[Federal Register Volume 63, Number 33 (Thursday, February 19, 1998)]
[Notices]
[Pages 8546-8558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4177]



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Part IV





Executive Office of the President





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Office of Management and Budget



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OMB Circular A-119; Federal Participation in the Development and Use of 
Voluntary Consensus Standards and in Conformity Assessment Activities; 
Notice

  Federal Register / Vol. 63, No. 33 / Thursday, February 19, 1998 / 
Notices  

[[Page 8546]]



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, EOP.

ACTION: Final Revision of Circular A-119.

-----------------------------------------------------------------------

SUMMARY: The Office of Management and Budget (OMB) has revised Circular 
A-119 on federal use and development of voluntary standards. OMB has 
revised this Circular in order to make the terminology of the Circular 
consistent with the National Technology Transfer and Advancement Act of 
1995, to issue guidance to the agencies on making their reports to OMB, 
to direct the Secretary of Commerce to issue policy guidance for 
conformity assessment, and to make changes for clarity.

DATES: Effective February 19, 1998.

ADDRESSES: Direct any comments or inquiries to the Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
NEOB Room 10236, Washington, D.C. 20503. Available at http://
www.whitehouse.gov/WH/EOP/omb or at (202) 395-7332.

FOR FURTHER INFORMATION CONTACT: Virginia Huth (202) 395-3785.

SUPPLEMENTARY INFORMATION:
I. Existing OMB Circular A-119
II. Authority
III. Notice and Request for Comments on Proposed Revision of OMB 
Circular 119-A
IV. Discussion of Significant Comments and Changes

I. Existing OMB Circular A-119

    Standards developed by voluntary consensus standards bodies are 
often appropriate for use in achieving federal policy objectives and in 
conducting federal activities, including procurement and regulation. 
The policies of OMB Circular A-119 are intended to: (1) Encourage 
federal agencies to benefit from the expertise of the private sector; 
(2) promote federal agency participation in such bodies to ensure 
creation of standards that are useable by federal agencies; and (3) 
reduce reliance on government-unique standards where an existing 
voluntary standard would suffice.
    OMB Circular A-119 was last revised on October 20, 1993. This 
revision stated that the policy of the federal government, in its 
procurement and regulatory activities, is to: (1) `[r]ely on voluntary 
standards, both domestic and international, whenever feasible and 
consistent with law and regulation;'' (2) ``[p]articipate in voluntary 
standards bodies when such participation is in the public interest and 
is compatible with agencies' missions, authorities, priorities, and 
budget resources;'' and (3) ``[c]oordinate agency participation in 
voluntary standards bodies so that * * * the most effective use is made 
of agency resources * * * and [that] the views expressed by such 
representatives are in the public interest and * * * do not conflict 
with the interests and established views of the agencies.'' [See 
section 6 entitled ``Policy'].

II. Authority

    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.
    In February 1996, Section 12(d) of Public Law 104-113, the 
``National Technology Transfer and Advancement Act of 1995,'' (or ``the 
Act'') was passed by the Congress in order to establish the policies of 
the existing OMB Circular A-119 in law. [See 142 Cong. Rec. H1264-1267 
(daily ed. February 27, 1996) (statement of Rep. Morella); 142 Cong. 
Rec. S1078-1082 (daily ed. February 7, 1996) (statement of Sen. 
Rockefeller); 141 Cong. Rec. H14333-34 (daily ed. December 12, 1995) 
(statements of Reps. Brown and Morella)]. The purposes of Section 12(d) 
of the Act are: (1) To direct ``federal agencies to focus upon 
increasing their use of [voluntary consensus] standards whenever 
possible,'' thus, reducing federal procurement and operating costs; and 
(2) to authorize the National Institute of Standards and Technology 
(NIST) as the ``federal coordinator for government entities responsible 
for the development of technical standards and conformity assessment 
activities,'' thus eliminating ``unnecessary duplication of conformity 
assessment activities.'' [See Cong. Rec. H1262 (daily ed. February 27, 
1996) (statements of Rep. Morella)].
    The Act gives the agencies discretion to use other standards in 
lieu of voluntary consensus standards where use of the latter would be 
``inconsistent with applicable law or otherwise impractical.'' However, 
in such cases, the head of an agency or department must send to OMB, 
through NIST, ``an explanation of the reasons for using such 
standards.'' The Act states that beginning with fiscal year 1997, OMB 
will transmit to Congress and its committees an annual report 
summarizing all explanations received in the preceding year.

III. Notice and Request for Comments on Proposed Revision of OMB 
Circular A-119

    On December 27, 1996, OMB published a ``Notice and Request for 
Comments on Proposed Revision of OMB Circular A-119'' (61 FR 68312). 
The purpose of the proposed revision was to provide policy guidance to 
the agencies, to provide instructions on the new reporting 
requirements, to conform the Circular's terminology to the Act, and to 
improve the Circular's clarity and effectiveness.
    On February 10, 1997, OMB conducted a public meeting to receive 
comments and answer questions.
    In response to the proposed revision, OMB received comments from 
over 50 sources, including voluntary consensus standards bodies or 
standards development organizations (SDOs), industry organizations, 
private companies, federal agencies, and individuals.

IV. Discussion of Significant Comments and Changes

    Although some commentators were critical of specific aspects of the 
proposed revision, the majority of commentators expressed support for 
the overall policies of the Circular and the approaches taken. The more 
substantive comments are summarized below, along with OMB's response.
    The Circular has also been converted into ``Plain English'' format. 
Specifically, the following changes were made. We placed definitions 
where the term is first used; replaced the term ``must'' with ``shall'' 
where the intent was to establish a requirement; created a question and 
answer format using ``you'' and ``I'; and added a Table of Contents.
    We replaced proposed sections 6, 7 and 10 (``Policy,'' 
``Guidance,'' and ``Conformity Assessment'') with sections 6, 7, and 8, 
which reorganized the material. We reorganized the definitions for 
``standard,'' ``technical standard,'' and ``voluntary consensus 
standard.'' We reorganized proposed section 8 on ``Procedures'' into 
sections 9, 10, 11, 12. For clarity, we have referenced provisions by 
their location both in the proposed Circular and in the final Circular.

Proposed Section 1--Purpose. Final Section 1

    1. Several commentators suggested that this section should be 
modified to make clear that the primary purpose of

[[Page 8547]]

the revision of the Circular is to interpret the provisions of section 
12(d) of Pub. L. 104-113 so that federal agencies can properly 
implement the statutory requirements. We revised the wording of this 
section to reflect this suggestion.

Proposed Section 2--Rescissions. Final Section 1

    2. We moved this section to Final Section 1.

Proposed Section 3--Background. Final Section 2

    3. Several commentators suggested substituting ``use'' for 
``adoption'' in this section to conform to the new set of definitions. 
We agree, and we modified the final Circular.

Proposed Section 4--Applicability. Final Section 5

    4. Several commentators found this section unclear. One commentator 
suggested deleting ``international standardization agreements,'' 
suggesting this section could be interpreted as conflicting with 
proposed section 7a(1) which encouraged consideration of international 
standards developed by voluntary consensus standards. We agree, and we 
modified the final Circular.

Proposed Section 5a--Definition of Agency. Final Section 5

    5. A commentator suggested defining the term ``agency mission.'' 
Upon consideration, we have decided that this term is sufficiently well 
understood as to not require further elaboration; it refers to the 
particular statutes and programs implemented by the agencies, which 
vary from one agency to the next. Thus, we did not add a definition.
    6. A commentator questioned whether federal contractors are 
intended to be included within the definition of ``agency.'' Federal 
contractors do not fall within the definition of ``agency.'' However, 
if a federal contractor participates in a voluntary consensus standards 
body on behalf of an agency (i.e., as an agency representative or 
liaison), then the contractor must comply with the ``participation'' 
policies in section 7 of this Circular (i.e., it may not dominate the 
proceedings of a voluntary consensus standards body.).

Proposed Section 5b--Conformity Assessment. Final Section 8

    7. In response to the large number of commentators with concerns 
over the definition of conformity assessment, we have decided to not 
define the term in this Circular but to defer to NIST when it issues 
its guidance on the subject. The Circular's policy statement on 
conformity assessment is limited to the statutory language.

Proposed Section 5c--Definition of Impractical. Final Section 6a(2)

    8. A commentator suggested that if an agency determines the use of 
a standard is impractical, the agency must develop an explanation of 
the reasons for impracticality and the steps necessary to overcome the 
use of the impractical reason. We decided that no change is necessary. 
The Act and the Circular already require agencies to provide an 
``explanation of the reasons.'' Requiring agencies to describe the 
steps necessary ``to overcome the use of the impractical reason'' is 
unnecessarily burdensome and not required by the Act.
    9. A commentator suggested that the definition of ``impractical'' 
is too broad and proposed deleting words such as ``infeasible'' or 
``inadequate.'' We have decided that the definition is appropriate, 
because things that are infeasible or inadequate are commonly 
considered to be impractical. Thus, we made no change.
    10. A commentator suggested eliminating the phrase ``unnecessarily 
duplicative'' because it is unlikely that a voluntary consensus 
standard that was considered ``impractical'' would also be 
``unnecessarily duplicative.'' We agree, and the final Circular is 
modified accordingly.
    11. A few commentators suggested adding ``ineffectual'' to the 
definition. A few other commentators suggested adding the phrase ``too 
costly or burdensome to the agency or regulated community.'' Another 
commentator suggested the same phrase but substituted the term 
``affected'' for ``regulated.'' We have decided that concerns for 
regulatory cost and burden fall under the term ``inefficient'' 
contained in this definition. Thus, we made no change.
    12. A few commentators suggested deleting the term ``demonstrably'' 
as it implies a greater level of proof than that required in the Act. 
Upon consideration, we have decided that the term ``demonstrably'' is 
unnecessary, as the Act already requires an explanation, and it may be 
reasonably inferred that an explanation can be demonstrated. Thus, we 
deleted the term.

Proposed Section 5d--Definition of Performance Standard. Final Section 
3c

    13. A commentator suggested deleting the ``and'' in the definition. 
We have decided that this suggestion would distort the meaning. 
Therefore, no change is made.
    14. A few commentators suggested substituting the term 
``prescriptive'' for ``design'' because of the multiple connotations 
associated with the term ``design.'' In addition, several commentators 
suggested related clarifying language. We agree, and we modified the 
final Circular.

Proposed Section 5f--Definition of Standard. Final Section 3

    15. Several commentators suggested overall clarification of this 
section, while other commentators endorsed the proposed section. One 
commentator suggested that ``clarification is necessary to distinguish 
the appropriate use of different types of standards for different 
purposes (i.e., acquisition, procurement, regulatory).'' This 
commentator proposed that, ``For example, regulatory Agencies should 
only rely upon national voluntary consensus standards (as defined in 
Section 5j) for use as technical criteria in regulations but a federal 
agency may want to use industry-developed standards (without a full 
consensus process) for certain acquisition purposes if there are no 
comparable consensus standards.'' We do not agree with this proposal. 
The same general principles apply in the procurement context as in the 
regulatory context.
    16. A commentator suggested that the definition of ``standard'' be 
limited to ensure that agencies are only required to consider adopting 
voluntary ``technical'' standards. The final Circular clarifies this by 
clearly equating ``standard'' with ``technical standard.''
    17. One commentator recommended adding to the definition of 
``standard'' an exclusion for State and local statutes, codes, and 
ordinances, because agency contracts often require contractors to meet 
State and local building codes, which contain technical standards which 
may not be consensus-based. For example, the Department of Energy 
builds facilities that must be compliant with local building codes, 
which may be more strict than nationally accepted codes. It is not the 
intent of this policy to preclude agencies from complying with State 
and local statutes, codes, and ordinances. No change is necessary, 
because the Act already states that, ``If compliance * * * is 
inconsistent with applicable law * * * a Federal agency may elect to 
use technical standards that are not developed or adopted by voluntary 
consensus standards bodies.''

Proposed Section 5f--Definition of Standard. Final Section 4

    18. Several commentators had concerns with this section, believing 
that the final sentence in the proposed

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version might imply that other-than-consensus standards may qualify as 
consensus processes. This is not the case. We have clarified this point 
through the reorganization of final sections 3 and 4 and through minor 
clarifying language. In addition, we note that the subject of the 
Circular is ``voluntary consensus standards,'' which are a subset of 
``standards.'' Consistent with the 1993 version, the final Circular 
defines ``standard'' generally to describe all the different types of 
standards, whether or not they are consensus-based, or industry- or 
company-based. Accordingly, we have inserted the phrase ``government-
unique'' in final section 4b(2) in order to provide a complete picture 
of the different sources of standards, while also adding a reference to 
``company standards'' in final section 4b(1), previously found in the 
definition of ``standard.''

Proposed Section 5g--Definition of Technical Standard. Final Section 3a

    19. Several commentators suggested combining this term with the 
definition of standard. We agree, and the terms have been merged.
    20. Another commentator suggested adding the phrase ``and related 
management practices'' because this phrase appears in Section 12(d)(4) 
of the Act. We agree, and we modified the final Circular.

Proposed Section 5h--Definition of Use. Final Section 6a(1)

    21. Several commentators suggested that limiting an agency's use to 
the latest edition of a voluntary consensus standard was unnecessarily 
restrictive. We agree, and we modified the final Circular.

Proposed Section 5i--Definition of Voluntary Consensus Standards. Final 
Section 4

    22. Several commentators objected to the phrase regarding making 
``intellectual property available on a non-discriminatory, royalty-free 
or reasonable royalty basis to all interested parties.'' Several 
commentators also supported this language. This section does not limit 
the ability of copyright holders to receive reasonable and fair 
royalties. Accordingly, we made no change.

Proposed Section 5j--Voluntary Consensus Standards Bodies. Final 
Section 4a(1)

    23. Several commentators proposed that the words ``but not 
necessarily unanimity'' be inserted for clarification. We agree, and we 
modified the final Circular.
    24. A commentator suggested deleting the examples of voluntary 
consensus standards bodies. We agree that the examples were unnecessary 
and confusing, and we modified the final Circular.
    25. A few commentators suggested that the Circular acknowledge the 
American National Standards Institute (ANSI) as the means of 
identifying voluntary consensus standards bodies. Since the purpose of 
the Circular is to provide general principles, rather than make 
determinations about specific organizations or guides, these 
determinations will be made by agencies in their implementation of the 
Act. Thus, we made no change.
    26. A commentator suggested that the definition be modified so 
``that only those organizations that permit an acceptable level of 
participation and approval by U.S. interests can be considered to 
qualify.'' We have decided that no change is necessary, because the 
requirements of consensus--openness, balance of interests, and due 
process--likewise apply to international organizations.
    27. The same commentator suggested adding the phrase ``the absence 
of sustained opposition'' to the definition of ``consensus.'' Although 
we did not make this change, we added other language that improves the 
definition.
    28. Several commentators proposed that the Circular further clarify 
aspects of this section, including further definitions of ``balance of 
interest,'' ``openness,'' and ``due process.'' We have decided that the 
definition provided is sufficient at this time, and no change is made.
    29. Several commentators proposed that this definition should be 
``clarified to state the Federal agencies considering the use of 
voluntary consensus standards, not the organizations themselves, are to 
decide whether particular organizations qualify as voluntary consensus 
standards bodies by meeting the operational requirements set out in the 
definition.'' For purposes of complying with the policies of this 
Circular, agencies may determine, according to criteria enumerated in 
final section 4, whether a standards body qualifies. However, it is the 
domain of the private sector to accredit voluntary consensus standards 
organizations, and accordingly, we have inserted clarifying language in 
final section 6l.

Proposed Section 6a. Final Section 6c

    30. A commentator proposed deleting in section 6a ``procurement 
guidelines'' suggesting it was confusing and inappropriate to mandate 
use of voluntary consensus standards for ``procurement guidelines or 
procedures.'' We have decided to delete the reference to ``procurement 
guidelines.'' The Circular says nothing about ``procurement 
procedures.''
    31. The same commentator suggested adding in section 6a 
``monitoring objectives'' as part of an agency's regulatory authorities 
and responsibilities. We have decided that, under the Act and the 
Circular, agencies already have sufficient discretion regarding the use 
and non-use of standards relating to such authorities and 
responsibilities. Thus, we have made no change.

Proposed Section 6a. Final Section 6f

    32. Some commentators expressed concern that once a standard was 
determined to be a voluntary consensus standard, an agency might 
incorporate such standard into a regulation without performing the 
proper regulatory analysis. To address this concern, another 
commentator suggested adding language referencing ``The Principles of 
Regulation'' enumerated in Section 1(b) of Executive Order 12866. We 
agree, and we modified the final Circular.

Proposed Section 6b. Final Section 7

    33. In the proposed revision of the Circular, sections 6b and 7b(2) 
were strengthened by adding language that directed agency 
representatives to refrain from actively participating in voluntary 
consensus standards bodies or their committees when participating did 
not relate to the mission of the agency.
    Several commentators were not satisfied with these changes and 
remain concerned that an agency member might dominate a voluntary 
consensus standards body as a result of the agency member chairing and/
or providing funding to such body, thus making the process not truly 
consensus. These commentators urged additional limitations on agency 
participation in voluntary consensus standards bodies, including: 
Prohibiting federal agency representatives from chairing committees or 
voting (or if chairing a committee, then denying them the authority to 
select committee members); having only an advisory role; participating 
only if directly related to an agency's mission or statutory authority; 
and participating only if there is an opportunity for a third party 
challenge to the participation through a public hearing.
    On the other hand, most commentators supported the proposed changes 
and agreed that federal participation in voluntary consensus

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standards bodies should not be further limited, because federal 
participation benefited both the government and the private sector. 
These commentators noted that agencies must be involved in the 
standards development process to provide a true consensus and to help 
support the creation of standards for agency use. These purposes are 
consistent with the intent of the Act.
    In the final Circular, we have added language to clarify the 
authorities in the Circular. We have also strengthened the final 
Circular by adding language in final section 7f that directs agency 
employees to avoid the practice or the appearance of undue influence 
relating to their agency representation in voluntary consensus 
standards activities. We would also like to underscore the importance 
of close cooperation with the private sector, including standards 
accreditors, in ensuring that federal participation is fair and 
appropriate.
    With respect to imposing specific limitations on agency 
participation in such bodies, which would result in unequal 
participation relative to other members, we have decided that such 
limitations would (1) not further the purposes of the Act and (2) could 
interfere with the internal operations of voluntary consensus standards 
organizations.
    First, the Act requires agencies to consult with voluntary 
consensus standards bodies and to participate with such bodies in the 
development of technical standards ``when such participation is in the 
public interest and is compatible with agency and departmental 
missions, authorities, and budget resources.'' The legislative history 
indicates that one of the purposes of the Act is to promote federal 
participation. [See 141 Cong. Rec. H14334 (daily ed. December 12, 1995) 
(Statement of Rep. Morella.)] Moreover, neither the Act nor its 
legislative history indicate that federal agency representatives are to 
have less than full and equal representation in such bodies. Given the 
explicit requirement to consult and participate and no concomitant 
statement as to any limitation on this participation, we believe the 
Act was intended to promote full and equal participation in voluntary 
consensus standards bodies by federal agencies.
    Second, although an agency is ultimately responsible for ensuring 
that its members are not participating in voluntary consensus standards 
bodies in a manner inconsistent with the Circular and the Act, it would 
be inappropriate for the federal government to direct the internal 
operations of private sector voluntary consensus standards bodies or 
standards development organizations (SDOs) by proscribing the 
activities of any of its members. The membership of an SDO is free to 
choose a chair, to establish voting procedures, and to accept funding 
as deemed appropriate. We expect that the SDO itself or a related 
parent or accrediting organization would act to ensure that the 
organization's proceedings remain fair and balanced. An SDO has a 
vested interest in ensuring that its consensus procedures and policies 
are followed in order to maintain its credibility.

Proposed Section 6b. Final Sections 7e, 7f, and 7h

    34. Other commentators were concerned that an agency representative 
could participate in the proceedings of a voluntary consensus standards 
body for which the agency has no mission-related or statutorily-based 
rationale to become involved. For example, a situation might exist in 
which a technical standard developed by the private sector could be so 
widely adopted as to result in the emergence of a de facto regulatory 
standard, albeit one endorsed by the private sector rather than by the 
government. For example, a construction standard for buildings could 
become so widely accepted in the private sector that the result is that 
the construction community acts as if it is regulated by such 
standards. The commentator suggested that if an agency were to 
participate in the development of such a technical standard, in an area 
for which it has no specific statutory authority to regulate, that 
agency could be perceived as attempting to regulate the private sector 
``through the back door.'' A perception of such activity, whether or 
not based in fact, would be detrimental to the interests of the federal 
government, and agencies should avoid such involvement.
    In response to this concern, we feel that changes initiated in the 
proposed revision and continued in the final Circular sufficiently 
strengthened the Circular in this regard. In particular, section 7 
expressly limits agency support (e.g., funding, participation, etc.) to 
``that which clearly furthers agency and departmental missions, 
authorities, priorities, and budget resources.'' Moreover, this 
language is consistent with the Act. Thus, if an agency has no mission-
related or statutory-related purpose in participation, then its 
participation would be contrary to the Circular.
    An agency is ultimately responsible for ensuring that its employees 
are not participating in such bodies in a manner inconsistent with the 
Act or this Circular. Agencies should monitor their participation in 
voluntary consensus standards bodies to prevent situations in which the 
agency could dominate proceedings or have the appearance of 
impropriety.
    Agencies should also work closely with private sector oversight 
organizations to ensure that no abuses occur. Comments provided by ANSI 
described the extensive oversight mechanisms it maintains in order to 
ensure that such abuses do not occur. We encourage this kind of active 
oversight on the part of the private sector, and we hope to promote 
cooperation between the agencies and the private sector to ensure that 
federal participation remains fair and equal.

Proposed Section 7--Policy Guidelines. Final Section 6c

    35. A few commentators inquired whether the Circular applies to 
``regulatory standards.'' In response, the final Circular distinguishes 
between a ``technical standard,'' which may be referenced in a 
regulation, and a ``regulatory standard,'' which establishes overall 
regulatory goals or outcomes. The Act and the Circular apply to the 
former, but not to the latter. As described in the legislative history, 
technical standards pertain to ``products and processes, such as the 
size, strength, or technical performance of a product, process or 
material'' and as such may be incorporated into a regulation. [See 142 
Cong. Rec. S1080 (daily ed. February 7, 1996) (Statement of Sen. 
Rockefeller.)] Neither the Act nor the Circular require any agency to 
use private sector standards which would set regulatory standards or 
requirements.

Proposed Section 7. Final Section 6g

    36. A commentator inquired whether the use of non-voluntary 
consensus standards meant use of any standards developed outside the 
voluntary consensus process, or just use of government-unique 
standards. The intent of the Circular over the years has been to 
discourage the government's reliance on government-unique standards and 
to encourage agencies to instead rely on voluntary consensus standards. 
It is has not been the intent of the Circular to create the basis for 
discrimination among standards developed in the private sector, whether 
consensus-based or, alternatively, industry-based or company-based. 
Accordingly, we added language to clarify this point.

Proposed Section 7. Final Section 6f

    37. One commentator inquired how OMB planned to carry out the 
``full

[[Page 8550]]

account'' of the impact of this policy on the economy, applicable 
federal laws, policies, and national objectives. This language is from 
the current Circular and refers to the considerations agencies should 
make when considering using a standard. No change is necessary.

Proposed Section 7. Final Section 17

    38. Several commentators noted that the proposed revision 
eliminated language from the current Circular which stated that its 
provisions ``are intended for internal management purposes only and are 
not intended to (1) create delay in the administrative process, (2) 
provide new grounds for judicial review, or (3) create legal rights 
enforceable against agencies or their officers.'' We have decided that, 
while some sections of the Circular incorporate statutory requirements, 
other sections remain internal Executive Branch management policy. 
Accordingly, we have retained the language, with minor revisions.

Proposed Section 7a

    39. One commentator inquired as to whether the use of a voluntary 
consensus standard by one agency would mandate that another agency must 
use such standard. Implementation of the policies of the Circular are 
on an agency by agency basis, and in fact, on a case by case basis. 
Agencies may have different needs and requirements, and the use of a 
voluntary consensus standard by one agency does not require that 
another agency must use the same standard. Each agency has the 
authority to decide whether, for a program, use of a voluntary 
consensus standard would be contrary to law or otherwise impractical.
    40. Another comment suggested that the Circular did not contain 
sufficient assurance that the standards chosen would be true consensus 
standards. We have expanded the guidance in the Circular to address 
this concern by first expanding the definition of ``consensus'' in 
final section 4a(1)(v). Second, we have described in final section 6l 
how agencies may identify voluntary consensus standards. Third, we have 
developed reporting procedures that allow for public comment.

Proposed Section 7a(1). Final Section 6h

    41. Several commentators suggested that ``international voluntary 
consensus standards body'' be defined in proposed section 5. We have 
decided that this definition is not necessary, as the term 
``international'' is sufficiently well understood in the standards 
community, and the term ``voluntary consensus standards body'' has 
already been defined. Moreover, the distinction between ``international 
standards'' and ``domestic standards'' is not relevant to the essential 
policies of the Circular, and this point is clarified in this section.
    42. Several commentators also noted that two trade agreements 
(``TBT'' and the ``Procurement Code'') of the World Trade Organization 
were mentioned but inquired as to why other international agreements 
like the World Trade Organization Agreement on Sanitary and 
Phytosanitary Measures or the North American Free Trade Agreement were 
not mentioned. We did not intend this list to be exhaustive. Therefore, 
we deleted this phrase to emphasize the main point of this section.
    43. Several commentators questioned why the Circular included 
language that standards developed by international voluntary consensus 
standards bodies ``should be considered in procurement and regulatory 
applications.'' We recognize that both domestic and international 
voluntary consensus standards may exist, sometimes in harmony, 
sometimes in competition. This language, which is unchanged from the 
current version of the Circular, states only that such international 
standards should be ``considered,'' not that they are mandated or that 
they should be given any preference. In addition, some confusion has 
emerged based on a perceived conflict between the commitments of the 
United States with respect to international treaties and this Circular. 
No part of this Circular is intended to preempt international treaties. 
Nor is this Circular intended to create the basis for discrimination 
between an international and a domestic voluntary consensus standard. 
However, wherever possible, agencies should consider the use of 
international voluntary consensus standards.

Proposed Section 7a(2). Final Section 6i

    44. One commentator suggested that the Circular promote the concept 
of performance-based requirements when regulating the conduct of work 
for safety or health reasons (e.g., safety standards). Where 
performance standards can be used in lieu of other types of standards 
(or technical standards), the Circular already accomplishes this by 
stating in final section 6i that ``preference should be given to 
standards based on performance criteria.''

Proposed Section 7a(3). Final Section 6j

    45. One commentator suggested using stronger language to protect 
the rights of copyright holders when referenced in a regulation. Others 
thought the language too strong. We have decided that the language is 
just right.

Proposed Section 7a(4). Final Section 6k, 7j

    46. One commentator suggested that legal obligations that supersede 
the Circular and cost and time burdens need to be emphasized as factors 
supporting agencies' developing and using their own government-unique 
standards. Another commentator suggested that untimeliness or 
unavailability of voluntary consensus standards development should be a 
reasonable justification for creation of a government standard. On the 
first point, these specific changes are not necessary, because the Act 
and the Circular already state that agencies may choose their own 
standard ``where inconsistent with applicable law or otherwise 
impractical.'' On the second point, we did clarify the language in 
final sections 6k and 7j.
    47. Another commentator suggested that the Circular should define 
in this section factors that are considered to be ``impractical.'' See 
comments on proposed section 5c. We made no change.

Proposed Section 7a(5). Final Section 6l.

    48. This section is intended to give agencies guidance on where 
they may go to identify voluntary consensus standards. One commentator 
proposed language to indicate that, in addition to NIST, voluntary 
consensus standards may also be identified through other federal 
agencies. Another commentator proposed language that such standards may 
also be identified through standards publishing companies. We agree, 
and the Circular is changed.

Proposed Section 7b

    49. Other commentators proposed that Federal Register notices be 
published whenever a federal employee is to participate in a voluntary 
consensus standards body. We have decided that this would be overly 
burdensome for the agencies and would provide comparatively little 
benefit for the public. Moreover, each agency is already required in 
section 15b(5) to publish a directory of federal participants in 
standards organizations. We made no change.

Proposed Section 7b(2). Final Section 7d

    50. Some commentators noted that the current Circular's language, 
which states that agency employees who ``at government expense'' 
participate in voluntary consensus standards bodies shall do so as 
specifically authorized agency representatives, has been deleted

[[Page 8551]]

from the proposed revision. These commentators opposed this deletion. 
This phrase has been reinstated. Federal employees who are representing 
their agency must do so at federal expense. (On the other hand, 
employees are free to maintain personal memberships in outside 
organizations, unless the employee's agency has a requirement for prior 
approval.) We expect that, as a general rule, federal participation in 
committees will not be a problem, while participation at higher levels, 
such as officers or as directors on boards, will require additional 
scrutiny. Employees should consult with their agency ethics officer to 
identify what restrictions may apply.

Proposed Section 7b(2). Final Section 7

    51. Several commentators suggested changing the language in this 
section from ``permitting agency participation when relating to agency 
mission,'' to ``permitting agency participation when compatible with 
agency and departmental missions, authorities, priorities, and budget 
resources,'' as stated in the Act. We have decided to accept this 
suggestion, and the Circular is changed.

Proposed Section 7b(4). Final Sections 7d, 7g

    52. One commentator suggested that the Circular should prohibit 
agency employees from serving as chairs or board members of voluntary 
consensus standards bodies. We have not amended the Circular to 
prohibit agency employees from serving as chairs or board members of 
voluntary consensus standards bodies. However, we have modified final 
section 7g to clarify that agency employees, whether or not in a 
position of leadership in a voluntary consensus standards body, must 
avoid the practice or appearance of undue influence relating to the 
agency's representation and activities in the voluntary consensus 
standards bodies. In addition, we added language in final section 7d to 
remind agencies to involve their agency ethics officers, as 
appropriate, prior to authorizing support for or participation in a 
voluntary consensus standards body.

Proposed Section 7b(5). Final Section 7h

    53. One commentator suggested changing the word ``should'' to 
``shall'' regarding keeping the number of individual agency 
participants to a minimum. We decided that this change is unnecessary 
and made no change.

Proposed Section 7b(6)

    54. A few commentators suggested requiring that the amount of 
federal support should be made public or at least made known to the 
supported committee of the voluntary consensus standards body or SDO. 
We have decided that this is unnecessary because we expect that the 
amount of federal support will already be known to a committee 
receiving the funds.

Proposed Section 7b(7). Final Section 7g

    55. A commentator suggested either deleting ``and administrative 
policies'' or inserting ``internal'' before ``administrative policies'' 
to clarify that the prohibition is intended to apply to the internal 
management of a voluntary consensus standard body. This phrase is 
parenthetical to the words ``internal management;'' thus, the suggested 
revision is unnecessary.

Proposed Section 7b(8). Final Section 7i

    56. One commentator questioned the relationship of the Circular to 
the Federal Advisory Committee Act (FACA). Federal participation in 
standards activities would not ordinarily be subject to FACA, because 
FACA applies to circumstances in which private individuals would be 
advising the government. The private sector members of standards 
organizations are not advising the government, but are developing 
standards. Nevertheless, issues may arise in which agencies should be 
aware of FACA.

Proposed Section 7b. Final Sections 7e, 7f

    57. Several commentators, fearing agency dominance, criticized the 
proposed revision of the Circular for promoting increased agency 
participation. We have decided that the revisions to the Circular are 
balanced, in that they encourage agency participation while also 
discouraging agency dominance. Moreover, legislative history states, 
``In fact, it is my hope that this section will help convince the 
Federal Government to participate more fully in these organizations' 
standards developing activities.'' [See 141 Cong. Rec. H14334 (daily 
ed. December 12, 1995) (Statement of Rep. Morella.)]

Proposed 7c (4). Final Section 15b

    58. A commentator suggested changing ``standards developing 
groups'' to ``voluntary consensus standards bodies'' for consistency. 
We agree, and we modified the final Circular.

Proposed 7c(6). Final Section 15b(7)

    59. The current and proposed versions of the Circular required 
agencies to review their existing standards every five years and to 
replace through applicable procedures such standards that can be 
replaced with voluntary consensus standards. Several commentators 
suggested adding language that either requires agencies to review 
standards referenced in regulations on an annual basis or an ongoing 
basis. Other commentators proposed extending the review period to ten 
years (in order to mirror the review cycle of the Regulatory 
Flexibility Act) or to eliminate the review entirely because it was 
burdensome.
    We decided to change this requirement to one in which agencies are 
responsible for ``establishing a process for ongoing review of the 
agency's use of standards for purposes of updating such use.'' We 
decided that this approach will encourage agencies to review the large 
numbers of regulations which may reference obsolete and out-dated 
standards in a timely manner. Agencies are encouraged to undertake a 
review of their uses of obsolete or government-unique standards as soon 
as practicable.
    60. A commentator proposed language to require agencies to respond 
to requests from voluntary consensus standards bodies to replace 
existing federal standards, specifications, or regulations with 
voluntary consensus standards. This change is not necessary, because 
the Circular already requires agencies to establish a process for 
reviewing standards. (See comment 59.) We made no change.

Proposed Section 8. Final Section 11

    61. Several commentators suggested eliminating the requirement in 
the proposed Circular for an analysis of the use and non-use of 
voluntary consensus standards in both the Notice of Proposed Rulemaking 
(NPRM) and the final rule in order to simplify and clarify Federal 
Register notices. As an alternative, these commentators proposed 
including such analysis in a separate document that accompanies the 
NPRM and the subsequent final rule.
    We have decided that, rather than simplifying the rulemaking 
process, this change would make it more difficult for the public to 
comment on the rule and would complicate the process by adding another 
source of information in a separate location. However, we did make some 
minor changes to this section to clarify that agencies are not expected 
to provide an extensive report with each NPRM, Interim Final 
Rulemaking, or Final Rule. The section was also modified to improve the 
ability of agencies to identify voluntary consensus standards that 
could be used in their regulations, to ensure public

[[Page 8552]]

notice, and to minimize burden. First, the notice required in the NPRM 
may merely contain/include (1) a few sentences to identify the proposed 
standard, if any; and, if applicable, (2) a simple explanation of why 
the agency proposes to use a government-unique standard in lieu of a 
voluntary consensus standard. This step places the public on notice and 
gives them an opportunity to comment formally. Second, we expect that 
the majority of rulemakings will not reference standards at all. In 
these cases, the agency is not required to make a statement or to file 
a report. In those instances where an agency proposes a government-
unique standard, the public, through the public comment process, will 
have an opportunity to identify a voluntary consensus standard (when 
the agency was not aware of it) or to argue that the agency should have 
used the voluntary consensus standard (when the agency had identified 
one, but rejected it).
    62. Several commentators suggested adding a new section entitled 
``Sufficiency of Agency Search.'' The purpose of this new section would 
be to limit an agency's obligation to search for existing voluntary 
consensus standards under the requirements of this section. We have 
decided that this section is unnecessary in light of the requirements 
elsewhere in the Circular for identifying voluntary consensus 
standards. Accordingly, we made no change.
    63. One commentator suggested that agencies be required to fully 
investigate and review the intent and capabilities of a standard before 
making a decision to use a particular voluntary consensus standard. We 
have decided that the effort an agency would have to undertake to 
conduct its own scientific review of a voluntary, consensus standard is 
unnecessary, as SDOs adhere to lengthy and complex procedures which 
already closely scrutinize the uses and capabilities of a standard. 
However, in adopting a standard for use, whether in procurement or in 
regulation, agencies are already required to undertake the review under 
the Act and the Circular, as well as the review and analysis, described 
in other sources, such as the Federal Acquisition Regulation or the 
Executive Order 12866 on Regulatory Planning and Review. Accordingly, 
we made no change.
    64. A few commentators suggested that the Circular should ensure 
prompt notification to interested parties when voluntary consensus 
standards activities are about to begin and should encourage greater 
public participation in such activities. Another commentator noted a 
lack of clear procedures on how voluntary consensus standards bodies 
handle public comments and whether those comments are available to 
interested persons or organizations. OMB has determined that these 
responsibilities fall within the jurisdiction of voluntary consensus 
standards bodies and are outside the scope of the Act and the Circular. 
Accordingly, we made no change.

Proposed Section 8. Final Sections 6g and 12c

    65. A few commentators requested clarification on the use of 
``commercial-off-the-shelf'' (``COTS'') products as they relate to 
voluntary consensus standards. In response, we have clarified final 
section 6g to state that this policy does not establish preferences 
between products developed in the private sector. Final section 12c 
clarified that there is no reporting requirement for such products.

Proposed Section 9--Responsibilities. Final Sections 13, 14, 15

    66. Several commentators proposed that OMB have more defined 
oversight responsibility in determining whether an agency's 
participation in a voluntary consensus standards body is consistent 
with the Circular. We did not make this change. Agency Standards 
Executives, with the advice of the Chair of the ICSP, are responsible 
for ensuring that agencies are in compliance with the requirements of 
this Circular.
    With respect to the issue of ``agency dominance'' of SDOs, we 
expect that SDOs will likewise ensure that members abide by their rules 
of conduct and participation, working closely with Standards Executives 
where necessary and appropriate. We inserted minor clarifying language 
in new sections 13, 14, and 15.

Proposed 9b(2). Final Section 14c

    67. A commentator suggested broadening the category of agencies 
that must designate a standards executive, from designating those 
agencies with a ``significant interest'' in the use of standards, to 
those agencies having either ``regulatory or procurement'' 
responsibilities. We decided that this proposed change was vague and 
would only confuse the scope of the Circular. Accordingly, we made no 
change.

Proposed Section 10. Final Sections 9 and 10

    68. One commentator expressed concern that the reporting 
requirements would require agencies to report reliance on commercial-
off-the-shelf (COTS) products as a decision not to rely on voluntary 
consensus standards. The Act and the Circular do not limit agencies' 
abilities to purchase COTS or other products or services containing 
private sector standards. The Circular specifically excludes reporting 
of COTS procurements in final section 12, and final sections 9a and 12 
require agencies to report only when an agency uses a government-unique 
standard in lieu of an existing voluntary consensus standard. 
Accordingly, we made no change.

Proposed 10b --Agency Reports on Standards Policy Activities. Final 
Section 9b

    69. One commentator suggested that agencies also report the 
identity of standards development bodies whose standards the agency 
relies on and the identities of all the standards developed or used by 
such bodies. We have decided that it would be unnecessary, duplicative, 
and burdensome to require agencies to identify this level of detail in 
the annual report. The identity of individual standards developed by a 
standards body may be obtained either through the standards body or 
through a standards publishing company. In addition, agencies are 
already required to provide in their annual report, under section 
9b(1), the number of voluntary consensus standards bodies in which an 
agency participates. Moreover, each agency is required under section 
15b(5) to identify the standards bodies in which it is involved. 
Accordingly, we made no change.

Proposed 10b(3). Final Section 9b

    70. A commentator suggested that agencies should be required to 
identify federal regulations and procurement specifications in which 
the standards were ``withdrawn'' and replaced with voluntary consensus 
standards. We have decided that this requirement is unnecessary, 
because information is already provided in the annual report described 
in final section 9b(3). Accordingly, we made no change.

Proposed Section 11--Conformity Assessment. Final Section 8

    71. A commentator expressed concern that the coordination by the 
National Institute of Standards and Technology (NIST) of standards 
activities between the public and private sector will undermine the 
coordination that ANSI has performed for many years for the private 
sector.
    In addition, the commentator expressed concern that NIST's 
involvement in such coordination will undermine the United States' 
ability to

[[Page 8553]]

compete internationally as two organizations are coordinating standards 
developing activities instead of one. The Act states that NIST is to 
``coordinate Federal, State, and local technical standards activities 
and conformity assessment activities with private sector technical 
standards activities and conformity assessment activities.'' This 
language makes clear that NIST will have responsibility for 
coordinating only the public sector and for working with the private 
sector. In addition, ANSI's role is affirmed in the Memorandum Of 
Understanding (MOU) issued on July 24, 1995, between NIST and ANSI. The 
MOU states ``[t]his MOU is intended to facilitate and strengthen the 
influence of ANSI and the entire U.S. standards community at the 
international level * * * and ensure that ANSI's representation of U.S. 
interests is respected by the other players on the international 
scene.'' Thus, we made no change.
    Accordingly, OMB Circular A-119 is revised as set forth below.
Sally Katzen,
Administrator, Office of Information and Regulatory Affairs.

EXECUTIVE OFFICE OF THE PRESIDENT

Office of Management and Budget

Washington, D.C. 20503

February 10, 1998.

Circular No. A-119

Revised

Memorandum for Heads of Executive Departments and Agencies

Subject: Federal Participation in the Development and Use of 
Voluntary Consensus Standards and in Conformity Assessment 
Activities

    Revised OMB Circular A-119 establishes policies on Federal use 
and development of voluntary consensus standards and on conformity 
assessment activities. Pub. L. 104-113, the ``National Technology 
Transfer and Advancement Act of 1995,'' codified existing policies 
in A-119, established reporting requirements, and authorized the 
National Institute of Standards and Technology to coordinate 
conformity assessment activities of the agencies. OMB is issuing 
this revision of the Circular in order to make the terminology of 
the Circular consistent with the National Technology Transfer and 
Advancement Act of 1995, to issue guidance to the agencies on making 
their reports to OMB, to direct the Secretary of Commerce to issue 
policy guidance for conformity assessment, and to make changes for 
clarity.
Franklin D. Raines,
Director.

Attachment

EXECUTIVE OFFICE OF THE PRESIDENT

Office of Management and Budget

Washington, D.C. 20503

February 10, 1998.

Circular No. A-119

Revised

To the Heads of Executive Departments and Establishments

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?
    2. What Are The Goals Of The Government Using Voluntary 
Consensus Standards?

DEFINITIONS OF STANDARDS

    3. What Is A Standard?
    4. What Are Voluntary, Consensus Standards?
    a. Definition of voluntary, consensus standard.
    (1) Definition of voluntary, consensus standards body.
    b. Other types of standards.
    (1) Non-consensus standards, industry standards, company 
standards, or de facto standards.
    (2) Government-unique standards.
    (3) Standards mandated by law.

POLICY

    5. Who Does This Policy Apply To?
    6. What Is The Policy For Federal Use Of Standards?
    a. When must my agency use voluntary consensus standards?
    (1) Definition of ``Use.''
    (2) Definition of ``Impractical.''
    b. What must my agency do when such use is determined by my 
agency to be inconsistent with applicable law or otherwise 
impractical?
    c. How does this policy affect my agency's regulatory 
authorities and responsibilities?
    d. How does this policy affect my agency's procurement 
authority?
    e. What are the goals of agency use of voluntary consensus 
standards?
    f. What considerations should my agency make when it is 
considering using a standard?
    g. Does this policy establish a preference between consensus and 
non-consensus standards that are developed in the private sector?
    h. Does this policy establish a preference between domestic and 
international voluntary consensus standards?
    i. Should my agency give preference to performance standards?
    j. How should my agency reference voluntary consensus standards?
    k. What if no voluntary consensus standard exists?
    l. How may my agency identify voluntary consensus standards?
    7. What Is The Policy For Federal Participation In Voluntary 
Consensus Standards Bodies?
    a. What are the purposes of agency participation?
    b. What are the general principles that apply to agency support?
    c. What forms of support may my agency provide?
    d. Must agency participants be authorized?
    e. Does agency participation indicate endorsement of any 
decisions reached by voluntary consensus standards bodies?
    f. Do agency representatives participate equally with other 
members?
    g. Are there any limitations on participation by agency 
representatives?
    h. Are there any limits on the number of federal participants in 
voluntary consensus standards bodies?
    i. Is there anything else agency representatives should know?
    j. What if a voluntary consensus standards body is likely to 
develop an acceptable, needed standard in a timely fashion?
    8. What Is The Policy On Conformity Assessment?

Management and Reporting of Standards Use

    9. What Is My Agency Required To Report?
    10. How Does My Agency Manage And Report On Its Development and 
Use Of Standards?
    11. What Are The Procedures For Reporting My Agency's Use Of 
Standards In Regulations?
    12. 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

    13. What Are The Responsibilities Of The Secretary Of Commerce?
    14. What Are The Responsibilities Of The Heads Of Agencies?
    15. What Are The Responsibilities Of Agency Standards 
Executives?

Supplementary Information

    16. When Will This Circular Be Reviewed?
    17. What Is The Legal Effect Of This Circular?
    18. Do You Have Further Questions?

Background

    1. What Is The Purpose Of This Circular?
    This Circular establishes policies to improve the internal 
management of the Executive Branch. Consistent with Section 12(d) of 
Pub. L. 104-113, the ``National Technology Transfer and Advancement Act 
of 1995'' (hereinafter ``the Act''), this Circular directs agencies to 
use voluntary consensus standards in lieu of government-unique 
standards except where inconsistent with law or otherwise impractical. 
It also provides guidance for agencies participating in voluntary 
consensus standards bodies and describes procedures for satisfying

[[Page 8554]]

the reporting requirements in the Act. The policies in this Circular 
are intended to reduce to a minimum the reliance by agencies on 
government-unique standards. These policies do not create the bases for 
discrimination in agency procurement or regulatory activities among 
standards developed in the private sector, whether or not they are 
developed by voluntary consensus standards bodies. Consistent with 
Section 12(b) of the Act, this Circular directs the Secretary of 
Commerce to issue guidance to the agencies in order to coordinate 
conformity assessment activities. This Circular replaces OMB Circular 
No. A-119, dated October 20, 1993.
    2. What Are The Goals Of The Government In Using Voluntary 
Consensus Standards?
    Many voluntary consensus standards are appropriate or adaptable for 
the Government's purposes. The use of such standards, whenever 
practicable and appropriate, is intended to achieve the following 
goals:
    a. Eliminate the cost to the Government of developing its own 
standards and decrease the cost of goods procured and the burden of 
complying with agency regulation.
    b. Provide incentives and opportunities to establish standards that 
serve national needs.
    c. Encourage long-term growth for U.S. enterprises and promote 
efficiency and economic competition through harmonization of standards.
    d. Further the policy of reliance upon the private sector to supply 
Government needs for goods and services.

Definitions of Standards

    3. What Is A Standard?
    a. The term standard, or technical standard as cited in the Act, 
includes all of the following:
    (1) Common and repeated use of rules, conditions, guidelines or 
characteristics for products or related processes and production 
methods, and related management systems practices.
    (2) The definition of terms; classification of components; 
delineation of procedures; specification of dimensions, materials, 
performance, designs, or operations; measurement of quality and 
quantity in describing materials, processes, products, systems, 
services, or practices; test methods and sampling procedures; or 
descriptions of fit and measurements of size or strength.
    b. The term standard does not include the following:
    (1) Professional standards of personal conduct.
    (2) Institutional codes of ethics.
    c. Performance standard is a standard as defined above that states 
requirements in terms of required results with criteria for verifying 
compliance but without stating the methods for achieving required 
results. A performance standard may define the functional requirements 
for the item, operational requirements, and/or interface and 
interchangeability characteristics. A performance standard may be 
viewed in juxtaposition to a prescriptive standard which 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.
    d. Non-government standard is a standard as defined above that is 
in the form of a standardization document developed by a private sector 
association, organization or technical society which plans, develops, 
establishes or coordinates standards, specifications, handbooks, or 
related documents.
    4. What Are Voluntary, Consensus Standards?
    a. For purposes of this policy, voluntary consensus standards are 
standards developed or adopted by voluntary consensus standards bodies, 
both domestic and international. These standards include provisions 
requiring that owners of relevant intellectual property have agreed to 
make that intellectual property available on a non-discriminatory, 
royalty-free or reasonable royalty basis to all interested parties. For 
purposes of this Circular, ``technical standards that are developed or 
adopted by voluntary consensus standard bodies'' is an equivalent term.
    (1) Voluntary consensus standards bodies are domestic or 
international organizations which plan, develop, establish, or 
coordinate voluntary consensus standards using agreed-upon procedures. 
For purposes of this Circular, ``voluntary, private sector, consensus 
standards bodies,'' as cited in Act, is an equivalent term. The Act and 
the Circular encourage the participation of federal representatives in 
these bodies to increase the likelihood that the standards they develop 
will meet both public and private sector needs. A voluntary consensus 
standards body is defined by the following attributes:
    (i) Openness.
    (ii) Balance of interest.
    (iii) Due process.
    (vi) An appeals process.
    (v) Consensus, which is defined as general agreement, but not 
necessarily unanimity, and includes a process for attempting to resolve 
objections by interested parties, as long as all comments have been 
fairly considered, each objector is advised of the disposition of his 
or her objection(s) and the reasons why, and the consensus body members 
are given an opportunity to change their votes after reviewing the 
comments.
    b. Other types of standards, which are distinct from voluntary 
consensus standards, are the following:
    (1) ``Non-consensus standards,'' ``Industry standards,'' ``Company 
standards,'' or ``de facto standards,'' which are developed in the 
private sector but not in the full consensus process.
    (2) ``Government-unique standards,'' which are developed by the 
government for its own uses.
    (3) Standards mandated by law, such as those contained in the 
United States Pharmacopeia and the National Formulary, as referenced in 
21 U.S.C. 351.

Policy

    5. Who Does This Policy Apply To?
    This Circular applies to all agencies and agency employees who use 
standards and participate in voluntary consensus standards activities, 
domestic and international, except for activities carried out pursuant 
to treaties. ``Agency'' means any executive department, independent 
commission, board, bureau, office, agency, 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.
    6. What Is The Policy For Federal Use Of Standards?
    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 to the Office of Management and 
Budget (OMB) through the National Institute of Standards and Technology 
(NIST).
    a. When must my agency use voluntary consensus standards?
    Your agency must use voluntary consensus standards, both domestic 
and international, in its regulatory and procurement activities in lieu 
of government-unique standards, unless use of such standards would be

[[Page 8555]]

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.
    (1) ``Use'' means incorporation of a standard in whole, in part, or 
by reference for procurement purposes, and the inclusion of a standard 
in whole, in part, or by reference in regulation(s).
    (2) ``Impractical'' includes circumstances in which such use would 
fail to serve the agency's program needs; would be infeasible; would be 
inadequate, ineffectual, inefficient, or inconsistent with agency 
mission; or would impose more burdens, or would be less useful, than 
the use of another standard.
    b. What must my agency do when such use is determined by my agency 
to be inconsistent with applicable law or otherwise impractical?
    The head of your agency must transmit to the Office of Management 
and Budget (OMB), through the National Institute of Standards and 
Technology (NIST), an explanation of the reason(s) for using 
government-unique standards in lieu of voluntary consensus standards. 
For more information on reporting, see section 9.
    c. 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; setting the level of protection; and 
balancing risk, cost, and availability of technology in establishing 
regulatory standards. However, to determine whether established 
regulatory limits or targets have been met, agencies should use 
voluntary consensus standards for test methods, sampling procedures, or 
protocols.
    d. 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 limits an agency's authority 
to pursue an identified capability through reliance on a government-
unique standard when a voluntary consensus standard exists (see Section 
6a).
    e. What are the goals of agency use of voluntary consensus 
standards?
    Agencies should recognize the positive contribution of standards 
development and related activities. When properly conducted, standards 
development can increase productivity and efficiency in Government and 
industry, expand opportunities for international trade, conserve 
resources, improve health and safety, and protect the environment.
    f. What considerations should my agency make when it is considering 
using a standard?
    When considering using a standard, your agency should take full 
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, and conflicts 
of interest. Your agency should also recognize that use of standards, 
if improperly conducted, can suppress free and fair competition; impede 
innovation and technical progress; exclude safer or less expensive 
products; or otherwise adversely affect trade, commerce, health, or 
safety. If your agency is proposing to incorporate a standard into a 
proposed or final rulemaking, your agency must comply with the 
``Principles of Regulation'' (enumerated in Section 1(b)) and with the 
other analytical requirements of Executive Order 12866, ``Regulatory 
Planning and Review.''
    g. Does this policy establish a preference between consensus and 
non-consensus standards that are developed in the private sector?
    This policy does not establish a preference among standards 
developed in the private sector. Specifically, agencies that promulgate 
regulations referencing non-consensus standards developed in the 
private sector are not required to report on these actions, and 
agencies that procure products or services based on non-consensus 
standards are not required to report on such procurements. For example, 
this policy allows agencies to select a non-consensus standard 
developed in the private sector as a means of establishing testing 
methods in a regulation and to choose among commercial-off-the-shelf 
products, regardless of whether the underlying standards are developed 
by voluntary consensus standards bodies or not.
    h. Does this policy establish a preference between domestic and 
international voluntary consensus standards?
    This policy does not establish a preference between domestic and 
international voluntary consensus standards. However, in the interests 
of promoting trade and implementing the provisions of international 
treaty agreements, your agency should consider international standards 
in procurement and regulatory applications.
    i. Should my agency give preference to performance standards?
    In using voluntary consensus standards, your agency should give 
preference to performance standards when such standards may reasonably 
be used in lieu of prescriptive standards.
    j. How should my agency reference voluntary consensus standards?
    Your agency should reference voluntary consensus standards, along 
with sources of availability, in appropriate publications, regulatory 
orders, and related internal documents. In regulations, the reference 
must include the date of issuance. For all other uses, your agency must 
determine the most appropriate form of reference, which may exclude the 
date of issuance as long as users are elsewhere directed to the latest 
issue. If a voluntary standard is used and published in an agency 
document, your agency must observe and protect the rights of the 
copyright holder and any other similar obligations.
    k. What if no voluntary consensus standard exists?
    In cases where no voluntary consensus standards exist, an agency 
may use government-unique standards (in addition to other standards, 
see Section 6g) and is not required to file a report on its use of 
government-unique standards. As explained above (see Section 6a), an 
agency may use government-unique standards in lieu of voluntary 
consensus standards if the use of such standards would be inconsistent 
with applicable law or otherwise impractical; in such cases, the agency 
must file a report under Section 9a regarding its use of government-
unique standards.
    l. How may my agency identify voluntary consensus standards?
    Your agency may identify voluntary consensus standards through 
databases of standards maintained by the National Institute of 
Standards and Technology (NIST), or by other organizations including 
voluntary consensus standards bodies, other federal agencies, or 
standards publishing companies.
    7. What Is The Policy For Federal Participation In Voluntary 
Consensus Standards Bodies?
    Agencies must consult with voluntary consensus standards bodies, 
both domestic and international, and must participate with such bodies 
in the development of voluntary consensus standards when consultation 
and participation is in the public interest

[[Page 8556]]

and is compatible with their missions, authorities, priorities, and 
budget resources.
    a. What are the purposes of agency participation?
    Agency representatives should participate in voluntary consensus 
standards activities in order to accomplish the following purposes:
    (1) Eliminate the necessity for development or maintenance of 
separate Government-unique standards.
    (2) Further such national goals and objectives as increased use of 
the metric system of measurement; use of environmentally sound and 
energy efficient materials, products, systems, services, or practices; 
and improvement of public health and safety.
    b. What are the general principles that apply to agency support?
    Agency support provided to a voluntary consensus standards activity 
must be limited to that which clearly furthers agency and departmental 
missions, authorities, priorities, and is consistent with budget 
resources. Agency support must not be contingent upon the outcome of 
the standards activity. Normally, the total amount of federal support 
should be no greater than that of other participants in that activity, 
except when it is in the direct and predominant interest of the 
Government to develop or revise a standard, and its timely development 
or revision appears unlikely in the absence of such support.
    c. What forms of support may my agency provide?
    The form of agency support, may include the following:
    (1) Direct financial support; e.g., grants, memberships, and 
contracts.
    (2) Administrative support; e.g., travel costs, hosting of 
meetings, and secretarial functions.
    (3) Technical support; e.g., cooperative testing for standards 
evaluation and participation of agency personnel in the activities of 
voluntary consensus standards bodies.
    (4) Joint planning with voluntary consensus standards bodies to 
promote the identification and development of needed standards.
    (5) Participation of agency personnel.
    d. Must agency participants be authorized?
    Agency employees who, at Government expense, participate in 
standards activities of voluntary consensus standards bodies on behalf 
of the agency must do so as specifically authorized agency 
representatives. Agency support for, and participation by agency 
personnel in, voluntary consensus 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 employees (whether or not on 
behalf of the agency) in the activities of voluntary consensus 
standards bodies is subject to the laws and regulations that apply to 
participation by federal employees in the activities of outside 
organizations. While we anticipate that participation in a committee 
that is developing a standard would generally not raise significant 
issues, participation as an officer, director, or trustee of an 
organization would raise more significant issues. An agency should 
involve its agency ethics officer, as appropriate, before authorizing 
support for or participation in a voluntary consensus standards body.
    e. Does agency participation indicate endorsement of any decisions 
reached by voluntary consensus standards bodies?
    Agency participation in voluntary consensus standards bodies does 
not necessarily connote agency agreement with, or endorsement of, 
decisions reached by such organizations.
    f. Do agency representatives participate equally with other 
members?
    Agency representatives serving as members of voluntary consensus 
standards bodies should participate actively and on an equal basis with 
other members, consistent with the procedures of those 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, serving as chairpersons or in other official 
capacities. Agency representatives may vote, in accordance with the 
procedures of the voluntary consensus standards body, at each stage of 
the standards development process unless prohibited from doing so by 
law or their agencies.
    g. Are there any limitations on participation by agency 
representatives?
    In order to maintain the independence of voluntary consensus 
standards bodies, agency representatives must refrain from involvement 
in the internal management of such organizations (e.g., selection of 
salaried officers and employees, establishment of staff salaries, and 
administrative policies). Agency representatives must not dominate such 
bodies, and in any case are bound by voluntary consensus standards 
bodies' rules and procedures, including those regarding domination of 
proceedings by any individual. Regardless, such agency employees must 
avoid the practice or the appearance of undue influence relating to 
their agency representation and activities in voluntary consensus 
standards bodies.
    h. Are there any limits on the number of federal participants in 
voluntary consensus standards bodies?
    The number of individual agency participants in a given voluntary 
standards activity should be kept to the minimum required for effective 
representation of the various program, technical, or other concerns of 
federal agencies.
    i. Is there anything else agency representatives should know?
    This Circular does not provide guidance concerning the internal 
operating procedures that may be applicable to voluntary consensus 
standards bodies because of their relationships to agencies under this 
Circular. Agencies should, however, carefully consider what laws or 
rules may apply in a particular instance because of these 
relationships. For example, these relationships may involve the Federal 
Advisory Committee Act, as amended (5 U.S.C. App. I), or a provision of 
an authorizing statute for a particular agency.
    j. What if a voluntary consensus standards body is likely to 
develop an acceptable, needed standard in a timely fashion?
    If a voluntary consensus standards body is in the process of 
developing or adopting a voluntary consensus standard that would likely 
be lawful and practical for an agency to use, and would likely be 
developed or adopted on a timely basis, an agency should not be 
developing its own government-unique standard and instead should be 
participating in the activities of the voluntary consensus standards 
body.
    8. What Is The Policy On Conformity Assessment?
    Section 12(b) of the Act requires NIST to coordinate Federal, 
State, and local standards activities and conformity assessment 
activities with private sector standards activities and conformity 
assessment activities, with the goal of eliminating unnecessary 
duplication and complexity in the development and promulgation of 
conformity assessment requirements and measures. To ensure effective 
coordination, the Secretary of Commerce must issue guidance to the 
agencies.

Management and Reporting of Standards Use

    9. What Is My Agency Required to Report?

[[Page 8557]]

    a. As required by the Act, 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. If no voluntary consensus standard 
exists, your agency does not need to report its use of government-
unique standards. (In addition, an agency is not required to report on 
its use of other standards. See Section 6g.) Your agency must include 
an explanation of the reason(s) why use of such voluntary consensus 
standard would be inconsistent with applicable law or otherwise 
impractical, as described in Sections 11b(2), 12a(3), and 12b(2) of 
this Circular. Your agency must report in accordance with format 
instructions issued by NIST.
    b. Your agency must report to NIST, no later than December 31 of 
each year, information on the nature and extent of agency participation 
in the development and use of voluntary consensus standards from the 
previous fiscal year. Your agency must report in accordance with format 
instructions issued by NIST. Such reporting must include the following:
    (1) The number of voluntary consensus standards bodies in which 
there is agency participation, as well as the number of agency 
employees participating.
    (2) The number of voluntary consensus standards the agency has used 
since the last report, based on the procedures set forth in sections 11 
and 12 of this Circular.
    (3) Identification of voluntary consensus standards that have been 
substituted for government-unique standards as a result of an agency 
review under section 15b(7) of this Circular.
    (4) An evaluation of the effectiveness of this policy and 
recommendations for any changes.
    c. No later than the following January 31, NIST must transmit to 
OMB a summary report of the information received.
    10. How Does My Agency Manage And Report Its Development and Use Of 
Standards?
    Your agency must establish a process to identify, manage, and 
review your agency's development and use of standards. At minimum, your 
agency must have the ability to (1) report to OMB through NIST on the 
agency's use of government-unique standards in lieu of voluntary 
consensus standards, along with an explanation of the reasons for such 
non-usage, as described in section 9a, and (2) report on your agency's 
participation in the development and use of voluntary consensus 
standards, as described in section 9b. 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 all uses of standards in one or both ways.
    11. What Are The Procedures For Reporting My Agency's Use Of 
Standards In Regulations?
    Your agency should use transaction based reporting 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 
must follow these procedures:
    a. Publish a request for comment within the preamble of a Notice of 
Proposed Rulemaking (NPRM) or Interim Final Rule (IFR). Such request 
must provide the appropriate information, as follows:
    (1) When your agency is proposing to use a voluntary consensus 
standard, provide a statement which identifies such standard.
    (2) When your agency is proposing to use a government-unique 
standard in lieu of a voluntary consensus standard, provide a statement 
which identifies such standards and provides a preliminary explanation 
for the proposed use of a government-unique standard in lieu of a 
voluntary consensus standard.
    (3) When your agency is proposing to use a government-unique 
standard, and no voluntary consensus standard has been identified, a 
statement to that effect and an invitation to identify any such 
standard and to explain why such standard should be used.
    b. Publish a discussion in the preamble of a Final Rulemaking that 
restates the statement in the NPRM or IFR, acknowledges and summarizes 
any comments received and responds to them, and explains the agency's 
final decision. This discussion must provide the appropriate 
information, as follows:
    (1) When a voluntary consensus standard is being used, provide a 
statement that identifies such standard and any alternative voluntary 
consensus standards which have been identified.
    (2) When a government-unique standard is being used in lieu of a 
voluntary consensus standard, provide a statement that identifies the 
standards and explains why using the voluntary consensus standard would 
be inconsistent with applicable law or otherwise impractical. Such 
explanation must be transmitted in accordance with the requirements of 
Section 9a.
    (3) When a government-unique standard is being used, and no 
voluntary consensus standard has been identified, provide a statement 
to that effect.
    12. What Are The Procedures For Reporting My Agency's Use Of 
Standards In Procurements?
    To identify, manage, and review the standards used in your agency's 
procurements, your agency must either report on a categorical basis or 
on a transaction basis.
    a. How does my agency report the use of standards in procurements 
on a categorical basis?
    Your agency must report on a category basis 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 which require replacement parts based on 
government-unique standards. To report use of government-unique 
standards on a categorical basis, your agency must:
    (1) Maintain a centralized standards management system that 
identifies how your agency uses both government-unique and voluntary 
consensus standards.
    (2) Systematically review your agency's use of government-unique 
standards for conversion to voluntary consensus standards.
    (3) Maintain records on the groups or categories in which your 
agency uses government-unique standards in lieu of voluntary consensus 
standards, including an explanation of the reasons for such use, which 
must be transmitted according to Section 9a.
    (4) Enable potential offerors to suggest voluntary consensus 
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 mostly through 
commercial products and services, but is occasionally 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:
    (1) In each solicitation which references government-unique 
standards, the solicitation must:
    (i) Identify such standards.

[[Page 8558]]

    (ii) Provide potential offerors an opportunity to suggest 
alternative voluntary consensus standards that meet the agency's 
requirements.
    (2) 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 report to OMB as described in Section 9a 
why using such voluntary consensus standards is inconsistent with 
applicable law or otherwise impractical.
    c. For those solicitations that are for commercial-off-the-shelf 
products (COTS), or for products or services that rely on voluntary 
consensus standards or non-consensus standards developed in the private 
sector, or for products that otherwise do not rely on government-unique 
standards, the requirements in this section do not apply.

Agency Responsibilities

    13. 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 Interagency Committee on Standards 
Policy (ICSP), chaired by the National Institute of Standards and 
Technology, 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.
    d. Establishes procedures for agencies to use when developing 
directories described in Section 15b(5) and establish procedures to 
make these directories available to the public.
    e. Issues guidance to the agencies to improve coordination on 
conformity assessment in accordance with section 8.
    14. What Are The Responsibilities Of The Heads Of Agencies?
    The Heads of Agencies:
    a. Implement the policies of this Circular in accordance with 
procedures described.
    b. Ensure agency compliance with the policies of the Circular.
    c. In the case of an agency with significant interest in the use of 
standards, designate a senior level official as the Standards Executive 
who will be responsible for the agency's implementation of this 
Circular and who will represent the agency on the ICSP.
    d. Transmit the annual report prepared by the Agency Standards 
Executive as described in Sections 9 and 15b(6).
    15. What Are The Responsibilities Of Agency Standards Executives?
    An Agency Standards Executive:
    a. Promotes the following goals:
    (1) Effective use of agency resources and participation.
    (2) The development of agency positions that are in the public 
interest and that do not conflict with each other.
    (3) The development of agency positions that are consistent with 
administration policy.
    (4) The development of agency technical and policy positions that 
are clearly defined and known in advance to all federal participants on 
a given committee.
    b. Coordinates his or her agency's participation in voluntary 
consensus standards bodies by:
    (1) Establishing procedures to ensure that agency representatives 
who participate in voluntary consensus standards bodies will, to the 
extent possible, ascertain the views of the agency on matters of 
paramount interest and will, at a minimum, express views that are not 
inconsistent or in conflict with established agency views.
    (2) To the extent possible, ensuring that the agency's 
participation in voluntary consensus standards bodies is consistent 
with agency missions, authorities, priorities, and budget resources.
    (3) Ensuring, when two or more agencies participate in a given 
voluntary consensus standards activity, that they coordinate their 
views on matters of paramount importance so as to present, whenever 
feasible, a single, unified position and, where not feasible, a mutual 
recognition of differences.
    (4) Cooperating with the Secretary in carrying out his or her 
responsibilities under this Circular.
    (5) Consulting with the Secretary, as necessary, in the development 
and issuance of internal agency procedures and guidance implementing 
this Circular, including the development and implementation of an 
agency-wide directory identifying agency employees participating in 
voluntary consensus standards bodies and the identification of 
voluntary consensus standards bodies.
    (6) Preparing, as described in Section 9, 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.
    (7) Establishing a process for ongoing review of the agency's use 
of standards for purposes of updating such use.
    (8) 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, voluntary 
consensus standards bodies, so that agency support and participation 
will comply with applicable laws and regulations.

Supplementary Information

    16. When Will This Circular Be Reviewed?
    This Circular will be reviewed for effectiveness by the OMB three 
years from the date of issuance.
    17. What Is The Legal Effect Of This Circular?
    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 Public Law 104-113 and to establish policies that will improve 
the internal management of the Executive Branch. This Circular is not 
intended to create delay in the administrative process, 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.
    18. Do You Have Further Questions?
    For information concerning this Circular, contact the Office of 
Management and Budget, Office of Information and Regulatory Affairs: 
Telephone 202/395-3785.

[FR Doc. 98-4177 Filed 2-18-98; 8:45 am]
BILLING CODE 3110-01-P