impact of japanese earthquake on excipients
TRANSCRIPT
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Impact of Japanese Earthquake on Excipients
IPEC 20 Anniversary ConferenceMay 9, 2011 Baltimore, MD
Richard Green, Beam Suffolk,VC Maker/Distributor Relations, IPEC Am IPEC Europe Chair, Global Director, Regulatory Affairs Product Regulatory Management
CP Kelco /Huber Engineered Materials Pharma/Food & Feed Additives Dow Europe
www.ipecamericas.org
March 11, 2011
International Seismic Safety Centre (ISSC) reported that at around 08:15 CET an earthquake of magnitude 8.9 near the east coast of Honshu, Japan.
Huffington Post
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Devastating Tsunami Followed
Tsunami Damage
The Tsunami damage to Fukushima Daiichi nuclear power plants results in radiation release.
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http://www.youtube.com/user/NEINetwork
Nuclear Energy Institute
Health Physicist Explains the Differences in Health Impacts From Fukushima Versus ChernobylFrom: NEINetwork | Apr 18, 2011 | 2,620 views Barbara Hamrick, radiation safety officer and certified health physicist at the University of California's Irvine Medical Center, discusses that the long-term health effects from the Fukushima accident in Japan will likely be far less severe than the ones suffered at the Chernobyl accident duebe far less severe than the ones suffered at the Chernobyl accident due to differences in reactor designs, radiation expulsion and government response. She also explains what it means to be a level 7 on the IAEA's International Nuclear and Radiological Event Scale. For more information on the differences between Chernobyl and Fukushima, see NEI's fact sheet: http://bitly.com/eyvecT. ... (more info)
In perspective
Japan is approximate 180Japan is approximate 180 Miles east to west and 800 miles north to south. The highest mountain is 12,400 feet.
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(Ministry of Health, Labour and Welfare Press Releases, 21 and 23 March 2011):
Restrictions:• Fukushima: Distribution and consumption of leafy• Fukushima: Distribution and consumption of leafy
vegetables (including broccoli, cabbage, cauliflower, kakina, komatsuna and spinach), turnip and unprocessed raw milk.
• Ibaraki: Distribution of spinach, kakina, parsley and unprocessed raw milk. Gunma: Distribution of spinach and kakina• Gunma: Distribution of spinach and kakina.
• Tochigi: Distribution of spinach and kakina. Later extended for spinach to: Chiba
From EU Food RegMiyagi (4), Yamagata (6), Fukushima (7), Ibaraki (8)
TESTING
Ibaraki (8), Tochigi (9), Gunma (10), Saitama (11),Chiba (12),Tokyo (13)Niigata (15), Yamanashi (19), Nagano (20),
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What is the FDA doing to ensure the safety of drugs coming from Japan?
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.
From FDA web site
Principal radionuclides involved in a nuclear reactor accident
From Washington Post
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What is the FDA doing to ensure the safety of drugs coming from Japan?
FDA’s screening procedures will remain vigilant andFDAs 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.
From FDA web site
http://www.youtube.com/user/NEINetwork#p/c/ECE49E00A076C7E9/0/vwvnhLYqbrg
Nuclear Energy Institute
http://www.youtube.com/user/NEINetwork#p/c/ECE49E00A076C7E9/0/vwvnhLYqbrg
Health Physicist Explains U.S. Radiation MonitoringFrom: NEINetwork | Apr 26, 2011 | 350 views Edward Maher, certified health physicist and Health Physics Society's president, discusses how the U.S. Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) monitor radiation levels in the environment For information on health and radiation safety see NEI'sthe environment. For information on health and radiation safety, see NEI's website: http://bit.ly/gwljV4. ... (more info)(less info)
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What does the FDA monitor?
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 alsofood items for these radionuclides and others as needed. FDA also continually evaluates data and information from the accident and adjusts monitoring activities as needed.
From FDA web site
What has FDA’s screening and testing shown so far?
As of Thursday, May 5, 2011, FDA import investigators y, y , , p ghad performed 9,634 field examinations for radionuclide contamination. FDA had tested 356 samples, 82 of which were seafood or seafood products. 355 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.
From FDA web site
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Measurement
Different units of measure are used depending on what aspect of radiation is being measured.aspect of radiation is being measured.
The amount of radiation being given off, or emitted, by a radioactive material is measured using the conventional unit curie (Ci), named for the famed scientist Marie Curie, or the SI unit becquerel (Bq).
The radiation dose absorbed by a person (that is, the amount of energy deposited in human tissue by radiation) is measured using the con entional nit rad or the SI nit gra (G )conventional unit rad or the SI unit gray (Gy).
The biological risk of exposure to radiation is measured using the conventional unit rem or the SI unit sievert (Sv).
A person's radiation exposure due to all natural sources
Background on Radiation
p pamounts on average to about 2.4 millisievert (mSv) per year. A sievert (Sv) is a unit of effective dose of radiation. Depending on geographical location, this figure can vary by several hundred percent. Since one sievert is a large quantity, radiation doses are typically expressed in millisievert (mSv) or microsievert (µSv), which is one-thousandth or one millionth of a sievert. For example, one chest X-ray will give about 0.2 mSv of radiation dose.
From International Atomic Energy Agency
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Typical Doses
Source of exposure Dose in sievert (Sv) • Exposure to cosmic rays during a roundtrip airplane flight
from New York to Los Angeles 0.03 mSv• One dental x-ray 0.15 mSv• One chest x-ray 0.1 mSv• One mammogram 0.7 mSv
One ear of e pos re to nat ral radiation (from soil• One year of exposure to natural radiation (from soil, cosmic rays, etc.) 3 mSv
From CDC
Real Risk
"The fear is out of proportion to the actual risk right now. With regard to health effects, probably the largest effect will be psychological." (CNN)-John Boice, Vanderbilt University epidemiologist
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"Th f t th t th d t t thi d 't
Real Risk
"The fact that they can detect something doesn't mean it's harmful. It's important to understand that difference." (USA Today)-Richard Morin, American College of Radiology safety committee chair
The reality of the situation on the ground in Japan (very
Real Risk
The reality of the situation on the ground in Japan (very limited area of risk), the controls put in place in Japan (IAEA and Government), the continuous radiation monitoring in Japan, and the testing done throughout the supply chain combined with the actions taken by a company to evaluate their supply chains are adequate to manage the risk.manage the risk.
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Biggest Risk
The biggest risk is not from Japan but from here in the USA and over the internet.
Fraudulent Products
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:KT Botanicals, LLC: - “Acute Radiation Exposure Support Formula" -http://www fda gov/ICECI/EnforcementActions/WarningLetters/uhttp://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm251311.htm22
Eidon, Inc. - ”Liquid Iodine” -http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm251793.htm23
From FDA web site
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FDA Regulations
TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER C--DRUGS: GENERALPART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALSSubpart K--Returned and Salvaged Drug Products Sec. 211.208 Drug product salvaging.
Drug products that have been subjected to improper storage conditions including extremes in temperature, humidity, smoke, fumes, pressure, age,
FDA Regulations 21 CFR 211.208
or radiation due to natural disasters, fires, accidents, or equipment failures shall not be salvaged and returned to the marketplace. Whenever there is a question whether drug products have been subjected to such conditions, salvaging operations may be conducted only if there is (a) evidence from laboratory tests and assays (including animal feeding studies where applicable) that the drug products meet all applicable standards of identity, strength, quality, and purity and (b) evidence from inspection of the premises that the drug products and their associated packaging were not subjected to improper storage conditions as a result of the disaster or accidentimproper storage conditions as a result of the disaster or accident. Organoleptic examinations shall be acceptable only as supplemental evidence that the drug products meet appropriate standards of identity, strength, quality, and purity. Records including name, lot number, and disposition shall be maintained for drug products subject to this section.
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For Excipients
• 21 CFR 211.208 applies to finished drug products• Many excipients do not have special storage conditions• Many excipients do not have special storage conditions
and when stored in a closed warehouse protected from environment are not affected by loss of power.
• Storage containers for Excipients are designed to withstand industrial settings and shipping across regions with temperature extremes.Highly likely that excipients store in prefectures around• Highly likely that excipients store in prefectures around Fukushima are not contaminated or affected by loss of power
IPEC Americas Paper
The recent earthquake and tsunami in Japan whichThe recent earthquake and tsunami in Japan which caused a major accident at the Fukushima Daiichi Nuclear Power Station has raised significant public concern regarding the safety of both raw materials and finished pharmaceutical excipient products. IPEC Americas members in response to this and other similar or analogous incidents, use science-based risk gmanagement to ensure the safety and supply of safe excipient products to customers around the world.
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IPEC Americas Paper
The effects of airborne radioactive isotopes Iodine 131The effects of airborne radioactive isotopes Iodine 131, Cesium 134 and 137 are believed to be limited in impact based on geography and weather conditions. Authorities in Japan and many other countries worldwide are monitoring background radiation levels to detect any possible impacts that may present hazards to human health.
IPEC Americas Paper
At this time, only materials originating from specifically identified prefectures in Japan are believed to be at riskidentified prefectures in Japan are believed to be at risk and are currently restricted by the regulations of Japan and the regulations of many other countries, including the EU, USA and China. It is our opinion that no other actions are currently necessary in this matter.
IPEC Americas member companies will be monitoringIPEC Americas member companies will be monitoring the situation as it develops, and will take actions to comply with all international safety requirements for the safety and purity of excipient substances.
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IPEC Americas Q&AHave the recent natural and man-made disasters in and
around Fukushima prefecture in Japan affected IPECaround Fukushima prefecture in Japan affected IPEC member companies’ ability to supply products to customers?
• IPEC members are all assessing the risk and taking appropriate actions to ensure a safe and secure supply of excipients so that there will be minimal, if any, supply chain disruptions.chain disruptions.
IPEC Americas Q&A
Are raw materials processing aids and excipients fromAre raw materials, processing aids and excipients from Japan safe for use?
• All materials outside the affected areas of Japan are believed to be safe and suitable for use, and will meet the requirements of even the new legislation restricting products from Japan in the EU and China
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IPEC Americas Q&AWhat about the same materials from the surrounding Asian
countries?countries?• At this time there has been no evidence of elevated
levels of radiation or contamination with isotopes that present a hazard to human health. It should be noted that iodine 131 has a half life of 8 days and so poses little health risk given the length of supply chains from Japan to the USA.Japan to the USA.
IPEC Americas Q&AAre packaging materials from the affected areas safe?• The Japanese government has set up an exclusion zone around the p g p
Fukushima plant. Nothing can be removed from this zone, therefore radiation levels outside this area are not considered to be a threat to human health.
What kind of testing can be done to ensure no contamination with radiation has occurred?
• A simple Geiger counter (if available) should detect gross contamination, but for greater sensitivity special equipment which measures the energy of the emitted radiation is required to identify the specific radioisotopes of greatest concern. Such equipment is unlikely to be found or to be available outside special laboratories or government facilities.
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IPEC Americas Q&AAre products safe if stored next to material that has come
from Japan?from Japan?• All items coming from the at-risk prefectures in Japan
are being screened by the governments concerned. Therefore there should be no additional risk to other material stored next to material originating from Japan.