill of container standard;

74

Products orServices

Food Inspection Personnel

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection



Term

Reciprocity

U.S. Department of Health and Human ServicesFood and Drug Administration (FDA)5600 Fishers LaneRockville, MD 20857(301) 443-1544

1976

Voluntary

Public Health Service Act, as amended

Achieve a high degree of uniformity throughoutthe nation in the inspection of sanitation forthe selling of food.

Program has provided uniform methods of train-ing, examination, and review of food inspec-tion personnel.

Certifier

Evaluation of individual's competence.

Government testing and audit

Federal and State examination and trainingfacilities

Federal and State Governments

Lists of certified inspectors are kept byparticipating State health departments.

Lists must be obtained at the State level.

Retesting every three years.

Recognition by:other Federal agencies,State agencies,private organizations.

75

standards. Codes, Agency prepares criteria documents,or Requlations

Keywords food; retail sales; sanitation; programevaluation; model ordinance; training; personnel certification;

76

Products orServices

Fresh and Frozen Molluscan Bivalves(oysters, clams and mussels)

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Functions

Type of Program

Methodology

U.S. Department of Health and Human ServicesFood and Druq Administration (FDA)Shellfish Sanitation Branch, HFF-344200 C Street, SW.Washington, DC 20204(202) 485-0149

1925

Voluntary/cooperative

Federal Food, Drug and Cosmetic Act(Sees. 402, 403, 701(a) as amendedPublic Health Service Act (Sees. 301, 308,311, 361) as amended

To identify actual or potential sourcesof pollution that may contaminate shellfishgrowing areas; prevent the harvesting ofshellfish from contaminated waters; and maintain sanitary conditions during the handlingand processing of shellfish.

Shellfish products marketed in interstatecommerce are safe for human consumption.

Administers program, evaluates Stateshellfish control programs, and developsprogram guidelines and standards.

Pre-market ing control of product throughclassification of shellfish growing areas,prevention of illegal harvesting, andinspection of harvesting and processingoperations.

State shellfish agencies have theresponsibility for classifying growing watersand assuring industry maintains adequatesanitary operating procedures. FDA evaluatesState programs to determine program compliancethrough field visits and office file reviews.

77

Testing

Inspection


FDA evaluates State and locallaboratories used for the examination ofsea water and shellfish. The laboratoriesare only evaluated for compliance withAmerican Public Health Association (APHA)procedures for the examination of sea waterand shellfish, not approved or certified.

State shellfish control officials conductall shellfish activities through field surveysand inspection of harvesting and processingoperations. State programs are evaluated byFDA shellfish specialists.

FDA publishes monthly the "InterstateCertified Shellfish Shippers List" (ICSSL)containing the names and certification numbersof State certified shellfish firms.



The ICSS is provided free to all States,shellfish industry, and other interestedindividuals upon reguest.

Shellfish industry is reguired to meetstate shellfish sanitary reguirements forharvesting, handling and processingoperations, conform to National ShellfishSanitation Program (NSSP) criteria and GoodManufacturing Practice Regulations.

Enforcement State decertifies firm; FDA is notifiedand removes firm from the ICSSL.

Term

Reciprocity


Indefinite term; reinspection aftercorrection of deficiencies.

FDA certification is recognized by otherFederal agencies. States and foreign govern-ment agencies.

NSSP Manual of Operations Part I and II;Laboratory Procedures for the Examinationof Seawater and Shellfish, Fifth Edition, 1985APHA. FDA develops and revises manual ofoperations. Manual revisions are approved bystate shellfish control agencies.

Keywords oysters; clams; mussels; shellfish;National Shellfish Sanitation Program; NSSP;interstate; seafood;

78

Products orServices

Infant Formula

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




Enforcement

U.S. Department of Health and Human ServicesFood and Drug Administration (FDA)Center for Food Safety and Applied NutritionDivision of Regulatory Guidance (HFF-310)200 C Street, SW.Washington, DC 20204(202) 245-3117

1980

Mandatory

Infant Formula Act of 1980 21 USC 412, 21 CFRChapter 1, Subchapters A and B

To establish minimum nutrition reguirementsfor infant formula.

Virtually all domestically produced infantformula now complies with this rule.



Manufacturer self-certificationCompliance with Good Manufacturing Practices(GMP)

.

Manufacturers lab

Government

Lists of approved suppliers and certifiedproducts


Quarterly recert if icat ion by each producer.Prompt notification to FDA of any suspectedbatch noncompliance, adulteration, ormisbranding

.

Maketing banProduct recall by agency or producer

79

Term Audit testing/inspectwith quality controlby agency.

ion to assure conformancerequirements prescribed

Reciprocity Certification recognized by other Federalagencies, State agencies, and private sectororganizations.

Standards, Codes, Technical requirements specified in the Act.or Regulations

Keywords infant formula; nutrition requirements; goodmanufacturing practices; quality control;adulteration; misbranding; product recall;

80

Products orServices

Medical Devices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection


U.S. Department of Health and Human ServicesFood and Drug Administration (FDA)Center for Devices and Radiological Health

(HFZ-1)5600 Fishers LaneRockville, MD 20857(301) 443-4690

1976

Mandatory

Medical Device Amendments P.L. 94-295 to FoodDrug and Cosmetic Act, Title 21 USC

To assure that medical devices are both safeand efficaceous in their intended use.

For Class III devices, the program providesa more thorough design review.For Classes I and II devices, the programprovides clear public expectations.

For Class III devices, certifier.For Classes I and II devices, program adminis

trator.


For Class III, Government design approval,audit inspection, and site approval; manu-facturers supply test data.For Classes I and II, manufacturer self-certification and compliance with Good Manu-facturing Practices (GMP).

Manufacturer's lab or third party lab.Audit testing may be done by labs undercontract to Government.

Government

For Class III devices only, list of approvedproducts maintained by FDA. For Classes I

and II, manufacturer self-certification is evdenced through information reguired inproduct labelling.

81


Official lists are available from FDA Centerfor Devices and Radiologic Health.


Manufacturers of all classes of medicaldevices are reguired to be registered and tocollect data on patient/practitioner expe-rience and report any hazardous events or non-compliances with Class III or Class II certi-fication.

Enforcement

Term

Marketing ban, product recall, delisting areall applicable to medical devices.

No specific term; retesting is based onchanges in product characteristics or use.A major consideration is any misbranding oradulteration.

Reciprocity


Keywords

Certifications recognized widely in U.S., butno foreign reciprocity.

FDA prepares reguirements for Class III;standards for Class II may be from privatesector; FDA develops and maintains GMP rules.

medical devices; classification; misbranding;adulteration; good manufacturing practices;investigation use; recall; premarket notifi-cation;

82

Products orServices

Respirators and other BreathingApparatus; Personal Coal Dust Samplers

Department/Agency U.S. Department of Health and Human ServicesNational Institute for OccupationalSafety and HealthCertification Branch944 Chestnut Ridge RoadMorgantown, WV 26505-2888(304) 291-4331

Initiated

Compliance

Authority

Aim

1972

Voluntary

CPR Title 30 Part 11CFR Title 30 Part 74

To assure a minimum level ofperformance and quality for respiratoryprotective devices in the marketplaceand provide an independent review ofmanufacturer's designs.

Benefits There are 21 domestic manufacturers andfive importers. The certifyinglaboratory evaluates approximately2000 samples of respiratory protectivedevices. These evaluations combinedwith an extensive defect notificationprogram, including both users andmanufacturers, assures that nearly allpotentially life-threatening problemswith respiratory protective equipmentare detected and corrected beforeequipment-related injuries occur.

Agency Function Certifier

Type of Program Pre-market inq evaluation and post-marketing assessment, in the formof defect investigation.

Methodology Federal agency design approval andtesting

Testing Government laboratory and manufacturerslabs

83

Inspection Federal agency representatives only




Enforcement

Approved products lists and government-approved labels applied by manufacturer.

Approved products lists available toeguipment users at above address.

Manufacturer must conduct pre-submi ttaltests; establish a quality control planfor agency approval; notify agency ofpossible or actual equipment or componentdefects; participate in agency-sponsoredinvestigations; and cease labelling ifapproval is suspended.

DelistingProduct recall (voluntary by manufacturer)Notification to users

Term

Reciprocity


Keywords

Indefinite term

Other Federal agencies (e.g. NRC

)

State agenciesGovernment of Canada (counterpart agencies)

Agency prepares criteria documents.Agency adopts standards prepared by others forquality plans and respirator maintenance.

respirators; air samplers; gas masks;breathing apparatus; face pieces;coal mine dust; pesticides; designapproval

;

84

Products orServices

Building Products for Construction

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

U.S. Department of Housingand Urban Development (HUD)

Office of Manufactured Housingand Construction Standards

451 Seventh Street SW.Washington, DC 20 410(202) 755-5929

1965

Voluntary

CFR Title 24 Part 200.935

Prevent product failures and mis-representations of products. Expediteintroduction of new or innovativebuilding materials. Alleviate safetyhazards associated with buildingmaterials, long term durability problems,and misleading test results.

Better assurance that the building prod-ucts arriving at the job site comply with thedesignated standard.


Ongoing validation of private certifica-tion of products included under a HUDmortgage insurance program.

Third-party certificationManufacturer ' s self-certif ication

Government-accredited labsThird-party validating labsManufacturer's labsState/local government labsAgency-accredited labs

85

Inspection Third party




Enforcement

Term

Reciprocity


Keywords

Authorized mark or label by manufactureror third-party validator. More thanseventy third-party validators partici-pate in the HUD Building Products Certi-fication Program for approximately twentyproducts ranging from carpeting to ply-wood.

All documentation is publishedin the Federal Register.

Manufacturers are obligated to ceasemarking products which do not meetrequired standards.

The principal means of enforcement isdelisting of manufacturers. Laboratorieswhose quality control is inadequate maybe disapproved. Administrators may besuspended under rules in 24 CFR Part 24.

All parties may operate indefinitely inthese programs. Laboratories are subject toperiodic reaccreditat ion.

Products in these programs enjoy a widedegree of reciprocal recognition including;other Federal agencies. State agencies,private sector organizations, foreigngovernments, and international organizations,There are participating organizations inCanada for certain building products.

HUD adopts standards prepared by others,and prepares criteria documents wherenecessary. Documents defining acceptanceare in 24 CFR 200 .935.

building products; certification; third-party validation; mortgage insurance;housing; administrators; acceptancecriteria;

86

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection



Manufactured Housing

U.S. Department of Housing andUrban Development (HUD)

Manufactured Housing Standards Division451 Seventh Street, SW.Washington, DC 20410(202) 755-6590

1976

Mandatory

National Manufactured Housing Constructionand Safety Standards Act, PL 93-382,42 U.S.C 5407; 24 CFR Part 3280

To reduce the number of personal injuriesand deaths, cost of insurance, and propertydamage resulting from manufactured homeaccidents and to improve the guality anddurability of manufactured homes.

Uniform nationwide certification programhas accomplished the stated purposes of theAct as well as improved interstate commercein manufactured housing.


Pre-emptive, mandatory, national regulation

Third-party certification of building plansand in-factory enforcement for compliance.

Third-party labsManufacturer's lab

Third-partyState government

Authorized label by manufacturerLists of approved manufacturers

Lists are maintained by the agency andthe State Approved Administrators.

87


Enforcement

Term

Reciprocity

Manufacturers must keep sufficientlyaccurate component data by finished unitserial number so that purchasers can benotified if an imminent safety hazard isalleged.

Marketing ban on unlabelled homes; productrecall on defective units; removal ofthird-party inspection agencies for repeatedinadeguate performance.

Indefinite term

Other Federal agenciesState agencies


Agency adopts standards prepared by othersand provides necessary integrating reguire-ments

.

Keywords inspection; product safety; design approval;

88

Products orServices

Surface and Subsurface Safety Valves

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




Enforcement

Term

Reciprocity

U.S. Department of the InteriorMinerals Management Service12203 Sunrise Valley Drive,Reston, VA 22091(703) 860-7506

1980

Mandatory

CFR Title 30, Part 250.11Outer Continental Shelf (OCS) Orders

Prevention of maior oil spills thatcause pollution.

Decreased pollution and accidents andimproved consistency of manufacturingand testing.



Third-party certification

Third-party accredited laboratories

Third-party

Authorized mark or label by manufacturer

Available from ASME at 345 E. 47thStreet, New York, New York 10017.

Traceability

.

Delisting.

3 years.

None

.

89

standards, Codes, orRegulations

Keywords

ANSI/ASME - SPPE-1, Quality Assuranceand Certification of Safety and Pollu-tion Prevention Equipment Used inOffshore Oil and Gas Operations

ANSI/ASME - SPPE-2, Accreditation ofTesting Laboratories for Safety andPollution Prevention Equipment Used inOffshore Oil and Gas Operations

safety valves; oil; qas; petroleum;pollution-prevention; offshore; OCS;

90

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




Diesel-Powered Equipment for Gassy Mines

U.S. Department of LaborMine Safety and Health AdministrationApproval and Certification Center, Box 251Triadelphia, WV 26059(304) 547-0400

1977

Mandatory for certain areas of non-coal mineswhere methane gas may be present.

PL 91-173; 30 U.S,C. 957PL 95-164; 30 U.S.C. 961, 951; 30 CFR 36

To provide a uniform means for evaluatingdiesel-powered eguipment used in non-coalmines for mining and transportation.

Accidents and deaths related to diesel-powered mine machinery have been minimized.

Certifier


Government design approval, testing,inspection

Government labs or other labs under governmentmonitoring

Government

Agency designated and issued mark

Agency publishes lists of certified andapproved eguipment.

Manufacturer must maintain productionaccording to type-approved drawings, includingmodifications to design reguired for approval,and employ acceptable guality control plan.

91

Enforcement Marketing ban; removal ^rom mine use of non-conforming equipment; legal action.

Term

Reciprocity


Keywords

Indefinite

Other international. Federal and State agenciesPrivate organizations

Agency prepares criteria documents.

non-coal mines; diese 1-powered equipment;mining machines; transporters; exhaust gases;flammable atmospheres; dust collectors;electrical components; ventilators; safety;

92

Products orServices

Electrical Equipment for Mines

Department/Agency

Initiated

Conqpliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




Enforcement

U.S. Department of LaborMine Safety and Health AdministrationApproval and Certification center. Box 251Triadelphia, WV 26059(304) 547-0400

1977

Mandatory

PL 95-164; 30 U.S.C. 961, 951; 30 CFR 18PL 91-173; 30 U.S.C. 957

To provide uniform means for evaluatingelectrical equipment used in gassy mines formining, illuminating, and measuring in orderto reduce workplace hazards.

Accidents and deaths related to electrically-powered mine machinery have been minimized.

Certifier


Government design approval, testing,and inspection

Government labs or other labs undergovernment monitoring

Government

Agency designated and issued mark

Agency publishes lists of certified andapproved equipment.

Manufacturer must maintain production accordingto type-approved drawings, including modifi-cations to design required for approval andemploy acceptable quality control plan.

Marketing ban; removal, from mine use, of non-conforming equipment; legal action.

93

Term

Reciprocity


Keywords

Indefinite

Other international, Federal and State agencies,private organizations


coal mines; electrical equipment; illumination;intrinsically-safe equipment; signallingdevices; pumps; fans; compressors; batterypowered equipment; instruments; shuttle cars;safety;

94

Products orServices

Equipment and Materials Used in theWorkplace

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

U.vS. Department of LaborOccupational Safety and Health

Administration (OSHA)Directorate of Safety Standards Programs200 Constitution Avenue, NW.Washington, DC 20210(202) 523-8061

1971

Mandatory

Occupational SafetyPL 91-596;29 CFR Part 1910 —Health Standards for29 CFR, Part 1915 —Health Standards for29 CFR, Part 1917-19and Health StandardsLongshor ing;29 CFR, Part 1926 —Health Standards;29 CFR, Part 1928 —Health Standards for

and Health Act of 1970,

Occupational Safety &

General industry;Occupational Safety &

Shipyard Employments;18 — Occupational Safetyfor Marine Terminals;

Construction Safety &

Occupational Safety &

Agricultural Employments,

To provide protection to the nation's workerson their job by reducing or eliminating thevarious hazards to which workers may be exposed.Certain equipment because of its nature or thetypes of hazards that may develop is requiredto be listed, labelled, or approved by third-party laboratories.

The Occupational Safety and Health Administra-tion (OSHA) certification program enablesemployers to install equipment which hasdemonstrated compliance with applicable standardsand regulations. OSHA workplace inspections canbe expedited when certified equipment is used.



95

Methodology

Testing

Inspection


Enforcement

Term

Reciprocity


Keywords


Third-party test labs

Accreditation of laboratories proposed inFederal Register Notice of March 6, 1984.

OSHA inspectors can inspect equipment in theworkplace

.

Comply with applicable standards

Ban from the workplace.

Indefinite term

Listing, labelling, or approval by foreigncertification agencies is recognized by OSHAso long as evaluation criteria are equal ormore stringent than the applicable OSHAstandards and regulations.

OSHA standards include extensions of Federalstandards and Federal and non-governmentstandards incorporated by reference. Theseinclude numerous standards of American NationalStandards Institute, American Society of MechanicalEngineers, National Fire Protection Association,Underwriters Laboratories and others.

safety; health; job safety; machinery; equip-ment; construction; agriculture; diving; fireprotection; medical services; ventilation;hazardous materials; personal protectiveeguipment; material handling; tools; welding;electrical

;

96

Products orServices

Maritime Cargo Handling Equipment

Department/Agency

Initiated

Conqpliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection

Conformity

Availabi1ityof Documentation


/

Vendor

U.S. Department of LaborOccupational Safety and Health Administration (OSHA)Division of Maritime Compliance Assistance200 Constitution Avenue, NW.Washington, DC 20210(202) 523-8133

1971

Mandatory

29 CFR 1915-1919

Assure that all covered equipment complieswith regulatory requirements. Most of theequipment is at marine terminals and ship-yards. Cargo gear on board U.S. inspectedvessels is under the jurisdiction of theUnited States Coast Guard.

Safety of longshoremen, seamen, and dockworkers has been improved by this programwhich fullfills U.S. responsibilities forInternational Labor Organization (ILO)Convention No. 32.

Program Administrator


Third party certification

Government accredited lab

Third party

List of certified products made on OSHAofficial forms.

Agency maintains a list of accredited inspec-tors. Such firms are not required to publi-cize a list of their clients.

Cooperate with a specific third-party certi-fier regarding design, fabrication, andinstallation data and maintenance require-ments .

97

Enforcement

Term

Reciprocity

Standards f Codes

»

or Regulations

Keywords

Delisting or ban on usage.

Annual retesting

Other Federal and State agencies

Agency adopts standards prepared by others.

accreditation; cranes; derricks; materialshandling equipment; wire rope; safe workingloads

;

98

Products orServices

Department/Agency

Initiated

Coitqpliance

Authority

Aim/Benefits

Agency Function

Type of Progreun

Methodology

Testing

Inspection




Packages and Containers for RadioactiveMaterial

Nuclear Regulatory CommissionOffice of Nuclear Material Safety

and SafeguardsWashington, DC 20555(301) 427-4122

1974

Mandatory

Title 10, Code of Federal Regulations,Part 71

Protection of public health and safetyand the environment.

Program administrator or and certifier

Review and assessment of packagedesigns prior to approval and grant ofcertificate of compliance. Approximately220 different designs have been certified.

Government design approval, inspection,and audit inspection/testing

Applicant/Government

App 1 icant/Government

Approved packages are assigned an indent-ification number.

Part 71 Docket FilesUnited States Nuclear Regulatory CommissionPublic Document RoomWashington, DC 20555(202) 634-3273

Report defects or noncompliance.Report significant reduction of effective-ness during use.

99

Enforcement

Term

Order, denial, fine.

5 year renewableInspection prior to each use

Reciprocity


Keywords

Recognition of certification by:-Department of Transportation (DOT)-Foreign governments upon issuance ofDOT Competent Authority Certificate.

U.S. Nuclear Regulatory CommissionRegulatory Guides (Division 7)

packaging, radioactive material; nu-clear; safety; environment;

100

Products orServices

Breath Alcohol Testers and Their CalibrationUnits

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

U.S. Department of Transportation (DoT)National Highway Traffic Safety AdministrationOffice of Alcohol Counterraeasures , NTS-21,400 Seventh Street, SW.Washington, DC 20590(202) 426-9581

1984

Voluntarily adopted by States and local juris-dictions .

Manufacturers voluntarily submit testers forevaluation and listing.

23 U.S.C. 402 and 49 CFR 1.50

Assist States and local communities by providinga centralized qualification test programfor breath-testing devices designed to collectevidence in law enforcement programs.

States have adopted the National HighwayTraffic Safety Administration (NHTSA) modelspecification for evidential breath testersand a calibration unit developed by theNational Bureau of Standards (NBS). Thisqualification program enables States andlocal jurisdictions to buy equipment that hasdemonstrated compliance with these model speci-fications. They avoid the cost of individualtests and use equipment that is ruqged andreliable and bears the scrutiny of challengesin court cases. Manufacturers benefit in nothaving to arrange for individual tests innumerous jurisdictions.

Certifier

Qualification testing

Government testing

Testing is accomplished by the Department ofTransportation Systems Center.

101




Term


Keywords

Qualified manufacturers are listed on aConforming Products List (CPL),

Model specifications and CPL's are publishedin the Federal Register; 49 FR 48854. Currentlythirteen manufacturers of breath measurement devicesare listed. Four of these are foreign suppliers.

Manufacturer must submit a unit for test.

Indef inite

Acceptance criteria have been developed byNHTSA in collaboration with NBS.

alcohol; highway safety; legal evidence;blood alcohol; breath alcohol; tester; cal-ibration; analysis; law enforcement;

102

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




Cylinders for Transportation of HazardousMaterials

U.S. Department of Transportation (DoT)Research and Special Programs AdministrationOffice of Hazardous Materials Regulation400 7th St. , NW.Washington, DC 20590(202) 426-2075

1964

Mandatory

49 CFR 178.36-178.68

To provide a uniform testing program forcylinders made from a variety of metals andused for many kinds of hazardous materials.

Consistent safety and durability ofcylinders for intended use.



Third-party certification or manufacturerself -certification

Third-party labManufacturer's lab

Third-party

Authorized identity by manufacturer

No central registry of manufacturers; allcylinders legal for service are marked.

Manufacturers must maintain guality control,Vendors must cycle inventory.Users must not use out-of-date cylinders.

103

Enforcement

Term

Reciprocity


Keywords

Product recall

15-year term; regulation has no specificprovision for retesting, but tanks insound physical condition may be tested andrecertified.

Marked cylinders are accepted throughoutU.S.A.

Agency has integrated product reguirementsbased on industry test methods.

cylinders; hazardous materials; hydrotest;guality control; inspection; maintenance;safety

;

I

104

ProductsServices

or Civilian Aircraft, Aircraft Engines,Propellers, and their Components andParts

In addition to these products, the com-prehensive FAA system provides for certi-fication of pilots, flight instructors,crew members, mechanics, parachuteriggers, control tower operators, dispatch-ers, air carriers in interstate or overseasair transportation, air taxi operators,agricultural aircraft operators, navigationalfacilities, airports and heliports servingcertificated air carriers, repair stations,parachute lofts and schools for pilots andmechanics. Certificates of designation andcertificates of authority are issued toaviation medical examiners, examiners of pilotsand technical personnel, designated engineeringrepresentatives, and designated manufacturinginspection representatives.

Department/Agency U.S. Department of Transportation (DoT)Federal Aviation Administration (FAA)Office of the Associate Administratorfor Aviation Standards800 Independence Avenue, SW.Washington, DC 20591(202) 426-3131

Initiated

Compliance

Authority

Aim

1926

Mandatory

Federal Aviation Act of 1958 (49 U.S.C.),CFR 14, Parts 1 to 199

Promote, regulate, and encourage thedevelopment of civil aviation in such amanner as to promote its development andprovide for the safe and efficient use ofthe airspace.

Benefits The FAA certification system has helpedproduce one of the safest and mostefficient air transportation systems inthe world.

105

National Transportation Safety Board datademonstrate that surface travel resultsin approximately 170 times more fatal-ities than air travel not only in totalbut in rate per passenger miles traveled.

Agency Function Program administrator and certifier.

Type of Program The comprehensive FAA product certifica-tion program includes assessment of theinitial design; evaluation of the initialproducts; compliance with demonstrateddesign, manufacturing, and qualitycontrol practices; approval ofmaintenance periods; and monitoring ofall service discrepancy reports.

Methodology A Type Certificate is granted by the FAAafter an applicant has identified anddemonstrated compliance with applicableregulations. A Type Certificate isissued for a specific make and model(type) of aircraft, engine, or propeller.Special Conditions may be issued fornovel or unusual design features.

A Production Certificate is issued toholders of type certificates upondemonstration that their quality controlsystem assures that products conform to thetype certificate.

An Airworthiness Certificate is grantedfor a specific aircraft that meets theapproved type design and is in conditionfor safe operation. Airworthinesscertificates are also issued for enginesthat are exported.

Parts Manufacturer Approval (PMA) isrequired for the manufacture of parts,materials, processes and equipment to beinstalled on a type certificated product.This requires demonstration of compliancewith applicable regulations, directives,and standards, and operation of an effec-tive quality control system.

106

Authorization to manufacture anddesignate products, in accordance withFAA Technical Standard Orders (TSO's),requires demonstration of compliancewith performance and quality controlrequirements specified in the respectiveTSO's.

Testing Compliance with the applicable require-ments is usually accomplished by theapplicant and the FAA will review, wit-ness and test as appropriate, prior toapproval of the desiqn. Certain fliqhttesting is performed by FAA personnel.Test data for PMA and TSO's are submit-ted to the FAA for review and approval.The FAA does not approve or accredittest laboratories; however, a manufac-turer must possess, or have access tofacilities that will enable it to testand inspect products to the requisitelevels.

Inspection




Inspection is accomplished by FAAspecialists and designated representatives.

Airworthiness Certificates are issued foreach approved aircraft. Engines andpropellers must list the Type Certificateand Production Certificate numbers ontheir data plates. Products conformingto Parts Manufacturer Approval are marked"FAA-PMA". Those manufactured in accordancewith a TSO authorization are marked withapplicable TSO number.

No lists of approved or qualifiedproducts or suppliers are published forgeneral distribution by the FAA.

Each manufacturer or user of certifiedproducts, including TSO items, shallreport any accident, failure, mal-function, or defect that could result infire, engine failure, primary structuraldefect, loss of more than one electricalor hydraulic power generating system, andsimilar critical occurrences. FAA personnelshall be provided access to inspect any

107

products manufactured under authorization,and to inspect the manufacturing facilities,quality control inspection and tests, andtechnical data files.

Enforcement Various civil penalties are provided forunder section 901 of the Federal AviationAct of 1958. Under section 903 a Stateor Federal law enforcement officer, or anFAA safety inspector may summarily seizean aircraft involved in a violation. Ifit is determined that the public interestand safety requires it, the FAA may issuean order amending, suspending or revoking,all or part of any Type Certificate,Production Certificate, AirworthinessCertificate, Air Carrier OperatingCertificate, or Air Navigation FacilityCertificate. Other enforcement optionsinclude cease and desist orders, ordersof denial and injunctions.

Term Type Certificates and Production Certifi-cates are effective until surrendered,suspended, revoked, or a termination dateis otherwise established. AirworthinessCertificates are effective as long asmaintenance, and alterations areperformed in accordance with establishedregulations and procedures, and theaircraft are registered in the UnitedStates. A PMA or TSO authorization is

not transferable and is effective untilsurrendered or withdrawn.

Reciprocity The International Civil Aviation Organiz-ation (ICAO) sets general guidelines forairworthiness certification systems inAnnex 8 to the Chicago Convention. TheFederal Aviation Regulations implementthe ICAO guidelines in the United States.The U.S. Department of Defense and the CoastGuard reguire that certain of theiraircraft and eguipment be FAA certified.

A Type Certificate may be issued fora product manufactured in a foreigncountry with which the United States has

108

a bilateral agreement for acceptance ofthese products for export and importif the country in which the product wasmanufactured certifies that the producthas been examined, tested, and found tomeet applicable FAA requirements and themanuals, placards, and instrumentmarkings are in English. Depending onthe design and any unique features,Special Conditions may be identified forapproval

.

An Airworthiness Certificate is grantedto imported aircraft for which a TypeCertificate has been issued if the coun-try in which the aircraft was manufac-tured certifies, and the FAA finds, thatthe aircraft conforms to the type designand is in condition for safe operation.

The FAA need not issue Production Certi-ficates, PMA's or TSO authorizations ifthe manufacturing facilities are locatedoutside the United States, unless thereis no undue burden in administering theapplicable requirements of the FederalAviation Act of 1958.


Keywords

Applicable design, performance, andquality requirements are specified inCFR Part 14, Parts 1 to 199. Approxi-mately 60 nongovernment standards areincorporated in TSO's. These areprimarily standards developed by theSociety of Automotive Engineers, RadioTechnical Commission for Aeronautics,and Aerospace Industries Association.

type certificate; production certificate;airworthiness; PMA; TSO; aircraft;engines; propellers; avionics; parts;materials; processes; bilateral agree-ments; safety; quality; performance;

109

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Lifesaving, Engineering, Fire Protection,and Pollution Prevention Equipment forRecreational Boats and Commercial Vessels

U.S. Department of Transportation (DoT)Coast GuardWashington, DC 20 593Telex: 892427For electrical, pneumatic, and hydraulicequipment:

Engineering Branch, G-MTH-2(202)426-2160

All other equipment:Survival Systems Branch, G-MVI-3(202)426-1444

1946

Mandatory for equipment required to beused on recreational boats and commercialvessels.

33 CFR 159; 46 CFR 2, 159-164

Approve equipment which meets minimumsafety and performance standards.

Approved equipment is intended to reducethe loss of life in marine accidents, andto prevent oil and sewage pollution ofwaterways by ships and boats.

Program administrator and certifier

Pre-market ing evaluation, inspection, andtesting

Government design approval, and audit oftesting and inspection

Third-party pre-approval testing, andproduction testing and inspection

111

Testing

Inspection




Enforcement

Term

Reciprocity


Keywords

Manufacturer self-certification and/orproduction testing and inspection onselected items

Coast Guard accredited laboratoryManufacturer testing on selected items

Coast Guard accredited laboratoryManufacturer inspection on selected items

List of approved/certified products andsuppliers

Items are marked with Coast Guard approvalnumber.

Laboratory listing or classificationmarking reguired on some items.

Publication "Equipment Lists" (U.S. CoastGuard COMDTINST M16714.3A) available for salethrough Government Printing Office, ordernumber 0 50-012-00 212-6.

Manufacturer is required to produceapproved item exactly as described inapproved plans. Some recordkeepingrequired.

Delisting. Civil and criminal penaltiesare also available in certain cases.

Five years. Renewal generally availableon request.

None

33 CFR 159.15 and 46CFR 160-164 defineapplicable requirements and criteria.

marine safety; marine pollutionprevention; recreational boats; commer-cial vessels; equipment;

112

Products orServices

Motor Vehicle Safety

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection



U.S. Department of Transportation (DOT)National Highway Traffic Safety Administration400 Seventh St. SW.

,

Washington, D.C. 20590(202) 426-2829

1966

Mandatory

National Traffic and Motor Vehicle Safety Actof 1966 as amended

Regulate design, construction, and perform-ance of motor vehicles to protect the publicagainst unreasonable risk of injury inaccidents.

Reduction of traffic accidents, and deaths andinjuries resulting from traffic accidents.



Government auditManufacturer self-certification

Government laboratories

Government


The agency maintains lists of vehicle andequipment manufacturers who have undertakenproduct recalls for the purpose of achievingcompliance with Federal Motor Vehicle SafetyStandards

.

113


Enforcement

Term

Reciprocity


Keywords

Manufacturers must inform the Agency, ownerspurchasers, and dealers of known defects andthe plans to correct the defect (s).


Indefinite

Other Federal agenciesState agenciesPrivate sector organizations may be paidcontractors to the agency for detection ofof defects or compliance research


automobiles; trucks? shoolbuses; motorvehicle equipment; used vehicles; compliancesafety; product recall; labelling;

114

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection


Packaging of Hazardous Materials for Export

U.S. Department of Transportation (DoT)Research and Special Programs AdministrationOffice of Hazardous Materials RegulationMaterials Transportation BureauWashington, DC 20590(202) 426-2075

March 13, 1985

Voluntary

49 U.S.C. 1804, 1805, 1808; 49 CFR 1.53;Appendix A to Part 1

Designate third-party testing agenciesthrough which shippers and container manufac-turers may demonstrate conformance of packagingdesigns with United Nations (U.N. ) standards.

Enhance the use of U.S. packaging in inter-national transportation and facilitate theability of U.S. companies to compete in exportmarkets

.

Program administrator and NationalCompetent Authority in accordance with U.N.Recommendat ions


Materials Transportation Bureau (MTB) desig-nates third-party approval agencies toevaluate and issue approval certificates forintermodal portable tanks and certificationsof conformance for other types of packaging.

Testing by third-party, manufacturers, andshippers labs is permitted if acceptable tothe approval agencies.

Subsequent inspection of packaging is notpart of this program.

Certificates are provided to shippers and/ormanufacturers by approval agencies.

115

Enforcement

Term

Reciprocity


Keywords

Designation of an approval agency to issuecertificates may be withdrawn for failure toabide by requirements of the program.

Indefinite

Certification in accordance with U.N. Recom-mendations is intended to avoid acceptancetesting and packaging approval in each countrywhich might have such requirements.

Standards set forth in the U.N. Recommen-dations (Transport of Dangerous Goods), andDepartment of Transportation requirementslisted as 49 CFR, Part 171, Subchapter C.

transportation; hazardous materials; packaging;containers; export; international; approval agenciesUnited Nations; National Competent Authority;

116

Products orServices

Packaging of Radioactive Materials forTransport

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection



U.S. Department of Transportation (DoT)Research and Special Programs AdministrationOffice of Hazardous Materials Regulation400 7th St. , NW.Washington, DC 20590(202) 436-2311

1975

49 U.S.C. 1803, 1808 as amended49 CFR 173. 465-. 469

Mandatory

To provide packaging for radioactive materialswhich maintains integrity under mild (Type A)or severe (Type B) fault conditions.

Transport of radioactive materials isaccomplished with minimum radiation exposureto personnel.

Certifier


Government design approval, inspection, andvalidation of test data submitted by manufacturerbased on own or third-party tests.

Third-party or manufacturer's lab

Government or third-party

Mark on packaging authorized by agency, knownas Competent Authority within InternationalAtomic Energy Agency acceptancescheme

.

Lists of approved manufacturers maintained ineach country. Packaging of certain radioactivematerials reguires acceptance by CompetentAuthority in both shipping and receivingcountries

.

117


Maintain specified quality control records,cooperate in investigation of any packagefai lures

,


Term

Reciprocity


Keywords

Indefinite, Certification is based onprototype acceptance.

Type A packaging for domestic use accepted byother Federal, State, and private organizations.Type B packaging for international use subtype U(unilateral) accepted with mark from onecountry.Subtype M (multilateral) reguires mark fromsending and receiving countries and transitcountries for certain materials.

Agency establishes reguirements andprocedures

.

fissile material; packaging; radioactivematerial; package approval; guality assurance;transportation; domestic; international; IAEA;safety

;

118

Products orServices

Department/Agency

Pipelines for Hazardous Fluids

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




fnt of Transportation (DoT)Special Programs Administration;ardous Materials Regulation

U.S. DepartmeResearch and opetjxaOffice of Hazardous400 7th Street, NW.Washington, DC 20590(202) 426-2392

1968

Mandatory

49 U.S.C. 1803-1809

To provide a mechanism for regulating theinstallation and maintenance of pipelines forthe transportation of hazardous materials.

Safety record of such pipelines in the UnitedStates meets expectations.


Pre-installation review with periodic test onsafety eguipraent throughout the useful life ofthe pipeline.

Third-party certification: welder and plasticpipe assemblers. Manufacturer self-certificationvalves, pressure-limiting devices, and overallinstallation to specified standards.

Manufacturer or third-party

Third-party

Lists of gualified welders/installers andapproved installations are published.

Certification of Welders by American WeldingSociety; comparable program by installingcontractor may be acceptable to DoT.List of approved pipelines kept by DoT.

Owner of pipeline is responsible for annualtests of pressure limiting devices and forreports on all accidents related to the use ofthe pipeline. Accidents involving deaths areinvestigated by the National TransportationSafety Board.

119

Enforcement

Term

Delisting; individual welders or installers maybe required to undergo additional training; faultyvalves or limiting devices may have to bereplaced; pipeline could be decommissionedtemporarily.

Pressure limiting devices must be inspected onan approximate annual cycle, not to exceed 17month intervals.

Reciprocity


Keywords

Approved pipelines are not regulated by anyother Federal or State agency or privateorganization.

Agency mainly adopts standards of otherorganizations.

pipelines; hazardous materials; certifiedwelder; qualified plastic pipe assembler;pressure-limiting devices; maintenance; safety;

I

120

Products orServices

Railway Tank Cars(includes pressurized, non-pressurized,multi unit, and cryogenic types)

Department/Agency U.S. Department of Transportation (DoT)Research and Special Programs AdministrationOffice of Hazardous Platerials Regulation400 Seventh Street, SW.Washington, DC 20590(202) 426-2075

Initiated

Compliance

Authority

Aim

Benefits

1965 (couplers subject to approval after1977)

Mandatory

49 CFR 179.100-400

To provide safe and reliable tank cars fortransport of hazardous materials.

Certification minimizes the risk of leakageor rupture of tanks, inadeguacy of couplers,and the improper use of tanks for designatedmaterials

.

Agency Function

Type of Program

Methodology



Third-party certification; Association ofAmerican Railroads (AAR) provides designapproval of couplers which is accepted by DoTunder this regulation.

Testing Third-party lab

Inspection Third-party

Conformity Direct marking on tanksIdentification Certificates of construction issued by

Agency.

Availability Certificates of construction are kept byof Documentation Agency and AAR.

Obligations of Manufacturer is obligated to use approvedManufacturer/ welders during construction.Vendor

121

Enforcement

Term

Reciprocity


Delisting or product recall if defectscan be repaired.

Certification is essentially indefinite.

Other Federal agenciesState agenciesPrivate sector organizationsCanadian government

Agency adopts standards of otherorganizations and provides integratingreguirements

.

Keywords railroads; hazardous materials; designapproval; witness testing; welder certifi-cation; railway car couplers;

Products or Rear End Marking Devices for Passenger,Services Commuter and Freight Trains

Department/Agency U.S. Department of Transportation (DOT)Federal Railroad Administration (FRA)Office of Standards and Procedures400 Seventh Street, SW.Washington, DC 20590(202) 426-0897

Initiated

Compliance

Authority

1978

Mandatory

Sec. 202, 84 Stat. 971, 45 U.S.C. 431 and49 CFR 1.49(n)

Aim To alleviate the potential for rear endcollisions by requiring use of marking deviceswhich have characteristics that assure visi-bility under adverse conditions encountered inservice.

Benefits Rear end collisions have decreased sinceimplementation of this certification program.

Agency Function

Type of Program

Methodology


Program administrator and certifier

Review of self-certification submitted byrai Iways.Review of test data submitted by devicemanufacturers or railways.Publication of Lists of Approved Rear EndMarking Devices. Currently twenty devicesproduced by six manufacturers are listed.

Testing to demonstrate compliance isaccomplished by manufacturers and railways intheir labs or independent labs that meetspecified gualif ications. Railways submit acertificate signed by the chief operatingofficer that devices used on the railwaysystem have been tested and comply with theFRA standard or are devices included in FRA'slist of approved devices.

Inclusion on FRA list of approved devices

Availability of 49 CFR, Part 221, Appendix B

123

Obligation ofManufacturer

Enforcement

Term

Reciprocity


Produce devices that are the same assamples tested for original approval.

Civil penalties ranging from $250 to$2500 for each violation. Each day of eachviolation constitutes a separate offense.

Indefinite

Recognition by State regulators asminimum requirements.

Guidelines for Testing of FRA Rear EndMarking Devices.

Keywords lights; reflectors; strobe; photometric;color imetric ; qualified laboratory; railroad;railway; transportation; safety;

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection

Conformity


Obligations ofManufacturer/

Enforcement

Shipboard Navigational Aides

U.S. Department of Transportation (DOT)Coast GuardWaterways Safety Branch (G-WWM-1)Washington, D.C. 20593(202) 426-1940

January 1985

Mandatory

CFR Title 33 Chapter 164Port and Tanker Safety Act of 1978

To improve the standard of collisionavoidance at sea.

Awareness and performance of observers isenhanced through automatically acquiredinformation.




Manufacturer ' s laboratory

Government


No lists of conforming products are published.

Conformity obligations rest on the equipmentuser who must perform and document testsspecified in Coast Guard regulations.

Product recall (i.e. user would be requiredto replace equipment not in compliance)

125

Term

Reciprocity


Keywords

Indefinite term

Other Federal agenciesForeign government agenciesInternational organizations

Agency adopts standards prepared by theInternational Maritime Organization and theU.S. Maritime Administration,

automatic radar plotting aids; speed indica-tors; gyro compasses; bearing encoders;collision avoidance systems; steering gear;alarms; loran receivers; depth soundingdevices

;

126

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing




Shipping Containers

U.S. Department of Transportation (DoT)Coast GuardMerchant Vessel Inspection DivisionOffice of Merchant Marine SafetyWashington, DC 20593(202) 426-4431

1977

Mandatory

International Safe Container Act

Provide procedures to certify containers as con-forming to the International Convention for SafeContainers.

International transport of containers is safer.

Program administrator and enforcement agency

Container must be certified before it can beentered into international traffic.


Manufacturer or owner and Certifying Authoritywitness tests for container design type approval.

Containers must display a safety approvalplate from the Certifying Authority in thecountry of registry.

List of approved manufacturers may beobtained from the Certifying Authority ineach signatory country. Coast Guard can identifyCertifying Authorities.

Owner and lessees are responsible for maintain-ing each container in a safe condition.

Enforcement Detention of unsafe and noncomplying containers.

127

Term Individual containers and vehicles aresubiect to re-inspection every 30 months.

Reciprocity

Standards r Codes,or Regulations

Certification is recognized by foreign govern-ments and international organizations.

Standards are included in the InternationalConvention for Safe Containers, regulationsin 49 CFR Parts 450-453.

Keywords cargo container; design approval; international;Convention for Safe Containers; CSC; ApprovedContinuous Examination; ACEP;

128

Products orServices

Department/Agency

Initiated

Compliance

Authority

Aim

Benef its

Agency Function

Type of Program

Methodology

Testing

Inspection




Special Tanks for Transportation ofHazardous Materials

U.S. Department of Transportation (DoT)Research and Special Programs AdministrationOffice of Hazardous Materials Regulation400 7th Street, NW.Washington, DC 20590(202) 426-2075

1964

Mandatory

49 CFR 178.270-272(special category reauthorized by PL 93-633)

To provide a uniform means for assuring thereliability of containers for shippingdesignated hazardous materials.

Materials are transported safely andefficiently and personal injuries due tocontainer failure are minimized.



Government design approvalThird-party certification

Third-party or manufacturer's lab

Third-party

Authorized mark applied by manufacturer

Agency maintains list of firms authorizedto manufacture such tanks.

Manufacturer must maintain integrity ofdesign, guality control, and cooperate ininvestigation of suspected faults.

129

Enforcement Product recallDelisting

Term

Reciprocity

Retest: user/owner to arrange ^or documentedvisual inspection at 2 1/2 year intervals;valves and pressure relief devices must beretested at 2 1/2 year intervals; and completetank must be hydrotested every 5 years.

Other Federal and State agencies, privateorganizations; Canadian government.


Keywords

Agency integrates standards from other sourcesinto program.

tanks; hazardous materials; transportation;hydrotesting; quality control; safety;

130

Products orServices

Tanks for Transport of Hazardous Materials

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection




U.S. Department of Transportation (DoT)Research and Special Programs AdministrationOffice of Hazardous Materials Regulation400 Seventh St. , NW.Washington, DC 20590(202) 755-2075

1964

Mandatory

49 U.S.C. 1803-180949 CFR 173.32-34

To provide safe and reliable containers fordomestic shipment of hazardous materials.

Certification minimizes the risk of leakage orrupture of tanks and the improper use of tanksfor designated materials.


Pre-market evaluation(Certain types of tanks in use at timeregulation went into effect which were made tospecific standards of the Association ofAmerican Railroads were approved).


Manufacturer or third-party lab

Periodic inspection is performed by owner.

Certified tanks are identified by marking asspecified in the regulation.

Agency maintains lists of manufacturers ofcertified tanks by type.

Manufacturer must maintain design control andsubmit design changes for approval.

131

Enforcement

Term

Reciprocity


Keywords

Marketing ban (also extends to distributors).

Tanks must be hydrotested every five years anddocumented inspection performed every 2 1/2years; safety relief valves must be tested at 2

1/2-year intervals to maintain certification.

Other Federal agencies and State agencies,private organizations and Canada.

Agency adopts standards from otherorganizations and provides integratingmaterial

.

portable tanks; hazardous materials; designapproval; hydrotest ing ; witness testing;

132

Products orServices

Electronic Fund Transfer Authentication Devices

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Inspection


U.S. Department of the TreasuryAssistant Secretary for Electronic Systemsand Information Technology15th Street and Pennsylvania Avenue NW.Washington, DC 20220(202) 566-2200

1984

Mandatory for all Government bureaus thatreceive or send funds or securities electroni-cally through the U.S. Treasury.

U.S. Treasury Directive 81-80

Assure that equipment which authenticates electron-ic fund transfers complies with designatedstandards to minimize exploitation of Electron-ic Fund Transfer (EFT) Systems.

It is a major milestone toward unifying theprotection and audit of the billions of dollarstransferred electronically every day.

Program Administrator and certifier: TreasuryStandard compliance: National Bureau of Standards(NBS), Institute for Computer Sciences andTechnology.Security evaluation guidance: National SecurityAgency (NSA).

Pre-market evaluationAssessment prior to government purchase

Testing by NBS and NSA

NBS Institute for Computer Sciences andTechnology and NSA

Treasury

A list of certified equipment and software ismaintained by Department of the Treasury.

133



Enforcement

Term

Reciprocity


Keywords

List and other technical documentationavailable from Department of Treasury AssistantSecretary, Electronic Systems and InformationTechnology

.

Comply with criteria.

Delisting

Indefinite term

None

Federal Information Processing Standard(FIPS) 46, Fed Std 1027, ANSIX9.9 and X9.17.Criteria documents are coordinated by Treasury.

communications security; electronic fundtransfer; EFT; encryption standard; vali-dation; interface requirements; computersecurity; cryptography; authentication devices;financial;

134

Products Automotive Driving Aids and AutomaticWheelchair Lifts

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Veterans AdministrationProsthetic & Sensory Aids Service (121)810 Vermont Avenue, NW.Washington, DC 20420(202) 389-2011

Driving aids, March 27, 1975; wheelchairlifts May 10, 1978.

Mandatory only for purchases funded bythe Veterans Administration (VA).

Public Law 91-666

Provide quality equipment and assuresafety of veteran passengers and driversas well as the general public.

Since developing the Quality ProductsList for hand controls and van lifts, 27out of 36 manufacturers of these unitshave been assisted by the VA in improvingthe quality of their products.Establishment of standards has fosteredcompet it ion.

Certification is made by the VA sponsoredAutomobile Adaptive Equipment Committee.

Assessment prior to government purchase

Compliance is assured by Governmenttest inq/inspect ion or third-party Governmentapproved certification, and manufacturers'self-cert if icat ion.

Testing Testing results are accepted from Govern-ment laboratories. Government approvedlabs, third-party labs and manufacturers'labs

.

135

Inspection



Term

Reciprocity


Keywords

Government

Listing in VA Circular 10-84-214.Currently, 15 wheelchair lift companiesand 12 hand control suppliers are certi-f ied.

The VA Quality Products List, DM&S Cir-cular 10-84-214, dated December 17, 1984lists certified suppliers of wheelchairlift sytems. Hand control suppliers areincluded in the January 1985 compliancelist.

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

Certification by other agencies isaccepted when current standards areapplied.

Federal Register, Vol, 40, No, 65 -

April 3, 1975, defines standards fordriving aides.

Requirements for wheelchair lifts arespecified in Federal Register, Vol. 43,No. 96 - May 17, 1978,

adaptive equipment; hand controls;prosthetic aids, driving aids; automo-tive; wheelchair lifts; safety; quality;

136

Products Self Propelled and Motorized Wheelchairs

Department/Agency

Initiated

Compliance

Authority

Aim

Benefits

Agency Function

Type of Program

Methodology

Testing

Veterans AdministrationProsthetic & Sensory Aids Service (121)810 Vermont Avenue, NW.Washington, DC 20420(202) 389-2011

Self propelled wheelchairs, December 7,1977; motorized wheelchairs, December 15,1981.

Mandatory only for purchases funded bythe Veterans Administration (VA).

Title 38 use 4101(c) (2)

Avoid hazardous conditions for disabledpersons caused by inferior products.

Product quality and safety has improvedand competition has increased. FederalSupply Schedule Contracts have beenestablished to enforce compliance.

Certification is made by the VA sponsoredProsthetic Technology Equipment Committee.

Assessment prior to Government purchase

Compliance is assured when made byGovernment testing/inspection or third-party Government approved certification,and manufacturers' self-certification.

Testing results are accepted from Govern-ment laboratories. Government approvedlabs, third-party labs and manufacturers'labs

.

137

Inspection



Term

Reciprocity


Keywords

Government

Ten VA propelled wheelchair suppliers andtwo motorized wheelchair suppliers arecurrently listed.

The General Services Administration's(GSA) Federal Supply Schedule for wheel-chairs provides particulars.

Testing of new products is on-going.Listings are updated annually and GSAcontracts are negotiated annually.

Certification by other agencies isaccepted when current standards areapplied.

Federal Register, Vol. 42, No. 239 -

December 13, 1977, defines standards forself propelled wheelchairs. Reguirementsfor motorized wheelchairs are specifiedin Federal Register, Vol. 46, No. 240 -

December 15, 1981.

prosthetic aids; wheelchairs; safety;guality

;

138

Products orServices

Department/Agency

Initiated

Compliance

Aim

Benefits

Agency Function

Type of Program

Methodology

Inspection



Enforcement

Tests and Procedures Performedby Veterans Administration Medical CenterLaboratories

Veterans AdministrationPathology Service, Department of Medicine

and Surgery810 Vermont Avenue, NW.Washington, D.C. 20240(202) 389-2348

1970

Voluntary

Standardization and uniformity inlaboratory test performance throughoutthe 204 clinical laboratories, 44 nuclearmedicine laboratories, 144 special purposelaboratories of the Veterans Administrationsystem.

Improved quality of care for patients.Peer-reviewed process provides cross-educational benefits for all laboratories.


Quality controlPhysician peer review

Third-party certification - College ofAmerican Pathologists (CAP)

Third-party

Authorized certificate by third-party -

College of American Pathologists

Maintained by Pathology Service andlocal laboratories, and at CAP.

Pathology Service, Veterans AdministrationCentral Office

139

Term

Reciprocity


Keywords

Indefinite term

Recognition of certification by JointCouncil of American Hospitals.

College of American PathologistsLaboratory Accreditation Program (CAPLAP).

pathology; clinical laboratories? nuclearmedicine

;

140

I

INDEX BY PRODUCT OR SERVICE CERTIFIED

PRODUCT PAGE

ADDITIVES, COLOR 63

ADHESIVES 61

AFTERMARKET PARTS 47

AGRICULTURAL SAFETY 95

AIR SAMPLERS 83

AIR TREATMENT FACILITIES 45

AIRCRAFT . 105

AIRCRAFT ENGINES 105

ALCOHOL TESTERS, BREATH 101

ANIMAL FEED 71

ANTIBIOTICS 69

APPLICATORS OF PESTICIDE 53

AUTHENTICATION DEVICES, ELECTRONIC FUND TRANSFER 13 3

AUTOMOBILE EMISSIONS 47, 51

AUTOMOBILE ENGINES 51

AUTOMOBILE PARTS & EQUIPMENT 47, 113

AUTOMOBILES 113

AUTOMOTIVE DRIVING AIDES 135

AUTOMOTIVE SAFETY 113

AVIATION WEATHER OBSERVERS 3 5

AVIONICS 105

BEEF .13

141

PRODUCT PAGE

BOATS, RECREATIONAL Ill

BREATH ALCOHOL TESTERS 101

BREATHING APPARATUS 83

BROADCAST EQUIPMENT 55

BUILDING PRODUCTS 85

BUTTER 9

CABINETS, FILING 61

CALIBRATION, INSTRUMENT 31, 101

CARGO HANDLING EQUIPMENT, MARITIME 95, 97

CARPET 85

CHEESE 9

CHEMICALS 41, 53

CHICKENS 17

CLAMS 33,77

CLINICAL LABORATORY TESTS 139

CLOTHING 39

COAL DUST SAMPLERS 83

COLOR ADDITIVES 63

COMMUNICATIONS EQUIPMENT 15, 55

COMPUTER INTERFACES 29

COMPUTERS 55

CONSTRUCTION SAFETY 9 5

CONSUMER PRODUCTS 37

CONTAINERS, CARGO 115, 127

142

PRODUCr PAGE

CONTAINERS FOR RADIOACTIVE MATERIALS 99, 117

COUPLERS, RAILWAY TANK CARS 121

CRANES 97

CYLINDERS FOR HAZARDOUS MATERIALS . .103

DAIRY PRODUCTS 9

DATA PROCESSING INTERFACES 29

DERRICKS 97

DENTAL INSTRUMENTS & DEVICES 81

DEVICES, MARINE SANITATION Ill

DIVING SAFETY 95

DOORS 85

DOORS, VAULT 61

DRIVING AIDS, AUTOMOTIVE 135

DRINKING WATER 49

DRUGS FOR ANIMALS 71

DRUGS FOR HUMANS 67, 69

EGGS & EGG PRODUCTS .17

ELECTRICAL EQUIPMENT & COMPONENTS 1 5 , 43 , 55 , 91 , 93

ELECTRONIC EQUIPMENT & COMPONENTS 15, 43, 55, 65, 105

ELECTRONIC FUND TRANSFER AUTHENTICATION DEVICES 133

ELECTRONIC RADIATION 55, 65

EMISSIONS, AUTO 47, 51

ENGINES, AIRCRAFT 105

143

PRODUCT PAGE

ENGINES, GASOLINE & DIESEL 51, 91

EQUIPMENT, AIRCRAFT. 105

EQUIPMENT, CARGO HANDLING 95, 97

EQUIPMENT, ELECTRIC 15, 55, 93

EQUIPMENT, MOTOR VEHICLE 113

EQUIPMENT FOR MINES 83, 91, 93

EQUIPMENT, OFFICE 55, 61

EQUIPMENT SAFETY 61, 83, 95, 111

EQUIPMENT, TELEPHONE 15, 55

EXHAUST EMISSIONS 47, 51, 91

FABRICS 39

FACTORY-BUILT HOUSING AND COMPONENTS 87

FILING CABINETS 61

FIRE PROTECTION 95

PISH, FRESH 73

PISH, PROCESSED 33

FISSILE MATERIAL PACKAGING 99, 117

PLAMMABILITY 39, 41

POOD 9, 11, 13, 17, 21, 33, 63, 73, 77

POOD FOR ANIMALS 71

FOOD FOR INFANTS 79"

FOOD, FROZEN 23

FOOD INSPECTION PERSONNEL 75

FOOD, PERISHABLE 23

144

PRODUCT PAGE

FOOD, TRANSPORTATION 23

FRESH FISH 73

FRESH FRUIT 11

FRESH SEAFOOD 73, 77

FRESH VEGETABLES 11

FROZEN SHELLFISH 77

FRUIT, FRESH 11

FRUIT, PROCESSED 21

FURNISHINGS, INTERIOR 37

GAS MASKS 83

HAZARDOUS MATERIALS, CONTAINERS 103, 115, 121, 129, 131& PACKAGING

HAZARDOUS SUBSTANCES 41, 53, 95

HOUSEHOLD PRODUCTS 37

HOUSING, MANUFACTURED 87

INDUSTRIAL SAFETY 95

INFANT FORMULA 79

INPUT /OUTPUT CHANNEL INTERFACES 29

INSECTICIDE APPLICATORS 53

INSTRUMENTS, MEASURING 27, 31

INSULIN 67

INTERFACES, INFORMATION PROCESSING EQUIPMENT 29

JOB SAFETY 95

LAMPS, MERCURY VAPOR 65

145

PRODUCT ^ PAGE

LAMPS, SUN 65

LASERS 65

LEGAL METROLOGY 27

LIFE SAVING EQUIPMENT Ill

LIFTS, WHEELCHAIR 135

LIGHTS, REAR END, RAILWAY TRAINS 123

LIVESTOCK 13

LONGSHORING SAFETY 95, 97

MACHINERY SAFETY 95

MANUFACTURED HOUSING & COMPONENTS 87

MARINE POLLUTION EQUIPMENT Ill

MARINE SAFETY EQUIPMENT Ill

MARINE TERMINAL SAFETY 95, 97

MARITIME CARGO HANDLING EQUIPMENT 95, 97

MATERIALS 15, 43, 61, 105

MEASURING INSTRUMENT CALIBRATION 31

MEASURING INSTRUMENT EVALUATION 27

MEDICAL DEVICES & EQUIPMENT 81

MEDICAL LABORATORY TESTS 139

MEDICAL SERVICES 95

MEDICINE 67, 69

MICROWAVE COMMUNICATIONS EQUIPMENT 15, 55

MICROWAVE OVENS 65

146

PRODUCT PAGE

MILITARY COMPONENTS 43

MINING MACHINES 91, 93

MOTOR VEHICLE ENGINES 51

MOTOR VEHICLES 113

MOTORIZED WHEELCHAIRS 113

MUSSELS 77

NAVAL STORES 25

NAVIGATION AIDES 125

NUCLEAR PACKAGES AND CONTAINERS 99, 117

NUTS 11

OBSERVER, WEATHER 35

OYSTERS 61

PACKAGES FOR RADIOACTIVE MATERIALS 99, 117

PACKAGING OF HAZARDOUS MATERIALS 103, 115, 121, 129, 131

PADLOCKS 61

PAINTS 61

PARTS 15, 43, 61, 105

PATHOLOGY TESTS 139

PERISHABLE FOOD TRANSPORTATION 2 3

PESTICIDE APPLICATORS 53

PET FOOD 71

PIPE ASSEMBLERS. . 119

147

PRODUCT PAGE

PIPELINES 119

POLLUTION CONTROL 45, 47, 51, 89, 111

PORK 13

POULT RY 17

PROCESSED FISH 33

PROCESSED FRUIT 21

PROCESSED SEAFOOD 3 3

PROCESSED VEGETABLES 21

PROSTHETIC AIDS 135

PROTECTIVE EQUIPMENT 61, 83, 95

QUALIFIED PRODUCTS LISTS 43, 61

RABBITS 17

RADAR OBSERVATION 35

RADIO FREQUENCY GENERATORS 55, 65

RADIOACTIVE MATERIAL PACKAGES & CONTAINERS 99, 117

RADIOACTIVITY 41 , 99

RADIOS 55

RAILWAY CARS, REFRIGERATED 23

RAILWAY TANK CARS 121

RAILWAY TRAIN REAR END MARKING DEVICES 123

RECEIVERS, RADIO 55

RECEIVERS, TELEVISION 55, 65

RECREATIONAL BOATS Ill

148

PRODUCT PAGE

RECREATIONAL PRODUCTS 37

REFLECTORS, RAILWAY TRAINS 123

REFRIGERATED RAILWAY CARS 23

REFRIGERATED VEHICLES 23

RESPIRATORS 83

ROSIN 25

SAFES 61

SAFETY & RELIEF VALVES 89

SAFETY EQUIPMENT 61, 83, 111

SANITATION DEVICES, MARINE . Ill

SCHOOL PRODUCTS 37

SCHOOLBUSES 113

SEAFOOD, FRESH 73

SEAFOOD, PROCESSED 33

SELF PROPELLED WHEELCHAIRS 137

SHELLFISH, FRESH 77

SHELLFISH, FROZEN 77

SHELLFISH, PROCESSED 33

SHIP SAFETY Ill

SHIPBOARD NAVIGATION AIDES ..... .125

SHIPPING CONTAINERS 115, 127

SHIPYARD SAFETY 95

SUNLAMPS 65

149

PRODUCT PAGE

VETERINARY MEDICINE 71

VISION 35

WATER QUALITY 45, 49

WATER TREATMENT FACILITIES 45

WEATHER OBSERVATION 3 5

WELDERS 119

WHEELCHAIR LIFTS 135

WHEELCHAIRS, MOTORIZED & SELF PROPELLED 137

WIRE ROPE 97

X-RAY EQUIPMENT 6 5

YACHTS Ill

l!^U.8. GOVERNMENT PRINTING OFFICE: 1986-<*91-070-t0052

150

NBS-n4A (REV. 2-8C)

U.S. DEPT. OF COMM. 1. rU BLl CA 1 lUN UK 2e Perforrning Organ, Report No, 0* nUDiicaLion uate

DIDI inPDADUir RATADlDLIUuKArnlO UMIAREPORT NO.

SHEET (See instructions) NBS/SP-714 April 1986

4. TITLE AND SUBTITLE

Federal Government Certification Programs for Products and Services

5. AUTHOR(S)


6. PERFORMING ORGANIZATION (If joint or other than NB5. see instructions)

R. B. Toth As-sOcfdte's

McTjean, VA 22101

7. Contract/Grant No,

8. Type of Report & Period Covered

Final9. SPONSORING ORGANIZATION NAME AND COMPLETE ADDRESS (Street. City. State. ZIP)

National Bureau of StandardsDepartment of CommerceGaithersburg, MD 20899

10. SUPPLEMENTARY NOTESLibrary of CongressCatalog Card Number: 86-600516

I I

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

11. ABSTRACT (A 200-word or less factual summary of most si gnificant information. If document includes a significantbibliography or literature survey, mention it here)

This directory presents information on 61 U.S. Government certification programs forproducts and services. Entries describe the scope and nature of each certificationprogram, testing and inspection practices, standards used, methods of identificationand enforcement, reciprocal recognition or acceptance of certification, and otherrelevant details.

This directory is part of an ongoing NBS effort to establish and maintain a compre-

hensive database on standards, regulations, certification programs and relatedinformation. This material has been compiled to meet the needs of government,

industry, and the public for information on U.S. Government certification programs in

accordance with the requirements of the U.S. Trade Agreements Act of 1979.

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

approved products; certification; certifiers; grading; inspection; listing; premarketevaluation; qualification; qualified products; specifications; standards; testing

13. AVAILABILITY

Unlimited

I IFor Official Distribution. Do Not Release to NTIS

fTJ Order From Superintendent of Documents, U.S. Government Printing Office, Washington, D.C.^ 20402.

[331 Order From National Technical Information Service (NTIS), Springfield, VA, 22161

14. NO. OFPRINTED PAGES

157

15. Price

USCOMM-DC 6043-P80

Technical Publications

Periodical

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

ana development in those disciplines of the physical and engineering sciences in which the Bureau is active.

These include physics, chemistry, engineering, mathematics, and computer sciences. Papers cover a broad

range of subjects, with major emphasis on measurement methodology and the basic technology underlying

standardization. Also included from time to time are survey articles on topics closely related to the Bureau's

technical and scientific programs. Issued six times a year.

Nonperiodicals

Monographs—Major contributions to the technical literature on various subjects related to the Bureau's scien-

tific and technical activities.

Handbooks—Recommended codes of engineering and industrial practice (including safety codes) developed in

cooperation with interested industries, professional organizations, and regulatory bodies.

Special Publications—Include proceedings of conferences sponsored by NBS, NBS annual reports, and other

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

Applied Mathematics Series—Mathematical tables, manuals, and studies of special interest to physicists,

engineers, chemists, biologists, mathematicians, computer programmers, and others engaged in scientific andtechnical work.

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

of materials, compiled from the world's literature and critically evaluated. Developed under a worldwide pro-

gram coordinated by NBS under the authority of the National Standard Data Act (Public Law 90-3%).

NOTE: The Journal of Physical and Chemical Reference Data (JPCRD) is published quarterly for NBS bythe 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 2(X)56.

Building Science Series—Disseminates technical information developed at the Bureau on building materials,

components, systems, and whole structures. The series presents research results, test methods, and perfor-

mance criteria related to the structural and environmental functions and the durability and safety

characteristics of building elements and systems.

Technical Notes—Studies or reports which are complete in themselves but restrictive in their treatment of a

subject. Analogous to monographs but not so comprehensive in scope or definitive in treatment of the subject

area. Often serve as a vehicle for final reports of work performed at NBS under the sponsorship of other

government agencies.

Voluntary Product Standards—Developed under procedures published by the Department of Commerce in

Part 10, Title 15, of the Code of Federal Regulations. The standards establish nationally recognized re-

quirements for products, and provide all concerned interests with a basis for common understanding of the

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

sector standardizing organizations.

Consumer Information Series—Practical information, based on NBS research and experience, covering areas

of interest to the consumer. Easily understandable language and iUustrations provide useful backgroundknowledge for shopping in today's technological marketplace.

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

Washington, DC 20402.

Order the following NBS publications—FIPS and NBSIR 's—from the National Technical Information Ser-

vice, Springfield, VA 22161.

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

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

information in the Federal Government regarding standards issued by NBS pursuant to the Federal Property

and Administrative Services Act of 1949 as amended. Public Law 89-306 (79 Stat. 1127), and as implementedby Executive Order 11717 (38 TO 12315, dated May 11, 1973) and Part 6 of Title 15 CFR (Code of Federal

Regulations).

NBS Interagency Reports (NBSIR)—A special series of interim or final reports on work performed by NBSfor outside sponsors (both government and non-government). In general, initial distribution is handled by the

sponsor; public distribution is by the National Technical Information Service, Springfield, VA 22161, in papercopy or microfiche form.

Products and Services - NIST

Documents

Transcript of Products and Services - NIST