Food Safety Remains at a Priority of the FDA and Local Health Agencies
The U.S. Food and Drug Administration, known almost universally as the FDA, is charged with the protection of the food supply chain in the United States. Nearly all food falls under FDA jurisdiction, with the exception of some foods (meat, poultry, and eggs) that are the purview of the United States Department of Agriculture, an agency founded by President Lincoln in 1862 that also had a large mandate in ensuring food safety related to American farming and ranching. The two agencies work cooperatively, instead of competitively, in ensuring food safety, food quality, and nutrition. The FDA is also well over a century old, coming into existence with the passage of the Pure Food and Drug Act of 1906 under President Theodore Roosevelt. As it has grown over the years, it became the guarantor of safe products from foods to prescription drugs, regulating nearly one trillion dollars a year in consumer goods in the U.S.
At the heart of the FDA is the guarantee of consumer safety, which in large part means (1) creating policies and procedures that guarantee food safety; and (2) preventing the spread of food borne illness.
Ensuring Food Safety From the Gate: Farm to Table Policies and Procedures
First and foremost is the prevention of food borne illness and adulteration of food that renders that food harmful to human consumption. When food is stamped by the prestigious “FDA Approved” label, that should mean something.
The role of food safety really came into focus at the FDA in 1969, when Congress and the FDA established Current Food Manufacturing Practices for food, called GMPs, that became part of 21 CFR Part 110, the U.S. Code. The GMPs were set in place to describe the “methods, equipment, facilities, and controls for producing processed food.” They serve as the “basement,” or minimum requirements, for producing safe and wholesome food. GMPs serve as an integral part of regulatory control over the safety of the nation’s food supply by serving as one basis for FDA inspections.
In 2015, as part of the FDA Food Safety Modernization Act (FSM), Congress adopted the modernized CGMPs as part of 21 CFR Part 117. The FSM and its ancillary regulations created rules that require both domestic and foreign food facilities that want to sell food in this lucrative market to register with the FDA, pursuant to Section 415 of the Federal Food, Drug, and Cosmetic Act. It also required companies to implement hazard analysis and risk-based preventive controls, and to adhere to industry-wide safe manufacturing practices.
Among the GMPs that have had a significant impact on food manufacturing are the provisions of section 402, including subsection (a)(3) and (4), that label as adulterated food that “is prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.”
Ensuring Food Borne Outbreaks are Stopped: Trace-backs and Recalls
When a food borne illness outbreak does happen, the FDA is at the center of efforts to identify and prevent further harm to consumers. Across the nation, there are as many as 65-70 reportable diseases, depending on how they are counted, of which Botulism, Cyclosporiasis, hepatitis A, Listeriosis, Salmonellosis, Shigellosis, E. coli, and Vibriosis are among the more common food-borne diseases. When a doctor identifies one of these diseases, they are required to report the finding in writing to the local health agency. Local agencies then investigate the occurrence – often considering the seriousness of the disease and the number of persons who have reportedly become ill. In many cases, an epidemiologist or case investigator will call and interview the victim and try to determine what foods that person ate during the established incubation period. If, for example, a person develops salmonellosis, the health agency may serotype the salmonella (for example the recent outbreak of Salmonella Newport linked to consumption of onions). If there turn out to be other victims of Salmonella Newport, for example, the health agency may decide to send the stool sample to the state lab for further genetic processing and to upload the finding into Pulse Net, the international registry of infectious diseases. once that is done, health agencies can see if this one person’s illness matches the illness of other people – in the recent Salmonella Newport outbreak linked to consumption of onions, government agencies in the U.S. and Canada identified 1600 victims.
If and when a pathogen is identified in more than one person, as was the case in the Salmonella Newport outbreak, the agencies involved know there is an outbreak. If the victims reside in more than one state, the Centers for Disease Control and Prevention (CDC) is often called upon to head-up the investigation. It is at this juncture that the FDA may be called in with its expertise. Once the CDC and state and local health agencies have pin-pointed a probable source (say Onions), the FDA will then work with health agencies to “trace-back” the onions victims consumed to the origin – the manufacturer or growing location where the adulterated onions came from. In the now infamous Salmonella Newport outbreak, the trace-back efforts led to Thomson International Inc., a California company. Following the identification of Thomson International Inc. as the source of the adulterated onions, the FDA worked with Thomson to issue a recall, identify vendors of the contaminated onions, and identify how the onions became contaminated in the first place.
The FDA, in SUM, has been an American institution charged with preventing consumer harm, including food borne illness, and does so through regulation of the industry and, when there is an outbreak, assisting in identifying and stamping it out as quickly as possible.
