Gene-Edited Plants: Regulation and Issues for Congress

Gene-Edited Plants: Regulation and Issues for Congress

Gene-Edited Plants: Regulation and Issues for
September 7, 2023
Congress
Eleni G. Bickell
Throughout history, farmers and plant breeders have employed selective breeding
Analyst in Agricultural
techniques to develop desirable traits in crops. This has involved crossing plants with
Policy
desired characteristics and selecting offspring with improved traits over successive

generations. While effective, conventional breeding techniques are time-consuming and
rely on naturally occurring genetic variation. Plant biotechnology, which includes gene

editing and genetic engineering, has introduced a way to integrate desired traits directly into a plant’s DNA.
The federal government’s 1986 Coordinated Framework for Regulation of Biotechnology outlines how
agricultural biotechnology products are regulated in the United States. The U.S. regulation and oversight of gene
editing in agriculture involve three federal agencies: the U.S. Department of Agriculture (USDA), the Food and
Drug Administration (FDA), and the Environmental Protection Agency (EPA). These agencies base their
evaluation of gene-edited products on the product’s characteristics and potential impacts on human health and the
environment. USDA’s Animal and Plant Health Inspection Service (APHIS) administers regulations on gene-
edited plants, particularly their importation, interstate movement, and field testing. In 2018, APHIS finalized the
Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule, which exempts certain
gene-edited plants from review based on their plant-pest risk. FDA oversees gene-edited plants intended for
human or animal consumption, evaluating their potential impact on food allergenicity, toxicity, and nutritional
composition. The agency generally does not require premarket review for gene-edited plants that closely resemble
their conventionally bred counterparts. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),
EPA regulates the pesticidal substance in a gene-edited plant and the genetic material used to produce the
pesticidal substance in the plant (i.e., plant-incorporated protectants or PIPs). FIFRA generally requires pesticides
subject to the act to be approved through a registration process before they may be commercially marketed. In
May 2023, EPA promulgated a final rule to exempt from the registration requirement two categories of PIPs that
the agency determined to pose little or no risk to human health and the environment. The EPA rule also
established recordkeeping requirements for certain exempted PIPs and a process for determining exemption
eligibility.
Public policy issues concerning gene editing in agriculture that could require congressional consideration are
multifaceted. Congress may examine whether federal labeling standards such as the National Bioengineered Food
Disclosure Standard (NBFDS) adequately address issues raised by gene-edited plants. Over time, the three
agencies that oversee agricultural products produced with biotechnology have been directed to update the Federal
regulatory system for the products of biotechnology and to establish mechanisms for periodic updates of that
system. Congress may review if the agencies are effectively coordinating with each other in their attempts to align
the regulations with the state of biotechnology developments and if the updates fulfill their mandates: to
accelerate innovation in plant biotechnology and to safeguard human health and the environment. Congress may
continue supporting research initiatives in gene editing to further explore agricultural applications. Some of the
possible future policy challenges regarding gene editing include managing different types of plants and other
gene-edited products as they are released into the environment; legal issues; and the impact of gene-edited plants
on ecosystems and biodiversity.
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Contents
Introduction ..................................................................................................................................... 1
U.S. Regulation and Oversight of Gene Editing in Plants ............................................................... 3
U.S. Department of Agriculture ................................................................................................ 4
Food and Drug Administration .................................................................................................. 5
Environmental Protection Agency ............................................................................................ 5
Attempts to Update Federal Biotechnology Regulation: Selected Chronology .............................. 6
International Regulation of Gene-Edited Plants .............................................................................. 8
Perspectives on Regulating Gene Editing as Genetic Engineering ........................................... 9
Issues Facing Congress ................................................................................................................. 10
Labeling Disclosure and Standards ......................................................................................... 10
Efficacy of Regulatory Updates .............................................................................................. 13
Differences in Regulation and Global Trade ........................................................................... 13
Research Investments in Gene Editing .................................................................................... 14
Off-Target Effects and Environmental Concerns .................................................................... 15

Figures
Figure 1. Plant Breeding Techniques ............................................................................................... 2
Figure 2. Primary Legislative Authorities of Federal Regulation of Biotechnology ....................... 3
Figure 3. The SECURE Rule Process ............................................................................................. 4
Figure 4. Disclosure Symbols of the Standard ............................................................................... 11

Contacts
Author Information ........................................................................................................................ 16

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Gene-Edited Plants: Regulation and Issues for Congress

Introduction
Over the past century, plant breeding in U.S. agriculture has experienced major transformation,
progressing from conventional plant propagation techniques to the more accelerated techniques of
gene editing. Although capable of producing significant advances, conventional plant breeding is
time-consuming and often limited by natural genetic variations.
One milestone in conventional agriculture was reached during the mid-20th century with the
advent of the Green Revolution.1 This agricultural breakthrough, reliant on mutagenesis and
selective breeding, increased crop productivity to combat global food shortages.2 It involved the
development and widespread adoption of high-yielding crop varieties, primarily focusing on
wheat, rice, and corn.3
In the 1980s, a new era in crop improvement emerged with the application of genetic engineering
techniques to agriculture, which became known as agricultural biotechnology. Agricultural
biotechnology uses both genetic engineering and conventional breeding methods to alter plants,
animals, microbes, and other organisms to improve agricultural productivity and address
challenges such as pests, diseases, and environmental conditions.4 Its main goals are to develop
agricultural products that are more resilient, productive, or nutritious. Genetic engineering in
agriculture involves the use of recombinant DNA5 technology to introduce specific genes or
genetic material into an organism’s genome. This process allows scientists to add desired traits to
the target organism, which may not be achievable through conventional breeding methods. It
typically involves identifying a trait of interest, locating the relevant gene, and then inserting the
gene into the host organism’s DNA which can be of a different species.6 This process has led to
the development of genetically engineered (GE) crops, also referred to as genetically modified
(GM) crops.7 Such crops can carry desired characteristics, such as pest and herbicide resistance,
as well as improved nutritional content. In 1994, the FlavrSavr® tomato became the first
genetically engineered food to enter the U.S. market, followed by genetically engineered cotton,

1 Mohd Fadhli Hamdan et al., “Green Revolution to Gene Revolution: Technological Advances in Agriculture to Feed
the World,” Plants, p. 1297, May 2022.
2 Selective breeding refers to the process by which humans choose specific plants or animals to reproduce based on
desired traits, with the goal of enhancing or strengthening these traits in future generations. For more details, see
“Selective breeding and genetics,” Britannica, last visited September 7, 2023. Mutagenesis is the process by which
genetic changes, or mutations, are introduced into an organism, either naturally or artificially. For more details, see
Justin Durland and Hamid Ahmadian-Moghadam, “Genetics, mutagenesis,” StatPearls Publishing, 2022.
3 Govindan Parayil, “Mapping Technological Trajectories of the Green Revolution and the Gene Revolution from
Modernization to Globalization,” Research Policy, pp. 971-990, June 2003.
4 For more information on Agricultural Biotechnology, see CRS Report R46737, Agricultural Biotechnology:
Overview, Regulation, and Selected Policy Issues.
5 DNA (deoxyribonucleic acid) is the molecule carrying genetic information for an organism's development and
function. It has a double helix structure with two strands made of sugar and phosphate. These strands are linked by
pairs of bases: adenine with thymine and cytosine with guanine. The sequence of these bases encodes biological
instructions, like making proteins. For more information, see National Human Genome Research Institute,
“Deoxyribonucleic Acid (DNA),” https://www.genome.gov/genetics-glossary/Deoxyribonucleic-Acid.
6 For more information on marker-assisted selection in plant breeding, see National Academies of Sciences,
Engineering and Medicine (NASEM), Genetically Engineered Crops: Experiences and Prospects, National Academies
Press, pp. 354-355, 2016.
7 For the purposes of this report, “Genetically Engineered or GE” products refer to all the products developed through
genetic engineering or biotechnology or the targeted or in vitro manipulation of genetic information of organisms,
including plants, animals, and microbes except those that have been gene-edited.
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soybeans, apples, pineapple, summer squash, and others. 8 In 2014, more than 90% of the corn,
cotton, and soybeans grown in the United States were genetically engineered.9
In the mid-2010s, gene editing (also called genome editing) tools, such as CRISPR-Cas9 were
introduced to agriculture in the United States.10 Gene editing in agriculture is a more precise and
advanced form of genetic engineering than the previous techniques.11 The use of gene editing
techniques on plants offers the potential to modify specific genes in plants, aiming to enhance
traits like disease resistance, yield, and nutritional value without introducing foreign genes into
the new products (Figure 1). Some commercially available food products developed using gene
editing are found in the United States, including high-oleic acid soybeans and a leafy green salad
mix.12
Figure 1. Plant Breeding Techniques
Source: CRS

8 FlavrSavr tomato, a genetically engineered tomato made to stay firm after harvest, was discontinued a few years later
and is not currently available in the U.S. market.
9 U.S. Department of Agriculture (USDA), Economic Research Service (ERS), “Adoption of Genetically Engineered
Crops in the U.S.,” September 14, 2022.
10 For more information on gene editing and CRISPR-Cas9, see CRS Report R44824, Advanced Gene Editing:
CRISPR-Cas9. Additionally, for a chronology of CRISPR development for gene editing, see Broad Institute, “CRISPR
Timeline,” at https://www.broadinstitute.org/what-broad/areas-focus/project-spotlight/crispr-timeline.
11 For more information, see Su Bin Moon et al., “Recent Advances in the CRISPR Genome Editing Tool Set,”
Experimental & Molecular Medicine, vol. 51, pp. 1-11, November 5, 2019.
12 For more information, see Calyxt, “First Commercial Sale of Calyxt High Oleic Soybean Oil on the U.S. Market,”
https://calyxt.com/first-commercial-sale-of-calyxt-high-oleic-soybean-oil-on-the-u-s-market/, February 2019 and
United States Food and Drug Administration (FDA), “High Oleic Soybean FAD2KO”, Biotechnology Notification File
No. 000164, February 2019, https://www.fda.gov/media/120708/download.Pairwise, “Pairwise Introduces Conscious™
Greens, into U.S. Restaurants,” May 2023, https://www.pairwise.com/news/pairwise-introduces-conscious-greens-into-
u.s.-restaurants.
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U.S. Regulation and Oversight of Gene Editing in
Plants
The U.S. regulation and oversight of gene editing in plants is facilitated by the Coordinated
Framework for Regulation of Biotechnology, which involves the U.S. Department of Agriculture
(USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency
(EPA) (Figure 2).13 The framework was established in 1986 by the Office of Science and
Technology Policy (OSTP) and outlines how the involved U.S. agencies apply their existing
statutory authority to evaluate and ensure that gene-edited products in the United States are safe.14
The premise of this regulatory approach is to focus on the characteristics and unique features of
the derived plants, the impacts on the environment in which they are introduced, and on human
health, rather than the process by which they are made. Thus, the regulations treat plants equally
regardless of whether they were derived through gene editing, genetic engineering, mutagenesis,
or selective breeding.15 This product-based evaluation contrasts with a process-based evaluation,
which focuses on the techniques and methods used to produce a plant.16
Figure 2. Primary Legislative Authorities of Federal Regulation of Biotechnology

Source: Figure created by CRS. See CRS Report R46737, Agricultural Biotechnology: Overview, Regulation, and
Selected Policy Issues.
Notes: The Coordinated Framework incorporates provisions in statutes beyond the primary statutes identified
in this figure.

13 White House, OSTP, “Coordinated Framework for Regulation of Biotechnology,” 51 Federal Register 23302, June
26, 1986.
14 For a compilation of information and resources about U.S. biotechnology regulation, see USDA, FDA, and EPA,
“The Unified Website for Biotechnology Regulation,” at https://usbiotechnologyregulation.mrp.usda.gov/
biotechnologygov/resources/faq/unified_biotech_faqs. Also, see CRS Report R47635, The White House Office of
Science and Technology Policy: Issues and Options for the 118th Congress.
15 For more information on the distinction of the process vs. product, see Giovanni Tagliabue, “Product, not process!
Explaining a basic concept in agricultural biotechnologies and food safety,” Life Sciences, Society and Policy 13, no. 1,
2017, pp. 1-9.
16 For more, see Elicia Maine, Sarah Lubik, and Elizabeth Garnsey, “Process-based vs. product-based innovation:
Value creation by nanotech ventures,” Technovation, pp.179-192, 2012.
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U.S. Department of Agriculture
The responsibility of regulating gene-edited plants primarily lies with USDA’s authority provided
by the Plant Protection Act (PPA, 7 U.S.C. §§ 7701 et seq.). USDA’s Animal and Plant Health
Inspection Service (APHIS) is responsible for protecting U.S. agriculture from pests and diseases
and it regulates the importation, interstate movement, and field testing of gene-edited plants and
organisms according to their plant-pest and noxious weed risk under the PPA,17 the Animal Health
Protection Act (7 U.S.C. §§ 8301 et seq.), and Virus-Serum-Toxin Act (21 U.S.C. §§ 151 et seq.).
In 2018, APHIS introduced the Sustainable, Ecological, Consistent, Uniform, Responsible,
Efficient (SECURE) Rule.18 The rule revised APHIS’s regulations governing certain gene-edited
plants19 (7 C.F.R. §340) and new genetically engineered plants.20 It exempts broad categories of
new plants from regulatory review based on APHIS’s current understanding of plant-pest risk,
provided they could have been produced through conventional breeding methods and that there
was no foreign genetic material incorporated from a plant pest or is intended for use as a plant
pest (Figure 3).21 If exempted, developers of gene-edited products can request a written
confirmation from APHIS that a plant is not subject to regulations (I). Plants that are not exempt
must undergo a regulatory status review (II), followed by a permitting process (III). The
SECURE rule was fully implemented in October 2021.22
Figure 3. The SECURE Rule Process

Source: CRS.

17 Plant-pest risk refers to the potential for injury, damage, or disease in any plant or plant product resulting from
introducing or disseminating a plant pest or the potential to exacerbate a plant pest’s impact. According to APHIS,
“The potential for direct or indirect injury to, damage to, or disease in any plant or plant product resulting from
introducing or disseminating a plant pest, or the potential for exacerbating the impact of a plant pest.”
18 In the context of the Coordinated Framework, if a gene-edited plant contains genetic material from a plant pest or if it
is intended for use as a plant pest, it falls under the purview of APHIS regulation as a genetically engineered organism.
This means that such plants would be subject to a more stringent regulatory process to assess their safety, potential
environmental impacts, and potential risks to agricultural systems.
19 APHIS, “Movement of Certain Genetically Engineered Organisms,” 85 Federal Register 29790-29838, August 17,
2020.
20 For additional background on the SECURE Rule, see CRS In Focus IF11573, USDA’s SECURE Rule to Regulate
Agricultural Biotechnology.
21 USDA APHIS, Final Rule, 85 Federal Register 29790, May 18, 2020.
22 For more information on the steps of the process under the SECURE rule, see Jochen Menz et al., “Genome Edited
Crops Touch the Market: A View on the Global Development and Regulatory Environment,” Frontiers in Plant
Science, vol. 11, no. 586027, October 9, 2020.
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Food and Drug Administration
FDA oversees gene-edited plants primarily under the Federal Food, Drug, and Cosmetic Act
(FFDCA, 21 U.S.C. §§ 301 et seq.) and the Public Health Service Act (PHSA, 42 U.S.C. §§ 201
et seq.). FDA regulates gene-edited plants that are intended for human or animal consumption,
based on food safety considerations. FDA also provides guidance on voluntary consultation for
developers to evaluate the safety of new plant varieties. New gene-edited plant varieties may be
evaluated by FDA for their potential impact on food allergenicity, toxicity, and nutritional
composition.23 Since its first consultation of a gene-edited product in 2019, none have been found
to contain a food additive and thus have not required FDA approval prior to marketing.24
Environmental Protection Agency
EPA regulates any pesticidal substance found in a gene-edited plant and the genetic material used
to produce the pesticidal substance in the plant (i.e., plant-incorporated protectants or PIPs). As
part of this regulation, EPA requires any PIP to be registered before the gene-edited plant that
contains the PIP can be commercially marketed. EPA’s authorities for regulating pesticidal
substances, including PIPs, are derived from the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA, 7 U.S.C. §§ 136 et seq.) and Section 408 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. § 346a). Under FIFRA, EPA may only register a pesticidal substance if the agency
determines that the pesticidal substance will perform its intended function and not generally cause
“unreasonable adverse effects on the environment” when used in accordance with the label.25 For
pesticidal substances that may be present in or on food, Section 408 of FFDCA requires EPA to
establish, through rulemaking, tolerances (i.e., maximum residue limits) or tolerance exemptions
for pesticidal substances. EPA initially proposed regulations for PIPs in the mid-1990s and
promulgated the final rule regulating PIPs in July 2001.26 EPA has also promulgated tolerance and
tolerance exemptions for PIPs, which are codified in 40 C.F.R. Part 174, Subpart W.
In July 2023, EPA promulgated a final rule to exempt two categories of PIPs from registration
requirements under FIFRA.27 The two categories of PIPs exempt from registration are (1) “PIPs
created through genetic engineering from a sexually compatible plant” and (2) “loss-of-function”
PIPs. The first category refers to PIPs created using genetic engineering (including gene editing)
in which a gene from a sexually compatible plant is either inserted into or used to modify the
genome of the recipient plant. The term “sexually compatible” is defined in regulation and means
that the plant from which genetic material was sourced and the recipient plant must be capable of
naturally interbreeding and producing viable offspring.28 In considering this exemption, EPA
found that “PIPs exempted through this rulemaking are equivalent to those that are created

23 For more information on FDA’s Plant Biotechnology Consultation Program, see FDA, “Consultation Programs on
Food from New Plant Varieties,” at https://www.fda.gov/food/food-new-plant-varieties/consultation-programs-food-
new-plant-varieties.
24 Under sections 201(s) and 409 of the Food, Drug, and Cosmetic Act, any substance that is intentionally added to
food is a food additive, and is therefore subject to premarket review and approval by FDA, unless the substance is
generally recognized, among qualified experts, as having been adequately shown to be safe.
25 7 U.S.C. § 136a(c)(5).
26 EPA, “Regulations under the Federal Insecticide, Fungicide, and Rodenticide Act for Plant-Incorporated Protectants
(Formerly Plant-Pesticides),” final rule, 66 Federal Register 37771-37817, July 11, 2001. The final rule amended 40
C.F.R. Part 152 (Pesticide Registration and Classification Procedures) and added 40 C.F.R. Part 174 (Procedures and
Requirements for Plant-Incorporated Protectants).
27 EPA, “Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived from Newer Technologies,”
88 Federal Register 34756-34779, May 31, 2023.
28 40 C.F.R. § 174.3.
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through conventional breeding,” which were already exempt from registration.29 Although PIPs in
this category are exempted from registration, the EPA rule establishes a process for determining
that a PIP is eligible for the exemption that may require the developer to submit data sufficient for
EPA to ensure that human dietary safety levels are not exceeded if the pesticidal substance is a
known allergen, toxin, or toxicant.30 Additionally, PIPs in this category are subject to certain
recordkeeping and adverse effects reporting requirements.31 The EPA rule also established a
tolerance exemption for PIPs in this category.32
Under the second category, the term “loss-of-function” refers to the reduction or elimination of a
gene’s usual activity, making the plant less attractive to pests or disrupting a pest’s ability to
exploit the plant in the context of PIPs.33 Instances in which the reduction or elimination of a
gene’s usual activity results in the intentional increase of another pesticidal gene are excluded
from the exemption. Similar to the first exemption, the EPA rule also establishes a process for
determining that a loss-of-function PIP is eligible for the exemption.34 Additionally, loss-of-
function is subject to certain recordkeeping and adverse effects reporting requirements.35
According to EPA, these exemptions are expected to reduce costs for the regulated community,
increase research and development activities and the commercialization of new pest control
options, and reduce the use of conventional pesticides.36 EPA also has stated that the rule is
consistent with Executive Order 14081 on advancing biotechnology, discussed below.37
Attempts to Update Federal Biotechnology
Regulation: Selected Chronology
The Coordinated Framework for Regulation of Biotechnology was established in 1986.38 Over
time, successive administrations have directed the responsible agencies to update their rules and
policies for regulating biotechnology products (also see “Efficacy of Regulatory Updates”).
Presented below is a selected chronology of the ongoing efforts to update the framework.
• In 1992, the Office of Science and Technology Policy (OSTP) issued an update
emphasizing a risk-based approach to overseeing biotechnology products.39 That

29 EPA, Cost Analysis for the Final Rule Exempting Certain Plant-Incorporated Protectants (PIPs) from Registration,
May 2023, https://www.regulations.gov/document/EPA-HQ-OPP-2019-0508-0125, p. 4.
30 40 C.F.R Part 174, Subpart E. See 40 C.F.R. § 174.95 for documentation that specifically applies to an exemption for
a PIP created through genetic engineering from a sexually compatible plant.
31 40 C.F.R. Part 174, Subpart D.
32 40 C.F.R. § 174.541.
33 40 C.F.R. § 174.3.
34 40 C.F.R Part 174, Subpart E. See 40 C.F.R. § 174.96 for documentation that specifically applies to an exemption for
a loss-of-function PIP.
35 40 C.F.R. Part 174, Subpart D.
36 EPA, “EPA Finalizes Rule to Accelerate Use of Plant-Incorporated Biotechnologies to Protect Against Pests,” May
25, 2023, https://www.epa.gov/pesticides/epa-finalizes-rule-accelerate-use-plant-incorporated-biotechnologies-protect-
against.
37 Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and
Secure American Bioeconomy,” 87 Federal Register 56849-56860, September 12, 2022.
38 White House, OSTP, “Coordinated Framework for Regulation of Biotechnology,” 51 Federal Register 23302, June
26, 1986.
39 White House, OSTP, “Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of
(continued...)
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update changed the focus from the process of creation to the characteristics of the
product and its introduction into the environment.
• On January 18, 2011, President Obama signed Executive Order 13563,
“Improving Regulation and Regulatory Review,” which laid out principles
intended to guide agency actions related to public participation, integration, and
innovation, the flexibility of approaches, science, and retrospective analyses of
existing laws.40
• In 2015, OSTP directed USDA, FDA, and EPA to update the Coordinated
Framework.41 The goals were to clarify agency roles, develop a long-term
strategy, and commission an independent analysis of the biotechnology landscape
to enhance public confidence, promote innovation, and ensure efficient regulation
while safeguarding health and the environment.42
• In 2016, the Biotechnology Working Group of the Emerging Technologies
Interagency Policy Coordination Committee published the National Strategy for
Modernizing the Regulatory System for Biotechnology, which outlined steps to
assess the risks associated with future biotechnology products and support
scientific underpinnings.43 Concurrently, the National Academies of Sciences,
Engineering, and Medicine (NASEM) was tasked to conduct a study to identify
advances, potential risks, and scientific capabilities relevant to future
biotechnology products.44
• In 2017, USDA, FDA, and EPA issued another update to the Coordinated
Framework, clarifying agency responsibilities and promoting coordination
through memoranda of understanding.45
• On June 11, 2019, President Trump issued Executive Order (E.O.) 13874,
“Modernizing the Regulatory Framework for Agricultural Biotechnology
Products.” E.O. 13874 requested further modernizing of the regulatory
framework and emphasizing the use of scientific evidence in decision-making.
The executive order also encouraged trade in agricultural biotechnology products
based on science and risk-based approaches.46
• In May 2020, responding to E.O. 13874, USDA’s APHIS revised its regulations
regarding the movement (importation, interstate movement, and environmental

Biotechnology Products into the Environment Update to the Coordinated Framework,” 57 Federal Register 6753,
February 27, 1992.
40 Executive Order 13563, “Improving Regulation and Regulatory Review,” 76 Federal Register 3821, January 18,
2011.
41 OSTP, “Memorandum for Heads of Food and Drug Administration, Environmental Protection Agency, and
Department of Agriculture Regarding Modernizing the Regulatory System for Biotechnology Products,” July 2, 2015.
42 White House, National Science and Technology Council (NSTC) and OSTP, “Clarifying Current Roles and
Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-
Term Strategy for the Regulation of the Products of Biotechnology,” 80 Federal Register 60414, October 6, 2015.
43 White House, NSTC, “National Strategy for Modernizing the Regulatory System for Biotechnology Products,”
September 2016.
44 NASEM, “Preparing for Future Products of Biotechnology,” National Academies Press, 2017.
45 EPA, FDA, and USDA “Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017
Update to the Coordinated Framework for the Regulation of Biotechnology,” 2017.
46 Executive Order 13874, “Modernizing the Regulatory Framework for Agricultural Biotechnology Products,” 84
Federal Register 27899, June 11, 2019.
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release) of certain genetically engineered plants to focus on plant properties
rather than production methods through its SECURE Rule, discussed above.47
• On September 12, 2022, President Biden issued Executive Order 14081,
“Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable,
Safe, and Secure American Bioeconomy.”48 The executive order aims to improve
regulatory clarity and efficiency, enhance coordination among federal agencies,
and encourage international regulatory cooperation. Among other things,
agencies are directed to address ambiguities and provide information to
stakeholders through an improved Unified Website for Biotechnology.49 The
order also prescribes the need for a “whole-of-government approach to advance
biotechnology and biomanufacturing towards innovative solutions in health,
climate change, energy, food security, agriculture, supply chain resilience, and
national and economic security.”50
• On May 25, 2023, in response to E.O. 14081, EPA announced changes to its
regulations concerning genetically engineered plant-incorporated protectants
(PIPs).51 These changes exempt certain PIPs from registration and tolerance
requirements while implementing a notification process for transparency. EPA
intends to consider additional exemptions and expand the list of categories not
requiring EPA confirmation as biotechnology progresses.
International Regulation of Gene-Edited Plants
The regulation of plants derived from gene editing varies across the globe. Various regulatory
jurisdictions and countries have adopted different policies and regulatory frameworks for the use
of gene editing techniques for plant products.52
The United States’ regulatory approach is product-based, which focuses on the characteristics of
the final product rather than the process used to create it. Generally speaking, if a gene-edited
plant does not contain foreign DNA, the final product is considered no different from a product
that was produced without gene editing. If the plant could have been produced with conventional
breeding, then it would not be subject to the additional regulations that products that are produced
through other types of biotechnology processes have to follow. Canada follows a similar product-

47 APHIS first issued these regulations in 1987 under the authority of the Federal Plant Pest Act of 1957 and the Plant
Quarantine Act of 1912, two acts that were subsumed into the Plant Protection Act (PPA, 7 U.S.C. §§ 7701 et seq.) in
2000, along with other provisions. Since 1987, APHIS has amended the regulations seven times (in 1988, 1990, 1993,
1994, 1997, 2005, and 2020) to institute exemptions from the requirement for permits to conduct activities for certain
organisms, to institute the current notification process and petition procedure, and to exclude plants engineered to
produce industrial compounds from the notification process. For more, see USDA APHIS, “Movement of Certain
Genetically Engineered Organisms,” May 18, 2020.
48 Executive Order “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure
American Bioeconomy,” 87 Federal Register 56849, September 12, 2022.
49 For more information, also see CRS Report CRS Report R47274, White House Initiative to Advance the Bioeconomy,
E.O. 14081: In Brief.
50 For more details on the Executive Order, the supporting federal investments announced by the Administration, and
policy considerations for Congress regarding the implementation of the executive order, see CRS Report R47274,
White House Initiative to Advance the Bioeconomy, E.O. 14081: In Brief.
51 EPA, “Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs) Derived from Newer Technologies -
Final Rule,” May 31, 2023.
52 For how the United Nations’ Food and Agriculture Organization approaches gene editing, see Caixia Gao et al.,
“Gene Editing and Agrifood Systems,” FAO Report, 2022.
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based risk assessment and governs all plants with novel traits, including those introduced through
genetic engineering and gene editing, under the same regulatory scheme. The United Kingdom,
under a March 2023 law, is to start allowing the development, release, and marketing of gene-
edited plants through a regulatory system different from that of plants developed through other
biotechnology processes, such as older techniques of genetic engineering.53
Other countries have different regulations in place, focusing on the process used to develop the
product and requiring extensive safety assessments and approval processes before gene-edited
plants can be cultivated or approved for human consumption.
The European Union (EU) has long followed the process-based approach. However, there have
been recent proposals to change its regulations. In 2021, the European Commission proposed a
draft law that would exempt gene-edited plants from the laws applying to genetically engineered
products, provided they are equivalent to what could be achieved with conventional plant
breeding.54 This proposal would apply to plants obtained using gene-editing techniques like
CRISPR, as long as the modifications are comparable to those achieved with conventional
breeding. The Commission expects to propose a legal framework for gene-edited plants and their
food and feed products in 2023.55
Other countries apply risk assessments to gene-edited plants that fall in between the strictly
product-based or process-based approaches, or have not finalized their decisions on how to
regulate gene-edited products. For example, Hungary, Switzerland, and Norway are considering
regulatory options that may be different from the region’s regulations on gene editing and
applying case-by-case assessment procedures for gene-edited products. Additionally, among the
ten most populous countries (many being major agricultural producers), nine have expressed
intentions to allow gene editing in commercial agriculture. During the last two years, China and
India have taken steps to clarify their policies and allow the cultivation of gene-edited plants.56
Perspectives on Regulating Gene Editing as Genetic Engineering
Ongoing debates exist regarding the regulation of gene editing as compared to genetic
engineering. These debates consider the biological, political, social, and legal differences between
the two technologies.57
Those who argue against regulating gene editing and genetic engineering in the same way assert
that the end products of gene editing are similar to those generated through conventional breeding
techniques or that similar changes could occur naturally. Therefore, they assert that regulations
and oversight imposed on regular genetically engineered products are unnecessary if the resulting
gene-edited products are substantially equivalent in terms of safety and potential environmental
impact. Furthermore, proponents of accelerated approvals for gene-edited products argue that

53 Department for Environment Food and Rural Affairs, “Game-changing Genetic Technology Bill Passes into Law in
England,” March 24, 2023; United Kingdom Parliament, Genetic Technology (Precision Breeding) Act 2023,
https://bills.parliament.uk/bills/3167.
54 Brigitte Voigt, “EU Regulation of Gene-edited Plants—A Reform Proposal,” Frontiers in Genome Editing, February
14, 2023.
55 European Commission (EC), “European Green Deal: More Sustainable Use of Plant and Soil Natural Resources,”
July 5, 2023.
56 Nadya Yeh, “After Decades of Bans, China Is Beginning to Plant Gene-edited Crops,” The China Project, May 18,
2023.
57 Aftab Ahmad et al., “An Outlook on Global Regulatory Landscape for Genome-edited Crops,” International Journal
of Molecular Sciences, p. 11753, October 29, 2021.
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other regulatory processes are burdensome, stifle innovation, and hinder the development of
beneficial gene-edited products.
Proponents of slower approvals for gene-edited plants raise concerns that accelerated regulatory
approvals may compromise the safety of the environment, animals, and human health. One
example they cite is the potential persistence of gene markers and gene-edited genes in
subsequent generations of plants.58 Additionally, opponents of regulating gene-edited and
genetically engineered products differently emphasize the importance of transparency in
regulating and labeling all products derived from genetic engineering, including those derived
from gene editing. They argue that treating gene-edited and genetically engineered products
differently can lead to consumer confusion.59
Issues Facing Congress
Congress may consider a range of issues and policy options concerning gene editing and genetic
engineering in agriculture. Past Congresses have already passed certain legislation on this matter
and may contemplate introducing more. In addition, Congress may choose to exercise its
oversight, appropriations, and legislative powers regarding the following topics. Selected issues
are discussed below, without any specific order.
Labeling Disclosure and Standards
The debate over labeling foods that include ingredients that have been genetically engineered has
been longstanding. At the heart of the debate, some stakeholders express worries about the health
implications of consuming genetically engineered foods, as well as other unforeseen long-term
health effects. Others maintain that genetically engineered foods approved for consumption are as
safe as their conventional counterparts. The debate also touches upon consumers’ right to
information, with many advocating for mandatory labeling, while opponents argue that such
labels might mislead consumers into thinking that genetically engineered products are inherently
harmful.
In 2016, Congress passed the United States Grain Standards Reauthorization Act of 2020 (P.L.
116-216), which instructed USDA’s Agricultural Marketing Service (AMS) to establish a
mandatory national standard for disclosing foods created with genetic engineering or
bioengineered foods. The implementation of the National Bioengineered Food Disclosure
Standard (NBFDS) began on January 1, 2022, and it defined bioengineered foods as those that
contain detectable genetic material modified through specific lab techniques, which cannot be
achieved through conventional breeding or found in nature.60

58 For example, concerns have been raised regarding epigenetic variations of gene-edited plants, see Yanfei Mao, Jose
Ramon Botella, Yaoguang Liu, and Jian-Kang Zhu, “Gene Editing in Plants: Progress and Challenges,” National
Science Review 6, no. 3, pp. 421-437, 2019. For more examples of concerns raised with accelerating regulatory reforms
see Jennifer Kuzma, “Regulating Gene-edited Crops-Advocates of Second-generation Genetically Modified Crops are
Making Choices Likely to Trigger Another Round of Public Opposition,” Issues in Science and Technology, 2018.
59 Food Marketing Institute (FMI), “Consumer Acceptance of Gene Edited Foods,” March 12, 2019. In 2020, the Food
Marketing Institute formally rebranded to use the acronym FMI. The organization adopted the tagline, The Food
Industry Association and FMI stands for Food Marketplace Inc.” For more details, see https://www.fmi.org/about-
us/history.
60 For more details, see CRS Report R46183, The National Bioengineered Food Disclosure Standard: Overview and
Selected Considerations.
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Figure 4. Disclosure Symbols of the Standard

Source: CRS from USDA, “BE Symbols,” https://www.ams.usda.gov/rules-regulations/be/symbols.
Notes: Foods that meet the criteria in the Standard must display the “bioengineered” symbol. The “derived
from bioengineering” symbol may be displayed on foods that do not meet the bioengineered food definition yet
derive from bioengineered food (e.g., refined foods that do not contain detectable modified DNA). For
background and more information, see CRS Report R46183, The National Bioengineered Food Disclosure Standard:
Overview and Selected Considerations.
USDA’s Agriculture Marketing Service, which is responsible for its implementation, has said that
the goal of the standard was to provide consistent information to consumers, to enhance
transparency:
By providing a uniform national standard for labeling bioengineered foods, we can increase
transparency in our food system and give consumers information about the bioengineered
status of their foods.61
Stakeholders had proposed that the labeling should explicitly cover all foods derived from
biotechnology, including gene editing, that may not fit the legal definition of bioengineering.
These suggestions were not incorporated into the enacted law. Under the standard, gene-edited
products or ingredients are not required to be labeled on a food product because the statutory
definition of bioengineered food in the standard does not explicitly mention gene editing and
other new plant breeding techniques. Specifically, gene editing is exempt from labeling
requirements when gene-edited products (a) do not contain recombinant DNA or (b) when their
modifications could be achieved through conventional breeding or found in nature.
Since the labeling standards went into effect, some consumer groups and grocery stores have
complained that the labels are confusing, specifically with respect to the term “bioengineered.”62
Congress has considered legislation regarding the NBDS and the applications of the labeling
standard. The legislation included provisions that would require the labeling of genetically
engineered salmon and other animals and added provisions into annual appropriations legislation
to require their labeling in FY2021-FY2023.63

61 Anna Waller, USDA AMS, “Overview of the National Bioengineered Food Disclosure Standard,” Webinar,
December 2020.
62 For example, after the enactment of the NBFDS, the Non-GMO project stated that USDA’s decision not to regulate
or label gene-edited products under the federal labeling law “signals a clear strategic shift further away from
transparency in the food system.” For more on the stakeholders’ views and reactions to the NBFDS, see Theresa Selfa,
Sonja Lindberg, and Carmen Bain, “Governing Gene Editing in Agriculture and Food in The United States: Tensions,
Contestations, and Realignments,” Elementa: Science of the Anthropocene, October 4, 2021, p. 00153.
63 Bills that would have required labeling of genetically engineered salmon regardless of when it was approved include
H.R. 270 and S. 1940 (117th Congress), H.R. 1103 (116th Congress), and S. 282 (116th Congress). Past annual
appropriations provisions include §778 of the Consolidated Appropriations Act, 2021 (P.L. 116-260), which requires
that “the acceptable market name of any engineered animal approved prior to the effective date of the National
(continued...)
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Congress may continue using its oversight authorities to (a) monitor the implementation of the
standard and (b) address the concerns on how existing genetically engineered products and gene-
edited products fit under the national labeling standard.64 If the discrepancies in labeling
requirements for genetically engineered vs. gene-edited products have important implications,
and harmonization of labeling requirements is needed, Congress may amend the standard or take
other actions such as establishing an independent or scientific body to oversee and review the
standard.
Additionally, some argue that consumers’ demands for labels in biotechnology-derived food are
motivated by an underlying distrust of the agrifood systems or a lack of education about new food
technologies.65 In 2017, Congress appropriated $7.5 million to support the “Agricultural
Biotechnology Education and Outreach Initiative.” This program required FDA to educate and
engage the public regarding agricultural biotechnology, as well as biotechnology-derived food
and animal feed ingredients. Congress provided annual appropriations for funding the program
for two more years in FY2018 and FY2019 in the amount of $1.5 and $3 million per year
respectively. FDA states that it “is currently working on this initiative in coordination with USDA
and EPA.”66
Additionally, in 2018, Congress included in the Agriculture Improvement Act of 2018 (P.L. 115-
334), known as the 2018 farm bill, a provision called “the Public Education on Biotechnology in
Food and Agriculture Sectors” provision.67 The goal of this program was to enhance public
awareness about the use of biotechnology in these sectors. This was to be achieved through a
national science-based education campaign that covered topics like the science and regulatory
review process for biotechnology products, the history and effects of plant and animal breeding,
and the impacts of biotechnology on food security, nutrition, and the environment. The initiative
aimed to provide transparent, accessible, and user-friendly information to the public, ensuring
they were well-informed about the role and implications of biotechnology in their food and the
broader agricultural landscape. Congress may monitor the effectiveness of the outreach initiative
and decide whether to allocate additional annual appropriations to the agencies for consumer
education and outreach initiatives intended to increase public trust in biotechnology and facilitate
public understanding of biotechnology and its potential benefits and risks.68

Bioengineered Food Disclosure Standard (February 19, 2019) shall include the words ‘genetically engineered’ prior to
the existing acceptable market name”; §765 of the Consolidated Appropriations Act, 2023 (P.L. 117-328) and §778 of
the Consolidated Appropriations Act, 2021 (P.L. 116-260).
64 For example, the 117th Congress considered S. 1940 and H.R. 270, which would have mandated that the market
name of genetically engineered salmon must include “Genetically Engineered” or “GE” as a prefix to the existing name
and require an independent scientific organization to review FDA’s environmental assessment for the approval of
AquAdvantage Salmon, a genetically engineered salmon.
65 Sinja A., Lindberg, David J. Peters, and Christopher L. Cummings, “Gene‐Edited Food Adoption Intentions and
Institutional Trust in the United States: Benefits, Acceptance, and Labeling,” Rural Sociology, 2023.
66 In the Consolidated Appropriations Act of 2017 (P.L. 115-31), Congress directed FDA to conduct “consumer
outreach and education regarding agricultural biotechnology and biotechnology-derived food products and animal feed,
including through publication and distribution of science-based educational information on the environmental,
nutritional, food safety, economic, and humanitarian impacts of such biotechnology, food products, and feed.” Since
then, additional funding for the program has been provided in the FY2018 and FY2019 Appropriations bills P.L. 115-
141 and P.L. 116-6). For more information, see FDA, “Agricultural Biotechnology Education and Outreach Initiative,”
August 3, 2022.
67 See H.Rept. 115-661, Sec. 7608.
68 For the goals, current efforts, and additional background see FDA, “Agricultural Biotechnology Education and
Outreach Initiative,” August 3, 2022.
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Efficacy of Regulatory Updates
As noted above, the regulatory bodies and agencies have attempted updates to the Coordinated
Framework for Biotechnology Regulation. In September 2022, President Biden issued Executive
Order 14081, which established “the National Biotechnology and Biomanufacturing Initiative”
(NBBI). The goals of the initiative include streamlining regulations in order to advance research,
bolster biosecurity measures, and stimulate economic growth.69 Congress may exercise its
oversight authorities and use the annual appropriation process to monitor and assess the
implementation of the efforts undertaken by the agencies to revise the regulations.
In addition to monitoring how the agencies’ revised regulatory requirements have affected the
development and commercialization of gene-edited products, Members of Congress may also
oversee how USDA, FDA, and EPA are collecting feedback on the effectiveness of the revised
regulations. For example, EPA’s latest PIPs regulations have caused some to raise questions
relating to the developer’s authority on making the decision whether a plant-incorporated
protectant should be exempt and why certain genetically engineered and gene-edited plants would
be considered exempt while others are not. Critics have also claimed that only PIPs that meet the
scientific low-risk criteria should be exempt and demand that EPA discloses a list of all exempt
PIPs.70 Legislation introduced in the 117th Congress would have amended EPA’s provisions in
relation to the FIFRA Act, including an amendment requiring EPA to provide a notice of at least
270 days in advance in the Federal Register before making changes to a pesticide registered
under the FIFRA Act (H.R. 9035), and an amendment of FIFRA to prohibit local regulations
relating to the sale, distribution, labeling, application, or use of any pesticide or device subject to
regulation by a state or EPA (H.R. 7266).
Differences in Regulation and Global Trade
Differing regulations and labeling requirements in relation to genetically engineered and gene-
edited products around the world can lead to important trade issues, such as restricted market
access for the products and inconsistencies in standards across nations.71 Recognizing these
challenges, Congress established the “Biotechnology and Agricultural Trade Program” in the
2018 farm bill.72 The program’s core mission is to alleviate trade barriers confronting U.S.
biotech products in international markets. These barriers emerge from diverse regulations and
varied perceptions of biotech products among countries. The program was also intended to
support private sector endeavors to boost biotech trade, educate international audiences on
biotech product safety, and devise strategies to navigate trade impediments.
Several international agreements touch on agricultural biotechnology. For instance, the U.S.-
Mexico-Canada Agreement (USMCA) became the first to address agricultural products derived

69 According to the U.S. Department of Health and Human Services (HHS), NBBI will use biotechnology and
biomanufacturing to promote groundbreaking research, development, and infrastructure in biotechnology while
minimizing risks. HHS is expected to lead the strategic progress of biosafety and biosecurity innovation within the
expanding bioeconomy. For more information, see U.S. Department of Health and Human Services, “Fact Sheet: HHS
Takes Action on Executive Order Launching a National Biotechnology and Biomanufacturing Initiative,” September
14, 2022.
70 Theresa Selfa, Sonja Lindberg, and Carmen Bain, “Governing Gene Editing in Agriculture and Food in The United
States: Tensions, Contestations, and Realignments,” Elementa: Science of the Anthropocene, p. 00153, October 4,
2021.
71 For more details, see CRS In Focus IF11399, Enforcing International Trade Obligations in USMCA: The State-State
Dispute Settlement Mechanism.
72 “Biotechnology and agricultural trade program,” 7 U.S.C. 5679, P.L. 115-334.
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through genetic engineering techniques.73 Furthermore, the U.S.-China Phase One trade
agreement saw China making commitments in the realm of agricultural biotechnology.74 Yet,
despite these advances, concerns over countries’ adherence to these agreements persist. One
example is the trade dispute between Mexico and the United States regarding genetically
engineered corn, which revolves around Mexico’s plan to phase out imports of U.S. genetically
engineered corn by 2024.75 The U.S. and Canadian governments have raised concerns over
Mexico’s presidential decree banning the use of genetically engineered corn in tortillas and the
gradual substitution of its use in all products for human and animal consumption.76 The U.S.
government asserts that Mexico’s biotechnology policies and actions are not based on science,
hinder agricultural innovation, and are inconsistent with its obligations under the United States-
Mexico-Canada Agreement (USMCA), a free trade pact that took effect in 2020 and replaced the
North American Free Trade Agreement (NAFTA).77
Congress may consider assessing the potential impacts of regulations on gene-edited plants on
market access for agricultural producers and evaluate any trade barriers that may arise due to
limited export opportunities and possible hindrances to the free flow of goods.78 As the funding
for the Biotechnology and Agricultural Trade Program is about to come to an end with the
expiration of the 2018 farm bill, Congress may assess whether the program’s implementation is
satisfactory and consider including a re-authorization provision in the upcoming farm bill.
Research Investments in Gene Editing
Congress may continue to be interested in better understanding the intricacies of using
biotechnology in agriculture and in exploring the potential uses of gene editing by supporting
research and development. The 2018 farm bill established “the Agricultural Genome to Phenome
Initiative or AG2PI,” a program dedicated to deepening our understanding of genetic information
and observable traits (phenotypes) in both crops and animals.79 The initiative aims to foster
collaboration among a diverse group of experts, including crop and livestock scientists, as well as
professionals from fields like data science, statistics, engineering, and social sciences.80 The 2018
farm bill also directed USDA’s National Institute of Food and Agriculture (7 U.S.C. §§ 5924 et

73 USTR, Chapter 3, §B in Agreement between the United States of America, the United Mexican States, and Canada
7/1/20 Text, at https://ustr.gov/trade-agreements/free-trade-agreements/united-states-mexico-canada-agreement/
agreement-between.
74 USTR, Chapter 3 in Economic and Trade Agreement Between the Government of the United States of America and
the Government of the People’s Republic of China, at https://ustr.gov/countries-regions/china-mongolia-taiwan/
peoples-republic-china/phase-one-trade-agreement/text.
75 Cassandra Garrison, “Mexico to Fight US Dispute Over GM Corn After Formal Consultations Fail,” Reuters, June 2,
2023.
76 Office of the United States Trade Representative, “United States Requests USMCA Dispute Settlement
Consultations on Mexico’s Agricultural Biotechnology Measures,” June 2, 2023, and Government of Canada,
“Ministers Bibeau and Ng Statement on Mexican Measures that Impact Agricultural Innovation,” Agriculture and Agri-
Food Canada, June 9, 2023.
77 For additional background on the Mexico-U.S. trade consultations, see CRS Report R45661, Agricultural Provisions
of the U.S.-Mexico-Canada Agreement and CRS Report R45661, Agricultural Provisions of the U.S.-Mexico-Canada
Agreement and CRS In Focus IF11399, Enforcing International Trade Obligations in USMCA: The State-State Dispute
Settlement Mechanism.
78 For more information, see Justus Wesseler and Nicholas Kalaitzandonakes, “Present and Future EU GMO Policy,”
EU Bioeconomy Economics and Policies: Volume II, pp. 245-256, 2019.
79 CRS Report R47313, Next Farm Bill Primer Series: A Guide to Agriculture and Food Programs in the 2018 Farm
Bill.
80 More information about the competitive grants is available at USDA NIFA, “Agricultural Genome to Phenome
Initiative (AG2PI),” last visited June 23, 2023.
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seq.) to establish a competitive grant program to support collaborative research aimed at
expanding knowledge about the genomes and other characteristics of crops and animals important
to the agricultural sector. It also aimed to increase understanding of how various factors such as
weather impact the growth and productivity of specific varieties of crops and species of animals.
Congress approved $40 million for each fiscal year from FY2019 through FY2023 to be
appropriated for the program. Congress may monitor the overall implementation or impacts of the
AG2PI and assess whether it has fulfilled the specified objectives, including researching
important crops and animals, deepening our understanding of agricultural genetics, and using
genetics to combat diseases. A bill was introduced in the 118th Congress (H.R. 3905) with the goal
of re-authorizing the AG2PI through FY2028; Congress may also re-authorize funding for the
program by including provisions for it in the upcoming farm bill with permanent funding.
Off-Target Effects and Environmental Concerns
The relationship between genetically engineered plants and the potential environmental risks is
ongoing.81 Stakeholders have long raised concerns regarding the introduction of products created
with genetic engineering into the environment and the possible unforeseen consequences,
including harm to biodiversity and ecosystem stability.82 These concerns, some of which persist
today, stem from potential gene flow between genetically engineered products and wild relatives,
the development of resistance in pests, and the unintended impacts on non-target organisms.83
Supporters of gene editing, leveraging technologies like CRISPR, argue that the newer
technologies offer greater precision and control, enabling more targeted modifications and the
potential for products with fewer unintended effects on the environment. Some stakeholders
contend that gene-edited plants could still pose ecological and environmental risks,84 emphasizing
the need for comprehensive risk assessments to ensure a thorough evaluation of potential effects
on ecosystems and biodiversity. For instance, while CRISPR systems are more precise, they have
not eliminated the potential for off-target effects. Off-target impacts can affect treatment
outcomes and have led to genotoxicity or chromosomal rearrangements when applied in fields
like therapeutics and farm animal breeding.85 Although off-target mutations have been observed
mostly in animals and human cells,86 studies also indicate possible off-target effects when used in
plants such as Arabidopsis, rice, and tomato, but these effects can generally be corrected in
subsequent generations.87
Biotechnology advancements have implications for food production, sustainability, innovation,
and consumer well-being. Many in Congress have been interested in understanding and
regulating their potential as well as examining the ethical, social, and environmental

81 Aftab Ahmad et al., “CRISPR Crops,” Regulatory, Ethical, and Social Aspects of CRISPR Crops, pp. 261–287, 2021.
82 Suzanne I. Warwick., Hugh J. Beckie, and Linda M. Hall, “Gene Flow, Invasiveness, and Ecological Impact of
Genetically Modified Crops,” Annals of the New York Academy of Sciences 1168.1, 72-99, 2009.
83 Krishan Kumar et al., “Genetically Modified Crops: Current Status and Future Prospects,” Planta 251, pp. 1-27,
2020.
84 Jennifer Kuzma, “Regulating Gene-Edited Crops-Advocates of Second-generation Genetically Modified Crops are
Making Choices Likely to Trigger Another Round of Public Opposition,” Issues in Science and Technology, 2018.
85 Keith R. Anderson et al., “CRISPR Off-target Analysis in Genetically Engineered Rats and Mice,” Nature Methods
15.7, pp. 512-514, 2018.
86 Alexey V. Deykin et al., “Using CRISPR/Cas9 for Generation the cd209 Knockout Is a Way to Get Cattle Breeds
Resistant to the Bovine Leukemia Virus (BLV),” E3S Web of Conferences, Vol. 176, EDP Sciences, 2020.
87 Aftab Ahmad et al., “An Outlook on Global Regulatory Landscape for Genome-Edited Crops,” International Journal
of Molecular Sciences, p. 11753, October 29, 2021.
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considerations. For example, Congress has authorized annual appropriations for USDA to award
grants “for biotechnology risk assessment research” for FY2020-FY2023 (P.L. 116-94, P.L. 116-
260, P.L. 117-103, and P.L. 117-328). Additional bills introduced in Congress have had differing
priorities for assessing the potential risks associated with biotechnology and gene editing.88
As gene editing technologies evolve, new issues may emerge of interest to Congress. Some of
these possible issues may involve managing the coexistence and legal challenges of organic,
conventional, and gene-edited plants and their long-term impact on ecosystems and biodiversity,
which could lead to conflicts between growers, trading partners, the industry, and consumers.89

Author Information

Eleni G. Bickell

Analyst in Agricultural Policy

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 been provided by CRS to Members of Congress in
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88 See, for example, H.R. 774 - Manufacturing Economy and National Security Act or the MEANS Act. This bill would
establish the Office of Manufacturing Security and Resilience within the Department of Commerce to make grants and
loans to support domestic manufacturing of critical goods and services, industrial equipment, and manufacturing
technology. Genomics and synthetic biology are included in the “key technology focus areas” for the grants and loans
in H.R. 2993 & S. 1368, the Preventing PLA Acquisition of United States Technology Act of 2023. These bills would
restrict scientific research and technical exchanges, including those relating to genetic engineering, between certain
U.S. entities and certain entities in China.
The 117th Congress established the National Security Commission on Emerging Biotechnology through Section 1091
of the FY2022 National Defense Authorization Act (P.L. 117-81). The Commission is tasked with evaluating emerging
biotechnology’s potential implications for U.S. strategic competitiveness, particularly with China, and for the U.S.
military and international security. In the 116th Congress, H.R. 8045- Genome Editing Threat Assessment Act, would
have required the Department of Homeland Security (DHS) to comprehensively assess the potential security risks
related to genome modification and editing. The assessment would have determined the risk of gene editing being used
to intentionally spread infectious diseases. This bill was not enacted.
89 Caixia Gao et al., “Gene Editing and Agrifood Systems,” FAO Report, 2022.
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