Biotech developers can decide for themselves whether crops are exempt from federal scrutiny under the USDA’s new regulatory structure for genetic engineering.
Even those crops that must be reviewed by USDA will often be simpler to introduce, since many won’t have to undergo the costly deregulatory process that genetically engineered plant traits previously faced.
The biotech industry expects the new rules to open the door for more small companies to commercialize niche products compared to the traditional system, which only the largest firms could often afford to navigate.
“It’s not as expensive, it’s not as time-consuming. It’s no longer one-size-fits-all,” said Clint Nesbitt, senior director of science and regulatory affairs for food and agriculture at the Biotechnology Industry Organization.
These same changes have also raised concerns among critics of federal biotech oversight, who fear the USDA has abdicated much of its regulatory power over genetically modified organisms — potentially exacerbating export market disruptions and herbicide resistance in weeds.
“They’re intentionally trying to avoid using their authority to deal with the issues with GMOs we’ve seen in recent years,” said Bill Freese, science policy analyst with the Center for Food Safety, a nonprofit that’s critical of USDA biotech oversight.
Under the previous regulations, crops genetically engineered with plant pests, such as agrobacterium, were considered regulated articles that needed federal permits for field trials and interstate shipping.
Before they could be commercialized, regulated crops had to go through a USDA deregulation process that often took years and required extensive analysis under the National Environmental Policy Act.
Crops that weren’t modified with plant pests — such as those altered with gene guns or gene editing techniques — could avoid this process if the developer confirmed with USDA that these plants weren’t regulated articles.
Under the new rules, which became final May 18 and will be fully phased in by October 2021, biotech developers can self-determine whether crops are exempt from USDA review. They can also voluntary ask the agency to confirm the product is exempt.
The agency has exempted crops whose alterations could have been achieved through conventional breeding, as well as those whose basic modes of action have already been evaluated by USDA and determined not to pose a plant pest risk.
If a developer decides a crop isn’t exempt, the USDA will subject it to a “regulatory status review” to determine whether it’s a plausible plant pest risk within six months.
If it’s not, then the crop can be commercialized. If it does pose a plausible risk, only then must the crop undergo a process similar to deregulation, including NEPA analysis and public comment.
Until now, clearing the USDA’s regulatory process has mostly been worthwhile for major developers with “big dollar crops” that would justify the time and money involved, said Nesbitt of BIO.
Now, commercialization will be more viable for smaller-acreage crops and traits that are more targeted to specific regions or growers, he said.
With the “bottleneck” of the traditional regulations gone, the USDA also won’t have to repeatedly deregulate crops with similar modes of action, he said.
“It really frees up the agency’s resources to focus on the things that really could pose a plant pest risk,” Nesbitt said.
The Center for Food Safety fears the change will remove regulatory checks on biotech developers while ignoring environmental and economic problems.
“It’s essentially an open field experiment taking place except it’s not being called an experiment,” said Sylvia Wu, senior attorney with the group. “Instead of providing more regulatory oversight, they basically provide none.”
The USDA has the jurisdiction to regulate noxious weeds — such as those that become resistant to herbicides sprayed on genetically engineered crops — but the agency chose only to use its power to regulate plant pests, said Freese, the nonprofit’s science policy analyst.
Preventing the spread of herbicide-resistant weeds would involve restrictions on biotech developers, such as limited planting of crops that also withstand these chemicals, he said. “That would hamper their sales of those crops and the USDA is not about to go against their interests, even if it helps farmers.”
The USDA won’t even be aware of new biotech traits that could cause trade disruptions if the developer claims an exemption, Freese said.
Meanwhile, the justification for these exemptions, and their effectiveness, is dubious — the impact of different crops is unique, even if they’re altered with a similar mode of action, he said.
Similarly, the agency won’t know if exempted genetically engineered traits could have been achieved with traditional breeding unless that work is actually performed, Freese said.
“You can’t really predict whether a GE plant could have been produced conventionally,” he said. “Scientifically, you can’t say that.”