federal register

8545

Thursday

February 19, 1998

Part IV

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; Notice
8546 Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices

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
Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices 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
8548 Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices

version might imply that other-thanconsensus 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 ‘‘governmentunique’’ 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
Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices 8549

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 missionrelated 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
8550 Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices

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
Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices 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 outdated 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
8552 Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices

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 ‘‘commercialoff-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
Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices 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
8554 Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices

the reporting requirements in the Act.

The policies in this Circular are

intended to reduce to a minimum the

reliance by agencies on governmentunique 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 nondiscriminatory, 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
Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices 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 nonconsensus 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 nonconsensus 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
8556 Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices

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 governmentunique 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?
Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices 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 governmentunique 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 governmentunique 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 governmentunique 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 governmentunique 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.
8558 Federal Register / Vol. 63, No. 33 /Thursday, February 19, 1998 / Notices

(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 governmentunique 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 governmentunique 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 governmentunique 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]

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