Understanding the Impacts and Needs in Biologicals Regulation

The Agriculture and Food Systems Institute (AFSI) is convening an in-person conference to bring together a diverse array of stakeholders engaged in the utilization and regulation of biologicals in agriculture. Preceded by an online session at the Dupont Summit on Science, Technology, and Environmental Policy to prime attendees, this one-day event will facilitate an exchange of ideas between researchers, product developers, and regulators, paving the way for future regulatory developments and providing a forum to stakeholders for discussion. This activity is supported by a grant from United States Department of Agriculture National Institute of Food and Agriculture and Food Research Initiative (USDA NIFA AFRI) Foundational and Applied Science Program (award no. 2024-67023-42836).

Background

The term “biologicals” refers to a broad category of products derived from or consisting of living organisms with a range of functionalities, including biofertilizers, plant growth regulators, biostimulants, and biopesticides. While biologicals are not new in agriculture, recent social, economic and technological developments have ignited renewed interest. The biologicals sector has seen an explosion of product start-ups, mergers, and investment from big agricultural companies. This growth has propelled innovation, leading to advances in biological isolates, refined biological compounds, symbiotic organisms, microbial based solutions, bioprocessing, fermentation techniques, and delivery systems.

Conference Objectives

Biologicals are currently regulated under policies designed for synthetic chemicals with single, easily categorized functions, but their variety and nature can result in overlapping functions. This challenge to protocol development and regulatory pathways can affect the perception, adoption, and competitiveness of these bio-based solutions, as well as create barriers to adoption, with economic and environmental impacts. There is a need for rational agricultural policy design and implementation that supports biologicals innovation while ensuring the potential impacts on growers, producers, consumers, and the environment are properly considered. This event will unite stakeholders to:

• Better comprehend the emerging biologicals landscape through the examination of recent research and product development.
• Enhance regulatory insight by producing an overview of current regulatory pathways for biological products and identify the potential impacts of these policies.
• Facilitate stakeholder dialogue to identify unintended impacts, definitional challenges, and need for future regulatory design aligned with the potential of biologicals.