An HTML version of this document is available at
http://vm.cfsan.fda.gov/~lrd/sea-ovr.html
------------------------------------------------------------
 
CFSAN Handout*
1995
 
 
The Food and Drug Administration's Seafood Regulatory Program
 
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.
 
 
*Office of Seafood
Center for Food Safety and Applied Nutrition, FDA
1995