On This Page:
- September 2021 Update
- April 2021 Update
- Questions about Food Safety
- Questions about Medical Products
Today FDA is deactivating Import Alert #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-foot 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, 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 Japan determined that certain food products in affected prefectures were not fit for human consumption, due to the public health risk associated with radionuclide contamination and prohibited those food products from sale (both within Japan and for export).
FDA responded by issuing the IA, “Detention Without Physical Examination of Products from Japan due to Radionuclide Contamination.” The basis for the IA is section 801(a)(2) of the Federal Food, Drug, and Cosmetic Act, which states that FDA-regulated products are subject to refusal and will be refused admission into the United States if the products appear 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 Japan’s restrictions at the prefecture level.
Now, after an extensive analysis of Japan’s robust control measures that include decontamination, monitoring and enforcement; after reviewing the results of 10 years of sampling food products from Japan; and after determining a very low risk to American consumers from radioactive contaminated foods imported from Japan, FDA has decided that the IA is no longer necessary to protect public health and therefore should be deactivated.
Japan’s control measures and FDA’s standard surveillance and sampling measures will provide multiple levels of oversight once the IA is deactivated, helping to ensure that food imported from Japan does not pose a food safety risk to U.S. consumers due to radionuclide contamination.
The FDA will continue communication and collaboration with the Government of Japan to monitor and ensure the safety of food products exported from Japan to the U.S., as it has since the days following the 2011 disaster.
On April 13, 2021, the Government of Japan announced it has decided to begin discharging into the ocean the wastewater that is currently being stored on site at the Fukushima Daiichi nuclear power plant in two years. The water, primarily the result 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 only the mildly radioactive and less harmful isotope, tritium.
Tritium presents an extremely low human and animal health risk if consumed and any health risk would be further minimized with the dilution effects of discharge into the ocean. Furthermore, FDA has no evidence that radionuclides from the Fukushima incident are present in the U.S. food supply at levels that are unsafe or would pose a public health concern and believes this action will have no effect on the safety of foods imported from Japan 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 Environment, Food and Health, came to this conclusion after 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 as well sampling of foods imported from Japan and U.S. domestic food products, we believe that there would be no impact to human and animal health if the treated wastewater were to be discharged into the ocean, as proposed by Japan. Consequently, FDA is not advising consumers to alter their consumption of specific foods imported from Japan 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 contain radionuclide contamination, remains active. In addition, FDA tests for radionuclides as part of its routine surveillance, through the toxic elements in food and foodware monitoring program and through its Total Diet Study.
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. Government agencies, including the environmental radiation monitoring program (RadNet) conducted by the Environmental Protection Agency. Additionally, FDA consults on a formal and informal basis with experts from U.S. government, academia and the private sector on radiation safety issues. FDA’s scientists also keep abreast of scientific publications and reports from both private and public scientific institutions, including oceanographic research institutions. For example, a study published in 2012 in the Proceedings of the National Academy of Sciences (PNAS) reported finding very low levels of Fukushima-related contamination in Pacific Bluefin tuna caught by recreational fisherman off the coast 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 further to determine if there were a health 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 close 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 it has since the start of the incident. The agency will use data and information from a variety of sources including its own testing and surveillance efforts and will continue to coordinate with other federal and state agencies to ensure the safety of food in the U.S. marketplace.
For more information from the U.S. Department of State, please visit https://www.state.gov/government-of-japans-announcement-on-fukushima-treated-water-release-decision/.
For more information on FDA’s radiological and nuclear emergency preparedness, visit our webpage.For more information on FDA’s radiological and nuclear emergency preparedness, visit our webpage.
What systems does FDA have in place to protect the U.S. food supply?
The U.S. enjoys one of the world’s safest food supplies. The FDA has systems in place to help ensure that our food supply is wholesome, safe 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 world. The FDA oversees the importation of the full range of regulated products, including food and animal feed, among other responsibilities.
The FDA works to inspect imports based on those that may pose a significant public health threat – by 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 reach our ports, the FDA’s imports entry reviews, inspections and sampling at the border help prevent these products from entering our food supply. The FDA also works cooperatively with U.S. Customs and Border Protection and other agencies to help identify shipments that may pose a threat.
What has FDA’s screening and testing shown so far?
As of July 27, 2021, the FDA has tested 1,749 import and domestic samples for contamination from the Fukushima/Daiichi facility. Three of these were found to contain detectable levels of Cesium, but the levels were well below the established Derived Intervention Level (DIL) and posed no public health concern. They were:
- Ginger Powder (sample no. 686901, collected April 2011)
- Green Tea Bag (sample no. 827430, collected August 2013)
- Green Tea Leaves (sample no. 887814, collected November 4, 2014)
What are the standards that FDA uses to determine the amounts of specific radioactive materials in foods and whether they may cause a safety concern?
The FDA uses Derived Intervention Levels (DILs) to help 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 diet;
- the amount of food typically eaten;
- the length of time that a person may be expected to eat contaminated food; and,
- the potential exposure to contaminated foods of different members of the population, including children.
In general, DILs apply to all foods. The FDA does not have different DILs for different types of food, though DILs may be adjusted based on factors such as: how much food is affected and/or how much of it is available, whether it’s a major food item or an ingredient in processed food, whether it is rehydrated before being ready to eat, etc.
How did FDA determine that there is no evidence that radionuclides from the Fukushima incident are present in the U.S. food supply at levels that are unsafe or would pose a public health concern?
The FDA has made this determination after collecting nearly 1,750 samples over the past ten years. None of the samples have been classified as being in violation of FDA laws and regulations. Only three of these samples were found to contain any detectable levels of Cesium, but these trace levels were well below the established Derived Intervention Level (DIL) and we did not find the levels to pose safety concerns in those foods.
What is tritium? What are its possible effects on human health?
Tritium is a radioactive isotope of hydrogen that is present naturally in our environment but also comes from certain man-made sources. Compared with other radionuclides, it carries an extremely low health risk. When present at concentrations much higher than typically found in food products or the environment, tritium is considered a health threat. No human health issues have been documented from exposure to tritium through food or the environment. Detailed information on tritium is available on the internet from sources such as the following:
- United States Environmental Protection Agency (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, as well as domestic seafood products from the Pacific coast of the U.S.
How will water contaminated with radioactive materials affect seafood safety?
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’s vastness. Radioactive material in water from the Fukushima/Daiichi facility would be 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 about eight days. This means that the level of radiation from I-131 drops by half every eight days. This process is called “radioactive decay”. This reduction in radiation level means that although I-131 was measured initially, it disappeared within a few months after the accident. Cs-134 has a half-life of about two years. While it may still be present at low levels in some food, including seafood, safety concern is minimal. Cs-137 has a half-life of about thirty years. However, 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 addition to testing performed in the export countries, U.S. Customs 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 health concern. Please see previous bullet on how the FDA is monitoring radionuclides in seafood.
- The distance from Japan to the U.S. fishing regions. Only certain types of fish, such as swordfish, have long-range migratory patterns capable of showing up on U.S. shores after passing through waters near Japan. Because natural biological processes deplete most radionuclides over time, radioactivity would drop while traveling such long distances and any radioactivity that remains would be at an extremely low level. This is confirmed through FDA’s routine testing of domestically caught seafood.
What does FDA look for when it tests food for radioactive contamination?
Since radioactivity is naturally present all around us (from soil, food, air, even our bodies), FDA tests only for radiation that is not normally present. Any extra radioactivity is evaluated to determine if follow up action is warranted on a case by case basis. For accidents involving nuclear reactors, the principal radionuclides for monitoring are typically I-131, Cs-134, and Cs-137.
Will the tritium being discharged with this wastewater affect the safety 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 find its way into an FDA-regulated product, the amount would only be at such an ultra-trace level that product safety would not be affected. The wastewater discharge is planned to occur over a several month period and the slow infusion will prevent any temporary localized spikes in tritium levels and maintain the levels low, far below any levels of concern.
What steps is the FDA taking to prepare for the discharge of this wastewater?
FDA’s radiological experts maintain on-going communication with their counterparts in U.S. and other government agencies with the express 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 continue to monitor the situation and maintain engagement with the Government of Japan and other government agencies. FDA will also continue to collect and analyze imported and domestic products to detect the presence of radionuclides, including imported seafood products from Japan, as well as domestic seafood products from the Pacific coast of the U.S.
Are other USG entities aware of/engaged on this issue?
Yes, FDA is working with other government agencies. Here are some additional resources from those agencies:
- Fukushima: EPA's Radiological Monitoring | RadNet | US EPA
- What to do in a Radiation Emergency | CDC
- Nevada National Security Site (nnss.gov)
- National Nuclear Security Administration | Department of Energy
What is FDA doing to ensure the safety of products imported from Japan?
FDA continues surveillance at U.S. borders including radiation screening of shipments. On March 22, 2011, FDA issued an import alert regarding the importation of all milk and milk products and fresh vegetables and fruits produced or manufactured from the four Japanese prefectures of Fukushima, Ibaraki, Tochigi and Gunma (Import Alert 99-33: Detention Without Physical Examination of Products from Japan 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 concern in fourteen prefectures: Fukushima, Aomori, Chiba, Gumna, Ibaraki, Iwate, Miyagi, Nagano, Niigata, Saitama, Shizuoka, Tochigi, Yamagata and Yamanashi and includes seafood products.
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. FDA and the government of Japan will continue to work to ensure products from the affected prefectures do not pose a health risk to U.S. consumers.
The Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) 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 Division of Food Defense and Targeting (DFDT), (Formally known as the Prior Notice Center (PNC)), enables the agency to stop these products upon arrival at the U.S. border or before they are distributed in U.S. commerce if a credible threat is identified for any shipment.
U. S. Customs and Border Protection (CBP) agents routinely use radiation detection equipment to screen food imports, cargo and travelers. This screening helps identify and resolve potential safety or security risks. FDA continues to work with CBP to identify shipments of FDA-regulated products originating from Japan before they arrive so that these shipments can be better targeted for examination. FDA's import staff will review each shipment of regulated goods originating from Japan and determine if it should be refused, examined and sampled or released.
What products come to the U.S. from Japan?
FDA-regulated products imported from Japan include human and animal foods, medical devices and radiation emitting products, cosmetics, animal and human drugs and biologics, dietary supplements and animal feeds. Foods imported from Japan make up less than 4 percent of foods imported from all sources. (Food products from Canada and Mexico make up about 57 percent of all imported foods.) Approximately 54 percent of all products imported from Japan are foods. The most common food 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 also 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 contamination in products and issued guidance in 1998 regarding safe levels.
What are the principal radionuclides involved in a nuclear reactor accident?
Iodine-131 (I-131), Cesium-134 (Cs-134) and Cesium-137 (Cs-137) are the radionuclides of greatest concern to the food supply following a nuclear power plant accident. Along with those three radionuclides, FDA also 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 as needed. FDA also continually evaluates data and information from the accident and adjusts monitoring activities as needed.
What about fish that swim from the reactor site into U.S. fishing waters?
Swimming from Japan to U.S. waters would take several days under the best of circumstances. Vessels fishing in waters far off U.S. shores must also travel several days to return to port. It is unlikely that a fish exposed to significant levels of radionuclides near the reactor could travel to U.S. waters and be 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 time needed to make the journey. At this time, Japanese tests have detected longer-lived radionuclides such as Cs-137 in only 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 have traveled to the U.S., FDA will work with the National Oceanic and Atmospheric Administration (NOAA) to test seafood caught in those areas. Together FDA and NOAA will also inspect facilities that process and sell seafood from those areas.
Where would the seafood be analyzed?
FDA's Winchester Engineering and Analytical Center (WEAC) will conduct any needed sample analysis. WEAC can also reach out to the Food Emergency Response Network (FERN) laboratories that are able to perform this analytical testing for assistance 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 Food and Health, including EPA, USDA and CDC. The Advisory Team is a radiological emergency response group of technical experts tasked with providing protective action recommendations to state and local governments on behalf of its member agencies.
What medications are available for radiation exposure?
Visit our webpage on Medical countermeasures (MCMs) for more information.
We have heard that potassium iodide is in short supply. Is that correct?
For more information, visit our webpage on frequently asked questions on potassium iodide (KI).
Does FDA recommend that consumers purchase potassium iodide as a protective step?
No. There is no public health event requiring anyone in the U.S. to take KI because of the ongoing situation in Japan.
With exports from Japan disrupted, is there any possibility that some medical products could be in short supply?
FDA has been contacted by a few companies who receive product from Japan and the agency is working with them on their supply issues.
Have U.S. manufacturers of potassium iodide been asked to ship any products to Japan?
At this time, FDA is not aware of any request from Japan to the U.S. manufacturers of FDA -approved potassium iodide. In addition, there is not a public health event requiring anyone in the U.S. to be taking KI because 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 meet certain legal requirements under the Federal Food, Drug and Cosmetic Act (FFDCA). If a drug is approved and is otherwise in compliance with the FFDCA’s requirements, there 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 certain conditions and requirements.
Can a sponsor of an investigational new drug export its product to Japan? Does FDA have to authorize such an export?
The sponsor of an investigational new drug can export its product to Japan. FDA regulations, found 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 current situation, prior FDA authorization is not required for the sponsor to export an investigational new drug under this section of the regulations.
If I see websites advertising potassium iodide or alternative 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 prevent and treat harmful effects caused by radiation exposure or contamination with radioactive materials. One drug, potassium iodide (KI), has been approved by the FDA to prevent thyroid cancer in people internally contaminated with radioactive iodine.
At this time, the U.S. Government is not recommending that residents of the United States or its territories take KI, even as a preventative measure. According to the Nuclear Regulatory Commission, all the available information continues to indicate that Hawaii, Alaska, the U.S. Territories and the U.S. West Coast are not expected to experience any harmful levels of radioactivity.
FDA is alerting consumers to be wary of internet sites and other retail outlets promoting products making false 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 can consumers identify products that may be violative?
Consumers should be wary of the following:
- claims implying that the product can prevent or treat the harmful effects of radiation exposure related to a nuclear incident (i.e., meltdown of a nuclear power plant);
- suggestions that a potassium iodide product will treat conditions other than those for which it is approved, i.e., KI floods the thyroid with non-radioactive iodine and prevents the uptake of the radioactive molecules, which are subsequently excreted in the urine
- product promotions using words such as “scientific breakthrough,” “new products,” “miraculous cure,” secret ingredient,” and “ancient remedy”;
- testimonials by consumers or doctors claiming amazing results;
- advance payment requirements or promises of no-risk, money-back guarantees;
- promises of an “easy” fix;
- claims implying the products are “natural” or have fewer side effects than FDA-approved drugs; and,
- claims that kelp, seaweed and other food products contain enough iodine to protect against radioactive iodine. These products contain very little iodine when compared to the approved drug products. There are no foods or dietary supplements approved by FDA for protection against radioactive iodine
Don't be fooled by professional-looking websites. Avoid websites that fail to list a physical address, phone number or other contact information. For more information, view our webpage on tips on purchasing prescription medicines from a safe online pharmacy.
Consumers and health 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 Adverse Event Reporting program at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or by calling 800-332-1088.