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.
Using Voluntary Standards 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.
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. 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.