Q - What are United States of America Food and Drug Administration requirements regarding Shellfish Certification?

A - Shellfish must comply with the general requirements of the Federal Food, Drug, and Cosmetic Act and also with requirements of State health agencies cooperating in the National Shellfish Sanitation Program (NSSP) administered by the United States of America Food and Drug Administration in cooperation with the Interstate Shellfish Sanitation Conference (ISSC).

Because raw shellfish-clams, mussels, and oysters-may transmit diseases such as typhoid fever, or be carriers of natural or chemical toxins, it is critical that they be obtained from unpolluted waters and handled and distributed in a sanitary manner.

Shellfish harvesting is prohibited in areas contaminated by sewage or industrial wastes. To enforce this prohibition, these areas are patrolled and warning signs are posted by State health or fishery control agencies. State inspectors also check to ensure shellfish are harvested from approved growing areas and that shellfish shippers meet the NSSP requirements before certifying the plant to United States of America Food and Drug Administration for listing in the Interstate Certified Shellfish List.

Shellfish plants certified by the State Shellfish Sanitation Control Authority (SSCA) are required to place their certification number on each container or package of shellfish shipped. The number indicates that the shipper is under State inspection, and that it meets the applicable state requirements. It also serves the important purpose of identifying and tracing shipments found to be contaminated or involved in disease outbreaks. Shippers are also required to keep records showing the origin and disposition of all shellfish handled and to make these records available to the control authorities.

Certain shellfish, mainly mussels and clams, may contain a naturally occurring marine toxin derived from plankton organisms upon which the shellfish feed. Such toxic shellfish may cause illness or even death. State shellfish control agencies also maintain surveillance of shellfish growing areas for marine biotoxins. The areas where these biotoxins periodically occur are from Maine to Massachusetts, the Southern Coast, and the West Coast including Alaska.

Standards of identity have been set for raw oysters, Pacific oysters, and canned oysters. The standards define the sizes of oysters and prescribe the methods of washing and draining to prevent adulteration with excess water. A fill-of-container standard for canned oysters fixes the drained weight at not less than 59% of the water capacity of the container (21 CFR 161.130 to 161.145).

Food Import / Export Regulations Advice Guidance and Information