Key facts
- FDA proposes expanding TOR exemption to allow toxic chemicals in food without safety review.
- Exemption applies if chemicals are not carcinogenic and added below 0.5 parts per billion.
- Advocates say many chemicals are dangerous at levels far below 0.5 ppb.
- Proposed rule allows chemicals as direct food ingredients like flavorings, preservatives, and stabilizers.
- Perchlorate, phthalates, bisphenols, and PFAS are among chemicals that could be used.
- Critics claim the expansion contradicts efforts to close the GRAS loophole.
The US Food and Drug Administration (FDA) is considering a significant expansion of a regulatory exemption that could allow certain toxic chemicals to be added directly to food without undergoing a safety review. The proposed change to the "threshold of regulation" (TOR) exemption, which currently applies to food contact materials, would permit chemicals to be used as ingredients in ultra-processed foods.
Campaigners and public health advocates are raising alarms, arguing that many chemicals, including known endocrine disruptors linked to developmental harm in children, are dangerous at levels far below the proposed 0.5 parts per billion threshold. These chemicals, such as perchlorate, phthalates, bisphenols, and PFAS, could potentially be incorporated into food as flavorings, preservatives, stabilizers, and other additives.
This development comes shortly after claims by Robert F. Kennedy Jr. and the FDA of closing a different regulatory loophole, the "generally regarded as safe" (GRAS) standard. However, critics allege that the proposed expansion of the TOR exemption was quietly included in the Federal Register submission, effectively counteracting any gains in food safety and leading some advocates to accuse Kennedy of deception.
Experts like Maricel Maffini, an independent food consultant, criticize the FDA's position that low levels of a substance are not problematic, stating it is not supported by science. She highlighted concerns about flavorings that may affect the nervous system to encourage overconsumption. Advocates also point out that the proposed rule fails to account for the cumulative effects of multiple chemical exposures and creates a secondary loophole for carcinogens if they appear as impurities.
The historical use of the TOR exemption for perchlorate in grain bags, which led to increased levels in children's cereal and potential links to reduced thyroid function and lower IQ scores, is cited as a cautionary example. Despite data showing increased perchlorate in cereal, the FDA reapproved its use in grain bags, a decision critics attribute to flawed science and a disregard for endocrine system harms.