EPA Grants Nationwide Tolerance Exemption for New Bacillus Biopesticide, Easing Path for Biological Crop Protection
16 September 2026, United States: The US Environmental Protection Agency has exempted a new microbial biopesticide, Bacillus amyloliquefaciens strain AT-332, from the requirement of a pesticide tolerance on all food and feed commodities in the United States, according to a final rule published in the Federal Register on September 15, 2026. The exemption takes effect immediately and removes one of the main regulatory hurdles for bringing biological crop protection products based on this bacterial strain to market.
The petition was filed by Gowan Company, an Arizona based crop protection manufacturer, in cooperation with Japan’s SDS Biotech K.K., under petition number PP 1F8915. EPA’s Biopesticides and Pollution Prevention Division reviewed the application under docket EPA-HQ-OPP-2024-0308 and concluded that residues of the bacterium and its metabolites pose no meaningful risk to human health, even under aggregate, worst case exposure scenarios that include infants and children.
Bacillus amyloliquefaciens is a naturally occurring soil and rhizosphere bacterium already used as an active ingredient in several commercial biofungicides. EPA’s assessment notes the organism is not expected to be toxic, pathogenic, or infective to humans. Notably, the agency removed the word “fungicide” from the original petition language, a technical change that broadens the scope of permitted end uses and, according to the notice, reduces the regulatory burden on the registrant by not tying the exemption to a single pesticide class.
Because tolerance exemptions apply across all food and feed commodities when a product is used according to label directions and good agricultural practice, this action effectively clears the residue chemistry barrier for any future end use product built on this strain, whether marketed as a fungicide, bactericide, or plant health input. Companies still need to secure a separate product registration under FIFRA before selling formulated products, but they no longer need to establish or seek exemption from a tolerance for each new use, which is typically one of the more time consuming and expensive steps in the US registration process.
The rule carries a standard 60 day objection and hearing request window, with the deadline set for November 16, 2026. Absent a successful legal challenge, the exemption stands as a permanent part of 40 CFR part 180.
Why this matters: For companies developing microbial and biological crop protection tools, US tolerance exemptions like this one are a leading indicator of where the EPA is lowering barriers to entry. Biologicals have struggled for years with registration timelines that lag far behind conventional synthetic chemistry, and a clean tolerance exemption removes one of the costliest data requirements from that process. Global agribusiness players watching the shift toward integrated and biological pest management, particularly in specialty crops and in markets moving away from certain synthetic residues, will read this as a signal that Bacillus based actives have a smoother regulatory runway in the United States than many synthetic alternatives currently working through registration review. It also strengthens the competitive position of Gowan and SDS Biotech in a biofungicide segment that already includes established players such as BASF’s Serifel.
| Detail | Information |
|---|---|
| Active ingredient | Bacillus amyloliquefaciens strain AT-332 |
| Petitioner | Gowan Company, with SDS Biotech K.K. |
| Petition number | PP 1F8915 |
| Docket ID | EPA-HQ-OPP-2024-0308 |
| Document number | 2026-18830 |
| Effective date | September 15, 2026 |
| Objection deadline | November 16, 2026 |
| Scope | All food and feed commodities, per label directions |
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