To: Seafood HACCP Mailing List
Fr: Pamela Tom
Sea Grant Extension Program
University of California
Davis, CA USA
On April 6, 2006 the US Food and Drug Administration issued "Guidance for
Industry, Questions and Answers Regarding Food Allergens, including the
Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004"
(Edition 3): http://www.cfsan.fda.gov/~dms/alrguid3.html
Of the 24 questions and answers in the latest Guidance. here are answers
of interest to the seafood processing and retail industries:
- A major food allergen includes: milk, egg, FISH, CRUSTACEAN SHELLFISH,
tree nuts, wheat, peanuts and soybeans.
- The species must be declared for fish (e.g., bass, flounder, or cod) and
Crustacean shellfish (crab, lobster, or shrimp).
- Under FALCPA, Crustacean shellfish (such as crab, lobster, or shrimp),
and ingredients that contain protein derived from Crustacean shellfish,
are major food allergens, but molluscan shellfish (such as oysters, clams,
mussels, or scallops) are not.
- FALCPA's requirements apply to all packaged foods sold in the U.S. that
are regulated under the Federal Food, Drug, & Cosmetic Act, including both
domestically manufactured and imported foods (except meat products,
poultry products, and egg products).
- A company and its management may be subject to civil sanctions, criminal
penalties, or both under the Federal Food, Drug, and Cosmetic Act if one
of its packaged food products does not comply with the FALCPA labeling
requirements. FDA may also request seizure of food products where the
label of the product does not conform to FALCPA's requirements. In
addition, FDA is likely to request that a food product containing an
undeclared allergen be recalled by the manufacturer or distributor.
- FALCPA's labeling requirements extend to foods packaged by a retail or
foodservice establishment that are offered for human consumption. However,
FALCPA's labeling requirements do not apply to foods provided by a retail
food establishment that are placed in a wrapper or container in response
to a consumer's order - such as the paper or box used to convey a sandwich
that has been prepared in response to a consumer's order.
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