The decision to allow the restricted importation of puffer fish were predicated on the Japanese Ministry of Health and Welfare (MHW) officials development and implementation of an export protocol for puffer fish, which would provide the assurance that FDA's concerns would be adequately addressed, thus ensuring the safety of imported puffer fish. Rather, both parties discussed and agreed to an intention to permit the import of Japanese puffer fish on the basis of "special occasions". The agreement was never established to permit the unrestricted importation of Japanese puffer fish into the United States. Torafugu Buyer's Association (conditions of membership) There is to be a recognized import organization ! Shimonoseki Fugu Export Association, Shimonoseki city, Yamaguchi, JapanĢ. There is to be a recognized export organization Certification (Department of Health of the city of Shimonoseki)ġ. Develop and implement the necessary conditions (Proposed Requisite Matters) for export of Japanese puffer fish into the United States.Ħ. Each entry is to be inspected by the appropriate official of the Japanese government and certified as safe. provided that following actions were taken: The four years of discussions between the FDA and the Japanese Ministry of Health and Welfare (MHW) officials were concerned with the actions the Japanese government would take to assure that FDA's concerns would be adequately addressed, thus ensuring the safety of imported puffer fish.īoth parties discussed and agreed to an intention to permit the import of Japanese puffer fish on the basis of "special occasions". These concerns are compounded by the fact there is no known antidote for tetrodotoxin. While progress has been made in analytical methodology to determine the presence of toxin, it is still inadequate. For puffer fish there is no adequate sampling scheme that can assure a safe lot, since any single fish may contain a lethal dose of the toxin. FDA's concerns prior to the decision to allow the importation of Japanese puffer into the United States, were associated with the sampling of puffer fish and the analytical methodology to determine the absence of tetrodotoxin. Puffer fish has been on FDA's Automatic Detention List since 1980, because the product ".appears to contain the poisonous and deleterious substance tetrodoxin." FDA's certification program requires the agency to audit sample proposed entries.
FOOD AND DRUG ADMINISTRATION REGARDING PUFFER FISH Import Conditions for Japanese Puffer Fish EXCHANGE OF LETTERS BETWEEN JAPAN AND THE U.S.