USDA’s Animal and Plant Health Inspection Service is proposing draft guidance for a new regulatory review process aimed at determining when genetically engineered plants need the department’s approval for commercialization.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