CIRCULAR NO. A-119 Revised
February 10, 1998
MEMORANDUM FOR HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES
SUBJECT: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities
Revised OMB CircularA-119 establishes policies on Federal use and development of voluntary consensus standards and on conformity assessment activities. Pub. L. 104-113, the "National Technology Transfer and Advancement Act of 1995," codified existing policies in A-119, established reporting requirements, and authorized the National Institute of Standards and Technology to coordinate conformity assessment activities of the agencies. OMB is issuing this revision of the Circular in order to make the terminology of the Circular consistent with the National Technology Transfer and Advancement Act of 1995, to issue guidance to the agencies on making their reports to OMB, to direct the Secretary of Commerce to issue policy guidance for conformity assessment, and to make changes for clarity.
Franklin D. Raines
Director
Circular No. A-119
Revised
(Accompanying Federal Register Materials - 2/10/98)
TO THE HEADS OF EXECUTIVE DEPARTMENTS AND ESTABLISHMENTS
SUBJECT: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities
TABLE OF CONTENTS
BACKGROUND
1. What Is The Purpose Of This Circular?2. What Are The Goals Of The Government Using Voluntary Consensus Standards?
DEFINITIONS OF STANDARDS
3.
What Is A Standard?
4. What Are Voluntary, Consensus Standards?
-
a. Definition
of voluntary, consensus standard.
-
(1) Definition
of voluntary, consensus standards body.
-
(1) Non-consensus
standards, industry standards, company standards, or de facto
standards.
(2) Government-unique standards.
(3) Standards mandated by law.
POLICY
5.
Who Does This Policy Apply To?
6. What Is The Policy For Federal Use Of Standards?
(2) Definition of "Impractical."
c. How does this policy affect my agency's regulatory authorities and responsibilities?
d. How does this policy affect my agency's procurement authority?
e. What are the goals of agency use of voluntary consensus standards?
f. What considerations should my agency make when it is considering using a standard?
g. Does this policy establish a preference between consensus and non-consensus standards that are developed in the private sector?
h. Does this policy establish a preference between domestic and international voluntary consensus standards?
i. Should my agency give preference to performance standards?
j. How should my agency reference voluntary consensus standards?
k. What if no voluntary consensus standard exists?
l. How may my agency identify voluntary consensus standards?
7.
What Is The Policy For Federal Participation In Voluntary Consensus
Standards Bodies?
b. What are the general principles that apply to agency support?
c. What forms of support may my agency provide?
d. Must agency participants be authorized?
e. Does agency participation indicate endorsement of any decisions reached by voluntary consensus standards bodies?
f. Do agency representatives participate equally with other members?
g. Are there any limitations on participation by agency representatives?
h. Are there any limits on the number of federal participants in voluntary consensus standards bodies?
i. Is there anything else agency representatives should know?
j. What if a voluntary consensus standards body is likely to develop an acceptable, needed standard in a timely fashion?
MANAGEMENT AND REPORTING OF STANDARDS USE
9.
What Is My Agency Required To Report?
10. How Does My Agency Manage And Report On Its Development
and Use Of Standards?
11. What Are The Procedures For Reporting My Agency's
Use Of Standards In Regulations?
12. What Are The Procedures For Reporting My Agency's
Use Of Standards In Procurements?
b. How does my agency report the use of standards in procurements on a transaction basis?
AGENCY RESPONSIBILITIES
13.
What Are The Responsibilities Of The Secretary Of Commerce?
14. What Are The Responsibilities Of The Heads Of
Agencies?
15. What Are The Responsibilities Of Agency Standards
Executives?
SUPPLEMENTARY INFORMATION
16.
When Will This Circular Be Reviewed?
17. What Is The Legal Effect Of This Circular?
18. Do You Have Further Questions?
BACKGROUND
1.
What Is The Purpose Of This Circular?
This Circular establishes policies to improve the internal management
of the Executive Branch. Consistent with Section 12(d) of P.L. 104-113,
the "National Technology Transfer and Advancement Act of 1995"
(hereinafter "the Act"), this Circular directs agencies
to use voluntary consensus standards in lieu of government-unique
standards except where inconsistent with law or otherwise impractical.
It also provides guidance for agencies participating in voluntary
consensus standards bodies and describes procedures for satisfying
the reporting requirements in the Act. The policies in this Circular
are intended to reduce to a minimum the reliance by agencies on
government-unique standards. These policies do not create the bases
for discrimination in agency procurement or regulatory activities
among standards developed in the private sector, whether or not
they are developed by voluntary consensus standards bodies. Consistent
with Section 12(b) of the Act, this Circular directs the Secretary
of Commerce to issue guidance to the agencies in order to coordinate
conformity assessment activities. This Circular replaces OMB Circular
No. A-119, dated October 20, 1993.
2. What Are The Goals Of The Government
In Using Voluntary Consensus Standards?
Many voluntary consensus standards are appropriate or adaptable
for the Government's purposes. The use of such standards, whenever
practicable and appropriate, is intended to achieve the following
goals:
b. Provide
incentives and opportunities to establish standards that serve national
needs.
c. Encourage long-term growth for U.S. enterprises andpromote efficiency
and economic competition through harmonization of standards.
d. Further the policy of reliance upon the private sector to supply
Government needs for goods and services.
WHAT DEFINITIONS OF STANDARDS
(2) The definition of terms; classification of components; delineation of procedures; specification of dimensions, materials, performance, designs, or operations; measurement of quality and quantity in describing materials, processes, products, systems, services, or practices; test methods and sampling procedures; or descriptions of fit and measurements of size or strength.
b. The term
"standard" does not include the following:
(2) Institutional codes of ethics.
c. "Performance
standard" is a standard as defined above that states requirements
in terms of required results with criteria for verifying compliance
but without stating the methods for achieving required results.
A performance standard may define the functional requirements for
the item, operational requirements, and/or interface and interchangeability
characteristics. A performance standard may be viewed in juxtaposition
to a prescriptive standard which may specify design requirements,
such as materials to be used, how a requirement is to be achieved,
or how an item is to be fabricated or constructed.
d. "Non-government standard" is a standard as defined
above that is in the form of a standardization document developed
by a private sector association, organization or technical society
which plans, develops, establishes or coordinates standards, specifications,
handbooks, or related documents.
4.
What Are Voluntary, Consensus Standards?
(ii) Balance of interest.
(iii) Due process.
(vi) An appeals process.
(v) Consensus, which is defined as general agreement, but not necessarily unanimity, and includes a process for attempting to resolve objections by interested parties, as long as all comments have been fairly considered, each objector is advised of the disposition of his or her objection(s) and the reasons why, and the consensus body members are given an opportunity to change their votes after reviewing the comments.
(2) "Government-unique standards," which are developed by the government for its own uses.
(3) Standards mandated by law, such as those contained in the United States Pharmacopeia and the National Formulary, as referenced in 21 U.S.C. 351.
POLICY
5.
Who Does This Policy Apply To?
This Circular applies to all agencies and agency employees who use
standards and participate in voluntary consensus standards
activities, domestic and international, except for activities carried
out pursuant to treaties. "Agency" means any executive
department, independent commission, board, bureau, office, agency,
Government-owned or controlled corporation or other establishment
of the Federal Government. It also includes any regulatory commission
or board, except for independent regulatory commissions insofar
as they are subject to separate statutory requirements regarding
the use of voluntary consensus standards. It does not include the
legislative or judicial branches of the Federal Government.
6.
What Is The Policy For Federal Use Of Standards?
All federal agencies must use voluntary consensus standards in lieu
of government-unique standards in their procurement and regulatory
activities, except where inconsistent with law or otherwise impractical.
In these circumstances, your agency must submit a report describing
the reason(s) for its use of government-unique standards in lieu
of voluntary consensus standards to the Office of Management and
Budget (OMB) through the National Institute of Standards and Technology
(NIST).
Your agency must use voluntary consensus standards, both domestic and international, in its regulatory and procurement activities in lieu of government-unique standards, unless use of such standards would be inconsistent with applicable law or otherwise impractical. In all cases, your agency has the discretion to decline to use existing voluntary consensus standards if your agency determines that such standards are inconsistent with applicable law or otherwise impractical.
(2) "Impractical" includes circumstances in which such use would fail to serve the agency's program needs; would be infeasible; would be inadequate, ineffectual, inefficient, or inconsistent with agency mission; or would impose more burdens, or would be less useful, than the use of another standard.
b. What must my agency do when such use is determined by my agency to be inconsistent with applicable law or otherwise impractical?
The head of
your agency must transmit to the Office of Management and Budget
(OMB), through the National Institute of Standards and Technology
(NIST), an explanation of the reason(s) for using government-unique
standards in lieu of voluntary consensus standards. For more information
on reporting, see section 9.
c. How does this policy affect my agency's regulatory authorities
and responsibilities?
This policy does not preempt or restrict agencies' authorities and
responsibilities to make regulatory decisions authorized by statute.
Such regulatory authorities and responsibilities include determining
the level of acceptable risk; setting the level of protection; and
balancing risk, cost, and availability of technology in establishing
regulatory standards. However, to determine whether established
regulatory limits or targets have been met, agencies should use
voluntary consensus standards for test methods, sampling procedures,
or protocols.
d. How does this policy affect my agency's procurement authority?
This policy does not preempt or restrict agencies' authorities and
responsibilities to identify the capabilities that they need to
obtain through procurements. Rather, this policy limits an agency's
authority to pursue an identified capability through reliance on
a government-unique standard when a voluntary consensus standard
exists (see Section 6a).
e. What
are the goals of agency use of voluntary consensus standards?
Agencies should recognize the positive contribution of standards
development and related activities. When properly conducted, standards
development can increase productivity and efficiency in Government
and industry, expand opportunities for international trade, conserve
resources, improve health and safety, and protect the environment.
f. What considerations should my agency make when it is
considering using a standard?
When considering using a standard, your agency should take full
account of the effect of using the standard on the economy, and
of applicable federal laws and policies, including laws and regulations
relating to antitrust, national security, small business, product
safety, environment, metrication, technology development, and conflicts
of interest. Your agency should also recognize that use of standards,
if improperly conducted, can suppress free and fair competition;
impede innovation and technical progress; exclude safer or less
expensive products; or otherwise adversely affect trade, commerce,
health, or safety. If your agency is proposing to incorporate a
standard into a proposed or final rulemaking, your agency must comply
with the "Principles of Regulation" (enumerated in Section
1(b)) and with the other analytical requirements of Executive Order
12866, "Regulatory Planning and Review."
g. Does
this policy establish a preference between consensus and non-consensus
standards that are developed in the private sector?
This policy does not establish a preference among standards developed
in the private sector. Specifically, agencies that promulgate regulations
referencing non-consensus standards developed in the private sector
are not required to report on these actions, and agencies that procure
products or services based on non-consensus standards are not required
to report on such procurements. For example, this policy allows
agencies to select a non-consensus standard developed in the private
sector as a means of establishing testing methods in a regulation
and to choose among commercial-off-the-shelf products, regardless
of whether the underlying standards are developed by voluntary consensus
standards bodies or not.
h. Does this policy establish a preference between domestic
and international voluntary consensus standards?
This policy does not establish a preference between domestic and international voluntary consensus standards. However, in the interests of promoting trade and implementing the provisions of international treaty agreements, your agency should consider international standards in procurement and regulatory applications.
i. Should my agency give preference to performance standards?
In using voluntary consensus standards, your agency should give preference to performance standards when such standards may reasonably be used in lieu of prescriptive standards.
j. How
should my agency reference voluntary consensus standards?
Your agency should reference voluntary consensus standards, along
with sources of availability, in appropriate publications, regulatory
orders, and related internal documents. In regulations, the reference
must include the date of issuance. For all other uses, your agency
must determine the most appropriate form of reference, which may
exclude the date of issuance as long as users are elsewhere directed
to the latest issue. If a voluntary standard is used and published
in an agency document, your agency must observe and protect the
rights of the copyright holder and any other similar obligations.
k. What if no voluntary consensus standard exists?
In cases where no voluntary consensus standards exist, an agency
may use government-unique standards (in addition to other standards,
see Section 6g) and is not required to file a report on its use
of government-unique standards. As explained above (see Section
6a), an agency may use government-unique standards in lieu of voluntary
consensus standards if the use of such standards would be inconsistent
with applicable law or otherwise impractical; in such cases, the
agency must file a report under Section 9a regarding its use of
government-unique standards.
l. How may my agency identify voluntary consensus standards?
Your agency may identify voluntary consensus standards through databases
of standards maintained by the National Institute of Standards and
Technology (NIST), or by other organizations including voluntary
consensus standards bodies, other federal agencies, or standards
publishing companies.
Agencies must
consult with voluntary consensus standards bodies, both domestic
and international, and must participate with such bodies in the
development of voluntary consensus standards when consultation and
participation is in the public interest and is compatible with their
missions, authorities, priorities, and budget resources.
Agency representatives should participate in voluntary consensus standards activities in order to accomplish the following purposes:
(2) Further such national goals and objectives as increased use of the metric system of measurement; use of environmentally sound and energy efficient materials, products, systems, services, or practices; and improvement of public health and safety.
Agency support provided to a voluntary consensus standards activity must be limited to that which clearly furthers agency and departmental missions, authorities, priorities, and is consistent with budget resources. Agency support must not be contingent upon the outcome of the standards activity. Normally, the total amount of federal support should be no greater than that of other participants in that activity, except when it is in the direct and predominant interest of the Government to develop or revise a standard, and its timely development or revision appears unlikely in the absence of such support.
c. What
forms of support may my agency provide?
The form of agency support, may include the following:
(2) Administrative support; e.g., travel costs, hosting of meetings, and secretarial functions.
(3) Technical support; e.g., cooperative testing for standards evaluation and participation of agency personnel in the activities of voluntary consensus standards bodies.
(4) Joint planning with voluntary consensus standards bodies to promote the identification and development of needed standards.
(5) Participation of agency personnel.
Agency employees who, at Government expense, participate in standards activities of voluntary consensus standards bodies on behalf of the agency must do so as specifically authorized agency representatives. Agency support for, and participation by agency personnel in, voluntary consensus standards bodies must be in compliance with applicable laws and regulations. For example, agency support is subject to legal and budgetary authority and availability of funds. Similarly, participation by agency employees (whether or not on behalf of the agency) in the activities of voluntary consensus standards bodies is subject to the laws and regulations that apply to participation by federal employees in the activities of outside organizations. While we anticipate that participation in a committee that is developing a standard would generally not raise significant issues, participation as an officer, director, or trustee of an organization would raise more significant issues. An agency should involve its agency ethics officer, as appropriate, before authorizing support for or participation in a voluntary consensus standards body.
e. Does agency participation indicate endorsement of any decisions reached by voluntary consensus standards bodies?
Agency participation in voluntary consensus standards bodies does not necessarily connote agency agreement with, or endorsement of, decisions reached by such organizations.
f. Do agency representatives participate equally with other members?
Agency representatives serving as members of voluntary consensus standards bodies should participate actively and on an equal basis with other members, consistent with the procedures of those bodies, particularly in matters such as establishing priorities, developing procedures for preparing, reviewing, and approving standards, and developing or adopting new standards. Active participation includes full involvement in discussions and technical debates, registering of opinions and, if selected, serving as chairpersons or in other official capacities. Agency representatives may vote, in accordance with the procedures of the voluntary consensus standards body, at each stage of the standards development process unless prohibited from doing so by law or their agencies.
g. Are there any limitations on participation by agency representatives?
In order to maintain the independence of voluntary consensus standards bodies, agency representatives must refrain from involvement in the internal management of such organizations (e.g., selection of salaried officers and employees, establishment of staff salaries, and administrative policies). Agency representatives must not dominate such bodies, and in any case are bound by voluntary consensus standards bodies' rules and procedures, including those regarding domination of proceedings by any individual. Regardless, such agency employees must avoid the practice or the appearance of undue influence relating to their agency representation and activities in voluntary consensus standards bodies.
h. Are there any limits on the number of federal participants in voluntary consensus standards bodies?
The number of individual agency participants in a given voluntary standards activity should be kept to the minimum required for effective representation of the various program, technical, or other concerns of federal agencies.
i. Is there anything else agency representatives should know?
This Circular
does not provide guidance concerning the internal operating procedures
that may be applicable to voluntary consensus standards
bodies because of their relationships to agencies under this Circular.
Agencies should, however, carefully consider what laws or rules
may apply in a particular instance because of these relationships.
For example, these relationships may involve the Federal Advisory
Committee Act, as amended (5 U.S.C. App. I), or a provision of an
authorizing statute for a particular agency.
j. What if a voluntary consensus standards body is likely
to develop an acceptable, needed standard in a timely fashion?
If a voluntary consensus standards body is in the process of developing
or adopting a voluntary consensus standard that would likely be
lawful and practical for an agency to use, and would likely be developed
or adopted on a timely basis, an agency should not be developing
its own government-unique standard and instead should be participating
in the activities of the voluntary consensus standards body.
Section 12(b) of the Act requires NIST to coordinate Federal, State, and local standards activities and conformity assessment activities with private sector standards activities and conformity assessment activities, with the goal of eliminating unnecessary duplication and complexity in the development and promulgation of conformity assessment requirements and measures. To ensure effective coordination, the Secretary of Commerce must issue guidance to the agencies.
MANAGEMENT AND REPORTING OF STANDARDS USE
9. What Is My Agency Required to Report?
b. Your agency must report to NIST, no later than December 31 of each year, information on the nature and extent of agency participation in the development and use of voluntary consensus standards from the previous fiscal year. Your agency must report in accordance with format instructions issued by NIST. Such reporting must include the following:
(2) The number of voluntary consensus standards the agency has used since the last report, based on the procedures set forth in sections 11 and 12 of this Circular.
(3) Identification
of voluntary consensus standards that have been substituted for
government-unique standards as a result of an agency review under
section 15b(7) of this Circular.
(4) An evaluation of the effectiveness of this policy and recommendations
for any changes.
10. How Does My Agency Manage And Report Its Development and Use Of Standards?
Your agency must establish a process to identify, manage, and review your agency's development and use of standards. At minimum, your agency must have the ability to (1) report to OMB through NIST on the agency's use of government-unique standards in lieu of voluntary consensus standards, along with an explanation of the reasons for such non-usage, as described in section 9a, and (2) report on your agency's participation in the development and use of voluntary consensus standards, as described in section 9b. This policy establishes two ways, category based reporting and transaction based reporting, for agencies to manage and report their use of standards. Your agency must report all uses of standards in one or both ways.
11. What Are The Procedures For Reporting My Agency's Use Of Standards In Regulations?
Your agency should use transaction based reporting if your agency issues regulations that use or reference standards. If your agency is issuing or revising a regulation that contains a standard, your agency must follow these procedures:
(2) When your agency is proposing to use a government-unique standard in lieu of a voluntary consensus standard, provide a statement which identifies such standards and provides a preliminary explanation for the proposed use of a government-unique standard in lieu of a voluntary consensus standard.
(3) When your agency is proposing to use a government-unique standard, and no voluntary consensus standard has been identified, a statement to that effect and an invitation to identify any such standard and to explain why such standard should be used.
b. Publish
a discussion in the preamble of a Final Rulemaking that restates
the statement in the NPRM or IFR, acknowledges and summarizes any
comments received and responds to them, and explains the agency's
final decision. This discussion must provide the appropriate information,
as follows:
(2) When a government-unique standard is being used in lieu of a voluntary consensus standard, provide a statement that identifies the standards and explains why using the voluntary consensus standard would be inconsistent with applicable law or otherwise impractical. Such explanation must be transmitted in accordance with the requirements of Section 9a.
(3) When a government-unique standard is being used, and no voluntary consensus standard has been identified, provide a statement to that effect.
12.
What Are The Procedures For Reporting My Agency's Use Of
Standards In Procurements?
To identify, manage, and review the standards used in your agency's
procurements, your agency must either report on a categorical basis
or on a transaction basis.
Your agency must report on a category basis when your agency identifies, manages, and reviews the use of standards by group or category. Category based reporting is especially useful when your agency either conducts large procurements or large numbers of procurements using government-unique standards, or is involved in long-term procurement contracts which require replacement parts based on government-unique standards. To report use of government-unique standards on a categorical basis, your agency must:
(2) Systematically review your agency's use of government-unique standards for conversion to voluntary consensus standards.
(3) Maintain
records on the groups or categories in which your agency uses government-unique
standards in lieu of voluntary consensus standards, including an
explanation of the reasons for such use, which must be transmitted
according to Section 9a.
(4) Enable potential offerors to suggest voluntary consensus standards
that can replace government-unique standards.
b. How
does my agency report the use of standards in procurements on a
transaction basis?
Your agency should report on a transaction basis when your agency
identifies, manages, and reviews the use of standards on a transaction
basis rather than a category basis. Transaction based reporting
is especially useful when your agency conducts procurement mostly
through commercial products and services, but is occasionally involved
in a procurement involving government-unique standards. To report
use of government-unique standards on a transaction basis, your
agency must follow the following procedures:
(ii) Provide potential offerors an opportunity to suggest alternative voluntary consensus standards that meet the agency's requirements.
AGENCY
RESPONSIBILITIES
13.
What Are The Responsibilities Of The Secretary Of Commerce?
The Secretary of Commerce:
b. Sponsors and supports the Interagency Committee on Standards Policy (ICSP), chaired by the National Institute of Standards and Technology, which considers agency views and advises the Secretary and agency heads on the Circular.
c. Reports to the Director of OMB concerning the implementation of the policy provisions of this Circular.
d. Establishes procedures for agencies to use when developing directories described in Section 15b(5) and establish procedures to make these directories available to the public.
e. Issues guidance to the agencies to improve coordination on conformity assessment in accordance with section 8.
14.
What Are The Responsibilities Of The Heads Of Agencies?
The Heads of Agencies:
b. Ensure agency compliance with the policies of the Circular.
c. In the case of an agency with significant interest in the use of standards, designate a senior level official as the Standards Executive who will be responsible for the agency's implementation of this Circular and who will represent the agency on the ICSP.
d. Transmit the annual report prepared by the Agency Standards Executive as described in Sections 9 and 15b(6).
An Agency Standards Executive:
(2) The development of agency positions that are in the public interest and that do not conflict with each other.
(3) The development of agency positions that are consistent with administration policy.
(4) The development of agency technical and policy positions that are clearly defined and known in advance to all federal participants on a given committee.
(2) To the extent possible, ensuring that the agency's participation in voluntary consensus standards bodies is consistent with agency missions, authorities, priorities, and budget resources.
(3) Ensuring, when two or more agencies participate in a given voluntary consensus standards activity, that they coordinate their views on matters of paramount importance so as to present, whenever feasible, a single, unified position and, where not feasible, a mutual recognition of differences.
(4) Cooperating with the Secretary in carrying out his or her responsibilities under this Circular.
(5) Consulting with the Secretary, as necessary, in the development and issuance of internal agency procedures and guidance implementing this Circular, including the development and implementation of an agency-wide directory identifying agency employees participating in voluntary consensus standards bodies and the identification of voluntary consensus standards bodies.
(6) Preparing, as described in Section 9, a report on uses of government-unique standards in lieu of voluntary consensus standards and a report on the status of agency standards policy activities.
(7) Establishing a process for ongoing review of the agency's use of standards for purposes of updating such use.
(8) Coordinating with appropriate agency offices (e.g., budget and legal offices) to ensure that effective processes exist for the review of proposed agency support for, and participation in, voluntary consensus standards bodies, so that agency support and participation will comply with applicable laws and regulations.
SUPPLEMENTARY INFORMATION
16.
When Will This Circular Be Reviewed?
This Circular will be reviewed for effectiveness by the OMB three
years from the date of issuance.
17.
What Is The Legal Effect Of This Circular?
Authority for this Circular is based on 31 U.S.C. 1111, which gives
OMB broad authority to establish policies for the improved management
of the Executive Branch. This Circular is intended to implement
Section 12(d) of P.L. 104-113 and to establish policies that will
improve the internal management of the Executive Branch. This Circular
is not intended to create delay in the administrative process, provide
new grounds for judicial review, or create new rights or benefits,
substantive or procedural, enforceable at law or equity by a party
against the United States, its agencies or instrumentalities, or
its officers or employees.
18. Do You Have Further Questions?
For information concerning this Circular, contact the Office of Management and Budget, Office of Information and Regulatory Affairs: Telephone 202/395-3785.