The Environmental Protection Agency issued a final rule on October 30, 2025, establishing an exemption from the requirement of a tolerance for residues of the ASFBIOF01-02 polypeptide in or on all food and feed commodities. This action, effective immediately, responds to a 2021 petition from Biotalys NV, a Belgium-based company specializing in agricultural biotechnology. The exemption eliminates the need for maximum permissible residue levels when the substance is used as a biofungicide according to label directions and good agricultural practices. It reflects the EPA's determination that the polypeptide poses no significant risk to human health or the environment, marking a step forward in biopesticide regulation amid growing demand for sustainable crop protection alternatives.
Background and Petition Process
The ASFBIOF01-02 polypeptide is an antigen-binding fragment of an antibody designed to combat fungal pathogens in crops. Developed by Biotalys NV, it functions by binding to specific components in fungal cell membranes, disrupting cell integrity and leading to fungal death. This mechanism positions it as a biofungicide for controlling pre-harvest and post-harvest crop diseases on both food and non-food crops.
Biotalys NV submitted pesticide tolerance petition PP 1F8895 in March 2021, requesting an exemption under section 408 of the Federal Food, Drug, and Cosmetic Act. The petition sought to amend 40 CFR part 180 to allow residues of ASFBIOF01-02 in or on all food commodities without tolerance limits. The EPA announced the petition in the Federal Register on March 22, 2021, and received no public comments. This lack of opposition facilitated a streamlined review process, culminating in the final rule published in Federal Register Volume 90, Number 208.
Key players include Biotalys NV as the petitioner, represented through SciReg, Inc. in the U.S., and the EPA's Biopesticides and Pollution Prevention Division, led by officials like Shannon Borges. The rule aligns with broader EPA efforts to promote biopesticides, which are derived from natural materials and often present lower risks than synthetic chemicals.
EPA's Safety Assessment and Risk Evaluation
The EPA's decision hinges on a comprehensive human health risk assessment, detailed in the document 'Product Characterization and Human Health Risk Assessment for a FIFRA Section 3 Registration Request for the New Active Ingredient ASFBIOF01-02.' This assessment evaluated toxicological data, including acute and subchronic oral toxicity studies, which placed ASFBIOF01-02 in EPA Toxicity Category IV, indicating low toxicity.
Exposure analysis considered dietary risks from treated crops and potential drinking water contamination. The EPA noted the polypeptide's lability - its tendency to break down through photodegradation, hydrolysis, and microbial activity - limiting persistence in the environment. As a protein, it degrades into amino acids, reducing the likelihood of accumulation. Bioinformatic analyses showed no significant similarity to known allergens, and in vitro digestion tests confirmed rapid breakdown in gastric and intestinal fluids.
Under FFDCA section 408(c)(2)(A), the EPA determined the exemption is 'safe,' meaning there is reasonable certainty of no harm from aggregate exposure. This includes special consideration for infants and children per section 408(b)(2)(C), where no additional safety margin was deemed necessary due to the absence of threshold effects. The assessment also accounted for cumulative effects under section 408(b)(2)(D), finding no common toxicity mechanisms with other substances.
No analytical enforcement method is required, as the exemption imposes no numerical limits. This approach is consistent with precedents for other biopesticides, such as exemptions for Bacillus thuringiensis proteins, where low risk profiles justify similar regulatory treatment.
Legal and Regulatory Context
This rule operates under the Federal Insecticide, Fungicide, and Rodenticide Act alongside the FFDCA, balancing pesticide efficacy with safety. It potentially affects agricultural producers (NAICS 111 and 112), food manufacturers (NAICS 311), and pesticide manufacturers (NAICS 32532). Objections or hearing requests must be filed by December 29, 2025, following 40 CFR part 178 procedures.
The action aligns with executive orders on regulatory review, though exempted from some due to its FFDCA basis. For instance, it is not subject to Executive Order 12866 review as a tolerance exemption. Perspectives vary: proponents, including biotechnology advocates, view it as advancing sustainable agriculture by reducing reliance on chemical fungicides. Critics in environmental groups might argue for more stringent long-term monitoring, though no comments were filed here. Agricultural stakeholders appreciate the broad applicability to all commodities, potentially lowering compliance costs.
Implications and Perspectives
Short-term implications include expanded options for farmers facing fungal threats like those from Botrytis or powdery mildew. By exempting tolerances, the rule simplifies market entry for Biotalys' products, such as the end-use formulation EVOCA, encouraging innovation in biopesticides.
Long-term, this could influence pesticide policy by setting precedents for protein-based actives. It reflects shifting political forces toward environmentally friendly alternatives, supported by initiatives like the EPA's biopesticide program. However, challenges remain in scaling production and ensuring efficacy across diverse crops. Different perspectives highlight benefits for organic farming versus concerns over unintended ecological impacts, though data indicate minimal risks.
The rule's broad exemption contrasts with more restrictive tolerances for synthetic pesticides, underscoring biopesticides' favorable regulatory pathway. This may spur further petitions, fostering competition in the agrotech sector.
In summary, the EPA's tolerance exemption for ASFBIOF01-02 represents a science-driven regulatory decision grounded in low toxicity and exposure risks. Potential next steps include Biotalys pursuing full product registration under FIFRA, with ongoing monitoring for real-world performance. Future challenges may involve adapting to evolving fungal resistance or integrating with integrated pest management strategies. Debates could focus on balancing innovation with precautionary principles, as stakeholders monitor implementation and any emerging data on safety or efficacy.