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 
,
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.
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:
- Iosat Tablets (130 mg), Anbex, Inc., Williamsburg, Va., http://www.anbex.com
- ThyroSafe Tablets (65 mg), Recipharm AB, Jordbro, Sweden,http://www.thyrosafe.com
- ThyroShield Solution (65 mg/mL), Fleming & Company Pharmaceuticals, Fenton, Mo. http://www.thyroshield.com
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.
