FDA's Role in Regulating Safety of GE Foods
转基因吧
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level 14
glanyyun 楼主
Foods from genetically engineered organisms, also known as biotech foods and referred to by some as food from genetically modified organisms (GMOs), have been in our food supply for about 20 years.
Genetic engineering refers to certain methods that scientists use to introduce new traits or characteristics to an organism. For example, plants may be genetically engineered to produce characteristics that enhance the growth or nutritional value of food crops.
Using a science-based approach, the Food and Drug Administration (FDA) regulates foods and ingredients made from genetically engineered plants to help ensure that they are safe to eat.
Since people have been modifying plants for thousands of years through breeding and selection, FDA uses the term "genetically engineered," or "GE," to distinguish plants that have been modified using modern biotechnology from those modified through traditional breeding.
FDA regulates food from GE crops in conjunction with the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA). USDA's Animal and Plant Health Inspection Service is responsible for protecting agriculture from pests and disease, including making sure that all new GE plant varieties pose no pest risk to other plants. EPA regulates pesticides, including those bioengineered into food crops, to make sure that pesticides are safe for human and animal consumption and do not pose unreasonable risks of harm to human health or the environment.
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In Field and Marketplace
The first genetically engineered microorganism was developed about 40 years ago; soon afterward the technology to genetically engineer plants and animals was developed. Food products made from GE microbial and plant sources have been in the food supply since the 1990s. The first food product from a GE microbe was an enzyme preparation used in the production of many cheeses.
Cotton, corn and soybeans are the most common GE crops in the U.S., according to USDA. In 2012, GE cotton accounted for 94 percent of all cotton planted, GE soybeans accounted for 93 percent of soybeans planted, and GE corn accounted for 88 percent of corn planted.
"Most GE crops are used as sources of food ingredients and as sources of animal feed," says Dennis Keefe, Ph.D., director of FDA's Office of Food Additive Safety. Corn, soybean and cotton plants—genetically engineered to ward off pests or to tolerate herbicides—are used extensively to produce food ingredients such as corn starch (in soups and sauces), corn syrup (as a sweetener) and cottonseed and soybean oil (in mayonnaise, salad dressings, cereals, breads and snack foods).
There are also new varieties of several other foods, such as squash and papayas, which are from plants engineered to resist plant diseases.
"A few plants have been engineered for nutritional traits," says Keefe. In 2012, FDA evaluated a soybean with increased amounts of omega-3 fatty acid—a polyunsaturated fatty acid that is associated with a reduced risk of heart disease.
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Safety
Food and food ingredients derived from GE plants must adhere to the same safety requirements under the Federal Food, Drug, and Cosmetic (FD&C) Act that apply to food and food ingredients derived from traditionally bred plants.
FDA encourages developers of GE plants to consult with the agency before marketing their products. Although the consultation is voluntary, Keefe says developers find it helpful in determining the steps necessary to ensure that food products made from their plants are safe and otherwise lawful.
The developer produces a safety assessment, which includes the identification of distinguishing attributes of new genetic traits, whether any new material in food made from the GE plant could be toxic or allergenic when eaten, and a comparison of the levels of nutrients in the GE plant to traditionally bred plants.
FDA scientists evaluate the safety assessment and also review relevant data and information that are publicly available in published scientific literature and the agency's own records.
The consultation is complete only when FDA's team of scientists are satisfied with the developer's safety assessment and have no further questions regarding safety or other regulatory issues.
As of May 2013, FDA has completed 96 consultations on genetically engineered crops. A complete list of all completed consultations and our responses are available at www.fda.gov/bioconinventory.
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Views on GE foods
While FDA regulates foods and ingredients, including foods made from GE plants, the agency neither supports GE plants based on their perceived benefits nor opposes them based on their perceived risks. FDA's priority is to ensure that all foods, including those derived from GE plants, are safe and otherwise in compliance with the FD&C Act and applicable regulations.
However, FDA recognizes that there are diverse views among food manufacturers, the agricultural industry and the public.
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Labeling
Many consumers are interested in knowing whether the food they serve their families is produced using genetic engineering. Food manufacturers may indicate through voluntary labeling whether foods have or have not been developed through genetic engineering, provided that such labeling is truthful and not misleading.
FDA supports such voluntary labeling and has issued draft guidance on this labeling to the food manufacturing industry.
Under the FD&C Act, food labeling that is false or misleading is generally prohibited. Food labeling is misleading if it fails to reveal "material" facts—information that is material in light of statements made or suggested on the label, or material with respect to consequences that may result from the use of the food.
The agency has received two citizen petitions regarding FDA's regulation of GE foods. These petitions request that FDA change its position on the labeling of such foods. The agency is currently reviewing those petitions and considering the issues presented.
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
May 14, 2013
2014年02月09日 06点02分 1
level 14
glanyyun 楼主
Biotechnology Consultation Agency Response Letter BNF No. 000080
Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties
See also Biotechnology: Genetically Engineered Plants for Food and Feed and about Submissions on Bioengineered New Plant Varieties
See FDA's memo on BNF No. 000080 for further details
July 22, 2004
William P. Pilacinski, Ph.D.
Regulatory Affairs Manager
Monsanto Company
St. Louis, MO 63167
Dear Dr. Pilacinski:
This is in regard to Monsanto Company's (Monsanto) consultation with the Food and Drug Administration (FDA) (Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition) on its genetically engineered wheat event MON 71800. According to Monsanto, this new line is engineered to express CP4 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) protein which confers tolerance to glyphosate herbicide. In a letter to FDA dated June 9, 2004, Monsanto states that the firm is deferring all further commercial development efforts to introduce glyphosate-tolerant wheat until such time that other wheat biotechnology traits are introduced. In its letter, Monsanto requests that FDA complete the consultation process for glyphosate-tolerant wheat event MON 71800. All materials relevant to this notification have been placed in a file designated BNF 0080. This file will be maintained in the Office of Food Additive Safety.
As part of bringing the consultation regarding this product to closure, Monsanto submitted a summary of its safety and nutritional assessment of the genetically engineered wheat on June 28, 2002. Monsanto provided additional information in a submission dated April 25, 2003. These communications informed the FDA of the steps taken by Monsanto to ensure that this product complies with the legal and regulatory requirements that fall within FDA's jurisdiction. Based on the safety and nutritional assessment Monsanto has conducted, it is our understanding that Monsanto has concluded that the wheat grain and forage derived from the new variety are not materially different in composition, safety, and other relevant parameters from wheat grain and forage currently on the market and that the genetically engineered wheat does not raise issues that would require premarket review or approval by FDA.
It is Monsanto's responsibility to obtain all appropriate clearances, including those from the Environmental Protection Agency and the United States Department of Agriculture, before marketing food or feed derived from genetically engineered wheat event MON 71800.
Based on the information Monsanto has presented to FDA, we have no further questions concerning grain and forage derived from glyphosate-tolerant wheat event MON 71800 at this time. However, as you are aware, it is Monsanto's continued responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements.
Sincerely yours,
Laura M. Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition
2014年02月09日 06点02分 2
真有转基因小麦。。@wraithliang
2014年02月09日 06点02分
回复 glanyyun :还在从柏林回家的火车上,回去细看啊。转基因小麦不是不能做,而是体系不完善,效率太低。不过这一年多有所突破也说不定
2014年02月09日 22点02分
两个问题,一是医保的范围是否全国一样?二是如果某种药物在医保,那么是不是所有该种药物无论哪个厂家的都在医保?
2014年02月13日 12点02分
level 14
glanyyun 楼主
2014年02月09日 06点02分 3
你能发链接,为什么我一发链接就被吞?而且发文字有时都不行。有什么诀窍?
2014年02月10日 23点02分
level 14
glanyyun 楼主
[滑稽]@Commonperson 求评判
上面我说只要生产厂商通过安全验证,所生产的产品是合格的,那么如果这个产品天然就存在缺陷,生产厂商未知,而审核验证部门也不知道,到后来这个产品造成危险,责任是否由生产厂商来负责,还是由GOV引入的社会保障工作所负责?
2014年02月10日 07点02分 6
上面说错了,是这个产品造成危害,不是危险。。
2014年02月10日 07点02分
@凌意舒 顺便求解答
2014年02月10日 07点02分
回复 glanyyun :世界上基本有两种立法例:一是生产者只对当时科学技术能发现的产品缺陷负责(即不对发展上的缺陷负责而只对设计缺陷、生产缺陷和营销缺陷负责),二是只要产品有缺陷,无论是否能为当时科学技术所发现,生产商都应负责。PS这里所述的限于产品缺陷导致的损害
2014年02月10日 13点02分
回复 glanyyun :我国采用第一种立法例。。。作死的最重要的一句居然忘了。。。至于工作所什么的不清楚。不过只要不知道应该没他什么事儿吧
2014年02月10日 13点02分
level 9
楼主,你没有看懂“逍遥自在1024”的潜台词。
他的潜台词很简单,他反对转基因的理由很简单,他的观点属于“风险封杀论”。
“风险封杀论”最早是我们搞技术的人创造的,为了挡住外国产品设置的借口。
这个借口的唯一弱点在于“风险”不等于“危害”。
你出门会被车撞死是风险,你被撞死了那是危害事实。无论是法院断案,还是FDA叫停一件产品,主要靠证据,证明它存在危害。因风险叫停的只有一种情况,即风险非常高,高于其他同类东西,或高于收益。
孟山都的材料是为了说明转基因食品的风险=普通食品的风险,在基因技术的层面、在农业技术的层面、在食品技术的层面、在自然科学的层面,这个说法是成立的。
“逍遥自在1024”这类人可能有三种逻辑:
1、他将非自然科学层面的风险,诸如政治风险、法律风险、国家安全风险计入了综合风险范畴,妄图说明转基因食品风险大大于普通食品,来驳斥孟山都不计科技外因素;然后用风险超高来否定转基因技术和产品。
2、他将“风险”=“危害”,即你脑子里想强奸,我就可以判你罪,不需要你实施强奸行为。转基因还没有造成实质危害,就可以用莫须有的罪名把你推上审判台。
这是一种刻意混淆”风险“和”危害“概念的做法,妄图搅乱是非。这种下三滥的说法拿到国际上是行不通的。我们技术派当年编造出”风险封杀论“是基于第一种逻辑,欧盟抵制美货也用第1种逻辑。第二种逻辑的使用者就是等着被人打脸。
3、他可能并不清楚前两种逻辑,无非只是纯粹反对,只要你举出例子,就跟你拽文抠字眼。知道你懂技术,刻意不跟你谈技术,而跟你绕圈。这种方式和第二种类型的人一样,没有技术含量。
我们技术派推出“风险封杀论”,是符合国际上通行的法律、政策和技术原则的,属于钻空子的行为。
而现在有些人盲目反转,口头上用这种借口,实际举出理由,反应的本质和原则都和钻空子背道而驰。他们这样做不但钻不了空子,还违反国际通行的原则;不仅保护不了自己,还会被人打脸。我认为这些外行人愚蠢到家。
楼主最好跟“逍遥自在1024”确认一下,他究竟是属于哪类。第一类人其实比较容易识别,很多政策和手段都是成套的,二三类人想打扮成第一类人很容易路出马脚。不过只要他们不讨论手段和政策内容,我们也看不出来他属于哪类。
2014年02月10日 10点02分 7
回复 逍遥自在1024 :你的意思我看得很清楚。你最需要明确一点:转基因食品的风险=普通食品风险,即达成技术上符合推广的条件。安全性永远是相对标准,拿不出底线的“安全性”、没有标准的“安全性”、绝对的安全性,只能证明普通食品都是垃圾。你们的标准不是在反转,而是在反普通食品。
2014年02月11日 00点02分
回复 逍遥自在1024 :反转者的所谓技术上的充分理由,证明了吃了千百年的非转基因食品都应该去死。用他们的标准来衡量非转,人类什么都不能吃。在技术上使用双重标准是找不到合理解释的,你只能去钻法律、政策的空子,这证明了转基因和普通食品的差异不是科技层面的问题,找技术的麻烦对反转毫无意义。
2014年02月11日 01点02分
回复 逍遥自在1024 :你这个要求不属于技术层面,属于法律、政治层面的理由。我说你“双重标准”,是说你把你这套标准用到普通食品上,得到的结果会和转基因没有区别,也就是证明了转和非转没差别。但是实际上你们在对待转基因的时候,对普通食品却使用了双重标准。技术上的双重标准是没有合理出处的。
2014年02月11日 03点02分
回复 逍遥自在1024 :双重标准的合理性,只存在于贸易、经济、国家安全、政治和法律这些层面,技术层面不存在双重标准的合理性。因为转基因食品和非转基因食品作为食品的内在本质是一致的,你想挑战这一点的前提是必须放弃科学,走进无法自圆其说的领域。
2014年02月11日 03点02分
level 1
我就问鼓吹转基因伟大的舔美狗自己吃不吃转基因食品,如果你和你的家庭一年每天都在吃,基因大豆转基因玉米我们相信你!
2020年03月27日 05点03分 9
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