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March 22, 2024
Gene-Edited Plants: Regulation and Issues for Congress
Plant biotechnology, which includes gene editing and
established agency-specific regulations and policy
genetic engineering, allows a more precise and efficient
documents outlining its regulatory approach to agricultural
method for developing desirable traits in crops than
biotechnology products and emphasizing safety evaluation
conventional breeding methods that rely on natural genetic
based on product characteristics rather than the process
variation. Gene editing techniques offer the potential to
used to develop them.
modify specific genes in plants without introducing foreign
genes as other methods of genetic engineering may. Gene-
Figure 1. Primary Legislative Authorities of Federal
edited plants are regulated under the U.S. Coordinated
Regulation of Agricultural Biotechnology
Framework for Regulation of Biotechnology. The
framework coordinates how different agencies regulate
biotechnology products aiming to ensure their safety. It
involves three federal agencies—the U.S. Department of
Agriculture (USDA), the Food and Drug Administration
(FDA), and the Environmental Protection Agency (EPA).
Over time, the three agencies have been directed by
Executive Orders (E.O.s) to update their regulatory
approaches to promote innovation in biotechnology and to
protect human health and the environment. Potential
congressional concerns could include examining whether
current policies appropriately weigh the potential risks and
rewards of new plant varieties developed using gene editing
and whether regulatory agencies are efficiently coordinating
their efforts.
Background
Genetic engineering in agriculture involves the use of
recombinant DNA technology to introduce specific genes
Source: CRS.
or genetic material into an organism’s genome. This
Notes: The Coordinated Framework incorporates provisions in
process allows scientists to add to target organisms desired
statutes beyond the primary statutes identified in this figure.
traits that may not be achievable through conventional
breeding methods. Genetically engineered (GE) crops, also
USDA Oversight
known as genetically modified (GM) crops, may carry
USDA’s Animal and Plant Health Inspection Service
desired characteristics, such as pest and herbicide
(APHIS) is responsible for protecting U.S. agriculture from
resistance, and improved nutritional content. The
pests and diseases, and it regulates the importation,
commercialization of GE crops began in the 1990s. In the
interstate movement, and field testing of gene-edited
mid-2010s, gene editing tools like CRISPR-Cas9 used on
organisms. These authorities were established primarily by
plants entered agriculture, offering more precise and
the Plant Protection Act (7 U.S.C. §§7701 et seq.), Animal
advanced methods for genetic modification. Gene editing
Health Protection Act (7 U.S.C. §§8301 et seq.), and Virus-
allows targeted modifications of specific genes in plants to
Serum-Toxin Act (21 U.S.C. §§151 et seq.). In 2018,
improve agronomic traits, such as yield, nutritional value,
APHIS introduced the SECURE Rule (85 Federal Register
and disease resistance, without introducing foreign genes.
29790), which revised regulations for certain gene-edited
Six gene-edited crop traits are approved for
and GE plants. Fully implemented in 2021, the rule
commercialization in the United States, including in
exempts some plants from regulatory review, while others
soybean, canola, rice, maize, mushroom, and camelina.
require review and permitting. Regulatory exemptions
Regulation and Oversight of Gene
apply to categories of modified plants that could have been
Editing in Plants
developed through conventional breeding techniques and
thus are deemed unlikely to pose an increased plant pest
The regulation and oversight of gene editing in plants in the
risk compared to conventionally bred plants. Plants that
United States is facilitated by the U.S. Coordinated
were previously reviewed and deemed by APHIS to be low-
Framework for Regulation of Biotechnology. USDA, FDA,
risk plant-trait-mechanism of action combinations are also
and EPA (Figure 1) collectively regulate the marketing and
exempt from the regulations.
environmental release of gene-edited products. The
framework relies on statutes predating newer types of
In addition to the exemptions above, in November 2023,
biotechnology, such as gene editing. Each agency has
APHIS proposed five new exemptions for plants with
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Gene-Edited Plants: Regulation and Issues for Congress
modifications achievable through conventional breeding
some of their regulations or other policy documents. The
(88 Federal Register 78285). These include modifications
most recent changes occurred amid a broader debate about
such as loss-of-function changes, deletions on
how the federal government should manage its roles in the
chromosomes, multiple simultaneous or sequential
biotechnology context, including those to protect
modifications, and certain modifications to plants
consumers from risk and to support businesses and
previously confirmed exempt through voluntary review.
innovation. Some stakeholders, including some scientists
Developers uncertain whether their plants qualify for an
and in industry, have called for updates to federal
exemption can request a determination from APHIS.
biotechnology regulations in light of scientific advances.
APHIS asserts that these new regulations align with
Some stakeholders claim that because gene editing allows
advancing technology and scientific understanding and
genetic changes in a more targeted way than the
facilitate innovation in agriculture while maintaining
biotechnology approaches available when the Coordinated
stringent safety standards. The period for public comments
Framework was designed, the newer methods should not
closed in December 2023, and APHIS has not announced
require the same regulatory scrutiny as products developed
its next steps.
through less-targeted techniques. Other stakeholders,
including consumer and environmental groups and other
FDA Oversight
scientists, assert that all biotechnology products may
FDA’s authority to oversee gene-edited plants intended for
present new risks, and unintended consequences, and
human or animal consumption comes from the Federal
should therefore be strictly or more strictly regulated.
Food, Drug, and Cosmetic Act (21 U.S.C. §§301 et seq.)
and the Public Health Service Act (42 U.S.C. §§201 et
In June 2019, the Trump Administration issued E.O. 13874,
seq.). New gene-edited plant varieties may undergo
“Modernizing the Regulatory Framework for Agricultural
evaluation for potential impact on food allergenicity,
Biotechnology Products” (84 Federal Register 27899). The
toxicity, and nutritional composition.
order called for USDA, FDA, and EPA to collaborate in
modernizing regulations for agricultural biotechnology
In February 2024, FDA issued new guidance for industry
products. It also required a review of existing policies and
on voluntary engagement before marketing food from gene-
regulations, identification of areas for streamlining
edited plants, aiming to clarify its policy toward such foods.
according to the E.O.’s guidance, implementation of
FDA stated that it reaffirms applying a risk-based approach
changes, and appropriate exemptions for low-risk products.
to foods from gene-edited plants, irrespective of the
In September 2022, the Biden Administration issued E.O.
development method, and that it focuses on objective
14081, “Advancing Biotechnology and Biomanufacturing
characteristics of the food and the intended use of the food
Innovation for a Sustainable, Safe, and Secure American
(or its components). The guidance also outlines two
Bioeconomy” (87 Federal Register 56849). This order
processes through which the industry may voluntarily
instructed the agencies to further improve the clarity and
inform the FDA of the steps they have taken to ensure the
efficiency of regulatory processes for biotechnology
safety of foods from their gene-edited plant varieties:
products and to increase coordination and communication
voluntary premarket consultations and voluntary premarket
among the federal regulatory agencies. The order aimed to
meetings. FDA asserted that these processes would help
streamline regulations to promote research, enhance
ease the pathway to market for foods from gene-edited
biosecurity, and stimulate economic growth. According to
plants while keeping FDA safeguards in place.
APHIS, its actions, such as proposals for additional
exemptions for five new categories of plants, align with the
EPA Oversight
goals of E.O. 14081. Similarly, FDA’s clarification of
EPA’s authority comes from the Federal Insecticide,
guidance for industry on voluntary engagement before
Fungicide, and Rodenticide Act (FIFRA; 7 U.S.C. §§136 et
marketing food from gene-edited plants is designed to align
seq.) and Section 408 of the Federal Food, Drug, and
with E.O. 14081. Additionally, according to EPA, the
Cosmetic Act (21 U.S.C. §346a). Under FIFRA, the EPA
changes to regulations regarding PIPs align regulations with
can register a pesticidal substance if it deems that it is
advancing technology and scientific understanding, as
effective and does not cause unreasonable adverse effects
directed by E.O. 14081.
on the environment. This involves regulating plant-
incorporated protectants (PIPs) and setting tolerances or
Options for Congress include examining how executive
exemptions for pesticidal substances in or on food.
branch efforts weigh the risks and potential rewards of new
Typically, because EPA regulates biotechnology products
plant varieties developed using gene editing. Members
for pesticidal purposes, it does not regulate gene-edited
might consider whether USDA, FDA, and EPA are
plants unless traits synthesize specific chemicals.
effectively implementing this approach and whether the
efforts of the agencies would benefit from additional
In May 2023, EPA issued a final rule (88 C.F.R. §§34756 et
congressional direction or amended authorities.
seq.) exempting certain categories of PIPs from registration
requirements under FIFRA. EPA intends to consider
Eleni G. Bickell, Analyst in Agricultural Policy
expanding exemptions as biotechnology advances.
IF12618
Changes to the Coordinated Framework for
Regulation of Biotechnology
The three agencies that oversee agricultural products
produced with biotechnology have periodically revised
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Gene-Edited Plants: Regulation and Issues for Congress
Disclaimer
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to
congressional committees and Members of Congress. It operates solely at the behest of and under the direction of Congress.
Information in a CRS Report should not be relied upon for purposes other than public understanding of information that has
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