Depending on a PBS product’s composition and intended use, technology developers must register their product as a fertilizer, soil amendment, beneficial substance, or inoculum with the Department of Agriculture in every state in which they intend to sell the product. Each state has its regulations and definitions for these products that may result in the same product considered a soil amendment in one state, a microbial inoculant in another, a fertilizer with nutrient guarantees that provide no nutritional value to the crop in another and still other states no registration may be necessary for sale. Consequently, the PBS industry has worked for many years with the AAPFCO to establish a model bill for individual States to adopt that would help to streamline the registration process across the nation including a uniform single product label. Over the past year, a collaborative effort between the PBS industry and AAPFCO resulted in a draft model bill reviewed at the AAPFCO Summer Annual Meeting on August 2, 2022, in St. Louis, Missouri. The finalization of this model bill is expected in 2023.
For the rest of 2022 and 2023, the PBS industry will continue focusing on these efforts to eventually establish a consistent regulatory framework and path to market for this unique category of plant health products.
Published October 31, 2022
BIOAG REGULATORY UPDATE AND OP-ED
Light at the End of the Tunnel for Consistent Regulatory Framework for Plant Health Products
by Terry Stone, Global Regulatory Leader, Biologicals, Corteva Agriscience
Industry associations play a critical role in supporting their respective sectors. The US associations supporting plant biostimulants (PBS), specifically the Biological Product Industry Alliance (BPIA) and The Fertilizer Institute, Biostimulant Council (TFIBC) advocate for appropriate regulatory policy, educate on the technology, advise on recommended practices for their use in crop management and communicate their numerous benefits to sustaining agriculture. Volunteers from member companies and association staff work together to prioritize objectives and activities that support the responsible growth of the sector. While the lack of a predictable regulatory process for selling and marketing PBS products in the U.S. remains in development, the PBS industry made significant progress against several important strategic initiatives including the introduction of the Plant Biostimulant Act (PBA) of 2022 (H.R. 7552), developing a definition for plant biostimulants in the U.S., developing science-based recommendations for US PBS developers to assess the efficacy, composition, and safety of their products, and working with the Association of American Plant Food Control Officials (AAPFCO) to develop a single label for plant biostimulants sold in the country.
The US biostimulant industry has consistently focused on several goals. Foremost among them is the establishment of an appropriate and consistent regulatory framework and path to market for this unique category of plant health products. Plant biostimulants are neither nutrient fertilizers nor pesticides yet continue to be regulated as one or the other by the United States Environmental Protection Agency (USEPA) and State Fertilizer officials. The lack of regulatory clarity prevents developers from registering products according to their intended use and specific benefits. Foundational to the development of a regulatory framework is a PBS definition recognized by US Federal and State regulatory agencies. With a recognized definition and regulatory framework, a more predictable process for achieving the ability to sell and market these products will follow. Such a framework will provide clarity on the data and information needed to support their efficacy and safety, appropriate benefit claims, product labeling, etc., that can further lead to broader acceptance, credibility, and regulatory harmonization of the category.
Progress against all these initiatives required a coordinated and concerted effort between BPIA, the TFIBC, and other associations such as the Humic Products Trade Association, American Seed Trade Association, and Biotechnology Innovation Organization accompanied by regular communication and collaboration with federal and state regulators including the United States Department of Agriculture (USDA), USEPA, AAPFCO, academic experts, NGOs, commodity organizations, and members of the US Congress.
The bipartisan PBA was introduced in May by US Congressman Jimmy Panetta (D) of California and Jim Baird (R) of Indiana. While we do not currently expect the PBA to pass as “stand alone legislation, it is intended to serve as a ‘marker bill’ the industry will work to have included as a provision in the 2023 US Farm Bill. If successful, the Bill will: (1) establish a federal definition for a PBS, (2) exclude plant biostimulants from regulation under the Federal Fungicide, Insecticide, and Rodenticide Act (FIFRA), (3) update the definition for “vitamin hormone” products, that reflects their current usage, and (4) authorize the Secretary of Agriculture to conduct a soil health study regarding PBS, to assess and recommend best management practices that will promote soil health and several other environmental and agronomic benefits.
Under the PBA, plant biostimulant is a substance(s), microorganism (s), or mixtures thereof, that, when applied to seeds, plants, the rhizosphere, soil, or other growth media, act to support a plant’s natural nutrition processes independently of the biostimulant’s nutrient content. The plant biostimulant thereby improves nutrient availability, uptake, or use efficiency, tolerance to abiotic stress, and consequent growth, development, crop quality or yield”.
This same definition was adopted by the International Standard Organization Technical Committee 134 on April 29, 2022, in ISO 7851:2022 (Fertilizers, soil conditioners, and beneficial substances — Classification) and by the AAPFCO at their Summer Annual Meeting on August 2, 2022, in St. Louis, Missouri. The definition is also very consistent with the official European Union definition of plant biostimulant and is the “preferred” definition developed by the U.S. Department of Agriculture in the biostimulant policy and regulatory analysis study authorized in the 2018 Farm Bill.
In the absence of unified state or federal requirements for biostimulants, the U.S. biostimulant industry developed a general, science-based framework that can be voluntarily employed by technology developers and marketers to demonstrate the efficacy, composition and safety of plant biostimulant products sold in the U.S. The recommendations were developed by the Biostimulant Industry Workgroup (BIW), a collaboration of BPIA and the TFIBC, and are the result of hundreds of volunteer work hours contributed by dozens of biostimulant industry subject matter experts with feedback from academic, regulatory, commodity organizations, and other stakeholders. The recommendations have been approved for publication and are currently “in press” by the peer-reviewed Journal of Regulatory Science.