EPA Updates Draft Guidance on Plant Biostimulant Products

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This updated guidance follows an earlier version EPA released for public comment in March 2019.
 

Last week, EPA released an updated guidance document aimed at assisting developers of plant biostimulant products regarding what products and product claims fall within, and without, EPA’s jurisdiction under the federal pesticide regulatory regime, FIFRA. This updated guidance follows an earlier version EPA released for public comment in March 2019.

EPA regulates pesticides pursuant to its authority under the Federal Insecticide, Rodenticide, and Fungicide Act (FIFRA). Under FIFRA, the definition of “pesticide” includes a “plant regulator” — a substance or mixture of substances intended “through physiological action, for accelerating or retarding the rate of growth or rate of maturation or for otherwise altering the behavior of plants or the produce thereof.” 7 U.S.C. § 136(v). Products meeting the definition of a plant regulator are subject to regulation by EPA as pesticides, unless they meet one of several enumerated exclusions, including plant nutrients and trace elements (e.g. fertilizers), plant inoculants, soil amendments, and vitamin hormone products. Id. Generally, pesticides must clear EPA’s registration process under FIFRA before they may be distributed or sold in the United States.

Plant biostimulants are, as EPA notes, “an increasingly popular category of products containing naturally-occurring substances and microbes that are used to stimulate plant growth, enhance resistance to plant pests, and reduce” stress from non-biological sources (e.g., climate). These products can promote increased water and nutrient use efficiency and can be useful tools in meeting sustainability goals. But neither FIFRA nor any other federal statute provides a regulatory definition for “plant biostimulant,” which has sometimes made it difficult for developers to ascertain whether their products fall within EPA’s scope of regulation under FIFRA.  In an effort to provide additional clarity, EPA’s updated draft guidance:

  1. provides examples of products and product claims EPA would consider to be plant regulators and plant regulator claims;
  2. provides examples of products and claims that it would not consider plant regulators or plant regulator claims, including examples of claims tied to a specific exclusion (e.g., plant nutrient) and “generic” claims;
  3. identifies specific substances that the agency could potentially recognize as plant regulators based on their mode of action; and
  4. outlines the agency’s potential regulatory approach to products that may have multiple modes of action, (i.e., products with both plant regulator and non-plant regulator modes of action).

This document is important reading for developers of plant biostimulant products; it provides valuable insight into EPA’s thinking regarding how products are categorized under its plant regulator authority and an opportunity for stakeholders to provide comment to EPA on its approach.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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