EPA Issues Final Rule to Reduce Regulatory Burden for Manufacturers of Certain Microorganisms

EPA finalized a rule to add two strains of microorganisms to the list of microorganisms eligible for an exemption from certain reporting requirements under the Toxic Substances Control Act (TSCA). Manufacturers of new intergeneric Trichoderma reesei (strain QM6a) and Bacillus amyloliquefaciens (subspecies amyloliquefaciens) may now be eligible to undergo a streamlined review process under TSCA's new chemicals review program with reduced TSCA fees. This final rule ensures the safety of human health and the environment while reducing regulatory burden for the biotechnology industry.

After reviewing all relevant health and safety data, EPA has determined that these two microorganisms can be added to the list of microorganisms eligible for exemption. Under TSCA, manufacturers of a new intergeneric microorganism may be eligible to submit an exemption request in lieu of a microbial commercial activity notice (MCAN) if the organism is on the list of species eligible for an exemption and meets other criteria. EPA is including these two microorganisms on the list because the agency has determined that these microorganisms will not present an unreasonable risk of injury to health or the environment provided that the other criteria relating to the introduced genetic material and the physical containment of the new microorganisms have been met.

Both microorganisms have a long history of safe use to produce a variety of commercial enzymes used in industrial and food-related industries. Trichoderma reesei is used by the animal feed, baking, beverages, textile processing, detergent, pulp and paper, industrial chemicals and biofuels industries. Bacillus amyloliquefaciens has been used to produce commercial enzymes for more than fifty years. It produces carbohydrases, proteases, nucleases, xylanases and phosphatases that have applications in the food, brewing, distilling, and textile industries.

To view the final rule, or for additional information, please visit https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/tsca-biotechnology-regulations.