スウエーデンの面白いものたち


by nyfiken
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U.S.Import Alert #99-33 (Products from Japan due to radionuclide Contamination)

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(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).


Import Alert # 99-33
Published Date: 04/05/2011
Type: DWPE Import Alert Name:
Detention Without Physical Examination of Products from Japan Due to
Radionuclide Contamination


Reason for Alert:
NOTE: The revision to this Import Alert dated 3/24/2011 adds an internet link to FDA's methodology used in radionuclide analysis; adds an internet link to question and answers related to FDAs activities; and revises the background language in the Import Alert. Changes marked with asterisks (***)

Previous revision to this Import Alert dated 3/23/2011 added additional products to the list of those restricted by the Government of Japan, in response to a decree issued the same day. Changes marked with asterisks.

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 and fresh produce 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.

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, and Gunma 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.

*** FDA has posted its methodology for use in radionuclide analysis on the internet: Determination of Gamma-Ray Emitting Radionuclides in Foods by High-Purity Germanium Spectrometry
http://www.fda.gov/downloads/ScienceResearch/FieldScience/UCM248262.doc
***
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301-796-5992.


*** More information about FDA�s activities to ensure the safety of products imported from Japan can be found on FDA�s website at:
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm247403.htm
***

PREPARED BY:
Megan R. McCurdy, DIOP, HFC-172, 301-796-8993

Product Description:
All specified products from the affected prefectures in Japan:
Fukushima
Gunma
Ibaraki
Tochigi

PROBLEM:
Radionuclide Contamination


Charge:
For the above specified products from the affected prefectures of Fukushima, Gunma, 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 spinach and kakina (a local Japanese vegetable) from the affected prefectures of Fukushima, Gunma, Ibaraki, and Tochigi in Japan; 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) from the Fukushima prefecture; AND
For milk from the Fukushima and Ibaraki 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
(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
(40 C - - 01) Milk Base Formula Product (Baby)
Desc:Milk based formula
(40 C - - 99) Formula Products (Baby)
Desc:Formula Products (Milk) Baby
by nyfiken | 2011-04-07 08:09