On March 25, 2019, the U.S. Environmental Protection Agency (EPA) finally weighed-in on the murky and often misunderstood topic of label claims for plant regulators and plant biostimulants in posting its Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants in Docket # EPA-HQ-OPP-2018-0258. EPA issued the notice of availability in the Federal Register on March 27, 2019. 84 Fed. Reg. 11538. EPA states that the draft guidance, issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), is intended to “provide guidance on identifying product label claims that are considered to be plant regulator claims” by EPA, thereby subjecting the products to regulation as pesticides under FIFRA. EPA notes that when determining whether a whether a plant biostimulant may trigger pesticide registration requirements, or may be excluded or exempt from FIFRA regulation, a “key consideration is what claims are being made on product labels.” Comments on the draft guidance are due by May 28, 2019.
EPA states that this draft guidance may be of particular interest to those who are producers of products making labeling claims that are considered to be plant regulator claims, and provides two North American Industrial Classification System (NAICS) codes to assist in determining if this action might apply to certain entities:
- Pesticide and Other Agricultural Chemical Manufacturing (NAICS 32532), e.g., pesticide manufacturers or formulators of pesticide products, pesticide importers or any person or company who seeks to register a pesticide; and
- Pesticide, Fertilizer, and Other Agricultural Chemical Manufacturing (NAICS 325300), e.g., establishments primarily engaged in manufacturing agricultural chemicals, including nitrogenous and phosphoric fertilizer materials, mixed fertilizers, and agricultural and household pest control chemicals.
In response to requests from the business community for greater clarity on what can and cannot be stated in claims for certain non-pesticide products, EPA has been working hard on the development of guidance for several years. The critical issue is whether “a [plant biostimulant] product, as understood by EPA, physiologically influences the growth and development of plants in such a way as to be considered plant regulators under FIFRA thereby triggering regulation as a pesticide.” FIFRA Section 2(u) includes plant regulators, defoliants, desiccants, and nitrogen stabilizers in its definition of a pesticide, making them subject to federal FIFRA registration as pesticides. FIFRA Section 2(v) both defines plant regulator and explains which substances are excluded from the definition; based on the plant regulator definition contained in FIFRA Section 2(v), EPA states that “many [plant biostimulant] products and substances may 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.” Of critical importance for FIFRA jurisdictional purposes is whether a plant biostimulant product fits within the specific FIFRA definition of how a plant regulator functions; if it does, it will trigger EPA oversight under FIFRA. If it does not, no EPA oversight under FIFRA will apply.
Defining Plant Biostimulant
One of the major issues addressed by the draft guidance is whether and how to define what is considered a “plant biostimulant.” FIFRA and EPA regulations define plant regulators, and those products excluded from the plant regulator definition (i.e., plant nutrients, plant inoculants, soil amendments, and vitamin-hormone products). Acknowledging that there is no applicable regulatory definition for a plant biostimulant under FIFRA, EPA in the draft guidance provides the following definition for discussion purposes:
[A] naturally-occurring substance or microbe that is used either by itself or in combination with other naturally-occurring substances or microbes for the purpose of stimulating natural processes in plants or in the soil in order to, among other things, improve nutrient and/or water use efficiency by plants, help plants tolerate abiotic stress, or improve the physical, chemical, and/or biological characteristics of the soil as a medium for plant growth.
EPA also states that plant biostimulants have the ability “to enhance agricultural productivity by stimulating natural processes in the plant and in soil using substances and microbes already present in the environment” and notes that plant biostimulants have greater water and nutrient use efficiency and are becoming increasingly attractive for use in sustainable agriculture production systems and integrated pest management (IPM) programs.
EPA also notes two other statutory definitions for plant biostimulants:
- The 2018 Farm Bill states that it considers a “plant biostimulant” to be “a substance or micro-organism that, when applied to seeds, plants, or the rhizosphere, stimulates natural processes to enhance or benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, or crop quality and yield.” The U.S. Department of Agriculture (USDA) can modify this definition, as appropriate, when it submits to the President and Congress by December 19, 2019, a report identifying “any potential regulatory, non-regulatory, and legislative recommendations, including the appropriateness of any definitions for plant biostimulant, to ensure the efficient and appropriate review, approval, uniform national labeling, and availability of plant biostimulant products to agricultural producers.”
- The proposed European Commission (EC) regulation definition states: “‘Plant biostimulant’ means a product stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant: (a) nutrient use efficiency; (b) tolerance to abiotic stress; and (c) crop quality traits.”
Importantly, EPA is seeking comment on whether it should develop a regulatory definition for plant biostimulant, a critically important issue for stakeholders. EPA notes that any such definition would require a rulemaking process.
Examples of Product Label Claims
In its draft guidance, EPA provides multiple examples of product label claims that are considered plant regulator claims and claims that that are not considered plant regulator claims. EPA intends this guidance to assist companies in identifying product label claims, including plant biostimulants, that are considered to be pesticidal in nature and thus subject to pesticide regulation. The examples are described in the tables below.
1. Non-Pesticidal Claims -- Exclusions: Tables 1a through 1c list examples of product label claims generally considered “non-pesticidal” (i.e., non-plant regulator claims) by EPA that are specifically associated with the exclusions described in 40 C.F.R. Sections 152.6(f) and (g), including: “plant nutrition-based claims” (Table 1a); “plant inoculant-based claims” (Table 1b); and “soil amendment-based claims” (Table 1c). EPA states these claims were developed from (1) claims found on commercially-available products used as fertilizers, plant inoculants, and soil amendments; (2) discussions with stakeholders in industry and state regulatory bodies, and (3) discussions across EPA program offices and regional offices. EPA listed claims for each currently defined exclusion except for vitamin-hormone products, stating that plant regulator claims may be made for vitamin-hormone products when they meet both criteria for exclusion from the plan regulator definition as specified under 40 C.F.R. Sections 152.6(g)(1) and (2).
2. Non-Pesticidal Claims -- Generic: Table 2 provides examples of generic product label claims generally considered “non-pesticidal” (i.e., non-plant regulator claims) by EPA. These claims are not associated with any particular regulatory exclusion or product application/use site, but must be fully compliant with the criteria of 40 C.F.R. Section 152.15. EPA states that it recognizes that the exclusions from the definition of a plant regulator, as listed under FIFRA Section 2(v), may not cover all current or proposed product applications or use sites for plant biostimulants.
3. Plant Growth Regulator Claims: Table 3 lists examples of plant regulator product label claims that are consistent with the FIFRA Section 2(v) plant regulator definition -- products making such claims must be registered with EPA. EPA states that in determining what natural substances are considered plant regulators and what may constitute a plant regulator claim on a product label, “the mode of action of the substance(s) and associated label claim(s) must be congruent with the intent of the plant regulator definition.” Further, based solely on the FIFRA section 2(v) “plant regulator” definition, a naturally occurring substance would be considered a “plant regulator,” and a product label claim would be considered a “plant regulator claim” if the substance or mixture of substances, through physiological action:
- Accelerates or retards the rate of plant growth;
- Accelerates or retards the rate of plant maturation; and
- Or otherwise alters the behavior of plants or the produce thereof; and if the substance or mixture of substances does not fall under one of the exclusion categories listed in 40 C.F.R. Sections 152.6(f) and (g) as vitamin-hormone products, plant nutrients, plant inoculants 183 or soil amendments; or under 40 C.F.R. Section 152.8(a) as a fertilizer.
4. Naturally-occurring, Plant Regulator Active Ingredients: Table 4 lists current EPA-registered, naturally-occurring, plant regulator active ingredients having modes of action and associated product label claims that are consistent with the FIFRA definition of a plant regulator. EPA states that it did not list conventional chemical plant regulators in Table 4, as if a conventional chemical plant regulator is contained within a plant biostimulant product, the product likely would be considered a Conventional Chemical pesticide by EPA and would be subject to registration under FIFRA.
EPA’s efforts are appreciated and much needed. We agree with EPA’s statement that it “anticipates that this guidance may reduce confusion, in both the regulated community and regulatory agencies, as to whether specific products are or are not subject to registration as a pesticide under FIFRA.” Guidance to distinguish between the types of claims that would be typical of a plant regulator product for which FIFRA registration is required from other claims that are non-plant regulator claims and permissible for products, including plant nutrients, plant inoculants, and soil amendments is needed, as the scope of claims that EPA would find pesticidal, or not, is an area of considerable debate.
Similarly, the need for a regulatory definition of plant biostimulant may be an important element to clarifying the FIFRA status of the products at issue. Companies with interests in this space are urged to review carefully how EPA has defined and distinguished the different categories of products and the respective claims that may be pesticidal or not, and consider submitting comments to identify any areas where the jurisdictional line remains undefined or where additional clarity in claims may be needed.
Comments submitted to EPA regarding this draft guidance may also assist EPA in providing future comments to USDA, which is required under Section 10111 of the 2018 Farm Bill, in consultation with EPA other stakeholders, to prepare a draft report to the President and Congress providing recommendations regarding regulatory and non-regulatory actions that will “ensure the efficient and appropriate review, approval, uniform national labeling, and availability of plant biostimulants products to agricultural producers.” This report must be submitted by USDA to the President and the Congress by December 20, 2019. It thus is important for both EPA’s draft guidance and EPA’s future consultation with USDA for companies to review and comment as necessary on the proposed definitions and claims related to plant biostimulants.