EXECUTIVE OFFICE OF THE PRESIDENT 

Office of Management and Budget 

OMB Circular A-119: Federal Participation in the Development and Use of Voluntary Consensus 

Standards and in Conformity Assessment Activities 

AGENCY: Office of Management and Budget, Executive Office of the President 

ACTION: Final Revision of OMB Circular A-119 

SUMMARY: The Office of Management and Budget (OMB) has revised Circular A-119, "Federal 

Participation in the Development and Use of Voluntary Consensus Standards and in Conformity 

Assessment Activities" (hereinafter, Circular A-119, or, the Circular) in light of developments in 

regulation, standards, and conformity assessment since the Circular was last revised in 1998. 

DATES: Effective upon publication 

ADDRESSES: Direct any comments or inquiries to the Office of Information and Regulatory 

Affairs, Office of Management and Budget at CircularA-119@omb.eop.gov. 

 SUPPLEMENTARY INFORMATION: 

I. Existing OMB Circular A-119 

II. Discussion and Responses to Significant Comments 

III. Section-by-Section Discussion 

Existing OMB Circular A-119. The vibrancy and effectiveness of the U.S. standards system in 

enabling innovation depends on continued private sector leadership and engagement. Our 

approach—reliance on private sector leadership, supplemented by Federal government contributions 

to discrete standardization processes as outlined in OMB Circular A-119—remains the primary 

strategy for government engagement in standards development. 

The policies of Circular A-119 are intended to encourage Federal agencies to benefit from the 

expertise of the private sector, promote Federal agency participation in standards bodies to support 

the creation of standards that are useable by Federal agencies, and minimize reliance on 

government-unique standards where an existing standard would meet the Federal government’s 

objective. 

The National Technology Transfer and Advancement Act of 1995 (Public Law 104-113; hereinafter 

known as “the NTTAA”) codified pre-existing policies on the development and use of voluntary 

consensus standards in OMB Circular A-119, established additional reporting requirements for 

agencies, and authorized the Department of Commerce’s National Institute of Standards and 

Technology (NIST) to coordinate conformity assessment activities. 

Revision of OMB Circular A-119. OMB is revising this Circular in light of developments in 

regulation, standards, and conformity assessment since the Circular was last revised in 1998. These 

revisions reflect the experience gained by U.S. agencies in implementing the Circular since 1998, 

and concluding and implementing U.S. trade agreements, as well as developments in domestic and 

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international regulatory, standards, and conformity assessment policies. 

The revised Circular reflects and supports the regulatory policies and principles set out in relevant 

executive orders. OMB notes, in particular, the requirements of four executive orders, three of 

which were issued after 1998: 

	 Executive Order 12866 (“Regulatory Planning and Review”) states that regulations must be 

consistent with law; regulations must identify the nature and significance of the problem; 

agencies must identify and assess alternatives to address the problem along with the costs 

and benefits of each alternative; and the approach selected should maximize net benefits to 

society; 

	 Executive Order 13563 (“Improving Regulation and Regulatory Review”) emphasizes that 

the U.S. regulatory system “must protect public health, welfare, safety, and [the] 

environment while promoting economic growth, innovation, competitiveness, and job 

creation,” and stresses the importance of public participation and careful consideration of 

both benefits and costs; 

	 Executive Order 13609 (“Promoting International Regulatory Cooperation”) directs Federal 

agencies to better coordinate U.S. priorities and positions with respect to international 

regulatory cooperation efforts across U.S. Federal agencies. This includes promoting good 

regulatory practices both in the United States and internationally, as appropriate, and 

considering reforms that address unnecessary differences in regulatory requirements 

between the United States and its major trading partners; and 

	 Executive Order 13610 (“Identifying and Reducing Regulatory Burdens”) institutionalizes 

the retrospective review mechanism set out in Executive Order 13563 and calls on agencies 

to reduce the cumulative effects, including the cumulative burdens, of regulation. 

In addition to the above Executive Orders, on January 17, 2012, OMB’s Office of Information and 

Regulatory Affairs (OIRA), the Office of Science and Technology Policy (OSTP), and the Office of 

the United States Trade Representative (USTR) released a Memorandum to Federal agencies on 

“Principles for Federal Engagement in Standards Activities to Address National Priorities” (see 

http://www.whitehouse.gov/sites/default/files/omb/memoranda/2012/m-12-08). 

The revisions to Circular A-119 inform agencies of their statutory obligations in standards-setting 

activities. Specifically, 19 U.S.C. § 2532 provides that “[n]o Federal agency may engage in any 

standards-related activity that creates unnecessary obstacles to the foreign commerce of the United 

States” and specifies four requirements for agencies’ standards-related activities: 

1. Ensuring that imported products are not treated less favorably than like domestic products or 

imported products from other countries; 

2. Taking into consideration international standards – and basing standards upon them if 

appropriate; 

3. Developing standards based on performance criteria rather than design criteria when 

appropriate; and 

4. Ensuring foreign suppliers have access to conformity assessment procedures on the same 

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basis as other domestic and foreign suppliers of like products. 

In order to gather relevant information for this revision, OMB published a Request for 

Information (RFI) in the Federal Register on March 30, 2012 (77 Fed. Reg. 19357) on “whether and 

how to supplement Circular A-119.” The notice also announced OMB would be holding a public 

workshop at NIST on May 15, 2012. 

The RFI and public workshop allowed interested stakeholders to provide valuable input to OMB, 

NIST, Federal regulators, and other relevant agencies on how the Federal government should 

address regulatory, standards, and conformity assessment issues that have emerged or moved to the 

forefront since the Circular was last promulgated in 1998. OMB received approximately 70 

comments from a wide range of stakeholders, including companies, trade associations, academics, 

public interest groups, standards developing bodies, conformity assessment bodies, and private 

citizens.1 

In response to those comments from 2012, OMB issued a Request for Comment on a Proposed 

Revision of OMB Circular A-119, “Federal Participation in the Development and Use of Voluntary 

Consensus Standards and in Conformity Assessment Activities,” on February 11, 2014 (79 Fed. 

Reg. 8207). OMB received over 80 comments from a wide range of stakeholders including 

companies and trade associations, academics, public interest groups, standards development bodies, 

conformity assessment bodies, and private citizens.2 

Discussion and Responses to Significant Comments 

Although some commenters were critical of specific aspects of the proposed revision, the majority 

of commenters expressed support for the overall revisions to the Circular and the approaches taken. 

The more substantive comments are summarized below, along with OMB’s responses. 

While OMB carefully considered the proposals and concerns of all commenters, many comments 

were not germane, given the scope of the Circular. The purpose of the Circular is only to provide 

guidance on agency use of standards at a level that is practical and useable for all agencies. 

For example, OMB received particularly detailed or individualized comments regarding conformity 

assessment requirements (OMB defers to NIST and its anticipated revisions to its Guidance on 

Federal Conformity Assessment), country-specific standards policy (OMB defers to USTR), and the 

publishing requirements for guidance and regulations for agencies (OMB defers to the Office of the 

Federal Register). The most current version of NIST’s conformity assessment guidance is available 

at http://www.nist.gov/standardsgov/. 

Based on OMB’s consideration and responses to these public comments, as well as developments in 

regulatory, standards, conformity assessment, and trade policy described above, the revised Circular 

A-119: 

1

 Public comments submitted in response to OMB’s RFI can be found at 

http://www.regulations.gov/#!documentDetail;D=OMB-2012-0003-0001. 2

 Public comments submitted in response to the Proposed Revisions can be found at
	

http://www.regulations.gov/#!documentDetail;D=OMB-2014-0001-0001.
	

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	 provides additional guidance for agency participation in standards development activities, 

including with respect to serving on standards technical committees as well as the boards of 

standards developing bodies; 

	 provides factors for agencies to consider when evaluating whether to use a standard to meet 

agency needs; 

	 strengthens the role of agency Standards Executives to encourage better internal 

coordination and training on standards; 

	 updates the provisions on how the U.S. Government manages and reports on the 

development and use of standards; 

	 sets out factors for agencies to consider when assessing the effectiveness of conformity 

assessment options and determining the type(s) of conformity assessment program(s) to 

employ; 

	 provides guidance to agencies on how they should implement provisions of the Circular in 

their rulemakings and guidance documents; 

	 encourages each agency to alert the public through the Federal Register or the agency’s 

webpage when the agency is considering whether to participate in the standards 

development process of a particular body. Such notification would give the public notice 

that the agency may use the resulting standard in support of significant regulatory action, 

international regulatory cooperation activities or to otherwise address issues of national 

priority; 

	 provides guidance to agencies on what factors to consider when incorporating standards by 

reference in regulation; 

	 requires agencies to utilize the retrospective review mechanism set out in Executive Orders 

13563 and 13610, to ensure, among other things, that regulations incorporating standards by 

reference are updated on a timely basis; 

	 encourages agencies to work together to reference the same version of standards in 

regulation and procurements and coordinate on conformity assessment requirements, where 

feasible; 

	 incorporates references to trade-related statutory obligations on standards-related measures 

and directs Federal agencies to consult with USTR on how to comply with international 

obligations with regard to standards, technical regulations, and conformity assessment; and 

	 maintains a strong preference for using voluntary consensus standards over governmentunique standards in Federal regulation and procurement. 

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The Circular does not preclude the use of standards other than voluntary consensus standards in 

rulemaking, procurement or other program activities in cases where: voluntary consensus standards 

do not exist or where use of existing voluntary consensus standards would be inconsistent with law 

or otherwise impractical, including where use of a voluntary consensus standard would not be as 

effective at meeting the agency’s regulatory, procurement, or program needs. The Circular also 

recommends that the agency consider allowing the use of other standards as alternative means for 

complying with agency regulatory, procurement, or program requirements based on voluntary 

consensus standards where such other standards are also found to be suitable under the agency’s 

analysis. 

Promoting Voluntary Consensus Standards: Comments received overwhelmingly supported a 

continued preference for Federal agencies’ use of voluntary consensus standards in lieu of 

developing their own standards, in line with the existing Circular and the requirements of Section 

12(d) of the NTTAA. 

There was also significant support among the commenters for providing Federal agencies the 

flexibility to choose among standards developed in the private sector, particularly standards 

developed for emerging technologies that may or may not precisely follow the traditional voluntary 

consensus standards development process. As such, and in order for agencies to choose the best 

standards for their mission needs, this policy maintains flexibility for agencies to use standards 

developed in the private sector that best meet agencies’ regulatory, procurement, or program needs, 

whether or not those standards are developed by voluntary consensus standards bodies. To assist 

agencies in deciding which standards to use, the Circular identifies factors to consider including, 

among others, the effectiveness and suitability of the standard for meeting agency regulatory, 

procurement, or program needs, the extent to which a standard meets the definition of a “voluntary 

consensus standard,” and whether the standard is reasonably available. 

Along these lines, many respondents provided valuable comments regarding the revised definitions 

in the Circular. The revised Circular incorporates a number of these suggestions intended to clarify 

the qualifications for a voluntary consensus standards development process. 

Several commenters asked for clarification on how the Circular addresses “leadership standards” (a 

term used to describe standards that exceed minimum threshold requirements). The Circular does 

not view leadership standards as different from other types of standards. As always, the Circular 

will indicate a preference for voluntary consensus standards over government-unique standards, and 

agencies may build on those standards as necessary to fulfill their obligations. 

In addition, the Circular does not indicate a preference for one type of conformity assessment 

procedure (e.g., supplier’s declaration of conformity, third-party certification) over others. 

Agencies must have flexibility to determine the most appropriate conformity assessment program to 

meet agency needs, consistent with law (see Section 7 of the Circular). 

OMB further notes the Circular serves as a floor—not a ceiling—for when and how an agency 

should use standards. Agencies can, and in many cases will, have additional guidance for agency 

components or programs based on mission needs and other factors. 

Updating Considerations for Conformity Assessment: Commenters who addressed this issue 

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expressed moderate to very strong support for OMB providing guidance to agencies with respect to 

conformity assessment. Commenters recommended that the Circular encourage agencies to rely on 

private sector conformity assessment activities; provide criteria for agencies to utilize when 

determining how to best meet their needs; and help agencies comply with relevant international 

obligations regarding conformity assessment. Since the Circular was last published in 1998, the 

evolution of an increasingly globalized marketplace has induced growth in the scope and 

importance of conformity assessment. Global supply and distribution chains may mean a greater 

number of variables for agencies to assess and more complex logistics to account for when 

conducting assessments of conformity. Accordingly, the revised Circular encourages agencies to 

consider leveraging existing private sector conformity assessment activities wherever consistent 

with law and mission. 

Ensuring Compliance with International Obligations: Numerous commenters on the RFI and 

the Proposed Revision support OMB guidance to agencies on how to comply with relevant 

international obligations, including the WTO Agreement on Technical Barriers to Trade and other 

trade agreements. Accordingly, OMB in coordination with USTR, which has statutory authority in 

this area pursuant to 19 U.S.C. § § 2171 & 2541, has updated the Circular to reflect this need. 

The Circular directs Federal agencies to consult with USTR on how to comply with international 

trade obligations relating to standards, technical regulations and conformity assessment, including 

those codified at 19 U.S.C. § 2531. In addition, the revisions direct Federal agencies to consult with 

the State Department, to the extent international obligations other than trade obligations may be 

implicated. With respect to the Federal government’s formulation of international policies on 

standards and conformity assessment, regulation, and trade, the revisions would encourage, 

consistent with Executive Order 13609, greater coordination between the Interagency Committee on 

Standards Policy, the Regulatory Working Group, the Trade Policy Staff Committee and its 

subcommittees, and any other relevant interagency groups or committees. 

Several commenters to the Proposed Revision voiced concerns over specific issues regarding 

reciprocity of standards use or recognition by other countries or trade unions. Since these 

comments fall outside the Circular’s scope of providing guidance to agencies about the Federal 

government’s use of standards, OMB encourages parties to address such concerns directly with 

USTR. 

Agency Considerations for Incorporation By Reference: A wide variety of commenters 

representing public interest groups, individuals, citizens, standards development organizations 

(SDOs), and companies provided comment on the question of incorporation by reference. Some 

comments advocated for the maintenance of current law and policy, noting many SDOs already 

freely publish their standards online in read-only formats, while others urged all standards 

incorporated by reference be made freely available on the Internet. 

The majority of these comments turned on particular interpretations of the “reasonably available” 

requirement in the Freedom of Information Act (FOIA), which requires that standards incorporated 

into regulation by reference be made reasonably available to the “class of persons affected.” As 

noted in the Draft Revision, it is not within the purview of the Circular to define reasonable 

availability. Rather, it is by statute the responsibility of the Office of the Federal Register (OFR) to 

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address this issue.3

 OFR revised its regulations on incorporation by reference in a final rule 

published November 7, 2014 at 79 Fed. Reg 66267. In that rule, OFR balanced its statutory 

obligations regarding reasonable availability of the standards with: (1) U.S. copyright law, (2) U.S. 

international trade obligations, and (3) agencies' ability to substantively regulate under their 

authorizing statutes. To address all of these obligations, the OFR rule required that agencies discuss 

how materials incorporated by reference were made available to parties (and where those materials 

are located) and to provide a summary of those materials in the preambles of their rulemaking 

documents. These requirements oblige agencies to provide more information on how they make 

material incorporated by reference available and a summary of the material, so readers can, if they 

like, find and review the standards. 

The revised Circular provides a non-exclusive set of factors to help agencies assess the availability 

of specific standards for particular regulatory contexts. These considerations may therefore inform 

the larger agency decision of whether to request approval for incorporation of those standards in 

regulation. As explained in the revised Circular, the basis of these factors for consideration is the 

Administrative Conference of the United States (ACUS) Recommendation 2011-5, Incorporation 

by Reference, 77 Fed. Reg. 2257 (January 17, 2012).4

 ACUS adopted the Recommendation through 

a consensus process in which a broad array of stakeholders participated, including standards 

developing bodies, academics, public interest groups, regulators, and industry. Based on the 

comments, the revised Circular bases its policy on the ACUS Recommendation, modified to 

enhance clarity. 

In general, the factors based on the ACUS Recommendation were well received, particularly the 

provision by SDOs of read-only access to their standards. OMB received numerous comments from 

SDOs highlighting the widespread existence of such a practice. In response to comments, OMB 

amended the Circular to recommend that agencies also consider the ease of access, registration, and 

navigation on those sites. OMB also received many comments on the option to provide a “freely 

available, non-technical summary.” Some commenters expressed the need for greater clarity as to 

what this might entail. Other commenters questioned the feasibility or utility of a non-technical 

summary for lengthy, complex, and/or highly technical standards. To clarify, OMB modified this 

factor to encourage agency discretion and collaboration with SDOs to enhance practical, impactful 

improvements to availability on a case-by-case basis. 

Additionally, OMB made clarifications emphasizing that: (1) the absence of one or more of such 

factors should not prevent an agency from using a particular standard; (2) agencies should work 

closely with SDOs to determine appropriate access to the standards for stakeholders; and (3) 

agencies should explain the reasoning for their choice of standard, including an explanation of how 

that standard may be accessed by stakeholders. 

Strengthening Guidance for Agency Participation in the Standards Development Process and 

the Role of Agency Standards Executives: Commenters expressed wide support for increased 

guidance for agency participation, including in standards development voting and standards body 

governance. As a floor, the revised Circular encourages agencies to participate fully in the 

standards development process—through voting as well as standards body governance—as equal 

3 See 5 U.S.C. §552(a)(1). 4 See http://www.gpo.gov/fdsys/pkg/FR-2012-01-17/html/2012-621.htm. 

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parties. OMB, however, defers to individual agencies on their policies for determining to what 

extent and under what circumstances agency representatives are authorized to engage in 

particular activities, based on agency requirements and priorities. Additionally, the Circular 

encourages strong coordination by Agency Standards Executives (ASEs) to allow for effective 

use of agency resources in the standards development process. 

In response to requests for greater notice by agencies of their involvement in the standards 

development process, the revised Circular provides guidance to agencies on how they should 

discuss implementation of the Circular in their rulemakings and guidance documents. The 

revised Circular also encourages each agency to alert the public through the Federal Register 

and/or its webpage when the agency is considering whether to participate in the standards 

development process of a particular body, with the intention of using the resulting standard to 

support significant regulatory action, promote international regulatory cooperation activities, or 

address issues of national priority. Many of the comments regarding agency participation 

included agency-specific details that are beyond the scope of the Circular. OMB encourages 

commenters to contact agencies directly with feedback regarding their voting, travel, or any other 

policies. 

Ensuring the Timely Updating of Regulations and Other Agency Materials Incorporating 

Standards: Many commenters expressed views on whether the most current version of a standard 

should always be the one used by an agency. OMB recognizes that agencies may have good 

reasons for not using the most recent version of a standard. For example, if use of a revised 

standard significantly increases compliance costs that are not justified by the benefits of using the 

standard, the agency should be free to decline to adopt it. 

To ensure the timely updating of standards, the revised Circular requires agencies to utilize the 

retrospective review mechanism set out in Executive Orders 13563 and 13610. Many commenters 

voiced strong support for such periodic review, with many agreeing with the suggested three-to-five 

year review timeframe. OMB believes the use of retrospective review, as outlined by Executive 

Orders 13563 and 13610, can help ensure (1) the optimal version of a standard is being used by 

agencies; (2) agencies minimize the impact of conflicting requirements on their shared regulated 

entities due to references to different versions of standards; and (3), more broadly, the need for the 

standard and the regulation referencing it still exists. 

Additionally, in response to comments, OMB encourages agencies to work closely with SDOs to 

ensure agencies are aware of, and thus able to consider, updates and alternatives to existing 

standards. OMB also encourages agencies to work together to reference the same version of 

standards in regulation and procurements, consistent with statute and agency mission and 

objectives. 

OMB also received comments on specific provisions of the Proposed Circular. Below are the 

significant comments OMB received and our responses. 

Section-by-Section Discussion 

Proposed Section 3e—Definition of Voluntary Consensus Standard. Final Section 2d. 

8 
Several clarifications have been made to the definition to increase its technical accuracy (no 

substantive changes are intended). A commenter suggested that the definition, which states 

that a voluntary consensus standard needs to be either developed or adopted by a voluntary 

consensus standards body, be clarified to make clear that the standard at issue was developed 

or adopted through the use of a voluntary consensus standards development process. OMB 

agrees and has clarified the final Circular accordingly. 

Several other clarifications have been made. We have clarified that it is the voluntary 

consensus standard bodies, not the standards, which have intellectual property policies. We 

have also clarified that the Reasonable and Non-discriminatory (RAND) license obligations 

extend to “implementers of the standard” (this replaces the term “all interested parties,” 

which is a term of art in the rulemaking context). 

Lastly, the Federal government does not make a distinction between standards bodies based 

on where they are domiciled, but rather with respect to the attributes that characterize their 

processes for standards development. Thus, we have deleted the phrase “both domestic and 

international.” This edit is not intended to make a change in terms of coverage (the Circular 

includes a discussion of “international standards” at Section 5h and 5i). 

Proposed Section 3f(i)—Definition of Openness. Final Section 2e(i). 

Many commenters expressed concern with the potential burden of the “at all stages” part of 

the clause requiring SDOs to provide meaningful opportunities to participate. Several 

commenters noted that, as a practical matter, this need is already covered by the 

requirements for transparent procedures or processes and for due process. In response, 

OMB modified the final Circular to omit the reference to “at all stages” and clarify that 

opportunities to participate in standards development be on a non-discriminatory basis. 

Proposed Section 3f(ii)—Definition of Balance of Representation. Final Section 2e(ii)—Definition 

of Balance. 

Several commenters questioned the utility of changing this element from “balance of 

interest,” found in the current version of Circular A-119 as well as the American National 

Standards Institute’s (ANSI) Essential Requirements, to “balance of representation.” OMB 

intended for the definition to be consistent with the concepts of both those documents and 

has simplified the term to “balance” to avoid confusion and to allow for flexibility in how 

balance is determined during the consensus phase of the development or adoption of the 

standard. 

Additionally, some commenters expressed concern with the ambiguity of “sectors” in this 

definition. Others commented that a key objective of “balance” is preventing a single 

interest from dominating the decision-making process. OMB agrees and modified the final 

Circular, adapting suggested insertions to the text of the definition. 

Proposed Section 3f(iii)—Definition of Due Process. Final Section 2e(iii). 

9 
Several commenters expressed concern with the burden and practicality of requiring “full 

access” to the views and objections of other participants in standards development. 

Commenters noted the risks of micromanagement and unnecessary overreach. OMB’s 

intention is to ensure an adequate record of proceedings for the purpose of resolving 

objections and appeals, so we have modified the final Circular to reflect this intent. 

Proposed Section 6e—When deciding to use a standard, what are some of the factors my agency 

should consider? Final Section 5a. 

Several commenters expressed a desire for greater clarity in the relationship between agency 

missions and the preference for voluntary consensus standards over government-unique 

standards. OMB agrees, and therefore the Circular maintains the preference for voluntary 

consensus standards, per the NTTAA, while still maintaining flexibility for agencies to best 

meet their missions. 

Additionally, some commenters highlighted the utility of considering the extent to which a 

standard is already used by a Federal agency, by State and local governments, as well as the 

prevalence of the standard in the national and international marketplace. These are 

important considerations precisely aligned with Executive Orders 13563, 13609, and 13610, 

discussed above. Accordingly, OMB agrees, and modified the Circular to include these 

considerations. 

Proposed Section 4g—How should my agency determine whether a voluntary standard is 

“reasonably available” in a regulatory or non-regulatory context? Final Section 5f -- What factors 

should my agency consider to aid the determination of whether a standard is “reasonably 

available” in a regulatory or non-regulatory context? 

In general, the factors based on the ACUS Recommendation were well received, particularly 

SDO provision of read-only access to standards. OMB received numerous comments from 

SDOs noting they already provide such access. One commenter, however, brought to 

OMB’s attention the disparate capabilities and requirements of various read-only standards 

websites. OMB agrees that this should be a consideration, and has amended the text to 

recommend agencies also consider the ease of access, registration, and navigation on those 

websites. 

As referenced above, OMB also received many comments on the option to provide a “freely 

available, non-technical summary.” Some commenters expressed the need for greater clarity 

as to what this might entail. Other commenters questioned the feasibility or utility of 

providing a non-technical summary for lengthy, complex, and highly technical standards. 

To clarify, OMB modified this factor and potential option to encourage agency discretion 

and cooperation with SDOs to enhance practical, impactful improvements to availability on 

a case-by-case basis. 

Additionally, in response to several comments asking for greater agency consideration of the 

accessibility of standards incorporated by reference, OMB revised the Circular to 

recommend that agencies provide, in the preamble of a Notice of Proposed Rulemaking 

(NPRM) or final rule or guidance document, an explanation of the incorporated materials; 

10 
how such incorporated standards may be accessed; and how the agency’s incorporation by 

reference of the standard would further the agency’s regulatory objective. 

Proposed Section 7—What is the Policy for Federal Participation in Voluntary Standards Bodies? 

Final Section 6 -- What is the Policy for Federal participation in Voluntary Consensus Standards 

Bodies? 

Several commenters questioned the reformatting of this section from the existing Circular, 

specifically the absence of explicit authorization to provide “direct financial support” to 

standards development activities. Many agencies do so, consistent with applicable law, and 

here OMB defers to agency policy. To provide agencies with flexibility to meet their 

missions, the Circular maintains the existing language. 

Proposed Section 8a—What considerations should my agency make when it is determining the type 

of conformity assessment procedure(s) to use? Final Section 7a—What considerations should my 

agency make when it is addressing the need for conformity assessment? 

In response to comments, OMB simplified this section. OMB has incorporated the previous 

Section 8a, “Should my agency consider relying on private sector conformity assessment 

activities in conjunction with, or where appropriate, in lieu of governmental conformity 

assessment?” into one question which is now Section 7a, “What considerations should my 

agency make when it is addressing the need for conformity assessment?” 

Additionally several commenters expressed concern over the apparent distinction between 

using “international conformity assessment schemes” or “private sector conformity 

assessment activities” as was phrased in the proposed revision. OMB agrees that such 

international conformity assessment schemes are just one example of private sector 

conformity assessment activity, and modified the Circular accordingly. 

Accordingly, OMB Circular A-119 is revised as set forth below. 

Howard Shelanski 

Administrator, Office of Information and Regulatory Affairs 

EXECUTIVE OFFICE OF THE PRESIDENT 

Office of Management and Budget 

Washington D.C. 20503 

[insert date] 

Circular No. A-119 

Revised 

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CIR CULA R NO. A - 1 19, R evi sed
	

TO THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES 

SUBJECT: Federal Participation in the Development and Use of Voluntary Consensus Standards 

and in Conformity Assessment Activities 

TABLE OF CONTENTS 

BACKGROUND 

1.		 What is the Purpose of this Circular? 

DEFINITIONS 

2.		 What is a Standard? 

3.		 What is Conformity Assessment? 

POLICY 

4.		 To Whom Does This Policy Apply? 

5.		 What is the Policy for Federal Use of Standards? 

a.		 When deciding to use a standard, what are some of the factors my agency should consider? 

b.		 Does this policy establish a preference between voluntary consensus standards and other 

types of standards? 

c.		 When must my agency use voluntary consensus standards? 

d.		 What if no voluntary consensus standard exists? 

e.		 Should my agency give preference to performance standards? 

f.		 What factors should my agency consider to aid the determination of whether a standard is 

“reasonably available” in a regulatory or non-regulatory context? 

g.		 How should my agency reference standards? 

h.		 Are there standards-related international trade obligations that agencies must adhere to 

regarding the use of standards? 

i.		 When should my agency consider using or recognizing a standard used by a trading partner? 

j.		 How does this policy affect my agency's regulatory authorities and responsibilities? 

k.		 How does this policy affect my agency's procurement authority? 

l.		 What factors should my agency consider when determining whether to allow the use of more 

than one standard? 

m. How should my agency ensure that standards incorporated by reference in regulation are 

updated on a timely basis? 

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6.		 What is the Policy for Federal Participation in Standards Bodies? 

a.		 Must agency participants be authorized? 

b.		 Does agency participation indicate endorsement of any decisions reached by standards 

bodies? 

c.		 What forms of support may my agency provide? 

d.		 Do agency representatives participate equally with other members? 

e.		 How should my agency alert the public of its potential participation in standards 

development activities that could be used as a basis for rulemaking or other mission-related 

activities? 

f.		 What if a voluntary consensus standards body is likely to publish a suitable standard in time 

for an agency to use it? 

7.		 What is the Policy on Conformity Assessment? 

a.		 What considerations should my agency make when it is addressing the needs for conformity 

assessment? 

b.		 Are there statutory and international obligations concerning conformity assessment? 

c.		 What obligations does my agency have when considering whether to recognize a conformity 

assessment procedure in use in the market of a trading partner? 

d.		 How does this policy affect my agency’s regulatory authorities and responsibilities? 

e.		 When should my agency utilize the retrospective review mechanism with respect to 

conformity assessment? 

8.		 How will the U.S. Government Coordinate Regulatory Policy with Standards and Conformity 

Assessment Policy? 

MANAGEMENT AND REPORTING OF STANDARDS USE 

9.		 How Does My Agency Manage and Report on the Implementation of the Circular? 

10. What are the Procedures for Reporting My Agency's Use of Standards in Regulations? 

11. What are the Procedures for Reporting My Agency's Use of Standards in Procurements? 

a. How does my agency report the use of standards in procurements on a categorical basis? 

b. How does my agency report the use of standards in procurements on a transaction basis? 

AGENCY RESPONSIBILITIES 

12. What are the Responsibilities of the Secretary of Commerce? 

13. What are the Responsibilities of the Heads of Agencies? 

14. What are the Qualifications and Responsibilities of Agency Standards Executives? 

SUPPLEMENTARY INFORMATION 

15. When will this Circular be reviewed? 

16. What is the Legal Effect of this Circular? 

17. Do You Have Further Questions? 

13 
 

 

BAC KGROUN D
	

1. What is the Purpose of this Circular? 

This Circular establishes policies to improve the internal management of the Executive Branch 

with respect to the U.S. Government’s role in the development and use of standards and 

conformity assessment. Consistent with section 12(d) of P.L. 104-113, the “National Technology 

Transfer and Advancement Act of 1995,” as amended (hereinafter “the NTTAA”), and U.S. 

Government executive orders, this Circular directs agencies to use standards developed or adopted 

by voluntary consensus standards bodies rather than government-unique standards, except where 

inconsistent with applicable law or otherwise impractical. The policies in this Circular are 

intended to facilitate agencies’ compliance with obligations under U.S. trade statutes and trade 

agreements. U.S. Federal law (19 U.S.C. § 2532) specifically prohibits any U.S. Government 

agency from engaging in standards-related activities that create unnecessary obstacles to the 

foreign commerce of the United States. 

This Circular provides guidance for agencies participating in the work of voluntary consensus 

standards bodies and describes procedures for satisfying the reporting requirements of the NTTAA. 

The policies in this Circular are intended to minimize the reliance by agencies on governmentunique standards. The Circular also provides policy guidance to agencies on the use of conformity 

assessment in procurement, regulatory, and program activities. This Circular replaces Office of 

Management and Budget (OMB) Circular No. A-119, dated February 10, 1998. 

Many voluntary consensus standards are appropriate or adaptable for the Federal government's 

purposes. The use of such standards, whenever practicable and appropriate, is intended to achieve 

the following goals: 

(i)		 eliminating the cost to the Federal government of developing its own standards 

and decreasing the cost of goods procured and the burden of complying with 

agency regulation; 

(ii)		 providing incentives and opportunities to establish standards that serve national 

needs, encouraging long-term growth for U.S. enterprises and promoting 

efficiency, economic competition, and trade; and 

(iii)		 furthering the reliance upon private sector expertise to supply the Federal 

government with cost-efficient goods and services. 

This Circular will also help agencies meet the five fundamental strategic objectives for Federal 

engagement in standards activities set out in Memorandum M-12-08, “Principles for Federal 

Engagement in Standards Activities to Address National Priorities” 

(http://www.whitehouse.gov/sites/default/files/omb/memoranda/2012/m-12-08_1.pdf), which was 

issued on January 17, 2012. 

While M-12-08 applies to Federal engagement in standards activities in those exceptional 

circumstances where the U.S. Government is playing a leading or convening role, OMB believes 

that the objectives are generally applicable to Federal engagement in standards and conformity 

assessment activities, absent contrary statutory requirements. 

14 
In addition, the Circular seeks to support efforts by the Federal government to ensure that: 

a.		 the benefits of regulations justify their costs, consistent with Executive Orders
	

12866, “Regulatory Planning and Review,” and 13563, “Improving Regulation and
	

Regulatory Review,” and OMB Circular A-4, “Regulatory Analysis”; 

b.		 agencies modify, streamline, expand, or repeal regulations that may be outmoded, 

ineffective, insufficient, or excessively burdensome through the retrospective review 

process, consistent with Executive Orders 13563 and 13610, “Identifying and Reducing 

Regulatory Burdens”; 

c.		 agencies work with their regulatory counterparts in other countries to address common 

health, safety, labor, security, or environmental issues, as well as unnecessary differences 

between the regulatory approaches of U.S. agencies and those of their foreign counterparts 

that may impair economic growth, innovation, competitiveness, and job creation, consistent 

with Executive Order 13609, “Promoting International Regulatory Cooperation”; and 

d.		 agencies consider the cumulative effects, including the cumulative burdens, of regulation, 

consistent with Executive Order 13610. 

DEFINITIONS 

2. What is a Standard? 

a.		 The term “standard,” or “technical standard,” (hereinafter “standard”) as cited in the 

NTTAA, includes all of the following: 

(i)		 common and repeated use of rules, conditions, guidelines or characteristics for 

products or related processes and production methods, and related management 

systems practices; 

(ii)		 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; formats for 

information and communication exchange; or descriptions of fit and measurements 

of size or strength; and 

(iii)		 terminology, symbols, packaging, marking or labeling requirements as they apply 

to a product, process, or production method. 

b.		 The term "standard" does not include the following: 

(i)		 professional standards of personal conduct; or 

(ii)		 institutional codes of ethics. 

15 
 

 

 

 

c.		 “Government-unique standard” is a standard developed by and for use by the Federal 

government in its regulations, procurements, or other program areas specifically for 

government use (i.e., it is not generally used by the private sector unless required by 

regulation, procurement, or program participation). The standard was not developed as a 

voluntary consensus standard as described in Sections 2d and 2e. 

d. “Voluntary consensus standard” is a type of standard developed or adopted by voluntary 

consensus standards bodies, through the use of a voluntary consensus standards 

development process as described in Section 2e. These bodies often have 

intellectual property rights (IPR) policies that include provisions requiring that 

owners of relevant patented technology incorporated into a standard make that 

intellectual property available to implementers of the standard on nondiscriminatory and royalty-free or reasonable royalty terms (and to bind subsequent 

owners of standards essential patents to the same terms). In order to qualify as a 

“voluntary consensus standard” for the purposes of this Circular, a standard that includes 

patented technology needs to be governed by such policies, which should be easily 

accessible, set out clear rules governing the disclosure and licensing of the relevant 

intellectual property, and take into account the interests of all stakeholders, including the 

IPR holders and those seeking to implement the standard. 

e.		 “Voluntary consensus standards body” is a type of association, organization, or technical 

society that plans, develops, establishes, or coordinates voluntary consensus standards 

using a voluntary consensus standards development process that includes the following 

attributes or elements: 

(i)		 Openness: The procedures or processes used are open to interested parties. Such 

parties are provided meaningful opportunities to participate in standards 

development on a non-discriminatory basis. The procedures or processes for 

participating in standards development and for developing the standard are 

transparent. 

(ii)		 Balance: The standards development process should be balanced. Specifically, 

there should be meaningful involvement from a broad range of parties, with no 

single interest dominating the decision-making. 

(iii)		 Due process: Due process shall include documented and publically available 

policies and procedures, adequate notice of meetings and standards development, 

sufficient time to review drafts and prepare views and objections, access to views 

and objections of other participants, and a fair and impartial process for resolving 

conflicting views. 

(iv)		 Appeals process: An appeals process shall be available for the impartial handling 

of procedural appeals. 

(v)		 Consensus: Consensus is defined as general agreement, but not necessarily 

unanimity. During the development of consensus, comments and objections are 

considered using fair, impartial, open, and transparent processes. 

See Section 5h of this Circular for a discussion of “international standards.” 

16 
 

  

 

3. What is Conformity Assessment? 

Conformity assessment” is a demonstration, whether directly or indirectly, that specified 

requirements relating to a product, process, system, person, or body are fulfilled. Conformity 

assessment includes sampling and testing, inspection, supplier’s declaration of conformity, 

certification, and management system assessment and registration. Conformity assessment also 

includes accreditation of the competence of those activities. 

POLICY 

4. To Whom Does This Policy Apply? 

This Circular applies to all agencies and agency representatives who use standards or conformity 

assessment and/or participate in the development of standards. “Agency” means any executive 

department, independent commission, board, bureau, office, government-owned or controlled 

corporation, or other establishment of the Federal government. It also includes any regulatory 

commission or board, except for independent regulatory commissions insofar as they are subject to 

separate statutory requirements regarding the use of voluntary consensus standards. It does not 

include the Legislative or Judicial branches of the Federal government. 

5. What is the Policy for Federal Use of Standards? 

Consistent with Section 12 (d)(1) of the NTTAA, all Federal agencies must use voluntary 

consensus standards in lieu of government-unique standards in their procurement and regulatory 

activities, except where inconsistent with law or otherwise impractical. In these circumstances, 

your agency must submit a report describing the reason(s) for its use of government-unique 

standards in lieu of voluntary consensus standards as explained in Sections 9-11. 

a.		 When deciding to use a standard, what are some of the factors my agency should 

consider? 

(i)		 In evaluating whether to use a standard, which should be done on a case-by-case basis, 

an agency should consider the following factors, where applicable: 

(1) Whether the standard is effective and otherwise suitable for meeting agency 

regulatory, procurement, or program needs, including as applicable: 

(a) the nature of the agency’s statutory mandate and the consistency of the 

standard with that mandate; 

(b) the level of protection the standard provides or is expected to provide for public 

health, welfare, safety, and the environment; 

(c) the clarity and detail of the standard's language, as the wording of a standard 

may contain too much detail as well as too little; 

17 
 

 

(d) the costs and benefits of implementing other available standards that may also 

meet the agency’s needs; 

(e) the costs and benefits to the Federal government and the regulated public of the 

agency developing its own standard; 

(f) the ongoing use of the standard by other agencies for the same or a similar 

requirement, the use of which in a particular instance would increase 

consistency across the Federal government; 

(g) the ongoing use of the standard by State and local governments for the same or 

a similar requirement, the use of which in a particular instance would increase 

consistency across jurisdictions; 

(h) the prevalence of the use of the standard in the national and international 

marketplaces; 

(i) the problems addressed by the standard and changes in the state of knowledge 

and technology since the standard was prepared or last revised; 

(j) the extent to which the standard establishes performance rather than design 

criteria, where feasible; 

(k) the ability of small- and medium-sized enterprises (SMEs) to comply with the 

standard; and 

(l) the agency’s ability to use, and enforce compliance with, the standard in its 

regulatory process. 

(2) The extent to which, when preparing the standard, the standards body reflected the 

attributes of a voluntary consensus standards body set out in Section 2e of the 

Circular. The procedures related to these attributes (e.g., openness, balance, due 

process, appeals process, and consensus) should be easily accessible, clear and 

unambiguous. 

(3) The extent to which the standard is an international standard (see Section 5h). 

(4) Any barriers to membership and participation in the standards development 

process, given that fee structures, modes of participation, and other factors can 

impact the ability of SMEs, public interest groups, and the general public to 

participate. 

(5) Whether the standard is “reasonably available.” See Section 5f of the Circular for 

additional information. 

(6) The standards maintenance process used by the relevant standards developing body 

or bodies. 

(ii)		 If an agency is proposing to use a standard in a proposed or final rulemaking, the 

agency must comply with the "Principles of Regulation" (enumerated in Section 1(b) 

of Executive Order 12866, “Regulatory Planning and Review”), the analytical 

requirements of other relevant executive orders, and other documents as applicable, 

including those described in Section 1 of the Circular. 

(iii) As a general matter, standards being considered for use in regulation that specify 

18 
nomenclature, basic reference units, or methods of measurement or testing, and that 

are primarily empirical in their formulation, will ordinarily warrant less scrutiny by an 

agency than standards that embody factors that are less objective. 

(iv)		 An agency should, to the extent permitted by law, take account of the effect of using 

the standard on the economy, and of applicable Federal laws and policies, including 

laws and regulations relating to antitrust, national security, small business, product 

safety, environment, metrication, technology development, international trade, 

intellectual property and copyright, privacy and security, and conflicts of interest. 

(v)		 An agency should take into consideration the standards developer’s intellectual 

property rights (IPR) policies. Many standards developing bodies have policies 

requiring participating IPR holders to commit to license any relevant patented 

technology incorporated into a standard on non-discriminatory and royalty-free or 

reasonable royalty terms and to bind subsequent owners of standards-essential patents 

to the same terms. Such policies should be easily accessible, set out clear rules 

governing the disclosure and licensing of the relevant IPR, and take into account the 

interests of all stakeholders, including the IPR holders and those seeking to implement 

the standard. 

b.		 Does this policy establish a preference between voluntary consensus standards and 

other types of standards? Consistent with Section 12(d)(1) of the NTTAA, this policy 

establishes a preference for the use of voluntary consensus standards in lieu of governmentunique standards. The Circular does not preclude the use of other standards in rulemaking, 

procurement, or other program activities in cases where voluntary consensus standards do not 

exist or use of existing voluntary consensus standards would be inconsistent with law or 

otherwise impractical, including where use of a voluntary consensus standard would not be as 

effective at meeting the agency’s regulatory, procurement or program needs. The Circular 

also recommends that the agency consider allowing the use of other standards as alternative 

means for complying with agency regulatory, procurement, or program requirements that 

incorporate voluntary consensus standards, where such other standards are also found to be 

suitable under the agency’s analysis. See Section 5l concerning the selection of multiple 

standards. 

c.		 When must my agency use voluntary consensus standards? Your agency must use 

voluntary consensus standards in its regulatory, procurement, and program activities in lieu of 

government-unique standards, unless use of such standards would be inconsistent with 

applicable law or otherwise impractical. In all cases, your agency has the discretion to 

decline to use existing voluntary consensus standards if your agency determines that such 

standards are inconsistent with applicable law or otherwise impractical, and instead to use a 

government-unique standard or other standard. 

In addition to consideration of voluntary consensus standards, this Circular recognizes the 

contributions of standardization activities that take place outside of the voluntary consensus 

standards process. Therefore, in instances where use of voluntary consensus standards 

would be inconsistent with applicable law or otherwise impracticable (e.g., no voluntary 

consensus standard would be effective in meeting agency regulatory, procurement, or 

19 
 

 

program needs), agencies should consider, to the extent consistent with applicable law – as 

an alternative to using a government-unique standard – other standards that meet the 

agency’s regulatory, procurement or program needs, deliver favorable technical and 

economic outcomes (such as improved interoperability) and are widely utilized in the 

marketplace. 

In those circumstances where an agency elects to use or develop a government-unique 

standard in lieu of using a voluntary consensus standard, Section 12(d) of the NTTAA 

requires the agency to submit a report describing the reason(s) to OMB. Under the Circular, 

this report is submitted to OMB through the National Institute of Standards and Technology 

(NIST). For more information on reporting, see Sections 9 -11 of this Circular. 

(i)		 “Use” means incorporation of a standard in whole, in part, or by reference for 

procurement purposes; inclusion of a standard in whole, in part, or by reference in 

regulation(s); or inclusion of a standard in whole, in part, or by reference in other 

mission-related activities. 

(ii)		 “Impractical” includes circumstances in which such use would fail to serve the 

agency's regulatory, procurement, or program needs; be infeasible; be inadequate, 

ineffectual, inefficient, or inconsistent with the agency mission or the goals of using 

voluntary consensus standards; be inconsistent with a provision of law; or impose more 

burdens, or be less useful, than the use of another standard. 

d.		 What if no voluntary consensus standard exists? In cases where no suitable voluntary 

consensus standards exist, an agency may use suitable standards that are not developed by 

voluntary consensus bodies. In addition, an agency may develop its own standards or use 

other government-unique standards, solicit interest from qualified standards development 

organizations for development of a standard, or develop a standard utilizing the process 

principles outlined in Section 2e of the Circular. As explained above (see Section 5c of the 

Circular), Section 12(d) of the NTTAA provides that an agency may use a governmentunique standard in lieu of a voluntary consensus standard if the use of a voluntary consensus 

standard would be inconsistent with applicable law or otherwise impractical. In such cases, 

the agency must file the statutorily required report (see Section 10). 

e.		 Should my agency give preference to performance standards? Yes. Pursuant to Section 

1(b)(8) of Executive Order 12866 and 19 U.S.C.§ 2532(3), your agency should give 

preference to performance standards where feasible and appropriate. The term “performance 

standard” refers to a standard that states requirements in terms of required results, but without 

stating the methods for achieving the required results. A performance standard may define 

the functional requirements for an item, operational requirements, and/or interface and 

interchangeability characteristics. A prescriptive standard, by contrast, may specify design 

requirements, such as materials to be used, how a requirement is to be achieved, or how an 

item is to be fabricated or constructed. It is important to recognize that, in many instances, a 

standard may contain both performance and prescriptive elements. In such cases, agencies 

should select standards that provide the most flexibility for achieving the desired results. In 

most instances, these will be standards that rely more heavily on performance-based criteria. 

f.		 What factors should my agency consider to aid the determination of whether a standard 

20 
 

is “reasonably available” in a regulatory or non-regulatory context? In determining 

whether a standard is “reasonably available” to regulated and other interested parties, 

agencies should take into account the following factors, given that reasonable availability is 

context-specific. The absence of one or more of these factors alone should not be used as a 

basis for an agency decision not to use the standard. This section shall also be applied in a 

manner consistent with U.S. international obligations to use relevant international standards 

(see Section 5h of the Circular); the “Principles of Regulation” (enumerated in Section 1(b) 

of Executive Order 12866); and the need to “protect public health, welfare, safety, and our 

environment while promoting economic growth, innovation, competitiveness, and job 

creation” (see Section 1 of Executive Order 13563). 

Factors to consider include: 

(i)		 whether the standards developer is willing to make read-only access to the standard 

available for free on its website during the comment period to facilitate more effective 

access, because access may be necessary during rulemaking to make public 

participation in the rulemaking process effective; 

(ii)		 the cost to regulated and other interested parties to access a copy of the material, 

including the cumulative cost to obtain incorporated materials, and their ability to bear 

the costs of accessing such materials in a particular context; 

(iii) the extent particular access is needed to achieve agency policy or to subject the 

effectiveness of agency programs to public scrutiny; and 

(iv) whether the standards developer can provide a summary that explains the content of 

the standard in a way that meets agency needs and is understandable to a member of 

the public who lacks relevant technical expertise. 

When considering incorporation by reference, agencies should include in the preamble of an 

NPRM, final rule, or guidance document an explanation of the incorporated materials, and 

how the agency’s incorporation by reference of the standard would further the agency’s 

regulatory objective (see 79 FR 66267 published November 7, 2014 entitled Incorporation 

by Reference). 

If an agency incorporates by reference material that is already freely available, the agency 

should ensure that the material is available electronically in a location where regulated and 

other interested parties will be able to find it easily by, for example, providing a link to the 

website of the standards body. If an agency incorporates by reference material that is 

copyrighted or otherwise subject to legal protection and not freely available, the agency 

should work with the relevant standards developer to promote the availability of the 

materials, consistent with applicable law, such as through the use of technological solutions, 

low-cost-publication, or other appropriate means, while respecting the copyright owner’s 

interest in protecting its intellectual property. To this end, the agency should explain, in the 

preamble of an NPRM, final rule, or guidance document how such incorporated standards 

may be accessed consistent with OFR’s regulations in 1 CFR Part 51. 

g.		 How should my agency reference standards? Where your agency seeks to incorporate a 

standard by reference, your agency should reference the standard, along with sources from 

21 
 

 

which a copy of the standard may be obtained, in relevant publications, regulations, and 

related internal documents. The Office of the Federal Register’s regulations at 1 CFR Part 

51 govern the use of incorporation by reference in regulation. For all other uses, your 

agency must determine the most appropriate form of reference. If a standard is used and 

published in an agency document, your agency must observe and protect the rights of the 

copyright holder and meet any other similar obligations, such as those relating to patented 

technology that must be used to comply with the standard. 

h.		 Are there standards-related international trade obligations that agencies must adhere to 

regarding the use of standards? Yes. There are statutory and international obligations 

governing “standards-related activities.” In particular, agencies should be aware of the 

obligations in 19 U.S.C. § 2532, which provides that “[n]o Federal agency may engage in any 

standards-related activity that creates unnecessary obstacles to the foreign commerce of the 

United States...” and that “[e]ach Federal agency shall ensure, in applying standards-related 

activities with respect to any imported product, that such product is treated no less favorably 

than are like domestic or imported products...” “Standards-related activity” is defined in 19 

U.S.C. § 2571 and covers certain standards and technical regulations as well as conformity 

assessment procedures. These statutory requirements reflect U.S. international obligations 

under the World Trade Organization (WTO) Agreement on Technical Barriers to Trade (TBT 

Agreement). Specifically, Articles 2.1 and 2.2 and Annex 3 of the Agreement commit the 

United States, with respect to standards and technical regulations, to provide no less 

favorable treatment to imported products than like domestic products and to avoid 

unnecessary obstacles to trade. 

In addition, the United States is obligated under the TBT Agreement to use relevant 

international standards, except where such standards would be an ineffective or 

inappropriate means to fulfill the legitimate objective pursued. In particular, the TBT 

Agreement, Article 2.4, provides that: “Where technical regulations are required and 

relevant international standards exist or their completion is imminent, [WTO] Members shall 

use them, or the relevant parts of them, as a basis for their technical regulations except when 

such international standards or relevant parts would be an ineffective or inappropriate means 

for the fulfillment of the legitimate objectives pursued, for instance because of fundamental 

climatic or geographical factors or fundamental technological problems.” In addition, 19 

U.S.C. § 2532 directs Federal agencies, in developing standards, to base the standards on 

international standards if appropriate. 

The WTO TBT Agreement defines “technical regulation” as a document which sets out 

product characteristics or their related processes and production methods, including 

applicable administrative provisions, with which compliance is mandatory, and states that 

the definition may include or deal exclusively with terminology, symbols, packaging, 

marking or labeling requirements as they apply to a product, process, or production method. 

The WTO TBT Agreement excludes services, sanitary and phytosanitary measures, and 

government procurement from its scope. These areas are covered by other WTO agreements 

discussed later in this section. 

The WTO TBT Agreement does not provide a list of bodies that develop international 

standards. However, in 2000, the WTO Committee on Technical Barriers to Trade adopted 

22 
a decision setting out principles that standards bodies should follow when developing 

international standards (the Decision on Principles for the Development of International 

Standards, Guides and Recommendations with Relation to Articles 2, 5 and Annex 3 of the 

WTO Agreement on Technical Barriers to Trade, hereinafter the Committee Decision). 

Please see the annex to this Circular for additional information. 

In addition, certain U.S. free trade agreements commit the United States to determine 

whether an international standard exists based on the principles set out in the Committee 

Decision. Agencies should, therefore, pay close attention to the Committee Decision and 

consult with USTR when questions arise as to evaluating whether a standard developed by a 

particular standards body is “international.” A voluntary consensus standard may be an 

international standard under the WTO TBT Agreement or provisions of U.S. trade 

agreements applying to technical barriers to trade, if it was developed in accordance with the 

Committee Decision principles. 

The WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS 

Agreement), which applies to sanitary and phytosanitary measures (e.g., food safety 

regulations), also addresses the use of relevant international standards. Article 3.1 of the 

WTO SPS Agreement states: “To harmonize sanitary and phytosanitary measures on as wide 

a basis as possible, [WTO] Members shall base their sanitary or phytosanitary measures on 

international standards, guidelines or recommendations, where they exist, except as 

otherwise provided for in this Agreement, and in particular paragraph 3.” Article 3.3 of the 

SPS Agreement also provides that: 

Members may introduce or maintain sanitary or phytosanitary measures which result 

in a higher level of sanitary or phytosanitary protection than would be achieved by 

measures based on the relevant international standards, guidelines or 

recommendations, if there is scientific justification, or as a consequence of the level 

of sanitary or phytosanitary protection a Member determines to be appropriate in 

accordance with the relevant provisions of paragraph 1 through 8 of Article 5. 

Notwithstanding the above, all measures which result in a level of sanitary or 

phytosanitary protection different from that which would be achieved by measures 

based on international standards, guidelines or recommendations shall not be 

inconsistent with any other provisions of this Agreement. 

The WTO SPS Agreement includes a detailed definition of “sanitary or phytosanitary 

measure” and generally covers measures related to food safety and the spread of disease or 

pests. Unlike the WTO TBT Agreement, the WTO SPS Agreement identifies three bodies, 

among others, that develop international standards, guidelines and recommendations for 

purposes of implementing the WTO SPS Agreement. In particular, the SPS Agreement 

identifies the following as international standards, guidelines and recommendations: for food 

safety, those established by the Codex Alimentarius Commission; for animal health and 

zoonoses, those developed under the auspices of the International Office of Epizootics; for 

plant health, those developed in the framework of the International Plant Protection 

Convention; and “for matters not covered by the above organizations, appropriate standards, 

guidelines and recommendations promulgated by other relevant international organizations 

open for membership to all [WTO] Members, as identified by the [SPS] Committee.” 

23 
 

The United States also has procurement obligations under the WTO Agreement on 

Government Procurement (GPA) and a number of Free Trade Agreements (see FAR Subpart 

25.4) to base the technical specifications on international standards, where available. Article 

X.2 of the WTO GPA provides: 

In prescribing the technical specifications for the goods or services being procured, a 

procuring entity shall, where appropriate: 

(i)		 set out the technical specification in terms of performance and functional 

requirements, rather than design or descriptive characteristics; and 

(ii)		 base the technical specification on international standards, where such exist; 

otherwise, on national technical regulations, recognized national standards or 

building codes. 

Agencies should consult with USTR on questions regarding international trade obligations 

relating to regulations, standards, conformity assessment procedures, or procurement or with 

respect to any requests from countries regarding the establishment of mutual arrangements 

with respect to standards-related activities. Pursuant to 19 U.S.C. § 2171 and 2541, USTR 

has statutory authorities and responsibilities in these areas including “for coordinating 

United States discussions and negotiations with foreign countries for the purpose of 

establishing mutual arrangements with respect to standards-related activities.” Agencies 

should consult with the Department of State on questions regarding the application of 

international agreements other than trade agreements. 

i.		 When should my agency consider using or recognizing a standard used by a trading 

partner? To the extent a standard used by a trading partner is an international standard or 

voluntary consensus standard, agencies should consider and use them as described in this 

Circular (see, e.g., Sections 5a and h). In addition, agencies should consider and use a 

standard used by a trading partner, where, pursuant to an international agreement, the United 

States has agreed to do so (e.g., pursuant to a mutual recognition agreement). Agencies 

should also examine how recognition or use of a standard used by a trading partner would 

impact the policy objectives set out in Section 1 of Executive Order 13609, “Promoting 

International Regulatory Cooperation.” An agency may have additional obligations to 

consider a standard used by a trading partner pursuant to Section 3(d) of Executive Order 

13609. 

In addition, the United States is obligated to adhere to certain international agreements with 

respect to accepting as equivalent standards used in the regulations of U.S. trading partners. 

In particular, the WTO TBT Agreement, Article 2.7, requires the United States and other 

WTO Members to “give positive consideration to accepting as equivalent technical 

regulations of other Members, even if these regulations differ from their own, provided they 

are satisfied that these regulations adequately fulfill the objectives of their own regulations.” 

The WTO SPS Agreement also contains obligations regarding equivalence determinations 

with respect to foreign country sanitary and phytosanitary measures (SPS measures). Article 

4 of the SPS Agreement provides: 

24 
 

 

(i)		 Members shall accept the sanitary or phytosanitary measures of other Members as 

equivalent, even if these measures differ from their own or from those used by 

other Members trading in the same product, if the exporting Member objectively 

demonstrates to the importing Member that its measures achieve the importing 

Member's appropriate level of sanitary or phytosanitary protection. For this 

purpose, reasonable access shall be given, upon request, to the importing Member 

for inspection, testing and other relevant procedures. 

(ii) Members shall, upon request, enter into consultations with the aim of achieving 

bilateral and multilateral agreements on recognition of the equivalence of 

specified sanitary or phytosanitary measures. Agencies should consult with USTR 

regarding entering into any such consultations. 

U.S. Federal law, as codified at 19 U.S.C. § 2578a, provides that an agency may not 

determine that a foreign country’s sanitary or phytosanitary measure is equivalent to a 

sanitary or phytosanitary measure established under the authority of Federal law unless the 

agency determines the foreign country measure provides the same level of sanitary or 

phytosanitary protection as the U.S. measure. 

See SPS Agreement, Annex A, for the definition of SPS measure. 

j.		 How does this policy affect my agency's regulatory authorities and responsibilities? 

This policy does not preempt or restrict agencies' authorities and responsibilities to make 

regulatory decisions authorized by statute. Such regulatory authorities and responsibilities 

include determining the level of acceptable risk and risk-management, and due care; setting 

the level of protection; and balancing risk, cost, and availability of alternative approaches in 

establishing regulatory requirements. However, agencies should consider using voluntary 

consensus standards, as described in this Circular, to achieve their regulatory, procurement, 

and program needs, including for test methods, sampling procedures, and protocols, if 

applicable. 

k.		 How does this policy affect my agency's procurement authority? This policy does not 

preempt or restrict agencies’ authorities and responsibilities to identify the capabilities that 

they need to obtain through procurements. Rather, this policy establishes a preference for 

using a voluntary consensus standard, to the extent a suitable one exists, instead of pursuing 

an identified capability through reliance on a government-unique standard. 

l.		 What factors should my agency consider when determining whether to allow the use of 

more than one standard? In considering whether to allow the use of more than one 

standard for suppliers to demonstrate that they meet a particular program, procurement, or 

regulatory requirement, your agency should consider whether doing so meets your agency’s 

regulatory, procurement, or program needs (see, e.g., Section 5a). It may be appropriate for 

the agency to allow the use of multiple standards in order, for example, to permit greater 

flexibility for producers and service providers in meeting program, procurement, or 

regulatory requirements, enhance competition in the marketplace, provide greater choice to 

consumers, and enable new innovative solutions to be developed. Allowing the use of more 

25 
 

than one standard may also allow producers and service providers to meet both U.S. 

requirements and requirements in different markets simultaneously, thereby reducing burdens 

for manufacturers and service providers while effectively addressing agency objectives. 

m. How should my agency ensure that references to standards incorporated in regulation 

are updated on a timely basis? Consistent with Executive Orders 13563, “Improving 

Regulation and Regulatory Review,” and 13610, “Identifying and Reducing Regulatory 

Burdens,” agencies should, on a regular basis, review and if necessary update references to 

standards that have been incorporated by reference. Each agency should undertake a 

standards-specific review of such incorporated standards every three-to-five years, or when 

stakeholders otherwise provide adequate information that a standards-specific review is 

necessary due to urgent matters of health and safety, the need to remain current with 

technological changes, or for other compelling reasons. For example, regulated entities may 

petition agencies to update incorporated standards. 

In accordance with the retrospective review provisions of Executive Orders 13563 and 

13610, an agency should also consult with stakeholders prior to issuance of an NPRM, for 

example through an Advanced Notice of Proposed Rulemaking (ANPRM) or an RFI. Such 

consultations will help the agency identify which updated or new standards would 

potentially be controversial (if incorporated by reference in regulation) and which ones 

would not, and also whether incorporation of new or updated standards may warrant 

substantive changes to the underlying regulation. 

(i)		 In the case of standards for which updating or substituting a new standard or standards 

would not be controversial, the agency should, to the extent permitted by law, consider 

issuing a standards-specific direct final rule. 

(ii)		 In the case of other standards for which an agency may wish to update or substitute a 

new standard or standards, the agency should publish a standards-specific NPRM. 

(iii) To promote efficiency, and to the extent feasible and appropriate, an agency is 

encouraged to consolidate proposals to update or substitute standards, rather than 

conducting separate rulemakings for each standard the agency wants to update or 

substitute. 

(iv)		 In the case of standards for which updating or substituting a new standard would 

require a substantial re-opening of a rule, such revisions should be addressed in the 

context of a broader-scope “look-back” NPRM (rather than through a standardsspecific NPRM), where such re-opening meets the objectives and criteria set out in 

Executive Orders 13563 and 13610. 

(v) If an agency decides not to adopt the most recent version of a standard, the agency 

should explain its reasons in the final rule. 

(vi) Except in urgent circumstances, and where consistent with law and international 

obligations, agencies must allow a reasonable interval between the publication of final 

rules and their effective dates, in order to provide affected stakeholders sufficient time 

26 
 

 

to adapt their products and methods of production to comply with the updated or new 

standard. 

6.		 What is the Policy for Federal Participation in Standards Bodies? 

Consistent with Section 12(d)(2) of the NTTAA, agencies must consult with voluntary 

consensus standards bodies and must participate with such bodies in the development of 

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

their missions, authorities, priorities, and budgetary resources. In voluntary consensus standards 

development processes, agency participation can be an important contribution to ensuring 

balance is achieved. 

The WTO TBT and SPS Agreements also contain obligations regarding participation in 

international standards developing bodies: 

(i)		 TBT Agreement, Article 2.6: “With a view to harmonizing technical regulations on as 

wide a basis as possible, Members shall play a full part, within the limits of their 

resources, in the preparation by appropriate international standardizing bodies of 

international standards for products for which they either have adopted, or expect to 

adopt, technical regulations.” 

(ii)		 TBT Agreement, Article 5.5: “With a view to harmonizing conformity assessment 

procedures on as wide a basis as possible, Members shall play a full part, within the 

limits of their resources, in the preparation by appropriate international standardizing 

bodies of guides and recommendations for conformity assessment procedures.” 

(iii)		 SPS Agreement, Article 3.4: “Members shall play a full part, within the limits of their 

resources, in the relevant international organizations and their subsidiary bodies, in 

particular the Codex Alimentarius Commission, the International Office of Epizootics, 

and the international and regional organizations operating within the framework of the 

International Plant Protection Convention, to promote within these organizations the 

development and periodic review of standards, guidelines and recommendations with 

respect to all aspects of sanitary and phytosanitary measures.” 

Each agency should arrange for qualified representatives to participate in standards development 

activities, as appropriate. The representatives’ function should be to participate in the standards 

writing and/or, as appropriate, act as a liaison, provide information and expertise, and 

communicate the views of the agency concerning the standards being developed and the 

procedures being followed. 

a.		 Must agency participants be authorized? Agency representatives who, at Government 

expense, participate in activities of standards bodies on behalf of the agency must do so as 

specifically authorized agency representatives. Agency support for, and participation by, 

agency representatives in standards bodies must be in compliance with applicable laws and 

regulations. For example, agency support is subject to legal and budgetary authority and 

availability of funds. Similarly, participation by agency representatives (whether or not on 

behalf of the agency) in the activities of standards bodies is subject to the laws and regulations 

that apply to participation by Federal employees in the activities of outside organizations. 

27 
 

 

                                                            

 

Additionally, in considering the applicability of 18 U.S.C. § 208, which addresses Federal 

participation in outside organizations, the Office of Legal Counsel (OLC) of the Department of 

Justice has determined the following: “When the board of an outside organization plays an 

integral role in the process of setting standards, it would therefore frustrate the statute [NTTAA] 

to forbid Federal employees from being on the board. They could not then take the “active” role 

that Congress mandated. To carry out the statute, therefore, employees may serve on these 

outside boards without running afoul of 18 U.S.C. § 208, if the boards are engaged in the 

standard-setting activities in which Congress directed Federal agencies to participate.”5 

Furthermore, in the 2001 amendment to the NTTAA (in Section 1115 of Public Law 107-107 

(which enacted a new paragraph of Section 12(d)), Congress expressly exempted application of 

5 U.S.C. § 5946 (which prohibits payments for membership and conference fees) with respect to 

activities of Federal agencies and personnel in carrying out Section 12(d) of the NTTAA (see 15 

U.S.C. § 272 note). As noted in the previous Section, active agency technical involvement and 

leadership in standards activities is encouraged by this Circular and the NTTAA. However, 

agency representatives should avoid the practice or the appearance of undue influence relating to 

their participation in standards bodies and activities. 

b.		 Does agency participation indicate endorsement of any decisions reached by standards 

bodies? Agency participation in standards bodies does not connote agency endorsement or 

agreement with decisions by such bodies. 

c.		 What forms of support may my agency provide to standards development? The forms of 

agency support may include: 

(i)		 direct financial support (e.g., grants, memberships, and contracts); 

(ii)		 administrative support (e.g., travel costs, hosting of meetings, and secretarial 

functions); 

(iii) technical support (e.g., cooperative testing for standards evaluation and participation of 

agency personnel in the activities of standards bodies); 

(iv) joint planning with standards bodies to promote identification and development of 

needed standards; and 

(v)		 participation of agency personnel. 

Federal agencies should give adequate priority in their budgets to the need for agency 

officials to participate in standards development. 

d.		 Do agency representatives participate equally with other members? Consistent with agency 

regulation and policy, agency representatives should participate actively and on an equal basis 

with other members, consistent with the procedures of standards bodies, particularly in matters 

such as establishing priorities, developing procedures for preparing, reviewing and approving 

standards, and developing or adopting new standards. Active participation includes full 

involvement in discussions and technical debates, registering of opinions and, if selected, 

5 See OLC’s opinion of August 24, 1998, on “Application of § 208 to Service by Executive Branch Employees on 

Boards of Standard-Setting Organizations,” http://oge.gov/DisplayTemplates/ModelSub.aspx?id=1826. 

28 
serving as chairpersons (or other leadership positions) or in other official capacities. Agency 

representatives may vote, in accordance with the procedures of the standards body, at each stage 

of the standards development process, unless prohibited from doing so by law or their agencies. 

e.		 How should my agency alert the public of its potential participation in standards 

development activities that could be used as a basis for rulemaking or other missionrelated activities? In the interest of enhancing transparency and information-sharing, agencies 

should advise the public about ongoing or planned participation in standards development 

activities, when, for instance, doing so to address issues of national priority, or in support of 

significant regulatory action or international regulatory cooperation activities. Methods could 

include publication of a notice in the Federal Register, providing notice on the agency’s public 

website, or using other appropriate mechanisms. The information provided could include, for 

example: 

(i) which body or organization is developing the standard; 

(ii) why the agency’s participation is relevant to the public; and 

(iii) methods by which the public can obtain more information. 

When an agency is unsure of the nature and extent of standards activity that may be relevant for 

an upcoming regulation, procurement, or non-regulatory action, the agency is encouraged to 

request information on standards development through, for example, an RFI or an ANPRM. 

Agencies could also use more informal means, such as contacting relevant bodies directly. 

Note that agency participation in the standards development process is not a prerequisite for 

incorporating or otherwise using a standard. 

f.		 What if a voluntary consensus standards body is likely to publish a suitable standard in 

time for an agency to use it? If a voluntary consensus standards body is in the process of 

developing or adopting a voluntary consensus standard that would likely be practical for an 

agency to use, and would likely be developed or adopted on a timely basis, an agency should not 

develop its own standard and instead should participate in the activities of the voluntary 

consensus standards body (or at least monitor the development of the standard) so that the 

agency is in a position to use the standard at the appropriate time. 

7.		 What is the Policy on Conformity Assessment? 

Section 12(b) of the NTTAA requires the NIST to coordinate Federal, State, and local standards 

activities and conformity assessment activities with private sector standards development and 

conformity assessment activities, with the goal of eliminating unnecessary duplication and 

complexity in the development and promulgation of conformity assessment requirements and 

measures. The Secretary of Commerce, through NIST, issues guidance to the agencies on 

conformity assessment (see www.standards.gov). 

Building upon the NTTAA, U.S. statutory and international obligations, and NIST’s previous 

guidance to agencies on conformity assessment, agencies may develop and use conformity 

assessments procedures that: 

29 
 

 

 

 

(i) are effective and appropriate in carrying out agency missions; 

(ii) minimize the regulatory and/or conformity assessment burden on regulated entities; 

(iii) are in accordance with statutory and international obligations; 

(iv) conserve and leverage agency resources; and 

(v) increase acceptance of U.S. products in domestic and foreign markets. 

Agencies should be aware that conformity assessment procedures and systems can be used in 

many different ways to support their missions. Conformity assessment procedures and systems 

may be integral to a regulatory agency’s compliance and enforcement system, or the results of 

conformity assessment may be an input to the regulatory system. The agency may have roles 

and responsibilities related to the development and maintenance of conformity assessment 

system requirements and/or the conduct of specific activities in these systems. Flexibility is 

essential when devising an optimal conformity assessment system tailored to the missions of 

regulatory agencies. 

Agencies should also design conformity assessment programs with the objectives of furthering 

outcomes that are closely aligned with market dynamics and otherwise maximize net benefits to 

society. In this context, agencies should recognize the possible contribution of private sector 

conformity assessment activities. When properly conducted, conformity assessments conducted 

by private sector conformity assessment bodies can increase productivity and efficiency in 

government and industry, expand opportunities for international trade, conserve resources, improve 

health and safety, and protect the environment. 

Working closely with NIST and OMB, agencies are encouraged to identify their conformity 

assessment needs in such areas as regulatory compliance and enforcement, procurement, and 

other programmatic contexts and to assess whether the use of private sector conformity 

assessment mechanisms in lieu of or in conjunction with government conformity assessment 

procedures would be beneficial, where such use is feasible and appropriate and not otherwise 

prohibited by law. Agencies should also consider whether reliance on international conformity 

assessment schemes would meet their conformity assessment needs. 

Agencies will continue to have the flexibility of choosing conformity assessment programs, 

whether private, public, or some combination thereof, to best achieve the objectives above. 

a.		 What considerations should my agency make when it is addressing the need for 

conformity assessment? Agencies should consider appropriate agency roles and 

responsibilities to carry out their missions in a way that protects health, safety, welfare, and the 

environment, while promoting economic growth, competitiveness, and job creation, and 

reducing costs and burdens, including the cumulative effects of regulation, on the affected 

public and the U.S. economy. When an agency is evaluating whether to put in place a 

conformity assessment program, it should, consistent with statute, resource constraints, and the 

instruments set out in Section 1 of this Circular, consider certain factors when assessing the 

effectiveness of conformity assessment options and determining the type(s) of conformity 

assessment to employ. These include: 

(i) the objective(s) of the underlying regulation, procurement, or program activity; 

(ii) the level of confidence required by the agency to ensure that the agency objective(s) 

30 
                                                            

 

 

 

has/have been achieved, weighing the risk of non-compliance and its associated 

consequences with the anticipated costs of demonstrating compliance (including time 

and resources) to the producers, suppliers, consumers, and the agency; 

(iii)		 whether there are existing private sector conformity assessment activities, acceptance 

schemes or arrangements, that may work in conjunction with or, where appropriate, in 

lieu of governmental conformity assessment activities, except where such activities 

are inconsistent with law, unfit for regulatory or other agency purpose, or otherwise 

impractical; 

(iv)		 their consistency with statutory and international obligations; 

(v)		 consideration of the available scientific and technical information, as relevant to the 

selection of the appropriate conformity assessment program; 

(vi)		 relevant industry practice and experience, and the industry’s history of compliance; 

(vii) the need to reduce duplication and complexity, and ensure consistency and 

coordination with the conformity assessment approaches of other agencies, where 

feasible, appropriate, and consistent with law;6 

(viii) the appropriateness of recognizing the results of private sector conformity assessment 

programs being utilized in State, local, and/or foreign government regulation, 

consistent with subsection (iii); and 

(ix)		 the degree of transparency to stakeholders and the public of the conformity 

assessment activity. 

b.		 Are there statutory and international obligations concerning conformity assessment? 

There are statutory and international obligations governing standards-related activities, which 

include conformity assessment procedures. In particular, agencies should be aware of the 

obligations in 19 U.S.C. § 2532, which provides that “[n]o Federal agency may engage in any 

standards-related activity that creates unnecessary obstacles to the foreign commerce of the 

United States...” and that “[e]ach Federal agency shall ensure, in applying standards-related 

activities with respect to any imported product, that such product is treated no less favorably 

than are like domestic or imported products...” Additionally, “[e]ach Federal agency shall, with 

respect to any conformity assessment procedure used by it, permit access for obtaining an 

assessment of conformity and the mark of the system, if any, to foreign suppliers of a product on 

the same basis as access is permitted to suppliers of like products, whether of domestic or other 

foreign origin.” 19 U.S.C. § 2532(4). Conformity assessment requirements and procedures are 

also subject to the WTO TBT Agreement, which requires the United States to ensure it does not 

prepare, adopt, or apply conformity assessment procedures with a view to, or with the effect of, 

creating unnecessary obstacles to international trade. Articles 5 through 9 of the WTO TBT 

Agreement set out detailed obligations on conformity assessment procedures falling within the 

scope of the WTO TBT Agreement, including the need to use relevant guides or 

recommendations issued by international standardizing bodies as a basis for conformity 

assessment procedures, except where ineffective or inappropriate, and to ensure that the 

conformity assessment procedures are not more strict or applied more strictly than necessary to 

give adequate assurance that products conform to applicable “technical regulations” or 

6

 Pursuant to 15 C.F.R. § 287.1, your agency should work with NIST to “coordinate conformity assessment activities 

with those of other appropriate government agencies and with those of the private sector to reduce unnecessary 

duplication....This will help ensure more productive use of the increasingly limited Federal resources available to 

conduct conformity assessment activities...” Consistent with 15 C.F.R. § 287.4, agencies should also “consider using 

the results of other agencies’ conformity assessment procedures (see also Section 7e).” 

31 
 

standards, taking into account the risks non-conformity would create. Article 9.1 of the WTO 

TBT Agreement provides: 

Where a positive assurance of conformity with a technical regulation or standard is required, 

Members shall, whenever practical, formulate and adopt international systems for 

conformity assessment and become members thereof or participate therein. 

The United States has also undertaken additional commitments on conformity assessment in 

U.S. free trade agreements (FTA). These include a commitment not to discriminate against 

conformity assessment bodies located in the territories of U.S. FTA partners when it comes to 

accrediting, approving, licensing or otherwise recognizing conformity assessment bodies. 

Agencies are urged to consult with USTR on questions regarding international obligations 

regarding conformity assessment. 

c.		 What obligations does my agency have when considering whether to use a conformity 

assessment procedure used by a trading partner? Agencies should use voluntary consensus 

standards and international guides and recommendations issued by international standardizing 

bodies in their conformity assessment procedures, as described in this Circular, including where 

such standards, guides and recommendations are used by a trading partner. In addition, Article 

6.1 of the WTO TBT Agreement obligates the United States (and other WTO members) to 

accept the results of conformity assessment procedures in other WTO member countries, 

provided it is satisfied that those procedures offer an assurance of conformity equivalent to its 

own procedures. U.S. free trade agreements may also have obligations with respect to 

recognition of trading partners’ conformity assessment procedures. Agencies should consult 

with USTR regarding compliance with these obligations. Agencies should consult with the 

Department of State in the case of other international obligations or to consider what other 

relevant international agreements may apply. Agencies should also examine how such use or 

recognition would impact the policy objectives set out in Executive Order 13609, “Promoting 

International Regulatory Cooperation.” An agency may have additional obligations to consider 

such procedures under Section 3(d) of Executive Order 13609. 

d.		 How does this policy affect my agency's regulatory authorities and responsibilities? This 

policy does not preempt or restrict agencies’ authorities and responsibilities to make regulatory 

decisions authorized by statute. 

e.		 When should my agency utilize the retrospective review mechanism with respect to 

conformity assessment? Pursuant to Executive Orders 13563, “Improving Regulation and 

Regulatory Review,” and 13610, “Identifying and Reducing Regulatory Burdens,” and 15 

C.F.R. § § 287.1 and 287.4, your agency should integrate meaningful review of its conformity 

assessment activities into its retrospective review plans on a periodic basis. Consistent with the 

NTTAA, this Circular (particularly Section 1), and NIST guidance, the review should evaluate 

alternative approaches to ensure that current conformity assessment schemes are effective and 

the burden on regulated entities is minimized. 

Agencies are encouraged to consider joint rulemaking to reduce redundancy, complexity, and 

the cumulative effects on the regulated public of needing to comply with different conformity 

assessment procedures where (1) agencies have the same or similar requirements for 

32 
conformity assessment for the same product/service attributes and (2) demonstrating 

compliance with one agency’s requirement is sufficient to demonstrate that a product or service 

attribute conforms to other agencies’ requirements for the same product or service attribute. 

Consistent with law and the need for agencies to maintain appropriate levels of protection, for 

example, in regulations affecting health, safety, and the environment, agencies should engage 

the regulated public and other stakeholders in public consultation as part of the retrospective 

review process described above before initiating such rulemakings. 

8.		 How will the U.S. Government Coordinate Regulatory Policy with Standards and 

Conformity Assessment Policy? 

The Interagency Committee on Standards Policy (ICSP) shall coordinate with the Trade Policy 

Staff Committee (TPSC), its subcommittee on Technical Barriers to Trade, and the designees, or 

“Seconds,” of the Regulatory Working Group (Working Group) created by Executive Order 

12866, “Regulatory Planning and Review,” with a view to encouraging more strategic and 

coordinated Federal participation in the development and use of standards and in conformity 

assessment activities, in accordance with the objectives of the executive orders set out in Section 

1 of this Circular. USTR has responsibility under 19 U.S.C. §§ 2171 and 2541 for coordinating 

the consideration of international trade policy issues with respect to standards-related activities. 

While a primary focus of this Circular is to encourage agency reliance on voluntary consensus 

standards, OMB recognizes Federal agencies also participate in the development of other 

standards with standards bodies that do not have all of the attributes described in Section 2(e), 

as well as in regulatory collaboration initiatives and encourages such participation. Under 

Section 2(a) of Executive Order 13609, “Promoting International Regulatory Cooperation,” and 

subject to Section 6 of that order, the Working Group serves “as a forum to discuss, coordinate, 

and develop a common understanding among agencies of U.S. Government positions and 

priorities with respect to: (A) international regulatory cooperation activities that are reasonably 

anticipated to lead to significant regulatory actions; . . .” Moreover, under Section 3(a) of 

Executive Order 13609, “if required to submit a Regulatory Plan pursuant to Executive Order 

12866, [each agency shall] include in that plan a summary of its international regulatory 

cooperation activities that are reasonably anticipated to lead to significant regulations, with an 

explanation of how these activities advance the purposes of Executive Order 13563 and 

[Executive Order 13609].” Regular discussions between the Working Group Seconds and the 

ICSP, as well as the TPSC, its subcommittee on Technical Barriers to Trade, and any other 

relevant interagency groups or committees, will help to coordinate U.S. Government activities 

relating to standards and conformity assessment, as well as regulation. 

MANAGEMENT AND REPORTING OF STANDARDS USE
	

9.		 How Does My Agency Manage and Report on the Implementation of the Circular? 

Your agency should establish a process to identify, manage, and review your agency's activities 

pursuant to the guidance in this Circular. At minimum, your agency must have the ability to 

provide to OMB, through NIST, (1) a report on the agency's use of government-unique standards 

in lieu of voluntary consensus standards, along with an explanation of the reasons for such 

33 
usage, as required by Section 12(d) of the NTTAA and as described in Section 5c of this 

Circular; and (2) a summary of your agency’s activities undertaken to carry out the provisions of 

this Circular. The summary should contain a link to the agency’s standards-specific website(s) 

where this information is available. This policy establishes two ways – category based reporting 

and transaction based reporting – for agencies to manage and report their use of standards. Your 

agency must report uses of government-unique standards in lieu of voluntary consensus 

standards in one or both ways, pursuant to the following guidance. 

As required by the NTTAA, your agency must report to NIST, no later than December 31 of 

each year, the decisions by your agency in the previous fiscal year to use government-unique 

standards in lieu of voluntary consensus standards. Your agency must include an explanation of 

the reason(s) why use of such voluntary consensus standards would be inconsistent with 

applicable law or otherwise impractical, as described in Sections 5c, 10a(ii), and 11b(ii) of this 

Circular. Your agency must report in accordance with the instructions issued by NIST. 

NIST must maintain the reports received on http://www.nist.gov/standardsgov/ and will report 

the use of government-unique standards in lieu of voluntary consensus standards, along with the 

agency’s explanations for such use, to OMB on an annual basis. 

10. What are the Procedures for Reporting My Agency's Use of Standards in Regulations? 

Your agency should use transaction based reporting – that is, report on each use of a 

government-unique standard in lieu of a voluntary consensus standard – in your annual report to 

NIST if your agency issues regulations that use or reference standards. If your agency is issuing 

or revising a regulation that contains a standard, your agency should follow these procedures: 

a.		 Publish in the preamble of rulemaking notices what steps the agency is taking to follow and 

implement the Circular. Such information should include the following elements if 

applicable: 

(i)		 When your agency is proposing or has decided to use a standard, provide a statement 

which identifies such standard and any alternative standards which have been 

identified. 

(ii)		 When your agency is proposing or has decided to use a government-unique standard in 

lieu of a voluntary consensus standard, provide a statement that identifies such 

standards and provide an explanation for why using the voluntary consensus standard 

would be inconsistent with law or otherwise impractical. Such explanation must be 

also included in the annual report. 

(iii) When your agency is proposing or has decided to use a government-unique standard 

and has not identified a voluntary consensus standard, your agency should include a 

statement to that effect in the preamble of the final rule or guidance document. For 

other rulemaking notices, your agency should invite the public to identify any standard 

and explain why your agency should use such a standard. 

b.		 For significant regulatory actions, agencies are also encouraged to include in their 

rulemaking notices a discussion in the regulatory preamble of the following elements: 

34 
 

 

 

 

 

 

(i)		 which bodies or organizations the agency consulted with to determine whether there 

are relevant standards in use in the marketplace (or completion of relevant standards is 

imminent) or if standards that are currently incorporated by reference have been 

revised; 

(ii)		 whether agency officials are participating in the work of such bodies or organizations, 

along with a description of their roles; 

(iii)		 whether the agency has worked with relevant bodies or organizations to try to ensure 

that the standards meet agency needs, and a description of the agency’s interactions 

with the technical committees and/or technical advisory groups involved; and 

(iv)		 whether the agency has coordinated its positions in technical advisory groups or 

technical committees of such bodies or organizations with (1) other interested agencies 

that are or should be participating in such work and, (2) where appropriate, foreign 

regulatory agencies that are participating in such work, where the work is relevant to 

regulatory cooperation council work plans described in Section 3(d) of Executive 

Order 13609, “Promoting International Regulatory Cooperation.” 

11. What are the Procedures for Reporting My Agency's Use of Standards in Procurements? 

Your agency must report on either a categorical basis or on a transaction basis to identify, 

manage, and review the standards used in your agency's procurements. 

a.		 How does my agency report the use of standards in procurements on a categorical 

basis? Your agency must use categorical based reporting when your agency identifies, 

manages, and reviews the use of standards by group or category. Category based reporting 

is especially useful when your agency either conducts large procurements or large numbers 

of procurements using government-unique standards, or is involved in long-term 

procurement contracts that require replacement parts based on government-unique 

standards. To report use of government-unique standards on a categorical basis, your 

agency must: 

(i)		 maintain a centralized standards management system that identifies how your agency 

uses government-unique, voluntary consensus, and other standards; 

(ii)		 systematically review your agency's use of government-unique standards for 

conversion to voluntary consensus standards and, where appropriate, other standards; 

(iii)		 maintain records on the groups or categories for which your agency uses governmentunique standards in lieu of voluntary consensus standards, including an explanation of 

the reasons for such use, which must be transmitted according to Sections 5c and 9; 

and 

(iv) enable potential offerors to suggest voluntary consensus standards and, where 

appropriate, other standards that can replace government-unique standards. 

b.		 How does my agency report the use of standards in procurements on a transaction 

basis? Your agency should report on a transaction basis when your agency identifies, 

manages, and reviews the use of standards on a transaction basis rather than a category 

basis. Transaction-based reporting is especially useful when your agency conducts 

procurement involving mostly commercial products and services, but is occasionally 

35 
 

 

 

involved in a procurement involving government-unique standards. To report use of 

government-unique standards on a transaction basis, your agency must follow the following 

procedures: 

(i)		 in each solicitation that references government-unique standards, the solicitation must 

identify such standards and provide potential offerors an opportunity to suggest 

alternative voluntary consensus standards (or, where appropriate, other standards) that 

meet the agency's requirements; and 

(ii)		 if such suggestions are made and the agency decides to use government-unique 

standards in lieu of voluntary consensus standards, the agency must explain in its 

annual report to OMB through NIST, as described in Sections 5c and 9, why using 

such voluntary consensus standards is inconsistent with applicable law or otherwise 

impractical. 

The requirements in this Section do not apply to those solicitations that are for: (1) 

commercial-off-the-shelf products (COTS), (2) products or services that rely on voluntary 

consensus standards or other standards, or (3) products that otherwise do not rely on 

government-unique standards. 

AGENCY RESPONSIBILITIES 

12. What are the Responsibilities of the Secretary of Commerce? 

The Secretary of Commerce: 

a.		 coordinates and fosters executive branch implementation of this Circular and, as 

appropriate, provides administrative guidance to assist agencies in implementing this 

Circular, including guidance on identifying voluntary consensus standards bodies and 

voluntary consensus standards; 

b.		 sponsors and supports the ICSP, chaired by NIST, which considers agency views and 

advises the Secretary and agency heads on the Circular; 

c.		 reports to the Director of OMB concerning the implementation of the policy provisions of 

this Circular; and 

d.		 issues guidance to the agencies to improve coordination on conformity assessment in 

accordance with Section 7 of this Circular. 

13. What are the Responsibilities of the Heads of Agencies? 

The Heads of Agencies: 

a.		 implement the policies of this Circular in accordance with the procedures described; 

b.		 ensure agency compliance with the policies of the Circular is a top priority and implement 

appropriate organizational changes as necessary to achieve such compliance; 

c.		 in the case of an agency that uses standards for regulatory, procurement, or other missionrelated activities, designate a senior level official as the Agency Standards Executive who 

36 
 

 

will be responsible for the agency's implementation of this Circular, including the 

responsibilities outlined in 15 C.F.R. 287.5; represent the agency on the ICSP; and be 

situated in the agency’s organizational structure such that he or she is kept regularly apprised 

of the agency’s regulatory, procurement, and other mission-related activities and has 

sufficient authority within the agency to ensure compliance with the Circular; and 

d.		 transmit the annual report prepared by the Agency Standards Executive as described in 

Section 9 of this Circular. 

14. What are the Qualifications and Responsibilities of Agency Standards Executives? 

An Agency Standards Executive, consistent with applicable law: 

a.		 Should be a senior level official; have demonstrated knowledge of, and experience in, the 

areas of standards, standardization processes and procedures, and conformity assessment; be 

broadly engaged in the agency’s standards and conformity assessment related activities so as 

to ensure intra-agency coordination; and be broadly familiar with how the agency uses 

standards and conformity assessment in its mission and how it participates in activities of 

standards bodies and conformity assessment systems, including international systems of 

conformity assessment. 

b.		 Promotes the following goals in the context of agency participation in the work of standards 

bodies and in conformity assessment activities: 

(i)		 effective use of agency resources and participation in standards bodies; 

(ii)		 the development of agency positions that are in the public interest and are coordinated 

across units; 

(iii) the development of agency positions that are consistent with Administration policy; 

(iv)		 the development of agency technical and policy positions that are clearly defined and 

coordinated with other Federal participants in a given standards activity; and 

(v)		 the development of agency policies on conformity assessment to implement the 

provisions of Section 7 of this Circular, consistent with 15 C.F.R. § 287. 

c.		 Coordinates the agency’s participation in standards bodies by: 

(i)		 establishing procedures to ensure that agency representatives who participate in 

standards bodies will, to the extent possible, ascertain the views of the agency on 

matters of paramount interest and express views and positions that are not inconsistent 

or in conflict with established agency views and positions; 

(ii)		 consulting other relevant agencies, as appropriate, to avoid to the extent practicable 

expressing views or positions in standards bodies that are inconsistent or in conflict 

with established views or positions of such other agencies; 

(iii) ensuring that the agency's participation in standards bodies is consistent with agency 

missions, authorities, priorities, and budget resources; 

(iv)		 coordinating with standards bodies, and notifying such bodies when the agency has 

incorporated their standards by reference in regulation; 

(v)		 ensuring, when two or more agencies participate in a given standards activity, that they 

coordinate their views on matters of paramount importance so as to present, whenever 

37 
 

 

 

 

feasible, a single, unified position and, where not feasible, a mutual recognition of 

differences; 

(vi)		 cooperating with the head of the agency or his or her designee in carrying out his or 

her responsibilities under this Circular; 

(vii) consulting with the head of the agency or his or her designee, as necessary, in the 

development and issuance of internal agency procedures and guidance implementing 

this Circular; 

(viii) preparing, as described in Sections 9 through 11 of this Circular, a report on uses of 

government-unique standards in lieu of voluntary consensus standards, and a report 

on the status of agency standards policy activities; 

(ix) establishing a process for ongoing review of the agency’s use of standards for 

purposes of updating or substituting, pursuant to Section 5m; 

(x)		 coordinating with appropriate agency offices (e.g., budget and legal offices) to ensure 

that effective processes exist for the review of proposed agency support for, and 

participation in, standards bodies, so that agency support and participation will comply 

with applicable laws and regulations; 

(xi)		 making agency employees aware of available standards training opportunities and 

providing training (consistent with an agency’s budgetary and other considerations) for 

agency employees participating in standards and conformity assessment activities so 

that participation is effective, efficient, and in keeping with the rules of the 

organizations in which they are participating; 

(xii) providing ongoing assistance and policy guidance to agency employees and managers 

on significant issues in standardization and conformity assessment; and 

(xiii) coordinating with the TPSC TBT Subcommittee or other relevant TPSC
	

subcommittees on the trade implications of standardization. 

d.		 Ensures that agency rulemaking, procurement, and other programmatic activities are 

consistent with this Circular by, for example: 

(i)		 providing ongoing assistance, training, and policy guidance to agency employees and 

managers on the Circular; 

(ii)		 being engaged in the development of the agency’s rulemakings, procurements, and 

other programmatic activities that have a standards and/or conformity assessment 

component and providing advice on compliance with the Circular; and 

(iii) participating in the ICSP and consulting on a regular basis with NIST, other Agency 

Standards Executives, USTR (and, if applicable, your agency’s representatives to the 

relevant subcommittee of the TPSC), and the desk officer for your agency in OMB’s 

OIRA. 

SUPPLEMENTARY INFORMATION 

15. When Will This Circular Be Reviewed? 

This Circular will be reviewed for effectiveness no later than five years from the date of 

issuance. 

38 
 

 

 

 

16. What Is the Legal Effect of This Circular? 

This Circular is not intended to delay the administrative process, and this Circular does not 

provide new grounds for judicial review, or create new rights or benefits, substantive or 

procedural, enforceable at law or equity by a party against the United States, its agencies or 

instrumentalities, or its officers or employees. Authority for this Circular is based on 31 U.S.C. 

§ 1111, which gives OMB broad authority to establish policies for the improved management of 

the Executive Branch. This Circular is intended to implement section 12(d) of the NTTAA (15 

U.S.C. § 272 note) and other instruments set out in Section 1 of the Circular; establish policies 

that will improve the internal management of the Executive Branch; and, in so doing, improve 

regulatory and other policy outcomes. 

17. Do You Have Further Questions? 

For information concerning this Circular, contact the Office of Management and Budget, Office 

of Information and Regulatory Affairs at CircularA-119@omb.eop.gov. 

39 
                                                            

ANNEX A 

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 

Decision7 

The following principles and procedures should be observed, when international standards, guides 

and recommendations (as mentioned under Articles 2, 5 and Annex 3 of the TBT Agreement for the 

preparation of mandatory technical regulations, conformity assessment procedures and voluntary 

standards) are elaborated, to ensure transparency, openness, impartiality and consensus, 

effectiveness and relevance, coherence, and to address the concerns of developing countries. 

The same principles should also be observed when technical work or a part of the international 

standard development is delegated under agreements or contracts by international standardizing 

bodies to other relevant organizations, including regional bodies. 

Transparency 

All essential information regarding current work programmes, as well as on proposals for standards, 

guides and recommendations under consideration and on the final results should be made easily 

accessible to at least all interested parties in the territories of at least all WTO Members. Procedures 

should be established so that adequate time and opportunities are provided for written comments. 

The information on these procedures should be effectively disseminated. 

In providing the essential information, the transparency procedures should, at a minimum, include: 

(a) The publication of a notice at an early appropriate stage, in such a manner as to enable 

interested parties to become acquainted with it, that the international standardizing body 

proposes to develop a particular standard; 

(b) The notification or other communication through established mechanisms to 

members of the international standardizing body, providing a brief description of the 

scope of the draft standard, including its objective and rationale. Such 

communications shall take place at an early appropriate stage, when amendments can 

still be introduced and comments taken into account; 

(c) Upon request, the prompt provision to members of the international standardizing body 

of the text of the draft standard; 

(d) The provision of an adequate period of time for interested parties in the territory of at 

least all members of the international standardizing body to make comments in writing 

7 G/TBT/9, 13 November 2000, para. 20 and Annex 4. 

40 
and take these written comments into account in the further consideration of the 

standard; 

(e) The prompt publication of a standard upon adoption; and 

(f) To publish periodically a work programme containing information on the standards 

currently being prepared and adopted. 

It is recognized that the publication and communication of notices, notifications, draft standards, 

comments, adopted standards or work programmes electronically, via the Internet, where feasible, 

can provide a useful means of ensuring the timely provision of information. At the same time, it is 

also recognized that the requisite technical means may not be available in some cases, particularly 

with regard to developing countries. Accordingly, it is important that procedures are in place to 

enable hard copies of such documents to be made available upon request. 

Openness 

Membership of an international standardizing body should be open on a non- discriminatory basis to 

relevant bodies of at least all WTO Members. This would include openness without discrimination 

with respect to the participation at the policy development level and at every stage of standards 

development, such as the: 

(a) Proposal and acceptance of new work items; 

(b) Technical discussion on proposals; 

(c) Submission of comments on drafts in order that they can be taken into account; 

(d) Reviewing existing standards; 

(e) Voting and adoption of standards; and 

(f) Dissemination of the adopted standards. 

Any interested member of the international standardizing body, including especially 

developing country Members, with an interest in a specific standardization activity should be 

provided with meaningful opportunities to participate at all stages of standard development. It is 

noted that with respect to standardizing bodies within the territory of a WTO Member that have 

accepted the Code of Good Practice for the Preparation, Adoption and Application of Standards by 

Standardizing Bodies (Annex 3 of the TBT Agreement) participation in a particular international 

standardization activity takes place, wherever possible, through one delegation representing all 

standardizing bodies in the territory that have adopted, or expected to adopt, standards for the 

subject-matter to which the international standardization activity relates. This is illustrative of the 

importance of participation in the international standardizing process accommodating all relevant 

interests. 

41 
Impartiality and Consensus 

All relevant bodies of WTO Members should be provided with meaningful opportunities to 

contribute to the elaboration of an international standard so that the standard development process 

will not give privilege to, or favour the interests of, a particular supplier/s, country/ies or region/s. 

Consensus procedures should be established that seek to take into account the views of all parties 

concerned and to reconcile any conflicting arguments. 

Impartiality should be accorded throughout all the standards development process with respect to, 

among other things: 

(a) Access to participation in work; 

(b) Submission of comments on drafts; 

(c) Consideration of views expressed and comments made; 

(d) Decision-making through consensus; 

(e) Obtaining of information and documents; 

(f) Dissemination of the international standard; 

(g) Fees charged for documents; 

(h) Right to transpose the international standard into a regional or national standard; and 

(i) Revision of the international standard. 

Effectiveness and Relevance 

In order to serve the interests of the WTO membership in facilitating international trade and 

preventing unnecessary trade barriers, international standards need to be relevant and to effectively 

respond to regulatory and market needs, as well as scientific and technological developments in 

various countries. They should not distort the global market, have adverse effects on fair 

competition, or stifle innovation and technological development. In addition, they should not give 

preference to the characteristics or requirements of specific countries or regions when different 

needs or interests exist in other countries or regions. Whenever possible, international standards 

should be performance based rather than based on design or descriptive characteristics. 

Accordingly, it is important that international standardizing bodies: 

(a) Take account of relevant regulatory or market needs, as feasible and appropriate, as well 

as scientific and technological developments in the elaboration of standards; 

(b) Put in place procedures aimed at identifying and reviewing standards that have become 

obsolete, inappropriate or ineffective for various reasons; and 

(c) Put in place procedures aimed at improving communication with the World Trade 

42 
Organization. 

Coherence 

In order to avoid the development of conflicting international standards, it is important that 

international standardizing bodies avoid duplication of, or overlap with, the work of other 

international standardizing bodies. In this respect, cooperation and coordination with other relevant 

international bodies is essential. 

Development Dimension 

Constraints on developing countries, in particular, to effectively participate in standards 

development, should be taken into consideration in the standards development process. Tangible 

ways of facilitating developing countries' participation in international standards development 

should be sought. The impartiality and openness of any international standardization process 

requires that developing countries are not excluded de facto from the process. With respect to 

improving participation by developing countries, it may be appropriate to use technical assistance, 

in line with Article 11 of the TBT Agreement. Provisions for capacity building and technical 

assistance within international standardizing bodies are important in this context. 

43