Plant Biostimulants Update Office of Chemical Safety & Pollution Prevention, Office of Pesticide Programs, Biopesticides & Pollution Prevention Division Plant Biostimulants Update Russell S. Jones, Ph.D., Senior Biologist Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division Office of Pesticide Programs Office of Chemical Safety & Pollution Prevention U. S. Environmental Protection Agency Jeff comstock asked about nitrification inhibitors…recently saw one iwth a epa reg. No. And wanted to understand that beter. Jones says not sure, but hte biostimulators are being considered biopesticides. Even though the products have fertilizer aspects, but they rate is so low that they are not used as fert. The claims make it seem as though they are to stimulate the growth of plants, to enhance growth and yuield, resist pathogens, etc. So it looks like a plant regulator. Rabe...these products are fairly extensive thses days..some of the labels and claimsare far reching, etc. Does the agency want notification of these types of products? As associations what can we do to get a handle on this ? Aafco is involved as well. Would be nice to get a handle now. Jones says goal is to hav eguidance sooner than later. At the moment it is case by case, trying to find a clear path. Lots of discussion on this....qu4estions from states are useful, please send them in, with all the info possible. Lopez...in co lots of use on mj. Last year the dept collected 25 different products and sent them to fort meade to understand what the components of the products are. Would your office like to analyze? Jones, would love to know what they components are and gert and analysis from a reputatble source, but can’t authorize.....lopez, claims are verbal more than written/labels/labeling. But antecdotally they are widely known.

What are Biostimulants? Products comprised of microbes and/or naturally-occurring plant growth substances derived from plants, animals, or microbes, used either alone or in combination with one another.

Intended Uses Biostimulants Enhancers of plant growth and development Increase yield and crop quality Improve nutrient and water efficiency Enhance resistance to abiotic and biotic stress Induce systemic resistance to pathogens Add or foster development of beneficial microorganisms in the rhizosphere

Plant Biostimulants Do Not: Act as fertilizers, or provide any fertilizer benefits to plants Act as fungicides, insecticides, rodenticides, herbicides, nematicides, and/or mitigate any plant pest

Biostimulant Market Relatively new, but growing category of products Global market expected to reach over $2.24 billion by 2018 Estimated compound growth rate of 12.5% between 2013 and 2018 Over 6.2 million hectares treated in Europe in 2013 In the US, the “typical” biostimulant product is a seaweed extract

Why Are Biostimulants Important to EPA Some components regulated under FIFRA - Plant hormones (auxins, cytokinins, etc.) - Other bioactive substances - Microbes Some product performance claims trigger regulation under FIFRA May contain Conventional Chemicals not listed on product label ingredients statement ----- Meeting Notes (12/7/15 08:34) ----- fifra section 2b or 2v? regulates there are some issues with folks spiking products

BIOSTIMULANT REGULATORY ISSUES No clear definition, statutory or otherwise Numerous products of uncertain composition Some product label claims may trigger State/Federal enforcement actions Uncertainty in the regulated community Uncertainty in the State/Federal regulating community FTE time devoted to enforcement issues Rapidly growing product category needing regulatory clarity

Where Do We Go From Here? Exempt/Exclude from Federal regulation? - Highly unlikely for all plant biostimulants “Light-Touch” regulatory pathway? - Based on existing human health/environmental information - Documented human food source - Long history of human/environmental exposure Align with proposed EU Fertilizer Law Revision? Business as usual – FIFRA Section 3 Registration?

Revision to EU Fertilizers Regulation (Reg. 2003/2003) Proposed statutory definition for plant biostimulants Four regulatory options for plant biostimulants Proposed implementation in early 2020s

Goals of the Proposed Regulatory Guidance for Biostimulants Describe the current “universe” of plant biostimulants for guidance purposes; Provide regulatory relief for certain types of plant biostimulants Provide regulatory clarity for Federal and State regulators Provide regulatory clarity for the regulated community