Import Alert 16-20

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 16-20

Published Date: 03/18/2011

Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Puffer Fish"

Reason for Alert:

Tetrodotoxin poisoning results from the ingestion of edible portions of the puffer fish, which may become contaminated from the poisonous excised tissue during processing, or from the transfer of the toxin from poisonous parts as a result of improper freezing and gradual hawing of unprocessed puffer fish. There is a 50% fatality rate among those who ingest tetrodotoxin (TTX). The toxin cannot be destroyed by cooking or freezing. While progress has been made in analytical methodology to determine the presence of toxin, the methodology is still inadequate.

Guidance:

Districts may detain, without physical examination, all shipments of Puffer Fish, Globe Fish, Swell Fish, Fugu, or other members of the order Tetradontiformes. Districts may also detain any food that lists these in the ingredient statement or anywhere on the product label.

NOTE: Experience has shown that the best method for obtaining a product which will not cause illness or death is the highly specialized training and knowledge for product preparation. Based on this premise, there is an agreement between FDA and the government of Japan, which permits the importation of the species Tora (Tiger) Fugu (fugu rubripes rubripes) for consumption in the United States. With this agreement, the puffer fish are:

a) processed and prepared, so that they are "ready" for consumption, by the Fugu Fish Market in the city of Shimonoseki, Yamaguchi Prefecture, Japan, which handles over 80% of the total Fugu consumption in Japan, and whose processing factories are manned by specialists licensed by the Government as special Fugu Chefs;

b) shipped certified , by the Department of Health of the City of Shiminoseki, in Yamaguchi Prefecture, Japan, as legally processed in an
authorized processing factory.

These shipments of puffer fish from Japan are allowed entry into the United States through JFK International Airport.

These puffer fish are brought into the United States no more than two or three times a year, between September and March.

The US import organization, Wako International, located in New York City, imports these fish into the United States.

In general, puffer fish appear to be adulterated under 402(a)(1) because of the presence of toxin. However, those Japanese puffer fish brought in to New York City's JFK International Airport do not have the appearance of adulteration because of the preparation process, as referenced in the agreement between the Japanese Government and the FDA.

Japan (JP); China (CN); Taiwan (TW); Philippines (PH); and Mexico (MX) are the countries that frequently export puffer fish.

For information on this and other requirements concerning this alert, contact DIOP, Imports Program Branch, CFSAN, Office of Compliance, Office of Food Safety.

Product Description:

Puffer Fish; Globe Fish; Swell Fish; Fugu; Members of the order Tetraodonitiformes, and products such as stews, bisques, congee, cereal and grain gruels containing puffer fish, fugu, Globefish, etc.

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous and deleterious substance (tetrodotoxin) which would ordinarily render it injurious to health [Adulteration, Section 402 (a)(1)]."

OASIS charge code - POISONOUS

Countries

CHINA

(16 A - - 65) Puffer