FDA's Seafood Safety Program

29/04/08 FDA has statutory authority and responsibility for the safety of all food, except for most meats, poultry and processed egg products, which are regulated by the U.S. Department of Agriculture.

With respect to seafood, FDA operates a mandatory safety program for all fish and fishery products under the provisions of the Federal Food, Drug and Cosmetic (FD&C) Act, the Public Health Service Act, and related regulations. The FDA program includes research, inspection, compliance, enforcement, outreach, and the development of regulations and guidance. As a cornerstone of that program, FDA publishes the Fish and Fisheries Products Hazards and Controls Guidance, an extensive compilation of the most up-to-date science and policy on the hazards that affect fish and fishery products and effective controls to prevent their occurrence. FDA is finalizing the fourth edition of this guidance document, which has become the foundation of fish and fishery product regulatory programs around the world.

FDA's program for fish and fishery products is comprehensive in its nature and is fully integrated into the food safety structures of FDA's Center for Food Safety and Applied Nutrition (CFSAN) and FDA's field organization, the Office of Regulatory Affairs (ORA). Because of the cold-blooded nature of fish and the nature of the aquatic environment in which they live, fish and fishery products pose unique food safety challenges which are quite different than those posed by land animals. FDA has developed extensive expertise in these areas over decades of regulating this commodity.

CFSAN experts are responsible for evaluating the hazard to public health presented by chemical and microbiological contaminants in fish and fishery products. FDA operates the Gulf Coast Seafood Laboratory in Alabama, which specializes in seafood microbiological, chemical and toxins research. In addition, seafood research is conducted at CFSAN's research laboratory in College Park, Maryland. FDA, in collaboration with the National Oceanic and Atmospheric Administration (NOAA) at the Department of Commerce, also represents the United States at the Codex Alimentarius Commission's Committee on Fish and Fishery Products, the international food safety standard setting body for this commodity.

Inspections

FDA's field staff is responsible for ensuring regulatory compliance for fish and fishery products produced in the United States and for those products imported from abroad. The field staff conducts inspections of fish and fishery product processing establishments, conducts follow-up investigations to track food-borne illnesses, and performs other activities designed to ensure the safety of these products. In FY 2007, FDA staff and state contractors conducted approximately 3,600 inspections of foreign and domestic seafood manufacturers, processors, importers, and storage facilities.

Processors of fish and fishery products are subject to FDA's Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, commonly known as the Seafood Hazard Analysis Critical Control Point (HACCP) Regulation, in 21 C.F.R. Part 123. In short, this regulation requires both domestic and foreign processors of fish and fishery products to understand the food safety hazards associated with their process and product and, through a system of preventive controls, to keep those hazards from occurring.

The HACCP inspection approach is used by FDA during domestic and foreign inspections of seafood processors to focus its attention on the parts of seafood production and processing that are most likely to affect the safety of the product. In contrast to historical methods of evaluating processing practices on the day of the inspection, the HACCP approach allows FDA to evaluate processors' overall implementation of their HACCP systems over a period of time by having access to the firms' HACCP Plans, including monitoring, corrective action, and verification records. In this model, it is the seafood industry's responsibility to develop and implement HACCP controls and the regulatory agency's to ensure that the industry complies.

Every three years, FDA issues compliance programs that outline the Agency's field staff's inspection responsibilities. The Domestic Fish and Fisheries Products Compliance Program (CP 7303.842) and the Import Seafood Compliance Program (CP 7303.844) provide a priority list for inspection coverage based mostly on risk. Examples of high priority products include ready-to-eat products, such as hot or cold smoked fish, scombrotoxin-forming fish, such as tuna or mahi-mahi, aquacultured seafood products, and fish packed in reduced oxygen packages.

Annually, FDA determines a "work plan" for each FDA district office that outlines the Agency's field staff's domestic inspection responsibilities. This work plan focuses on areas that are a priority for the Agency, and allocates available resources.

Even though inspectional coverage is based primarily on product risk, FDA district offices may adjust that coverage to a particular establishment, such as one that may have been associated with a consumer complaint or illness or one with a poor compliance history. For example, the work plan may dictate that a processor be inspected annually, but if during an inspection the processor is found out of compliance re-inspection will occur more rapidly.

The regulatory sanctions that FDA has available to apply to domestic processors of fish and fishery products that are non-compliant are warning letters, seizure of products, injunction against further noncompliant practices, or prosecution of an individual or establishment.