1

Annual Report to the Office of Management and Budget on

Implementation of OMB Circular A-119

1. SCOPE 

This report provides an account of the progress that Federal agencies have made in the use of

voluntary consensus standards (VCS) and their participation in standardization activities. It also 

provides highlights of the status of agencies’ interactions with private-sector voluntary consensus

standards bodies, agencies’ use of government-unique standards, and the activities of the

Interagency Committee on Standards Policy (ICSP). It also reports the progress that the National

Institute of Standards and Technology (NIST) has made in coordinating Federal agencies’

standards-related efforts, including interactions with key private-sector organizations. This report

covers the period from October 1, 1997, through September 30, 1998.

Appendices A and B provide copies of the full reports that NIST received from Cabinet

Departments and Independent Agencies. Appendices C, D, and E, respectively, provide copies of 

the ICSP Charter, ICSP membership, and a list of NIST publications related to P.L. 104-113. 

2. FEDERAL STATUTES

2.1 National Technology Transfer and Advancement Act (NTTAA) - Public Law 104-113,

the National Technology Transfer and Advancement Act of 1995, codified existing policies of

OMB Circular A-119, established reporting requirements, and authorized NIST to coordinate

standards-conformity assessment activities of Federal agencies, and with the private sector.

2.2 OMB Circular A-119 and Public Law 104-113 - On February 19, 1998, the Office of

Management and Budget (OMB) issued the newly-revised Circular A-119, Federal Participation

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

Activities, to replace the Circular dated October 20, 1993. The purpose was “to make the

terminology of the Circular consistent with Public Law 104-113, to issue guidance to 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.” 

 2.2.1 Agencies’ use of voluntary consensus standards versus government-unique 

standards - Consistent with Section 12(d) of the NTTAA, the 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 the reporting

requirements of the NTTAA. The policies in the Circular are intended to minimize reliance by

agencies on government-unique standards. These policies do not create the basis for
2

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. 

2.2.2 Guidance to agencies - Consistent with Section 12(b) of the NTTAA, the Circular directs

the Secretary of Commerce to issue guidance to agencies in order to coordinate conformity

assessment activities. The goal is: (1) to 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, (2) to provide incentives and opportunities to establish standards that serve national

needs, (3) encourage long-term growth for U.S. enterprises and promote efficiency and economic

competition through harmonization of standards, and (4) further the policy of reliance upon the

private sector to supply Government needs for goods and services.

2.2.3 Other issues covered by the Circular - The Circular states policies with regard to whom

is affected, Federal use of standards, Federal participation in voluntary consensus standards

bodies, and policy on conformity assessment. It covers the use of standards in regulations and

provides the procedures for managing and reporting on agency use of standards in procurement

and regulations. It also covers what must be reported and how an agency is to report on its

development and use of standards. The Circular also specifies the responsibilities of the Secretary

of Commerce, the heads of agencies, and the Standards Executives of agencies.

2.2.4 Role of Secretary of Commerce and NIST - The NTTAA and the Circular assign several

policy coordination and implementation tasks to the Secretary of Commerce and specifically to

NIST. To carry out these tasks, NIST provides the Chair and Secretariat for the Interagency

Committee on Standards Policy (ICSP). NIST must also submit this annual report to OMB on

agency implementation activities, requiring the full cooperation and assistance of all departments

and agencies in complying with reporting requirements of the Circular. 

2.2.5 Agency Standards Executives - The revised Circular clarifies the role of Agency

Standards Executives, particularly regarding agency-wide compliance with the new legal

requirements. The Standards Executive must have responsibility for coordinating agency-wide

standards-related activities, coordination of implementation of the Circular, and serving on the

ICSP. In 1998, at the request of the Secretary of Commerce, each cabinet department and

independent agency of the executive branch designated an individual to serve as the Agency

Standards Executive for its department or agency.

3. INTERAGENCY COMMITTEE ON STANDARDS POLICY (ICSP) 

3.1 Purpose - The Interagency Committee on Standards Policy (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, with similar goals. A copy is

provided as Appendix C.
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3.2. ICSP chair - The Director of the NIST Office of Standards Services chairs the ICSP on

behalf of the NIST Director and the Secretary of Commerce. The ICSP is the primary vehicle for

coordinating Federal activities under the NTTAA and the OMB Circular. NIST develops very

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

the NTTAA. 

3.3 ICSP membership - The ICSP is currently composed of representatives of the 14 Federal

Cabinet departments, 11 independent Federal agencies, and several offices in the Executive Office

of the President. The composition of the ICSP is shown in figure 1 on the next page. The ICSP

membership is provided in Appendix D.

4. HIGHLIGHTS OF ICSP ACTIVITIES

4.1 General - The ICSP met six times in FY 1998. The meetings focused on such main topics

as the NTTAA, the revision of the OMB Circular A-119, and the annual report to OMB. There

were presentations and discussions of planning activities for implementation of the NTTAA,

various agency standards-related policy issues, and proposed guidelines on Federal conformity

assessment activities. ICSP members heard presentations from NIST regarding the Government

Industry Quality Liaison Panel (GIQLP), the status of the NIST Standards Assistance and

Management Information (SAMI) project on-line, and agency ethics guidance and waivers for

service on the boards of directors of non-Federal standards organizations. Of paramount interest

were three conferences: the September 1997 Open Seminar on Use of and Participation in

Voluntary Standards in Government, the March 1998 NIST/OMB seminar on The Revised OMB

Circular, and the September 1998 NIST/ANSI Summit: Toward a National Standards Strategy

to Meet Global Needs. The ICSP chair reported on the September 1997 Open Seminar at the

December 1997 meeting, and the Director of NIST and the President of ANSI (American

National Standards Institute) reported on the NIST/ANSI Summit at the 1998 September ICSP

meeting.

4.2 Interaction with private-sector standards organizations - Representatives from several

private-sector organizations gave presentations on topics of interest. The speakers represented

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

(ANSI), National Fire Protection Association (NFPA), the National Cooperation for Laboratory

Accreditation (NACLA), and the ICF Kaiser Consulting Group.

4.3 ICSP working groups - During1998 a variety of ICSP activities were carried out by

workings groups whose participants were designated by ICSP representatives. The ICSP

Working Groups, with their secretariats, are shown in figure 1 on the next page.
figure 1

Interagency Committee

on Standards Policy

Interior

Health and

Human Services

and

Transportation

Treasury

Justice

State

Labor

International Trade

Commission

Postal Service

National Science

Foundation

Nuclear Regulatory

Commission

National Archives and

Records Admin.

National Aeronautics

and Space Admin.

Energy General Services

Administration

Education Federal Trade

Commission

Defense Federal Emergency

Management Agency

Veterans Affairs

Fed. Communications

Commission

Commerce Environmental 

Protection Agency

Office of Management and Budget

Agriculture Consumer Product

Safety Commission

Office of the U.S.

 Trade Representative

CABINET 

DEPARTMENTS

OTHER 

AGENCIES

EXECUTIVE OFFICE

OF THE PRESIDENT

NIST

Housing and Urban

 Development

ICSP

ICSP Working Groups

Laboratory Accreditation

 Chair: NIST

 Secretariat: NIST

 Directory Database

 Chair: NIST

 Secretariat: NIST

Strategic Standards Management

 Chair: DOE

 Secretariat: DOE

Regulatory Agency

 Chair: CPSC

 Secretariat: NIST

Procurement Agency Procedures

 Chair: DOD

 Secretariat: DOD

Agency Participation

 Chair: DOD

 Secretariat: DOD

ISO 9000

 Chair: NIST

 Secretariat: NIST

ISO 14000

 Chair: NIST, EPA, & DOE

 Secretariat: NIST

CIO Interoperability Standards

 Chair: NIST

 Secretariat: NIST

44
5

 Their activities are described as follows:

C Federal procurement - Dr. Belinda Collins, ICSP chair, asked that a working group be

formed to discuss issues shared by Federal Procurement agencies. Representatives from 

DOD, NASA, and EPA attended the first subcommittee meeting. This meeting focused on

NASA’s proposed change to the FAR (FAR Case 98-004), which would invite alternatives to

government specifications in contracting. At the time of the meeting, language was still

being debated in the FAR Council; thus, committee members could not voice a group opinion

on the case. The working group did not identify any other pressing needs and decided to

meet on an “as required” basis.

C Agency participation in voluntary standards activities - Dr. Collins, requested that a 

working group look into the extent of “actual” versus “perceived” decline in Federal

Government participation in the work of voluntary consensus standards development

organizations. Representatives from DOD, AIA, NIST, NRC, ICC, NASA, NFPA, ANSI,

and TIA attended the first meeting. The ANSI Organization Member Council was asked to

distribute a survey to its members to determine whether there has been a decline in Federal

participation and what areas of standards development could benefit from Federal

participation in the future. The subcommittee will continue to focus on analyzing survey

responses, evaluating reporting procedures, and determining the next course of action. It

should be noted that the steep decline in committee memberships reported in the FY 97

Annual Report has not continued. 

C The regulatory agencies’ working group (ICSP-RAWG) - This working group chaired by

Mr. Colin Church, CPSC, helps to develop and implement standards policies of interest to

regulatory entities of the Federal Government. Membership includes representatives from

CPSC, DOE, DOL, EPA, FCC, FDA, FERC, GSA, HUD, NASA, NHTSA, NIST, NRC,

NSA, and USDA. The working group reports to the ICSP and serves as a forum for

interagency information exchange and discussion of issues of mutual interest.

During 1998 the working group focused on issues and activities related to the development

and implementation of the OMB Circular A-119 dated February 1998. Working group

representatives actively participated in discussions of major issues with the ICSP and OMB

representatives during the drafting of the document. After the Circular was approved, the

working group directed its attention to issues related to implementing its provisions. Other

issues that were addressed included: (1) coordination of conformity assessment activities, 

(2) expediting revision of standards to reflect the most current versions of referenced

standards, and (3) on-line standards development.

C Working group on quality management (ISO 9000) - NIST provided material to agencies

on the current proposed revisions to the ISO 9000 family of standards, but did not hold any

formal working group meetings in FY 98.
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C Working group on ISO 14000 - This working group, chaired by the EPA, met

approximately every other month over the past year. Membership in the group now extends

to 44 people, representing 14 Federal agencies and the President's Council on Sustainable

Development. A strong interest in putting together Federal agencies' issues and perspectives

on ISO 14000 continues. However, as the group has matured, its range of activities and

interests has expanded. The group continues to invite members to make presentations

regarding issues, approaches, and lessons learned by their individual agency or program.

These presentations have been very well received and have provided extensive, practical

information. Group members also shared ISO 14000 materials and such documents as the

EMS (Environmental Management Systems) Primer for Federal Facilities, jointly developed

by DOE and EPA, and web sites developed for their programs. Group members also reported

on key meetings, such as the TC-207 meeting hosted by the United States in June. 

A central feature of the group's effort this year was work toward a “White Paper” on

Environmental Management Systems (EMS) issues. The group conducted meetings,

including facilitated group discussions and conference calls, to define key elements. This

process highlighted the range of ways in which Federal agencies are evaluating and

implementing EMSs. The meetings provided a basis for a draft document outlining: (1) an

overview of issues and status of EMSs in Federal agencies, (2) trends and key issues to be

addressed, and (3) impacts of ISO 14000 on Federal agencies’ potential to influence

standards. 

An index of references and materials is also being developed. This will include policy or

position statements by participating agencies on ISO 14001 documents, web sites, and

resource directories.

C Working group on laboratory accreditation (WGLA) - This working group, chaired by

Mr. James Cigler of NIST, has kept the ICSP current on public- and private-sector activities

related to laboratory accreditation throughout the country. The WGLA members attended

various government agency meetings, such as the Department of Energy Topical Group on

Laboratory Accreditation and the annual meeting of the National Environmental Laboratory

Accreditation Conference (NELAC). WGLA members commented on the Draft International

Standard, DIS 17025, which is the revision of ISO/IEC Guide 25 General requirements for

the competence of testing and calibration laboratories. Several members reported on

activities within their agencies related to laboratory accreditation and an attempt will be made

to catalog those activities so that members can meet and share experiences that might be of

value to each other in their efforts.

Some members of the WGLA also serve on the Government liaison group that works with the

private sector National Cooperation for Laboratory Accreditation (NACLA). Considerable

effort has been expended in developing consensus on a Government position regarding the

recognition of public- and private-sector laboratory accrediting bodies in the United States. 
7

This is seen as fulfilling the mandate in the NTTAA for the Government to work with the

private sector in the use of national and international consensus standards.

C Working group on directory database - The ICSP working group on directory database did

not meet in 1998; however, NIST developed and implemented procedures for on-line

registration of staff participation in standards activities which will be made available to all

ICSP members. This working group will reconvene in 1999 to review and revise current

government-wide guidelines for identifying, collecting and developing directories of Federal

Government staff on standards developing committees.

C Working group on standards management - During 1998, the ICSP’s Standards

Management Working Group, chaired by Mr. Richard Serbu of DOE, coordinated the first

Federal Technical Standards Workshop, held at Loews L’Enfant Plaza Hotel in Washington,

D.C., on August 4-6, 1998. Sponsors included the Department of Energy (DOE-host), the

National Institute of Standards and Technology (NIST), the Environmental Protection

Agency (EPA), the Food and Drug Administration (FDA), and the Partnership in Reliability,

Maintainability, and Supportability (RMS) Standards (a consortium of professional societies,

industrial associations, and Government agencies working together to help implement

acquisition and standardization reform). The Workshop supported implementation of the

NTTAA (Public Law 104-113) through sharing of standards management success stories,

“lessons learned,” and discussions of emerging initiatives from within the Federal

Government. The Workshop was well-attended by representatives from Federal agencies and

their support contractors, standards development organizations, and private industry.

5. HIGHLIGHTS OF AGENCY ACTIVITIES

5.1 Department of Commerce (DOC) - Within DOC, NIST has responsibility for the primary

activities for implementation of P.L.104-113 and OMB Circular A-119. During FY 98, NIST

carried out a number of activities to strengthen coordination between agencies and the private

sector. Among these were:

C participating in the September 1997 Open Seminar on Use of and Participation in Voluntary

Standards in Government;

C conducting a workshop with OMB in March 1998 on the requirements contained in the

revised OMB Circular A119, as a means of acquainting Federal agencies and the private

sector with the revised Circular;

C convening a successful summit conference, Toward a National Standards Strategy to Meet

Global Needs in September 1998, in cooperation with ANSI;

C revising and signing an ANSI/NIST Memorandum of Understanding on September 24, 1998;
8

C promulgating a NIST policy on voluntary consensus standards and a template for strategic

standards management that serves as a model for adoption by Federal agencies;

C developing an electronic form for registering NIST/DOC standards participants on-line;

C hosting a public workshop in April 1998 to facilitate establishment and private-sector

incorporation of the National Cooperation for Laboratory Accreditation (NACLA) in its

mission of providing coordination and worldwide acceptance of competent laboratory

accreditation in the United States and to become the U.S. point-of-contact for international

laboratory accreditation efforts;

C obtaining international recognition of leadership in laboratory accreditation through the

election of the Director of the Office of Standards Services of NIST as Chairman of the

International Laboratory Accreditation Cooperation (ILAC).

5.2 Department of Defense (DOD) - A major aspect of the Department’s Mil Spec reform

initiative continues to be replacement of military specifications and standards with voluntary

consensus standards wherever there is a dual-use application. As a result of this initiative, DOD

completed a review of its 30,000+ military specifications and standards to determine whether a

replacement voluntary standard already exists or whether one could be developed. DOD reported

that as of FY 98 that DOD had adopted 7991 voluntary consensus standards (464 of those were

adopted during FY 98). DOD reported that it has identified more than 3000 candidate military

specifications and standards with potential to be replaced by voluntary consensus standards. The

Department has installed procedures to ensure that proliferation of military documents will not

recur.

The Department is also continuing to pro-actively enlist the support of industry associations and

voluntary consensus standards-developing organization to help review, identify, and plan for

replacement of military specifications and standards with voluntary consensus standards. In

situations where a military standardization document is also used by commercial firms, the

department is working with the appropriate standards developing organization to create a suitable

replacement.

5.3 Department of Energy (DOE) - At DOE, departmental policies on the use of voluntary

consensus standards have been implemented by means of 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 consensus standards in

preference to Federal and DOE standards, consistent with P.L. 104-113 and OMB Circular

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. The Order encourages and supports staff

participation in the planning, development, and coordination activities of voluntary consensus

standards committees.
9

In October 1998, DOE Order 1300.2A was updated to incorporate references to P.L. 104-113

and the February 1998 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. The Department had already incorporated the technical standards

provisions of P.L. 104-113 and OMB Circular A-119 into its current Technical Standards

Program Procedures, and currently manages its technical-standards activities in conformance with

the Procedures requirements. In addition, DOE hosted a Federal Technical Standards Workshop

with broad participation from Federal agencies in August of 1998 to discuss standards

management issues and share experience related to implementing P.L. 104-113 and OMB Circular

A-119.

5.4 Department of Health and Human Services (HHS), Food and Drug Administration 

(FDA) - FDA has conducted standards activities for more than 20 years. In January 1977 the

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

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

FDA participation in standards 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

development and use of standards 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 pre-decisional documents

with State and foreign officials. The final rule, Public Information; Communications with State

and Foreign Government Officials, was published on December 8, 1995.

5.5 Department of Housing and Urban Development (HUD) - The Department selected the

National Fire Protection Association (NFPA) to function as the secretariat for the Federal

Manufactured Home Construction and Safety Standards in 1998. This is the first step in the

Department’s process to adopt these as consensus-based standards consistent with OMB Circular

A-119. The appropriate committees have been established with three members of the HUD staff

participating as voting members. The first deliberations were held in December 1998.

5.6 Department of Transportation (DOT) - DOT recognizes the importance and the

advantages of using voluntary consensus technical standards since the use of voluntary consensus

standards can save both time and money for regulatory agencies. The Department also recognizes

the value in participating in standards-developing organizations. For example, NHTSA’s

participation in standards-developing organizations has helped the agency to be on the cutting

edge of motor-vehicle related technological innovations and the development of regulatory

solutions to vehicle safety problems.
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5.7 Environmental Protection Agency (EPA) - EPA implemented the following initiatives to

improve its system for promoting compliance with the NTTAA in rulemaking:

C EPA regulators now routinely consider the use of voluntary consensus standards in proposed

and final agency regulations. Nearly100 Federal Register documents published in fiscal year

1998 contained preamble sections addressing the NTTAA. In these sections, the rule writers

summarized the requirements of the NTTAA, explained how they searched for potentially

applicable voluntary consensus standards, and described their tentative or final decisions

about the use of such standards in the regulation. 

C EPA’s Office of Policy, working with the Standards Executive and the Office of General

Counsel, has developed the comprehensive EPA Rule-Writer’s Guide to the NTTAA

explaining the procedures needed to systematically assess the application of the NTTAA to

proposed and final rules. When finalized, the Guide will be available on EPA’s internal

electronic network and will be periodically updated. In the meantime, the draft document is in

regular use.

C EPA rule writers regularly use model language concerning the NTTAA and the use of

voluntary consensus standards in both proposed and final regulations. This greatly facilitates

the electronic tracking of the use, or consideration of the use, of voluntary consensus

standards in EPA regulations. This, in turn, promotes the management of the EPA standards

program and improves the quality and ease of preparing the agency annual report. 

C The Assistant Administrator for the Office of Prevention, Pesticides and Toxic Substances

(OPPTS) elevated the Standards Program within OPPTS to enhance the importance of

voluntary consensus standards to EPA policies and programs and to facilitate agency-wide

implementation of the requirements of the NTTAA and the Circular. 

C EPA also revised the agency ethics guidance on participation in voluntary consensus

standards organizations. The new EPA guidance, issued in September 1998, finally

reconciled the competing interests of the criminal code provisions concerning financial

conflicts of interest with the NTTAA directive that Federal employees participate in

standard-setting activities of voluntary consensus standards organizations. Relying on recent

memoranda from the Office of Legal Counsel of the Department of Justice and the Office of

Government Ethics, the new guidance provides a clear pathway for EPA employee

membership in standards development organizations, including serving on boards of directors

and as committee chairs. 

5.8 Federal Communications Commission (FCC) - The Commission continued to increase its

use of voluntary consensus standards. In many instances the FCC has 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

Service do not include transmission protocol standards because industry has voluntarily developed
11

these standards. In other instances, where the adoption of a standard is or may be in the public

interest, the FCC has attempted to use voluntary consensus standards whenever possible. For

example, the FCC allows 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 though the negotiated rulemaking process to resolve technical compatibility

issues.

5.9 National Aeronautics and Space Administration (NASA) - In 1998, NASA began an

intensive effort to identify Voluntary Consensus Standards (VCS) currently used in NASA

programs and to review them as candidates for formal adoption. Since October 1, 1997, NASA

has adopted 414 voluntary consensus standards products based on current use by one or more

NASA installations. Approximately 85 percent of the VCS adopted are in the area of materials

and processes specifications. Also included are 10 standards for data communications that were

converted in 1998 from international, inter-governmental standards to ISO standards. The

adoptions were based on staff recommendations, concurrence of the NASA Engineering

Standards Steering Council, and formal approval by the NASA EMC and the NASA Standards

Executive. An additional 400 voluntary consensus standards are now in the final stages of the

review process as candidates for formal adoption by NASA. The process will be completed in FY

1999.

5.10 Nuclear Regulatory Commission (NRC) - The NRC staff conducted two stakeholder

meetings to identify issues and develop options for improving its participation in the development

and use of consensus standards. The first meeting, held in July 1998, was with NRC staff

(internal stakeholders) from various NRC offices to discuss issues and options related primarily to

NRC participation on standards committees. Discussions focused on identifying options for

improving the effectiveness and efficiency of NRC staff participation in developing consensus

standards. The second meeting, held in Chicago in September 1998, was with external

stakeholders to discuss their concerns regarding NRC staff participation in the development and

use of consensus standards. This meeting included representatives from individual utilities

(reactor licensees), the Nuclear Energy Institute (NEI), standards developing organizations

(SDOs) such as the American Society of Mechanical Engineers (ASME), nuclear steam supply

system (NSSS) vendors, the Department of Energy, NIST, state governments, and the public. A

transcript of this meeting was made available at the NRC web site shortly after the meeting. 

Information gained from this meeting, and other sources, will be used to formulate a program to

improve NRC participation in the development and use of consensus standards. 
12

6. AGENCY USE OF GOVERNMENT-UNIQUE STANDARDS IN LIEU OF

 VOLUNTARY CONSENSUS STANDARDS

P.L. 104-113 (NTTAA) requires agencies to identify all instances when they use governmentunique standards in lieu of voluntary consensus standards. During the FY 98 reporting period, six

agencies reported 20 such actions. This compared with seven instances reported by only two

agencies in FY 97, the first year in which agencies reported according to the law. The rationales

and backgrounds are summarized below.

6.1 Department of Agriculture (USDA) - The Agricultural Marketing Service (AMS) uses

government-unique specifications for the grading and certification of tobacco products. Authority

for this program is contained in the Tobacco Statistics Act of 1929 and the Tobacco Inspection

Act of 1935, as amended. Provisions of these acts require that all tobacco sold at auction must be

inspected and graded by the USDA according to the U.S. standards.

The AMS also uses government-unique specifications for purchases of commodities for the

School Lunch Program and other domestic feeding programs when voluntary consensus standards

do not meet the nutritional or program requirements of these programs.

6.2 Environmental Protection Agency (EPA) - The EPA identified three final regulations

where the use of an identified voluntary consensus standard was rejected in favor of a

government-unique standard. It should be noted, however, that each of these regulations also

cited or contained other technical standards where voluntary consensus standards were used. EPA

rationales follow:

C 63 FR 48806 (9/11/98), National Volatile Organic Compound Emission Standards for

Automobile Refinish Coatings: EPA considered the use of ASTM D-3960 as a possible

substitute for EPA Method 24, which already relies on several ASTM methods. However,

ASTM D-3960 contains some requirements above and beyond those needed for EPA

regulatory purposes. As stated in the FR notice: “Because this other method [ASTM

3960] does not specify which units to use, it may result in inconsistent applications of the

procedure and could make the standard more difficult to enforce. Consequently, the EPA

determined that this other voluntary consensus method would be impractical to adopt. In

addition, the EPA believes that it is appropriate to use Method 24 both because it has

proven reliable and practical to achieve the goals of reducing VOC and because the EPA

wishes to foster uniformity in testing nationwide.” For this Rule, then, EPA specified

EPA Method 24 which refers to ASTM Methods 2369, 1460, and 3970 (as does Method

D-3960) while avoiding possible confusion caused by the presence of additional,

unnecessary requirements.

C 63 FR 48848 (9/11/98), National Volatile Organic Compound Emission Standards for

Architectural Coatings: EPA deemed ASTM-3960, modeled on EPA Method 24, itself
13

 referring to other ASTM methods, to be impractical for use in lieu of EPA Method 24

(see #1 above).

C 63 FR 18504 (4/15/98), National Emission Standards for Hazardous Air Pollutants for

Source Category: Pulp and Paper Productions: EPA decided to use EPA Method 1650. 

This Method was developed by drawing on various procedures contained in the methods

of voluntary consensus standards bodies and other standards developers, such as ISO,

DIN, SCAN, and Standard Methods (SM 5320). However, none of these more narrowly

focused voluntary consensus standards contained the standardized quality control and

quality control compliance criteria that EPA requires for data verification and validation in

its water programs. Therefore, EPA found none of these VCS standing alone to meet

EPA’s needs.

There was also one proposed regulation where EPA proposed to reject the use of a particular

voluntary consensus standard in favor of a government-unique standard:

C R 41134 (7/31/98), National Primary Drinking Water Regulations: Analytical Methods

for Certain Pesticides and Microbial Contaminations: Standard Methods 6640B for acid

herbicides was tentatively deemed impractical for EPA’s needs because its sample

preparation and quality control procedures were not similar enough to EPA Method 515.1

to ensure that there would not be under reporting of acid herbicide contamination. EPA

plans to offer to work with the Standard Methods committee to resolve this issue prior to

the next publication.

6.3 National Aeronautics and Space Administration (NASA) - Because NASA uses the

“categorical” method of reporting, “use” of government-unique standards is reported in terms of

additions to the NASA Technical Standards Management System, rather than tracking individual

procurement transactions. During FY 98 NASA developed 10 NASA-unique technical standards

in three categories, namely: information technology, engineering, and safety and mission

assurance. The 10 new standards are listed in the table on the next page.

The two NASA Information Technology (IT) standards developed in FY 98 (Items 1 and 2 of the

table) 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. 

NASA Engineering standards are developed either to consolidate internal practices, or to provide

guidance where no suitable national or international standards are available. Item 3 documented a

unique set of requirements developed from failure experience on planetary spacecraft; Item 4

updates an existing standard which is now in the process of being converted into an ISO standard. 

NASA is participating with industry plus domestic and international voluntary consensus standard

bodies to target those standards with external application for eventual transition to voluntary

consensus standards. 
14

In the Safety and Mission Assurance area, Items 5 and 6, are manuals establishing safety

requirements for NASA internal facilities and launch vehicle operations. Items 7-9 are interim reissues of existing NASA standards based on failure experience in NASA unique space systems

and in one case, Item 10, an area for which a fully adequate VCS has not been available. The

Safety and Mission Assurance function has initiated an effort to identify possible VCS sponsors

for these last four workmanship standards in FY 1999.

STANDARDS PUBLISHED IN FY 98 (October 1997 - October 1998)

1. NASA-STD-2807A The NASA Directory Service - Architecture, Standards, and Products (Previously Released as

NASA X.500 Directory)

2. NASA-STD-2808A Interoperability Profile for NASA E-Mail Clients

3. NASA-HDBK-4001 Electrical Grounding Architecture for Unmanned Spacecraft

4. NASA-STD-6001 Flammability, Odor, Off gassing, and Compatibility Requirements and Test Procedures for

Materials in Environments that Support Combustion (Formerly Published as NHB 8060.1C)

5. NASA-STD-8719.7 Facility System Safety Guidebook

6. NASA-STD-8719.8 Expendable Launch Vehicle Payload Safety Review Process Standard

7. NASA-STD-8739.3 Soldered Electrical Connections. (Previous Version Published as NHB 5300.4(3A-2)

8. NASA-STD-8739.4 Crimping, Interconnecting Cables, Harnesses, and Wiring (Previous Version Published as NAS

5300.4(3G-1))

9. NASA-STD-8739.7 Electrostatic Discharge Control (Excluding Electrically Initiated Explosive Devices)

10. NASA-STD-8739.5 Fiber Optic Terminations, Cable Assemblies, and Installation

6.4 National Archives and Records Administration (NARA) - During this past reporting

period, the NARA signed an agreement with the Department of Defense (DOD) to develop

design criteria for electronic records management software applications. On December 19 of this

year, NARA endorsed DOD’s standard 5015.2. While this is a mandatory DOD standard, it is

possible that it may one day become a government-wide mandate. There are currently no

voluntary consensus standards that address this issue.

6.5 Department of Transportation (DOT) - During fiscal year 1998, there was one such

instance of a government-unique standard. NHTSA issued a notice of proposed rulemaking

(NPRM) that did not propose in all instances to use the requirements of a voluntary standard

instead of government-unique requirements (63 FR 17976; April 13, 1998).
2

 This standard was not considered by the focus groups in their deliberations. 

15

NHTSA explained in the NPRM that the American National Standards Institute (ANSI) has a

standard2 for product safety signs and labels (ANSI Z535.4) that identifies a hierarchy of hazard

levels ranges from extremely serious to moderately serious and specifies corresponding hierarchies

of signal words, i.e., “danger,” “warning,” and “caution,” and of colors. For the header, the

ANSI standard specifies a red background with white text for “danger,” an orange background

with black text for “warning,” and a yellow background with black text for “caution.” 

ANSI Requirements for Color-Coded Header Messages for the Different Levels of Hazard

(Listed in declining level of hazard)

Imminently hazardous situation which will result in

death or serious injury if not avoided 

“Danger” Red background with

white text

Potentially hazardous situation which could result in

death or serious injury. 

“Warning” Orange background

with black text

Potentially hazardous situation which could result in

minor or moderate injury. 

“Caution” Yellow background

with black text

The ANSI standard specifies that pictograms should be black on white, with occasional uses of

color for emphasis, and that message text should be black on white.

The agency noted in the NPRM that when it earlier updated the requirements for air bag warning

labels to require the addition of color and pictograms, it had chosen not to adopt the colors

specified in the ANSI standard. NHTSA chose to use yellow instead of orange in the background

of the heading for the air bag warning label, even though the word “warning” was used, because

of overwhelming focus group preference for yellow. Only two of the 53 participants preferred

orange. Participants generally stated that yellow was more eye-catching than orange. 

Participants also noted that red (stop) and yellow (caution) had meaning to them, but not orange.

NHTSA asked for comment on three color options for the revised utility vehicle rollover warning

label. Proposed label 1 used the ANSI color format with the heading background in orange with

the words in black. The remainder of the label had a white background with black text and

drawings. Proposed label 2 used a color scheme like the air bag warning labels, which is the same

as the ANSI color format except that the background color for the heading in the label is yellow. 

Proposed label 3 employed the color scheme used in the focus groups - the heading area had a red

background with white text. The graphic areas had a yellow background with black and white

drawings. The text area had a black background with yellow text.
16

Despite focus group preference for the signal word “danger,” the agency proposed the use of the

word “warning” as more appropriate to the level of risk. The agency also noted that the word

“warning” is used in the air bag warning label. 

Recognizing that it might encounter additional conflicts between focus group preferences and the

ANSI standard in future rulemakings, NHTSA requested comments in the NPRM on the extent to

which any final choice regarding colors and signal words should be guided by the focus group

preferences instead of the ANSI standard. NHTSA also requested comments on the broader issue

of the circumstances in which it would be appropriate for agency rulemaking decisions to be

guided by focus group results or other information when such information is contrary to a

voluntary consensus standard such as the ANSI standard. 

At this time (February 22, 1999), a final decision is still pending regarding its proposal to upgrade

the rollover-warning label. As to the general questions it posed in the NPRM, NHTSA

recognizes that ANSI’s mission differs somewhat from that of the agency’s focus groups with

respect to the labeling of hazardous situations. ANSI’s mission is to develop and maintain a

standard for communicating information about a comprehensive hierarchy of hazards, while the

focus groups’ mission is to design an effective label for a specific hazard. The agency recognizes

further that, given the difference in their missions, their conclusions about the appropriate manner

of communication might differ on occasion. 

Since agency labeling decisions are highly dependent on the facts regarding the specific hazard

being addressed, NHTSA anticipates making case-by-case determinations of the extent to which it

should follow voluntary consensus standards versus information from focus groups and other

sources. NHTSA will rely on its own expertise and judgement in making determinations under

the NTTAA and the statutory provisions regarding vehicle safety standards.

6.6 Department of the Treasury (Treasury) - The Customs Service continues to support two

government-unique standards. Customs and Trade Automated Interface Requirements

(CATAIR) (Amendment 1, April 1996, Amendment 2, December 1996, Amendment 3,

September 1997, and Amendment 4, 1998) and Customs Automated Manifest Interface

Requirements (CAMIR) (Amendment 1, April 1997 and Amendment 2, July 1998). CATAIR is

used by the Customs brokerage industry, and some parties in the transportation sector used

CAMIR. The maintenance of the government-unique standards within Customs applications (the

CATAIR and CAMIR formats) is at the request of the participating industry groups that use those

standards.
17

Table 1. FEDERAL AGENCY INFORMATION ON PARTICIPATION/ADOPTION OF

VOLUNTARY STANDARDS ACTIVITIES REQUIRED BY OMB CIRCULAR A-119

 (DATA AS OF 9/30/98)

AGENCY NO. OF

VOLUNTARY

CONSENSUS

STANDARDS

BODIES IN WHICH

AGENCY

PARTICIPATES

CHANGE

FROM FY 97

NO. OF AGENCY

EMPLOYEES

PARTICIPATING

CHANGE

FROM FY 97

NO. OF

VOLUNTARY

CONSENSUS

STANDARDS

USED SINCE

10/97

NO. OF

VOLUNTARY

CONSENSUS

STANDARDS

SUBSTITUTED

FOR GOVT.-

UNIQUE

STANDARDS

NO. OF GOVT.-

UNIQUE

STANDARDS

USED IN LIEU

OF

VOLUNTARY

CONSENSUS

STANDARDS

USDA 46 0 68 +8 6 0

DOC 143 +2 411 +25 0

DOD 89 +3 683 +83 464 (1) 125 0

NCS (DOD) 17 0 14 -2 2 0

DOED 1 - 6 - 17 0 0

DOE 65 -10 681 -190 31 (2) 0 0

HHS 46 0 274 (4) +32 370 (5) 0 0

HUD 10 +1 7 -1 0 0

DOI 54 +16 84 -25 144 0 0

DOJ 3 +2 8 +2 0 0

DOL 22 +12 63 +35 2 0 0

STATE 1 (8) 0 6 0 0

DOT 106 -27 292 0 197 7 1

TREASURY 8 -2 21 -4 3 0 0

VA 3 -25 4 -22 50 0 0

CPSC 50 +4 21 -1 10 0 0

EPA 14 +3 200 0 157 0 3

FCC 24 +14 49 +5 0 0 0

FEMA - 

(3)

- 

(3) 4 0

GSA 91 -9 45 -9 1 10 0

NASA 43 -4 148 -6 414 (6) 4 0

NARA 14 -6 8 -10 4 0 0

NSF 3 +1 4 +1 0 0 0

NRC 16 0 145 (7) -20 0 0 0

TOTALS 869 -25 3242 -99 1876 146 4

(1) Total number of DOD-adopted voluntary consensus standards is 7991.
18

(2) Total number of DOE-adopted voluntary consensus standards is 840.

(3) Information not available on an agency basis.

(4) Includes participation on 553 voluntary consensus standards development committees within the 46 standards bodies indicated.

(5) Includes standards recognized under the Food and Drug Administration Modernization Act of 1997 (FDAMA).

(6) An additional 400 voluntary consensus standards are in the final stages of review as candidates for formal adoption at NASA.

(7) Includes participation on a total of 254 consensus standards development and board level committees.

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

of the United Nations System.
3Federal Agencies Participation in the Development and Use of Voluntary Standards,

ICF Kaiser Consulting Group, October 1997.

19

7. CONCLUSIONS

Federal agencies have continued to implement P.L. 104 -113 and the revised OMB Circular 

A-119 successfully. Many agencies, including EPA, DOD, and NASA, have developed

procedures for alerting the public about proposed regulations and procurement actions that

involve voluntary consensus standards. Thus, EPA has developed wording for inclusion in its

notices of proposed rulemaking to draw attention to opportunities for using voluntary consensus

standards. This allows standards developing organizations the opportunity to bring possible

standards activities to the attention of the agency.

The report also describes four instances in which government-unique standards were used in lieu

of voluntary consensus standards, three at the Environmental protection Agency and one at the

Department of Transportation. Some agencies provided additional information on their use of

government-unique standards where no voluntary consensus standard alternative existed.

Agencies are continuing to improve their procedures by which they track their uses of standards in

both regulation and procurement activities, according to the requirements of OMB Circular

A-119. The decline noted in the FY 97 report in agency participation standards committees

appears to have leveled off, but will be monitored on an ongoing basis.

8. RECOMMENDATIONS

All Federal agencies should continue to 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 consensus standard activities.

Most Federal agencies have continued to make progress in their use of voluntary consensus

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

procurement and regulatory activities. Where appropriate, strategic alliances and teaming

arrangements by Federal agencies with standards development organizations may be beneficial.

Federal agencies should continue to develop specific policy and programmatic elements to

support the implementation of the NTTA and OMB Circular A-119. Elements for consideration

should be the establishment of agency standards policy and units for monitoring standards

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

The study by ICF Kaiser for the Environmental Protection Agency3 provides more details on

appropriate elements.

C Agencies should consider their own strategic needs when planning for agency participation

in standards activities. They should use available resources, including NIST, to determine
20

applicable Standards Development Organizations (SDOs) (both national and

international), relevant voluntary standards, and the need for new standards emerging

technologies and processes. NIST should continue to facilitate interactions between

agencies and voluntary standards process.

C The ICSP should develop guidelines for use by agencies in preparing their staff for

participation in standards-related activities. These guidelines, which the NIST Policy on

Voluntary Standards might be used as a model, should reflect the need to prepare agency

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

needs are reflected as standards are developed. Consideration should be given to the

appropriate agency role in committee activities to avoid the appearance of dominance and

consideration of likely future agency and national needs during the development and

revision of voluntary standards.

C Federal agencies should continue to develop, improve and utilize systems for tracking the

adoption or referencing of voluntary standards, as well as the level of staff participation in

voluntary standards developing bodies. Agencies should consider the use of electronic

means for setting up directory databases of participants and exchanging information about

standards-related issues.

C NIST should consider developing a newsletter and accompanying WEB-site to

periodically provide current information about Federal agency standardization activities

and other matters of interest to the ICSP membership and others.
A-1

APPENDIX A:

 Cabinet Department Reports
A-2

DEPARTMENT OF AGRICULTURE

The following information was prepared for the National Institute of Standards and Technology

(NIST) by the Department of Agriculture (USDA) as required annually under Office of

Management and Budget Circular A-119, “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 Circular A-119 activities.

METHOD

To prepare this report, OCIO sought information from USDA Agency Heads. Based on the

requirements sent out by NIST, the CIO requested information on the number of agency

employees engaged in the voluntary consensus standards-developing bodies and the number of

such bodies; the number of voluntary consensus standards used since October 1, 1997; the

number of voluntary consensus standards substituted for government-unique standards in FY

1998; an evaluation of the effectiveness of Circular A-119 and recommendations for changes; and

identification of all instances when the agency used government-unique standards in lieu of

voluntary consensus standards. For each instance the CIO requested the inclusion of the agency

rationale for such use, as well as specific government-unique standard used.

DEPARTMENTAL VIEWS

While the standards program falls under the CIO, standards, in a broader sense, include all

standards, not just IT (Information Technology). Circular A-119 introduces opportunities for

agencies to be involved directly in the voluntary consensus standards development activities

through external standards bodies comprised of participants from Government, industry,

universities, and international standards organizations. The voluntary consensus standards can be

adopted by Federal agencies in lieu of government-unique standards. NIST traditionally publishes

mandatory and optional standards for the Federal Government through the FIPS PUBs. Those

standards may or may not meet the needs of the individual agencies. This rigidity can be

mitigated by applying provisions of Circular A-119. However, voluntary consensus standards

activities are subject to OMB, NIST, and Congressional oversight. 

The Department of Agriculture encourages its agencies to participate in consensus standards

development activities under A-119 to take advantage of the expertise from private industry,

academic communities, and international standards bodies. Familiarization with international
A-3

standards development activities also benefits USDA agencies in the area of Internet, trade, and

other matters of global nature. 

USDA PARTICIPATION BY FUNCTIONAL AREAS

FARM AND FOREIGN AGRICULTURAL SERVICES

Foreign Agricultural Service (FAS)

NATURAL RESOURCES AND ENVIRONMENT

Natural Resources Conservation Service (NRCS)

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 participated in the Open

Geographic Information Systems (GIS) Consortium, a nonprofit public/private partnership

focusing on GIS. 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 GIS or be adopted by

the GIS industry.

NRCS has at least five people involved with the Federal Geographic Data Committee composed

of primarily Federal agency representatives. The committee has done some work in the area of

geospatial data standards, seeking to attain commonality among the Federal agencies to facilitate

geospatial data sharing.

For FY 1998, NRCS reports that several employees have worked with a number of committees

within the American Society for Testing and Materials (ASTM). Those Committees develop

standards on materials, products, systems, and services. NRCS uses several hundred of ASTM

standards for design and construction activities throughout the entire range of its conservation

programs. The FY 1998 ASTM standards have not yet replaced the existing conservation

practice standards developed internally by NRCS. 

Several NRCS employees also were involved in the development of industry specifications under

the sponsorship of the American Society of Agricultural Engineers (ASAE) and American Society

of Civil Engineers (ASCE). Although those standards and specifications have not been adopted

by NRCS, many agricultural communities have already applied some of the specifications for

construction and quality products. One NRCS employee was actively involved in the

development of voluntary consensus standards with the American Concrete Institute (ACI),

particularly on the “Code for Environmental Engineering Concrete Structures.”
A-4

Although none of the above standards developed with NRCS involvement have yet replaced the

agency’s existing standards or specifications, NRCS is moving toward adopting those standards.

 RESEARCH, EDUCATION AND ECONOMICS (REE)

Economic Research Service (ERS)

In FY 1998, ERS participated in six standards bodies. These activities involved eleven

employees. There has been no substitution of voluntary consensus standards for governmentunique standards in response to agency reviews and no government-unique standards were used in

lieu of voluntary consensus standards.

ERS reports that three analysts participated on technical advisory teams associated with the

creation of the North American Industry Classification System (NAICS). The purpose of NAICS

is to create 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 inputs and outputs will improve inter-country measuring of

productivity, unit labor costs, and level of capital intensity in production; estimating of

employment-output relationships; constructing of input-output tables; and analyzing production

relationships in the economy. ERS analysts participated on the Agriculture, Forestry,

Manufacturing, and Fishing and Hunting sectors of the NAICS system. 

ERS has one analyst who maintains contact with the Conservation Technology Information

Center (CTIC) and attends the annual meeting regularly. CTIC periodically coordinates the

definitions and standards for various crop residue management systems (CRMS). These systems

are used to reduce wind and water erosion and are part of the farm conservation plans that must

be implemented by the 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 and in USDA’s Agricultural Resource Management Study to analyze

economic and environmental effects of alternative crops.

ERS has one analyst who was a cooperator on the Environmental Stewardship Program (ESP)

sponsored by the Environment Protection Agency (EPA). The ESP project was concluded last

year and the group submitted a draft report on the voluntary standards for the Integrated Pest

Management (IPM) on Potatoes. The activities involved in building the national definitions on

potatoes included: developing a comprehensive list of State-level IPM practices; making a

tentative rating of the practices in terms of their values; conducting an extensive review of the

draft definitions. The State Extension specialists and commodity associations provided the basic

information on potato pest management practices to IPM. The rating of the practices was based

on the University of Massachusetts “Partners with Nature” IPM certification system model. The

draft IPM definitions were reviewed by soliciting comments from EPA, land-grant university IPM
A-5

specialists, food processors and commodity associations, chemical industries, suppliers,

environmental groups, and others. 

ERS has one analyst who regularly participates in the USDA Ecological Risk Assessment

Working Group charged by the Secretary to develop standards and guidelines for USDA program

managers to conduct risk assessments in their respective programmatic areas. Activities involve

working with representatives from USDA agencies to define terms and develop standards and

guidelines on how to conduct risk assessments.

ERS analysts monitor materials released by the Farm Financial Standards Council (FFSC) for use

in developing measurements of financial indicators for farm businesses. FFSC standards are also

used in developing questionnaires and 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 a report on July 20, 1998,

establishing standards for use by the Federal and State governments, universities, nonprofit

institutes, and other entities in the private sector when developing estimates on costs and return of

agricultural commodities. ERS sought consensus with the American Agricultural Economics

Association and experts in the agricultural economics profession in developing the estimates.

National Agriculture Statistics Service (NASS)

For FY 1998, NASS reports that one staff member was involved in the creation of the National

Vegetation Classification and Information Standards for the Federal Geographic Data Committee. 

These standards will be used by Federal agencies and their cooperators in classifying vegetation. 

Otherwise, NASS relies mainly on off-the-shelf software and hardware for its statistical work. 

Circular A-119 has little effect on NASS. 

NASS did not issue any regulations on the consensus standards during FY 1998, nor did it use

any government-unique standards in procurement. 

The Office of Procurement and Property Management (OPPM)

Last year’s response: 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

forprocurement which involved electronic commerce. Nor did OPPM comment on the

effectiveness of guidelines in Section 7 of the proposed revision to Circular A-119.
A-6

MARKETING AND REGULATORY PROGRAMS

Agricultural Marketing Service (AMS)

AMS reports that 20 employees participated in eight national voluntary standards bodies, and 17

employees participated in 17 international voluntary consensus standards bodies in FY 1998 and

prior.

Since October 1, 1997, the agency has used the following voluntary consensus standards:

Agreement on the International Carriage of Perishable Foodstuffs and Special Equipment;

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 (ASTM); and International Meat Purchase Specifications

(IMPS). With the participation of the industry, AMS has developed 602 grade and classification

standards that have been accepted by the industry for marketing of 230 agricultural commodities.

These standards were created in response to the needs expressed by the industry for uniform

standards that could be used and certified nationwide. The usage of these standards is voluntary.

The American Dairy Products Institute (ADPI) has published a series of milk and dry milk

standards that can be used when USDA certification is not requested by the buyer or seller. 

These standards are based on the USDA standards and contain the same requirements as the U.S.

Grade standards. Majority of the industry however prefers USDA certification because of its

official value in certification. 

The American National Standards Institute (ANSI) and American Society for Testing and

Materials (ASTM) standards are used for most testings and analyses conducted by AMS in

providing the certification services to the industry. 

AMS has developed numerous grade standards and classifications in response to requests from

industry. AMS does 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.

The authority for AMS’s development of the government-unique specifications for the grading

and certification of tobacco products is contained in the Tobacco Statistics Act of 1929 and the

Tobacco Inspection Act of 1935, as amended. Major provisions of these Acts dictate that all

tobacco sold at auction must be inspected and graded by USDA personnel according to the U.S.

standards. AMS’s Tobacco Standards are published in the Code of Federal Regulations.

The Farmer Service Agency (FSA) in USDA handles most commodity purchases. The Food and

Nutrition Service (FNS) is involved in the food and child nutrition programs authorized by the

National School Lunch Act and the Child Nutrition Act of 1966 to provide nutritious foods and
A-7

milk products to the school children. As partner agencies, FSA, FNS and AMS all have to agree

with each other’s standards in purchasing the commodities for the School Lunch and other

feeding programs, particularly the nutritional guidelines set by FNS. In addition, AMS accepts

commercial standards on the foods. When commercial standards fail to meet the nutritional

requirements of the School Lunch and feeding programs, AMS sets specifications on the fat,

salt and sugar contents, particularly on the canned and frozen foods. These requirements are

included in the individual bids on a case-by-case basis, they are not coded permanently as the

government-unique standards.

AMS also sets government-unique standards on beef, chicken, eggs, fish, juice, nuts and

beans, pork, turkey, fruits, vegetables, milk, and dairy products through the grading process. 

Such standards can be found in USDA’s Home Page (www.usda.gov).
A-8

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 411 of the Commerce Department staff

participated in the outside standards committees of 143 (100 national and 43 international)

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

participated in 42 standards organizations (28 national and 14 international) encompassing 138

committees, holding 63 memberships on those committees. Eight of those standards

organizations had five or more DOC participants. NIST had 343 participants in the activities of

101 standards organizations (72 national and 29 international). This participation encompassed

361 committees and 1,205 NIST memberships on these committees. Eleven of the standards

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

The following organizations/agencies accounted for 28 percent (39) of the 141 other DOC

committee memberships.

Organizations Whose Standards Committees Have

DOC Members: No. of Committee Memberships

American National Standards Institute 19

International Organization for Standardization 8
A-9

International Telecommunication Union - Telegraph 7

International Telecommunication Union - Radio 5

 _____ 

 Total 39

The following standards organizations accounted for 81 percent (1,002) of the 1,205 NIST

committee memberships:

Organizations Whose Standards Committees Have

NIST Members: No. of Committee Memberships

American Society for Testing and Materials 603

American National Standards Institute 107

Institute of Electrical and Electronic Engineers 43

International Organization for Standardization 76

American Society of Mechanical Engineers 33

International Organization of Legal Metrology 24

International Electrotechnical Commission 34

American Concrete Institute 16

Telecommunications Industry Association 24

National Conference on Weights and Measures 21

CIE 21 

 _______ 

 Total 1002 

 

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

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-10

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

C 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.

C 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-11

C 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.

C 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, drafted a

standards policy for NIST participation in Voluntary Consensus Standards 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).

National Cooperation for Laboratory Accreditation

The NIST Office of Standards Services hosted a public workshop and facilitated the incorporation

of the National Cooperation for Laboratory Accreditation (NACLA) as the recognized body to

provide coordination and focus for laboratory accreditation programs in the United States and to

become the U.S. point-of-contact for international accreditation efforts. 

Workshop on Circular A-119

NIST conducted a Workshop with OMB on requirements contained in the revised OMB Circular

A-119 in March 1998 to acquaint Federal agencies and the private sector with its requirements.
A-12

DEPARTMENT OF DEFENSE (DoD)

1. DoD Employee Participation. The DoD has over 683 employees participating in the standards

development activities of over 89 voluntary standards bodies.

2. DoD Adopted Voluntary Standards. Since our input for the FY 97 report, we have adopted

an additional 464 voluntary standards, bringing the total number of DoD adopted voluntary

standards to 7991.

3. Government Standards Replaced by Voluntary Standards. The following 125 Government

specifications and standards were replaced by voluntary standards since our input for the FY 97

report:

GOVERNMENT

SPECIFICATION/STANDARD REPLACEMENT VOLUNTARY STANDARD

MIL-851D SAE J1993, SAE J827 SAE J441 

MIL-A-3029 ASTM D449

MIL-C-5778 SAE AS5778

MIL-B-6039 SAE AS6039

MIL-H-6088 SAE AMS6088

MIL-S-6144 SAE AS6144

MIL-T-6480 SAE AS6480

MIL-S-6625 SAE AS6625

MIL-S-6852 SAE AS6852

MIL-S-7720 SAE AMS-S-7720

MIL-S-7916 SAE AS-S-7916

MIL-D-8181 SAE AS8181

MIL-A-8576 SAE AMS-A-8576

MIL-V-8712 SAE-AS8712

MIL-R-8791 SAE AS8791

MIL-D-8804 SAE AS8804

MIL-B-9972 AWS-C3.6

MIL-S-10520 ASTM-A711, ASTM-A575

MIL-M-12218 ASTM-D5632

MIL-B-12672 ANSI/AWS-C3.4

MIL-S-13165 SAE AMS-S-13165

MIL-S-13727 AWWA-B504

MIL-L-13762 ASTM-A308

MIL-C-14550 SAE-AMS2418

MIL-G-16491 NASM16491

GOVERNMENT

SPECIFICATION/STANDARD REPLACEMENT VOLUNTARY STANDARD

MIL-T-18607 SAE AS18607

MIL-V-18796 ASME B16.34, ASTM-F1508

MIL-I-18802 SAE AS18802

MIL-F-20236 ANSI/ASME B16.9
A-13

MIL-I-25135 SAE AMS2644

MIL-G-3036 NASM 3036

MIL-G-45204 SAE AMS2422

MIL-G-45209 ASTM B679

MIL-L-46064 ASTM B200

MIL-A-46165 ASTM D579, ASTM D2343

MIL-P-46184 ASTM D5205

MIL-C-46971 ASTM B220

MIL-B-81935 SAE AS81935

MS2548 SAE AS25481

MS3109 SAE AS31091

MS3117 SAE AS31171

MS3197 SAE AS31971

MS3368 SAE AS33681

MS3373 SAE AS33731

MS3393 SAE AS33931

MS9068 SAE AS3582

MS9134 SAE AS3491

MS9135 SAE AS3492

MS9136 SAE AS3493

MS9137 SAE AS3494

MS9138 SAE AS3495

MS9139 SAE AS3496

MS9140 SAE AS3497

MS9350 NAS1715

MS9153 NAS1715

MS9352 NAS1715

MS99353 SAE AS9353

MS9377 SAE AS3498

MS9391 SAE AS9391

MS9600 SAE AS9600

MS9603 SAE AS9603

MS9970 SAE AS3581

MS14102 SAE AS14102

MS14103 SAE AS14103

MS14104 SAE AS14104

MS14105 SAE AS14105

MS14153 SAE AS14153

MS14154 SAE AS14154

MS14227 SAE AS14227

GOVERNMENT

SPECIFICATION/STANDARD REPLACEMENT VOLUNTARY STANDARD

MS14238 SAE AS14238

MS17143 SAE AS17143

MS17184 SAE AS17184

MS17731 NASM 1773

MS17732 NASM 1772
A-14

MS20995 NASM 20995

MS21122 NAS 1715

MS21209 NASM 21209

MS21323 NASM 21323

MS21327 NASM 21327

MS21332 NASM 21332

MS21397 NASM 21332

MS25420 NASM 25420

MS27969 BHMA-A156.20

MS27980 NASM 27980

MS27981 NASM 27981

MS27983 NASM 27983

MS33530 SAE AMS2253

MS33531 SAE AMS2243

MS33583 SAE AS33583

MS33611 SAE AS3361

MS63044 NAS 1711

MIL-STD-17/1 ASTM F100, ASTM F856, ASTM Y32.2.6

MIL-STD-29 ASTM Y14.13

MIL-STD-285 IEEE 299

MIL-STD-373 ASTM D5449

MIL-STD-374 ASTM D5448

MIL-STD-410 NAS 410

MIL-STD-498 IEEE/EIA 12207

MIL-STD-1312 NASM 1312

MIL-STD-1942 ASTM C1161

A-A-43 ASTM D2955

A-A-47 ASTM D2356

A-A-48 ASTM D455

A-A-49 ASTM D499

A-A-50 ASTM D2958

A-A-269 ASTM D2356

A-A-373 ASTM C669

A-A-374 ASTM D928

A-A-392 UL 626

A-A-895 ASTM D456

A-A-1109 ASTM F887

A-A-1818 ASTM D5370

A-A-51125 ASME B94.51

A-A-51184 ASME B94.51

GOVERNMENT

SPECIFICATION/STANDARD REPLACEMENT VOLUNTARY STANDARD

A-A-51185 ASME B94.51

L-F-36 ASME B94.51

O-S-598 ANSI Z87

O-S-604 ASTM D456

QQ-A-225 ASTM D537
A-15

QQ-A-250 ASTM B211, SAE AMS-QQ-A-225

QQ-W-321 ASTM B209, SAE AMS-QQ-A-250

RR-D-2841 ASTM B134, B159, B206

SS-T-312 ASTM F918

VV-B-680 ASTM F1066, ASTM F1700

VV-B-680 SAE J1703

4. The current OMB Circular A-119 provides clear guidance on using voluntary consensus

standards and participating in voluntary consensus standards bodies. As written, this circular

reinforces DoD policies regarding use of voluntary standards, reliance on performance

documents, and encouragement of participation in voluntary standards bodies. DoD believes the

Circular’s plain language format greatly enhances its effectiveness. DoD does not believe

additional changes are required at this time.

5. The DoD implements the provisions of P.L. 104-113 and OMB Circular A-119 through DoD

4120.3-M, “Defense Standardization Program Policies and Procedures.” As set forth in existing

DoD policies, items or materials that are normally procured using a voluntary standard by

commercial firms, DoD activities also should be using a voluntary standard. Furthermore, DoD

4120.3-M requires DoD standards developers to actively look for opportunities to replace

government documents with voluntary standards.

One aspect of the Department’s MilSpec Reform initiative continues to be the replacement of

military specifications and standards with voluntary standards wherever there is a dual-use

application. As a result of this initiative, DoD completed a review of its 30,000+ military

specifications and standards to determine whether a replacement voluntary standard already

existed or whether one could be developed. We identified over 3000 candidate military

specifications and standards with potential to become voluntary standards. The Department has

put procedures in place to ensure proliferation of military documents does not reoccur. 

DoD is continuing to proactively enlist the support of industry associations and voluntary

standards developing organization to help us review, identify, and plan for replacement of military

specifications and standards with voluntary standards. In situations where a military

standardization document is also used by commercial firms, DoD is working with the appropriate

standards developing organization to create a suitable replacement. The Department relies on

military specifications and standards in lieu of voluntary standards when the requirement can be

justified as truly military-unique; when a voluntary standard does not exist and development is not

imminent; when there is no industry interest to develop a voluntary standard to address DoD

requirements. Since DoD has a large number of procurements, DoD has chosen to use the

categorical basis as our means of conveying information on its voluntary consensus standards use.
A-16

NATIONAL COMMUNICATION SYSTEM (NCS)

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

the Federal Telecommunications Standards Committee (FTSC). This interagency committee

prepares standards and recommendations 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 1998, two Federal Telecommunications Recommendations (FTR), based on

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

publication.

a. FTR 1024B-1998. Project 25 Radio Equipment [land mobile radio systems]. (Combination

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

b. FTR-1050-1998. Group 3 Facsimile Apparatus for Document Transmission in the General

Switched Telephone Network. (Based on ANSI/TIA/EIA-465-A-1995.)

3. Dr. Peter M. Fonash, Chief, Technology and Standards Division, and Chair, FTSC, is the

OMNCS focal point for telecommunications and related information system standards. His

telephone number is (703) 607-6200, and his email address is fonashp@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 14 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 OMNCS participate:

a. Organizations Accredited by the American National Standards Institute (ANSI)

- Committee T1, Telecommunications

- National Committee for Information Technology Standards (NCITS)

- TR-8, TR-29, TR-45, TR-46

- JTC1 TAG Information Technology

b. Commercial and International Organizations Not Accredited by ANSI

- ATM Forum

- Multimedia Forum

- Telecommunications Industry Forum (TCIF)

- Electronic Communications Implementation Committee (ECIC)

c. Federal Interagency Committees

- Federal Telecommunication Standards Committee (OMNCS furnishes Chair and

 Executive Secretary)
A-17

- Federal Wireless Policy Committee (OMNCS furnishes Vice-Chair)

- Federal Wireless User’s Forum (OMNCS furnishes Co-Chair)

- Information Infrastructure Task Force (IITF)

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

d. Federal, State, and Local Committees

- Association of Public Safety Communications Officials (APCO)

- Project 25

- Project 31

e. International Organizations

- International Telecommunications Union-Telecommunications Sector (ITU-T) 

(OMNCS heads U.S. delegations to 2 study groups)

- International Telecommunications Union-Radio Sector (ITU-R)

- International Organization for Standardization (ISO) and the International

 Electrotechnical Committee (IEC)
A-18

DEPARTMENT OF EDUCATION

For the past several years the U.S. Department of Education (ED) has been actively working with

the American National Standards Institute (ANSI) on developing EDI transaction sets through

their Accredited Standards Committee (ASC) X12 committee. This committee is charged with

developing uniform standards for electronic interchange of business transactions. The X12

Committee develops standards to facilitate electronic interchange relating to such business

transactions as order placement and processing, shipping and receiving, invoicing, payment, and

cash application data associated with the provision of products and services. 

The Department of Education’s National Center for Education Statistics (NCES) has one voting

member and has sponsored the work of task groups to attend ANSI ASC X12 meetings.

Information about the activities that NCES has been involved in can be obtained at: 

http://nces.ed.gov/edi. In addition, ED has had another voting member that is part of the

Department’s Office of Postsecondary Education. The Department has been involved in

developing EDI transaction sets for Student Financial Aid. These activities fall under the umbrella

of Project EASI. For more information on Project EASI please visit:

http://easi.ed.gov/inside_projecteasi/HTML/inside_main.html. Participation in this voluntary

consensus building body has allowed ED to forge ahead in developing standards while including

the necessary members of the affected communities to help transition to adoption.

Transaction sets that ED has promulgated for information about students (both at the

elementary/secondary level and at the postsecondary level) and other aspects of education are the

following:

Transaction Sets Relating to Individual Student Records

 TS 130 - Student Educational Record (Transcript) 

 TS 131 - Student Educational Record (Transcript) Acknowledgment 

 TS 138 - Testing Results Request and Report 

 TS 146 - Request for Student Educational Record (Transcript) 

 TS 147 - Response to Request for Student Educational Record (Transcript) 

 TS 189 - Application for Admission to Educational Institutions 

Implementation Guides

Transaction Sets Relating to Personnel Records 

 TS 132 - Personnel Information 

Transaction Sets Relating to Student Financial Aid Records 

 TS 135 - Student Loan Application 
A-19

 TS 139 - Student Loan Guarantee Result 

 TS 144 - Student Loan Transfer and Status Verification 

 TS 190 - Student Enrollment Verification 

 TS 191 - Student Loan Pre-Claims and Claims 

 TS 810 - Invoice

 TS 820 - Payment Order/Remittance Advice

Transaction Sets Relating to Institutional Records 

 TS 133 - Educational Institutional Profile 

 TS 152 - Statistical Government Information used to transmit CCD, IPEDS and Library 

 surveys to NCES 

 TS 188 - Educational Course Inventory 
A-20

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 directives (policy, requirements, guides, and technical

standards) 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 requirements in

Orders and rules reference appropriate voluntary consensus standards when they are acceptable to

meet the 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 October 1998, DOE Order 1300.2A is being updated to incorporate references to P.L.

104-113 and the February 1998 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. The Department had already incorporated the

technical standards provisions of P.L. 104-113 and OMB Circular A-119 into its current

Technical Standards Program Procedures, and currently manages its technical standards activities

in conformance with their requirements. Furthermore, DOE hosted a Federal Technical Standards

Workshop with broad participation from Federal agencies in August of 1998 to discuss standards
A-21

management issues and share experience related to implementing P.L. 104-113 and OMB Circular

A-119. 

Another element serving to manage implementation of P.L. 104-113 and OMB Circular A-119 is

DOE’s Department Standards Program. This Program 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 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 (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

DOE-developed standards if it is appropriate for the work. This “Work Smart” standards

approach (also referred to as the “necessary and sufficient” process) enables DOE laboratory and

management and operating or integrating 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 fiscal year (FY)

1998, 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 Department is reviewing our

experience with "Work Smart" to assess the need for revised or additional guidance.

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.
A-22

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

Department’s Technical Standards Program Office (TSPO) operates under this directive to

implement program policy, support the conversion of Department standards to voluntary

standards, identify voluntary standards that can suit Department needs, develop and maintain data

bases to support the program and meet reporting requirements, and coordinate 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 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 70 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.

In FY 1998, the Technical Standards Program continued 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 1998, 19

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

committees are identified on the program Internet address listed above).

The Department has also established a DOE Information Technology Standards Program

(Internet address is http://cio.doe.gov) that is conducted in accordance with the DOE Technical

Standards Program. The DOE Information Technology Standards Program is managed by staff

from DOE's Office of the Chief Information Officer with assistance from over 70 designated DOE

and contractor Information Technology Points-of-Contact representing key programs and sites. 

It coordinates information technology standards activities Department wide, including the

identification, adoption, implementation, and retirement of non-government and government

information technology standards in support of the DOE Information Architecture. This program
A-23

has stressed the use of international and voluntary consensus information technology standards

over development of internal standards in its adoption processes. 

The Department also implements a legislatively mandated, multi-year effort to improve the energy

efficiency in the Nation's buildings through energy efficiency standards, codes and guidelines for

buildings, building equipment, and appliances through its Office of Energy Efficiency and

Renewable Energy (Internet address is http://www.eren.doe.gov/). The Department's codes and

standards development efforts in these areas are closely coordinated with standards development

organizations and include early involvement of industry and state stakeholders and relevant

Federal agencies.

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 work force, DOE continues to actively use and support

the development of voluntary standards to meet its needs. In FY 1998, the number of voluntary

standards adopted for use increased to 840 (809 in 1997). However, the number of individuals

participating in voluntary standards activities decreased to 681 (871 in 1997), and the number of

documented participation in standards developing groups declined to 1321 (1540 in 1997). We

believe this reflects the very significant "downsizing" and budget cuts experienced by DOE in

recent years, rather than any reduced interest on the part of Departmental organizations. 

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 a meeting in August 1998 with representatives of several voluntary

standards organizations (ASTM, ASME, ANS, NFPA, IEEE, 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:

C From FY 1993 through FY 1997, DOE conducted annual national workshops promoting the

Technical Standards Program and the use of voluntary standards within the Department. Each

workshop was attended by approximately 150 standards developers and users.

C In FY 1998, DOE hosted the first-ever Federal Technical Standards Workshop with the goal

of furthering the implementation of P.L. 104-113 throughout the Federal Government. The

Workshop was co-sponsored with the National Institute of Standards and Technology
A-24

(NIST), the Environmental Protection Agency (EPA), the National Aeronautics and Space

Administration (NASA), the Food and Drug Administration (FDA), and the Partnership in

Reliability, Maintainability, and Supportability (RMS) Standards. More than 200 standards

developers and users attended the workshop. Another Federal Technical Standards

Workshop is being planned for FY 2000.

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

Reporting Requirements for OMB Circular A-119:

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: 65

--Number of agency personnel participating: 681

--Total number of agency participation: 1321

2) The number of voluntary consensus standards the agency has used since October 1, 1997,

based on the procedures set forth in sections 11 and 12 of the Circular: 840

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 the

Circular: 0

4) An evaluation of the effectiveness of this policy and recommendations for any changes.

Response -- The guidance in 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 1998 where the Department selected to use

an internal standard in-lieu-of an equivalent, existing voluntary standard.
A-25

FEDERAL ENERGY REGULATORY COMMISSION

The Federal Energy Regulatory Commission (FERC or Commission) regulates in the public

interest electric power, natural gas, oil pipelines and nonfederal hydroelectric power. The

Commission ensures that the rates, terms and conditions of service for the electric power, natural

gas, and oil industries are just and reasonable and not unduly discriminatory or preferential, and

that licensing, administration, and safety actions for the hydropower industry and other approvals

for all four industries are consistent with the public interest.

As a consequence of changes in the energy marketplace, the Commission is reconsidering the

proper role of traditional command and control economic regulation. The evolving electric power

and natural gas industries, encouraged to be competitive by the Congress and driven by economic

and technological developments, are challenging long-held regulatory assumptions and practices. 

The Commission is committed to promoting competition where feasible, thus providing the

benefits of competitive commodity markets to consumers of electricity and natural gas.

With respect to natural gas, the Commission issued a series of measures (Order Nos. 436, 500,

and 636) that opened pipeline transportation to all on equal terms and that eventually resulted in

the interstate pipelines relinquishing their traditional merchant function. The Commission is

seeking to develop alternative regulatory methods that encourage further competition by

continually examining its regulations and revising them to foster the mixed competitive regulatory

market.

Natural gas commodity markets can be made better by continuing to improve standardization

among pipeline systems for both information and business so that gas can be moved more

efficiently. With the encouragement of the Commission, the Gas Industry Standards Board

(GISB) has adopted more than 150 business practice standards, including standards relating to

electronic communication over the Internet, aimed at simplifying the process of transacting

business across the interstate natural gas pipeline grid. To implement the standards, each natural

gas pipeline was required to make a tariff filing with the Commission. The Commission reviewed

the filings and any comments, requiring revisions as appropriate. The majority of filings required

at least one compliance filing in order to effect implementation. In total, over 500 GISB

implementation filings were processed.

GISB

Before Order 636, transportation contracts between pipelines (transportation service providers)

and shippers prohibited any assignment or sale of the contract to any other shipper. Without prior

approval of the Commission, availability of natural gas (capacity) could only be used by the

contracting shipper. Order 636 gave shippers the right to sell all or any portion of a contract's
A-26

rights for all or any portion of capacity release. This process of selling capacity is known as

capacity release. 

The process of standardizing business practices in the natural gas industry began with a

Commission initiative to convene a technical conference to standardize electronic communication

of natural gas capacity release transactions. To develop the required standards, the participants at

the conference agreed to form working groups composed of representatives from all segments of

the industry. In addition to the capacity release standards, the conference participants decided

that standardization of other business transactions, such as nominations and flowing gas, was

important and formed an additional working group to begin developing standards for these

transactions. By consensus of that working group, recommendations were made that industry be

permitted to develop and implement such standards voluntarily. While the Commission endorsed

the importance of this effort in helping to facilitate gas movement across the pipeline grid, it was

not actively involved in the process. The Commission pledged to reevaluate its role in the

development and implementation of standards based on the progress made by the industry.

At the same time, industry sought to formalize the working group by forming a private standards

organization to continue and expand the working group's efforts to develop electronic standards. 

In 1995, the industry formed GISB as a consensus standards organization open to all members of

the gas industry. GISB's procedures require balanced voting representation from all five segments

of the industry--pipelines, local distribution companies, natural gas producers, end-users, and

services (including marketers, brokers, financial services companies, consultants, law firms,

computer firms and other businesses). At the Executive Committee level, a consensus of the five

segments must approve each standard. In addition, the industry, under the auspices of the

Interstate Natural Gas Association of America (INGAA) and the Associated Gas Distributors

(AGD) began a Grid Integration Project to consider standards for coordinating pipeline business

practices to simplify the process of shipping gas across multiple pipelines. After GISB expanded

its scope from electronic standards to encompass business practice standards, the Grid Integration

Project was folded into GISB. 

GISB is governed by two 25-member governing boards with members from each segment; the

Board of Directors, which has responsibility for administrative and financial matters; and the

Executive Committee, which, with the assistance of a number of working groups and task forces,

is responsible for developing the standards themselves. There is also an Advisory Committee

made up of regulatory and legislative representatives. GISB's voting rules ensure that all

decisions are the result of a genuine industry consensus. Prospective standards must get at least

17 affirmative votes in the Executive Committee, and there must be at least two affirmative votes

for each segment. Standards must then be ratified by the GISB membership; a 67 percent

affirmative vote of those submitting ballots is required for a standard to get approval. On the

Board of Directors, changes in bylaws or articles of incorporation need at least 19 affirmative

votes, with at least two affirmative votes from each segment. GISB has filed with American

National Standards Institute (ANSI) to be approved as an accredited standards organization. 
A-27

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

well as the number of agency employees participating.

At present, FERC does not actively participate in any consensus standards body as specified in

section 7 of the Circular. FERC instead incorporates standards by reference in its regulations. 

These standards are adopted by recommendation and issuance of industry groups and set for

review and possible incorporation by the Commission.

With regard to the gas industry, the Commission in 1995 issued an advanced notice of proposed

rulemaking requesting the submission of detailed proposals from the industry by March of 1996

that would enable the Commission to adopt regulations for business practices and procedures

involving transactions between pipelines and their customers. The Commission established

January 1997 as the target deadline for compliance with the standards and urged the segments of

the industry to work together to achieve consensus on standards. FERC anticipated then that

GISB would become the forum for coordinating these industry efforts and has given great weight

to consensus proposals emanating from the GISB process.

2) The number of voluntary consensus standards the agency has used since October 1, 1997

based on the procedures set forth in section 11 and 12 of the Circular.

The Commission has adopted the standards developed by GISB for application throughout the

natural gas industry. Since March, 1996, GISB has submitted over 150 proposed standards to

FERC, which were accepted by FERC in Order No. 587 and in successive orders. In Order Nos.

587, 587-B, and 587-C the Commission adopted regulations to standardize the business practices

and communication methodologies of interstate pipelines in order to create a more integrated and

efficient pipeline grid. On July 15, 1998, the Commission issued Order No. 587-H, a Final Rule

which incorporates by reference the standards relating to intra day nominations and nomination

and scheduling procedures issued by GISB on March 12, 1998.

The nominations process is the way in which those who want to transport natural gas (local

distribution companies and other shippers) request space on interstate pipelines. Nominations are

notices to transportation service providers of how much gas the shipper wishes to transport,

where the gas will be entering the pipeline system (receipt point), and where it will be delivered

(delivery point). An intra-day nomination is a nomination submitted after the initial nomination

deadline at 11:30 a.m. to change a shipper's scheduled quantities for the next gas day.

3) Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of agency review under section 15(b)7 of the Circular.

FERC has relied on the standards developed by the voluntary consensus organizations, in

particular GISB, rather than develop its own or government-unique standards. GISB sets

standards for the entire industry.
A-28

4) An evaluation of the effectiveness of Circular A-119 policy and recommendations for any

changes.

This report is FERC's initial submission to comply with the reporting provisions of OMB Circular

A-119 as codified in P.L.104-113 "National Technology Transfer and Advancement Act of 1995". 

Currently, FERC is implementing the standards of the voluntary consensus organization, GISB.

Because of FERC's limited application of voluntary consensus standards it lacks the familiarity to

apply all of the Circular's provisions. These provisions are directed to agencies that are in the

process of continually developing or adopting standards issued by voluntary consensus

organizations. However, as a regulatory agency FERC has taken specific interest in Section 11 of

the circular. As FERC does not have a significant interest in standards and its FERC's exposure

to the implementation of standards has been limited to a specific industry, FERC requests further

elaboration on the particular forums that should be used by regulatory agencies to increase their

awareness of available voluntary consensus standards and when can they be substituted for

government-unique standards. FERC is following the provisions of Section 11(1)(b) of the

Circular to notify the public of the standards it has adopted. However, FERC is not subject to the

requirements of Executive Order 12866.

5) As required by P.L. 104-113, identification of all instances when the agency used governmentunique standards in lieu of voluntary consensus standards (for each instance include agency

rationale for such use, as well as the specific government-unique standard).

As noted above, FERC has relied on the standards issued by a single voluntary consensus

organization (GISB). Where GISB has not reached consensus, FERC has stepped in to

implement the use of such standards.

In the Commission's earlier orders, the Commission adopted standards only when all segments of

the industry concurred that the standard was needed to improve efficiency. However, the

Commission has recognized that policy disputes between the segments may prevent the

development of an integrated pipeline grid. The Commission has identified several disputed

standards where four industry segments supported the standards, but the pipeline segment

prevented a consensus from being reached. These standards included the following:

• intra-day nominations (intra-day nomination is a nomination submitted after the initial

nomination deadline at 11:30 a.m. to change a shipper's scheduled quantities for the next gas

day. See above for Nominations);

• operational balancing agreements (OBAs) (contract between two parties that specifies the

procedures to be used to manage operating variances at an interconnection. The OBA specifies

how imbalances or differences in hourly flow of gas will be handled by the two parties);

• netting and trading of imbalances (imbalance is a discrepancy between the quantity of gas a

shipper tenders to the pipeline at a receipt point and the amount of gas the shipper takes at the
A-29

delivery point. This is the ability of shippers to offset a positive imbalance on one contract with

a negative imbalance on another contract.);

• notices of operational flow orders (OFOs) (OFOs are orders by a pipeline requiring shippers

to take certain actions to alleviate emergency operational conditions on the pipeline's system).
A-30

HEALTH AND HUMAN SERVICES, DEPARTMENT OF (HHS)

Food and Drug Administration (FDA)

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 =

46;

 the number of agency employees participating = 274; * (on 553 voluntary consensus

standards development committees)

* NOTE: Individual employees with specific expertise often participate simultaneously on

two or more standards development committees within the same or different standards bodies. 

Therefore, 274 agency employees participate on 553 standards development committees,

within 46 voluntary consensus standards development bodies.

2) The number of voluntary consensus standards the agency has used since October 1, 1997,

based on the procedures set forth in sections 11 and 12 of the Circular = 370; *

* NOTE: Includes standards recognized under the Food and Drug Administration

Modernization Act of 1997 (FDAMA).

3) Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of an agency review under section 15b(7) of the Circular) = 0; *

* NOTE: Although certification to these standards does not replace any government-unique

standards, it does replace some data submission requirements manufacturers must meet when

seeking premarket approval for medical devices.

4) An evaluation of the effectiveness of Circular A-119 policy and recommendations for any

changes;

The policy and recommendations contained in Circular A-119 are consistent with FDA’s

framework for standards management as announced in the Federal Register of October 11, 1995,

and enhanced by FDAMA. Resource constraints oblige the agency to focus attention on the

highest priority activities and to strive to make its participation in those activities very effective. 

Voluntary consensus standards are most relevant for medical devices, where they are used

extensively in the agency’s regulatory work and where the majority of the agency’s standards

activities are centered. Voluntary consensus standards are less relevant in the areas of human and

veterinary pharmaceuticals, biologicals, and food, where such standards are generally neither

available nor being developed, and where standards of other international organizations (WHO,

FAO, ICH) as well as regulatory standards predominate.
A-31

5) Number of instances when the agency used government-unique standards in lieu of voluntary

consensus standards = 0.

Narrative Summary:

The central purpose for 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 protection. 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. In January 1977 the

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

employees in standards development activities outside the agency. This regulation encourages

FDA participation in standards 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

development and use of standards 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, Public Information; Communications with State and

Foreign Government Officials, was published on December 8, 1995.

FDA’s development and use of voluntary consensus standards varies within each of the agency’s

centers, because of differing availability and applicability of such standards in each product area. 

Voluntary consensus standards are most relevant to medical devices, and consequently the

majority of the agency’s standards activities addressed by Circular A-119 are centered there. 

Center for Devices and Radiological Health (CDRH)

On October 10, 1997, a draft guidance document was made available for public comment on the

agency’s Internet home page, which provided guidance to FDA medical device reviewers on the

use of the International Electrotechnical Commission (IEC) 60601 series of standards, including

declaration of conformity to the standards, during the evaluation of premarket submissions for

electrical medical devices. A notice announcing the availability of the draft guidance, entitled Use

of IEC 60601 Standards - Medical Electrical Equipment, was published in the Federal Register

on January 13, 1998. Written comments were due to the agency by April 13, 1998.
A-32

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub.

L. 105-115, 111 Stat. 2296), November 21, 1997, amended section 514 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360d), allowing the agency to recognize consensus standards

established by international and national standards development organizations that may be used to

satisfy identified portions of device premarket review submissions or other requirements. In a

Federal Register notice published on February 25, 1998, the agency announced the availability of

a guidance document entitled Recognition and Use of Consensus Standards describing how FDA

planned to implement that part of FDAMA, and providing an initial list of recognized standards.

The agency decided not to finalize the draft guidance document entitled Use of IEC 60601

Standards - Medical Electrical Equipment, and withdrew it in a Federal Register notice on

October 16, 1998. In its place the agency published modifications to the initial list of standards

(originally published in the February 25, 1998 notice) that will be recognized for use in the

premarket review process. Recognition of the standards became effective on November 16, 1998,

and will assist manufacturers who elect to declare conformity with consensus standards to meet all

or part of medical device review requirements. Periodic updates are contemplated.

Due to its extensive participation in voluntary consensus standards activities, CDRH has

maintained a database to track the standards activities of its employees for many years. The

Center recently invested in, and routinely uses searchable ROM databases of voluntary consensus

standards to facilitate reference to current voluntary consensus standards by agency reviewers.

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

Research (CBER)

Voluntary consensus standards are less applicable to pharmaceutical and biological products. 

CDER and CBER therefore have extremely limited involvement in such activities, but do

participate on relevant committees of at least two voluntary consensus standards bodies. 

While the agency’s involvement with voluntary consensus standards development is limited in

these particular areas (mostly because such standards are not available nor under development in

these areas), it should be noted that the agency does participate in many other types of standards

development activities which are excluded from Circular A-119 reporting requirements. 

Seventy-three employees in 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. However, it does not meet the criteria for a voluntary consensus

standards organization as defined in OMB Circular A-119. Both CDER and the CBER

participate 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 responsible for regulation of pharmaceuticals and by

industry trade organizations for the European Union (EU), Japan, and the United States ICH
A-33

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 guideline documents to harmonize pharmaceutical testing guidelines. 

FDA officials also participate in a consensus standards development 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 actively participates with the World Health Organization (WHO) in developing international

standards for ensuring the quality of pharmaceutical and biological products, and the Organization

for Economic Cooperation and Development (OECD) on good laboratory practices for animal

studies. In 1997, a new hemispheric initiative was launched on pharmaceutical harmonization in

the Americas, with emphasis on relevant ICH and WHO standards. The Pan American Health

Organization (PAHO) is the convener. A conference to be held in January 1999 will help advance

this initiative, and FDA plans to send four participants.

Although FDA’s work with USP is specifically excluded from reporting under Circular A-119,

and ICH, OECD 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 the core part of FDA’s overall standards activities for pharmaceuticals.

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

While voluntary consensus standards have minimal relevance to food and veterinary medicine

products, standards activities of multilateral organizations such as the WHO and the OECD are

often important in these areas, and CFSAN and CVM are actively engaged in standards and policy 

development with these organizations. 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). FDA experts from CFSAN, CVM, Office of

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

CVM is very active in a harmonization initiative similar to the ICH for human pharmaceuticals,

that is developing harmonized requirements for the registration of veterinary drugs. It is known

as VICH, for Veterinary ICH. Agency employees participate on numerous committees that are

drafting VICH guidelines. 

International/Treaty Standards-Related Activities

FDA takes part in a variety of international standards activities which fall under treaty

organizations, and thus are not reportable under the provisions of 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. 
A-34

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

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

Agreement on Sanitary and Phytosanitary Measures (SPS), and the same counterpart committees

of the North American Free Trade Agreement (NAFTA), to ensure that FDA’s requirements are

preserved and 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, standards for latex gloves and condoms, and medical device regulation.

FDA Standards Policy and Program Management

The FDA 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 periodically 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 policies regarding 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 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. 

FDA conducts a comprehensive review of its existing regulations on an ongoing basis. As part of

this review, the agency considers the appropriateness of existing regulations and policies, as

specified in Circular A-119. During 1998 the agency plans to conduct training on the

requirements set forth in Circular A-119, for both regulation writers and employees involved in

standards development and management activities. The FDA standards executive also serves as

the HHS standards executive. During 1998 training will be conducted for other HHS agencies

that are increasingly involved in the development and use of voluntary consensus standards. 
A-35

 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 seven HUD employees participating in standards development groups. 

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

from the Office of Lead Hazard Control are participating on ten 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

j. National Fire Protection Association

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

participation in a standards development group since October 1, 1997.

(3) The Department published a proposed rule in the FR to update the reference standards

incorporated into the Federal Manufactured Home Construction and Safety Standards, 24CFR

3280, to the latest edition on October 30, 1998. The Department expects to issue the final rule

during the first half of 1999. This will cover 163 standards incorporated by reference except: 

3 standards will require separate rulemaking because of significant changes in requirements,

12 new standards are being added, and 11 are being deleted.

(4) The Department selected The National Fire Protection Association to function as the

secretariat for the Federal Manufactured Home Construction and Safety Standards (Standards) in

1998. This is the first step in the Department’s process to have these Standards a consensus based

standards consistent with OMB Circular A-119. The appropriate committees have been

established with 3 HUD staff participating as voting members. The first deliberations were held in

December 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.
A-36

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

consensus standards than any other Federal agency.
A-37

DEPARTMENT OF THE INTERIOR

Based on a survey of offices and bureaus, the Department of the Interior’s response is as follows:

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

54, with 84 agency employees participating.

2) The number of voluntary consensus standards the agency has used since October 1, 1997,

based on the procedures set forth in sections 11 and 12 of the Circular: 144

3) Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of an agency review under section 15b(7) of the Circular: None

(0)

4) An evaluation of the effectiveness of the guidelines Circular A-119 and recommendations for

any changes: The Department of the Interior has no recommendations for any changes to the

Circular at this time.

5) As required by P.L. 104-1113, identification of all instances when the agency used

government-unique standards in lieu of voluntary consensus standards: None.
A-38

DEPARTMENT OF JUSTICE (DOJ)

Based on our previous conversations, the following information is being submitted in accordance

with circular A-119:

1. We have 8 individuals that participate in 3 consensus standard bodies; this is an increase of

2 additional consensus bodies, and two new participants.

2. The Department is currently in the final stages of approving its technical reference model (part

of the Information Technology Architecture), which will be used in the analysis of projects

selected in the future for information technology investments. The Department has not officially

added any consensus standards since last year. There will be a suite of standards identified during

this calendar year which reflect OMB requirement for development of an Information Technology

Architecture.

3. A process is included in the draft technical reference model for identification of consensus

standards that have been substituted for government-unique standards. We anticipated the

attached list of standards to be used during calendar year 1999. Additionally, standards

recommended by APCO 25 are under serious consideration by the Department.

4. The department uses all standards involved in complying with Public Law 102.486, Executive

Orders 12759 and 12845, and Federal Regulation Interim Rule 1 and Bulletin C-35 concerning

Energy-Star-qualifying computer equipment. The Government also is required to use the security

standards for protection of information unless a wavier is granted. A list of security related

standards are attached. Additional standards attached are standards that are currently under

analyses for selection to the Technical Reference Model, which is part of the Information

Technology Architecture.

Computer Security:

FIPS 46-2 Data Encryption Standard

FIPS 102 Certification and Accreditation

FIPS 112 Password Usage

FIPS 140-1 Cryptographic Modules

FIPS 171 Key Management using ANSI X9.17

FIPS 180-1 Secure Hash Standard

FIPS 185 Escrowed Encryption Standard

FIPS 186-1 Digital Signature Standard

FIPS 196 Enity Authenication Using Public Key Cryptography

Secure Socket Layer (SSL)

ISAKMP X.509 Certificates

NIST PUB 800-18 System Security Plans (New)

Computer Security Act of 1987
A-39

OMB A-130 particularly Appendix III

IPSec IETF RFC 1825

Internet Security Association & Key Management Protocol (ISAKMP)

E-Mail:

Simple Mail Transfer Protocol (SMTP)

Multi-purpose Internet Message Extensions (MIME)

Secure MIME (S/MIME)

Hyper Text Transfer Protocol (HTTP)

Internet Message Access Protocol (IMAP4)

Store information for exchange:

Rich Text Format (RTF)

ASCII Text

Tag Image File Format (TIFF)

Joint Photographic Experts Group (JPEG)

Moving Pictures Experts Group (MPEG)

File Transfer Protocol (FTP)

Portable Document Format (PDF)

Directory Services:

X.500

ITU X.400

Directory Access Protocol (DAP)

Lightweight DAP (LDAP)

Distributed Computing Environment (DCE)

Resource naming and resolution

Domain Name Service (DNS)

Video Teleconferencing:

 ITU H.320, H.323, H.324, H.310, T.120, & IETF RFC 1112

Electronic Commerce

FIPS 161-2 ANSI X.12 Electronic Data Interchange (EDI)

Database Store & Retrieve:

 FIPS 127-2 ANSI X3.135, System Query Language (SQL)

Calendaring - iCalendar, vCalendar, Calendaring Interoperability (CIP), Calendaring

Interoperability under HTTP (CIH)

Wire Standards

Category 5, FDDI

LAN

IEEE 802.1.3 Ethernet, 802.3u 100BaseT Ethernet, 802.11 wireless
A-40

LAN & WAN

Transmission Control Protocol (TCP)

Internet Protocol (IP) IPv4, RFCs for IP, IPv6

Dynamic Host Configuration Protocol (DCHP) IETF 1997

Internet Control Message Protocol (ICMP)

Asynchronous LAN

Point to Point Protocol (PPP)

Serial Line Internet Protocol (SLIP)

Multilink Point-to-Point Protocol (MPP)

WAN

Integrated Service Digital Network (ISDN)

Frame Relay ANSI T1.606:1990

Asynchronous Transfer Mode (ATM)

Support Network Management

Simple Network Management Protocol (SNMP) version 2

Management Information Base (MIB)

Facsimile

ITU T.4 Group 3, & T.6 Group 4

Remote Access

Telnet InterNIC IS 0008-1983

TN3270

Wireless

Project 25 

Cellular Digital Packet Data (CDPD)

Desktop

Microsoft Windows

JAVA OS

Common Object Request Broker Architecture (CORBA)

Distributed Component Object Model (DCOM)

Object Linking and Embedding (OLE)

FIPS 127-2 SQL
A-41

DEPARTMENT OF LABOR (DOL)

Below are the responses from the only two agencies within the Department of Labor that have

activities to report:

Mine Safety and Health Administration (MSHA) and Occupational Safety and Health

Administration (OSHA)

1. MSHA’s involvement with organizations and use of national consensus standards is the same

as last year. We now have 35 individuals on 51 separate committees or subcommittees of 17

organizations. Some committees are joint ventures of two organizations. OSHA currently has

representation (about 100 people) on about 50 national consensus standards committees of

organizations such as ANSI (the American National Standards Institute); NFPA (the National Fire

Protection Association); ASTM (the American Society for Testing and Materials); and ASME

(the American Society of Mechanical Engineers).

2. MSHA participated in the development of ASTM F432-95, “Standard Specification for Roof

and Rock Bolts and Accessories.” We subsequently revised our standards to include this revision

on April 22, 1998 (63 FR 20026). OSHA has reviewed about 25 voluntary standards as a

resource in its standards development work.

3. We have not identified any voluntary standards that are suitable to be substituted for an MSHA

mine-specific standard. OSHA has not substituted any voluntary consensus standards for

government unique standards.

4. MSHA has no recommendations. OSHA has no comment on this question.

5. Zero. For the most part, MSHA has already used the voluntary consensus standards that are

applicable to mining. Any further action would be to update the revision referenced. There were

no instances where OSHA used government-unique standards in lieu of voluntary consensus

standards.

It should be noted that Section 6 of the OSHA Act requires “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 standards.” It is for this

reason that OSHA is so involved in consensus standards making committees. 
A-42

DEPARTMENT OF STATE

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), Minneapolis, 1998, 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 the 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.

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
A-43

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-44

DEPARTMENT OF TRANSPORTATION

In response to the request by the Office of Management and Budget (OMB) for information

regarding the Department of Transportation’s (DOT) 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 1998 fiscal year activities for the department

and its agencies.

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

agency participation, as well as the number of agency employees

participating:

Six DOT agencies have reported varying degrees of participation in

standards-setting organizations and related activities.

C The total reported number of DOT employees participating in at least one-standardsdeveloping group is approximately two hundred and ninety-two (292) although there are

three operating administrations who have yet to report their activities (BTS, FHWA, and

FRA).

C The total number of voluntary standards groups in which DOT employees participate is one

hundred and six (106).

Bureau of Transportation Statistics (BTS)

This year, BTS did not provide a response, although based on last year’s response, BTS does

participate in voluntary standards organizations

Federal Aviation Administration (FAA)

Approximately one hundred and eleven (111) employees of FAA participate in at least one

standards-developing group. These employees participate in approximately eight (8)

standards-developing groups.

Federal Highway Administration (FHWA)

This year, FHWA did not provide a response, although, based on last year’s response, FHWA

does participate in voluntary standards organizations.

Federal Railroad Administration (FRA)

This year, FRA did not provide a response, although, based on last year’s response, FRA does

participate in voluntary standards organizations.
A-45

Federal Transit Administration (FTA)

Five (5) employees of FTA participate in at least one standards-developing group.

Maritime Administration (MARAD)

Six (6) employees of MARAD participate in at least one standards-developing group. 

National Highway Traffic Safety Administration (NHTSA)

Twenty-nine (29) employees of NHTSA participate in at least one standards-developing

group. 

Office of the Secretary (OST)

No employees participate in standards-developing groups.

Research and Special Programs Administration (RSPA)

Forty (40) employees of RSPA participate in at least one standards-developing group. 

St. Lawrence Seaway Development Corporation (SLSDC)

No employees participate in standards-developing groups.

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.

2) The number of voluntary consensus standards the agency has used since October 1, 1997

based on the procedures set forth in sections 11 and 12 of the Circular.

C The total reported number of voluntary consensus standards used by DOT since October 1,

1997 based on the procedures set forth in sections 11 and 12 of the Circular is one hundred

and ninety-seven (197).

Federal Aviation Administration (FAA)

Since October 1, 1997, FAA has used approximately 30 voluntary standards based on the

procedures set forth in sections 11 and 12 of the Circular.
A-46

National Highway Traffic Safety Administration (NHTSA)

Since October 1, 1997, NHTSA has proposed to adopt one voluntary consensus standard based

on the procedures set forth in sections 11 and 12 of the Circular.

Research and Special Programs Administration (RSPA)

Since October 1, 1997, RSPA has used approximately 160 voluntary standards based on the

procedures set forth in sections 11 and 12 of the Circular.

United States Coast Guard (USCG)

Since October 1, 1997, USCG has used approximately 6 voluntary standards based on the

procedures set forth in section 11 of the Circular. Regarding section 12 of the Circular, the

Coast Guard’s Office of Procurement Management (G-CPM) reports that there is currently no

database which can provide information on how Coast Guard procurement offices identify,

manage, review and use voluntary consensus standards in procurement. Plans are being

developed to gather this information for FY 99 and beyond.

3) The 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 the

Circular:

Federal Aviation Administration

Aerospace Material Specification AMS 2647B, Fluorescent Penetrant Inspection, Aircraft and

Engine Component Maintenance.

AIA-NAS-410, Aerospace Industries Association, National Aerospace Standard, NAS

Certification and Qualification of Nondestructive Test Personnel.

ATA Specification 105, Air Transport Association, Guidelines for Training and Qualifying

Personnel in Nondestructive Testing Methods.

HBAW98-01, Air Carrier Strobe Light Maintenance Program, resulted from collaboration with

NIST Physics Laboratory and SAE ARP 5029 Task Group.

MIL-STD-410E, Military Standard, Nondestructive Testing Personnel Qualification and

Certification.

In addition, the FAA is considering adopting a portion of the voluntary standards put out by

NFPA, ASTM and Illuminating Engineering Society (CIE).

National Highway Traffic Safety Administration

Heavy Truck Conspicuity Treatments (63 FR 8143, February 18, 1998) -- NHTSA substituted

compliance with an SAE Recommended Practice for a government-unique standard.

Research and Special Programs Administration
4

 This standard was not considered by the focus groups in their deliberations. 

A-47

During fiscal years 1997 and 1998, RSPA’s Office of Hazardous Materials Safety (OHMS) did

not adopt any rules that substituted voluntary consensus standards for government-unique

standards. However, RSPA has issued a Notice of Proposed Rulemaking under Docket HM-220

to adopt approximately 10 new standards that will substitute for the existing government-unique

regulations for the manufacture, testing and retesting of cylinders used in compressed gas service. 

In addition, in Docket HM-215C, OHMS has proposed to update the references to approximately

10 voluntary consensus standards that are incorporated in the Hazardous Materials Regulations.

During fiscal year 1998, RSPA’s Office of Pipeline Safety (OPS) did not adopt any rules that

substituted voluntary consensus standards for government-unique standards. However, OPS is

currently reviewing rulemakings to adopt more than 12 new 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 rulemakings will

be completed in early 1999.

4) An evaluation of the effectiveness of Circular A-119 policy and recommendations for any

changes:

While all of the individual operating administrations within the Department of Transportation have

not performed an evaluation of the effectiveness of Circular A-119, the general consensus is that

Circular A-119 is working effectively. DOT recognizes the importance and the advantages of

using voluntary consensus technical standards since the use of voluntary standards can save both

time and money for regulatory agencies. The Department also recognizes the value in

participating in standards-developing organizations. For example, NHTSA’s participation in

standards-developing organizations has helped the agency to be on the cutting edge of motor

vehicle-related technological innovations and the development of regulatory solutions to vehicle

safety problems. 

5) As required by P.L. 104-113, identification of all instances when the agency used governmentunique standards in lieu of voluntary consensus standards (for each instance include agency

rationale for such use, as well as the specific government standard used:

During fiscal year 1998, there was one such instance. NHTSA issued a notice of proposed

rulemaking (NPRM) that did not propose in all instances to use the requirements of a voluntary

standard instead of government-unique requirements. (63 FR 17976; April 13, 1998) 

NHTSA explained in the NPRM that the American National Standard Institute (ANSI) has a

standard4 for product safety signs and labels (ANSI Z535.4) that identifies a hierarchy of hazard

levels ranging from extremely serious to moderately serious and specifies corresponding

hierarchies of signal words, i.e., “danger,” “warning,” and “caution,” and of colors. For the

header, the ANSI standard specifies a red background with white text for “danger,” an orange

background with black text for “warning,” and a yellow background with black text for “caution.” 
A-48

ANSI Requirements for Color Coded Header Messages for the Different Levels of

Hazard

(Listed in declining level of hazard)

Imminently hazardous situation which will

result in death or serious injury if not avoided 

“Danger” Red background with

white text

Potentially hazardous situation which could

result in death or serious injury. 

“Warning” Orange background

with black text

Potentially hazardous situation which could

result in minor or moderate injury. 

“Caution” Yellow background

with black text

The ANSI standard specifies that pictograms should be black on white, with occasional uses of

color for emphasis, and that message text should be black on white.

The agency noted in the NPRM that when it earlier updated the requirements for air bag warning

labels to require the addition of color and pictograms, it had chosen not to adopt the colors

specified in the ANSI standard. NHTSA chose to use yellow instead of orange in the background

of the heading for the air bag warning label, even though the word “warning” was used, because

of overwhelming focus group preference for yellow. Only two of the 53 participants preferred

orange. Participants generally stated that yellow was more eye-catching than orange. Participants

also noted that red (stop) and yellow (caution) had meaning to them, but not orange.

NHTSA asked for comment on three color options for the revised utility vehicle rollover warning

label. Proposed label 1 used the ANSI color format with the heading background in orange with

the words in black. The remainder of the label had a white background with black text and

drawings. Proposed label 2 used a color scheme like the air bag warning labels, which is the same

as the ANSI color format except that the background color for the heading in the label is yellow. 

Proposed label 3 employed the color scheme used in the focus groups - the heading area had a red

background with white text. The graphic areas had a yellow background with black and white

drawings. The text area had a black background with yellow text.

Despite focus group preference for the signal word “danger,” the agency proposed the use of the

word “warning” as more appropriate to the level of risk. The agency also noted that the word

“warning” is used in the air bag warning label. 

Recognizing that it might encounter additional conflicts between focus group preferences and the

ANSI standard in future rulemakings, NHTSA requested comments in the NPRM on the extent to

which any final choice regarding colors and signal words should be guided by the focus group
A-49

preferences instead of the ANSI standard. NHTSA also requested comments on the broader issue

of the circumstances in which it would be appropriate for agency rulemaking decisions to be

guided by focus group results or other information when such information is contrary to a

voluntary consensus standard such as the ANSI standard. 

At this time (February 22, 1999), a final decision is still pending regarding its proposal to upgrade

the rollover warning label. As to the general questions it posed in the NPRM, NHTSA recognizes

that ANSI’s mission differs somewhat from that of the agency’s focus groups with respect to the

labeling of hazardous situations. ANSI’s mission is to develop and maintain a standard for

communicating information about a comprehensive hierarchy of hazards, while the focus groups’

mission is to design an effective label for a specific hazard. The agency recognizes further that,

given the difference in their missions, their conclusions about the appropriate manner of

communication might differ on occasion. 

Since agency labeling decisions are highly dependent on the facts regarding the specific hazard

being addressed, NHTSA anticipates making case-by-case determinations of the extent to which it

should follow voluntary standards versus information from focus groups and other sources. 

NHTSA will rely on its own expertise and judgement in making determinations under the NTTAA

and the statutory provisions regarding vehicle safety standards.
A-50

DEPARTMENT OF TREASURY (TREASURY)

The Department of the Treasury reports 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;

The Department participated in eight voluntary consensus standards bodies that accounted for

approximately twenty-one employees participating.

2) The number of voluntary consensus standards the agency has used since October 1, 1997

based on the procedures set forth in Sections 11 and 12 of the Circular;

The Department has used three voluntary consensus standards. In addition, an unknown

number of voluntary consensus standards are used as a result of implementing commercial-offthe-shelf hardware and software.

3) Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of an agency review under section 15b(7) of the Circular;

No voluntary consensus standards have been substituted for government-unique standard as a

result of our Department-wide review of existing standards. 

4) An evaluation of the effectiveness of A-119 policy and recommendations for any changes; and

We believe that the guidelines prescribed in Circular A-119 are effective. Circular A-119 has

placed the focus on using voluntary consensus standards as opposed to the development of

government-unique standards. Wide use of voluntary consensus standards promotes the

development of an increased number of standards compliant products facilitating the use of

new technology and increasing flexibility to meet new requirements. 

 

5) As required by P.L. 104-113, identification of all instances when the agency used governmentunique standards in lieu of voluntary consensus standards (for each instance include agency

rational for such use, as well as the specific government-unique standards used.)

Customs continues to support two government-unique standards which are Customs And

Trade Automated Interface Requirements (CATAIR) (Amendment 1, April 1996, Amendment

2, December 1996, Amendment 3, September 1997, and Amendment 4, 1998) and Customs

Automated Manifest Interface Requirements (CAMIR) (Amendment 1, April 1997 and

Amendment 2, July 1998). CATAIR is used by the Customs brokerage industry and CAMIR

is used by some parties in the transportation sector. The maintenance of the government-
A-51

unique standards within Customs applications (the CATAIR and CAMIR formats), are at the

request of the participating industry groups that use those standards.
A-52

DEPARTMENT OF VETERANS AFFAIRS (VA)

The following information was requested from the Department of Commerce for inclusion in the

1998 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 4 employees participating in three voluntary consensus standards bodies.

2. The number of voluntary consensus standards the agency has used since October 1, 1997 based

on the procedures set forth in sections 11 and 12 of the Circular.

40 from ANSI/RESNA and 10 from SAE (Security of Automotive Engineers)

3. Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of an agency review under section 15b(7) of the Circular.

None.

4. An evaluation of the effectiveness of Circular A-119 policy and recommendations for any

changes.

The Circular has had no unexpected side effects to our present Department goal. We accept and

conform to the standards developed by the Joint Commission on Accreditation of Hospitals

Organization (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 and nursing homes under VA contract, state home facilities, hospital

based care programs, and various JCAHO 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, costeffectiveness, and quality control. These national standards have been adopted by industry and are

familiar to those in the building profession.

5. As required by P. L. 104-113, identification of all instances when the agency used governmentunique standards in lieu of voluntary consensus standards (for each instance include agency

rationale for such use, as well as the specific government-unique standard used.)

None.
B-1

Appendix B:

Other Agency Reports
B-2

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 OMB Circular A-119 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 A-119 and

provides general oversight for staff involvement in existing standards projects including the

development of strategies for increasing the level of involvement by the CPSC staff in voluntary

standards activities. The Voluntary Standards Coordinator provides reports on voluntary

standards activities as well as provides similar information for the Commission's Annual Report.

The Commission had 21 employees directly participating in 50 voluntary standards development

projects during FY 1998. Since October 1, 1997, the Commission incorporated by reference 

portions of 10 voluntary standards in CPSC regulations. During FY 1998, there were no

voluntary consensus standards that were substituted for government-unique standards as a result

of an agency review of existing standards. 

During FY 1998, the Commission's efforts to enhance voluntary standards development was

complemented by the overall Federal policy set forth in the Circular. CPSC involvement in

voluntary standards activities was consistent with Circular A-119 Revised. There are no

recommendations for changes in the Circular at this time.

As part of the implementation of the provisions of the Circular, Mr. Colin B. Church was

appointed the agency Standards Executive. 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. 
B-3

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. 
B-4

ENVIRONMENTAL PROTECTION AGENCY (EPA)

The U.S. Environmental Protection Agency is pleased to submit to the National Institute for

Standards and Technology (NIST), for submission to the Office of Management and Budget

(OMB) and Congress, the following report on EPA’s fiscal year 1998 implementation of the

National Technology Transfer and Advancement Act (NTTAA), Sec 12 (d) and the OMB

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

Standards and in Conformity Assessment Activities.

HIGHLIGHTS

The following highlight EPA’s 1997-98 accomplishments associated with the implementation

of the NTTAA and Circular A-119.

i EPA has significantly improved its system for promoting compliance with the NTTAA in

rulemaking:

1) EPA regulators now routinely consider the use of voluntary consensus standards in

proposed and final Agency regulations. Nearly one hundred Federal Register documents

published in fiscal year 1998 contained preamble sections addressing the NTTAA. In these

sections, the rule writers summarized the requirements of the NTTAA, explained how they

searched for potentially applicable voluntary consensus standards, and described their tentative

or final decisions about the use of such standards in the regulation. EPA’s Office of Policy,

working with the Standards Executive and the Office of General Counsel has developed a

comprehensive “EPA Rule Writer’s Guide to the NTTAA” explaining the procedures needed

to systematically assess the application of NTTAA to a proposed and final rules. When

finalized, the Guide will be available on EPA’s internal electronic network and will be

periodically updated. In the meantime, the draft document is in regular use.

2) EPA rule writers are regularly using model language concerning the NTTAA and the use

of voluntary consensus standards in both proposed and final regulations. This greatly

facilitates the electronic tracking of the use, or consideration of the use, of voluntary standards

in EPA regulations. This, in turn, promotes the management of EPA standards program and

improves the quality and ease of preparing this annual report. More detail on the extent to

which standards have been considered and used is provided below.

i The EPA Standards Program has increased visibility and stature within the Agency.

In August, EPA Administrator Carol Browner appointed Dr. Mary C. McKiel, of the

Office of Prevention, Pesticides and Toxic Substances (OPPTS), to be the new EPA Standards

Executive. More recently, the Assistant Administrator for OPPTS elevated the Standards

Program within OPPTS to enhance the importance of voluntary standards to EPA policies and
B-5

programs and to facilitate Agency-wide implement of the requirements of The NTTAA and the

Circular. The Standards Executive represents the Agency on the Interagency Committee on

Standards Policy Standards Policy and works cooperatively with the Office of the General

Counsel, all applicable EPA program and policy offices, and intra-agency groups with

standards-related interests.

i EPA revised the Agency ethics guidance on participation in voluntary standards

organizations.

The new EPA guidance, issued in September 1998, finally reconciled the competing

interests of the criminal code provisions concerning financial conflicts of interest with the

NTTAA directive that Federal employees participate in standard-setting activities of voluntary

standards organizations. Relying on recent memoranda from the Office of Legal Counsel of

the Department of Justice and the Office of Government Ethics, the new guidance provides a

clear pathway for EPA employee membership in standards development organizations,

including serving on boards of directors and as committee chairs. A copy of the guidance is

attached. 

REQUIRED REPORTING ELEMENTS UNDER OMB CIRCULAR A-119

1. The number of voluntary consensus standards bodies in which there is Agency participation

and the number of employees participating.

A. Approximately 200 EPA employees participate in the following 14 standards

organizations:

< The American National Standards Institute (ANSI)

< The American Gas Association (AGA)

< The American Petroleum Institute (API)

< The American Society of Quality Control (ASQ)

< The American Society for Mechanical Engineers (ASME)

< ASTM, (formerly known as the American Society of Testing and Materials)

< The National Fire Protection Association (NFPA)

< NSF International

< The Society of Automotive Engineers (SAE)

< The Technical Association of the Pulp and Paper Industry (TAPPI)

< Underwriters Laboratories, Inc. (UL)

< The International Organization for Standardization (ISO)

< The International Electrotechnical Commission (IEC)

< NACE International (formerly National Association of Corrosion Engineers)

B. In addition to participation, several of the above number of employees serve as officers

on Boards and Committees. These include but are not limited to:
B-6

< Board of Directors, American National Standards Institute

< Technical Advisory Board, Society of Automotive Engineers

< Chairman’s Advisory Council, Underwriters Laboratories, Inc.

< ANSI Accredited Standards Committee Z-1 on Quality and Environmental Management

< U.S. Technical Advisory Group to ISO Technical Committee 176 on Quality Management

< U.S. Technical Advisory Group to ISO Technical Committee 207 on Environmental

Management

2. The number of voluntary consensus standards the Agency has used since October 1, 1997.

This response addresses EPA’s use of voluntary standards in regulations, not procurement

activities. In 1998, EPA published 6 final regulations incorporating (by reference) more than

90 voluntary consensus standards. Some of these standards were newly included in EPA

regulations. In other cases, EPA decided to continue the use of the same voluntary consensus

standards. EPA cites the same test methods (for example, the fuels test methods of ASTM) in

multiple rules -- some of which are new and others increase stringency of existing rules. EPA

may also cite updated versions of a standard currently in use. 

In addition, EPA published 10 proposed regulations, or documents requesting comments on

prior proposals, that would incorporate voluntary consensus standards. These included

reference to 67 voluntary consensus standards. 

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

government-unique standards as a result of an Agency review of existing standards.

A. EPA identified no instances for this year where the preamble (following the model

language) stated that a voluntary standard was being substituted for a pre-existing governmentunique standard. 

However, an excellent example of an Agency review process this past year was done by the

Emission Measurement Center (EMC) within EPA’s Office of Air Quality Planning and

Standards (OAQPS). EMC undertook and completed a study to search the National Standards

System Network (NSSN) and to identify and compare potentially applicable voluntary

consensus standards in that data base to (A) all existing EMC emission methods, (B) technical

standards in EPA’s official list of Hazardous Air Pollutants, and (C) technical standards in

new, forthcoming MACT -- Maximum Achievable Control Technology -- Standards. The

work currently is being reviewed to determine next appropriate steps. Results of the analysis

and any subsequent actions will be reported in the Agency’s 1999 report. 

B. In the area of quality management, the voluntary American National Standard

ANSI/ASQC E4-1994 (“Specifications and Guidelines for Quality Systems for Environmental

Data Collection and Environmental Technology Programs”) has been adopted, by means of

EPA Order 5360.1 CHG1, as the technical basis for the Agency-wide mandatory quality
B-7

system. Furthermore, by means of revision to FAR Part 46, (48 CFR Part 46) the Federal

Acquisition Regulation now acknowledge E-4 as a “high level standard”. Previously, the

regulations in 40 CFR Part 30 governing financial assistance to non-profit organizations were

revised to include conformance to E4 as the quality requirements. Currently, EPA is

completing action on a new Term and Condition for financial assistance to State and local

governments (under 40 CFR Part 31) to establish the same requirement. When these actions

are completed, the quality requirements for all extramural agreements will be the same as for

internal Agency programs. 

4. Evaluation of the effectiveness of Circular A-119 policy and recommendations for any

changes

EPA enthusiastically endorsed the publication of the final, revised Circular in February. 

While EPA notes a few minor issues in A-119, the Agency finds that the policies and

procedures set out work well. EPA does not recommend any changes at this time. 

5. Agency use of government-unique standards in lieu of voluntary consensus standards.

In FY 1998, EPA identified 3 final regulations where the use of an identified voluntary

consensus standard was rejected in favor of a government-unique standard. It should be noted,

however, that each of these regulations also contained other technical standards where

voluntary consensus standards were used. EPA rationale for each instance follows:

< 63 FR 48806 (9/11/98), National Volatile Organic Compound Emission Standards for

Automobile Refinish Coatings: EPA considered the use of ASTM D-3960 as a possible

substitute for EPA Method 24 which already relies on several ASTM methods.

However, ASTM D-3960 contains some requirements above and beyond those needed

for EPA regulatory purposes. As stated in the FR notice: ABecause this other method

[ASTM 3960] does not specify which units to use, it may result in inconsistent

applications of the procedure and could make the standard more difficult to enforce. 

Consequently, the EPA determined that this other voluntary consensus method would be

impractical to adopt. In addition, the EPA believes that it is appropriate to use Method 24

both because it has proven reliable and practical to achieve the goals of reducing VOC and

because the EPA wishes to foster uniformity in testing nationwide.” For this Rule, then,

EPA specified EPA Method 24 which refers to ASTM Methods 2369, 1460, and 3970

(as does Method D-3960) while avoiding possible confusion caused by the presence of

additional, unnecessary requirements.

< 63 FR 48848 (9/11/98), National Volatile Organic Compound Emission Standards for

Architectural Coatings: EPA deemed ASTM-3960, modeled on EPA Method 24,

iteself referring to other ASTM methods, to be impractical for use in lieu of EPA

Method 24 (see #1 above);
B-8

< 63 FR 18504 (4/15/98), National Emission Standards for Hazardous Air Pollutants for

Source Category: Pulp and Paper Productions: EPA decided to use EPA Method

1650. This Method was developed by drawing on various procedures contained in the

methods of voluntary consensus standards bodies and other standards developers, such

as ISO, DIN, SCAN, and Standard Methods (SM 5320). However, none of these more

narrowly focused voluntary consensus standards contained the standardized quality

control and quality control compliance criteria that EPA requires for data verification

and validation in its water programs. Therefore, EPA found none of these VCS

standing alone to meet EPA’s needs.

< There was also one proposed regulation where EPA proposed to reject the use of a

particular voluntary consensus standard in favor of a government-unique standard:

< 63 FR 41134 (7/31/98), National Primary Drinking Water Regulations: Analytical

Methods for Certain Pesticides and Microbial Contaminations: Standard Methods

6640B for acid herbicides was tentatively deemed impractical for EPA’s needs because

its sample preparation and quality control procedures were not similar enough to EPA

Method 515.1 to ensure that there would not be underreporting of acid herbicide

contamination. EPA plans to offer to work with the Standard Methods committee to

resolve this issue prior to the next publication. 

EPA STANDARDS-RELATED ACTIVITIES

EPA standards-related activities go well beyond what is required by the NTTAA and the

Circular. Innovative programs, driven by Administration objectives for better public

communication, more efficient and effective protection and a focus on pollution prevention,

are using a variety of tools. Among those tools is an increased reliance on voluntary consensus

standards and conformity assessment mechanisms. 

By no means an exhaustive list, these examples do represent accomplishments since the last

EPA report, and illustrate the variety of voluntary standards applications at the Agency. 

Work on New Standards

Productive communication between EPA and standards developers has spurred the

development of voluntary standards, some of which may be incorporated into EPA guidance

standards. For example, EPA representatives in the Underground Storage Tank program

successfully worked with ASTM to develop multiple standards. One (ASTM G 158 “Standard

Guide for Three Methods of Assessing Buried Steel Tanks”) generally satisfies one of two

options in an EPA guidance and is expected to supplant the other option: actual third-party

evaluation according to a particular EPA protocol or its equivalent. Another (ASTM E 1990

“Standard Guide for Performing Evaluations of Underground Storage Tank Systems for
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Operational Conformance with 40 CFR Part 280 Regulations”) allows general compliance

status to be easily determined.

In another instance, cooperation among ASTM, manufacturers of opacity monitors and the

Emission Measurement Center (EMC) within the EPA’s Office of Air Quality Planning and

Standards resulted in a new voluntary standard for quality assurance / quality control applicable

to the monitors. EMC is reviewing the standard for inclusion in a revised EPA Performance

standard (PS-1). This is expected to provide major benefits to all concerned. Until now, the

EPA method, extensively used, has lacked a standard, agreed-upon quality assurance for

manufacturers of the monitors. Inclusion of the ASTM method may go a long way toward

addressing the problem which has vexed regulator and regulated alike.

International Standards

In the area of international voluntary standards, EPA continues to have very active roles in

the development and revision of standards within the International Organization for

Standardization’s (ISO) Technical Committees # 176 for Quality Management Systems, and #

207 for Environmental Management Systems. These international standards play an

increasingly important role in U.S. business, manufacturing and trade as well as environmental

performance and measurement. In 1997, the international community stepped up efforts to

make the quality and environmental standards compatible. A major focus of these efforts is to

make it easier for organizations to obtain certification to both without going through entirely

separate processes. EPA employees are working to help advance this goal while maintaining

the integrity, and benefits, of the environmental management system.

 

The Use of Standards in EPA Procurement

EPA will evaluate the proposed amendments to the FAR designed to address NTTAA

implementation issues. The proposed rule was published December 10 (63 FR 68344). In

1998 at least one RFP solicited information about voluntary consensus standards that might be

usable in lieu of a government-unique standard proposed for use to evaluate software. No

suggestions were made.

Standards in EPA Voluntary Programs

Several programs and initiatives within EPA, while not specifically required to report

under the OMB Circular, use voluntary consensus standards in substantive ways to meet

program or project goals. Two examples are given below.

1. Usage of the ISO 14001 EMS Specification by the EPA Region I StarTrack Program. The

StarTrack Program is a voluntary compliance and environmental management systems

third-party certification program in EPA Region I. Participants agree to implement an

EMS modeled on the ISO 14001 EMS specification. An independent third-party certifies
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that the StarTrack participant has an acceptable compliance program and an effective

overall EMS, or an implementation plan to fully implement an ISO 14001-based EMS. 

Current program policy is to accept ISO 14001 conformity assessments performed by

ANSI-RAB* accredited registrars as meeting the StarTrack program requirements for EMS

implementation and independent third-party certification of the EMS. The StarTrack

Program is currently evaluating the extent to which ISO 14001 conformity assessments

performed by ANSI-RAB accredited registrars meet the compliance certification

requirements of the program. At this time, 5 of the 15 organizations participating in the

StarTrack Program are registered as conforming to ISO 14001.

*(American National Standards Institute and the Registrar Accreditation Board cooperative run

the U.S. National Accreditation Program for ISO 14001)

2. Environmentally Preferable Products Program. In 1998, EPA and the Office of the Federal

Environmental Executive issued policy on how Federal agencies can use Non-Governmental

Entities to help achieve the Administration’s mandate of purchasing environmentally preferable

goods and services. Non-Governmental Entities (NGE’s)/ Third Parties are defined as including

but not limited to, standard setting organizations, third party certification programs, environmental

labeling or environmental report card programs, and other environmental consulting

organizations.

 The purpose of the pilot project approach is to demonstrate how Executive Agencies can use

NGEs to support Federal environmentally preferable purchasing efforts. EPA believes there are

several advantages to this approach.

 First, it increases the variety of product categories which are studied. Second, through the

pilot project approach EPA may determine where the use of outside expertise is appropriate and

helpful. Third, the most effective and practical ways to achieve the goal of environmentally

preferable purchasing will be identified. Finally, this approach may encourage increased

competition among existing and new organizations/programs that can support the procurement of

environmentally preferable products.

ISSUES & PLANS FOR ENHANCEMENTS

1. Strategic Standardization Program. Under the Standards Program, EPA is improving internal

coordination on voluntary standards use, and on establishing mechanisms for effective resource

allocation to meet standards needs. The aim of Agency standards program is to increase

efficiency and effectiveness. More work is needed to ensure that EPA has the right people on the

right committees to meet the needs of the Agency. This may mean that some Agency personnel,

serving on standards committees in their own capacity as technical experts, would be reassigned

committee work based on the needs of the Agency and in some cases, committee work will be

dropped entirely.
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2. Improved Tracking. In some cases, EPA employees are members of more than one committee

or standards organization. Analysis of the number of involved employees gives only part of the

picture. A format for more accurate tracking of the total involvement is currently underway. The

Office of Standards Services at NIST and the standards office at the Department of Energy have

provided some model formats which EPA will use in developing a more accurate tracking system.

3. Participation Guide and Training Programs. EPA employees represent an impressive variety

and depth of expertise in technical matters important to environmental protection. A Guide

document is under development to assist EPA technical experts in making the most of

participation on voluntary standards committees. Again, existing documents from NIST and other

Federal agencies is being used in the development of the EPA guide. In addition, formal training

programs for EPA personnel are also under development in cooperation with standards

development organizations.

cc: The Administrator

The Deputy Administrator

Lynn Goldman, M.D.

Susan Wayland, OPPTS

Scott Fulton, OGC

James Nelson, OGC
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FEDERAL COMMUNICATIONS COMMISSION (FCC)

This is in reply to your letter of December 8, 1998, requesting a report on the Federal

Communications Commission’s interaction with voluntary consensus standards bodies, as required

by proposed revision of OMB Circular A-119. In keeping with your suggested outline, the

Commission’s report is as follows:

1. 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 49 employees involved in more than 24 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/TI 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 comminations systems.
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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 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

though the negotiated rulemaking process to resolve technical compatibility issues.

2. The Commission has not used or adopted any voluntary consensus standards since

October 1, 1997.

3. No voluntary consensus standards have replaced government-unique standards as

result of agency review of existing standards since October 1, 1997.

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:

Dale N. Hatfield

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 standardsrelated issues;

b. monitoring the standards-setting activities of the agency’s bureau 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;

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.
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The Commission’s Office of Engineering and Technology, which is under the

leadership of 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 or adopted any government-unique standards in lieu of

voluntary consensus standards since October 1, 1997.
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FEDERAL EMERGENCY MANAGEMENT ASSOCIATION (FEMA)

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

well as the number of agency employees participating;

During the reporting period, FEMA has not collected that information on an agency basis.

The number of voluntary consensus standards the agency has used since October 1, 1997 based on

the procedures set forth in sections 11 and 12 of the Circular;

On November 2, 1998, FEMA issued initial Information Technology Architecture,

which discusses in detail the agency=s approach to standards. FEMA is committed

to an enterprise IT architecture based on open system standards for interoperability,

portability, and scalability. Until now, FEMA has had an implied IT architecture as a

de facto agency-wide standard. The common practice has been to declare a

commercial tool as the agency standard. Therefore, the adoption of open systems

standards over company or industry standards is among the highest priorities for

FEMA. However, unless open system standards are also industry consensus

standards, vendor support will fall short of architectural objectives.

In many instances, FEMA is using consensus standards when possible. 

For example: 

Digital Line Graph Level 3 (DLG3) as the standard data model for the distribution and

storage of digital flood insurance rate map (DFIRM) products;

Hypertext Markup Language (HTML) as the standard for FEMA=s web site; discussion is

underway to replace HTML with Extensible Markup Language (XML);

Multi-purpose Internet Mail Extension (MIME) is used to encode e-mail attachments. 

FEMA uses standard protocols to run the e-mail operations

Portable Document Format (PDF) is used to retrieve and post formatted documents

between differing computing environments. 

Identification of voluntary standards that have been substituted for government-unique standards

as a result of an agency review under section 15b(7) of the Circular;

Voluntary standards are preferred; but because FEMA is a small agency, no formal review

has been imposed on the program directors.

An evaluation of the effectiveness of Circular A-119 policy and recommendations for an changes;

and cost-savings and operational efficiency are the driving factors in FEMA adopting consensus
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standards. Ease of interoperability, portability, scalability force a small agency like FEMA to seek

out these products. As important for adoption are the availability of training, documentation, and

regular upgrades at modest cost to the agency. 

As required by P.L. 104-113, identification of all instances when the agency used governmentunique standards in lieu of voluntary consensus standards (for each instance include the agency

rationale for such use, as well as the specific government-unique standard used.)

Interview conducted with program managers for the IT architecture found no use government

standards in lieu of voluntary consensus standards. 
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GENERAL SERVICES ADMINISTRATION (GSA)

GSA has 45 employees participating in 91 voluntary consensus standards bodies. The decrease

from last year’s report is due to a reorganization that involved the reassignment of technical

personnel to other functional areas, and to our continuing emphasis on the procurement of

commercial off-the-shelf products and services.

The GSA Public Buildings Service has adopted the Building Owners and Managers Association

International (BOMA) standard method of measuring floor area in office buildings.

As a result of the review of existing standards, the following voluntary standards have been

substituted for government-unique standards.

Voluntary Standard Government Standard*

ASTM D 456 O-S-598

NFPA STD. NO. 1961 A-A-2160

NFPA STD. NO. 1964 A-A-2279, A-A-2280 and A-A2281

ANSI/ASME B94.9 A-A-624, A-A-1267, GGG-T-60 

and GGG-T-70

ASME B107.14M GGG-W-686

ASTM F1085** V-M-96

ASME B56.11.12** FF-H-106/GEN

ASTM C547, C553, 

C592 and C612** HH-I-558

ASTM E11 and E323** RR-S-366

*Includes Federal specifications, standards and commercial item descriptions.

**These were substituted during FY 1997, but overlooked in last year’s report.

We have no comments or recommendations for changes concerning OMB Circular A-119.

No government-unique standards are being used in lieu of existing voluntary standards.
B-18

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION (NASA)

NASA policy for technical standards is documented in NASA Policy Directive (NPD) 8070.6,

which was revised in 1998 to reflect the new requirements of Public Law 104-113 and Office of

Management and Budget (OMB) Circular A-119. NPD 8070.6 specifically cites the preference

for use of Voluntary Consensus Standards (VCS), encourages participation in VCS development

to meet NASA needs, establishes responsibilities for standards management in NASA, and

references OMB Circular A-119 for detailed requirements.

The NASA Chief Engineer is the NASA Standards Executive. Policy level issues are coordinated

through the Engineering Management Council (EMC), an Agencywide group of senior

management officials from the NASA Engineering and the Safety and Mission Assurance

Functions. The Chief Engineer has total responsibility for administration of the NASA Technical

Standards Program, with some discipline oversight responsibilities delegated to other functional

offices.

Implementation and management responsibility for the NASA Technical standards program has

been assigned to the Marshall Space Flight Center which chairs an Agencywide Engineering

Standards Steering Council responsible for procedures and the coordination of internal document

development and adoption of VCS.

NASA’s use of standards is entirely for procurement purposes, so the Agency has chosen a

“categorical” or standards management system approach for reporting in response to OMB

Circular A-119. The NASA Technical Standards Management System is still under development,

but currently contains listings of preferred technical standards, lists of NASA participants in VCS

activities, and extensive links to other sources of technical standards. The ”home page” for the

NASA Technical Standards Management System can be found on the Internet at

http://standards.msfc.nasa.gov.

I. The number of voluntary consensus standards bodies in which there is Agency participation, as

well as the number of Agency employees participating.

In fiscal year 1998, NASA had 148 employees participating in 43 voluntary consensus standards

(VCS) developing bodies, both domestic and international. This is approximately 10 percent less

than reported in 1997, largely due to corrections deleting the names of employees who were

members of professional societies but not directly involved in the development of standards. The

total turnover of participants in the past year was approximately 30 percent.
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II. The number of voluntary consensus standards the Agency has used since

October 1, 1997, based on the procedures set forth in sections 11 and 12 of the Circular.

In 1998, NASA began an intensive effort to identify VCS currently being used on NASA

programs and to review them as candidates for formal adoption. Since October 1, 1997, NASA

has adopted 414 voluntary consensus standards products based on current use by one or more

NASA installations. Approximately 85 percent of the VCS adopted are in the area of materials

and processes specifications. Also included are10 data communications standards that were

converted in 1998 from international inter-governmental standards to ISO standards. The

adoptions were based on staff recommendations, concurrence of the NASA Engineering

Standards Steering Council, and formal approval by the NASA EMC and the NASA Standards

Executive. An additional 400 voluntary consensus standards are now in the final stages of the

review process as candidates for formal adoption by NASA. The process will be completed in FY

1999.

III. Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of an Agency review under section 15b(7) of the Circular.

NASA participates in the Department of Defense (DoD) Single Process Initiative (SPI) to

eliminate the use of redundant and conflicting Government specifications at contractor facilities

for meeting common requirements. In 1998, as a result of SPI proposals, the NASA Lewis

Research Center has accepted replacement of four Government (MIL-) standards with VCS. 

In 1998, NASA began an extensive of review of Government standards currently in use, including

both installation-unique technical standards, and standards of other Government agencies, such as

the Department of Defense. The objective of this review is to identify all Government standards

used across the Agency for inclusion in the NASA Technical Standards Management System. The

next phase is to identify which government-unique technical standards in the system can be

eliminated or replaced with VCS. Completion of this review is a major objective for the Technical

NASA Standards Program during 1999.

IV. An evaluation of the effectiveness of Circular A-119 policy and recommendations for any

changes.

OMB Circular A-119 continues to provide stimulus for NASA's effort to improve the standards

management system, enhance the use of voluntary consensus standards products, and challenge

the need for NASA-unique technical standards requirements. It is an integral part of the NASA

Technical Standards Program. 

For example, as part of an internal system review in 1998, the Jet Propulsion Laboratory

eliminated 1700 Center specific standards either because of obsolescence or replacement with

VCS.
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Promoting the participation of NASA employees in voluntary consensus developing bodies

received major emphasis in the NASA Technical Standards Awareness Initiative begun in 1998.

V. As required by P.L.104-113, identification of all instances when the Agency used governmentunique standards in lieu of voluntary consensus standards (for each instance include Agency

rationale for such use, as well as the specific government-unique standard used).

Because NASA uses the “categorical” method of reporting, “use” of government-unique

standards is reported in terms of additions to the NASA Technical Standards Management System

as opposed to tracking individual procurement transactions. During 1998 NASA has developed

ten NASA-unique technical standards in three categories, namely: information technology,

engineering, and safety and mission assurance. The new standards are listed in a table at the end

of this report.

The two NASA Information Technology (IT) standards developed in 1998 (Items 1 and 2 below)

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. NASA Engineering

standards are developed either to consolidate internal practices, or to provide guidance where no

suitable national or international standards are available. Item 3 below documented a unique set

of requirements developed from failure experience on planetary spacecraft; Item 4 updates an

existing standard which is now in the process of being converted into an ISO standard. NASA is

participating with industry, plus domestic and international voluntary consensus standard bodies,

to target those standards with external application for eventual transition to voluntary consensus

standards. 

In the Safety and Mission Assurance area, Items 5 and 6 are manuals establishing safety

requirements for NASA internal facilities and launch vehicle operations. Items 7-9 are interim reissues of existing NASA standards based on failure experience in NASA unique space systems and

in one case, (Item 10) an area for which a fully adequate VCS has not been available. The Safety

and Mission Assurance function has initiated an effort to identify possible VCS sponsors for these

last four workmanship standards in FY 1999.

STANDARDS PUBLISHED IN 1998 (October 1997 - October 1998)

1. NASA-STD-2807A The NASA Directory Service - Architecture, Standards, and

Products (Previously Released as "NASA X.500 Directory"

2. NASA-STD-2808A Interoperability Profile for NASA E-Mail Clients

3. NASA-HDBK-4001 Electrical Grounding Architecture for Unmanned Spacecraft

4. NASA-STD-6001 Flammability, Odor, Offgassing, and Compatibility Requirements

and Test Procedures for Materials in Environments that Support

Combustion (Formerly Published as NHB 8060.1C)

5. NASA-STD-8719.7 Facility System Safety Guidebook

6. NASA-STD-8719.8 Expendable Launch Vehicle Payload Safety Review Process

Standard
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7. NASA-STD-8739.3 Soldered Electrical Connections. (Previous Version Published as

NHB 5300.4(3A-2

8. NASA-STD-8739.4 Crimping, Interconnecting Cables, Harnesses, and Wiring (Previous

Version Published as NAS 5300.4(3G-1)

9. NASA-STD-8739.7 Electrostatic Discharge Control (Excluding Electrically Initiated

Explosive Devices

10. NASA-STD-8739.5 Fiber Optic Terminations, Cable Assemblies, and Installation
B-22

NATIONAL ARCHIVES AND RECORDS ADMINISTRATION (NARA)

The National Archives and Records Administration (NARA) continues to be active in the area of

voluntary standards. Unfortunately, due to limited resources, attrition, and other priorities, the

number of NARA staff involved in standards activities during this period has declined.

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 eight NARA employees are active on a variety of voluntary consensus standards

organizations, committees, and subcommittees either as official NARA representatives or

alternates. These eight individuals serve on approximately fourteen voluntary standards bodies at

the organization, committee, or subcommittee level. In addition, NARA is also a voting member

of the National Information Standards Organization (NISO). During this past year, NARA staff

members participated in the review of drafts for various International Organization for

Standardization (ISO) standards. NARA also was asked by NISO to represent them in the

development of an ISO records management standard. By working on a common set of methods,

processes, and materials, we can help foster standards that further NARA’s central mission of

ensuring ready access to essential evidence.

2. The number of voluntary consensus standards the agency has used since October 1, 1997,

based on the procedures set forth in sections 11 and 12 of the Circular.

Although NARA has incorporated by reference in our regulations twenty-five voluntary

standards outlined in 36 CFR Chapter 12, staff this past year worked on revisions to four

standards that are reflected in our regulations.

3. Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of an agency review under section 15b(7) of the Circular.

No government-unique standards were replaced with voluntary consensus standards

during the fiscal year. Any government-unique standards currently used by NARA reflect

performance standards currently unavailable as voluntary standards.

4. An evaluation of the effectiveness of Circular A-119 policy and recommendations for any

changes.

The question and answer format used in the development of this circular is very helpful in

understanding the complexities of voluntary consensus standards. NARA has no recommendation

for changes.
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5. As required by P.L. 104-113, identification of all instances when the agency used

government-unique standards in lieu of voluntary consensus standards (for each instance include

agency rational for such use, as well as the specific government-unique standards used.)

During this past reporting period, NARA signed an agreement with the Department of

Defense (DOD) to develop design criteria for electronic records management software

applications. On December 19 of this year, NARA endorsed DOD’s standard 5015.2. While this

is a mandatory DOD standard, it is possible that it may one day become a government-wide

mandate. There are currently no voluntary standards that address this issue.

Adoption of standards will continue to be important to the work of the National Archives

and Records Administration. As much as possible, the agency will continue to provide time and

travel support for staff members who contribute to the work of standards organizations.
B-24

NUCLEAR REGULATORY COMMISSION (NRC)

The NRC Strategic Plan for fiscal year 1997 - fiscal year 2002 establishes a 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. The 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 arenas,

one 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 1995,” enacted March 7, 1996, NRC will encourage industry to develop

codes, standards, and guides that can be endorsed by the NRC and carried out by the industry. 

Agency-wide procedures are being developed to further promote the efficiency and effectiveness

of the NRC process for implementing Public Law 104-113 and the supporting procedures in OMB

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

Conformity Activities,” issued February 19, 1998.

During the period for this annual report, the NRC staff conducted two stakeholder meetings to

identify issues and develop options for improving its participation in the development and use of

consensus standards. The first meeting, held in July 1998, was with NRC staff (internal

stakeholders) from various NRC offices to discuss issues and options related primarily to NRC

participation on standards committees. Discussions focused on identifying options for improving

the effectiveness and efficiency of NRC staff participation in developing consensus standards. The

second meeting, held in Chicago in September 1998, was with external stakeholders to discuss

their concerns regarding NRC staff participation in the development and use of consensus

standards. This meeting included representatives from individual utilities (reactor licensees), the

Nuclear Energy Institute (NEI), standards developing organizations (SDOs) such as the American

Society of Mechanical Engineers (ASME), nuclear steam supply system (NSSS) vendors, the

Department of Energy, State governments, and the public. A transcript of this meeting was made

available at the NRC web site shortly after the meeting. Information gained from this meeting,

and other sources, will be used to formulate a program to improve NRC participation in the

development and use of consensus standards. 

The following is the NRC response to the reporting provisions of OMB Circular A-119.

1. The number of voluntary standards bodies in which there is agency participation, as well as

the number of agency employees participating

There are 145 NRC staff members who participate on 16 standards developing

organizations (SDOs). NRC staff participate on a total of 254 standards writing,

consensus, and board level committees.
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2. The number of voluntary consensus standards the agency has used since October 1, 1997,

based on the procedures set forth in Sections 11 and 12 of the Circular

None. Procedures are in place to ensure that proposed and final rulemakings request

information on the use of government-unique standards in accordance with the Circular.

The NRC endorsed 27 standards in regulatory guides, which provide one method

acceptable to the NRC staff for meeting NRC regulations, and 28 standards in NUREG

reports, which contain consolidated guidance for material licensees. These standards and

the means of endorsement are identified in the table below.

3. Identification of voluntary consensus standards that have been substituted for governmentunique standards as a result of an agency review under section 15b(7) of the Circular

No voluntary consensus standards were substituted for government-unique standards.

4. An evaluation of the effectiveness of Circular A-119 policy and recommendations for any

changes

The NRC believes that OMB Circular A-119 has been effective in providing a basis for

uniform implementation of P.L. 104-113 by Federal agencies, and that coordination by the

Interagency Committee on Standards Policy has been equally effective. We do

recommend, however, that additional guidance be provided regarding whether a report

need be provided to OMB if an agency places limitations or modifications on a voluntary

consensus standard that it uses in a regulation. Depending on the guidelines, this could

appreciably increase the number of instances in which a report would be required to be

submitted to OMB.

5. As required by P.L. 104-113, identification of all instances when the agency used

government-unique standards in lieu of voluntary consensus standards (for each instance

include agency rationale for such use, as well as the specific government-unique standard

used)

No government-unique standards were used by NRC in lieu of voluntary consensus

standards.
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STANDARDS ENDORSED BY NRC

OCTOBER 1, 1997 - SEPTEMBER 30, 1998

SD

O

Standard Dat

e 

Title

Method

of

Endorse

ment

AN

S

3.2 199

4

Administrative Controls and Quality Assurance

for the Operational Phase of Nuclear Power

Plants

R.G.

1.176

3.4 199

6

Medical Certification and Monitoring of

Personnel Requiring Operator Licenses for

Nuclear Power Plants

R.G.1.13

4

8.1 198

8

Nuclear Criticality Safety in Operations with

Fissionable Materials Outside Reactors

R.G. 3.71

8.3 199

7

Criticality Accident Alarm System

8.5 199

6

Use of Borosilicate-Glass Raschig Rings as a

Neutron Absorber in Solutions of Fissile

Material

8.6 199

5

Safety in Conducting Subcritical NeutronMultiplication Measurements In Situ

8.7 198

7

Guide for Nuclear Criticality Safety in the

Storage of Fissile Materials

8.9 199

5

Nuclear Criticality Safety Criteria for Steel-Pipe

Intersections Containing Aqueous Solutions of

Fissile Materials

8.10 198

8

Criteria for Nuclear Criticality Safety Controls

in Operations with Shielding and Confinement

8.12 199

3

Nuclear Criticality Control and Safety of

Plutonium-Uranium Fuel Mixtures Outside

Reactors

8.15 199

5

Nuclear Criticality Control of Special Actinide

Elements
SD

O

Standard Dat

e 

Title

Method

of

Endorse

ment

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AN

S

8.17 199

7

Criticality Safety Criteria for the Handling,

Storage, and Transportation of LWR Fuel

Outside Reactors

R.G. 3.71

8.19 199

6

Administrative Practices for Nuclear Criticality

Safety

8.20 199

1

Nuclear Criticality Safety Training

8.21 199

5

Use of Fixed Neutron Absorbers in Nuclear

Facilities Outside Reactors

8.22 199

7

Nuclear Criticality Safety Based on Limiting and

Controlling Moderators

8.23 199

7

Nuclear Criticality Accident Emergency

Planning and Response

HP

S

ANSI N13.1 199

3

Sampling Airborne Radioactive Materials in

Nuclear Facilities

NUREG1556

ANSI N13.4 198

3

Specification of Portable X- or Gamma

Radiation Survey Instruments

ANSI N13.5 198

9

Performance and Specifications for Direct

Reading and Indirect Reading Pocket

Dosimeters for X- and Gamma Radiation

ANSI N13.6 198

9

Practice for Occupational Radiation Exposure

Records Systems

IN

M

M

ANSI N14.5 199

7

Leakage Tests on Packages for Shipment of

Radioactive Materials

IEE

E

ANSI

N42.12

199

5

Calibration and Usage of Sodium Iodide

Detector Systems

ANSI

N42.13

198

5

Calibration and Usage of Dose Calibrator

Ionization Chambers for the Assay of

Radionuclides
SD

O

Standard Dat

e 

Title

Method

of

Endorse

ment

B-28

ANSI

N42.15

199

7

Performance Verification of Liquid Scintillation

Counting Systems

ANSI

N42.17A

198

9

Performance Specifications for Health Physics

Instrumentation–Portable Instrumentation for

Use in Normal Environmental Conditions

IEE

E

ANSI

N42.18

199

1

Specification and Performance of On-site

Instrumentation for Continuously Monitoring

Radioactive Effluents

NUREG1556

HP

S

ANSI N43.2 198

9

Radiation Safety for X-Ray Diffraction and

Fluorescense Analysis Equipment 

ANSI N43.4 198

9

Classification of Radioactive Self-Luminous

Light Sources

ANSI N43.9 199

1

Specifications for Design and Testing of

Apparatus for Gamma Radiography

ANSI

N43.10

198

4

Safe Design and Use of Panoramic, Wet Source

Storage Gamma Irradiators (Category IV)

AN

SI

ANSI N44.1 198

4

Integrity and Test Specifications for Selected

Brachytherapy Sources

ANSI N44.2 198

4

For Leak-Testing Radioactive Brachtherapy

Sources

AS

ME

ANSI

N45.2.2

197

2

Packaging, Shipping, Receiving, Storage and

Handling of Items for Nuclear Power Plants

(During the Construction Phase)

R.G.

1.176

ANSI

N45.2.11

197

4

Quality Assurance Requirements for the Design

of Nuclear Power Plants

ANSI

N45.2.12

197

7

Requirements for Auditing of Quality Assurance

Programs for Nuclear Power Plants

ANSI

N45.2.13

197

6

Quality Assurance Requirements for Control of

Procurement of Items and Services for Nuclear

Power Plants
SD

O

Standard Dat

e 

Title

Method

of

Endorse

ment

B-29

IEE

E

ANSI N322 199

7

Inspection and Test Specifications for Direct and

Indirect Reading Quartz Fiber Pocket

Dosimeters

NUREG1556

ANSI N323 198

3

Radiation Protection Instrumentation Test and

Calibration

IEE

E

ANSI

N323A

199

7

Radiation Protection Instrumentation Test and

Calibration, Portable Survey Instruments

NUREG1556;

AN

SI

ANSI N432 198

0

Radiological Safety for the Design and

Construction of Apparatus for Gamma

Radiography

ANSI

N433.1

197

7

Safe Design and Use of Self-Contained Dry

Source Storage Gamma Irradiators (Category I)

IEE

E

ANSI

N449.1

198

4

Procedures for Periodic Inspection of Cobalt-60

and Cesium-137 Teletherapy Equipment

AN

SI

ANSI N537 197

6

Radiological Safety Standard for the Design of

Radiographic and Fluoroscopic Industrial XRay Equipment

ANSI N538 197

9

Classification of Industrial Ionizing Radiation

Gauging Devices

ANSI N542 197

7

Sealed Radiation Sources, Classification

AS

ME

BPVC

Section XI

198

9

Rules for Inservice Inspection of Nuclear Power

Plant Components

R.G.

1.175

OM Code 199

5

Operation and Maintenance of Nuclear Power

Plants

Code Case

N-560

199

6

Alternative Examination Requirements for Class

1, Category B-J Piping Welds (Section XI)

R.G.

1.178

Code Case

N-577

199

7

Risk-Informed Requirements for Class 1, 2, and

3 Piping, Method A (Section XI)
SD

O

Standard Dat

e 

Title

Method

of

Endorse

ment

B-30

Code Case

N-578

199

7

Risk-Informed Requirements for Class 1, 2, and

3 Piping, Method B (Section XI)

IEE

E

450 198

7

Recommended Practice for Maintenance,

Testing, and Replacement of Large Lead Storage

Batteries for Generating Stations and

Substations

R.G. 5.44

IS

O

3999 197

7

Apparatus for Gamma Radiography--

Specification

NUREG1556

7205 198

6

Radionuclide Gauges -- Gauges Designed for

Permanent Installation

2919 198

0

Sealed Radiation Sources, Classification

1. ANSI: American National Standards Institute

ASME: American Society of Mechanical Engineers

HPS: Health Physics Society

IEEE: Institute of Electrical and Electronics Engineers

INMM: Institute of Nuclear Materials Management

ISO: International Standards Organization

2. R.G. 1.134: Regulatory Guide 1.134 (Revision 3) -- Medical Evaluation of Licensed

Personnel at Nuclear Power Plants (March 1998)

R.G. 1.175: Regulatory Guide 1.175 -- An Approach for Plant-Specific, RiskInformed Decision-Making: Inservice Testing (August 1998)

R.G. 1.176: Regulatory Guide 1.176 -- An Approach for Plant-Specific, RiskInformed Decision-Making: Graded Quality Assurance (August 1998)

R.G. 1.178: Regulatory Guide 1.178 -- An Approach for Plant-Specific, RiskInformed Decision-Making: Inservice Inspection of Piping (September 1998)

R.G. 3.71: Regulatory Guide 3.71 -- Nuclear Criticality Safety Standards for Fuels

and Materials Facilities (August 1998)
B-31

R.G. 5.44: Regulatory Guide 5.44 (Revision 3) -- Perimeter Intrusion Alarm Systems

(October 1997)

NUREG-1556: Consolidated Guidance About Materials Licenses (Program specific

guidance in nine volumes)
B-32

NATIONAL SCIENCE FOUNDATION (NSF)

1) there are three voluntary consensus standards bodies in which there is agency participation,

with four employees participating;

2) the number of voluntary consensus standards the agency has used since October 1, 1997 is

zero;

3) the number of voluntary consensus standards that have been substituted for governmentunique 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 during this reporting period.
C-1

Appendix C: 

 Charter of the Interagency Committee

on Standards Policy
C-2

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.
C-3

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 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;
C-4

(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.

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
C-5

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" 

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.
C-6

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

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

------

FY 1998
D-2

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

 Email: jmurphy@usaid.gov

Agriculture, Department 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

 Mr. Ronald Garbin

 Program, Planning & Management

Division

 Office of the Chief Information Officer

 Stop 7603 Room 447-W

 Jamie L. Whitten Federal Building

 1400 Independence Avenue, SW

 Washington, DC 20250-7603

 Phone: 202-720-8026

 Fax: 202-690-2688

Commerce, Department of Dr. Belinda L. Collins

 Director, Office of Standards Services

 National Institute of Standards and

Technology

 100 Bureau Drive STOP 2100

 Gaithersburg, MD 20899-2100

 Phone: 301-975-4000

 Fax: 301-963-2871

 Email: belinda.collins@nist.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

 Deputy Assistant Executive Director

 Room 702

 Bethesda MD 20207

 Phone: 301-504-0554 x 2254

 Fax: 301-504-0407

 Email: jelder@cpsc.gov
D-3

Defense, Department of (DOD) Mr. Gregory E. Saunders

 Director, Defense Standardization Program 

 Office

 Defense Standardization Program Office

 ATTN: DLSC-LM

 8725 John J. Kingman Road, Suite 2533

 Fort Belvoir VA 22060-6221

 Phone: 703-767-6888

 Fax: 703-767-6876

 Email: gregory_saunders@hq.dla.mil

 

Alternate: Ms. Trudie Williams

 Defense Standardization Program Office

 ATTN: DLSC-LM

 8725 John J. Kingman Road, Suite 2533

 Fort Belvoir VA 22060-6221

 Phone: 703-767-6875

 Fax: 703-767-6876

Education, Department of (DOEd) Mr. Gerald Malitz

 National Center for Education Statistics

 555 New Jersey Avenue, NW

 Washington, DC 20208

 Phone: 202-219-1364

 Fax: 202-219-1728

 Email: gerald_malitz@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: Mr. Richard J. Serbu

 Manager, DOE Technical Standards

Program (EH-31)

 19901 Germantown Road

 Germantown MD

 Phone: 301-903-2856; Fax: 301-903-6172

 Email: richard.servu@eh.doe.gov

Environmental Protection Agency (EPA) Ms. Mary McKiel

 Director, EPA Voluntary Standards

Network

 Office of Pollution Prevention & Toxics

 401 M Street, S.W., MC 7409

 Washington, DC 20460

 Phone: 202-260-3584

 Fax: 202-260-0178

 Email: mckiel.mary@epamail.epa.gov
D-4

Alternate: 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. Julius P. Knapp

 Chief, Office of Engineering and

Technology

 1919 M Street, NW

 Mail Stop Code 1300

 Washington, DC 20554

 Phone: 202-418-2468

 Fax: 202-418-1944

 Email: jknapp@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 (FC)

 Jefferson Davis Highway

 Room 710

 Arlington, VA 22202

 Phone: 703-305-7901

 Fax: 703-305-6851

 Email: william.gormley@gsa.gov

 

Alternate: Charles P. Gallagher

 Director, Environmental & Engineering 

 Policy (FCOE)

 Jefferson Davis Highway

 Room 703

 Arlington, VA 22202

Phone: 703-305-6930

 Fax: 703-305-6731

 Email: charles.gallagher@gsa.gov
D-5

Government Printing Office, U.S. (GPO) Mr. Robert H. Thomas

 Actg. Manager, Quality Control and

Technical Department

 North Capital NH Streets

 Washington, DC 20401

 Phone: 202-512-0766

 Fax: 202-512-0015

 Email: rthomas@gpo.gov

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) Mr. Xavier de Souza Briggs

 Deputy Assistant Secretary for Research, 

 Evaluation and Monitoring

 Office of Policy Development & Research

 451 7th Street, SW, Room 8146

 Washington, DC 20410

 Phone: 202-708-4230 x5716

 Fax: 202-708-3141

 Email: xavier_briggs@hud.gov

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
D-6

Interior, Department of the (DOI) Mr. Claude J. Christensen

 Chief, IRM Program Planning, Review,

 and Standards Division

 1849 C Street, NW

 Mail Stop ? 5312

 Washington, DC 20240

 Phone: 202-208-3028

 Fax: 202-501-2360

 Email: claude_christensen@ios.doi.gov

International Trade Commission (ITC) Mr. Stephen A. McLaughlin

 Acting Director, Office of Administration

 500 E Street, SW

 Room 212

 Washington, DC 20436

 Phone: 202-205-3131

 Fax: 202-205-2034

Justice, Department of (DOJ) Dr. M. Wayne Shiveley

 Information Management and Security Staff

 1001 G Street NW, Suite 850

 Washington, DC 20530

 Phone: 202-305-4107

 Fax: 202-616-5455

 Email: shivelew@usdoj.gov

 Labor, Department of (DOL) Mr. Roland G. Droitsch

 Deputy Assistant Secretary for Policy

 Room S 2312

 200 Constitution Avenue, NW

 Washington, DC 20210

 Phone: 202-219-9058

 Fax: 202-219-9216

 Email: droitsch-roland@dol.gov

National Aeronautics and Space Administration (NASA) Mr. Daniel R. Mulville

 Mail Code AE

 NASA Headquarters

 300 E Street, SW

 Washington, DC 20546-1823

 Phone: 202-358-1823

 Fax: 202-358-3296

 Email: daniel.mulville@hq.nasa.com

Alternate: Mr. Richard H. Weinstein

 Mail Code AE

 NASA Headquarters

 300 E Street, SW

 Washington DC 20546-1823

 Phone: 202-358-0538

 Fax: 202-358-3296

 Email: richard.weinstein@hq.nasa.gov
D-7

National Archives and Records Administration (NARA) Ms. Mary Ann Hadyka

 National Archives and Records

Administration

 Policy and Communication Staff

 8601 Adelphi Road 

 Suite 4100

 College Park, MD 20740-6001

 Phone: 301-713-7360 ext. 222

 Fax: 301-713-7270

 Email: maryann.hadyka@arch2.nara.gov

National Communications System (NCS) Mr. Gary Fereno

 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: ferenog@ncs.gov

National Science Foundation (NSF) Dr. William S. Butcher

 Senior Engineering Advisor

 Engineering Education and Centers

Division

 4201 Wilson Boulevard, Suite 585

 Arlington, VA 22230

 Phone: 703-306-1380

 Fax: 703-306-0289

 Email: wbutcher@nsf.gov

Nuclear Regulatory Commission (NRC) Mr. John W. Craig

 Director, Division of Regulatory

Applications

 Office of Nuclear Regulatory Research

 Mail Stop T-9-F-33

 Washington, DC 20555

 Phone: 301-415-6207

 Fax: 301-415-5385

 Email: JWC1@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

 Email: HUTH_V@A1.EOP.GOV
D-8

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) Ms. Marian Gordon

 Director for Telecommunications and 

 Information Standards

 2201 C St. NW, Room 2529

 Washington, DC 20520

 Phone: 202-647-0197

 Fax: 202-647-7407

 Email: gordonmr@ms6820wpoa.usstate.gov

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@clo.treas.gov

U. S. Trade Representative (USTR) Ms. Suzanne Troje

 Director, Technical Trade Barriers

 600 17th Street, NW

 Washington, DC 20508

 Phone: 202-395-9444

 Fax: 202-395-5674 
D-9

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 

National Institute of Standards and Technology Maureen Breitenberg

 100 Bureau Drive STOP 2100

 Gaithersburg, MD 20899-2100

 Phone: 301-975-4031

 Email: maureen.breitenberg@nist.gov

National Institute of Standards and Technology James Cigler

 100 Bureau Drive STOP 2140

 Gaithersburg, MD 20899-2140

 Phone: 301-975-4171

 Email: james.cigler@nist.gov

National Institute of Standards and Technology Patrick Cooke

 100 Bureau Drive STOP 2150

 Gaithersburg, MD 20899-2150

 Phone: 301-975-4033

 Fax: 301-926-1559

 Email: patrick.cooke@nist.gov

National Institute of Standards and Technology Christine DeVaux

 100 Bureau Drive STOP 2110

 Gaithersburg, MD 20899-2110

 Phone: 301-975-5503

 Email: christine.devaux@nist.gov

National Institute of Standards and Technology Krista Johnsen-Leuteritz

 100 Bureau Drive STOP 2100

 Gaithersburg, MD 20899-2100

 Phone: 301-975-5104

 Email: krista.leuteritz@nist.gov

National Institute of Standards and Technology JoAnne Overman

 100 Bureau Drive STOP 2150

 Gaithersburg, MD 20899-2150

 Phone: 301-975-4037

 Email: joanne.overman@nist.gov
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APPENDIX E:

LIST OF NIST PUBLICATIONS 

RELATED TO P. L. 104-113

Publications on Standards And Conformity Assessment Activities
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Office of Standards Services

National Institute of Standards and Technology

Gaithersburg, Maryland 20899

The ABC's of Standards-Related Activities in the United States (NBSIR 87-3576) - This report is

an introduction to voluntary standardization, product certification and laboratory accreditation for

readers not fully familiar with these topics. It stresses some of the more important aspects of

these fields; furnishes the reader with both historical and current information on these topics;

describes the importance and impact of the development and use of standards; and serves as

background for using available documents and services. 

The ABC'S of Certification Activities in the United States (NBSIR 88-3821) - This report, a

sequel to NBSIR 87-3576, The ABC'S of Standards-Related Activities in the United States,

provides an introduction to certification for readers not entirely familiar with this topic. It

highlights some of the more important aspects of this field, furnishes the reader with information

necessary to make informed purchases, and serves as background for using available documents

and services.

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. 

Laboratory Accreditation in the United States (NISTIR 4576) - This report, a companion to

NBSIR 87-3576 The ABC'S of Standards-Related Activities in the United States and NBSIR 88-

3821 The ABC'S of Certification Activities in the United States, is designed to provide

information on laboratory accreditation to readers who are new to this field. It discusses some of

the more significant facets of this topic, provides information necessary to make informed

decisions on the selection and use of laboratories, and serves as background for using other

available documents and services.

Questions and Answers on Quality, the ISO 9000 Standard Series, Quality System Registration,

and Related Issues (NISTIR 4721) - This report provides information on the development,

content and application of the ISO 9000 standards to readers who are unfamiliar with these

aspects of the standards. It attempts to answer some of the most commonly asked questions on

quality; quality systems; the content, application and revision of the ISO 9000 standards; quality

system approval/registration; European Community requirements for quality system approval/

registration; and sources for additional help.

More Questions and Answers on the ISO 9000 Standard Series and Related Issues (NISTIR

5122) - This report, a sequel to NISTIR 4721, provides additional information on the ISO 9000

standards and related issues to readers unfamiliar with some of the new developments in this area. 

It attempts to answer additional questions on ISO 9000 standards related issues which NIST has
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received since the publication of NISTIR 4721 and identifies sources for further help in this area. 

 

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.

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. 

 

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. 

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.

Proceedings of the Open Forum on Laboratory Accreditation at the National Institute of

Standards and Technology October 13, 1995 (NIST SP 902) - The American National Standards

Institute and ACIL requested that NIST work with them in an informal Laboratory Accreditation

working group (LAWG) to evaluate the current situation in laboratory accreditation in the United

States. This group sponsored a forum to hear reports from various sectors and to arrive at some
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consensus on the need to improve the current situation and infrastructure for laboratory

accreditation in the United States.

 

Survey on the Implementation of ISO/IEC Guide 25 by National Laboratory Accreditation

Programs (NISTIR 5473) - ISO/IEC Guide 25, General Requirements for the Competence of

Calibration and Testing Laboratories, has been used by many laboratory accreditation programs

worldwide to establish accreditation requirements designed to promote confidence in the

calibrations and testing results of laboratories. National delegations to the International

Laboratory Accreditation Conference (ILAC) were surveyed to collect information on the

implementation and supplementation of the requirements of ISO/IEC Guide 25 within the context

of their countries' laboratory accreditation programs. This report summarizes the results of that

survey and includes a bibliographic list of publications concerned with ISO/IEC Guide 25

implementation complied from the information by the national delegations.

Directory of International and Regional Organizations Conducting Standards-Related Activities

(NIST SP 767) - This directory contains information on 338 international and regional

organizations which conduct standardization, certification, laboratory accreditation, or other

standards-related activities. It describes their work in these areas, as well as the scope of each

organization, national affiliations of members, U.S. participants, restrictions on membership, and

the availability of any standards in English.

Directory of European Regional Standards-Related Organizations (NIST SP 795) - This directory

identifies more than 150 European regional organizations - both governmental and private - that

engage in standards development, certification, laboratory accreditation, and other standardsrelated activities, such as quality assurance. Entries describe the type and purpose of each

organization; acronyms; national affiliations of members; the nature of the standards-related

activity; and other related information.

Standards Activities of Organizations in the United States (NIST SP 806, 1996 Edition) - The

directory identifies and describes activities of over 700 U.S. public and private sector

organizations which develop, publish, and revise standards; participate in this process; or identify

standards and make them available through information centers or distribution channels. The

revision covers activities related to both mandatory and voluntary U.S. standards. It also contains

a subject index and related listings that cover acronyms and initials, defunct bodies and

organizations with name changes.

Directory of Federal Government Certification Programs (NBS SP 739) - This directory presents

information on U.S. Government certification programs for products and services. Entries

describe the scope and nature of each certification program, testing and inspection practices,

standards used, methods of identification and enforcement, reciprocal recognition or acceptance

of certification, and other relevant details.
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Directory of U.S. Private Sector Certification Programs (NIST SP 903) - This publication

presents information on 178 private sector groups in the United States which engage in product

certification activities. Entries describe the type and purpose of each organization, the nature of

the activity, a pictorial representation of the organization’s mark (if available), products certified,

standards used, certification requirements, any accreditation or recognition by a U.S. or foreign

private sector or government agency, availability of services, methods of cost determination, and

other relevant details.

Directory of Federal Government Laboratory Accreditation/Designation Programs

(NIST SP 808) - This directory provides updated information on 31 Federal government

laboratory accreditation and similar type programs conducted by the Federal government. These

programs, which include some type of assessment regarding laboratory capability, designate sets

of laboratories or other entities to conduct testing to assist Federal agencies in carrying out their

responsibilities. The directory also lists 13 other federal agency programs of possible interest,

including programs involving very limited laboratory assessment and programs still under

development.

Directory of State and Local Government Laboratory Accreditation/Designation Programs (NIST

SP 815) - This directory provides updated information on 21 state and 11 local government

laboratory accreditation and similar type programs. These programs, which include some type of

assessment regarding laboratory capability, designate private sector laboratories or other entities

to conduct testing to assist state and local government agencies in carrying out their

responsibilities. Entries describe the scope and nature of each program, laboratory assessment

criteria and procedures used in the program, products and fields of testing covered, program

authority, and other relevant details.

Directory of Professional/Trade Organization Laboratory Accreditation/Designation Programs

(NIST SP 831) - This directory is a guide to laboratory accreditation and similar types of

programs conducted by professional and trade organizations. These programs accredit or

designate laboratories or other entities to assist private sector professional societies, trade

associations, related certification bodies, their membership, as well as government agencies, in

carrying out their responsibilities. This accreditation or designation is based on an assessment of

the capability of the laboratory to conduct the testing. However, the nature of the assessment

varies considerably by organization and program.

ISO Environmental Management Standardization Efforts (NISTIR 5638-1) - This report

describes the development of planned "environmental management" standards by the International

Organization for Standardization (ISO). These standards address management systems and the

environmental aspects of products in the areas of life cycle assessment and labeling. The report

outlines the current status of the ISO standards and also covers developments relating to third

party certification of environmental management systems.

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,
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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.

Profiles of National Standards-Related Activities (NIST SP 912) - 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 worldwide MSTQ activities.

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 standards-related information.

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.

Environmental Management Systems Voluntary Project Evaluation Guidance (NISTIR 6120) -

The intent of this document is to provide a framework for the collection of information of value to

regulatory agencies and others interested in determining the impact in several key areas of

environmental management systems based on ISO 14001.

National Voluntary Laboratory Accreditation Program (NVLAP) Directory (SP 810, 1998

Edition) - This annual directory lists laboratories that have been found to be competent to perform

certain tests or calibrations as specified. These laboratories are allowed to use the NVLAP logo

on their test or calibration certificates or reports, which implies that the processes used to achieve

the tests or calibrations have been evaluated by NVLAP as being technically adequate when

performed under the conditions specified in the laboratories’ quality manuals and associated

documentation.