Enforcing Regulations on GE Organisms
Center for Food Safety successfully challenged the Trump administration's revisions to federal regulations (the Part 340 Regulations) of genetically engineered (GE) organisms. The rules significantly reduce federal oversight and allow many genetically engineered crops to enter the marketplace without meaningful review.
What Are Part 340 Regulations?
In 2020, the first Trump administration’s Department of Agriculture (USDA) finalized a sweeping rewrite of the rules governing genetically engineered (GE) crops, trees, and grasses. This rule change was known as Part 340.
For decades, nearly all GE plants had been required to go through USDA review before open-air testing or commercial sale. The new rule instead exempted broad categories of GE organisms from any pre-market review at all, and for the rest, let biotech and pesticide companies “self-determine” whether their own products needed to be regulated.
The resulting Part 340 proposed regulations significantly weakened USDA’s oversight over GMOs. By leaving it largely up to the biotechnology industry to self-regulate, they opened the door for new genetically engineered plants and crops to enter the marketplace without adequate government oversight.
Case Overview and Significance
In July 2021, CFS and a coalition of farm, farmworker, and conservation groups sued USDA, arguing the rule change was unlawful on multiple grounds: it violated several pieces of federal legislation including the Plant Protection Act and Endangered Species Act, and it improperly handed USDA’s regulatory responsibilities to the very industry it was supposed to be overseeing.
In the case, National Family Farm Coalition, et al. v. Vilsack, we argued the rule change effectively gave pesticide companies free rein over future GE products regardless of the consequences for farmers and the environment.
The complaint pointed to decades of real-world harm already caused by GE crop systems: contamination of organic and conventional crops leading to billions of dollars in market losses, a sharp rise in herbicide use, and an epidemic of herbicide-resistant “superweeds” now infesting some 120 million acres. The expansion of GE herbicide-tolerant crops is also tied to pollinator and biodiversity losses, including the decline of monarch butterflies from the loss of milkweed in Midwest farm fields, and to widespread dicamba drift damage to neighboring farms and wild plants.
In 2024, a federal court ruled in our favor, holding that USDA’s 2020 rule violated the Plant Protection Act and the Administrative Procedure Act. The court found the agency’s justification for the rule directly conflicted with its own experts’ prior conclusions, and that USDA had failed to address a single one of the concerns it had itself previously raised about GE crop risks over more than a decade. The court also found the rule’s core exemptions were contradicted by the scientific record.
Following the ruling, USDA’s Animal and Plant Health Inspection Service reverted to its pre-2020 regulatory framework, restoring case-by-case review for GE organisms.
The decision was critical win for farmers and scientific integrity, as the court rejected USDA’s attempt to hand regulatory responsibilities over to and the pesticide and biotech industry. The ruling restored basic protections for family farmers, consumers, and the environment against a seed and pesticide market increasingly dominated by a handful of agrochemical companies.
Key Issues with Part 340 Regulations
Center for Food Safety argued that USDA’s revised Part 340 regulations substantially weakened federal oversight by exempting many genetically engineered crops from review and allowing biotechnology companies to determine for themselves whether their products qualify for exemptions.
The rules shifted USDA from a regulatory system toward a largely deregulatory approach that leaves many genetically engineered organisms outside meaningful government oversight. We contend this creates risks for farmers, consumers, and the environment.
We believe these regulations failed to adequately address issues such as genetic contamination of conventional and organic crops, herbicide-resistant weeds, environmental impacts, and emerging genetic engineering technologies.
The regulations would have exempted broad categories of genetically engineered plants from review, including certain gene-edited crops and plants containing genetic changes USDA considers similar to conventional breeding outcomes.
Genetically engineered crops can contribute to herbicide-resistant weeds, increased pesticide use, genetic contamination of non-GE crops, and other environmental concerns that require stronger oversight.
