On This Page:

  • September 2021 Update
  • April 2021 Update
  • Questions nearly Nutrient Safety
  • Questions most Medical Products

September 2021 Update

Today FDA is deactivating Import Alarm #99-33 (IA) that has targeted certain food products from Japanese prefectures (Japan's equivalent of a U.S. state) located near the damaged Fukushima Daiichi nuclear power plant since 2011.

On March 11, 2011, a 9-magnitude earthquake triggering an approximately 40-pes tsunami struck the Pacific Declension of Nihon. The strength of the tsunami destroyed a great deal of the infrastructure along portions of the Japanese coast, including the Fukushima plant, and damage to the plant released radiological contamination to the surrounding areas.

In the wake of the disaster, the Government of Nihon determined that certain food products in afflicted prefectures were not fit for human consumption, due to the public wellness risk associated with radionuclide contamination and prohibited those food products from sale (both inside Japan and for export).

FDA responded by issuing the IA, "Detention Without Physical Test of Products from Japan due to Radionuclide Contamination." The basis for the IA is section 801(a)(two) of the Federal Food, Drug, and Cosmetic Act, which states that FDA-regulated products are subject field to refusal and will be refused admission into the United States if the products announced to be forbidden or restricted for sale in the country in which they were produced or from which they were exported. The IA was designed to match Nippon's restrictions at the prefecture level.

Now, afterward an extensive assay of Japan'south robust control measures that include decontamination, monitoring and enforcement; afterwards reviewing the results of x years of sampling food products from Japan; and later determining a very low adventure to American consumers from radioactive contaminated foods imported from Nihon, FDA has decided that the IA is no longer necessary to protect public health and therefore should exist deactivated.

Japan'due south command measures and FDA's standard surveillance and sampling measures will provide multiple levels of oversight one time the IA is deactivated, helping to ensure that nutrient imported from Japan does non pose a food safe hazard to U.South. consumers due to radionuclide contagion.

The FDA will continue communication and collaboration with the Government of Japan to monitor and ensure the condom of food products exported from Japan to the U.S., as it has since the days following the 2011 disaster.

April 2021 Update

On April 13, 2021, the Government of Japan announced it has decided to begin discharging into the ocean the wastewater that is currently beingness stored on site at the Fukushima Daiichi nuclear power plant in two years. The water, primarily the upshot of ocean and groundwater seepage through the damaged core reactor, has been treated with the Advanced Liquid Processing System (ALPS) to remove harmful radionuclides such as cesium and strontium, leaving merely the mildly radioactive and less harmful isotope, tritium.

Tritium presents an extremely depression human and beast wellness risk if consumed and any health run a risk would be further minimized with the dilution effects of belch into the ocean. Furthermore, FDA has no evidence that radionuclides from the Fukushima incident are present in the U.S. nutrient supply at levels that are unsafe or would pose a public health concern and believes this activity will take no consequence on the safety of foods imported from Nippon and U.S. domestic food products, including seafood caught off the U.S. coast.

Scientific experts from interagency advisory teams, including FDA's representatives to the U.S. Advisory Team for Environs, Food and Health, came to this conclusion afterward studying the technical aspects and reviewing international reports from interagency bodies that evaluated options for dealing with the waste water. Based on this scientific review likewise sampling of foods imported from Japan and U.S. domestic food products, nosotros believe that at that place would be no bear on to human and animal health if the treated wastewater were to exist discharged into the ocean, as proposed by Japan. Consequently, FDA is non advising consumers to modify their consumption of specific foods imported from Nihon or domestically produced foods, including seafood.

FDA Import Alert # 99-33, which instructs FDA field personnel to detain foods shipments from Japan if the food is likely to incorporate radionuclide contamination, remains active. In addition, FDA tests for radionuclides as function of its routine surveillance, through the toxic elements in food and foodware monitoring program and through its Total Diet Written report.

On top of the information obtained from its testing of imported and domestic foods, FDA stays current on radiation monitoring efforts by other U.S. Authorities agencies, including the ecology radiation monitoring program (RadNet) conducted by the Environmental Protection Bureau. Additionally, FDA consults on a formal and informal basis with experts from U.S. government, academia and the private sector on radiations condom issues. FDA's scientists also keep abreast of scientific publications and reports from both individual and public scientific institutions, including oceanographic research institutions. For example, a study published in 2012 in the Proceedings of the National University of Sciences (PNAS) reported finding very depression levels of Fukushima-related contamination in Pacific Bluefin tuna caught past recreational fisherman off the declension of California in August 2011. FDA reviewed this study and determined that the levels of contamination were roughly 300 times lower than levels that would prompt FDA to investigate farther to decide if there were a health business concern

FDA also closely monitors information and data from a number of foreign governments and international organizations. This includes monitoring:

  • the Japanese government's food sample testing program;
  • the import sample testing programs of nations geographically shut to Japan that import significant amounts of food from Japan; and,
  • Fukushima Daiichi incident related activities of international organizations such as the International Atomic Energy Agency (IAEA).

FDA continues to closely monitor the situation at and around the Fukushima Daiichi facility, as information technology has since the commencement of the incident. The bureau will use data and information from a multifariousness of sources including its own testing and surveillance efforts and volition continue to coordinate with other federal and land agencies to ensure the rubber of food in the U.S. market place.

For more information from the U.S. Department of Country, please visit https://www.land.gov/authorities-of-japans-announcement-on-fukushima-treated-water-release-decision/.

For more information on FDA'due south radiological and nuclear emergency preparedness, visit our webpage.For more data on FDA's radiological and nuclear emergency preparedness, visit our webpage.

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Questions most Nutrient Safety

What systems does FDA have in place to protect the U.South. food supply?

The U.S. enjoys one of the world's safest nutrient supplies. The FDA has systems in identify to assistance ensure that our food supply is wholesome, safety to eat, and produced under sanitary conditions.

The FDA conducts inspections and collects and analyzes samples of products from shipments offered for import from all over the earth. The FDA oversees the importation of the full range of regulated products, including food and animate being feed, amid other responsibilities.

The FDA works to inspect imports based on those that may pose a significant public health threat – past carrying out targeted risk-based analyses of imports at the points of entry. This work can take place independently of the Import Alert process.

If unsafe products attain our ports, the FDA'southward imports entry reviews, inspections and sampling at the border assistance preclude these products from entering our nutrient supply. The FDA also works cooperatively with U.Due south. Community and Edge Protection and other agencies to help identify shipments that may pose a threat.

What has FDA's screening and testing shown and so far?

As of July 27, 2021, the FDA has tested 1,749 import and domestic samples for contagion from the Fukushima/Daiichi facility. Three of these were establish to contain detectable levels of Cesium, but the levels were well beneath the established Derived Intervention Level (DIL) and posed no public wellness concern. They were:

  • Ginger Powder (sample no. 686901, nerveless April 2011)
  • Green Tea Pocketbook (sample no. 827430, nerveless August 2013)
  • Dark-green Tea Leaves (sample no. 887814, collected November iv, 2014)

FDA radionuclide in food assay results (PDF)

What are the standards that FDA uses to determine the amounts of specific radioactive materials in foods and whether they may cause a safety business?

The FDA uses Derived Intervention Levels (DILs) to aid determine describe the radionuclide activity concentrations at which introduction of protective measures should be considered. The factors used to set DILs include:

  • the percentage of potentially contaminated foods in a person's nutrition;
  • the amount of food typically eaten;
  • the length of time that a person may be expected to eat contaminated nutrient; and,
  • the potential exposure to contaminated foods of different members of the population, including children.

In full general, DILs employ to all foods. The FDA does not have different DILs for unlike types of food, though DILs may exist adjusted based on factors such as: how much food is affected and/or how much of information technology is available, whether it'south a major nutrient item or an ingredient in candy food, whether it is rehydrated before being gear up to eat, etc.

How did FDA decide that there is no prove that radionuclides from the Fukushima incident are nowadays in the U.S. food supply at levels that are dangerous or would pose a public wellness business?

The FDA has fabricated this conclusion later collecting nigh 1,750 samples over the by ten years. None of the samples have been classified as beingness in violation of FDA laws and regulations. Only three of these samples were found to comprise whatsoever detectable levels of Cesium, but these trace levels were well below the established Derived Intervention Level (DIL) and we did not discover the levels to pose safety concerns in those foods.

What is tritium? What are its possible furnishings on human wellness?

Tritium is a radioactive isotope of hydrogen that is present naturally in our surroundings only also comes from certain man-made sources. Compared with other radionuclides, information technology carries an extremely low health chance. When nowadays at concentrations much higher than typically institute in food products or the environment, tritium is considered a health threat. No human health bug have been documented from exposure to tritium through nutrient or the surroundings. Detailed information on tritium is available on the internet from sources such as the following:

  • United states of america Environmental Protection Bureau (EPA)
  • United States Nuclear Regulatory Commission (NRC)
  • Health Physics Society Specialists in Radiation Safety (HPS)

How does the FDA monitor for radionuclides in domestic and imported foods, including seafood from Japan?

FDA collects and analyzes imported and domestic products to detect the presence of radionuclides, including those that would pose the greatest risk from the Fukushima/Daiichi contamination. Samples include imported seafood products from Japan, also as domestic seafood products from the Pacific coast of the U.Due south.

How volition h2o contaminated with radioactive materials affect seafood condom?

The FDA does not anticipate any public health effect on seafood safety in the U.S. This is due to a number of factors:

  • The ocean'south vastness. Radioactive material in water from the Fukushima/Daiichi facility would exist quickly diluted to extremely low concentrations. The exposure levels are therefore very small for any affected seafood species.
  • Most radionuclides from the Fukushima/Daiichi facility have disappeared due to radioactive decay. For example, the half-life of I-131 is nigh eight days. This means that the level of radiation from I-131 drops by half every viii days. This procedure is called "radioactive disuse". This reduction in radiation level means that although I-131 was measured initially, information technology disappeared within a few months afterward the blow. Cs-134 has a half-life of about two years. While information technology may still be nowadays at low levels in some nutrient, including seafood, safety concern is minimal. Cs-137 has a one-half-life of near thirty years. Withal, Cs-137 is readily excreted and does not accumulate in seafood. Despite this, FDA continues to monitor seafood for these radionuclides.
  • Seafood that is imported is screened. In add-on to testing performed in the consign countries, U.S. Community and Border Protection procedures include routine screening for radioactivity. The available screening method is capable of detecting radioactivity at trace levels well below levels of wellness concern. Please encounter previous bullet on how the FDA is monitoring radionuclides in seafood.
  • The altitude from Japan to the U.S. fishing regions. Just sure types of fish, such as swordfish, have long-range migratory patterns capable of showing up on U.S. shores afterwards passing through waters near Japan. Because natural biological processes deplete about radionuclides over fourth dimension, radioactivity would drop while traveling such long distances and whatever radioactivity that remains would be at an extremely depression level. This is confirmed through FDA's routine testing of domestically defenseless seafood.

What does FDA wait for when information technology tests food for radioactive contamination?

Since radioactivity is naturally present all around us (from soil, food, air, fifty-fifty our bodies), FDA tests only for radiation that is non normally present. Any extra radioactivity is evaluated to determine if follow upward action is warranted on a case by case basis. For accidents involving nuclear reactors, the primary radionuclides for monitoring are typically I-131, Cs-134, and Cs-137.

Will the tritium being discharged with this wastewater bear upon the rubber of FDA-regulated products from Japan or the surrounding countries?

No. When the wastewater is discharged, the tritium level in the ocean will be extremely low. Even if any of this tritium were to discover its way into an FDA-regulated product, the amount would only be at such an ultra-trace level that product safety would non exist affected. The wastewater discharge is planned to occur over a several calendar month menstruation and the slow infusion will foreclose any temporary localized spikes in tritium levels and maintain the levels low, far below any levels of business organization.

What steps is the FDA taking to fix for the belch of this wastewater?

FDA'due south radiological experts maintain on-going advice with their counterparts in U.S. and other authorities agencies with the limited objective of planning for radiological emergencies. Because of this, FDA is aware of international technical discussions on the need for Japan to address this wastewater and will go on to monitor the situation and maintain appointment with the Government of Nippon and other government agencies. FDA will besides proceed to collect and clarify imported and domestic products to detect the presence of radionuclides, including imported seafood products from Japan, likewise every bit domestic seafood products from the Pacific coast of the U.South.

Are other USG entities aware of/engaged on this issue?

Yep, FDA is working with other government agencies. Here are some boosted resource from those agencies:

  • Fukushima: EPA'south Radiological Monitoring | RadNet | Usa EPA
  • What to do in a Radiations Emergency | CDC
  • Nevada National Security Site (nnss.gov)
  • National Nuclear Security Assistants | Department of Energy

What is FDA doing to ensure the safety of products imported from Nippon?

FDA continues surveillance at U.Southward. borders including radiation screening of shipments. On March 22, 2011, FDA issued an import alarm regarding the importation of all milk and milk products and fresh vegetables and fruits produced or manufactured from the iv Japanese prefectures of Fukushima, Ibaraki, Tochigi and Gunma (Import Alert 99-33: Detention Without Concrete Examination of Products from Nihon Due to Radionuclide Contamination).

Revisions to the import alert provided updates to the products and/or prefectures subject to detention without physical examination. The import alert currently reflects the areas of business organization in 14 prefectures: Fukushima, Aomori, Chiba, Gumna, Ibaraki, Iwate, Miyagi, Nagano, Niigata, Saitama, Shizuoka, Tochigi, Yamagata and Yamanashi and includes seafood products.

FDA may adapt this strategy based on additional information received from monitoring results in Nippon. FDA may too further evaluate this strategy if the Government of Japan makes changes to its list of prohibited exports. FDA and the government of Nippon volition continue to work to ensure products from the affected prefectures do not pose a wellness risk to U.S. consumers.

The Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Deed) requires shippers to submit, and FDA to receive, prior notice of a shipment before the arrival of any shipments of FDA-regulated food/feed products. FDA's Sectionalisation of Food Defence force and Targeting (DFDT), (Formally known equally the Prior Notice Heart (PNC)), enables the agency to stop these products upon arrival at the U.Southward. border or before they are distributed in U.S. commerce if a credible threat is identified for any shipment.

U. S. Community and Edge Protection (CBP) agents routinely utilise radiation detection equipment to screen nutrient imports, cargo and travelers. This screening helps identify and resolve potential condom or security risks. FDA continues to work with CBP to place shipments of FDA-regulated products originating from Japan before they arrive and so that these shipments tin be better targeted for examination. FDA's import staff will review each shipment of regulated goods originating from Japan and determine if information technology should be refused, examined and sampled or released.

What products come up to the U.S. from Japan?

FDA-regulated products imported from Japan include homo and animal foods, medical devices and radiation emitting products, cosmetics, animal and human being drugs and biologics, dietary supplements and animal feeds. Foods imported from Japan make up less than iv percent of foods imported from all sources. (Food products from Canada and Mexico make upwardly about 57 percent of all imported foods.) Approximately 54 percent of all products imported from Japan are foods. The most common nutrient products imported include seafood, bakery products and vegetables and vegetable products.

What specific tests is FDA using?

FDA has procedures and laboratory techniques for measuring radionuclide levels in food and can as well utilize the Food Emergency Response Network (FERN). FERN integrates the nation's food-testing laboratories at the local, state and federal levels into a network that is able to respond to emergencies involving biological, chemical or radiological contamination of food. FDA is working with CPB to share resources and techniques for measuring contamination. FDA has excellent capabilities for measuring radioactive contagion in products and issued guidance in 1998 regarding safe levels.

What are the principal radionuclides involved in a nuclear reactor blow?

Iodine-131 (I-131), Cesium-134 (Cs-134) and Cesium-137 (Cs-137) are the radionuclides of greatest business concern to the food supply following a nuclear power establish accident. Along with those three radionuclides, FDA too monitors others as needed – among them, Strontium-90, Ruthenium-103 (Ru-103) and Ruthenium-106 (Ru-106).

Since the Fukushima nuclear accident, FDA has screened incoming food items for these radionuclides and others every bit needed. FDA besides continually evaluates data and information from the blow and adjusts monitoring activities as needed.

What about fish that swim from the reactor site into U.S. fishing waters?

Swimming from Nihon to U.Southward. waters would take several days nether the best of circumstances. Vessels fishing in waters far off U.S. shores must besides travel several days to return to port. Information technology is unlikely that a fish exposed to significant levels of radionuclides virtually the reactor could travel to U.S. waters and exist caught and harvested. If this improbable trip did occur, the level of short-lived radionuclides such as I-131 would drop significantly through natural radioactive decay during the fourth dimension needed to make the journeying. At this time, Japanese tests have detected longer-lived radionuclides such every bit Cs-137 in just a few samples and at levels below FDA DILs. FDA's testing of fish imported from Japan has not detected the presence of Cs-137.

In the unlikely scenario that pollutants could affect fish that take traveled to the U.S., FDA will work with the National Oceanic and Atmospheric Administration (NOAA) to exam seafood caught in those areas. Together FDA and NOAA will likewise inspect facilities that process and sell seafood from those areas.

Where would the seafood be analyzed?

FDA'due south Winchester Engineering and Analytical Center (WEAC) will carry any needed sample analysis. WEAC can also accomplish out to the Food Emergency Response Network (FERN) laboratories that are able to perform this analytical testing for help if needed.

What are other Federal agencies doing to protect the food supply?

FDA continues to work with its fellow members of the Federal Advisory Team for Environment Nutrient and Health, including EPA, USDA and CDC. The Advisory Team is a radiological emergency response grouping of technical experts tasked with providing protective action recommendations to state and local governments on behalf of its member agencies.

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Questions about Medical Products

What medications are available for radiation exposure?

Visit our webpage on Medical countermeasures (MCMs) for more data.

We take heard that potassium iodide is in short supply. Is that correct?

For more than information, visit our webpage on often asked questions on potassium iodide (KI).

Does FDA recommend that consumers purchase potassium iodide every bit a protective footstep?

No. There is no public health event requiring anyone in the U.Southward. to have KI because of the ongoing state of affairs in Japan.

With exports from Japan disrupted, is there any possibility that some medical products could exist in brusk supply?

FDA has been contacted by a few companies who receive product from Nihon and the agency is working with them on their supply issues.

Have U.Due south. manufacturers of potassium iodide been asked to ship whatever products to Japan?

At this fourth dimension, FDA is non aware of whatsoever request from Japan to the U.S. manufacturers of FDA -canonical potassium iodide. In addition, in that location is not a public health upshot requiring anyone in the U.S. to be taking KI considering of the ongoing situation in Japan.

Drugs shipped to a foreign country, including as part of a humanitarian relief effort, are considered exports, and therefore, need to encounter certain legal requirements under the Federal Food, Drug and Cosmetic Deed (FFDCA). If a drug is approved and is otherwise in compliance with the FFDCA's requirements, at that place are no additional restrictions by FDA on its exportation. Drugs that are not approved or that otherwise are not in compliance with the FFDCA's requirements may be exported if the exportation meets sure conditions and requirements.

Tin can a sponsor of an investigational new drug consign its production to Japan? Does FDA take to authorize such an export?

The sponsor of an investigational new drug can consign its production to Nihon. FDA regulations, establish at 21 CFR 312.110(b), outline several ways for the sponsor to export its investigational new drug provided the new drug satisfies the terms listed. For exports most relevant to the electric current situation, prior FDA authorization is not required for the sponsor to consign an investigational new drug under this section of the regulations.

If I see websites advertising potassium iodide or culling cures, should I buy the products?

No. Due to public concern related to the nuclear incident in Japan, there is an increased demand for drugs used to forbid and treat harmful furnishings caused by radiation exposure or contamination with radioactive materials. One drug, potassium iodide (KI), has been approved past the FDA to forestall thyroid cancer in people internally contaminated with radioactive iodine.

At this time, the U.South. Government is non recommending that residents of the U.s. or its territories take KI, even as a preventative mensurate. According to the Nuclear Regulatory Commission, all the available information continues to indicate that Hawaii, Alaska, the U.Due south. Territories and the U.Due south. West Coast are not expected to feel any harmful levels of radioactive decay.

FDA is alerting consumers to exist wary of internet sites and other retail outlets promoting products making faux claims to prevent or treat effects of radiation or products that are not FDA-approved. These fraudulent products come in all varieties and could include dietary supplements, food items or claims for products purporting to be drugs, devices or vaccines.

How tin can consumers place products that may be violative?

Consumers should be wary of the following:

  • claims implying that the product can forbid or treat the harmful furnishings of radiations exposure related to a nuclear incident (i.e., meltdown of a nuclear power plant);
  • suggestions that a potassium iodide production will care for weather condition other than those for which it is approved, i.e., KI floods the thyroid with not-radioactive iodine and prevents the uptake of the radioactive molecules, which are later excreted in the urine
  • production promotions using words such as "scientific breakthrough," "new products," "miraculous cure," secret ingredient," and "ancient remedy";
  • testimonials past consumers or doctors claiming amazing results;
  • advance payment requirements or promises of no-hazard, money-back guarantees;
  • promises of an "easy" prepare;
  • claims implying the products are "natural" or take fewer side furnishings than FDA-approved drugs; and,
  • claims that kelp, seaweed and other food products incorporate plenty iodine to protect confronting radioactive iodine. These products incorporate very piffling iodine when compared to the approved drug products. There are no foods or dietary supplements canonical by FDA for protection confronting radioactive iodine

Don't exist fooled by professional-looking websites. Avert websites that fail to list a physical accost, phone number or other contact data. For more information, view our webpage on tips on purchasing prescription medicines from a rubber online chemist's shop.

To decide if a item drug is FDA approved, check The Orange Book or Drugs@FDA.

Consumers and wellness care professionals are encouraged to report adverse side effects or medication errors from the use of both approved and unapproved radiation exposure products to the FDA's MedWatch Agin Issue Reporting plan at https://world wide web.fda.gov/safe/medwatch-fda-safety-data-and-adverse-effect-reporting-program or by calling 800-332-1088 .

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