直言了 | 轉(zhuǎn)基因：美國認(rèn)錯了

　　今年07月02日，美國白宮以科技顧問備忘錄形式頒布了行政令，標(biāo)題挺長：

　　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：給(美國)FDA、環(huán)保署和農(nóng)業(yè)部的頭頭們的備忘錄：生物技術(shù)產(chǎn)品管理的現(xiàn)代化。為本備忘錄目標(biāo)，這里所說的生物技術(shù)產(chǎn)品，指的是通過基因工程等技術(shù)開發(fā)的植物、動物和微生物;本錄不涉及人類使用的醫(yī)藥用品。(原文全文附后)。

　　顯然，該備忘錄的目標(biāo)是俗稱“轉(zhuǎn)基因食品作物”的國家管理體系的改造。

　　【美國認(rèn)錯了】：

　　該備忘錄說：現(xiàn)有的轉(zhuǎn)基因食品作物的國家管理體系已經(jīng)歷時30年，且是該類作物商業(yè)化之前制定的。該體系已經(jīng)過時，它不能勝任相關(guān)國家管理，尤其是不能獲得民眾對相關(guān)國家管理和對相關(guān)產(chǎn)品的信任、不能確保民眾健康和生態(tài)安全，同時，也不能促進(jìn)生物技術(shù)發(fā)展(尤其不能促進(jìn)生物技術(shù)領(lǐng)域的中小企業(yè)幸存發(fā)展)。

　　該備忘錄說：相關(guān)部門要在限定時間內(nèi)完成改造現(xiàn)有體系的方案制定：要以民眾健康和生態(tài)安全為目標(biāo)、以風(fēng)險管理為基礎(chǔ)，來提升國家管理質(zhì)量和相關(guān)標(biāo)準(zhǔn)規(guī)范;要提高管理部門的透明度、預(yù)見性、工作效率和互相協(xié)調(diào);要促進(jìn)美國王大媽即美國民眾對相關(guān)國家管理的知情、參與和監(jiān)督，要確保民眾對相關(guān)國家管理體系是有信心的。

　　再明白不過：美國白宮承認(rèn)美國現(xiàn)有的轉(zhuǎn)基因食品作物管理體系不是以民眾健康和生態(tài)安全為目標(biāo)的(而是為孟山都和杜邦等極少數(shù)人的商業(yè)利益為目標(biāo)的);承認(rèn)現(xiàn)有體系的標(biāo)準(zhǔn)規(guī)范和管理質(zhì)量不能確保法規(guī)要求的國家管理透明、危害風(fēng)險預(yù)見和應(yīng)對，甚至頗有違反法規(guī)要求的王大媽即民眾的知情權(quán)、參與權(quán)和監(jiān)督權(quán)而不能獲得民眾信任的成分(轉(zhuǎn)基因食品不做標(biāo)識是主要案例之一)，而在美國、國家幸存和實(shí)施國家管理的基本依據(jù)之一就是民眾的信任和參與。一句話，美國白宮承認(rèn)了美國現(xiàn)有的轉(zhuǎn)基因食品作物國家管理體系是大有錯誤而需要糾正了。

　　【歐洲媒體反響：嘿、嘿、嘿！】：

　　就此，歐美主要媒體都做了報道評論，反響足夠強(qiáng)烈。不過，歐美媒體反應(yīng)卻有明顯不同。

　　譬如，歐洲的路透社引用批評界說，該備忘錄發(fā)表意味著美國現(xiàn)有的轉(zhuǎn)基因食品作物管理體系的失敗。歐洲媒體說話如此痛快，是有底氣的：歐洲發(fā)達(dá)國家(尤其是盟國，下同)一開始就不同意美國的管理方法和管理體系，尤其不同意其轉(zhuǎn)基因食品作物不做標(biāo)識和所謂“實(shí)質(zhì)等同”原則的政策;這幾年，歐洲發(fā)達(dá)國家則是干脆把轉(zhuǎn)基因種子公司趕出了歐洲食品市場，有的還立法禁止轉(zhuǎn)基因食品作物及其商業(yè)化種植，等于是更直接和更堅(jiān)決地挑戰(zhàn)美國的轉(zhuǎn)基因食品作物管理思想及其體系。

　　當(dāng)然，歐洲媒體如此痛快說明美國轉(zhuǎn)基因食品作物管理體系失敗，還有個“反報復(fù)”緣故：美國方面曾威脅法國等歐洲發(fā)達(dá)國家說，若不采取美國的轉(zhuǎn)基因化工農(nóng)業(yè)方式和繼續(xù)抵制轉(zhuǎn)基因食品作物商業(yè)化全球化，那就將采取外交報復(fù)手段。如今，歐洲發(fā)達(dá)國家繼續(xù)且更明確地堅(jiān)持自己的立場，而美國方面終于不得不承認(rèn)自己的管理體系失敗了。如此，難免，相關(guān)歐洲發(fā)達(dá)國家要對美國來幾聲“嘿、嘿、嘿!”。不過，他們畢竟彼此是盟國、其地緣政治和生物國防的戰(zhàn)略利益是互相依賴的，因此，相關(guān)歐洲發(fā)達(dá)國家不會借機(jī)給美國來個“落井下石”或“幸災(zāi)樂禍”，相反，他們倒很可能伸出援助之手、幫助美國糾正錯誤和跳出轉(zhuǎn)基因食品作物那個垃圾技術(shù)的陷阱，以此來強(qiáng)化盟國之間共享的生物國防安全體系和地緣政治合作。

　　【美國媒體反響：無可奈何和悲觀】：

　　譬如，過去一向“親轉(zhuǎn)”的美國紐約時報述評頗有無可奈何和悲觀的味道，但也承認(rèn)美國的現(xiàn)有轉(zhuǎn)基因食品作物管理體系是“太陳舊”和“太混亂”了、且不能獲得民眾對國家管理的信心。該述評說，看到白宮發(fā)表的這份備忘錄，美國社會的“挺轉(zhuǎn)”和“反轉(zhuǎn)”等各個方面似乎都激動起來了，都說備忘錄發(fā)表是自己的勝利、且預(yù)計(jì)更新后的管理體系將符合自己的要求;然而，各方面似乎都期望過高了，更新結(jié)果可能讓各方都失望。

　　該媒體如此悲觀，也有其理由：且不說過去20來年美國官方內(nèi)部的挺轉(zhuǎn)和反轉(zhuǎn)的爭執(zhí)沒有積極結(jié)果，就其管理來說，似乎連清晰規(guī)范都沒有建立起來。譬如，轉(zhuǎn)基因作物到底是藥品還是食品?若是藥品，為什么FDA按照食品做“咨詢”、且不在藥店而在食品柜出售?若是食品，為什么不能按照所有食品管理的規(guī)范來管理轉(zhuǎn)基因食品(如轉(zhuǎn)基因食品就可以不遵守全國統(tǒng)一的食品標(biāo)識規(guī)范)?若是食品且“實(shí)質(zhì)等同”，那么，其添加的抗蟲劑和除草劑等毒素農(nóng)藥是否也可以作為食品、在超市出售且上到全國民眾的餐桌了呢?此外，現(xiàn)有管理體系是基于DNA-水平的“中心法則”的，而RNA-水平的科學(xué)事實(shí)已經(jīng)證明那個法則是錯誤的，且多數(shù)生物技術(shù)開發(fā)已經(jīng)轉(zhuǎn)移到RNA-水平的“基因編輯”了(即不再是用DNA水平的技術(shù)把農(nóng)藥加入作物基因序列，而是用RNA-技術(shù)改造作物基因序列本身及其功能、因而危害風(fēng)險更大和更隱蔽)，因此，基于DNA-水平“中心法則”的管理體系根本無法有效管理危害風(fēng)險更大的RNA-水平的食品作物的開發(fā)及其工商業(yè)。就白宮發(fā)布的備忘錄看，并沒有清楚說明解決這些美國社會早已提出的管理規(guī)范混亂的問題的原則或思路。

　　【美國當(dāng)局其實(shí)是“全知道”】：

　　必須說說的是，紐約時報等美國媒體相關(guān)報道沒說到的故事是：頒布那份備忘錄之前，白宮已經(jīng)為強(qiáng)化生物國防而給國防部款出專款10億美元、籌建一個開發(fā)RNA-水平的轉(zhuǎn)基因作物快速檢測技術(shù);之后，又再為國防部生物國防建設(shè)增加專款29億美元，用來籌建一個中心，專職負(fù)責(zé)快速發(fā)現(xiàn)和快速檢測未知轉(zhuǎn)基因技術(shù)及其作物產(chǎn)品、未知疾病疫情、未知基因藥品、未知微生物等方面的科技開發(fā)和人員網(wǎng)羅。于此同時，白宮數(shù)次發(fā)公文，強(qiáng)調(diào)生物科學(xué)技術(shù)具有雙重性即危害風(fēng)險，并發(fā)出行政令、要求全國各地管理部門從項(xiàng)目一開始就做好基于生物國防需要的危害風(fēng)險管理工作。而就更新管理體系的備忘錄看，則是特別強(qiáng)調(diào)了美國王大媽即民眾的參與和信任。可說，這個強(qiáng)調(diào)說明，轉(zhuǎn)基因食品作物商業(yè)化不僅給人口安全和國土安全帶來了嚴(yán)重危害風(fēng)險，且也給國家信用帶來了嚴(yán)重?fù)p害風(fēng)險。

　　其實(shí)，關(guān)于生物國防和民眾信任是轉(zhuǎn)基因技術(shù)開發(fā)應(yīng)用的首位考慮，那是轉(zhuǎn)基因技術(shù)開拓人伯格博士一開始就說明的。他說，轉(zhuǎn)基因技術(shù)可用來制造發(fā)動生物戰(zhàn)爭的大規(guī)模殺傷武器，對人類健康和生態(tài)環(huán)境都有嚴(yán)重危害風(fēng)險。因此，就轉(zhuǎn)基因技術(shù)開發(fā)應(yīng)用，必須有民眾的充分信任，必須有國家的嚴(yán)限嚴(yán)管，從事者必須有嚴(yán)格的道德自律。伯格博士是美國著名生物學(xué)家(曾獲得諾獎)。他的那番話，是美國當(dāng)局和西方發(fā)達(dá)國家從事相關(guān)國家管理的“座右銘”，至今還掛在諾獎網(wǎng)站。(注意：伯格博士把王大媽即民眾的充分信任放在首位，而建立民眾信任的起碼條件之一是知情、參與和監(jiān)督;第二位是基于風(fēng)險(risk-based)而不是基于企業(yè)利潤效益的國家管理。這種思路，在該備忘錄里得到足夠體現(xiàn)。)

　　可見，美國白宮當(dāng)局很清楚地知道轉(zhuǎn)基因食品作物具有嚴(yán)重危害風(fēng)險，因而，其以防御轉(zhuǎn)基因技術(shù)武器進(jìn)攻為主要內(nèi)容的生物國防和防疫體系建設(shè)的那根弦、一直是繃得很緊很緊的;美國白宮當(dāng)局也清楚地知道RNA-水平的轉(zhuǎn)基因食品作物的危害風(fēng)險更大和更隱蔽，因而幾十億美元專項(xiàng)撥款幾乎都是與RNA-水平的生物國防和防疫體系建設(shè)是直接相關(guān)的。有了這個基礎(chǔ)性的國家安全體系建設(shè)作后盾，那就不管市場如何，美國官方至少能維護(hù)最起碼的國家安全，因而，白宮就敢于頒布那個可能讓美國社會的挺轉(zhuǎn)和反轉(zhuǎn)等各方面都會感到失望的備忘錄了。

　　再說了，世界衛(wèi)生組織已經(jīng)頒文，說明轉(zhuǎn)基因作物捆綁農(nóng)藥草甘膦可致癌;糧農(nóng)組織已經(jīng)向全體成員國提出了“讓農(nóng)業(yè)回歸自然”的現(xiàn)代化農(nóng)業(yè)發(fā)展政策建議;美國官方不反對聯(lián)合國世貿(mào)標(biāo)準(zhǔn)機(jī)構(gòu)關(guān)于轉(zhuǎn)基因食品標(biāo)識的立法提案，……。在那些國際官方機(jī)構(gòu)里，美國還是享有“老大”的影響力。可以說，那些國際官方機(jī)構(gòu)的表態(tài)實(shí)際上反映了美國官方立場。更不要說，奧巴馬上臺不久，其夫人就帶領(lǐng)全家以身作則、向全國推薦有機(jī)食品和避免轉(zhuǎn)基因食品，為此把白宮玫瑰園改造成有機(jī)農(nóng)田展示園地、搞了個“讓我們行動起來”的全國運(yùn)動，還促使美國農(nóng)業(yè)部大力支持本國的天然有機(jī)農(nóng)業(yè)發(fā)展、且與歐洲盟國建立了保障天然有機(jī)食品供應(yīng)的戰(zhàn)略合作協(xié)約。

　　換句話說，美國官方知道和看到了，轉(zhuǎn)基因食品作物商業(yè)化不但給人口安全和國土安全帶來了前所未有的嚴(yán)重威脅和嚴(yán)重危害，且給美國的國家管理信用帶來了足夠嚴(yán)重的損害;由此，美國官方其實(shí)很知道該怎么改造現(xiàn)有的轉(zhuǎn)基因食品作物管理體系，那就是：干脆放棄轉(zhuǎn)基因食品作物、干脆放棄轉(zhuǎn)基因化工農(nóng)業(yè)，大力發(fā)展天然有機(jī)農(nóng)業(yè)即“讓農(nóng)業(yè)回歸自然”，同時，必須確保鄰居王大媽即民眾對國家管理的知情權(quán)、發(fā)言權(quán)、參與權(quán)和監(jiān)督權(quán)。實(shí)際上，美國官方已經(jīng)開始靜悄悄地告別轉(zhuǎn)基因化工農(nóng)業(yè)了。問題是，在美國，轉(zhuǎn)基因食品作物那個垃圾技術(shù)泛濫了30多年、在不少其它國家也有嚴(yán)重泛濫(譬如中國、阿根廷和巴西)且已造成嚴(yán)重危害;清除那些垃圾和治理補(bǔ)救危害都不是那么容易的，而如何向受害國做出妥善交代也是個難題。再說了，奧巴馬競選時候做了轉(zhuǎn)基因食品標(biāo)識即改造現(xiàn)有管理體系的承諾;如此，白宮于今頒布了那個改造現(xiàn)有的轉(zhuǎn)基因食品作物管理體系的備忘錄，也算是奧巴馬當(dāng)局給選民做了個交代;而如何實(shí)現(xiàn)備忘錄，那就是下屆白宮的事情了。

　　【附議】：美國建立和反思其轉(zhuǎn)基因食品作物國家管理的事件

　　（并非全部而只是與本文直接相關(guān)的事件）：

　　1970年代：轉(zhuǎn)基因技術(shù)應(yīng)用及產(chǎn)品方法等問世。美蘇全球冷戰(zhàn)增添了轉(zhuǎn)基因技術(shù)武器軍備競賽內(nèi)容。美國科學(xué)家特敏等學(xué)者以RNA-水平科研指出了基于DNA-水平的“中心法則”是錯誤的。

　　1980年代：轉(zhuǎn)基因食品作物商業(yè)化提上日程。副總統(tǒng)老布什認(rèn)為，至少要等到美國的生物國防和防疫體系可以對蘇聯(lián)轉(zhuǎn)基因技術(shù)武器進(jìn)攻實(shí)施有效防御和有效反攻的水平之后。同時，1986年，白宮牽頭、制定了基于“中心法則”的轉(zhuǎn)基因食品作物商業(yè)化管理框架。

　　1992到1994年：冷戰(zhàn)結(jié)束，為美國把轉(zhuǎn)基因技術(shù)從軍用為主轉(zhuǎn)為食品作物商業(yè)化民用為主而提供了國際條件。在1986年框架的基礎(chǔ)上，白宮牽頭、制定了基于“實(shí)質(zhì)等同”為原則的轉(zhuǎn)基因食品作物商業(yè)化管理框架。隨之，轉(zhuǎn)基因食品作物商業(yè)化開始。

　　1996到1998年：西方學(xué)界多數(shù)人同意RNA-水平科研事實(shí)證明基于DNA-水平的中心法則是錯誤的。后來，美國衛(wèi)生部發(fā)文承認(rèn)了這一點(diǎn)。然而，美國當(dāng)局的基于DNA-水平的“中心法則”的轉(zhuǎn)基因食品作物管理體系已經(jīng)付諸商業(yè)化管理實(shí)施且試圖推向全球化。

　　2004年，值轉(zhuǎn)基因食品作物商業(yè)化十周年，美國學(xué)界反思并提出了轉(zhuǎn)基因食品作物是“垃圾技術(shù)”、轉(zhuǎn)“垃圾技術(shù)”為“黃金技術(shù)”不在于歐美發(fā)達(dá)國家而在于中國印度等亞洲發(fā)展中國家的消費(fèi)的見解。從此，孟山都等轉(zhuǎn)基因公司把市場重點(diǎn)戰(zhàn)略目標(biāo)轉(zhuǎn)向了中國。2007年，該戰(zhàn)略轉(zhuǎn)移在中國獲得極大成功，突出案例是那些轉(zhuǎn)基因公司收買滲透了中科院生物部門、中國農(nóng)業(yè)部、科協(xié)、科技部等相關(guān)部門，通過獎學(xué)金和基金會等方式滲透了不少高等院校，收買滲透了中國的高層和地方機(jī)構(gòu)的決策官員，同時，還滲透買通了一些喉舌官方媒體，從此，在中國，一個壟斷了話語權(quán)、可以影響甚至左右中國國家相關(guān)決策及其人事政策的官商學(xué)媒“四位一體”的轉(zhuǎn)基因商業(yè)既得利益集團(tuán)浮出水面(中國挺轉(zhuǎn)幫把那個既得利益集團(tuán)稱為“科學(xué)家共同體”)。

　　2006年，諾獎頒發(fā)給RNA-水平科研。據(jù)美國主要媒體報道分析，在美國等西方發(fā)達(dá)國家，RNA-水平技術(shù)產(chǎn)品開發(fā)已經(jīng)替代了DNA-水平技術(shù)產(chǎn)品開發(fā)而成為所謂的“主流”。2007年前后，基于“中心法則”的生物技術(shù)經(jīng)濟(jì)泡沫破裂。

　　2010年，美國學(xué)界再次反思美國的轉(zhuǎn)基因食品作物商業(yè)化，提出了長期種植使用是得不償失或事與愿違的見解。這次學(xué)界反思，有孟山都等轉(zhuǎn)基因公司學(xué)者的參與。鑒于事前有中國高層決策人私下和公開地向美國傳達(dá)了堅(jiān)決支持轉(zhuǎn)基因食品作物商業(yè)化、要大力促進(jìn)轉(zhuǎn)基因化工農(nóng)業(yè)和大批進(jìn)口轉(zhuǎn)基因食品作物、且轉(zhuǎn)基因大米三五年在中國全國上餐桌等等信息，有孟山都公司參與的這次學(xué)界反思就沒有涉及如何改造現(xiàn)有管理體系的問題(盡管他們清楚看到轉(zhuǎn)基因食品作物商業(yè)化是得不償失或事與愿違)。同年，美國國會召集聽政會，要求美國農(nóng)業(yè)部等主管部門和相關(guān)企業(yè)為“超級雜草”泛濫成災(zāi)而提出治理和補(bǔ)救方案。

　　2011年，聯(lián)合國糧農(nóng)組織向全體成員國提出了“讓農(nóng)業(yè)回歸自然”和“小農(nóng)經(jīng)營”的現(xiàn)代化農(nóng)業(yè)發(fā)展的政策主張。這標(biāo)志著美國當(dāng)局開始考慮如何糾正轉(zhuǎn)基因化工農(nóng)業(yè)的錯誤路線、如何改造其現(xiàn)有轉(zhuǎn)基因食品作物管理體系了。就文獻(xiàn)看，實(shí)際上，這一年，白宮已經(jīng)開始著手籌劃和起草改造方案(即當(dāng)今公布的備忘錄)了。

　　2012到2014年：美國大體完成了生物國防和防疫系統(tǒng)的建設(shè)思路和決策籌劃從DNA-水平向RNA-水平的轉(zhuǎn)變。白宮數(shù)次強(qiáng)化全國生物國防建設(shè)，并以行政命令方式要求聯(lián)邦各部門和全國各地管理部門要充分認(rèn)識到生物科研及其技術(shù)開發(fā)的雙重性即危害風(fēng)險、要從項(xiàng)目一開始就做好以生物國防安全為思路的國家管理，并把相關(guān)管理貫徹于項(xiàng)目始終和付諸于事后跟蹤監(jiān)控。

　　2013到2014年：歐洲發(fā)達(dá)國家把轉(zhuǎn)基因種子公司趕出了歐洲市場。歐盟國家完成了轉(zhuǎn)基因作物捆綁農(nóng)藥乙草胺的淘汰手續(xù)。歐盟總部通過決議，是否采用轉(zhuǎn)基因化工農(nóng)業(yè)和如何審批其產(chǎn)品的決定權(quán)在各成員國自己;從此，美國公司通過歐盟總部來強(qiáng)迫歐洲各國接受其轉(zhuǎn)基因食品作物的途徑大體沒意義了，歐盟總部如何審批轉(zhuǎn)基因食品作物也變得幾乎再無意義。

　　2015年03月，世衛(wèi)組織發(fā)布公文說明轉(zhuǎn)基因作物捆綁農(nóng)藥草甘膦可致癌。

　　2015年04月，美國農(nóng)業(yè)部發(fā)文回答國會2010年聽政會要求，字里行間表示“沒招”應(yīng)對“超級雜草”泛濫成災(zāi)。

　　2015年05月，美國白宮發(fā)布了拯救蜜蜂的公文(等于公開承認(rèn)轉(zhuǎn)基因作物商業(yè)化造成蜜蜂大批消亡等嚴(yán)重的生態(tài)危害)。

　　2015年07月，白宮發(fā)布備忘錄，提出了改造美國現(xiàn)有的轉(zhuǎn)基因食品作物國家管理體系的行政令。

　　【附件】：美國白宮關(guān)于改造現(xiàn)有轉(zhuǎn)基因食品作物國家管理體系的備忘錄原文：

　　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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