Progress 09/01/24 to 02/28/25

Outputs
Target Audience:There has been rapid growth in the field of biologicals, and there is a push to integrate them into existing agricultural systems. For safe products to be released in a timely manner, clarity is needed around regulatory frameworks to ensure they support innovation while safeguarding environmental and social interests. This conference brought together researchers and product developers who are involved in biologicals product research and development. The audience also includes regulators who review applications for safety assessment of these products. Discussions at the conference centered around regulatory framework and technical capacity building to enable regulators to review applications, assess the safety of these products, and make decisions in a timely manner as well as a clear pathway to market that allows them to develop innovations into a robust pipeline of products. A total of 56 people attended the conference with 37 people in the room and 19 online through Zoom. First Name Last Name Country/Region Organization Job Title Type Amam Siddiki Bangladesh CVASU Professor Online Virginia Guardia Uruguay Ministry of Livestock, Agriculture and Fisheries General Director of Biosafety and Food Safety Online Marcos Grigioni Argentina Agromedicina Argentina Dr Online Nwadike Albert Nnabugo Nigeria National Biosafety Management Agency Senior Scientific Officer Online Coralie Farinas United States Ball Horticultural Company Scientist and Regulatory Manager Online Muhammad Irfan Pakistan Forman Christian College University Professor Online Mohammad Shaef Ullah Bangladesh Bangladesh Agricultural University Professor Online Andrew Kiggundu Uganda National Agricultral Research Organisation Principal Research Officer, Biotechnology Online Kwesi Anderson Ghana National Biosafety Authority Senior Biosafety Officer Online Dr. Mohammad Nurul Islam Bangladesh Dhaka University, Dhaka Professor Online Azhar Iqbal Pakistan Government Graduate College & MNS Agricultural University Assistant Professor and Ph.D. Research Scholar Online Sofia Ibarra Argentina SENASA Técnica Online Sathya Adimulam United States J.R. simplot Reg Manager Online Shade Sabitu United States Pivot Bio Director, Regulatory Science and Operations Online Lisa Baker United States Corteva Agriscience Global Biologicals Permitting and Compliance Online Matthew Pence United States J.R. Simplot Regulatory Manager Online Erin Whitteck United States Bayer Science Engagement Lead Online ToanPV Vietnam Vietnam Academy of Agricultural Sciences Vice president Online Mohammad Rahbari United States BioLiNE Executive Vice President Online John Dunmore United States BPIA Director of Government and External Affairs In-person Keith Jones United States BPIA Executive Director In-person Jennifer Rowland United States USDA Biotechnology Coordinator In-person Linda Kinkel United States Jord BioScience Chief Science Officer In-person Dharmendra Kumar Singh United States USDA Biological Scientist In-person Rachel Hiles United States USDA APHIS BRS Biological Scientist APHIS Science Fellow In-person Ariel Heminger United States USDA-APHIS-BRS Biological Scientist In-person Alan Pearson United States USDA/APHIS/Biotechnology Regulatory Services Assistant Deputy Administrator In-person Keith Jones United States BPIA Executive Director In-person Arik Shams United States U.S. Department of State Biotechnology Advisor In-person Chuck Frazier United States Temporal Agriculture CEO and Founder In-person Deirdre Griffin LaHue United States Washington State University Assistant Professor, Soil Health In-person Richard Colback United States International Finance Corporation (World Bank Group) Industry Specialist In-person Rachel Hiles United States USDA APHIS BRS Biological Scientist APHIS Fellow In-person John Dunmore United States BPIA Director of Government and External Affairs In-person Elke Duwenig Germany BASF SE Senior Expert Regulatory, Governmental Relations Biotechnology In-person Terry Stone United States Stone Biological Solutions Founder In-person Suma Chakravarthy United States USDA Senior Science Advisor In-person Shannon Borges United States Biopesticides and Pollution Prevention Division, US EPA Deputy Director In-person Andrew Roberts United States Agriculture and Food Systems Institute CEO In-person Karen Hokanson United States Agriculture & Food Systems Institute Senior Manager, Scientific Programs In-person Stephanie Carter United States Agriculture & Food Systems Institute Senior Manager, Operations and Logistics In-person Bhavneet Bajaj United States Agriculture and Food Systems Institute Senior Manager, Scientific Programs In-person Layla Tarar United States Agriculture and Food Systems Institute Communications Manager In-person Jane Fife United States 3Bar Bio Chief Technical Officer In-person Willem Janssen United States World Bank Consultant In-person Rodimiro Ortiz Sweden Swedish University of Agricultural Sciences Professor In-person Mark Rosegrant United States International Food Policy Research Institute Fellow (Emeritus) In-person Natasha Dixon United States Bayer - Crop Science Regulatory Policy Manager In-person Lucía Zeballos Uruguay Ministery of Livestock, Agriculture an Fisheries, Uruguay. Coordinator on Biosafety In-person Rachel Hiles United States USDA-APHIS-BRS Biological Science APHIS Fellow In-person Heather Gilbert United States Department of State Bioteach Team Lead In-person Scott Brown United States DC Lobbying and Government Relations Service In-person Rick Melnick United States DunhamTrimmer, LLC Managing Partner & Chief Operating Officer In-person Jeana Cadby United States Western Growers Director of Environment and Climate In-person Jonathan Sarager United States Western Growers Senior Director of Federal Government Affairs In-person Bob Tansey The Nature Conservancy In-person Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided? Nothing Reported How have the results been disseminated to communities of interest?Theconference was publicized in AFSI's newsletter and on social media accounts. In addition, a publication is in preparation for submission to a peer reviewed journal based on the following outline. This report will provide practical recommendations for future actions by researchers, developers, and regulators. It will contribute towards a transparent, scientifically sound, and effective regulatory environment for the use of biologicals in the emerging bio-economy. Introduction: An area of renewed interest given the challenges that agriculture is facing today. Moving toward integrated crop management systems: Ability to complement chemical inputs and contribute to sustainable agricultural practices. Role in Integrated Pest Management programs. Conference objective. Purpose of this manuscript. Overview of Categories of Biological Products: Biologicals represent a broad array of agricultural inputs that originate from natural sources. These have different functions and are being used to improve plant productivity, soil health, and ecosystem health. As there are so many different biological products it is pertinent to discuss the categories with a view to providing clarity on the origin and function of each category of products. Biocontrols Biopesticides Macroorganisms Biostimulants Microbial origin: Biofertilizers Non-microbial origin Overview of Regulations for Biological Products in the United States: The diverse range of biological products is evocative of confusion around the regulation of these products. Clarity is needed on how biologicals are regulated in the United States. This manuscript is not intended to be a primer on regulations in the United States, but a brief discussion of the following is warranted: Federal Regulations State Regulations Local Regulations The regulatory frameworks for biological products differ between countries and regions. While regulations in other countries are beyond the scope of this manuscript, it is suggested that we recognize the need for consistent approach to review and risk assessment of these products to support innovation. Landscape of Product Developers in the United States and Beyond: Big Agricultural Companies Start ups Themes Emerging from Expert Discussions at the Conference: The following are some considerations that have emerged from discussions at the conference to focus on as this area of agriculture continues to evolve: Training in the status of regulations Tools to familiarize developers and other stakeholders with regulations so that they have a shared understanding of what is expected of them. Work Force Development Training the next generation of regulators. Addressing the need for capacity building and discussions around regulations. Developing collaborations between regulators in North America, South America, and Europe. Innovation in Regulatory Practice AI to support regulators in identifying potential hazards/ Innovation in regulation Knowledge of bioinformatic tools such as protein folding software, protein interactions; genome mapping to select strains with highest potential efficacy, stability, and adaptability Synthetic laboratory testing Support for Efficacy Testing of New Biological Products Developing guidance to bring conformity to efficacy testing. Discuss the value of a mechanism to allow companies to share precompetitive efficacy data. Learning from Other Application Areas Regulatory success in Agricultural biotechnology - Principles of food safety assessment and environmental risk assessment, their recognition through international organizations. Establishment of common principles that formed a fundamental foundation of rational regulation and national regulatory frameworks. Regulatory success in Pharmaceuticals - Mutual Acceptance of Data to reduce regulatory burden. Biologicals and Food Safety What needs to be assessed from a safety point of view and how can these be assessed? Areas of Research that will Facilitate Innovation and Regulation of Biological Products Conclusions: Biological products are a vital tool in enhancing the toolbox of modern agriculture Continuing stakeholder engagement Push for consistency in risk assessment approach What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? The conference provided a platform for: Comprehending the emerging biologicals landscape through the examination of recent research and product development. Enhancing regulatory insight by producing an overview of current regulatory pathways for biological products and identifying potential impacts of these policies. Facilitating stakeholder dialogue for the identification of unintended impact, definitional challenges, and need for future regulatory design aligned with the potential of biologicals. All the objectives of the conference were met in terms of outcomes. On the basis of 14% response rate to the post-event survey, the respondents indicated an increase in the level of knowledge of biologicals after the conference relative to before attending the event (chart available on request). Respondents also agreed that the objectives of the conference were clearly defined and it was useful to them in their current job (chart available on request). Respondents also indicated that they gained diverse perspectives from technologists, regulatory professionals, and companies. The talks provided valuable insights into market complexities and the landscape of product developers (chart available on request).

Publications