INFORM September 2024

inform September 2024, Vol. 35 (8) • 29

and its sexually compatible relatives; (2) the trait and mecha nism-of-action of the modification; and (3) the effect of the trait and mechanism-of-action on the (a) distribution, density, or development of the plant and its sexually compatible relatives, (b) production, creation, or enhancement of a plant pest or a reservoir for a plant pest, (c) harm to non-target organisms ben eficial to agriculture, and (d) weedy impacts of the plant. As of last summer, the varieties, including the new yel low-seeded, low fiber lines TT8 and Y1126 (TTG1 mutant) are exempt from regulation (non-regulated status) in the United States, as confirmed by USDA Animal and Plant Health Inspection Service (USDA APHIS, Regulatory Status Review, 2023a; Regulatory Processes-Confirmations, 2023b). The single gene modification to alter seed composition of pennycress/covercress™ was found to meet the exemption described in the Code of Federal Regulations (CFR) 7 CFR part 340 and the crops with such alteration are also achievable by traditional breeding and unlikely to cause increased plant pest risk compared with conventionally bred counterparts. However, like other crops borne of gene editing, they are pro hibited in organic products (Organic Trade Association, 2021). APHIS did not identify any plausible pathway by which the modified pennycress would pose an increased plant pest risk relative to comparator pennycress plants. APHIS determined that pennycress is unlikely to pose an increased plant pest risk relative to its comparators.

Based on the USDA’s review, they confirmed that the pennycress to be modified for altered seed composition would meet the exemption described in § 340.1(b)(1) and be exempt from regulation under 7 CFR part 340. Plants with modifications that are exempt pursuant to § 340.1(b)(1) are achievable by conventional breeding and unlikely to pose an increased plant pest risk relative to their conventionally bred counterparts. Once APHIS determines that a plant product is unlikely to pose an increased plant pest risk relative to its comparator and, thus, is not a plant pest or a plant that requires regulation because it is capable of introducing or disseminating a plant pest, APHIS has no authority to regulate it under 7 CFR part 340. Accordingly, pennycress is not subject to the regulations under 7 CFR part 340. APHIS’ determination that this modified plant is not subject to the regulations extends to any progeny of the modified plant that is derived from crosses with other non-modified plants or other modified plants that are also not subject to the regulations in 7 CFR part 340. Relieved of any regulatory burden, the team continued their work to ensure pennycress can be used as a novel plant based protein. They demonstrated that cold-pressing, ethanol defatting, and saline extraction are all suitable, environmen tally friendly methods for TT8 protein production, capable of generating a protein isolate with enhanced functionality (https://doi.org/10.1002/sfp2.1029).

EXCLUSIVE, MEMBER-ONLY MASTERCLASS

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9 a.m. - 10:30 a.m. CDT (UTC−5:00)

October 2, 2024 Wednesday

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