Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year.
The year 2023 witnessed dramatic shifts in this regulation around the world. Within the U.S., the USDA and EPA each issued final rules that will affect a wide variety of gene-edited plants. We detail two of these final rules below. For further international context of the growing momentum around genetically engineered plants, see the following: Considerations on NGTs in the EU, Comparing the EU’s Proposal to U.S. Regulation, Industry Specialists Considering CRISPR’s Future.
I. After a long wait, EPA finally overhauled its regulation of PIPs in 2023 with a controversial update
On May 31, 2023, the EPA published a final rule (88 FR 34756) regarding Plant-Incorporated Protectants (PIPs), following both an initial proposal on October 9, 2020, and a period of public comments that ended on December 8, 2020. This final rule came into effect July 31, 2023, and has already been met with some controversy in the industry.
This regulation follows on the heels of massive revisions between 2020 and 2021 to USDA APHIS’s SECURE rule, redesigning APHIS’s assessment (and exemption therefrom) of various genetically engineered plants.
i. PIP relevance to the EPA
The EPA regulates pesticides broadly under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). PIPs refer to pesticides produced by plants as well as the genetic material necessary for the plants to produce those pesticides. EPA is authorized to regulate PIPs produced through genetic engineering (rather than native production by a plant).
While the EPA regulates the PIPs and their genes in plants, the edited plants themselves are not regulated by the EPA. Rather, branches of the USDA and FDA likely regulate the actual plants.
ii. Which PIPs receive which regulation?
The EPA’s previous regulations, 40 CFR 174.71 (66 FR 37772; July 19, 2001), exempted PIPs that were transferred solely through conventional breeding methods, and the 2020 proposed rule (85 FR 64308) offered that PIPs may be exempt from FIFRA registration and FFDCA tolerance requirements in cases where, in addition to meeting EPA safety requirements, the PIPs could have been transferred through conventional breeding methods: i.e., in cases where the PIPs are equivalent to pesticides (or genes) from sexually compatible plants.
The final rule largely incorporated the proposed exemptions and further delineated which PIPs remain exempt or will be newly exempt. (Note, however, that these are only exemptions from FIFRA; other regulations may still apply. Developers of exempt PIPS must still comply with recordkeeping and eligibility determinations requirements to maintain the exemption.)
The final rule exempts PIPs that fall into the following two categories:
1) “PIPs created through genetic engineering from a sexually compatible plant” (i.e., by insertion of genetic material from a sexual compatible species or through modifying existing genetic material) (quote from final rule summarizing 40 CFR 174.26(a)(1)-(2)); and
2) PIPs that are characterized as “loss-of-function” (quote from final rule summarizing 40 CFR 174.27).
From a scientific perspective, changes from the 2020 proposed rule focused on clarifying the boundaries of the exempted PIPs. For example, the first category was revised to account for “regulatory regions inserted as part of the native gene,” in addition to the coding sequence. Further, as proposed, the first category would have only exempted pesticides with the same sequence found in a native compatible plant; the final rule also exempts some instances of PIPs having identified polymorphisms.
In the final rule, the first category exempts modified genetic material and the insertion of genetic material into a recipient plant, so long as the genetic material is native to a plant that is sexually compatible with the recipient plant. Additionally, any inserted regulatory regions of genes must be identical to the native plant’s corresponding regulatory regions.
The second category, “loss-of-function” PIPs, which was elevated from a sub-category in the proposed rule to its own category in the final rule, exempts protectants that are derived from the reduction or elimination of a gene’s activity, regardless of the genetic modification method or the particular modification used to accomplish the reduction or elimination. According to a list of “hypothetical examples” from the EPA, this category does not apply to PIPs in which, for example, the editing downregulates a first inhibiting gene, which then allows increased expression of another, “secondary” gene that possesses the actual pesticidal activity.
PIP developers may decide for themselves whether exemption applies to their PIP(s) under the second category (loss-of-function), but instances of the first category still require EPA confirmation of exemption. Further, edits to multiple genes may be exempt as long as each individually meets an exemption criterion.
Additional information about the final rule, including background, clarification, and submission support, is available from the EPA.
II. USDA-AMS continued expanding the list of available plant products on the market
On November 29, 2023, the AMS published a final rule (88 FR 83305) that expanded the USDA’s List of Bioengineered (BE) Foods (“the List”) associated with the labeling requirements of the National Bioengineered Food Disclosure Standard (NBFDS). The List originated from the 2016 Public Law 114–216, which amended the Agricultural Marketing Act of 1946. The Nov. 29 final rule that updated the List came into effect on December 29, 2023; regulated entities must be in compliance by June 23, 2025.
The List identifies, albeit non-exclusively, “crops or foods that are available in a bioengineered form throughout the world and for which regulated entities must maintain records” under the NBFDS. A “BE” food is considered to be a food containing genetic material modified through in vitro recombinant DNA techniques that could not have been modified as such by nature or conventional breeding alone.
This final rule follows a June 2022 proposed rule, altering the List as follows:
- Adding “sugarcane (Bt insect-resistant varieties)” to the List; and
- Amending the previously listed “squash (summer)” line to “squash (summer, coat protein-mediated virus-resistant varieties).”
This effort helps establish and disseminate reasonable presumptions of what foods are considered “BE.” However, as reiterated in the final rule, even if foods are not on the List, if a regulated entity has actual knowledge that a food or food ingredient is “BE” as defined by the NBFDS, the entity is required to comply with the regulations.
In 2024, we may see further changes to the U.S. and international GE plant regulatory landscape; please follow our blog for future updates on this and related topics.