The U.S. national regulatory authority for public protection and seafood regulation is vested in the Food and Drug Administration (FDA). The FDA operates an oversight compliance program for fishery products under which responsibility for the product's safety, wholesomeness, identity and economic integrity rests with the processor or importer, who must comply with regulations promulgated under the Federal Food, Drug and Cosmetic (FD&C) Act, as amended, and the Fair Packaging and Labeling Act (FPLA). In addition, FDA operates the Low-Acid Canned Food (LACF) program which is based on the Hazard Analysis Critical Control Point (HACCP) concept, and is focused on thermally processed, commercially sterile foods, including seafood such as canned tuna and salmon.
Most FDA in-plant inspections consider product safety, plant/food hygiene and economic fraud issues, while other inspections address subsets of these compliance concerns. Samples may be taken during FDA inspections in accordance with the agency's annual compliance programs and operational plans or because of concerns raised during individual inspections. The FDA has laboratories around the country to analyze samples taken by its investigators. These analyses are for a vast array of defects including chemical contaminants, decomposition, net weight, radionuclides, various microbial pathogens, food and color additives, drugs, pesticides, filth and marine toxins such as Paralytic Shellfish Poison (PSP) and domoic acid.
In addition, FDA has the authority to detain or temporarily hold food being imported into the U.S. while it determines if the product is misbranded or adulterated. The FDA receives notice of every seafood entry, and at its option, conducts wharf examinations, collects and analyzes samples, and where appropriate, detains individual shipments or invokes "Automatic Detention," requiring private or source country analysis of every shipment of product when recurring problems are found, before the product is allowed entry.
Further, FDA has the authority to set tolerances in food for natural and man-made contaminants, except for pesticides, which are set by EPA. The FDA regulates the use of food and color additives in seafood and feed additives and drugs in aquaculture. FDA also has the authority to promulgate regulations for food plant sanitation (i.e., Good Manufacturing Practices (GMP) regulations), standards of identity, and common or usual names for food products. The agency has in force a set of GMP regulations for LACF and Acidified Foods (AF), including seafood. FDA also conducts risk assessments and other laboratory evaluations through experts at its Center for Food Safety and Applied Nutrition.
FDA has the authority to take legal action against adulterated and misbranded seafood and to recommend criminal prosecution or injunction of responsible firms and individuals.
FDA conducts both mandatory surveillance and enforcement inspections of domestic seafood harvesters, growers, wholesalers, warehouses, carriers and processors under the authority of the FD&C Act. The frequency of inspection is at the agency's discretion, and firms are required to submit to these inspections which are backed by federal statutes containing both criminal and civil penalties.
FDA provides financial support by contract to state regulatory agencies for the inspection of food plants, including seafood. Additionally, FDA provides technical assistance and training to the states through its State training and Information Branch. To provide a sound, scientific approach for its inspections, FDA conducts training through its Education and Training Staff. The agency operates small business assistance and consumer affairs functions at the District, Regional and Headquarters levels to foster compliance with regulations, to provide a greater understanding of the need for industry controls, to help exchange information among FDA, consumers and regulated industry, and to provide consumer advisories. To these same ends, the Center for Food Safety and Applied Nutrition (CFSAN) provides assistance directly to the industry and the consuming public through staffs dedicated to information and education activities. FDA provides extensive technical assistance in the area of seafood safety and sanitation to foreign governments through direct contacts and through the World Health Organization (FAO), both United Nations organizations.
The FDA also operates two other specific regulatory programs directed at seafood -- the Salmon Control Plan and the National Shellfish Sanitation Program (NSSP), recently augmented by the Interstate Shellfish Sanitation Conference (ISSC). These are voluntary programs involving the individual states and the industry.
The Salmon Control Plan is a voluntary, cooperative program among the industry, FDA and the National Food Processors Association (NFPA). The plan is designed to provide control over processing, plant sanitation, and to address concerns about decomposition in the salmon canning industry.
Consumer concerns about molluscan shellfish are addressed through the National Shellfish Sanitation Program ((NSSP). It is administered by FDA and provides for the sanitary harvest and production of fresh and frozen molluscan shellfish (oysters, clams and mussels). Participants include the 23 coastal shellfish-producing states and nine foreign countries.
The NSSP was created upon public health principles and controls formulated at the original conference on shellfish sanitation called by the Surgeon General of the U.S. Public Health Service in 1925. These fundamental components have evolved into the National Shellfish Sanitation Program Manual of Operations. A prime control is proper evaluation and control of harvest waters and a system of product identification which enables trace back to harvest waters.
FDA conducts reviews of foreign and domestic molluscan shellfish safety programs. Foreign reviews are conducted under a Memorandum of Understanding (MOU) which FDA negotiates with each foreign government to assure that molluscan shellfish products exported to the U.S. are acceptable.
The FDA conducts research in support of its seafood program. This research is directed to understanding the nature and degree of severity posed by various safety hazards, and other defects which may affect quality and economic integrity. Research also finds means to defect and to control these identified hazards. The FDA laboratories specializing exclusively in seafood research are located on the Atlantic, Gulf, and Pacific coasts in order to better address unique, regionally associated problems of toxins, contaminants, decomposition, and unsafe or deceptive harvest and processing practices.
Hypertext updated by ear 2001-AUG-15