本帖最后由 风在手 于 2017-1-29 17:49 编辑
2017转基因变局：美欧战略诱导成功，开始撤退，中国深陷转基因泥潭。2017-01-27 顾秀林 民间智库论坛
题目：美国FDA给王大妈递话筒了
美国FDA给坚决拒绝转基因的中国人民送新春大礼了！ 这是一个实实在在、正正经经的拜年！ 请看：美国联邦政府公告，2017年1月19日：
https://www.federalregister.gov/documents/2017/01/19/2017-00840/genome-editing-in-new-plant-varieties-used-for-foods-request-for-comments
食品药品监督管理局（FDA）开启征询公众意见网页，对作为人类和动物食用为目标开发的基因编辑技术新植物，请公众评论和提供信息。
英文全文在文末。
整个文件的核心，是关于基因编辑植物与以往任何一种育种技术（特别是转插DNA片段那种生物育种技术）的异同和适用的管理规则。文中一段（2c）说：“由于基因编辑技术会导致植物单个基因被删除、造成全新的基因等重大的基因修饰后果”——也就是说，FDA心里很清楚：问题是什么，问题在哪里。基因编辑法就是转基因，和第一代技术具有同样的、甚至危险。
FDA自称要“广开思路”（to help inform our thinking)。
英文原文附在文末。
我先评论。
转基因的风向已经变了，而且是不停地变：美国又走出了下贼船的重要一步。表面上是民主操作，把话筒递给王大妈，请她们对基因编辑法的新产品提意见（但是必须拿出科学根据），实际上呢？只要看一看，不论在哪个国家只要让人说话，转基因直接就没戏，转基因的天一定塌。所以转匪帮的看家招数，就是不让人说话，只许自己搭台自己上台唱假戏。这次，是美国FDA邀请王大妈来说话，出这一招的潜台词只能是：搭个跳板下贼船。跳板还挺长，不是一步就能走下船的。基因编辑产品会死在摇篮里——我们骑驴看唱本，走着瞧。
让人说话的形式可以有几种。美国FDA直接递话筒给王大妈是一种，法国和俄罗斯等国家的话筒，是真正的独立的科学家报告转基因的危害，虽然被疯狂打压，但是人民听见了真科学家的声音。在德国，则是静悄悄的联邦议会立法。德国2016年11月2日通过禁转立法，全世界的媒体对此都装聋作哑，连我的一位很敏感的德国记者朋友都没有发现。
其中说：“现有的转基因食品作物的国家管理体系已经历时30年，且是该类作物商业化之前制定的。该体系已经过时，它不能胜任相关国家管理，尤其是不能获得民众对相关国家管理和对相关产品的信任、不能确保民众健康和生态安全，同时，也不能促进生物技术发展(尤其不能促进生物技术领域的中小企业幸存发展)”。
该备忘录说：“相关部门要在限定时间内完成改造现有体系的方案制定：要以民众健康和生态安全为目标、以风险管理为基础，来提升国家管理质量和相关标准规范；要提高管理部门的透明度、预见性、工作效率和互相协调；要促进美国王大妈即美国民众对相关国家管理的知情、参与和监督，要确保民众对相关国家管理体系是有信心的”【转摘自直言了译文】。
冠冕堂皇，信誓旦旦，两年后才兑现。两年前相信风向会变的人不多。我当时曾发电邮请教国际科学家组，此举是否具有实质性意义；我得到的是一致的回复：“No”，换汤不换药而已。
一年后，2016年7月29日，上届总统奥巴马签署了转基因食品的强制标识法。该法明确规定，只有第一代转基因技术，即基因的转移和插入所造成的产品才是必须标识的。美国的朋友们、中国的反转同仁们的反映，是极其不满意，他们正确地指出，这个法案为下一代转基因技术即基因编辑法刻意留了后门。国内外的反转同仁们都称它为“黑暗法案”。“Black bill”的说法来自更早一点的事件，孟山都公司曾在2014年的例行公事的联邦拨款法案中夹带私货，塞进去一个特别条款：孟山都公司在任何条件下都享有不受任何法院干扰其经营活动的特权，不久后被正义的美国人民用行动和60万个签名废除掉。
美国2016-7-29转基因标识法案，的确是孟山都插手和推动的，它的目的是废掉2016年7月1日刚刚生效的、十分严格的佛芒特州转基因标识法。达到这样一个目的，孟山都公司游刃有余。
时间才过去5个半月，作为执行机构的美国FDA就放口风，出新招，递话筒，为“塌天”铺路。
我们该怎么接风？
我的回答是：美国FDA向坚决拒绝转基因主粮的中国人民献上了新春贺礼——让转基因的天塌下来吧。美国自己是要撤了。中国往哪里走？虽然美国早就为中国制定了三驾马车（棉花玉米水稻）和三步走（纤维饲料主粮）计划，并且为中国培养了全球最强大的转基因食品开发生产和推广体系，一切都按部就班，唯一失算之处，就是搞不定王大妈。中国人民誓死反对转基因，而且是越科普越反对。
虽然美国为中国的转基因大业谋篇布局很成功，但是路总是自己走的，中国是中国人民的。我们的目的，就清除转基因，现在立即拉闸一刀切，停止转基因农作物的开发推广应用销售。中国的科匪帮转匪帮所要的正相反：立即全面转基因化，非法推广的转基因也全部合法化。
现在，中国科匪转匪的大老板美国FDA，给自己的脚底抹上油，摆出了开溜的架势，把中国科匪转匪留在转基因泥潭里，自娱自乐终于占领了转基因主粮制高点。
感谢美国FDA送来的新春贺礼。我佩服对手的定力：稳扎稳打，按部就班，主导权在手，稳稳地把握着全球大局：俄欧美撤，中国上。
雄鸡高唱新春来。天不会永远不亮。天边现曙光了，中国这里也不会永远是暗夜。
再次联系生物技术巨头公司的并购案。孟山都和先正达几年的业绩都非常差。把孟山都塞给德国，背景条件是美国在德国还有将近60个军事基地；把先正达塞给中国，背景条件是自从2009年9月就存在的“中美农业战略合作联合工作委员会”，由双方农业部长等人组成——中国农业的事情，美国农业部说了是算数滴。
下面是美国FDA向王大妈递话筒的一文要点。以综述方式列出。最后是英文原文。
1. 表明基因编辑植物与以往所有的育种技术和结果不同的科学证据
2. 现有的知识和经验对新产品（基因编辑）的安全评估是否有用？现有的管理规则是否继续适用？
3. 怎么做基因编辑产品的安全评估？需要包括何种数据和信息？
4. 假如基因编辑植物没问题，是否需要把它从一直在做的【转基因产品上市前自愿咨询程序】区别开？
5. 如果连自愿咨询都不必，开发商应该如何知会FDA?他们应该提交什么数据？
6. 由于基因编辑技术会导致植物单个基因被删除、造成全新的基因等重大的基因修饰后果，而某些相似的结果在某些情况下也会出现在传统育种中，那将这类基因变化也包括在转基因的安全检测类别中，所依据的理由是什么？
7. 基因编辑法食物的安全性风险超过传统食物的科学证据，例如表型信息、基因修饰信息（在基因编辑过程中发生的插入，删除和替代）、风险更大的数据。
大礼送来了，朋友们一起来拆包吧！转基因的天黑了20年，但是天不会永远黑！明天就是鸡年了，雄鸡高唱迎接曙光。
加两条今天的信息：
俄罗斯出口小麦2500万吨，占领了制高点，全球之冠，【http://sputniknews.cn/russia/201701271021709264/】
中国农业走邪路，给农业科技人员加冕“首席”， http://mp.weixin.qq.com/s/esu_9t2lot4y-kuHE_snRg
我的评论 这条精英统治农民和消费者的路是黑路。路线彻底走歪了。首席科学家？首席垄断者。谁出的这恶毒计划？我想起了前苏联【苏联快解体时，官员精英们最卖力干的事，是你给我发勋章，我给你授学位】亦步亦趋哈 ——玉米等9大产业体系首席科学家候选人名单公布！O玉米等9大产业体系首席科学家候选人名单公布！ 美国FDA公开征询 原文 AGENCY:Food and Drug Administration, HHS. ACTION:Notification; establishment of docket; request for comments. SUMMARY:The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive comments on the use of genome editing techniques to produce new plant varieties that are used for human or animal food. We invite comment on specific questions contained in this document related to foods derived from such genome edited plant varieties. FDA is taking this action to help inform our thinking about foods derived from new plant varieties produced using genome editing techniques. DATES:Submit either electronic or written comments by April 19, 2017. ADDRESSES:You may submit comments as follows: Electronic SubmissionsSubmit electronic comments in the following way: · Federal eRulemaking Portal:https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, tohttps://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted onhttps://www.regulations.gov. · If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). Written/Paper SubmissionsSubmit written/paper submissions as follows: · Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. · For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions: All submissions received must include the Docket No. FDA-2016-N-4389 for “Genome Editing in New Plant Varieties Used For Foods; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. · Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments Start Printed Page 6565received, go to https://www.regulations.govand insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT:Regarding human food issues: Jason Dietz, Center for Food Safety and Applied Nutrition (HFS-205), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2282. Regarding animal food issues: Kathleen Jones, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5938. SUPPLEMENTARY INFORMATION:I. BackgroundUse of Genome Editing Techniques To Produce New Plant Varieties Used for Human or Animal FoodRecently, new technologies have emerged that are intended to alter the genomes of various organisms, including plants. FDA is aware that these technologies make it easier for plant developers to produce new plant varieties with targeted genetic modifications. Using deoxyribonucleic acid (DNA) sequence information from a plant, plant breeders can make targeted changes to a plant's DNA sequence to alter expression of traits in the plant. These new methods include processes using targeted nucleases (clustered regulatory interspersed short palindromic repeat associated nucleases, zinc-finger nucleases, meganucleases, and transcription activator-like effector nucleases or targeted oligonucleotides (oligonucleotide-directed mutagenesis) intended to modify a plant's DNA sequence by insertion, deletion, or substitution of nucleotides at a specific site in a plant's genome. The process of producing these targeted DNA sequence alterations is often referred to as “genome editing.” In the National Strategy for Modernizing the Regulatory System for Biotechnology Products (theStrategy; released by the White House Office of Science and Technology Policy on September 16, 2016),[1] FDA noted its intent to clarify its policy for the regulation of products derived from genome editing techniques, including, as appropriate, identifying and/or updating relevant existing guidance documents. Consistent with this commitment in the Strategy document, FDA is opening this docket to inform its thinking on foods derived from plants produced using genome editing techniques. FDA also looks forward to receiving the results from the study being conducted by the National Academies of Sciences, Engineering, and Medicine entitled “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System” commissioned under the Update to the Coordinated Framework for Regulation of Biotechnology, available at http://nas-sites.org/biotech/. As we consider this issue, we intend for our actions to be guided by the principles for the regulation of biotechnology products articulated in the 2017 Update to the Coordinated Framework (https://www.whitehouse.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf) and the goals and objectives of the July 2015 EOP memorandum (https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_memo_final.pdf). Producers of foods from plant varieties developed using genome editing techniques, like all food producers, have an obligation under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to ensure that the foods they offer consumers are safe and in compliance with applicable legal requirements (57 FR 22984 at 22985), available athttp://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Biotechnology/ucm096095.htm. The FD&C Act gives FDA broad authority to initiate legal action against a food that is adulterated or misbranded within the meaning of the statute (id.). In 1992, FDA issued a statement of policy (57 FR 22984) that discussed scientific issues and provided guidance relevant to the safety assessment of foods derived from new plant varieties derived by traditional methods, tissue culture methods, and recombinant DNA methods (57 FR 22984 at 22991). The guidance provided in the 1992 policy has helped to ensure that developers of new plant varieties make market entry decisions consistent with the FD&C Act. FDA also explained that we have long regarded it to be a prudent practice for producers of foods using new technologies to work cooperatively with us to ensure that the new products are safe and comply with applicable legal requirements (57 FR 22984 at 22991). Over the past 20 years, developers have routinely consulted FDA about the safety and legality of foods from new genetically engineered plant varieties prior to marketing. These consultations have relied on the objective characteristics of foods to consider their safety and legality prior to marketing. This process has worked well and has helped developers ensure that all safety and other legal issues are satisfactorily addressed prior to market entry of foods derived from these new varieties. FDA intends to continue offering consultations for developers of new plant varieties, including those produced using genome editing, in order to help developers ensure that applicable safety and legal questions are resolved prior to market. In addition to the information we anticipate gathering from developers in the course of consultations, we recognize that developers, researchers, and other stakeholders may have valuable factual information and data about foods derived from new plant varieties produced using genome editing, which can help inform FDA's thinking for these specific products. Therefore, we invite comment in this notice. II. Additional Issues for Consideration and Invitation for Comment: Genome Editing in PlantsTo help inform our thinking on foods derived from new plant varieties produced using genome editing, we invite comment on the following questions: 1. In what ways are the food safety risks associated with human and animal foods from genome edited plants the same as or different from those associated with other plant development methods (e.g., hybridization, chemical or radiation-induced mutagenesis and non-targeted genetic modifications using in vitro recombinant DNA technologies)? Please provide data and/or information to support your view. · To what extent is the scientific knowledge of and experience with current new plant varieties (such as those developed with in vitro recombinant DNA technologies that have gone through the voluntary consultation process) relevant to the safety assessment and regulatory status of food from new plant varieties produced using genome editing? Is there additional scientific knowledge that would be relevant specifically to the safety assessment and regulatory status of new plant varieties produced using genome editing? Please provide data and/or information to support your view.Start Printed Page 6566 2. Are there categories of genome edited plant varieties for which there are scientific bases to conclude that foods from such categories are unlikely to present food safety risks different from or greater than those for traditional plant breeding? Similarly, are there categories of genome edited plant varieties for which the regulatory status of the food derived from such plant varieties can be said to be no different from that of traditionally-bred plants? If there are such categories, is there a basis upon which to determine that there would be no reason to include them in any voluntary premarket consultation process? If so, please describe the characteristics of such categories (including, for example, information about the types of phenotypes and modifications (insertions, deletions or substitutions) achieved through genome editing) and provide data and/or information for why plant varieties in these categories are unlikely to present food safety risks or regulatory status questions. Regulatory status questions may include, for example, whether food from the new plant variety contains an unapproved food or color additive such that premarket review and approval is required (see sections 409 and 721 of the FD&C Act). As another example, if food from the new plant variety has a different nutritional profile from food from traditionally-bred plants, then certain labeling may be required to disclose a material change in the food. a. If such categories exist, how do plant developers ensure the safety of foods from new plant varieties in these categories? For example, how are safety assessments of foods from these varieties accomplished, and what data and information are or should be considered in such assessments? b. If certain categories of genome edited plants do not raise questions of safety or regulatory status, should there nevertheless be a mechanism separate from the voluntary premarket consultation process through which plant developers may voluntarily notify FDA about their intent to market a food derived from a genome edited new plant variety that falls within these categories? If so, what process should plant developers use to notify FDA? What kind of information should be included in such a notification to FDA? c. Given that genome editing techniques can give rise to a broad range of plant modifications, from simple gene deletions to totally novel genes, and that some such modifications can be achieved through traditional breeding, please discuss the basis upon which to determine that there would or would not be a reason to include, in any voluntary premarket consultation process, foods from genome edited crops with modifications that could have been achieved through traditional breeding. 3. Are there categories of genome edited plant varieties for which there are scientific bases to conclude that foods from these categories are more likely than traditionally-bred plants to present food safety risks? If so, please describe the characteristics of these categories (including, for example, information about the types of phenotypes and modifications (insertions, deletions or substitutions) achieved through genome editing) and provide data and/or information to support why plant varieties in these categories are more likely to present food safety risks than traditionally-bred plants. 4. What steps can we take to help small firms, including those who may be considering using genome editing to produce new plant varieties for use in human or animal food, to engage with FDA about any questions related to food safety or the regulatory status of foods from their new plant varieties? Please provide supporting data and other information to support your comments and responses to this question. Dated: January 11, 2017. Leslie Kux, Associate Commissioner for Policy. Footnotes1.  https://www.whitehouse.gov/sites/default/files/microsites/ostp/biotech_national_strategy_final.pdf. Back to Citation [FR Doc. 2017-00840 Filed 1-18-17; 8:45 am] BILLING CODE 4164-01-P
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