Bioengineering is one of the modern era’s most powerful tools to address food insecurity, climate change, and other sustainability issues. But our ability to bring these transformative crops to market was just dealt a major blow.
Early in December, the Northern California District Court vacated rules adopted in 2020 by the U.S. Department of Agriculture through its Animal and Plant Health Inspection Service (APHIS). The lawsuit, brought by anti-bioengineering activists (pretending to be worried about family farms), reinstates a regulatory framework in place since 1986, while the technology was only in its infancy — and not yet even commercially available.
So what does this mean for the future of bioengineered crops? And what can be done about it?
The Original GMO Regulations
The best place to start, of course, is the beginning. Before 2020, the regulatory framework for genetically engineered crops was handled by the Food and Drug Administration, the Environmental Protection Agency, and APHIS (through the USDA). The USDA’s authority stems from the Plant Protection Act passed in 2000 to combine several previous statutes into one unitary scheme.
The USDA’s pre-2020 regulations had four key features: process-based regulation; pre-market authorization; deregulation pathway; and focus on plant-pest risk. Most importantly, developers were required to notify APHIS and obtain permits for field testing, interstate movement, and environmental release of BE crops. Eventually companies could petition APHIS to exempt its specific GMO and allow commercial production. Obtaining the exemption often required extensive data submission and managing a lengthy process.
While this system provided a robust mechanism for ensuring safety, it was outdated and overly burdensome, particularly as genetic engineering technologies advanced and became more precise. New GMO crops were held back by red tape for years. And clearing the hurdles to commercialization cost millions of dollars.
These shortcomings inspired a reexamination of the regulatory framework.
The 2020 Rule
In 2008, the USDA recognized it was time to take a critical look at GMO regulations. Over a decade later, in May 2020, it finally adopted a new scheme that more accurately reflected the precision of modern technology and reflected the voluminous amount of scientific data on these crops.
One of the most impactful changes under the 2020 rule was the shift from process-based regulation to trait-based oversight. Previously, GE organisms were regulated largely because they were developed using genetic engineering methods, often involving plant-pest material. This framework, while appropriate in the early days of biotechnology, no longer reflected the diversity and precision of modern genetic engineering techniques. The new rule focuses on the specific traits introduced into crops and their potential to pose plant-pest risks, rather than the method of their creation.
This approach aligns regulatory efforts with scientific principles, ensuring that oversight is focused on tangible risks rather than outdated assumptions.
But the biggest difference was the expanded exemptions — genetic changes that didn’t require the odious pre-market limitations and further assessment before deregulation. In other words, some categories of bioengineered crops were fast-tracked to commercial use.
- The first exemption applies to conventional breeding equivalents. If a BE crops could’ve been developed through traditional breeding or mutagenesis, then it was exempt from regulatory oversight. This change reflected decades of scientific consensus that genetic engineering, as a tool, does not inherently introduce greater risks than conventional methods. So if scientists could have reached the same result with the old fashioned way of creating new varieties (a process that took much longer than current technologies), it didn’t need burdensome oversight.
- There was also an automatic exemption for low-risk plant-trait combinations. This exemption applied to specific plant-trait-mechanism of action that APHIS deemed unlikely to pose plant-pest risks (a legal term from the Plant Protection Act). That meant companies didn’t have to waste millions of dollars proving new crops were safe if the risk associated with the changes was minimal.
- Finally, genetically modified organisms that had already undergone APHIS’s rigorous risk assessment and passed didn’t require another trip through bureaucratic red tape. An illustration helps to explain the concept. Broccoli and cauliflower are closely related plants. If scientists bioengineered a variety of broccoli that was drought resistant, and that new crop achieve commercial status, then the developer could skip the process for inserting the same genes into cauliflower. This exemption cut down on redundancies in the regulatory framework.
Despite these changes, the 2020 rule didn’t water down oversight. Any GE crops with potential risks were still subject to rigorous review. The rule maintained the agency’s ability to regulate GE organisms that pose plant-pest risks while removing unnecessary oversight for low-risk crops. At the same time, it imposed new recordkeeping requirements for those GMOs receiving the automatic exemption.
This balance was essential for supporting both innovation and safety.
The Legal Challenge
And now we come to the frustrating portion of this story. A group of anti-GMO organizations and nonprofits challenged APHIS’s 2020 rule (in a case titled National Family Farm Coalition v. Tom Vilsack) by arguing it was arbitrary, capricious, and violated federal statutes, including the Plant Protection Act and the Endangered Species Act. Without getting into all of the legalese underpinning these types of challenges, their argument was that the new rules lacked a reasonable basis, and that’s enough to vacate the rule.
Unfortunately, the court agreed with that assessment, but not in the way you might expect. The court relied on a 2002 National Academy of Sciences (NAS) report to find examples of scientific data contradicting APHIS’s assumptions.
It certainly seems odd to rely on a report that is more than 20 years old, especially when we’re using methods that weren’t even dreamed of back then, but that’s exactly what the court did.
Take the conventional breeding exemption under the 2020 rule. APHIS’s assumption is that any plant traits that could be developed using traditional breeding methods don’t need heightened regulatory scrutiny. But the NAS report rejected that reasoning because we can’t just assume that conventionally bred crops have “acceptable risks.”
Although the assumption is broad, imagine being worried that your Gala apples might be too dangerous because they’re a cross between a Golden Delicious and another variety.
During litigation, APHIS even noted that the anti-GMO plaintiffs were cherry-picking their data, saying that the 2002 NAS study also concluded that “the genetic engineering process, per se, presents no new categories of risk compared to conventional breeding.”
But the case isn’t all bad news. Though the court vacated the rule (boo!), it remanded the matter back to APHIS to consider the supposed contradictions and find ways to better support its assumptions. The real question is how the Trump administration’s USDA will choose to respond, if at all. With people like RFK Jr. (he’s questioned the safety of GMOs) throwing their weight around in the agricultural space, that’s unknown.
Here’s what I know for sure: If we want to continue developing, progressing, and problem solving, we better find a way to streamline bioengineered regulations. We know a lot more today than we did in 1986, and the way we implement bioengineering has drastically changed. Our regulatory framework needs to keep up.
Amanda Zaluckyj blogs under the name The Farmer’s Daughter USA. Her goal is to promote farmers and tackle the misinformation swirling around the U.S. food industry.
