As a signatory of the World Trade Organization, the U.S. is responsible for pursuing standardization activities that are in full compliance with the WTO/TBT, as this is the key international agreement which mandates how countries use standards and conformity assessment in regulation.
Speciﬁcally, section 2.4 should be noted as this is one of the key linkages the agreement makes regarding how standards should be used in technical regulations:
2.4 Where technical regulations are required and relevant international standards exist or their completion is imminent, members shall use them, or the relevant parts of them, as a basis for their technical regulations except; when such international standards or relevant parts would be an ineffective or inappropriate means for the fulﬁllment of the legitimate objectives pursued, for instance because of fundamental climatic or geographical factors or fundamental technological problems.
The U.S. federal government is the largest single creator and user of speciﬁcations and standards — current estimates point to more than 44 000 distinct statutes, technical regulations or purchasing speciﬁcations. Decisions about which standards are most appropriate for U.S. government use are left to the discretion of individual agencies, though recent trends indicate that voluntary consensus standards from both national and international sources are being increasingly referenced by U.S. agencies and regulatory bodies. Add the more than 50 000 standards estimated to come from the private sector in America and the nation’s total inventory of standards quickly approaches 100 000. These documents are produced and maintained by nearly 600 standards organizations in the United States, over 200 of which are accredited by ANSI as developers of American National Standards (ANSs). In addition, the full catalogues of ISO and IEC have the potential to be used or referenced in regulation by U.S. federal government agencies if deemed appropriate.
ISO Member Body
The American National Standards Institute (ANSI) is the ISO Member body in the U.S.A.
Government agencies can use externally developed standards in a wide variety of ways, including the following:
- Adoption: An agency may adopt a voluntary standard without change by incorporating the standard in an agency’s regulation or by listing (or referencing) the standard by title. For example, the Occupational Safety and Health Administration (OSHA) adopted the National Electrical Code (NEC) by incorporating it into its regulations by reference.
- Strong deference: An agency may grant strong deference to standards developed by a particular organization for a speciﬁc purpose. The agency will then use the standards in its regulatory programmer unless someone demonstrates to the agency why it should not.
- Basis for rulemaking: This is the most common use of externally developed standards. The agency reviews a standard, makes appropriate changes, and then publishes the revision in the Federal Register as a proposed regulation. Comments received from the public during the rulemaking proceeding may result in changes to the proposed rule before it is instituted.
- Regulatory guides: An agency may permit adherence to a speciﬁc standard as an acceptable, though not compulsory, way of complying with a regulation.
- Guidelines: An agency may use standards as guidelines for complying with general requirements. The guidelines are advisory only; even if a ﬁrm complies with the applicable standards, the agency may conceivably still ﬁnd that the general regulation has been violated.
- Deference in lieu of developing a mandatory standard: An agency may decide that it does not need to issue a mandatory regulation because voluntary compliance with either an existing standard or one developed for the purpose will sufﬁce for meeting the needs of the agency.
Where standards are referenced in regulations, regulatory policies emphasize that regulations (including any referenced standards) be cost- effective, consistent, sensible and understandable, and that the regulatory process should be open, transparent and fair to all interested parties. Government regulations may address health, product safety, operator/user safety, environmental effects, quarantine requirements, consumer protection, packaging and labelling, product characteristics, or other matters in the public interest.
Federal policy regarding the use of standards and conformity assessments is contained in certain key provisions of the National Technology Transfer and Advancement Act (NTTAA) (Public Law 104-113), signed into law in early 1996. The NTTAA requires that:
- All Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments except where such
- Federal agencies and departments shall consult with voluntary, private sector, consensus standards bodies and shall, when such participation is in the public interest and is compatible with agency and departmental missions, authorities, priorities and budget resources, participate with such bodies in the development of technical standards.
Ofﬁce of Management and Budget (OMB) Circular A-119, Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, provides federal agencies with guidance on how to implement these requirements in the NTTAA.
Other laws and policies that reinforce the strong public-private partnership approach to standards and conformity assessment in speciﬁc sectors or areas of interest include the following:
Standards Development Organization Advancement Act of 2004 (H.R. 1086)
HR 1086 provides qualiﬁed standards developers with an opportunity to ﬁle for, and obtain, a limited exclusion from antitrust liability for treble damages. This protection is identical to the protection which has been available to joint ventures under the National Cooperative Research and Production Act since 1993, which also remains available to those utilizing a consortium or other informal processes to develop standards.
The Consumer Product Safety Act
Under the Consumer Product Safety Act, the Consumer Product Safety Commission speciﬁcally relies upon voluntary consensus consumer product safety standards rather than promulgate its own standards. The relevant portion of the law is set forth below:
...The Commission shall rely upon voluntary consumer product safety standards rather than promulgate a consumer product safety standard prescribing requirements described in Subsection (a) whenever compliance with such voluntary standards would eliminate or adequately reduce the risk of injury addressed and it is likely that there will be substantial compliance with such voluntary standards.
(Source: Section 7(b) (1) of the Consumer Product Safety Act (15 USC 2056; PL 92-573; 86 Stat. 1207, Oct. 27, 1972, as amended in 1981.)
The Health Insurance Portability and Accountability Act of 1995
This Act requires the Secretary of Health and Human Services to adopt standards developed by ANSI-accredited standards developers whenever possible.
The Telecommunications Act of 1996
The ﬁrst major overhaul of U.S. telecommunications law in almost 62 years, the act contains several provisions that propel the Federal Communications Commission (FCC) toward reliance upon private sector standards. In particular, the FCC is seeking to ensure that the standards development process in the telecommunications area is open and consensus- based — the very things provided for by ANSI accreditation requirements.
The Food and Drug Administration (FDA) Modernization Act of 1997
This act contains provisions which allow the FDA in some instances to accept manufacturers’ declarations of compliance to certain standards during the evaluation of pre-market submissions for electrical medical devices. This is expected to result in a substantial reduction of time-to-market for some medical devices while still ensuring that fundamental regulatory health and safety responsibilities are met.
In addition, the U.S. Government has increased its reliance on private sector standards in its procurement activities. In 1994, Secretary of Defense, William Perry, announced that one of the Department of Defense’s (DoD’s) top priorities would be to move away from military-unique speciﬁcations and standards (milspecs) and toward reliance upon private sector standards to ensure that DoD continued to meet its military, economic and policy objectives in the future in a cost-effective manner.
The United States considers standards to be a fundamental factor in the nation’s economy and vital to world commerce. Within the United States, standards are developed through a complex but effective system administered by the private sector, with the participation of industry, academia, consumers and government. The U.S. system has evolved over the last 100 years to meet the needs of U.S. industry and society in general. Rooted in the private sector, it has successfully met domestic marketplace needs on a sector-by-sector basis. Responsibility for coordination of the U.S. private sector standards system rests with the American National Standards Institute (ANSI). ANSI is also the U.S. member body within ISO and IEC. Organizations that are accredited by ANSI to develop American National Standards (ANSs) or to serve as U.S. Technical Advisory Groups (U.S. TAGs) to the International Organization for Standardization (ISO), or organizations that are approved by ANSI’s U.S. National Committee (USNC) of the International Electrotechnical Commission (IEC) to serve as U.S. TAGs to IEC committees, are required to adhere to a set of essential requirements that are aligned with the WTO principles. These principles include transparency, openness, impartiality, effectiveness and relevance, consensus, performance-based coherence, due process, and the provision of technical assistance where appropriate. The U.S. system, both domestically and internationally, beneﬁts from strong industry support and participation of both government and private sector technical experts as equals at all levels in the process.
|U.S.A. Policy / Regulation||Reference to standard/s|
47 CFR 15.109
Part 15_Radio frequency devices
Sec. 15.109 Radiated emission limits.
g) As an alternative to the radiated emission limits shown in paragraphs (a) and (b) of this section, digital devices may be shown to comply with the standards contained in the Third Edition of the International Special Committee on Radio Interference (CISPR),
Characteristics — Limits and Methods of Measurement”.
10 CFR 73.26
Part 73_Physical Protection of
Sec. 73.26 Transportation of physical protection systems, subsystems, components, and procedures.
(l) Shipment by sea. (1) Shipments shall be made only on container-ships.
The ANSI Standard MH5.1 (1971) and the (ISO) 1496 (1978) have been approved for incorporation by reference by the Director of the Federal Register. A copy of each of these standards is available for inspection at the NRC Library, 11545 Rockville Pike, and Rockville, Maryland 20852-2738.
46 CFR 111.105-11 Title 46 — Shipping Chapter I — Coast Guard, Department Of Homeland Security
Part 111_Electric Systems — General Requirements
Sec. 111.105-11 Intrinsically safe systems.
(a) Each system required under this subpart to be intrinsically safe must use approved components meeting UL 913 or IEC 79-11.
47 CFR 15.109(g)
As an alternative to the radiated emission limits shown in paragraphs (a) and (b) of this section, digital devices may be shown to comply with the standards contained in Third Edition of the International Special Committee on Radio Interference (CISPR), Pub. 22, “Information Technology Equipment — Radio Disturbance Characteristics — Limits and Methods of Measurement” (incorporated by reference, see §15.38). In addition:
Note: CISPR is a Committee within the IEC.
47 CFR 15.31(a)(3)
Other intentional and unintentional radiators are to be measured for compliance using the following procedure excluding
Note to paragraph(a)(3): Digital devices tested to show compliance with the provisions of §§15.107(e) and 15.109(g) must be tested following the ANSI C63.4 procedure described in paragraph (a)(3) of this section.