EPA Draft Guidance helps Distinguish When Biostimulants are Pesticides under FIFRA

On March 27, 2019, EPA published Draft Guidance for Plant Regulator Label Claims, Including Plant Biostimulants.  The guidance is intended to help companies that produce products that the Agency considers to make claims that are considered plant growth regulator (PGR) claims. This is because making PGR claims subjects the products to regulation under FIFRA as pesticides.  According to EPA, “plant biostimulants” (PBS) are a relatively new category of products containing naturally-occurring substances and microbes that are used to stimulate plant growth, enhance resistance to plant pests, and reduce abiotic stress.

A product makes a PGR claim if, through physiological action, it claims to:

  • Accelerate or retards the rate of plant growth;
  • Accelerate or retards the rate of plant maturation; or
  • Otherwise alter the behavior of plants or the produce thereof.

The draft guidance does not provide a definition for “plant biostimulant,” nor does any EPA regulation. The Guidance does provide the following “description” of PBS: 

“Generally speaking, a ‘plant biostimulant’ is 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.”

The Agency is asking for comments on whether EPA should develop a definition for plant biostimulants, noting that the development of a definition would require rulemaking.

At the heart of the issue is whether a PBS product, as understood by EPA, physiologically influences the growth and development of plants in such a way as to be considered plant regulators by the Agency, and thereby triggering regulation under FIFRA as a pesticide. FIFRA section 2(u) includes plant regulators in its definition of a pesticide.  

Based on the plant regulator definition contained in FIFRA section 2(v), EPA believes that many PBS 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.  

A key consideration in determining whether or not a product is a pesticide is what claims are being made on product labels. The draft guidance is intended to provide assistance for identifying product label claims that are considered to be plant regulator claims by the Agency, thereby subjecting the products to regulation under FIFRA as pesticides. The guidance provides examples of product label claims generally considered “non-pesticidal:”

  • Plant nutrition-based claims (i.e., necessary for normal growth of plants and in a form readily useable by plants);
  • Plant inoculant-based claims (i.e., enhance availability/update of plant nutrients through root system); and
  • Soil amendment-based claims (i.e., intended for the purpose of improving soil characteristics favorable for plant growth).

The guidance also provides examples of generic product label claims generally considered by the Agency to be “non-pesticidal.”  In addition, examples of label claims that are considered by the Agency to be PGR claims that trigger regulation under FIFRA as a pesticide are included.  A list of PGR active ingredients contained in EPA-Registered Products is included as well.

The Federal Register notice announcing the guidance notes that as guidance the document is not binding on the Agency or any outside parties, and that the Agency may depart from it where circumstances warrant and without prior notice.