The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on November 13, 2024, that it added modifications a plant may contain and qualify for exemption from regulations governing movement of organisms modified or produced using genetic engineering because the modifications are achievable through conventional breeding. 89 Fed. Reg. 89569. As reported in our November 16, 2023, blog item, APHIS had proposed five types of modifications:
- 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 (proposed additional modification 1 (AM1));
- Diploid or autopolyploid plants with a single contiguous deletion of any size on one or more chromosomes (proposed AM2);
- Autopolyploid plants containing any modification described in existing exemptions that previously applied only to diploid plants (proposed AM3);
- 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 (proposed AM4); and
- 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 (proposed AM5).
According to APHIS, based on its review of public comments, it made several revisions to the five proposed modifications, simplifying and consolidating them into two modification categories, final AM1 and final AM2. To achieve this, APHIS consolidated proposed AM1 and proposed AM2 to create the final AM1. APHIS states that as described in the final notice, “[final] AM1 allows plants with modifications involving an insertion or deletion (indel), or contiguous deletion of any size, made at a targeted location, with or without insertion of DNA if generated without using a repair template, or without insertion of DNA if generated using a repair template, to qualify for exemption.”
APHIS notes that it similarly consolidated proposed AM3 and proposed AM4 to create final AM2. Final AM2 exempts plants with up to 12 modifications, made simultaneously or sequentially, if each modification occurs in a different gene and is of a type listed under 7 C.F.R. Section 340.1(b). APHIS states that by increasing the number of modifications that can be made to a plant, final AM2 also effectively allows all modifications listed in Section 340.1(b) to be made in all polyploids.
Proposed AM5 would have required developers to complete a confirmation process to verify a plant’s exempt status before making sequential modifications and outlined conditions to ensure that simultaneous or sequential modifications were made in plants that had been produced, grown, and observed, consistent with conventional breeding practices. APHIS notes that it has not made a final modification associated with proposed AM5. APHIS states that “[i]nstead, to stay true to the voluntary nature of APHIS’ confirmation request process and ensure that plants are developed consistent with conventional breeding practices, APHIS will only accept voluntary requests to confirm a plant’s exempt status for plants that have been produced.” According to APHIS, this means that it will no longer accept confirmation requests involving plants with hypothetical modifications because, if produced, the plants may not be viable, may not have the intended phenotype, or have a different genotype than originally requested.
The notice took effect November 13, 2024. Developers can voluntarily request that APHIS confirm their modified plant meets the criteria for regulatory exemption. Materials regarding regulatory exemptions and confirmations are available on the APHIS website.
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