SECTION 1. PURPOSE.

This Order establishes policies and prescribes responsibilities for implementing Office of Management and Budget Circular No. A-119, "Federal Participation in the Development and Use of Voluntary Standards," within the Department of Commerce.

SECTION 2. GENERAL.

.01 Department Organization Order 30-2A delegates to the Director, National Bureau of Standards (hereinafter the "Director") the Secretary's authority to participate in the development and use of voluntary standards under Office of Management and Budget (OMB) Circular A-119, including any revisions or reissuances of that Circular, except that the function of submitting any report to OMB required by the Circular is reserved to the Secretary. This Order elaborates on that delegation of authority.

.02 OMB Circular A-119 provides policy and administrative guidance to Federal agencies on using voluntary standards for procurement and regulatory purposes, on participating with private sector organizations to develop such standards, and coordinating executive branch participation in the development of voluntary standards (see Appendix A to this Order).

.03 The Circular requires the Secretary of Commerce to:

Coordinate and foster executive branch implementation of the policy set forth in paragraph 6 of the Circular (see paragraph .04 of this Section), and provide, at the Secretary's discretion, administrative guidance to assist agencies in implementing paragraph 8.b.(5) of the Circular, which states that the heads of agencies concerned with standards will "consult with the Secretary, as necessary, in the development and issuance of, internal agency procedures and guidance implementing this Circular, and submit, in response to the request of the Secretary, summary reports on the status of agency interaction with voluntary standards bodies;:

Establish an interagency consultative mechanism to advise the Secretary and agency heads in the implementation of the policy contained in the Circular; and

Report to OMB concerning implementation of the Circular.

.04 The Circular requires the Department to:

a. Rely on voluntary standards, both domestic and international, whenever feasible and consistent with law and regulation pursuant to law;

b. Participate in voluntary standards bodies when such participation is in the public interest and is compatible with the Department's mission, authorities, priorities, and budget resources; and

c. Coordinate the Department's participation in voluntary standards bodies so that (1) the most effective use is made of the Department's resources and representatives; and (2) the views expressed by such representatives are in the public interest and, as a minimum, do not conflict with the interests and established views of the Department.

SECTION 3. POLICIES AND SCOPE.

The provisions of OMB Circular A-119 shall be implemented and followed within the Department, as interpreted or expended upon in: (1) this Order; (2) issuances by the Director, or the Director's designee, in accordance with Section 4. of this Order; or (3) other Department directives and regulations which may affect OMB Circular A-119.

SECTION 4. RESPONSIBILITIES.

.01 The Director, or the Director's designee, is hereby delegated responsibility for the implementation, monitoring, and general administration of the Secretary's and the Department's responsibilities under OMB Circular A-119. However, the responsibility for providing formal administrative guidance under paragraph 8.a.(1) of the Circular to agencies outside the Department is reserved to the Director. The functions of the Director, or the designee, shall include the following:

a. Issue guidance and procedures to the Department's operating units as may be necessary to carry out the Department's responsibilities under OMB Circular A-119, and otherwise comply with its provisions;

b. Prepare reports for the Secretary on the nature and extent of the Department's or other Federal agencies' participation in the development and utilization of voluntary standards, as required or requested by OMB or the Congress; and

c. Request summary reports on the status of interaction with voluntary standards bodies as necessary to carry out the Department's responsibilities under OMB Circular A-119. Reports will be requested, on behalf of the Secretary, from the heads of Department operating units and heads of other Federal agencies involved with standards.

.02 The heads of those Departmental operating units which engage in voluntary standards activities or are otherwise affected by the Circular shall be responsible for implementing, within their respective units, the requirements of the Circular including the requirements stated in paragraph 2.04 of this Order in a manner which is consistent with any and all interpretations or expansions referenced in Section 3. of this Order. In particular, the heads of those Departmental operating units shall:

a. Implement within their respective operating units, insofar as is applicable to agency activities, the guidelines of paragraph 7 of the Circular consistent with guidance and procedures issued under paragraph 4.01a. of this Order;

b. At the invitation of the Director, or the Director's designee, participate in interdepartmental coordination under Section 5. of this Order; and

c. Prepare reports as requested by the Director, or the Director's designee, to enable the Director or designee to comply with the requirements of paragraphs b. or c. of paragraph 4.01 of this Order, or any other reporting requirement under or relating to the Circular.

SECTION 5. DEPARTMENTAL COORDINATION.

.01 The Director shall establish a Departmental Committee on Standards Policy to advise the Director and the Secretary of Commerce through the Director on the implementation of the policy established in the Circular. The Committee will report and be responsible to the Director.

.02 The purpose of the Committee shall be to facilitate the effective participation by the Department of Commerce in domestic and international standards activities and to promote the development of uniform policies among operating units of the Department participating in these activities. The objective of the Committee shall be to promote effective and consistent standards policies of Departmental concern in furtherance of United States domestic and foreign goals and, to this end, to foster cooperative participation by the Department in standards activities, including the related activities of product testing, certification and accreditation programs.

.03 The functions, membership and operations of the Committee shall be as specified in its charter to be issued by the Director, after consulting with the Assistant Secretary for Administration and representatives of those operating units identified in paragraph 4.02 of this Order.

Signed by: Secretary of Commerce

Office of Primary Interest: Office of Product Standards Policy, NBS

Index Changes.

Add.

Department of Commerce Participation in the Development and Use of Voluntary Standards 216-14

Development and Use of Voluntary Standards, Department of Commerce Participation in the 216-14

Voluntary Standards, Department of Commerce Participation in the Development and Use of 216-14

APPENDIX A DAO 216-14

49496 Federal Register / Vol. 47, No. 211 / Monday, November 1, 1982 / Notices



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OFFICE OF MANAGEMENT AND BUDGET

Issuance of Circular No. A-119, "Federal Participation in the Development and Use of Voluntary Standards"

AGENCY: Office of Management and Budget.

ACTION: Final Issuance of OMB Circular No. A-119, "Federal Participation in the Development and Use of Voluntary Standards."



--------------------------------------------------------------------------------
SUMMARY: This OMB Circular provides policy and administrative guidance to Federal agencies on using voluntary standards for procurement and regulatory purposes, on participating with private sector organizations to develop such standards, and coordinating Executive Branch participation in the development of voluntary standards. Implementation of this Circular is expected to result in reduced costs to the Government in developing and maintaining standards for products, systems and services.
EFFECTIVE DATE: This Circular, which supersedes OMB Circular No. A-119, dated January 17, 1980, is effective upon publication.

FOR FURTHER INFORMATION CONTACT:

David F. Baker, Office of Federal Procurement Policy, Office of Management and Budget, Washington, DC 20503 (202) 395-7207.

SUPPLEMENTARY INFORMATION: On April 21, 1982, the Office of Management and Budget published a draft Circular, subject as above, for a 60-day period of public and agency comment. Comments were received from more than 120 individuals and organizations, including Federal agencies, business firms, industry associations, professional groups and private citizens.

There follows a summary of the major comments grouped by subject and a response to each-including a brief description of changes made as a result of the comments. Many other changes of a less significant character were made to increase clarity, simplicity, precision and readability, and to reduce the burdens of compliance as much as possible.

A. Procedural Criteria Imposed on Standards Developers

Comment: Several commenters objected to OMB's deletion of specific procedural criteria which the previous version of the Circular imposed on voluntary standards bodies as a precondition to Federal participation. They argued that such criteria- intended to increase public participation and openness-would help to minimize the potential for anti-trust activities. Other commenters suggested that while such procedures should not be mandatorily imposed, OMB should instruct agencies to encourage private standards developers to follow such procedures.

Response: With regard to the inclusion of procedural criteria and their mandatory imposition on standard developers, we have concluded that imposition of the mandatory procedures contained in the previous edition of the Circular is inappropriate, burdensome and costly and that the question of imposing such criteria is peripheral to the fundamental aims of the Circular. We do agree that, as with any human endeavor, the voluntary standards development process is vulnerable to abuse. Consequently, we have cautioned Federal agencies to beware of such potential (Para. 7). We have also provided guidance to agencies in the form of a letter from the Department of Justice, dated June 22, 1982, which discusses suggested agency approaches to the question of public participation in private sector standards development.

B. Regulatory Applications

Comment: Some commenters suggested that the Circular should be limited to procurement applications, and that Federal agencies should not be required to use voluntary standards for regulatory purposes. Some commenters suggested, in addition, that the Circular should not apply to "independent regulatory agencies".

Response: We believe the benefits to be derived from the procurement use of standards are equally valid for regulatory applications-particularly the benefits of assuring private sector input into Federal regulatory activities while reducing the potential for duplicating existing, adequate voluntary standards with Government standards. With regard to the second concern, the Circular does not "require" Federal agencies to use voluntary standards for regulatory purposes. It establishes a policy preference in that regard but leaves to the agencies, themselves, the decision as to whether to adopt a given voluntary standard for a specific Federal regulatory purpose. [The legal requirements associated with such adoption, such as those of the Administrative Procedures Act, will, of course, continue to apply.] We believe such an approach is entirely appropriate with respect to independent regulatory agencies as with the rest of the Executive Branch.

C. Role of the Department of Commerce

Comment: Several commenters objected to the requirements that the Department of Commerce maintain listings of (1) voluntary and Government standards, (2) voluntary standards bodies, and (3) those standards organizations with which Federal agencies interact-on the grounds that this would result in extensive and costly reporting requirements. Other commenters suggested that the agency reporting requirements contained in the Circular were , themselves, overly burdensome.

Response: We agree. The requirements to maintain various listings have been eliminated. The provisions dealing with reports on agency implementation of the Circular have been revised to require that reports be summary, as opposed to detailed, in nature.

D. Voluntary Dispute Resolution Service

Comment: Some commenters objected to our deletion of the requirement that the Department of Commerce establish a program to make available a "voluntary dispute resolution service" to handle procedural complaints brought by interested parties against voluntary standards bodies. Those commenters suggested that such a mechanism would provide an impartial means of resolving standards disputes without costly and lengthy litigation.

Response: While we take no position on the substantive merits of such a mechanism, we are satisfied that the requirement to establish such a service is not an appropriate element for inclusion in this Circular. Agencies with mission concerns in this area (e.g. Commerce, Justice, etc.) may, of course, consider establishing such a service as it is within their province to do so. The creation of the mechanism is clearly peripheral to the policy issues dealt with in the Circular, however, which are limited to Federal participation in the development and use of voluntary standards.

E. Single Federal Position

Comment: Many commenters suggested that the provisions of the Circular that required agencies to coordinate their views and express a single Federal position in private sector standards development activities where unnecessary and unworkable-and that establishment of a mechanism to achieve these purposes would be costly and lead to lengthy delays in the standards development process.

Response: We continue to believe that agencies should endeavor to coordinate their views and present single Federal positions in matters of paramount importance. We agree, however, that the requirement to do so in all such instances is unreasonable and could lead to bureaucratic delays.

Consequently, we have eliminated the requirement that Federal positions must be developed in all instances, as well as those provisions which would have required the Secretary of Commerce to appoint a "lead" agency when disagreements as to the nature of the Government's position occurred on a given issue. We continue to expect agency representatives to make a reasonable effort to present a single Federal position reflective of the public interest on matters on paramount interest in those standards activities wherein two or more agencies participate. Candice C. Bryant, Acting Deputy Assistant, Director for Administration.

Executive Office of the President

Office of Management and Budget October 26, 1982.

Memorandum to Heads of Executive Departments and Agencies From: David A Stockman

Subject: OMB Circular No. A-119, "Federal Participation in the Development and Use of Voluntary Standards:

Attached, for your implementation, is a revision to OMB Circular No. A-119 which provides guidance to agencies in working with, and using the products of, private sector standards organizations. The effect of this revision is to eliminate the costly, unnecessary, and burdensome aspects of the Circular, while continuing to encourage agency participation in the development of private sector standards.

Also attached for your information and use is a letter, dated June 22, 1982, from the Department of Justice, which provides guidance in the implementation of the Circular-particularly as it relates to working with private sector groups to develop needed standards.

Executive Office of the President

Office of Management and Budget

October 26, 1982.

Circular No. A-119-Revised

To the Heads of Executive Departments and Establishments

Subject: Federal Participation in the Development and Use of Voluntary Standards

1. Purpose. This Circular establishes policy to be followed by executive agencies in working with voluntary standards bodies. It also establishes policy to be followed by executive branch agencies in adopting and using voluntary standards.

2. Rescissions. This Circular supersedes OMB Circular No. A-119, dated January 17, 1980, which is rescinded.

3. Background. Many Governmental functions involve products or services that must meet reliable standards. Many such standards, appropriate or adaptable for the Government's purposes, are available from private voluntary standards bodies. Government participation in the standards-related activities of these voluntary bodies provides incentives and opportunities to establish standards that serve national needs, and the adoption of voluntary standards, whenever practicable and appropriate, eliminates the cost o the Government of developing its own standards. Adoption of such standards also furthers the policy of reliance upon the private sector to supply Government needs for goods and services, as enunciated in OMB Circular No. A-76.

4. Applicability. This Circular applies to all executive agency participation in voluntary standards activities, domestic and international, but not to activities carried out pursuant to treaties and international standardization agreements.

5. Definitions. As used in this Circular:

a. Executive agency (hereinafter referred to as "agency") means any executive department, independent commission, board, bureau, office, agency, Government-owned or-controlled corporation or other establishment of the Federal Government, including regulatory commission or board. It does not include the legislative or judicial branches of the Federal Government.

b. Standard means a prescribed set of rules, conditions, or requirements concerned with the definition of terms; classification of components; delineation of procedures; specification of dimensions, materials, performance, design, or operations; measurement of quality and quantity in describing materials, products, systems, services, or practices; or descriptions of fit and measurement of size.

c. Voluntary standards are established generally by private sector bodies and are available for use by any person or organization, private or governmental ,the term includes what are commonly referred to as "industry standards", as well as "consensus standards", but does not include professional standards of personal conduct, institutional codes of ethics, private standards of individual firms, or standards mandated by law, such as those contained in the United States Pharmacopeia and the National Formulary, as referenced in 21 U.S.C. 351.

d. Government standards include individual agency standards and specifications as well as Federal and Military standards and specifications.

e. Voluntary standards bodies are private sector domestic or multinational organizations-such as nonprofit organizations, industry associations, professional and technical societies, institutes, or groups, and recognized test laboratories-that plan, develop, establish, or coordinate voluntary standards.

f. Standards-developing groups are committees, boards, or any other principal subdivisions of voluntary standards bodies, established by such bodies for the purpose of developing, revising, or reviewing standards, and which are bound by the procedures of those bodies.

g. Adoption means the use of the latest edition of a voluntary standard in whole, in part, or by reference for procurement purposes and the inclusion of the latest edition of a voluntary standard in whole, in part, or by reference in regulation(s).

h. Secretary means the Secretary of Commerce or that Secretary's designee.

6. Policy. It is the policy of the Federal Government in its procurement and regulatory activities to:

a. Rely on voluntary standards, both domestic and international, whenever feasible and consistent with law and regulation pursuant to law;

b. Participation in voluntary standards bodies when such participation is in the public interest and is compatible with agencies' missions, authorities, priorities, and budget resources; and

c. Coordinate agency participation in voluntary standards bodies so that (1) the most effective use is made of agency resources and representatives; and (2) the views expressed by such representatives are in the public interest and, as a minimum, do not conflict with the interests and established views of the agencies.

7. Policy Guidelines. In implementing the policy established by this Circular, agencies should recognize the positive contribution of standards development and related activities. When properly conducted, standards development can increase productivity and efficiency in industry, expand opportunities for international trade, conserve resources, and improve health and safety. It also must be recognized, however, that these activities, if improperly conducted, can suppress free and fair competition, impede innovation and technical progress, exclude safer and less expensive products, or otherwise adversely affect trade, commerce, health, or safety. Full account shall be taken of the impact on the economy, applicable Federal laws, policies, and national objectives, including, for example, laws and regulations relating to antitrust, national security, small business, product safety, environment, technological development, and conflicts of interest. It should also be noted, however, that the provisions of this Circular are intended for internal management purposes only and are not intended to (1) create delay in the administrative process, (2) provide new grounds for judicial review, or (3) create legal rights enforceable against agencies or their officers. The following policy guidelines are provided to assist and govern implementation of the policy enunciated in paragraph 6.

a. Reliance on Voluntary Standards. (1) Voluntary standards that will serve agencies purposes and are consistent with applicable laws and regulations should be adopted and used by Federal agencies in the interests of greater economy and efficiency, unless they are specifically prohibited by law from doing so.

(2) Voluntary standards should be given performance over non-mandatory Government standards unless use of such voluntary standards would adversely affect performance or cost, reduce competition, or have other significant disadvantages. Agencies responsible for developing Government standards should review their existing standards at least every five years and cancel those for which an adequate and appropriate voluntary standard can be substituted.

(3) In adopting and using voluntary standards, preference should be given to those based on performance criteria when such criteria may reasonably be used in lieu of design, material, or construction criteria.

(4) Voluntary standards adopted by Federal agencies should be referenced, along with their dates of issuance and sources of availability, in appropriate publications, regulatory orders, and related in-house documents. Such adoption should take into account the requirements of copyright and other similar restrictions.

(5) Agencies should not be inhibited, if within their statutory authorities, from developing and using Government standards in the event that voluntary standards bodies cannot or does not develop a needed, acceptable standard in a timely fashion. Nor should the policy contained in this Circular be construed to commit any agency to the use of a voluntary standard which, after due consideration, is, in its opinion, inadequate, does not meet statutory criteria, or is otherwise inappropriate.

b. Participation in Voluntary Standards Bodies. (1) Participation by knowledgeable agency employees in the standards activities of voluntary standards bodies and standards-developing groups should be actively encouraged and promoted by agency officials when consistent with the provisions of paragraph 6b.

(2) Agency employees who, at Government expense, participate in standards activities of voluntary standards bodies and standards-developing groups should do so as specifically authorized agency representatives.

(3) Agency participation in voluntary standards bodies and standard-developing groups does not, of itself, connote agency agreement with, or endorsement of, decisions reached by such bodies and groups or of standards approved and published by voluntary standards bodies.

(4) Participation by agency representatives should be aimed at contributing to the development of voluntary standards that will eliminate the necessity for development or maintenance of separate Government standards.

(5) Agency representatives serving as members of standards-developing groups should participate actively and on a basis of equality with private sector representatives. In doing so, agency representatives should not seek to dominate such groups. Active participation is intended to include full involvement in discussions and technical debates, registering of opinions and, if selected, serving as chairpersons or in other official capacities. Agency representatives may vote, in accordance with the procedures of the voluntary standards body, at each stage of standards development, unless specifically prohibited from doing so by law or their agencies.

(6) The number of individual agency participants in a given voluntary standards activity should be kept to a minimum required for effective presentation of the various program, technical, or other concerns of Federal agencies.

(7) The providing of Agency support to a voluntary standards activity should be limited to that which is clearly in furtherance of an agency's mission and responsibility. Normally, the total amount of Federal support should be no greater than that of all private sector participants in that activity except when it is in the direct and predominant interest of the Government to develop a standard or revision thereto and its development appears unlikely in the absence of such support. The form of agency support, subject to legal and budgetary authority, may include:

(a) Direct financial support; e.g., grants, sustaining memberships, and contracts;

(b) Administrative support; e.g., travel costs, hosting of meetings, and secretarial functions;

(c) Technical support; e.g., cooperative testing for standards evaluation and participation of agency personnel in the activities of standards-developing groups; and

(d) Joint planning with voluntary standards bodies to facilitate a coordinated effort in identifying and developing needed standards.

(8) Participation by agency representatives in the policymaking process of voluntary standards bodies, in accordance with the procedures of those bodies, is encouraged-particularly in matters such as establishing priorities, developing procedures for preparing, reviewing and approving standards, and creating standards-developing groups. In order to maintain the private, nongovernmental nature of such bodies, however, agency representative should refrain from decisionmaking involvement in the internal day-to-day management of such bodies (e.g., selection of salaried officers and employees, establishment of staff salaries and administrative policies).

(9) This Circular does not provide guidance concerning the internal operating procedures that may be applicable to voluntary standards bodies because of their relationships to agencies under this Circular. Agencies should, however, carefully consider what laws or rules may apply in particular instance because of these relationships. For example, these relationships may involve the Federal Advisory Committee Act, as amended (5 U.S.C. App. 1), or a provision of an authorizing statute for a particular agency. Agencies are best able to determine what laws and policies should govern particular relationship and to assess the extent to which competition may be enhanced and cost-effectiveness increased. Questions relating to anti-trust implications of such relationships should be addressed to the Attorney General.

8. Responsibilities. a. The Secretary will:

(1) Coordinate and foster executive branch implementation of the policy in paragraph 6 of this Circular, and may provide administrative guidance to assist agencies in implementing paragraph 8.b. (5) of this Circular.

(2) Establish an interagency consultative mechanism to advise the Secretary and agency heads in implementing the policy contained herein. That mechanism shall provide for participation by all affected agencies and ensure that their views are considered; and

(3) Report to the Office of Management and Budget concerning implementation of this Circular.

b. The heads of agencies concerned with standards will:

(1) Implement the policy in paragraph 6 of this Circular in accordance with the policy guidelines in paragraph 7 within 120 days of issuance;

(2) Establish procedures to ensure that agency representatives participating in voluntary standards bodies and standards-developing groups will, to the extent possible, ascertain the views of the agency on matters of paramount interest and will, as a minimum, express views that are not inconsistent or in conflict with established agency views;

(3) Endeavor, when two or more agencies participate in a given voluntary standards body or standards-developing group, to coordinate their views on matters of paramount importance so as to present, whenever feasible, a single unified position.

(4) Cooperate with the Secretary in carrying out his responsibilities under this Circular; and

(5) Consult with the Secretary, as necessary, in the development and issuance of, internal agency procedures and guidance implementing this Circular, and submit, in response to the request of the Secretary, summary reports on the status of agency interaction with voluntary standards bodies.

9. Reporting Requirements. Three years from the date of issuance of this Circular, and each third year thereafter, the Secretary will submit to the Office of Management and Budget a brief summary report on the status of agency interaction with voluntary standards bodies. As a minimum, the report will include the following information.

a. The nature and extent of agency participation in the development and utilization of voluntary standards; and

b. An evaluation of the effectiveness of the policy promulgated in this Circular and recommendations of change.

10. Policy Review. The policy contained in this Circular shall be reviewed for effectiveness by the Office of Management and Budget three years from the date of issuance.

11. Inquiries. For information concerning this Circular, contact the Office of Management and Budget, Office of Federal Procurement Policy, telephone 202/395-7202.

David A. Stockman, Director.

Department of Justice

Antitrust Division

Office of the Assistant Attorney General June 22, 1982 Mr. Donald E. Sowle, Administrator for Federal Procurement Policy Office of Management and Budget Washington, D.C. 20503 Dear Mr. Sowle: I am writing to express the views of the Department of Justice on competition policy issues raised by the Revised OMB Circular N0. A-119, "Federal Participation in the Development and Use of Voluntary Standards" published for comment in the Federal Register on April 29, 1982 (47 Fed. Reg. 16, 919).

In our comments on previous drafts of the Circular, dated December 26, 1976 and June 13, 1978, we have supported a policy of federal adoption of privately developed standards when appropriate. Through participation in, and support for, private standards making activities, agencies may benefit greatly from private expertise and will avoid the wasteful duplication of cost and effort involved in developing their own in-house standards. The Department of Justice is not opposed to the policy announced in Revised OMB Circular A-119, which would eliminate the rigid "due process" precondition to federal participation in private standards activities. Such a precondition is overly restrictive, since as a practical matter federal agencies will often be required to adopt the standards developed regardless of federal participation in their development. Thus, in our view, the better solution is to participate in setting bodies and work within them to assure that appropriate procedures and adopted.

The Department believes that federal participants should encourage the adoption of procedures to foster access to standard setting activities and transparency in such activities. Such procedures facilitate the development of standards acceptable to the entire affected industry as well as to consumers. In particular, notice and opportunity for comment help assure that standards will be based on adequate information as to their utility and consequences. Moreover, it is especially important that performance criteria be given a prominent, perhaps predominant, place in any standards activity. Federal agency representatives, therefore, should advocate, as strongly as possible, procedures designed to assure that a broad range of information is solicited, and that performance criteria are central elements of the resulting standards.

In addition to the practical advantages of open standards proceedings, such safeguards would mitigate the substantial anticompetitive potential inherent in private standards groups. The importance of assuring adequate consideration of competition in the work of private standards bodies was noted recently by the Supreme Court in American Society of Mechanical Engineers, Inc. v. Hydrolevel Corp. The case involved a product standard which had been adopted in 46 states and all but one of the Canadian provinces. The Court observed that organizations creating such standards could be "rife with opportunities for anticompetitive activity." Federal agencies ought to strongly encourage these private groups to ensure consideration of all relevant viewpoints and interests in including those of consumers, and potential or existing industry participants.

This country's international obligations and policy, as expressed in the Standards Code negotiated during the Tokyo Round of the Multilateral Trade Negotiations, see the Agreement on Technical Barriers to Trade, codified at 19 U.S.C.A. 2531 et seq. (1980), provide another important reason for federal agency participants to encourage the adoption of open procedures for private standards groups. This Code, approved by Congress as well as by our leading trading partners, seeks to prevent the creation of product standards which discriminate against import competition. It requires central governmental bodies to provide notice and opportunity to comment in their own standards making activities, and encourages governments to take reasonable measures to ensure that non-governmental bodies provide similar protection. Where the federal government is in fact involved in the private group, the obligations of the Standards Code would appear even stronger. Open procedures, specifically adequate notice and opportunity to comment, would further the objectives of the Standards Code, and would substantially reduce the possibility that discriminatory, anticompetitive standards will be developed.

The Circular would encourage use of voluntary standards for regulatory and other purposes. Although we applaud this expansion of the scope of the Circular, we believe that broadened federal use of privately developed standards should be accompanied with broad federal awareness of the practical and competitive advantages of industry-wide access to private standards bodies. Such access is an asset to federal participation in private standards activities, but it is also of great importance when federal agencies, without participation in the process, merely adopt standards for procurement or regulatory use.

As we indicated in our previous comments, private activity is not, by virtue of governmental participation or approval, shielded from the antitrust laws. Federal agency participation in a standards body, however, may imply federal approval of the process and of the resulting standard, and perhaps lead private participants to become lax in their own antitrust scrutiny. To dispel any false impressions, federal agency representatives should inform private participants that federal participation does not remove antitrust concerns, as well as advocate that appropriate procedures be employed in the standards proceedings. Sincerely yours, Ronald G. Carr.

Acting Assistant Attorney General, Antitrust Division.

[FR Doc. 82-30017 Filed 10-29-82; 8:45 am] BILLING CODE 3110-01-M

Amendment 1

Effective Date: 1984-06-04

 

DEPARTMENT OF COMMERCE PARTICIPATION IN THE DEVELOPMENT AND USE OF VOLUNTARY STANDARDS

Department Administrative Order 216-14, dated February 23, 1983, is hereby amended as shown below. The purpose of this amendment is to incorporate Appendixes B, C, and D into the Order, and provide for their implementation.

SECTION 4. RESPONSIBILITIES. In pen and ink, at the end of subparagraph .02b. delete the word "and"; at the end of subparagraph .02c. change the period to a semicolon; and add subparagraphs d. and e. to read as follows:

"d. Implement the 'Guidelines for Participation by U.S. Government Agencies, Employees, or Representatives in International Standards-Related Activities' (see Appendix B to this Order) in operating unit programs involving standardization, certification, or laboratory accreditation activities at the international level; and

"e. Implement the 'Guidelines for Federal Agency Use of Private Sector Third-Party Certification Program' (see Appendix C to this Order) and the 'Guidelines for Federal Agency Use of Self-Certification by Producer of Supplier' (see Appendix D to this Order) in operating unit procurement programs, and in any other Departmental programs that require certification of products or services to a specific standard or specification."

Signed by: Secretary of Commerce

APPENDIX B DAO 216-14

Guidelines

for

Participation by U.S. Government Agencies,

Employees, or Representatives in International

Standards-Related Activities

Introduction

The important role that standards-related activities have played throughout the whole fabric of national and international economic activities has received increased recognition in recent years. Standards have consolidated and extended the application of technology, helped to conserve scarce resources, improved industrial efficiency, enhanced the general welfare of the public, promoted commerce, and generally improved communication and understanding among the drafters and users of standards. In particular, governments have bene giving more attention to the part played by standards as technical barriers to trade. If improperly conducted, international standards activities can suppress free and fair competition, impeded innovation and technical progress, exclude safer and less expensive products, or otherwise adversely affect domestic and international commerce.

The role and functions of U.S. Government agencies, employees, and representatives in international standards-related activities have not been clearly defined. Consequently, the interpretation of that role has varied among Federal agencies, the private sector, and foreign countries. Other factors have also promoted the need to establish uniform Federal guidelines in the international standards area, notably:

1. The increasing tendency of governments to regulate or procure by "reference to standards";

2. The growing impact of national standards upon domestic and international commerce;

3. Current international activity aimed at preventing barriers to trade that arise from differing national mandatory and voluntary standards, including heightened interest in the development of international standards and their subsequent national adoption; and

4. An expressed desire by several U.S. Government agencies for such guidelines. A recent U.S. development covering the subject of standardization gives further impetus for the development of guidelines covering Federal participation in international standardization activities:

Trade Agreements Act of 1979, Title IV - Technical Barriers to Trade (Standards), effective January 1, 1980. Section 413 of that Act deals specifically with representation of U.S. interests before international standards organizations. Regarding private international organizations, this section recognizes the role of U.S. private sector member of such organizations and grants the Secretaries of Commerce and Agriculture authority, under certain circumstances, to provide for adequate U.S. representation in those private international standards organizations through the U.S. member bodies. Regarding representation of U.S. interests by Federal agencies, Section 413 (c) encourages cooperation among Federal agencies regarding the development of uniform positions, and encourages such Federal to seek information from and to cooperate with domestic U.S. interests. Paragraph 2.3 of the international Standards Agreement itself calls upon parties (e.g., the U.S. Government) to "play a full part within the limits of their resources in the preparation by appropriate international standardizing bodies of international standards for products for which they have either adopted, or expect to adopt, technical regulations or standards." The recent and rapid expansion of international cooperation in trade and defense emphasizes the need for effective government involvement in the development of acceptable international standards (including test methods and certification) and requires that the limited U.S. Government resources contributing to such standards be expended effectively through efficient Government representation in and coordination with international standards organizations. These guidelines provide direction for strengthening such efficiency and effectiveness. Accordingly, the aim of this document is to provide guidance to U.S. Government agencies, employees, and representatives who participate in:

(a) international organizations in which the U.S. Government is the official U.S. member body (commonly called intergovernmental organizations), e.g., International Organization of Legal Metrology (OIML).

(b) international organizations in which the U.S. Government is not the official U.S. member body and where the United States is represented by a domestic private sector organization that is recognized by a private international organization as the U.S. member body, e.g., International Organization for Standardization (ISO) and International Electro-technical Commission (IEC), where the U.S. member body is the American National Standards Institute (ANSI).

Although the two types of organizations are treated separately in these guidelines, such guidelines are uniform by being applicable to both types to the maximum extent possible.

These guidelines cover not only Federal participation in international conferences and meetings, but also participation in the development of U.S. positions in preparation for these conferences and meetings.

The application of these guidelines will vary from time to time and from committee to committee according to the end-use of a standard. Much will depend on whether the international standard under development is to be considered for reference in regulations, and, if so, whether compliance with its provisions is likely to be mandatory, and whether there are relevant existing or proposed national or international requirements. These and similar considerations will influence the role of the U.S. Government representatives participating in standards-develop groups. This document is intended to help such representatives discharge their responsibilities while promoting the development of reasonable and effective international standards.

It should be noted that individual U.S. Government department may, in order to cover special interests, issue supplementary instructions to their representatives. Where possible, these instructions should be compatible with the principles contained in these guidelines.

GLOSSARY

Accredited - Official authorization to serve as a member of a delegation to an international standards-related activity.

Delegation - Representatives of a nation or member-body empowered to act at an international standards-related meeting.

Delegate - An accredited member of a delegation.

Head of Delegation - The person responsible for guiding the delegation at the international meeting and presenting the U.S. position.

Representative - An individual designated by a Federal agency as its official participant in international standard-related activities and/or development of U.S. positions thereon.

Principal Representative - The Federal representative designated to act as the primary U.S. Government spokesperson and coordinator when two or more Federal agencies participate in an international standard-related activity. The principal representative may function also as head of the delegation.

International Standards or Standards-Related Activities or Organizations. Includes standards, testing, and certification.

Lead Agency - A Federal agency which assumes responsibility for effective U.S. Federal representation in the international standards-related matter concerned.

Technical Offices

Department of Commerce
Technical Office for Implementation of Title IV of Trade Agreements Act/1979
Office of Product Standards Policy
National Bureau of Standards
U.S. Department of Commerce
Washington, D.C. 20234

Department of Agriculture
Technical Office
Trade Relations Division
International Trade Policy
Foreign Agriculture Service
South Agriculture Building
Washington, D.C. 20250

SECTION I

GUIDELINES FOR PARTICIPATION BY U.S. GOVERNMENT AGENCIES, EMPLOYEES, OR REPRESENTATIVES IN INTERNATIONAL STANDARDS-RELATED ORGANIZATIONS IN WHICH THE U.S. GOVERNMENT IS THE OFFICIAL U.S. MEMBER BODY

Subsection A. Delegation Accredited by U.S. Department of State

Scope. Subsection A applies only to international conferences, which are defined as meetings of three or more governments whose representatives are formally accredited by their governments to the sponsoring international organizations or host government. When this is the case, the U.S. delegation represents the U.S. Government as a whole. Such meetings may result in a formal commitment(s) by the U.S. Government of a policy nature. Subsection A does not apply to bilateral discussions or meeting of subsidiary international bodies which are intended to produce only recommendations to a higher authority of the organization concerned, and whose subject-matter is predominantly technical (in contrast to policy). The final arbiter as to whether or not a particular meeting meets the definition of an international conference (i.e., whether it falls under Subsection A or Subsection B) rests with the Office of International Conferences, U.S. Department of State.

Lead Agency. The U.S. Federal agency having primary responsibility or authority for the subject matter of the meeting normally is designated by the Department of State as lead agency. In cases where such primacy is not clear or is in dispute, the Department of State determines the lead agency. The lead agency should assume responsibility for U.S. preparations to the conference, assure that nominations for the delegation reach the Office of International Conferences in a timely fashion, and take responsibility for the effective representation of U.S. interests in the matter concerned.

Nomination and Accreditation of Delegation. The delegation should be proposed to the Office of International Conference (OIC), U.S. Department of State by the lead agency or by an interagency committee headed by the lead agency. That office (OIC) recognizes that particularly in standards matters and effective representation therein, experience and continuity of participation are important considerations in the composition of delegations. Each person proposed for delegation membership including the U.S. representative (head of delegation), alternate, government advisors, and private sector advisors, as appropriate, will be justified on the basis of his or her essentiality to the work of the delegation. Because the delegation will represent the United States Government as a whole and will be instructed on U.S. positions on all major points, each interested agency need not have a representative on the delegation. OIC exercises delegated Presidential authority in accrediting U.S. delegations. Final decisions on the size and make-up of delegations including the resolution of any interagency differences thereon will be made by OIC.

Development of U.S. Positions. It is the responsibility of the lead agency to insure that a position paper is drafted on each relevant agenda item and that these papers are properly coordinated and cleared. In the discretion of the lead agency, U.S. positions may also be drafted on points which do not appear on the official agenda.

Coordination Outside of Government. The lead agency should seek the advice of persons and organizations outside the U.S. Government whose interests may be materially affected by the subject-matter of the conference, especially U.S. trade interests. Such advice should be solicited in writing or through meetings prior to the development of the U.S. positions.

Intra-government coordination. It is the responsibility of the lead agency to insure that all interested government departments and agencies have the opportunity to review proposed U.S. positions and to resolve any differences which may occur prior to the international conference. It is the responsibility of the head of the delegation to all members to the delegation and, if unclassified, to any interested party. Wherever possible, reports should be unclassified. Where security classification is necessary, only that portion of the report which merits classification should be so classified and indicated as such (see Executive Order 12356). When international trade is involved, the head of the delegation should transmit a copy of the report promptly to appropriate agencies and organizations, including the Department of Commerce's Technical Office for implementation of Title IV of the Trade Agreement Act of 1979 on matters relating to non-agriculture products, and the Department of Agriculture's Technical Office for implementation of Title IV on matters concerning agricultural products. Recommended contents of the report are:

Results of meetings in terms of U.S. objectives, including issues which were discussed but which did not appear on the agenda, if any;

Matters for further U.S. action or consideration, especially significant problem areas which might affect U.S. trade;

Information on future meeting(s), if available; and

Implications, if any, for U.S. export prospects and for competition in domestic markets.
Subsection B. Delegations Not Accredited by U.S. Department of State

Scope. these guidelines apply to all participation by U.S. delegations in standards-related meetings of international organizations in which the U.S. Government is the official U.S. member body, except those in which the U.S. Department of State accredits the U.S. delegation, in which case Subsection A shall apply.

Lead Agency. The Federal agency having primary responsibility for U.S. participation in the international organization under whose auspices the meeting is to be held is responsible for assuring adequate U.S. participation at the meeting. In the case of planned meetings (e.g., topical conferences, symposia) which are not under the auspices of a single international organization, the U.S. Government agencies having interests in the subject matter should cooperate in deciding which will act as lead agency. The lead agency should inform the relevant "Technical Office" of the Department of Commerce or Agriculture, as appropriate, of standards meeting whose outcome may affect U.S. trade.

Meeting Preparations. The lead agency is responsible for coordinating the many details involved in preparing for U.S. participation in international standards-related meetings. It is incumbent on the lead agency to take all reasonable steps to: assure adequate funding of the U.S. delegation; obtain necessary clearances (travel or otherwise); and, instruct the delegation in its responsibilities and duties.
3.1 Formulation of Delegation. The lead agency is normally responsible for formation of the delegation and for the specific assignments of work to the delegation. In carrying out these responsibilities the following points should be taken into consideration:

3.1.1 Size of Delegation. The lead agency should use sufficiently selective criteria to ensure that the size of the delegation is justifiable in terms of the importance of the meeting of U.S. national interests.

3.1.2 Balanced Representation. The composition of the delegation requires careful consideration and planning. In selecting the delegation, the lead agency should take into consideration: the nature and purpose of the meeting; the possible impact of the meeting's results; the use of qualified women and minorities; and, the interests of all parties that may be substantially affected within the United States. In those cases where the meeting may result in technical requirements or standards which may measurably affect trade, or which may be adopted as law or regulation within the United States, it is particularly important to seek representation on the delegation from the affected community (e.g., industry, other Federal agencies, State and local governments, labor, universities, consuming public). The lead agency may find that, while there is interest in participation in the delegation by such groups, they may lack the necessary funds to do so (particularly to pay for international travel). In such cases a balanced U.S. viewpoint can often still be achieved by having al interested parties participate in preparatory meetings held to review, comment on, and agree on positions to be taken by the delegation during the international meeting.

3.1.3 Head of Delegation. In making its selection the lead agency should appoint as head of delegation an able negotiator who is: experienced in the subject matter of the meeting; familiar with the policies and procedures of the international organization sponsoring the meeting; and capable of maintaining harmony within the delegation.

3.1.4 Accreditation of Delegation. Once the composition of the U.S. delegation had been decided, the lead agency is responsible for satisfying any requirements imposed by the relevant international organization as regards accrediting or advanced notice of delegations. Generally, sponsors of international intergovernmental meetings request advance notification of participation. Every effort should be made by the lead agency to respect such requests in a timely fashion. Often, a simple letter of appointment to each delegate serves many useful purposes even when not required. For example, a letter of appointment is often useful in justifying participation in a standards meeting to higher management.

3.1.5 Continuity of Delegation. In recognizing that the effectiveness of a delegation is enhanced by the long-term continuity of participation by particular delegates, the lead agency should endeavor to provide and maintain that continuity.

3.2 Preparation of Position Papers. While it is advantageous to prepare position papers in advance of the meeting, there are many instances when advanced preparation of position papers is not practical because of the technical nature of the meeting, insufficient information as to the exact agenda to be discussed, or insufficient time. Consideration should be given to the nature, purpose, and status of the meeting in determining the need for position papers. For example, there are many meetings of a technical nature where delegates participate as experts under the rules of the organization and are free to take positions without commiting their governments to a particular course of action. Delegates to such meeting should be prepared to take positions which have been coordinated with appropriate U.S. interests, although it may not have been possible to prepare position papers concerning the points involved. Further, technical discussions, particularly in the early stages of standards development, are free-wheeling and delegations should have the latitude to freely debate technical issues. In the standardization process, there are normally a number of iterations of a draft standard as it moves through the system. Position papers may, therefore, be more appropriate in guiding the delegation in later stages of standards development when delegations are expected to vote on adoption of the standard. It is sometimes also useful to prepare position papers for items not on the official meeting agenda but which are deemed likely to arise or otherwise be relevant to U.S. interests. In any case, the lead agency and the head of delegation should determine whether position papers are appropriate. When they are, the following guidelines should be followed.

3.2.1 Unresolved Issues. The head of delegation, with assistance as appropriate from the lead agency, should be responsible for the preparation of position papers. If agreement on a U.S. position on all major issues cannot be reached, the head of delegation should elevate any unresolved issue to the lead agency for resolution, in consultation with affected interest (other agencies, private sector, etc.) where possible and practical.

3.2.2 Clearance of Position Papers. The head of delegation in cooperation with the lead agency should determine on a case-by-case basis agency assistance, the head of delegation should also be responsible for obtaining such clearances.

3.3 Coordination With Affected Interests. Ensuring that affected U.S. interests have been taken into account in the preparation for the international meeting is perhaps the most difficult and yet most important responsibility of the lead agency and head of delegation. For obvious reasons of time and resources, there must be limits to the effort of coordinating positions. Accordingly, the lead agency and head of delegation should decide what actions need to be taken. If the meeting involves the development of technical standards which may become the basis for the conduct of international trade or of law or regulation in this country or in other countries, U.S. interests which may be materially affected by these standards should be notified of the meeting and provided with relevant information and the opportunity to comment on proposed positions. This may be accomplished in any feasible manner, including the solicitation of written comments or a meeting. The lead agency and head of delegation should be particularly aware of international standards activities which may overlap or duplicate ongoing activities either in other international organizations (intergovernmental or voluntary) in which the U.S. is a member, or within U.S. standards bodies, and should wherever possible take steps to reduce the possibility of duplication of effort.

3.4 Prevention of Trade Barriers. Government agencies and employees should be mindful that a standard may, if improperly written, create an unnecessary barrier to trade. Likewise, they should also be aware that some standards may be written in such a way as to impede innovation and technological progress and should strive to provide standards that promote innovation processes and technological advances when they are in the public interest. In general, standards based on performance criteria are less likely to pose competitive concerns than design, material, or construction criteria. Accordingly, preference should be given to performance criterion whenever they reasonably may be used in lieu of design, material, or construction criterion.

3.4.1 While a standard may include a product incorporating a device or process which is patented, it is undesirable for a standard to be written in such a way as to require the use of the patented device or process in order to be in conformance with the standard. Normally this problem can be avoided by writing standards based on performance criteria rather than design, materials, or construction criteria. There may be occasions, however, where there is a great need for a particular standard to be written to specify a patented item. Most standards organizations have patent policies which require that if an item which is patented is included in a standard, the owner of a patent must declare that the patent is available for unrestricted licensing under reasonable terms and conditions. Government participants should familiarize themselves with the patent policies of the organizations in which they are participating, and discuss them with their agency counsel should there be any questions.

3.5 Technical Quality to Standards. It is particularly important that a standard under development is technically sound, within the operating scope of the organization and meets defined needs of the member nations. This may require that the Government representative consult with other Government experts or with persons in other organizations who are not directly involved with the standard under consideration. Where a standard does not meet a particular set of needs or is not technically sound in the view of the Government participant, he/she should work with the committee to make the necessary corrections. If unsuccessful, the participant should oppose the adoption of the standard and report such action to agency management.

Meeting Participation. To be effective at international standards-related meetings, a U.S. delegation has to be prepared not only for the substance of the meeting, but also for possible side issues and actions that can have a significant impact on the success of the delegation. Instructions to a delegation should include information on how to cope with unforeseen matters or with extraneous political issues that might arise during the meeting, and should stress the importance of team work and the need for the delegation to be constantly aware that their actions, in and outside of the meeting, should reflect credit upon the United States.
4.1 Responsibilities of the Delegation. Delegates shall at all times maintain the highest standards of personal and professional conduct.

4.1.1 Head of Delegation. The head of delegation is responsible for guiding the delegation and for presenting the U.S. position, taking into account the guidelines contained in 4.1.3.

4.1.2 Delegation Members. Members should assist the head of delegation wherever possible to ensure the success of U.S. participation in the meeting and should accept such responsibilities as are assigned, taking into account the guidelines contained in 4.1.3.

4.1.3 Participation Guidelines. Delegates to standards meetings represent the pubic interest of the United States. Serving the public interest requires a consideration of the viewpoints and objectives of all affected parties and the choice of alternatives which promise to yield the greatest economic and societal benefits to the United States. Participation should be guided by the following points.

4.1.3.1 Unforeseen Matters. At the discretion of the head of delegation, unforeseen matters which arise during the meeting should be addressed by the delegation. If the delegation cannot agree on a position on-the-spot, the head of delegation should either seek time to obtain instructions from the lead agency, or abstain from expressing a U.S. point of view.

4.1.3.2 Unauthorized Personnel. Only persons names as members of the delegation should participate in the work of the delegation. There may be instances when qualified American citizens are at the site of the meeting, and the head of delegation may wish to consult them on technical matters. Such consultation is permissible, but the persons may not be accredited or speak as members of the U.S. delegation without expressed prior authority from the lead agency.

4.1.3.3 Press/Media Relations . The head of delegation is responsible for any press, media, or public statements of the delegation. Except as specifically instructed to the contrary, the head of delegation is under no obligation to make any public statements regarding the meeting or on actions or positions taken by the delegation during the meeting. Public statements to the press/media should be made only after careful deliberation, keeping the general interests of the United States in mind. Where possible, the head of delegation may wish to consult with Embassy, Consulate, or appropriate Mission officials before making public statements.

4.1.3.4 Meetings in the United States. Arrangements for hosting an international meeting in the United States are likely to require a very long lead time and may involve considerable expense. The head of delegation should neither invite a meeting of any kind to the United States nor imply that the United States would be willing to host a specific meeting without prior approval as appropriate.

4.1.3.5 Extraneous Political Issues. It is the policy of the United States Government that at standards-related meetings or at conferences of a technical, professional, scientific, or other specialized nature, it is inappropriate to inject extraneous political subjects. Accordingly, the U.S. delegation may not initiate political discussions and should oppose on a point of order the injection of political matters into the meeting by other delegations.

4.1.3.6 Commitments of U.S. Participation in International Activities. At the meeting, careful consideration should be given to any possible commitments that may entail significant expenditures of U.S. resources. This applies in particular to: participation of U.S. persons on committees, working groups, etc., other than for the duration of the meeting; undertaking Secretariat duties or committee chairmanships; and, hosting of meetings in the United States. The U.S. delegation should make tentative commitments only when necessary. In such cases, care should be taken to ensure that the commitments being made are clearly understood as tentative pending official confirmation.

4.1.3.7 Expression of Personal Opinion. Delegates should refrain from publicly or privately expressing opinions on U.S. policies or programs not germane to the meeting. When personal opinions, germane to the meeting are expressed, they should be clearly identified as personal and unofficial.

4.1.3.8 Presentation of U.S. Positions. As stated in 4.1.1, the head of delegation is responsible for presenting the U.S. position during the meeting. During the meeting, members of the U.S. delegation should not speak on behalf of the delegation without the approval of the head of delegation.

4.2 Voting Guidelines. During certain international standards meetings, entire standards are approved by ballot and the U.S. delegation will be expected to vote on adoption of a standard(s). The procedures of international standards bodies generally require approval of draft international standards at a number of successive levels (e.g., at the subcommittee, committee, and final or plenary level) before final adoption. The following guidelines for establishing U.S. positions on approval of draft standards are intended as a step towards a unified Federal Government approach to the development and use of international standards.

4.2.1 Voting "Yes" to Approve Draft Standards. Subject to the guidelines concerning trade barriers in section 3.4, consider voting "Yes" to approve an entire draft standard under any one of the following circumstances:

a.) If there is a U.S. national standard (a standard generally accepted within the U.S.), or a relevant regulation, or Federal agency policy which can be considered to be equivalent to the international document under consideration.

b.) If any conflict between the international document and U.S. practice (standard, regulation or policy) is such that the U.S. practice could be modified to conform without losing equivalence. In such cases the affirmative vote should be accompanied by a statement that, "the U.S. affirmative vote recognizes the following minor technical additions, or changes, which may be included in the national standard, regulation or policy."

c.) If no relevant U.S. standard, regulation or policy exists and the international document is technically acceptable and could be used to develop national standards.

4.2.2 Voting "No" to Disapprove Draft Standards. Consider voting "No" to not approve an entire draft standard under anyone of the following circumstances:

a.) If the international document is considered to be not equivalent to or in clear conflict with a U.S. national standard, regulation or Federal agency policy.

b.) The international document is not technically acceptable.

c.) If a U.S. standard, regulation or policy exists which differs from the international document only because the national practice (standard, regulation or policy) includes additional or more stringent requirements. In such a scale, the U.S. vote should be accompanied by comments pointing out that additional requirements must be met to satisfy the national practice.

d.) The international document unnecessarily creates a barrier to domestic or international trade, or impedes innovation or technological progress.

Reasons must be given for a negative vote. The U.S. vote must, therefore, be accompanied by reasons for the negative vote, such as exceptions and/or additions that will be required to conform with our safety practices or regulations.

4.2.3 Voting to "Abstain" on Draft Standards. Consider "Abstaining" on an entire draft standard under any one of the following circumstances:

a.) If the international document is considered to be of little interest to the U.S.

b.) If no U.S. standard, regulation or Federal agency policy exists and there is no intent to develop such.

c.) If no consensus position can be established on the international document.

4.2.4 Exceptions. Exceptions to the above stated voting guidelines should be carefully considered and based on a consensus.

5. Post Meeting Responsibilities. The delegation should prepare a written report to provide basic information with which to evaluate the results of the meeting and to plan for future meetings.

5.1 Report of the Delegation. The head of delegation should be responsible for preparing a report on the meeting within thirty (30) days of the close of meeting. As a minimum, the report should provide the following information:

a.) Title of the meeting, site, and inclusive dates.

b.) Meeting agenda as finally adopted.

c.) List of participants.

d.) Summary of the work of the meeting including titles of draft standards discussed, major issues presented (technical, procedural, or administrative), actions approved, and major positions taken by the delegation.

e.) Conclusions of the delegation as regards the work and accomplishments of the meeting from the point of view of U.S. interests (e.g., U.S. positions versus decisions of the meeting as a whole).

f.) Recommendations of the delegation as regards the nature and scope of the U.S. participation in future meetings and follow-up actions needed to ameliorate significant problems, particularly those concerning the possible negative impact of any standards requirements on existing or future U.S. trade.

5.2 Distribution of Report. As a minimum the report should be distributed to the lead agency and to each delegate. When problems of a trade nature have been identified or when the delegation has voted not to approve an entire draft standard based on the voting guidelines in section 4.2, the report should be sent to the appropriate Technical Office within the Department of Commerce or Department of Agriculture. Circulation of the report should also be made to any U.S. interests that were consulted in the development of positions and, particularly, to U.S. voluntary standards bodies involved in activities related to the subjects covered in the meeting.

SECTION II

GUIDELINES FOR PARTICIPATION BY U.S. GOVERNMENT AGENCIES, EMPLOYEES, OR REPRESENTATIVES IN INTERNATIONAL STANDARDS-RELATED ORGANIZATIONS IN WHICH THE U.S. GOVERNMENT IS NOT THE OFFICIAL U.S. MEMBER-BODY

1. Scope. These guidelines apply to participation by U.S. Government agencies, employees, or representatives in international standards activities in which the U.S. government is not the official U.S. member-body, such as in the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). The guidelines supplement OMB Circular No. A-119, "Federal Participation in the Development and Use of Voluntary Standards," which establishes policy to be followed by executive branch agencies in working with voluntary standards organizations.

2. Authorization. In accordance with OMB Circular A-119, agencies and their employees are encouraged to participate in the activities of international standards bodies and standards-developing groups when such participation is in the public interest and is compatible with agencies' missions, authorities, priorities, and budget limitations.

3. Role. U.S. Government agencies and their employees should assist the U.S. member-body in ensuring effective participation and representation of U.S. interests in international standards bodies and standards-developing groups. Such assistance generally falls into one or more of the following types of international standards-related activities.

3.1 Secretariat of an International Standards Activity. A U.S. Government agency may be designated by the U.S. member-body to function as secretariat of an international standards committee, subcommittee, working group or task force.

3.2 Administrator/Participant in an Advisory Group. A U.S. Government agency may be requested by the U.S. member-body to function as administrator of an advisory group responsible for coordinating U.S. participation in an international standards activity. Such an advisory group is normally constituted to bring together all interested parties (public and private) in an international standards activity for the purpose of guiding U.S. participation in that activity. Similarly, agencies or their employees may be asked by the U.S. member-body, or designated advisory group administrator, to participate as a member or officer of the advisory group.

3.3 Delegate to an International Standards Meeting. U.S. Government employees may be invited by the U.S. member-body, or designated advisory group administrator, to participate as a member or head of delegation assembled to represent the member-body during an international standards committee meeting.

4. Participation Principles. Participation in international standards activities shall be at all times consistent with the highest standards of personal and professional ethics.

4.1 Decision to Participate. Effective participation in international standards activities outlined in sections 3.1. to 3.3 requires much more effort than merely attending meetings. Before accepting responsibility as secretariat or advisory group administrator of an international standards activity, agencies should thoroughly explore the resource implications and match to mission of such activity and make sure that the work can be undertaken and completed in an effective and timely manner. Likewise, agency employees serving as participants in international standards activities should devote adequate time and effort in preparing for meetings and other related activities to assure the development of meaningful and technically sound standards. The participant should inform his/her supervisor of the estimated time to be devoted to these activities and reach an understanding as to the extent and cost of participation, governed by individual workload and other official commitments.

4.2 Adherence to Policies and Procedures of Member Body. In all of the activities listed in 3.1 and 3.3, agencies and their employees are responsible for adhering to the guidelines and working procedures of both the parent international standards body and the respective U.S. member-body through which their participation is channeled.

4.3 Representing the Public Interest. Agencies and employees involved in international standards activities should represent the public interest of the United States in the broadest sense. The public interest involves the interest of those parties who are substantially affected by the standards under consideration and includes manufactures and producers, industrial users, distributors and retailers, government agencies, individual consumers, and the public at large. In serving the public interest, one promotes the general or national welfare rather than the self-interest of private individuals or organizations.

4.4 Consideration of Balanced Representation. Agencies responsible for administering international standards committee secretariats or advisory groups which develop U.S. input to international standards committees should seek a balance of viewpoints. In those cases where an international standard may measurably affect trade, or which may be proposed for adoption as law or regulation within the United States, it is particularly important to seek representation from the affected community (e.g., industry, other agencies, State and local governments, labor, universities, consuming public). Similarly, agency employees who participate on U.S. advisory groups, or as members of U.S. delegations preparing positions on proposed international standards, should offer to assist the responsible parties in assuring that balanced representation has been considered and sought.

4.5 Coordination of Government Viewpoint. There are occasions when Government participants from different agencies are members of the same standards advisory group or serve together as members of a U.S. delegation to an international standards meeting. Generally, their presence is recognition of professional expertise and competence in a particular subject area and/or recognition of differing roles played by their agencies in the subject area. Such participants may even represent different disciplines (chemist versus economist). In such instances it is entirely possible for views to be expressed which are different and which reflect the differing role of the agencies involved. When this occurs, the participants should try to resolve substantive differences, particularly if they have a bearing on existing law or regulation. If the differences are serious and cannot be resolved by the involved participants, they should be brought to the attention of higher management within the involved agencies.

4.6 Prevention of Trade Barriers. The Government participant should be mindful that a standard may, if improperly written, create an unnecessary barrier to trade. Likewise, the participant should also be aware that some standards may be written in such a way as to impede innovation and technological progress and should strive to provide standards that do not unnecessarily hinder innovative processes and technological advances when they are in the public interest. In general, standards based on performance criteria are less likely to pose competitive concerns than design, material, or construction criteria. Accordingly, preference should be given to performance criterion whenever they reasonably may be used in lieu of design, material, or construction criterion.

4.7 Technical Quality of Standards. It is particularly important that a standard under development is technically sound, within the operating scope of the organization and meets defined needs of the member nations. This may require that the Government representative consult with other Government experts or with persons in other organizations who are not directly involved with the standard under consideration. Where a standard does not meet a particular set of needs or is not technically sound in the view of the Government participant, he/she should work with the committee to make the necessary corrections. If unsuccessful, the participant should oppose the adoption of the standard and report such action to agency management.

4.8 Voting, When Authorized. In accordance with OMB Circular A-119, Government participants may vote at each stage of standards development unless specifically prohibited from doing so by the head of the agency or that official's designee. The procedures of international standards bodies generally require approval of draft international standards at a number of successive levels (e.g., at the subcommittee, committee, and final or plenary level) before final adoption. The following voting guidelines relate to agency participation in technical advisory groups to international standards committees or in U.S. delegations to international standards committee meetings. The guidelines recognize the policy that U.S. positions relative to international standards activities are developed through a consensus of the participants.

4.8.1 Voting "Yes ' to Approve Draft Standards. Subject to the guidelines concerning trade barriers in section 4.6, consider voting "Yes" to approve an entire draft standard under any one of the following circumstances:

a.) If there is a U.S. national standard (a standard generally accepted within the U.S.), or a relevant regulation, or Federal agency policy which can be considered to be equivalent to the international document under consideration.

b.) If any conflict between the international document and U.S. practice (standard, regulation or policy) is such that the U.S. practice could be modified to conform without losing equivalence. In such cases the affirmative vote should be accompanied by a statement that, "the U.S. affirmative vote recognizes the following minor technical additions, or changes, which may be included in the national standard, regulation or policy.

c.) If no relevant U.S. standard, regulation or policy exists and the international document is technically acceptable and could be used to develop national standards.

4.8.2 Voting "No" to Disapprove Draft Standards. Consider voting "No" to not approve an entire draft standard under any one of the following circumstances:

a.) If the international document is considered to be not equivalent to or in clear conflict with a U.S. national standard, regulation or Federal agency policy.

b.) The international document is not technically acceptable.

c.) If a U.S. standard, regulation or policy exists which differs from the international document only because the national practice (standard, regulation or policy) includes additional or more stringent requirements. In such a case, the U.S. vote should be accompanied by comments pointing out that additional requirements must be met to satisfy the national practice.

d.) The international document unnecessarily creates a barrier to domestic or international trade, or impedes innovation or technological progress.

Reasons must be given for a negative vote. The U.S. vote must, therefore, be accompanied by reasons for the negative vote, such as exceptions and/or additions that will be required to conform with our safety practices or regulations.

4.8.3 Voting to "Abstain" on Draft Standards. Consider "Abstaining" on an entire draft standard under any one of the following circumstances:

a.) If the international document is considered to be of little interest to the U.S.

b.) If no U.S. standard, regulation or Federal agency policy exists and there is no intent to develop such.

c.) If no consensus position can be established on the international document.

4.8.4 Exceptions. Exceptions to the above stated voting guidelines should be carefully considered and based on a consensus.

4.8.5 Registering a Dissenting Viewpoint. Government participants may be confronted with the situation where they consider a proposed U.S. vote as being in conflict with the public interest, the interests of the Federal Government, and/or their own professional judgment. Should such a conflict exist, participants should attempt to resolve them within the framework of the advisory group or delegation on which they serve. If unsuccessful, participants should make their position clear in writing to the U.S. member-body for the particular standards organization in question and inform their agency of the perceived conflict.

4.9 Patents. While a standard may include a product incorporating a device or process which is patented, it is undesirable for a standard to be written in such a way as to require the use of the patented device or process in order to be in conformance with the standard. Normally this problem can be avoided by writing standards based on performance criteria rather than design, materials, or construction criteria. There may be occasions, however, where there is a great need for a particular standard to be written to specify a patented item. Most standards organizations have patent policies which require that if an item which is patented is available for unrestricted licensing under reasonable terms and conditions. Government participants should familiarize themselves with the patent policies of the organizations in which they are participating, and discuss them with their agency counsel should there be any questions.

5. Reports. Government participants who serve as members of U.S. delegations to international standards meetings should prepare a written report on their participation within thirty (30) days after the close of the meeting. Distribution of the report depends upon agency procedures covering such matters. As a minimum, the report should cover important actions and decisions taken during the meeting. Where problems are encountered, particularly as regards a U.S. vote on a standard, participants should consider sending a copy of their report to the appropriate Technical Office identified on page 3.

APPENDIX C DAO 216-14

Guidelines for Federal Agency Use of Private Sector Third-Party Certification Programs

O. Introduction

When purchasers receive a product or service, they may seek assurance that it conforms to a specified standard or specification. The process by which such assurance is provided is referred to as certification. These procedures are intended to provide guidelines for Federal agency acceptance and use of private sector third-party certification. Agencies should be aware of the competitive implications inherent in relying upon third parties and should be sure that programs used do not raise anti-trust concerns or otherwise adversely affect trade. The development of these procedures is based on ANSI Z34.1-1982, "for certification -- third-party certification program" and ISO/IEC Guide 28, "General rules for a model third-party certification system for products."1/

1. Purpose

1.1 This document sets forth procedures for third party certification under which a producer or supplier is authorized by a third party to use the program mark of conformity (certification mark) or a certificate of conformity to indicate that a product or service is in conformity with specific standards or specifications.

1.2 It is intended that these procedures be used when claiming conformance to Federal Government guidelines for third-party certification.

1.3 When conformance to these procedures is claimed, it shall pertain to all provisions of these procedures unless exceptions or alternatives are specifically authorized by the accepting authority.

2. Standard

2.1 The certification program shall be based on the entire contents of a standard unless full disclosure of limitations is made. 2/

2.2 This document is directed towards conformity with publicly available standards and technical specifications with a broad level of recognized acceptance, selected from among the following:

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1/ Documents referred to here and subsequently of the American National Standards Institute (ANSI), the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) are available for purchase from ANSI at 1430 Broadway, New York, New York 10018. The documents are available for reference at the National Center for Standards and Certification Information of the National Bureau of Standards located in Gaithersburg, Maryland.

2/ Guidance for the determination of the suitability of a standard for certification purposes is given in ISO/IEC Guide 7, "Requirements for standards suitable for product certification."

(a) American National Standards.

(b) A standard or specification of a qualified technical society, trade association, agency, society or other organization of national or international scope and recognition.

(c) A Federal, state, or local government standard or specification.

3. Definitions

3.1 Certification: the procedure by which written assurance is given that a product or service conforms to a standard or technical specification.

3.2 Third-Party Certification: a form of certification in which the producer's or suppliers's claim of conformity is validated, as part of a third-party program, by a technically competent body other than one controlled by the producer, supplier, or buyer.

3.3 Producer or Supplier: The manufacturer, distributor, or other party providing the product or service who is responsible for assuring conformance to all requirements of the standard or specification.

3.4 Third-Party Certification Program: an organized system under which similar products or services of any numbers of producers or suppliers may be certified as conforming to specified standards on a uniform and equitable basis, which is operated by or uses a validating laboratory that is independent of the producer or supplier, and which authorizes the use of controlled certification marks as evidence of conformity.

3.5 Certification Mark: the sign or symbol, owned and controlled by the certification body, which is used exclusively by the third-party certification program to identify products or services as being certified and is registered as a certification mark with the U.S. Patent Office under the Trade Mark Act of 1946.

3.6 Certification Body: an impartial body possessing the necessary competence and reliability to sponsor and operate a certification program.

3.7 Third-Party Testing/Inspection Body: an organization possessing the necessary technical competence which is other than one operated or controlled by and is independent of, the manufacturer, supplier or buyer of the certified product in that it has no organizational, financial or commercial involvement with the supplier (manufacturer or vendor) as to pose a potential conflict of interest situation.

3.8 Other terms as noted in ISO Guide 2:1980; "General terms and their definitions concerning standardization and certification," published by the International Organization for Standardization, and its addendum 1:1981.

4. Certification Body

4.1 The certification body whose name is identified with the program shall be from among the following organizations:

(a) A trade association.

(b) A professional or technical society.

(c) An organization of producers or service-rendering entities.

(d) A consumer-oriented organization.

(e) A third-party testing/inspection organization.

4.2 The certification body shall meet the general requirements of ISO/IEC Guide 40 for the acceptance of certification bodies. The body shall be responsible for and qualified to sponsor and operate a program to ensure uniform compliance with the provisions contained herein for the use of a mark of conformity.

4.3 The procedures under which the body operates shall be administered in a non-discriminatory manner. The body shall make participation in the certification program available to any applicant, and shall not require membership status for participation.

4.4 It shall be the responsibility of the certification body to:

(a) Organize and make available full operating details and procedures. Application procedure shall be included with provision for identifying standards applicable, products covered, and their place of origin. Procedures shall also be specified for determination of conformity and issuance of authorization to use the mark of conformity, conditions identified for the appropriateness of its subsequent extension, and terms detailed for its suspension and subsequent restoration.

(b) Designate the standards that shall serve as the basis of the certification program and to notify participants of the effective date of scheduled modifications thereto.

(c) Provide a system of validation (See 7. below) to determine that products or services bearing the mark of conformity (certification mark) conform to the applicable standard or specification and other requirements of the program. The certification body may conduct its own validation activities or oversee these activities carried out on its behalf by other bodies.

(d) Effect the provisions of due process, providing an appeals mechanism for resolving disputes regarding the program.

(e) Maintain adequate communication with all participating parties to assure relevancy, acceptability, and continuity of the program.

(f) Make available general information on procedures and operations and a program directory which includes a list of participants, the products and/or services authorized to bear the mark of conformity, a description of the mark of conformity, the identification of the referenced standard or specification, and the identification of the certification body and any other parties to the program in a form that discloses their relationship to the producer or supplier.

(g) Maintain the confidentiality of proprietary information, access to which results from contacts with participating producers or suppliers.

(h) Provide for the operation of the program on a continuing basis. The certification body may itself administer the program's activities or may oversee their administration carried out on its behalf by another body meeting all the requirements for acceptance as a certification body.

(i) Safeguard proper use of the mark of conformity. Procedures shall be established and used to detect incorrect citations of authorization or misleading use of the mark of conformity and, when warranted, corrective action taken. The basis for cancellation of authorization and procedures for its withdrawal shall be established for participating producers or suppliers. There shall be incorporated a means to provide timely notification to the user community of cancellations and unauthorized use.

(j) Implement a uniform, legally binding agreement (contract) between the certification body and the program participants to provide for proper use and control of the mark of conformity and other key operational elements of the certification program.

5. Quality Assurance

5.1 The producer shall establish, maintain, and use a system which will assure compliance with the requirements of the referenced standard(s) or specification(s). The system shall include the methods, procedures, controls, records, and maintenance of the system to provide continuing assurance of compliance with the referenced standard(s) or specification(s). The extent of this system will be dependent on the characteristics of the product(s) or service(s) and the requirements of the standard(s) or specification(s).

5.2 The producer shall conduct or contract for all necessary inspection and testing. Sampling and the frequency of sampling shall be according to accepted quality control practice. Testing shall be performed by a competent laboratory, properly equipped and having trained personnel.

5.3 The producer shall inform the certification body of any intended modification in the product, manufacturing process, or quality assurance system which may affect conformance to standards or specifications covered by the applicable authorization.

5.4 Where the assurance of conformity is provided by a supplier who is not the producer, the supplier shall account for these actions by the producer.

5.5 The system shall be documented by the producer or supplier to permit review and evaluation by the certification body. The documentation shall include a record of all complaints received relative to claims of conformity as well as their resolution.

6. Methods of Indicating Conformity

6.1 The program mark of conformity (certification mark) or, when permitted, a certificate of conformity issued under the authority of the certification body, shall be used to indicate to the recipient of the product or service that it has been found to conform with all requirements for third-party certification.

6.2 The mark of conformity (certification mark), when practicable, shall be in the form of a non-transferable label or mark on the product; otherwise on the package or container. Certificates of conformity, as in the case of services and other permissible situations, shall be included with other appropriate documents. The information appearing with the mark or on the certificate of conformity shall identify:

(a) The producer or supplier of the product or service.

(b) The product or service: name, type or model number and supplementary information providing product traceability.

(c) The applicable standard(s) or specification(s).

(d) The certification body (and the validating organization if different) in a form which discloses any organizational relationship to the producer or supplier. Where the name of an association or organization describes the relationship between the association or organization and the program participants, such name fulfills this requirement.

(e) In the case of certificates of conformity, the following additions:

(1) lot, batch or other identifying source of the product or service covered by the certificate. (2) date of issue of the certificate.

(3) signature and title of the authorized officer or other evidence of company authorization.

6.3 Use of and conformance with these procedures shall in no way authorize, imply or require the use of any mark or certificate of conformity except as authorized by the certification body.

6.4 The certification mark authorized and used shall be owned and controlled by the certification body and shall be registered as a certification mark under the Trade Mark Act of 1964.

6.5 As permitted by the certification body, the certification mark may be used in advertising, publicity, or public promotions.

6.6 The use of marks or certificates of conformity and other public declarations shall be unambiguous and provide no basis for misinterpretation:

(a) It shall be clear what products are covered.

(b) It shall be clear what characteristics are covered by the certification or declaration.

(c) It shall be clearly distinguished from any other claims, marking, or labeling not related to the authorized use of the mark or certificate of conformity.

7. Validation

7.1 The certification program shall provide for a system of both initial and continuing validation to determine that products or services conform with the standard or specification and other program requirements. The certification body shall prescribe detailed requirements for the system and be responsible for its operation by performing required inspection, surveillance, and testing itself or overseeing these activities carried out on its behalf by other bodies.

7.2 Those conducting the specified activities shall meet the general requirements of ISO/IEC Guides 38 and 39 for the acceptance of testing bodies and inspection bodies. The testing/inspection body shall be an independent organization with no organizational, managerial or financial affiliation with producers, suppliers, or buyers of the products or services covered by the certification program.

7.3 The process of validating shall consist of the following actions on the part of those responsible for its conduct:

(a) Determination that the producer or vendor has the necessary facilities, test equ