美国关于农业生物技术产品监管框架现代化的总统令

2019-06-17 编辑:Traveler 来源:THE WHITE HOUSE
关于农业生物技术产品监管框架现代化的行政命令
Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products
——土地与农业
发布于:2019年6月11日

根据宪法和美利坚合众国法律授予总统的权力,为了对以科学为基础的农业生物技术产品进行及时、有效、透明的联邦监督,现命令如下:

第1节 目的
最新的生物技术的发展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,美国必须采用一种以科学为基础的监管体系,根据人类健康和安全、潜在的利益以及对环境的风险等方面来评估产品。这种制度必须既能增强公众对生物技术的信心,又能避免不必要的监管负担。
2016年9月国家生物技术产品监管体系现代化战略(国家战略)和2017年1月生物技术监管协调框架的更新(协调框架)是明确联邦政府在农业生物技术监管方面的作用和责任的重要步骤。2017年4月成立的农业和农村繁荣工作组建议采取进一步措施,进一步实现农业生物技术产品监管框架的现代化,以促进创新,确保各监管机构之间的协调,并安全地使全美和全世界的数十亿人能够从这类产品的好处中获得收益。以下指令旨在执行这些建议。

第2节 定义
就本命令而言,“农业生物技术产品”的概念是指,通过基因工程或通过对遗传信息进行有针对性的体内或体外操作而开发的植物或动物,或这种植物或动物的产品,此中不包括为非农业目的而开发的植物或动物或其产品,例如用于生产药物或工业化合物。

第3节 政策 
联邦政府的政策是通过对农业生物技术产品进行监管的方式来保护公众健康和环境,对这些产品可能带来的风险的作出合理反应,并避免对通过不同技术开发出的类似产品之间作出武断或不合理的区分。农业生物技术产品的任何监管制度都应确保公众对监督此类产品的信心,以提高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管制决定,并酌情考虑到符合适用法律的经济因素;
(b)及时有效地审查农业生物技术产品的管制申请;
(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)在适当和符合适用法律的情况下,通过向公众提供公平通知并允许其参与的程序,制定规章和指导;
(e)根据与产品及其预期最终用途有关的风险作出规管决定;和
(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管制办法。

第4节 精简监管
农业部长(秘书)、环境保护局局长(局长)及食物及药物监理专员(专员),在符合法例及本命令第3条所载原则的情况下,须:
(a)在本命令发出之日起180天内,在其各自管辖范围内确定相关法规和指导文件,可采取适当并必要的方式来简化对农业生物技术监管,但应确保其管理符合本命令第3节规定的原则;和
(b)酌情利用现有法定权力,使通过利用农业生物技术产生的低风险产品免受不当管制。

第5节 统一生物技术网络监管平台
为确保创新者能够轻松了解农业生物技术产品的监管体系,农业部、环境保护局和食品药品管理局(统称“机构”)应在此日期后180天内,共同制定计划并建立一个网络平台,其中包含并提供相关美国政府监管信息的链接。本网络平台应允许农业生物技术产品的开发者提交有关特定产品的查询请求,并迅速收到通过各机构协调后的统一回复,各机构在可行的范围内提供信息,并在适当时提供有关该过程的非正式指导,开发者必须遵循联邦监管审查。 本网络平台应由农业部资助,其他机构也可提供资金支持,但应在合规范围现有拨款范围内,通过适当的机构间协议,包括《经济法》下的协议,进行此类活动。

第6节 审查当前授权、法规和指导文件
(a)每个机构应酌情审查可能适用于基因组编辑的特殊作物、植物产品的规章和指导文件,这些产品应对人类健康健康,农业或环境有重大效益,特别是那些可能会使农村社区受益匪浅的产品。根据其审查结果,每个机构应采取具体措施,在必要和适当的情况下更新其规章和指导文件,以消除妨碍美国私人开发商,美国政府和学术机构的不当障碍,并带来一个创新和安全的基因组编辑特殊作物植物产品市场。
(b)本命令发出之日起2年内,每90天,每个机构应向管理和预算办公室主任、科学和技术政策办公室主任、经济政策总统助理和国内政策总统助理提供关于其执行本命令第6节进展的最新情况。

第7节 国内参与战略
(a)在本命令发出之日起180天内,秘书应与署长、专员和秘书讨论,并适当与其他主管部门官员协调,制定一行动计划,促进与消费者的交流,以便建立公众对在农业和食品领域中使用安全生物技术的信心和接受程度。
(b)在制定本节(a)小节所述的计划时,应考虑以下方面:支持有效的科学传播和教育研究;开发将农业生物技术纳入科学教育的教材;创建面向消费者的网页内容;开发其他宣传材料,清楚地传达已经证明的农业生物技术的好处、监管系统的安全记录以及生物技术如何应对农业挑战的策略内容。策略应当考虑到正在进行的农业生物技术教育和宣传工作计划,这要求美国食品和药物管理局与农业部合作,开展公共教育和外联农业生物技术活动,并利用这种技术开发食品和动物饲料原料。作为该策略的一部分,秘书应与公共卫生和农业领域的国家领导人协调。

第8节 国际推广
在本命令发出之日起120天内,秘书和国务卿(统称“秘书”)与美国贸易代表、局长、专员以及秘书认为的任何其他政府官员进行适当协商,并制定国际交流和外联战略,以促进政策制定者、消费者、行业和其他利益相关者的海外参与。该战略的目标应是提高国际上对农业生物技术产品的接受程度,以便扩大和维持出口至国外的美国农产品市场。

第9节 国际贸易战略
在本命令发布之日起120天内,美国贸易代表、秘书和贸易政策工作人员委员会共同协商,制定一项国际战略,旨在消除不合理的贸易壁垒,扩大农业生物技术产品的市场。

第10节 一般规定
(a)本命令的任何内容均不得解释为损害或以其他方式影响:
(i)法律授予执行部门、机构或其负责人的权力;或
(ii)管理和预算办公室主任与预算、行政或立法提案有关的职能。
(b)本命令的适用应符合法律法规,并视具体拨款情况而定。
(c)本命令无意创设任何对美国、其部门、机构或实体、其官员、雇员或代理人或任何其他人在法律上或衡平法上可强制执行的权利或利益,无论是实质性的还是程序性的。

DONALD J. TRUMP
白宫
2019年6月11日

(华中农业大学文法学院冯冠南翻译)

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附:英文原文

EXECUTIVE ORDERS
Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products
 LAND & AGRICULTURE
 Issued on: June 11, 2019
 
By the authority vested in me as President by the Constitution and the laws of the United States of America, and in order to conduct Federal oversight of agricultural biotechnology products that is science-based, timely, efficient, and transparent, it is hereby ordered as follows:

Section 1.  Purpose.  Recent advances in biotechnology have the potential to revolutionize agriculture and thereby enhance rural prosperity and improve the quality of American lives.  Biotechnology can help the Nation meet its food production needs, raise the productivity of the American farmer, improve crop and animal characteristics, increase the nutritional value of crop and animal products, and enhance food safety.  In order to realize these potential benefits, however, the United States must employ a science-based regulatory system that evaluates products based on human health and safety and potential benefits and risks to the environment.  Such a system must both foster public confidence in biotechnology and avoid undue regulatory burdens.
The September 2016 National Strategy for Modernizing the Regulatory System for Biotechnology Products (National Strategy) and the January 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) were important steps in clarifying Federal regulatory roles and responsibilities with respect to agricultural biotechnology.  The Agriculture and Rural Prosperity Task Force established in April 2017 recommended additional steps to further modernize the regulatory framework for agricultural biotechnology products so as to facilitate innovation, ensure coordination across regulatory agencies, and safely enable billions of people across America and the world to reap the benefits of such products.  The directives below are intended to implement those recommendations.

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 engineering or through the targeted in vivo or in vitro manipulation of genetic information, with the exception of plants or animals, or the products thereof, developed for non agricultural purposes, such as to produce pharmaceutical or industrial compounds.

Sec. 3.  Policy.  It is the policy of the Federal Government to protect public health and the environment by adopting regulatory approaches for the products of agricultural biotechnology that are proportionate responses to the risks such products pose, and that avoid arbitrary or unjustifiable distinctions across like products developed through different technologies.  Any regulatory regime for products of agricultural biotechnology should ensure public confidence in the oversight of such products and also promote future innovation and competitiveness.  To support these goals, the Federal Government shall:
(a)  base regulatory decisions on scientific and technical evidence, and take into account, as appropriate and consistent with applicable law, economic factors;
(b)  review regulatory applications for products of agricultural biotechnology in a timely and efficient manner;
(c)  ensure the transparency, predictability, and consistency of the regulation of products of agricultural biotechnology, to the extent permitted by law;
(d)  as appropriate and consistent with applicable law, develop regulations and guidance through processes that provide fair notice to the public and allow for its participation;
(e)  make regulatory determinations based on risks associated with the product and its intended end use; and
(f)  promote trade in products of agricultural biotechnology by urging trading partners to adopt science- and risk-based regulatory approaches.

Sec. 4.  Regulatory Streamlining.  The Secretary of Agriculture (Secretary), the Administrator of the Environmental Protection Agency (Administrator), and the Commissioner of Food and Drugs (Commissioner), to the extent consistent with law and the principles set forth in section 3 of this order, shall:
(a)  within 180 days of the date of this order, identify relevant regulations and guidance documents within their respective jurisdictions that can be streamlined to ensure that products of agricultural biotechnology are regulated in accordance with the policy set forth in section 3 of this order and take the steps appropriate and necessary to accomplish such streamlining; and
(b)  use existing statutory authority, as appropriate, to exempt low-risk products of agricultural biotechnology from undue regulation.

Sec. 5.  Unified Biotechnology Web-based Platform.  To ensure that innovators can easily navigate the regulatory system for products of agricultural biotechnology, the Department of Agriculture, the Environmental Protection Agency, and the Food and Drug Administration (collectively, the “agencies”) shall, within 180 days of the date of this order, work together to design a plan to establish a web-based platform that contains and provides links to relevant United States Government regulatory information.  This web-based platform shall allow developers of products of agricultural biotechnology to submit inquiries about a particular product and promptly receive from the agencies a single, coordinated response that provides, to the extent practicable, information and, when appropriate, informal guidance regarding the process that the developers must follow for Federal regulatory review.  The web-based platform shall be funded by the Department of Agriculture, with the other agencies providing support, to the extent consistent with applicable law and within existing appropriations, through appropriate interagency agreements, including agreements under the Economy Act.

Sec. 6.  Review of Current Authorities, Regulations, and Guidance.  (a)  Each of the agencies shall, as appropriate, conduct a review of its regulations and guidance that may apply to genome-edited-specialty-crop-plant products designed to have significant health, agricultural, or environmental benefits, in particular those that are likely to benefit rural communities significantly.  Based on the findings of its review, each of the agencies shall take steps to update its regulations and guidance, as necessary and appropriate, to remove undue barriers that impede small, private United States developers, the United States Government, and academic institutions from bringing innovative and safe genome-edited-specialty-crop-plant products to the marketplace.
(b)  Every 90 days after the date of this order, for a period of 2 years, each of the agencies shall provide an update regarding its progress in implementing section 6 of this order to the Director of the Office of Management and Budget, the Director of the Office of Science and Technology Policy, the Assistant to the President for Economic Policy, and the Assistant to the President for Domestic Policy.

Sec. 7.  Domestic Engagement Strategy.  (a)  Within 180 days of the date of this order, the Secretary, in coordination with the Administrator, the Commissioner, and any other Administration officials that the Secretary deems appropriate, shall develop an action plan to facilitate engagement with consumers in order to build public confidence in, and acceptance of, the use of safe biotechnology in agriculture and the food system.
(b)  In developing the plan described in subsection (a)  of this section, the following shall be considered:  supporting research and education on effective science communication; developing educational materials that integrate agricultural biotechnology into science education; creating consumer-facing web content; and developing other outreach materials that clearly communicate the demonstrated benefits of agricultural biotechnology, the safety record of the regulatory system, and how biotechnology can address agricultural challenges.  The strategy shall take into account the ongoing work of the Agricultural Biotechnology Education and Outreach Initiative, which calls on the Food and Drug Administration to work with the Department of Agriculture to conduct public education and outreach on agricultural biotechnology and food and animal-feed ingredients derived from such technology.  The Secretary shall coordinate with State leaders in the fields of public health and agriculture as part of this strategy.

Sec. 8.  International Outreach.  Within 120 days of the date of this order, the Secretary and the Secretary of State (collectively, the “Secretaries”), in consultation with the United States Trade Representative, the Administrator, the Commissioner, and any other Administration officials that the Secretaries deem appropriate, shall develop an international communications and outreach strategy to facilitate engagement abroad with policymakers, consumers, industry, and other stakeholders.  The goal of the strategy shall be to increase international acceptance of products of agricultural biotechnology in order to open and maintain markets for United States agricultural exports abroad.

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

Sec. 10.  General Provisions.  (a)  Nothing in this 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 of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b)  This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c)  This order 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.

DONALD J. TRUMP
THE WHITE HOUSE,
June 11, 2019.
 
 
原文来源:https://www.whitehouse.gov/presidential-actions/executive-order-modernizing-regulatory-framework-agricultural-biotechnology-products/