Legal Definitions - agency regulation

An agency regulation is a specific rule or directive issued by a government administrative agency, rather than directly by a legislative body like Congress or a state legislature. These regulations are created by agencies to implement, interpret, or prescribe law or policy, often to carry out the broader mandates set forth in statutes (laws) passed by legislative bodies. Once properly enacted, agency regulations have the full force and effect of law, meaning they are legally binding and enforceable upon individuals, businesses, and other entities.

• Example 1: Environmental Protection

  The Environmental Protection Agency (EPA) issues a regulation requiring all new industrial facilities to install specific types of air pollution control technology to limit emissions of certain harmful chemicals. This regulation also sets maximum allowable levels for these pollutants.

  This illustrates an agency regulation because the EPA, a federal administrative agency, has created a detailed, legally binding rule to implement the broader environmental protection laws passed by Congress. Industrial companies must comply with these specific technology and emission standards, or they face legal penalties.

• Example 2: Financial Industry Oversight

  The Securities and Exchange Commission (SEC) publishes a regulation mandating that publicly traded companies must disclose specific financial information, such as executive compensation and potential risks to investors, in a standardized format in their annual reports.

  This is an agency regulation because the SEC, an administrative agency responsible for regulating the securities markets, has established a precise rule to ensure transparency and protect investors, thereby fulfilling its statutory duty under federal securities laws. Public companies are legally obligated to follow these disclosure requirements.

• Example 3: Public Health and Safety

  The Food and Drug Administration (FDA) issues a regulation requiring pharmaceutical companies to conduct extensive clinical trials and submit detailed data demonstrating the safety and efficacy of any new drug before it can be marketed to the public.

  This demonstrates an agency regulation because the FDA, a federal agency tasked with protecting public health, has created a rigorous, legally enforceable process that drug manufacturers must follow. This rule implements the broader laws governing drug approval and ensures that only safe and effective medications reach consumers.