12. Food Safety & Regulation / Natural, Organic, & Bioengineered Foods / Problem 6
A start‑up develops a tomato with a small gene edit introduced by CRISPR without inserting foreign DNA. Analyze regulatory implications under current U.S. frameworks and identify the most likely oversight gap.
Products with CRISPR edits are required under current rules to be labeled identically to organic products, including the USDA organic seal, because they are derived from nontraditional breeding methods.
Because CRISPR edits may not involve recombinant DNA, they can fall outside frameworks designed for transgenic organisms, creating regulatory ambiguity: USDA bioengineered rules focused on recombinant DNA may not clearly apply, potentially leaving labeling and oversight uncertain until agencies update guidance.
All new gene edits are uniformly regulated by the EPA as pesticides, because edits are reclassified as environmental control agents regardless of method used.
CRISPR edits are automatically considered illegal under USDA law, and no oversight is possible until the company obtains a special congressional waiver.
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