Citrus Tristeza Virus (CTV) T36 Exemption from Tolerance Requirement
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This regulation establishes an exemption from the requirement of a tolerance for residues of Citrus tristeza virus (CTV) strain T36 that expresses Spinach Defensin Proteins SoD2, SoD2-1, and SoD2* in citrus food and feed commodities. This exemption, requested by Silvec Biologics, Inc, means that there is no need to set a maximum allowable level for these residues under the Federal Food, Drug, and Cosmetic Act (FFDCA). The EPA has concluded that the use of this genetically engineered virus will not pose unreasonable risks to human health, including infants and children.
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Key Changes
- Established an exemption from tolerance requirements for specific CTV residues
- Evaluated safety data demonstrating that these residues are not harmful
- Clarified that this action does not require an analytical method for enforcement
Obligations
What this law requires
No tolerance level (maximum permissible residue limit) is required for CTV strain T36 expressing Spinach Defensin Proteins SoD2, SoD2-1, and SoD2* in citrus food and feed commodities when used in accordance with this exemption
File any objections or requests for hearings regarding this regulation with the EPA Hearing Clerk by June 8, 2026, in accordance with 40 CFR part 178 instructions
Include docket ID number EPA-HQ-OPP-2025-0176 in the subject line on the first page of any objection or hearing request submission to EPA
Submit a copy of any objection or hearing request filing (excluding Confidential Business Information) to the public docket at https://www.regulations.gov following online submission instructions
Clearly mark any information claimed to be Confidential Business Information (CBI) in submissions and follow applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules