How GMOs Are Regulated in the United States: From the 1986 Coordinated Framework to the 2025 Reform Proposals

Genetically modified organisms (GMOs) have been part of the American food supply for more than 30 years. The first commercially grown genetically engineered crop, the Flavr Savr tomato, entered U.S. markets in 1994. Today, more than 90% of the corn, soybeans, and cotton grown in the United States are genetically engineered varieties. Yet the regulatory framework governing these products has remained remarkably stable since it was first established in the 1980s — a fact that both supporters and critics of the current system find remarkable for very different reasons.

Supporters see the framework’s durability as evidence that it works: products are evaluated based on their characteristics rather than the process used to create them, allowing innovation to proceed without unnecessary regulatory burden while maintaining food safety. Critics argue that the framework was never designed for the scale and diversity of biotechnology products that now exist, that its reliance on 40-year-old statutory authorities creates regulatory gaps, and that its voluntary elements leave enforcement largely to industry self-regulation.

This article traces the evolution of U.S. biotechnology regulation from its origins in the 1980s through the major executive orders and rule changes of the 2019–2026 period, explains how the labeling system works, and examines the challenges posed by gene-editing technologies that do not fit neatly into the existing framework.

The Coordinated Framework (1986)

The foundation of U.S. biotechnology regulation is the Coordinated Framework for the Regulation of Biotechnology, published by the White House Office of Science and Technology Policy (OSTP) in 1986. Rather than creating a new law specifically for genetically engineered products, the Coordinated Framework directed three existing federal agencies to regulate biotech products using their existing statutory authorities:

The USDA’s Animal and Plant Health Inspection Service (APHIS) regulates genetically engineered plants under the Plant Protection Act. APHIS assesses whether a genetically engineered plant poses a risk to other plants or the agricultural environment — essentially, whether it could act as a “plant pest.” This authority derives from APHIS’s longstanding role in preventing the introduction of plant diseases and invasive species into U.S. agriculture. Companies that want to field-test or commercially release a new genetically engineered plant must either obtain a permit from APHIS or qualify for an exemption based on the plant’s characteristics.

The EPA regulates genetically engineered pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This authority is most relevant for plants engineered to produce their own pest-resistant proteins — known as plant-incorporated protectants (PIPs). The most commercially significant example is Bt corn and Bt cotton, which are engineered to produce insecticidal proteins derived from the soil bacterium Bacillus thuringiensis. The EPA evaluates these proteins for safety to humans, animals, and non-target organisms, and sets tolerance levels for any residues that may remain in food products. The EPA also regulates herbicide-tolerant crops (such as Roundup Ready soybeans) insofar as the herbicide itself falls under FIFRA jurisdiction.

The FDA regulates genetically engineered foods under the Federal Food, Drug, and Cosmetic Act. The FDA’s approach is based on the principle of “substantial equivalence”: if a genetically engineered food is substantially equivalent in composition, nutritional value, and intended use to its conventional counterpart, it is generally recognized as safe (GRAS) and does not require pre-market approval. When the modification introduces a new allergen, toxin, or significant nutritional change, the FDA evaluates the product more rigorously. The FDA’s consultation process is technically voluntary — companies are expected but not legally required to consult with the agency before marketing a new bioengineered food — though in practice, all major companies do participate.

A central principle of the Coordinated Framework is that products are regulated based on their characteristics and potential risks, not based on the process used to create them. This “product-based” approach means that a plant developed through genetic engineering is evaluated using the same safety standards as a plant developed through conventional breeding, if both plants have similar characteristics. This contrasts with the “process-based” regulation adopted by the European Union, which subjects all genetically engineered products to a distinct and generally more restrictive regulatory pathway, regardless of the product’s characteristics.

FDA’s 1992 Policy and the Substantial Equivalence Doctrine

The FDA’s approach to genetically engineered foods was formalized in its 1992 Statement of Policy on “Foods Derived from New Plant Varieties.” This document established the principle of substantial equivalence: if a new food, whether developed through genetic engineering or conventional breeding, is substantially equivalent to an existing food in composition, nutritional value, and safety, it does not require pre-market approval. The FDA concluded that genetic engineering per se does not make foods unsafe, and that the agency’s existing statutory authority under the Federal Food, Drug, and Cosmetic Act was sufficient to regulate any safety issues that arose.

The 1992 policy was controversial from the start. Internal FDA scientists, including Dr. Louis Pribyl (a microbiologist in the FDA’s Division of Toxicological Research) and Dr. Linda Kahl (an FDA compliance officer), wrote memos questioning whether the policy adequately addressed the potential for unintended effects of genetic modification. These internal documents, later obtained through Freedom of Information Act requests and litigation, showed that the agency’s political leadership had overridden concerns raised by its own scientists about the sufficiency of the voluntary consultation process.

Despite these controversies, the substantial equivalence framework has remained the basis of FDA food safety assessment for genetically engineered products for more than three decades. All major GE food products currently on the U.S. market have gone through the FDA’s voluntary consultation process, and the FDA has maintained that none of the foods it has evaluated presents any safety concern. Critics respond that the voluntary nature of the process means the FDA is reviewing data provided by the companies themselves, without independent testing requirements or mandatory pre-market safety studies.

The Rise of GE Crops in America: 1996–2025

The commercial adoption of genetically engineered crops in the United States has been one of the fastest technology transitions in agricultural history. When herbicide-tolerant soybeans and insect-resistant Bt corn were first commercialized in 1996, adoption rates were in the single digits. Within a decade, genetically engineered varieties dominated U.S. plantings for the three major commodity crops. By 2025, according to USDA Economic Research Service data, 94% of soybeans, 92% of corn, and 96% of upland cotton planted in the United States were genetically engineered varieties.

This rapid adoption was driven by clear economic incentives for farmers: herbicide-tolerant crops simplified weed management by allowing farmers to apply broad-spectrum herbicides without killing the crop, while Bt crops reduced insecticide applications and associated pest damage. University extension economists estimated that GE crop technology generated billions of dollars in cumulative economic benefits for U.S. farmers between 1996 and 2020, though the distribution of those benefits between farmers, seed companies, and downstream processors has been contested.

The concentration of the seed industry that accompanied GE crop adoption has also raised competition concerns. Four companies — Bayer (which acquired Monsanto in 2018), Corteva Agriscience (formed from the DowDuPont merger), Syngenta (acquired by ChemChina/Sinochem in 2017), and BASF — now control the vast majority of the global commercial seed and crop protection market. Critics argue that this consolidation has reduced farmer choice, increased seed prices, and concentrated control over the genetic resources that underpin the food supply.

Executive Order 13874 (2019): Streamlining Biotech Regulation

On June 11, 2019, President Trump signed Executive Order 13874, titled “Modernizing the Regulatory Framework for Agricultural Biotechnology Products.” The order directed federal agencies to streamline and simplify the regulatory process for agricultural biotechnology, with the stated goal of reducing unnecessary barriers to innovation while maintaining safety.

The executive order did not weaken safety standards — it could not, because those standards are set by statute, not by executive order. What it did was direct agencies to review and update their regulatory procedures to reduce delays, eliminate redundant reviews, and create clearer pathways for developers of new biotechnology products to navigate the regulatory process. It also directed the creation of a unified website (usbiotechnologyregulation.mrp.usda.gov) where developers could determine which agencies had jurisdiction over their products.

The practical effect of EO 13874 was most visible at USDA-APHIS, which used the executive order as impetus for its SECURE Rule (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient), finalized in May 2020. The SECURE Rule represented the first comprehensive revision of APHIS’s biotechnology regulations since they were established in 1987. It replaced the decades-old regulatory framework with a new system organized around two key principles: regulating products by their plant-pest risk rather than by the method used to create them, and exempting low-risk modifications that could have been produced through conventional breeding techniques.

Under the SECURE Rule, certain categories of genetically engineered plants were automatically exempt from regulation, including plants with modifications that deleted genetic material without adding any new DNA, and plants with modifications that introduced genetic material already present in the species’ gene pool. For all other genetically engineered plants, APHIS established a new review process based on plant pest risk assessment. More than 200 biotech crops went through APHIS’s SECURE-defined review process during the four years the rule was in effect.

The SECURE Rule’s Vacatur

The SECURE Rule was one of the most significant changes to U.S. biotech regulation in decades, but it proved short-lived. In December 2024, the U.S. District Court for the Northern District of California vacated the rule in a lawsuit brought by the Center for Food Safety and other anti-GMO advocacy groups. The court found that APHIS had not adequately considered the environmental impacts of the rule under the National Environmental Policy Act (NEPA), particularly regarding the cumulative effects of exempting large categories of gene-edited plants from regulatory review.

The vacatur was not retroactive — crops already reviewed under the SECURE Rule did not need to be re-reviewed — but it meant that going forward, APHIS reverted to its pre-2020 regulations. In June 2025, APHIS issued technical amendments to the Code of Federal Regulations to conform to the court’s decision. The Spring 2025 Unified Agenda of Regulatory and Deregulatory Actions listed an anticipated interim final rule, “Regaining Lost Efficiencies for Products of Biotechnology” (RIN 0579-AE84), indicating that USDA intends to restore some of the SECURE Rule’s provisions through a new rulemaking that better satisfies NEPA requirements. Publication is projected for 2026.

The vacatur of the SECURE Rule has created significant uncertainty for the biotech crop industry, particularly for developers of gene-edited crops. Under the pre-2020 regulations, APHIS’s regulatory authority is triggered by the presence of “plant pest” DNA sequences — a framework that was designed for transgenic organisms and does not cleanly apply to gene-edited plants that contain no foreign DNA. Developers of gene-edited crops now face an ambiguous regulatory environment in which their products may or may not fall under APHIS jurisdiction, depending on the specific nature of the modification.

Executive Order 14081 (2022): The Biden Administration’s Approach

On September 12, 2022, President Biden signed Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy.” This order took a broader approach than EO 13874, addressing not just agricultural biotechnology but the entire bioeconomy, including pharmaceutical manufacturing, industrial biotechnology, and bioenergy.

For agricultural biotechnology specifically, EO 14081 directed agencies to improve and streamline regulatory processes while maintaining rigorous safety standards. It emphasized the role of biotechnology in addressing climate change, food security, and public health. The order also directed the development of new regulations for emerging biotechnology products, including gene-edited crops and cell-cultivated meat and seafood.

A notable feature of EO 14081 was its explicit recognition that the Coordinated Framework — now nearly four decades old — may not be adequate for the range of biotechnology products being developed today. The order directed the National Science and Technology Council to assess whether the existing regulatory framework could accommodate new categories of biotech products, including products of synthetic biology, living therapeutics, and biomanufactured materials that do not fit neatly into the FDA/USDA/EPA jurisdictional divisions established in 1986.

Notable GE Products and Their Regulatory Paths

The regulatory framework’s practical implications are best illustrated through specific cases. AquAdvantage salmon, developed by AquaBounty Technologies, is the only genetically engineered animal approved for human consumption in the United States. The salmon contains a growth hormone gene from Chinook salmon and a promoter sequence from ocean pout, an eel-like fish, allowing it to grow to market size in roughly 18 months instead of the 28–36 months required by conventional Atlantic salmon. The FDA approved AquAdvantage salmon in November 2015 after a review process that lasted more than 20 years — one of the longest regulatory reviews in FDA history.

The extended review reflected both scientific complexity and political pressure. The FDA regulated the salmon’s genetic modification as a “new animal drug” under the Federal Food, Drug, and Cosmetic Act — a statutory framework designed for veterinary pharmaceuticals, not food-producing animals. Critics argued that this framework was poorly suited for evaluating the environmental risks of a novel organism, while supporters argued that it provided a rigorous safety assessment. Congress repeatedly inserted provisions into appropriations bills preventing the FDA from finalizing its review, delaying the decision for years.

The AquAdvantage case illustrates a broader challenge: because the Coordinated Framework relies on existing statutory authorities rather than purpose-built biotechnology legislation, new categories of products must be shoehorned into regulatory frameworks designed for different purposes. The FDA’s decision to regulate gene-edited animals under its “new animal drug” authority has been particularly controversial, as the framework subjects simple genetic modifications (such as deleting the gene responsible for horn growth in cattle, which conventional ranchers achieve through painful manual dehorning) to the same approval process required for complex pharmaceutical products.

Gene-edited crops have had a smoother regulatory path, at least when the SECURE Rule was in effect. The USDA approved several gene-edited crops through streamlined processes, including a non-browning white button mushroom developed at Penn State (which APHIS determined was not subject to regulation because it contained no introduced DNA from plant pests), high-oleic acid soybeans developed by Calyxt, and a drought-tolerant corn variety. With the SECURE Rule vacated, the regulatory pathway for these and similar products has become less predictable.

Cell-cultivated meat and seafood present yet another regulatory frontier. In 2023, the FDA and USDA jointly approved the first cell-cultivated chicken products for commercial sale, with the FDA overseeing pre-market safety evaluation and USDA-FSIS handling inspection and labeling. This dual-agency framework was developed through informal interagency agreement rather than through rulemaking, raising questions about its durability and its applicability to future products. Several states have since enacted or proposed bans on the sale of cell-cultivated meat, creating a new layer of regulatory fragmentation.

The Bioengineered Food Disclosure Standard

Parallel to the regulatory framework for approving biotech products, the United States has developed a separate system for labeling foods that contain bioengineered ingredients. This labeling system has its own complex history and its own set of controversies.

For decades, the United States had no mandatory labeling requirement for foods containing genetically engineered ingredients. The FDA’s position, based on its 1992 Statement of Policy, was that labeling should be required only when a food differed materially from its conventional counterpart in composition, nutritional profile, or allergenicity — not simply because it was produced using genetic engineering. This position was contested by consumer advocacy groups, organic food producers, and several state governments, which argued that consumers had a right to know whether their food contained GE ingredients regardless of whether the modification affected the food’s composition.

Between 2012 and 2016, several states attempted to pass mandatory GMO labeling laws through ballot initiatives (California’s Proposition 37 in 2012, Washington’s Initiative 522 in 2013) or legislation (Vermont’s Act 120, signed into law in 2014 and briefly in effect before being preempted by federal action). The prospect of a patchwork of state labeling requirements alarmed the food industry, which pushed for a uniform federal standard.

In July 2016, Congress passed the National Bioengineered Food Disclosure Act (P.L. 114-216), which required USDA to establish a national mandatory disclosure standard for bioengineered foods. The act preempted all state GMO labeling laws, including Vermont’s, and delegated implementation to USDA’s Agricultural Marketing Service (AMS). The final rule was published in December 2018, with a voluntary compliance period beginning January 1, 2020, and mandatory compliance taking effect January 1, 2022.

How the Disclosure Standard Works

The National Bioengineered Food Disclosure Standard defines a “bioengineered food” as one that “contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.” This definition is deliberately narrower than many consumer advocates had sought: it excludes foods produced using gene-editing technologies that do not involve the insertion of foreign DNA, and it relies on detectability — if the genetic modification cannot be detected in the final food product, disclosure is not required.

The standard offers regulated entities (food manufacturers, importers, and retailers) several disclosure options: a text statement (“Contains a bioengineered food ingredient”), the USDA-designed BE symbol (a green circle with the sun over crop rows), a digital link (such as a QR code) that directs consumers to disclosure information online, or a text-message option. AMS maintains a list of bioengineered foods — currently including alfalfa, Arctic apples, canola, corn, cotton, eggplant, papaya (ringspot virus-resistant), pineapple (pink-flesh), potato, salmon (AquAdvantage), soybean, squash, and sugarbeet — to help regulated entities determine whether disclosure may be required.

The Ninth Circuit Challenge

The disclosure standard has faced legal challenges. In October 2025, the Ninth Circuit Court of Appeals ruled in Natural Grocers v. Rollins that USDA had erred in two key respects: by exempting highly refined foods (such as oils and sugars processed from bioengineered crops) from disclosure requirements on the grounds that the bioengineered DNA was no longer detectable in the final product, and by allowing digital-link and text-message disclosures as alternatives to on-package text or symbols. The court found that the detectability exemption was inconsistent with the statute’s intent, and that digital disclosures created barriers for consumers without smartphones or reliable internet access.

As of 2026, the case has been remanded to the district court for further proceedings. The parties have submitted supplemental briefs, and USDA has initiated a new rulemaking process to address the Ninth Circuit’s concerns. Plaintiffs seek prospective vacatur of the challenged provisions effective January 1, 2028, to allow industry time to implement label changes. The outcome could significantly expand the range of foods that must carry bioengineered disclosures.

Consumer Awareness and Public Opinion

Surveys consistently show that a majority of American consumers support mandatory labeling of genetically engineered foods. A 2020 Pew Research Center survey found that 49% of Americans believed GE foods were worse for health than non-GE foods, while only 5% thought they were better — a perception gap that conflicts sharply with the scientific consensus, expressed by the National Academies of Sciences, Engineering, and Medicine in a comprehensive 2016 report, that currently commercialized GE crops do not pose different health risks than their conventional counterparts.

The gap between public perception and scientific consensus on GE food safety is one of the largest such gaps on any scientific issue. Researchers attribute this to several factors: the unfamiliarity and perceived unnaturalness of genetic modification, general distrust of the food industry, confusion between genetic engineering and other food production practices (such as pesticide use), and the effectiveness of advocacy campaigns that have linked GE foods to broader concerns about corporate control of the food supply, environmental sustainability, and consumer autonomy.

The bioengineered food disclosure standard has not resolved these debates. Consumer advocacy groups have criticized the standard’s use of the term “bioengineered” rather than the more familiar “genetically modified” or “GMO,” arguing that the unfamiliar terminology reduces the effectiveness of the disclosure. They have also criticized the availability of digital-link (QR code) disclosures as an alternative to on-package text, arguing that this creates a digital divide that disadvantages low-income consumers, elderly consumers, and those without reliable internet access — a concern that the Ninth Circuit validated in its 2025 ruling.

Gene Editing: The Next Regulatory Challenge

The most significant challenge facing the Coordinated Framework is how to regulate products developed using gene-editing technologies, particularly CRISPR-Cas9. Unlike traditional genetic engineering, which typically involves inserting DNA from one species into another (transgenesis), gene editing can make precise modifications to an organism’s own genome — deletions, substitutions, or rearrangements that could theoretically have occurred through natural mutation or conventional breeding.

This distinction matters because the Coordinated Framework’s regulatory triggers were designed for transgenic organisms. APHIS’s authority derives from the Plant Protection Act, which focuses on plant pest risk — and gene-edited plants that contain no foreign DNA often do not present the same kind of risk that transgenic plants do. The FDA’s substantial equivalence framework similarly struggles with gene-edited foods that are compositionally identical to their conventional counterparts. These regulatory gaps are not theoretical: dozens of gene-edited crop varieties are already in development, including non-browning mushrooms, drought-tolerant soybeans, high-oleic soybeans, reduced-gluten wheat, and disease-resistant citrus.

The SECURE Rule had addressed this gap by establishing clear exemption criteria for gene-edited plants that met certain conditions. With the rule’s vacatur, the regulatory status of many gene-edited crops is once again uncertain. APHIS can still evaluate individual products through its legacy petition process, but the absence of a clear, predictable regulatory pathway discourages investment in gene-editing applications for smaller crops and specialty products where the regulatory cost of the petition process is disproportionate to the market opportunity.

International Divergence

The regulatory divergence between how different countries handle gene-edited products has significant trade implications. The European Union’s Court of Justice ruled in 2018 that gene-edited organisms must be regulated under the same strict framework as traditional GMOs — a decision that effectively blocked the commercialization of gene-edited crops in Europe. The EU has since proposed reforms that would create a tiered system, with simplified approval for gene-edited plants that could have been produced through conventional breeding, but these proposals have stalled in the European Parliament.

The United Kingdom, following Brexit, enacted the Genetic Technology (Precision Breeding) Act 2023, which exempts certain gene-edited organisms from GMO regulations — aligning more closely with the U.S. approach. Argentina, Brazil, and several other major agricultural exporters have similarly adopted regulatory frameworks that distinguish gene-edited organisms from traditional GMOs.

These divergent approaches create trade barriers: a gene-edited crop variety that is unregulated in the United States or Argentina may be classified as a regulated GMO in Europe, requiring expensive approval processes and mandatory labeling. For commodity crops that move through global supply chains, the presence of gene-edited varieties creates compliance challenges that the current patchwork of national regulations does not adequately address.

The 2026 Political Landscape

The current regulatory environment for biotechnology in the United States is shaped by several converging political pressures. The second Trump administration has signaled continued support for agricultural biotechnology innovation, consistent with the deregulatory approach of EO 13874. At the same time, the SECURE Rule’s vacatur and the Ninth Circuit’s labeling decision have created legal constraints that limit how far executive action alone can go without new legislation or successful rulemaking.

Congressional action on biotechnology reform faces the same polarization that affects most legislative efforts. Some members favor a science-based, streamlined approach that would reduce regulatory barriers for gene-edited products and align U.S. regulations more closely with trading partners like Argentina, Brazil, and the United Kingdom. Others advocate for a precautionary approach that would strengthen pre-market testing requirements, expand mandatory labeling, and give the EPA a larger role in environmental risk assessment. Still others focus primarily on competition concerns, arguing that any reform must address the concentration of the seed and agrochemical industry alongside the regulatory framework itself.

Meanwhile, state legislatures have become increasingly active in biotechnology regulation, particularly around cell-cultivated meat and gene-edited products. This state-level activity creates the same patchwork regulatory environment that Congress sought to prevent when it passed the National Bioengineered Food Disclosure Act in 2016, and may eventually force Congress to address preemption questions for new categories of biotechnology products.

The Scientific Consensus and the Public Perception Gap

One of the most striking features of the GMO debate is the gulf between the scientific consensus on safety and public opinion about it. Every major scientific and regulatory body that has evaluated the evidence has reached essentially the same conclusion: foods derived from genetically engineered crops currently on the market are as safe as their conventionally bred counterparts.

The most comprehensive evaluation to date remains the 2016 report by the National Academies of Sciences, Engineering, and Medicine (NASEM), which reviewed more than 1,000 studies and concluded that it “could not find persuasive evidence of adverse health effects directly attributable to consumption of GE foods.” The report further noted “some evidence that GE insect-resistant crops have had benefits to human health by reducing insecticide poisonings and decreasing exposure to fumonisins.” The World Health Organization has stated that “no adverse health effects have been reported from the consumption of GM foods.” A compilation by the Genetic Literacy Project identified more than 280 scientific institutions and over 3,000 studies supporting the safety conclusion. And a 2026 review by Favaratto, Gleim, and Smyth in GM Crops & Food documented that more than 4,400 risk assessments have been conducted across over 70 countries since the first evaluation in 1994 — with no approved product found to pose a substantiated health risk.

Despite this consensus, public perception tells a different story. Pew Research Center surveys found that by 2020, 49% of Americans believed GMO foods were worse for their health than non-GMO foods — up from 39% in 2016. The shift was concentrated among people with lower levels of scientific knowledge; among those with high scientific knowledge, the figure remained stable at 38%. Separate polling by Consumer Reports showed that 92% of American consumers wanted GMO foods to be labeled, while research from Rutgers University found that only 7% of respondents spontaneously mentioned GMO content when asked what information they wanted to see on food labels — suggesting that awareness of GMOs as a concern rises sharply when the topic is introduced, but is not top-of-mind for most shoppers.

The gap between expert consensus and public opinion has practical market consequences. The Non-GMO Project, a private labeling initiative, has grown into a major market force, with its butterfly logo appearing on tens of thousands of verified products. This growth has occurred despite — or perhaps because of — the scientific consensus that the underlying safety distinction the label implies does not exist. Several factors contribute to the persistence of the perception gap. Food is an emotionally charged domain, and abstract scientific consensus competes with concrete concerns about corporate control, environmental impact, and the perceived unnaturalness of genetic modification. Risk-perception research consistently shows that people evaluate novel technologies using criteria that extend beyond toxicology — including whether exposure feels voluntary, whether it is controllable, and whether the institutions managing it are trusted.

Environmental Impacts: The Herbicide Resistance Challenge

While the scientific consensus on human health is robust, the environmental impacts of GE crops are more complex and contested. The most significant concern involves herbicide-tolerant (Ht) crops, which account for the majority of GE crop acreage, and the evolution of herbicide-resistant weeds.

When the first Roundup Ready (glyphosate-tolerant) soybeans were introduced in 1996, glyphosate was considered a near-ideal herbicide: broad-spectrum, low-toxicity to mammals, quickly degraded in soil, and without a significant history of weed resistance. The availability of glyphosate-tolerant crops led to a dramatic simplification of weed management, as farmers could apply a single herbicide over their entire crop at virtually any point in the season. Glyphosate use in American agriculture increased more than fifteenfold between 1996 and 2016.

The inevitable biological response followed. According to the International Survey of Herbicide Resistant Weeds (weedscience.org), glyphosate resistance has been confirmed in 62 weed species across 31 countries as of 2025. In the United States, Palmer amaranth (Amaranthus palmeri) has become particularly problematic — a single plant can produce more than 500,000 seeds, grows up to three inches per day, and has developed multiple resistance mechanisms. Globally, the International Survey documents 548 unique cases of herbicide-resistant weeds involving 275 species, with resistance confirmed to 168 different herbicides across 102 crops in 76 countries.

Scientists emphasize that herbicide resistance is not unique to GMO-associated herbicides. Weeds had evolved resistance to dozens of herbicides long before the first GE crop was planted, and resistance is an inherent biological response to any consistent selective pressure. However, the near-exclusive reliance on a single herbicide that Roundup Ready crops encouraged did accelerate the rate at which glyphosate resistance evolved. The agricultural industry has responded by developing crops with tolerance to multiple herbicides — “stacked” trait packages combining tolerance to glyphosate, glufosinate, 2,4-D, or dicamba. A 2026 review in Pest Management Science cautioned that this approach may not be sustainable indefinitely, given that no new herbicide mode of action has been discovered in more than 30 years.

On the other side of the environmental ledger, GE crops have delivered measurable benefits. Bt crops (engineered to produce insecticidal proteins from Bacillus thuringiensis) have reduced insecticide applications on corn and cotton by an estimated 25–40% compared to pre-Bt baselines. Herbicide-tolerant crops have also facilitated the adoption of no-till and conservation-tillage farming, which reduces soil erosion, improves soil structure, and decreases fuel consumption — though these benefits are partially offset when the herbicide-resistance treadmill leads to more intensive chemical applications.

Seed Market Concentration and Farmer Economics

The economics of GE crops are intertwined with a decades-long consolidation of the global seed and agrochemical industries. When the Coordinated Framework was published in 1986, the seed industry was highly fragmented, with hundreds of independent companies serving regional markets. By 2026, three corporations — Bayer (which acquired Monsanto in 2018), Corteva Agriscience (formed from the DowDuPont merger), and Syngenta (acquired by ChemChina in 2017) — control approximately 60% of the global proprietary seed market and an even larger share of the GE trait market.

This concentration raises concerns about market power, seed pricing, and farmer autonomy. GE seeds are protected by patents and technology use agreements that prohibit farmers from saving and replanting seeds from their harvest — a practice that had been routine with many conventional crop varieties for centuries. Seed prices for corn and soybeans have roughly tripled in inflation-adjusted terms since the mid-1990s, though separating the effects of market concentration from the genuine value delivered by improved genetics is analytically difficult. Supporters of the current system argue that rising seed costs have been more than offset by yield gains, reduced input costs (particularly insecticide savings from Bt crops), and simplified management. Critics counter that the consolidated market structure leaves farmers with diminishing alternatives and that technology use agreements represent an unprecedented assertion of corporate control over agricultural inputs.

The market concentration issue intersects with the regulatory framework in important ways. The costs of navigating regulatory approval for a traditional GE trait — estimated at $30 million to $136 million per event, depending on the crop and the number of countries requiring separate approval — create significant barriers to entry that favor large corporations with deep regulatory expertise and financial resources. This dynamic is one of the strongest arguments for streamlined regulation of gene-edited crops: lower regulatory costs could enable smaller companies and public-sector researchers at land-grant universities to bring improved varieties to market, potentially counteracting the market concentration that has characterized the transgenic crop era. Whether the anticipated APHIS replacement rule, if and when it arrives, will achieve this goal remains one of the pivotal open questions in U.S. agricultural policy.

Looking Forward: Proposals for Reform

In April 2025, the National Science and Technology Council’s Subcommittee on Emerging Biotechnology (NSCEB) published recommendations calling for Congress to modernize the Coordinated Framework. The recommendations included creating a centralized submission portal so developers can determine which agencies have jurisdiction over a product without navigating multiple agency websites; conducting horizon scanning for future biotech products that may not fit existing regulatory categories; exempting low-risk products from full regulatory review; and harmonizing the terminology used across agencies, which currently varies in ways that create confusion for developers and the public alike.

Whether Congress will act on these recommendations remains an open question. The Coordinated Framework has persisted for four decades in part because it does not require new legislation — each agency relies on its existing statutory authority. Creating a new legislative framework for biotechnology would require congressional consensus on contentious issues including the appropriate role of precautionary versus evidence-based regulation, the scope of mandatory labeling, the rights of states to impose their own biotech regulations, and the treatment of gene-edited organisms. Given the current political environment, comprehensive reform appears unlikely in the near term, though the SECURE Rule vacatur and the Ninth Circuit labeling decision have increased pressure on all sides to revisit the framework’s foundations.

The fundamental tension at the heart of U.S. biotechnology regulation has not changed since 1986: the same products that one group sees as indistinguishable from conventionally bred organisms, another group sees as fundamentally different because of the process used to create them. How that tension is resolved — or managed — will shape the future of agricultural innovation, food labeling, and consumer choice for decades to come.

The stakes of these regulatory decisions extend beyond the United States. American biotechnology companies develop products for global markets, and U.S. regulatory decisions influence international norms. Countries that lack the institutional capacity to conduct their own risk assessments often rely on FDA, USDA, or EPA determinations when evaluating whether to approve new biotechnology products for their own markets. A U.S. regulatory framework that is perceived as insufficiently rigorous could undermine international confidence in American agricultural exports, while a framework that is perceived as excessively burdensome could drive innovation to countries with more predictable regulatory environments.

Ultimately, the most fundamental question facing U.S. biotechnology regulation is whether a framework designed in the pre-internet era for a handful of transgenic crop varieties can adequately govern a technology sector that now encompasses gene editing, synthetic biology, cell-cultivated proteins, RNA interference, gene drives, microbiome engineering, and dozens of other applications that the 1986 Coordinated Framework’s authors could not have imagined. The answer to that question will shape not only American food and agriculture but the global trajectory of biological innovation for decades to come.

References

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Last updated: September 26, 2026