10/21/2011 List of Alerts of Physical Examination of Products from Japan Due to Radionuclide Contamination

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Import Alert # 99-33
Published Date: 10/21/2011
Type: DWPE
Import Alert Name:
Detention Without Physical Examination of Products from Japan Due to
Radionuclide Contamination

Reason for Alert:
Revision to this Import Alert dated October 20, 2011 provides that yuzu from the Fukushima prefecture and beef from the Fukushima, Tochigi, Miyagi, and Iwate prefectures have been added to the list of products restricted by the Government of Japan, in response to decrees issued from 07/19/2011 to 08/29/2011. 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, and July 6, 2011 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, Tochigi, Miyagi, and Iwate 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.

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

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

PRODUCT
CODE:
09[][][][] Milk/Butter/Dried Milk Products
14[][][][] Filled Milk/Imitation Milk Products
16A [][]99 Fish, N.E.C.
***17[][][][] Meat, Meat Products, and Poultry (beef 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

Charge:
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 milk, mushrooms, sand lance (a type of fish), dace, cherry salmon (yamame), kakina (a local Japanese vegetable), ayu, and *** yuzu ** from the Fukushima prefecture; AND

For head type leafy vegetables (i.e. Spinach, Lettuce, Celery, Cress, Endive, Escarole, Chard, and Collards) from the Fukushima prefecture; AND

For non-head type leafy vegetables (i.e. turnip), flower head brassicas (i.e. broccoli and cauliflower), and mushrooms from the Fukushima prefecture; AND

For spinach from the Tochigi prefecture; AND

For tea leaves from the Ibaraki, Tochigi, Kanagawa, Gunma, and Chiba prefectures; AND

***For beef from the Fukushima, Tochigi, Miyagi, and Iwate prefectures: ***

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

Countries

JAPAN
(09 – – – –) Milk/Butter/Dried Milk Prod
Desc:Milk /Butter/Dried Milk Products
(14 – – – –) Filled Milk/Imit Milk Prod
Desc:Filled Milk/Imitation Milk Products
(16 A – – 99) Fish, N.E.C.
Desc:Fish; N.E.C.
(17 – – – –) Meat, Meat Products and Poultry
(20 – – – –) Fruit/Fruit Prod
Desc:Fruit/Fruit Prod
(21 – – – –) Fruit/Fruit Prod
Desc:Fruit/Fruit Prod
(22 – – – –) Fruit/Fruit Prod
Desc:Fruit/Fruit Prod
(24 – – – –) Vegetables/Vegetable Products
Desc:Vegetables/Vegetable Prod
(25 – – – –) Vegetables/Vegetable Products
Desc:Vegetables/Vegetable Prod
(31 – – – –) Coffee/Tea
Desc:Coffee/Tea
(40 C – – 01) Milk Base Formula Product (Baby)
Desc:Milk based formula
(40 C – – 99) Formula Products (Baby)
Desc:Formula Products (Milk) Baby
(54 E – – –) Herbal and Botanical
Desc:Herbal Botanical Tea

Source: accessdata.fda.gov

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