The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has proposed five new types of genetic modifications a plant can contain and be exempt from APHIS’s biotechnology regulations (7 C.F.R. Part 340). APHIS’s biotechnology regulations apply to plants and plant pests developed through genetic engineering and which may pose a risk to plant health. APHIS proposes to exempt these genetic modifications from regulation because these modifications could otherwise be achieved through conventional breeding methods. The proposed exemptions are as follows:
(1) Plants that have any combination of loss-of-function modifications (i.e., 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 alleles 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 (i.e., existing exemptions 340.1(b)(2) and 340.1(b)(3)).
(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 APHIS 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.
Previously, on May 18, 2020, APHIS published a final rule that marked the first comprehensive revision of the regulations since they were established in 1987 and included regulatory exemptions for modified plants with a single modification of a type listed at 7 C.F.R. § 340.1(b). In addition, the new section 340.1(b)(4) provided that APHIS may expand the list of exempted modifications, either upon an adequately supported request from the public or at APHIS’s initiation, if such modification could be achieved through conventional breeding. Such exemptions are identified on an APHIS website, rather than necessarily incorporated into the biotechnology regulations.
In July 2021, APHIS published proposed exemptions for plants with any of the following additional modifications: (1) cellular repair of a targeted DNA break in the same location on two homologous chromosomes, in the absence of a repair template, resulting in homozygous or heterozygous biallelic mutations, each of which is a loss of function mutation; (2) contiguous deletion of any size resulting from cellular repair of a targeted DNA break in the presence of an externally supplied repair template; or (3) cellular repair of two targeted DNA breaks on a single chromosome or at the same location on two homologous chromosomes, when the repair results in a contiguous deletion of any size in the presence or absence of a repair template, or in a contiguous deletion of any size combined with an insertion of DNA in the absence of a repair template. Public comments received on this proposal suggested the exemptions were fragmentary and should be expanded to be systematic. Commenters also suggested additional exemptions beyond those proposed. As a result of the public feedback, APHIS has withdrawn the three proposed exemptions and proposed these five new exemptions.
By proposing these exemptions, APHIS hopes to 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. These exemptions also would allow APHIS to focus its resources on reviewing plants with more novel modifications. APHIS encourages public comments that support the Agency’s determinations for the proposed exemptions that the genetic modifications could otherwise be achieved through conventional breeding methods. APHIS will be accepting comments until December 15, 2023.
Finally, APHIS emphasized that the Agency welcomes comments or requests on additional exemptions or potential expansions of the exemptions to other plant types.