Import Alert 99-33
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(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: 12/29/2016

Type: DWPE

Import Alert Name:

Detention Without Physical Examination of Products from Japan Due to Radionuclide Contamination

Reason for Alert:

NOTE: Revision to this Import Alert dated December 27, 2016 removes products from the list of products restricted by the Government of Japan. The format of the product listing has also been amended. Changes are noted and bracketed by three asterisks (***).

Previous revisions to this Import Alert dated March 23, April 12, April 14, April 20, April 21, May 9, June 13, July 6, October 21, 2011, February 1, 2012, July 25, 2012 September 9, 2013, February 24, 2015, March 31, 2015, April 3, 2015, July 16, 2015, August 4, 2015, November 17, 2015, January 19, 2016, March 4, 2016, April 8, 2016, July 18, 2016, August 26, 2016, ***September 13, 2016 and October 7, 2016*** provided updates to the products and/or prefectures subject to detention without physical examination.

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 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 pose 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, fresh produce, and infant formula 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. 

Review of additional data received after March 23, 2011, indicated vegetables from two additional prefectures contain unsafe levels of Iodine-131. These additional prefectures are Chiba and Saitama. We do not have specific geographic 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 pastures, the entire area of the two prefectures has been included in this Import Alert. In addition, we are 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 radionuclides on certain vegetation.

On April 12, 2011, the Japanese government lifted its restriction from distribution of spinach and kakina from the Gunma prefecture; and kakina from the Tochigi prefecture based on data received. Because this restriction of sale by the Government of Japan has been lifted, detention under section 801(a)(2) is no longer appropriate for spinach and kakina from the Gunma prefecture; and kakina from the Tochigi prefecture. 

On April 13, 2011, the Government of Japan ordered the addition of mushrooms to the group of products previously restricted from distribution into the market on March 21, 2011. 

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. Because this restriction of sale by the Government of Japan has been lifted, detention under section 801(a)(2) is no longer appropriate for milk, kakina, and spinach from the Ibaraki prefecture. 

On April 20, 2011, the Government of Japan ordered the addition of sand lance from Fukushima prefecture to the group of products previously restricted from distribution into the market on March 21, 2011.

On May 9, 2011, FDA reviewed additional data received from the Government of Japan indicating radiation is no longer being detected in food products from the prefectures of Gunma, Chiba, and Saitama. Products from these prefectures are removed from Detention Without Physical Examination.

On June 2, 2011, the Japanese Prime Minister ordered the addition of tea leaves to the group of products previously restricted from distribution into the market from the Ibaraki and Tochigi prefectures. 

On June 27, 2011, the Japanese Prime Minister ordered the addition of tea leaves to the group of products previously restricted from distribution into the market from the Kanagawa prefecture; and dace, ayu, and Salmon (landlocked) (yamame) from the Fukushima prefecture. 

On June 30, 2011 and July 4, 2011 the Japanese Prime Minister ordered the addition of tea leaves to the group of products previously restricted from distribution into the market on from the Gunma and Chiba prefectures. 

From July 19 to August 29, 2011, the Japanese Prime Minister ordered the addition of yuzu to the group of products previously restricted from distribution into the market from the Fukushima prefecture; and beef from the Fukushima, Kanagawa, Tochigi, Gunma, Chiba, Miyagi, and Iwata prefectures. 

From November 7, 2011 to January 16, 2012, the Japanese Prime Minister ordered the addition of kiwi fruit, rice, and bear meat, to the group of products previously restricted from distribution into the market from the Fukushima prefecture; boar meat from the Fukushima, Ibaraki, and Tochigi prefectures; shitake mushrooms from the Chiba, Ibaraki, and Miyagi prefectures; brick-cap mushrooms and pholiota nameko from the Tochigi prefecture; and deer meat from the Tochigi prefecture. 

From January 17, 2012 to May 31, 2012, the Japanese Prime Minister ordered the addition of hatakewasabi, wild Japanese butterbur scape, and common carp (not farm raised) from the Fukushima prefecture; bamboo shoots and log-grown shitake mushrooms from the Tochigi, Ibaraki, Chiba, Miyagi, and Iwate prefectures; boar meat from the Miyagi prefecture; Japanese pepper from Tochigi prefecture; Japanese parsley from the Iwata prefecture; eel, rockfish, Nibe croaker, and channel catfish (not farm raised) from the Ibaraki prefecture; panther puffer from the Miyagi prefecture; seabass and olive flounder from the Ibaraki and Miyagi prefectures; Pacific cod from the Miyagi and Iwata prefectures; dace from Gunma, Miyagi, and Iwata prefectures; wild white spotted char (not farm raised) from the Fukushima, Miyagi, and Iwata prefectures; crucian carp (not farm raised)from the Fukushima and Ibaraki prefectures; land locked salmon from the Fukushima, Gunma, and Miyagi prefectures; pteridium aquilinum (bracken fern) from the Fukushima, Tochigi, and Iwata; koshiabura (wild tree sprout) from the Fukushima, Ibaraki, Tochigi, Miyagi, and Iwata prefectures; royal fern from the Fukushima, Tochigi, Miyagi, and Iwata prefectures; and wild Arelia root from the Fukushima and Tochigi prefectures. 

From June 1, 2012 to July 10, 2013, the Japanese Prime Minister ordered the addition of the following products to the group of products restricted from distribution into the market mushrooms from the Aomori prefecture; aralia sprout, azuki bean, bamboo shouts, chestnuts, ostrich fern, soybean, ume, giant butterbur, uwabamisou, Alaska Pollock, barfin flounder, black cow-tongue, black rockfish, braddblotched rockfish, brown hakeling, conger eel, fat greenling, flathead, flathead flounder, fox jacopever, goldeye rockfish, gurnard, halfbeak, black porgy, eel, seabass, littlemounth flounder, long shanny, marbled flounder, nibe croaker, northern sea urchin, ocellate spot skate, olive flounder, pacific cod, panther puffer, poacher, red tongue sole, ridged-eye flounder, rockfish (sebastes cheni), sea raven, shotted halibut, slime flounder, spotted halibut, starspotted smooth-hound, starry flounder, stone flounder, surfperch, venus clam, vermiculated puffer, cooper pheasant, green pheasant, hare, and spot-billed duck from the Fukushima prefecture; mushrooms, Salmon (landlocked)(excluding farm raised), whitespotted char(excluding farm raised), Bear meat, boar, cooper pheasant and venison from the Gunma prefecture; ocellate spot skate, pacific cod, stone flounder from the Ibaraki prefecture; buckwheat, soybean, black porgy, seabass, bear meat, venison, and cooper pheasant from the Iwate prefecture; buckwheat, ostrich ferns, rice, soybean, ayu(excluding farm raised), Salmon (landlocked) (excluding farm raised), black porgy, and bear meat from the Miyagi prefecture; mushrooms from the Nagano prefecture; bear meat from the Niigata prefecture; mushrooms from the Saitama prefecture; mushrooms from Shizuoka prefectures; chestnut, wild ostrich fern, and whitespotted char(excluding farm raised) from the Tochigi prefecture; bear meat from the Yamagata prefecture; and mushrooms from the Yamanashi prefecture. 

From June 1, 2012 to July 10, 2013, the Japanese Prime Minister also ordered the removal of the following products from the group of products restricted from distribution into the market tea leaves from the Chiba, Gumna, Kangawa, and Tochigi prefectures; and Pacific cod from the Iwate and Miyagi prefectures.

February 2015, the Government of Japan ordered the addition of the Iwate, Miyagi and Gunma Prefectures and the removal of the Ibaraki prefecture for milk, filled milk, and milk-based infant formula. Also the addition of eel from the Chiba prefecture; the correction of milk to raw milk, Braddblotched rockfish to Brass Blotched Rockfish, the removal of Cultivated wasabi, starspotted smooth-hound, Flathead Flounder, Gurnard, Halfbeak, Littlemounth Flounder, and Northern Sea Urchin, and the addition of Turnips and Scorpion Fish from the Fukushima prefecture; the removal of Tea leaves, Nibe Croaker, Olive Flounder and Pacific Cod from the Ibaraki prefecture; the removal of buckwheat from the Iwate Prefecture; the removal of buckwheat, Olive Flounder, and Panther Puff and the addition of Wild Araila Sprouts from the Miyagi Prefecture; and the addition of Koshiabura from the Nagano prefecture. 

February and March 2015, the Government of Japan ordered the removal of restricted Pacific Cod from Fukushima and Dace from Iwate from distribution into the market. 

March 2015, the Government of Japan ordered the removal of restricted Silver Crucian Carp from the Ibaraki Prefecture from distribution into the market.

April 2015, the Government of Japan ordered the removal of restricted Ridged-eye Flounder and Nibe Croaker from the Fukushima Prefecture from distribution into the market.

July 2015, the Government of Japan lifted ordered the removal of restricted Whitespotted Char from the Tochigi Prefecture from distribution into the market.
August 2015, the Government of Japan lifted the ban on distribution of Sea Raven from Fukushima Prefecture and Soybean from Iwate Prefecture. 

November 2015, the Government of Japan lifted the ban on distribution of Azuki Beans from Fukushima Prefecture. 

January 2016, the Government of Japan lifted the ban on distribution of Panther Puffer from Fukushima Prefecture. 

March 2016, the Government of Japan lifted the ban on distribution of Seabass from Ibaraki Prefecture and soybeans form Miyagi Prefecture.

April 2016, the Government of Japan lifted the ban on distribution of soybean from Fukushima Prefecture and rice from Miyagi Prefecture.

June 2016, the Government of Japan lifted the ban on distribution of Olive Flounder and Conger Eel from Fukushima Prefecture.

July 2016, the Government of Japan lifted the ban on distribution of Barfin Flounder, Flathead, Long Shanny, Poacher and Spotted Halibut from Fukushima Prefecture.

August 2016, the Government of Japan lifted the ban on distribution of Brown Hakeling, Fat Greenling, Marbled Flounder, Ocellate Spot Skate, and Red Tongue Sole from Fukushima Prefecture.

September 2016, the Government of Japan lifted the ban on distribution of Bamboo Shoots from Chiba Prefecture. 

***November 2016, the Government of Japan lifted the ban on distribution of Slime Flounder from Fukushima Prefecture.*** 

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, Aomori, Chiba, Gumna, Ibaraki, Iwate, Miyagi, Nagano, Niigata, Saitama Shizuoka, Tochigig, Yamagata and Yamanashi 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 deactivate the Import Alert and resume routine coverage of entries.

Questions or issues involving import operations should be addressed to the Division of Import Operations at 301-796-0356. 

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at 301-796-6600.

Product Description:

PRODUCTS:	

All specified products from the affected noted prefectures in Japan (see �Charge� section for listing).

PRODUCT
CODE:  
02A[][]05 Rice, Cultivated, Whole Grain 
09[][][][] Milk/Butter/Dried Milk Products
14[][][][] Filled Milk/Imitation Milk Products
16A [][][] Fish, N.E.C.
16E[][]02 Venus Clams
16M[][]11 Sea Urchin/ Uni
17[][][][] Meat, Meat Products, and Poultry 
(beef, boar, bear, deer, duck, hare and pheasant products only) 
20H[][]01, 20J[][]01, 20K[][]01, 20L[][]M, 20M[][]01Yuzu Fruit	
21R[][]11, 21S[][]11, 21T[][]11, 21U[][]11, 21V[][]11, 21X[][]11 Kiwi Fruit
24[][][][] Vegetables/Vegetable Prod
25[][][][] Vegetables/Vegetable Prod
40C[][]99 Formula Products (Milk) Baby 
40C[][]01 Milk based formula	

PROBLEM: Radionuclide Contamination

Charge:

For milk, filled milk, and milk-based infant formula, from the affected prefectures of Fukushima, Iwate, Miyagi and Gunma 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 the listed products from the indicated prefectures: 	

AOMORI PREFECTURE:

Wild Mushrooms

CHIBA PREFECTURE:

Shitake mushrooms;

Common Carp;
Silver Crucian Carp
Eel 

Boar

FUKUSHIMA PREFECTURE:

Raw Milk;

Wild Aralia Sprout;
Bamboo Shoot;
Non-head type leafy vegetables (i.e. Japanese Mustard Spinach (Komatsuna), Garland Chrysanthemum, Qing-geng-cai, Potherb Mustard (Mizuna), Leaf Lettuce (red), Spinach and other non-heading leafy vegetables);
Head type leafy vegetables (i.e. Cabbage, Chinese Cabbage and Lettuce);
Flower head brassicas Vegetables (i.e. Broccoli and Cauliflower);
Chestnuts;
Wild Japanese Butterbur Scrape;
Japanese Royal Fern;
Kiwi Fruit;
Koshiabura (wild tree sprout);
Log-grown Shitake mushrooms;
Log-grown Pholiota Nameko (outdoor cultivation)
Mushroom;
Ostrich Fern;
Pteridium Aquilinum (bracken fern);
Rice;
Turnips 
Ume;
Giant Butterbur;
Uwabamisou;
Yuzu Fruit;

Alaska Pollock;
Ayu (excluding farm raised);
Black cow-tongue;
Black rockfish;
Brass blotched rockfish; 
Salmon (landlocked) (excluding farm raised);
Common Carp (excluding farm raised);
Fox Jacopever;
Goldeye rockfish;
Black Porgy;
Dace;
Eel;
Sandlance (excluding juvenile);
Seabass;
Rockfish (Sebastes cheni);
Scorpion Fish 
Shotted Halibut;
*** ***
Starry Flounder;
Stone Flounder;
Surfperch;
Venus Clam;
Vermiculated Puffer;
Whitespotted Char (excluding farm raised);

Bear meat;
Beef;
Boar;
Cooper Pheasant;
Green Pheasant;
Hare Meat;
Spot-Billed Duck

GUMNA PREFECTURE:

Wild Mushrooms;

Salmon (landlocked) (excluding farm raised);
Whitespotted Char (excluding farm raised);

Bear meat;
Boar;
Copper Pheasant;
Venison;

IBARAKI PREFECTURE:

Log-grown Shitake mushrooms;
Bamboo shoots;
Koshiabura (wild tree sprout);

Eel;
Rockfish;
Ocellate Spot Skate;
Channel Catfish (excluding farm raised); 
Stone Flounder;

Boar

IWATE PREFECTURE:

Bamboo shoots;
Log-grown Brick-cap mushrooms (outdoor cultivation)
Log-grown Shitake mushrooms;
Log-grown Pholiota Nameko (outdoor cultivation)
Wild Mushrooms;
Wild Japanese parsley;
Royal fern;
Koshiabura (wild tree sprout);
Pteridium aquilinum (bracken fern);

Black Porgy;
Seabass;
Whitespotted Char (excluding farm raised);

Bear meat; 
Beef;
Venison;
Cooper Pheasant 

MIYAGI PREFECTURE:

Royal Fern;
Bamboo Shoots;
Koshiabura (wild tree sprout);
Wild Araila Sprout 
Ostrich Ferns;
Log-grown Shitake mushrooms (outdoor cultivation);
Wild Mushrooms;

Ayu (excluding farm raised);
Salmon (landlocked) (excluding farm raised);
Black Porgy;
Dace;
Seabass;
Whitespotted Char (excluding farm raised);

Beef;
Bear Meat;
Boar meat

NAGANO PREFECTURE:

Wild Mushrooms
Koshisabura 

NIIGATA PREFECTURE: 

Bear Meat

SAITAMA PREFECTURE:

Wild Mushrooms

SHIZUOKA PREFECTURE:

Wild Mushrooms

TOCHIGI PREFECTURE:

Wild Aralai Sprouts;
Bamboo Shoots;
Chestnuts;
Wild Japanese Peppers;
Wild Royal Fern;
Koshiabura (wild tree sprout);
Wild Pteridium aquilinum (bracken fern);
Wild Ostrich Ferns;
Log-grown Brick-cap mushrooms (outdoor cultivation)
Log-grown Shitake mushrooms;
Log-grown Pholiota Nameko (outdoor cultivation)
Wild Mushrooms;

Beef;
Boar meat;
Venison

YAMAGATA PREFECTURE:

Bear Meat

YAMANASHI PREFECTURE:

Wild Mushrooms

�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

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

Desc:Formula Products (Milk) Baby

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

Desc:Milk based formula

(24 - - - --) Vegetables/Vegetable Products

Desc:Vegetables/Vegetable Prod

(25 - - - --) Vegetables/Vegetable Products

Desc:Vegetables/Vegetable Prod

(02 A - - 05) Rice, Cultivated, Whole Grain

(16 A - - --) Fish

(17 - - - --) Meat, Meat Products and Poultry

Desc:beef; boar; bear; deer; duck; hare and pheasant products only

(16 E - - 02) Clams

Desc:Venus clams

(16 M - - 11) Sea Urchin, Other Aquatic Species

Desc:Sea Urchin/Uni

(20 H - - 01) Citron, Dried or Paste

Desc:Yuzu Fruit

(20 J - - 01) Citron, Jam, Jelly, Preserves, Marmalade, Butter and Candied

Desc:Yuzu Fruit

(20 K - - 01) Citron, Citrus Fruit Juices or Concentrates

Desc:Yuzu Fruit

(20 L - - 01) Citron, Topping or Syrup

Desc:Yuzu Fruit

(20 M - - 01) Citron (Citrus Fruit Purees)

Desc:Yuzu Fruit

(21 R - - 11) Kiwi Fruit (Subtropical and Tropical Fruit Purees)

Desc:Kiwi Fruit

(21 S - - 11) Kiwi Fruit (Subtropical and Tropical Fruit)

Desc:Kiwi Fruit

(21 T - - 11) Kiwi Fruit, Dried or Paste

Desc:Kiwi Fruit

(21 U - - 11) Kiwi Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied

Desc:Kiwi Fruit

(21 V - - 11) Kiwi Fruit, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit

Desc:Kiwi Fruit

(21 X - - 11) Kiwi Fruit (Subtropical/Tropical Fruit Pulp)

Desc:Kiwi Fruit


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