Modernizing the Regulatory Framework for Agricultural Biotechnology Products
| Published date | 14 June 2019 |
| Citation | 84 FR 27899 |
| Record Number | 2019-12802 |
| Section | Presidential Documents |
| Court | Executive Office Of The President |
Federal Register, Volume 84 Issue 115 (Friday, June 14, 2019)
[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]
[[Page 27897]]
Vol. 84
Friday,
No. 115
June 14, 2019
Part IIIThe President-----------------------------------------------------------------------
Executive Order 13874--Modernizing the Regulatory Framework for
Agricultural Biotechnology Products
Presidential Documents
Federal Register / Vol. 84 , No. 115 / Friday, June 14, 2019 /
Presidential Documents
___________________________________________________________________
Title 3--
The President
[[Page 27899]]
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;
[[Page 27900]]
(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.
[[Page 27901]]
(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.
[[Page 27902]]
(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
