WASHINGTON, November 14, 2023 – The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is proposing five additional exemptions for plants with modifications that could be achieved through conventional breeding. The proposed exemptions would be in addition to those exemptions already in place.

Specifically, the proposed exemptions include:

1. Plants that have any combination of loss-of-function modifications (modifications that reduce or eliminate a gene’s function) in one to all alleles of a single genetic locus in diploid and autopolyploid plants, or in one or both copies of a single genetic locus on up to four pairs of homoeologous chromosomes in allopolyploid plants.
2. Diploid or autopolyploid plants with a single contiguous deletion of any size on one or more chromosomes.
3. Autopolyploid plants containing any modification described in existing exemptions that previously applied only to diploid plants.
4. Plants with up to four modifications made simultaneously or sequentially, provided that each modification individually qualifies for exemption and is at a different genetic locus.
5. Plants that have previously completed a voluntary review confirming exempt status and that have subsequently been produced, grown, and observed consistent with conventional breeding methods appropriate for the plant species, could be successively modified in accordance with the exemptions.

APHIS regulates organisms developed using genetic engineering under the Plant Protection Act to ensure they are safe for agriculture and agriculturally important resources. Under our regulations, developers can review existing exemptions to determine if their modified plant is exempt from regulation under 7 CFR part 340. They can also voluntarily request that APHIS confirm their modified plant meets the criteria for regulatory exemption.

You can learn more about the exemption process in the 340 final rule in 2020. The process allows us to expand the exemptions related to modifications that could otherwise be achieved through conventional breeding to ensure the regulations remain current with technology and science.

The Federal Register notice can be viewed now on the News page of the APHIS Biotechnology Regulatory Services website. Beginning tomorrow members of the public will be able to submit comments through December 15, 2023, by going to www.regulations.gov and entering “APHIS-2020-0022” into the Search field.