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 ۰.۵ 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 ۰.۵ppb. 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 and industry have this position that if there’s only a little bit of something in the diet, then it’s not going to be problematic, but that isn’t supported by science of any kind,” said Maricel Maffini, an independent food consultant who worked on TOR issues.
“I don’t know how they’re going to square that circle because there are many ingredients that at very low levels also cause serious issues in the body,” Maffini added.
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 ۰.۵ppb. 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.
Meanwhile, there is no way for consumers to know if a product contains a TOR-exempted chemical.
“They’re widening another loophole, but trying to say they made our food safer,” said Maria Doa, a scientist with the Environmental Defense Fund (EDF) non-profit. “They did not make our food safer.”
How TOR led to children eating rocket fuel chemicals
The problems with perchlorate in kids’ cereal are a warning about TOR’s risks, advocates say. In ۲۰۰۵, German chemical giant BASF used TOR to exempt perchlorate from regulations for use in “super sacks”, which are one-ton polypropylene plastic storage bags used on farms to move grains, including rice, flour and oats.
Perchlorate stops grains from sticking to super sacks. But the grains are loaded into and emptied from the sacks at high velocity, which can cause perchlorate and microplastics to break off. The FDA’s own data published in ۲۰۱۷ showed the number of samples of kids’ cereal with perchlorate increased after the ۲۰۰۵ TOR exemption. The agency similarly detailed a broad increase in the levels in each sample.
Perchlorate reduces the thyroid gland’s ability to absorb iodine, which is a raw material needed to produce the hormone T۴, an essential component of proper brain development. Very low levels of perchlorate exposure are linked to lower T۴ production, and lower IQ scores for children.
Still, six months after it published its data, the FDA reapproved perchlorate for use in super sacks. Advocates say the agency used flawed science and manipulated the data. The FDA wrote that there was no meaningful increase in perchlorate across all the ۲۵۰ foods it measured. But critics countered that the problem was not in all the food – the problem was in kids’ cereal.
The FDA largely ignored the cereal findings, and mostly does not consider endocrine system harms when developing regulations, said Tom Neltner, a former scientist with the EDF who is now director of the Unleaded Kids non-profit. He helped lead litigation over perchlorate, which was ultimately dismissed.
“They put their blinders on and approved the exemption based on data that never considered the harms posed by endocrine disruptors,” Neltner said.
Kennedy deceived on Gras?
Kennedy leads the Make America Healthy Again (Maha) movement, of which eliminating toxic chemicals from food is a cornerstone. During the run-up to the ۲۰۲۴ US presidential election, he held up the Gras standard as an example of the broken regulatory system that he would take bold steps to fix as he stands up to big food and makes America healthy again. The loophole drew outrage because campaigners say it virtually eliminates regulatory oversight for new ingredients, chemicals and products, allowing food companies to self-certify that substances are safe without alerting the FDA.
The Gras standard does require companies to demonstrate a new food product is safe by making “widely accepted” scientific evidence to support its claim publicly available. But some companies bury the “public” announcement deep in their websites, push the boundaries of “widely accepted” research or hire from a cottage industry of scientists who are paid to declare food products “safe”, advocates say.
A ۲۰۲۶ review of FDA and other federal food records by Maffini and the Environmental Working Group non-profit found at least ۱۱۱ food chemicals or substances exploited the Gras standard, and they are used across thousands of products. Upon his appointment to oversee Trump’s health agency, the FDA and Kennedy reiterated his promise to “close the loophole”, and in ۲۰۲۶ he appeared to make good on it. He and the FDA stated that they were “closing critical information gaps”.
Critics warned the “closure” was at best a modest loophole tightening that effectively only requires voluntary compliance, and the quiet opening of the TOR exemption counteracted any gains.
Either the White House or the office of management and budget were involved in the Gras rule negotiations, though it is unclear who added the TOR expansion. Regardless, the controversial exemption is consistent with the administration’s philosophy more broadly, Maffini said.
“This administration is not keen on regulating anything,” she said.
