USDA’s Proposed Revised Part 340: Key Takeaways

Background. USDA last proposed a revised Part 340 in January 2017, but ultimately withdrew that proposal, opting instead to take a “fresh look” at the issue and engage more broadly with stakeholders. In the interim, the Secretary of Agriculture released a statement addressing the Agency’s planned approach to regulating products developed through new, innovative breeding techniques, like gene editing. The new proposal largely codifies that approach and provides expanded opportunities for regulatory self-determination, a new, streamlined framework for assessing plant pest risk, and extensive provisions related to permitting, inspections, reporting, recordkeeping, and compliance.

The Agency has asked for public comment on many specific aspects of its proposal; all public comments on the proposed rule are due on August 5.

Key proposal takeaways are as follows:

• The regulations apply to GE organisms; while “GE organism” is not defined in the proposal, Section 340.3 defines “genetic engineering” as “[t]echniques that use recombinant or synthetic nucleic acids to modify or create a genome.” “Organisms” is defined broadly and is consistent with the definition found in the current version of the regulations.

• Product developers whose plant products either (i) satisfy criteria derived from the Secretary’s March 2018 statement, e.g., are plants whose genetic modifications are “solely deletions of any size,” or a “single base pair substitution,” among two others, or (ii) consist of a GE plant-trait-mode of action combination that has previously undergone a regulatory status review, described below, and found unlikely to pose a plant pest risk, may either self-determine, or may seek from the Agency a “confirmation,” that “the plant is not within the scope” of Part 340. (§340.1) It is anticipated that many plant products of gene editing would be subject to the self-determination provisions of the proposed rule.

• For GE plants not meeting the criteria identified in Section 340.1, a developer may (i) seek a permit from the Agency to enable the “movement” of such plant, with movement broadly defined to include release into the environment, and/or (ii) apply to the Agency for a “regulatory status review” (RSR), comprised of an Initial Review phase and, if needed, a more robust Plant Pest Risk Assessment (PPRA) (§340.2, 340.4), described more fully in a separate document accompanying the proposed rule. The RSR is aimed at assessing the potential for the GE plant, and specifically its plant-trait-mechanism of action combination, to pose a plant pest risk, defined as “the possibility of harm to plants resulting from introducing or disseminating a plant pest or exacerbating the impact of a plant pest.” (§340.3)

• The Agency has identified several specific areas of focus for the RSR (§340.5(b)), and the types of information to be submitted by a developer to assist with the RSR process. (§340.5(a)(4)); 84 FR 26525) USDA has indicated that field trial data will no longer be required in many instances. (84 FR 26526)

• Non-plant GE organisms subject to Part 340 are not eligible for self-determination under Section 340.1 or for the RSR process under Section 340.4, and may only be “moved” under permit. (§340.2) The Agency has proposed exemptions to the permit requirement for GE Arabidopsis thaliana, GE disarmed Agrobacterium tumefaciens, and certain microbial pesticides, so long as certain conditions are met. (§§340.5 (c), (d), (e))

• Requests for and results of RSRs will be maintained on the Agency’s website. (§340.4(c)) If an RSR proceeds to the PPRA stage, the results of the Agency’s Initial Review and PPRA will be published in the Federal Register for public comment. Information regarding anticipated timelines for review of permits or RSR processes has not yet been provided.

• Along with opportunities for self-determination and a streamlined approach to assessing plant pest risk, the Agency also proposes significantly more detailed provisions relating to permit application requirements, permit conditions, inspections, reporting, recordkeeping, and compliance, all of which stakeholders should review carefully. (§§340.5, and 340.6)