Manufacturers and distributors of seafood products, which
include all fish and fishery products intended for human
consumption, are required to obtain a Processed Food
Registration from the California Department of Public Health, Food and Drug
Branch (FDB). Fish and fishery products, include, but are not
limited to the following: finfish (i.e. fresh and saltwater),
crustaceans (i.e. crabs, shrimps and lobsters), echinoderms (i.e. sea cucumbers
and sea urchins), reptiles (i.e. alligators and turtles), amphibians (i.e.
frogs) and mollusks (i.e. escargot and abalones). Molluscan
shellfish is not considered a seafood product. All seafood
manufacturers and distributors are regulated by California statutes and Federal
regulations under the current Good Manufacturing Practices (21 CFR Part 117) and
the Seafood Hazard Analysis Critical Control Point (HACCP) Regulations (21 CFR
“Shellfish” includes all species of
native and nonnative raw oysters, clams, mussels and whole scallops, either
fresh or frozen, and either shucked or in-the-shell. Firms that process, handle,
and distribute shellfish must obtain a Shellfish Handling and Marketing
Certificate from FDB. This includes businesses involved in the distribution of
shellfish that do not take physical possession of the shellfish.
The Shellfish Handling and Marketing Certificate is
required even if the facility has a Processed Food
Registration (PFR). The Shellfish Handling and Marketing
Certificate is free of charge.
A Processed Food Registration is not required if firms
exclusively manufacture, handle and distribute raw, fresh or frozen (shucked or
The Shellfish Handling and Marketing Certificate assigns a
dealer’s number for each certified facility and authorizes a dealer to engage in
specific activities such as repacking, reshipping and shucking shellfish.
The dealer’s number is required to be listed on all shellfish tags and
labels to indicate that the shellfish has originated from a certified
Shellfish dealers shipping products into interstate commerce
are required to meet the requirements of the National Shellfish Sanitation
Program (NSSP) and must be certified for listing on the Interstate Certified
Shellfish Shippers List (ICSSL).