CSMS# 11-000071 – Japanese product review by FDA
Wed, 23 Mar 2011 13:43:00 -0500
Automated Broker Interface
FDA is updating the importing community on its activities related to the ongoing crisis in Japan.
On March 22, 2011, FDA issued Import Alert 99-33, “Detention Without Physical Examination of Products from Japan due to Radionuclide Contamination”.
The alert can be found at the following link: http://www.accessdata.fda.gov/cms_ia/importalert_621.html
Import Alert 99-33 indicates detention without physical examination (DWPE) for the specific food products of concern listed in the Import Alert that have originated from the prefectures of Fukushima, Gunma, Ibaraki, and Tochigi in Japan.
On March, 21, 2011 the government of Japan, in concert with the governments of the affected prefectures of Fukushima, Gunman, Ibaraki, and Tochigi, has stopped milk, spinach and kakina (a local Japanese vegetable) from those prefectures from being marketed either domestically or for export.
Detained products covered by the Import Alert may be released after detention by either providing evidence that:
1. The products do not originate from the prefectures of Fukushima, Gunma, Ibaraki, and Tochigi in Japan; or
2. The products do not contain violative levels of radionuclide contamination, by means of laboratory analysis
Additionally, the importing community should be aware FDA has increased its surveillance of all products from the affected prefectures of Fukushima, Gunman, Ibaraki, and Tochigi; and has increased its surveillance of products from other areas of Japan. Importers can expect FDA to conduct many more document reviews for Japanese shipments and can expect examinations and sample collections at a much higher rate than usual. FDA Districts may be asking for additional information related to regions where products originate and to the date of shipment from that region.
Importers are advised that it may speed FDA’s review process if entry documentation is provided in a timely manner and, for those shipments indicated for examination or sampling, if location and availability information is provided in a timely manner.
As indicated in the Import Alert, 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 potential for public health risks due to possible radionuclide contamination and, when appropriate, will remove the Import Alert and resume routine coverage of entries.
