322 CMR 16.01
Background and Purpose
The National Shellfish Sanitation Program (NSSP) is a program under the U.S. Food and
Drug Administration (FDA) to promote the sanitary control of molluscan shellfish produced,
harvested and sold for human consumption. The Interstate Shellfish Sanitation Conference
(ISSC), comprised of representatives of the federal government, the states and industry, reviews,
revises and updates the NSSP as needed. The NSSP has established a Model Ordinance (MO),
which is updated on a biannual basis. The MO sets forth stringent guidelines addressing the
harvest, handling, transportation and sale of shellfish to ensure that risks to public health
associated with the consumption of shellfish are avoided.
To safeguard public health and to allow for shellfish produced, harvested and sold for
consumption to enter interstate commerce, states must manage commercial shellfisheries in a
manner that conforms to the NSSP’s MO. The actions required by the MO include, but are not
limited to: establishing shellfish growing area classifications and subsequent restrictions on the
harvest of contaminated shellfish; adopting best practices for the harvest, handling and transport
of shellfish to minimize the risk of foodborne illness; establishing a framework that provides for
the expeditious recall of nonconforming shellfish product; addressing risks associated with
Vibrio parahaemolyticus; describing the conditions bywhich contaminated shellfish harvest may
be conducted; and managing marine biotoxin events.
The Division of Marine Fisheries manages its shellfish resources and commercial shellfish
fisheries in strict conformity with the NSSP’s MO. The Division has adopted the provisions of
the MO in regulations at 322 CMR 16.00 to provide notice to the public of the comprehensive
requirements applicable to the safe management of commercial shellfisheries and give the
Division, through the Massachusetts Environmental Police, the authority to enforce against
violations of 322 CMR 16.00. 322 CMR 16.00 also serves to safeguard public health, maintains
consumer confidence and promotes the state’s shellfish fisheries.
The Division also manages the states shellfish resources and shellfisheries to enhance the
propagation of naturally occurring populations, reduce the risk of spreading veterinary diseases,
protect important fisheries habitat (e.g., eel grass), and promote commercial shellfisheries. To
these ends, 322 CMR 16.00 establishes minimum sizes, shellfish management areas and related
best practices.