Import Alert 16-50

"Detention Without Physical Examination of Molluscan Shellfish"

Examination of shipments of molluscan seafood from firms on the red list have been made. Salmonella, Vibrio cholera, other bacteria and/or viruses (e.g. Hepatitis A, Norwalk, etc.) were found, or epidemiological evidence associated the product with a food-borne illness outbreak.

Additionally, some shipments were labeled as "cooked" when in fact the product only received a minimal heat treatment in order to "open" the shells.

Districts may detain, without physical examination, the specified product from the manufacturers on the attachment for this alert regardless of whether they are from a certified shipper under the Interstate Certified Shellfish Program.

Removal of Firms from this Import Alert:

Firms (other than certified shellfish shippers) requesting removal from this import alert will need to provide CFSAN, Office of Compliance, HFS-606, with a detailed HACCP plan for the foreign processor. This includes firms on the alert due to labeling problems (cooked vs. raw); firms whose products have been found with bacterial or viral contamination; and firms whose products have been associated with a food-borne illness outbreak. A copy of the petition letter should be forwarded to DIOP, HFC-170.

Certified shellfish shippers can be removed from this Import Alert when inspected and found in-compliance by the country's competent authority with the National Shellfish Sanitation Program (NSSP) as required by the MOU between the United States and the signatory country. The competent authority can then request that the certified shellfish shipper be removed from this Import Alert by providing evidence to CFSAN, Office of Compliance, HFS-606. This includes products that have been found with bacterial or viral contamination and firms whose products have been associated with a food-borne illness outbreak. A copy of the petition letter should be forwarded to DIOP, HFC-170.

For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Raw Molluscan shellfish

For microbiological (including viruses) violations:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, Vibrio cholera, and/or other bacteria or viruses, deleterious substances which may render it injurious to health. [Adulterated, Section 402(a)(1)]"

OASIS charge code - SALMONELLA, BACTERIA

For Epidemiological Evidence (Association with a Food-borne Illness Outbreak), charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(1) in that it appears to have been manufactured, processed, or packed under insanitary conditions. [Adulteration, Section 402(a)(4)]"

OASIS Charge code - MFR INSAN

For labeling violations, charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the labeling of the product appears to be false and misleading. [Misbranded, Section 403(a)(1)]"

OASIS Charge code - FALSE