1

US-EU HIGH-LEVEL REGULATORY COOPERATION FORUM

Report on the Use of Voluntary Standards1

in Support of Regulation in the United States

October 2009

1. PURPOSE OF THIS REPORT 

This report responds to a request by the United States-European Union (US-EU) High-Level 

Regulatory Cooperation Forum to provide information on the use of standards in support of 

regulation in the United States. The report outlines the U.S. legal and institutional framework 

regarding the use of standards in support of regulation. The report includes a case study from 

the Federal Communications Commission (FCC).

2. BACKGROUND

The Administrative Procedures Act (APA), the Trade Agreements Act of 1979 (TAA), 

Executive Orders and other official guidance provide a framework for regulatory agencies 

concerning the development and implementation of regulations. As part of this framework,

agencies consider cost, enforcement mechanisms, use of voluntary consensus standards and 

other factors, including the avoidance of unnecessary obstacles to trade.

How these procedures and considerations are applied may also depend on statutes applicable 

to individual agencies. The laws and policies governing regulations reflect the fact that 

regulations should achieve their intended objectives, and avoid imposing burdensome or 

unnecessary costs. Such costs may include harm to the economy and higher prices for goods 

and services including through the creation of unnecessary trade barriers. The use of 

standards within a regulation is one aspect of a much larger analysis and decision making 

process that must be undertaken by a U.S. regulatory agency. Agencies are required to look at 

many aspects of a proposed regulation, unless directed to do otherwise by the authorizing 

statute, including but not limited to:

 whether a market failure or other compelling public need exists for a regulation, 

 whether regulation at the Federal level is the best approach, 

 the use of alternative regulatory approaches, 

 how well those approaches meet an agency’s regulatory objectives, 

 the costs and benefits associated with a proposed regulation, 

 the cost-effectiveness of a proposed regulation, 

 

1Office of Management and Budget (OMB) Circular A-119 defines the term "standard," or "technical standard" 

to include all of the following: (1) common and repeated use of rules, conditions, guidelines or characteristics for 

products or related processes and production methods, and related management systems practices; and (2) the 

definition of terms; classification of components; delineation of procedures; specification of dimensions, 

materials, performance, designs, or operations; measurement of quality and quantity in describing materials, 

processes, products, systems, services, or practices; test methods and sampling procedures; or descriptions of fit 

and measurements of size or strength.
2

 whether to use specific standards or parts of standards, and 

 how the requirements contained in the regulation will be enforced. 

Agencies review and analyze such issues -- both individually and collectively -- to determine 

the overall quality and effectiveness of the regulation. 

2.1 Overview of the U.S. Regulatory Process

To better understand how the United States uses standards in regulation, it is necessary to first 

present a basic overview of the U.S. regulatory requirements and processes. Embedded in 

statutes and other documents guiding rulemaking in the United States are certain key 

principles, including: 

 Transparency in the making of technical assessments, factual findings, and normative 

policy choices, and transparent and open opportunities for public participation 

regarding those matters to ensure effective monitoring, critiquing and reviewing of 

rulemaking;

 Regulatory analyses, based on sound science and data and the consideration of 

alternative approaches to and stringency of regulation;

 Strong support from the government for the use of regulatory best practices; and

 Accountability of government agencies within the executive, legislative and judicial 

branches of the Federal government.

Compliance with these principles increases the quality and effectiveness of the U.S. 

rulemaking process in meeting regulatory objectives, while minimizing the burden on 

industry and the public.

Article I, Section 1, of the Constitution gives the U.S. Congress the sole power to make 

statutes or laws. However, Congress has passed a number of statutes that delegate certain 

specified rulemaking authority to Executive Branch regulatory agencies, such as the U.S. 

Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA). 

In so doing, Congress generally establishes factors/criteria within the statute to guide and 

limit how the agency exercises its use of that authority. The degree of specificity in Congress' 

delegation of authority and guidance varies from statute to statute. Each regulatory agency 

implements the authority given to it by Congress by developing and establishing regulations 

or rules to the extent necessary to achieve agency objectives. These regulations or rules, 

when finalized, have the force and effect of law. Regulations are almost always much more 

detailed than the statues or laws that authorize the regulation’s issuance. The statute or law 

containing the rulemaking authority granted by Congress to an agency is known as the 

agency's authorizing or “enabling” statute. An agency may have more than one enabling 

statute. 

Congress may also supplement an agency's enabling statute(s) by later enacting new statutes 

or laws giving agencies other authorities or directing the regulatory agency to use its existing 

general rulemaking authority in a specific way to meet legitimate national objectives, such as 

the preservation of health and safety, animal welfare, protection of the environment, or the 

protection of consumer choice. In some cases, an agency’s appropriation acts may also add to 

or limit the implementation of an agency’s authorities.
3

All such statutes are first made publicly available in final enacted form as a Public Law. They 

are then codified in the United States Code, which is also publicly available. In addition, 

proposed and final regulations are published in the Federal Register, which is publicly 

available. The regulatory text in final rules is then codified in the Code of Federal 

Regulations, which is again publicly available.

In addition to enabling and related statutes, there are other requirements that govern the 

development and issuance of rules or regulations by Federal agencies. These requirements 

include other statutes, such as the APA, TAA, the National Technology Transfer and 

Advancement Act (NTAA), as well as Presidential E.O.s and Office of Management and 

Budget (OMB) Circulars. These requirements impose procedural obligations that are

intended to ensure reasoned and fair decision making, and to ensure international trade 

obligations are met. These other statutes, E.O.s, and Circulars typically require that the 

agencies adopt regulations only after thoroughly analyzing the potential impact of the 

proposed regulations and considering alternative regulatory approaches. For all economically 

significant regulatory actions, this analysis includes an assessment and comparison of the 

benefits and costs of the regulation, the regulation’s cost-effectiveness, an analysis of 

alternative regulatory approaches, and an analysis of the impact of alternative levels of 

stringency in the requirements contained in the regulation. These requirements are designed to 

ensure an open and transparent U.S. rulemaking process that gives all members of the public 

the opportunity to participate. The process seeks to give the public the information needed to 

understand what the regulatory agency is proposing to do and the rationale for its actions. 

If a proposed or final regulation is likely to have a “significant” impact, that is it’s impact on 

the economy exceeding $100 million in any one year-as defined by E.O. 12866, the agency 

proposing the regulation must generally submit both the proposed and final versions of the 

rule to the OMB for review before it is published in the Federal Register. There are some 

limited exceptions to this requirement. OMB reviews each economically significant 

regulatory proposal to ensure that it is supported by adequate regulatory analyses and is 

consistent with the statutes enacted by Congress and the President’s priorities. Regulatory 

analyses undertaken by an agency for economically significant rulemakings must include an

analysis of a reasonable number of regulatory alternatives. Such analyses must also include 

an explanation and justification as to why a particular regulatory approach was selected.

Congress also requires that regulatory analyses give special attention to the impact of the 

proposed regulation on small businesses; small, not-for profit organizations; and U.S. State, 

local, and tribal governments. Certain specific burdens that will be placed on the public as the 

result of the regulation, such as the time and effort necessary to complete any required 

paperwork, energy impact, the disproportionate impacts on children, and a number of other 

issues also have to be considered.

2.2 Process of Rulemaking

In general, the public portion of a rulemaking begins with the publication by the agency of a 

Notice of Proposed Rulemaking (NPRM)2notifying the public that the Agency may adopt a 

 

2

In some cases, agencies will first issue an Advanced Notice of a Proposed Rulemaking (ANPRM) to solicit 

public comment and feedback on a regulatory issue to determine the need for further rulemaking. This is a 

particularly useful tool when an agency is considering undertaking rulemaking in a new area. The ANPRM 

process can also be useful when an agency wants to test out a proposal or solicit ideas before it drafts its NPRM.
4

specific regulation in the future and providing an opportunity for the public to comment by 

submitting written data, views, and arguments. The NPRM must provide sufficient 

information to enable the public to envision and anticipate the major aspects of the Final Rule. 

The NPRM typically consists of two parts: a preamble, which is a narrative discussion; and 

the text of the proposed regulation. The preamble informs the public of the relevant issues 

and considerations and may include: information on the problem to be addressed by the 

proposal; an explanation as to why the agency has tentatively concluded that a regulatory 

response is warranted; the nature of the proposed regulatory approach as well as the details 

about the requirements, their levels of stringency, any relevant test procedures, and the 

proposed use of any standards; and a description of the available research studies and 

empirical data on which the proposed regulation was based. 

In addition, the NPRM provides instructions for submitting written comments, either 

electronic or hard copy, and identifies an agency contact person who can respond to 

questions. The agency also generally has discretion on whether to supplement the opportunity 

to submit written comments with an opportunity to make oral presentations at a public 

meeting or hearing. In some cases, agencies are required to make such an opportunity 

available. To the extent that the NPRM does not set forth and explain all of the factual 

assumptions, analyses, and methodologies that underlie the proposal, the agency will place 

documents addressing those matters in a public docket3so that the public has an opportunity 

to read and comment on them. The agency also places all comments it receives in response to 

the NPRM in the public docket, with the exception of documents containing confidential 

business information, including trade secrets. Most Federal agencies also participate in 

Regulations.gov, an internet website that facilitates public participation in the Federal 

regulatory process by improving the public’s ability to locate, review, and provide comment 

on Federal regulations.

There are no restrictions on who may participate in the comment process. The comment 

process is open to all, including individuals, businesses, and government agencies of other 

countries and regions. Persons wishing to comment are not subject to any governmentally 

controlled or sponsored selection process. Businesses and consumers decide for themselves 

whether to participate and may participate directly (i.e., individually), indirectly through 

associations and other representatives, or both. Inquiry Point operations in the U.S. 

Departments of Commerce and Agriculture facilitate access to the comment process by 

interested parties, including those in other countries.

Comments can include suggestions for the adoption of all or parts of a specific standard 

within the proposed regulation, as well as comments both for and against any standard or 

parts of a standard that the agency has proposed to incorporate into the regulation. Comments 

may also cover many other aspects of the proposed regulation.

The comment process serves a number of purposes, including enabling the public to: 

 Provide the agency with information, including information on standards, to enhance 

the agency's knowledge;

 

3 A public docket is a repository for rulemaking and supporting documents (e.g., Federal Register notices, 

supporting analyses, and comments) for public access and comment.
5

 Challenge the agency's interpretation and application of data and research, factual 

assumptions, analytical methodologies, tentative factual, technical, legal, and policy 

conclusions, practicability assessments, and assessments of the benefits and other 

impacts of the proposal, including those that are standard-related; and 

 Suggest alternatives (including standards-related alternatives) to the proposed 

requirements and test procedures. 

The agency must then consider the data, views, and arguments submitted by the public, 

including any substantive comments related to the use and content of standards that may be 

incorporated into the regulation. In issuing any Final Rules (the revised version of a proposed 

regulation which will be binding on the public when effective), the agency must provide a 

statement of the rule's basis and purpose and include the agency’s discussion of and response 

to the public comments, which again includes those that are standards-related. Although 

many of the analytic requirements for rulemakings are established by Executive Order and 

other Executive Branch guidance, some of the requirements of a final rule have developed 

from case law, such as the obligation of agencies to adequately respond to significant

comments and to provide a reasonable basis for the regulatory approach that the agencies has 

chosen and therefore may be challenged in court. It should be noted that there are exceptions 

to this process in cases where emergency rulemaking is necessary.

3. POLICY AND LEGAL CONTEXT FOR THE USE OF STANDARDS IN 

SUPPORT OF REGULATIONS/ PROCUREMENT

3.1 Obligations at the National Level

The U.S. Federal regulatory system, described above, is designed to protect and improve the 

health, safety, and well being of U.S. citizens and to protect the environment. It seeks to 

improve the effectiveness of regulation without imposing unacceptable or unreasonable costs 

on society. U.S. regulatory policies recognize that marketplace forces are generally the best 

engine for driving economic growth. U.S. regulatory policies emphasize that regulations 

should be cost-effective, consistent, sensible, and understandable, and that the regulatory 

process should be open, transparent and fair to all interested parties. Consistent with this 

philosophy and to codify a long standing practice by Federal agencies, the U.S. Congress 

enacted Public Law 104-113, also known as the National Technology Transfer and 

Advancement Act (NTTAA), in March 1996.

4

 The NTTAA and the Trade Agreements Act of 

1979, as amended (TAA) 5are two key pieces of U.S. legislation affecting the regulatory and 

procurement use of standards. The NTTAA directs federal agencies to use, when practical 

and not otherwise prohibited by law, standards developed by voluntary consensus standards 

bodies to achieve public policy and procurement objectives, and the TAA prohibits federal 

agencies from engaging in any standards-related activity that creates unnecessary obstacles to 

trade and requires federal agencies to take into consideration international standards. 

 

4 A copy of the entire text of the law is available at: http://standards.gov/standards_gov/nttaa.cfm.

5 The standards-related provisions of the TAA are codified at United States Code, Title 19, Chapter 13, 

Subchapter II, Technical Barriers to Trade (Standards).
6

The NTTAA directs U.S. Federal agencies on their use of standards developed by voluntary 

consensus standards bodies for both regulatory and procurement purposes. It instructs U.S. 

Federal agencies to use voluntary consensus standards wherever practical, in lieu of creating 

government-unique standards. In addition, the Act instructs agencies to review their 

development and promulgation of conformity assessment requirements and measures with the

goal of eliminating unnecessary duplication and complexity in such requirements. The Act 

also charges the National Institute of Standards and Technology (NIST)6 with coordinating 

the standards needs of U.S. Federal agencies to achieve greater reliance on voluntary 

consensus standards. 

Further guidance on implementing the NTTAA is contained in the Office of Management and 

Budget’s (OMB) Circular A-119, Federal Participation in the Development and Use of 

Voluntary Consensus Standards and in Conformity Assessment Activities.

7

 This Circular 

instructs agencies to use voluntary consensus standards in lieu of government-unique 

standards, except where such usage is inconsistent with law or otherwise impractical. It 

defines “voluntary consensus standards” as standards developed or adopted by a voluntary 

consensus body. It also defines a “voluntary consensus body” as an organization – whether 

domiciled in the United States or elsewhere – that has the following attributes: openness, 

balance of interests, due process, an appeals process, and consensus. The Circular also 

provides guidance for agencies participating in voluntary consensus standards bodies and 

describes procedures for satisfying the reporting requirements in the NTTAA. The aim of the 

Circular is minimize agency reliance on government-unique standards.

The law and the Circular also recognize that participation in voluntary standards development 

can benefit agencies in a wide range of activities. U.S. agencies and departments, including 

regulatory agencies, participate in the development of domestic and international standards as 

one means of helping to achieve specific goals and missions through cooperative efforts in a 

wide range of health, safety, environmental, technical and other areas. The Circular directs 

aagencies to consult with voluntary consensus standards bodies, both domestic and 

international, and to participate with such bodies in the development of voluntary consensus 

standards when consultation and participation is in the public interest and is compatible with 

the agencies’ missions, authorities, priorities, and budget resources. Such participation also is 

carried out in accordance with other applicable policies and laws as well as international 

agreements such as the WTO Agreement on Technical Barriers to Trade (TBT). 

The TAA implements U.S. obligations under the TBT Agreement regarding the development, 

adoption, and application of technical regulations, standards, and conformity assessment 

procedures. Specifically, the TAA prohibits Federal agencies from engaging in any 

standards-related activity that creates unnecessary obstacles to trade. It further directs Federal 

agencies to ensure non-discriminatory treatment in applying standards–related activities to 

any imported product. The TAA directs each Federal agency to use performance based 

requirements, if appropriate; to take into consideration international standards; and, if 

appropriate, to base technical regulations on international standards. Further, the TAA 

 

6 The National Institute of Standards and Technology (NIST) is an agency with the U.S. Department of 

Commerce.

7 A copy of the entire text of OMB Circular A-119 is available at: http://standards.gov/standards_gov/a119.cfm.
7

provides an illustrative list of reasons that it may not be appropriate to base a technical 

regulation on an international standard. 

There are also other policies and statutes that direct agencies to rely on voluntary consensus 

standards and avoid use of government-unique standards. For example, such policies and

statutes include:8

 The Consumer Product Safety Act, which directs the Consumer Product Safety 

Commission to rely on voluntary consensus consumer product safety standards rather

than promulgate its own standards; 

 The Telecommunications Act of 1996, which contains several provisions that 

encourage Federal Communications Commission (FCC) reliance on private sector 

standards;

 The Food and Drug Administration (FDA) Modernization Act of 1997, which contains

provisions that allow the FDA in some instances to accept attestation to certain 

standards during the evaluation of premarket submissions for electrical medical 

devices; and

 MILSPEC Reform, which has resulted in the Department of Defense’s (DoD’s) 

moving away from unique specifications and standards (MILSPECS) and toward 

reliance on private sector standards.

These Acts of Congress and executive branch policies set forth requirements and goals 

regarding Federal usage of standards.

3.2 Stakeholder Participation in the Regulatory Use of Standards

In accordance with the NTTAA, the TAA, and U.S. international obligations, U.S. regulators 

(in considering what standards to use in regulations) look to standards that have been 

developed in accordance with certain principles. These principles include: transparency, 

openness, impartiality/balance and consensus. Most standards developers within the U.S. 

standards system endorse the principles of openness, balance, and lack of dominance in the 

standards development activities.9 Standards developed in accordance with such principles 

 

8 Based on information compiled by the American National Standards Institute (ANSI), “Significant Federal 

Laws and Policies,”http://www.ansi.org/government_affairs/laws_policies/laws.aspx?menuid=6

9 The American National Standards Institute (ANSI) has established a process to approve standards as “ANS” 

standards. ANS standards must have been developed in accordance with the following principles:

Openness means that participation in a standards development activity is open to all persons who are 

directly and materially affected by the activity in question. There shall be no undue financial barriers to 

participation, and voting membership on the consensus body shall not be conditional upon membership in 

any organization, nor unreasonably restricted on the basis of technical qualifications or other such 

requirements.

Lack of dominance means that the standards development process is not to be dominated by any single 

interest category, individual or organization. This applies to government agencies that choose to participate 

in a standards development process. Dominance means a position or exercise of dominant authority, 

leadership, or influence by reason of superior leverage, strength, or representation to the exclusion of fair 

and equitable consideration of other viewpoints.

Balance means that standards development process should have a balance of interests. Participants from 

diverse interest categories shall be sought with the objective of achieving balance.
8

allow any interested party or stakeholder, whether or not based in the United States, to 

participate as an equal member in the standards development process and to have his or her 

viewpoint fairly considered. A representative from one or more government agencies may 

participate and have his or her viewpoint(s) heard, but such viewpoints do not carry more 

weight than those of other stakeholders in the process. In other words, agency representatives

are not to dominate the process.

Thus, during the standards development process, stakeholders have the opportunity to 

influence the content of any standard developed by bodies that adhere to these principles, 

including standards that might be used in regulatory applications. During the rulemaking 

process, stakeholders have a second opportunity to influence the choice of standard or parts of 

a standard that a regulatory agency may be considering for adoption. As noted above, the U.S. 

rulemaking process is committed to transparency in the development of technical 

assessments, factual findings, and normative policy choices. It is also committed to 

transparency and openness in the public participation process regarding those matters to 

ensure effective monitoring, critiquing and reviewing of the rulemaking process.

4. IMPLEMENTATION 

4.1 Implementation of Legislation and Policies

As mentioned above, OMB Circular A-119 provides support for the implementation of the 

NTTAA. The Circular contains guidance for Federal agencies and sets forth policies on 

Federal use of and participation in the development of voluntary consensus standards and on 

conformity assessment activities. NIST is charged with carrying out the responsibility of the 

Secretary of Commerce to coordinate, foster and otherwise implement the provisions of the 

Circular within the Executive Branch of the U.S. government NIST provides administrative 

guidance and assistance to other Federal agencies, including identifying voluntary consensus 

standards and conformity assessment bodies that support agencies’ missions. The TAA gives 

the United States Trade Representative (USTR) the lead role within the Federal government 

on the coordination and development of international trade policy related to implementation 

of the standards-related provisions of the Act. The TAA also gives USTR the responsibility 

for coordinating discussions and negotiations with foreign countries for the purpose of 

establishing mutual arrangements with respect to standards-related activities. Coordination 

under the NTTAA and the TAA is conducted through two interagency committees.

The Interagency Committee on Standards Policy (ICSP) is charged with providing consistent 

and effective standards policies across government. The ICSP was authorized by OMB 

Circular A-119 and is chaired by NIST. The ICSP provides advice and recommendations to 

the Secretary of Commerce and other Executive Branch agencies on matters related to Federal 

standards policy. Besides promoting effective and consistent standards policies, the ICSP 

fosters cooperation between government, industry, and other private organizations involved in 

 

In addition, public and private sectors joined together under ANSI auspices and published the United States 

Standards Strategy (USSS) in 2005. The Strategy confirms the U.S. commitment to these and other 

internationally accepted principles of standardization endorsed by the World Trade Organization

(WTO) – transparency, openness, impartiality, effectiveness and relevance, consensus, performance-based, 

coherence, due process, and technical assistance. A copy of the USSS is available at: 

http://www.ansi.org/standards_activities/nss/usss.aspx?menuid=3
9

standards activities. The ICSP also seeks furtherance of U.S. domestic and foreign goals, and, 

to this end, fosters cooperative participation by the Federal government and U.S. industry and 

other private organizations in standards activities. This includes the related activities of 

sampling, inspection and testing; management system registration; certification; and 

accreditation. The ICSP meets three to four times a year and is composed of Federal agency 

standards executives or their designated representatives.

To ensure that agencies are following the provisions of the NTTAA and the Circular, Federal 

agencies must annually report to NIST on: their participation in standards development 

organizations and conformity assessment activities; their adoption and use of voluntary 

standards; and on the promulgation of any government-unique standards, along with agencies’ 

rationales for such use. This results in an annual review of the standards activities of the U.S. 

government. NIST files annual summary reports with the OMB, which are sent to Congress. 

Individual agency reports and the annual summary reports to OMB and Congress are 

available at Standards.gov, a NIST-supported web portal for government standards activities.

Meanwhile, USTR oversees an interagency trade policy process that incorporates input from 

numerous government agencies, including regulatory agencies, in the implementation and 

coordination of U.S. trade policy.10 The vast majority of decision-making on standardsrelated activities takes place at the Trade Policy Staff Committee (TPSC) Subcommittee on 

Technical Barriers to Trade. In cooperation and coordination with relevant agencies, 

including regulatory agencies, the USTR monitors U.S. compliance with WTO and any other 

international obligations related to technical regulations, standards, and conformity 

assessment procedures, including those associated with the use of international and 

performance-based standards.

As noted previously, agencies are required to use relevant international standards to the extent 

provided in Article 2.4 of the WTO TBT Agreement and other trade agreements, as a basis for 

their technical regulations. However, agencies are not prevented from taking measures at 

levels the agencies consider necessary for the protection of human, animal, plant life or 

health, and the environment; or for the prevention of deceptive practices. International 

standards can be used by regulatory agencies to meet these objectives. The policy of the U.S. 

government is to use the term “international standard” to refer those standards developed in a 

manner that is consistent with the World Trade Organization (WTO) Technical Barrier to 

Trade (TBT) Committee’s Decision of the Committee on Principles for the Development of 

International Standards, Guides and Recommendations with relation to Articles 2, 5 and 

Annex 3 of the Agreement.

11

All economically significant government regulations require the preparation of a detailed 

Regulatory Impact Analysis (Presidential Executive Order (E.O.) 12866).

12

 According to 

 

10 The interagency coordination process among U.S. Federal agencies related to good regulatory practice is 

described in detail in the Communication from the United States to the WTO Committee on Technical Barriers 

to Trade, “Good Regulatory Practice: The Role of Strong Central Government Coordination in TBT Agreement 

Implementation,” G/TBT/W/315.

11 See Annex B of G/TBT/1/Rev.9.

12 For a copy of E.O. 12866, see http://www.whitehouse.gov/omb/inforeg/eo12866.pdf.
10

OMB Circular A-4, which provides more detail on how to conduct a proper Regulatory 

Impact Analysis (RIA), the agency should carefully analyze any concerns that their 

rulemaking could create a non-tariff barrier. Although Circular A-4 does not specifically 

require it, many agencies do consider the costs and benefits of using international standards as 

a part of their analyses. In fact, an OMB-EC joint report on considering the international 

impacts of regulation recommended that agencies should consider existing international 

standards or regulatory approaches as an explicit regulatory alternative in an RIA. OMB 

encourages such analysis of standards under Circular A-4, concluding that such analysis

would satisfy an agency’s obligation to consider standards under OMB Circular A-119 and 

the NTTAA. In addition, as noted above, the TAA requires Federal agencies to take into 

consideration international standards and to base an agency’s requirements on international 

standards where appropriate. 

For example, on November 23, 2005, the U.S. Federal Aviation Administration (FAA) 

published a Notice of Proposed Rulemaking (NPRM) in the Federal Register entitled 

“Reduction of Fuel Tank Flammability in Transport Category Airplanes.” This NPRM was 

designed to alleviate a risk that had led to several fatal airplane accidents caused by fuel tank 

explosions, including the Boeing 747 TWA Flight 800 explosion off Long Island, New York 

in 1996. The FAA proposed new rules that would require operators and manufacturers of all 

transport-category airplanes in operation in the United States, including airplanes 

manufactured by Airbus, to take steps to prevent electrical and other systems from igniting 

flammable vapors in the fuel tank. In its analysis of the impact of the proposal, the FAA 

specifically noted that the FAA had also considered the interaction of this rulemaking with 

international standards. Specifically, in keeping with U.S. obligations under the Convention 

on International Civil Aviation, FAA’s policy was to comply with International Civil 

Aviation Organization (ICAO) Standards and Recommended Practices to the maximum 

extent practicable. The FAA determined for purposes of the proposed rulemaking that there 

were no applicable ICAO Standards and Recommended Practices.

On August 23, 2007, the U.S. Customs and Border Protection (CBP) of the Department of 

Homeland Security (DHS) published a final rule in the Federal Register entitled “Advance 

Electronic Transmission of Passenger and Crew Member Manifests for Commercial Aircraft 

and Vessels.” This final rule required electronic manifest transmission to CBP of passenger 

and crew member information for those onboard international commercial flights and voyages 

to and from the United States. The rule noted that CBP policies allowed data transmission 

under this rule to follow the UN/EDIFACT (United Nations/Electrical Data Interchange for 

Administration, Commerce, and Trade), an international electronic data interchange standard 

developed under the auspices of the United Nations. 

Standards are also a key element of the Coast Guard's strategic plan for maritime regulatory 

reform. The U.S. Coast Guard has stated that “The Office of Marine Safety, Security, and 

Environmental Protection is committed to developing nationally and internationally 

recognized standards as a means to improve maritime safety and marine environmental 

protection, and to promote an internationally competitive U.S. maritime industry.” However, 

the U.S. Coast Guard also recognizes that safety must be cost-effective. In 1995 the Coast 

Guard began an effort to look at its regulations, eliminate those that were outdated or 

inefficient, and adopt international standards where possible. As an example of the Coast 

Guard’s effort, in 1996 the Coast Guard revised its electrical regulations adopting 86 new 

standards including 32 standards developed by the International Electrotechnical Commission 
11

(IEC). To date, the Coast Guard has adopted approximately 450 industry standards, saving 

over 25,000 pages of federal regulations and the associated regulation maintenance, while 

specifying standards already familiar to the regulated industry.

In addition to often examining the possibility of using international standards within a 

regulation during the analysis of the proposed regulation’s impact, agencies must consider and 

respond to substantive comments made during the rulemaking process (including comments 

on the use or non-use of international standards) and justify their final decision in that regard 

before publishing a final rule.

Some agencies, such as the U.S. Department of Transportation’s Pipeline and Hazardous 

Materials Safety Administration (PHMSA), also participate in a number of international 

forums. PHMSA is involved in an ongoing process of harmonizing the U.S. Hazardous 

Materials Regulations (HMR) with international standards and regulations. Participation 

helps ensure that U.S. interests are communicated and considered in the development of such 

international standards. PHMSA’s objective is to establish and maintain a global regulatory 

system for hazardous materials transportation that will enhance the safe, secure, and efficient 

movement of hazardous materials.

In addition, E.O. 12866 specifically addresses the use of performance-based standards, 

informing agencies that:

“... (P)erformance standards are generally to be preferred to engineering or design standards 

because performance standards provide the regulated parties the flexibility to achieve the 

regulatory objective in a more cost-effective way. It is therefore misleading and inappropriate 

to characterize a standard as a performance standard if it is set so that there is only one 

feasible way to meet it; as a practical matter, such a standard is a design standard. In 

general, a performance standard should be preferred wherever that performance can be 

measured or reasonably imputed. Performance standards should be applied with a scope 

appropriate to the problem the regulation seeks to address. For example, to create the 

greatest opportunities for the regulated parties to achieve cost savings while meeting the 

regulatory objective, compliance with air emission standards can be allowed on a plant-wide, 

firm-wide, or region-wide basis rather than vent by vent, provided this does not produce 

unacceptable air quality outcomes (such as "hot spots" from local pollution concentration).”

4.2 Mechanisms and Methods to Make Use of Standards

The U.S. standards system is primarily voluntary, private sector, and marketplace driven with 

multiple standards developers taking an active role. The U.S. Federal government participates 

as one of many stakeholders in the standards development process, not as the driver of the 

process. By comparison, governments in other nations play a more active role; and the 

process is more centralized. 

Although not a driver of the process, as noted above, the U.S. government is committed to 

reliance on voluntary standards for procurement and regulation, where such usage is 

consistent with regulatory and procurement objectives. Government regulatory agencies use 

externally developed standards in a wide variety of ways, including the following:
12

 Incorporation by Reference: An agency may adopt a voluntary standard without 

change by incorporating the standard in an agency's regulation or by listing (or 

referencing) the standard by title. For example, the Occupational Safety and Health 

Administration (OSHA) adopted the National Electrical Code (NEC) by incorporating 

it into its regulations by reference. 

 Strong Deference: An agency may grant strong deference to standards developed by a 

particular organization for a specific purpose. The agency will then use the standards 

in its regulatory program unless someone demonstrates to the agency why it should 

not. 

 Basis for Rulemaking: The agency reviews a standard, makes appropriate changes, 

and then publishes the revision in the Federal Register as a proposed regulation. 

Substantive comments received from the public during the rulemaking proceeding may 

result in changes to the proposed rule before it is issued as a final rule. 

 Regulatory Guidance: An agency may permit adherence to a specific standard as an 

acceptable, though not compulsory, way of complying with a regulation. The agency 

provides in the rule text that a regulated entity may comply with the rule set out in the 

text or may comply with a referenced voluntary standard.

 Guidelines: An agency may use standards as guidelines for complying with general 

requirements. The guidelines are advisory only and therefore compliance with them is 

not mandatory.

 Deference in Lieu of Developing a Mandatory Standard: An agency may decide that it 

does not need to issue a mandatory regulation because voluntary compliance with 

either an existing standard or one developed for the purpose will suffice in meeting the 

needs of the agency.

A regulatory agency’s approach to the use of standards in a particular application is based on 

the statutes under which the rulemaking is proceeding; the nature of the public comments

received; and often the costs, benefits and cost-effectiveness of the various approaches to such 

usage.

Guidance on the use of voluntary standards in procurement applications may be found in the 

General Services Administration’s Federal Standardization Manual.13 The manual notes that 

when a government agency is in the initial stages of developing a Federal Product Description 

(FPD)14, the use of voluntary standards are to be given preference over the development of 

government unique FPDs. The agency is required to do extensive research to determine if a 

voluntary standard exists that will satisfy its needs and is consistent with applicable laws and 

regulations. If an existing voluntary standard will satisfy the agency’s needs, the agency must 

adopt the standard by one of the following processes:

 Either the procedure must satisfy the adoption requirement established in OMB 

Circular A-119, or

 The agency may formally adopt the standard in whole and issue an adoption notice, or

 

13 For a copy of this manual, see http://www.dsp.dla.mil/APP_UIL/content/policy/docs/fsman.pdf

14 Federal Product Descriptions or FPDs consist of Federal specifications and related Federal qualified products 

lists, Federal standards, and commercial item descriptions (CIDs).
13

 The agency may reference the voluntary standard in whole or in part in its 

procurement documents or regulations. 

It is also the U.S. Department of Defense’s (DoD) policy to make maximum use of nonGovernment standards and commercial technologies, products, and practices.15

 DoD is 

committed to the adoption and use of voluntary consensus standards (defined in DoD 

4120.24-M as "non-Government standards") where practical, instead of developing new or 

updating existing government specifications and standards. This policy is consistent with P.L. 

104-113, the NTTAA and with OMB Circular A-119. 

In addition, the U.S. government, as represented by DoD, is a member of the North Atlantic 

Treaty Organization (NATO) and endorses the NATO Policy for Standardization that 

emphasizes the adoption of suitable civil standards (or non-government standards) for use 

within NATO. The NATO Committee for Standardization (NCS) has issued the NATO 

Framework Document on Civil Standards, which describes the Alliance’s role with respect to 

relations with Civil Standards Bodies (private sector standards bodies), to make best use of 

civil standards within the full range of NATO tasks. The document provides that, whenever 

possible and where advantageous, NATO members use the most appropriate and openly 

available civil standards, rather than develop military standards. It also stresses that NATO

should only develop its own standards when no suitable civil standards exist.

5. MAINTAINING AND UPDATING STANDARDS

5.1 Agency Participation in and Knowledge of Standards Development

Within budgetary constraints, regulatory agencies are encouraged to participate in standards 

development activities that are consistent with their mission. Such participation is designed to 

keep agencies aware of standards under development or revision, as well as to contribute to 

the development of standards that will eliminate the need for government unique standards to 

be used in regulatory applications. 

In the procurement area, the GSA Federal Standardization Manual directs Federal agencies to 

participate in activities of voluntary standard bodies, where participation has been determined 

to be beneficial to the agency. The government agency is to participate in a voluntary standard 

body when participation is in the public interest and is compatible with agency’s mission, 

authorities, priorities and budget limitations. The manual notes that the benefits of such 

participation include:

 Allowing agencies to stay abreast of new technologies;

 Reducing the cost to the Federal government of developing government unique 

standards; 

 Providing agencies with opportunities to learn from both manufacturers and end 

users; and 

 

15 For Information on the U.S. Department of Defense’s Standardization policy, see: 

http://www.dsp.dla.mil/APP_UIL/policy.aspx?action=content&accounttype=displaypolicy&contentid=79#GSA
14

 Encouraging reliance on the private sector to supply government’s needs for goods 

and services.

Agencies also have access to a number of sources for standards-related information, including 

standards libraries and the services of NIST’s National Center for Standards and Certification 

Information (NCSCI) that can provide agencies with information regarding potential 

standards that may be of interest in a regulatory or procurement action.

Regulatory agencies may also receive information on standards that may be appropriate or 

inappropriate for regulatory use during the extensive public comment process that most 

proposed regulations must undergo.

5.2 Maintenance, Updating and Revision of Standards Used in Regulation

The U.S. regulatory process, while very open and transparent, is also resource intensive. 

Agencies are not only required to involve the public when rules are developed and issued, 

they are also required to involve the public in amendments, revisions, or repeals of such rules. 

To ensure that the public is informed, agencies are generally required to publish proposed and 

final rules in the Federal Register. They are also required to publish amendments, revisions 

or repeals of such rules in the Federal Register, including changes to rules that are designed to 

incorporate a new or revised edition of a standard. 

Standards referenced in regulations are generally required to include the title, date, edition, 

author, publisher, and identification number of the publication. Future amendments or 

revisions of standards that are incorporated by reference do not automatically amend the 

requirements of a regulation. Agencies that wish to update a standard that is referenced 

within a regulation must generally undertake another rulemaking process. Because 

rulemaking resources are often limited, updating references to standards that have been 

amended or revised is often not a high priority, particularly if the version currently referenced 

in the regulation still meets the agency’s regulatory objectives.

 

Many agencies have been actively exploring the use of methods to speed the process of 

updating references to standards included within regulations, and some creative solutions 

have been undertaken to speed the rulemaking process in specific cases. For example, some 

agencies have adopted small, non-controversial revisions to standards through a “direct” final 

rule. Such a rulemaking stage is not preceded by a proposed rule. However, it includes a 

public comment period on the implementation of the direct final rule. An agency is obligated 

to withdraw the direct final rule and proceed with the normal proposed rulemaking process if 

it receives any adverse comment to the direct final rulemaking process. This is just one 

example. To date, no one-size-fits-all solution to this issue has been developed.

Currency is less of a problem in the procurement area. The General Services Administration’s 

Federal Standardization Manual16 requires that agencies not cite the issue date of a standard in 

the FPD when referencing the voluntary standard, unless a specific issue of the voluntary 

standard is needed.

 

16 For a copy of this manual, see http://www.dsp.dla.mil/APP_UIL/content/policy/docs/fsman.pdf
15

5.3 Normative References Included in Standards Used in Regulation and 

Procurement

Currency, as well as applicability, are also issues associated with normative references that 

are contained in standards that have been incorporated into regulations or included within 

procurement requirements. A number of private sector, voluntary, consensus standards, 

including those published by the International Organization for Standardization (ISO), contain 

a section that lists one or more additional standards that are deemed to be “Normative 

References.” “Normative references” are defined by ISO and the American National 

Standards Institute (ANSI) as being “indispensable for the application of the document” or 

standard in which they are listed. Standards referenced in both regulations and in procurement 

documents may contain a list of “normative references.” 

CASE STUDY EXAMPLE

CASE STUDY: Federal Communications Commission 

The U.S. Federal Communications Commission (FCC), a United States government agency 

established by the Communications Act of 1934, regulates interstate and international 

communications by radio, television, wire, satellite and cable. The FCC's jurisdiction covers 

the 50 States, the District of Columbia, and U.S. possessions. 

The FCC regulates the private sector communications industry by establishing technical 

regulations found in Volume 47 of the Code of Federal Regulations (C.F.R.) Parts 0 to 101.17 

These technical regulations aim at minimizing the potential of causing harmful interference to 

radio services from transmitters and other equipment. 

There are a number of ways that the FCC uses standards in support of the technical regulations 

and conformity assessment procedures. The FCC provides for the use of standards as follows:

 Incorporation by reference;

 Measurement procedures published by national engineering societies;

 Reference to technical limits in a standard; and

 Technical criteria established by standards development organizations.

Incorporation by reference was established by statute and allows Federal agencies to publish 

regulations in the Federal Register by referring to materials already published elsewhere. The 

legal effect of incorporation by reference is that the material is treated as if it were published in 

full in the Federal Register. The FCC has incorporated by reference standards developed by 

the following standards development organizations:

 Advanced Television Systems Committee (ATSC)

 American Society for Testing Materials (ASTM)

 Consumer Electronics Association (CEA)

 Electronic Industry Association (EIA)

 Federal Aviation Administration (FAA)

 

17 47 C.F.R. §§ 0 – 101.
16

 International Electrotechnical Commission (IEC)

 International Maritime Organization (IMO)

 International Radio Consultative Committee (IRC)

 International Organization for Standardization (ISO)

 International Special Committee on Radio Interference (CISPR)

 International Telecommunication Union (ITU)

 International Telegraph and Telephone Consultative Committee (CCITT)

 North American Numbering Council (NANC)

 Radio Technical Commission for Aeronautics (RTCA)

 Radio Technical Commission for Maritime Services (RCTM)

 Society of Cable Telecommunications Engineers (SCTE)

 Telecommunications Industry Association (TIA)

Measurement Procedures – Several measurement procedures have been identified in the FCC 

regulations by incorporation by reference. In addition to measurement procedures identified 

by the FCC, the rules provide flexibility to use standards developed by standards development 

organizations. Those measurement procedures found to be acceptable by the FCC may be 

used to demonstrate compliance with the technical regulations. 

Reference to technical limits in a standard – For example, the technical requirements for 

digital devices found in §15.107 have harmonized the conducted emission requirements with 

the international standards found in CISPR 22.

18

 In §15.109, the FCC rules allow equipment 

to comply with the radiated emission limits in CISPR 22, third edition, as an alternative to the 

limits given in FCC Part 15.19

Technical Criteria established by standards development organizations – For example, the 

FCC created the Administrative Council for Terminal Attachment (ACTA), which is 

sponsored by the Telecommunications Industry Association (TIA) and the Alliance for 

Telecommunications Industry Solutions (ATIS).20 Standards development organizations 

(SDO) accredited by ANSI may establish technical criteria for terminal equipment pursuant to 

ANSI consensus decision making procedures and submit such criteria to ACTA.

Conformity Assessment Procedures

The FCC administers an authorization program to ensure that equipment reaching the market 

complies with the technical requirements in the rules. The FCC uses three different equipment 

authorization procedures, depending on the type of equipment, as specified in the rules. The 

procedure applicable to a particular device depends on the risk of interference that the device 

poses to licensed radio services. The three equipment authorization procedures are as 

follows:21

 

18 See Information technology equipment – Radio disturbance characteristics – Limits and methods of 

measurement, International Electrotechnical Commission (IEC), International Special Committee on Radio 

Interference (CISPR), Publication 22.

19 47 C.F.R. § 15.109.

20 47 C.F.R. § 68.602.

21 47 C.F.R. § 2.907.
17

Verification is a self-approval procedure whereby the responsible party makes measurements 

or takes the necessary steps to ensure that the equipment complies with the appropriate 

technical standards.22 Examples of devices subject to Verification include business Class A 

computer equipment, Television (TV) and Frequency Modulated (FM) receivers, and nonconsumer Industrial, Scientific and Medical (ISM) equipment. 

Declaration of Conformity (DoC) is a manufacturer’s self-approval procedure where the 

responsible party (who could be the manufacturer, the grantee or the importer of the 

equipment) makes measurements at a recognized accredited test laboratory to ensure that the 

equipment complies with the appropriate technical standards. A test lab must be accredited 

by the National Voluntary Laboratory Accreditation Program (NVLAP) or the American 

Association of Laboratory Accreditation (A2LA); or be a designated accredited laboratory 

under the terms of a negotiated Mutual Recognition Agreement (MRA).23 The testing 

laboratory is required to be accredited to the international standard ISO/IEC Guide 17025.24 

Devices subject to DoC must be properly labelled in accordance with FCC Rules.25 Examples 

of devices subject to DoC include: certain personal computers and peripherals; Citizen Band 

(CB) receivers; super-regenerative receivers; TV interface devices; and consumer ISM 

equipment. 

Certification is an equipment authorization issued by the FCC or its designated entities based 

on representations and test data submitted by the applicant. Third party certification bodies, 

accredited to ISO/IEC Guide 65, may be recognized by the FCC to perform the certification of

equipment.26 The FCC is notified when products are certified. A complete copy of the 

application for certification is maintained in the FCC database. Examples of devices subject to 

certification include: high power transmitters operating in Licensed Radio Services; low power 

transmitters, such as cordless telephones; garage door opener controllers; radio control toys; 

security alarm systems; and scanning receivers. Personal computers and peripherals; superregenerative receivers; and TV interface devices, such as video cassette recorders (VCR), may 

show compliance with the FCC rules by using either certification or DoC equipment 

authorization procedures. 

Requirements for Digital Devices

The use of digital technologies has become very common in the design of electronic 

equipment. Such equipment is known as digital devices and is classified by the FCC as 

unintentional radiators.27 Digital devices have the potential for causing interference with 

 

22 47 C.F.R. § 2.909.

23 47 C.F.R. §§ 2.1071 - 2.1077.

24 See General Requirements for the Competence of Testing and Calibration Laboratories, International 

Standards Organization (ISO) International Electrotechnical Commission (IEC), ISO/IEC 17025:2005.

25 47 C.F.R. § 15.19.

26 See General Requirements for Bodies Operating Product Certification Systems, ISO/IEC 65:1996.

27 An unintentional radiator is defined in the FCC rules as a device that intentionally generates radio 

frequency energy for use within the device, or that sends radio frequency signals by conduction to associated 

equipment via connecting wiring, but which is not intended to emit RF energy by radiation or induction. See 47 

C.F.R. § 15.3(z).
18

licensed radio services and are subject to the technical regulations in FCC Part 15. Examples 

of such devices include: personal computers, calculators, digital cameras, telephones and 

similar electronic devices.

Technical requirements – For digital devices, there are two major requirements: conducted 

and radiated emissions. The FCC has harmonized the conducted emission requirements with 

the international standards found in CISPR 22. For radiated emissions, the FCC rules allow 

equipment to comply with the radiated emission limits in CISPR 22, third edition, as an

alternative to the limits given in FCC Part 15.28 Since CISPR 22 does not provide limits for 

radiated emissions above 6 GHz, it is necessary for a digital device to also comply with the 

FCC limits at these frequencies.

Measurement procedures – Measurement procedures for digital devices have been developed 

by the ANSI Accredited Standards Committee, C63®. Digital devices are required to be 

tested to the measurement procedures found in C63.4-2003.29 This standard is specified in the 

FCC rules by incorporation by reference.30

Conformity Assessment – A digital device such as a personal computer is required to 

demonstrate compliance with the FCC rules by use of the Declaration of Conformity 

procedures. Testing is to be performed by a recognized testing laboratory that has been 

accredited to ISO/IEC Guide 17025.

31

 

28 47 C.F.R. § 15.109.

29 See American National Standard for Methods of Measurement of Radio-Noise Emissions from 

Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz, IEEE C63.4-2003.

30 47 C.F.R. § 15.31.

31 47 C.F.R. § 2.948.