The public comment period for EPA’s updated “Draft Guidance for Plant Regulator Products and Claims, Including Plant Biostimulants,” closes on December 30, 2020. The updated guidance was announced by EPA on November 24, 2020 and published in the Federal Register on November 30, 2020. Public comment, identified by docket number EPA-HQ-OPP-2018-0258, may be submitted through the federal eRulemaking portal which may be accessed by clicking here.
The proposed guidance is intended to clarify that products with claims that are considered plant regulator claims are subject to regulation as pesticides under FIFRA. The document provides examples of claims that are plant regulator claims and claims that are not plant regulator claims.
EPA explains that while FIFRA does not define the term plant biostimulants, some products being sold as plant biostimulants may trigger regulation under FIFRA as plant regulators. Other plant biostimulant products will be excluded or exempt from regulation under FIFRA depending upon their intended uses as plant nutrients (e.g., fertilizers), plant inoculants, soil amendments, and vitamin-hormone products. The Agency emphasizes that a key consideration is what claims are being made for products. EPA adds that when evaluating whether a product is a pesticide, it also considers product composition.
The draft guidance was originally released for public comment in March 2019. Among the issues for which EPA sought feedback at that time was whether the Agency should develop a definition for plant biostimulants. The development of a definition for plant biostimulants would have required a rulemaking. EPA states that based upon the public comments it received in response to the March 2019 draft guidance, it is no longer considering the establishment of any definition for plant biostimulant, nor is it recommending any changes to FIFRA or the CFR.
In other changes, EPA has removed Table 4 appearing in the March 2019 draft which set forth a list of plant growth regulator active ingredients. EPA agreed with commenters that certain substances listed in Table 4 as contained in the initial draft “are likely not plant regulators as defined by FIFRA Section 2(v) and can be removed from consideration as plant regulator active ingredients.” However, in its response to comments posted to the docket, EPA emphasizes that “While the Agency has historically followed a claims-based approach to pesticide regulation, claims made about the product are only one factor. The Agency has always considered the composition of a product, as well as its associated claims, when making a regulatory determination.”
EPA has signaled it hopes to finalize the draft guidance by January 20, 2021. The document will need to go through expedited OMB review to meet that goal.
