USDA has proposed a new rule that could substantially change how the agency regulates genetically-modified (GM) crops. The rule will be open for public comment through Aug. 5.

The new rule would allow crops produced with GM techniques with a long history of safety within the industry to bypass USDA’s regulatory process in the future. Crops produced with gene-editing techniques such as CRISPR-Cas9 would also continue to be nonregulated, as long as they do not pose a plant pest risk.

“It is only doing what people have been saying for years about how we need to evaluate risk in new-crop traits,” said Washington State University crop scientist Allan Felsot. “The risk is not in how we breed the plant — it’s in what the result is.”

That said, crops with the potential to become a plant pest will continue to fall under the agency’s regulatory authority, as will any crops produced with novel methods for which USDA has no history of safety data. “Genetic modifications made in the future may result in increasingly complex products, which in turn, may pose new types of risks with which the Agency has less familiarity,” the proposed rule reads. “This latter category of engineered plants would be subject to review under our new regulations.”

The rule will not affect how other agencies, namely EPA and FDA, regulate GM crops and food products. But it could still be a boon to researchers and companies that develop biotech crop traits by allowing them to avoid costly and time-consuming field and laboratory tests required by USDA and move to market faster.

“We anticipate that adopting the new framework will result in significant savings for developers of GE [genetically engineered] organisms,” the rule noted, adding later that, “APHIS anticipates that benefits will accrue to developers of all sizes, including small and mid-sized ones, as well as academic institutions.”

Felsot agreed, noting that universities in particular might find themselves freed to put new trait technology on the market.

“It will definitely help universities, many of which have a tremendous number of innovations — traits for drought resistance, cold resistance, salt tolerance — sitting in laboratories, but no money available to do the level of testing required to register crops with these,” he said.

Many of those traits are produced by gene editing. But many also use older GM technologies, such as using a bacterium called Agrobacterium tumefaciens to enter a plant’s DNA and make the desired genetic changes. In the past, this type of breeding fell under USDA’s regulatory authority because the bacterium was a potential plant pest. Under the proposed new rule, USDA has concluded that it has a sufficient history to rule this GM technique does not produce a plant pest risk — and crops produced with it would not automatically fall under the agency’s regulation anymore.

The current GM regulatory framework for USDA “reflects the concern in the 1980s that if an organism was modified using genetic material taken from a plant pest, or a plant pest was used as a vector or vector agent to carry genetic material into an organism, the resulting GE organism could also be a plant pest,” the rule stated. “Based on APHIS’ experience evaluating field trial data from thousands of authorized environmental releases of regulated organisms, as well as the 130 determinations of nonregulated status for GE plants, this generally stated concern has not proven to be valid.”

The new rule is likely to spark controversy among anti-GMO activists and nongovernmental organizations, which believe GM techniques like this are not safe, and view gene editing as another form of genetic engineering in need of more regulation, not less.

The rule’s effect on international trade relations is also unclear. GM crops face use and import restrictions among many U.S. trade partners, and the regulatory status of gene-edited crops remains in flux in many countries.

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Countries that use the GM trait import approval process for political leverage and market control, like China, will likely continue to do so regardless of the science behind the trait approval process in the U.S., Felsot noted. “The question left open is if other trading partners will feel now that USDA is doing less of a risk assessment, and they might demand more information” for trait import approvals, he said.

Trait developers would have the option, under the new rule, to “make a self-determination” that their trait is exempt from USDA regulation and request written confirmation from APHIS that they are correct. “APHIS anticipates a timely turnaround time” for providing these confirmations, the rule stated. These confirmations “may be useful to developers wishing to market their products domestically or overseas by allowing them to provide verification to an importing country or other party that APHIS concurs with their self-determinations.” The new rule was heavily influenced by a National Academy of the Sciences report released in 2017, which examined how regulatory agencies could modernize their oversight of new crop breeding techniques.

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USDA said it had also “met with more than 80 organizations, including 17 universities, State Departments of Agriculture, and farmer organizations” while formulating the rule. The proposed rule is the agency’s third attempt to rework its regulatory framework for GM plants. Two others, one in 2008 and one in 2017, were withdrawn after the public comment period.

This rule’s public comment period is open for 60 days. The rule can be viewed here:…, and members of the public can submit their comments here:….

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Source: Emily Unglesbee, DTN