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Association of Food & Drug Officials
 
 
Resolution Year 2003
Resolution Number 2:

Imported, Cooked, Uncertified Bivalve Molluscan Shellfish

Whereas, the harvesting, processing and distribution of fresh and fresh-frozen bivalve molluscan shellfish (clams, mussels, oysters and whole or roe-on scallops) are regulated by the states under the strict standards of the National Shellfish Sanitation Program (NSSP), and

Whereas, the fresh or fresh-frozen shellfish from foreign countries not produced in accordance with the NSSP under a Memorandum of Understanding (MOU) with the Food and Drug Administration (FDA) are termed “uncertified” and are prohibited by state laws or regulations from being sold in the states, and

Whereas, the imported, uncertified, shellfish from foreign countries is permitted to be sold in all states only if the product is processed by adequate heat treatment (“cooked”) and, therefore, deemed to no longer be fresh or fresh-frozen, provided it is safe, wholesome and labeled in accordance with the Food, Drug & Cosmetic Act, and

Whereas, imported frozen shellfish, originating from uncertified sources, that actually is cooked and then frozen, is often not labeled as “cooked,” for reasons known only to the individual shipper, thereby creating confusion for FDA and state and local field inspectors who must determine the true status of the product they encounter on the job, including whether it meets the criteria for embargo or federal seizure, and

Whereas, each such determination usually involves a significant expenditure of resources for sample collection, analysis, interagency communication, and potential inspection and reporting, therefore be it

Resolved, that in order to conserve badly needed resources, yet provide increased protection for the consumer, AFDO recommends to FDA that it require that all imported, uncertified shellfish that have been sufficiently heat processed to eliminate all aerobic pathogens, be prominently labeled as “cooked,” and be it further

Resolved, that any uncertified processed shellfish lacking this label designation be considered adulterated under Section 402(a) (4) of the FD&C Act and automatically refused entry into U.S. commerce, since the microbiological quality of the harvest area from which these apparently uncooked shellfish were taken is unknown.

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