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SPECIAL SESSION: Beneficial Microbes: From Isolation to Product Registration and the Regulatory Process

Microbes as biocontrol, biofertilizer and biostimulant products: the pathway to regulatory approval
Susan Cohen - Center for Regulatory Research LLC.

Historically, regulations have focused on microbial biological control products and regulations for newer products such as biofertilizers and biostimulants are not as well developed. The international community, (IPPC) has published a regulatory standard (ISPM 3) that establishes guidelines for export, shipment, import and release of biological control agents and other beneficial organisms (May 29, 2017). The USA handles biological control organisms at the federal level through USDA APHIS under the Plant Protection Act 2000. A 526 permit is required for the importation, interstate movement and environmental release of biological control organisms of plant pests and weeds. Each state also has the authority to establish state regulatory statutes regulating biological control organisms. Biofertilizer microbes are governed under fertilizer regulations for use in the USDA National Organic Program. Biostimulant products are the latest products to come to market. The USA Farm Bill (December 2018) published the first legal definition as “a substance or micro-organism that, when applied to seeds, plants, or the rhizosphere, stimulates natural processes to enhance or benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, or crop quality and yield”. This is a first step toward developing a regulatory framework for this product category.