FDA proposes expanding loophole to let toxic chemicals enter foods without safety review

The U.S. Food and Drug Administration has drafted a rule that would extend the existing “threshold of regulation” (TOR) exemption, allowing a range of chemicals to be added directly to foods without undergoing a safety review. The exemption, which currently applies only to substances in packaging or processing equipment at levels below 0.5 ppb and that are not classified as carcinogenic, would be broadened to cover flavorings, preservatives, enzymes and other ultra-processed food ingredients.

Advocates point to past TOR use of perchlorate in grain bags, which raised perchlorate levels in children’s cereals and is linked to thyroid disruption and lower IQ. Critics argue the definition of “appreciable risk” is too narrow and fails to consider cumulative exposure to neurotoxic or endocrine-disrupting chemicals such as certain phthalates, bisphenols, PFAS and flame retardants. The proposal follows a publicized “closure” of the “generally regarded as safe” loophole, a claim that some say hides the TOR expansion. Scientists from the Environmental Defense Fund and other groups say the rule would make it impossible for shoppers to know if their food contains these exempted substances, potentially increasing health risks.