[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]
[[Page 8545]]
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Part IV
Executive Office of the President
_______________________________________________________________________
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.
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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
[[Page 8548]]
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
