IA #16-20, 10/28/03 IMPORT ALERT #16-20, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF PUFFER FISH *** AND FOODS THAT CONTAIN PUFFER FISH***"
NOTE: This revision updates the products and product codes subject to the
alert. Changes are bracketed by asterisks (***).
TYPE OF ALERT: Detention Without Physical Examination
NOTE: This import alert represents the Agency's current guidance to FDA field
personnel regarding the manufacturer (s) and/or product(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.
PRODUCT: 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.***
PRODUCT CODE: 16A- - 65, 16B- - 65, 16C- - 65, *** 16S- - 65, 16I- - 65,
16W- - 15, 16W- - 21, 16W- - 23, 38A- - 99, 38A- - 09 ***
PROBLEM: Tetrodotoxin, a poisonous substance
PAC: 07844
PAF: BIO
COUNTRY: All
MANUFACTURER/
SHIPPER: All
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
Codes: BIO TOXIN
RECOMMENDING
OFFICE: Division of Import Operations and Policy (HFC-170), Office
of Seafood/Policy Guidance Branch (HFS-416), ***Office of
Compliance/ Division of Enforcement and Programs/Imports
Program Branch(HFS-606)***.
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 thawing 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; and
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 (301) 443-6553 or *** Angel M.
Suarez, Imports Program Branch, Office of Compliance (301)
436-2146, or Mildred Benjamin, Policy Guidance Branch,
Office of Seafood (301) 436-1424 ***
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required.
KEY WORDS: Puffer Fish, Globe Fish, Swell Fish, Fugu, Tetrodotoxin,
Tetradontiformes.
PREPARED BY: Stella Notzon, DIOP, (301) 443-6553
DATE LOADED
INTO FIARS: October 28, 2003
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