SHELLFISH SANITATION PROTOCOL IN FEDERAL WATERS

Diane Windham* and Janet Whaley
NOAA Fisheries West Coast Region
501 West Ocean Blvd., Suite 4200
Long Beach, CA 90802
(562) 980-3238
 diane.windham@noaa.gov
 

The National Shellfish Sanitation Program (NSSP) is the cooperative state-federal-industry program for the sanitary control of shellfish to ensure that shellfish produced in accordance with these guidelines will be safe and sanitary. The Interstate Shellfish Sanitation Conference (ISSC) is the organization consisting of agencies from shellfish producing and receiving States, the U.S. Food and Drug Administration (FDA), the shellfish industry, the National Oceanographic and Atmospheric Administration (NOAA), and the Environmental Protection Agency (EPA). The ISSC provides the formal structure wherein State regulatory authorities, with FDA concurrence, can establish updated guidelines and procedures regarding the sanitary control of the shellfish industry, which are published in the NSSP Guide for the Control of Molluscan Shellfish.   The NSSP Guide does not explicitly cover requirements for the sanitary control of shellfish harvested from federal waters. The lack of an NSSP pathway for this activity has impeded the harvest of shellfish in federal waters to date, and potentially impacts expansion of shellfish aquaculture in federal waters, a NOAA priority.  While microbiological and marine biotoxin testing and tagging requirements are established in the NSSP for shellfish products destined for interstate commerce, there was no established framework for requirements associated specifically for growing and harvesting cultured shellfish in federal waters.  

In response to a previous request by industry to harvest shellfish from federal waters where toxic algae were known to be a risk, FDA collaborated with NOAA, the shellfish industry, and the States where the product was intended to be landed to find a solution that would allow industry access to valuable surf clam and ocean quahog resources with processes in place to protect public health.  A Memorandum of Understanding (MOU) was established to clarify the roles and responsibilities of all parties to ensure the shellfish were harvested in a manner consistent with NSSP requirements for product harvested in State waters.  The most recent request to harvest shellfish from federal waters posed another challenge - it was related to aquaculture (i.e., an offshore mussel farm).  While some of the considerations employed by FDA during the previous case to classify growing areas and control for marine biotoxins were applicable to the proposed aquaculture activity in federal waters, there were several other NSSP requirements that FDA did not have the legal authority or means to address (e.g., permitting and inspections for aquaculture). Thus, the NOAA Seafood Inspection Program (SIP) offered assistance and worked with FDA to develop a pathway that industry could use to comply with the necessary permitting and tagging requirements.