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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.
Government agencies use externally developed standards in a wide variety of ways, including the following:
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: