[Note: Five new rules as to the nature, size, and number of mutations in plants are being proposed to reduce regulatory burden. The public is asked to provide comments.]
AGENCY: Animal and Plant Health Inspection Service, USDA.
We are advising the public that we are proposing 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 because such modifications could otherwise be achieved through conventional breeding methods.
First, we propose any diploid or autopolyploid plant with any combination of loss of function modifications (i.e., a modification that eliminates a gene's function) 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, would qualify for exemption. Second, we propose that 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, would qualify for exemption. Third, we propose 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. Fourth, we propose that plants with up to four modifications that individually qualify for exemption and are made simultaneously or sequentially would be exempt from regulation, provided that each modification is at a different genetic locus. Fifth, we propose that 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. This action would reduce the regulatory burden for developers of certain plants modified using genetic engineering that are not expected to pose plant pest risks greater than the plant pest risks posed by plants modified by conventional breeding methods.
We will consider all comments that we receive on or before December 15, 2023.