FDA Adds Mushrooms to Japan Import Alert, New Q&A Info on Drug Sampling

On April 21, FDA also updated its question and answer document on what it is doing to ensure the safety of products imported from Japan. The update made numerous changes, including characterizing how it processes food products from Japan into four categories; what FDA is doing to ensure the safety of drugs coming from Japan; what FDA’s screening and testing have shown so far; warning letters it has issued; etc.

Mushrooms from Fukushima to Be Detained & Refused Admission Under 801(a)(2)

The revision adds mushrooms from the Fukushima prefecture to the list of products restricted by the Government of Japan, in response to a decree issued on April 13, 2011. FDA states in its updated Q&A document that all products restricted by Japan, including mushrooms from Fukushima, are subject to detention and refused admission under section 801(a)(2) of the Federal Food, Drug, and Cosmetic Act.

FDA Processing All Food Products from Japan According to Four Categories

Among the numerous changes to the Q&A was a characterization of FDA’s processing of food products from Japan into the following four categories:

Restricted products from 2 Prefectures detained & refused entry. The first category consists of products that the Government of Japan has restricted for sale or export. Authorities will prevent these products from entering the U.S. These products cannot gain entry by providing sample results. The Q&A says as of April 20, 2011, these include:

• Spinach, lettuce, celery, cress, endive, escarole, chard, collards, and other head-type leafy vegetables from the Fukushima Prefecture.
• Turnips and other non-head type leafy vegetables, as well as broccoli, cauliflower, flower head brassicas (i.e. broccoli and cauliflower), and mushrooms from the Fukushima Prefecture.
• Milk from the Fukushima and Ibaraki Prefectures.
• Spinach and kakina from the Fukushima and Ibaraki Prefectures

Products from 6 Prefectures detained & released if compliant. The second category consists of products from the Fukushima, Gunma, Ibaraki, Tochigi, Chiba or Saitama Prefectures that the Government of Japan has not currently banned for sale or export. These specific products include dairy products and fresh produce. Authorities may detain these products when they arrive in the U.S. and will release these products from detention if the importer can show the products are compliant.

Other food & feed from 10 prefectures examined. The third category consists of food and feed products not specifically listed in FDA’s Import Alert that come from ten Japanese prefectures. FDA will examine these products and conduct sampling and testing as needed to determine if they are safe to enter the U.S. The ten Prefectures are: Fukushima, Gunma, Ibaraki, Tochigi, Chiba, Saitama, Kanagawa, Miyagi, Niigata, and Tokyo.

All other food products reviewed. The fourth category consists of all other FDA-regulated food products from Japan that are not specifically listed in the Import Alert and do not belong to one of the other categories. Authorities will review these products using standard procedures, and as part of this may monitor and sample products as resources permit.

FDA May Adjust this Strategy Based on Info Received and Monitoring

FDA may adjust this strategy based on additional information received from monitoring results in Japan. FDA may also further evaluate this strategy if the Government of Japan makes changes to its list of prohibited exports.

All Drugs Will Be Screened, Those from 10 Prefectures Examined, Injectable Drugs Tested

Regarding its screening of drugs from Japan, FDA has added information stating that its procedures will remain vigilant and will be augmented with screening of all Japanese shipments entering the U.S. The agency has established special procedures to evaluate drugs originating from the ten prefectures in closest proximity to the Fukushima Daiichi nuclear plant.

FDA will physically examine for radiation all drugs originating from these ten prefectures. Based on the results of those physical examinations, FDA may also test products to determine if they are safe to admit into the U.S. FDA will also physically examine and test all injectable and inhalable drugs regardless of their place of origin within Japan because these drugs more directly enter into the bloodstream.

All other drugs originating from outside of the ten prefectures in closest proximity to the Fukushima Daiichi nuclear plant will be subject to normal processing for examination, sampling, and testing.

FDA Food Testing Has Shown no Gamma-Ray Emitting Radionuclides of Concern

The Q&A also states that as of April 19, 2011, FDA import investigators had performed 3,533 field examinations for radionuclide contamination. FDA had tested 89 food samples, 23 of which were fish, and had found no I-131, Cesium-134, Cesium-137 or other gamma-ray emitting radionuclides of concern.

Warning Letters Issued to Firms for Fraudulent Anti-Radiation Products

FDA adds that it has issued Warning Letters to two firms promoting a variety of fraudulent products that claim to prevent or treat the harmful effects of radiation exposure from the nuclear power plant incident in Japan as a consequence of the earthquake and tsunami.

(See the Q&A for updated information on what specific tests FDA is using; what FDA will do if grass or feed crop in the U.S. does become contaminated; and how consumers can identify products that may be violative.

See the Q&A for new information on what products come to the U.S. from Japan; what FDA looks for when it tests food for radioactive contamination; the principal radionuclides involved in a nuclear reactor accident; the standards that FDA uses to determine the amounts of specific radioactive materials in foods and whether they may cause a safety concern; how water contaminated with radioactive materials could affect seafood safety; fish that swim from the reactor site into U.S. fishing waters; where seafood is analyzed; the U.S. Environmental Protection Agency’s reported low levels of radionuclides in milk in the U.S; and what are other Federal agencies doing to protect the food supply.)

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

FDA Q&A, updated 04/21/11, available here.