Sep 03, 2020
This week, EPA published a proposed revision to its Plant Incorporated Protectants (PIP) rule to address products derived from new genetic modification technologies such as gene editing and to establish additional exemptions for PIPs based on compatible plants created from biotechnology. Generally, if a gene edited plant uses genetic material native to a compatible plant to produce a pesticidal substance, and the resulting plant could have been created through conventional breeding, the proposed rule will exempt the pesticidal substance from most registration requirements. Much like USDA’s recent final Part 340 biotech rule (SECURE Rule), this rule would allow developers to self-determine if they qualify for one of the exemptions; though unlike the USDA rule, it would require them to notify EPA if they are claiming exemption. If a PIP qualifies for one of the exemptions, it would be exempt from both the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration process and the Federal Food, Drug, and Cosmetic Act (FFDCA) tolerance establishment, save for minor record keeping requirements and adverse event reporting.
EPA proposes two main categories of exemptions for PIPs based on compatible plants created from biotechnology – the insertion of new genetic material and the modification of existing genetic material. In both cases, the only exemptions permitted under the proposed rule are modifications inserting or modifying native genes using only native alleles (i.e. variations of a gene) from compatible plants. Also, the type of pesticidal substance expressed after the modification must be preserved in both cases – no novel pesticidal substances not already native to compatible plants will be permitted through exemption. Finally, no large-scale mutations such as transmutations (i.e. large sections of chromosome swapping locations) are permitted, despite that these mutations are also naturally-occurring.
EPA permits developers two methods to seek exemption from registration and tolerance establishment – by submitting a mandatory notification letter to EPA self-determining that a PIP based on compatible plants created from biotechnology meets an exemption, or by requesting EPA make a determination that the aforementioned PIP meets the exemption. Developers are permitted to take both steps if they would prefer.