NISTIR 6077 

THE U.S. CERTIFICATION SYSTEM FROM A

GOVERNMENTAL PERSPECTIVE

Maureen A. Breitenberg 

Office of Standards Services 

National Institute of Standards and Technology 

Gaithersburg, MD 20899 

October 1997 

 
Foreword

The Office of Standards Services periodically publishes information 

related to certification as a service to producers and users of such 

systems -- both in the government and in the private sector. This 

report provides those not fully familiar with this field with an 

introduction to some of its complexities from a governmental 

perspective. We hope that this material will be informative and will 

serve to stimulate wider understanding of the purpose and nature of 

the government's involvement in certification programs. 

The interested reader may wish to take advantage of other available 

publications and services provided by the Office of Standards 

Services. 

iii
Acknowledgements

I would like to thank Charles Hyer, The Marley Organization; Patrick 

Cooke, Walter Leight, and Mary Saunders, NIST; and many others for 

their careful review of and comments on this document. 

 Maureen A. Breitenberg 

 Office of Standards Services 

iv
Abstract 

This report is designed to provide the reader with an introduction 

to the U.S. certification system from a governmental perspective. It 

highlights some of the relationships that exist between federal and 

state agencies and the private sector and discusses some of the 

history and philosophy behind the U.S. system. 

Key Words: certificates of conformity; certification; certification 

marks; conformity assessment; product approval; standardization; 

standards; testing 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 v 
Table of Contents 

 

Foreword ......................................................................................................................................................iii 

 

Acknowledgements .............................................................................................................................. iv 

Abstract ...................................................................................................................................................... v 

Introduction .......................................................................................................................................... 1 

U.S. Regulatory Philosophy ................................................................................................ 2 

False and Misleading Advertising Prohibitions ....................................... 3 

Industry Self-Policing Efforts .................................................................................... 3 

Government Involvement ............................................................................................................ 4 

Federal Involvement ..................................................................................................................... 4 

Federal Involvement in Certification Program Accreditation... 6 

Certification Marks ..................................................................................................................... 7 

State/Local Government Involvement ........................................................................ 10 

Transparency in the Development of U.S. Regulations ..................... 11 

Other U.S. Statutory and Legal Obligations in the Certification 

 Area ......................................................................................................................................................... 12 

Conclusion ................................................................................................................................................ 13 

vii
INTRODUCTION

After declaring independence from England and prior to the formation 

of the United States of America, authority to regulate products and 

to conduct such product assessments as were deemed necessary rested 

with the individual states. With the signing of the U.S. 

Constitution, states gave to the federal government the authority to 

"regulate Commerce with foreign Nations, and among the several 

States, and with the Indian tribes..." However, in the first ten 

amendments to the Constitution, also known as the "Bill of Rights," 

the States spelled out that the "..powers not delegated to the United 

States by the Constitution, nor prohibited by it to the States, are 

reserved to the States respectively, or to the people." As a result, 

authority in the United States to regulate products (and to assess 

the conformity of products to mandatory requirements) is split 

between the federal and state governments. 

Conformity assessment is defined in ISO/IEC1

 Guide 2: 1996 as: "any 

activity concerned with determining directly or indirectly that 

relevant requirements are fulfilled." Conformity assessment 

procedures provide a means of ensuring that the products, services, 

or systems produced or operated have the required characteristics, 

and that these characteristics are consistent from product to 

product, service to service, or system to system. Conformity 

assessment includes: sampling and testing; inspection; 

certification

2

 (of both products and personnel); and quality and 

environmental system assessment and registration.3 Conformity 

assessment also includes accreditation of the competence of those 

activities by a third party and recognition (usually by a 

 1

 ISO is the acronym for the International Organization for 

Standardization, while IEC stands for the International 

Electrotechnical Commission. The International Organization for 

Standardization (ISO) is a worldwide federation of over 90 national 

standards bodies. ISO covers standardization in all fields, except 

the electrical and electronics fields which are covered by the 

International Electrotechnical Commission (IEC). IEC has members 

from over 40 countries which represent some 80% of the world's 

population. Together ISO and IEC form the world's largest 

nongovernmental system for voluntary industrial and technical 

collaboration in the field of standardization. 

2

 Some organizations use other terms to refer to the process, such 

as product listing, product evaluation, product regulation, product approval, or the publication of research reports, but in this 

discussion, we will use the term "certification." The reader should 

be aware of the existence and use of other terms, however, to describe 

this activity. 

3

 In Europe, quality and environmental system registration is often referred to as certification. 
 
government agency) of an accreditation program's capability. It 

should be recognized that product certification, the type of 

conformity assessment discussed in this paper, is only one type of 

conformity assessment. 

At the federal level, one of the first instances of major regulatory 

involvement in product certification occurred approximately 60 years 

ago. At that time U.S. drug manufacturers could produce and sell 

drugs without testing them on either animals or humans and without 

any kind of governmental approval. Governmental action could be 

taken only against drugs which were misbranded or adulterated. In 

1937, physicians in Tulsa, Oklahoma reported to the American Medical 

Association (AMA) the deaths of six patients from a liquified version 

of the then wonder drug sulfa. This drug ultimately killed 107 

people, mostly children, before doctors realized what was happening 

and the drug was recalled. This tragedy led to the enactment of the 

1938 Food, Drug and Cosmetic Act, which requires that drugs be tested 

and approved by the Food and Drug Administration (FDA) before 

marketing. From such early beginnings, the federal involvement in 

certification has grown both in extent and complexity. 

U.S. REGULATORY PHILOSOPHY

It might be useful to know something about the United States' 

regulatory philosophy to understand when federal or state government 

agencies are likely to become involved in conformity assessment, 

especially product certification. The United States's regulatory 

philosophy relies heavily on a manufacturer's declaration of 

conformity (or self-certification) wherever possible. 

Manufacturers' declaration of conformity is one of the oldest and 

simplest forms of certification. The vast majority of U.S. 

marketplace transactions involve only the buyer and the seller -- 

without intervention by any third party, whether government or the 

private sector. 

There are a number of reasons why this approach is successful in the 

United States. These include: (1) the sometimes severe penalties 

imposed by the U.S. legal and judicial system on products proven to 

be defective or hazardous to the public safety or environment; (2) 

the increasing access that the U.S. consumer has to information about 

poor quality or hazardous and defective products through various news 

and publications media; (3) the size of the U.S. marketplace and the 

ability of the U.S. consumer to switch to a competing product if 

dissatisfied; and (4) U.S. laws and regulations regarding truth in 

labeling and advertising. 

2 
The last three serve to increase consumer protection by enabling U.S. 

consumers to make better informed decisions regarding the products 

they purchase and to switch to brands if dissatisfied. 
FALSE AND MISLEADING ADVERTISING PROHIBITIONS

As noted above, one reason why the U.S. system works is that there 

are a number of federal and state laws and regulations4

 that prohibit 

the use of false or misleading labeling or advertising of products 

or services sold in the United States. In some cases, U.S. laws and 

regulations not only prohibit false or misleading labeling or 

advertising, but also mandate that information regarding certain 

characteristics of a product or service be disclosed to buyers. At 

the federal level, one of most important laws in this area, which is 

enforced by the Federal Trade Commission (FTC), is The Fair Packaging 

and Labeling Act. This Act requires consumer commodities to be 

accurately labeled regarding the description of the product's 

identity and net quantity. The Textile, Wool, and Fur Acts, also 

enforced by the FTC, protect consumers against misleading or false 

advertising and invoicing of textile, wool, and fur products. On the 

other hand, the Appliance Labeling Rule, a joint FTC/U.S. Department 

of Energy (DOE) regulation, is an example of a regulation that 

requires the disclosure of information to buyers, namely specific 

information on the energy costs or efficiencies of major home 

appliances. 

While the FTC is not authorized to resolve individual consumer 

complaints (though most states have established offices for this 

purpose), letters from consumers can trigger investigations of an 

industry or of a specific company. If, during an investigation, the 

FTC staff find reason to believe that a company has violated the law, 

and if the case is not settled by a formal agreement with the company 

(a consent order), the Commission can decide to sue the company. 

Depending on circumstances, the case may be tried before an 

administrative law judge or in federal court. The FTC may seek a 

cease and desist order, a preliminary or permanent injunction against 

the sale of the product, consumer redress, or other appropriate 

relief. 

INDUSTRY SELF-POLICING EFFORTS

When a manufacturer's declaration of conformity combined with federal 

and state prohibitions on the use of false or misleading labeling or 

advertising, does not afford sufficient marketplace protection, the 

government will frequently rely on self-policing efforts by the 

affected industry. A number of private sector industry or trade 

associations conduct conformity assessment programs, especially 

product certification programs, to: 

 4

 These laws are enforced by the U.S. Federal Trade Commission (FTC) 

at the national level and by most states through the Offices of the 

State's Attorney General. 

3 
(1) enhance the reputation of their industry; 

(2) provide manufacturers with some assurance regarding 

 product quality, safety, environmental impact, or 

 compliance with mandatory requirements; 

(3) level the playing field, that is, establish a minimum 

 level of quality or safety for products produced by 

 their industry and provide consumers with a means to 

 identify products which meet those minimum requirements; 

 and 

(4) avoid the need for government regulation. 

GOVERNMENT INVOLVEMENT

Although the U.S. Government relies to a large extent on 

manufacturers' declarations of conformity to both mandatory and 

voluntary product requirements, as well as on industry's 

self-policing efforts, if a product fails to meet mandatory 

requirements, the federal agency with jurisdiction over that product 

has the authority to take enforcement action against the producer, 

supplier or distributor of the product. Governmental reliance on a 

manufacturer's or supplier's declaration of conformity does not 

preclude the federal government from taking whatever action it deems 

necessary against a manufacturer or supplier if the government 

determines that a product is not in compliance with regulatory 

requirements. 

In addition, when manufacturer's self-declarations or industry 

self-policing efforts are not effective or adequate, government 

agencies may become more directly involved in the assessment of 

compliance with mandatory product requirements. If the problem with 

a specific product or service is a local one, states and local 

government agencies are likely to be the responsible authorities. If 

a serious problem exists, which is national in scope and which cannot 

be adequately or economically addressed at the state and local levels, 

then the federal government is likely to get involved. 

FEDERAL INVOLVEMENT

Federal government involvement generally occurs when Congress passes 

a law giving a specific federal agency the statutory authority 

required to address such a problem at the national level. Federal 

agencies then develop regulations to implement that law. As required 

4 
by the Administrative Procedure Act, such regulations go through an 

extensive public review and comment process before they become final 

-- a process discussed in more detail later. 

In addition to regulatory programs, federal agencies also conduct a 

number of other types of certification programs. In general, federal 

government certification programs can be classified into several 

general categories: 

 o Programs to certify products which directly affect the 

 health or safety of the user or the general public. 

 o Programs to test products to avoid the necessity for 

 retesting at local levels or prior to each procurement. 

 o Programs to provide a uniform basis for trade by assessing 

 the quality and condition of products offered for sale. 

Examples of the first type of certification program include the 

evaluation and approval by the Food and Drug Administration (FDA), 

U.S. Department of Health and Human Services, of new animal and human 

drugs, medical devices, biologicals, and other products; the 

certification by the Federal Aviation Administration (FAA), U.S. 

Department of Transportation, of airplanes and major airplane 

components; respirators and other breathing apparatus by the National 

Institute for Occupational Safety and Health; and the certification 

by the Mine Safety and Health Administration (MSHA), Department of 

Labor, of electrical and other potentially hazardous equipment used 

in mines. 

An example of the second type of program is the Department of Defense's 

(DOD) Qualified Products Listing (QPL) Program for parts, materials 

and components used in military systems. This program reduces 

retesting prior to each government purchase by testing products and 

placing those approved on appropriate QPL's. An extension of this 

concept also underlies the DOD Qualified Manufacturing Lists (QML's) 

Program, in which a manufacturer's process controls and manufacturing 

capabilities are evaluated and approved for an entire range of 

products. 

An example of the third type of program is the U.S. Department of 

Agriculture's (USDA) program to grade and certify meat and meat 

products (on a voluntary basis) using uniform grading standards for 

the buying and selling of such products. The USDA also certifies 

dairy products, fresh and processed fruits, vegetables, nuts and 

related products. The National Oceanic and Atmospheric 

Administration (NOAA), U.S. Department of Commerce, likewise 

inspects and grades processed fish and shellfish at a seafood 

processor's request. 

5 
The complexity of such programs and the procedures used by each can 

vary extensively depending on purpose, the nature of the product or 

service, as well as the extent to which private sector programs are 

available and effective and can be used to supplement federal efforts. 

More complex and comprehensive programs tend to be more effective, 

but they also tend to be more costly. The federal government is 

obligated (by law in the regulatory area) to consider both 

effectiveness and cost and to weigh the two when establishing a new 

program. 

FEDERAL GOVERNMENT INVOLVEMENT IN CERTIFICATION PROGRAM 

ACCREDITATION

The U.S. accreditation system for certification programs is less 

complex than other U.S. conformity assessment areas, primarily 

because the United States only has a few major programs. The most 

prominent government program of this type is operated by Occupational 

Safety and Health Administration (OSHA) within the U.S. Department 

of Labor (DOL). 

OSHA's program covers electrical equipment/materials used in the work 

place. By law, all electrical products used in the work place must 

be tested and listed or labelled by a certifier (known as a Nationally 

Recognized Testing Laboratory, or NRTL) which is recognized/approved 

by OSHA. NRTLs are private sector certifiers, and participation in 

the OSHA program is voluntary. However, if certifiers wish to test 

such products, they must be recognized/approved by OSHA.5

 NRTLs are 

subject to review at least once every 5 years. Applicants for OSHA 

recognition as an NRTL must have adequate administrative and 

technical capability to be able to certify products in the areas for 

which they seek approval/recognition. They must also be able to 

inspect factory production runs as part of a product's evaluation and 

to conduct field inspections to ensure proper use of the certifier's 

identifying mark or label on the product. The program is open to all 

U.S. certifiers and to foreign certifiers if the countries of those 

foreign certifiers are open to U.S. certifiers. 

The National Institute of Standards and Technology can also accredit 

certifiers under its National Voluntary Conformity Assessment 

Evaluation (NVCASE) Program. The program is intended to enable the 

Department of Commerce, acting through NIST, to evaluate and 

recognize competently conducted U.S. conformity assessment 

activities, including certification, which are capable of meeting 

regulatory requirements of another country with which the United 

 5

 OSHA is responsible for the regulation of all electrical products 

used in the work place. For a list of the products under OSHA's 

jurisdiction which require certification by a Nationally Recognized 

Testing Laboratory (NRTL), see 29 CFR 1910. 

6 
States has an applicable mutual recognition agreement. The program 

supplements the programs of other federal agencies and is generally 

initiated upon NIST's receipt of a request for assistance from the 

appropriate U.S. regulatory agency. The results of NIST evaluations 

provide a basis for the U.S. Government to assure foreign governments 

that qualified U.S. conformity assessment bodies are competent and 

can satisfy foreign regulatory requirements. NIST will conduct 

evaluations using publicly developed requirements based to the 

maximum extent possible on international guides and standards for the 

acceptance of conformity assessment activities. The program 

operates on a fee-for-service basis. NIST provides a certificate of 

recognition to a body meeting the requirements and maintain lists of 

all qualified conformity assessment bodies. 

CERTIFICATION MARKS

The federal government is also concerned with the registration of 

marks used in certification programs due to the increasing 

international use and importance of these marks in the marketplace. 

One of the most interesting things NIST learned during the latest 

revision of NIST SP 774, the Directory of Private Sector Product 

Certification Programs, was that while many, but not all, of the marks 

used in certification programs are registered with the U.S. Patent 

and Trademark Office (PTO), many of these registered marks are not 

"certification marks" as defined by U.S. law. 

To explain this situation, it may be helpful to quote selectively from 

the definitions for the various types of registered marks and related 

definitions contained in Section 1127, "Construction and 

Definitions," of the Trademark Act of 1946 ("Lanham Act") as amended. 

"The term 'person' and any other word used to designate the applicant

or other entitled to a benefit or privilege or rendered liable under 

the provisions of this Act ... includes a juristic person as well as 

a natural person. The term 'juristic person' includes a firm, 

corporation, union, association, or other organization capable of 

suing and being sued in a court of law." 

"The term 'person' ... includes any State, instrumentality of a State 

and any officer or employee of a State or instrumentality of a State 

acting in his or her official capacity. Any State, and any such 

instrumentality, officer or employee, shall be subject to the 

provisions of this Act in the same manner and to the same extent as 

any nongovernmental entity." 

7 
"The terms 'applicant' and 'registrant' embrace the legal 

representatives, predecessors, successors and assigns of such 

applicant or registrant." 

"The term 'related company' means any person whose use of a mark is 

controlled by the owner of the mark with respect to the nature and 

quality of the goods and services on or in connection with which the 

mark is used." 

"The terms 'trade name' and 'commercial name' mean any name used by 

a person to identify his or her business or vocation." 

"The term 'trademark' includes any word, name, symbol, or device or 

any combination thereof -- 

(1) used by a person; or 

(2) which a person has a bona fide intention to use in 

commerce and applies to register on the principal register

established by this Act, 

to identify and distinguish his or her goods, including a unique 

product, from those manufactured or sold by others and to indicate 

the source of goods, even if that source is unknown." 

"The term 'service mark' means any word, name, symbol, or device or 

any combination thereof -- 

(1) used by a person, or 

(2) which a person has a bona fide intention to use in commerce

and applies to register on the principal register established 

by this Act, 

to identify and distinguish the services of one person, including a 

unique service, from the services of others and to indicate the source 

of the services, even if that source is unknown. Titles, character 

names, and other distinctive features of radio or television programs 

may be registered as service marks notwithstanding that they, or the 

programs, may advertise the goods of the sponsor." 

"The term 'certification mark' means any word, name, symbol, or device 

or any combination thereof -- 

(1) used by a person other than its owner, or 

(2) which its owner has a bona fide intention to permit a person

other than the owner to use in commerce and files an application 

to register on the principal register established by this Act, 

to certify regional or other origin, material, mode of manufacture, 

quality, accuracy, or other characteristics of such person's goods 

or services or that the work or labor on the goods or services was 

performed by members of a union or other organization." 

8 
"The term 'collective mark' means a trademark or service mark -- 

(1) used by members of a cooperative, an association or other 

collective group or organization, or 

(2) which such cooperative, association, or other collective 

group or organization has a bona fide intention to use in 

commerce and applies to register on the principal register

established by this Act, 

and includes marks indicating membership in a union, an association 

or other organization." 

"The term 'used in commerce' means the bona fide use of a mark in the 

ordinary course of trade, and not made merely to reserve a right in 

a mark." 

"The term 'mark' includes any trademark, service mark, collective 

mark, or certification mark." 

U.S. certification programs use ALL of these types of registration 

marks defined in the Trademark Act. In fact, only a few programs use 

federally-registered certification marks as defined by the Trademark 

Act. In addition, unregistered marks (often 

initializations/acronyms and/or symbols/logos used on letterheads 

and reports to identify the organizations that provide product 

certification) are also used in U.S. certification programs. The 

type of mark used by a particular program is based on the type of 

organization which runs the program (e.g., an independent laboratory 

or a trade association); existing ownership of a well recognized 

trademark, service mark, or collective mark; familiarity on the part 

of the certifier with the different categories of marks; and the cost 

and perceived need for a registered mark. 

In drafting certification-related regulations, several government 

agencies have already learned that the terminology used in connection 

with marking requirements can have a major impact on the number and 

types of organizations eligible to participate in the conformity 

assessment program. For example, requiring certification programs 

to have a certification mark (as distinct from some other type of mark) 

can eliminate many U.S. certification programs from participation. 

Some agencies also own certification marks which are registered with 

the U.S. Patent and Trademark Office and which are used in their 

product approval/certification programs. Examples include the 

Department of Transportation mark in its program for tanks used in 

the transport of hazardous materials. The U.S. Department of 

Agriculture owns and uses several marks in connection with its poultry 

and meat grading programs, and the Environmental Protection Agency 

uses its Energy Star mark in programs designed to promote the 

manufacture and use of more energy efficient products. 

9 
STATE/LOCAL GOVERNMENT INVOLVEMENT

As noted above, federal agencies are not the only U.S. governmental 

agencies with authority regarding certification. States administer 

many different types of certification programs covering a diversity 

of products. In some cases, states inspect or test products under 

authority delegated by the federal government. For example, many 

states inspect meat and meat products, certifying those that meet 

standards established by the USDA. These states then authorize the 

use of the appropriate USDA marks. Many states also inspect and issue 

certificates of conformity for manufactured homes under authority 

delegated by the U.S. Department of Housing and Urban Development 

(HUD). Most state and local jurisdictions also have responsibility 

for water quality testing under authority delegated to them by the 

U.S. Environmental Protection Agency (EPA). States may also impose 

additional state requirements and simultaneously check for 

conformity to both state and federal requirements. 

States regulate products under their own authority for health and 

safety reasons, including amusement rides and thermal insulation, 

depending on each state's perception of the health and safety impact 

of such products on its population. Products may be inspected and/or 

tested directly by the states themselves, or indirectly through a 

requirement that such products be inspected and/or tested and 

certified by an approved body, such as a nationally recognized 

laboratory. An example of the latter is the regulation of electrical 

building products by imposing a state requirement that they be 

tested/inspected and bear the mark of a "nationally recognized 

testing laboratory." The term "nationally recognized laboratory" is 

currently defined by each state and/or municipality. 

States regulate products of direct or indirect economic importance. 

Florida and California, for example, inspect products important to 

their citrus fruit industry. Nebraska, with a considerable 

agricultural industry, regulates tractors through a testing program 

at the University of Nebraska and issues certificates of conformity 

for approved models. California, with its air pollution problem, 

stringently regulates auto emissions equipment. 

States inspect, test, and/or certify materials, products, systems and 

services they procure, such as materials for the construction of state 

roads and bridges. In yet other cases, the states establish 

standards, but leave enforcement (testing, inspection, etc.) to local 

authorities. This is sometimes true for building and construction 

materials. 

10 

 
Again, the complexity of such state and local programs and the 

procedures used can differ greatly just as they can at the federal 

level, depending on the purpose of the program, the nature of the 

product or service, and the extent to which private sector programs 

are available and effective. 

TRANSPARENCY IN THE DEVELOPMENT OF U.S. REGULATIONS

As mentioned earlier in this paper, the federal government develops 

regulations, including those with conformity assessment 

requirements, only after an extensive public review and comment 

process. The Administrative Procedure Act (APA) establishes general 

procedures for rulemaking which must be followed by U.S. federal 

government agencies (5 U.S.C. section 551 et seq.). At a 

minimum, the APA requires that for the issuance of a substantive rule 

(as distinguished from a procedural rule or statement of policy), an 

agency must: 

(1) Publish a notice of proposed rulemaking in the Federal 

Register. This notice must set forth the text or the substance 

of the proposed rule, the legal authority for the rulemaking 

proceeding, and applicable times and places for public 

participation. 

(2) Provide all interested parties -- national and non-national 

alike -- an adequate opportunity for submission of written 

comments on the proposed rule. This public comment process 

serves a number of purposes, including giving interested persons 

the opportunity to provide the agency with information that will 

enhance the agency's knowledge of the subject matter of the 

rulemaking. The public comment process also provides 

interested persons with the opportunity to challenge the factual 

assumptions on which the agency is proceeding, and to show in 

what respect such assumptions are in error. 

(3) Publish a notice of final rulemaking at least thirty days 

before the effective date of the rule, which includes a statement 

of the basis and purpose of the rule and which responds to all 

substantive comments received. The APA makes an exception from 

the requirement for publication of the final rule thirty days 

before its effective date if the rule makes an exemption or 

relieves a restriction, or if the agency makes and publishes a 

finding that an earlier effective date is required "for good 

cause." 

Rulemaking proceedings are usually started by an agency at its own 

initiative. However, the APA provides that each agency of the U.S. 

Government shall afford interested persons the right to petition for 

11 
the issuance, amendment, or repeal of a rule. According to law, 

agencies must respond to the request. If the request has merit, work 

will commence on developing a proposed rule. In some cases, Congress 

(by statute) directs an agency to begin a rulemaking proceeding. 

The APA also contains provisions for advance notice of proposed 

rulemaking. This allow agencies to seek general comments on issues 

prior to developing the specific regulatory proposal. 

OTHER U.S. STATUTORY AND LEGAL OBLIGATIONS IN THE 

CERTIFICATION AREA

In addition to its openness and transparency obligations under the 

APA Act, the U.S. Government has other domestic and international 

obligations which affect the conformity assessment area. The U.S. 

Government is a signatory to a number of international trade 

agreements which affect conformity assessment, including 

certification. For example, the U.S. Government was a signatory to 

the Agreement on Technical Barriers to Trade (also known as the 

"Standards Code") under the General Agreement on Tariffs and Trade 

(GATT), one of the first international agreements related to trade 

that recognized the importance of standards and certification systems 

for "improving efficiency of production and facilitating the conduct 

of international trade." The U.S. Trade Agreements Act of 1979 

implemented the Standards Code in the United States. Title IV of the 

Act specifies obligations for the federal government, including 

responsibilities bearing on certification. Each federal agency must 

ensure that foreign products are treated in the same manner as 

domestic goods. Moreover, the federal government is to take 

reasonable measures to promote similar practices by state governments 

and the private sector. 

December 15, 1993 saw a successful conclusion of the Uruguay Round 

of trade negotiations. In April 1994, the United States signed the 

Uruguay Round Agreements. These Agreements included a revision of 

the Agreement on Technical Barriers to Trade (the TBT Agreement). 

The Uruguay Round also created a new institution as a successor to 

the General Agreement on Tariffs and Trade (GATT), the World Trade 

Organization (WTO). 

The new TBT Agreement sought to ensure that technical regulations and 

standards, as well as testing and certification procedures, do not 

create unnecessary obstacles to trade. However, it recognized that 

countries have the right to establish protection at levels they 

consider appropriate (for example for human, animal or plant life or 

health or the environment), and should not be prevented from taking 

measures necessary to ensure that those levels of protection are met. 

 

12 
The new agreement encourages countries to use international standards 

whenever appropriate, but does not require them to change their 

prescribed levels of protection as a result of standardization. The 

revised agreement also covers processing and production methods 

related to the characteristics of the product itself. The coverage 

of conformity assessment procedures was enlarged and the disciplines 

made more precise. Provisions applying to subnational government 

and non-government bodies were elaborated in more detail than in the 

prior TBT agreement. 

In addition to its obligations under the new TBT Agreement, the U.S. 

Government has related conformity assessment obligations under the 

North American Free Trade Agreement (NAFTA). The U.S. Government 

actively participates in a number of regional efforts, designed to 

harmonize conformity assessment procedures and requirements and to 

promote the mutual recognition and acceptance of conformity 

assessment results. 

The U.S. Government also has domestic requirements placed on it with 

respect to the conduct of conformity assessment activities. 

Recently, Section 12, "Standards Conformity," of the National 

Technology Transfer and Advancement Act of 1995 was passed with "the 

goal of eliminating unnecessary duplication and complexity in the 

development and promulgation of conformity assessment requirements 

and measures." NIST was given responsibility for coordinating 

"Federal, State, and local technical standards activities and 

conformity assessment activities, with private sector technical 

standards activities and conformity assessment activities." The 

objective of Section 12 is to encourage federal agencies to make 

greater use of and place increased reliance on private sector 

standards and conformity assessment activities and programs. 

CONCLUSION

The United States has an extensive and sometimes complex system for 

ensuring the conformity of products sold in the U.S. marketplace to 

both mandatory and voluntary standards and requirements. Like the 

U.S. standards system, the U.S. certification system has evolved in 

a decentralized manner. It is based largely on declarations of 

conformity by manufacturers and suppliers of products sold in the U.S. 

marketplace, as well as on industry self-regulation. Many U.S. 

private sector organizations, as well as federal, state and local 

government agencies are involved in certification for a variety of 

reasons. The assurance of product conformity can involve one or more 

levels of government and increasingly involves reliance on private 

sector programs and activities. As both federal and state budgets 

shrink, greater emphasis is likely to be placed by government agencies 

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at all levels on the use of and cooperation with certification 

programs available within the private sector. Despite its 

complexity, however, the U.S. certification system remains one of the 

most effective, open, and transparent systems in the world. 

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