Trump’s agriculture department reverses course on biotech rules
The U.S. Department of Agriculture (USDA) has withdrawn a plan
to overhaul how it regulates biotechnology products such as genetically
engineered (GE) crops.
The proposed rules,
released in January as part of a broader update to federal biotech
regulations, would have formally exempted some modern gene-edited plants
from regulation, but industry and academic groups worried it would also
add more onerous requirements for safety assessments early in the
development of such products.
USDA’s announcement and its notice in the federal register
today provided little detail about the motivation for the reversal. The
agency is taking another look at the rules to balance “regulatory
requirements [that] foster public confidence” with a “review process
that doesn’t restrict innovation,” Secretary of Agriculture Sonny Purdue
said in a statement. USDA will now start fresh discussions with
stakeholders to consider other approaches, the statement said.
It’s a predictable move by President Donald Trump’s White House
to take another look at the policies of the previous administration,
says Jennifer Kuzma, a social scientist who co-directs the Genetic
Engineering and Society Center at North Carolina State University in
Raleigh. “I expected them to eventually catch wind that this was
something that USDA was doing, and reverse it.”
The January proposal was in part an attempt to clarify
whether and how the agency would oversee plants made through new
genetic technologies such as CRISPR gene editing. Unlike older methods
that insert a gene using the bacterial vector Agrobacterium,
which USDA classifies as a “plant pest,” CRISPR editing does not
automatically trigger the agency’s current premarket review process.
(Last spring, USDA announced that it would not regulate a CRISPR-edited nonbrowning mushroom
for that reason.) The proposed rules would have exempted certain
gene-edited products from the GE definition—if they contained inserted
DNA from a sexually compatible species, for example, or if their DNA
changes could also have been achieved through older chemical or
radiation-based methods.
But the proposal also gave the USDA’s Animal and Plant Health
Inspection Service (APHIS) the new responsibility of evaluating plants
for their potential to become noxious weeds that could damage crops,
livestock, agriculture, public health, or the environment. Under the
proposal, the absence of bacterial DNA would no longer have been enough
to exempt a gene-edited product from regulation, Kuzma explains, and
more products would fall “under the initial umbrella to analyze” for
safety. “I see sticking with the status quo as less regulation,” she
says.
Industry and research groups also feared new risk assessment
requirements. In June, more than 100 biotechnology and agriculture trade
groups submitted a letter
to USDA laying out their objections to the proposal. It would require a
lengthy risk assessment simply to learn whether a GE product would be
regulated, the signatories said, and would slow the early development of
new crop varieties by creating a hurdle to even small-scale field
trials.
I’m happy that [USDA is] taking a step back.- Harry Klee, University of Florida
The burden would be especially great for academic researchers
and small companies, says Harry Klee, a molecular biologist who studies
the genetics of tomato flavor at the University of Florida in
Gainesville and is president of the American Society of Plant
Biologists—one of the signatories on the letter. “I can’t afford to … go
through the processes for risk assessment the same way that a company
like a Monsanto can do,” he says. “I’m happy that [USDA is] taking a
step back.”
In January, the U.S. Food and Drug Administration also released a
proposal to update the regulation of GE animals. Those rules would have
swept such animals under the definition of a “new animal drug” and
subjected them to the agency’s approval process, even if they didn’t
contain DNA from another species, and even if their genome sequences
could have been created with conventional breeding. Last month,
lawmakers in the U.S. House of Representatives wrote a letter
to Purdue, along with FDA Commissioner Scott Gottlieb and Environmental
Protection Agency Administrator Scott Pruitt warning that the USDA's
and FDA's approaches “offer deeply conflicting regulatory approaches”
that “have sent inconsistent signals to our trade partners.”
The public comment period for the FDA rules ended in June, but the
agency has not finalized the proposal. “I would bet that [the
administration] would probably pull back on that too, eventually,” Kuzma
says.
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