The US Food and Drug Administration (FDA) is proposing to expand a regulation that would allow certain chemicals to be added to food without undergoing a safety review. This proposal focuses on the 'threshold of regulation' (TOR) exemption, which currently permits the use of hazardous compounds in food contact materials, such as packaging, if they are not carcinogenic and are present at levels below 0.5 parts per billion (ppb). Critics argue that many chemicals can be harmful at levels lower than 0.5 ppb, particularly hormone disruptors linked to developmental issues in children.
The proposed expansion would enable companies to incorporate these chemicals directly into food as flavorings, preservatives, and other additives. This follows a previous announcement by Robert F. Kennedy Jr. and the FDA regarding changes to the 'generally regarded as safe' (GRAS) standard, which has faced criticism for allowing potentially harmful ingredients into the market.
Public health advocates have raised concerns about the implications of the TOR expansion, warning that it could lead to increased levels of toxic chemicals in food products. They argue that the definition of 'appreciable risk' is problematic, as certain chemicals, while not classified as carcinogenic, can still pose health risks at low doses.
Maricel Maffini, an independent food consultant, expressed skepticism about the FDA's stance, stating that the belief that small amounts of harmful substances are safe is not supported by scientific evidence. The proposed rule states that any substance used in food will be exempt from regulation as a food additive if there is no appreciable risk to human health.
Concerns have also been raised regarding the cumulative effects of multiple small doses of TOR-exempted chemicals, which may pose health risks. The FDA has not provided a comment on the proposal. Critics, including Maria Doa from the Environmental Defense Fund, argue that the expansion of the TOR exemption does not enhance food safety.
The FDA's previous approval of perchlorate, a chemical linked to thyroid issues and brain development problems in children, has been cited as a warning regarding the risks associated with the TOR exemption. Despite evidence of increased perchlorate levels in children's cereal following its exemption, the FDA reapproved its use in grain storage bags.
Kennedy, who leads the Make America Healthy Again movement, has framed the issue of toxic chemicals in food as a critical concern in his presidential campaign. The GRAS standard, while requiring companies to demonstrate safety, has been criticized for allowing companies to self-certify the safety of substances without sufficient oversight.
A review by Maffini and the Environmental Working Group found that numerous food chemicals have exploited the GRAS standard, raising further concerns about regulatory oversight. Critics argue that the proposed changes to the TOR exemption reflect a broader trend of reduced regulation under the current administration.