March 19, 2024

Biotech Matters: Innovation in Agricultural Biotechnology

The Role and Impact of U.S. Regulations

In 1986, the United States established a “Coordinated Framework for the Regulation of Biotechnology.” In the decades since, this policy helped to enable the rapid development and commercialization of new varieties of plants improved through biotechnology. Innovations in microbial applications and livestock followed more slowly, however, and the primary reason for this differential is illuminating.

A growing global population with rising standards of living increases demands on agriculture to produce more, faster, with fewer inputs and lower environmental impacts. Thanks to technological advances and sound policies, the United States quickly emerged as the global leader in agricultural biotechnology innovation. This happened even though the most critical technology platform of the time (Agrobacterium-based transformation) relied on foundational advances made partly in Europe.

The U.S. Department of Agriculture (USDA) was the first agency to adopt new regulations for dealing with crops improved through biotechnology. This enabled an explosion in field trials, which, in turn, led to rapid commercialization of new seed varieties. Clear guidance from the U.S. Environmental Protection Agency (EPA) for microbial applications was slower to emerge, lingering uncertainties discouraged investment, and technological advances and commercial development followed a much slower trajectory. The Food and Drug Administration (FDA) laid out timely guidance to ensure the safety of foods produced through biotechnology, which was critical to their commercial adoption. Guidance for animals improved through biotechnology was much slower to emerge, delaying their commercial development.

Europe adopted new regulations for genetically engineered crops in 1990. Rather than focus on the characteristics and qualities of the new crop varieties, the EU prioritized attention to the use of recombinant DNA technologies, even though this tells regulators nothing helpful in assessing or managing risk. Politics and special interests have driven the resulting process-based system, with groups such as Greenpeace, the Soil Association, and Friends of the Earth leading the charge. The EU’s process-based system made it difficult to obtain permission for field trials, thus depriving what had been a world-class seed sector of the newest, safest technologies for variety improvement. The misguided regulations drove leading companies to relocate their R&D from the EU to the United States, further consolidating the U.S. lead.

In the years since, U.S. regulatory agencies have adapted their regulations several times but still have not kept pace with the rapid improvements in understanding the performance and safety of crops through biotechnology. Most of these regulations now fall far short of the science-based approach mandated by U.S. regulatory policy. Meanwhile, the EU has recognized its process-based approach’s failure and is trying to avoid repeating its errors while ensuring the safety of the next generation of innovations produced through gene editing.

The question for policymakers, then, is what would a successful, science-based regulatory regime look like for innovations produced with recombinant DNA and gene editing techniques? Similarly, how can regulators design a system that focuses oversight on areas where genuine hazards require practical risk assessment and management? The past half-century offers a few simple lessons.

Lesson 1: The primary purpose of regulation is to ensure safety. Policymakers should resist pressures to use regulation to advance other objectives. Regulation loses efficacy and credibility when extraneous interests—such as protecting a trade advantage or national land use patterns—creep into the equation. Effective regulation avoids this.

Lesson 2: The first requirement for a credible regulatory regime is to focus on products with genuine hazards. Millennia of experience have made humans familiar with the hazards associated with new crop varieties, such as ingesting toxins, allergens, or microbial disease from poor food preparation. Unfamiliar and novel hazards in this space are vanishingly rare, reflecting that humans and our ancestors have always been opportunistic omnivores.

Lesson 3: Risk results from exposure to a hazard (R = H x E). If a product does not have a trait or characteristic that is hazardous to humans, then there is no risk (hazard exposure) from its use and no basis for regulation. Most regulations covering innovations derived through genetic technologies presume risk exists without identifying a hazard or articulating a credible exposure scenario. Such regulations do nothing to protect against real risks, are not fit for purpose, and should be set aside.

Lesson 4: Successful regulations seek to avoid unreasonable risk, not achieve zero risk. Reasonable people may disagree about where to draw the line between acceptable and unacceptable levels of risk, but no reasonable person seeks zero risk—which is unachievable.

Lesson 5: Successful regulations evaluate relative risk, not absolute risk. Establishing the absolute risk associated with a product can be nearly impossible. But it is much easier to determine its relative risk—in effect, comparing the potential dangers of a new product with those of the old one it would supplant. Regulations that require assessments of absolute risk have needlessly obstructed R&D on many innovations with no credible risks. This does not serve the public good.

A regulatory framework grounded in these solid lessons from experience would (and should) eliminate the vast majority of regulations for crops, microbes, and livestock improved through genetic technologies in the United States and worldwide and dramatically improve human welfare.

Given the stakes, what concrete steps can regulators take to modernize regulations for crops, livestock, and microbes improved through biotechnology?

The first step is to discard regulatory triggers based on a specific production technology. Regulators should replace them with triggers based on demonstrated or plausible hazards to humans, livestock, wildlife, or ecosystems. The White House Office of Science and Technology Policy has reminded agencies of their responsibility to do this. The USDA has made commendable progress, but the EPA and FDA continue to lag—to say nothing of regulators in other countries.

The second step is to reorient risk assessment to focus on potential exposure to hazards that would produce an unacceptable level of risk. This should entail a solid predisposition for accelerating approval and adoption of novel products with a lower potential for unacceptable levels of risk compared to existing products. This will require that regulators evaluating new technologies resist the temptation to demand answers to questions that may be nice to know but have little or no utility for mitigating unreasonable risks—for example, requiring animal feeding safety trials to duplicate those already performed in other jurisdictions. To date, very few regulators worldwide have been able to resist this temptation. This must change.

Regulations rooted in these lessons would deliver science-based, innovation-friendly rules to provide a high level of safety while promoting innovation. Republican and Democratic administrations have mandated that U.S. regulatory agencies do this, while their peers in the EU are still trying to recover from their disastrous legacy policies. Other countries around the world should do the same, with enthusiasm. Human welfare will be the principal beneficiary.

About the Author

L. Val Giddings is a Senior Fellow with the Information Technology and Innovation Foundation (ITIF) in Washington, D.C., where he deals with issues related to agricultural biotechnology. Before joining ITIF he was Vice President for Food & Agriculture of the Biotechnology Industry Organization, following service with the biotechnology products regulatory division of USDA. Giddings came to Washington in 1984 to join the Congressional Office of Technology Assessment, where he contributed to and directed studies on biotechnology, the environment, and regulatory policy. He also served as an expert consultant to the United Nations Environment Programme; the World Bank; USDA; The United States Agency for International Development; and companies, organizations, and governments around the world. His writing on agricultural biotechnology can be found at the ITIF site ( and on X @PrometheusGreen.


The author is grateful to C. S. Prakash, Vivek Chilukuri, Hannah Kelley, and Maura McCarthy for their valuable feedback and suggestions on earlier drafts of this commentary, as well as to Melody Cook and Rin Rothback for their design support.

This commentary series was made possible with general support to CNAS.

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  • Dr. L. Val Giddings

    Member, BioTech Task Force, Senior Fellow, Information Technology and Innovation Foundation

    L. Val Giddings is a senior fellow at the Information Technology and Innovation Foundation (ITIF). Giddings joined ITIF after nearly three decades of experience in science and...

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