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FDA Amends Japan Import Alert for Certain Milk, Spinach, Kakina and Fish

On April 22, 2011, the Food and Drug Administration updated Import Alert #99-33 on detention without physical examination of certain milk, milk products, fruit, vegetables, and baby formula from Japan due to radionuclide contamination. The update affects milk, kakina, and spinach from the Ibaraki prefecture and sand lance (a type of fish also known as sand eels) from the Fukushima prefecture. It also updates the product codes subject to the import alert.

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Milk, Spinach, Kakina from Ibaraki no Longer Detained & Refused Admission under 801(a)(2)

The import alert states that 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.

Therefore, FDA states it is no longer appropriate to detain these products under section 801(a)(2) of the Federal Food, Drug, and Cosmetic Act, under which products are detained and refused admission because they are forbidden or restricted in sale in the country in which they were produced or exported.

Will detain under 801(a)(3), only enter if radionuclide free. Instead, these products will be subject to detention under section 801(a)(3), under which the products will be refused admission, unless shown to be free from radionuclide contamination.

Sand Lance Fish from Fukushima Will Be Detained& Refused Admission under 801(a)(2)

In addition, the import alert is being revised to add sand lance fish from the Fukushima prefecture to the list of products restricted by the Government of Japan, due to a Japanese order issued on April 20, 2011. Therefore, sand lance from the Fukushima prefecture will be detained and refused admission under section 801(a)(2) because it is forbidden or restricted in sale in the country in which it was produced or exported.

PAC codes updated to add fish. Accordingly, the product codes have been updated to add fish (underlined below) to the list of products subject to the import alert:

09 - - - -- Milk/Butter/Dried Milk Products

14 - - - -- Filled Milk/Imitation Milk Products

16 A - - 99 Fish, N.E.C.

20 - - - -- Fruit/Fruit Products

21 - - - -- Fruit/Fruit Products

22 - - - -- Fruit/Fruit Products

24 - - - -- Vegetables/Vegetable Products

25 - - - -- Vegetables/Vegetable Products

40 C - - 01 Milk Base Formula Product (Baby)

40 C - - 99 Formula Products (Milk) Baby

(See ITT’s Online Archives or 04/21/11, 04/19/11, 04/14/11, 03/25/11, 03/24/11, 03/22/11, and 04/14/11 news, 11042130, 11041929, 11041416, 10032522, 11032438, 11032225, and 11041416, for BP summaries of previous versions of Import Alert #99-33 and FDA’s Q&A document on the topic.)