http://www.fda.gov/RetailFoodProtection November 2023

New Food Code Definition: 

“In-Shell Product” 

In the 2022 Food Code, the FDA included a new term defining “in-shell product” as non-living, 

processed shellfish with one or both shells present. In-shell product falls under the broader 

definition of molluscan shellfish.

Specifically, “in-shell product” is:

• A non-living (dead) molluscan shellfish product with one or both shells attached. 

• Common examples include, but are not limited to:

- individually quick frozen (IQF) oysters

- whole frozen shellfish 

- banded high pressure treated oysters

- irradiated oysters.

These products may or may not be treated to limit pathogens, such as Vibrio sp.

Flow Chart of FDA Food Code Terminology

Molluscan Shellfish

Any edible species of fresh or frozen oysters, clams, mussels, and scallops or edible portions thereof. 

(Except when the scallop product consists only of the shucked adductor muscle.)

Oysters Clams Mussels Scallops

Shellstock

 LIVE in the shell(s)

Shucked Shellfish

Both shells removed

NEW 

FOOD CODE DEFINITION

In-Shell Product

Non-living, processed 

in the shell(s)

“Molluscan Shellfish” includes the following: shellstock, shucked shellfish, in-shell product. 
New Food Code Definition: “In-Shell Product” (continued)

http://www.fda.gov/RetailFoodProtection 2 November 2023

Foodborne Illness Prevention for “In-Shell Product” 

in Food Establishments

In-shell products are a subset of molluscan shellfish, which includes oysters, clams, mussels, and 

scallops (except where the final product is the shucked adductor muscle only). Pathogens, both 

bacteria and viruses, found where these molluscan shellfish live can cause disease in humans.

These pathogens are of particular concern to in-shell products because:

(1) Environments in which molluscan shellfish grow are commonly subject to contamination 

from sewage, which may contain pathogens, and to naturally occurring bacteria, which may 

also be pathogens.

(2) Molluscan shellfish filter and concentrate pathogens that may be present in surrounding 

waters. 

(3) Molluscan shellfish are often consumed whole, either raw or partially cooked.

All updates to the FDA Food Code referring to “in-shell product” are as follows:

Update to Container Requirements: 

• For display purposes, IN-SHELL PRODUCT may be removed from the container in which they 

are received, displayed on drained ice, or held in a display container, and a quantity specified 

by a CONSUMER may be removed from the display or display container and provided to the 

CONSUMER if:

- The source of the IN-SHELL PRODUCT on display is identified as specified under 

§ 3-202.18 and recorded as specified under § 3-203.12; and

- It is protected from contamination. (¶ 3-203.11 C).

Why? 

Accurate source identification of the harvesting area, harvester, and dealers must be contained 

on molluscan shellstock identification tags so that if a shellfish-borne disease outbreak occurs, 

the information is available to expedite the epidemiological investigation and regulatory action.

Lot separation is critical to isolating shellfish implicated in illness outbreaks and tracking 

them to their source. Proper identification is needed for tracing the origin and determining 

conditions of shellfish processing and shipment. If the lots are commingled at retail, traceability 

is undermined and the root of the problem may remain undetected. If no causative factors are 

identified in the food establishment, tracing the incriminated lot helps in identifying products 

that need to be recalled or growing waters that may need to be closed to harvesting.

When shucked shellfish are prepackaged in consumer self service containers, the labeling 

information as specified under § 3-202.18 must be recorded on a log sheet to correlate with the 

date of sale of the consumer sized containers.
New Food Code Definition: “In-Shell Product” (continued)

http://www.fda.gov/RetailFoodProtection 3 November 2023

Update to Labeling Requirements:

• If IN-SHELL PRODUCT is removed from its tagged or labeled container the source identification 

will be preserved by using a record keeping system as specified under sub¶ 3-203.12 (C)(1).

Why? 

Accurate records that are maintained in a manner that allows them to be readily matched to 

each lot of molluscan shellfish provide the principal mechanism for tracing molluscan shellfish 

to its original source. If an outbreak occurs, regulatory authorities must move quickly to close 

affected growing areas or take other appropriate actions to prevent further illnesses. Records 

must be kept for 90 days to allow time for hepatitis A virus infections, which have an incubation 

period that is significantly longer than other shellfish-borne diseases, to come to light.

For more information: 

• The FDA Food Code is available at: http://www.fda.gov/FoodCode

• See the NSSP Guide for the Control of Molluscan Shellfish (Model Ordinance): 

https://www.fda.gov/media/143238/download

• Conference for Food Protection (CFP) developed guide for: 

Retail Industry Best Practices and Regulatory Guidance Toolkit for Shellstock Investigations

http://www.foodprotect.org/guides-documents/retail-industry-best-practices-and-regulatoryguidance-toolkit-for-shellstock-investigations/