Feds flesh out biotech regulation, drawing mixed reactions
Published 2:30 pm Wednesday, May 15, 2024

- A lawsuit alleges that USDA's new regulations for biotech crops violate several federal laws by giving more leeway to developers. Roundup Ready alfalfa, which was genetically engineered to withstand glyphosate herbicides, faced litigation under the old rules.
As federal agencies flesh out plans for greater cooperation under their “coordinated framework” for regulating biotechnology, the reactions are predictably mixed.
The biotech industry is encouraged by the possibility of fewer government hurdles to innovation, while its critics claim federal agencies are abdicating their responsibility to mitigate risks.
“We’re excited to see these relationships continue to grow,” said Leah Buchman, senior agriculture and environment regulatory policy manager at the Biotechnology Innovation Organization.
The Center for Food Safety, a leading critic of federal genetic engineering policies, believes the recent regulatory plans are basically a front for scaling back government scrutiny of biotech.
“It’s all about moving faster: Let’s wield that rubber stamp faster so people can get on with their experiments,” said Bill Freese, the nonprofit’s science policy analyst.
Nearly three decades ago, the U.S. government adopted the “coordinated framework for regulation of biotechnology,” under which the USDA, Environmental Protection Agency and Food and Drug Administration work together to oversee genetic engineering using their existing legal powers.
Critics of the approach would prefer if Congress enacted specific laws to anticipate and prevent adverse consequences from biotechnology, rather than federal legal authorities that predate such scientific developments.
“In our view, it’s very inadequate and it’s being streamlined in this order,” Freese said of the latest coordinated framework plan.
In the past five years, both the Trump and Biden administrations have issued executive orders intended to modernize the coordinated framework and strengthen ties between the three federal agencies.
The biotech industry wants the USDA, EPA and FDA to create more of a “one stop shop” for developers, reducing the redundancies and gaps in oversight that unnecessarily impede the introduction of new GE crops, said Buchman of BIO.
“What’s most important here is they are working together,” she said of the recent plan.
If the federal agencies regulate GE crops according to different timelines, the slowest process creates a “bottleneck” for developers, Buchman said.
It’s also more effective if the federal agencies anticipate how they’ll mutually resolve regulatory questions that may arise, instead of being surprised by unexpected circumstances, she said.
The government’s new plan doesn’t delve into regulatory minutiae but explains what roles will be performed by each agency in regulating GE plants, animals, microbes and pharmaceuticals, Buchman said.
“I’m glad I wasn’t surprised by anything in here,” she said.
Freese of the Center for Food Safety agreed the latest plan doesn’t veer from the established trajectory of federal biotech policy.
Under both Democratic and Republican administrations, the government has sought to abbreviate regulatory processes for genetically modified organisms or exempt them from oversight altogether, he said.
“It’s clear they’re only listening to the GMO developers,” Freese said.
Since the coordinated framework was originally issued nearly 30 years ago, the federal government has considered biotechnology a “holy grail” for American agriculture and other industries, he said.
To ensure the U.S. stays ahead of the global pack, federal agencies have limited regulation to “public relations” rather than fully analyze the consequences of biotechnology, Freese said.
“It doesn’t really have anything to do with safety,” he said.
For example, the new plan fails to address how USDA or EPA will examine the hazards posed by herbicide drift from crops that have been modified to withstand such chemicals, Freese said.
“Neither agency is taking responsibility for that,” he said.