To those who have long laboured to attempt to find a way out of the labyrinth that is the U.S. regulatory scheme applicable to plant biostimulants, it appears that the first actual meaningful light in this tunnel may in fact have appeared.
On May 24, the U.S. House of Representatives Committee on Agriculture released a “Discussion Draft” of a 2024 Farm Bill. Subtitle C (Regulatory Reform), of Title X (Horticulture, Marketing, and Regulatory Reform) of the bill, proposes several amendments to FIFRA (the Federal Insecticide, Fungicide, and Rodenticide Act), the U.S. pesticides law. Pertinent to this article, proposed FIFRA amendments impacting plant biostimulants would (1) exclude certain plant biostimulants from the definition of “Plant Regulator”, thereby precluding their regulation as pesticides in the U.S., and (2) enact a U.S. statutory definition of plant biostimulants.
Taking these provisions in reverse order, the definition of plant biostimulant is unremarkable. The bill proposes to define “plant biostimulant” as: any substance or mixture of substances that, when applied to seeds, plants, the rhizosphere, or soil or other growth media, acts to support a plant’s natural nutrition processes independently of the nutrient content of that substance or mixture of substances, and that thereby improves—
(1) nutrient availability, uptake, or use efficiency;
(2) tolerance to abiotic stress; or
(3) consequent growth, development, quality, or yield.
Close observers will recognize this as a reasonably similar analogue to definition 1 from the USDA’s 2019 Report to Congress on Plant Biostimulants. As I have noted on a number of occasions in various writings and speaking engagements, the myriad definitions of plant biostimulants that have been proposed over the years in various contexts have been, for the most part, substantively consistent, notwithstanding slight variations in how they have been phrased. The Farm Bill definition similarly is similar: a plant biostimulant is a substance or mixture of substances that act to affect the plant’s physiology in a way that improves plant nutritional processes (e.g., uptake, use efficiency, or availability of plant nutrients); enhances tolerance to abiotic stress; or improves the growth, development, quality, or yield of plants. Excluding such products from the requirement of FIFRA regulation would be a very welcome change, because these are exactly the types of claims that plant biostimulant product developers and producers want to make – but not if they have to register their products as pesticides to do so.
As for the other statutory change, removing certain biostimulants from the FIFRA definition of pesticides, this would be a significant improvement in the current regulatory posture of these substances. A quirk of U.S. pesticide law is that FIFRA defines as a “pesticide” not only substances that are intended to prevent, repel, destroy, or mitigate pests, but also substances that are intended to alter the rate of growth or maturation of plants, or to otherwise alter the behaviour of plants. Substances that have these latter effects are termed plant growth regulators and are regulated as pesticides. Given the substantial costs, time, and ongoing obligations associated with pesticides regulation, most, if not all, plant biostimulant product developers and distributors desire to avoid characterization of their products as a pesticide by any workable means.
If enacted into law, the Farm Bill provisions would do that – at least for plant biostimulants that (1) have a “lowrisk profile” in relation to humans and other organisms, as determined by EPA; and (2) are of biological origin or include chemical compounds that are synthetically derived, but structurally similar
and functionally identical to, biological substances.
That said, it will be interesting to see how the ‘as determined by EPA’ provision is implemented. Will EPA require pre-market review of biostimulants prior to determining that a particular biostimulant is low-risk, or will it issue categorical exclusions of certain chemical substances or mixtures that it presumptively deems to be low-risk, or will its regulatory approach be a mix of both options? Bottom line, even if the House Farm Bill plant biostimulants provisions are enacted into law, there will remain an element of ‘stay tuned’.
Keith Matthews has practiced environmental law focusing on the regulation of chemicals, biopesticides, and genetically engineered organisms for over 25 years. He has practiced in the private sector, and for over 13 years was a staff attorney and assistant general counsel in the Office of General Counsel at the U.S. Environmental Protection Agency. He then served for four years as the Director of the Biopesticides and Pollution Prevention Division (BPPD) in EPA’s Office of Pesticide Programs (OPP). Today, Keith is principle at Matthews Law LLC, where he counsels clients on the regulation of biopesticides, biostimulants, and genetically engineered organisms regulated by the EPA, FDA, and the U. S. Department of Agriculture.