Is a Solution to the Plant Biostimulants Conundrum in the Offing?
Potential applicability of the pesticides registration requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to certain products marketed or described as “plant biostimulants” has long vexed the plant biostimulants industry. Because the FIFRA definition of “pesticide,” in addition to including substances that prevent, destroy, repel, or mitigate pests, also includes “plant regulators,” i.e., substances that, in pertinent part, are meant to alter the physiological behavior of plants, a subset of plant biostimulant substances are potentially subject to regulation as pesticides – with the attendant costs and time-consuming regulatory processes that come with regulation under FIFRA.
As I have discussed previously in Wiley Alerts addressing the U.S. Environmental Protection Agency (EPA) Biopesticides and Pollution Prevention Division’s (BPPD’s) draft guidance on “Plant Regulator” claims here and here, BPPD has signaled its intent to provide clarity to the types of marketing claims that will render a product subject to FIFRA regulation as a plant regulator, i.e., as a pesticide, and claims that won’t. EPA’s plant regulator guidance document has been in development since 2019, and a final operable version has been promised on a number of occasions since 2020. But, even if EPA issued the plant regulator guidance tomorrow, it wouldn’t address the underlying problem facing plant biostimulants – that they should not be regulated in any respect under the same regulatory scheme that applies to substances intended to prevent or destroy pests.
I have said for years that the best, most effective, and most certain way to provide clarity on whether a plant biostimulant product is subject to FIFRA regulation is to amend FIFRA to expressly remove, alter, or limit the problematic plant regulator language currently in the statute. The plant regulator language was added to FIFRA in 1959, when FIFRA was still, in essence, a marketing and not a regulatory statute. The 1972 Federal Employees Pay Comparability Act (FEPCA) amendments that transformed FIFRA into a mandatory pre-market regulatory approval statute should have also narrowed the scope of the definition of pesticide to better fit that statutory purpose, but didn’t.
Well, as is said, better late than never. Representatives Jimmy Panetta and Ryan Hughes (Democrat and Republican, it should be noted) have introduced a bill to amend FIFRA to remove plant biostimulants from its regulatory purview. The Plant Biostimulant Act of 2022, H.R. 7752, would amend FIFRA to expressly exclude plant biostimulants from FIFRA regulation, and would define “plant biostimulant” as “a substance, micro-organism, or mixture thereof, that, when applied to seeds, plants, the rhizosphere, soil, or other growth media, act to support a plant’s natural processes independently of the biostimulant’s nutrient content, including by improving nutrient availability, uptake or use efficiency, tolerance to abiotic stress, and consequent growth, development, quality, or yield.” This definition is consistent with a number of relatively similar, but non-identical, definitions of plant biostimulants that have been circulated the past few years, and is an improved version of the definition that was included in a provision of the 2018 Farm Bill that directed the U.S. Department of Agriculture (USDA) to produce a report addressing the issue of improving the regulatory status of plant biostimulants.
Although a welcome development, the likelihood is that H.R. 7752 will not pass in the present Congress. I think it fair to say that there simply isn’t sufficient time remaining in the 2022 legislative calendar. But, the bill is a useful development in that it gets the legislative process started for these amendments. Assuming that both Representatives Panetta and Hughes are in relatively safe Districts, they can both be expected to return in the 118th Congress – a Congress that will have to take up the 2023 Farm Bill. I can see H.R. 7752 being rolled into the 2023 Farm Bill, and this vexing conundrum finally solved in the best manner possible – by conforming FIFRA to present agricultural reality.