The US Food and Drug Administration is proposing to expand the “threshold of regulation” (TOR) exemption, a controversial loophole that would allow toxic chemicals to be added directly to food without a safety review, according to the proposal submitted to the Federal Register.
Currently, the TOR exemption permits dangerous compounds to be used 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). The proposed expansion would allow companies to use these chemicals as direct food ingredients—functioning as flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers, and binders—without the same restrictions.
Public health advocates argue the expansion is based on flawed science. Many chemicals, particularly hormone disruptors linked to brain damage and reproductive harm in children, are considered dangerous at levels far below 0.5ppb. Maricel Maffini, an independent food consultant who worked on TOR issues, stated: “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.”
The proposal defines exempted substances as those posing “no appreciable risk to human health.” Critics say the problem lies in defining “appreciable risk.” Chemicals like perchlorate, some phthalates, bisphenols, “forever chemicals” (Pfas), and flame retardants are not classified as carcinogenic but can cause harm at doses far lower than 0.5ppb, potentially qualifying for TOR exemption despite their health impacts.
Perchlorate provides a cautionary example. In 2005, BASF used TOR to exempt perchlorate for use in grain storage bags. The FDA’s 2017 data showed the number of samples of children’s cereal containing perchlorate increased after the exemption. Perchlorate reduces the thyroid’s ability to absorb iodine, essential for proper brain development, and low-level exposure is linked to lower IQ scores in children. Despite publishing this data, the FDA reapproved perchlorate six months later.
The expansion also creates concerns about cumulative effects—one small dose of a TOR-exempted chemical may be harmless, but multiple small doses of various toxic chemicals could pose problems. Additionally, the rule allows carcinogens if they are created as impurities and provides no consumer labeling requirement for TOR-exempted chemicals.
Maria Doa of the Environmental Defense Fund said: “They’re widening another loophole, but trying to say they made our food safer. They did not make our food safer.” The FDA did not respond to requests for comment.
Key facts
- The FDA is proposing to expand the TOR exemption to allow toxic chemicals to be added directly to food as ingredients without safety review
- Current TOR exemption permits dangerous compounds in food contact materials if not carcinogenic and below 0.5 parts per billion
- Public health advocates argue many chemicals are dangerous at levels far below 0.5ppb, including hormone disruptors linked to brain damage in children
- Perchlorate, approved under TOR in 2005 for grain storage bags, increased in children’s cereal samples and is linked to lower IQ scores
- The proposal lacks provisions for cumulative effects of multiple toxic chemicals and offers no consumer labeling requirements for TOR-exempted chemicals