[Federal Register Volume 84, Number 115 (Friday, June 14, 2019)]
[Presidential Documents]
[Pages 27899-27902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12802]



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Vol. 84

Friday,

No. 115

June 14, 2019

Part III





The President





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Executive Order 13874--Modernizing the Regulatory Framework for 
Agricultural Biotechnology Products
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                         Presidential Documents 
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  Federal Register / Vol. 84 , No. 115 / Friday, June 14, 2019 / 
Presidential Documents  

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 Title 3--
 The President

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                Executive Order 13874 of June 11, 2019

                
Modernizing the Regulatory Framework for 
                Agricultural Biotechnology Products

                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;

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                    (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.

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                    (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.

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                    (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.
                
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    June 11, 2019.

[FR Doc. 2019-12802
Filed 6-13-19; 11:15 am]
Billing code 3295-F9-P