The US Food and Drug Administration (FDA) is proposing to expand a controversial loophole to allow some of the world’s most toxic chemicals to be added directly to food without a safety review. The “threshold of regulation” (TOR) exemption currently allows dangerous compounds to be used without review in food contact materials, such as packaging or processing equipment, if they are not carcinogenic, and are added at levels below 0.5 parts per billion (ppb). But campaigners say many chemicals, especially hormone disruptors linked to brain damage and reproductive harm in children, are considered dangerous at levels far below 0.5ppb.
Even in its limited form, the loophole has already raised alarm. One TOR exemption that allows the rocket fuel chemical perchlorate to be used in grain bags dramatically increased the amount of the compound found in kids’ cereal, which advocates say could cause brain damage. The new proposed TOR expansion would allow companies to use the chemicals as an ingredient added directly to food, as flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers and binders, and for myriad other uses, in ultra-processing.
The revelation comes after Robert F Kennedy Jr and the FDA claimed victory and declared “promises kept” in August for “closing” a different controversial regulatory loophole called “generally regarded as safe” (Gras), which over the decades was used to send ingredients to the market that campaigners said could sicken, injure or kill people. But Kennedy and the FDA did not mention in their public relations material that the proposed Gras rule submitted quietly to the Federal Register includes the TOR expansion, which public health advocates warn will also send alarming levels of toxic chemicals to grocery store shelves. Some advocates have accused Kennedy of deception.
Regardless, the proposal represents a major win for big food, advocates say, and is based on flawed science. The FDA did not respond to a request for comment. The proposed rule states that “any substance used in food (both directly or indirectly added) will be exempted from regulation as a food additive” if there is “no appreciable risk to human health”.
Advocates say the problem lies in the definition of “appreciable risk”. Chemicals like perchlorate, some phthalates, some bisphenols, some Pfas “forever chemicals” and some flame retardants are not classified as carcinogenic, but they can cause harm at doses far lower than 0.5ppb. These could in theory be used as TOR ingredients, as could chemicals that are neurotoxic, cause brain damage, attack the immune system, harm the microbiota or give rise to any number of other adverse health impacts.
Maffini said she was particularly concerned about flavorings because ultra-processed food companies use chemicals that “play around with the nervous system and receptors in your mouth to try to make us eat more and more of something”. Advocates say the rule also does not take into account cumulative effects – one small dose of a TOR-exempted chemical may not be harmful, but many small doses of multiple toxic chemicals could be a problem. It also creates a secondary loophole in allowing carcinogens if the substance is created as an impurity.
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