Regulations

What are Regulations?

Governmental regulations, also called rules, specify mandatory (legal) requirements that (1) must be met under specific laws and (2) implement general agency objectives. These requirements may address health, product safety, operator/user safety, environmental effects, quarantine requirements, consumer protection, packaging and labeling, product characteristics, or other matters in the public interest. A regulation may consist of agency-developed technical specifications or requirements, or may permit use of particular private sector standards as a means of compliance.

The U.S. Federal regulatory system is designed to protect and improve the health, safety, and well being of U.S. citizens and to protect the environment. It seeks to improve the performance of the economy without imposing unacceptable or unreasonable costs on society. U.S. regulatory policies recognize that market-place forces are generally the best engine for driving economic growth. U.S. regulatory policies emphasize that regulations should be cost effective, consistent, sensible, and understandable, and that the regulatory process should be open, transparent and fair to all interested parties. The NTTAA endorses the use of private sector standards to achieve these objectives.

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How are Voluntary Standards used in Regulations?

Government agencies 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 program 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 I 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.

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Finding Regulations in Force

Code of Federal Regulations (CFR)
The CFR is the codification of final rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year.
The Federal Register (FR)
Published by the Office of the Federal Register, National Archives and Records Administration (NARA), the FR is the official daily publication for rules, proposed rules, and notices of Federal organizations, as well as executive orders and other presidential documents.
RegInfo.gov
The Regulatory Information Service Center has established the RegInfo.gov site to assist users who want to find information about Federal, State, and local regulation. It contains links to Federal regulatory agendas and regulatory plans, regulatory and information collection reviews by the Office of Management and Budget, legislation, the Federal Register, the Code of Federal Regulations, and state and local regulatory information. It also contains "The Reg Map," a chart that gives an overview of the Federal rulemaking process.

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Standards Incorporated in Laws, Polices and Regulations

Standards Incorporated by Reference (SIBR) Database
The Standards Incorporated by Reference (SIBR) Databases are searchable collections of standards separated into two main categories:
- Standards referenced in regulations - Voluntary consensus standards, government-unique standards, industry standards, and international standards referenced in the Code of Federal Regulations (CFR)
- Standards referenced in procurement - Voluntary consensus standards used by U.S. Government agencies in their procurement activities.

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Proposed Regulations

RegInfo.gov
The Regulatory Information Service Center has established the RegInfo.gov site to assist users who want to find information about Federal, State, and local regulation. It contains links to Federal regulatory agendas and regulatory plans, regulatory and information collection reviews by the Office of Management and Budget, legislation, the Federal Register, the Code of Federal Regulations, and state and local regulatory information. It also contains "The Reg Map," a chart that gives an overview of the Federal rulemaking process.
The Federal Register (FR)
Published by the Office of the Federal Register, National Archives and Records Administration (NARA), the Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents.
Regulations.gov
Regulations.gov is the U.S. Government web site that enables participation in Federal rulemaking. On this site, you can find, review, and submit comments on Federal documents that are open for comment and published in the Federal Register.
Unified Agenda
The Unified Agenda (also known as the Semiannual Regulatory Agenda), published twice a year (usually in April and October) in the Federal Register (FR), summarizes the rules and proposed rules that each Federal agency expects to issue during the next six months. It is published by the Office of the Federal Register National Archives and Records Administration (NARA).

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Regulations and Conformity Assessment

Federal conformity assessment procedures are a means of providing assurance that the products and services regulated or procured by federal agencies have the required characteristics and/or perform in a specified manner. Agency conformity assessment procedures may include: sampling and testing, inspection, and/or certification by the agency or other specified organization; licensing; product listing; the submission to an agency of manufacturing, operational, and related data for review; manufacturer self-declaration of conformity to agency requirements; mandatory labeling and advertising requirements; establishment of national requirements which are adopted/enforced at state and local government levels; issuance of regulatory guidelines; pre-marketing approval requirements; post-marketing monitoring requirements; and the conduct of environmental impact assessments.

While federal agencies may use a number of different conformity assessment approaches to achieve the required level of assurance of compliance, the U.S. regulatory philosophy relies heavily on manufacturer's or supplier's declaration of conformity - PDF Document PDF File . Among the reasons why this approach is successful in the United States are:

The sometimes severe penalties imposed by the U.S. legal and judicial system on products proven to be defective or hazardous to the public safety or environment.
The increasing access that the U.S. consumer has to information about poor quality or hazardous and defective products through various media.
The size of the U.S. marketplace and the ability of the U.S. consumer to switch to a competing product if dissatisfied.
U.S. laws and regulations that establish operational requirements for the U.S. marketplace, such as truth in labeling and advertising.