EPA Greenlights Gene-Editing Protein in Food Without Limits
Published Date: 12/16/2025
Rule
Summary
The EPA just made it official: the SpCas9 protein used in citrus plants doesn’t need a safety limit for leftover residues on food or animal feed. This means farmers and food makers can use this protein without worrying about strict residue rules, starting December 16, 2025. If anyone has concerns, they have until February 17, 2026, to speak up—no extra costs or delays expected!
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Exemption for SpCas9 Residues in Citrus
The EPA established an exemption from the requirement of a tolerance for residues of the SpCas9 protein in or on food and feed commodities of citrus when used as a plant-incorporated protectant (PIP). The rule is effective December 16, 2025, and the exemption eliminates the need to set a numerical maximum permissible residue level for SpCas9 in citrus.
EPA Found No Safety Risk to Children
EPA concluded there is a reasonable certainty of no harm from aggregate exposure to SpCas9 residues and determined an additional tenfold safety margin for infants and children is unnecessary. This determination is part of the final rule effective December 16, 2025.
No Enforcement Test Required for SpCas9
Because EPA is establishing an exemption without a numerical limit, the Agency determined an analytical enforcement method is not required. A Western blot method was submitted to detect SpCas9 (via a FLAG tag), but EPA concluded no enforcement method is necessary for this tolerance exemption.
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