Background: U.S. food safety regulation dates to the early 20th century, when unsafe practices and tainted products in the meatpacking industry created pressure for a federal role. Scientific advances in recent decades have moved food safety regulation far beyond the traditional “organoleptic” model where contamination was only what an inspector could taste, touch or smell. U.S. food manufacturing systems are now built around Hazard Analysis and Critical Control Point (HACCP) principles, with extensive product testing, redundant measures to ensure safety, and constant attention to biosecurity and other protective measures.

Operation: A variety of federal and state agencies have a role in food safety, but the two primary federal regulators are the Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS). FSIS regulates meat, poultry and processed egg products. The basic FSIS model is continuous inspection in slaughter plants – i.e., an inspector must be physically present whenever the plant is operating – with frequent but not continuous inspection at processing facilities that do not slaughter animals or break eggs, e.g., sausage plants.

Since 1996, meat and poultry plants have been required to develop HACCP plans. Under HACCP, the burden is on the regulated facility to demonstrate that its procedures ensure safe products. HACCP is widely accepted worldwide as the best way to minimize foodborne illness and other hazards. HACCP commences with analyzing hazards and involves the identification of Critical Control Point (CCPs) – stages in food processing where hazards must be controlled – and the use of monitoring, corrective action, verification, validation and record-keeping to minimize risk.

Foods that are not under FSIS’s jurisdiction are the responsibility of the FDA, which has broad powers to demand records, seize foods, order recalls and take other steps when it believes products are adulterated or misbranded. (FDA also regulates animal feed.) All FDA-regulated food facilities are subject to periodic inspections. FDA also acts in response to foodborne illness outbreaks, prompting recalls and other steps to get unsafe foods out of commerce.

Congress gave FDA major new powers in the Food Safety Modernization Act (FSMA). This law is the most thorough revision of FDA’s authorities since the 1930s. Among FSMA’s major themes is a requirement for all food and feed facilities to implement preventive controls – essentially incorporating all the elements of HACCP plans. In addition to the sweeping new regulations on domestic industry, FSMA places new emphasis on ensuring the safety of imported foods, both through stepping up FDA’s own offshore presence and by accrediting third parties who will certify foreign food facilities’ safety. Regulations to implement FSMA, filling hundreds of pages in the Federal Register, became final in 2015.

Administration and Enforcement: The two major food safety agencies are the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) and the Food Safety and Inspection Service (FSIS) within the Department of Agriculture. The Centers for Disease Control and Prevention (CDC), also part of HHS, has a major role in monitoring and reporting outbreaks of foodborne illness and works closely with FDA in addressing outbreaks. Health agencies within the states also play a role, in many cases carrying out inspections and other tasks for FDA.

Statutory Authority (partial): 21 U.S.C. 301-399a; 42 U.S.C. 201; 21 U.S.C. 601-695; 21 U.S.C. 451-472; 7 U.S.C. 1902, 1904.