Commonly Asked Questions About BSE in Products Regulated by FDA's Center for Food Safety and Applied Nutrition (CFSAN)
In light of the June 24, 2005 announcement of the second case of BSE in a cow in the United States, CFSAN has reviewed the products it regulates to ensure their safety.
광우병(Bovine Spongiform Encephalopathy/BSE)이란 무엇인가?
광우병은 (Bovine Spongiform Encephalopathy/BSE)를 부르는 일반적인 병명으로 성체가 된 소의 중앙신경계를 감염시켜 천천히 진행되는 퇴행성 질환으로 상당히 치명적인 병이다. 1990년 이후 미 농무부는 미국 내 도축장에서 있을지도 모르는 위험을 감시 감독하고 있다.
BSE의 원인은 무엇인가
BSE의 정확한 원인은 모른다.
하지만, 관련 과학 단체에서는 BSE 원인 생물에서 일반적으로 발견되는 감염성을 지닌 단백질 입자 즉, 단백질 타입의 전염 형태가 원인인 것으로 받아들여 지고 있다. 감염된 소의 경우, 처음에는 장과 편도에서 이러한 비정상적인 감염성 단백질 입자가 발견 되며, 이후에 중앙신경계 세포에서도 발견 되고 마자마지막 단계에서는 척추의 삭상조직과 다른 세포에서도 발견된다.
2005년 6월 두번째 BSE로 판명난 소가 있었나?
그렇다. USDA의 감독 및 통제 계획에 의해 미국에서 두 번째로 BSE 감염사례로 확인 되었다. 이 소가 발견된 것은 원래 2004년 11월 이었다. 당시 적격심사에서는 확정적이지 않았을 뿐아니라, 조직검사에서도 음성 판명이 났었다. 최근 검사를 추가하여 정밀한 검사를 한 결과 BSE에 양성 결과가 나왔다.
USDA는 즉 이 소의 샘플을 영국 Weybridge실험실로 보내 재차 확인했따.
역학조사를 통해 감염경로를 추적중에 있다. 소들의 감염 확산을 막기 위해서 모든 반추동물에게 동물성 사료 투입을 금지시켰다.
2005년 6월 발견된 소가 음싱으로 만들어졌나?
그렇지 않으며, 바로 살 처분 되었다.
USDA와 FDA 에서는 BSE 발병 소가 절대 사람이 먹는 음식에 들어가지 못하게끔 최대한 협조 하고 있다.
2003년 12월에 BSE 발병소가 처음으로 발견 됐나?
그렇다 USDA 감시 계획에 의해서 미국 워싱턴 주에서 첫 BSE발병 소가 발견되었다. 이소는 캐나다에서 수입된 소다.
당시 BSE감연 소가 육류 혹은 가공식품의 형태로 시중에 유통되었나?
BSE 감염 소의 도축이 확실시 되자, USDA와 FDA 양 기관에서는 즉각적으로 BSE 사태 선포" 육류의 리콜을실시했으며, 가공육으로 시중 유통되었을 가망성을 예측, 추적 작업을 벌여 신속히 제거했다. 이후에도, 식품관련 모든 기관에서 계속적으로 감시했으며, 모든 가공 비가공 음식물을 제거했기 대문에 시장 유통은 없었다고 확신한다. 이러한 정부의 BSE 확산 다중 방어 체계는 소비자들에게 신임을 얻고 있다.
육고기 소비자가 반드시 알아야 할 사항은 과학적 연구 결과 소고기의 근육 부분에서는 절대 전염성 단백질이 발견되지 않는다는 점이다.
BSE에 감염된 사람이 있나?
BSE와 유사한 증세를 보이는 환자가 발견되기도 하는데, Creutzfeldt-Facob Disease(cjd)라고 부른다.
사람을 감염시키는 CJD의 감염은 BSE 감염 소로 만든 음식물이나 육류를 럽취 했을때 감염된다고 믿고 있다 하지만 전 세계적으로 BSE 감염 소의 제품을 소비한 사람의 수는 수천만명에 이를 것으로 추정되지만, CJD에 감염이 확실히 확인된 사람은 155명이다. 미국에서의 발병사례는 단 한건이며, 영국에서 이주한 여성으로, 영국에서 감염, 미국으로이주한 것으로 확인 되었다.
(본문 자료)
www.fda.gov ?http:> www.fda.gov ?http:> www.cfsan.fda.gov> www.hhs.gov> January 14, 2004; Updated July 9, 2004, June 30, 2005 and September 14, 2005
Commonly Asked Questions About BSE in Products Regulated by FDA's Center for Food Safety and Applied Nutrition (CFSAN)
In light of the June 24, 2005 announcement of the second case of BSE in a cow in the United States, CFSAN has reviewed the products it regulates to ensure their safety.What is "Mad Cow Disease" (Bovine Spongiform Encephalopathy/BSE)?
Mad Cow Disease is the commonly used name for Bovine Spongiform Encephalopathy (BSE), a slowly progressive, degenerative, fatal disease affecting the central nervous system of adult cattle. Since 1990, the U.S. Department of Agriculture (USDA) has conducted aggressive surveillance of the highest risk cattle going to slaughter in the United States.
What causes BSE?
The exact cause of BSE is not known but it is generally accepted by the scientific community that the likely cause is infectious forms of a type of protein, prions, normally found in animals cause BSE. In cattle with BSE, these abnormal prions initially occur in the small intestines and tonsils, and are found in central nervous tissues, such as the brain and spinal cord, and other tissues of infected animals experiencing later stages of the disease.
Was a second case of BSE identified in the U.S. in June 2005?
Yes, the USDA surveillance program identified the second BSE case in the U.S. This cow was originally identified in November 2004. Results from this animal were inconclusive in screening tests, but negative in confirmatory immunohistochemical tests. USDA recently conducted an additional confirmatory test, Western Blot, and the results were positive for BSE. USDA sent the samples to the Weybridge, UK lab where BSE was confirmed. An epidemiological investigation to trace the origins of the cow is underway. USDA confirms that the cow was born before the U.S. instituted its ban on the use of most mammalian protein in feed for ruminant animals-believed to be the most critical protective measure in preventing the spread of BSE among cattle.
Did meat and meat products from the June 2005 cow enter the food supply?
No, the cow was presented at slaughter as non-ambulatory (a downer). Therefore, in accordance with BSE regulations established by USDA and FDA the material from the animal did not enter the human food supply.
Was a case of BSE identified in the U.S. in December 2003?
Yes, the USDA surveillance program identified the first BSE case in the U.S. in a dairy cow in Washington State. The cow was bought from a farm in Canada.
Did meat and meat products from the 2003 BSE cow enter the food supply?
As soon as the BSE case was identified, both USDA and FDA activated their BSE Emergency Response Plans, and USDA immediately recalled the meat. Meat that did enter the food supply was quickly traced and was removed from the marketplace. Moreover, all the organs in which infectious prions occur were removed at slaughter and did not enter the food supply. Consumers should feel very confident that the system of multiple firewalls maintained by Federal agencies protects them from possible exposure to BSE. In addition, we believe it is important for consumers to also understand that scientific research indicates that muscle meat is not a source of infectious prions.
Will there be additional cases?
In 1998, USDA commisioned the Harvard Center for Risk Analysis to conduct an analysis and evoluation of the U.S. regulatory measures to prevent the spread of BSE in the U.S. and to reduce the potential exposure of U.S. consumers to BSE. The Harvard study concluded that, if introduced, due to the preventive measures currently in place in the U.S., BSE is extremely unlikely to become established in the United States.
FDA and other Federal agencies have been vigilant in strengthening protective measures to reduce the U.S. consumer's risk of exposure to BSE-contaminated food and cosmetic products. Since 1989, USDA has banned imports of live ruminants, such as cattle, sheep and goats, and most products from these animals from countries known to have BSE. Subsequently, USDA expanded this ban to include both countries with BSE and countries at risk for BSE. In 1997, FDA prohibited, with some exceptions, the use of protein derived from mammalian tissues in animal feed intended for cows and other ruminants. See the FDA/CVM website at www.fda.gov ?http: default.html? cvm>www.fda.gov/cvm for information on the "ruminant feed ban."
On Jan. 8, 2004, the USDA's Food Safety and Inspection Service issued new rules to enhance safeguards against BSE. Details on these rules may be found at USDA's website, www.usda.gov>www.usda.gov. Also in 2004, FDA issued a rule that prohibits the use of certain cattle material, because of the risk of BSE, in human food and cosmetics.
Does BSE affect people?
There is a disease similar to BSE called Creutzfeldt-Jacob Disease (CJD) that is found in people. A variant form of CJD (vCJD) is believed to be caused by eating contaminated beef products from BSE-affected cattle. To date, there have been 155 confirmed and probable cases of vCJD worldwide among the hundreds of thousands of people that may have consumed BSE-contaminated beef products. The one reported case of vCJD in the United States was in a young woman who contracted the disease while residing in the UK and developed symptoms after moving to the U.S.
What measures are being taken to ensure food safety in the U.S. from BSE?
Since 1989, the FDA and other federal agencies have had ongoing regulatory measures in place to prevent BSE contamination of U.S. food and food products. Following the identification in a Washington state dairy herd of a BSE-positive cow imported from Canada, USDA issued new regulations containing additional safeguards to further minimize risk for introduction of the BSE agent into the U.S. food supply. See USDA's website www.usda.gov>www.usda.gov for further information.
Similarly, FDA has prohibited the use of the cattle materials that carry the highest risk of BSE in human food, including dietary supplements, and in cosmetics. FDA's rule (and September 2005 amendments) prohibit use of the following cattle material in human food and cosmetics:
- cattle material from non-ambulatory, disabled cattle,
- cattle material from organs from cattle 30 months of age or older in which infectious prions are most likely to occur, and the tonsils and the distal ileum of the small intestine of cattle of all ages,
- cattle material from mechanically separated (MS) (beef), and
- cattle material from cattle that are not inspected and passed for human consumption
FDA's rule also requires that food and cosmetics manufacturers and processors make available to FDA any existing records relevant to their compliance with these prohibitions. FDA has also published a proposal requiring manufacturers and processors of food and cosmetics made with cattle material to establish and maintain records demonstrating that their products do not contain prohibited cattle material.
In September 2005, FDA amended the interim final rule to allow use of the small intestine in human food and cosmetics, provided the distal ileum has been removed. FDA also clarified that milk and milk products, hide and hide-derived products and tallow derivatives are not considered prohibited cattle materials. Finally, in response to comments the agency has reconsidered the method cited in the interim final rule for determining insoluble impurities in tallow and is citing a method that is less costly and requires less specialized equipment.
Are the protective measures in place sufficient to ensure the safety of the human food supply in light of the June 2005 BSE positive cow?
Yes, the protective measures put into place in July 2004 by FDA ensure that cattle materials that carry the highest risk of transmitting the agent that causes BSE are excluded from human food, including dietary supplements, and cosmetics. These measures, along with similar measures established by USDA, provide a uniform national BSE policy and ensure the safety of human food.
Is the food in the U.S. likely to be a BSE risk to consumers?
FDA and other federal agencies have had preventive measures in place to reduce the U.S. consumer's risk of exposure to any BSE-contaminated meat and food products. Since 1989, USDA has prohibited the importation of live animals and animal products from BSE-positive countries. Subsequently, USDA expanded the ban to include both countries with BSE and countries at risk for BSE. Since 1997, FDA has prohibited the use of most mammalian protein in the manufacture of ruminant feed. In 2004, FDA issued a rule prohibiting the use of certain cattle materials in human food and cosmetics, and USDA issued a rule prohibiting certain cattle materials from use as human food.
Is cow's milk a source of BSE?
Scientific research indicates that BSE is not transmitted in cow's milk, even if the milk comes from a cow with BSE. Milk and milk products, even in countries with a high incidence of BSE are, therefore, considered safe.
Can milk be infected with BSE from a BSE-positive cow?
No detectable infectivity in cow's milk has been reported from any BSE-infected cows. Infectious prions have not been detected by bioassay of milk from cattle with BSE.
Does the use of bovine-derived ingredients in dietary supplements mean that they are not safe?
No. The requirements that FDA has in place should give consumers confidence that their food, including dietary supplements, is safe. Most recently, FDA published a rule that prohibits the use in human food, including dietary supplements, of the cattle materials that have the highest risk of harboring BSE infectivity. The rule applies to both imported and domestic dietary supplements and their ingredients. Furthermore, most ingredients used to produce dietary supplements and most other food ingredients come from cattle that are slaughtered when they are less than 30-months of age and, because of their age, present little risk of being BSE-positive. It is not a common occurrence for animals younger than 30 months to develop BSE.
Since the BSE-positive cows were discovered in the U.S., does that mean that dietary supplements made with domestic ingredients might be unsafe?
No. The requirements that FDA has in place should give consumers confidence that their food, including dietary supplements, is safe. Most recently, FDA published a rule that prohibits the use in human food, including dietary supplements, of the cattle materials that have the highest risk of harboring BSE infectivity. Furthermore, most ingredients used to produce dietary supplements and most other food ingredients come from cattle that are slaughtered when they are less than 30-months of age and, because of their age, present little risk of being BSE-positive.
Even though BSE-positive cows have been identified in the U.S., one of which was imported, the risk to human health from dietary supplements and other foods containing cattle-derived ingredients is extremely low.
What steps is FDA currently taking to ensure the safety of dietary supplements that contain bovine ingredients?
Most recently, FDA published a rule that prohibits the use in human food, including dietary supplements, of the cattle materials that have the highest risk of harboring BSE infectivity. The rule applies to both domestic and imported dietary supplements and their ingredients. In addition, most ingredients used to produce dietary supplements and most other food ingredients come from cattle that are slaughtered when they are less than 30-months of age and, because of their age, present little risk of being BSE-positive. Further, the restrictions by USDA on the use of certain cattle and cattle tissues in human food also reduce the risks that potentially infective tissue would be used in dietary supplements. FDA also has proposed a requirement that manufacturers and processors that use cattle material in their products would be required to keep records demonstrating that these materials do not contain prohibited cattle material and that these records be made available to FDA for inspection.
Given the BSE case in Washington State and the case in Texas, should consumers be concerned about cosmetics made using tallow from the rendering process?
No. The World Health Organization considers tallow to be a low risk for transmision of BSE. Specifically, the rendering process separates fats from proteins. Because the disease is transmitted by prions, which are a type of protein, they would be separated by the rendering process from the tallow or fat, which is the portion that goes into cosmetics. Additionally, the tallow is processed with excessive heat and pressure which may further minimize any risk of infectivity prior to use in cosmetics.
What about the use of gelatin, another bovine-related material, in cosmetics and dietary supplements and other foods?
FDA's rule prohibiting the use of the cattle materials that have the highest risk of harboring BSE infectivity in human food applies to gelatin. Therefore, gelatin used in human food may not be made from these cattle materials.
When and how did BSE in cattle occur?
BSE in cattle was first reported in 1986 in the United Kingdom (UK). The exact origins of BSE remain uncertain, but it is thought that cattle initially may have become infected when fed feed contaminated with scrapie-infected sheep meat-and-bone meal (MBM). Scrapie is a prion disease in sheep similar to BSE in cattle. The scientific evidence suggests that the U.K. BSE outbreak in cattle then was expanded by feeding BSE-contaminated cattle protein (MBM) to calves. The definitive nature of the BSE agent is not completely known. The agent is thought to be a modified form of a protein, called a prion, which becomes infectious and accumulates in neural tissues causing a fatal, degenerative, neurological disease. These abnormal prions are resistant to common food disinfection treatments, such as heat, to reduce or eliminate their infectivity or presence. Research is ongoing to better understand TSE diseases and the nature of prion transmision.
Is BSE in cattle the same disease as CWD in deer and elk in the U.S.?
BSE is a Transmissible Spongiform Encephalopathy (TSE), a family of similar diseases that may infect certain species of animals and people such as scrapie in sheep and goats, BSE in cattle, chronic wasting disease (CWD) in deer and elk, and variant Creutzfeldt-Jakob disease (vCJD) in people.
To date, there is no scientific evidence that BSE in cattle is related to CWD in deer and elk. FDA is working closely with other government agencies and the public health community to address CWD in wild and domesticated deer and elk herds. Wildlife and public health officials advise people not to harvest, handle, or consume any wild deer or elk that appear to be sick, regardless of the cause, especially in those states where CWD has been detected.
What countries have reported cases of BSE or are considered to have a substantial risk associated with BSE?
These countries are: Albania, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark, Federal Republic of Yugoslavia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Liechtenstein, Luxembourg, former Yugoslavia Republic of Macedonia, The Netherlands, Norway, Oman, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Japan, and United Kingdom (Great Britain including Northern Ireland and the Falkland Islands).