Thursday, September 19, 2013

FDA Response to the Fukushima Dai-ichi Nuclear Power Facility Incident

Press release from:  http://www.fda.gov/newsevents/publichealthfocus/ucm247403.htm

September 2013 Update

To date, FDA has no evidence that radionuclides from the Fukushima incident are present in the U.S. food supply at levels that would pose a public health concern. This is true for both FDA-regulated food products imported from Japan and U.S. domestic food products, including seafood caught off the coast of the United States. Consequently, FDA is not advising consumers to alter their consumption of specific foods imported from Japan or domestically produced foods, including seafood. FDA continues to closely monitor the situation at and around the Fukushima Dai-ichi facility, as it has since the start of the incident and will coordinate with other Federal and state agencies as necessary, standing ready to take action if needed, to ensure the safety of food in the U.S. marketplace.

Import Alert # 99-33 disclaimer icon , 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 (EPA). Additionally, the Agency consults on a formal and informal basis with experts from government, academia and the private sector on radiation safety issues. FDA 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 Cesium 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 cesium 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
  • Fukushima Dai-ichi incident related activities of international organizations such as the International Atomic Energy Agency (IAEA).
FDA continues to pay close attention to the situation at the Fukushima Dai-ichi facility and to use data, and information from the variety of sources described above, including the results of its own testing and surveillance efforts to ensure that any FDA-regulated food with harmful levels of radiation as a result of the Fukushima incident is kept out of the U.S. market.

Questions about Food Safety
 

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. FDA has systems in place to help assure that our food supply is wholesome, safe to eat, and produced under sanitary conditions.
 
FDA has a team of more than 900 investigators and 450 analysts in the Foods program who conduct inspections and collect and analyze product samples. FDA oversees the importation of the full range of regulated products, including food and animal feed, among other responsibilities.
 
Altogether, FDA electronically screens all import entries and performs multiple analyses on about 31,000 import product samples annually. During Fiscal Year (FY) 2010, the Agency performed more than 175,000 food and feed field exams and conducted more than 350 foreign food and feed inspections.
 
FDA works to inspect the right imports—those that may pose a significant public health threat – by carrying out targeted risk-based analyses of imports at the points of entry.
 
If unsafe products reach our ports, FDA’s imports entry reviews, inspections, and sampling at the border help prevent these products from entering our food supply. FDA also works cooperatively with U.S. Customs and Border Protection and other agencies to help identify shipments that may pose a threat. If radiation levels in any food reach the FDA intervention level, FDA will take action to remove the food from distribution.
 
We will continue to keep you updated about this situation. For more information about milk and other food screening, please visit www.usa.gov/japan2011. 
 

 

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

FDA’s screening at U.S. borders will remain vigilant and will be augmented with radiation screening of shipments. On March 22, 2011, in order to complement the measures taken by the Government of Japan and to strengthen the global food safety net regarding certain products, FDA issued Import Alert 99-33(http://www.accessdata.fda.gov/cms_ia/importalert_621.html) 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. As of May 17, FDA has reduce the area of concern to three prefectures: Fukushima, Ibaraki, and Tochigi. This import alert was revised on March 25, April 12, April 15 and April 20, April 21, May 17, and July 11.
FDA is processing all food products from Japan in four categories:
  • Category 1 consists of products that the Government of Japan has restricted for sale or export. Authorities will prevent these products from entering the U.S. These products cannot gain entry by providing sample results. As of July 11, 2011, these include:
    • Tea leaves from Ibaraki, Tochigi, Gunma, Kanagawa, and Chiba prefectures, and dace, ayu, and cherry salmon (yamame) from Fukushima.
    • Spinach, lettuce, celery, cress, endive, escarole, chard, collards, and other head-type leafy vegetables from the Fukushima Prefecture.
    • Turnips and other non-head type leafy vegetables, as well as broccoli, cauliflower, flower head brassicas (i.e. broccoli and cauliflower), mushrooms bamboo shoots, and Ostrich fern from the Fukushima Prefecture.
    • Sand lance from Fukushima Prefecture
    • Milk from the Fukushima and Ibaraki Prefectures.
    • Spinach and kakina from the Fukushima and Ibaraki Prefectures.
  • Category 2 consists of products from the Fukushima, Ibaraki, and Tochigi Prefectures that the Government of Japan has not currently banned for sale or export. These specific products include dairy products and fresh produce. Under Import Alert 99-33, authorities may detain these products when they arrive in the U.S. Authorities will release these products from detention if the importer can show the products are compliant.
  • Category 3 consists of food and feed products not covered by FDA’s Import Alert that come from these three Japanese prefectures:
    • Fukushima
    • Ibaraki
    • Tochigi
FDA will examine these products, sampling and testing as needed, to determine if they are safe to enter the U.S.
  • Category 4 consists of all other FDA-regulated food products from Japan that are not listed in the Import Alert and do not belong to one of the other categories. Authorities will review these products using standard procedures, and as part of this may monitor and sample products as resources permit.

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’s import tracking system has been programmed to automatically flag all shipments of FDA-regulated products from Japan, and the Agency maintains a registry of companies that prepare, pack, manufacture, or hold food for intended consumption in the U.S. The Agency will be paying special attention to shipments from those companies in the affected area.

Standard operating procedure 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 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.

United States 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 is working with CBP to determine if their Automated Targeting System can assist in identifying shipments of FDA-regulated products, other than food or feed, 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 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 each make up about 29 percent of all imported foods.) Almost 60 percent of all products imported from Japan are foods. The most common food products imported include seafood, snack foods and processed fruits and vegetables.

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 Customs and Border Protection (CPB) to share resources and techniques for measuring contamination. FDA has the ability to measure contamination in products and issued guidance in 1998 regarding safe levels.
 
For those food and feed imports from the areas in proximity to the reactor but not covered by the import alert, FDA will:
  • Conduct a field examination, including time/temperature changes, water damage. 
  • Collect a sample for radionuclide analysis at FDA laboratories.
For food and feed imports from Japan that originate outside the area of concern, FDA will:
  • Collect a sample for any radiation pager reading significantly above background.
  • As additional surveillance and as resources allow, collect other samples for radionuclide analysis as resources permit, for readings of 0 on the radionuclide pager. 
 
 

 

What does FDA look for when it tests food for radioactive contamination?

When FDA tests food for radioactive contamination, it measures how much radiation is released by radioactive materials that are not expected to be naturally present.

Radioactive materials are substances that release high energy particles or electromagnetic radiation. These high energy particles or electromagnetic radiation are emitted by unstable atoms as they go through transition to a more stable state. The energy that is released from radioactive materials is called radiation. Radioactive materials can be natural (for example, some rocks in the earth are radioactive) or man-made.

 

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

FDA uses Derived Intervention Levels (PDF) (DILs) to help determine whether food presents a safety concern. The criteria 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
  • the potential exposure to contaminated foods of different members of the population, including infants and children.
In general, DILs apply to all foods.  FDA does not have different DILs for different types of food, though DILs may be adjusted based on, for example, whether a food must be rehydrated before being ready to eat.

For more information about the DILs, please see the following links:

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

As of June 20th, 2012, FDA import investigators had performed 32,685 field examinations for radionuclide contamination. FDA had tested 1313 samples, 199 which were seafood or seafood products. 1312 samples had no Iodine-131, Cesium-134, Cesium-137, or other gamma-ray emitting radionuclides of concern. 1 sample was found to contain detectable levels of Cesium, but was below the established Derived Intervention Level (DIL) and posed no public health concern.
MS Excel Data File

How will water contaminated with radioactive materials affect seafood safety?

FDA does not anticipate any public health effect on seafood safety. This is due to a number of factors:
  • Little or no harvesting of fish is taking place in the area around the reactor. The initial earthquake and tsunami caused significant damage to fishing vessels and dock areas prior to the release of radiation. Additionally, many of the remaining ocean-worthy vessels are being used for recovery missions. Because of this, fishing is not a priority at this time.
  • Water acts as both a shield and a diluent. Airborne radioactive particles settle on the surface of the water. The volume of water between particles and fish absorbs radiation, “shielding” the fish. In the case of a direct release into the sea, the amount of water in the ocean rapidly dilutes and disperses the radiation to negligible levels.
  • Some radioactive isotopes rapidly decay. The half life of I-131 is about eight days. That means that the level of radiation drops by half every eight days. This process is called “radioactive decay.” This drop in the level of radiation means that the level does not stay constant through the lifetime of the fish. While Cesium isotopes have longer half-lives (Cs-134 has a half-life of about two years, Cs-137 a longer half-life of about 30 years), the radionuclides also undergo biological excretion and do not continue to build up in fish forever.
  • FDA and Customs and Border Protection (CBP) are screening all imported food from Japan. Fish harvested in Japan undergo the same screening for radiation when they arrive in the U.S. as other food products from Japan. This means that whole shipping containers are screened by CBP.  FDA field staff also conduct field examinations. They carry hand-held equipment that detects radiation. If the detectors indicate radiation above background levels, FDA samples and tests the shipment to determine the amount of radiation.

 

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

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.

Is FDA looking at products that might have traveled through Japan at the time of the explosion?


FDA will be examining both food products labeled as having originated in Japan or having passed through Japan in transit. The same is true for raw ingredients.
  

Are there dairy products that come from Japan?

Foods imported from Japan constitute less than 4 percent of foods imported from all sources. Dairy products make up only one-tenth of one percent of all FDA-regulated products imported from Japan. Most dairy products in the U.S. market are produced domestically.
  

The U.S. Environmental Protection Agency (EPA) has reported low levels of radionuclides in milk in the U.S. Is this a cause for concern?

At this time, there is no radiation safety risk related to milk produced in the U.S.

EPA monitors milk for radiation under its RADNET program, and has reported extremely low levels of I-131 and Cesium in some milk samples. These results are expected and are far below FDA’s Derived Intervention Levels. Even for a person who drinks a lot of milk, it would be virtually impossible to consume enough milk to approach the level of concern.

As federal and state agencies test milk samples, low levels of I-131 may be found in different samples, and the levels may vary slightly. However these low levels are not expected to cause adverse health effects, even for the developing fetus, babies, or children.

At this time, there is no public health threat in the U.S. related to radiation exposure. FDA, together with other agencies, is carefully monitoring any possibility for distribution of radiation to the United States. At this time, theoretical models do not indicate that significant amounts of radiation will reach the U.S. Please see www.epa.gov for more information about monitoring efforts.
 

What will FDA do if grass or feed crop in the US does become contaminated?

FDA's response will depend on the nature of the risk determined to exist. If the grass or feed crop in the U.S. becomes contaminated, FDA will evaluate the risk based on:
A. the extent/type of contamination in terms of radionuclides and their levels
B. the area contaminated and whether it is used for food production
C. if used for food production, what types of foods or crops produced and whether those foods or crops would be further processed and if so, what foods would ultimately result from that further processing.

 

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

Information about the U.S. Government’s comprehensive efforts to protect the food supply can be found in this joint fact sheet from the U.S. Department of Agriculture (USDA) and the National Oceanic and Atmospheric Administration (NOAA).

Additionally FDA continues to work with its fellow member 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.


Questions about Medical Products 

What is the FDA doing to ensure the safety of drugs coming from Japan? 

FDA’s screening procedures will remain vigilant and will be augmented with screening of all Japanese shipments entering the United States.  The agency has established special procedures to evaluate drugs originating from the ten prefectures in closest proximity to the Fukushima Daiichi nuclear plant.

FDA will physically examine for radiation all drugs originating from these ten prefectures.   Based on the results of those physical examinations, FDA may also test products to determine if they are safe to admit into the U.S.  FDA will also physically examine and test all injectable and inhalable drugs regardless of their place of origin within Japan.
 

Why is FDA paying special attention to injectable and inhalable drugs? 

Injectable and inhalable drugs will be subject to physical examination and testing regardless of their place of origin within Japan because these drugs more directly enter into the bloodstream.  All other drugs originating from outside of the ten prefectures in closest proximity to the Fukushima Daiichi nuclear plant will be subject to normal processing for examination, sampling, and testing.
 

How long will FDA maintain this heightened level of scrutiny for drugs coming from Japan? 

FDA will adjust the evaluation and testing procedures based upon additional information about conditions in Japan, and the results of testing procedures of drugs originating from Japan.

Hypothetically, if they were needed, what are the FDA-approved products for treatment of internal contamination with radioactive iodine?

There are three FDA-approved potassium iodide (KI) products for use as an adjunct to other public health protective measures in the event that radioactive iodine is released into the environment. The three over-the-counter products are:
When administered at the recommended dose, KI is effective in reducing the risk of thyroid cancer in people at risk for inhalation or ingestion of radioactive iodine. KI floods the thyroid with non-radioactive iodine and prevents the uptake of the radioactive molecules. Potassium iodide works only to prevent the thyroid from uptaking radioactive iodine. It is not a general radioprotective agent.

Is potassium iodide the only medication available for radiation exposure?

Potassium iodide is the only FDA-approved medication available to treat contamination with radioactive iodine. There are FDA-approved products available that increase the rate of elimination of other radioactive elements. They include:
  • Calcium-DTPA and Zinc DTPA, Hameln Pharmaceuticals. Approved to treat known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination.
  • Radiogardase (Prussian blue insoluble capsules), HEYL Chemisch-Pharmazeutische Fabrik GmbH & Co. KG. Approved to treat known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium to increase their rates of elimination.

 

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

FDA daily evaluates the pharmaceutical supply for a wide variety of drugs to assess shortage issues.
Despite the fact that there is no public health event in the U.S. requiring KI, FDA is aware of an increased demand for KI products. FDA is working with these companies to facilitate increased production. FDA can’t provide an exact date on when that might happen but it will occur as quickly as possible.

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. At this time, however, the U.S. Government is not recommending that residents of the United States or its territories take potassium iodide, even as a preventative measure.

According to the Nuclear Regulatory Commission, all the available information continues to indicate that the U.S. Territories and the U.S. West Coast are not expected to experience any harmful levels of radioactivity. Based on this, it is not expected that U.S. citizens will need potassium iodide.

Nonetheless, the FDA is working with manufacturers to facilitate increased production of this medicine as quickly as possible.

 

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, the 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.  The 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 web sites advertising potassium iodide or alternative cures, should I buy the products?

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.

The 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 products purporting to be drugs, devices or vaccines.


Has FDA taken any action on these types of products thus far?

FDA has issued Warning Letters to firms promoting a variety of fraudulent products that claim to prevent or treat the harmful effects of radiation exposure from the nuclear power plant incident in Japan as a consequence of the earthquake and tsunami. The firms that received the letters, along with the radiation protection products they market, are:
 

How can consumers identify products that may be violative?

Consumers should be wary of the following:
  • claims that a product not approved by FDA 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;
  • promotions using words such as “scientific breakthrough,” “new products,” “miraculous cure,” ”secret ingredient,” and ”ancient remedy”;
  • testimonials by consumers or doctors claiming amazing results;
  • limited availability and advance payment requirements;
  • promises of no-risk, money-back guarantees;
  • promises of an “easy” fix; and,
  • claims that the product is “natural” or has fewer side effects than approved drugs.
  • 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 Web sites. Avoid Web sites that fail to list the company's name, physical address, phone number, or other contact information. For more tips for online buying, visit Buying Medicines and Medical Products Online. To determine if a particular drug is FDA approved, check The Orange Book17 or Drugs@FDA.

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 www.fda.gov/MedWatch or by calling 800-332-1088.
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