How the U.S. Decided to Regulate GMOs: The 1986 Coordinated Framework, the 1987 Bush–Monsanto Visit, and the 1992 FDA Policy

A grainy piece of video footage has circulated online for years with captions promising “seven infamous words that would change everything.” It shows then-Vice President George H. W. Bush touring Monsanto’s laboratories in St. Louis in 1987. When company scientists mention the regulatory hurdles facing their genetically engineered products, Bush responds with a line usually quoted as “Call me. We’re in the dereg business.” The clip is typically presented as the moment the U.S. government decided to let biotech companies regulate themselves.

The real history is more interesting and, in places, counterintuitive. Monsanto did lobby the White House in the 1980s, but by the company’s own former executives’ account, it lobbied for federal regulation, not against it. The policy that emerged, built across the Reagan and George H. W. Bush administrations, still shapes how genetically engineered crops and foods are overseen in the United States today. And that system has been revised, challenged, and in one major case struck down by a federal court as recently as December 2024.

This article traces how U.S. regulation of genetically engineered food was built, what the 1987 remark does and does not tell us, how the system works now, and how it compares with other approaches.

What the 1987 Footage Shows

The footage comes from a visit Vice President Bush made to Monsanto’s facilities in St. Louis. Bush, who led the Reagan administration’s Task Force on Regulatory Relief, had made reducing federal regulation a signature issue. U.S. Right to Know, a nonprofit that investigates the food industry, describes the moment this way: during a 1987 walkthrough of Monsanto’s laboratories, when the company’s regulatory concerns came up, Bush replied, “Call me, I’m in the dereg business. I can help.” Versions of the quote vary slightly depending on the transcription.

Taken at face value, the remark sounds like a promise to strip away oversight. In context, it reflected the Reagan administration’s broad deregulatory agenda, which Bush championed across many industries. What the footage does not show is the conversation that had taken place months earlier, which points in a different direction.

The Meeting That Came First: Monsanto Asks for Regulation

In January 2001, The New York Times published a lengthy investigation into the history of agricultural biotechnology, “Biotechnology Food: From the Lab to a Debacle” (reprinted by the Institute for Agriculture and Trade Policy), reported by Kurt Eichenwald, Gina Kolata, and Melody Petersen. It opened with a scene from late 1986, when four Monsanto executives visited Vice President Bush at the White House.

According to the Times, the executives made an unusual pitch for the era. Although the administration was championing deregulation, Monsanto wanted genetically modified food to be governed by rules issued in Washington and wanted the White House to champion that idea. A former Monsanto executive who attended the meeting, Leonard Guarraia, told the Times there were no products at the time, but the company “bugged him for regulation.”

The reasoning, as the Times described it, was strategic. Federal guidelines would reassure a public that was growing nervous about genetic engineering. Without them, executives feared consumer wariness could doom the industry’s enormous investment. The Times reported that in the following weeks and months, the White House worked behind the scenes to help Monsanto get the kind of regulatory framework it wanted.

That history complicates the viral framing. The industry did not simply seek freedom from oversight. It sought a particular kind of oversight: federal, predictable, based on existing laws, and designed to give the public confidence without subjecting products to a new, restrictive approval system. Whether that approach served the public well is the real question, and it is still debated.

The 1980s Backdrop: Public Anxiety About a New Science

Monsanto’s request for regulation makes more sense against the events of the mid-1980s. Genetic engineering was new, and early attempts to move it out of the laboratory ran into public resistance. The Times investigation recounted how the company’s genetically engineered bovine growth hormone, designed to increase milk production in dairy cows, drew opposition from consumer groups and some dairy farmers, with several dairy states moving to restrict it. The article also described the fight over “ice-minus” bacteria, engineered to help protect crops from frost damage; in 1987 the EPA allowed another company, Advanced Genetic Sciences, to field test them, but only under requirements that labeled them a pesticide, and the tests drew protests and vandalism.

Against that background, biotech executives feared that without a clear federal framework, public alarm and local restrictions could make it impossible to bring any product to market. A federal system based on existing laws, overseen by respected agencies, offered a way to signal that products were being checked without creating a new, potentially restrictive approval process. That logic helps explain both why Monsanto sought regulation and why the regulation that emerged was relatively light-touch.

The bovine growth hormone, known as rbST or rBGH, was eventually approved by the FDA in 1993. It remained controversial for years, leading many dairy processors and retailers to market milk from cows not treated with it, one of the earliest examples of consumer-driven labeling around a biotech product.

The 1986 Coordinated Framework

The foundation of U.S. biotech regulation was laid before the 1987 visit. In 1984, the White House Office of Science and Technology Policy proposed a framework for regulating products of biotechnology, and in June 1986 it published the final Coordinated Framework for Regulation of Biotechnology in the Federal Register.

The framework rested on a few core ideas. First, regulation would focus on the characteristics of the product rather than the process used to make it; genetic engineering itself was not considered inherently risky. Second, restrictions would be based on verifiable scientific risk. Third, existing laws were considered adequate, so no new biotech-specific statute was needed. Instead, oversight was divided among three agencies under laws they already administered.

As the Congressional Research Service has explained, USDA’s Animal and Plant Health Inspection Service (APHIS) regulates GE plants that are or might be plant pests, using authority now found in the Plant Protection Act. USDA published proposed rules as part of the 1986 framework and finalized them in June 1987. The Environmental Protection Agency regulates plants engineered to produce pesticidal substances, such as insect-resistant Bt crops, along with the pesticides used on herbicide-tolerant crops. The Food and Drug Administration oversees the safety of food and animal feed.

From Framework to Food Policy: The 1992 FDA Statement

The Coordinated Framework settled which agencies would be responsible, but not exactly how food from genetically engineered plants would be treated. That question was answered during the George H. W. Bush administration, shaped in part by the White House Council on Competitiveness, which Bush created in 1989 and placed under Vice President Dan Quayle. The council’s mission was to reduce regulatory burdens on business.

On May 26, 1992, according to the Times investigation, Quayle announced the administration’s policy on bioengineered food, telling an audience of executives and reporters that the reforms would speed up and simplify bringing biotech agricultural products to market and that such products would receive the same oversight as other products rather than being hampered by unnecessary regulation. Days later, the FDA published its Statement of Policy: Foods Derived from New Plant Varieties.

The FDA policy had several key features that still apply:

Same standard as other foods. Foods from GE plants are held to the same safety requirements as foods from conventionally bred plants. The method of development does not by itself trigger special review.

Developer responsibility. Companies are responsible for ensuring the foods they market are safe and lawful. New substances introduced into food through genetic engineering may require FDA approval as food additives, but many are expected to be generally recognized as safe if they are similar to substances already in the food supply.

Voluntary consultation. The FDA encouraged developers to consult with it before marketing. In practice, developers have used the consultation program for GE crops brought to market, submitting data on composition, nutrients, potential allergens, and toxicants. At the end, the FDA issues a letter stating whether it has further questions. The consultation is not a formal approval.

No special labeling. Labeling would be required only if a food differed materially from its conventional counterpart, for example in nutritional content or the presence of a new allergen. Being genetically engineered was not in itself considered a material difference.

The Idea of “Substantial Equivalence”

A concept closely tied to the 1992 policy is “substantial equivalence.” Developed internationally through the Organisation for Economic Co-operation and Development in the early 1990s, it holds that if a food from a genetically engineered plant is shown to be comparable to its conventional counterpart in composition, nutrients, known toxicants, and allergens, it can be considered as safe as that counterpart, with further testing focused on any identified differences. The FDA’s consultation process reflects this comparative approach, and international food safety guidelines developed through the Codex Alimentarius Commission build on it as a starting point for safety assessment.

The concept has been criticized from the start. In a 1999 commentary in Nature, Erik Millstone, Eric Brunner, and Sue Mayer argued that substantial equivalence was ill-defined, that it relied too heavily on chemical comparisons that might miss unexpected biological effects, and that it should be replaced by more rigorous biological, toxicological, and immunological testing. Supporters respond that the comparative approach has been refined over time into a structured starting point for assessment rather than an endpoint, and that decades of experience with approved crops support its use.

The debate matters because substantial equivalence is, in effect, the scientific rationale for the 1992 decision to treat most GE foods like conventional foods. Where one stands on that concept largely determines whether one sees the U.S. system as sensibly proportionate or as too permissive.

Internal Objections and Legal Challenges

The 1992 policy was not adopted without dissent. The Times investigation included a section on objections raised by scientists, and documents later made public through litigation showed that some FDA scientists had raised questions during the policy’s development about the potential for unintended effects from genetic engineering and whether the agency should require more testing. The agency’s leadership concluded that the evidence did not support treating GE foods as a distinct class.

In 1998, a coalition of scientists, religious leaders, and consumers led by the Alliance for Bio-Integrity sued the FDA, arguing that the policy violated federal law by presuming GE foods safe and by not requiring labels. In 2000, a federal district court upheld the FDA’s approach, finding that the agency’s conclusions were entitled to deference and that the absence of labeling was consistent with the law as written. The ruling left the policy in place.

The debate over whether the 1992 policy was scientifically sound or overly deferential to industry has continued ever since. Supporters point out that decades of experience and major scientific reviews have not found GE foods on the market to be less safe than conventional foods. Critics argue that the voluntary, developer-driven nature of the process, and the reliance on data supplied by the companies seeking to market products, gave the public less assurance than a mandatory approval system would have.

The Framework Since 1992: Updates and Court Fights

The basic structure set in 1986 and 1992 has lasted for more than three decades, but the details have been revised repeatedly, often under pressure from new technology.

The 2017 update

In 2015, the Obama administration directed the three agencies to update the Coordinated Framework, clarify their roles, and plan for future biotechnology products. The resulting 2017 update described each agency’s responsibilities in more detail and was accompanied by a strategy for modernizing the regulatory system. The agencies later launched a unified website for biotechnology regulation to help developers and the public understand which agency oversees which products.

The 2019 executive order and the SECURE rule

In June 2019, President Trump signed an executive order directing agencies to streamline regulation of agricultural biotechnology products. In May 2020, USDA finalized a major rewrite of its biotechnology regulations, known as the SECURE rule. It exempted many genetically engineered plants, particularly those with modifications that could have been achieved through conventional breeding, and replaced the older system with a process focused on the plant’s characteristics and plant pest risk.

The 2024 court ruling

Farm, food safety, and environmental groups challenged the SECURE rule. On December 2, 2024, the U.S. District Court for the Northern District of California ruled in National Family Farm Coalition v. Vilsack that USDA had acted arbitrarily in parts of the rule, including by failing to incorporate its noxious weed authority and in how it implemented exemptions, and vacated the rule. APHIS responded by re-establishing its pre-2020 regulations, restarting permitting and its “Am I Regulated” process for developers seeking to know whether a product falls under oversight. Decisions and permits issued before the ruling remained valid. Subsequent Federal Register documents note that APHIS issued technical conforming amendments in June 2025 to reflect the court’s vacatur, and the agency has continued rulemaking on its biotechnology regulations in 2026.

The ruling was a reminder that the U.S. approach has always been built on agency interpretation of existing statutes rather than on a dedicated biotechnology law. That flexibility allowed regulators to adapt quickly, but it also leaves the system open to legal challenge whenever an agency changes course without adequate justification.

How the U.S. Approach Compares With the EU

The U.S. framework is often contrasted with the European Union’s, which starts from a different premise. The table below summarizes the main differences.

Each approach has trade-offs. The U.S. system has allowed rapid adoption of new crops and relatively low regulatory costs for developers, which supporters credit with keeping American agriculture competitive. The EU system has given consumers clear labeling and a more precautionary review but has been criticized by scientists for regulating by process rather than risk, and for slow, politically influenced approval decisions.

The 2016 National Academies report on genetically engineered crops weighed in on this question. It concluded that the distinction between conventional breeding and genetic engineering is becoming less meaningful as technologies advance, and recommended that regulators focus on the characteristics and potential risks of new products, with a tiered approach in which more novel products receive more scrutiny, regardless of the technique used. That recommendation is closer to the U.S. product-based philosophy, though the report also called for greater transparency and public participation in regulatory decisions.

Separating Myth From History

The viral framing of the Bush footage compresses a complicated history into a single moment. Several common claims deserve a closer look.

Claim: Seven words from Bush created the U.S. GMO policy. The Coordinated Framework was proposed in 1984 and finalized in 1986, before the 1987 visit. The FDA food policy came in 1992. The remark reflects the administration’s attitude, but the policy was built through formal documents over many years.

Claim: Monsanto wanted no regulation. According to former Monsanto executives quoted by the Times, the company actively asked for federal regulation in 1986, seeing it as a way to build public trust. What it wanted was a predictable, science-based federal framework rather than a restrictive new approval system or a patchwork of state rules.

Claim: GE foods in the U.S. are not reviewed at all. GE plants are reviewed by USDA for plant pest risks where they fall under its rules, by EPA when they produce pesticidal substances, and by FDA through its consultation program. The FDA review is voluntary in form, which critics consider a real weakness, but it has been widely used.

Claim: The system has not changed since the 1980s. It has been updated repeatedly, most recently through the 2017 framework update, the 2020 SECURE rule, the 2024 court decision vacating that rule, and ongoing rulemaking.

Claim: The industry got everything it wanted. The industry got much of what it asked for in the 1980s and 1990s. But it also faced the state labeling fights of the 2010s, a mandatory national disclosure law in 2016, and a court ruling in 2024 that overturned a rule it had supported.

Why Trust Remains the Central Issue

The Times investigation argued that the policy Monsanto sought ultimately backfired on the industry. By persuading the government to treat GE foods as essentially no different from conventional foods, and by resisting labeling, the industry avoided regulatory costs but failed to build the public confidence it had said it wanted. The article quoted Monsanto’s former chief executive, Robert Shapiro, acknowledging in hindsight that there was often a fine line between scientific confidence and corporate arrogance, and that the company had not listened well to people raising ethical, cultural, social, and economic concerns.

That observation still resonates. Public skepticism of genetically engineered food in the United States has less to do with any specific safety finding than with trust: in companies, in regulators, and in the relationship between the two. Critics have long pointed to the movement of individuals between the biotech industry and the agencies that regulate it as a source of distrust. Defenders respond that expertise inevitably flows between sectors and that decisions are made by career scientists under public rules. Transparency measures, such as publishing consultation documents and regulatory decisions online, are one way agencies have tried to address those concerns.

Gene Editing and the Next Chapter

The framework built in the 1980s was designed for a technology that inserted genes, often from other species, into crops. Newer gene-editing tools such as CRISPR can make small, targeted changes to a plant’s own DNA, sometimes producing results indistinguishable from what conventional breeding or natural mutation could achieve.

That development has reopened basic questions the Coordinated Framework was meant to settle. If regulation should focus on the product rather than the process, as the U.S. has argued since 1986, then a gene-edited plant with a change that could have occurred naturally arguably should not be regulated differently from a conventionally bred plant. USDA’s SECURE rule largely took that position before it was vacated. Critics counter that gene editing can produce unintended changes, that exemptions based on developer self-determination lack oversight, and that consumers deserve to know how their food was made.

How U.S. agencies handle gene-edited crops under the restored pre-2020 rules and any new rulemaking will be one of the most consequential regulatory questions for agriculture in the coming years. The same debates are playing out in other countries, many of which are revising their own rules for gene-edited organisms.

How to Look Up a Product’s Regulatory History

One practical consequence of the U.S. system is that the regulatory record for a genetically engineered crop is spread across several agencies. Anyone curious about a specific product can check several public sources:

FDA consultations. The FDA publishes a list of completed consultations on foods from new plant varieties, with the agency’s response letters and, for many products, a summary of the developer’s submission.

USDA determinations. APHIS publishes petitions for determinations of nonregulated status, environmental assessments, and, under the restored rules, responses to “Am I Regulated” inquiries.

EPA registrations. For crops that produce pesticidal substances, EPA registration documents describe the risk assessment and any conditions of use, such as insect resistance management requirements.

The unified biotechnology website. The agencies’ joint site links to these resources and explains which agency is responsible for which type of product.

What This History Means for Consumers Today

For shoppers, the practical implications of this regulatory history are fairly direct. Foods containing ingredients from genetically engineered crops are widely available in the United States and have been reviewed under the framework described above. Since 2022, many packaged foods containing detectable bioengineered material must carry a disclosure, which may be text, a symbol, or a QR code. Highly refined ingredients such as many oils and sugars often do not require disclosure. Shoppers who want to avoid GE ingredients entirely can look for USDA Organic certification or third-party non-GMO verification.

For citizens interested in policy, the more important lesson is that the rules governing biotechnology are not fixed. They were built through executive policy, agency rules, and court decisions, and they continue to change through the same channels. Public comment periods on proposed rules, published in the Federal Register, are one of the few direct ways individuals can weigh in.

Frequently Asked Questions

What did George H. W. Bush say at Monsanto in 1987?

During a tour of Monsanto’s St. Louis laboratories, when regulatory hurdles came up, the then-vice president responded with a remark usually quoted as “Call me, I’m in the dereg business,” in some versions adding “I can help.” Exact wording varies by transcription.

Did Monsanto want GMOs to be unregulated?

According to former Monsanto executives interviewed by The New York Times in 2001, the company asked the White House for federal regulation in 1986, believing government oversight would reassure the public. It sought a predictable framework under existing laws rather than no regulation.

What is the Coordinated Framework?

The federal policy, finalized in 1986 and updated in 2017, that divides oversight of biotechnology products among USDA, EPA, and FDA under existing laws, based on the principle that products should be regulated by their characteristics rather than the process used to create them.

Does the FDA approve genetically engineered foods?

The FDA does not issue formal approvals for most GE foods. Under its 1992 policy, developers are responsible for food safety and use a voluntary consultation process, after which the FDA states whether it has further questions. New substances that do not qualify as generally recognized as safe would require food additive approval.

What happened to USDA’s SECURE rule?

A federal court in California vacated it on December 2, 2024, finding parts of it arbitrary and capricious. USDA restored its pre-2020 regulations, made technical amendments in 2025, and has continued rulemaking.

How is the EU approach different?

The EU regulates genetically modified organisms as a category, requires pre-market authorization with a risk assessment, and mandates labeling above 0.9 percent GM content per ingredient. The U.S. regulates based on product characteristics under existing laws.

References

1. Eichenwald K, Kolata G, Petersen M. Biotechnology Food: From the Lab to a Debacle. The New York Times. January 25, 2001 (reprinted by IATP). iatp.org
2. U.S. Right to Know. U.S. GMO Policy is Legacy of Vice President Dan Quayle. usrtk.org
3. Congressional Research Service. Deregulating Genetically Engineered Alfalfa and Sugar Beets: Legal and Administrative Responses (R41395). 2013. everycrsreport.com
4. U.S. Food and Drug Administration. Statement of Policy: Foods Derived from New Plant Varieties. 1992. fda.gov
5. U.S. Food and Drug Administration. Consultation Programs on Food from New Plant Varieties. fda.gov
6. Executive Office of the President. Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework. January 2017. obamawhitehouse.archives.gov
7. USDA, EPA, FDA. The Unified Website for Biotechnology Regulation. usbiotechnologyregulation.mrp.usda.gov
8. U.S. District Court, N.D. California. National Family Farm Coalition v. Vilsack, No. 21-cv-05695-JD, Order re Summary Judgment. December 2, 2024. aglaw.psu.edu
9. Bergeson & Campbell. APHIS Restarts Permitting and “Am I Regulated” Processes for Products of Biotechnology. January 2, 2025. lawbc.com
10. Federal Register (public inspection). APHIS document 2026-09833. 2026. federalregister.gov
11. Millstone E, Brunner E, Mayer S. Beyond ‘substantial equivalence’. Nature. 1999;401:525–526. PMID 10524614
12. National Academies of Sciences, Engineering, and Medicine. Genetically Engineered Crops: Experiences and Prospects. 2016. nap.nationalacademies.org
13. Executive Order 13874, Modernizing the Regulatory Framework for Agricultural Biotechnology Products. Federal Register. June 14, 2019. federalregister.gov

Last updated: September 26, 2026