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3 for use in cosmetics and externally applied drugs and the provisional listing of the lakes of FD&C Red No. [...] 3 to be a carcinogen when ingested are relevant and appropriate to the evaluation of the safety of this color additive for noningested uses.”26 In fact, the agency concluded that the evidence was robust enough to “firmly establish” that FD&C Red No. [...] 3 for all uses because the agency found, three decades ago, that the color additive induces cancer in animals.45 Section 721(b)(4) [previously 706(b)(4)] of the Food, Drug, and Cosmetic Act (FDCA) prohibits the FDA from listing a color additive for a particular use unless the data presented to the FDA establishes that the color additive is safe for such use.46 Since 1960, the Delaney Clause has ra. [...] The proponents further contended that, if a secondary mechanism exists, a threshold or ‘no effect’ level for the hormonal effects could be established that would permit the determination of a safe dose of the color additive.”61 FDA extended the closing date for the provisional listed uses of FD&C Red No. [...] Reviewing these studies, the agency concluded: After a full evaluation of the data submitted in support of the petition and of the other pertinent data that relate to the use of FD&C Red No.