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直言了 | 转基因:美国认错了

直言了 · 2015-08-24 · 来源:乌有之乡
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美国白宫承认美国现有的转基因食品作物管理体系不是以民众健康和生态安全为目标的(而是为孟山都和杜邦等极少数人的商业利益为目标的)。

  今年07月02日,美国白宫以科技顾问备忘录形式颁布了行政令,标题挺长:

 

  MEMORANDUM FOR HEADS OF FOOD AND DRUG ADMINISTRATION, ENVIRONMENTAL PROTECTION AGENCY, AND DEPARTMENT OF AGRICULTURE。 SUBJECT: Modernizing the Regulatory System for Biotechnology Products [1]。

  [1] For the purpose of this memo, “biotechnology products” refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes or their derived products as determined by existing statutes and regulations. Products such as human drugs and medical devices are not the focus of the activities described in this memo.。

  大意:给(美国)FDA、环保署和农业部的头头们的备忘录:生物技术产品管理的现代化。为本备忘录目标,这里所说的生物技术产品,指的是通过基因工程等技术开发的植物、动物和微生物;本录不涉及人类使用的医药用品。(原文全文附后)。

 

  显然,该备忘录的目标是俗称“转基因食品作物”的国家管理体系的改造。

 

 

  【美国认错了】:

  该备忘录说: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。

 

  再明白不过:美国白宫承认美国现有的转基因食品作物管理体系不是以民众健康和生态安全为目标的(而是为孟山都和杜邦等极少数人的商业利益为目标的);承认现有体系的标准规范和管理质量不能确保法规要求的国家管理透明、危害风险预见和应对,甚至颇有违反法规要求的王大妈即民众的知情权、参与权和监督权而不能获得民众信任的成分(转基因食品不做标识是主要案例之一),而在美国、国家幸存和实施国家管理的基本依据之一就是民众的信任和参与。一句话,美国白宫承认了美国现有的转基因食品作物国家管理体系是大有错误而需要纠正了。

 

 

  【欧洲媒体反响:嘿、嘿、嘿!】:

  就此,欧美主要媒体都做了报道评论,反响足够强烈。不过,欧美媒体反应却有明显不同。

 

  譬如,欧洲的路透社引用批评界说,该备忘录发表意味着美国现有的转基因食品作物管理体系的失败。欧洲媒体说话如此痛快,是有底气的:欧洲发达国家(尤其是盟国,下同)一开始就不同意美国的管理方法和管理体系,尤其不同意其转基因食品作物不做标识和所谓“实质等同”原则的政策;这几年,欧洲发达国家则是干脆把转基因种子公司赶出了欧洲食品市场,有的还立法禁止转基因食品作物及其商业化种植,等于是更直接和更坚决地挑战美国的转基因食品作物管理思想及其体系。

 

  当然,欧洲媒体如此痛快说明美国转基因食品作物管理体系失败,还有个“反报复”缘故:美国方面曾威胁法国等欧洲发达国家说,若不采取美国的转基因化工农业方式和继续抵制转基因食品作物商业化全球化,那就将采取外交报复手段。如今,欧洲发达国家继续且更明确地坚持自己的立场,而美国方面终于不得不承认自己的管理体系失败了。如此,难免,相关欧洲发达国家要对美国来几声“嘿、嘿、嘿!”。不过,他们毕竟彼此是盟国、其地缘政治和生物国防的战略利益是互相依赖的,因此,相关欧洲发达国家不会借机给美国来个“落井下石”或“幸灾乐祸”,相反,他们倒很可能伸出援助之手、帮助美国纠正错误和跳出转基因食品作物那个垃圾技术的陷阱,以此来强化盟国之间共享的生物国防安全体系和地缘政治合作。

 

 

  【美国媒体反响:无可奈何和悲观】:

  譬如,过去一向“亲转”的美国纽约时报述评颇有无可奈何和悲观的味道,但也承认美国的现有转基因食品作物管理体系是“太陈旧”和“太混乱”了、且不能获得民众对国家管理的信心。该述评说,看到白宫发表的这份备忘录,美国社会的“挺转”和“反转”等各个方面似乎都激动起来了,都说备忘录发表是自己的胜利、且预计更新后的管理体系将符合自己的要求;然而,各方面似乎都期望过高了,更新结果可能让各方都失望。

 

  该媒体如此悲观,也有其理由:且不说过去20来年美国官方内部的挺转和反转的争执没有积极结果,就其管理来说,似乎连清晰规范都没有建立起来。譬如,转基因作物到底是药品还是食品?若是药品,为什么FDA按照食品做“咨询”、且不在药店而在食品柜出售?若是食品,为什么不能按照所有食品管理的规范来管理转基因食品(如转基因食品就可以不遵守全国统一的食品标识规范)?若是食品且“实质等同”,那么,其添加的抗虫剂和除草剂等毒素农药是否也可以作为食品、在超市出售且上到全国民众的餐桌了呢?此外,现有管理体系是基于DNA-水平的“中心法则”的,而RNA-水平的科学事实已经证明那个法则是错误的,且多数生物技术开发已经转移到RNA-水平的“基因编辑”了(即不再是用DNA水平的技术把农药加入作物基因序列,而是用RNA-技术改造作物基因序列本身及其功能、因而危害风险更大和更隐蔽),因此,基于DNA-水平“中心法则”的管理体系根本无法有效管理危害风险更大的RNA-水平的食品作物的开发及其工商业。就白宫发布的备忘录看,并没有清楚说明解决这些美国社会早已提出的管理规范混乱的问题的原则或思路。

 

 

  【美国当局其实是“全知道”】:

  必须说说的是,纽约时报等美国媒体相关报道没说到的故事是:颁布那份备忘录之前,白宫已经为强化生物国防而给国防部款出专款10亿美元、筹建一个开发RNA-水平的转基因作物快速检测技术;之后,又再为国防部生物国防建设增加专款29亿美元,用来筹建一个中心,专职负责快速发现和快速检测未知转基因技术及其作物产品、未知疾病疫情、未知基因药品、未知微生物等方面的科技开发和人员网罗。于此同时,白宫数次发公文,强调生物科学技术具有双重性即危害风险,并发出行政令、要求全国各地管理部门从项目一开始就做好基于生物国防需要的危害风险管理工作。而就更新管理体系的备忘录看,则是特别强调了美国王大妈即民众的参与和信任。可说,这个强调说明,转基因食品作物商业化不仅给人口安全和国土安全带来了严重危害风险,且也给国家信用带来了严重损害风险。

 

  其实,关于生物国防和民众信任是转基因技术开发应用的首位考虑,那是转基因技术开拓人伯格博士一开始就说明的。他说,转基因技术可用来制造发动生物战争的大规模杀伤武器,对人类健康和生态环境都有严重危害风险。因此,就转基因技术开发应用,必须有民众的充分信任,必须有国家的严限严管,从事者必须有严格的道德自律。伯格博士是美国著名生物学家(曾获得诺奖)。他的那番话,是美国当局和西方发达国家从事相关国家管理的“座右铭”,至今还挂在诺奖网站。(注意:伯格博士把王大妈即民众的充分信任放在首位,而建立民众信任的起码条件之一是知情、参与和监督;第二位是基于风险(risk-based)而不是基于企业利润效益的国家管理。这种思路,在该备忘录里得到足够体现。)

 

  可见,美国白宫当局很清楚地知道转基因食品作物具有严重危害风险,因而,其以防御转基因技术武器进攻为主要内容的生物国防和防疫体系建设的那根弦、一直是绷得很紧很紧的;美国白宫当局也清楚地知道RNA-水平的转基因食品作物的危害风险更大和更隐蔽,因而几十亿美元专项拨款几乎都是与RNA-水平的生物国防和防疫体系建设是直接相关的。有了这个基础性的国家安全体系建设作后盾,那就不管市场如何,美国官方至少能维护最起码的国家安全,因而,白宫就敢于颁布那个可能让美国社会的挺转和反转等各方面都会感到失望的备忘录了。

 

  再说了,世界卫生组织已经颁文,说明转基因作物捆绑农药草甘膦可致癌;粮农组织已经向全体成员国提出了“让农业回归自然”的现代化农业发展政策建议;美国官方不反对联合国世贸标准机构关于转基因食品标识的立法提案,……。在那些国际官方机构里,美国还是享有“老大”的影响力。可以说,那些国际官方机构的表态实际上反映了美国官方立场。更不要说,奥巴马上台不久,其夫人就带领全家以身作则、向全国推荐有机食品和避免转基因食品,为此把白宫玫瑰园改造成有机农田展示园地、搞了个“让我们行动起来”的全国运动,还促使美国农业部大力支持本国的天然有机农业发展、且与欧洲盟国建立了保障天然有机食品供应的战略合作协约。

 

  换句话说,美国官方知道和看到了,转基因食品作物商业化不但给人口安全和国土安全带来了前所未有的严重威胁和严重危害,且给美国的国家管理信用带来了足够严重的损害;由此,美国官方其实很知道该怎么改造现有的转基因食品作物管理体系,那就是:干脆放弃转基因食品作物、干脆放弃转基因化工农业,大力发展天然有机农业即“让农业回归自然”,同时,必须确保邻居王大妈即民众对国家管理的知情权、发言权、参与权和监督权。实际上,美国官方已经开始静悄悄地告别转基因化工农业了。问题是,在美国,转基因食品作物那个垃圾技术泛滥了30多年、在不少其它国家也有严重泛滥(譬如中国、阿根廷和巴西)且已造成严重危害;清除那些垃圾和治理补救危害都不是那么容易的,而如何向受害国做出妥善交代也是个难题。再说了,奥巴马竞选时候做了转基因食品标识即改造现有管理体系的承诺;如此,白宫于今颁布了那个改造现有的转基因食品作物管理体系的备忘录,也算是奥巴马当局给选民做了个交代;而如何实现备忘录,那就是下届白宫的事情了。

 

 

  【附议】:美国建立和反思其转基因食品作物国家管理的事件

  并非全部而只是与本文直接相关的事件):

  1970年代:转基因技术应用及产品方法等问世。美苏全球冷战增添了转基因技术武器军备竞赛内容。美国科学家特敏等学者以RNA-水平科研指出了基于DNA-水平的“中心法则”是错误的。

 

  1980年代:转基因食品作物商业化提上日程。副总统老布什认为,至少要等到美国的生物国防和防疫体系可以对苏联转基因技术武器进攻实施有效防御和有效反攻的水平之后。同时,1986年,白宫牵头、制定了基于“中心法则”的转基因食品作物商业化管理框架。

 

  1992到1994年:冷战结束,为美国把转基因技术从军用为主转为食品作物商业化民用为主而提供了国际条件。在1986年框架的基础上,白宫牵头、制定了基于“实质等同”为原则的转基因食品作物商业化管理框架。随之,转基因食品作物商业化开始。

 

  1996到1998年:西方学界多数人同意RNA-水平科研事实证明基于DNA-水平的中心法则是错误的。后来,美国卫生部发文承认了这一点。然而,美国当局的基于DNA-水平的“中心法则”的转基因食品作物管理体系已经付诸商业化管理实施且试图推向全球化。

 

  2004年,值转基因食品作物商业化十周年,美国学界反思并提出了转基因食品作物是“垃圾技术”、转“垃圾技术”为“黄金技术”不在于欧美发达国家而在于中国印度等亚洲发展中国家的消费的见解。从此,孟山都等转基因公司把市场重点战略目标转向了中国。2007年,该战略转移在中国获得极大成功,突出案例是那些转基因公司收买渗透了中科院生物部门、中国农业部、科协、科技部等相关部门,通过奖学金和基金会等方式渗透了不少高等院校,收买渗透了中国的高层和地方机构的决策官员,同时,还渗透买通了一些喉舌官方媒体,从此,在中国,一个垄断了话语权、可以影响甚至左右中国国家相关决策及其人事政策的官商学媒“四位一体”的转基因商业既得利益集团浮出水面(中国挺转帮把那个既得利益集团称为“科学家共同体”)。

 

  2006年,诺奖颁发给RNA-水平科研。据美国主要媒体报道分析,在美国等西方发达国家,RNA-水平技术产品开发已经替代了DNA-水平技术产品开发而成为所谓的“主流”。2007年前后,基于“中心法则”的生物技术经济泡沫破裂。

 

  2010年,美国学界再次反思美国的转基因食品作物商业化,提出了长期种植使用是得不偿失或事与愿违的见解。这次学界反思,有孟山都等转基因公司学者的参与。鉴于事前有中国高层决策人私下和公开地向美国传达了坚决支持转基因食品作物商业化、要大力促进转基因化工农业和大批进口转基因食品作物、且转基因大米三五年在中国全国上餐桌等等信息,有孟山都公司参与的这次学界反思就没有涉及如何改造现有管理体系的问题(尽管他们清楚看到转基因食品作物商业化是得不偿失或事与愿违)。同年,美国国会召集听政会,要求美国农业部等主管部门和相关企业为“超级杂草”泛滥成灾而提出治理和补救方案。

 

  2011年,联合国粮农组织向全体成员国提出了“让农业回归自然”和“小农经营”的现代化农业发展的政策主张。这标志着美国当局开始考虑如何纠正转基因化工农业的错误路线、如何改造其现有转基因食品作物管理体系了。就文献看,实际上,这一年,白宫已经开始着手筹划和起草改造方案(即当今公布的备忘录)了。

 

  2012到2014年:美国大体完成了生物国防和防疫系统的建设思路和决策筹划从DNA-水平向RNA-水平的转变。白宫数次强化全国生物国防建设,并以行政命令方式要求联邦各部门和全国各地管理部门要充分认识到生物科研及其技术开发的双重性即危害风险、要从项目一开始就做好以生物国防安全为思路的国家管理,并把相关管理贯彻于项目始终和付诸于事后跟踪监控。

 

  2013到2014年:欧洲发达国家把转基因种子公司赶出了欧洲市场。欧盟国家完成了转基因作物捆绑农药乙草胺的淘汰手续。欧盟总部通过决议,是否采用转基因化工农业和如何审批其产品的决定权在各成员国自己;从此,美国公司通过欧盟总部来强迫欧洲各国接受其转基因食品作物的途径大体没意义了,欧盟总部如何审批转基因食品作物也变得几乎再无意义。

 

  2015年03月,世卫组织发布公文说明转基因作物捆绑农药草甘膦可致癌。

 

  2015年04月,美国农业部发文回答国会2010年听政会要求,字里行间表示“没招”应对“超级杂草”泛滥成灾。

 

  2015年05月,美国白宫发布了拯救蜜蜂的公文(等于公开承认转基因作物商业化造成蜜蜂大批消亡等严重的生态危害)。

 

  2015年07月,白宫发布备忘录,提出了改造美国现有的转基因食品作物国家管理体系的行政令。

 

 

 

  【附件】:美国白宫关于改造现有转基因食品作物国家管理体系的备忘录原文:

 

  MEMORANDUM FOR HEADS OF FOOD AND DRUG ADMINISTRATION,ENVIRONMENTAL PROTECTION AGENCY, AND DEPARTMENT OF AGRICULTURE。July 2, 2015。

  https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_memo_final.pdf 。

 

  FROM:

  John P. Holdren, Assistant to the President for Science and Technology, Director, Office of Science and Technology Policy.

  Howard Shelanski, Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget.

  Darci Vetter, Chief Agricultural Negotiator, United States Trade Representative.

  Christy Goldfuss, Managing Director, Council on Environmental Quality.

 

 

  SUBJECT: Modernizing the Regulatory System for Biotechnology Products [1]

 

  Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.[2] This memorandum initiates a process to modernize the Federal regulatory system for the products of biotechnology and to establish mechanisms for periodic updates of that system. The objectives are to ensure public confidence in the regulatory system and to prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products while continuing to protect health and the environment.

 

  This memorandum shall be implemented consistent with applicable law, Executive Order 13563, Executive Order 13610, and the 2011 “Principles for Regulation and Oversight of Emerging Technologies” memorandum. [2, 3, 4]. Through those policies, this Administration has sought regulatory approaches that protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers. These principles must now be applied to updating the regulatory framework and systems that regulate the products of biotechnology.

 

 

  Background

  In 1986, the Office of Science and Technology Policy (OSTP) issued the Coordinated Framework for the Regulation of Biotechnology (CF),[5] which describes the comprehensive Federal regulatory policy for ensuring the safety of biotechnology products. The CF sought to achieve a balance between regulation adequate to ensure the protection of health and the environment while maintaining sufficient regulatory flexibility to avoid impeding innovation. In 1992, OSTP issued an update to the CF6 that sets forth a risk-based, scientifically sound basis for the oversight of activities that introduce biotechnology products into the environment. The update affirmed that Federal oversight should focus on the characteristics of the product and the environment into which it is being introduced, rather than the process by which the product is created.

 

  Each of the Federal regulatory agencies with jurisdiction over the products of biotechnology has developed regulations and guidance documents to implement its authority under existing laws, resulting in a complex system for assessing and managing health and environmental risks of the products of biotechnology. While the current regulatory system for the products of biotechnology effectively protects health and the environment, in some cases unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other processes have arisen. These costs and burdens have limited the ability of small and mid-sized companies to navigate the regulatory process and of the public to understand easily how the safety of these products is assured; and, accordingly, they have the potential to reduce economic growth, innovation, and competitiveness.

 

  Advances in science and technology, moreover, have dramatically altered the biotechnology landscape since the 1992 update of the CF. Such advances can enable the development of products that were not previously possible. A further update of the CF is needed to facilitate the appropriate Federal oversight by the regulatory system and increase transparency, while continuing to provide a framework for advancing innovation.

 

 

  Goals and Guidance

  Federal agencies that regulate biotechnology products should continually strive to improve predictability, increase efficiency, and reduce uncertainty in their regulatory processes and requirements. It is critical that these improvements:

  maintain high standards that are based on the best available science and that deliver appropriate health and environmental protection;

  establish transparent, coordinated, predictable, and efficient regulatory practices across agencies with overlapping jurisdiction; and

  promote public confidence in the oversight of the products of biotechnology through clear and transparent public engagement.

 

  This memo initiates a process to help advance these aims, beginning with the following one-year objectives: (1) development of an updated CF to clarify the roles and responsibilities of the agencies that regulate the products of biotechnology; (2) formulation of a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, promoting public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens; and (3) commissioning an external, independent analysis of the future landscape of biotechnology products.

 

 

  The following elements will support the process to achieve these objectives:

 

 

  Section I. Biotechnology Working Group Under the Emerging Technologies Interagency Policy Coordination Committee.

  The new Biotechnology Working Group under the Emerging Technologies Interagency Policy Coordination Committee (ETIPC) will include representatives from the Executive Office of the President, as well as the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and United States Department of Agriculture (USDA). The working group shall coordinate with other Federal agencies and offices as necessary.

 

 

  Section II. Mission and Function of the Working Group.

  Within one year of the date of this memorandum, the working group shall take steps detailed below and others, as appropriate, to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology. Specifically, the working group shall:

 

  (a) update the CF to clarify the current roles and responsibilities of the agencies that regulate the products of biotechnology, after input from the public, by clarifying:

  (i) which biotechnology product areas are within the authority and responsibility of each agency;

 

  (ii) the roles that each agency plays for different product areas, particularly for those product areas that fall within the responsibility of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment;

 

  (iii) a standard mechanism for communication and, as appropriate, coordination among agencies, while they perform their respective regulatory functions, and for identifying agency designees responsible for this coordination function; and

 

  (iv) the mechanism and timeline for regularly reviewing, and updating as appropriate, the CF to minimize delays, support innovation, protect health and the environment and promote the public trust in the regulatory systems for biotechnology products; and

 

  (b) develop a long-term strategy to ensure that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens by:

 

  (i) developing a plan for periodic formal horizon-scanning assessments of new biotechnology products to ensure that regulatory agencies are prepared for future products well before they reach the regulatory system;

 

  (ii) working with other Federal agencies, as appropriate, to develop a coordinated and goal-oriented plan for supporting the science that informs regulatory activities with regard to the assessment of biotechnology products, and to reflect these priorities in agency budget submissions starting with the fiscal year (FY) 2017 budget;

 

  (iii) ensuring that product evaluations are risk-based and grounded in the best science available, including regularly adjusting regulatory activities based on experience with specific products and the environments into which those products have been introduced;

 

  (iv) establishing a timetable and mechanisms to work with stakeholders to identify impediments to innovation, focusing on building new, and augmenting existing, stakeholder collaborations to inform efforts, increase transparency, streamline processes, reduce costs and response times, and ensure the protection of health and the environment;

 

  (v) coordinating the development of tools and mechanisms for assisting small businesses developing biotechnology products to navigate the regulatory system;

 

  (vi) identifying changes to authorities, regulations, and policies, if any, that could improve agencies’ abilities to assess expeditiously the potential impacts and risks arising from future products of biotechnology and to ensure the transparency, predictability, and efficiency of regulatory oversight for such products;

 

  (vii) initiating development of a modernized, user-friendly set of tools for presenting the regulatory agencies’ authorities, practices, and bases for decision making for the regulation of biotechnology products to the public, including digital services to improve the interactions between the FDA, EPA, USDA, the general public, and product developers and updating these tools and practices regularly to ensure optimal transparency; and

 

  (viii) proactively engaging with the public to discuss how the Federal government uses a risk-based, scientifically sound approach to regulating the products of biotechnology, and clearly communicating to the public which types of products are regulated, which types of products are not regulated, and why.

 

 

  Sec. III. Independent Assessment.

  The EPA, FDA, and USDA shall commission an external, independent analysis of the future landscape of biotechnology products that will identify (1) potential new risks and frameworks for risk assessment and (2) areas in which the risks or lack of risks relating to the products of biotechnology are well understood. The review will help inform future policy making. Due to the rapid pace of change in this arena, an external analysis should be completed at least every five years.

 

  Sec. IV. Budgeting for Efficiency.

  The EPA, FDA, and USDA shall work with OSTP and OMB, within the annual President’s budget formulation process, to develop a plan for supporting the implementation of this memo in Agency FY 2017 budget requests and, as appropriate, in future budget submissions.

 

  Sec. V. Annual Reporting.

  For at least five years, starting one year after the release of the strategy described in Section II, the working group will produce an annual report on specific steps that agencies are taking to implement that strategy and any other steps that the agencies are taking to improve the transparency, coordination, predictability, and efficiency of the regulation of biotechnology products. This report will be made available to the public by the Executive Office of the President.

 

  Sec. VI. General Provisions. Nothing in this memorandum shall be construed to impair or otherwise affect:

  (a) the mission as established by law for any agency;

  (b) the authority granted by law to any agency or the head thereof; or

  (c) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, regulatory, or legislative proposals.

 

  Nothing in this memorandum shall be construed to require the disclosure of confidential business information or trade secrets, classified information, law enforcement sensitive information, or other information that must be protected in the interest of national security or public safety.

 

  This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

 

 

  Notes:

  [1] For the purpose of this memo, “biotechnology products” refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes or their derived products as determined by existing statutes and regulations. Products such as human drugs and medical devices are not the focus of the activities described in this memo.

 

  [2] “Improving Regulation and Regulatory Review”, Executive Order 13563, January 18, 2011.

  [3] “Identifying and Reducing Regulatory Barriers”, Executive Order 13610, January 10, 2012.

 

  [4]“Principles for Regulation and Oversight of Emerging Technologies”, Memorandum for the Heads of Departments and Agencies, March 11, 2011.

 

  [5] http://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf

  [6] https://www.whitehouse.gov/sites/default/files/microsites/ostp/57_fed_reg_6753__1992.pdf

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