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Details of FDA Alert Expanding to 2 More Japanese Prefectures

On April 12, 2011, the Food and Drug Administration updated its Import Alert (IA # 99-33) on detention without physical examination of certain milk, milk products, fruit, vegetables, and baby formula from Japan due to radionuclide contamination. The updated Import Alert expands the area of concern to six (from four) Japanese prefectures and updates the product assignment codes (PAC) for Japan activities.

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(See ITT's Online Archives or 04/13/11 news, 11041332, for initial BP summary announcing the updated import alert.)

Expansion due to Unsafe Iodine Levels Found in Vegetables in Chiba & Saitama

Review of data since FDA’s last update of its import alert indicates that vegetables from two additional prefectures, Chiba and Saitama, contain unsafe levels of Iodine-131. FDA does 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.

All Milk/Products & Produce from Chiba & Saitama Added to Import Alert

In addition, FDA is 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.

FDA May Detain and Refuse Admission to Specified Products from 6 (not 4) Prefectures

The updated import alert states that its field personnel may detain without physical examination and subject to refusal of admission the following products from firms in the Fukushima, Ibaraki, Tochigi, Gunma, Chiba, and Saitama prefectures:

09 - - - --Milk/Butter/Dried Milk Products
14 - - - --Filled Milk/Imitation Milk Products
20 - - - --Fruit/Fruit Products
21 - - - --Fruit/Fruit Products
22 - - - --Fruit/Fruit Products
24 - - - --Vegetables/Vegetable Products
25 - - - --Vegetables/Vegetable Products
40 C - - 01Milk Base Formula Product (Baby)1
40 C - - 99Formula Products (Milk) Baby1

Detained Milk/Products, Produce from 6 Prefectures Must be Free of Radionuclide Contamination to Enter

FDA officials confirm that all milk and milk products and vegetables and fruits produced or manufactured from the four Japanese prefectures of Fukushima, Ibaraki, Tochigi, Gunma, and Chiba and Saitama will be detained upon entry into the U.S. They will not be allowed to enter the U.S. food supply, unless shown to be free from radionuclide contamination.

Spinach, Kakina & Milk Restricted by Japan from 4 Prefectures Will Be Refused Admission

The officials explain that this is in contrast to certain specific products that were restricted by the Government of Japan (i.e., spinach and kakina from Fukushima, Ibaraki, Tochigi, Gunma; and milk from Fukushima and Ibaraki; and head type leafy vegetables, non-head type leafy vegetables, and flower head brassicas from Fukushima). These products will be refused admission into the U.S.

1Under the previous import alert, the product descriptions of the following codes were slightly different and read as follows:

40 C - - 01 Milk Base Formula Product (Similac, Enfamil, Etc) (Baby)

40 C - - 99 Formula Products (Milk and Milk Substitutes) (Baby)

(See ITT’s Online Archives or 03/25/11, 03/24/11, and 03/22/11 news, 10032522, 11032438, and 11032225, for BP summaries of previous versions of Import Alert #99-33 and FDA’s Question and Answer document on the situation.)

FDA Q&A document, updated 04/11/11, available here.