About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

1 1 (January 10, 2025)

handle is hein.crs/goverzg0001 and id is 1 raw text is: Congressional Research Service nforming the IegisI9tive debate since 1914 0 January 10, 2025 FDA Oversight of Food Safety and Foodborne Illness Outbreaks ackround The Centers for Disease Control and Prevention (CDC) estimate that foodborne pathogens account for 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths per year. In 2024, the Food and Drug Administration (FDA) investigated more than 20 foodborne illness outbreaks responsible for causing at least 1,364 illnesses, 357 hospitalizations, and 7 deaths. FDA regulates 77% of the U.S. food supply, covering more than 220,000 facilities, including farms, food manufacturing facilities, distributors, and other entities in the food supply chain. About 40% of these facilities are located domestically. FDA-regulated foods include produce, seafood, shell eggs, infant formula, packaged foods, and others. The U.S. Department of Agriculture's (USDA's) Food Safety and Inspection Service regulates the rest of the U.S. food supply, including most meat and poultry and some egg products. Several federal, state, and local public health agencies play a role in food safety and foodborne illness response. The FDA Human Foods Program coordinates all FDA activities related to food safety and nutrition. This In Focus summarizes FDA's role in preventing and responding to foodborne illnesses. Food Safety Risks Many pathogens that cause foodborne illnesses, including E. coli, Listeria, Salmonella, and Clostridium botulinum, reside throughout the environment. Given the appropriate conditions, these pathogens can multiply quickly and contaminate foods during production. Food safety procedures work to limit the risks of contamination that ingestion causes illness. Some measures, such as using heat (e.g., pasteurization, cooking), pressure, or pH control, directly reduce the number of active pathogens. Such methods are not useful for some foods that are not fully cooked or otherwise processed before consumption, such as fresh produce or eggs. Additionally, some foodborne illnesses, notably botulism, are caused by bacteria making a toxin that is not eliminated by cooking. Food Safety Laws and Regu ations The Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§301 et seq.) is a major federal law on food safety. The act authorizes FDA to regulate certain foods and prohibits the introduction of adulterated foods into interstate commerce. Examples of how food is deemed adulterated include if it bears or contains any poisonous or deleterious substance which may render it injurious to health or if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth (21 U.S.C. §342(a)-(c)). Adulterated foods include those with pathogens or their toxins. Congress has provided FDA with additional authorities and has influenced the level and direction of food safety oversight. Congress directed FDA to establish manufacturing and nutritional standards for infant formula and provided mandatory recall authority in 1986 (P.L. 99- 570). In 2011, the Food Safety Modernization Act (FSMA; P.L. 111-353) amended FDA's existing structure and authorities to require comprehensive preventive controls across the food supply to minimize contamination risk. FSMA directed FDA to regulate foods and operations that previously lacked detailed requirements. FSMA also provided FDA with additional inspection authorities and mandatory recall authority if the agency deemed or suspected regulated foods to be adulterated. FDA often bases its food safety regulations on a risk assessment framework to control or prevent hazards, prioritizing those that have a high risk or likelihood of contaminating food. In 1969, FDA established current good manufacturing practices (cGMP, 21 C.F.R. Part 110) to ensure food manufacturers were maintaining clean facilities and ensuring food safety. FDA has since updated cGMP regulations by adding preventive, monitoring, and recordkeeping requirements. Some foods are considered high-risk for being more often associated with foodborne illnesses than others due to pathogen growth conditions and consumption habits. FDA issued specific regulations to address unique safety issues in products such as low-acid canned foods, acidified foods, and shell eggs, with a focus on certain pathogens. Other food-specific regulations, such as those for juice and seafood, are based on systems that analyze and control specific hazards at critical control points (HACCP). Following FSMA enactment, FDA issued other regulations (e.g., Preventive Controls for Human Foods Rule; Produce Safety Rule; and Food Traceability Rule) to reduce foodborne illnesses by preventing food contamination, keeping necessary records to monitor control methods for efficacy and removing potentially contaminated food from the market. Outbreak Response When preventive approaches fail, reactive approaches to food safety, such as food recalls, can be implemented with the appropriate traceback information. In 2011, FDA established the Coordinated Outbreak Response and Evaluation Network (CORE) to be responsible for surveillance, response, and post-response activities associated with illness outbreaks caused by food, dietary supplements, and cosmetics. CORE works with CDC, FDA field offices, and state agencies to monitor emerging

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Already a HeinOnline Subscriber?

Log In

profiles profiles most