by Alice Carli*
Humans have been altering plants for upwards of 10,000 years through a wide variety of techniques for genetic modification. In the 20th century, scientists developed transgenic genetic engineering, which combines DNA from two or more sources to achieve a desired trait. This discovery fundamentally altered our ability to manipulate crops and opened a Pandora’s box of commercial possibilities and political conflicts. More recently, the advent of CRISPR and other precision gene editing technologies has resurfaced tensions around the role of genetically modified (“GM”) crops in our agricultural and food systems.
Despite these longstanding tensions, the U.S. has the world’s largest production of GM crops by acreage, and it is estimated that over 75% of processed foods on our supermarket shelves contain genetically engineered ingredients.
At the same time, the country faces systemic sustainability challenges exacerbated by climate change and intensive monoculture farming. These include flooding, soil degradation, air and water pollution, and biodiversity collapse. Significant and holistic changes to U.S. agriculture are needed to tackle these problems.
If regulated effectively, GM crops have the potential to make U.S. agriculture more sustainable and climate resilient. When designed with climate-smart features, these crops can significantly enhance nutrient or photosynthesis efficiency, provide flood, drought, and disease resistance, and even improve soil carbon sequestration.
However, the current regulatory framework governing GM crops is not aligned with these goals. It is outdated, fragmented, and does not adequately protect farmers or the environment. To address these issues, a comprehensive legislative intervention and a new set of core principles are urgently needed to regulate GM crops in a manner that aligns with the evolving understanding of sustainable agriculture.
The Coordinated Framework for Regulation of Biotechnology was established under the Reagan administration to appease growing public concern about biotechnology while allowing the genetic engineering industry to innovate with minimal hindrance. The Framework delegated regulation to three existing agencies: the United States Department of Agriculture (“USDA”), the Environmental Protection Agency (“EPA”), and the Food and Drug Administration (“FDA”). However, it did not give these agencies any new statutory authority, and it largely pre-empted states from participating in GM crop regulation.
The USDA primarily governs GM crops through the Animal and Plant Health Inspection Service (“APHIS”). APHIS regulates crops that are plant pests or which can create risk in a plant product. APHIS has exempted various GM plants from regulation where they could have otherwise been developed through conventional breeding. It also exempts plants that it considers less risky due to a specific combination of species types, GM traits, and modification mechanisms.
The EPA has the authority to regulate GM crops engineered to produce a pesticide. It employs post-approval monitoring and management programs and requires permits for field testing crops with an experimental pesticide gene. In 2023, the EPA announced changes to its regulations to exempt crops with modifications that reduce or eliminate the activity of a gene or in which a modification matches a gene found in a sexually compatible plant.
Meanwhile, transgenic proteins are subject to FDA oversight because they are considered food additives. However, the FDA considers most GM crops exempt from pre-market approval because they are “substantially equivalent” to non-GM crops.
As a result of its piecemeal design, the Framework fails to address the environmental sustainability and economic equity issues raised by climate change and consolidation in the GM seed market.
New genetic engineering methods blur the lines of existing regulatory authority, while others lie outside the jurisdiction of any agency. Proponents of new GM crops are forced to navigate a “bureaucratic maze” and an “alphabet soup” of initiatives. Also, the system is not designed to distinguish between genetic engineering that aligns with the public interest and that which threatens harmful ecological impacts or is geared only towards increasing short-term yields.
This inefficacy culminates in a striking lack of independent, accurate, and credible risk assessment for GM crop approval. The intellectual property protections granted to GM crops have significantly strengthened the market power of seed conglomerates. Patent holders of GM seeds can use licensing restrictions to prevent access to their products for independent safety testing, and manufacturers are not required to submit independent safety studies as part of their permitting review.
A comprehensive legislative package is necessary to address the core failings of the existing framework, including centralizing and expanding regulatory authority, reducing intellectual property protections for GM seeds, and creating a new regulatory role for states.
GM crop regulation should facilitate a holistic and integrated approach to sustainable agriculture and support economic diversification and independent research in the GM crop market. Regulatory approval should prioritize diversified farming that enhances biodiversity and supports ecosystem services (e.g., nutrient cycling and weed, disease, and pest management).GM crops designed within this frame must utilize fewer chemical inputs and be compatible with crop rotation and intercropping. They must also be designed to prioritize system resiliency and sustainability through traits such as enhanced nutrient use efficiency and natural pest and disease resistance.
To accomplish these aims, legislation should delegate authority to a single federal agency with a regulatory mandate that emphasizes ecological and economic sustainability. The agency should be required to adopt a robust risk assessment methodology that applies regardless of whether crops were produced using transgenic engineering or new precision techniques. The regulatory framework should balance profit measures, such as crop yields, with measures of ecological health, including soil health, pollution, and biodiversity. Regulators should ensure that GM crops are designed and managed to minimize potential adverse environmental impacts and maximize positive ecological interactions. This includes preventing gene flow to non-GM crops and wild relatives and conserving soil health.
The legislation should also reserve, rather than pre-empt, regulatory authority for the states. States are better positioned to regulate the development, testing, and deployment of GM crops in a way that considers the socioeconomic context and regional ecological needs of farmers. States are also the more appropriate venue to ensure the active engagement of all stakeholders, which is necessary to build trust and align the use of GM crops with the needs of the communities where they are grown.
Lastly, legislative intervention is needed to modify the intellectual property rights available for GM seeds. At a minimum, this should codify a research exemption to immunize all independent researchers from infringement liability. This would re-open the doors to independent scrutiny of GM crops, especially regarding health and environmental safety. It would also ensure that GM crops do not increase dependency on proprietary seeds or create barriers to seed saving and sharing. This could be further bolstered by investments in a public-sector education and research infrastructure that can support the development of GM crops that address the specific needs of smallholder farmers.
As our agricultural systems face increasing stressors and risks, this is not a moment to turn away from potential solutions. Instead, it is a moment to rethink how we govern those solutions and for whose benefit they are deployed. The aim of GM regulation should be to create a system that fosters biotechnology while aligning its governance with changing norms and understandings about the needs of the U.S. food system. This moment of rapidly developing biotechnology presents the perfect opportunity to shift the direction of the GM market toward supporting broader social and environmental goals through effective public oversight.
*Alice Carli is a member of the 2024 class of J.D. graduates from the UCLA School of Law. She is passionate about energy and environmental policy and has a background in public health, food education, and non-profit administration.
This post is excerpted from a longer article. Contact winters@law.ucla.edu to request the full article.
On Food Law 