关于农业生物技术产品现代化监管框架的总统令

2019年6月11日颁布

根据美利坚合众国宪法和法律赋予我作为总统的权力，为了对农业生物技术产品开展以科学为基础，及时、有效和透明的进行联邦监督，现下令如下：

第1节 目的。

最近生物技术的进步有可能彻底改变农业，从而促进农村繁荣，提高美国人的生活质量。生物技术可以帮助国家满足其粮食生产需要，提高美国农民的生产力，改善作物和动物特性，增加作物和动物产品的营养价值，提高食品安全。然而，为了实现这些潜在的好处，美国必须采用一种基于科学的监管体系，根据人类健康和安全以及对环境的潜在好处和风险来评估产品。这样的体系既要增进公众对生物技术及其产品的信心，又要避免过度的监管负担。

2016年9月《生物技术产品监管体系现代化国家战略》和2017年1月《生物技术监管协调框架》的更新是明确联邦政府在农业生物技术方面的监管角色和责任的重要步骤。成立于2017年4月的农业和农村繁荣跨部门工作组建议采取更多步骤进一步促进农业生物技术产品的监管框架的现代化进程，以促进创新，确保监管机构之间取得协调，并使美国及世界几十亿人安全地获得这些产品的裨益。下面的指示旨在实施这些建议。

第2节 定义。

对于本命令而言，“农业生物技术产品”一词指的是，一种植物或动物，或者通过基因工程或通过从体内或体外操纵目标遗传信息所创制的一种植物或动物产品；但排除非农业目的的植物或动物产品，如为药品生产或工业化合物所创制的植物或动物及其产品除外。

第3节 政策。

联邦政府的政策是通过对不同农业生物技术产品采取相应的监管方法来保护公共健康和环境，这些各种类型的监管方法将对这些产品构成的风险作出相应的反应，从而避免对通过不同技术开发的类似产品作出武断或无理的区别对待。任何农业生物技术产品的监管制度都应确保公众对监督此类产品的信心，并促进未来的创新和竞争力。为了支持这些目标，联邦政府应：

(a)根据科学和技术证据作出监管决定，并同时考虑法律的符合性和适用性，及经济因素；

(b)及时有效地审查农业生物技术产品的监管申请；

(c)确保在法律允许的范围内，农业生物技术产品管制的透明度、可预测性和一致性；

(d)根据法律的适当和符合性原则制定规章和指导意见，制定意见的程序和过程需要向公众提供公平的知情权，并允许公众参与规章的制定；

(e)根据与产品及其预期最终用途有关的风险作出监管决定；

(f)促进农业生物技术产品的贸易，敦促贸易伙伴采用以科学和风险为基础的监管办法。

第4节 监管机构的精简。

农业部长、环境保护署署长及食品和药物管理局局长，在符合法律范围内及本命令前述第3条所设原则的情况下，须：

(a)本命令发布之日起180天内， 确定职责范围内可简化的有关规定和指导文档，以确保农业生物技术产品按照本命令第三节所设政策受到监管，并采取适当和必要的步骤来完成这样的简化；

(b)酌情利用现有的法定权力，在适用的情况下，使农业生物技术的低风险产品免受不适当的过度管制。

第5节 统一的生物技术网络平台。

确保创新者可以很容易地浏览农业生物技术产品的监管体系，农业部、环境保护局和食品和药物管理局 (以上并称“机构”)， 应当在本命令发布之日起180天内， 共同设计建立一个网络平台计划，包含并提供有关美国政府监管信息的链接。本网络平台允许农业生物技术的产品研发者提交针对某一特定产品的询问，并及时收到机构单份且一致的回应；该回应内容应包含切实可行的指导信息，必要的时候还需提供关于研发者必须遵循联邦监管审查流程的非正式指导建议。该网络平台应由农业部提供建设资金，其他机构提供支持，在符合适用法律的范围内，并在现有拨款范围内，通过适当的机构间协议，包括《经济法》下的协议提供资金。

第6节 当前授权力、法规和指引等审查。

(a) 每一机构应酌情审查其可适用于基因组编辑的特性作物-植物产品的规章和指导，这些产品是被设计具有显著健康、农业或环境效益，特别是可能使农村社区显著受益的产品。根据评估的结果，每个机构应当采取措施来更新其规定和指导，在必要和适当时，去除那些过度阻碍小型或私人的美国研发者、美国政府和学术机构将创新和安全基因编辑特性农作物产品带入市场的障碍。

(b) 本命令发布之日起的2年时间内，每隔90天，每个机构应当向管理和预算办公室主任、科技政策办公室主任、经济政策总统助理和国内政策总统助理提供一份关于本命令的第6节执行情况的更新。

第7节 国内参与。

(a) 在本命令发布之日起180天内, 由农业部长协调环保署长、食品药品监督局长以及农业部长认为适合的任何其他行政官员, 制定一项促进消费者参与的行动计划，以建立公众对在农业和食品中使用安全生物技术体系的信心和可接纳性。

(b)在制定本节 (a) 款所述计划时, 应考虑以下因素：支持关于高效科学交流的研究和教育；编写农业生物技术纳入科学教育的科普材料；创建面向消费者的网页内容；编写共他延伸性材料以明确宣传农业生物技术已展现的益处、监管体系安全记录以及生物技术如何解决农业挑战。该战略应考虑到正在进行中的“农业生物技术教育和延伸倡议”工作，此项工作旨在召集食品和药物管理局、农业部共同承担关于农业生物技术以及该技术衍生出的食品、动物饲料成份的公众教育和延伸教育。作为这一战略的一部分, 农业部长应与国家领导人在公共健康和农业领域进行协调。

第8节 国际推广。

在本命令发布之日起120天内, 农业部长和国务卿，应与美国贸易代表、环保署长、食品药品监督管理局局长和农业部长认为适当的任何其他行政官员协商，制定一项国际传播和对外交流战略，以促进境外决策者、消费者、行业和其他利益相关方的参与。该战略的目标是提高国际社会对农业生物技术产品的接受程度, 以便打开并维持美国农业的出口市场。

第9节 国际贸易的策略。

本命令发布之日起120天内，美国贸易代表与国务卿、农业部长及贸易政策工作组委员会协商，制定一项国际战略，以消除不公平的贸易壁垒并扩大农业生物技术产品市场。

第10节 一般规定。

（a）本命令的任何内容不得解释为损害或以其他方式影响：

（i）法律赋予执行部门、机构或其负责人的权力; 或

（ii）管理办公室主任的职能，以及与预算、行政和立法相关的经费。

（b）本命令应在符合适用法律的情况下并在有拨款的情况下执行。

（c）本命令无意也不涉及任何一方针对美国、其部门、机构或实体企业、其官员、雇员或代理人，或任何在现行普通法律上或衡平法上可强制执行的任何实质性或程序性的权利或利益。

唐纳德•特朗普

                                                                                 白宫

2019年6月11日

Executive Order on Modernizing the Regulatory Framework forAgricultural Biotechnology Products

 LAND& AGRICULTURE

 Issued on: June11, 2019

By the authority vested in me as President by theConstitution and the laws of the United States of America, and in order toconduct Federal oversight of agricultural biotechnology products that isscience-based, timely, efficient, and transparent, it is hereby ordered asfollows:

Section 1.  Purpose.  Recent advances in biotechnologyhave the potential to revolutionize agriculture and thereby enhance ruralprosperity and improve the quality of American lives.  Biotechnology canhelp the Nation meet its food production needs, raise the productivity of theAmerican farmer, improve crop and animal characteristics, increase thenutritional value of crop and animal products, and enhance food safety. In order to realize these potential benefits, however, the United Statesmust employ a science-based regulatory system that evaluates products based onhuman health and safety and potential benefits and risks to the environment.  Sucha system must both foster public confidence in biotechnology and avoid undueregulatory burdens.

The September 2016 National Strategy for Modernizing theRegulatory System for Biotechnology Products (National Strategy) and theJanuary 2017 Update to the Coordinated Framework for the Regulation ofBiotechnology (Coordinated Framework) were important steps in clarifyingFederal regulatory roles and responsibilities with respect to agriculturalbiotechnology.  The Agriculture and Rural Prosperity Task Force establishedin April 2017 recommended additional steps to further modernize the regulatoryframework for agricultural biotechnology products so as to facilitateinnovation, ensure coordination across regulatory agencies, and safely enablebillions of people across America and the world to reap the benefits of suchproducts.  The directives below are intended to implement thoserecommendations.

Sec. 2.  Definition.  For the purposes of this order,the term “product of agricultural biotechnology” refers to a plant or animal,or a product of such a plant or animal, developed through genetic engineeringor through the targeted in vivo or in vitro manipulation of geneticinformation, with the exception of plants or animals, or the products thereof,developed for non agricultural purposes, such as to produce pharmaceutical orindustrial compounds.

Sec. 3.  Policy.  It is the policy of the FederalGovernment to protect public health and the environment by adopting regulatoryapproaches for the products of agricultural biotechnology that areproportionate responses to the risks such products pose, and that avoidarbitrary or unjustifiable distinctions across like products developed throughdifferent technologies.  Any regulatory regime for products ofagricultural biotechnology should ensure public confidence in the oversight ofsuch products and also promote future innovation and competitiveness.  Tosupport these goals, the Federal Government shall:

(a)  base regulatory decisions on scientific and technicalevidence, and take into account, as appropriate and consistent with applicablelaw, economic factors;

(b)  review regulatory applications for products ofagricultural biotechnology in a timely and efficient manner;

(c)  ensure the transparency, predictability, andconsistency of the regulation of products of agricultural biotechnology, to theextent permitted by law;

(d)  as appropriate and consistent with applicable law,develop regulations and guidance through processes that provide fair notice tothe public and allow for its participation;

(e)  make regulatory determinations based on risksassociated with the product and its intended end use; and

(f)  promote trade in products of agriculturalbiotechnology by urging trading partners to adopt science- and risk-basedregulatory approaches.

Sec. 4.  Regulatory Streamlining.  The Secretary ofAgriculture (Secretary), the Administrator of the Environmental ProtectionAgency (Administrator), and the Commissioner of Food and Drugs (Commissioner),to the extent consistent with law and the principles set forth in section 3 ofthis order, shall:

(a)  within 180 days of the date of this order, identifyrelevant regulations and guidance documents within their respective jurisdictionsthat can be streamlined to ensure that products of agricultural biotechnologyare regulated in accordance with the policy set forth in section 3 of thisorder and take the steps appropriate and necessary to accomplish suchstreamlining; and

(b)  use existing statutory authority, as appropriate, toexempt low-risk products of agricultural biotechnology from undue regulation.

Sec. 5.  Unified Biotechnology Web-based Platform.  Toensure that innovators can easily navigate the regulatory system for productsof agricultural biotechnology, the Department of Agriculture, the EnvironmentalProtection Agency, and the Food and Drug Administration (collectively, the“agencies”) shall, within 180 days of the date of this order, work together todesign a plan to establish a web-based platform that contains and provideslinks to relevant United States Government regulatory information.  Thisweb-based platform shall allow developers of products of agriculturalbiotechnology to submit inquiries about a particular product and promptlyreceive from the agencies a single, coordinated response that provides, to theextent practicable, information and, when appropriate, informal guidanceregarding the process that the developers must follow for Federal regulatoryreview.  The web-based platform shall be funded by the Department ofAgriculture, with the other agencies providing support, to the extentconsistent with applicable law and within existing appropriations, throughappropriate interagency agreements, including agreements under the Economy Act.

Sec. 6.  Review of Current Authorities, Regulations, andGuidance.  (a)  Each of the agencies shall, as appropriate, conduct areview of its regulations and guidance that may apply togenome-edited-specialty-crop-plant products designed to have significanthealth, agricultural, or environmental benefits, in particular those that arelikely to benefit rural communities significantly.  Based on the findingsof its review, each of the agencies shall take steps to update its regulationsand guidance, as necessary and appropriate, to remove undue barriers thatimpede small, private United States developers, the United States Government,and academic institutions from bringing innovative and safegenome-edited-specialty-crop-plant products to the marketplace.

(b)  Every 90 days after the date of this order, for aperiod of 2 years, each of the agencies shall provide an update regarding itsprogress in implementing section 6 of this order to the Director of the Officeof Management and Budget, the Director of the Office of Science and TechnologyPolicy, the Assistant to the President for Economic Policy, and the Assistantto the President for Domestic Policy.

Sec. 7.  Domestic Engagement Strategy.  (a) Within 180 days of the date of this order, the Secretary, in coordinationwith the Administrator, the Commissioner, and any other Administrationofficials that the Secretary deems appropriate, shall develop an action plan tofacilitate engagement with consumers in order to build public confidence in,and acceptance of, the use of safe biotechnology in agriculture and the foodsystem.

(b)  In developing the plan described in subsection (a) of this section, the following shall be considered:  supportingresearch and education on effective science communication; developingeducational materials that integrate agricultural biotechnology into scienceeducation; creating consumer-facing web content; and developing other outreachmaterials that clearly communicate the demonstrated benefits of agriculturalbiotechnology, the safety record of the regulatory system, and howbiotechnology can address agricultural challenges.  The strategy shalltake into account the ongoing work of the Agricultural Biotechnology Educationand Outreach Initiative, which calls on the Food and Drug Administration towork with the Department of Agriculture to conduct public education andoutreach on agricultural biotechnology and food and animal-feed ingredientsderived from such technology.  The Secretary shall coordinate with Stateleaders in the fields of public health and agriculture as part of thisstrategy.

Sec. 8.  International Outreach.  Within 120 days ofthe date of this order, the Secretary and the Secretary of State (collectively,the “Secretaries”), in consultation with the United States TradeRepresentative, the Administrator, the Commissioner, and any otherAdministration officials that the Secretaries deem appropriate, shall developan international communications and outreach strategy to facilitate engagementabroad with policymakers, consumers, industry, and other stakeholders. The goal of the strategy shall be to increase international acceptance ofproducts of agricultural biotechnology in order to open and maintain marketsfor United States agricultural exports abroad.

Sec. 9.  International Trade Strategy.  Within 120days of the date of this order, the United States Trade Representative, inconsultation with the Secretaries and the Trade Policy Staff Committee, shalldevelop an international strategy to remove unjustified trade barriers andexpand markets for products of agricultural biotechnology.

Sec. 10.  General Provisions.  (a)  Nothing inthis order shall be construed to impair or otherwise affect:

(i)   the authority granted by law to an executive department,agency, or the head thereof; or

(ii)  the functions of the Director of the Office ofManagement and Budget relating to budgetary, administrative, or legislativeproposals.

(b)  This order shall be implemented consistent withapplicable law and subject to the availability of appropriations.

(c)  This order is not intended to, and does not, createany right or benefit, substantive or procedural, enforceable at law or inequity by any party against the United States, its departments, agencies, or entities,its officers, employees, or agents, or any other person.

DONALD J.TRUMP

THE WHITEHOUSE,
June 11, 2019.

（来源：国科农研院）