USDA’s Animal and Plant Health Inspection Service is proposing draft guidance for a new regulatory review process aimed at determining when genetically engineered plants need the department's approval for commercialization.

Under its new biotech rule issued in May 2020, APHIS is replacing the petition process for approval of genetically modified plants with a regulatory status review (RSR) process under which developers may voluntarily submit information to APHIS for a determination as to whether the modified plant needs USDA approval. 

Many exporters and food companies criticized the proposal for allowing commercialization without notification, but USDA declined to make it mandatory.

Even though the review process is voluntary, most developers whose plants do not already qualify as exempt from regulations under the new rule will eventually have to use the new review process, said Clint Nesbitt, senior director of science and regulatory affairs for food and agriculture at the Biotechnology Innovation Organization.

“This is guidance that we've been waiting for for quite some time, because I think how it looks will be a key determinant in how well the new rule is going to work,” Nesbitt said.

The regulatory review process went into effect in April for six crops — corn, soybean, cotton, potato, tomato, and alfalfa — and will be used for all remaining crops starting Oct. 1. Nesbitt, however, said no reviews have been completed yet. APHIS could not immediately provide statistics on the status of any current reviews reviews.

If a developer requests an RSR, APHIS will evaluate whether it “requires oversight based on the characteristics of the plant itself rather than on the use of a plant pest in its development,” APHIS said on its website. “If a plant developed using genetic engineering is found to be unlikely to pose a plant pest risk, APHIS will not require regulation under 7 CFR part 340.”

If APHIS finds the plant poses a plant pest risk, then the plant would require a permit, APHIS said. If it does not, “subsequent transformation events using the same plant-trait-mechanism of action combination would not be regulated,” APHIS said on the website. 

The RSR will require one or two steps. In its initial review, which APHIS anticipates will take about six months, it will determine whether there is a “plausible pathway by which the plant or its sexually compatible relatives would pose an increased plant pest risk relative to” comparator(s) in the initial review,” according to the draft guidance.

APHIS defines a “comparator” as “a plant used as a comparison or reference for a plant developed using genetic engineering to determine if the plant being evaluated poses an increased plant pest risk.”

“The ideal comparator plant is the plant from which the plant developed using genetic engineering is derived,” the guidance says. “The comparator plant can also be a plant that was developed using genetic engineering if it: 1) is not regulated under 7 CFR part 340; and 2) is determined to be the most appropriate baseline for comparison to a plant that is the subject of the RSR request.”

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If APHIS does identify a plant pest risk, “the requestor [of the RSR] may ask that APHIS evaluate the factor(s) of concern identified in the initial review and evaluate the likelihood and consequence of the plausible increase in plant pest risk,” the draft guidance says.

APHIS will make its determination after conducting a plant pest risk assessment. The requestor also can choose to pause the RSR process and ask APHIS at any time to complete a risk assessment.

The rule is the subject of a lawsuit filed by Center for Food Safety and other groups who say it gets rid of most oversight over genetically engineered organisms.

The RSR provides only a “cursory review,” the complaint says, and adds, “The existence of a voluntary confirmation process does not guarantee transparency or agency review.”

“In those few cases in which the regulatory status review does not clear a GE plant of posing a plant pest risk, it could still be grown under a permit,” the complaint says. “Developers can also request a permit to grow a GE plant in lieu of a regulatory status review.”

The rule exempts certain “single targeted modifications” from regulatory review: 

  • The genetic modification is a change resulting from cellular repair of a targeted DNA break in the absence of an externally provided repair template;
  • The genetic modification is a targeted single base pair substitution;
  • The genetic modification introduces a gene known to occur in the plant’s gene pool, or makes changes in a targeted sequence to correspond to a known allele of such a gene or to a known structural variation present in the gene pool

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