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]

BILLING CODE 3110–01–P

2

The present report describes NIST’s coordination activities, with special emphasis on

implementing NTTAA and the activities of the ICSP, including an overview of standards policy

coordination, related external events, compliance with NTTAA, and future courses of action. 

The reports submitted to NIST by other Federal departments and agencies are appended, along

with the recently revised charter of the Interagency Committee on Standards Policy, a list of

members of the Interagency Committee on Standards Policy, and NIST publications related to

P.L. 104-113. The agency reports, with minimal or no editing and formatting, are in Appendix A

for Cabinet level departments and Appendix B for independent agencies, the Executive Office of

the President, and one legislative branch agency. Information was not available from all agencies

due to institutional reorganizations and personnel changes. Moreover, some agencies simply

had little to report or were not directly involved in standardization.

The NTTAA requires new agency information on requirements regarding the status of its

implementation activities. The agency data collected here reflects the shift in required reporting

(data on number of agency participants in voluntary standards bodies, voluntary standards used

and number of voluntary standards substituted for government-unique standards, and information

regarding agency use of "government-unique standards"). In contrast to these new requirements,

reported in Table 1, the current Circular (i.e., the October 20, 1993, version) requested

information of a similar but somewhat different nature. That information included: number of

agency employees participating in at least one standards-developing group; number of voluntary

standards adopted from participating in such groups; number of existing standards replaced as a

result of the five-year review cycle; and identification of voluntary standards that promote

environmentally-sound and energy-efficient principles.

The summary data provided by agencies indicate significant changes in the numbers of Federal

employees participating in voluntary standards bodies, a matter of grave concern for Federal

policy makers. Table 1 presents a significant decrease from the more than 5200 Federal

participants reported in 1996 to less than 3300 reported in 1997. The striking decrease was

particularly apparent in a number of agencies, including the Departments of Commerce, Defense

(DOD), Health and Human Services, Transportation and Treasury, and such independent

agencies as the Federal Communications Commission and Environmental Protection Agency,

and may have been due to agency downsizing and retirements. At the same time, modest

increases were noted at the Departments of Energy (DOE), Interior, and Veterans Affairs,

General Services Administration and National Aeronautics and Space Administration. 

Moreover, agencies reported the development of very few agency-specific standards, while

noting a markedly increased use of voluntary standards. In particular, DOD has now adopted

7257 voluntary standards, while DOE has adopted 809, many in the last year.

Thus, agencies have successfully initiated the shift to greater use of voluntary standards, with an

accompanying decrease in the development of new agency-specific standards. At the same time,

the dramatic decrease in the number of Federal participants in voluntary standards committees is

a major concern since Federal input to the standards process is likely to become less effective. 
3

Introduction

The October 20, 1993, Office of Management and Budget (OMB) revised Circular A-119,

"Federal Participation in the Development and Use of Voluntary Standards," establishes a policy

for all Federal executive branch agencies concerning the use of voluntary standards and

participation of Federal employees in their development. It sets forth ". . .the policy of the

Federal Government in its procurement and regulatory activities to rely on voluntary standards,

both domestic and international, whenever feasible and consistent with the law and regulation

pursuant to the law." Voluntary standards should be adopted and used by Federal agencies ". . .in

the interests of greater economy and efficiency" and should be given preference over nonmandatory government standards unless use of such voluntary standards would adversely affect

performance or cost, reduce competition, or have other significant disadvantages.

The Circular encourages Federal agency employees to participate when voluntary standards

activities ". . .are in the public interest, and when it is compatible with the agency’s missions,

authorities, priorities, and budget resources." Participation should be aimed at contributing to the

development of voluntary standards that will eliminate the need to develop and maintain separate

government standards.

The Circular requires coordination of agency participation so that: (1) the most effective use is

made of agency resources and representatives; and (2) the views expressed by those

representatives are in the public interest and, at a minimum, do not conflict with the interests and

established views of the agencies. Agencies must establish procedures to ensure that their

representatives who participate in voluntary standards activities comply with the requirement to

coordinate agency views.

The Circular provides a policy statement with strengthened administrative guidance to Federal

agencies on using domestic and international voluntary standards for procurement and regulatory

purposes, on further improving interaction with private sector organizations to develop such

standards, and coordinating Executive Branch responsibilities for participation in the

development of voluntary standards. To achieve these goals each agency has designated a

standards executive to provide agency leadership on standards policy issues with agency-wide

responsibilities for implementing the Circular. The Circular also requires improved agency

accountability, coordination, and recognition of trade policy objectives, along with World Trade

Organization standards code obligations in the treatment of standards by Federal agencies. It

requires significant changes in agency administration, adoption, utilization and reporting of

standards-related activities to implement the Circular, as well as increases the responsibility of

the Secretary of Commerce for Executive Branch implementation.
4

National Technology Transfer and Advancement Act

The National Technology Transfer and Advancement Act (NTTAA), P.L. 104-113, directs NIST

to provide public sector leadership in standards and conformity assessment and to work with

other Federal, state, and local agencies and the private sector to support the creation and

maintenance of a sound technical infrastructure for standards and conformity assessment

activities for the United States. 

NIST activities for implementing P.L. 104-113 are largely the responsibility of the Office of

Standards Services (OSS). The Director of OSS chairs the Interagency Committee on Standards

Policy (ICSP) on behalf of the NIST Director and the Secretary of Commerce, and uses the ICSP

as the primary vehicle for coordinating Federal activities under the NTTAA and Circular. NIST

develops few agency-unique standards for either procurement or regulation purposes, but plays a

major role in standards-related technical and policy-related activities, as directed by both the

Circular and NTTAA. 

Coordination of Agency Activity

The ICSP was established in 1968 to encourage coordination and liaison among Federal agencies

on matters related to standards. In 1992, the Secretary of Commerce reconstituted the ICSP to

provide the required "interagency consultative mechanism to advise the Secretary and agency

heads in implementing the policy." In October 1997, the Secretary of Commerce approved a new

Charter for the ICSP, attached as Appendix C, with similar goals.

The ICSP is currently composed of representatives of the 14 Federal Cabinet departments,

11 independent Federal agencies and, three offices in the Executive Office of the President. 

NIST provides the Chair and the Secretariat for the ICSP.

Representatives on the ICSP are from:

Cabinet Departments

- Department of Agriculture (USDA)

- Department of Commerce (DOC)

- Department of Defense (DOD)

- Department of Education (DOEd)

- Department of Energy (DOE)

- Department of Health and Human Services (HHS)

- Department of Housing and Urban Development (HUD)

- Department of Interior (DOI)

- Department of Justice (DOJ)

- Department of Labor (DOL)

- Department of State (DOS)
5

- Department of Transportation (DOT)

- Department of Treasury (TREASURY)

- Department of Veterans Affairs (VA)

Independent Agencies

- Consumer Product Safety Commission (CPSC)

- Environmental Protection Agency (EPA)

- Federal Communications Commission (FCC)

- Federal Emergency Management Agency (FEMA)

- Federal Trade Commission (FTC)

- General Services Administration (GSA)

- International Trade Commission (ITC)

- National Aeronautics and Space Administration (NASA)

- National Archives and Records Administration (ARCHIVES)

- National Science Foundation (NSF)

- Nuclear Regulatory Commission (NRC)

- U.S. Postal Service (USPS)

- U.S. Agency for International Development (USAID)

Executive Office of the President

- Office of Management and Budget (OMB)

- Office of the United States Trade Representative (USTR)

- Office of Consumer Affairs (USOCA)

The ICSP membership roster is given in Appendix D.

ICSP Activities During 1997

The ICSP addressed issues to stimulate implementation activities within and among Federal

agencies in a series of six meetings in FY 1997.

ICSP meetings focused on such topics as revision of the OMB Circular A-119, strategic

standards management, effective participation in standards committees, updating regulatory

references to out-of-date standards, and information resources available to agencies. Several

agencies including NRC, HUD, and DOE described agency processes for coordinating activities

both internally and externally. Several ICSP meetings also included presentations by private

sector bodies such as the American Society for Testing and Materials (ASTM), the American

National Standards Institute (ANSI), Council of American Building Officials (CABO), ACIL

(formerly the American Council of Independent Laboratories), Underwriters Laboratories (UL),

and others. As a result of the ICSP meetings, EPA and ASTM met subsequently to develop and

implement procedures for updating EPA references to out-of-date ASTM standards. 
2

International Organization for Standardization

6

During 1997, OSS served as secretariat for the five working groups of the ICSP in which specific

topics such as ISO2 9000, ISO 14000, laboratory accreditation, standards information and

directories, and regulatory issues were addressed to meet Federal needs. Specific ICSP work

activities were carried out by ICSP Working Groups with participants designated by ICSP

representatives. These activities are described below.

1. Working Group on Regulatory Agencies. The Working Group is composed of

representatives from Federal regulatory agencies which identify areas of mutual interest,

serve as a forum for information exchange, and bring agencies together on activities of

common concern. During FY 1997, the Working Group provided revisions to the OMB

Circular A-119 to meet particular regulatory needs and developed plans for regulatory

agencies to implement the NTTAA.

2. Working Group on Quality Management Systems (ISO 9000). The Government and Industry

Quality Liaison Panel (GIQLP) is co-chaired by DOD, NASA, and a representative from the

Electronics Industry Association (EIA). The GIQLP is a partnership of 12 Federal agencies,

three major trade associations, the American National Standards Institute (ANSI) and the

American Society for Quality (ASQ). Its goals include: providing contractors with guidance

on the establishment of a single quality management system in a contractor's facility that is

capable of meeting each customer's requirements; promotion of the effective use of advanced

practices; and promotion of effective and efficient oversight methods. The single quality

management system is defined by the contractor for a specific facility and contains a basic

quality management system (based on the appropriate elements of ISO 9001) augmented by

facility-wide advanced quality practices, as appropriate.

In October 1997 the GIQLP completed its second revision of the Quality Management

Systems Guide (Guide), which provides an overview of the work of the GIQLP in

harmonization of procurement practices in the quality area. This Guide and other supporting

material have been placed on an Internet site established by the GIQLP. The URL address of

that site is: http://www.giqlp.org. The supporting material explains the GIQLP concepts in

greater detail and provides examples, training material, and lessons learned. 

3. Working Group on ISO 14000. The Working Group met bimonthly over the past year to

define agency needs related to ISO 14000, Environmental Management Systems (EMS). The

Working Group evidenced a strong commitment and enthusiasm for putting together Federal

agencies’ issues and perspectives on ISO 14000. Participants are successfully identifying and

devising means for meeting Federal issues and needs with regard to ISO 14000/EMS.

The Working Group created an operating guide to provide information and recommendations

to the ICSP regarding development and implementation of the ISO 14000 standards in the

Federal sector through: information sharing; identifying current uses of ISO 14000 by
7

agencies; identifying capabilities and initiatives; and identifying and supporting ways to link

agency efforts.

Throughout the year, the Working Group addressed topics such as: Air Force Interim Policy

on Environmental Safety and Health EMS, DOE’s Raising Awareness of EMS within the

Agency, ISO 14000 and Procurement, and the work of various offices within EPA on

ISO 14000 and EMS. These topical discussions provided guidance to agencies for resolving

agency-specific issues.

4. Working Group on Laboratory Accreditation. The Working Group met at NIST in June 1997

with representatives from the many Government agencies that either operate accreditation

programs or have a strong interest in laboratory accreditation. Each attendee presented a

short briefing on the nature of his or her agency’s accreditation activities, showing a diversity

of programs and ideas, and leading to an excellent exchange of information. 

Five topics were highlighted for consideration at future meetings: (1) applicability of ISO

Guide 25, “General requirements for the competence of calibration and testing laboratories,”

to Federal programs, especially in light of laboratories that operate in accordance with Good

Laboratory Practice (GLP); (2) value of international recognition of accreditation programs;

(3) duplication of accreditation programs within the Federal sector; (4) ISO 9000 versus ISO

Guide 25 in the accreditation of laboratories; and (5) the role of Federal agencies in the

National Cooperation for Laboratory Accreditation (NACLA). 

Subsequent meetings were held between the chairman and representatives of the Department

of the Navy (Strategic Systems Program Office and Naval Sea Systems Command), Air

Force, Department of Energy, and the Food and Drug Administration to gain a better

understanding of specific programs and to discuss specific agency roles in laboratory

accreditation. Planning is underway for a meeting in spring 1998 to further develop and

discuss laboratory accreditation issues facing Federal agencies. 

5. Working Group on Directory Database. The Working Group revised and distributed its final

report to reflect comments from group members. The report included "Guidelines for the

Development of Harmonized Federal Agency Directories," and forms for collecting

information contained in the directories. The Working Group met once in 1997 and

discussed the trend by agencies of using the Internet to collect and maintain directory

information.

In April, a questionnaire was sent out to all ICSP members to determine which agencies have

developed directories, how they are published and made available, methods for collecting

information, and Internet use and access. Thirteen agencies responded to the questionnaire: 

seven agencies currently have directories; two are planning to develop one; three agencies

publish their directories; and three agencies have them available via the Internet.
8

The Working Group recommends that agencies that have not developed directories should be

encouraged to do so. Once all agencies have directories available, the ICSP will need to

determine how best to access this information.

6. Working Group on Standards Management. The Working Group is directed at sharing

information and activities supporting the efficient and effective management of each agency's

and department's standards activities, including electronic information sharing and

coordination. Working Group members and their representatives attended DOE's Standards

Management Workshop and observed DOE's Technical Standards Managers Committee

meetings and Department Standards Committee meetings. Members are now planning a joint

Federal technical standards conference and workshop for fiscal year 1998 to share standards

management information and lessons learned. 

Conclusions

Table 1 summarizes data provided by agencies as required by Circular A-119 on participation

activities and adoption of voluntary standards. Major improvements were noted in the activities

of the ICSP in the number of participating agencies, frequency of committee meetings, and the

accomplishments of the Working Groups as reported earlier.

In summary, the data provided by agencies and presented in Table 1 indicate a significant

decrease from 1996 to 1997 in the numbers of Federal employees participating in voluntary

standards bodies. This decrease should be a matter of grave concern for Federal policy makers. 

There was a significant decrease from the more than 5200 Federal participants reported in 1996

to less than 3300 reported in 1997 for a number of reasons, most likely including agency

downsizing and retirement. The striking decrease was particularly apparent in seven agencies,

including the Departments of Commerce, Defense, Health and Human Services, Transportation

and Treasury, and such independent agencies as the Federal Communications Commission and

the Environmental Protection Agency. At the same time, modest increases were noted at the

Departments of Energy, Interior, and Veterans Affairs, General Services Administration and

NASA. The decline in participants means that Federal input to the standards process is likely to

continue to decrease and be less effective. While most of the decrease in personnel is likely

attributable to retirements, downsizing and buy-outs, some may have been due to unclear

guidance about the ethics implications of participating in voluntary standards committees. The

more specific guidance anticipated in the 1998 revision of the Circular may remove this

uncertainty.

On the other hand, agencies reported the development of very few agency-specific standards,

while noting a markedly increased use of voluntary standards. Agencies reported using

543 voluntary standards in 1997, and substituting 187 voluntary standards for government-unique
3“Federal Agencies Participation in the Development and Use of Voluntary Standards,”

ICF Kaiser Consulting Group, October 1997.

9

standards. Only HHS and DOT reported the development of new agency-specific standards

during 1997. By contrast, DOD has now adopted 7257 voluntary standards, while DOE has

adopted 809, many in the last year. 

Thus, agencies have successfully initiated the shift to greater use of voluntary standards, with an

accompanying decrease in the development of new agency-specific standards. At the same time,

the dramatic decrease in the number of Federal participants in voluntary standards committees

must be a major concern for standards policy makers, since this is a key avenue for Federal

agencies to provide input into the standards they will need in the future. 

Recommendations

1. All Federal agencies should strengthen their efforts to implement the NTTAA and OMB

Circular A-119, particularly in planning for resource and staff allocation for participation in

appropriate voluntary standards activities. 

2. Most Federal agencies have already made significant progress in their use of voluntary

standards for agency programs and missions. This trend should be vigorously continued for

both procurement and regulatory activities. Agencies should increase their participation in

those activities.

3. Federal agencies should develop specific policy and programmatic elements to support the

implementation of the NTTAA and OMB Circular A-119. Elements for consideration are

presented in a report prepared by ICF Kaiser for the Environmental Protection Agency3,

regarding the establishment of agency standards policy and units for monitoring standards

activities; resource allocation; infrastructure; reporting; and assessing program effectiveness.

4. Agencies should consider their own strategic needs when planning for agency participation in

standards activities. They should use available resources, including NIST, to determine

applicable Standards Developing Organizations (SDOs) (both national and international),

relevant voluntary standards, and the need for new standards in emerging technologies and

processes. NIST should continue to facilitate interactions between agencies and the

voluntary standards process.

5. The ICSP should develop guidelines for use when agencies prepare staff for participation in

standards-related activities. These guidelines should reflect: the need to prepare agency

views and coordinate positions with other relevant agencies so that all Federal needs are

reflected as standards are developed; appropriate activities in committees to avoid the

appearance of dominance; and consideration of likely future agency and national needs

during the development and revision of voluntary standards.
10

6. Federal agencies should improve and utilize systems for tracking the adoption or referencing

of voluntary standards, as well as the level of staff participation in voluntary standardsdeveloping bodies. Agencies should use electronic means for setting up directory databases

of participants and exchanging information about standards related issues.
11

Table 1. FEDERAL AGENCY INFORMATION ON PARTICIPATION/ADOPTION OF

VOLUNTARY STANDARDS ACTIVITIES REQUIRED BY OMB CIRCULAR A-119 (DATA AS OF 9/30/97)

AGENCY

NO. OF

VOLUNTARY

CONSENSUS

STANDARDS

BODIES IN WHICH

AGENCY

PARTICIPATES

NO. OF AGENCY

EMPLOYEES

PARTICIPATING

CHANGE

FROM

FY ‘96

NO. OF 

VOLUNTARY

CONSENSUS

STANDARDS

USED SINCE

10/96

NO. OF

VOLUNTARY

CONSENSUS

STANDARDS

SUBSTITUTED

FOR GOVT.-

UNIQUE

STANDARDS

NO. OF GOVT.-

UNIQUE

STANDARDS

USED IN LIEU

OF

VOLUNTARY 

CONSENSUS 

STANDARDS

DOC 141 386 -134 33

OCA 4 1 0

CPSC 46 22 +1 0 0

DOD 86 >600 -1600 73158

DOE 75 871 +23 1020 0

EPA 11 200 -22 3134

4

0

FCC 10 44 -56 1 0 0

GSA 100 54 +22 4 0 0

HHS 140 242 -88 72 0 5

HUD 9 8 -6 0

DOI 38 109 +47 205 0 0

DOJ 1 6

DOL 10 28 +2 6

NASA 47 154 +15

5

92

ARCHIVES 20 18 +4 20 0 0

NCS 17 16 +1 5

NSF 2 3 0 0 0 0

NRC 16 165 +2 54 0 0

STATE 1

6

6 0

DOT 133 292 -128 54 2

TREASURY 10 25 -15 3 0

VA 28 26 +10 0 0 0

TOTALS 945 3276 -1922 543 187 7

1Total number of DOD-adopted voluntary standards is 7527.

2

 Total number of DOE-adopted voluntary standards is 809.

3

 EPA’s 31 final regulations reference at least one or more voluntary standards.

4

 EPA report provides additional information.

5NASA has “identified” 414 standards for potential adoption

6

 Department of State represents the United States in the International Telelcommunication Union (ITU). ITU is an intergovernmental

organization of the United Nations System whose membership is composed of so states.
12

APPENDICES

Appendix A: Cabinet Department Reports ................... . A-1

Appendix B: Independent Agency Reports ................... . B-1

Appendix C: Charter of the Interagency Committee on 

Standards Policy ............................. . C-1

Appendix D: Membership of the Interagency Committee on 

Standards Policy ............................. . D-1

Appendix E: List of NIST Publications Related to

P.L. 104-113 ................................ . E-1
A-1

Appendix A: Cabinet Department Reports
A-2
A-3

DEPARTMENT OF COMMERCE (DOC)

The Department of Commerce encourages and supports its staff to participate in standards

committee activities relating to the mission of the Department, particularly in response to Office

of Management and Budget (OMB) Circular A-119, "Federal Participation in the Development

and Use of Voluntary Standards." Agency employees participate in the standards development

activities of: U.S. private sector standardization bodies; local, state, and Federal governments;

industry; and private and governmental (both treaty and non-treaty) international organizations. 

Standards of interest to the Department cover such areas as energy conservation, information and

computer technology, telecommunications and environmental safety and health, and a variety of

other product sectors and fields of technology.

The Standards Assistance and Management Information (SAMI) project in the Office of

Standards Services, National Institute of Standards and Technology (NIST), collects and

disseminates information on DOC staff participation in outside standards-writing activities. A

directory, published annually, contains statistics on standards committee participation,

alphabetical listings of staff participants and standards organizations and committees, and a list

of acronyms and abbreviations. Department employees are encouraged to provide the SAMI

office with additional information concerning participation in standards activities not already

included in the directory.

The DOC information maintained by the SAMI office is divided into two parts: NIST and nonNIST agencies. During this reporting period, a total of 386 Commerce Department staff

participated in the outside standards committees of 141 (97 national and 44 international)

standards-developing organizations. Sixty-three staff members of non-NIST Commerce agencies

participated in 42 standards organizations (28 national and 14 international) encompassing 108

committees, holding 138 memberships on those committees. Nine of those standards

organizations had five or more DOC participants. NIST had 323 participants in the activities of

99 standards organizations (69 national and 30 international). This participation encompassed

769 committees and 1,162 NIST memberships on these committees. Ten of the standards

organizations in which NIST staff members participated had 15 or more NIST memberships.

The following organizations/agencies accounted for 66 percent (91) of the 141 other DOC

committee memberships.

Organizations with Other DOC Members: No. of Committee 

Memberships

American National Standards Institute 19

Office of Management and Budget 24

Department of Defense/Federal Aviation

 Administration/Department of Commerce 7
A-4

Federal Committee for Metrological Service and

 Supporting Research 6

Department of State 15

International Organization for Standardization 8

International Telecommunication Union - Telegraph 7

International Telecommunication Union - Radio 5

The following standards organizations accounted for 86 percent (952) of the 1162 NIST

committee memberships:

Organizations with NIST Members: No. of Committee 

Memberships

American Society for Testing and Materials 569

American National Standards Institute 107

Institute of Electrical and Electronic Engineers 74

International Organization for Standardization 49

American Society of Mechanical Engineers 32

International Organization of Legal Metrology 24

International Electrotechnical Commission 36

American Concrete Institute 16

Telecommunications Industry Association 24

National Conference on Weights and Measures 21

Other DOC Agencies: Summary of Standards-Related Activities

National Oceanic and Atmospheric Administration (NOAA)

Standardization of data acquisition and data management practices is vital to the mission at

DOC’s National Oceanic and Atmospheric Administration (NOAA). NOAA seeks to establish

voluntary standards with selected industrial associations, academia, and national organizations of

state and local governments (e.g., the American Association of State Climatologists), as well as

through participation in professional societies (e.g., American Meteorological Society). All

NOAA line organizations engage in standards development for disciplines of interest to them. In

general, standards that apply to many NOAA activities are established with other Federal

agencies (e.g., DOD, FAA, USDA); through participation in international organizations such as

the World Metrological Organization; and by means of bilateral and multilateral agreements with

other nations. These standardization activities apply to all phases of environmental data

acquisition, processing and distribution.
A-5

National Telecommunications and Information Administration (NTIA)

The NTIA contributes to the development and application of national and international

telecommunication standards by way of participation and leadership roles in various voluntary

standards committees at national and international levels (e.g., Telecommunications Industry

Association, International Telecommunication Union). These standards enhance the quality and

reliability of the domestic telecommunications infrastructure, promote healthy competition in

telecommunications products and services, and expand international trade opportunities for U.S.

telecommunications firms. 

Patent and Trademark Office (PTO)

The Patent and Trademark Office participates and contributes to the resolution of identified

requirements for international standards, primarily through the Permanent Committee on

Industrial Property Information of the World Intellectual Property Organization (WIPO). PTO

staff also participate in standardization activities of the International Patent Classification Union

and the ANSI committee on Patent Standards.

Bureau of the Census

DOC’s Bureau of the Census is active in the development of standards and specifications for

definition of metropolitan statistical areas, digitizing of geographic information, and statistical,

economic and geographic definitions.

National Institute of Standards and Technology (NIST): Summary of Standards-Related

Activities

In addition to the activities described above in support of P.L. 104-113, the NIST’s Office of

Standards Services (OSS) operates a number of standards-related programs and services to assist

business, industry, and government in using and understanding standards, technical regulations,

and conformity assessment procedures affecting trade in the global marketplace.

! The National Center for Standards and Certification Information (NCSCI) is the U.S. focal

point for standards information and related activities at home and abroad; it provides

information on U.S., foreign, regional, and international voluntary standards bodies,

mandatory government regulations, and conformity assessment procedures for nonagricultural products. NCSCI is the U.S. member of the International Organization for

Standardization Information Network (ISONET), and serves as the U.S. inquiry point under

the World Trade Organization (WTO) Agreement on Technical Barriers to Trade, the North

American Free Trade Agreement (NAFTA), and the Asia Pacific Economic Cooperation

(APEC) Subcommittee on Standards and Conformance.
A-6

! NCSCI maintains an extensive collection of reference materials, including U.S. military and

other Federal Government specifications, U.S. industry and national standards, international

standards, and selected foreign national standards. Staff members respond to requests for

specialized standards information; arrange for translations of foreign standards and

regulations; and disseminate information to U.S. industry concerning proposed foreign

regulations and general standards issues.

! Two telephone hotlines provide weekly updates on draft European standards and on proposed

foreign technical regulations that might significantly affect trade.

NIST Standards Advisory Committee

The NIST Standards Advisory Committee implements the Office of Management and Budget's

(OMB) Circular A-119 at NIST, coordinating voluntary standards activities and addresses

concerns across the Institute and providing a mechanism for information exchange among NIST

professional staff on standards activities.

The Standards Advisory Committee, with broad representation, held five meetings during 1997

to develop recommendations for NIST standards policies and procedures. Committee members

provided input into the Standards Assistance and Management Information project, which

collects and disseminates information on a NIST-wide basis on staff participation in standards

activities. The Committee has initiated a framework for Strategic Standards Management at

NIST, and is currently reviewing the Institute’s standards policies, including the structure for

handling standards participation fees and dues. The Chair of the Standards Advisory Committee

provided two briefings on national and international standards to the NIST Visiting Committee

on Advanced Technology (VCAT).

Federal Information Processing Standards (FIPS)

During 1997, NIST’s Information Technology Laboratory continued to review Federal

Information Processing Standards (FIPS) to ensure that all FIPS are up-to-date and still needed. 

FIPS are issued by the National Institute of Standards and Technology (NIST) after approval by

the Secretary of Commerce pursuant to Section 5131 of the Information Technology

Management Reform Act of 1996 and the Computer Security Act of 1987, Public Law 104-106. 

In July 1997, the Information Technology Laboratory withdrew thirty-three FIPS after conducting

an open process to solicit public review and comments. These FIPS were withdrawn because

they were obsolete or had not been updated to adopt current voluntary industry standards. 

Federal agencies and departments are directed by the National Technology Transfer and

Advancement Act of 1995, Public Law 104-113, to use technical standards that are developed in
A-7

voluntary consensus standards bodies. Consequently, there is no longer a need to establish FIPS

that duplicate these available industry standards. 

National Technology Transfer and Advancement Act

NIST standards-related activities were formalized by the passage of the National Technology

Transfer and Advancement Act (P.L. 104-113), which directed NIST to take responsibility to

provide public sector leadership in standards and conformity assessment and in working with

other Federal agencies and the private sector to support the creation and maintenance of a sound

technical infrastructure for the United States. NIST chairs the Interagency Committee for

Standards Policy and has the unique position for coordination and policy input for standards and

conformity assessment structures and activities in the United States, and for leading the

development of a realistic, workable technical infrastructure to support the goal of an effective

global market. NIST activities in support of P.L. 104-113 are described below.

NIST Coordination and Policy Activities in Support of the Law and Circular

In 1996, NIST published a broad, overarching implementation plan (NIST IR 5967) for fulfilling

DOC/NIST requirements under the NTTAA. This plan is also available on the NIST website at

http://ts.nist.gov/ts/htdocs/210/nttaa/nttaa.htm. This plan contains five broad strategic areas: 

Guidance to Federal Agencies; Strategic Standards Management for Federal Agencies;

Coordination with States and Localities on Standards Activities; Coordination with Standards

Developing Organizations (SDOs) and the American National Standards Institute (ANSI); and

Conformity Assessment. NIST also created an operational level plan specifying tasks in the five

areas, and has thus far completed the following tasks:

Guidance to Federal Agencies 

1. During 1997, the Office of Standards Services (OSS) assisted the Office of Management and

Budget in its analysis of the comments and response to the comments for its proposed

revision of OMB Circular A-119. As part of this activity, NIST hosted seven meetings with

Federal agencies for input to the revision, as well as convening an ANSI/NIST/OMB joint

workshop on the Circular in February 1997.

2. OSS developed and maintains an NTTAA website (URL: http://ts.nist.gov/ts/htdocs/

210/nttaa/nttaa.htm, or ts.nist.gov/oss) with frequent updates of NTTAA implementation

activities. The website provides linkages for other Federal agencies (and others) to key sites

on the web related to NTTAA matters. 

Strategic Standards Management
A-8

1. Strategic standards management is defined as setting organizational needs, priorities, and

strategies for participating in the development and use of voluntary standards. It requires

identification of resources to meet organizational needs, target areas for developing or

revising voluntary standards, and coordination of standards positions, policies, and votes

within an organization. Guidance for internal NIST activities is developed through a NIST

Standards Advisory Committee comprised of representatives from all NIST operating units,

and is developing a strategic standards management plan for Commerce. In addition, one

ICSP meeting focused on Strategic Standards Management with a keynote presentation by

the American National Standards Institute (ANSI). The possibility of additional activities

with ANSI will be explored to assist NIST and Federal agencies with developing strategic

standards management plans and procedures.

2. On September 8, 1997, NIST held a day-long conference on “Using Voluntary Standards in

the Federal Government” which focused on successful use by Federal agencies of voluntary

consensus standards developed by the private sector. The conference was attended by more

than 200 participants, including representatives from eight major standard-developing

organizations and from 21 Federal agencies that work with the private sector to develop

mutually beneficial standards, resolve policy issues, and use standards for Federal

procurement or regulation. 

Coordination with the States and Localities

1. NIST is currently working with state and local agencies to identify and develop procedures

for using and implementing voluntary standards, as well as identifying organizations and

stakeholders who can contribute and benefit from a coordinated effort to join together in

bringing technology-based regulations, codes, standards and testing to state and local

agencies. 

2. Activities include efforts with several groups to establish an oversight council to work with

and advise state and local agencies in standards-related activities. Through this council states

will be able to develop cooperative agreements to support specific areas of need. Such

agreements may help state and local agencies to lower overall technology costs, avoid

unnecessary duplication and redundancy, create shared information technology solutions, and

gain market visibility for their needs in standards and conformity assessment. NIST is also

scheduling and conducting workshops on standards and conformity assessment in an effort to

educate state and local agencies in the advantages of using voluntary standards. NIST will

form an active State-Federal Partnership to help fill the apparent void in knowledge about

standards and technological advancements. 

3. Beginning in the fall of 1997, NIST staff provided information on standards activities for the

American Society of Mechanical Engineers’ Western Regional Conference on Accessing

Technology and other major groups. NIST plans several workshops and conferences in 1998,

including a NIST-State Workshop on the theme of “Innovation and Technology” where a
A-9

special track will address implementation of the National Technology Transfer and

Advancement Act at the state and local levels.

4. In 1997, NIST assisted the Multi-State Working Group (MSWG) on ISO 14000/

Environmental Management Systems (EMS), which comprises more than ten states, NIST,

EPA, plus environmental, academic, and regulated community representatives. The group is

examining ways to achieve environmental gains through more effective, less-costly

compliance and through the promotion of pollution prevention methods and technologies. 

EPA and a number of states are interested in coordinating the implementation and data

collection/analysis phases of their ISO 14001 pilot projects. The MSWG's goal is to share

pilot project performance information and results and thus substantially increase the value of

the projects for all interested parties. 

NIST funds the MSWG Secretariat and is also in the process of publishing the group's

Environmental Management Systems Voluntary Project Evaluation Guidance. 

Coordination with the SDOs and ANSI

1. As mentioned above, NIST sponsored a conference on success stories of Federal agencies in

using voluntary standards. The conference presented material in three areas: use of

voluntary standards in regulation and working with key SDOs, in procurement, and in

meeting future national needs. Another conference on Federal use of voluntary standards is

scheduled for August 1998, this time in conjunction with DOE, EPA and DOD. 

2. NIST staff attended and participated in Board and Council meetings of ANSI, including the

Government Member Council, Company Member Council and Organizational Member

Council meetings, American Society of Mechanical Engineers (ASME), American Society on

Testing and Materials (ASTM), U.S. National Committee of the International

Electrotechnical Commission (IEC), the Institute of Electrical and Electronics Engineers

(IEEE), and other standards developing organizations. These meetings focused on overarching standards-related policy issues.

3. NIST also supported ANSI in creating the NSSN (National Standards Service Network), a

web-based information site covering more than 250,000 standards from over 600 standardsdeveloping bodies. The system allows users to make simple word search queries about

standards. NIST is currently procuring a site-wide license for NSSN, to enhance its existing

information resources in the National Center for Standards and Certification Information

(NCSCI).

Coordination of Conformity Assessment Activities
A-10

1. NIST hosted an open forum in January 1997 and subsequent monthly meetings throughout

the year on the formation of the National Cooperation for Laboratory Accreditation

(NACLA). A report on the forum (NIST IR 6008) describes needs, goals, and possible

solutions for coordinating laboratory accreditation activities in the United States. NACLA’s

goal is to formalize a public/private organization to coordinate U.S. laboratory accreditation

activities, to recognize the technical competence of accrediting bodies for use by government

and private sector activities, and, as directed by the Law, to reduce redundant, duplicative

conformity assessment activities. An interim board has been developing operational

procedures, and plans to inaugurate a more formal structure in the Spring of 1998 in response

to the needs identified in the January 1997 forum. 

2. During 1997 NIST conducted other conformity assessment activities, including establishment

of the Accrediting Body Evaluation Program (ABEP) to recognize the competence of

laboratory accreditation bodies under the Fastener Quality Act (P.L. 101-592, amended by

P.L. 104-113). It also began the implementation of the National Voluntary Conformity

Assessment System Evaluation (NVCASE) to notify U.S. conformity assessment bodies as

competent to meet foreign government requirements, particularly under the U.S.-EU MRA.

3. Additional conformity assessment activities were carried out by ICSP working groups

focusing on quality management (ISO 9000), environmental management systems (ISO

14000), and laboratory accreditation. Specific activities are described above for each group.

4. NIST continues to operate the National Voluntary Laboratory Accreditation Program

(NVLAP) in response to Federal laws and regulations and to specific private sector demands. 

NVLAP currently has programs in support of the Asbestos Hazard Emergency Response Act

(P.L. 99-519) and the Environmental Protection Agency for asbestos testing, the Nuclear

Regulatory Commission for radiation dosimetry, the Department of Commerce for energy

efficient motors and lighting, Fastener Quality Act for fasteners, the Department of Housing

and Urban Development for construction materials, the Federal Communications

Commission for electromagnetic compatibility (EMC), and the National Conference of

Standards Laboratories for calibration. NVLAP performs approximately 900 annual

accreditations.
A-11

DEPARTMENT OF DEFENSE (DoD)

1. DoD Employee Participation. The DoD currently has over 600 employees participating in

the standards development activities of 86 voluntary standards bodies.

2. DoD Adopted Voluntary Standards. Since our input for the FY 1996 report, we have adopted

an additional 73 voluntary standards, bringing the total number of DoD-adopted voluntary

standards to 7,527.

3. Government Standards Replaced by Voluntary Standards. The following 58 Government

specifications and standards were replaced by voluntary standards since our input for the

FY 1996 report:

GO VERNM ENT

SPECIFICATIO N/STANDARD REPLACEM ENT VO LUNTARY STANDARD

M IL-M -14 ASTM D59 48-9 6

M IL-F-5509 SAE AS4841, SAE AS4842, 

SAE AS4843, SAE AS4875

M IL-T-6737 SAE AMS5575, SAE AMS 5576

M IL-S-7108 SAE AMS6425

M IL-S-8503 SAE AMS6448

M IL-S-869 0 SAE AMS6274

M IL-D-10662 ASTM D59 60

M IL-T-10727 ASTM B545, ASTM B339

M IL-F-139 27 ASTM G21

M IL-S-18728 SAE AMS6350, SAE AMS6351,

SAE AMS 6345, SAE AMS4130

M IL-S-18729 SAE AMS6350, SAE AMS6351,

SAE AMS5345, SAE AMS4130

M IL-S-25043 SAE AMS5528, SAE AMS5529

M IL-S-38249 SAE AMS3374

M IL-S-51078 ANSI/AWWA B502-9 4

M S9 020 SAE AS3578

M S9 021 SAE AS3578

M S9 024 NAS 1715

M S9 825 NAS 1715

M S279 61 ANSI/BH MA A1556.1, ANSI/BH MA A2133
A-12

GO VERNM ENT

SPECIFICATIO N/STANDARD REPLACEM ENT VO LUNTARY STANDARD

M S279 62 ANSI/BH MA A156.17

M S279 70 ANSI/BH MA A156.20

M S279 63 ANSI/BH MA A156.17

M S279 71 ANSI/BH MA A156.20

M S33584 SAE AS4330

M S51538 ASTM F1667

M S51539 ASTM F1667

M S51541 ASTM F1667

M S51543 ASTM F1667

M S51544 ASTM F1667

M S51545 ASTM F1667

M S51546 ASTM F1667

M S51547 ASTM F1667

M S51548 ASTM F1667

M S51549 ASTM F1667

M S63044 NAS 1711

M S9 0710 ASTM F1667

M S9 0711 ASTM F1667

M S9 0712 ASTM F1667

M S9 0713 ASTM F1667

M S9 0714 ASTM F1667

M S9 0715 ASTM F1667

M S9 0717 ASTM F1667

M S9 0718 ASTM F1667

M IL-STD-453 ASTM E1742

M IL-STD-1189 AIM BC1

M IL-STD-6866 ASTM E1417-9 5

A-A-460 ANSI/BH MA A156.14

A-A-19 9 5 ANSI Z 87.1

A-A-19 9 6 ANSI Z 87.1

J-W -19 9 7 NEMA NW -1000

R-P-355 ASTM D-5727
A-13

GO VERNM ENT

SPECIFICATIO N/STANDARD REPLACEM ENT VO LUNTARY STANDARD

FF-N-105 ASTM F1667

GG-G-531 ANSI Z 87.1

H H -I-558 ASTM C612, ASTM C553, ASTM C59 2,

ASTM C547

QQ-C-523 ASTM B30-9 5

QQ-P-35 ASTM A9 67

Rr-S-366 ASTM E-11, ASTM E-323

Z Z -H -461 RMA IP-7

4. Section 7 of the proposed revision to OMB Circular A-119 provides guidelines for using

voluntary consensus standards bodies. As written, this section reinforces current DoD policies

regarding use of voluntary standards, reliance on performance documents, and encouragement of

participation in voluntary standards bodies. The intent of this section is clear, we do not believe

further changes are necessary at this time.
A-14

NATIONAL COMMUNICATIONS SYSTEM (NCS)

1. The Office of the Manager, National Communications System (OMNCS) provides the chair

of the Federal Telecommunication Standards Committee (FTSC). This committee prepares

standards on matters affecting national security and emergency preparedness (NS/EP) and in

other areas of communications approved by the committee on the basis of requests from

members.

2. During FY 1997, five Federal Telecommunications Recommendations (FTR), based on

consensus standards committee approved documents, were approved by the FTSC for

publication.

a. FTR 1024A-1997. Project 25 Radio Equipment [land mobile radio systems]. Combination of

Telecommunications Industry Association (TIA) documents in the 102 series.

b. FTR 1062-1997. Group 3 Facsimile Apparatus for Document Transmission. Based on

ANSI/TIA/EIA-465-A-1995.

c. FTT 1063-1997. Procedures for Document Facsimile Transmission. Based on

ANSI/TIA/EIA-466-A-1996.

d. FTR 1070-1997. Detail Specification for 62.5 um Core Diameter/125-um Cladding diameter

Class 1a Multimode, Graded Index Optical Waveguide Fibers. Based on

ANSI/EIA/TIA-492AAAA-1989.

e. FTR 1090-1997. Commercial Building Telecommunications Cabling Standard. Based on

ANSI/TIA/EIA-568-A-1995.

3. Dr. Dennis Bodson, Chief, Technology and Standards Division, and Chair, FTSC, is the

OMNCS focal point for communication standards matters. His telephone number is

703.607.6200, and his e-mail address is bodsond@ncs.gov.

4. The FTSC and members of the Office of the Manager, NCS (OMNCS) work extensively

with voluntary standards organizations to ensure that Government requirements are considered as

the standards are developed. The OMNCS has 17 employees who participate in industry

voluntary standards activities. Paragraph 6 lists the committees in which they participate.

5. Voluntary standards related committees in which the staff of the Office of the Manager,

National Communications System, participate.

Commercial and International Organizations Accredited by ANSI-T1, Telecommunications,

ISDN, BISDN, Signaling Systems, Personal Communications services (PCS) Asynchronous
A-15

Transfer Mode (ATM), Synchronous Optical Networks (SONET), Network Management (The

secretariat of T1 is the Alliance for Telecommunications Industry Solutions (ATIS).

- Participate in 6 subcommittees

- National Committee for Information Technology 

- Standards (NCITS, formerly X3), Data Communications, Information Processing Systems,

Data Interchange, OSI Protocols (The secretariat of NCITS is the Informational Technology

Industry Council (ITI)

- Participate in 8 subcommittees

- TR-8, TR-29, TR-30, TR-45, TR-46, Land Mobile Radio (LMR), Data communications,

Cellular, PCS, Facsimile (The secretariat of the TR committees is the Telecommunications

Industry Association)

- Participate in 7 subcommittees

- JTC1 TAG Information Technology (U.S. Preparatory Meeting for JTC1 input) 

Commercial and International Organizations Not Accredited by ANSI-ATM Forum

- Multimedia Forum

- Telecommunications Industry Forum (TCIF) and Electronic Communications

Implementation Committee (ECIC) (The secretariat of TCIF and ECIC is ATIS.)

Federal Interagency Committees

- Federal Telecommunication Standards Committee (Chair & Executive Secretary)

- Federal Wireless Policy Committee (Vice-Chair)

- Federal Wireless User's Forum (Chair)

- IITF (Information Infrastructure Task Force) (Standards Panel Member)

- FLEWUG (Federal Law Enforcement Wireless User's Group) 

(Member)

Federal, State, and Local Committees

- APCO (Association of Public Safety Communications Officials)

- Project 25 (LMR) (Member Steering Committee)

- Project 31 (Wireless/E911)

International Organizations

- NATO (North Atlantic Treaty Organization)

- Protocol Interoperability Working Group

- Civilian Communications Planning Committee

- International Telecommunication Union - Telecommunications Sector (United Nations

Treaty Organization )

- Participate in 7 Study Groups

- International Telecommunication Union - Radio Sector (United Nations Treaty Organization)

- Participate in 2 Study Groups
A-16

- International Organization for Standardization (ISO) and the International Electrotechnical

Commission (IEC)

- Joint Technical Committee 1

Office of the Manager, National Communications System, Status of Agency Interaction With

Voluntary Standards Bodies
A-17

HEALTH AND HUMAN SERVICES, DEPARTMENT OF (HHS)

Food and Drug Administration (FDA)

HHS (FDA) Standards Executive: Linda Horton

Director, International Policy

Food and Drug Administration

Office of the Commissioner/Office of Policy

5600 Fishers Lane, Room 15-74 (HF-23)

Rockville, MD 20857

Ph (301) 827-3344

FAX (301) 443-6906

lhorton@oc.fda.gov

Summary of the nature and extent of FDA participation in the development and utilization

of voluntary consensus standards.

1) The number of voluntary consensus standards bodies in which there is agency

participation = 140;

the number of agency employees participating = 242;

2) the number of voluntary consensus standards the agency has used since October 1, 1996

(or those based on the procedures set forth in Section 8 of the proposed revision to OMB

Circular A-119 (December 27, 1996) = 72;

* 3) identification of voluntary consensus standards that have been substituted for

government-unique standards as a result of an agency review of existing standards (or as

outlined under paragraph 7c(6) of the proposed revision to the Circular) = 0; 

4) an evaluation of the effectiveness of the guidelines in Section 7 of the proposed revision

to the Circular and recommendations for any changes;

The guidelines in Section 7 of the proposed revision to OMB Circular A-119 will assist

in establishing a framework within which to evaluate an agency’s standards management

program. FDA has met most of the objectives contained in the guidelines, and is

continuing to develop procedures to more effectively participate in and track its standards

development activities, as well as to increase its utilization of voluntary consensus

standards. 

* 5) the number of times the agency used government-unique standards in lieu of voluntary

consensus standards = 5.
A-18

* = FDA utilizes voluntary consensus standards except in cases when none are available or

appropriate in meeting regulatory levels of protection, such as for food/color additives,

pesticides, and certain veterinary medicine products.

Explanatory Notes

The central purpose of Food and Drug Administration (FDA) involvement in the development

and use of standards is to assist the agency in fulfilling its domestic public health and regulatory

missions. The agency participates widely in the development of standards, both domestic and

international, and adopts or uses standards when this action will enhance its ability to protect

consumers and the effectiveness or efficiency of its regulatory efforts. Further, using standards,

especially international ones, is a means to facilitate the harmonization of FDA regulatory

requirements with those of foreign governments, and thus to further domestic and global public

health. Therefore, FDA encourages participation in the development of standards as a useful

adjunct to regulatory controls.

FDA has been involved in standards activities for more than twenty years, and in January 1977

the agency promulgated a final regulation now found at 21 CFR 10.95 covering the participation

by FDA employees in standards-setting activities outside the agency. This regulation encourages

FDA participation in standards setting activities that are in the public interest, and specifies the

circumstances under which FDA employees can participate in various types of standards bodies.

The agency built upon that rule with a draft policy statement published in the Federal Register on

November 28, 1994, and a subsequent final policy published on October 11, 1995. Entitled

International Harmonization; Policy on Standards, it provides the agency’s overall policy on use

and participation in standards development for all product areas regulated by the agency.

In an initiative aimed at furthering harmonization, on January 28, 1995, FDA published in the

Federal Register a proposed rule to facilitate the sharing of draft regulations and other

predecisional documents with state and foreign officials. The final rule, entitled Public

Information; Communications with State and Foreign Government Officials was published on

December 8, 1995.

FDA participation in standards activities varies within each of the agency’s centers, because of

differing applicability of voluntary consensus standards in each substantive area. Voluntary

consensus standards are most relevant in the medical device area, and consequently the majority

of the agency’s activities are centered there. 

Center for Devices and Radiological Health (CDRH)

On October 7, 1996, FDA published in the Federal Register its final rule revising the current

good manufacturing practice (CGMP) requirements for medical devices. The new quality

systems regulation is compatible with specifications for quality systems contained in an

international quality standard developed through the International Organization for
A-19

Standardization (ISO), namely ISO 9001 “Quality Systems Part 1. Specifications for

Design/Development, Production, Installation, and Servicing.” This action was taken to add

preproduction design controls and to achieve consistency with quality system requirements for

medical devices worldwide. 

On August 1, 1996, FDA began a voluntary pilot program using private sector third parties to

review marketing applications for certain low and moderate risk medical devices, utilizing

standards developed by ISO and the International Electrotechnical Commission (IEC). This

program is being evaluated as part of the agency’s efforts to carry out its mission more efficiently

while maintaining an appropriate level of public protection and will be extended as a result of the

recent FDA Modernization Act of 1997.

On May 9, 1997, FDA issued a final rule establishing a mandatory performance standard for

electrode lead wires and patient cables, based in part on an IEC standard. The agency took this

action because it determined that a performance standard was needed to prevent electrical

connections between patients and electrical power sources, to substantially reduce the risk of

electrocution from unprotected electrode lead wires and patient cables. This is an example of a 

mandatory regulation based on a voluntary consensus standard.

In October 1997, a draft guidance document was made available for public comment on the

agency’s Internet home page, which instructs FDA medical device reviewers to utilize the criteria

contained in the IEC 601 series of standards in the device approval programs. Independent (third

party) certification to the standards will be sufficient to demonstrate the safety of electrical

medical devices for the aspects of safety addressed by the standards.

CDRH has maintained a database to track the standards activities of its employees for several

years. Recently, the Center purchased searchable (ROM) databases of voluntary consensus

standards from a private company (IHS) as well as several standards development organizations,

to facilitate reference to such standards by agency reviewers.

Center for Drug Evaluation and Research (CDER) / Center for Biologics Evaluation and

Research (CBER)

Numerous employees in FDA’s Center for Drug Evaluation and Research (CDER) and other

FDA Centers are involved in the standards development activities of the U.S. Pharmacopeia

(USP), a private, voluntary, not-for-profit national standard setting body of more than 1500

health care professionals, recognized authorities in medicine, pharmacy, and allied sciences. 

USP publishes and revises the United States Pharmacopeia and the National Formulary (NF), the

legally recognized compendia of drug standards in the United States.

Both CDER and the CBER are major FDA participants in the International Conference on

Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human

Use (ICH). This ongoing project, begun in 1989, has been undertaken by Government agencies
A-20

responsible for regulation of drugs and by industry trade organizations for the European Union

(EU), Japan, and the United States. ICH brings together regulatory authorities and experts from

the pharmaceutical industry in the three regions to discuss scientific and technical aspects of new

product registration. The work products, created in working groups of experts from the

regulatory agencies and industry, consist of a series of consensus guidelines documents to

harmonize pharmaceutical testing guidelines. FDA officials also participate in a consensus

standard setting activity sponsored by the Council for International Organizations of Medical

Sciences and implemented in ICH, that is aimed at standardizing the safety-related terminology

used in adverse experience reporting.

FDA also actively participates with the World Health Organization (WHO) in setting

international criteria for regulating drugs and biologics.

Although FDA’s work with USP is specifically excluded from reporting under OMB Circular 

A-119 and ICH and WHO do not meet the definition of voluntary consensus standard bodies

under the Circular, substantial agency resources are devoted to the development of these various 

standards, and this work is an important part of FDA’s overall standards activities.

Center for Food Safety and Applied Nutrition (CFSAN) / Center for Veterinary Medicine (CVM)

Standards activities of multilateral organizations, such as the WHO and the Organization for

Economic Cooperation and Development (OECD) are often important to FDA and frequently

involve multiple product types. The principal international standards activities in the areas of

food and veterinary medicine fall under the activities of the Codex Alimentarius Commission

under the Food and Agricultural Organization (FAO) and the WHO, and the Office of

International Epizooties (for veterinary medicine). Experts from FDA’s CFSAN, CVM, Office

of Policy and Office of Regulatory Affairs are heavily involved in Codex activities.

FDA’s CVM has recently begun a harmonization initiative similar to the ICH, that will develop

harmonized requirements for the registration of veterinary drugs. It is known as VICH, for

Veterinary ICH. 

International/Treaty Standards-Related Activities

FDA takes part in numerous international standards activities which fall under treaty

organizations, (and thus are not reportable under the provisions of OMB Circular A-119). These

standards activities are nonetheless important to the agency in fulfilling its public health

regulatory mission. Some of these are referred to above, i.e. WHO, FAO, and OECD. 

The agency also participates in international trade discussions of the World Trade Organization

(WTO) specifically, the Agreement on Technical Barriers to Trade, and the Agreement on

Sanitary and Phytosanitary Measures, and the same counterpart committees of the North

American Free Trade Agreement (NAFTA), to ensure that FDA’s requirements are preserved and
A-21

its regulatory practices can remain focused on fulfilling the agency’s mission to protect the public

health while being supportive of emerging, broader U.S. Government obligations and policies. 

FDA has participated in several initiatives that are part of the Asia Pacific Economic Cooperation

(APEC) forum. FDA topics have included food safety, food labeling, bulk drugs, and standards

for latex gloves and condoms. FDA also participates in activities leading toward a Free Trade

Area of the Americas (FTAA) through representation on working groups on standards, and

sanitary and Phytosanitary measures.

FDA Standards Policy and Program Management

The FDA’s Standards Policy Committee (SPC) is chaired by the agency standards executive, and

composed of top management representatives from all centers and offices within the agency. The

SPC meets quarterly to review and discuss both domestic and international standards issues, and

recommend agency-wide standards policy to the Commissioner. The committee oversees the

coordination of FDA standards activities and official participation of employees in standards

development endeavors both within and outside FDA; tracks, compiles and reports required

information; and ensures appropriate standards review when applicable.

The agency experts on quality systems and environmental management serve as liaison members

to the FDA’s SPC, to strengthen agency expertise and participation in issues and activities related

to these areas. The agency also has a contact group of experts on private laboratory issues that

holds meetings as needed to assure coordination of testing and conformity assessment issues.

It is the intent of FDA’s standards policy to (1) enable the agency to participate in international

standards activities that will assist it in implementing statutory provisions for safeguarding the

public health; (2) increase its efforts to harmonize its regulatory requirements with those of

foreign governments, including setting new standards that better serve the public health; and,

(3) respond to laws and policies that encourage agencies to use voluntary standards that provide

the desired degree of protection. 

As part of the President’s and Vice President’s National Performance Review, FDA is currently

carrying out a comprehensive review of its existing regulations. As part of this review, the

agency is considering the appropriateness of existing regulations and policies, as specified in the

proposed revision to OMB Circular A-119. During 1997, the American Society for Testing and

Materials (ASTM) identified various FDA food additive and medical device regulations which

contained references to out-of-date ASTM standards. FDA is currently drafting a proposed rule

to amend those regulations, to update the references to various standards to reflect current

standards designations.
A-22

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HUD)

In response to the reporting requirements of OMB Circular A-119, Paragraph 9 dated October 20,

1993, HUD reports the following information:

A. (1) There are a total of eight HUD employees participating in standards development groups. 

Six employees from the Manufactured Housing & Standards Division and two employees from

the Office of Lead Hazard Control are participating on nine voluntary consensus standards bodies

and a NIST standards activity. Organizations with which they participate are:

a. American Architectural Materials Association

b. American Hardboard Association

c. American National Standards Institute

d. American Society for Civil Engineers

e. American Society for Testing & Materials

f. Council of American Building Officials

g. International Approval Services

h. NSF International

i. Underwriters Laboratories

 (2) No new voluntary consensus standards have been adopted which resulted from agency

participation in a standards development group since October 1, 1996.

 (3) HUD’s Office of Consumer and Regulatory Affairs is currently conducting a

comprehensive review of its existing standards and expects to update many references during

calendar 1998.

B. No voluntary consensus standards have been adopted during this period for the purpose of

promoting environmentally sound and energy efficient materials, products, systems, services, or

practices. HUD is updating its reference to the CABO Model Energy Code for housing insured

under the FHA mortgage insurance programs to incorporate the 1995 revisions.

C. HUD supports the policy of OMB Circular A-119 and references more ASTM voluntary

consensus standards than any other Federal Agency.

If you have any questions concerning the above, please contact Ms. Marion Connell at 

(202) 708-6409.
A-23

DEPARTMENT OF ENERGY (DOE)

The DOE implements the Federal guidance and requirements in OMB Circular A-119 and the

statutory requirements in Public Law (P.L.) 104-113 (15 USC 272) on the use of voluntary

standards through specific Departmental policy and supporting management systems. 

DOE P 251.1, "Directives System," establishes a Directives System for managing DOE

requirements and guidance documents and incorporates technical standards (i.e., those standards

that are specifically addressed in P.L. 104-113) as the foundation of the Department's directives

system hierarchy. This policy clearly states DOE's preference to "adopt National Consensus

Standards and other commercial and industry standards. . ." in the conduct of Departmental

activities. The policy also contains provisions restricting the use of mandated technical standards

in DOE rulemaking and orders stipulating DOE-specific requirements.

DOE P 410.1A, “Promulgating Nuclear Safety Requirements,” also requires notice and comment

rulemaking to promulgate new nuclear safety requirements. The new nuclear safety requirements

promulgated by the Department are “performance-based” rules which permit the adoption of

commercial and industry standards as acceptable methods to implement the rules when

appropriate for the work to be conducted and the hazards to be encountered. 

These Departmental policies on the use of voluntary standards are subsequently implemented

through a management system established through DOE Order 1300.2A, "Department of

Energy Technical Standards Program." This Order requires DOE elements to use international

and national voluntary standards in preference to Federal and DOE standards, consistent with

P.L. 104-113 and OMB A-119. It also establishes an integrated Department-wide Technical

Standards Program and supporting infrastructure designed to implement Federal and DOE

technical standards requirements and manage related activities within DOE. As advocated in

OMB Circular A-119 and P.L. 104-113, the Order encourages and supports staff participation in

the planning, development, and coordination activities of voluntary standards committees. 

As of November 1997, DOE Order 1300.2A is being updated to incorporate references to 

P.L. 104-113 and the pending revision to OMB Circular A-119. In the interim, the Assistant

Secretary for Environment, Safety and Health issued an information memorandum to the

Department’s cognizant secretarial officers (i.e., senior DOE line managers in Washington, D.C.)

describing the new Public Law, its impact upon DOE, and the planned implementation of the law

through the Technical Standards Program. 

Another element serving to manage implementation of OMB Circular A-119 is DOE’s 

Department Standards Program. This was established to institute "standards" (in this application,

"standards" include policy, laws, rules, guides, and technical standards) as the basis for work

throughout the Department. A Department Standards Committee (DSC) was established in 1994

and served to establish DOE standards policy and remove barriers to implementing a

Department-wide standards-based culture. The DSC assists DOE line organizations in the
A-24

implementation of this Department Standards Program. The "Criteria for the Department's

Standards Program," DOE/EH/-0416, August 1994, describes elements of the standards-based

operating culture envisioned by DOE leadership. Information on the Department Standards

Program and the DSC can be accessed at the following Internet address (Universal Resource

Locator [URL]):

http://www.dsc.doe.gov

The DSC has sponsored development and implementation of a DOE-wide process that enables

DOE contractors to select voluntary consensus standards as the basis for their work in-lieu-of

mandated DOE-developed standards. This "Work Smart" standards approach (also referred to as

the "necessary and sufficient" process) enables DOE laboratory and management and operating

contractors, with DOE approval, to identify and apply the set of standards (including technical

standards) that best fits their activities. This approach focuses on outcomes and performance,

rather than "how" things are to be done within DOE, and is supported by a major contract reform

effort designed to more closely link performance expectations with contractual obligations based

on standards. 

Key Departmental policy and requirements documents defining this approach include

DOE P 450.3, "Authorizing Use of the Necessary and Sufficient Process for Standards-Based

Environment, Safety and Health Management," and DOE M 450.3-1, "The Department of Energy

Closure Process for Necessary and Sufficient Sets of Standards." Field pilot projects of the

approach have been completed, and significant efficiencies and cost savings have been

demonstrated. Based on the success of the pilot projects, the "Work Smart" standards approach

was expanded to cover a broad range of Department programs and facilities. In FY 1997, key

Technical Standards Program personnel participated in several DSC working groups that focused

on tailoring/integration of “Work-Smart” standards activities and DSC support for the

Department’s “Integrated Safety Management” initiative.

The DOE Standards Executive, Richard L. Black, Director, Office of Nuclear Safety Policy and

Standards, continues to be responsible for developing and implementing the DOE Technical

Standards Program throughout the Department. He also advises and provides staff support to the

Department Standards Committee. Through Mr. Black's participation on the Interagency

Committee on Standards Policy, DOE continues to provide information to other Federal agencies

on the Department's approach to establishing a standards-based culture.

DOE Order 1300.2A emphasizes the use of technical standards within the Department. The

Department's Technical Standards Program Office (TSPO) operates to implement program

policy, supports the conversion of Department standards to voluntary standards, identifies

voluntary standards that can suit Department needs, develops and maintains data bases to support

the program and meet reporting requirements, and coordinates day-to-day Department technical

standards activities. The TSPO has developed procedures, methods, and training approaches to

implement the DOE Technical Standards Program and communicate the policy to use voluntary
A-25

standards throughout DOE and, when appropriate, participate in voluntary standards committee

activities. The program procedures establish a five-year standards review cycle to check for

continued applicability; the procedures also provide guidance on the conversion of Department

standards to voluntary standards.

Information on the Technical Standards Program and the TSPO can be accessed at the following

Internet address (URL):

http://apollo.osti.gov/html/techstds/techstds.html

Technical Standards Managers (approximately 80 individuals representing the various

Department headquarters, field, laboratory and contractor organizations) have been designated to

coordinate the consistent implementation of the program. Established in 1992, the Technical

Standards Managers' Committee (comprised of these Technical Standards Managers) operates

under the DOE Technical Standards Program, supports the DOE sites in technical standards

activities, facilitates communications on program implementation issues, and participates in

establishing program goals and procedures. Publications documenting the voluntary standards

adopted by DOE and the personnel participating in the activities of voluntary standards groups

are developed by the TSPO; the information in those publications is electronically posted for

Internet access.

A new initiative undertaken in FY 1997 involves the recognition of “topical” standards

committees within the Department. These committees are composed of subject matter experts in

the DOE community and can be used as a focal point for standards activities in specific technical

areas. The topical committees provide a forum for all interested DOE parties to join and

participate in reviewing technical standards produced by counterpart voluntary standards

organizations, address standards application issues within their area of technical expertise, and

work to develop Department and Federal positions on standards issues. As of October 1997,

12 DOE topical committees have been recognized by the Technical Standards Program. (These

committees are identified on the program Internet address listed at the top of this page).

In summary, DOE continues to take a "pro-active" approach to standards and standards

management even as its mission continues to evolve in response to the conclusion of the Cold

War and shrinking Congressional appropriations. A number of programs and facilities have

shifted their focus from production, research, and/or development to environmental remediation

and restoration, where DOE will literally be breaking new ground and setting standards for others

to follow. In addition, Department staffing levels are declining to meet Congressional budget

constraints. Still, in the face of a changing mission and a reduced workforce, DOE continues to

actively use and support the development of voluntary standards to meet its needs. In FY 1997,

the number of voluntary standards adopted for use increased to 809 (799 in 1996). In addition,

the number of individuals participating in voluntary standards activities has increased to 871 (848

in 1996); however, the number of documented participation in standards developing groups

declined to 1540 (1618 in 1996).
A-26

Also, DOE (through the TSPO) is continuing its initiative (in response to contacts from voluntary

standards organizations on how the Department is meeting P.L. 104-113) to better define

"candidate" DOE technical standards for conversion to voluntary standards. We are continuing

to work with representatives of the American National Standards Institute's Nuclear Standards

Board (ANSI-NSB) on the conversion of selected DOE technical standards to voluntary

standards. (Four candidate standards have been identified to date). 

In addition, DOE sponsored meetings in October 1996 and July 1997 with representatives of

several voluntary standards organizations (ASTM, ASME, ANS, NFPA, ASCE, et al.) as part of

a more structured program interface with the voluntary standards community to promote

developing new standards that may be needed through those organizations rather than within

DOE.

Other highlights of DOE's interaction with voluntary standards bodies include the following:

• In FY 1993, DOE began conducting an annual national workshop promoting the Technical

Standards Program and the use of voluntary standards. These workshops featured

presentations by standards executives from various voluntary standards bodies and major

U.S. companies. Each workshop was attended by approximately 150 standards developers

and users. The FY 1997 Technical Standards Program workshop was held on July 8-10,

1997; another workshop is planned for FY 1998.

C In addition to the ANSI-NSB, DOE representatives participate on ANSI's Board of Directors

and Executive Standards Council. DOE also participates in a number of international

standards groups such as ISO/TC 85, Nuclear Energy, ISO/TC 176, Quality Assurance, and

ISO/TC 207, Environmental Management. 
A-27

Reporting requirements for OMB Circular A-119 (paragraph 10 of proposed revision):

1) The number of voluntary consensus standards bodies in which there is agency participation,

as well as the number of agency employees participating.

- Number of standards bodies: 75

- Number of agency personnel participating: 871

- Total number of agency participation: 1540

2) The number of voluntary consensus standards the agency has used since October 1, 1996

(or, as appropriate, those based on the procedures set forth in Section 8 of the proposed

revision to the Circular). 809 (adopted for use)

3) Identification of voluntary consensus standards that have been substituted for

government-unique standards as a result of an agency review of existing standards (or as

outlined under paragraph 7.c(6) of the proposed revision of the Circular. 0

4) An evaluation of the effectiveness of the guidelines in Section 7 of the proposed revision

to the Circular and recommendations for any changes.

Response - The guidance in Section 7 of the proposed revision to OMB Circular A-119

appears to be sufficient in terms of outlining the basic functions and responsibilities of

Federal agency standards management and standards participation activities. It allows

sufficient latitude for each Federal agency to develop its own approach tailored to specific

agency needs, and places the emphasis on outcomes rather than processes.

5) As required by P.L. 104-113, when the agency used government-unique standards 

in-lieu-of voluntary consensus standards.

Response - There were no recorded cases in FY 1997 where the Department selected to

use an internal standard in-lieu-of an equivalent, existing voluntary standard.
A-28

DEPARTMENT OF THE INTERIOR (DOI)

Based on a survey of offices and bureaus, the Department of the Interior’s response to your

questions is, as follows:

1) a. The number of voluntary consensus standards bodies in which there is agency

participation: 38

1) b. The number of agency employees participating: 109

2) The number of voluntary consensus standards the agency has used since October 1, 1996:

205

3) Identification of voluntary consensus standards that have been substituted for

government-unique standards as a result of an agency review of existing standards: None

4) An evaluation of the effectiveness of the guidelines in Section 7 of the proposed revision

to the Circular and recommendations for any changes: The Department of the Interior has

no additional comments on the proposed revision of the Circular beyond those which

have already been provided at meetings of the Interagency Committee on Standards

Policy.

5) When the agency used government-unique standards in lieu of voluntary consensus

standards: None

If you have any questions concerning this response, please call me at (202) 208-4915, email me

at Donald_Bieniewicz@ios.doi.gov or fax me at (202) 208-5602.
A-29

DEPARTMENT OF JUSTICE (DOJ)

The Department of Justice’s Standards Executive, Mary Ellen Condon, Director, Information

Management and Security Staff, Justice Management Division, coordinates agency participation

in information technology voluntary standards development, and will coordinate future agency

reporting requirements covering all technologies. To the extent that standards are identified as

falling under the responsibility of the Department of Justice for five-year review pursuant to

paragraph 8b.(3) of OMB Circular A-119, the Standards Executive will establish the appropriate

procedures.

The voluntary standards issues and decisions of greatest concern to the Department of Justice

have been those that relate to antitrust matters. That is why the Antitrust Division has been for

many years the Department’s primary participant in the Interagency Committee on Standards

Policy. The Department continues to hold this interest, and will continue to contribute its views

on the antitrust considerations in voluntary standards creation and adoption.

Identification of voluntary standards adopted for the purpose of promoting environmentally

sound and energy efficient materials, products, systems, services or practices:

All standards involved in complying with Public Law 102.486, Executive Orders 12759

and 12845, and Federal IRM Regulation Interim Rule 1 and Bulletin C-35 concerning

Energy-Star-qualifying computer equipment.

APCO 25, which promotes radio frequency spectrum efficiency. (More efficient use of

radio frequencies is believed to be both environmentally sound and energy efficient.)
A-30

DEPARTMENT OF LABOR (DOL)

OSHA Activities in Voluntary Standards

OSHA has 28 employees participating in 102 voluntary consensus standards development

committees. These committees are sponsored by ten major standards development organizations:

American National Standards Institute (ANSI);

American Society of Testing Materials (ASTM);

National Fire Protection Association (NFPA);

American Society of Mechanical Engineers (ASME);

American Conference of Governmental Industrial Hygienists (ACGIH).

 Institute of Electrical, Electronics Engineers (IEEE)

 Wood Machinery Manufacturers Association (WMMA)

 National Safety Council (NSC)

 Underwriters Laboratories (UL)

 National Sanitation Foundation (NSF)

Since October 1, 1996, OSHA has issued one final rule referencing six voluntary consensus

standards while participating in these standards development groups.

On July 25, 1997, OSHA published a final rule covering Longshoring and Marine Terminals. 

The Agency referenced the following national consensus standards:

1. ANSI A14.1-1990 Safety Requirements for Portable Wood Ladders 

2. ANSI A14.2-1990 Safety Requirements for Portable Metal Ladders

3. ANSI A14.5-1992 Safety Requirements for Portable Reinforced Plastic Ladders

4. ANSI Z-87.1-1989 Practice for Occupational and Educational Eye and Face Protection

5. ANSI Z-89.1-1986 Personnel Protection-Protective Headwear for Industrial Workers- 

 Requirements

6. ANSI Z-41-1991 American National Standard for Personal Protection-Protective Footwear 

OSHA has not adopted any voluntary standards for the purpose of promoting environmentally 

sound and energy efficient materials, products, systems, services, or practices.

In addition to implementing OMB Circular A-119, OSHA must consider the use of national

consensus standards in its standards development programs, since this consideration is required
A-31

under section 6(b)(8) of the Occupational Safety and Health Act of 1970 (P.L. 91-596). This

section reads as follows: Whenever a rule promulgated by the Secretary differs substantially

from an existing national consensus standard, the Secretary shall, at the same time, publish in the

Federal Register a statement of the reasons why the rule as adopted will better effectuate the

purposes of this Act than the national consensus standard.

MSHA ACTIVITIES

For the past several years, MSHA has been engaged in an ambitious review of its regulations for

occupational safety and health in mining. Although this review does not adhere to a 5-year cycle,

it is comprehensive in nature.

MSHA frequently uses national consensus standards as the basis for its rulemaking. In some

areas such as health, the Agency relies heavily on such standards. Although MSHA limits

incorporation by reference of voluntary standards as much as possible, the Agency has often

included them in non-mandatory appendices to its rules.

MSHA believes that encouraging the use of voluntary standards prompts the health and safety of

miners. We attempt to do this by supporting membership in groups promoting various aspects of

occupational health and safety.

The Department of Labor’s Standards Executive is Patricia Lattimore, Assistant Secretary for

Administration and Management. Her telephone number is (202) 219-9086, and her address is

200 Constitution Avenue, N.W., Room S2203, Washington, D.C. 20210. 
A-32

DEPARTMENT OF STATE (DOS)

The Department of State has a major interest in standards from a policy perspective, but less

direct involvement in the actual development of technical standards, with the important

exception as outlined in the following paragraphs discussion the Department’s policy role as

obligated by international treaty. The Bureau of Economic and Business Affairs (EB) represents

the Department of State on the Interagency Committee on Standards Policy (ICSP) and the

Government Member Council and the Information Infrastructure Standardization Panel (IISP)

and its steering committee of the American National Standards Institute.

Acting as the United States Administration under the treaty obligations found in the Convention

of the International Telecommunication Union (ITU), Nairobi, 1982, the Department of State,

through its Communications and Information Policy Deputate of the Bureau of Economic and

Business Affairs, provides the forum where the United States telecommunications industry, both

public and private sectors, develops positions and contributions for presentation at meetings of

the three permanent organs of the ITU, responsible for international telecommunications

recommendations (voluntary standards). The Department authorizes and/or hosts open public

meetings under the Federal Advisory Act, wherein U.S. telecommunications standard-setting

positions are established. The Department coordinates, leads, and/or accredits United States

delegations to meetings of the International Telecommunication Union’s Telecommunications

Standardization Sector (ITU-T)*, the Radio Communications Sector (ITU-R)*, the Development

Sector (ITU-D), and the Inter-American Telecommunication Commission (CITEL), an organ of

the OAS.

More than eighty-five (85) U.S. corporations are paying and participating members of the ITU-T

and the ITU-R, more than 30 are associate members of CITEL’s permanent consultative

committee, under the sponsorship of the State Department. Those entities, along with all

interested governmental agencies, including but not limited to the Department of Defense,

National Institute of Standards and Technology (NIST), National Telecommunications and

Information Administration (NTIA), National Aeronautics and Space Administration (NASA), 

Federal Communications Commission (FCC), participate and play major roles in the voluntary

standard-setting process. Within that process, a great deal of interaction takes place with other

organizations involved in telecommunications standard-setting, such as, but not limited to the

International Organization for Standardization (ISO), the American National Standards Institute

(ANSI), Committee T1 (the ANSI accredited committee for U.S. domestic telecommunications

standards). CITEL’s committees extend this interaction to a number of Latin American and

Caribbean regional organizations as well.

______________

*Formally CCITT and CCIR.
A-33

Study Groups and Working parties of these sectors convene international standardization

meetings on a frequent basis to develop international voluntary telecommunications standards. 

In addition to accrediting and supporting delegations to the ITU and its Standardization Sectors,

as well as CITEL, the State Department’s Bureau of International Organization Affairs, although

it has no direct interaction with voluntary standards bodies, serves as policy overseer and

contributors to overall standardization policy within the Economic Commission for Europe

(ECE) by ensuring participation by relevant specialized agencies and private sector groups in the

deliberations of the ECE’s Working Party on Standardization, especially where they have a direct

bearing on U.S. commercial interests.

For example, each year the Bureau of International Organization Affairs accredits and funds

representatives from the Department of Agriculture, the Department of Commerce, the

Department of Transportation, and the National Institute of Standards and Technology and also

accredits their industrial representatives to key ECE meetings on standardization policies. These

gatherings seek to harmonize standards and/or make recommendations on standardization

policies in such areas as trade, transport, agricultural products, motor vehicles, timber and coal to

improve industrial efficiency and quality as well as to facilitate international trade in these areas. 

While the standards developed in the ECE are not officially adopted for use in the United States,

they serve as guides for adjusting product design and are widely taken into account in

manufacturing plans.
A-34

DEPARTMENT OF TRANSPORTATION (DOT)

In response to the request by the Office of Management and Budget for information regarding the

Department of Transportation’s implementation of OMB Circular A-119, “Federal Participation

in the Development and Use of Voluntary Standards,” we respectfully submit this report. The

included data represent the 1997 Fiscal Year activities for the department and its agencies. 

DOT Participation in Voluntary Standards Organizations

DOT recognizes the importance and the advantages of using voluntary consensus technical

standards. The reduction of duplication and waste as well as the maintenance of our competitive

edge are goals that DOT strives to achieve. Through its participation in the activities of

standards-developing organizations, DOT continues to be on the cutting-edge of transportationrelated technological innovations. Additionally, in the international realm, DOT looks to shape

the creation of new standards which are adopted by other nations. The Department recognizes,

as well, that, when appropriate, incorporation by reference of voluntary consensus technical

standards saves the regulatory agencies both time and money. 

Seven DOT agencies have reported varying degrees of participation in standards-setting

organizations and related activities. 

! The total number of DOT employees participating in at least one standards-developing

group is two hundred and ninety-two (292). 

! The total number of voluntary standards groups in which DOT employees participate

is one hundred and thirty-three (133).

! Since October 1, 1996, DOT has adopted fifty-four (54) voluntary standards as a result

of agency participation in a standards-developing group. 
A-35

Bureau of Transportation Statistics (BTS) 

Five (5) employees of BTS participate in at least one standards-developing group. 

These employees participate in four (4) standards-developing groups.

BTS has not adopted any voluntary standards since October 1, 1996. 

Federal Aviation Administration (FAA) 

This year, FAA did not provide a response, although, based on last year’s response,

FAA does participate in voluntary standards organizations.

Federal Highway Administration (FHWA) 

Sixty (60) employees of FHWA participate in at least one standards-developing group. 

These employees participate in twenty (20) standards-developing groups.

Since October 1, 1996, FHWA has not adopted any voluntary standards. 

Federal Railroad Administration (FRA)

Approximately thirty (30) employees of FRA participate in at least one standardsdeveloping group. These employees participate in nine (9) standards-developing

groups.

Federal Transit Administration (FTA) 

Ten (10) employees of FTA participate in at least one standards-developing group.

These employees participate in eight (8) standards-developing groups.

Since October 1, 1996, FTA has adopted no voluntary standard as a result of agency

participation in a standards-developing group.

Maritime Administration (MARAD)

Seven (7) employees of MARAD participate in at least one standards-developing

group. These employees participate in five (5) standards-developing groups. 

Although MARAD does not write, issue, or enforce shipbuilding regulations or

consensus technical standards, it is, nevertheless, wholly engaged in the area of

regulation and consensus standards. MARAD’s principal role in the regulatory area is

that of a facilitator and collaborator with the U.S. Coast Guard in seeking to eliminate
A-36

unnecessary regulations which may inhibit U.S. shipbuilding competitiveness in the

international marketplace. In the field of consensus technical standards, MARAD,

through the National Maritime Research and Education Center (NMREC), is an active

player in promoting, sponsoring, developing, and supporting the adoption of consensus

technical shipbuilding standards both on the national and international level. For

example MARAD has worked with the American Pilots Association (APA) through a

Cooperative Agreement and helped co-sponsor a workshop on “Masters Pilot

Information Exchange.” The workshop brought the industry together to talk about

current practices. After the workshop a “Best Practices Summary” was developed as a

“standard” to be followed by member piloting organizations of the APA. While not a

“standards” group, this organization represents most of the piloting associations in the

United States and in effect sets standards for the industry.

National Highway Traffic Safety Administration (NHTSA) 

Thirty-four (34) employees of NHTSA participate in at least one standards-developing

group. The breakdown is as follows: Twenty-seven (27) employees in the Research

and Development Office, two (2) employees in the Office of Defects Investigation, one

(1) employee in the Office of International Harmonization, three (3) employees in the

Light Duty Vehicle Division, and one (1) employee of the Special Vehicles and

Systems Division. These employees participate in five (5) standards-developing

groups.

Since October 1, 1996, NHTSA has adopted one (1) voluntary standards as a result of

agency participation in a standards developing group. This was Compressed Natural

Gas Fuel Containers. NHTSA proposed to amend its requirements for compressed

natural gas fuel containers to be consistent with the recent revisions of the ANSI

standard. 

Office of the Secretary (OST) 

No employees of OST participate in standards-developing groups. 

Research and Special Programs Administration (RSPA) 

Forty-five (45) employees of RSPA participate in at least one standards-developing

group. The breakdown is as follows: Twenty-eight (28) employees of the Office of

Pipeline Safety, and twelve (12) employees of the Office of Hazardous Materials

Safety. These employees participate in thirty-two (40) standards-developing groups.

Since October 1, 1996, RSPA has adopted eleven (11) voluntary standards as a result

of agency participation in a standards-developing group. 
A-37

United States Coast Guard (USCG) 

One hundred and one (101) employees of USCG participate in at least one standardsdeveloping group. These employees participate in forty-two (42) standards-developing

groups.

Since October 1, 1996, USCG has adopted forty-two (42) voluntary standards as a

result of agency participation in a standards-developing group. 

The Saint Lawrence Seaway Development Corporation (SLSDC) does not participate in

standards-developing bodies. SLSDC does not work with the standards of the type that

are examined by the Circular. The operations of the SLSDC are affected by the standards

covered by other agencies’ regulations such as the USCG. 

DOT Agencies participate in the following standards-developing organizations:

The Aluminum Association

American Association for Budget and Program Analysis

American Association of State Highway and Transportation Officials

American Boat and Yacht Council

American Bureau of Shipping

American Concrete Institute

American Defense Preparedness Association

American Gas Association (AGA)

American Institute of Aeronautics and Astronautics (AIAA)

American National Standards Institute (ANSI)

American Petroleum Institute (API)

American Public Transit Association

American Public Works Association-Utility Locating Coordination Committee

American Pyrotechnics Association (APA)

American Railway Bridge and Building Association

American Railway Engineering Association

American Society of Civil Engineers (ASCE)

American Society of Mechanical Engineers (ASME)

American Society of Naval Architects and Marine Engineers

American Society of Naval Engineers

American Society for Nondestructive Testing 

American Society for Testing and Materials (ASTM)

American Towing Tank Conference

American Water Works Association
A-38

American Welding Society

Association of American Railroads (AAR)

Association of Diving Contractors

Chlorine Institute

Coast Guard Interagency Committee on Waterways Management

Compressed Gas Association (CGA)

Electronics Industry Association

Factory Mutual Research Corporation

Far East Radio Navigation Service

Federal Work Group on Marine Diesel Exhaust Emissions

The Fertilizer Institute (TFI)

Gas Research Institute-Incident Reporting and Trending System

Illuminating Engineering Society of North America

International Association of Drilling Contractors

International Association of Lighthouse Authorities

International Atomic Energy Agency (IAEA)

International Civil Aviation Organization (ICAO)

International Commission of Illumination

International Conference of Building Officials

International Electrotechnical Commission

International Loran Association

International Maritime Association (IMA)

International Omega Technical Commission

International Organization of Standards

International Radio Maritime Committee

International Ship Structure Conference

International Sorbent Committee

International Ship Structure Congress

International Standards Organization (ISO)

Institute of Electrical and Electronics Engineers (IEEE)

Institute of Makers of Explosives (IME)

Institute of Navigation Council

Institute of Traffic Engineers

Instrumentation Society of America

Joint Aeronautical Commander’s Group

Manufacturers Standardization Society of the Valve and Fittings Industry, Inc. (MSS)

Marine Spill Response Corporation

Marine Technology Society

National Association of Corrosion Engineers

National Association of Regulatory Utility Commissioner

National Board of Boiler and Pressure Vessel Inspectors

National Cargo Bureau, Inc.

National Committee on International Trade Documentation
A-39

National Committee on Uniform Traffic Control Devices (NCUTCD)

National Committee on Uniform Traffic Laws and Ordinances (NCTLO)

National Council on Radiation Protection and Measurements

National Electrical Manufacturers Association

National Fire Protection Association (NFPA)

National Marine Electronics Association

National Marine Manufacturers Association

National Motor Freight Traffic Association

National Sanitation Foundation

National Standards for School Transportation

National Transportation Communications for Intelligent Protocol Joints Standards Group 

Committee

North American Industrial Classification System (NAICS)

One-call Systems International

Open Group

Open Software Foundation (OSF)

Organization for Economic Cooperation and Development (OECD)

Petroleum Education Council

Pipeline Committee of the Transportation Research Board

Pipeline Research Committee International

Prestressed Concrete Institute

Radio Technical Commission for Aeronautics (RTCA)

Rehabilitation Engineering Society of North America (RESNA)

Society of Automotive Engineers (SAE)

Society of Naval Architects and Marine Engineers (SNAME)

Truck Trailer Manufacturers Association (TTMA)

Underwriters Laboratories, Radio Technical Commission for Maritime Services

U.S. Working Advisory Group 8 for Public Transportation and Emergency Services

Standards Replaced as a Result of the Five-Year Review

The consistent examination of regulations is a policy shared by all of the DOT agencies. RSPA,

for example, has replaced 22 standards with voluntary standards as a result of its five-year review

cycle. Each of its offices is continually examining its regulations, and nearly every standard

adopted has been updated to reflect the most recent edition based on staff participation in

standards committee activities. For example the Office of Pipeline Safety is reviewing

rulemakings to adopt standards that will substitute for the existing government-unique

regulations for aboveground oil storage tanks, corrosion protection procedures and facilities, and

computational pipeline monitoring systems. These rulemaking will be completed during the next

four to six months. The Office of Hazardous Safety Materials Safety has under review

rulemakings that will substitute for the existing government-unique regulations for manufacture,

testing, and retesting of cylinders to be used in compressed gas service. 
A-40

Additionally, the USCG has substituted 3 voluntary standards for government-unique standards

in following regulations: (1) National Fire Protection Association (NFPA) 13-1996, Standard for

the Installation of Sprinkler Systems, in subpart 34.30, section 76.25-1, subpart 95.30, section

108.430, and subpart 193.30 of Harmonization with International Safety Standards Final Rule

(CGD 95-028) (62 FR 5118 - September 30, 1997; (2) National Fire Protection Association

(NFPA) 13-1996, Standard for the Installation of Sprinkler Systems, in sections 116.439 and

116.440 of Small Passenger Vessel Inspection and Certification Final Rule (CGD 85-080) (62

FR 51326 - September 30, 1997); and (3) Underwriters laboratories UL 1191, Standards for

Components for Personal Flotation Devices, May 16, 1996, in section 164.013-3 of

Harmonization with International Safety Standards Final Rule (CGD 95-028) (62 FR 51188 -

September 30, 1997).

Finally, while FRA has not yet had the opportunity to replace existing standards, it intends to

investigate such possibilities and implement such changes as existing rules are reviewed and

revised.

Future Implementation of Circular A-119

Although the revised Circular has not yet been released, the Department of Transportation has

already begun its preparations for meeting the expected, new requirements. Individually, the

DOT agencies are taking actions appropriate to their legislative mandates. The USCG, for

example, has established Headquarters Notice 5420 which keeps track of all committee

membership listings, including employee participation with voluntary consensus standards

groups. Furthermore, to ensure a timely review of all consensus standards adopted by the USCG,

all standards are examined on an ongoing basis. 

DOT discussed what changes would have to be made in order to efficiently implement the

directives of the revised Circular. Some ideas that are being considered are: a department-wide

database of voluntary consensus standards organizations in which DOT employees participate; a

statement addressing the Circular which would be added to the text of all final rules; and other

suggestions that would facilitate and coordinate the participation in and implementation of

Circular A-119. 

This year, NHTSA had one instance in which it used a government-unique standard in lieu of a

voluntary standard in fiscal 1997 which was Air Bag Warning Label. This label uses yellow as

the background color, instead of orange, in accordance with an ANSI standard, and uses a

graphic developed by Chrysler Corporation to depict the hazards of being too close to an air bag,

instead of the graphic recommended by the ISO. These decisions were based on focus group

testing sponsored by the agency which strongly indicated that these unique requirements would

be far more effective with respect to safety than the industry standards. The decisions not to use

the industry standards were explained in detail in the final rule on this subject.
A-41

Additionally, the USCG reported that it used a government-unique standard in lieu of a voluntary

consensus standard with respect to the tank level or pressure monitoring devices temporary rule. 

The rule established minimum performance standards for tank level or pressure monitoring

devices for single-hull tank vessels that carry oil in bulk on cargo. The reason for adopting such

a government-unique standard is because, at the present time, there are no existing voluntary

standards for tank level or pressure monitoring devices.
A-42

DEPARTMENT OF TREASURY (TREASURY)

1) The number of voluntary consensus standards bodies in which there is agency

participation, and the number of agency employees participating;

The Department participated in ten voluntary consensus standards bodies that

accounted for approximately twenty-five employees participating.

2) The number of voluntary consensus standards the agency has used since October 1,

1996 (or, as appropriate, those based on the procedures set forth in Section 8 of the

proposed revision to the Circular);

The Department has used three voluntary consensus standards since October 1, 1996. 

Customs continues to support two government-unique standards which are CATAIR

and CAMTR. CATAIR is used by the Customs brokerage industry and CAMIR is

used by some parties in the transportation sector.

3) Identification of voluntary consensus standards that have been substituted for

government-unique standards as a result of an agency review of existing standards

(or as outlined under paragraph 7c(6) of the proposed revision to the Circular);

No government-unique standards have been substituted by voluntary consensus

standards as a result of agency review of existing standards. The maintenance of the

government-unique standards within Customs applications, the CATAIR and CAMIR

formats, are at the request of the participating industry groups that use those standards.

4) An evaluation of the effectiveness of the guidelines in Section 7 of the proposed

revision to the Circular and recommendations for any changes;

We believe that the guidelines in Section 7 and the proposed revision to the Circular

are effective. Use of voluntary standards facilitates our ability to respond to rapidly

changing technology and to meet the needs of the government and the public in a

timely manner.

1) The nature and extent of the Department's participation in the development and uses of

voluntary consensus standards are as follows:

 • Accredited Standards Committee X12 (ASC X12) on Electronic Data Interchange

(EDI), accredited by the American National Standards Institute (ANSI): ANSI ASC X12

sets U.S. standards for Electronic Data Interchange, develops U.S. EDI applications and

coordinates standards activities with the Pan American Electronic Data Interchange
A-43

For Administration, Commerce, and Transport (EDIFACT) Board. The Pan

American EDIFACT Board is responsible for setting international standards for EDI.

Three Treasury bureaus’ representatives are active voting members of ASC X12. 

These bureaus are the Internal Revenue Service (IRS), the U.S. Customs Service, and

the Financial Management Service (FMS). The Departments’ participation enables the

representatives to advocate for the completion of standards pertinent to the

Department's business needs, and to understand the evolution of these open standards.

Customs chairs Task Group 9 under the Transportation Subcommittee (I) of the ANSI

ASC X12 Committee. This group develops and maintains all transaction sets and

record segments in the Customs transaction sets.

The FMS representative holds the elected position as Co-Chairs for Task Group 2

(Payments and Invoices) within the ASC X 12 Finance Subcommittee (F). The

Finance Subcommittee maintains all financial transaction sets for ANSI ASC X12 that

includes payment and collection standards used by FMS.

Two IRS representatives are voting members of ASC X12: one representative is the

primary voting member, the other acts as the alternate. Additionally, IRS and Customs

play an active role in the Pan American EDIFACT Board. A representative from the

Departmental Offices/Chief Information Officer’s staff member (DO/CIO) serves as

the Government Delegate to the Pan American EDIFACT Board.

 • The National Automated Clearing House Association (NACHA) is the regulatory

body for the Automated Clearing House (ACH) Network. NACHA maintains and

develops ACH payment standards and oversees policy of ACH Network and various

regional ACH associations. FMS follow NACHA rules and uses the ACH Network in

disbursement and collection activities for the Federal Government. FMS also

participate in various NACHA work groups to review and revise ACH operating

procedures. 

 • Customs continues to participates in the NCBFAA ABI Automation Committee

standards development body. This joint Customs/industry committee establishes

standards and certification criteria for exchange of data between Customs and

automated importers and brokers. Customs has eight official members on this

Committee.

 • The Open Group User's Council (formerly X/Open): The Open Group is an

independent open systems standard setting organization with members worldwide. 
A-44

The Open Group publishes open systems standards and brands products that are

compliant with its standards.

The IRS currently has one representative to the Open Group User's Council, to keep

abreast of industry's use of open systems standards.

 • Electronic Messaging Association: The Electronic Messaging Association is a

voluntary association of vendors and users of electronic messaging products and

services which influence’s industry standards both nationally and internationally. A

Treasury’s representative serves on the EMA Board of Directors, and is the only

representative of a Federal agency to do so. In April of 1997, EMA recognized

Treasury as its Messaging User of the Year at its annual conference. This recognition

was based on its agency wide and interagency efforts to establish interoperable

electronic messaging services based on industry standards.

A representative from the DO/CIO is a board member. In addition, representatives

from the IRS and the Bureau of Alcohol, Tobacco and Firearms (ATF) also participate

in this voluntary standard group. 

 • The U.S. Secret Service (USSS) and DO/CIO participates in a joint government and

industry effort developing narrow-band digital land mobile radio standards. This effort

is known as Project-25. Project 25 standards are forwarded to the

Telecommunications Industry Association (TIA) TR8 Engineering Committee for

ballot and later published as TIA/EIA-102 Technical Service Bulletins or Technical

Standards. The Department has adopted these voluntary consensus standards for its

next generation of land mobile radio systems.

The DO/CIO representative, representing the Federal Law Enforcement Wireless Users

Group (FLEWUG), is a full voting member of the Project 25 Steering Committee. 

Currently, Project-25 has four USSS employees and one DO/CIO employee

representing the Department.

 • IEEE’s Year 2000 Terminology Study Group of the Portable Applications

Standards Committee addresses the key industry concern over the existence of

multiple terms and lexicons that carry varied meanings. IEEE has formed this group to

establish a standard to help individuals and organizations in developing Year 2000

solutions. Having a baseline set of terms and definitions that can serve as a foundation

for such efforts is vital. With this effort, the IEEE has established test method's and 

recommended practice group, to provide the framework for detailed planning and

execution, of all steps and tasks involved in testing for Year 2000 compliance.

The DO/CIO staff has one active participant on both committees.
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The Department's Chief Information Official with agency-wide responsibility for standards

activity is:

 Mr. James J. Flyzik

 Deputy Assistant Secretary

 (Information Systems) and

 Chief Information Officer

 1500 Pennsylvania Avenue, NW, Room 2464

 Washington, D.C. 20220

 Tel.: (202) 622-1200 Fax: (202) 622-2224
A-46

DEPARTMENT OF VETERANS AFFAIRS (VA)

The following information was requested from the Department of Commerce for inclusion in the

1997 Annual Report to the Office of Management and Budget (OMB).

1. The number of voluntary consensus standards bodies in which there is agency participation, as

well as the number of agency employees participating.

We have 26 employees participating in 28 voluntary consensus standards bodies.

2. The number of voluntary consensus standards the agency has used since October 1, 1996 (or,

as appropriate, those based on the procedures set forth in section 8 of the proposed revision to the

circular).

None

3. Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of an agency review of existing standards (or as outlined under

paragraph 7c(6) of the proposed revision to the circular).

None

4. An evaluation of the effectiveness of the guidelines in section 7 of the proposed revision to

the circular and commendations for any changes and recommendations for any changes.

The proposed revision to the circular will have no side effects to our present Department goal. 

We accept and conform to standards developed by the Joint Commission on the Accreditation of

Hospitals Organizations (JCAHO) for the VA health care system in order to obtain JCAHO

certification of VA health care facilities. Standards as outlined in the accreditation program for

hospitals, psychiatric facilities, mental health centers, long-term and hospice programs,

ambulatory health care facilities, community nursing homes under accreditation standards

(National Fire Protection Association, Life Safety Code requirements, and other building,

plumbing, electrical, mechanical, and equipment standards/requirements) continue to be utilized

in the regulatory, contractual, and grant determinations executed by the Veterans Health

Administration. Standards are benchmarked with both private and public sectors to assure

industry compliance, cost-effectiveness and quality control. These national standards have been

adopted by industry and are familiar to those in the building profession.

5. As required by Public Law 104-113, when the agency used government-unique standards in

lieu of voluntary consensus standards.
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None

Appendix B: Independent Agency Reports
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U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC)

The Consumer Product Safety Act (CPSA), as amended, requires the Commission to defer to

issued voluntary standards, rather than promulgate mandatory standards, when the voluntary

standards would eliminate or adequately reduce the risk of injury addressed and it is likely that

there will be substantial compliance with the voluntary standards. In addition, the Commission is

required, after any notice or advance notice of proposed rulemaking, to provide technical and

administrative assistance to persons or groups who propose to develop or modify an appropriate

voluntary standard. Additionally, the Commission is encouraged to provide technical and

administrative assistance to groups developing product safety standards and test methods, taking

into account Commission resources and priorities.

Since its inception in 1973, the Commission has promoted the development of voluntary product

safety standards. Policy statements in support of voluntary standards were published by the

CPSC in 1975 and 1978. These policy statements were updated in 1988 (16 U.S.C. 1031), and a

staff directive on implementation of portions of these policy statements was promulgated in

October 1989.

Since the principles set forth in the revised OMB Circular A-119 Rev. were published, they have

been consistently supported by the Commission. The CPSC Voluntary Standards Coordinator

also serves as CPSC's Standards Executive for the purpose of implementing OMB Circular A119 and provides general oversight for staff involvement in existing standards projects including

the development of strategies for increasing the level of involvement by the staff in voluntary

standards activities. The Voluntary Standards Coordinator provides the Commission with reports

on voluntary standards activities as well as provides similar information for the Commission's

Annual Report.

The Commission's efforts to enhance voluntary standards development is complemented by the

overall Federal policy set forth in the Circular. 

The Commission had 22 employees directly participating in 46 voluntary standards development

projects during FY 1997. Since October 1, 1996, the Commission has not incorporated in

regulations portions of voluntary standards which resulted from agency participation in a

standards development group. During FY 1997, there were no voluntary consensus standards

that were substituted for government-unique standards as a result of an agency review of existing

standards. CPSC involvement in voluntary standards activities was consistent with the "Policy

for Federal Participation in Voluntary Consensus Standards Bodies" as set forth in Section 7 of

the proposed revision to Circular A-119 Revised. There are no recommendations for changes at

this time. 

As part of the implementation of the provisions of the Circular the following CPSC

representative was appointed the agency Standards Executive:
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Mr. Colin B. Church

Voluntary Standards and International

Activities Coordinator

U.S. Consumer Product Safety Commission

Room 702

Washington, D.C. 20207

Tel. 301-504-0554 ext. 2229

Fax. 301-504-0407

E-mail: cchurch@cpsc.gov

The executive establishes agency views on standards issues and decisions through Commission

response to staff briefing packages and recommendations. These views are reflected in the

Commission's Operating Plan and Budget. Coordinating participation within the Commission

and with others in voluntary standards activities is a responsibility of the Voluntary Standards

Coordinator. Likewise the Voluntary Standards Coordinator is responsible for meeting reporting

requirements applicable to voluntary standards involvement of Commission staff. 
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U.S. ENVIRONMENTAL PROTECTION AGENCY (EPA)

The U.S. Environmental Protection Agency is pleased to submit the following report on the

status of the Agency's implementation of the National Technology Transfer and Advancement

Act, Sec. 12. (P.L. 104-113) and the current proposed OMB Circular A-119: "Federal

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

Activities". This submittal provides required information for the Agency's annual report on

Standards Policy Activities as outlined in the latest proposed revision to Circular A-119. 

In addition, the report will also indicate improvements EPA has undertaken to facilitate the

Agency's commitment to effective participation in the development and use of voluntary

consensus standards. Examples of some current and future activities illustrate this commitment. 

The two most significant advancements made in the past year are:

1. Establishment of a procedural mechanism, and a corresponding written guideline, by

which rule writers now routinely check adherence to the NTTAA and,

2. Establishment of an electronic data base search mechanism and early alert service by

which anyone in the Agency can retrieve current information on existing and proposed voluntary

standards.

EPA is in the process of developing an improved internal tracking system for monitoring Agency

participation in standards activities and is also providing standards-related training to employees. 

EPA continues to be an active member of the Interagency Committee on Standards Policy (ICSP)

chaired by the National Institute on Standards and Technology (NIST). 

ANNUAL REQUIRED INFORMATION

1. The number of voluntary consensus standards bodies and conformity assessment

bodies in which there is Agency participation and the number of employees participating. 

Approximately 200 EPA employees participate in the following standards bodies: 

< The American National Standards Institute (ANSI)

< ANSI / Registrar Accreditation Board Council for ISO 14001

< Registrar Accreditation Board Council for ISO 9000

< NACLA, Laboratory Accreditation 

< ASTM, (formerly known as the American Society of Testing and Materials)

< The National Sanitation Foundation, (NSF International)

< The American Society of Quality Control (ASQC)

< The Society of Automotive Engineers (SAE)

< Underwriters Laboratory (UL)
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< The International Organization for Standardization (ISO)

< The International Electrotechnical Commission (IEC)

2. The number of voluntary consensus standards the agency has used since 

October 1, 1996.

While EPA is putting its tracking system in place at the end of FY 1997 and the beginning of FY

1998, the Agency is, nevertheless, able to report that numerous voluntary consensus standards are

used in its regulations. We searched EPA’s final regulations published in FY 1997 and found the

following:

< 16 final rules use, or make reference to, ASTM standards; each rule cites between 1 and

15 ASTM standards each;

< 4 final rules referred to SAE materials (specifications, recommended practices, and

papers); each rule cites between 1 and 3 SAE documents;

< 5 final rules cited Standard Methods, each referencing between 1 and 6 standards; these

examples normally also cited standards of American Public Health Association, the

American Water Works Association, and the Water Environmental Federation;

< 3 final rules cited ISO, with each referencing either 1 or 2 standards;

< 2 final rules used ASME standards; each rule cited between 1 and 6 standards; and 

< 1 final rule cited a standard of ASQC.

3. Identification of voluntary consensus standards that have been substituted for

government -unique standards as a result of an agency review of existing standards.

Reviews are conducted through each media-specific office. While some Offices are in the

process of getting trained on voluntary standards and undertaking reviews, the Office of Air and

Radiation, Emission Measurement Center (EMC) and the Office of Research and Development,

Quality Assurance Division have completed several important reviews and updates in 1996

which resulted in the following:

< EMC, working with ASTM, completed a review of all regulations and updated all ASTM

 references to current versions. Much of this work required public notification. 

 Citing outdated ASTM standards was, in effect, supporting government-unique

 standards. This duplication has been eliminated. 

< EMC's final revised PS-1 rule incorporated by reference a new Quality Control

 Document generated by the ASTM D-22 Committee which undertook its work

 specifically to address the Agency's quality control needs in the area of defining

 methods for measuring opacity of particulates in stacks. 

< EMC and the National Electrical Manufacturers Association successfully
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 partnered with ASTM to produce acceptable, alternative methods for

 measurements of surface coatings, since EPA's Method 24 did not work well for

 some applications. The alternative ASTM methods have been published

 through the EMC procedures documents. 

< In ORD's Quality Assurance office, EPA Order 5360.1 is currently in the Agency

 Directives Clearance Process and invokes the ANSI/ASQC E4-1994 standard as

 the basis for EPA's quality system. This will further lead to changes in the

 extramural agreement regulations pertaining to quality. For example, 40 CFR

 30 for non-profit organizations receiving financial assistance has already been

 revised to require conformance to E4. 

4. Evaluation of the effectiveness of the guidelines in Section 7 of the proposed revision

to the Circular and recommendations for any changes.

EPA has been an active participant in the admirably open process through which OMB and NIST

have developed the revisions to OMB Circular A-119 that are necessary to implement the

National Technology Transfer Act. EPA helped lead a Regulatory Agencies Workgroup

considering the various drafts of the Circular; the Agency participated in meetings of the

Interagency Committee on Standards Policy where features of NTTAA and the draft Circular

were discussed; and EPA submitted two sets of written comments during the public comment

period. The Agency is in the process of implementing the NTTAA and A-119, as we expect it

will be ultimately promulgated. 

We are quite satisfied with the draft procedures at the moment. We will, however, continue to

coordinate with other agencies through the Regulatory Agencies Workgroup and the ICSP to

compare approaches, to identify inconsistencies and problems, and to collaboratively attempt to

resolve issues. As a result of this process and, with the benefit of more experience in

implementing the Act and Circular, we may suggest potential improvements to A-119.

5. As required by P.L. 104-113, report on Agency use of government-unique standards in

lieu of voluntary consensus standards.

As explained elsewhere in this report, EPA is currently in the process of putting in place the

procedures necessary to accurately track the consideration and use of voluntary consensus

standards in Agency regulations. These procedures will provide for rule writers’ insertions of

statements about NTTAA implementation into published preambles to regulations. This will

allow the Agency to capture examples of, and explanations for, those times when we use

government-unique standards in lieu of voluntary consensus standards. For FY 1997, the

Agency is not able to report on any instances of these decisions.
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OTHER STANDARDS-RELATED ACTIVITIES

Throughout 1996 EPA employees continued to be active participants in several key U.S.

Technical Advisory Groups to Committees within the International Organization for

Standardization (ISO). These include ISO's Technical Committee 207 for Environmental

Management Standards -- the ISO 14000 series of standards, Technical Committee 179 for

Quality Management -- the ISO 9000 series and Technical Committee 146 for Air Quality. 

The Agency also successfully continued its work in the Organization for Economic Cooperation

and Development (OECD),with governments and private sector participants, on the development

and implementation of Good Laboratory Practice Guidelines. 

PLANS FOR ENHANCEMENTS

One of the most significant developments underway is the establishment of an Agency-wide

electronic system which can make use of the National Standards Service Network (NSSN)

developed and maintained by ANSI, through cooperative government-private sector funding. 

The NSSN will allow Agency rule writers to easily and accurately search for national and

international voluntary standards. This includes standards that are proposed for development as

well as existing, final standards. Through this process, EPA will help ensure that employees are

alerted to standards and the opportunity for participation in relevant standards development

activities. 

 

In 1998 the Alert Service of the NSSN will be set up and made operational within EPA. In

addition to the search capabilities of the NSSN, Agency employees can be altered, via Agency Email, to any activity on specific standards of interest. This will enhance the ability of both the

standards bodies and the Agency to take advantage of early-as-possible collaboration on areas of

critical interest.

RESPONSE TO NIST’S INVITATION TO PROVIDE SUPPLEMENTARY

INFORMATION ABOUT NEW AGENCY DIRECTIVES, GUIDELINES OR POLICY

STATEMENTS RELATING TO A-119 PRINCIPLES AND OBJECTIVES

EPA is actively engaged in several activities designed to ensure full implementation of the

NTTAA and Circular A-119 at the Agency.

A subcommittee of the EPA’s intra-Agency Regulatory Steering Committee has convened to

develop guidance for the Agency’s rule writers. Its first task was the creation of the “Interim

Guidance on Rulemaking Requirements of the National Technology Transfer and Advancement

Act (NTTAA).” The subcommittee intended this document to provide temporary guidance
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pending the ultimate promulgation of OMB Circular A-119. Attached is the August 6, 1997,

transmittal memorandum along with the “EPA Rule Writer’s Checklist for Voluntary Consensus

Standards.” These documents have since been provided to all EPA offices engaged in writing

regulations. Briefings about the guidance have been provided within various divisions of the

Office of General Counsel and other offices on request. 

As a result of this effort, an increasing number of EPA’s regulatory documents published in the

Federal Register contain preamble sections entitled “National Technology Transfer Act.” In

accordance with the Interim Guidance, these sections summarize the requirements of the

NTTAA; describe the Agency’s efforts to identify potentially applicable voluntary consensus

standards; identify those standards EPA intends to use in the rule, or explains why the use of

particular voluntary consensus standards would be inconsistent with applicable law or otherwise

impractical; and, for proposed rules, solicits comments from the public both as to additional

voluntary consensus standards the Agency should consider and about EPA’s analysis under

NTTAA. During FY 1997, there were only three direct references to NTTAA. In FY 1998, we

expect a substantial increase in such references. 

In an activity related to the use of voluntary consensus standards under NTTAA, the Agency

plans to implement a Performance Based Measurement System (PBMS) for environmental

monitoring in all its media programs, to the extent feasible. In a Federal Register notice signed

by the Administrator and published at 62 FR 52098 (October 6, 1997), EPA explained:

The Agency defines PBMS as a set of processes wherein the data quality needs, mandates

or limitations of a program or project are specified, and serve a criteria for selecting

appropriate methods to meet those needs in a cost-effective manner. Where PBMS is

implemented, the regulated community would be able to select any appropriate analytical

test method for use in complying with EPA regulations. It is EPA’s intent that

implementation of PBMS have the overall effect of improving data quality and

encouraging advancement of analytical technologies. The Agency anticipates proposing

amendments to certain of its regulations, as needed, to incorporate PBMS into its

regulatory programs. 

EPA expects the implementation of PBMS to be consistent with the expanded use of voluntary

consensus standards. Where such standards meet the criteria for environmental monitoring set

out in programmatic regulations, they may be used by the regulated community. The Agency

expects that PBMS will reduce the problems associated with the explicit incorporation into

regulations of out-of-date versions of voluntary consensus standards; setting out the criteria for

selecting appropriate methods, rather than prescribing particular, dated, methods, should

facilitate the use of updated, improved methods. 

The subcommittee of the Regulatory Steering Committee is now developing more

comprehensive, permanent guidance to implement NTTAA and A-119. Starting with a detailed

analysis of the decision-making process that needs to be followed to implement NTTAA, the
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subcommittee will identify specific elements of the process which are to be documented in

regulatory preambles. The comprehensive document will also provide expanded guidance about

how to search for potentially applicable voluntary consensus standards; how to decide whether a

standard can be used or must be rejected as “impractical” by the Agency; and how to use PBMS. 

The comprehensive guidance will also address requirements flowing from international

agreements related to trade and environment and international harmonization. 

Following the development of the comprehensive guidance for rule writers, EPA intends to

develop guidance to employees about participating in the standard-setting activities of voluntary

consensus standards bodies. This guidance will build on the provisions of A-119 and will, to the

extent feasible, be coordinated with other agencies. 

Attachment 
B-11

August 6, 1997

MEMORANDUM

SUBJECT: Interim Guidance on Rulemaking Requirements of the National Technology

Transfer and Advancement Act (NTTAA)

FROM: Thomas E. Kelly, Director /s/

Office of Regulatory Management and Information

TO: Regulatory Policy Council (see Addressees)

The National Technology Transfer and Advancement Act (NTTAA) was effective in

March 1996 and requires agencies to use “technical standards that are developed or adopted by

voluntary consensus standards bodies” to carry out policy objectives or activities. “Technical

standards” are “performance-based or design-specific technical specifications and related

management systems practices.” To encourage uniform Agency-wide compliance with the rulerelated aspects of NTTAA, I am asking program offices to immediately begin using the attached

interim checklist for all rules under development. 

This checklist, prepared by a cross-agency work group, outlines the basic requirements of

NTTAA and gives enough guidance to inform and lead a rule writer through those requirements. 

Bear in mind that the work group that prepared this checklist is also developing a more

comprehensive guidance document for rule writers. This latter document will address all of the

standards-related considerations for Agency rule-making activities, as well as further clarifying

our responsibilities under NTTAA. Among other things, this will include suggested language

for rule preambles, additional methods for locating potentially useful standards, and means of

evaluating existing standards. 

OMB has proposed but not finalized a revision to Circular A-119, Federal Participation

in the Development and Use of Voluntary Standards. A-119 will provide government-wide

interpretations of the NTTAA and our comprehensive guidance will supplement the provisions

established by OMB. During the interim period before Agency and OMB guidance is completed,

rule writers should rely on the checklist and work with their program office’s Regulatory

Steering Committee Representative and their OGC representative for additional help.

Because the requirements are applicable now, we must try to implement the Act’s

requirements as fully as possible, even for regulations in the pipeline, and including those that

have already been proposed. For example, if your comment period has already closed for a

proposed rule that contains technical standards, you should still check the sources identified in

the checklist to identify any potentially applicable voluntary consensus standards. If you do
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identify one, or if a commenter has already suggested consideration of a particular voluntary

consensus standard, be sure to address it. If you determine that a voluntary consensus standard

shows promise for Agency adoption, you should consider issuing a supplemental notice, if

practicable. Alternatively, if you decide not to use the standard, explain your reasons in the final

rule.

As you may know, the scope of NTTAA goes beyond rule-making considerations. The

Act requires Federal agencies to participate in the standards development activities of voluntary

consensus standards bodies (such as ASTM) when such participation would be in the public

interest and compatible with the Agency’s mission, authorities, priorities, and budget resources. 

This would further the goals of the Agency by facilitating compliance with the rule-making

aspect of the Act, complementing our commitment to reach key stakeholders, and potentially

reducing the cost and burden of Federal regulation. Such firsthand involvement would also

provide an opportunity to influence the outcome of these activities in a manner that meets the

Agency’s goals and objectives, as well as those of other participants in the process. The

officially designated EPA Standards Executive, Pep Fuller of OPPTS, will be providing guidance

on Agency participation in the future.

 

As I mentioned earlier, the comprehensive guidance for rule writers will address other

important standards-related regulatory issues. For the sake of expediency and to avoid confusion,

these issues were not covered in this interim checklist. The future guidance will more fully

explain the rule-making requirements of the NTTAA, and deal with the rule-making implications

of several other standards-related topics, as follows:

! The Deputy Administrator’s recent decision concerning the implementation of the

Performance Based Measurement System (PBMS) in all programs will be relevant to

Agency rule writers. This policy will influence the Agency’s deliberative process and

will affect our consideration of alternative technical standards and approaches. (Each

program has been charged with developing an implementation plan.) 

! The United States is party to an increasing number of international environmental and

trade agreements which explicitly require the use of international standards if they

provide an acceptable level of protection. We need to take U.S. obligations under these

international agreements into account when we set domestic environmental standards if

we are to avoid international legal disputes. 

If you have any preliminary questions about these guidelines, you can contact Michael McDavit

of my staff at 260-7202, or Craig Annear in OGC at 260-5328.

Attachment
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Addressees:

Fred Hansen, Deputy Administrator 

Margaret Schneider, OA

Dana Minerva, OW

Mahesh Podar, OW

Cynthia Puskar, OW

Rob Wolcott, OPPE

Susan Wayland, OPPTS

Angela Hofmann, OPPTS

David Doniger, OAR 

Robert Brenner, OAR 

Richard Wilson, OAR 

Tom Eagles, OAR 

Barbara Hostage, OSWER 

Michael Shapiro, OSWER 

Scott Fulton, OGC 

Nancy Ketcham-Colwill, OGC 

Jim Nelson, OGC 

Sylvia Lowrance, OECA 

Jon Silberman, OECA 

Jay Benforado, Reinvention Team

Shelley Metzenbaum, OROSLR 

John Sandy, OARM 

Lynne Ross, OCLA 

Julie Anderson, OCLA 

Karen Brown, OSDBU 

Dorothy Patton, ORD

Kevin Teichman, ORD 

Elaine Wright, CSI 

Stan Laskowski, Region III

cc:

Steering Committee Representatives

Standards Coordinators
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EPA RULE WRITER’S CHECKLIST FOR

VOLUNTARY CONSENSUS STANDARDS

Interim Internal Guidance for Complying with the National Technology Transfer &

Advancement Act of 1995 (NTTAA)

1. WHAT IS THE NTTAA?

Section 12 of the National Technology Transfer & Advancement Act of 1995 (Attached)

is intended to avoid “re-inventing the wheel”. It aims to reduce the costs to the private and

public sectors by requiring Federal agencies to draw upon any existing, suitable technical

standards used in commerce or industry. To comply with the Act, which went into effect in

March 1996, EPA must consider and use “voluntary consensus standards” (VCS’s), if available

and applicable, when implementing policies and programs, unless doing so would be

“inconsistent with applicable law or otherwise impractical”. This checklist briefly describes how

the NTTAA affects the development of new rules at EPA. OMB must report annually to

Congress any decisions by EPA and other agencies to use a government-unique standard in lieu

of an existing VCS, along with an explanation.

2. WHAT IS THE PURPOSE OF THIS CHECKLIST?

This checklist serves as interim guidance for rule writers while an Agency work group

develops more detailed guidance, and OMB completes the revisions to Circular A-119, Federal

Participation in the Development and Use of Voluntary Standards. OMB Circular A-119 will

provide Government-wide interpretations of the NTTAA. In the absence of OMB guidance and

until more detailed Agency guidance is produced, this checklist shall be used in the development

of all EPA rules.

3. WHAT IS A VOLUNTARY CONSENSUS STANDARD?

A “voluntary consensus standard” is a technical standard developed or adopted by a

legitimate standards-developing organization (“voluntary consensus standards body”). The Act

defines “technical standards” as “performance-based or design-specific technical specifications

and related management systems practices.” According to NTTAA’s legislative history, a

“technical standard” pertains to “products and processes, such as the size, strength, or technical

performance of a product, process or material”. A legitimate standards-developing organization

must produce standards by consensus and observe the principles of due process, openness, and

balance of interests. 

Examples of organizations generally regarded as voluntary consensus standards bodies

include the American Society for Testing and Materials (ASTM), International Organization for

Standardization (ISO), International Electrotechnical Commission (IEC),
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American Petroleum Institute (API), National Fire Protection Association (NFPA) and Society of

Automotive Engineers (SAE).

The well-known American National Standards Institute (ANSI) evaluates the standards

development processes of these bodies and, when requested by one of them, certifies standards

meeting the above criteria as American National Standards. Such a designation is an important

indicator for determining whether a given standard qualifies as a legitimate voluntary consensus

standard.

While you should search for all potentially useful standards, EPA is not required to give

even limited deference under NTTAA to a standard which does not qualify as a “voluntary

consensus standard.” You may seek the advice of OGC in making this determination and in

drafting the rationale. If you have any questions, consult with the OGC staff attorney on the rule

or contact your Regulatory Steering Committee Representative (see attached list).

4. WHICH RULES ARE LIKELY TO INVOLVE VCS’S? 

If your rule establishes a technical standard, like a special method for collecting a water

sample, or a new field or laboratory procedure for measuring a chemical parameter, it is very

likely that there are existing VCS’s that you will need to consider in the development of the

regulation.

For the purposes of EPA, the most common, potentially useful VCS’s include field and

laboratory test methods, sampling protocols and material specifications. Depending on the

subject of your rule, however, there may be other less likely types of VCS’s which could apply

(e.g., quality and environmental management systems, business practices, definitional standards

and installation safety codes).

In most cases, rule writers should seek out and consider any and all potentially-applicable

VCS’s, either domestic or international, which might be used to carry out some or all of the

rule’s objectives. If your rule, however, does not involve the establishment or modification of

technical standards, you have neither an obligation to address the rulemaking requirements of

NTTAA nor to discuss the matter in the preamble to your rule.

5. WHERE DO YOU FIND POTENTIAL VCS’S FOR NEW RULES?

# The National Standards System Network (NSSN), a consolidated database maintained by

ANSI, provides highlights of technical standards from different standards organizations. 

The web-site, “http://www.nssn.org”, provides basic information about more than

250,000 VCS’s from over 600 standards setting bodies. Any on-line user may make

simple word search queries. To make your search even simpler, the EPA Standards

Network is planning to make “enhanced” NSSN services available Agency-wide in the

near future. (Visit the web site for details on the scope of these services.)
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# The National Center for Standards and Certification Information, a telephone service

provided by the National Institute of Standards and Technology (NIST) at (301)-975-

4040, provides free library research on applicable standards.

# Your program office’s Standards Coordinator (see attached list) may have other ideas

about how to identify standards which may be applicable to your rule. 

# Seek public comment on potentially-applicable VCS’s during the rule-making process

(see below), both during stakeholder outreach and as part of the notice and comment

phase for a proposed rule.

6. HOW SHOULD YOU ADDRESS THE NTTAA IN ADVANCE NOTICES OF

PROPOSED RULE-MAKING AND PROPOSED RULES?

# Include a brief discussion of NTTAA and its rule-related requirements in the rule’s

preamble.

# Solicit public comment on the use of VCS’s in ANPRMs and NPRMs. 

# If you have identified a VCS for possible inclusion in the rule, identify the VCS and

explain why EPA is considering using it. Request comment on the Agency’s tentative

position. 

# If you have initially decided not to propose the use of an existing VCS, explain your

reasoning. Request comment on the proposed decision.

# Request comments from the public on the existence of VCS’s that should be

considered for inclusion in your rule.

7. WHAT ARE THE REQUIREMENTS FOR FINAL RULES?

# Include a brief discussion of NTTAA and its rule-related requirements in the rule’s

preamble.

# Describe your efforts to find potential VCS’s (specifically mention any outreach

activities that you have conducted with voluntary consensus standards bodies). 

# If you elect to use an existing VCS, identify the VCS and any alternatives that you

considered and explain the decision. (This is in addition to the basic rulemaking

requirement that EPA provide an appropriate explanation for its regulatory decisions.)
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# If you elect not to use an existing, potentially-applicable VCS in your rule, identify

the VCS and explain how the use of it would be inconsistent with applicable law or

otherwise impractical.

8. WHERE IN THE PREAMBLE DO YOU PLACE THE NTTAA DISCUSSION

# In your NPRM and FRM, include any detailed NTTAA discussions in a separate

section in an appropriate location within the “Supplementary Information” section of

the preamble.

# Include summary information at the end of the preamble, in a section titled “National

Technology Transfer and Advancement Act”, along with the other Regulatory

Assessment Requirements. (The summary statements will be extracted for inclusion

in the annual report that OMB is required to send to Congress. The Agency work

group is developing template language for this section.) 

9. HOW DO YOU REFERENCE ADOPTED VCS’S?

# If a VCS was suggested by comment, you should address it in your response to

comments section of the preamble and your response to comments document in the

docket. A summary explanation must also be in the NTTAA Section.

# Typically, the text of a VCS may not be quoted in a rule. Rather, it must be

incorporated by reference. To incorporate a VCS by reference, you must have written

approval from the Federal Register Office. At least three weeks prior to signature,

initiate a formal request to the Director of the Federal Register for approval to

incorporate a voluntary consensus standard by reference. (Attached procedures

provide additional information on this topic.)

Attachments:

List of Regulatory Steering Committee Members

List of EPA Standards Coordinators

Copy of the NTTAA, § 12

Copy of Incorporation by Reference Procedures
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LIST OF REGULATORY STEERING COMMITTEE MEMBERS

(Alternates in parentheses) (as of 8/1/97)

CHAIR THOMAS KELLY (Paul Lapsley, 260-5480)

Office of Regulatory Management and Information (ORMI) 

2136, W1017, 260-4001, FAX: 260-0513

ORD BURNELL VINCENT

Office of Research and Development

8105, W603, 260-0591, FAX 260-6932

OAR TOM EAGLES (Wanda Farrar, 260-5324)

Office of Air and Radiation

6103, W925, 260-5585, FAX: 260-9766

OPPE MARYANN FROEHLICH (Willard Smith, 260-2789)

Office of Policy, Planning and Evaluation

2126, M3202, 260-2789, FAX: 260-0512

OROSLR JIM WIEBER

Office of Regional Operations and State/Local Relations

1502, W346, 260-4462, FAX: 260-2159

OECA AVI GARBOW

Office of Enforcement and Compliance Assurance

2201-A, 202-564-2440, FAX: 501-3842

OARM JUDITH KOONTZ

Office of Administration and Resources Management

3102, M2632D, 260-8608, FAX: 260-9887 

OW CYNTHIA PUSKAR

Office of Water

4102, E1027A, 260-8532, FAX: 401-3372

OSWER BARBARA HOSTAGE (Lynn Johnson, 260-4478)

Office of Solid Waste and Emergency Response

5103, SE306K, 260-7979, FAX: 401-1496

OPPTS ANGELA HOFMANN (Patricia A. Johnson, 260-2893)

Office of Prevention, Pesticides and Toxic Substances

7101, E629, 260-2922, FAX: 260-0951
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OGC NANCY KETCHAM-COLWILL

Office of General Counsel

2322, W501D, 260-7624, FAX: 260-0586 

LIST OF EPA STANDARDS COORDINATORS

(as of July 1997)

OW OECA OPPTS

Jim Horne Brian Riedel Mary McKiel

OAR OSWER ORD

Ken Feith Dana Arnold Penny Hansen

OIA OGC OPPE

Greg Mertz Craig Annear Jerry Newsome

OCEPA OARM

Elaine Koerner David Scott Smith

Region 1 Region 2 Region 3

David Guest Jehuda Menczel Jeff Burke

Region 4 Region 5 Region 6

David Abbott Catherine Allen Robert Clark

Region 7 Region 8 Region 9

Chilton McLaughlin David Schaller Bonnie Barkett

Region 10

Nancy Helm

EPA Standards Executive

Pep Fuller (OPPTS)
B-20

Public Law 104-113

104th Congress

An Act

To amend the Stevenson-Wydler Technology Innovation Act of 1980 with respect to inventions

made under cooperative research and development agreements, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in

Congress assembled, 

SECTION 1. SHORT TITLE.

This Act may be cited as the “National Technology Transfer and Advancement Act of 1995"

* * * * *

SECTION 12. STANDARDS CONFORMITY.

(a) USE OF STANDARDS. Section 2(b) of the National Institute of Standards and

Technology Act (15 U.S.C. 272(b)) is amended--

(1) in paragraph (2), by striking “, including comparing standards” and all that

follows through “Federal Government”;

(2) by redesignating paragraphs (3) through (11) as paragraphs (4) through (12),

Respectively; and

(3) by inserting after paragraph (2) the following new paragraph:

“(3) to compare standards used in scientific investigations, engineering,

manufacturing, commerce, industry, and educational institutions with the standards adopted or

recognized by the Federal Government and to coordinate the use by Federal agencies of private

sector standards, emphasizing where possible the use of standards developed by private,

consensus organizations;”.

(b) CONFORMITY ASSESSMENT ACTIVITIES. Section 2(b) of the National Institute of

Standards and Technology Act (15 U.S.C. 272(b)) is amended--

(1) by striking “and” at the end of paragraph (11), as so redesignated by

subsection (a)(2) of this section;

(2) by striking the period at the end of paragraph (12), as so redesignated by

subsection (a)(2) of this section, and inserting in lieu thereof “; and”; and

(3) by adding at the end the following new paragraph:

“(13) to coordinate Federal, State, and local technical standards activities and

conformity assessment activities, with private sector technical standards activities and conformity

assessment activities, with the goal of eliminating unnecessary duplication and
B-21

complexity in the development and promulgation of conformity assessment requirements and

measures.”.

(c) TRANSMITTAL OF PLAN TO CONGRESS. The National Institute of Standards and

Technology shall, within 90 days after the date of enactment of this Act, transmit to the Congress

a plan for implementing the amendments made by this section.

(d) UTILIZATION OF CONSENSUS TECHNICAL STANDARDS BY FEDERAL

AGENCIES; REPORTS.

(1) IN GENERAL. Except as provided in paragraph (3) of this subsection, all

Federal agencies and departments shall use technical standards that are developed or adopted by

voluntary consensus standards bodies, using such technical standards as a means to carry out

policy objectives or activities determined by the agencies and departments.

(2) CONSULTATION; PARTICIPATION. In carrying out paragraph (1) of this

subsection, Federal agencies and departments shall consult with voluntary, private sector,

consensus standards bodies and shall, when such participation is in the public interest and is

compatible with agency and departmental missions, authorities, priorities, and budget resources,

participate with such bodies in the development of technical standards.

(3) EXCEPTION. If compliance with paragraph (1) of this subsection is

inconsistent with applicable law or otherwise impractical, a Federal agency or department may

elect to use technical standards that are not developed or adopted by voluntary consensus

standards bodies if the head of each such agency or department transmits to the Office of

Management and Budget an explanation of the reasons for using such standards. Each year,

beginning with fiscal year 1997, the Office of Management and Budget shall transmit to

Congress and its committees a report summarizing all explanations received in the preceding

year under this paragraph.

(4) DEFINITION OF TECHNICAL STANDARDS. As used in this subsection,

the term “technical standards” means performance-based or design-specific technical

specifications and related management systems practices.

 program should be spent in support of the goals of the program.

Approved March 7, 1996.
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 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 WASHINGTON, D.C. 20460

OFFICE OF 

GENERAL

COUNSEL

JAN 12 1995

MEMORANDUM

SUBJECT: Use of Incorporation by Reference as a Mechanism for Shortening Federal

Register Notices

FROM: Gerald H. Yamada

Principal Deputy General Counsel

TO: Regulatory Policy Council

We have been asked to provide guidance on the legal requirements that would govern EPA’s

use of incorporation by reference to reduce the length of Federal Register notices. This

memorandum provides that information.

In recent guidance, a copy of which is attached, this office has described the minimum legal

requirements for Federal Register preambles of proposed and final rules. In that guidance we

indicated that the Administrative Procedure Act (APA) and the procedural; requirements of

certain environmental statutes (e.g., the Clean Air Act) would permit EPA to shift much of what

we customarily include in Federal Register preambles into the rulemaking dockets accompanying

the Federal Register notices. Under that approach, the Federal Register preambles could then

include simple references to those accompanying materials and inform the public as to how to

access them.

By contrast, “incorporation by reference” (IBR) is a term of art describing a somewhat

different procedure with a narrower purpose. IBR is a mechanism for avoiding the task and cost

of publishing certain materials in the rule text published in the Federal Register.

The concept of IBR stems from the requirements of the APA codified at 5 U.S.C. Section

552(a)(1). That section requires agencies to publish all substantive rules of general applicability
B-23

in the Federal Register, and provides that no member of the public may be adversely affected by

a matter required to be published in the Federal Register unless that person has actual notice of

that matter. Finally, that section provides that matter reasonably available to the affected public

is deemed published in the Federal Register when it is incorporated by reference therein with the

approval of the Director of the Federal Register.

Thus, IBR is a mechanism for applying to the regulated community, as a binding legal

requirement, material that an agency chooses, for cost or other reasons, not to publish verbatim in

the Federal Register. For example, EPA currently employs IBR to avoid publishing in the text of

its rules certain test methods issued by independent scientific organizations. The Agency also

incorporates by reference into the Code of Federal Regulations the regulatory portions of state

submittals that EPA approves into Federal law (e.g., State Implementation Plan (SIP) submittals

that EPA approves under the Clean Air Act). 

As indicated above, however, the APA directs that an agency’s incorporation by reference of

any particular material is not effective unless and until the Director of the Federal Register

approves it. Moreover, the decision whether to approve an agency’s request for the IBR of a

particular set of material is guided by, among other things, whether the material is “reasonably

available” to the affected public.

The Director of the Federal Register has promulgated regulations governing when she will

approve agency requests for IBR. 1 CFR Part 51. The attached summary of those requirements,

prepared by the Office of Policy, Planning and Evaluation, includes all of the significant

requirements contained in those regulations. As those regulations have been interpreted and

applied by the Office of the Federal Register, they substantially restrict the ability of agencies to

use IBR as a mechanism to shorten the regulator text to be published in the Federal Register and

the Code of Federal Regulations.

Perhaps most significant for EPA’s effort to shorten Federal Register notices is the rule’s

provision that the Director “will assume that a publication produced by the same agency that is

seeking its approval is inappropriate for incorporation by reference.” 1 CFR 51.7(b). Although

the rule goes on to say that a publication produced by the agency may be approved it is meets

certain basic requirements and “possesses other unique or highly unusual qualities,” the Office of

the Federal Register does not typically approve such requests. Thus, for example, we would not

be able to shorten published rule text by including in the rule only short references to other rule

text residing in the docket for that rulemaking. Rather, we could expect to use IBR primarily in

the way EPA already uses it -- e.g., to incorporate state-generated documents like SIP submittals

under the Clean Air Act, as well as other independently published materials like test methods

issued by the independent scientific organizations.

Please let us know if you would like further guidance on the legal requirements for

incorporating materials by reference into the Federal Register.
4Clean Air Act section 307(d) and TSCA section 411 impose additional requirements on

specified rulemakings. OGC should be consulted about requirements specific to these statutes.

B-24

Attachments

Working Draft 12/8/94

MINIMUM LEGAL REQUIREMENTS FOR FEDERAL REGISTER PREAMBLES

OF PROPOSED AND FINAL RULES

This description of minimum legal requirements is a limited exercise, addressing only the legal

aspects and not the policy implications of including certain information in Federal Register

preambles of proposed and final rules.

For particular rulemakings, many factors need to be considered in determining which material

should be included in the Federal Register notice and which should be included in the public

docket. OGC should therefore be consulted regarding particular rulemakings. OPPE should be

consulted about specific Federal Register publication requirements of the Office of Federal

Register; a summary of these requirements accompanies this outline.

PROPOSED RULES

Administrative Procedure Act section 553(b)(3) sets forth certain minimum requirements for

Federal Register publication of “general notice of proposed rule making.”

4

Minimum Federal Register Publication Requirements for Proposed Rules

Statement of the time, place, and nature of public rulemaking proceedings.

Reference to the legal authority under which the rule is proposed.

Either the text of the proposal, substance of the proposal, or description of subjects and issues

involved.

Description of who may be affected by the regulation.

Description of any additional information relevant to the rulemaking but not included in the

Federal Register notice, and how to obtain it, such as public docket access, electronic bulletin

board access, and mailing instructions.
5CAA section 307(d) requires the proposed rule to specify the period available for public

comment and to state the docket number, the location or locations of the docket, and the times it

will be open to public inspection. The proposal must be “accompanied by” a statement of basis

and purpose, which must include a summary of factual data on which the proposed rule is based,

the methodology used in obtaining and analyzing the data, and the major legal interpretations and

policy considerations underlying the proposed rule. Such data, information and documents must

be included in the docket on the date of publication of the proposed rule. We interpret the phrase

“accompanied by” to allow contemporaneous placement in the docket of the relevant

information.

6Similarly, CAA section 307(d) requires the promulgated rule to be “accompanied by” a

statement of basis and purpose, an explanation of the reasons for any major changes from the

proposal, and a response to each of the significant comments, criticisms, and new information

B-25

Identification of provisions that may be changed in the final rule, solicitation of comment on

controversial provisions that may change from proposal to final rule, and how to submit

comments.

Description of regulatory requirements imposed by other statutes, such as the Paperwork

Reduction Act and the Regulatory Flexibility Act.

Under applicable case law, the notice of proposed rulemaking serves three purposes:

 • improve quality of rulemaking by exposing proposed regulations to diverse public

comment;

 • provide opportunity to be heard and participate meaningfully in rulemaking

process; and

 • enhance quality of judicial review by giving parties an opportunity to develop

evidence I the record.

To ensure adequate notice to the public and to fulfill the purposes of the notice, the Federal

Register notice must contain certain minimum information. Additional information must either

be published in the Federal Register or be available to the public in an easily accessible location,

such as a public docket.5 Although the information on which the Agency relies and the

methodology used to analyze the information must be exposed to public view, the information

does not necessary need to be published in the Federal Register, as long as it is easily accessible. 

Thus, information on which the Agency relies as the basis for a proposed or final rule may be

placed in a public docket.

APA section 552(a)(1) and 553(c) require EPA to publish in the Federal Register “substantive

rules of general applicability adopted as authorized by law” and to “incorporate in the rules

adopted a concise general statement of their basis and purpose.”

6
submitted during the public comment period. We interpret the phrases “accompanied by” and

“incorporate in” to allow contemporaneous placement of the relevant material in the public

docket.

B-26

Minimum Federal Register Publication Requirements for Final Rule

Text of the rule.

Description of statement of basis and purpose and where it is available.

Description of response to comments document and where it is available.

Description of document discussing major changes from proposal and where it is available.

Description of regulatory requirements imposed by other statutes, such as the Paperwork

Reduction Act and the Regulatory Flexibility Act [this list may not be complete].

Like notices of proposed rulemaking, Federal Register notices of final rules must contain certain

minimum information. Additional information must either be published in the Federal Register

or be available to the public in an easily accessible location, such as a public docket.

General questions concerning these requirements should be directed to Judy Tracy, (202) 

260-7987. Questions concerning the fulfillment of these requirements in any specific action

should be directed to the assigned staff attorney.
B-27

INCORPORATION BY REFERENCE (IBR)

“Incorporation by reference” (IBR) is a method of incorporating material into Agency

regulations in the CFR by referencing the original document without publishing the full text of

the material. In order for the content of the IBR to be federally enforceable, its use must be

approved by the Director of the Federal Register. The Director is authorized to decide when an

Agency may incorporate material by reference. The Director’s office makes it determination on a

case-by-case basis after review of the Agency document and materials proposed for

incorporation. Material is eligible for incorporation if it:

 • Is published data, criteria, standards, specifications, techniques, illustrations, or

similar material;

 • Is reasonably available to and usable by the class of persons affected by the

publication;

 • Does not reduce the usefulness of the Federal Register publication system;

 • Benefits the Federal Government and members of affected classes; and

 • Substantially reduces the volume of material published in the Federal Register.

The Director will not approve an Agency’s request to incorporate by reference material

produced by that same Agency if that material can be printed using the Federal Register/Code

of Federal Regulations printing system. Also, the Director has determined that materials

previously published in the Federal Register or in the United States Code are not appropriate for

use as IBR. However, new Agency documents can include materials the Agency previously

published in the Code of Federal Regulations through the use of a cross-reference.

Statements of incorporation by reference in regulatory text must:

 • Include the words “incorporation by reference”;

 • Identify the standard and/or material to be incorporated, including the title, date,

editing, author, and identification number of the publication;

 • Contain a statement of availability stating where and how copies may be obtained

and examined; and

 • Refer to 5 U.S.C. 552(a) or include an approval statement that the Director of the

Federal Register approves the incorporation by reference

The preamble in the final rule document must make reference to the IBR in two locations:

 1. The DATES caption must include an approval statement that indicates the

effective date of the incorporation by reference as approved by the Director of the

Federal Register.
B-28

 2. The List of Subjects in the SUPPLEMENTARY INFORMATION must include

the term “incorporation by reference.”

The Agency must submit a written request for incorporation by reference approval to the

Director of the Federal Register. Although the Office of Federal Register (OFR) encourages

submission of requests as far in advance of publication as possible, the request must be submitted

no less than 20 working days before the final rule document is submitted to OFR for publication. 

The OFR does not consider any package for approval that does not include the following:

 1. A letter requesting approval of the incorporation;

 2. A copy of the material to incorporated; and

 3. A copy of the final rule document.

In order to secure IBR approval prior to signature and ensure timely publication, early requests

for IBR approval submissions may include an unsigned copy of the rule. The OFR will notify the

Agency of its decision to approve or disapprove the request for incorporation by reference

Materials forwarded to OFR must be legible, complete, and contain identifying data

including the title date, author, publisher, and identification number of the publication.

The OFR stresses that:

 • IBR material must be legible. It is considered unacceptable if the copy is either

too light or the words are blurred and unclear. The material must be complete and

have no part of the text cut off (e.g., hole punched).

 • EPA must submit an official version of the material proposed for IBR; it is useful

to have title pages or an official document identifying the material as the official

version.

 • The titles and numbers referencing the IBR material in the rule text must be

identified completely and specifically. The OFR provides guidance language in

the “Document Drafting Handbook” (see page 38, examples 57 and 58).

 • Material should be organized. It is preferable to package it in a binder with tabs if

the material is lengthy. The material should be organized in the same order as it is

set out in the rule language.

Questions regarding these requirements can be addressed to Vickie Reed of the Regulatory

Development Branch (RDB) in OPPE at (202) 260-7204. Further information is also available in

the “Document Drafting Handbook,” published by the Office of the Federal Register. The

Handbook is available by contacting Bridgette Dent in RDB at (202) 260-4333.
B-29

FEDERAL COMMUNICATIONS COMMISSION (FCC)

8. The Federal Communications Commission participates in a variety of organizations that

develop telecommunications standards. The actual level of participation with each

organization varies depending on the need for Commission involvement and importance of

the work relative to our objectives. The Commission presently has approximately 44

employees involved in more than 10 standards bodies and approximately 100 sub-groups

within these bodies. The Commission uses voluntary standards in several different ways:

To satisfy industry and user requirements where it appears that mandatory

standards are unnecessary. Examples include telephone industry standards

for network protocols and interfaces, International Special Committee on

Radio Interference (CISPR) standards to control radio emissions from

automobiles, Telecommunications Industry Association (TIA) standards

for digital cellular radio protocols, and TIA/Tl standards for protocols in

the personal communications service.

To correct problems that might otherwise require regulation. For example,

the Commission has strongly encouraged compliance with Electronics

Industry Association (EIA) standards on television susceptibility to

interference rather than moving swiftly to mandatory regulations. It has

worked with the industry and local governments to develop voluntary

measurement standards for testing the signal quality of cable systems, and

is working with TIA to encourage development and voluntary

implementation of a standard for telephone immunity to interference.

As the basis for mandatory requirements, either by incorporating voluntary

standards by reference, or including the normative portion of the standard

in the FCC rules. Examples include ANSI measurement procedures for

radio noise emitted by digital devices, ANSI/EIA standards on AM

broadcast transmission specifications, EIA standards for telephone

compatibility with hearing aids, International Telecommunications Union

(ITU-R) recommendations on digital selective calling equipment for use in

ship and coast marine stations, EIA task-force recommendations on

standards for displaying closed-captioning information on television

receivers, and an EIA/TIA standard for protection of microwave systems

from interference from personal communications systems.

The Commission continues to increase its use of voluntary standards. In many

instances we have chosen not to implement regulations (or more detailed

regulations) because adequate voluntary industry standards already exist or are

under development. For example, the regulations for Personal Communications
B-30

Service do not include transmission protocol standards because industry has

voluntarily developed these standards. In other instances, where the adoption of a

standard is or may be in the public interest, we have attempted to use voluntary

standards whenever possible. For example, we are allowing the industry to

establish a "spectrum etiquette" policy for devices operating at millimeter

wavelengths and are working with and looking to industry to develop standards

for the transmission of digital radio. In addition, the Commission regularly works

closely with industry through the negotiated rule making process to resolve

technical compatibility issues. 

2. The Commission has adopted one voluntary consensus standard since October 1,

1996. Specifically, on December 24, 1996, the Commission adopted the standard

for digital television (DTV) broadcast as developed by the Advanced Television

Systems Committee (ATSC).

3. No voluntary consensus standards have replaced government-unique standards as

result of agency review of existing standards since October 1, 1996.

4. The Commission recognizes the benefits of using voluntary consensus standards

when applicable and endeavors to comply with the guidance provided in OMB

Circular A-119 and the mandates of P.L. 104-113. The Commission's current

standards Executive is:

Richard M. Smith

Chief, Office of Engineering and Technology

Federal Communications Commission

1919 M Street, N.W., MS 1300

Washington, DC 20554

Telephone: (202) 418-2470

The Standards Executive will carry out his responsibilities by:

a. Providing guidance to each of the agency's Commissioners on

standards-related issues;

b. monitoring the standards-setting activities of the agency's bureaus

and offices, and providing guidance to each one on how its

activities relate to the requirements of OMB Circular A-119;

c. producing the reports required by OMB Circular A-119;
B-31

d. developing a five-year standards review cycle to be followed by

each of the Commission's bureaus and offices that will ensure

compliance with OMB Circular A-119.

The Commission's Office of Engineering and Technology, which is under the

leadership the Commission's Standards Executive, monitors, participates, and

coordinates Commission efforts with respect to on ongoing national and

international developments in the standards area. Specifically, the Office of

Engineering and Technology's Standards Development Branch is tasked, in part,

with coordinating standards activities within the FCC and with participating in

and monitoring the work of standards committees. The Commission endeavors to

increase its interaction with the private sector in the area of standards

development to promote a greater use of voluntary standards where appropriate.

5. The Commission has not used any government-unique standards in lieu of

voluntary consensus standards since October 1, 1996. 

If you should need further information, please contact David Sylvar of my staff at (202) 418-

2424 or via e-mail at dsylvar@fcc.gov.
B-32

FEDERAL TRADE COMMISSION (FTC)

The Federal Trade Commission does not participate in the development of voluntary

consensus standards. The Commission's only contact with voluntary standards organizations is

in connection with the enforcement of the Federal Trade Commission Act, which proscribes

unfair methods of competition and unfair or deceptive acts or practices affecting commerce. In

recent years, Commission staff has conducted several in-depth investigations of standards setting

organizations and of participants in standards setting to determine whether they were engaged in

unfair methods of competition or unfair or deceptive acts or practices. Based on these

investigations, the Commission has filed lawsuits alleging deceptive use of standards against an

accredited testing laboratory, the private standards developer that accredited the laboratory, and a

product manufacturer. In each case, a settlement was approved by the Commission and the court. 

Further, the Federal Trade Commission staff has not actively participated in any standards

activities pertinent to OMB Circular A-119 and Commission procurement programs and

regulations have not used government-unique standards in lieu of voluntary consensus standards

or substituted such standards for government-unique standards. 
B-33

GENERAL SERVICES ADMINISTRATION (GSA)

1. GSA has 54 employees participating in 100 voluntary consensus standards bodies.

2. GSA has used 4 additional voluntary standards since the 1996 report. Note that one of these

was for the purpose of promoting environmentally sound products.

3. No additional voluntary standards have been substituted for government-unique standards

during the past year, as a result of the review of existing standards.

4. We have no comments or recommendations for changes concerning the proposed revision to

the circular.

5. No government-unique standards are being used in lieu of existing voluntary standards.
B-34

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION (NASA)

1. The number of voluntary consensus standards bodies in which there is agency participation,

as well as the number of agency employees participating (Sec. 9.b.(1)).

In 1997, NASA had 154 employees participating in 47 standards developing domestic and

international voluntary consensus standards bodies. This compares with 148 employees

participating in 45 organizations last year.

2. The number of voluntary consensus standards the agency has adopted since October 1, 1996

(Sec. 9.b.(2)).

NASA has identified 414 voluntary consensus standards and specifications for potential

adoption, based on current use by one or more NASA installations; about 85% of these

documents are for commonly used parts and materials. Adoption has been recommended by the

Engineering Standards Steering Council and formal adoption is pending approval by the

Engineering Management Council and NASA’s Standards Executive.

3. Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of an agency review of existing standards (Sec. 9.b.(3)).

In 1997, NASA initiated development of an Agency-wide standards management system to

be used for support of Agency missions, and as a basis for reporting use of voluntary consensus

standards, replacement of Government standards etc. Although this Agency system is not yet

complete, elimination and replacement of Government standards is underway at component field

installations. For over three years, the Kennedy Space Center, has had an aggressive program of

reviewing all currently used standards and specifications for potential cancellation or

replacement with voluntary consensus standards. In the past year, they have canceled and/or

superseded 92 government documents with voluntary consensus standards. The NASA Jet

Propulsion Laboratory has eliminated 300 internal standards and identified another 100 standards

for which voluntary consensus standards are being sought. NASA also participates with the

Department of Defense in its Single Process Initiative to eliminate the use of multiple

Government specifications at individual facilities for meeting common requirements. As a result

of SPI proposals, three NASA Centers, the NASA Goddard Space Flight Center, Lewis Research

Center, and the Marshall Space Flight Center have accepted replacement of some 18 Government

standards (in the areas of quality, calibration and configuration management) with national and

international standards. In the coming year, NASA will consider making these replacements on

an Agency-wide basis.

4. An evaluation of the effectiveness of the guidelines in the proposed revision to the Circular

and recommendations for any changes (Sec. 9.b.(4)).
B-35

OMB Circular A-119 has stimulated a very useful re-examination of standards use in NASA

that reinforces internal re-structuring initiatives that will enable more direct cooperation with

industry and among NASA Centers. Focusing attention on national and international standards

vs. locally developed technical procedures will directly support these goals. Revisions to the

Circular that permit selection of a “categorical” or standards management basis for reporting are

useful and important for a procurement based agency like NASA; a transaction basis for

reporting would have imposed a very burdensome administrative reporting requirement on the

Agency.

5. Agency use of government-unique standards in lieu of voluntary consensus standards (Sec.

9.a and 6.a.(1)).

The NASA has chosen a “categorical” (Standards Management System) based approach for

reporting use of voluntary consensus standards and elimination of Government standards. That

system is still under development and, at present, lists only internally developed NASA

Standards.

The NASA Standards currently listed in the management system fall principally in three

categories, namely information technology, safety and mission assurance, and engineering. 

The NASA information technology standards are for internal use only, and specify internal

procedures or preferred use of COTS (Commercial off the Shelf) products; they do not duplicate

voluntary consensus standards.

The safety and mission assurance standards are either (I) to document corrective procedures

in the areas of electronics, which are required on the basis of failures in past space missions, or

(ii) to document safety procedures in all areas required for use of NASA space systems such as

the Space Shuttle and International Space Station. NASA is now in the process of identifying

replacements for those government-unique engineering standards that do not relate directly to

safety procedures required for the use of NASA space systems. 

The NASA engineering standards, developed more recently, have been established to consolidate

internal practices and generally relate to system testing and design practices for payloads to be

flown on NASA systems. Until recently, no national or international standards were available in

many of the specific areas covered, but Voluntary Consensus Standards bodies are now

beginning to address these needs. NASA is participating with industry, plus domestic and

international voluntary consensus standard bodies, to identify relevant voluntary consensus

standards for possible adoption by NASA, and to develop standards of common interest.. The 

NASA Standards development activity will continue to consolidate internal practices but will

target standards with external application for eventual transition to voluntary consensus

standards. The NASA Standards Management System is key to this effort. 
B-36

In the coming year, the NASA Standards Management System will be completed to permit

more complete reporting on other government-unique standards still in use.

6. NASA Implementation of OMB Circular A-119

(a) The NASA Standards Executive is:

Dr. Daniel R. Mulville

Chief Engineer

Code AE

NASA Headquarters

Washington, D.C. 20546-0001

Phone. (202) 358-1823, Fax: (202) 358-3296

E-mail: daniel.mulville@hq.nasa.gov

(b) NASA implements the provisions of OMB Circular A-119 through NASA Policy Directive

NPD 8070.6A, “Technical Standards”, which was revised in 1997 to reflect pending revisions to

OMB Circular A-119. References to the Circular and its provisions have also been added to a

new, major policy guideline on “Program and Projects Management” (NASA NPD 7120.5A). 

NASA NPD 8070.6A establishes the policy and organizational responsibilities for the

development, management, and use of technical standards on NASA programs, including the

adoption and use of voluntary consensus standards. 

(c) NASA NPD 8070.6A delegates to the NASA Marshall Space Flight Center the authority to

serve as the NASA Lead Center for Standardization, in support of the NASA Standards

Executive. The Lead Center is responsible for developing program initiatives and operating

procedures, and administration of the NASA Standards Management System. The Lead Center

operates through an Agency-wide Engineering Standards Steering Council which reports to the

NASA Standards Executive and the NASA Engineering Management Council, which consists of

the senior engineering and safety management officials from each of the NASA Field Centers. 
B-37

NATIONAL ARCHIVES AND RECORDS ADMINISTRATION (NARA)

The National Archives and Records Administration (NARA) has continued this year to be active

in the area of voluntary standards. NARA staff members are active on a number of standards

committees. In addition, the agency continues, where possible, to cite voluntary standards in its

regulations and procurement documents.

1. The number of voluntary consensus standards bodies in which there is agency participation, as

well as the number of agency employees participating:

 A total of eighteen National Archives and Records Administration employees are active on a

variety of voluntary consensus standards organizations, committees, and subcommittees either as

official NARA representatives or alternates. In addition, a number of other staff review drafts of

various standards that may have an impact on our work. The eighteen individuals serve on

approximately twenty voluntary standards bodies at the organization, committee, or

subcommittee level. This standards work assists in the development of a common set of

methods, processes, materials, and products that we, other Federal agencies, and our colleagues

in the information and preservation world can share. Moreover, our participation helps foster

standards that further our central mission of ensuring, for the citizen and the public servant, for

the President and the Congress and the Courts, ready access to essential evidence.

2. The number of voluntary consensus standards the agency has used since October 1, 1996:

 The agency currently uses twenty voluntary standards which have been incorporated by

reference in our regulations outlined in 36 CFR Chapter 12.

3. Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of an agency review of existing standards:

 Although members of NARA staff have actively worked on standards activities during the

past year, no voluntary standards were substituted for government-unique standards during the

reporting period.

4. An evaluation of the effectiveness of the guidelines in the proposed revision to the Circular

and recommendations for any changes:

 Responsibility for standards activities shifted to another organization in NARA at the end of

the reporting period. Therefore, we were not able to do a careful analysis of proposed revisions

to OMB Circular A-119.

5. As required by P.L. 104-113, when the agency used government-unique standards in lieu of

voluntary consensus standards.
B-38

 We are not aware of any government-unique standards used by NARA. The agency actively

pursues adoption of voluntary standards. NARA has adopted standards by the American

National Standards Institute (ANSI), National Fire Protection Association ( NFPA), and the

National Information Standard Organization (NISO). However, NARA has just signed an

agreement with Department of Defense in which NARA will review the government-wide

usefulness of a DoD standard has been established for electronic records-management software. 

Hopefully successful implementation of this standard throughout the Federal Government will

lead to adoption of a voluntary standard.

As previously stated, responsibility for Standards Executive has shifted to the Policy and

Communications Staff which is part of the Office of the Archivist. The new Standards Executive

is Mary Ann Hadyka, Policy and Communications Staff (NPOL), National Archives and Records

Administration, Suite 4100, 8601 Adelphi Road, College Park, Maryland 20740-6001. 

Telephone: 301-713-7360. Fax: 301-713-7270. E-mail address: 

maryann.hadyka@arch2.nara.gov

Voluntary standards continue to be important to the work of the National Archives and Records

Administration. The agency will continue to provide time and travel support for staff members

who contribute to the work of standards organizations.
B-39

NATIONAL SCIENCE FOUNDATION (NSF)

1) there are two voluntary consensus standards bodies in which there is agency participation,

with three employees participating;

2) the number of voluntary consensus standards the agency has used since October 1, 1996 is

zero;

3) the number of voluntary consensus standards that have been substituted for

government-unique standards is zero;

4) an evaluation of the effectiveness of the guidelines in Section 7 of the proposed revision of the

Circular and recommendations for any changes;

The proposed guidelines allow appropriate agency participation in standards activities. No

changes are recommended.

5) the National Science Foundation has not used any government-unique standards in lieu of

voluntary consensus standards.
B-40

U.S. NUCLEAR REGULATORY COMMISSION (NRC)

The NRC developed and issued a strategic plan for FY 1997 - 2002. The strategic plan

establishes a strategic framework that will guide future decision-making and will help the NRC

continue to meet its responsibility for protecting public health and safety, promoting the common

defense and security, and protecting the environment. This plan includes general goals consistent

with the NRC’s mission in specific strategic arenas that include nuclear reactor safety and

nuclear materials safety. In these two arenas, the strategy is to increase the involvement of

licensees and others in the NRC regulatory process consistent with the provisions of Public Law

104-113, “National Technology Transfer and Advancement Act of 1955.” NRC will encourage

industry to develop codes, standards, and guides that can be endorsed by the NRC and carried out

by the industry. In this regard procedures are being developed to further promote the efficiency 

and effectiveness of the NRC process for implementing P.L. 104-113 and the supporting OMB

Circular A-119, “Federal Participation in the Development and Use of Voluntary Standards.” 

Following is the NRC response to the reporting provisions of OMB Circular A-119.

1) The number of voluntary consensus bodies in which there is agency participation, as well as

the number of employees participating

165 NRC staff participate on 16 standards development organizations (SDOs). NRC staff

participate on a total of 350 standards writing, consensus, and board level committees.

2) The number of voluntary consensus standards the agency has used since October 1, 1996 (or,

as appropriate, those based on the procedures set forth in Section 8 of the proposed revision

of the Circular)

During FY 96, the NRC “incorporated by reference” 2 standards into 1 final NRC regulation,

endorsed 15 standards in 8 final regulatory guides, and endorsed 37 standards in 8 draft

regulatory guides which were issued for comment. Table 1 identifies these standards, with

applicable date, and the specific method of endorsement.

3) Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of an agency review of existing standards (or as outlined under

paragraph 7c (6) of the proposed revision to the Circular)

None.

4) An evaluation of the effectiveness of the guidelines in Section 7 of the proposed revision to

the Circular and recommendations for any changes
B-41

The policy guidelines provided in Section 7 for using voluntary consensus standards and

participating in voluntary consensus standards bodies are generally consistent with

longstanding NRC staff practices. The staff believes that these guidelines provide

appropriate direction and encouragement for Federal agencies to use voluntary consensus

standards, while at the same time providing sufficient flexibility for each agency to make an

independent case-by-case determination as to the usability of a particular standard within that

agency’s scope and responsibility. 

5) As required by P.L. 104-113, when the agency used government-unique standards in lieu of

voluntary consensus standards

None.
7RG: Regulatory Guide. RGs frequently endorse consensus standards. They are issued

by the NRC to describe acceptable methods for implementing regulations, techniques used by the

staff in evaluating specific problems or postulated accidents, and data used by the NRC staff in

its review of applications for permits and licenses. RGs are not substitutes for regulations, and

compliance with them is not required. Draft RGs are typically issued for 60 - 90 day public

comment. Following a review of comments received, the draft RG may be revised and issued

final.

8B&PVC: Boiler & Pressure Vessel Code

9CC: Code cases are new or revised, and have various dates

B-42

TABLE 1

Standards Endorsed by NRC

October 1, 1996 - September 30, 1997

SDO Standard

Number Year Title Method ofEndorsement

ANS 3.4 1996

Medical Certification and Monitoring of personnel

Requiring Operator Licenses for Nuclear power

plants

RG7 (draft)

ANS 8.21 1995 Use of Fixed Neutron Absorbers in Nuclear

Facilities Outside Reactors RG (final)

ANS 58.8 1994 Time Response Design Criteria for Safety-Related

Operator Actions RG (draft)

ASME

B&PVC8

Section XI

Subsection IWE

1995 Ed,

1996 Add.

Requirements for Class MC and Metallic Liners of

Class CC Components of Light-Water Cooled Plants Regulation (final)

ASME

B&PVC Section

XI Subsection

IWL

1995 Ed,

1996 Add.

Requirements for Class CC Concrete Components

of Light-Water Cooled Plants Regulation (final)

ASME B&PVC Section

XI Code Cases CC9 18 code case that address inspection, repair andreplacement of nuclear power plant components RG (draft)

ASME

B&PVC

Section III

Code Cases

CC3 16 code cases that address materials and design for

nuclear power plant components RG (draft)

IEEE 7-4.3.2 1993 Std Criteria for Digital Computers in Safety Systems

of NP Gen Stas RG (final)

IEEE 279 1971 Criteria for Protection Systems for NP Gen Stas RG (final)
SDO Standard

Number Year Title Method ofEndorsement

B-43

IEEE 450 1987

Recommended Practice for Maintenance, Testing,

and Replacement of large Lead Storage Batteries for

Generating Stations and Substations

RG (final)

IEEE 610.12 1990 IEEE Std Glossary of Software Engineering

Terminology RG (final)

IEEE 729 1983 IEEE Std Glossary of Software Engineering

Technology RG (final)

IEEE 828 1990 IEEE Std for Software Configuration Management

Plans RG (final)

IEEE 829 1983 IEEE Std for Software Test Documentation RG (final)

IEEE 830 1993 IEEE Recommended Practice for Software Reqs

Specs RG (final)

IEEE 610L12 1990 IEEE Standard Glossary of Software Eng

Terminology RG (final)

IEEE 1008 1987 IEEE Std for Software Unit Testing RG (final)

IEEE 1012 1986 IEEE Std for Software Verification and Validation

Plans RG (final)

IEEE 1028 1988 IEEE Std for Software Review and Audits RG (final)

IEEE 1042 1987 IEEE Guide to Software Configuration Management RG (final)

IEEE 1074 1991 IEEE Std for Developing Software Life Cycle

Processes RG (final)

ISA S67.04 1994 Setpoints for Nuclear Safety-Related

Instrumentation RG (draft)
B-44

U.S. OFFICE OF CONSUMER AFFAIRS (OCA)

STANDARDS EXECUTIVE: Howard Seltzer, Director for Policy

(202) 565-0051

Fax: (202) 565-0065

Email: hseltzer@os.dhhs.gov

1) USOCA participates in 4 voluntary standards bodies through one agency employee, as

follows:

American National Standards Institute

Member, Board of Directors 

Member, Consumer Interest Council

Member, International Affairs Committee

ASTM

Member, Committee F15 Executive Committee

International Organization for Standardization (ISO)

Consumer Policy Council (COPOLCO) 

 Representative to the Ad Hoc Advisory Group on 

 Privacy 

Underwriters Laboratory

Member, Consumer Advisory Council

2) N/A.

3) N/A

4) As USOCA's mission relates entirely to consumer advocacy and consumer policy analysis, it

is too early to judge what effect, if any, the revisions to the Circular will have on consumers. 
C-1

Appendix C: Charter of the Interagency Committee on 

Standards Policy
C-2
C-3

DEPARTMENT OF COMMERCE

CHARTER

of the

Interagency Committee on Standards Policy

ESTABLISHMENT

1. The Interagency Committee on Standards Policy (herein after referred to as the Committee)

is established to advise the Secretary of Commerce and the heads of other Federal agencies

in matters relating to standards policy.

2. The Committee fulfills the mandates set out in paragraph 8.a.2 of the Office of Management

and Budget (OMB) Circular No. A-119, "Federal Participation in the Development and Use

of Voluntary Standards," in its revision of October 20, 1993.

3. The Committee reports to the Secretary of Commerce through the Director of the National

Institute of Standards and Technology.

PURPOSE

The purpose of the Committee is to ensure effective participation by the Federal Government in

domestic and international standards activities and to promote the adherence to uniform policies

by Federal agencies in the development and use of standards. Well-considered Federal policies

reflecting the public interest can expedite the development and adoption of standards that

stimulate competition, promote innovation, and protect the public safety and welfare. The

establishment and application of appropriate standards for the characteristics or performance of

goods, processes, and services can contribute significantly to national and international

prosperity, economic growth, and public health and safety. The establishment of such standards

can also further national goals for environmentally sound and energy efficient materials,

products, systems, services, or practices. Heightened national and international awareness of the

importance of standards activities, as reflected by enactment of the National Technology Transfer

and Advancement Act of 1995 (P.L. 104-113, signed into law March 7, 1996), and

recommendations presented in the National Research Council’s report "Standards, Conformity

Assessment, and Trade into the 21st Century" (National Academy Press, 1995) call for the

Committee to intensify its efforts to identify the broad roles and appropriate interactions of

agencies in exercising the Government's authority.

OBJECTIVE

The objective of the Committee shall be to promote effective and consistent standards policies in

furtherance of U.S. domestic and foreign goals and, to this end, to foster cooperative

participation by the Federal Government and U.S. industry and other private organizations in
C-4

standards activities, including the related activities of product testing, quality system registration,

certification, and accreditation programs.

FUNCTIONS

1. As appropriate, the Committee shall gather, analyze, and maintain current information about

standards, product testing, quality system registration, accreditation and certification, and

related regulations, rules, policies, and activities:

(a) conducted within or established by Federal agencies;

(b) conducted by private domestic and foreign national standards bodies and by regional

and international private and intergovernmental organizations engaged in such

programs; and

(c) pertaining to the relationships among agencies of the Federal Government with

industry and the various national, regional, and international organizations engaged in

such programs.

2. On the basis of such information and when appropriate with respect to the activities named

in paragraph one above, the Committee shall make recommendations to the Secretary of

Commerce to:

(a) strengthen coordination of the standards-related policies and activities among the

Federal agencies;

(b) improve the efficiency within the Federal Government of standardization efforts with

the U.S. private sector, as well as with regional and international organizations, both

private and governmental;

(c) promote standards-related policies, including directory of personnel participating in

standards activities, within the Federal Government consistent with statutory

obligations in regard to interactions with non-federal government organizations;

(d) ensure effective representation of the Federal Government at significant regional and

international standards-related meetings and conferences;

(e) promote the use of internationally acceptable standards and related activities with a

view to increasing trade and economic integration and development;

(f) monitor U.S. technical obligations as a signatory to the World Trade Organization, the

U.S.-Canada Free Trade

Agreement, the North American Free Trade Agreement, and other treaties

encompassing standards-related trade issues; 

(g) encourage the development of agency strategic plans for managing and monitoring

use of voluntary standards and participation in standards-related activities;

(h) promote the use of standards that serve national goals related to increased use of the

metric system of measurement and environmentally sound and energy efficient

materials, products, systems, services, and practices; and

(I) assess and improve the adequacy of such agency plans and activities.
C-5

MEMBERSHIP

1. Together with the Department of Commerce the following agencies constitute the

membership of the Committee:

Department of Agriculture

Department of Defense

Department of Education

Department of Energy

Department of Health and Human Services

Department of Housing and Urban Development

Department of the Interior

Department of Justice

Department of Labor

Department of State

Department of Transportation

Department of the Treasury

Department of Veterans Affairs

Office of Consumer Affairs

Consumer Product Safety Commission

Environmental Protection Agency

Federal Communications Commission

Federal Emergency Management Agency

Federal Trade Commission

General Services Administration

International Trade Commission

Office of Management and Budget

National Aeronautics and Space Administration

National Archives and Records Administration

National Communications Systems (Dept. of Defense) 

 (non-voting member)

National Science Foundation

Nuclear Regulatory Commission

U.S. Agency for International Development

U.S. Government Printing Office (legislative liaison -

 non-voting member)

U.S. Postal Service

Office of the U.S. Trade Representative

The head of each member agency shall ensure representation by a responsible high level

policy official (Senior Executive Service or higher) who serves as the agency representative

on the Committee. Such agency representative shall also serve as the "Standards Executive" 
C-6

as defined in section 8.b.2 of OMB Circular No. A-119. Appointments to the Committee

shall be for an indefinite term.

2. Agency representatives may designate alternates of equivalent senior status to serve in their

absence.

3. Experts from organizations within the member agency may be designated by agency

representatives to serve on task groups established by the Committee.

4. Other Federal agencies may become members of the Committee upon application to or

invitation by the Secretary of Commerce.

ADMINISTRATIVE PROVISIONS

1. The Director of the National Institute of Standards and Technology (NIST) or the Director's

designee shall chair the Committee.

2. NIST shall provide administrative arrangements for the Committee including secretarial

services, calling of meetings, arranging for a meeting place, and preparation of an agenda,

discussion material, and reports.

3. The Committee shall meet at least three times each year. Other meetings may be called at

the discretion of the Chair or at the written request of five (5) members of the Committee.

4. The Committee may establish task groups as appropriate.

5. Attendance at Committee meetings by at least one half of the designated members of the

Committee shall constitute a quorum. Decisions internal to the Committee's operations,

such as formation of a task group, shall be made by a majority of those present and voting. 

Voting on Committee business and proposals shall be limited to designated agency

members. Decisions concerning Committee recommendations to the Secretary of

Commerce on governmental policy or other matters set out in paragraph two of the section

entitled "Functions" shall require ratification by two-thirds of the members present and

voting. Dissenting positions of the decision may be made a matter of record. The Chair

shall not vote except in the case of a tie vote.

6. The annual cost of operating the Committee is estimated at $31,000 (with overhead) which

includes 0.20 staff year for staff support.

7. The Committee shall submit an annual report to the Secretary of Commerce so that the

Secretary may satisfy the reporting requirements set forth in OMB Circular No. A-119, as

applicable to the Secretary, and in P.L. 104-113, as applicable to the head of each agency. 

Each such report shall also summarize the Committee's activity during the period covered
C-7

and shall include a listing of all recommendations formulated by the Committee during that

period.

DURATION

The need and mission of the Committee shall be reexamined three years after the date of this

Charter to determine the need for the Committee's continuation.

/signed/

 Secretary of Commerce

Dated: October 29, 1997
D-1

Appendix D: Membership of the Interagency Committee

on Standards Policy
D-2
D-3

Interagency Committee on Standards Policy Members - FY97

AGENCY MEMBER REPRESENTATIVE

Agency for International Development, U. S. (USAID) Mr. James Murphy

 Deputy Director, Office of Procurement

 13000 Pennsylvania Ave

 Washington, DC 20523-7900

 Phone: 202-712-0610

 Fax: 202-216-3395

 

Agriculture, Deparment of (USDA) Ms. Anne F. Thomson Reed

 Acting Chief Information Officer

 Room 416-W

 Jamie L. Whitten Federal Building

 1400 Independence Avenue, SW

 Washington, DC 20250-7603

 Phone: 202-720-8833

 Fax: 202-720-1031

 

Commerce, Department of Dr. Belinda L. Collins

 Director, Office of Standards Services

 National Institute of Standards and Technology

 Building 820, Room 282

 Gaithersburg, MD 20899

 Phone: 301-975-4000

 Fax: 301-963-2871

 Email: belinda.collins@nist.gov

 

Consumer Affairs, Office of (OCA) Mr. Howard Seltzer

 Director for Policy

 808 17th Street NW

 Washington, DC 20006

 Phone: 202-565-0051

 Fax: 202-565-0065

 Email: hseltzer@os.dhhs.gov

 

Consumer Product Safety Commission (CPSC) Mr. Colin B. Church

 Voluntary Stnds & International Activities Coordinator

 4340 East-West Highway

 Room 604-C

 Bethesda, MD 20207

 Phone: 301-504-0554 x 2229

 Fax: 301-504-0407

 Email: cchurch@cpsc.gov

Alternate: Ms. Jacquie Elder

 Room 702

 Bethesda, MD 20207

 Phone: 301-504-0554 x 2254

 Fax: 301-504-0407

 

 

Defense, Department of (DOD) Mr. Walter B. Bergmann, II
D-4

 Director, Acquisition Practices

 Office of the Deputy Under Secretary for Industrial

 Affairs & Installations

 Room 3B253, Pentagon

 Washington, DC 20301-3330

 Phone: 703-697-0957

 Fax: 703-693-6990

 Email: bergmawb@acq.osd.mil

 

Alternate: Ms. Trudie Williams

 Defense Standardization Program

 5203 Leesburg Pike

 Suite 1403

 Falls Church, VA 22041

 Phone: 703-681-9340

 Fax: 703-681-7622

 Email: williatl@acq.osd.mil

Education, Department of (DOEd) Mr. Paul Planchon

 National Center for Education Statistics

 555 New Jersey Avenue, NW

 Washington, DC 20208

 Phone: 202-219-1614

 Fax: 202-219-1728

 Email: paul_plancho@Ed.gov

 

Energy, Department of (DOE) Mr. Richard L. Black

 Director, Office of Nuclear Safety Policy and 

 Standards (EH-31)

 Room A-430, GTN

 Washington, DC 20854

 Phone: 301-903-3465

 Fax: 301-903-6172

 Email: r.black@eh.doe.gov

 

Alternate: Richard J. Serbu, EH-31

 Manager, DOE Technical Standards Program Century XXI

 19901 Germantown Road 

 Germantown, MD

 Phone: 301-903-2856

 Fax: 301-903-6172

 Email: richard.serbu@eh.doe.gov

Environmental Protection Agency (EPA) Mr. Irving (Pep) L. Fuller, Jr.

 Counselor for International Affairs

 Office of Prevention, Pesticides and Toxic Substances

 401 M Street, SW, MC-7101

 Washington, DC 20460

 Phone: 202-260-2897

 Fax: 202-260-1847

Alternates: Mr. Richard D. White

 Senior Advisor for International Affairs

 Office of Prevention, Pesticides and Toxic Substances

 401 M Street, S.W., MC 7101

 Washington, DC 20460

 Phone: 202-564-6473
D-5

 Fax: 202-565-2409

 Email: white.dick@epamail.epa.gov

 Ms. Mary McKiel

 Director, EPA Voluntary Standards Network

 Office of Pollution Prevention & Toxics

 401 M Street, S.W., MC 749

 Washington, DC 20460

 Phone: 202-260-3584

 Fax: 202-260-0178

 Email: mckiel.mary@epamail.epa.gov

 Mr. Craig Annear

 Office of General Council (2322)

 401 M Street, SW

 Washington, DC 20460

 Phone: 202-260-5328

 Fax: 202-260-8392

 Email: annear-craig@epamail.epa.gov

 

Federal Communications Commission (FCC) Mr. Richard M. Smith

 Chief, Office of Engineering and Technology

 2000 M Street, NW

 Suite 480, MS 1300

 Washington, DC 20554

 Phone: 202-418-2470

 Fax: 202-418-1944

 Email: rmsmith@fcc.gov

 

Federal Emergency Management Agency (FEMA) Ms. Rosetta Bowsky

 Information Technology Svcs Directorate

 FEMA Room 252 FCP

 Washington, DC 20472

 Phone: 202-646-3827

 Fax: 202-646-3074

 Email: rosetta.bowsky@fema.gov

 

Federal Trade Commission (FTC) Mr. Dean Graybill

 Associate Director for the Division of Service 

 Industry Practices

 Bureau of Consumer Protection

 6th and Pennsylvania Avenue, NW

 Room 200

 Washington, DC 20580

 Phone: 202-326-3284

 Fax: 202-326-3392

 

General Services Administrations (GSA) Mr. William N. Gormley

 Assistant Commissioner

 Office of Acquisition, Federal Supply Service

 Washington, DC 20406

 Phone: 703-305-7901

 Fax: 703-305-6851

 Email: william.gormley@gsa.gov

 

Alternate: Charles P. Gallagher

 Phone: 703-305-6930
D-6

 Fax: 703-305-6731

 Email: charles.gallagher@gsa.gov

Government Printing Office, U.S. (GPO) Mr. Robert H. Thomas

 Actg. Manager, Quality Control and Technical Department

 Washington, DC 20401

 Phone: 202-512-0766

 Fax: 202-512-0015

Health and Human Services, Department of (HHS) Ms. Linda R. Horton

 Director, International Policy

 Food and Drug Administration, HHS

 HF-23

 5600 Fishers Lane Rm 15-74

 Rockville, MD 20857

 Phone: 301-827-3344

 Fax: 301-443-6906

 Email: lhorton@oc.fda.gov

Alternate: Kathleen Hastings

 Office of International Policy

 Food and Drug Administration, HHS

 HF-23

 5600 Fishers Lane Rm 15-74

 Rockville, MD 20857

 Phone: 301-827-3344

 Fax: 301-443-6906

 Email: khasting@oc.fda.gov 

Housing and Urban Development, Department of (HUD) Ms. Marion Connell

 Director, Manufactuned Housing & Standards

 Office of Consumer & Regulatory Affairs

 451 7th Street, SW

 Washington, DC 20410

 Phone: 202-708-6409

 Fax: 202-708-4213

Alternates: Mr. Les Breden

 Materials Engineer

 451 7th Street, SW

 Room 9152

 Washington, DC 20410

 Phone: 202-708-6423

 Fax: 202-708-4213

 Email: leslie_h._breden@hud.gov

 Dr. Warren Friedman

 Research Manager

 Office of Lead Hazard Control (LS)

 451 7th Street, SW

 Washington, DC 20410

 Phone: 202-755-1785 x#159

 Fax: 202-755-1000

 Email: Warren_Friedman@HUD.gov

Interior, Department of the (DOI) Mr. Don Bieniewicz

 Office of Policy Analysis
D-7

 1849 C Street, NW

 Mail Stop - 4426 - MIB

 Washington, DC 20240

 Phone: 202-208-4915

 Fax: 202-208-5602

 Email: Donald_Bieniewicz@ios.doi.gov

 

International Trade Commission (ITC) Mr. Stephen A. McLaughlin

 Acting Director, Office of Administration

 Room 212

 500 E Street, SW

 Washington, DC 20436

 Phone: 202-205-3131

 Fax: 202-205-2034

 

Justice, Department of (DOJ) Ms. Mary Ellen Condon

 Director, Information Management and Security Staff

 Justice Management Division

 Suite 850 WCTR

 Washington, DC 20530

 Phone: 202-514-4292

 Fax: 202-514-1534

 Email: condonma@justice.doj.gov

 

Alternate: Mr. Rick Mihaly

 Washington, DC 20530

 Phone: 202-514-7936

 Fax: 202-514-1534

Labor, Department of (DOL) Ms. Patricia Lattimore

 Assistant Secretary for Administration and Management

 Room S 2203

 200 Constitution Avenue, NW

 Washington, DC 20210

 Phone: 202-219-9086

 Fax: 202-219-1270

 Email: plattimo@dol.gov

National Aeronautics and Space Administration (NASA) Mr. Daniel R. Mulville

 Chief Engineer, Code AE

 Washington, DC 20546-0001

 Phone: 202-358-1823

 Fax: 202-358-3296

 Email: d_mulville@admingw.hq.nasa.gov 

 

Alternate: Mr. Richard H. Weinstein

 Phone: 202-358-1823

 Fax: 202-358-3296

 Email: richard.weinstein@hq.nasa.gov

 

National Archives and Records Administration (NARA) Mr. Reynolds Cahoon

 Assistant Archivist for Policy and Info. Resources 

 Mgt. Services

 National Archives at College Park

 8601 Adelphi Road

 College Park, MD 20740-6001
D-8

 Phone: 301-713-6730

 Fax: 301-713-6497

Alternate: Ms. Mary Ann Hadyka 

 National Archives and Records Administration

 Policy and Communication Staff

 Suite 4100

 8601 Adelphi Road

 College Park, MD 20740-6001

 Phone: 301-713-7360

 Fax: 301-713-7270

 Email: maryann.hadyka@arch2.nara.gov

National Communications System (NCS) Dr. Dennis Bodson

 Chief, Technology and Standards Division

 Office of the Manager

 701 South Court House Road

 Arlington, VA 22 204-2198

 Phone: 703-607-6200

 Fax: 703-607-4830

 Email: bodsond@ncs.gov 

 

National Science Foundation (NSF) Dr. William S. Butcher

 Senior Engineering Advisor

 Office of the Assistant Director for Engineering

 Room 505

 4201 Wilson Boulevard

 Arlington, VA 22230

 Phone: 703-306-1380

 Fax: 703-306-0289

 Email: wbutcher@nsf.gov

Nuclear Regulatory Commission (NRC) Mr. John W. Craig

 Deputy Director, Division of Engineering

 Office of Nuclear Regulatory Research

 Mail Stop T-10-D20

 Washington, DC 20555

 Phone: 301-415-6982

 Fax: 301-415-5074

 Email: JWCI@nrc.gov 

 

Alternate: Gilbert C. Millman

 Program Manager C & S

 Office of Nuclear Regulatory Research

 Mail Stop T-10-D20

 Washington, DC 20555

 Phone: 301-415-5843

 Fax: 301-415-5151

 Email: gcm@nrc.gov

Office of Management and Budget (OMB) Liaison Ms. Virginia A. Huth

 Policy Analyst, Information Policy Branch

 Office of Information and Regulatory Affairs

 NEOB, Room 10236

 Washington, DC 20503

 Phone: 202-395-3785

 Fax: 202-395-5167
D-9

 Email: HUTH_V@A1.EOP.GOV

 

Office of Management and Budget (OMB) Liaison Mr. Bruce McConnell

 Chief, Information Policy Branch

 Office of Information and Regulatory Affairs

 NEOB, Room 10236

 Washington, DC 20503

 Phone: 202-395-3785

 Fax: 202-395-5167

 Email: bruce.mcconnell@al.eop.gov

 

Postal Service, U.S. Mr. Myles A. Jackson

 Manager, Configuration Management

 Engineering Research and Development

 Merrifield, VA 22082-8101

 Phone: 703-280-7281

 Fax: 703-280-8414

 Email: mjackson@email.usps.gov 

 

State, Department of (STATE) Mr. Earl S. Barbely

 Director for Telecommunications and Information Standards

 Room 5820

 Washington, DC 20520

 Phone: 202-647-0197

 Fax: 202-647-7407

Transportation, Department of (DOT) Mr. Frank Turpin

 Director of International Harmonization

 National Highway Traffic Safety Administration

 400 Seventh Street, SW

 Suite 5220

 Washington, DC 20590

 Phone: 202-366-2114

 Fax: 202-366-2106 

 

Treasury, Department of (Treasury) Mr. James J. Flyzik

 Deputy Assistant Secretary (Information Systems)

 & Chief Information Officer

 1500 Pennsylvania Avenue, NW

 Room 2464

 Washington, DC 20220

 Phone: 202-622-1200

 Fax: 202-622-2224

 Email: jim.flyzik@cio.treas.gov

 

Meeting Correspondence to: Mrs. Helen W. Whatley

 Office of Information Resources Management

 1425 New York Avenue, NW

 Washington DC 20220

 Phone: 202-622-1541

 Fax: 202-622-1595

 Email: helen.whatley@treas.sprint.com

 

Treasury, Department of , Internal Revenue Service Abdul-Hakeem Muhammad

 IRS Building # NCFB-8-453

 1111 Constitution Avenue, NW

 Washington, DC 20220
D-10

 Phone: 202-283-6094

 Fax: 202-283-4227

U. S. Trade Representative (USTR) Ms. Suzanne Troje

 Director, Technical Trade Barriers

 Washington, DC 20508

 Phone: 202-395-9444

 Fax: 202-395-5674

 

Veterans Affairs, Department of (VA) Mr. Gary J. Krump

 Deputy Asst Secretary for Acquisition & 

 Materiel Management (90)

 810 Vermont Avenue, NW

 Washington, DC 20420

 Phone: 202-273-6029

 Fax: 202-273-6163

 Email: krugar@mail.va.gov 

 
E-1

Appendix E: List of NIST Publications Related to

P.L. 104-113
E-2
E-3

Publications on Standards and Conformity Assessment Activities

Office of Standards Services

National Institute of Standards and Technology

Gaithersburg, Maryland 20899 

o TBT Agreement Activities of the National Institute of Standards and Technology

 This annual report describes the World Trade Organization (WTO) Agreement on Technical

Barriers to Trade (TBT) activities conducted by NIST. NIST receives notifications of proposed

foreign technical regulations related to trade, responds to inquiries on proposed technical

regulations, participates in various bilateral and multilateral standards-related trade discussions,

and respond to inquiries on the existence, source and availability of standards and standardsrelated information. 

o The National Technology Transfer and Advancement Act - Plan for Implementation (NISTIR

5967)

 The National Technology Transfer and Advancement Act (P.L. 104-113) gives NIST

responsibility to coordinate standards and conformity assessment activities with other Federal

agencies, state and local governments, and with the private sector. Congress required NIST to

submit a plan for implementing the coordination activities. Specific activities in strategic

standards management, responsiveness to international trade concerns, greater use of voluntary

standards, and conformity assessment procedures are described. Responsibilities of

governments, standards developers, and private sector interests are outlined, as are a number of

specific tasks.

o Standards Setting in the European Union - Standards Organizations and Officials in EU

Standards Activities (NIST SP 891, 1997 Edition)

 The guide is designed to help U.S. manufacturers, exporters, and other interested persons in 

locating contact points for important information on the development of standards and

conformity assessment issues. The report includes a history of the role of standards in the

European Union (EU) and the latest information on the EU’s harmonization directives for

implementing the “New Approach” and the “Global Approach” for harmonizing technical

regulations and standards to reduce barriers to trade. 

o ABC’s of the U.S. Conformity Assessment System (NISTIR 6014)

 This report is designed to provide the reader with an introduction to conformity assessment and

information on how the various conformity assessment activities are interlinked. It highlights

some of the field’s more important aspects and serves as background for using available

documents and services.
E-4

o Profiles of National Standards-Related Activities (NIST SP912)

 This directory describes the metrology, standardization, testing and quality (MSTQ) activities

of more than 70 countries. Each entry includes basic data on the country’s economy and trade;

agencies and institutions responsible for metrology and calibration, standards development,

testing, product certification, quality and environmental system registration and accreditation;

and key contacts and information sources. Entries are formatted to facilitate access to specific

information. An introductory section provides general information on development of the

directory and an overview of world-wise MSTQ activities.

o Report on the Open Forum on Establishment of the National Council for Laboratory

Accreditation (NACLA) at the National Institute of Standards and Technology January 7, 1997

(NISTIR 6008)

 The forum was jointly sponsored by NIST, ACIL (formerly the American Council of

Independent Laboratories), and the American National Standards Institute (ANSI). It was

attended by more than 300 representatives from private industry and the government. The

purpose of the Forum was to discuss a proposal to establish the National Council for Laboratory

Accreditation (NACLA), which would be a cooperative partnership between the public and

private sectors designed to provide a national infrastructure for laboratory accreditation in the

United States.

o Examination of Laboratory Accreditation Programs in the United States and the Potential Role

for a National Laboratory Accreditation System (NIST GCR 97-714)

 This report presents an initial study of existing U.S. laboratory accreditation programs, with a

focus on government programs, particularly at the Federal level. The study was conducted in two

phases: Phase I established categories of existing laboratory accreditation programs in the

Federal government, at the state and local level, and in the private sector. Phase II compared

technical standards used by five Federal government laboratory accreditation programs with

general standards for laboratory accreditation established by ISO.

o Using Voluntary Standards in the Federal Government (NISTIR 6086)

 This report is a compilation of presentations given at a NIST-sponsored conference held on

September 8, 1997 to foster better understanding among Federal agencies of the private sector

standardization process. The conference took place as part of a major effort by NIST to

implement the National Technology Transfer and Advancement Act which gives NIST

responsibility to coordinate standards and conformity assessment activities with other Federal

agencies, state and local governments, and with the private sector.

o The U.S. Certification System from a Government Perspective (NISTIR 6077)

 This report is designed to provide the reader with an introduction to the U.S. certification

system from a governmental perspective. It highlights some of the relationships that exist

between federal and state agencies and the private sector and discusses some of the history and

philosophy behind the U.S. system.
E-5

Breitenberg, Maureen, Conformity Assessment, ASTM Standardization News, Nov. 1997. This

article defines the term, highlights the importance of conformity assessment in maintaining the

economic competitiveness of U.S. industry, and explains the relationship between

standardization and conformity assessment
AUG 28 1998

Ms. Virginia Huth

Information Policy Branch

Office of Information and Regulatory Affairs

Office of Management and Budget

Washington, D.C.

Dear Ms. Huth:

 Attached is a Report on the Department of Agriculture's implementation during fiscal year

1997 of Circular A-119, "Federal Participation in the Development and Use of Voluntary

Consensus Standards."

Because this is a delayed report, we send it directly to you, as was agreed in phone

conversations between you and Dr. Ron Garbin of my staff, and with the agreement of Dr.

Collins at the Department of Commerce. Thank you for agreeing to receive the submission at this

time.

If you have questions, please contact Ron Garbin at (202) 720-8026.

Sincerely,

United States

Department of

Agriculture

Office of the Chief

Information Officer

1400 Independence

Avenue, SW

Washington, DC 20250

^^c^Ann F. Anne F. Thompson Reed

Chief Information Officer
DEPARTMENT OF AGRICULTURE

Agency Report on Circular A-119 Compliance

1997

The following information was prepared for the National Institute of Standards and

Technology (NISI) by the Department of Agriculture (USDA) as required annually

under Office of Management and Budget Circular A-l19, "Federal Participation in the

Development and Use of Voluntary Standards."

BACKGROUND

In the Department of Agriculture, the Standards Executive serves also as the Chief

Information Officer (CIO), a position established in August 1996. "This has made the

Office of the CIO (OCIO) the coordinating organization within USDA for reporting on A119 activities. The present report was compiled, however, only after a delay.

METHOD

To prepare this report, OCIO sought information from USDA Agency Heads. The CIO

requested accounts of A-l 19 activities, and for information on the number of agency

employees engaged in at least one standards-developing group; the resulting number

of voluntary standards therefore adopted since the previous year; and the number of

government-unique standards adapted during fiscal 1997, together in each such

instance with some explanation of why such a standard was chosen in lieu of a

voluntary consensus standard. To facilitate responses, OCIO also placed telephone

calls to selected agency members to determine, where possible, if at least no change

had occurred in the agency's information for FY 1996.

DEPARTMENTAL VIEWS

The reorganization of USDA in late 1994, the effect of ITMRA, and the advent of a CIO

have shifted emphasis from information technology (IT) to examination of fundamental

factors like mission, prior identification of program needs, management strategies, and

the making of decisions. In this broader context, USDA still sees IT infrastructure as a

key to comprehensive progress. Standards, IT and otherwise, will play a part. Neither

of these things is primary; each is subordinate to agency programs and must support

them. We understand that this point of view accords completely with Circular A-119.
USDA PARTICIPATION BY FUNCTIONAL AREA

Natural Resources and Environment

Natural Resources Conservation Service (NRCS) has an Engineering mission to

provide quality engineering products to its customers. Many of its employees have

participated in organizations for the development of voluntary standards.

This year the agency reports that at least three of its members participate in the Open

Geographic Information Systems (GIS) Consortium, a public/private partnership

operating through a nonprofit entity, and one that focuses on GIS's. The report indicates

that the Consortium has done some work in the area of standards, especially regarding

standards to facilitate the interoperability of geographic information systems. These

standards may become de facto standards for the GIS industry, or possibly ones that

the GIS industry agrees to adopt.

NRCS has at least five people involved with the Federal Geographic Data Committee,

which has a focus on geospatial data. They are cited as having done some work in the

area of geospatial data standards, seeking to attain commonality among the federal

agencies to facilitate geospatial data sharing. However, this committee is composed

primarily, perhaps entirely, of federal agency representatives.

For FY 1996, NRCS had reported employees working with several committees within

the American Society for Testing and Materials (ASTM). The Society develops

standards on materials, products, systems, and services. These ASTM standards have

not replaced existing conservation practices adopted by NRCS; but NRCS has used

many ASTM standards as reference specifications, and cited them as guidance for

many design and construction activities throughout the whole range of NRCS

conservation programs. The present report has no information on the extent of

participation during FY 1997.

Throuogh fiscal 1996, NRCS employees were involved in developing industry

specifications within the American Society of Agricultural Engineers (ASAE).

Although the practice standards or specifications developed through ASAE

have not been adopted for use with the NRCS workload, much of the

agricultural community applies these specifications for construction and for

provision of quality products.

In previous years NRCS members took part in developing industry voluntary standards

with the American Concrete Institute (ACI). No further information is available for FY

1997 at this time.

Although none of the above standards developed with NRCS involvement had in FY

1996 yet replaced the agency's existing practice standards or specifications, NRCS said

it was moving toward their adoption. For FY 1997 NRCS provides no information on

this. The report for FY 1998 will have to address it.
Farm and Foreign Agricultural Services

Farm Service Agency indicated that in FY 1997 no interactions or activities occurred

under Circular A-119.

Research, Education, and Economics

Neither the Agricultural Research Service, nor the Cooperative State Research,

Education, and Extension Service, nor the National Agricultural Statistics Service

reported interactions with voluntary standards bodies. The Economic Research Service

(ERS) did report such interactions.

During FY 1997, ERS participated in or followed consensus standards for seven

standards. These activities involved twelve employees. There has been no substitution

of voluntary consensus standards for government-unique standards in response to

agency reviews, nor any use of government-unique standards in lieu of voluntary

standards.

Three ERS analysts participated on technical advisory teams associated with the

creation of the North American Industry Classification System (NAICS). The analysts

participated on both the Agriculture, Forestry, Fishing and Hunting and the

Manufacturing sector teams. The NAICS creates a common industry classification

system to replace the current individual systems of Canada, Mexico, and the United

States. Common industry definitions for collecting and publishing data and information

on both inputs and outputs will improve inter-country measuring of productivity, unit

labor costs, and the capital intensity of production, estimating employment-output

relationships, constructing input-output tables, and other uses that imply the analysis of

production relationships in the economy.

ERS has one analyst who maintains contact with the Conservation Technology

Information Center (CTIC) and attends its annual meeting. CTIC periodically

coordinates the definition and standards for crop residue management systems.

Various crop residue management systems used to reduce wind and water erosion are

often part of farm conservation plans that must be implemented by farmers to be

eligible for most Federal Farm Program benefits. USDA agencies, including NRCS,

ERS, and CSREES, along with representatives from other natural resource

organizations and private industry establish criteria for different classes of crop residue

management. These criteria are used in surveys conducted by CTIC to measure the

adoption of conservation tillage. The criteria are also applied to USDA's Agricultural

Resource Management Study to analyze economic and environmental effects of

alternative crop residue management systems.

ERS has one analyst who was a cooperator on an EPA Environmental Stewardship

Program (PESP) project, completed last year, that developed draft voluntary standards

for potato Integrated Pest Management (IPM). The steps for building the national

definition included developing a comprehensive listing of State-level potato IPM

practices, making a tentative rating of the practices in terms of their value in an IPM

program, and conducting an
extensive review of the draft definition. State Extension IPM specialists and commodity

associations provided information on State-level potato pest management practices,

and the rating system was based on the University of Massachusetts "Partners with

Nature" IPM certification system model. The draft IPM definition was reviewed by

soliciting comments from EPA, land-great university IPM specialists, food processors

and commodity associations, chemical industries and other input suppliers,

environmental groups and others.

ERS has one analyst who participated in the Current Research Information System

(CRIS) enhancement effort. The CRIS Enhancement group was charged with

evaluating and improving the CRIS system, which is used to classify all publicly funded

agricultural research. A national advisory steering committee guided the effort, and

included representatives from major science and agricultural foundations, government

agencies, Congressional staff, and university cooperators. Members of the Working

Group and Task Groups included USDA personal and representatives from the State

Agricultural Experiment Station system and the Land Grant Universities.

Accomplishments included revising the current classification structure to more

accurately and efficiently capture the research of USDA and its partners. An

implementation team has begun work to execute the recommendations of the

enhancement effort.

ERS has one analyst who participates in the USDA Ecological Risk Assessment

Working Group, charged by the Secretary to develop standards and guidelines for

USDA program managers to follow in conducting risk assessments for their programs.

Activity involves working with representative from other USDA agencies to define terms

and develop practical guidelines to assist program managers.

ERS analysts monitor materials released by the Farm Financial Standards Council for

developments in the measurement of financial indicators for farm businesses. FFSC

standards are used in the development of questionnaires and in preparing summary

financial statements connected with farm financial performance.

ERS analysts interact with the American Agricultural Economics Association

Commodity Costs and Returns Accounting Task Force. The Task Force published its

report on July 20, 1998, establishing standards for university, government, non-profit

institute, private sector and other analysts to consider when developing estimates of

agricultural commodity costs and returns. ERS has always sought consensus with the

American Agricultural Economics Association and the agricultural economics

profession in measuring costs and returns.

Marketing and Regulators' Programs

The Agricultural Marketing Service (AMS) reports that 20 employees participated

in 8 national voluntary consensus standards bodies, and 17 employees

participated in 17 international voluntary consensus standards bodies.

Since October 1, 1996, the agency has used the following voluntary consensus

standards:
Agreement on the International Carriage of Perishable Foodstuffs and the Special

Equipment to be Used for Such Carriage; Certification Standards of the American

Association of Seed Certifying Agencies; Codex Alimentarius International Grade

Standards; Universal Cotton Standards Agreement; Analytical Standards of the

American National Standards Institute (ANSI); Test Standards of the American Society

for Testing and Materials; International Meat Purchase Specifications (IMPS). In

addition, AMS, at the request from and with the full participation of the industry, has

developed and currently uses 584 grade and classification standards that are generally

recognized by the industry for use in the marketing of 230 agricultural commodities.

While developed and maintained by AMS, these standards were created in response

to a need expressed by industry for uniform standards that could be recognized and

certified to nationwide. The usage of these standards by the industry is voluntary.

The American Dairy Products Institute has published a series of milk and dry milk

standards that are usually referenced when USDA certification is not requested by the

buyer or seller. These standards are based on the USDA standards and contain

basically the same requirements as the U.S. Grade Standards. We see no reason to

adopt these standards because they are the same as those of USDA and the majority

of the industry utilizes USDA certification services, recognizing the value of official

certification.

The IMPS mentioned above are voluntary standards for meat cuts and meat products

for the U.S. livestock and meat industry.

ANSI and ASTM standards are used for testing and analysis required to provide

AMS certification activities.

AMS believes the guidelines in Section 7 are reasonable and effective, and

recommends they be adopted.

As noted above, AMS has developed numerous grade standards and classifications in

response to requests from industry. They do not view these standards and

classifications as government-unique since they were developed with full consultation

and participation of the industry and their usage by the industry is voluntary. AMS uses

government-unique specifications for purchases of some commodities for distribution

to the School Lunch Program and other domestic feeding programs when voluntary

consensus standards do not meet the nutritional or program requirements of the USDA

programs.

National Appeals Division

Under the mandate of the Federal Crop Insurance Reform and Department of

Agriculture Reorganization Act of 1994 (P.L. 103-354), the Secretary's Memorandum

No. 1010, of October 20, 1994 created the National Appeals Division (NAD). The Act

consolidated the appellate functions and staffs of several former agencies (Agricultural

Stabilization and Conservation Service, Farmers Home Administration, Federal Crop

Insurance Corporation,
Soil Conservation Service to provide for independent hearings and reviews of adverse

agency decisons. NAD assumed transfer of employees previously assigned to appeal

functions in their former agencies. On December 29, 1995 were published interim final

regulations governing NAD appeals. On May 14, 1996, the Secretary approved NAD's

organizational structure.

In last year's Report, NAD declared that a number of NAD employees belong to certain

National or State professional organizations founded for the general purpose of

educating, and improving the adjudication of cases, but asserted also that NAD's

Statutory appeal process cannot properly depend on voluntary standards. To this

year's Report NAD had no response.

Assistant Secretary for Administration

From the Office of Procurement and Property Management (OPPM), one staff member

participates on one standards setting body. Since October 1, 1996, one set of

standards is used. The organization stated that no prior standards were used by

OPPM for procurement which involved electronic commerce. Nor did OPPM

comment on the effectiveness of guidelines in Section 7 of the proposed revision to

Circular A-119.

Office of the Chief Information Officer

A member of the OCIO continues to take part on a Subcommittee of the Electrical

Industries Association/Telecommunications Industry Association (EIA/TIA). The

Subcommittee deals with Commercial and Residential Building Cabling Systems, and

functions under the EIA/TIA Engineering Committee on User Premises

Telecommunications Requirements. The Subcommittee meets quarterly and,

afterward, information from the sessions circulates to relevant parties in the

Department.

Memorandum

Date: September 3, I998

From: Acting Director, Office of Cosmetics and Colors, HFS-100

Subject: OMB Annual Standards Report - update

To: John Gordon, Executive Operations Staff, HFS-22

This is in response to your request of September 1, 1998 for additional information on the 5

government unique standards that the Office of Cosmetics and Colors (OCAC) uses in lieu of

voluntary consensus standards in the certification of color additives, as reported in our

memorandum of November 18. 1937.

OCAC uses 5 government-unique standards in lieu of voluntary consensus standards in the

certification of color additives. For all of these standards, the voluntary consensus standard

methods are based on old technology and determine impurities found In frequently certified

color additives. The Color Certification Program developed and uses government unique

standards in lieu of these voluntary consensus standards because the government unique

standards utilize newer, more accurate and more cost-effective technology. A search of all

available standards is routinely done before developing a new standard.

The voluntary consensus standards, and their replacement standards are:

1. AOAC Official Method 981.13 Cresidine Sulfonic Acid, Schaeffer's Salt, 4,4'

(Diazo-amino) bis (5-methoxy-2-methyl-benzenesulfonic Acid), and 6,6" - Oxybis (2

naphthalenesulfonic Acid) in FD&C Red No. 40

Liquid Chromatographic Method - Final Action 1982

The voluntary consensus standard uses ion exchange LC with gradient elution and

determines 4 sulfonated impurities in FD&C Red No. 40; the replacement government

unique standard uses reversed phase HPLC with gradient elution and determines 7

sulfonated impurities in FD&C Red No. 40.

2. AOAC Official Method 982.28 Intermediates and Reaction By-Products in FD&C Yellow

No.5

Liquid Chromatographic Method - Final Action 1983

The voluntary consensus standard uses ion exchange LC with gradient elution and

determines 5 sulfonated impurities in FD&C Yellow No. 5; the replacement government

unique standard uses reversed phase HPLC with gradient elution and determines 7

sulfonated impurities in FD&C Yellow No. 5.

3. AOAC Official Method 980.24 Sulfanilic Acid, Schaeffer's Salt, 4,4'-(Diazoaminc)-

dibenzene-sulfonic Acid and 6,6'-Oxybis(2-Naphthalene Sulfonic Acid) in FD&C Yellow

No. 6

Liquid Chromatographic Method - Final Action 1981

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
The voluntary consensus standard uses ion exchange LC with gradient elution and

determines 4 sulfonated impurities in FD&C Yellow No. 6; the replacement government

unique standard is a reversed phase HPLC method with gradient elution that determines

6 sulfonated impurities in FD&C Yellow No. 6.

4a. AOAC Official Method 947.12 Lead in Color Additives (Applicable to colors not

containing Ca, Ba, or Sr)

4b. AOAC Official Method 948.24 Lead in Color Additives (Applicable to Al

Lakes)

4c. AOAC Official Method 948.25 Lead in Color Additives (Applicable to Ca, Ba and Sr

lakes)

The replacement government unique standard for Methods 947.12. 947.24 and 928.25)

is an X-ray fluorescence spectrometry method that determines lead in all color additives.

5. AOAC Official Method 950.79 Chlorides in Water-Soluble Color

Additives

Potentiometric titration with silver nitrate - final action 1961.

The voluntary consensus standard is still used as a confirmatory method; however the

government unique standard, which uses an automated ion chromatograph, is routinely

used for chloride analyses.

John E. Bailey, Ph.D.

cc: HFS-100 (Bailey)

HFS-105 (Decker, Barrows)

HFS-106 (Richfield-Fratz)

HFS-125 (Dennis)

HFS-126 (Bell)
 August 10, 1998

Beth Nolan

Deputy Assistant Attorney General

Office of Legal Counsel

U.S. Department of Justice

Washington, DC 20530

Dear Ms. Nolan:

I recently met with representatives of the Office of Management and Budget (0MB) and

the Department of Commerce to discuss their concerns about impediments to Federal

employees participating in the activities of private voluntary standards organizations. One of the

issues discussed at the meeting was whether the enclosed language from the National

Technology Transfer and Advancement Act of 1995 (Act), Pub. L. No. 104-113, § 12(d)(2), 110

Stat. 775, provides the requisite statutory authority, as discussed in your November 19, 1996

memorandum, to permit employees to serve as officers or directors of outside standards bodies

in their official capacities.

The legislative history of the Act describes the importance of developing standards

appropriate to rapidly changing technology, and acknowledges that Federal agencies should be

major participants in the United States standards system. H.R. Rep. No. 104-390, at 24 (1995),

reprinted in 1996 U.S.C.C.A.N. (110 Stat.) 493, 510. It details a recommendation made by the

National Research Council, in a March 1995, report which recommended that Congress amend

the National Institute of Standards and Technology's (NIST) organic act to "clarify NIST's lead

role in the implementation of a government-wide policy of phasing out the use of federallydeveloped standards wherever possible, in favor of standards developed by private sector,

consensus standards organizations, with input from affected agencies." Id. Congress adopted

this recommendation, as reflected in section 12 of the Act. The Report of the House Science

Committee states that section 12 "will have the effect of assisting agencies in focusing their

attention on the need to work with these voluntary consensus standards bodies, whenever

and wherever appropriate." H.R. Rep. No. 104-390, at 25 (1995), reprinted in 1996

U.S.C.C.A.N. (110 Stat.) 493, 512.

The Act also codified existing policies in 0MB Circular A-119, dated October 20, 1993,

which required Federal agencies to adopt and use standards, developed by voluntary consensus

standards bodies, and to work closely with these organizations to ensure that developed

standards are consistent with agency needs. Revised 0MB Circular A-119, also enclosed, was

published in the Federal Register on Thursday, February 19, 1998, and replaced the previous

Circular No. A-119, to make the terminology consistent with the Act and to provide other

guidance consistent with the Act. Question 7 of the Circular sets forth guidance with respect to

participation of agency personnel in voluntary consensus standards bodies. More specifically, it

addresses issues on authorization to participate and limitations on participation.

In order to provide definitive guidance to 0MB and other agencies, I am interested in

your views on whether the Act provides sufficient authority for employees to serve, consistent

with the requirements of 18 U.S.C. §208, as officers or directors of standards organizations. In

discussing this issue with members of your staff, I understood that your office's preliminary

view was that, notwithstanding the prohibition in §208 (a), section 12 of the Act would

authorize employees to serve as officers or directors of voluntary standards bodies, if

participating in setting the standards were an integral part of the duties of officers or directors

of the particular organization. As I understand it, however, performing only the administrative

duties of officer or director would not be authorized by the Act.

Finally, the 0MB and Commerce employees with whom I met mentioned that some

agencies appeared to be concerned that employees were barred by § 208 from serving in

an official capacity as Chairpersons of working committees or subcommittees of the
standards organizations. I explained that, to the extent that those positions do not impose a

fiduciary responsibility on employees serving in them, or do not create an employer-employee

relationship, the prohibition of §208 does not apply. Please let me know if you disagree with

this conclusion.

Thank you for reviewing this matter. Please let me know if any additional information is

necessary.

Sincerely,

Marilyn L. Glynn

General Counsel

Enclosures
 VIA FAX

Office of the Deputy Assistant Attorney General Washington, D. C. 20530

 August 24, 1998

MEMORANDUM FOR MARILYN L. GLYNN

GENERAL COUNSEL

OFFICE OF GOVERNMINT ETHICS

From: Beth Nolan

 Deputy Assistant Attorney General

Subject: Application of 18 U.S.C. §208 to Service on Boards of Standard-Setting Organizations

This responds to your request of August 10, 1998 for our opinion whether, absent a waiver, 18

U.S.C. § 208 would forbid employees of the executive branch from serving, in their official

capacities, 85 members of the boards of private voluntary standards organizations. We believe

that, to the extent necessary to permit the federal employees to take part in the standard-setting

activities, § 208 does not bar such service.

Section 208 prohibits an officer or employee from taking part as a government official in any "particular

matter" in which he or she has a financial interest. The statute imputes to the employee the financial

interests of certain other persons and entities, including an "organization in which he is serving as officer,

director, trustee, general partner or employee." 18 U.S.C. § 208(a). In an earlier opinion, we observed

that when an employee is acting in his or her official capacity as a director or officer of an outside entity,

the work for that entity necessarily entails official action affecting the entity's financial interests. We

therefore concluded that, under 18 U.S.C. §208, the "broad prohibition against conflicts of interest within

the federal government would prevent a government employee from serving on the board of directors of

an outside organization in his or her official capacity, in the absence of: (1) statutory authority or a

release of fiduciary obligations by the organization that might eliminate the conflict of interest, or (2) a

waiver of the requirements of §208(a), pursuant to 18 U.S.C. §208(b)." Memorandum for Howard M.

Shapiro, General Counsel, Federal Bureau of Investigation, from Beth Nolan, Deputy Assistant Attorney

General, Office of Legal Counsel, re: Service on the Board of Directors of Non-Federal Entities by

Bureau Personnel in Their Official Capacities, at 1 (Nov. 19, 1996) ("FBI Opinion"). In particular, if

"Congress has authorized the service by statute, the official 'serves . . . in an ex officio rather than

personal capacity,' owes a duty only to the United States, and does not violate section 208."

Memorandum for J. Virgil Mattingly, Jr., General Counsel, Federal Reserve Board, from Richard L.

Shiffrin, Deputy Assistant Attorney General, Office of Legal Counsel, re: Directorships of Bank for

International Settlements, at 2 (May 6, 1997) (citation omitted) ("FRB Opinion").

U.S. Department of Justice

Office of Legal Counsel
Since the FBI Opinion, we have had a number of occasions to consider whether particular statutes

confer authority for service on outside boards. We have found such authority in a range of

circumstances. Sometimes the statutes expressly contemplated official service on an outside board.

See Memorandum for Files, from Daniel Koffsky, re: Foundations and Commissions Under Fulbright

Program (Oct. 24, 1997); Memorandum for Files, from Daniel Koffsky, re: Service on Outside Board

(Feb. 27, 1998) (United States-India Fund for Cultural, Educational, and Scientific Cooperation). In

another instance, the statute was less explicit, but we found the authority because service on the

outside entity was a means by which the United States negotiated with foreign governments and “the

breadth of the President’s power [in that area] counsels a broad reading of congressional authorization

for particular means by which the power may be exercised.” FRB Opinion at 3 (citation omitted). In

one other instance, where the agency largely conducts its operations in secret and had to create the

outside entity to preserve the secrecy of its work, we concluded that the outside organization was, for

relevant purposes, a part of the federal government, and thus no conflict existed.

As this experience in applying the principles of the FBI Opinion has made clear. Congress has

enacted a variety of arrangements contemplating, directly or indirectly, that federal employees will

participate in outside organizations, including by serving on their boards, and it would frustrate these

arrangements if such service were considered a disqualifying “director[ship]” under 18 U.S.C. § 208.

See Memorandum for Kenneth R. Schmalzbach, Assistant General Counsel, Department of the

Treasury, re: Applicabilitv of 18 U.S.C. §208 to the Proposed Appointment of the Deputy Assistant

Secretary to the Board of the College Construction Loan Insurance Association, at 3 (June 22,1994)

(categories of service considered outside statute). We believe that there are circumstances in which

statutory authority for service on an outside board can be found even though Congress has not

expressly addressed that service. When Congress has specifically provided for participation in outside

organizations and such participation, to carry out the statutory purposes, entails service on a board,

statutory authorization may be inferred.

Here, Congress has provided that, in general federal agencies and departments “shall use technical

standards that are developed or adopted by voluntary consensus standards bodies” and, in carrying

out this requirement, “shall consult with voluntary, private sector, consensus standards bodies and

shall, when such participation is in the public interest and is compatible with agency and departmental

missions, authorities, priorities and budget resources, participate with such bodies in the development

of technical standards.” Pub. L. No. 104-113, § 12(d)(1)&(2) 110 Stat. 775, 783 (1996), 15 U.S.C.

§272 note (emphasis added). As the legislative history explains, Congress desired and anticipated that

federal agencies would “work closely” with voluntary standard-setting organizations, that these

organizations would “include active government participation,” and that agencies would “work with

these voluntary consensus standards bodies, whenever and whoever appropriate.” H. R. Rep. 104-

390, at 15.25 (1995). When the board of an outside organization plays an integral role in the process

of setting standards, it would therefore frustrate the statute to forbid federal employees from being on

the board. They could not then take the “active” role that Congress mandated. To carry out the statute,

therefore, employees may serve on these outside boards without running afoul of 18 U.S.C. § 208, if

the boards are engaged in the standard-setting activities in which Congress directed federal agencies

to participate.

To be sure, § 208 allows for waivers when the employee's "interest is not so substantial as to be

deemed likely to affect the integrity of the services which the Government may expect," 18 U.S.C. §

208(b)(1), and thus a conclusion that § 208 generally would bar employees from serving on standardsetting bodies in their official capacities would not necessarily have prevented the service in every

instance. Nevertheless, reliance on the waiver procedure would not be consonant with the statutory

scheme here. Congress itself has resolved the possible conflict between duties to the organization

and duties to the United States, at least to the extent that the criminal prohibition may be at issue.

We would not reach the same conclusion, however, if the board of an organization had only

administrative responsibilities and was not directly involved in standard-setting. In that event,

the congressional direction to "participate . . . in the development of technical standards" would

not apply. Consequently, in accordance with the FBI Opinion, §208 would bar the service on
the board, absent a waiver or an effective release from fiduciary duty.

Finally, you also ask us to confirm your view that an employee's service in an official capacity

as the chair of a working committee or subcommittee of a standard-setting organization, to the

extent the position imposes no fiduciary duty and creates no employer-employee relationship,

would not implicate 18 U.S.C. §208. We agree that service in such a position would not itself

trigger the statute. Indeed, we are far from certain that a position other than one specified in

§208 - "officer, director, trustee, general partner or employee" - could be the basis for imputing

an organization's financial interest to the employee, even if that other position created a

fiduciary duty to the organization. In any event, the positions you describe would not give rise

to an imputed disqualification.

Please let us know if we may be of further assistance.