In late December 2023, the US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) reopened the comment period on a recent proposal that outlined five additional exemptions for “plants with modifications that could be achieved through conventional breeding.”
USDA APHIS coordinates responsibilities for Biotechnology Regulatory Services, which protect plant health and implement regulations for organisms that have been genetically engineered.
The proposal, published to the Federal Register (88 FR 78285–78291, Docket No. APHIS–2023–0022) specifically aimed to add five “new types of genetic modifications a plant can contain and be exempt from the regulations for the movement of organisms modified or produced through genetic engineering.” The proposed exemptions are:
- Any diploid or autopolyploid plant with any combination of loss of function modifications in one to all alleles of a single genetic locus, or any allopolyploid plant with any combination of loss of function modifications in one or both alleles of a single genetic locus on up to four pairs of homoeologous chromosomes, without the insertion of exogenous DNA.
- Any diploid or autopolyploid plant in which the genetic modification is a single contiguous deletion of any size, resulting from cellular repair of one or two targeted DNA breaks on a single chromosome or at the same location(s) on two or more homologous chromosomes, without insertion of DNA, or with insertion of DNA in the absence of a repair template.
- To extend the modifications described in certain existing exemptions in the regulations to all alleles of a genetic locus on the homologous chromosomes of an autopolyploid plant.
- Plants with up to four modifications that individually qualify for exemption and are made simultaneously or sequentially, provided that each modification is at a different genetic locus.
- 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.
ASPB responded with in-depth comments that ultimately support the five proposed exemptions and offer improvements to address concerns raised by the exemptions as currently drafted.
These comments were sent to Dr. Neil Hoffman at APHIS, and are available for reader review below.
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