Sep 5, 2019
EPA’s biostimulant regulations remain in flux
The EPA’s consideration of a regulation touching on biostimulants is drawing substantial interest from the industry.
The agency collected comments on a draft document, “Guidance for Plant Regulator Label Claims, Including Plant Biostimulants,” in formal rule-making proceedings. The non-binding document is meant to clear up what product label language claims that the Environmental Protection Agency would consider to be plant regulator claims, under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).
Biostimulants are a significant tool for growing specialty crops, especially on an organic farm. But even what legally qualifies as a plant biostimulant is up for definition. The EPA noted an existing definition in the farm bill as well as a proposed description by the European Commission before giving its own definition:
“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 EPA wrote in an overview of the draft document that many plant biostimulants don’t fit FIFRA’s definitions of how plant regulators work, and that many others would be exempt from FIFRA due to their intended use as simple nutrients, fertilizers, “plant inoculants, soil amendments and vitamin-hormone products.”
But it also wrote: “A key consideration is what claims are being made on product labels.”
Keith Jones is executive director of the Biological Products Industry Alliance, which, with more than 150 other organizations and individuals, formally participated in the rule-making period that ended in late June. He provided insight to the process.
These federal rule-making procedures are baffling to many. What just happened?
Keith Jones: EPA issued draft guidance in an attempt to add clarity to what is regulated under the federal pesticide law, and we expect that the document will continue to evolve as EPA learns more from information provided during the comment period. A couple of important things to note about the EPA draft guidance for plant regulators, including plant biostimulants:
- It is still a “draft” version meaning that state regulators and industry should not use or cite it yet. It is not intended to be used or cited while EPA continues to refine the draft pending comments.
- It is “guidance,” which is different than rule-making. Rules are legally binding; guidance is not. Guidance conveys the agency’s “current thinking” on a topic but has not gone through a formal review process like rule-making would. Stakeholders look forward to working with EPA so that is final guidance clarifies the agency’s perspective.
The EPA seems to be concerned that some products were making claims along the lines of plant growth regulators.
KJ: Most of the regulatory confusion on this topic boils down to the definition of “plant regulator” in the FIFRA/pesticide law. This law originated in 1959 and has been revised several times since. The definition of plant regulator contained in it is quite broad and how it is interpreted can create regulatory ambiguity.
Our industry was hoping the EPA guidance document primarily would focus on clarifying which claims would fall under that definition and those which would not. EPA did include three tables which provide a list of these types of claim examples. These are just examples of claims and should not be the only claims allowed going forward. We think these three tables in general are helpful in trying to explain the types of claims that would fall under or outside of the FIFRA law.
We did not agree, however, with the inclusion of an additional table, Table 4, which provides a list of materials, some of which had previously been registered at EPA as plant regulators. The assumption is that state regulators will see this table and argue that any product containing these materials will therefore need to be registered with EPA as plant regulators, despite the fact that many products containing these materials have been registered at the state level as soil amendments or fertilizers for decades.
This list of materials include substances such as seaweed extracts and humic acid. There are over 500 products at the state level that are registered containing one of these materials and have a history of safe use. These two materials currently are included in about 60% of biostimulant product lines, so it would be tremendously disruptive to the industry if these products would have to pursue an EPA registration for these types of products going forward.
How concerned should specialty crop growers, especially organic growers, be about this proposed rule-making?
KJ: Specialty crop growers, organic growers, conventional growers and anyone who has previously used a plant biostimulant product that contained seaweed extract, humic acid or related materials that are listed in Table 4 of the EPA draft guidance document should be concerned that they may no longer have access to these products, or that they will potentially be more expensive, if this guidance is implemented as currently written.
What’s the next step in the process, as you understand it?
KJ: EPA will likely spend several months reviewing the public comments and then revise the draft guidance before issuing a final version of the guidance. We have been told that it likely won’t be finalized until the spring of 2020. Overall, this is still the early stages of what could be a long process of getting more clarity.
