Agricultural Biotechnology: Overview,
March 29, 2021
Regulation, and Selected Policy Issues
Genevieve K. Croft
Agricultural biotechnology refers to a range of tools —including genetic engineering and some
Analyst in Agricultural
conventional breeding techniques—to genetically modify living plants, animals, microbes, and
Policy
other organisms for agricultural uses (e.g., food, feed, fiber). The term commonly refers to

recombinant DNA techniques that introduce desired characteristics into target organisms,
predominantly pest and herbicide resistance in crops. It also encompasses a range of new genome

editing technologies (e.g., CRISPR-Cas9) that manipulate genetic material at precise locations in
the genome. Most genetically engineered (GE) agricultural products are crops—in the United States, the only GE animals
currently approved for human consumption are the AquAdvantage salmon and the GalSafe pig.
When foods containing GE ingredients were first introduced in the 1990s, some members of the public called for banning
them based on concerns about their potential to harm human health. In terms of the health and safety of the people consuming
them, research repeatedly has found no difference between foods developed with and without genetic engineering. Even so,
some consumers remain concerned about genetic engineering, citing health, personal preference, environmental, economic,
and other objections. As such, the views of the scientific community, consumers, farmers and ranchers, and the organic
industry on the safety, utility, and ethics of agricultural biotechnology do not always overlap. Society continues to debate
these issues, and numerous advocacy and trade organizations promote various sides of the debate.
In the United States, three federal agencies share responsibility for regulating the products of agricultural biotechnology
within a regulatory system established in 1986, known as the Coordinated Framework. Within this framework, the U.S.
Department of Agriculture (USDA), Food and Drug Administration (FDA), and Environmental Protection Agency (EPA)
regulate the marketing and environmental release of agricultural biotechnology products under statutes that predate the
invention of modern biotechnology.
Within the Coordinated Framework, USDA’s Animal and Plant Health Inspection Service (APHIS) and Food Safety
Inspection Service (FSIS) each have authorities for aspects of the regulation of agricultural biotechnology products. APHIS
authorities derive primarily from the Plant Protection Act (PPA, 7 U.S.C. §7701 et seq.), Animal Health Protection Act
(AHPA, 7 U.S.C. §8301 et seq.), and Virus-Serum-Toxin Act (VSTA, 21 U.S.C. §151 et seq.). FSIS authorities derive from
the Federal Meat Inspection Act (FMIA, 21 U.S.C. §601 et seq.), Poultry Products Inspection Act (PPIA, 21 U.S.C. §451 et
seq.), and Egg Products Inspection Act (EPIA, 21 U.S.C. §1031 et seq.). FDA authorities derive from the Federal Food,
Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §301 et seq.) and Public Health Service Act (PHSA, 42 U.S.C. §201 et seq.).
EPA authorities derive from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. §136 et seq.).
With the enactment of the National Bioengineered Food Disclosure Standard (P.L. 114-216) in 2016, and the subsequent
regulations promulgated by USDA’s Agricultural Marketing Service (AMS), the United States joined over 60 nations that
require some form of GE labeling. Additional voluntary public and private labeling schemes signal t o consumers that labeled
food products do not contain GE foods or food ingredients, or they are produced with practices that exclude genetic
engineering.
Disparate global views, consumer acceptance, and legal requirements with respect to agricultural biotechnology and its
products have raised global trade concerns. The United States is a leading cultivator of GE crops, and market access for
agricultural biotechnology products is a major U.S. trade objective. While the policies of some global trading partners
support access to biotechnology products, other countries’ policies pose a challenge to achieving this objective.
Public debate around agricultural biotechnology includes topics such as its place in the U.S. food system, global food
security, global trade, and other matters. Emerging issues that may be of interest to Congress include the ongoing efficacy of
the Coordinated Framework; challenges and opportunities of new genetic engineering techniques; the labeling of foods to
distinguish between GE and non-GE products; global trade concerns; and potential environmental concerns.
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Introduction
People have been changing plants, animals, and other organisms for more than 10,000 years.
After agriculture began, the development of traditional farming practices, followed by
conventional breeding, and final y biotechnology techniques has al owed people to shape the
characteristics of agricultural species with increasing precision. Recent advances in genetic
engineering permit scientists to introduce or suppress—in a single generation—specific traits in
organisms raised for food, fiber, pharmaceutical, or industrial uses. This changing landscape has
increased interest in the development and regulation of the products of agricultural biotechnology.
The United States is the world’s leading cultivator of genetical y engineered (GE) crops,
accounting for nearly 40% (185 mil ion acres) of total GE crop acres planted worldwide.1 The
vast majority of these crops are commodities destined for processed foods and animal feed. There
are also noncommodity GE crops, such as fruits and vegetables, and noncrop agricultural GE
products, such as salmon and enzymes used in food processing. The use of biotechnology is
predicted to grow in scale and scope, with new agricultural species, trait types, and
methodologies employed.2
In the United States, three federal agencies share responsibility for regulating the products of
agricultural biotechnology, in a regulatory system that has changed little since it was first
established in 1986. Scientific reviews of the safety of these products for human health have
repeatedly found no difference between GE and non-GE products. Reviews of environmental
safety have been less conclusive. Public concerns about the safety and desirability of GE foods
and agricultural products persist.
Agricultural biotechnology continues to be a topic of public debate, including its place in the U.S.
food system, global food security, global trade, and other matters. Emerging issues include the
chal enges and opportunities of new genetic engineering techniques and the labeling of foods to
distinguish between GE and non-GE products. This report provides an overview of agricultural
biotechnology, the U.S. biotechnology regulatory system, scientific and stakeholder views, and
issues in international trade. It concludes with an examination of selected issues for Congress and
appendices with acronyms (Appendix A) and definitions of selected scientific and related terms
used in this report (Appendix B).
Background
Agricultural biotechnology refers to a range of tools—including genetic engineering and some
conventional breeding techniques—to genetical y modify living plants, animals, microbes, and
other organisms for agricultural uses (e.g., food, feed, fiber). The term commonly refers to
recombinant DNA techniques that introduce desired characteristics into target organisms,
predominantly pest and herbicide resistance in crops. It also encompasses a range of new genome

1 International Service for the Acquisition of Agri-biotech Applications (ISAAA), Global Status of Commercialized
Biotech/GM Crops in 2018: Biotech Crops Continue to Help Meet the Challenges of Increased Population and Clim ate
Change, Executive Summary, ISAAA Brief no. 54, 2018, at http://www.isaaa.org/resources/publications/briefs/54/
executivesummary/default.asp (hereinafter ISAAA, Global Status of Com m ercialized Biotech/GM Crops in 2018).
2 See, for example, National Academies of Sciences, Engineering, and Medicine ( NASEM), Preparing for Future
Products of Biotechnology, National Academies Press, 2017 (hereinafter NASEM, Future Products of Biotechnology,
2017); and NASEM, Genetically Engineered Crops: Experiences and Prospects, National Academies Press, 2016
(hereinafter NASEM, Genetically Engineered Crops, 2016).
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editing technologies (e.g., CRISPR-Cas9) that manipulate genetic material at precise locations in
the genome. Most GE agricultural products are crops—in the United States, the only GE animals
currently approved for human consumption are the AquAdvantage salmon and the GalSafe pig.3
The public has come to refer to plants and animals altered through modern biotechnology and
genetic engineering as genetically modified organisms (GMOs).4 Scientific and federal
government experts identify the term genetically modified as more general than genetically
engineered; as such, genetical y modified may include conventional breeding.5 In this report,
genetic engineering refers to the use of genetic modification techniques other than conventional
breeding.
Conventional Breeding
Genetic modification predates agriculture, but the pace of such changes accelerated with the onset
of agriculture. Agricultural breeding practices referred to as conventional, or traditional, include
selective breeding, hybridization, mutation breeding, and marker-assisted selection. These have
yielded agricultural varieties with enhanced size, growth rates, and other valuable characteristics.
Many conventional breeding practices rely on laboratory techniques and genetic analysis, but
they do not employ genetic engineering. Three such examples are mutation breeding, marker-
assisted selection, and genomic selection (see text box, below).
Selected Laboratory-Based Conventional Breeding Practices
Mutation Breeding. Mutations arise natural y at low levels in plants and animals. In mutation breeding, in use
since the 1920s, plant seeds are intentional y exposed to radiation (e.g., x-rays, gamma rays, neutrons, alpha
particles, beta particles) or chemical mutagens (e.g., sodium azide, ethyl methanesulphonate) to rapidly generate
many mutations. Breeders can select plants with desirable qualities from among the resulting mutants for further
development. In one example, farmers sought grapefruits with deeper red coloration and sweeter flavor than they
could find in existing variants. Scientists in Texas irradiated grapefruit seeds to try to induce the desired changes.
This research led to the commercial release of the Star Ruby and Rio Red grapefruits in the 1970s and 1980s—the
progenitors of most grapefruit now grown in Texas.6 Although this technique can be successful for plant breeding,
it is not suitable for animal breeding.
Marker-Assisted Selection. Since the 1980s, the availability and use of genetic information has strengthened
the ability to modify agricultural varieties. Marker-assisted selection is an example of a conventional breeding
technique that relies on genetic analysis. With this technique, researchers can reduce the time it takes to develop
a new variety with desired qualities by first screening potential breeding candidates for specific molecular markers
(DNA sequences known to be associated with certain traits).7 Only those candidates that have the genetic
markers are used in further breeding experiments. Researchers save time because they do not need to wait until
the screened individual grows up to express those traits—they can screen many individuals (e.g., seeds, embryos,
adolescent animals) without growing or raising al of them to reproductive maturity.

3 Food and Drug Administration (FDA), “ FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of
Domestic Pigs for Both Human Food, Potential T herapeutic Uses,” press release, December 14, 2020.
4 Modern biotechnology includes the tools of genetic engineering and other approaches (e.g., fusion of cells from
different types of organisms to create new varieties). See Codex Alimentarius Commission, Principles for the Risk
Analysis of Foods Derived from Modern Biotechnology, CAC/GL 44-2003, World Health Organization and Food and
Agriculture Organization (FAO), 2003.
5 NASEM, Genetically Engineered Crops, 2016.
6 For more information on mutation breeding and T exas grapefruit, see Amanda Kastrinos, “Delicious Mutant Foods:
Mutagenesis and the Genetic Modification Controversy,” Genetic Literacy Project (GLP), June 13, 2016, at
https://geneticliteracyproject.org/2016/06/13/pasta-ruby-grapefruits-why-organic-devotees-love-foods-mutated-by-
radiation-and-chemicals.
7 For more information on marker-assisted selection in plant breeding, see NASEM, Genetically Engineered Crops,
2016, pp. 354-355.
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Genomic Selection. Genomic selection is a subcategory of marker-assisted selection in which many more
markers throughout the genome have been identified and can be used to screen individuals for targeted breeding
programs. Genomic selection uses tens of thousands to hundreds of thousands of markers to identify breeding
candidates. As such, it requires more prior genetic information and data analytics capability than is needed for
marker-assisted selection. This detailed genetic information is not readily available for al species, and this
approach may be more resource-intensive than other approaches breeders may use to develop new varieties.
Genetic Engineering
Advances in molecular biology in the 1980s led to the development of techniques to introduce
specific traits into organisms where they did not exist before: adding DNA sequences into their
genomes. These genetic engineering techniques can change agricultural organisms in ways that
would not be possible with conventional breeding, or could take decades to achieve. Recent
developments in genetic engineering have al owed for increasingly specific genetic manipulation
that does not always require the introduction of foreign DNA.
Genetic engineering includes recombinant DNA technology, genome editing, and other new
breeding techniques (NBTs). In each case, genetical y engineering agricultural species to express
traits of interest is a multistep process that can involve significant time and resources to achieve.
Genetic engineering may create changes that are heritable (i.e., changes that can be passed to
offspring) or nonheritable (i.e., changes that affect only the GE organism and cannot be passed to
offspring).
Recombinant DNA Technology
With recombinant DNA technology, scientists use certain techniques to combine DNA from two
or more sources to achieve desired outcomes.8 Organisms bearing recombinant DNA from an
individual of the same species are cisgenic, and organisms bearing recombinant DNA from an
individual of a different species are transgenic. Using this approach, scientists are general y
unaware of where in the organism’s genome the recombinant DNA has been placed; only that it
has been integrated into the genome.
In the most general sense, to genetical y engineer an organism using recombinant DNA
technology, scientists must
 identify a trait of interest (e.g., herbicide tolerance, rapid growth, pink
coloration),
 locate or identify the gene underlying that trait,
 extract the gene from the donor organism or synthesize its DNA sequence,
 construct a recombinant DNA vector with the gene,
 insert the vector into the host cel (i.e., transform it), and
 grow the transformed cel into the new GE organism.

8 See University of Leicester, Virtual Genetics Education Centre, “ Recombinant DNA and genetic techniques,” at
https://www2.le.ac.uk/projects/vgec/schoolsandcolleges/topics/recombinanttechniques.
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Researchers have used this approach to develop many of the GE organisms currently in the U.S.
food supply, such as nonbrowning apples,9 herbicide-tolerant corn and soybeans (see “Plants”),
and fast-growing salmon (see “Agricultural Animals”).
Genome Editing
Genome editing is a more precise form of genetic engineering than recombinant DNA technology.
With genome editing, researchers can make specific changes to an organism’s DNA by inserting,
deleting, or modifying genes or gene sequences. Early genome editing tools include ZFNs (zinc-
finger nucleases) and TALENs (transcription activator-like effector nucleases). Use of these tools
largely has been eclipsed by the rapid adoption of CRISPR (clustered regularly-interspaced short
palindromic repeats) combined with Cas9 (CRISPR-associated protein 9).10
The CRISPR-Cas9 system was first used for genome editing in 2013, and researchers and
developers have adopted it rapidly since that time.11 Although ZFNs, TALENs, and CRISPR-
Cas9 can al be used to perform genome editing, CRISPR-Cas9 is faster, more effective, and less
expensive in many cases (Figure 1). Researchers continue to experiment with different CRISPR-
associated proteins (e.g., Cas12a, Cas13a) as they work to fine-tune genome editing performance
in a variety of circumstances.12 Researchers have used genome editing to develop crops that are
grown commercial y in the United States, including genome-edited varieties of canola and
soybean.13

9 For more information, see Allison Baker, “Arctic Apples: A Fresh New T ake on Genetic Engineering,” Harvard
University, January 15, 2018, at http://sitn.hms.harvard.edu/flash/2018/arctic-apples-fresh-new-take-genetic-
engineering/. Researchers created Arctic apples using recombinant DNA technology in combination with a process
known as RNA interference.
10 For more information on genome editing and CRISPR-Cas9, see CRS Report R44824, Advanced Gene Editing:
CRISPR-Cas9, by Marcy E. Gallo et al.
11 For a chronology of CRISPR development for genome editing, see Broad Institute, “CRISPR T imeline,” at
https://www.broadinstitute.org/what-broad/areas-focus/project -spotlight/crispr-timeline.
12 For more information, see Su Bin Moon et al., “Recent Advances in the CRISPR Genome Editing T ool Set,”
Experim ental & Molecular Medicine, vol. 51 (November 5, 2019), pp. 1-11.
13 Jochen Menz et al., “Genome Edited Crops T ouch 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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Figure 1. CRISPR-Cas9

Source: Figure and figure notes adapted by CRS from National Institutes of Health, “Gene Editing—Digital
Media Kit,” at https://www.nih.gov/news-events/gene-editing-digital-press-kit.
Notes: (a) The CRISPR system has two components joined together: a finely tuned targeting device (a smal
strand of RNA programmed to look for a specific DNA sequence) and a strong cutting device (an enzyme cal ed
Cas9 that can cut through a double strand of DNA). (b) Once inside a cel , the CRISPR system locates the DNA
it is programmed to find. The CRISPR seeking device recognizes and binds to the target DNA (circled, black). (c)
The Cas9 enzyme cuts both strands of the DNA. (d) Researchers can insert into the cel new sections of DNA.
The cel automatical y incorporates the new DNA into the gap when it repairs the broken DNA.
New Breeding Techniques (Plants)
NBTs is an umbrel a term that includes some genetic engineering approaches and other plant
breeding techniques developed in recent years. Some advocates—particularly in the European
Union (EU)—have used this term to distinguish between breeding technologies and approaches
that use recombinant DNA technology, on the one hand, and those that do not, on the other. While
there is no universal y agreed upon definition of what approaches are included within the scope of
NBTs, they include (1) techniques that change an organism’s genetic sequence (e.g., genome
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editing and site-directed mutagenesis), and (2) epigenetic techniques that change when and how
an organism expresses certain genes without changing the underlying genetic sequence.
Epigenetic techniques use various mechanisms to silence gene expression, such as RNA
interference (RNAi)14 and RNA-directed DNA methylation.15
Cloning (Animals)
Animal biotechnology includes cloning. Cloning is an assisted-reproduction technique that is not
considered genetic engineering, as it does not involve adding or altering genes in an organism. It
is used to make a genetic copy of an existing individual. Scientists remove the nucleus from an
egg cel of the recipient animal (this nucleus contains half of that animal’s genomic DNA) and
replace it with an adult-cel nucleus from the donor animal (this nucleus contains the full
complement of the donor’s genomic DNA) to form an embryo. That embryo is then implanted
into the uterus of a surrogate female where it can develop into an animal, just as any other
embryo would. Scientists have successfully cloned livestock, including sheep, cattle, horses,
goats, and swine.
Adoption of Genetic Engineering in Agriculture
The United States has been a global leader in developing advanced genetic technologies and
applying them to crops and livestock.16 Federal regulators first approved a GE food, the Flavr
Savr tomato, for sale in 1994.17 As additional GE crops gained federal approval, farmers rapidly
adopted them. Today, about 90% of canola, corn, cotton, soybean, and sugarbeet acres in the
United States are planted with GE varieties.18 GE foods predominantly enter commerce as
processed foods and food ingredients (e.g., soybean oil, corn syrup, sugar).19 Although GE crops
are prevalent in the United States, some members of the public seek to avoid consuming GE
foods.
Plants
Adoption of genetic engineering in agricultural plants has been robust, with an estimated 474
mil ion acres planted worldwide in 2018 (Table 1), an increase of about 185 mil ion acres since
2008. These GE crops include plants grown for food, feed, and fiber in 26 countries. Such
plantings are highly concentrated among four crops—soybeans, corn, cotton, and canola—and
five countries. The United States accounts for approximately 39% of global GE crop acreage
(185.3 mil ion acres), followed by Brazil (27%, or 126.8 mil ion acres); Argentina (12%, or 59.1

14 For more information on RNAi, see ISAAA, “Pocket K No. 34: RNAi for Crop Improvement,” at
https://www.isaaa.org/resources/publications/pocketk/34/default.asp.
15 For more information on RNA-directed DNA methylation, see NBT Platform, Fact Sheet RNA-Directed DNA
Methylation, 2014, at http://www.nbtplatform.org/background-documents/factsheets/factsheet-rna-directed-dna-
methylation.pdf.
16 For a history of the development of genetic engineering in agriculture and related regulatory policies, see NASEM,
Genetically Engineered Crops, 2016, pp. 65-96.
17 In 1994, FDA approved for sale the Flavr Savr tomato, genetically engineered to stay firm after harvest.
18 Daniel Hellerstein, Dennis Vilorio, and March Ribaudo, eds., Agricultural Resources and Environmental Indicators,
2019, U.S. Department of Agriculture (USDA), Economic Research Service (ERS), Economic Information Bulletin
(EIB) 208, May 2019, pp. 30-34.
19 Gregory Jaffe, Straight Talk on Genetically Engineered Foods: Answers to Frequently Asked Questions, Center for
Science in the Public Interest, 2015.
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mil ion acres); Canada (7%, or 31.4 mil ion acres); and India (6%, or 28.7 mil ion acres). These
five countries account for about 91% of the global GE crop acreage.
Table 1. Global Area of Genetically Engineered (GE) Crops by Country, 2018
Rank
Country
Area (million acres)
GE Crops
1
USA
185.3
Corn, soybeans, cotton, canola, sugar beets, alfalfa, papaya,
squash, potatoes, apples
2
Brazil
126.8
Soybeans, corn, cotton, sugarcane
3
Argentina
59.1
Soybeans, corn, cotton
4
Canada
31.4
Canola, corn, soybeans, sugar beets, alfalfa, potatoes
5
India
28.7
Cotton
6
Paraguay
9.4
Soybeans, corn, cotton
7
China
7.2
Cotton, papaya
8
Pakistan
6.9
Cotton
9
South Africa
6.7
Corn, soybeans, cotton
10
Uruguay
3.2
Soybeans, corn
11
Bolivia
3.2
Soybeans
12
Australia
2.0
Cotton, canola
13
Philippines
1.5
Corn
14
Myanmar
0.7
Cotton
15
Sudan
0.5
Cotton
16
Mexico
0.5
Cotton
17
Spain
0.2
Corn
18
Colombia
0.2
Cotton, corn
19
Vietnam
<0.2
Corn
20
Honduras
<0.2
Corn
21
Chile
<0.2
Corn, soybeans, canola
22
Portugal
<0.2
Corn
23
Bangladesh
<0.2
Eggplant
24
Costa Rica
<0.2
Cotton, soybeans
25
Indonesia
<0.2
Sugarcane
26
eSwatinia
<0.2
Cotton

Total
473.7

Source: International Service for the Acquisition of Agri-biotech Applications (ISAAA), Global Status of
Commercialized Biotech/GM Crops in 2018: Biotech Crops Continue to Help Meet the Chal enges of Increased Population
and Climate Change, ISAAA Brief no. 54, 2018.
a. eSwatini was formerly known as Swaziland.
U.S. farmers do not commercial y grow al GE crops that have approvals or al GE crops
available for sale in the United States. As of the writing of this report, U.S. farmers commercial y
grew 10 GE crop species (see Table 1). These do not include GE tomatoes and tobacco, which
have approvals but are not grown commercial y. Other GE crops that are not grown in the United
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States may enter the U.S. food system via importation from other countries (e.g., the GE
PinkGlow pineapple ). According to the U.S. Department of Agriculture (USDA) Economic
Research Service (ERS), “over 90% of al corn, upland cotton, soybeans, canola, and sugarbeets
are produced using GE varieties” (see Figure 2).
Production-Oriented Traits
The vast majority of commercial applications of GE crops benefit the production side of
agriculture, with herbicide tolerance and pest-resistance by far the most widespread applications
of GE crops in the United States and abroad. GE crops may possess a single GE trait (e.g.,
herbicide tolerance, insect resistance, or pathogen resistance) or multiple GE traits (stacked
traits).
 Herbicide Tolerance. Herbicide-tolerant (HT) GE crops are engineered to
tolerate herbicides that would otherwise kil them along with the targeted weeds.
HT crops currently on the market include HT soybeans, HT upland cotton, and
HT corn. Many HT crops are referred to as “Roundup Ready” because they are
engineered to resist Bayer’s (formerly Monsanto’s) glyphosate herbicide,
marketed under the brand name Roundup. Stacked-trait HT varieties that
combine traits for glyphosate resistance and resistance to other herbicides (e.g.,
dicamba; 2,4-D choline) have been developed in recent years. Increasing weed
resistance to glyphosate has motivated demand for and development of these
newer HT stacked trait varieties.
 Insect Resistance. Insect-resistant GE crops are genetical y engineered to
produce smal amounts of pesticides in their cel s, with the aim of controlling
insect pests without needing to apply chemical pesticides external y. GE traits for
insect resistance are referred to as plant-incorporated protectants (PIPs). The
most common PIP is Bt, a natural y occurring pesticide derived from the Bacillus
thuringiensis soil bacterium.20 Bt crop varieties are most prevalent in upland
cotton (to control tobacco budworm, bollworm, and pink bollworm) and corn (to
control earworm and several types of corn borers).
 Stacked Traits for Herbicide Tolerance and Insect Resistance. Some stacked
trait crop varieties in some cases combine HT and insect-resistant traits. As these
became available for corn and upland cotton, they soon overtook single-trait GE
varieties with HT or insect-resistant GE traits (Figure 2).
 Pathogen Resistance. Plant pathogens (e.g., viruses, fungi, bacteria) can damage
crops and can make growing them untenable in affected geographic regions.
Traditional methods of combating some virulent plant pathogens (e.g., pruning,
burning, spraying with chemicals) can damage or destroy the infected plants.
Researchers have identified pathogen-resistance traits in some living organisms
and have used genetic engineering to introduce them into some otherwise
susceptible plant varieties. For example, the GE Rainbow papaya, resistant to the
papaya ringspot virus, is largely credited with saving the Hawai an papaya

20 Because Bacillus thuringiensis (Bt) is a natural occurring pesticide, it can be applied ont o organically produced
plants under certain conditions. Bt’s incorporation into genetically engineered (GE) commodities concern some organic
producers because of the risk of creating Bt -tolerant pests, thereby decreasing its effectiveness for organic farming
operations.
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industry.21 In 2018, 77% of Hawai an papaya acreage was planted with virus-
resistant GE papaya.22 Citrus greening, also known as Huanglongbing, is a
bacterial disease that ruins citrus fruits and has no known treatment. Citrus
greening has impacted citrus groves global y, is present in al Florida counties,
and has arisen in California and Texas.23 Researchers are working to develop GE
citrus varieties with protection against citrus greening.24
Figure 2. Adoption of Selected Genetically Engineered Crops in the United States
(2000-2020)

Source: U.S. Department of Agriculture (USDA), Economic Research Service (ERS), “Adoption of Genetical y
Engineered Crops in the U.S.,” last updated July 17, 2020, at https://www.ers.usda.gov/data-products/adoption-of-
genetical y-engineered-crops-in-the-us.
Notes: Genetical y engineered traits include herbicide tolerance (HT), insect resistance via Bacil us thuringiensis
(Bt), and combined HT and Bt (stacked traits).
Consumer-Oriented Traits
In addition to producer-oriented traits, agricultural plants also can be genetical y engineered to
address consumer needs and preferences.25 Such consumer-oriented GE traits in crops may

21 See, for example, Amy Harmond, “ A Lonely Quest for Facts on Genetically Modified Crops,” New York Times,
January 4, 2013, at https://www.nytimes.com/2014/01/05/us/on-hawaii-a-lonely-quest-for-facts-about-gmos.html.
22 ISAAA, Global Status of Commercialized Biotech/GM Crops in 2018.
23 University of Florida, Emerging Pathogens Institute, “Citrus Greening,” at https://epi.ufl.edu/pathogens/plant-
pathogens/citrus-greening/.
24 See, for example, Juliana M. Soares et al., “Development of genetically modified citrus plants for the contro l of
citrus canker and huanglongbing,” Tropical Plant Pathology, vol. 45 (May 25, 2020), pp. 237-250.
25 While consumer-oriented traits address consumer needs and preferences directly, producer-oriented traits may also
benefit consumers indirectly (e.g., t hrough lower food prices or higher quality foods).
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include aesthetic changes (e.g., nonbrowning and pink color), enhanced nutritional qualities (e.g.,
added vitamins, altered fatty acid profile), or reduced al ergenicity. Some of these GE crops are
on the market, and others are under research or pending regulatory approval. GE agricultural
products with consumer-oriented traits have not been adopted by producers and consumers to the
same extent as those GE products with producer-oriented traits. A few examples are described
below.
 Aesthetic Changes. In 2015, USDA’s Animal and Plant Health Inspection
Service (APHIS) granted nonregulated status to the first GE apple varieties—
Arctic apples were genetical y engineered to silence, or turn off, the gene
responsible for an enzyme that causes browning when a sliced apple is exposed
to air.26 These apples became commercial y available in the United States in
2017, and they have been marketed as a way to reduce food waste.27 In 2016, the
U.S. Food and Drug Administration (FDA) approved for sale in the United States
a GE pink-fleshed pineapple—PinkGlow pineapples were genetical y engineered
to suppress the enzyme that turns a natural y occurring pink pigment in
pineapples yel ow.28 This pineapple first became available for purchase in the
United States in October 2020, following research and development since 2005.
 Enhanced Nutritional Qualities. In 2018, FDA approved a GE rice variety with
enhanced nutritional properties—Golden Rice was genetical y engineered to
serve as a source of Vitamin A, key to preventing a form of blindness.29 This rice
was developed to address nutrient deficiency concerns in Asia and is not intended
for consumption in the United States. Following decades of research and
development, it has not been sold commercial y as of the date of this report. In
2018, USDA first granted nonregulated status to a GE variety of canola with an
altered oil profile.30 Genetic engineering altered this canola variety to increase
levels of an omega-3 fatty acid (docosahexaenoic acid) in its seeds. It has been
marketed as an alternative to sourcing omega-3 dietary supplements from fish.31
 Reduced Allergenicity. Researchers have long investigated ways to reduce or
eliminate proteins in plants that trigger severe al ergic responses in some
individuals. Genetic engineering is one path under investigation in crops such as

26 Under the Animal and Plant Health Inspection Service’s (APHIS’s) biotechnology regulations prior to revisions
effective in 2021, the granting of nonregulated status to a GE product was a final step towar d full commercialization,
following a lengthy regulatory review and testing process. For more information on this process and revisions effective
in 2021, see “ Animal and Plant Health Inspection Service.” For information on USDA’s granting of nonregulated status
to Arctic apples, see APHIS, “Questions and Answers: Arctic Apple Deregulation,” February 2015, at
https://www.aphis.usda.gov/publications/biotechnology/2015/faq_arctic_apples.pdf.
27 Arctic Apples, “About Us,” at https://arcticapples.com/about-us.
28 For information on FDA approval of this GE pineapple, see FDA, “ FDA Concludes Consultation on Pink Flesh
Pineapple,” December 14, 2016, at https://www.fda.gov/food/cfsan-constituent -updates/fda-concludes-consultation-
pink-flesh-pineapple.
29 For information on FDA approval of Golden Rice, see Letter from Dennis M. Keefe, Ph.D., director of FDA’s Office
of Food Additive Safety to Donald J. MacKenzie, Ph.D., International Rice Research Institute Regulatory Affairs &
Stewardship leader, May 24, 2018, at https://www.fda.gov/media/113719/download.
30 APHIS, “Nuseed Americas Inc.; Determination of Nonregulated Status of Canola Genetically Engineered for Altered
Oil Profile,” 83 Federal Register 43634, August 27, 2018.
31 Nuseed, “First Land-Based Omega-3,” at https://nuseed.com/us/omega-3_beyondyield.
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peanuts and wheat.32 These applications of genetic engineering have not
advanced to commercialization as of the date of this report.
Agricultural Animals and Animal Products (Pharmaceuticals)
Commercialization of genetic engineering in agricultural animals, including those used for food,
feed, and fiber, has been limited.33 Researchers reported production of the first GE agricultural
animals in 1985;34 as of the date of this report, the federal government has approved two such
animals for food use: the AquAdvantage salmon and the GalSafe pig. Many in the scientific
community assert that the regulation of GE animals is overly burdensome and impedes
innovation.35 FDA has argued that rigorous review of GE animals is necessary to protect animals
and public health.36 Some research has shown that consumer views of GE animals may depend on
the intended purpose of the GE changes.37 This research suggests stronger public support for GE
animals intended to benefit human health than for other purposes.
Animals
Researchers have used genetic engineering to introduce a variety of traits into agricultural
animals. These include producer- and consumer-oriented traits, some of which also may address
worker safety and animal welfare. Among producer-oriented traits are those that increase growth
rates, reduce susceptibility to pests and diseases, and reduce physical dangers of animal rearing.
Consumer-oriented traits include those that eliminate al ergens and those that alter the nutritional
profile of animal products. A few examples are discussed below.
 AquAdvantage Salmon. In November 2015, FDA announced its first approval
of a GE animal intended for food use: a GE salmon developed by the
Massachusetts biotechnology firm AquaBounty.38 The AquAdvantage Atlantic
salmon grows at approximately twice the rate of non-GE Atlantic salmon.
AquaBounty used genetic engineering to introduce DNA—sourced from
Chinook salmon and an ocean pout—into Atlantic salmon, so that the GE
Atlantic salmon expresses the Chinook salmon growth hormone. AquAdvantage
salmon may become commercial y available in the United States in 2021.

32 For selected examples, see ISAAA, “ Anti-Allergy Biotech Crops,” Pocket K no. 53, October 2017.
33 T his report does not provide in-depth discussion of nonagricultural GE animals, which may include animals
genetically engineered to produce pharmaceuticals or to limit the spread of insect -borne disease.
34 R.E. Hammer et al., “Production of T ransgenic Rabbits, Sheep, and Pigs by Microinjection,” Nature, vol. 315, no.
6021 (June 20-26, 1985), pp. 680-683.
35 See, for example, T he Editors, “Course Correction,” Nature Biotechnology, vol. 38, no. 2 (February 7, 2020), pp.
142-143; and Alison L. Van Eenennaam et al., “ Genetic Engineering of Livestock: T he Oppo rtunity Cost of Regulatory
Delay,” Annual Reviews of Biosciences, vol. 9 (February 2021), pp. 453-478.
36 Steven M. Solomon, “ Genome Editing in Animals: Why FDA Regulation Matters,” Nature Biotechnology, vol. 38,
no. 2 (February 7, 2020), p. 113.
37 Cary Funk and Meg Hefferon, Most Americans Accept Genetic Engineering of Animals That Benefits Human Health,
but Many Oppose Other Uses, Pew Research Center, August 16, 2016, at https://www.pewresearch.org/science/
2018/08/16/most-americans-accept-genetic-engineering-of-animals-that-benefits-human-health-but-many-oppose-
other-uses.
38 FDA, “ AquAdvantage Salmon Approval Letter and Appendix,” NADA 141-454, November 19, 2015, at
https://www.fda.gov/animal-veterinary/animals-intentional-genomic-alterations/aquadvantage-salmon-approval-letter-
and-appendix.
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 GalSafe Pigs. In December 2020, FDA announced its second approval of a GE
animal intended for food use and, coincidental y, its first approval of a GE animal
for both food use and human therapeutics: a GE pig free of a sugar that causes
al ergic reactions in some people.39 GalSafe pigs have been genetical y
engineered to inhibit production of alpha-gal sugar, which can cause al ergic
reactions in people with alpha-gal syndrome. These pigs may be used to produce
pork products or biomedical materials, such as blood thinners or transplant
tissues, safe for people with alpha-gal syndrome. These GE pigs are not yet on
the market as of the date of this report.
 Polled Cattle. Dairy cows natural y develop horns, which most farmers and
ranchers remove—in a bid to protect animals and people from goring—via
mechanical processes that have raised some concerns with animal welfare
advocates. Recombinetics, a Minnesota-based gene editing company, has been
researching and developing hornless, or polled, GE dairy cows. In these cattle,
DNA for the polled trait—sourced from a natural y hornless Angus breed—was
introduced into a Holstein dairy breed through genetic engineering. A voluntary
review by FDA identified the unintended inclusion of nontarget DNA in one of
these cattle in 2019, and they remain under development.40
Animal Products (Pharmaceuticals)
In addition to genetical y engineering animals to express producer- and consumer-oriented traits,
researchers have used genetic engineering to induce animals to produce biological products, such
as pharmaceuticals. A few examples are discussed below.
 Goats: Blood Anti-clotting Protein. In February 2009, FDA approved the first
human drug produced by a transgenic animal, as wel as the GE animal used to
produce it.41 Researchers used genetic engineering to induce goats to produce
antithrombin III, a human anti-clotting protein, in their milk. Since FDA
approval, antithrombin III extracted from GE goats’ milk remains in use.
 Rabbits: Blood-Clotting Protein. Researchers genetical y engineered rabbits to
produce recombinant human blood-clotting proteins for use in patients with
hemophilia. These rabbits express the proteins in their milk, which can be
purified for use as a human drug. In December 2018, FDA approved production
of the GE rabbits; in April 2020, it approved the drug derived from these rabbits
for therapeutic use in people.42

39 FDA, “ FDA Approves First-of-its-Kind Intentional Genomic Alteration in Line of Domestic Pigs for Both Human
Food, Potential Therapeutic Uses,” press release, December 14, 2020, at https://www.fda.gov/news-events/press-
announcements/fda-approves-first-its-kind-intentional-genomic-alteration-line-domestic-pigs-both-human-food.
40 For information on the development and regulatory setbacks associated with these GE polled cattle, see Antonio
Regalado, “Gene-Edited Cattle Have a Major Screwup in T heir DNA,” MIT Technology Review, August 29, 2019.
41 Andrew Pollack, “F.D.A. Approves Drug From Gene-Altered Goats,” New York Times, February 6, 2009.
42 FDA, Freedom of Information Summary: Original New Animal Drug Application: NADA 141 -511, Bc2371 rDNA
Construct in R69 New Zealand White Rabbits, December 27, 2018; and FDA, “ FDA Approves Additional T reatment
for Adults and Adolescents with Hemophilia A or B and Inhibitors,” press release, April 1, 2020.
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Other Organisms
Beyond plants and animals, biotechnology has been used to alter various types of microorganisms
(e.g., bacteria, algae, yeast) and fungi for food, feed, pharmaceutical, energy, and other purposes.
A 2017 report by the National Academies of Sciences, Engineering, and Medicine (NASEM)
includes such applications of genetic engineering among the future products of biotechnology that
may diverge from those applications currently in use.43 Some of these applications use
microorganisms to produce enzymes or hormones original y derived from animals. Some,
including fungi intended for food use (i.e., mushrooms), are GE food organisms other than plants
and animals. A few current applications are discussed below, and many others are under research
and development.
 Bacteria: Food-Production Enzymes. Chymosin is an enzyme that natural y
occurs in newborn ruminant animals (e.g., cattle, sheep, goats), and it has the
effect of curdling milk. It has been used in cheese production for thousands of
years. In 1990, chymosin produced in a GE strain of the bacterium Escherichia
coli (E. coli) became the first GE food ingredient approved by FDA.44 Currently,
GE chymosin is used in most hard cheeses produced in the United States.45
 Bacteria: Animal Drugs. Bovine somatotropin (bST, also known as “bovine
growth hormone”) is a hormone that natural y occurs in cattle, and it can increase
milk production in lactating cows. In the 1980s, researchers began developing
ways to produce large quantities of bST with genetic engineering. They
introduced the gene for bST into a strain of E. coli, which could then produce the
hormone in quantities that could be isolated for use in dairy cows. FDA first
approved Posilac, a GE bST (an rbST), in 1993.46 More than 20 countries have
approved rbST, though it remains prohibited by many U.S. trading partners.47 Its
use in the United States has declined from about 15% of al dairy operations in
2007 to about 10% in 2014.48
 Mushrooms: Food. In 2016, a white button mushroom became the first test case
for USDA regulation of a genome-edited agricultural product.49 A researcher at
Pennsylvania State University used CRISPR-Cas9 to create a nonbrowning
mushroom by deleting a few DNA base pairs in a gene linked to browning. In a
letter to the researcher, USDA confirmed that the mushroom is not subject to
USDA regulation because it does not contain DNA from a plant pest or pathogen

43 NASEM, Future Products of Biotechnology, 2017.
44 See Eric L. Flamm, “How FDA Approved Chymosin: A Case History,” Nature Biotechnology, vol. 9 (April 1, 1991),
pp. 349-351.
45 Jon Entine and XiaoZhi Lim, “Cheese: T he GMO Food Die-Hard GMO Opponents Love, but Don’t Want to Label,”
GLP, November 2, 2018, at https://geneticliteracyproject.org/2018/11/02/cheese-gmo-food-die-hard-gmo-opponents-
love-and-oppose-a-label-for.
46 FDA, “ Bovine Somatotropin (bST ),” at https://www.fda.gov/animal-veterinary/product-safety-information/bovine-
somatotropin-bst.
47 Among other countries, Japan, Australia, Canada, New Zealand, and the European Union (EU) prohibit use of rbST
in dairy cows. Milk containing rbST has fallen out of favor in some places in the United States.
48 APHIS, Dairy 2007, Part I: Reference of Dairy Cattle Health and Management Practices in the United States, 2007,
October 2007; and APHIS, Dairy 2014: Dairy Cattle Managem ent Practices in the United States (Report 1), February
2016.
49 Emily Waltz, “Gene-Edited CRISPR Mushroom Escapes US Regulation,” Nature, vol. 532, no. 7599 (April 14,
2016), p. 293.
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or contain any introduced DNA at al .50 Reports indicate that as of early 2019,
these mushrooms were not commercial y available.51
Views of Agricultural Biotechnology
When foods containing GE ingredients were introduced in the 1990s, some members of the
public cal ed for banning them based on concerns about potential harm to human
health.52 Research has repeatedly found no difference between foods developed with and without
genetic engineering, in terms of the health and safety of the people consuming them.53 Even so,
some consumers remain concerned about genetic engineering, citing health, personal preference,
environmental, economic, and other objections.54 As such, the views of the scientific community,
consumers, and farmers and ranchers on the safety, utility, and ethics of agricultural
biotechnology do not always align. Society continues to debate these issues, and numerous
advocacy and trade organizations promote various sides of the debate.
Scientific Assessments
NASEM is an independent scientific organization chartered by Congress with a mandate to
provide the federal government with analyses of scientific topics upon request.55 Over the years,
NASEM has examined and reported its findings on the effects, if any, of GE crops and foods on
human health, economics, the environment, and other matters. NASEM’s findings align with
those of many other national and international scientific organizations.
The federal regulatory process also provides scientific assessments of individual GE agricultural
products (see “U.S. Regulatory System’s Coordinated Framework”). Prior to providing any
approvals to release, transport, market, or sel GE environmental products, the federal
government evaluates their safety for human and animal consumption and potential
environmental release.

50 Letter from Michael J. Firko, Ph.D., deputy administrator, APHIS, to Dr. Yinong Yang of the Pennsylvania State
University, April 13, 2016, at https://www.aphis.usda.gov/biotechnology/downloads/reg_loi/15-321-
01_air_response_signed.pdf.
51 Ashley P. T aylor, “Companies Use CRISPR to Improve Crops,” The Scientist, February 1, 2019.
52 Bloomberg BNA, “Group Encourages Consumer Support for U.S. Ban on Genetically Altered Food,” Daily Report
for Executives (BNA), August 31, 1999; and Alan Yonan Jr., “ Environmentalists Escalate Fight Against Altered
Crops,” Dow Jones, August 24, 1999.
53 See FDA, “Questions & Answers on Food from Genetically Engineered Plants,” January 4, 2018; NASEM,
Genetically Engineered Crops, 2016; and Institute of Medicine (IOM) and National Research Council (NRC), Safety of
Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects, 2004.
54 For reviews of some of these concerns, see Emmanuel B. Omobowale, Peter A. Singer, and Abdallah S. Daar, “T he
T hree Main Monotheistic Religions and GM Food T echnology: An Overview of Perspectives, ” BMC International
Health and Hum an Rights, vol. 9, no. 18 (August 2009); and Stefaan Blacke, “ Why People Oppose GMOs Even
T hough Science Says T hey Are Safe,” Scientific Am erican, August 18, 2015. See also Non-GMO Project, “ GMO
Facts,” at https://www.nongmoproject.org/gmo-facts.
55 36 U.S.C. §150301. In 2015, the National Academy of Sciences (NAS), the National Academy of Engineering
(NAE), the IOM, and the NRC were rebranded collectively as NASEM. Reports prior to 2015 may note authorship of
individual academies, the NRC, or both, and reports after this date note authorship of NASEM.
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Human Health
The potential effects of consuming GE foods on human health has been a major public concern
since they were first developed. Before data on health outcomes for people consuming GE foods
were available, the potential risks associated with this new technology were unknown. In the
decades since the first GE food entered the market, data and evidence have accumulated.
Numerous scientific analyses have been conducted, and peer-reviewed scientific studies have
been published. The scientific community is now general y in agreement that commercial y
available GE foods are safe to eat. NASEM has successively reported findings of no difference in
the health effects of GE and non-GE foods.56 Other scientific bodies, including federal agencies
and international organizations, also have reached this conclusion (see text box, below).

56 NASEM, Genetically Engineered Crops, 2016; and IOM and NRC, Safety of Genetically Engineered Foods:
Approaches to Assessing Unintended Health Effects, 2004.
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Selected Statements of Scientific, Federal, and International Organizations on the
Safety of Genetically Engineered (GE) Foods
As reflected in the statements below, the scientific community is general y in agreement that commercial y
available GE foods are safe to eat.
National Academies of Sciences, Engineering, and Medicine (NASEM)
“On the basis of detailed examination of comparisons of currently commercialized GE and non-GE foods in
compositional analysis, acute and chronic animal-toxicity tests, long-term data on health of livestock fed GE foods,
and human epidemiological data, the committee found no differences that implicate a higher risk to human health
from GE foods than from their non-GE counterparts.”
-
NASEM, Genetical y Engineered Crops: Experiences and Prospects, 2016, at https://doi.org/10.17226/23395.
American Association for the Advancement of Science (AAAS)
“Indeed, the science is quite clear: crop improvement by the modern molecular techniques of biotechnology is
safe.”
-
AAAS, Statement by the AAAS Board of Directors on Labeling of Genetical y Modified Foods, 2012, at
https://www.aaas.org/news/statement-aaas-board-directors-labeling-genetical y-modified-foods (accessed
March 24, 2021).
U.S. Food and Drug Administration (FDA)
“GMO foods are as healthful and safe to eat as their non-GMO counterparts. Some GMO plants have actual y
been modified to improve their nutritional value.”
-
FDA, “Agricultural Biotechnology,” at https://www.fda.gov/food/consumers/agricultural-biotechnology
(accessed March 24, 2021).
World Health Organization (WHO)
“GM foods currently available on the international market have passed safety assessments and are not likely to
present risks for human health. In addition, no effects on human health have been shown as a result of the
consumption of such foods by the general population in the countries where they have been approved.”
-
WHO, “Q&A Detail: Food, Genetical y Modified,” May 1, 2014, at https://www.who.int/news-room/q-a-
detail/food-genetical y-modified (accessed March 24, 2021).
European Commission (EC)
“The main conclusion to be drawn from the efforts of more than 130 research projects, covering a period of
more than 25 years of research, and involving more than 500 independent research groups, is that biotechnology,
and in particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies.”
-
EC, A Decade of EU-funded GMO Research (2001–2010), 2010, at https://doi.org/10.2777/97784.
The Royal Society (United Kingdom)
“Al reliable evidence produced to date shows that currently available GM food is at least as safe to eat as non -GM
food.”
-
The Royal Society, “Is it Safe to Eat GM Crops?,” at https://royalsociety.org/topics-policy/projects/g m-
plants/is-it-safe-to-eat-gm-crops (accessed March 24, 2021).
Environmental Effects
Some have expressed concerns that GE crops and agricultural products may harm the
environment now or in the future. Specifical y, these concerns include that
 HT crops may increase herbicide resistance in agricultural weeds;
 Bt crops may increase pest resistance to agricultural pesticides;
 Bt crops may harm nontarget species, such as butterflies and bees; and
 GE traits may escape into native species through interbreeding or other means.
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NASEM has examined these issues in various reports.57 A 2010 NASEM report found that GE
crops general y had fewer negative environmental effects than non-GE crops, but it also warned
that this could change over time due to some of the ways that farmers use GE crops as pest
management tools.58 A 2016 NASEM report presented more uncertainty:
Overall, the committee found no conclusive evidence of cause-and-effect relationships
between GE crops and environmental problems. However, the complex nature of assessing
long-term environmental changes often made it difficult to reach definitive conclusions.59
Other scientific bodies provide similar assessments. A 2019 report by the World Resources
Institute, a global nonprofit research organization, researched and proposed solutions intended to
address global food security in an environmental y sustainable manner.60 This report’s
environmental analysis of GE crops focused on HT and Bt traits and concluded the following:
Although claims both for and against GM technology have often been overstated, the best
evidence is that GM technology has already provided some yield gains from Bt crops and
has probably reduced toxicity both to humans and the environment, relative to the use of
alternative crop varieties that require more pesticide use.61
HT and pest-resistant GE crops have been associated with lower use of chemical herbicides and
pesticides than are in use in non-GE crop fields. However, over time, herbicide use on HT crops
can lead to herbicide-resistance in agricultural weeds, and agricultural pests can develop
resistance to pest-resistant GE crops. If these changes lead farmers to apply more or different
types of herbicides and pesticides, then doing so could reverse this trend and increase potential
environmental harms associated with these GE crops. Figure 3 shows that whereas adopters of
HT corn varieties used fewer herbicides (pounds per planted acre) than nonadopters in 2001 and
2005, by 2010, there was almost no difference in herbicide use. Figure 4 shows a similar trend in
the use of pesticides by adopters and nonadopters of Bt corn varieties over the same time period.

57 See, for example, NASEM, Genetically Engineered Crops, 2016; NRC, The Impact of Genetically Engineered Crops
on Farm Sustainability in the United States, National Academies Press, 2010; NAS and NRC, Environm ental Effects of
Transgenic Plants: The Scope and Adequacy of Regulation , National Academies Press, 2002; NAS and NRC,
Genetically Modified Pest-Protected Plants: Science and Regulation , National Academies Press, 2000.
58 NRC, The Impact of Genetically Engineered Crops on Farm Sustainability in the United States, National Academies
Press, 2010.
59 NASEM, Genetically Engineered Crops, 2016.
60 T im Searchinger et al., Creating a Sustainable Food Future, World Resources Report, World Resources Institute,
July 2019. For the report’s discussion of genetic engineering, see section on “ Genetic Modification,” p p. 185-192.
61 Ibid., p. 190.
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Figure 3. Insecticide Use, GE and Non-GE Corn Fields
(2001-2010)

Source: Adapted by CRS from Jorge Fernandez-Cornejo et al., Genetical y Engineered Crops in the United States,
ERS, ERR-162, Figure 13, February 2014.
Notes: Bt corn is genetical y engineered to have insect-resistant traits.
Figure 4. Herbicide Use, GE and Non-GE Corn Fields
(2001-2010)

Source: Adapted by CRS from Jorge Fernandez-Cornejo et al., Genetical y Engineered Crops in the United States,
ERS, ERR-162, Figure 14b, February 2014.
Notes: HT corn is genetical y engineered to have herbicide-tolerant traits.
Economic Effects
The use of GE crops has been associated with various economic outcomes for farmers, under
different conditions and at different points in time. Some have raised concerns about the
profitability of GE crops for the farmers that use them, as wel as potential economic impacts of
GE crops on farmers who use only organic practices.
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Some have asserted that GE crops commit some farmers to purchasing agricultural products that
they cannot afford, asserting that GE seeds may be more expensive than non-GE seeds and that
farmers cannot save harvested GE seeds for future use and so must purchase new seeds each
season. A 2016 NASEM report found general y favorable economic outcomes for farmers that use
GE commodity crops. It also highlighted that these outcomes vary depending on a number of
factors, including pest prevalence, farming practices in use, and agricultural infrastructure.62 A
2014 study by USDA’s ERS found that a majority of U.S. farmers had adopted GE varieties of
major commodity crops, and it stated that farmers would continue to use GE crops as long as GE
crops are benefiting them.63 The report advised that increased pest resistance to Bt crops and
weed resistance to the herbicide glyphosate, incorporated into many HT crops, may change this
calculus in the future. Beyond U.S. farmers, a widely publicized theory attributed farmer suicides
in India to economic hardships experienced due to their reliance on GE cotton.64 Numerous
scientific studies have concluded that there is no causal relationship between use of GE cotton
and farmer suicides in India.65
Others have raised concerns that some farmers’ use of GE crops may negatively affect economic
outcomes for neighboring farmers who grow and market organic crops. A 2016 ERS report stated,
“only 87 organic producers suffered economic losses from the unintended presence of GE
material during 2011-14.”66 It concluded that problems of coexistence between GE and non-GE
farms might grow in the future as more GE crops are commercialized. Further, the report
identified several gaps in available data about GE and non-GE crop production that prevent
detailed analysis.
Public Opinion
Agricultural biotechnology has provoked strong public sentiment, both in favor of and against its
use. Some have argued that genetic engineering and other biotechnologies are essential tools to
address global food insecurity, environmental degradation, global warming, food safety, and
animal welfare. Others have argued that agricultural biotechnology is unsafe, poorly tested, a
danger to the environment, and a potential source of food safety concerns.
A 2016 survey by the Pew Research Center showed that about half of Americans surveyed
believed there is no difference in the health effects of GE versus non-GE foods (Figure 5).67 This
survey also showed that 16% of al respondents care a great deal about the issue of GE foods, and
among these respondents, most believe that GE foods pose risks to human health and to the
environment. Some scholarship suggests that for many individuals, anti-biotechnology arguments

62 NASEM, Genetically Engineered Crops, 2016.
63 Jorge Fernandez-Cornejo et al., Genetically Engineered Crops in the United States, ERR 162, ERS, February 2014
(hereinafter Fernandez-Cornejo et al., GE Crops in the United States, 2014), p. 41.
64 See, for example, Natasha Gilbert, “Case studies: A hard look at GM crops,” Nature, vol. 497 (May 2, 2013), pp. 24-
26; and GM Watch, “ Vandana Shiva on seed monopolies, GMOs, and farmer suicides in India,” November 16, 2013, at
https://www.gmwatch.org/en/news/archive/2013/15165-vandana-shiva-on-seed-monopolies-gmos-and-farmer-suicides-
in-india.
65 See, for example, Keith Kloor, “T he GMO-Suicide Myth,” Issues in Science and Technology, vol. 30, no. 2 (Winter
2014), pp. 65-78; and Guillaume Gruère and Debdatta Sengupta, “ Bt cotton and farmer suicides in India: An evidence-
based assessment,” The Journal of Development Studies, vol. 47, no. 2 (February 2011), pp. 316–337.
66 Catherine Greene et al., Economic Issues in the Coexistence of Organic, Genetically Engineered (GE), and Non-GE
Crops, ERS, EIB-149, February 2016, p. 29.
67 Cary Funk and Brian Kennedy, The New Food Fights: U.S. Public Divides Over Food Science, Pew Research
Center, December 1, 2016.
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that appeal to intuition and emotion may be more influential than scientific evidence about GE
safety.68
A 2014 report by USDA’s ERS reviewed research on consumer acceptance of GE foods, among
other issues.69 It reported that U.S. consumers are wil ing to pay a premium for non-GE foods. It
also concluded that information about biotechnology can influence consumer wil ingness to pay
for GE foods. Positive information can increase wil ingness to pay, and negative information can
decrease it.
Figure 5. Public Opinion: Health Effects of Genetically Engineered (GE) Foods (2016)

Source: Figure created by CRS from Cary Funk and Brian Kennedy, The New Food Fights: U.S. Public Divides Over
Food Science, Pew Research Center, December 1, 2016.
Notes: Data are drawn from a survey conducted as part of the American Trends Panel, a national y
representative panel of randomly selected U.S. adults living in households, created by Pew Research Center.
Views of Agricultural Producers
Many U.S. farmers and ranchers—including a majority of those that grow commodity crops70—
use GE biotechnology products, including GE seeds and animal feed made with GE grains. Other
farmers and ranchers, including organic farmers, avoid GE agricultural products. Economic
factors may influence agricultural producers’ views and use of GE versus non-GE products. For
example, farmers who use GE products may do so because they are cost effective for their
circumstances, while organic farmers who do not use GE products may receive a price premium
for non-GE certification. Producer associations that advocate on behalf of U.S. farmers and
ranchers have expressed different views of biotechnology through their statements on specific
issues and policy platforms. Some of these views are discussed below.

68 See, for example, Stefaan Blancke, “Why People Oppose GMOs Even T hough Science Says T hey Are Safe,”
Scientific Am erican, August 18, 2015, at https://www.scientificamerican.com/article/why-people-oppose-gmos-even-
though-science-says-they-are-safe.
69 Fernandez-Cornejo et al., GE Crops in the United States, 2014.
70 Fernandez-Cornejo et al., GE Crops in the United States, 2014.
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Crop Producers
The American Soybean Association (ASA) and the National Corn Growers Association (NCGA)
maintain biotechnology as a “key issue.”71 Both organizations support efforts to update the
federal regulatory system for biotechnology products, including USDA’s 2020 regulatory
revision that largely exempts genome-edited agricultural products from regulatory review.72 Since
2007, ASA has maintained a Biotechnology Working Group as a forum for soybean farmers and
technology providers. United Fresh Produce Association, which represents stakeholders from
across the produce industry (e.g., retailers, distributors, industry associations, researchers), has
also expressed support for updating USDA’s regulation of GE plants and federal standards for
disclosing the GE status of foods.73
Livestock and Producers
In 2019, the National Pork Producers Council (NPPC) launched its “Keep America First in
Agriculture” campaign in support of genome editing in livestock.74 This campaign advocates for
revisions to the U.S. regulatory system to facilitate the use of genome editing in livestock and
“enabl[e] America’s farmers to remain competitive in the global market.”75 The National
Cattleman’s Beef Association (NCBA) opposes the labeling of meat products solely because the
livestock consumed GE feed, and it supports moving regulation of GE livestock from FDA to
USDA.76
Seafood Industry
The GE salmon known as AquAdvantage salmon was first developed in 1989; in 2015, it became
the first GE animal approved by FDA for food use (see also “Animals”). AquaBounty, the
company that developed the AquAdvantage salmon, describes these salmon as “fresh, healthy and
affordable Atlantic salmon that’s ready to feed – and change – the world.”77 Some Members of
Congress have raised concerns about GE salmon. They have chal enged the FDA approval
process,78 proposed legislation requiring the labeling of GE salmon,79 and added provisions into
annual appropriations legislation to require their labeling.80

71 American Soybean Association (ASA), “Biotechnology,” at https://soygrowers.com/key-issues-initiatives/key-issues/
biotechnology/; and National Corn Growers Association (NCGA), “ Biotechnology,” at https://ncga.com/key-issues/
other-topics/biotechnology.
72 ASA, “ ASA Pleased with USDA Final Rule on Biotech Crop Approval,” press release, May 15, 2020; and NCGA,
“NCGA Commends USDA Rule Updating Biotech Regulation Process,” press release, May 15, 2020.
73 United Fresh Produce Association, “Biotechnology,” at https://www.unitedfresh.org/advocacy/biotechnology.
74 National Pork Producers Council (NPPC), “NPPC Launches ‘Keep America First in Agriculture Campaign,” press
release, June 25, 2019; and NPPC, “Keep America First in Agriculture,” at https://nppc.org/kafa.
75 Ibid.
76 National Cattleman’s Beef Associat ion (NCBA), 2021 Policy Book, January 2021.
77 AquaBounty, “About Us,” at https://aquabounty.com/about-us (accessed March 24, 2021).
78 See, for example, letter from eight Senators to FDA Commissioner Margaret Hamburg, July 15, 2011; and letter
from 15 U.S. Representatives to FDA Commissioner Margaret Hamburg, July 15, 2011, at https://donyoung.house.gov/
uploadedfiles/fish_letter_final_final.pdf.
79 FDA approved AquAdvantage salmon before the enactment of the National Bioengineered Food Disclosure Standard
(the Standard), and they are not required to be labeled under the Standard. Proposed legislation that would have
required GE labeling of salmon regardless of when it was approved included H.R. 270, H.R. 1103, and S. 282.
80 For example, §778 of the Consolidated Appropriations Act, 2021 ( P.L. 116-260) requires that “the acceptable market
name of any engineered animal approved prior to the effective date of the National Bioengineered Food Disclosure
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Organic Agriculture
Various groups representing the organic sector advocate on policies related to genetic engineering
in agriculture. USDA’s National Organic Program (NOP),81 and other organic certification
programs, exclude any practices or inputs involving genetic engineering or GE products. The
Organic Trade Association, which represents organic farmers, retailers, and others involved in
organic trade, issued a 2011 policy position that cal s for a moratorium on GE organisms in
agriculture, supports mandatory labeling of GE products, and commits to continued advocacy on
other issues related to genetic engineering.82 CCOF (California Certified Organic Farmers), an
organic-certifying entity and trade association, opposes the use and new approvals of GE
agricultural products and supports GE labeling.83 Policy positions of the National Organic
Coalition, which consists of member organizations that represent organic stakeholders, support
the prohibition of synthetic biology and genome editing in organic production, criticize the
National Bioengineered Disclosure Standard as insufficiently transparent to consumers (see “GE
Labeling”), and express concern over the unintentional introduction of GE traits into organic
products through gene flow (e.g., pollen transfer) from GE crop fields.84
Advocacy Organizations
Numerous advocacy organizations, including Greenpeace, Friends of the Earth, the Center for
Food Safety, and Food and Water Watch, have managed long-running campaigns against
agricultural genetic engineering.85 These campaigns publish information questioning the safety,
commercial interests, and ethics of GE products, and they have raised legal chal enges to
biotechnology applications.
Other organizations, including the Biotechnology Information Organization (BIO, a trade
organization founded in 1993) and the International Service for the Acquisition of Agri-biotech
Applications (ISAAA, an international nonprofit organization founded in 1992), have promoted
the use of biotechnology. These organizations publish data on the global use of agricultural
biotechnology and information promoting the safety, economic value, and other perceived
advantages of biotechnology applications.
Some have argued that funding for advocacy on the part of pro-biotechnology or anti-
biotechnology organizations polarizes the debate.86 The Genetic Literacy Project (GLP), a

Standard (February 19, 2019) shall include the words ‘genetically engineered’ prior to the existing acceptable market
name.”
81 7 C.F.R. §205.105. For more information on USDA’s National Organic Program (NOP), see USDA, AMS, “National
Organic Program,” at https://www.ams.usda.gov/about-ams/programs-offices/national-organic-program.
82 Organic T rade Association (OT A), “ Organic T rade Association’s Position on GMOs,” July 28, 2011, at
https://ota.com/organic-trade-association%E2%80%99s-position-gmos (accessed March 24, 2021).
83 CCOF (California Certified Organic Farmers), “Genetically Modified Organisms/Genetic Engineering,” at
https://www.ccof.org/policy-advocacy/genetically-modified-organismsgenetic-engineering (accessed March 24, 2021).
84 National Organic Coalition, “Genetic Engineering,” at https://www.nationalorganiccoalition.org/genetic-engineering
(accessed March 24, 2021).
85 See, for example, Greenpeace, “GMOs and T oxic Pesticides,” at https://www.greenpeace.org/usa/sustainable-
agriculture/issues/gmos; Friends of the Earth, “ Genetic Engineering,” at https://foe.org/projects/genetic-engineering/?
issue=8; Center for Food Safety, “ GE Foods,” at https://www.centerforfoodsafety.org/issues/311/ge-foods; and Food
and Water Watch, “GMOs,” at https://www.foodandwaterwatch.org/problems/gmos.
86 See, for example, Lisa Cornish, “Understanding the Continued Opposition to GMOs,” Devex, January 22, 2018, at
https://www.devex.com/news/understanding-the-continued-opposition-to-gmos-91888; and Lisa Cornish, “ How do
corporations perceive their role in the GMO debate?,” Devex, May 11, 2018, at https://www.devex.com/news/how-do-
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nonprofit organization that publishes information and commentary about genetic engineering,87
compiles and publishes data on the funding of anti-biotechnology organizations and pro-
biotechnology industry.88
U.S. Regulatory System’s Coordinated Framework
With a few exceptions, the U.S. regulatory system for the products of biotechnology has changed
little since it was established in 1986. At that time, no GE products were commercial y available,
and modern biotechnology was viewed as an “infant industry.”89 The regulatory system discussed
below adapted existing laws—which provided regulatory authorities to three primary federal
agencies—to a new purpose: ensuring the safety of biotechnology products produced with then-
known and anticipated future technologies and techniques. As new biotechnology approaches and
applications have arisen in the decades since the original system was put in place, the federal
government has revisited this system through individual agency actions and interagency
initiatives coordinated by the White House Office of Science and Technology Policy (OSTP).
The federal government’s 1986 Coordinated Framework for Regulation of Biotechnology
(Coordinated Framework) governs how USDA, FDA, and the U.S. Environmental Protection
Agency (EPA) apply existing statutes to evaluate and ensure the safety of biotechnology products
(Figure 6).90 A key principle of the Coordinated Framework is to regulate products according to
their characteristics and unique features rather than the processes used to develop them—that is
whether or not they were developed with biotechnology. This approach contrasts with the
approach of some other countries—notably EU countries—that regulate products differently,
depending on whether or not they were developed with biotechnology. These countries apply the
precautionary principle, according to which a product should not be approved for use so long as
there is scientific uncertainty regarding the risks that it may pose (see text box, next page).
OSTP updated the Coordinated Framework in 1992 and 2017.91 These updates provided further
policy guidance to federal agencies and summarized the statutes under w hich they regulate
biotechnology products.

corporations-perceive-their-role-in-the-gmo-debate-92507.
87 For additional information on the GLP, see GLP, “ Mission, Financial T ransparency, Governorship, and Editorial
Ethics and Corrections,” at https://geneticliteracyproject.org/mission-financials-governorship/. T his web page states,
the GLP’s goal, through our website and outreach efforts, including the dissemination of
educational materials, organizing public and private conferences and initiating briefings with
regulators and government officials, is to prevent legislative overreach grounded in ideology rather
than science, help in the creation of reasonable ethical and religious oversight of biotechnological
innovation, and encourage cooperation among academic and industry researchers, all in an effort to
promote the public interest.
88 GLP, “Anti-GMO Advocacy Funding T racker,” at https://anti-gmo-advocacy-funding-
tracker.geneticliteracyproject.org.
89 Executive Office of the President (EOP), Office of Science and T echnology Policy, “Coordinated Framework for
Regulation of Biotechnology,” 51 Federal Register 23302, June 26, 1986.
90 Ibid; and FDA, “Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the
Regulation of Biotechnology and Developing a Long-T erm Strategy for the Regulation of the Products of
Biotechnology; Public Meeting,” 51 Federal Register 23302, June 26, 1986. For a compilation of information and
resources about U.S. biotechnology regulation, see USDA, FDA, and EPA, “T he Unified Website for Biotechnology
Regulation,” at https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/resources/faq/unified_biotech_faqs.
91 EOP, OST P, “ Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of
Biotechnology Products Into the Environment,” 57 Federal Register 6753, February 27, 1992; and OST P,
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Genetically Engineered Regulatory Principles of the United States vs. the
European Union
The United States and the EU apply contrasting approaches to the regulation of biotechnology and tolerance of
associated risks. The U.S. approach is product-based, while the EU approach is process-based, as described below.
Fundamental differences in the principles that guide these approaches drive much of the global debate around
biotechnology products in commerce. Regulatory systems may differ among countries, but the guiding principles
underlying these systems are likely to align more closely with the principles of either the United States or the EU.
United States: Principles of the Coordinated Framework for Regulation of Biotechnology
The U.S. regulatory approach is product-based. It endeavors to evaluate the risks of new products with the same
laws, and to the same standards of risk, irrespective of whether the product was developed with biotechnology.
The Coordinated Framework relies on the fol owing principles, among others, as quoted from the 1992 update to
the framework:

Federal oversight “focuses on the characteristics of the biotechnology product and the environment into
which it is being introduced, not the process by which the product is created.”

“Exercise of oversight [by federal agencies] in the scope of discretion afforded by statute should be based on
the risk posed by the introduction and should not turn on the fact that an organism has been modified by a
particular process or technique.”

“In order to ensure that limited Federal oversight resources are applied where they wil accomplish the
greatest net beneficial protection of public health and the environment, oversight wil be exercised only
where the risk posed by the introduction is unreasonable, that is, when the value of the reduction in risk
obtained by additional oversight is greater than the cost thereby imposed.”
In practice, federal agencies have promulgated regulations specific to genetical y engineered (GE) organisms using
authorities provided by preexisting statutes. While some have lauded this approach as evidence-based and
supportive of innovation, others have argued that it is insufficiently cautious and ignores risks associated with
uncertainty.
EU: The Precautionary Principle
The European regulatory approach is process-based. It evaluates the risks associated with new products
differently, depending on whether or not they were produced with biotechnology. The European Commission’s
2001 GMO Directive (Directive 2001/18/EC), which regulates the deliberate release of GE organisms into the
environment, is guided by the precautionary principle. The European Commission does not define this principle but
described it in a 2000 Communication from the Commission on the Precautionary Principle:

“Where action is deemed necessary, measures based on the precautionary principle should be, inter alia:
proportional to the chosen level of protection, non-discriminatory in their application, consistent with similar
measures already taken, based on an examination of the potential benefits and costs of action or lack of action ... ,
subject to review, in the light of new scientific data, and capable of assigning responsibility for producing the
scientific evidence necessary for a more comprehensive risk assessment.”
In practice, the precautionary principle has been interpreted to mean that a biotechnology product should not be
approved for use so long as there is scientific uncertainty regarding risks (e.g., societal, environmental) that it may
pose. While some have lauded this approach as protective of people and the environment, others have argued
that it is not evidence-based and does not account for risks associated with not approving such products.
Within the broader Coordinated Framework, the jurisdiction of the various agencies depends on
how the GE products are used. Jurisdiction, authorizing statutes, regulations, and other issues are
discussed below for USDA, FDA, and EPA, with respect to GE agricultural products. In practice,
al three agencies have more detailed procedures than described below for monitoring and
approving the development and commercialization of GE crops and foods, particularly for new
uses (e.g., pharmaceuticals). The fundamental guiding policy assumption since 1986 has been that
biotechnology processes, such as genetic engineering, pose no unique or special risks; therefore,
the general framework demands no new laws beyond those already governing the health, safety,
efficacy, and environmental impact of more traditional production methods.

“Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated
Framework for the Regulation of Biotechnology ,” January 4, 2017.
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Figure 6. Primary Legislative Authorities of Federal Biotechnology Regulation

Source: Figure created by CRS.
Notes: The Coordinated Framework for Regulation of Biotechnology incorporates provisions in statutes beyond the
primary statutes identified in this figure.
U.S. Department of Agriculture
Two USDA agencies engage in the Coordinated Framework: the Animal and Plant Health
Inspection Service and the Food Safety Inspection Service (FSIS). APHIS regulates new plants
and other organisms according to their plant-pest and noxious weed risks; biotechnology products
that are animal pests or may cause disease in livestock; and veterinary biologics. FSIS regulates
food products prepared from domestic livestock and poultry.
Animal and Plant Health Inspection Service
APHIS regulates agricultural biotechnology with respect to both plant and animal health.
Plant Health
USDA’s primary engagement with the regulation of biotechnology has been through APHIS’s
oversight of GE plants under the Plant Protection Act (PPA, 7 U.S.C. §7701 et seq.). Under the
PPA, APHIS regulates the importation, interstate movement, and environmental release
(including field testing) of GE plants and organisms that do or may pose a plant-pest risk. 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. APHIS’s PPA regulations for GE organisms (7 C.F.R. §340) define regulated
articles (i.e., the organisms subject to these PPA regulations; most are plants), processes to
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determine whether they are regulated, and how APHIS regulates them. In 2020, APHIS finalized
a rule updating these regulations.
Prior to 2020, APHIS assessed the plant-pest risk of every new GE variety, regardless of how
similar it was to a GE variety that APHIS had evaluated in the past.92 Product developers could
seek an APHIS determination of whether a new organism met the definition of regulated article
through the APHIS “Am I Regulated?” process. Regulated articles required either permits for
their importation, interstate transportation, or environmental release or use of a notification
process in lieu of permits when the plant was not considered a noxious weed and met other
standards. Regardless of the process used, after testing was completed, a developer could seek
nonregulated status from APHIS, the typical route to full commercialization and no further formal
oversight. In seeking nonregulated status, the developer was required to provide APHIS with
extensive information on plant biology and genetics and potential environmental and plant-pest
impacts that could result from the modification. APHIS would conduct a formal environmental
assessment under the National Environmental Protection Act (42 U.S.C. §4321 et seq.) and hold a
public comment period before deciding whether to grant nonregulated status. A determination of
nonregulated status ended further federal regulatory oversight of the GE plant or other organism.
In 2019, APHIS issued a proposed rule to exempt several categories of GE plants from regulatory
review under the PPA, citing 30 years of evidence indicating that “genetical y engineering a plant
with a plant pest as a vector, vector agent, or donor does not in and of itself result in a GE plant
that presents a plant pest risk.”93 The proposed rule further stated that new genetic engineering
technologies, such as genome editing, do not engage with plant pests in any way.94 APHIS
finalized this “SECURE Rule,” in May 2020.95
Unlike the prior regulations, USDA’s SECURE rule does not require that APHIS assess the risk
of every new GE variety. It applies APHIS’s current understanding of plant-pest risk to exempt
broad categories of new plants from review:
APHIS’ evaluations to date have provided evidence that genetically engineering a plant
with a plant pest as a vector, vector agent, or donor does not result in a GE plant that
presents a plant pest risk. Further, genetic engineering techniques have been developed that
do not employ plant pests … yet may result in organisms that do pose a plant pest risk.
The new regulations identify certain categories of modified plants that are exempt from the
regulations.96 These include plants that APHIS considers could have been developed through
conventional breeding (e.g., certain genome-edited varieties) and those that bear sufficient
similarity to GE plants for which APHIS has previously granted nonregulated status or
determined not to be regulated. Developers can request a written confirmation from APHIS that a
plant is not subject to the regulations. Plants that are not exempt must undergo a regulatory status

92 For example, under the regulations effective prior to the SECURE Rule, the same gene introduced into two different
varieties of corn required separate APHIS assessments.
93 APHIS, “Movement of Certain Genetically Engineered Organisms,” 84 Federal Register 26514, June 6, 2019.
94 Under the proposed rule change, APHIS may evaluate new plant varieties created through gene editing for noxi ous
weed risk.
95 USDA, “ Movement of Certain Genetically Engineered Organisms,” 85 Federal Register 29790, May 18, 2020.
SECURE stands for Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient. For additional information,
see CRS In Focus IF11573, USDA’s SECURE Rule to Regulate Agricultural Biotechnology, by Genevieve K. Croft and
T adlock Cowan.
96 Only plants, not other organism types, can be exempt.
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review, which replaces the prior petition process. This review is followed by a new permitting
process, which replaces the prior notification process.
Animal Health
Statutes cited in the Coordinated Framework also give APHIS regulatory oversight over
biotechnology products that are animal pests or may cause disease in livestock and veterinary
biologics (e.g., viruses, serums, toxins for animal vaccines). Under the Animal Health Protection
Act (AHPA, 7 U.S.C. §8301 et seq.), APHIS has the authority to restrict or prohibit the
importation, transportation, or environmental release of any live animal—including GE and non-
GE animals—to prevent the introduction and spread of pests and diseases of livestock.97 Under
the Virus-Serum-Toxins Act (VSTA, 21 U.S.C. §151 et seq.), APHIS has the authority to ensure
that veterinary biologics—including GE and non-GE-derived biologics—are pure, safe, potent,
and effective. APHIS licenses and continues oversight of veterinary biologics.
Food Safety Inspection Service
Within the Coordinated Framework, FSIS’s authority to regulate GE products derives from three
statutes: the Federal Meat Inspection Act (FMIA, 21 U.S.C. §601 et seq.), the Poultry Products
Inspection Act (PPIA, 21 U.S.C. §451 et seq.), and the Egg Products Inspection Act (EPIA, 21
U.S.C. §1031 et seq.). Under these statutes, FSIS has the authority to review the safety,
wholesomeness, and correct labeling of meat, catfish, poultry, and processed egg products
intended for human consumption.
Federal Drug Administration
FDA regulates food, animal feed additives, and human and animal drugs, 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’s regulation is intended primarily to ensure
that these foods and drugs pose no risks to human health. FDA regulations include oversight of
plants, animals, and other organisms produced with biotechnology.
Plants
Under the FFDCA, al food and feed manufacturers must ensure that the domestic and imported
products they market are safe and properly labeled. Al domestic and imported foods and feeds
must meet the same standards, whether or not they are derived from GE plants. Under the
FFDCA, FDA must approve any food additive before it can be marketed, unless the additive is
generally recognized as safe (GRAS).98
A May 1992 FDA policy statement clarified FDA policy with respect to foods derived from GE
plants.99 FDA treats most foods derived from GE plants as GRAS, unless the product or products

97 Under the Animal Health Protection Act (AHPA), animal is defined as “any member of the animal kingdom (except
a human)” (7 U.S.C. §8302(1)), and livestock is defined as “all farm-raised animals” (7 U.S.C. §8302(10)). In this
context, animal may be interpreted to include mammals, birds, insects, and other animals, and livestock may be
interpreted to include horses, cattle, bison, cervids, camelids, sheep, goats, swine, and other farm -raised animals.
98 For more information on GRAS, see FDA, “ Generally Recognized as Safe (GRAS),” at https://www.fda.gov/food/
food-ingredients-packaging/generally-recognized-safe-gras.
99 FDA, “Statement of Policy – Foods Derived from New Plant Varieties,” 57 Federal Register 22984, May 29, 1992;
and FDA, “ Guidance for Industry: Consultation Procedures under FDA’s 1992 Statement of Policy for Foods Derived
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that the plant expresses due to GE changes (e.g., proteins, carbohydrates, fats) “differ
significantly in structure, function or composition from substances found currently in food.”100
Such substances may be GRAS, or they may be considered to be food additives. The 1992 policy
statement noted that foods and feeds from GE plants must undergo a special review under certain
conditions. These include if the GE plant would be used to host an industrial or pharmaceutical
substance or if the change introduced through genetic engineering produces unexpected genetic
effects, changes nutrients or toxicant levels from levels in the food’s traditional variety, or might
introduce a new al ergen.
FDA encourages sponsors of foods and feeds derived from GE plants to participate in its
voluntary Plant Biotechnology Consultation Program to help these sponsors with regulatory
compliance.101 GE plant developers have routinely participated in this program since the first
such consultation in 1994. In 2019, FDA concluded its first consultation on a plant genetical y
engineered via genome editing. With few exceptions, the foods and feeds that FDA has reviewed
have not been considered to contain a food additive and thus have not required FDA approval
prior to marketing.
In June 2006, FDA published new guidance under which developers of new plant varieties
intended for food use—including those that are genetical y engineered—can provide FDA with
any information about new proteins they are using in the early stages of crop development.102
This Early Food Safety Evaluation Program (also known as a New Protein Consultation) is
designed to take place earlier in the development process than a voluntary plant biotechnology
consultation and prior to the stage of development when a new protein might “inadvertently”
enter the food supply. FDA designed this early consultation to address the possibility that field
testing of GE crops—through cross-pollination with other crops—could inadvertently introduce
smal amounts of proteins into the food supply that FDA has not evaluated (e.g., potential toxins
or al ergens).
Animals
FDA has regulated GE animals under the new drug provision of the FFDCA (21 U.S.C. §360b)
since issuing final guidance on the topic in 2009.103 The 2009 policy identifies the regulated
article (the new animal drug) as “the rDNA construct in a GE animal that is intended to affect the
structure or function of the body of the GE animal, regardless of the intended use of products that
may be produced by the GE animal.” That is to say, the DNA inserted into the animal’s genome
through genetic engineering is considered a new animal drug. Developers of GE animals and GE-
derived animal products must obtain FDA new animal drug approval before these animals and
products can be marketed and sold.

from New Plant Varieties,” October 2017.
100 FDA, “Statement of Policy – Foods Derived from New Plant Varieties,” 57 Federal Register 22984, May 29, 1992.
101 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.
102 FDA, “Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New
Plant Varieties Intended for Food Use,” 71 Federal Register 35688, June 21, 2006.
103 FDA, “Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs,”
Guidance for Industry #187, 74 Federal Register 3057, January 16, 2009.
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In 2017, FDA issued draft guidance for industry on the “Regulation of Intentional y Altered
Genomic DNA in Animals.”104 This draft guidance updates the prior guidance, in which the
regulated article was the recombinant DNA construct, to define the regulated article as the
“intentional y altered genomic DNA.” FDA describes intentional genomic alterations (IGAs)—a
term that FDA seemingly coined—as including genetic changes introduced through
biotechnology techniques that use recombinant DNA, as wel as those techniques that do not.
This guidance expands FDA oversight of GE animals to include those derived from genome
editing. It also clarifies that FDA intends to exercise enforcement discretion, including its
intention not to enforce certain requirements for animals of nonfood producing species that (1)
are regulated by other government agencies; (2) are raised and used in contained and controlled
conditions; or (3) other cases based on FDA evaluation of risk factors. Such GE animals include
GE insects regulated by APHIS, GE laboratory animals, and, in a specific example, GloFish
(aquarium fish genetical y engineered to fluoresce).105
FDA also has addressed the regulation of animal cloning. In 2008, FDA released a final risk
assessment and industry guidance on the safety of meat and milk from cloned cattle, pigs, and
goats, as wel as their offspring.106 This guidance found that such products are as safe to eat as
those of conventional y bred animals. FDA also concluded that cloning poses the same risks to
animal health as those found in animals created through other assisted reproductive technologies,
although the frequency of such problems is higher in cloned animals. FDA does not require
premarket approval of food products from cloned cattle, swine, or goats or their offspring.
Environmental Protection Agency
EPA registers and approves the use of al plant pesticides, including those incorporated through
genetic engineering (i.e., plant-incorporated protectants, or PIPs), under the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA, 7 U.S.C. §136 et seq.). EPA uses this process to
determine a PIP’s environmental safety. EPA also regulates pesticides with respect to human
health. Under the FFDCA, EPA establishes tolerances (i.e., safe levels) for pesticides in foods.
Pre-commercial regulation occurs through a system of notifications (for smal -scale field-tests) or
experimental use permits (for larger field-tests). As with any pesticide, EPA requires the
manufacturer of a PIP to obtain a registration through a regulatory process intended to ensure its
safe use environmental y.
Pending Proposal: The Regulation of GE Animals
As of the writing of this report, FDA regulates animal biotechnology under the FFDCA. The
original 1986 Coordinated Framework anticipated that (1) GE food animals would be regulated
by FSIS under the FMIA and PPIA, (2) many GE animals would not differ substantial y from
non-GE animals, and (3) these animals would be subject to the same inspection procedures and
regulations as non-GE animals. In 2009, FDA issued guidance on its regulation of GE animals

104 FDA, “ Regulation of Intentionally Altered Genomic DNA in Animals,” Draft Revised Guidance for Industry #187,
82 Federal Register 6561, January 19, 2017.
105 For information on intentional genomic alterations (IGAs) in animals for which FDA has used enforcement
discretion, including GloFish, see FDA, “ Intentional Genomic Alterations in Animals: Enforcement Discretion,” at
https://www.fda.gov/animal-veterinary/animals-intentional-genomic-alterations/intentional-genomic-alterations-
animals-enforcement -discretion.
106 FDA, “ Use of Animal Clones and Clone Progeny for Human Food and Animal Feed,” Guidance for Industry #179,
73 Federal Register 2923, January 16, 2008.
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and animal products under the new animal drug provision of the FFDCA (see “Federal Drug
Administration”), identifying the recombinant DNA construct as the new animal drug.
Nonetheless, developers of GE animals and of GE-derived products must gain FDA premarket
approval.
In December 2020, USDA issued an advance notice in the Federal Register, proposing a
framework to move the regulation of certain animals genetical y engineered for agricultural
purposes from FDA to USDA.107 In January 2021, USDA and the U.S. Department of Health and
Human Services (HHS) signed a memorandum of understanding (MOU). In this MOU, USDA
committed to establishing new regulatory programs for premarket and post-market review of GE
agricultural animals through federal rulemaking, using its authorities under the APHA, FMIA,
and PPIA. FDA committed to continuing its regulatory oversight of genetic engineering in
animals for nonagricultural purposes and certain other products, including dairy, table and shel
eggs, and certain meat products. USDA and FDA committed to working together to achieve
comprehensive regulatory oversight.
These proposals were put forward in the final weeks of the Trump Administration, over the
objections of the then-commissioner of FDA.108 As of the writing of this report, it remains to be
seen whether these proposals wil be implemented.
Defining Boundaries of GE and Non-GE Products
In some cases, the GE status of an agricultural product may be unclear, due to inadvertent
comingling of GE and non-GE material or unresolved questions regarding the regulatory
treatment of new and emerging technologies. Treatment of the low -level presence of GE material
in otherwise non-GE food, feed, and grains, and the regulation of genome-edited products, are
discussed below. These issues are relevant to both domestic commerce and international trade
(see also “Biotechnology and Global Trade”).
Low-Level Presence of GE Material
Low-level presence (LLP) refers to any incidental appearance of very smal amounts of foreign
material in a food, feed, or grain, which can occur at any time during production, harvesting,
storage, or marketing. Presently in the U.S. grain business, even shipments of the highest grades
are permitted to contain some specified low levels of unwanted material, such as weeds, damaged
kernels, and leaves. For example, U.S. grain standards permit corn graded No. 1 to contain up to
2% foreign material.109 In the context of biotechnology, LLP and the similar term adventitious
presence, refer to the unintended inclusion of GE material in otherwise non-GE commercial food,
feed, or grain.110 This incidental inclusion is known as LLP when the GE source has been
authorized for use in food, feed, or grain (in at least one country when the concern involves
international trade) and as adventitious presence when the GE source has not been authorized

107 USDA, “Regulation of the Movement of Animals Modified or Developed by Genetic Engineering,” 85 Federal
Register 84269, December 28, 2020. FDA found that insufficient information was available to make a determination on
cloned sheep, and it did not examine other animals.
108 See Sarah Owermohle and Adam Cancryn, “FDA Fights for Independence in T rump Administration’s Final Days,”
Politico, January 12, 2021.
109 7 C.F.R. §810.404.
110 See, for example, APHIS, “APHIS Policy on Responding to the Low-Level Presence of Regulated Genetically
Engineered Plant Materials,” 72 Federal Register 14649, March 20, 2007.
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(e.g., contamination from a field trial of a GE crop that has not yet received regulatory
approval).111
As more crops and acreage are devoted to GE varieties, it becomes increasingly difficult to avoid
their trace presence in non-GE varieties. Beyond setting thresholds and developing testing
protocols, a related issue is assessing liability if such mixing occurs or if GE plants prove harmful
to the environment. For example, to what extent, if any, should biotechnology companies share
liability with producers and others who use their products? This is an ongoing issue for U.S.
exports (see “Biotechnology and Global Trade”).
APHIS published a notice in the Federal Register in March 2007, describing its policy on
responding to the LLP of regulated GE plant materials in commercial seed or grain that might be
used for food or feed. Under this policy, an LLP event would not be subject to regulatory action
unless APHIS determines that it is likely to result in the introduction or dissemination of a plant
pest or noxious weed.112
Regulation of Genome-Edited Products
Since the emergence of CRISPR-Cas9 in 2013, and its rapid adoption as an efficient and targeted
genome editing technique, questions have arisen regarding its place within regulatory systems
that assess the safety of foods developed with biotechnology. Some have proposed that products
of genome editing in agriculture should not be regulated as GE products and should be treated in
the same manner as the products of conventional breeding.113 Some of these advocates have
argued that because genome editing does not necessarily require the use of recombinant DNA,
which defines the products of genetic engineering in some policies and regulations, it does not
meet the definition of genetic engineering. Others have stated that the changes induced by
genome editing could otherwise be found in nature or produced through conventional breeding,
albeit on a much longer timeline, and thus genome-edited products do not pose the same potential
risks as GE products. Further arguments state that because genome editing is more precise and
targeted than other forms of biotechnology, it is safer.
In contrast, some have proposed that genome-edited organisms should be regulated in the same
manner as GE organisms.114 Some of these advocates have argued that genome-edited organisms
may experience unintended genetic changes or demonstrate unexpected interactions with the
environment, and close regulatory oversight is necessary to ensure they are safe.
Beyond these questions, concerns have been raised about the technical ability to detect genome
editing in agricultural products and how such chal enges may affect regulatory enforcement.115

111 See Food and Agriculture Organization (FAO), Technical Consultation on Low Levels of Genetically Modified
(GM) Crops in International Food and Feed Trade, T echnical Background Paper 2, T C-LLP/2014/3, March 20-21,
2014, p. 5.
112 APHIS, “APHIS Policy on Responding to the Low-Level Presence of Regulated Genetically Engineered Plant
Materials,” 72 Federal Register 14649, March 29, 2007.
113 See, for example, Biotechnology Innovation Organization (BIO), Issue Brief: Plant Genome Editing, at
https://archive.bio.org/genome-editing/plant -animal-genome-editing/issue-brief-plant -genome-editing; and BIO, Issue
Brief: Anim al Genom e Editing, at https://archive.bio.org/genome-editing/plant-animal-genome-editing/issue-brief-
animal-genome-editing.
114 See, for example, Janet Cotter and Dana Perls, Gene-Edited Organisms in Agriculture: Risks and Unexpected
Consequences, Friends of the Earth and Logos International, September 2018.
115 Joachim Schiemann et al., “Editorial: Plant Genome Editing – Policies and Governance,” Frontiers in Plant Science,
vol. 11, no. 284 (March 11, 2020).
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Within the federal government, USDA and FDA have taken different approaches to the regulation
of genome-edited agricultural products (see “U.S. Regulatory System’s Coordinated
Framework”). Whereas USDA’s 2020 revision of its biotechnology regulations under the Plant
Health Act largely exempts genome-edited plants,116 FDA’s 2017 draft guidance on the regulation
of animals developed through biotechnology expanded its oversight of GE animals under the
FFDCA’s new animal drug provision to include genome-edited animals.117
GE Labeling
Consumer groups have long advocated for the labeling of GE foods, arguing that consumers
should have the opportunity to see the GE status of their food and make food choices based on
their own views about its perceived quality or safety. Many in the food and biotechnology
industries have opposed mandatory GE labeling. Among other concerns, they contended that
consumers might interpret GE labels as “warning labels,” implying that the foods are less safe or
nutritious than conventional foods, despite scientific evidence indicating otherwise. The 2016
enactment of P.L. 114-216 (the 2016 Act) established the National Bioengineered Food
Disclosure Standard (the Standard), marking the first time the United States would require some
form of GE labeling, or on-package disclosure of GE foods or food ingredients.118 USDA’s
Agricultural Marketing Service (AMS) is responsible for the Standard (see “Mandatory Labeling:
The National Bioengineered Food Disclosure Standard”). Along with this mandatory standard,
various voluntary food labeling programs address consumer demand for information about the
GE content of food. These include public and private initiatives that directly or indirectly certify
the absence of GE food and food ingredients. Federal responsibilities for food labeling, as wel as
several existing GE labeling approaches, are discussed below.
Federal Responsibility for Food Labeling
FDA and USDA (through FSIS) are the primary federal authorities responsible for assuring that
foods sold in the United States are safe, wholesome, and properly labeled (neither false nor
misleading).119 FDA released a policy statement on GE foods in 1992, indicating that in most
cases, these foods are “substantial y similar” to non-GE foods and do not require additional
regulation or labeling beyond what is required for comparable non-GE foods.120 A legal decision
in 2000 upheld this policy.121 FDA requires labeling of GE foods that (1) have nutritional
characteristics that differ from comparable non-GE foods, (2) contain GE material from known
al ergenic sources, or (3) have elevated levels of toxic compounds. This labeling is required to
identify the different characteristic and is not required to indicate the GE status of the food. Prior

116 USDA, “ Movement of Certain Genetically Engineered Organisms,” 85 Federal Register 29790, May 18, 2020.
117 FDA, “ Regulation of Intentionally Altered Genomic DNA in Animals,” Draft Revised Guidance for Industry #187,
82 Federal Register 6561, January 19, 2017.
118 A disclosure may be a discrete statement or symbol; a label may provide more comprehensive information about a
product. T his report may use labeling as a proxy for disclosure.
119 For more information, see CRS In Focus IF10650, Understanding Process Labels and Certification for Foods.
120 FDA, “ Statement of Policy: Foods Derived from New Plant Varieties,” 57 Federal Register 22984, May 29, 1992.
T hrough this document, FDA permitted voluntary labeling to indicate that foods have or have not derived from GE
plants or animals. For updated draft guidance documents, see FDA, Guidance for Industry: Voluntary Labeling
Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants, Regulations.gov,
FDA-2000-D-0075-0017, updated March 3, 2019; and FDA, Voluntary Labeling Indicating Whether Food Has or Has
Not Been Derived from Genetically Engineered Atlantic Salm on: Guidance for I ndustry, Regulations.gov, FDA-2015-
D-4272, revised March 11, 2019.
121 Alliance for Bio-Integrity v. Shalala, 116 F.Supp.2d 166 (D.D.C. 2000).
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to enactment of P.L. 114-216, the federal government did not require that GE foods be labeled as
such.
Mandatory Labeling: The National Bioengineered Food Disclosure
Standard
In July 2016, Congress enacted the 2016 Act
(P.L. 114-216),
Figure 7. National Bioengineered Food
122 requiring USDA to
establish mandatory labeling of bioengineered
Disclosure Standard Symbols
food products—the Standard—within two
years.123 The 2016 Act followed decades of
societal debate about genetic engineering, and
it marked the first time that the federal
government would mandate the disclosure of
the presence of GE foods to consumers (the
2016 Act and the Standard use the term
bioengineered, which is similar to GE).124
AMS finalized the regulations for the
Standard in December 2018, and mandatory

compliance begins in January 2022. The
Source: Figure created by CRS from USDA, “BE
Standard requires on-package disclosure of
Symbols,” at https://www.ams.usda.gov/rules-
regulations/be/symbols.
bioengineered foods or food ingredients via
Notes: Foods that meet criteria in the Standard must
options that include written text, symbol
display the “bioengineered” symbol. The “derived
(Figure 7), electronic or digital link, and text
from bioengineering” symbol may be displayed on
message. The Standard does not apply to
foods that do not meet the criteria but derive from
certain meat, poultry, and egg products (7
bioengineered foods (e.g., refined foods that do not
U.S.C. §1636a)125 or refined products that do
contain detectable modified DNA).
not contain detectable modified DNA (e.g., oils, sugars). The Standard identifies certain
exemptions, including food served in restaurants, food produced by very small food
manufacturers,126 and food containing bioengineered substances below a threshold amount. Both

122 P.L. 114-216 (2016 Act), “An Act to Reauthorize and Amend the National Sea Grant College Program Act, and for
Other Purposes,” enacted July 29, 2016. Congress used the reauthorization of the National Sea Grant College Program
Act as a legislative vehicle to enact GE labeling legislation. T he 2016 Act amended the Agricultural Marketing Act of
1946 (7 U.S.C. §1621 et seq.) to add the National Bioengineered Food Disclosure Standard (the Standard) as a new
subtitle.
123 For additional information about the 2016 Act and the subsequent USDA regulations, see CRS Report R46183, The
National Bioengineered Food Disclosure Standard: Overview and Select Considerations, by Genevieve K. Croft .
124 T he 2016 Act defined bioengineering (7 U.S.C. §1639(1)), with respect to food, as a food “(A) that contains genetic
material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and (B) for
which the modification could not otherwise be obtained through conventional breeding or found in nature.” Many
groups interpret the Standard as not applying to foods derived from gene editing and other new technologies that do not
use recombinant DNA.
125 T he Standard applies to foods subject to the Federal Meat Inspection Act (21 U.S.C. §601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. §451 et seq.), or the Egg Products Inspection Act (21 U.S.C. §1031 et seq.) , only if
the most predominant ingredient of the food (or the second-most predominant ingredient if the first is water or broth)
would independently be subject to labeling requirements of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301
et seq.).
126 T he Standard defines a very small food manufacturer as having annual receipts under $2,500 (7 C.F.R. §66.1).
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proponents and opponents of mandatory GE labeling continue to express concerns about the
Standard (see “GE and Non-GE Labeling”).
Voluntary Labeling Programs
Voluntary labeling programs that identify the absence of GE ingredients predate the Standard.
On-package symbols from these private and public-private programs indicate to consumers that
foods do not contain GE ingredients. They may either certify the absence of GE foods or food
ingredients directly (i.e., the food does not contain GE ingredients) or indirectly (i.e., the food
was produced according to a suite of standards that exclude genetic engineering). Food producers
and manufacturers may choose to opt into these programs and to bear associated costs. The Non-
GMO Project Verified label is an example of a private, voluntary labeling program that directly
certifies the absence of GE foods or food ingredients.127 Examples of voluntary labeling programs
that indirectly certify the absence of GE foods or food ingredients or materials include USDA’s
NOP and the Global Organic Textile Standard.128
Biotechnology and Global Trade
Disparate global views, consumer acceptance, and legal requirements with respect to agricultural
biotechnology and its products have raised global trade concerns. U.S. trade objectives and
selected policy issues relevant to trade are discussed below.129
U.S. Trade Objectives and Trade Agreements
The United States is the leading cultivator of GE crops,130 and market access for agricultural
biotechnology products is a major U.S. trade objective.131 These objectives include establishing a
common framework for GE approvals and adoption, as wel as creating labeling practices
consistent with U.S. guidelines and harmonized regulatory procedures concerning GE presence in
agricultural products.132 In other countries, adoption of GE crops has been mixed.133

127 T his program considers GE presence of less than 0.9% of the inputs and ingredients of “wholesale or retail goods
for human or pet use that are either ingested or topically applied including OT C drugs and homeopathic remedies” to
be below its “action threshold”—that is, products with GE content below this threshold are compliant with the
program. See Non-GMO Project, Non-GMO Project Standard (Version 16), December 30, 2020.
128 For more information on certified organic production, see USDA, AMS, “National Organic Program,” at
https://www.ams.usda.gov/about-ams/programs-offices/national-organic-program; and CRS In Focus IF10278, U.S.
Farm Policy: Certified Organic Agricultural Production , by Renée Johnson. For more information on the Global
Organic T extile Standard, see Global Organic T extile Standard, “T he Standard,” at https://global-standard.org/the-
standard.
129 For more information on biotechnology in agricultural trade, see also CRS Report R46653, Major Agricultural
Trade Issues in the 117th Congress, coordinated by Anita Regmi.
130 ISAAA, Global Status of Commercialized Biotech/GM Crops: 2018, Executive Summary.
131 See U.S. T rade Representative (UST R), 2021 Trade Policy Agenda and 2020 Annual Report, March 2021; and
UST R, 2020 National Trade Estim ate Report on Foreign Trade Barriers, March 2020.
132 T he United States seeks harmonization consistent with the Codex Alimentarius Commission guidelines available at
FAO, “Annex 3: Food Safety Assessment in Situations of Low-Level Presence of Recombinant-DNA Plant Material in
Food,” in Guideline for the Conduct of Food Safety Assessment of Food Derived from Recombinant-DNA Plants,
CAC/GL 45-2003.
133 For a review of restrictions on GE organisms in other countries, see Law Library of Congress, Global Legal
Research Center, Restrictions on Genetically Modified Organism s, March 2014.
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Several international trade agreements include provisions related to agricultural biotechnology.
These provisions may focus on improving transparency and coordination in approving and
bringing such products to market. The U.S.-Mexico-Canada Agreement (USMCA), for example,
was the first free trade agreement to include provisions addressing agricultural products created
with genome editing and other genetic engineering techniques.134 In another example, China
made commitments related to agricultural biotechnology in the U.S.-China Phase One trade
agreement.135 Despite increased attention to biotechnology concerns through trade agreements,
some have questioned some countries’ compliance with the terms of certain of these trade
agreements.136 Many differences remain to be negotiated, resolved, or both.137
Standards for Low-Level Presence of GE Material
There are no international y recognized standards for what amounts, if any, of GE material should
be permitted in non-GE commodities. In the absence of international standards—and given the
increasing global sourcing of food—individual countries are establishing their own, often
varying, thresholds. The biotechnology industry and other trade groups have asserted that the lack
of consistent, scientifical y sound standards confuses consumers and disrupts trade.138 See “Low-
Level Presence of GE Material,” above.
Treatment of Genome Editing
Countries have begun to address the issue of how to regulate agricultural products developed with
genome editing, and their approaches have varied.139 For example, in 2015, Argentina became the
first country to determine that it would not regulate genome-edited plants under its biosafety
regulations if foreign DNA had not been introduced into the plant.140 Since 2020, U.S. regulations
have largely exempted genome-edited plants from its GE plant regulations.141 In contrast, the
European Court of Justice ruled in July 2018 that in principle, organisms deriving from genome

134 UST R, 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.
135 UST R, 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.
136 See, for example, Letter from 192 farm groups to President T rump, June 16, 2020, available at
https://www.profarmer.com/system/files/inline-files/ChinaLetterPhase1.pdf; Letter from Sen. Ron Wyden, ranking
member of the Senate Committee on Finance, to President T rump, October 30, 2020. See also, Inside U.S. T rade,
“Grassley: Lighthizer Prepared to T ake Enforcement Action on USMCA,” World Trade Online, November 3, 2020.
137 See, for example, Foreign Agricultural Service, United Kingdom: Agricultural Biotechnology Annual, GAIN Report
UK2019-0013, April 9, 2020. This required annual report is no longer available on the USDA website.
138 See, for example, Global Alliance for Ag Biotech T rade, “Low-Level Presence,” at http://www.gaabt.org/agbiotech-
and-trade/low-level-presence; and CropLife, “ Adventitious Presence (AP) or Low Level Presence (LLP) ,” fact sheet, at
https://croplife.org/wp-content/uploads/pdf_files/Fact -Sheet -Adventitious-Presence-or-Low-Level-Presence.pdf.
139 For a 2020 summary of global approaches to genome editing in agriculture, see Sarah M. Schmidt, Melinda Belisle,
and Wolf B. Fromer, “T he Evolving Landscape around Genome Editing in Agriculture,” EMBO Reports, May 19,
2020. See also Genetic Literacy Project, “Global Gene Editing Regulation T racker,” at https://crispr-gene-editing-regs-
tracker.geneticliteracyproject.org.
140 Ministry of Agriculture, Livestock, and Fisheries of Argentina, Resolution No. 173/2015, May 12, 2015.
141 For additional information, see CRS In Focus IF11573, USDA’s SECURE Rule to Regulate Agricultural
Biotechnology.
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editing and similar processes are within the scope the EU’s existing GMO regulations.142 As of
the writing of this report, in New Zealand, genome-edited foods are regulated in the same manner
as other GE foods; the country is reviewing the regulatory treatment of genome editing and other
NBTs.143
GE Labeling Policies
Trade negotiations concerning agricultural biotechnology may also involve GE labeling issues.
More than 60 countries require some form of GE labeling of food.144 These countries include the
EU countries, Australia, Brazil, China, Russia, Saudi Arabia, and others. Countries that do not
require GE food labeling include Canada, Mexico, most in Africa, and most in Central and South
America. Differences exist among the labeling requirements of those countries that require it,
including in the types of foods that must be labeled, the threshold of GE content above which
foods must be labeled, and the manner in which foods must be labeled. Countries also differ in
their requirements for standards, testing, certification, and enforcement. Food products exported
from the United States must be labeled in compliance with the requirements of their destinations.
Similarly, U.S. importers are responsible for the compliance of their goods with the Standard (see
“Mandatory Labeling: The National Bioengineered Food Disclosure Standard”).145 USDA
notified this rule to the World Trade Organization (WTO), and USDA has stated that it does not
expect the Standard to disrupt foreign trade.146
Cartagena Protocol on Biosafety
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an
international agreement relating to the safe handling, transportation, and use of GE organisms.
The United States is not a party to the Convention on Biodiversity; thus, it is not a party to the
protocol. However, as the protocol affects U.S. exports to ratifying countries, the United States
has actively participated as an observer in related negotiations and preparations for
implementation.
The protocol, adopted in 2000, took effect in 2003, and more than 170 countries have signed onto
it. The protocol permits a country to require formal prior notification from countries exporting
biotech seeds and living modified organisms (LMOs) intended for introduction into the
environment.147 It requires that shipments of products that may contain LMOs, such as bulk

142 For additional information, see European Court of Justice, Organisms Obtained by Mutagenesis are GMOs and are,
in Principle, Subject to the Obligations Laid Down by the GMO Directive, press release, July 25, 2018.
143 See Food Standards Australia New Zealand, “ Food derived using new breeding techniques – review,” April 2020, at
https://www.foodstandards.gov.au/consumer/gmfood/Pages/Review-of-new-breeding-technologies-.aspx; and Food
Standards Australia New Zealand, Final Report: Review of Food Derived Using New Breeding Techniques, December
2019.
144 For a summary of international laws, see Center for Food Safety, “International Labeling Laws,” at
https://www.centerforfoodsafety.org/issues/976/ge-food-labeling/international-labeling-laws. T his summary may not be
comprehensive.
145 T he labeling standard does not require refined products derived from bioengineered crops (e.g., refined soy oil,
high-fructose corn syrup) to be labeled if the modified genetic material is not detectable in the food product.
146 USDA, AMS, “BE Frequently Asked Questions—General,” at https://www.ams.usda.gov/rules-regulations/be/faq/
general. See also 7 U.S.C. §1639c(a), a provision in the act that states, “ This subchapter shall be applied in a manner
consistent with United States obligations under international agreements. ”
147 T he Cartagena Protocol on Biosafety defines a living modified organism as “any living organism that possesses a
novel combination of genetic material obtained through the use of modern biotechnology.” It defines m odern
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grains, be appropriately labeled and documented and provides for an international clearinghouse
for the exchange of LMO information, among other provisions. The protocol further establishes a
process for considering more detailed identification and documentation of LMO commodities in
international trade.
Issues for Congress
Biotechnology has yielded opportunities and chal enges for agriculture and its stakeholders.
Several policy issues have captured the attention of industry, consumer groups, and policymakers.
In some respects, the key policy and regulatory issues of the coming decade may not be
fundamental y new or different from the biotechnology issues of the past 20 years. Rather, certain
issues are increasing in importance as the industry matures, technologies evolve, and long-
standing regulatory issues take new forms. A selection of potential issues are discussed below.
Congress has passed, or may consider, legislation relating to some of these issues, and it may
choose to exercise its oversight responsibilities for these and other issues.
Efficacy of the Coordinated Framework
Led by OSTP, the federal government has revisited and updated the Coordinated Framework over
the years since 1986. Each time, the federal government has concluded that the underlying
legislation is sufficient to address the regulation of biotechnology, and these updates have
clarified the roles and responsibilities of USDA, FDA, and EPA as interpreted through agency
policies and regulations. The agencies have updated their policies and regulations over the years
as new issues have arisen, largely in consultation with each other. Recent concerns regarding the
regulation of the products of new technologies, regulation and oversight of biotechnology in
agricultural animals, and labeling foods with respect to their GE status have chal enged this
coordinated system. Congress may choose to exercise its oversight, appropriations, and legislative
authorities with respect to these concerns.
Regulation of New Technologies and New Trait Types
The development and rapid adoption of genome editing has chal enged the U.S. biotechnology
regulatory system. Some observers have noted that although genome editing is the current new
technology of concern, scientific advancements may lead to new technologies that might pose
chal enges to the U.S. regulatory system.148 New types of traits introduced into agricultural plants
and animals might present regulatory questions. For example, the introduction of stacked trait
varieties (i.e., plant varieties with multiple GE traits) is likely to increase and may result in GE
varieties that intersect with the regulatory authorities and responsibilities of multiple federal
agencies. GE traits that confer improved nutritional qualities and resistance to environmental
stress (e.g., drought) might also chal enge existing regulatory processes.

biotechnology as “ the application of (a) In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid
(DNA) and direct injection of nucleic acid into cells or organelles, or (b) Fusion of cells beyond the taxonomic family,
that overcome natural physiological reproductive or recombination barriers and that are not techniques used in
traditional breeding and selection.” UN Convention on Biodiversity, “ Article 3. Use of T erms,” in Cartagena Protocol
on Biodiversity, January 19, 2000.
148 See, for example, NASEM, Future Products of Biotechnology, 2017.
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GE and Non-GE Labeling
Implementation of the Standard, which requires the on-package disclosure of most bioengineered
foods, is expected to affect consumers, food producers, processors and importers, and USDA’s
AMS as the federal agency overseeing implementation. As implementation proceeds, questions
remain regarding stakeholder reactions to the scope and manner of disclosure, impacts, if any, on
market demand for bioengineered versus nonbioengineered products, and any interactions with
international trade. Some have raised questions regarding FDA’s oversight of non-GMO labeling,
as wel as consumer demand for these labels in light of the Standard.149 Congress may choose to
monitor the Standard’s implementation, as wel as related issues, in accordance with its oversight
responsibilities.
Global Trade Concerns
Global y, countries have different policies, regulations, and attitudes toward agricultural
biotechnology. Differences in the definition and terms used to describe GE organisms, LLP
tolerance levels for commodity shipments, GE labeling requirements, and other issues can raise
global trade concerns. U.S. trade policy supports market access for biotechnology products.
Various bilateral and multilateral trade agreements between the United States and other nations
include biotechnology provisions and commitments. Some have questioned the compliance of
some countries with the terms of these agreements. Congress could consider whether to grant
Trade Promotion Authority to the executive branch to direct it to address U.S. trade concerns over
GE products in trade negotiations.150
Environmental Concerns
As noted above, the evolution of herbicide-resistant weeds, especial y those resistant to
glyphosate, is a growing concern. As herbicide resistance increases among weed varieties, there
could be increased reliance on herbicides that are arguably less benign than glyphosate (e.g.,
dicamba; 2,4 D). Biotechnology companies have engineered new plant varieties that are tolerant
to these herbicides and varieties for which several herbicide-tolerant traits are “stacked” into a
single variety. The environmental effects of the increasing herbicide resistance and the resort to
other herbicides may raise environmental questions for policymakers as companies
commercialize new plant varieties.

149 See, for example, C. Dean McGrath, Jr., “Is the ‘Non-GMO’ Butterfly an Endangered Species?,” The Hill, June 5,
2019, at https://thehill.com/opinion/energy-environment/447026-is-the-non-gmo-butterfly-an-endangered-species.
150 For information on T rade Promotion Authority, see CRS In Focus IF10038, Trade Promotion Authority (TPA), by
Ian F. Fergusson.
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Appendix A. Acronyms
AHPA
Animal Health Protection Act
AMS
Agricultural Marketing Service of USDA
APHIS
Animal and Plant Health Inspection Service of USDA
ARS
Agricultural Research Service of USDA
BRS
Biotechnology Regulatory Service of APHIS
Bt
Bacil us thuringiensis, a bacterium with pesticidal properties
bST
Bovine somatotropin, also known as bovine growth hormone
CRISPR
Clustered regularly interspaced short palindromic repeats, a genome editing technique
EPA
U.S. Environmental Protection Agency
EPIA
Egg Products Inspection Act
ERS
Economic Research Service of USDA
FAO
Food and Agriculture Organization of the United Nations
FDA
U.S. Food and Drug Administration
FFDCA
Federal Food, Drug, and Cosmetic Act
FIFRA
Federal Insecticide, Fungicide, and Rodenticide Act
FMIA
Federal Meat Inspection Act
GE
Genetical y engineered
GMO
Genetical y modified organism
GRAS
General y recognized as safe
HT
Herbicide tolerant
ISAAA
International Service for the Acquisition of Agri-biotech Applications
LLP
Low-level presence
LMO
Living modified organism
NASEM
National Academies of Sciences, Engineering, and Medicine
NBT
New breeding technique
OSTP
Office of Science and Technology Policy of the Executive Office of the President
PHSA
Public Health Safety Act
PPA
Plant Protection Act
PPIA
Poultry Products Inspection Act
PIP
Plant-incorporated protectant, a GE pesticide
rbST
Recombinant bovine somatotropin
RNA
Ribonucleic acid
RNAi
RNA interference
TALEN
Transcription activator-like effector nuclease, a genome editing tool
TSCA
Toxic Substances Control Act
USDA
U.S. Department of Agriculture
VSTA
Virus-Serum-Toxin Act
WHO
World Health Organization of the United Nations
WTO
World Trade Organization
ZFN
Zinc finger nuclease, a genome editing tool

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Appendix B. Glossary of Selected Scientific Terms
Many terms are used to describe human alterations of plants and animals. Unless otherwise noted, these definitions
derive from the U.S. Department of Agriculture’s online Agricultural Biotechnology Glossary.151
Adventitious
Detection of the unintentional presence of GM crops that have not been approved
presence
in any countries on the basis of a food safety assessment according to the relevant
Codex guidelines.152
Agricultural
A range of tools, including traditional breeding techniques, that alter living
biotechnology
organisms, or parts of organisms, to make or modify products; improve plants or
animals; or develop microorganisms for specific agricultural uses. Modern
biotechnology includes the tools of genetic engineering.
Conventional
Undefined in USDA’s Agricultural Biotechnology Glossary, which defines the similar
breeding
term, traditional breeding, as “modification of plants and animals through selective
breeding. Practices used in traditional plant breeding may include aspects of
biotechnology such as tissue culture and mutational breeding.”
DNA
The chemical substance from which genes are made. A long, double-stranded
(deoxyribonucleic
helical molecule made up of nucleotides composed of sugars, phosphates, and
acid)
derivatives of four bases: adenine (A), guanine (G), cytosine (C), and thymine (T).
The sequence of base pairs in DNA strands determines its genetic information.
Epigenome
The physical factors affecting the expression of genes without affecting the actual
DNA sequence of the genome.153
GE labeling
On-package disclosure of genetical y engineered (GE) foods or food ingredients.154
Genetic engineering
Manipulation of an organism’s genes by introducing, eliminating, substituting, or
rearranging specific genes using the methods of modern molecular biology,
particularly those techniques referred to as recombinant DNA techniques.
Genetic
The introduction of heritable improvements in plants or animals for specific uses
modification
via genetic engineering or more traditional methods. Some countries other than
the United States use this term to refer specifical y to genetic engineering.
Genetically
Produced through genetic engineering.155
engineered (GE)
Genetically modified
An organism produced through genetic modification.
organism (GMO)
Genome
Al the genetic material in al the chromosomes of a particular organism.
Genome editing
Specific modification of the DNA of an organism to create mutations or introduce
new al eles or new genes.156

151 Available at USDA, Agricultural Biotechnology Glossary, at https://www.usda.gov/topics/biotechnology/
biotechnology-glossary.
152 FAO, Technical Consultation on Low Levels of Genetically Modified (GM) Crops in International Food and Feed
Trade, T echnical Background Paper 2, T C-LLP/2014/3, March 20-21, 2014, p. 5 (hereinafter FAO, Technical
Consultation on Low Levels of GM Crops, 2014).
153 NASEM, “Appendix G: Glossary,” in Genetically Engineered Crops: Experiences and Prospects, National
Academies Press, 2016 (hereinafter NASEM, “ Appendix G: Glossary,” in Genetically Engineered Crops, 2016).
154 CRS.
155 CRS.
156 NASEM, “Appendix G: Glossary,” in Genetically Engineered Crops, 2016.
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Living modified
A term specific to the Cartagena Protocol on Biosafety to the Convention on
organism (LMO)
Biological Diversity, defined as any living organism that possesses a novel
combination of genetic material obtained via modern biotechnology.157
Low-level presence
The detection of low levels of GM crops that have been approved in at least one
country on the basis of a food safety assessment according to the relevant Codex
guidelines.158
Marker-assisted
The use of DNA sequences to determine which selection plants or organisms have
selection
a particular version (al ele) of existing genes. Markers do not become part of the
plant’s genome.159
Mutation
Any heritable change in DNA structure or sequence. The identification and
incorporation of useful mutations has been essential for traditional crop breeding.
Mutation breeding
A plant breeding technique in which radiation or chemical mutagens are used to
produce new genetic variation.160
New breeding
Also known as new breeding technologies (also NBTs) and new plant breeding
techniques (NBTs)
techniques (NPBTs). While there is no universal y agreed upon set of components,
NBTs are general y considered to include (1) techniques that change an organism’s
genetic sequence (e.g., genome editing and site-directed mutagenesis), and (2)
epigenetic techniques that change when and how an organism expresses certain
genes, without changing the underlying genetic sequence.161
Plant pest
An organism that may directly or indirectly cause disease, spoilage, or damage to
plants, plant parts, or processed plant materials. Common examples include certain
insects, mites, nematodes, fungi, molds, viruses, and bacteria.
Recombinant DNA
A molecule of DNA formed by joining different DNA segments using recombinant
(rDNA)
DNA technology.
Recombinant DNA
Tools, techniques, and procedures used to join DNA segments in a cel -free
technology
system (e.g., in a test tube outside living cel s or organisms). Under appropriate
conditions, a recombinant DNA molecule can be introduced into a cel and copy
itself (replicate), either as an independent entity (autonomously) or as an integral
part of a cel ular chromosome.
RNA (ribonucleic
A chemical substance made up of nucleotide compounds of sugars, phosphates,
acid)
and derivatives of four bases: adenine (A), guanine (G), cytosine (C), and uracil (U).
RNAs function in cel s as messengers of information from DNA that are translated
into protein or as molecules that have certain structural or catalytic functions in
the synthesis of proteins. RNA is also the carrier of genetic information for certain
viruses. RNAs may be single or double stranded.
Selective breeding
Making deliberate crosses or matings of organisms so the offspring wil have
particular desired characteristics derived from one or both parents.
Traditional breeding
Modification of plants and animals through selective breeding. Practices used in
traditional plant breeding may include aspects of biotechnology, such as tissue
culture and mutational breeding.
Transgene
Any gene transferred into an organism by genetic engineering.162

157 UN Convention on Biodiversity, “Article 3. Use of T erms,” in Cartagena Protocol on Biodiversity, January 19,
2000.
158 FAO, Technical Consultation on Low Levels of GM Crops, 2014, p. 5.
159 NASEM, “Appendix G: Glossary,” in Genetically Engineered Crops, 2016.
160 CRS.
161 CRS.
162 NASEM, “Appendix G: Glossary,” in Genetically Engineered Crops, 2016.
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Transgenic event
A unique insertion of a transgene into a genome.163
Transgenic
An organism resulting from the insertion of genetic material from another
organism
organism using recombinant DNA techniques.
Variety
A subdivision of a species for taxonomic classification also referred to as a
“cultivar.” A variety is a group of individual plants that is uniform, stable, and
distinct genetical y from other groups of individuals in the same species.

Author Information

Genevieve K. Croft

Analyst in Agricultural Policy

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