3-30-2011
OLYMPIA – Gov. Chris Gregoire today issued the following statement on ongoing radiological monitoring of milk, precipitation and drinking water:
“Tests performed by the Environmental Protection Agency confirm that Washington milk is safe to drink. A screening sample of milk taken from Spokane on March 25 detected 0.8 pCi/L of iodine-131, which is more than 5,000 times lower than levels that would signal concern. This morning I spoke with the chief advisors for both the EPA and the FDA and they confirmed that these levels are miniscule and are far below levels of public health concern, including for infants and children.
“According to them, a pint of milk at these levels would expose an individual to less radiation than would a five hour airplane flight.
“Since the situation in Japan we have been monitoring for radiation. We will continue our monitoring and work closely with the EPA, FDA and CDC. At no point have detection levels come close to levels of concern.”
For more information, visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249146.htm
Wednesday, March 30, 2011
Wednesday, March 23, 2011
DEL MONTE FRESH PRODUCE VOLUNTARILY RECALLS CANTALOUPES BECAUSE OF POSSIBLE HEALTH RISK
DATE 3/22/2011
Del Monte Fresh Produce N.A., Inc. (“Del Monte Fresh”) of Coral Gables, Florida is voluntarily recalling 4,992 cartons of cantaloupes, each containing 4 plastic mesh sleeves with 3 cantaloupes per sleeve, because they have the potential to be contaminated with Salmonella Panama, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella Panama often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella Panama can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The cantaloupes were distributed through warehouse clubs in Alaska, California, Colorado, Idaho, Montana, Oregon, and Washington.
The recalled products consist of cartons of cantaloupes, each containing 4 plastic beige mesh sleeves each sealed with a plastic orange handle with the Del Monte Logo and indication “3 count, Product of Guatemala” with 3 cantaloupes per sleeve and were available for sale between the 10th of March and the 21st of March, 2011. The cantaloupes, grown in and shipped from Del Monte Freshs’ farm Asuncion Mita in Guatemala, have a light brown color skin on the exterior, with orange flesh. The recalled cartons of cantaloupes are dark brown cardboard with the “Del Monte” logo in red lettering and “cantaloupes” in yellow lettering on a green background. The cantaloupes have the lot codes: 02-15-24-10, 02-15-25-10, 02-15-26-10 and 02-15-28-10
This cantaloupe recall is being implemented following a notification from the FDA that there is an epidemiologic link between the cantaloupes and approximately 12 reported cases of Salmonella Panama. Del Monte Fresh has put on hold the production and distribution of the product from the affected farm. The FDA and the Company will continue their investigation as to what, including whether the Company’s product, caused the problem.
Consumers who believe that they are in possession of uneaten cantaloupe affected by this recall should return it to the place of purchase for a refund and for more information may contact 1-800-659-6500 (operational 24 hours a day, seven days a week) or email Del Monte Fresh at Contact-US-Executive-Office@freshdelmonte.com
Del Monte Fresh Produce N.A., Inc. (“Del Monte Fresh”) of Coral Gables, Florida is voluntarily recalling 4,992 cartons of cantaloupes, each containing 4 plastic mesh sleeves with 3 cantaloupes per sleeve, because they have the potential to be contaminated with Salmonella Panama, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella Panama often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella Panama can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The cantaloupes were distributed through warehouse clubs in Alaska, California, Colorado, Idaho, Montana, Oregon, and Washington.
The recalled products consist of cartons of cantaloupes, each containing 4 plastic beige mesh sleeves each sealed with a plastic orange handle with the Del Monte Logo and indication “3 count, Product of Guatemala” with 3 cantaloupes per sleeve and were available for sale between the 10th of March and the 21st of March, 2011. The cantaloupes, grown in and shipped from Del Monte Freshs’ farm Asuncion Mita in Guatemala, have a light brown color skin on the exterior, with orange flesh. The recalled cartons of cantaloupes are dark brown cardboard with the “Del Monte” logo in red lettering and “cantaloupes” in yellow lettering on a green background. The cantaloupes have the lot codes: 02-15-24-10, 02-15-25-10, 02-15-26-10 and 02-15-28-10
This cantaloupe recall is being implemented following a notification from the FDA that there is an epidemiologic link between the cantaloupes and approximately 12 reported cases of Salmonella Panama. Del Monte Fresh has put on hold the production and distribution of the product from the affected farm. The FDA and the Company will continue their investigation as to what, including whether the Company’s product, caused the problem.
Consumers who believe that they are in possession of uneaten cantaloupe affected by this recall should return it to the place of purchase for a refund and for more information may contact 1-800-659-6500 (operational 24 hours a day, seven days a week) or email Del Monte Fresh at Contact-US-Executive-Office@freshdelmonte.com
Friday, March 18, 2011
A Note from the U.S. Food and Drug Administration - Radiation and Food Safety
Questions about Food Safety
What is FDA doing to assess the situation in Japan?
Based on current information, there is no risk to the U.S. food supply. FDA is closely monitoring the situation in Japan and is working with the Japanese government and other U.S. agencies to continue to ensure that imported food remains safe. FDA already has a very robust screening process for imports and has staff in place at the ports to monitor incoming products. FDA does not have concerns with the safety of imported food products that have already reached the U.S. and that are in distribution.
As part of our investigation, FDA is collecting information on all FDA regulated food products exported to the U.S. from Japan, including where they are grown, harvested, or manufactured, so the Agency can further evaluate whether, in the future, they may pose a risk to consumers in the U.S. As FDA assesses whether there is a potential health risk associated with FDA-regulated food products imported from Japan, the Agency will develop a monitoring strategy that may include increased and targeted product sampling at the border.
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.
Although FDA doesn’t physically inspect every product, the Agency electronically screens 100 percent of imported foods products before they reach our borders. Based on Agency risk criteria, an automated system alerts FDA to any concerns. Then inspectors investigate further and, if warranted, do a physical examination of the product.
FDA also works cooperatively with U.S. Customs and Border Protection and other agencies to help identify shipments that may pose a threat.
What products come to the U.S. from Japan?
Imports 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.
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. FDA is consulting with USDA’s Animal Plant Health Inspection Service (APHIS) to ensure the continued safety of dairy products.
Are there food harvesting (fields, fisheries) or processing facilities in the area of the Fukushima nuclear reactor?
While FDA does not track fields or fishery areas in foreign countries, it’s important to note that the damage caused by the earthquake and ensuing tsunami has reportedly halted production prior to the explosion at the reactor.
Is there any reason for concern about radiation from these products when they are imported into the US?
Right now, due to the damage to the infrastructure in Japan, FDA believes that export activity is severely limited. FDA is monitoring all import records for Japan to determine when importation will resume and will conduct surveillance to assure safety. FDA does not have any concerns for products that were already in transit when the explosion occurred at the reactor.
What are the current procedures for measuring radiation contamination in food? How will these change? How will FDA ensure consumers’ safety?
FDA has procedures and laboratory techniques for measuring radionuclide levels in food, and can also utilize the Food Emergency Response Network (FERN)1. 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.
Will FDA issue an import bulletin? What sort of techniques will FDA use to measure radiation in food?
FDA will issue an import bulletin or an assignment to the field once an assessment is completed on products and appropriate testing that can be completed. Products travel by vessel, the typical transit time for products to reach the U.S. is about 8 days. FDA and other domestic regulatory labs have validated analytical methods to detect radiological contamination in food.
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.
How will the radiation affect fish and seafood that have not yet been fished or harvested?
The great quantity of water in the Pacific Ocean rapidly and effectively dilutes radioactive material, so fish and seafood are likely to be unaffected. However, FDA is taking all steps to evaluate and measure any contamination in fish presented for import into the US.
What are the chances of radiation affecting growing areas in the US? What action will FDA take to ensure the safety of consumers of those products?
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. coast or affect U.S. fishing waters. Please see www.epa.gov2 for more information about monitoring efforts.
Back to top
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Questions about Medical Products
Hypothetically, if they were needed, what are the FDA-approved products for radiation exposure?
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.com3 4
ThyroSafe Tablets (65 mg), Recipharm AB, Jordbro, Sweden, http://www.thyrosafe.com5 6
ThyroShield Solution (65 mg/mL), Fleming & Company Pharmaceuticals, Fenton, Mo. http://www.thyroshield.com7 8
When administered in the recommended dose, KI is effective in reducing the risk of thyroid cancer in individuals or populations 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, which are subsequently excreted in the urine. Potassium iodide works only to prevent the thyroid from uptaking radioactive iodine. It is not a general radioprotective agent.
There are three FDA-approved potassium iodide drugs marketed as over the counter products. They are: Iosat Tablets (130 mg), manufactured by Anbex, Inc.; ThyroSafe Tablets (65 mg), manufactured by Recipharm and ThyroShield Solution (65 mg/mL), manufactured by Fleming & Company Pharmaceuticals.
Is potassium iodide the only medication available for radiation exposure?
Potassium iodide is the only FDA-approved medication available for exposure to 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.
Several components of the federal government maintain stockpiles of medical supplies for emergency situations. For instance, the CDC maintains the Strategic National Stockpile for civilian use, while the Department of Defense maintains their own supplies for support of military operations. The respective federal organizations should be contacted with any additional requests about the specific items and quantities in those stockpiles. Deployment of these stockpiles is governed by policies and procedures developed by the individual organizations based on available information and potential benefits and risks to public health.
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 for 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.
If I see web sites advertising potassium iodide or alternative cures, should I buy the products?
Due to the public concern related the nuclear incident in Japan, there has been an increased demand for drugs, such as Potassium iodide (KI), used to prevent and treat the harmful effects of radiation.
According to the Nuclear Regulatory Commission, all the available information continues to indicate that the United States, including U.S. Territories, are not expected to experience any harmful levels of radiation from the event in Japan.
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.
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;
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.
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 Online9. To determine if a particular drug is FDA approved, check The Orange Book10 or Drugs@FDA11.
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/MedWatch12 or by calling 800-332-1088.
What is FDA doing to assess the situation in Japan?
Based on current information, there is no risk to the U.S. food supply. FDA is closely monitoring the situation in Japan and is working with the Japanese government and other U.S. agencies to continue to ensure that imported food remains safe. FDA already has a very robust screening process for imports and has staff in place at the ports to monitor incoming products. FDA does not have concerns with the safety of imported food products that have already reached the U.S. and that are in distribution.
As part of our investigation, FDA is collecting information on all FDA regulated food products exported to the U.S. from Japan, including where they are grown, harvested, or manufactured, so the Agency can further evaluate whether, in the future, they may pose a risk to consumers in the U.S. As FDA assesses whether there is a potential health risk associated with FDA-regulated food products imported from Japan, the Agency will develop a monitoring strategy that may include increased and targeted product sampling at the border.
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.
Although FDA doesn’t physically inspect every product, the Agency electronically screens 100 percent of imported foods products before they reach our borders. Based on Agency risk criteria, an automated system alerts FDA to any concerns. Then inspectors investigate further and, if warranted, do a physical examination of the product.
FDA also works cooperatively with U.S. Customs and Border Protection and other agencies to help identify shipments that may pose a threat.
What products come to the U.S. from Japan?
Imports 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.
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. FDA is consulting with USDA’s Animal Plant Health Inspection Service (APHIS) to ensure the continued safety of dairy products.
Are there food harvesting (fields, fisheries) or processing facilities in the area of the Fukushima nuclear reactor?
While FDA does not track fields or fishery areas in foreign countries, it’s important to note that the damage caused by the earthquake and ensuing tsunami has reportedly halted production prior to the explosion at the reactor.
Is there any reason for concern about radiation from these products when they are imported into the US?
Right now, due to the damage to the infrastructure in Japan, FDA believes that export activity is severely limited. FDA is monitoring all import records for Japan to determine when importation will resume and will conduct surveillance to assure safety. FDA does not have any concerns for products that were already in transit when the explosion occurred at the reactor.
What are the current procedures for measuring radiation contamination in food? How will these change? How will FDA ensure consumers’ safety?
FDA has procedures and laboratory techniques for measuring radionuclide levels in food, and can also utilize the Food Emergency Response Network (FERN)1. 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.
Will FDA issue an import bulletin? What sort of techniques will FDA use to measure radiation in food?
FDA will issue an import bulletin or an assignment to the field once an assessment is completed on products and appropriate testing that can be completed. Products travel by vessel, the typical transit time for products to reach the U.S. is about 8 days. FDA and other domestic regulatory labs have validated analytical methods to detect radiological contamination in food.
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.
How will the radiation affect fish and seafood that have not yet been fished or harvested?
The great quantity of water in the Pacific Ocean rapidly and effectively dilutes radioactive material, so fish and seafood are likely to be unaffected. However, FDA is taking all steps to evaluate and measure any contamination in fish presented for import into the US.
What are the chances of radiation affecting growing areas in the US? What action will FDA take to ensure the safety of consumers of those products?
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. coast or affect U.S. fishing waters. Please see www.epa.gov2 for more information about monitoring efforts.
Back to top
--------------------------------------------------------------------------------
Questions about Medical Products
Hypothetically, if they were needed, what are the FDA-approved products for radiation exposure?
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.com3 4
ThyroSafe Tablets (65 mg), Recipharm AB, Jordbro, Sweden, http://www.thyrosafe.com5 6
ThyroShield Solution (65 mg/mL), Fleming & Company Pharmaceuticals, Fenton, Mo. http://www.thyroshield.com7 8
When administered in the recommended dose, KI is effective in reducing the risk of thyroid cancer in individuals or populations 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, which are subsequently excreted in the urine. Potassium iodide works only to prevent the thyroid from uptaking radioactive iodine. It is not a general radioprotective agent.
There are three FDA-approved potassium iodide drugs marketed as over the counter products. They are: Iosat Tablets (130 mg), manufactured by Anbex, Inc.; ThyroSafe Tablets (65 mg), manufactured by Recipharm and ThyroShield Solution (65 mg/mL), manufactured by Fleming & Company Pharmaceuticals.
Is potassium iodide the only medication available for radiation exposure?
Potassium iodide is the only FDA-approved medication available for exposure to 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.
Several components of the federal government maintain stockpiles of medical supplies for emergency situations. For instance, the CDC maintains the Strategic National Stockpile for civilian use, while the Department of Defense maintains their own supplies for support of military operations. The respective federal organizations should be contacted with any additional requests about the specific items and quantities in those stockpiles. Deployment of these stockpiles is governed by policies and procedures developed by the individual organizations based on available information and potential benefits and risks to public health.
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 for 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.
If I see web sites advertising potassium iodide or alternative cures, should I buy the products?
Due to the public concern related the nuclear incident in Japan, there has been an increased demand for drugs, such as Potassium iodide (KI), used to prevent and treat the harmful effects of radiation.
According to the Nuclear Regulatory Commission, all the available information continues to indicate that the United States, including U.S. Territories, are not expected to experience any harmful levels of radiation from the event in Japan.
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.
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;
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.
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 Online9. To determine if a particular drug is FDA approved, check The Orange Book10 or Drugs@FDA11.
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/MedWatch12 or by calling 800-332-1088.
Domestic Resposne to the Disaster in Japan
Over the last several days, the American people have been both heartbroken and deeply concerned about the developments in Japan.
We’ve seen an earthquake and tsunami render unimaginable -- an unimaginable toll of death and destruction on one of our closest friends and allies in the world. And we’ve seen this powerful natural disaster cause even more catastrophe through its impact on nuclear reactors that bring peaceful energy to the people of Japan.
First, we are bringing all available resources to bear to closely monitor the situation, and to protect American citizens who may be in harm’s way. Even as Japanese responders continue to do heroic work, we know that the damage to the nuclear reactors in Fukushima Daiichi plant poses a substantial risk to people who are nearby. That is why, we have called for an evacuation of American citizens who are within 50 miles of the plant. This decision was based upon a careful scientific evaluation and the guidelines that we would use to keep our citizens safe here in the United States, or anywhere in the world.
Beyond this 50-mile radius, the risks do not currently call for an evacuation. But we do have a responsibility to take prudent and precautionary measures to educate those Americans who may be endangered by exposure to radiation if the situation deteriorates. That’s why the President authorized the voluntary departures of family members and dependents of U.S. officials working in northeastern Japan.
All U.S. citizens in Japan should continue to carefully monitor the situation and follow the guidance of the U.S. and Japanese governments. And those who are seeking assistance should contact our embassy and consulates, which continue to be open and operational.
Here at a home, the government is doing a number of things as well: The US Government will be studying every aspect of the Japanese disaster and the Japanese government's response, with the goal of learning as much as possible from that review.
As the Nuclear Regulatory Commission has said as well as other nuclear and public health experts, we do not expect to see radiation at harmful levels reaching the U.S. from damaged Japanese nuclear power plants. You just aren't going to have any radiological material that, by the time it traveled those large distances, could present any risk to the American public.
Accordingly, public health experts and the CDC do not recommend that people in the United States take precautionary measures in response to the nuclear power plant explosions in Japan beyond staying informed. And going forward, we will continue to keep the American people fully updated.
As part of the federal government's continuing effort to make our activities and science transparent and available to the public, the Environmental Protection Agency (EPA) will continue to keep all RadNet data available in the current online database. RadNet is an existing nationwide radiation monitoring system that continuously monitors the nation's air and regularly monitors drinking water, milk and precipitation for environmental radiation. In addition, EPA is working with its federal partners to deploy additional monitoring capabilities to parts of the western U.S. and U.S. territories.
The FDA, USPS and CBP are of course closely monitoring the situation in Japan and all are working with other U.S agencies and or the Japanese government to continue to ensure that imported food, mail and airplanes remains safe.
And finally, given the range of potential manmade and natural disasters we can see here in America, the United States Government has in place preparedness and response plans that provide the flexibility and agility we need to respond aggressively and effectively to any hazard, including nuclear accidents. FEMA and the Department of Homeland Security thoroughly and regularly exercise these plans with their federal, state and local partners, and will be working to apply the lessons learned from the current situation in Japan to their planning efforts.
We’ve seen an earthquake and tsunami render unimaginable -- an unimaginable toll of death and destruction on one of our closest friends and allies in the world. And we’ve seen this powerful natural disaster cause even more catastrophe through its impact on nuclear reactors that bring peaceful energy to the people of Japan.
First, we are bringing all available resources to bear to closely monitor the situation, and to protect American citizens who may be in harm’s way. Even as Japanese responders continue to do heroic work, we know that the damage to the nuclear reactors in Fukushima Daiichi plant poses a substantial risk to people who are nearby. That is why, we have called for an evacuation of American citizens who are within 50 miles of the plant. This decision was based upon a careful scientific evaluation and the guidelines that we would use to keep our citizens safe here in the United States, or anywhere in the world.
Beyond this 50-mile radius, the risks do not currently call for an evacuation. But we do have a responsibility to take prudent and precautionary measures to educate those Americans who may be endangered by exposure to radiation if the situation deteriorates. That’s why the President authorized the voluntary departures of family members and dependents of U.S. officials working in northeastern Japan.
All U.S. citizens in Japan should continue to carefully monitor the situation and follow the guidance of the U.S. and Japanese governments. And those who are seeking assistance should contact our embassy and consulates, which continue to be open and operational.
Here at a home, the government is doing a number of things as well: The US Government will be studying every aspect of the Japanese disaster and the Japanese government's response, with the goal of learning as much as possible from that review.
As the Nuclear Regulatory Commission has said as well as other nuclear and public health experts, we do not expect to see radiation at harmful levels reaching the U.S. from damaged Japanese nuclear power plants. You just aren't going to have any radiological material that, by the time it traveled those large distances, could present any risk to the American public.
Accordingly, public health experts and the CDC do not recommend that people in the United States take precautionary measures in response to the nuclear power plant explosions in Japan beyond staying informed. And going forward, we will continue to keep the American people fully updated.
As part of the federal government's continuing effort to make our activities and science transparent and available to the public, the Environmental Protection Agency (EPA) will continue to keep all RadNet data available in the current online database. RadNet is an existing nationwide radiation monitoring system that continuously monitors the nation's air and regularly monitors drinking water, milk and precipitation for environmental radiation. In addition, EPA is working with its federal partners to deploy additional monitoring capabilities to parts of the western U.S. and U.S. territories.
The FDA, USPS and CBP are of course closely monitoring the situation in Japan and all are working with other U.S agencies and or the Japanese government to continue to ensure that imported food, mail and airplanes remains safe.
And finally, given the range of potential manmade and natural disasters we can see here in America, the United States Government has in place preparedness and response plans that provide the flexibility and agility we need to respond aggressively and effectively to any hazard, including nuclear accidents. FEMA and the Department of Homeland Security thoroughly and regularly exercise these plans with their federal, state and local partners, and will be working to apply the lessons learned from the current situation in Japan to their planning efforts.
A Note from U.S. Customs and Border Protection - Radiation & International Travel
U.S. Customs and Border Protection (CBP) is monitoring developments in Japan carefully and is specifically assessing the potential for radiological contamination associated with the ongoing impact of the earthquake and tsunami to Japan’s nuclear facilities.
Out of an abundance of caution, CBP has issued field guidance reiterating its operational protocols and providing specific field personnel direction with regard to monitoring of maritime and air traffic from Japan.
In general, travelers that have been exposed to radiation are not a risk to other persons. When a radiation alarm occurs, CBP has protocols in place to isolate the affected traveler, baggage, or cargo, and resolve the concern. Travelers who manifest signs of radiation sickness will be referred to health authorities and provided appropriate treatment.
CBP employs several types of radiation detection equipment in its operations at both air and sea ports. CBP frontline personnel are equipped with Personal Radiation Detectors (PRDs) that can detect the presence of radiological materials. All airports and seaports have sensitive Radiation Isotope Identification Devices (RIIDs) to determine both the presence and type of radiation encountered. Upon radiation detection, CBP exercises specific protocols to resolve any security or safety concerns for inbound travelers, baggage, and cargo.
CBP resolves over half a million radiation alarms per year in the course of their normal duties.
In addition to airplanes and ports, CBP utilizes radiation portal monitors at international mail facilities as well. The monitors provide a non-intrusive method to screen mail items for the presence of nuclear and radiological materials. The U.S. Postal Service assists Customs and Border Protection officers with response and mitigation of items when radiation is detected to ensure the safety of our employees and the American public.
Out of an abundance of caution, CBP has issued field guidance reiterating its operational protocols and providing specific field personnel direction with regard to monitoring of maritime and air traffic from Japan.
In general, travelers that have been exposed to radiation are not a risk to other persons. When a radiation alarm occurs, CBP has protocols in place to isolate the affected traveler, baggage, or cargo, and resolve the concern. Travelers who manifest signs of radiation sickness will be referred to health authorities and provided appropriate treatment.
CBP employs several types of radiation detection equipment in its operations at both air and sea ports. CBP frontline personnel are equipped with Personal Radiation Detectors (PRDs) that can detect the presence of radiological materials. All airports and seaports have sensitive Radiation Isotope Identification Devices (RIIDs) to determine both the presence and type of radiation encountered. Upon radiation detection, CBP exercises specific protocols to resolve any security or safety concerns for inbound travelers, baggage, and cargo.
CBP resolves over half a million radiation alarms per year in the course of their normal duties.
In addition to airplanes and ports, CBP utilizes radiation portal monitors at international mail facilities as well. The monitors provide a non-intrusive method to screen mail items for the presence of nuclear and radiological materials. The U.S. Postal Service assists Customs and Border Protection officers with response and mitigation of items when radiation is detected to ensure the safety of our employees and the American public.
A Note from EPA - Radiation Monitoring
As the Nuclear Regulatory Commission has said, we do not expect to see radiation at harmful levels reaching the U.S. from damaged Japanese nuclear power plants. As part of the federal government's continuing effort to make our activities and science transparent and available to the public, the Environmental Protection Agency (EPA) will continue to keep all RadNet data available in the current online database. EPA is working with its federal partners and has deployed additional monitors to Hawaii, Alaska, Guam and the Northern Mariana Islands.
As always, EPA is utilizing this existing nationwide radiation monitoring system, RadNet, which continuously monitors the nation's air and regularly monitors drinking water, milk and precipitation for environmental radiation. The RadNet online searchable database contains historical data of environmental radiation monitoring data from all fifty states and U.S. territories.
EPA monitors are not picking up any harmful levels of radiation on our RadNet monitors across the US.
As always, EPA is utilizing this existing nationwide radiation monitoring system, RadNet, which continuously monitors the nation's air and regularly monitors drinking water, milk and precipitation for environmental radiation. The RadNet online searchable database contains historical data of environmental radiation monitoring data from all fifty states and U.S. territories.
EPA monitors are not picking up any harmful levels of radiation on our RadNet monitors across the US.
Wednesday, March 16, 2011
Radiation from the nuclear power plants in Japan is not a health risk for Washington.
Washington State Department of Health 3/16/2011
Since the failure of the power plants in Japan, radiation levels in Washington have not climbed above normal background levels and we do not expect they will.
Several factors play a role in protecting us from the release of radiation occurring at the damaged reactors in Japan:
• Most of the radioactive material is contained at the damaged plants; even if radioactive material reaches the upper atmosphere, it would not reach Washington in concentrations high enough to cause a health risk.
• The radioactive material that was released did not reach the upper atmosphere where it could be carried toward North America by the jet stream in amounts that would cause public health impact
• The fires and explosions at the Japanese reactors have not been as intense as the Chernobyl accident. Radioactive material ejected into the jet stream from Chernobyl did reach Washington in small amounts. Even after the Chernobyl disaster, protective action was not needed in our state, and the Japan incident is much smaller than Chernobyl.
• Even if radioactive material is released in Japan and reaches the jet stream, it would take several days to get here because the nuclear plants are about 5,000 miles from our state. In the time it would take to cross the Pacific, it would mix with lots of air as it’s blown in the wind (thus diluted); rain would wash some of the material from the air into the ocean.
• Radioactive decay, especially for short half-life radioactive materials such as iodine-131, would substantially reduce the amount of the radioactive material that could reach here.
For these reasons, it’s unlikely that we will see an increase in background levels of radiation in Washington. Even if a small amount of radiation did reach us, it would be well below levels that would pose public health concerns.
Since the failure of the power plants in Japan, radiation levels in Washington have not climbed above normal background levels and we do not expect they will.
Several factors play a role in protecting us from the release of radiation occurring at the damaged reactors in Japan:
• Most of the radioactive material is contained at the damaged plants; even if radioactive material reaches the upper atmosphere, it would not reach Washington in concentrations high enough to cause a health risk.
• The radioactive material that was released did not reach the upper atmosphere where it could be carried toward North America by the jet stream in amounts that would cause public health impact
• The fires and explosions at the Japanese reactors have not been as intense as the Chernobyl accident. Radioactive material ejected into the jet stream from Chernobyl did reach Washington in small amounts. Even after the Chernobyl disaster, protective action was not needed in our state, and the Japan incident is much smaller than Chernobyl.
• Even if radioactive material is released in Japan and reaches the jet stream, it would take several days to get here because the nuclear plants are about 5,000 miles from our state. In the time it would take to cross the Pacific, it would mix with lots of air as it’s blown in the wind (thus diluted); rain would wash some of the material from the air into the ocean.
• Radioactive decay, especially for short half-life radioactive materials such as iodine-131, would substantially reduce the amount of the radioactive material that could reach here.
For these reasons, it’s unlikely that we will see an increase in background levels of radiation in Washington. Even if a small amount of radiation did reach us, it would be well below levels that would pose public health concerns.
How the nuclear reactor event in Japan affects King County
The information below was created by Public Health Seattle King County and is being provided as an FYI. For Official information from the Washington State Department of Health use this link: Japanese Earthquake 2011 - What does it mean for Washington?
How the nuclear reactor event in Japan affects King County
Updated 3/15/11, 3:00 PM
I’m alarmed by the news about the nuclear reactors in Japan. Do experts here think we’re at risk from radioactivity coming from Japan?
News of the unfolding events at the nuclear reactors shows a very serious radiological situation in northeast Japan. Here in our state, experts at the Nuclear Regulatory Commission and the Washington Department of Health Radiation Protection agency do not expect significant levels of radioactivity or any health risk from the situation in Japan. We could see a very small increase in radiation levels, but they would be well below levels that would be a health concern. As a precaution, federal and state agencies will continue to monitor radiation levels in the air and rain water.
Why would radioactivity from Japan not be dangerous if it arrived here?
Radioactivity can travel, but it thins out as it moves away from the source. Any radioactivity from the reactors would be diluted by the winds and the distance it takes to travel to Washington. Radiation experts at the Nuclear Regulatory Commission and Washington State Department of Health expect that the concentration of radioactivity would be too low to cause any health effects to people in the Pacific Northwest.
Is there a pill that will protect me?
No, there is no pill that completely protects against radiation. Potassium iodide (KI) pills protect part of the body against very specific kinds of radiation (radioactive iodine), but they only helpful under a very specific set of conditions. Some people could also be harmed by the high concentration of iodine in KI because of allergies or other health issues. We do not recommend purchasing or using KI as the situation. There’s no scenario involving the nuclear plants in Japan that would lead to a recommendation for people in Washington to take KI. More information on KI is available online from the Centers for Disease Control and Prevention: http://www.bt.cdc.gov/radiation/ki.asp
Internet sources suggest taking large doses of iodine water purification tablets. Is that a good alternative?
NO. In fact, state health officials counsel against taking anything to prevent against radiation exposure when there’s no unusual radiation source.
What if the situation gets worse with the reactors in Japan?
We don’t know what will happen in Japan, but the state Department of Health has determined that even in the event of a significant release from the reactor, radiation should be diluted before reaching our state. In that radiation levels would be so low that no protective action would be necessary. The state health department will continue its monitoring work as the situation in Japan develops and changes.
For more information: http://www.doh.wa.gov/Topics/japan2011.htm
How the nuclear reactor event in Japan affects King County
Updated 3/15/11, 3:00 PM
I’m alarmed by the news about the nuclear reactors in Japan. Do experts here think we’re at risk from radioactivity coming from Japan?
News of the unfolding events at the nuclear reactors shows a very serious radiological situation in northeast Japan. Here in our state, experts at the Nuclear Regulatory Commission and the Washington Department of Health Radiation Protection agency do not expect significant levels of radioactivity or any health risk from the situation in Japan. We could see a very small increase in radiation levels, but they would be well below levels that would be a health concern. As a precaution, federal and state agencies will continue to monitor radiation levels in the air and rain water.
Why would radioactivity from Japan not be dangerous if it arrived here?
Radioactivity can travel, but it thins out as it moves away from the source. Any radioactivity from the reactors would be diluted by the winds and the distance it takes to travel to Washington. Radiation experts at the Nuclear Regulatory Commission and Washington State Department of Health expect that the concentration of radioactivity would be too low to cause any health effects to people in the Pacific Northwest.
Is there a pill that will protect me?
No, there is no pill that completely protects against radiation. Potassium iodide (KI) pills protect part of the body against very specific kinds of radiation (radioactive iodine), but they only helpful under a very specific set of conditions. Some people could also be harmed by the high concentration of iodine in KI because of allergies or other health issues. We do not recommend purchasing or using KI as the situation. There’s no scenario involving the nuclear plants in Japan that would lead to a recommendation for people in Washington to take KI. More information on KI is available online from the Centers for Disease Control and Prevention: http://www.bt.cdc.gov/radiation/ki.asp
Internet sources suggest taking large doses of iodine water purification tablets. Is that a good alternative?
NO. In fact, state health officials counsel against taking anything to prevent against radiation exposure when there’s no unusual radiation source.
What if the situation gets worse with the reactors in Japan?
We don’t know what will happen in Japan, but the state Department of Health has determined that even in the event of a significant release from the reactor, radiation should be diluted before reaching our state. In that radiation levels would be so low that no protective action would be necessary. The state health department will continue its monitoring work as the situation in Japan develops and changes.
For more information: http://www.doh.wa.gov/Topics/japan2011.htm
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