FDA Issues Guidelines on 'In-Shell Product' Definition and Regulations for Shellfish in Accordance with 2022 Food Code

The U.S. Food and Drug Administration (FDA) has recently published a factsheet detailing the definition and regulatory requirements for "in-shell product" as outlined in the 2022 Food Code. This category, a subset of molluscan shellfish, necessitates specific guidelines for safe handling, aligning with the National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish.

FDA In-shell requirements

The 2022 FDA Food Code classifies "in-shell product" as nonliving, processed shellfish with one or both shells intact. Examples include, but are not limited to, individually quick-frozen (IQF) oysters, whole frozen shellfish, banded high-pressure treated oysters, and irradiated oysters. The concern arises from the vulnerability of in-shell products to pathogens such as Vibrio due to their growth environments, potential contamination, and the fact that molluscan shellfish are often consumed whole, either raw or partially cooked.

Notable updates to the FDA Food Code include specific container and labeling requirements for in-shell products. For display purposes, these products may be presented on drained ice or held in a display container, with a consumer-specified quantity allowed for removal if the source is identified and recorded as per Food Code specifications. Protection against contamination is emphasized during these processes.

Accurate source identification on molluscan shellstock identification tags is crucial for expedited epidemiological investigations and regulatory actions in the event of a foodborne illness outbreak linked to shellfish. Lot separation is emphasized to isolate implicated shellfish during outbreaks and trace them back to their source.

Proper labeling is mandated for prepackaged, consumer self-service containers of shucked shellfish, with labeling information recorded on a log sheet correlating with the date of sale. If in-shell products are removed from their labeled containers, preservation of source identification through record-keeping systems is required.

Maintaining accurate records that can be readily matched to each lot of molluscan shellfish is essential for efficient traceability to the original source. The 90-day record-keeping requirement allows time for the identification of hepatitis A virus infections, which have a longer incubation period compared to other shellfish-borne diseases. These guidelines aim to enhance safety measures and streamline regulatory responses in the shellfish industry.