Detention Without Physical Examination of Products from Japan Due to
Radionuclide Contamination

NOTE: Revision to this Import Alert dated July 25, 2012 adds multiple products to the list of products restricted by the Government of Japan, in response to decrees issued from 01/17/2012 to 05/31/2012. The format of the product listing has also been amended. Changes are noted and bracketed by three asterisks (***).

Previous revisions to this Import Alert dated March 23, April 12, April 14, April 20, April 21, May 9, June 13, July 6, October 21, 2011, and February 1, 2012 provided updates to the products and/or prefectures subject to detention without physical examination.

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.

On March 11, 2011, an 8.9 magnitude earthquake triggering a 30 ft tsunami struck the Pacific Coast of Japan. The force of the tsunami destroyed a great deal of the infrastructure along portions of the Japanese coast. The most notable damage from the tsunami has affected the Fukushima Daiichi nuclear plant. The following prefectures are in the closest proximity to the Fukushima Daiichi nuclear plant: Fukushima, Gunma Ibaraki, and Tochigi.

The Fukushima Daiichi nuclear plant houses several nuclear reactors that have posed signs of a potential threat of radiological contamination to the surrounding areas. Due to the public health concerns that are associated with radiation and nuclear contamination, FDA has increased surveillance of regulated products from Japan.

On March 19, 2011 the Japanese Ministry of Health, Labour and Welfare confirmed the presence of radioactive iodine contamination in dairy, fresh produce, and infant formula products. Japanese data analyses revealed that the food products measured from March 16-18, 2011 indicated the presence of radioactive iodine was five times the acceptable levels. The elevated levels were identified in products tested in Kawamata Town, Fukushima Prefecture and Ibaraki Prefecture, areas around the Fukushima Daiichi nuclear power plant.

Though radioactive iodine has a short half-life of about 8 days and decays naturally within a matter of weeks, there is a risk to human health if radioactive iodine in food is absorbed into the human body. If ingested, it can accumulate in and cause damage to the thyroid. Children and young people are particularly at risk of thyroid damage due to the ingestion of radioactive iodine.

On March 21, 2011 the Japanese Prime Minister ordered the Governors of the affected prefectures of Fukushima, Gunma, Ibaraki, and Tochigi to stop the distribution of spinach and kakina (a local Japanese vegetable) into the market, and ordered the Governor of Fukushima prefecture to stop the distribution of raw milk.

On March 23, 2011 the Japanese Prime Minister ordered the addition of flowerhead brassicas, head leafy vegetables, and non-head leafy vegetables to the group of products previously restricted from distribution into the market on March 21, 2011. The Governor of the Ibaraki prefecture was also ordered to stop the distribution of raw milk and fresh parsley. This means no such products may lawfully be placed in the domestic or export markets.

Review of additional data received after March 23, 2011, indicated vegetables from two additional prefectures contain unsafe levels of Iodine-131. These additional prefectures are Chiba and Saitama. We do not have specific geographical information for the samples found to contain unsafe levels of radionuclides beyond which prefectures they were from. However, the samples were from a variety of vegetables and were taken on different dates. In light of this, and due to the unpredictability of weather patterns and the distribution patterns of any radioactive material that may reach crops and pasture, the entire area of the two prefectures has been included in this Import Alert. In addition, we are including in this Import Alert not just those vegetables found to contain unsafe levels radionuclides, but all milk, milk products, and produce from these prefectures, because there is no known specificity for deposition of radionuclide on certain vegetation but not others.

On April 12, 2011 the Japanese government lifted its restriction from distribution of spinach and kakina from the Gunma prefecture, and kakina from the Tochigi prefecture based on data received. Because this restriction of sale by the Government of Japan has been lifted, detention under section 801(a)(2) is no longer appropriate for spinach and kakina from the Gunma prefecture, and kakina from the Tochigi prefecture.

On April 13, 2011 the Government of Japan ordered the addition of mushrooms to the group of products previously restricted from distribution into the market on March 21, 2011.

On April 10, April 14, and April 17, 2011 the Japanese government lifted its restriction from distribution of milk, kakina, and spinach from the Ibaraki prefecture respectively, based on data received. Because this restriction of sale by the Government of Japan has been lifted, detention under section 801(a)(2) is no longer appropriate for milk, kakina, and spinach from the Ibaraki prefecture.

On April 20, 2011 the Government of Japan ordered the addition of sand lance from Fukushima prefecture to the group of products previously restricted from distribution into the market on March 21, 2011.

On May 9, 2011 FDA reviewed additional data received from the Government of Japan indicating radiation is no longer being detected in food products from the prefectures of Gunma, Chiba, and Saitama. Products from these prefectures are removed from Detention Without Physical Examination.

On June 2, 2011 the Japanese Prime Minister ordered the addition of tea leaves to the group of products previously restricted from distribution into the market on from the Ibaraki and Tochigi prefectures.

On June 27, 2011 the Japanese Prime Minister ordered the addition of tea leaves to the group of products previously restricted from distribution into the market on from the Kanagawa prefecture, and dace, ayu, and cherry salmon (yamame) from the Fukushima prefecture. On June 30, 2011 and July 4, 2011 the Japanese Prime Minister ordered the addition of tea leaves to the group of products previously restricted from distribution into the market on from the Gunma and Chiba prefectures.

From July 19 to August 29, 2011 the Japanese Prime Minister ordered the addition of yuzu to the group of products previously restricted from distribution into the market on from the Fukushima prefecture, and beef from the Fukushima, Kanagawa, Tochigi, Gunma, Chiba, Miyagi, and Iwata prefectures.

From November 7, 2011 to January 16, 2012 the Japanese Prime Minister ordered the addition of kiwi fruit, rice, and bear meat, to the group of products previously restricted from distribution into the market on from the Fukushima prefecture, boar meat from the Fukushima, Ibaraki, and Tochigi prefectures, shitake mushrooms from the Chiba, Ibaraki, and Miyagi prefectures, brick-cap mushrooms and pholiota nameko from the Tochigi prefecture, and deer meat from the Tochigi prefecture.

***From Janaury 17, 2012 to May 31, 2012 the Japanese Prime Minister ordered the addition of hatakewasabi, wild Japanese butterbur scape, and common carp (not farm raised) from the Fukushima prefecture; bamboo shoots and log-grown shitake mushrooms from the Tochigi, Ibaraki, Chiba, Miyagi, and Iwate prefectures; boar meat from the Miyagi prefecture; Japanese pepper from Tochigi prefecture; Japanese celery from the Iwata prefecture; eel, rockfish, Nibe croaker, and channel catfish (not farm raised) from the Ibaraki prefecture; panther puffer from the Miyagi prefecture; seabass and olive flounder from the Ibaraki and Miyagi prefectures; Pacific cod from the Miyagi and Iwata prefectures; dace from Gunma, Miyagi, and Iwata prefectures; wild white spotted char (not farm raised) from the Fukushima, Miyagi, and Iwata prefectures; crucian carp (not farm raised)from the Fukushima and Ibaraki prefectures; land locked salmon from the Fukushima, Gunma, and Miyagi prefectures; pteridium aquilinum (bracken fern) from the Fukushima, Tochigi, and Iwata; koshiabura (wild tree sprout) from the Fukushima, Ibaraki, Tochigi, Miyagi, and Iwata prefectures; royal fern from the Fukushima, Tochigi, Miyagi, and Iwata prefectures and wild Arelia root from the Fukushima and Tochigi prefectures. This means no such products may lawfully be placed in the domestic or export markets.

***

FDA recognizes that the government of Japan is taking steps to address this issue and FDA will continue to provide support to their efforts.

Districts may detain, without physical examination, the specified products from firms in the *** Fukushima, Ibaraki, Tochigi, Gunma, Kanagawa, Chiba, Miyagi, and Iwata*** prefectures.

FDA and the Japanese government will continue to collaborate to ensure products from the affected prefectures do not pose a health risk to U.S. consumers. FDA will continue monitoring the public health risks due to radionuclide contamination, and when appropriate will remove the Import Alert and resume routine coverage of entries.

Questions or issues involving import operations should be addressed to the Division of Import Operations & Policy at 301-796-0356.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301-796-6600.

All specified products from the affected noted prefectures in Japan (see Charge section for listing).



02A[][]05 Rice, Cultivated, Whole Grain
09[][][][] Milk/Butter/Dried Milk Products
14[][][][] Filled Milk/Imitation Milk Products
*** 16A [][][] Fish, N.E.C. ***
17[][][][] Meat, Meat Products, and Poultry
(beef, boar, bear, and deer products only)
20[][][][] Fruit/Fruit Prod
21[][][][] Fruit/Fruit Prod
22[][][][] Fruit/Fruit Prod
24[][][][] Vegetables/Vegetable Prod
25[][][][] Vegetables/Vegetable Prod
31[][][][] Coffee/Tea
40C[][]99 Formula Products (Milk) Baby
40C[][]01 Milk based formula
54E[][][] Herbal Botanical Tea

For milk, filled milk, milk-based infant formula, and produce products from the affected prefectures of Fukushima, Ibaraki, and Tochigi in Japan:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a radionuclide, a poisonous or deleterious substance which may render it injurious to health [Adulteration, Section 402(a)(1)]."
OASIS Charge Code: RADIONUC

AND, for the listed products from the indicated prefectures:


***
CHIBA PREFECTURE:

Shitake mushrooms;
Tea leaves;
Bamboo shoots;
Log-grown shitake mushrooms

FUKUSHIMA PREFECTURE:

Milk;
Mushrooms;
Kakina (a local Japanese vegetable);
Ayu;
Yuzu;
Rice;
Kiwi fruit;
Head type leafy vegetables (i.e. Spinach, Lettuce, Celery, Cress, Endive, Escarole, Chard, and Collards);
Non-head type leafy vegetables (i.e. turnip), flower head brassicas (i.e. broccoli and cauliflower);
Mushrooms;
Hatakewasabi;
Wild Japanese butterbur scape;
Pteridium aquilinum (bracken fern);
Koshiabura (wild tree sprout);
Royal fern;
Wild Arelia root;

Sand lance (a type of fish);
Dace;
Cherry salmon (yamame);
Common carp (not farm raised);
Wild white spotted char (not farm raised);
Crucian carp;
Land locked salmon;

Bear meat;
Beef;
Boar

GUNMA PREFECTURE:

Tea leaves;

Dace;
Land locked salmon


IBARAKI PREFECTURE:

Shitake mushrooms;
Tea leaves;
Bamboo shoots;
Koshiabura (wild tree sprout);

Eel;
Rockfish;
Nibe croaker;
Channel catfish (not farm raised);
Seabass;
Olive flounder;
Crucian carp (not farm raised);

Boar meat


IWATA PREFECTURE:

Bamboo shoots;
Log-grown shitake mushrooms;
Japanese celery;
Pteridium aquilinum (bracken fern);
Koshiabura (wild tree sprout);
Royal fern;

Pacific cod;
Dace;
Wild white spotted char (not farm raised);

Beef

KANGAWA PREFECTURE:

Tea leaves


MIYAGI PREFECTURE:

Shitake mushrooms;
Bamboo shoots;
Log-grown shitake mushrooms;
Koshiabura (wild tree sprout);
Royal fern;

Panther puffer;
Seabass;
olive flounder;
Pacific cod;
Dace;
Wild white spotted char (not farm raised);
Land locked salmon;

Beef;
Boar meat


TOCHIGI PREFECTURE:

Brick-cap mushrooms;
Pholiota nameko;
Tea leaves;
Bamboo shoots;
Log-grown shitake mushrooms;
Japanese pepper;
Pteridium aquilinum (bracken fern);
Koshiabura (wild tree sprout);
Royal fern;
Wild Arelia root;

Beef;
Boar meat;
Deer meat

***

The article is subject to refusal of admission pursuant to Section 801(a)(2) in that it appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported. [Section 801(a)(2)].
OASIS Charge Code: FORBIDDEN