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APHIS Expands Exemptions From Genetically Modified Plant Regulations

The Animal and Plant Health Inspection Service is finalizing changes to exemptions from regulations governing imports of genetically modified plants, the agency said Nov. 12. The changes become effective Nov. 13, APHIS said in a notice.

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APHIS first issued a final rule governing the importation and other movements of genetically engineered organisms in May 2020 (see 2005180023). Under the final rule, importers have the choice of either an APHIS review pre-importation to determine whether a permit is necessary, or just applying for a permit. Developers of genetically engineered (GE) organisms are also able to self-determine that their GE organism is exempt, though invalid self-determinations will be subject to penalties.

The Nov. 13 notice allows some additional modifications that plants can have and what qualifies for exemption from the regulations. The intent is to provide developers with more flexibility in how they can use biotechnology to create modified plants that could have been achieved through conventional breeding, APHIS said. The changes also include an increase in the number of modifications a plant can contain, from one modification to as many as 12 modifications, and what modifications qualify for exemption.

"This notice brings APHIS’ biotechnology regulations up to date with advances in science, technology, and conventional breeding techniques and ensures that plants with similar characteristics are treated similarly from a regulatory perspective," APHIS said. "APHIS anticipates that expanding the scope of modifications that plants can contain and be exempt from its regulations will foster innovation, enable a larger number of smaller businesses and academic institutions to engage in innovative agricultural product development, and expand the number and variety of new crops being developed through biotechnology."