The FDA is proposing to expand its "threshold of regulation" exemption — a mechanism that currently allows dangerous compounds into food-contact materials like packaging without safety review — to cover chemicals added directly to food as ingredients. Flavorings, preservatives, emulsifiers, stabilizers, enzymes, and processing aids would all qualify if they fall below 0.5 parts per billion and are not classified as carcinogenic. The proposal was buried inside a Federal Register filing that the administration publicly marketed as closing the separate "generally regarded as safe" (GRAS) loophole. The timing and packaging are the story. Robert F. Kennedy Jr. and the FDA announced in August 2026 that they were "closing critical information gaps" in the GRAS system — a centerpiece of Kennedy's Make America Healthy Again platform. What they did not publicize: the same rule that modestly tightens GRAS simultaneously opens TOR to direct food additives for the first time. Public health advocates, including scientists at the Environmental Defense Fund and the Environmental Working Group, call this a net expansion of industry's ability to bypass safety review. The science underlying the 0.5ppb threshold is the structural weakness. Endocrine disruptors — chemicals that interfere with hormonal systems — can cause harm at concentrations far below that threshold. Perchlorate, phthalates, bisphenols, PFAS, and flame retardants are all non-carcinogenic compounds that would technically qualify for TOR exemption. The rule's standard of "no appreciable risk to human health" does not account for endocrine disruption, cumulative exposure across multiple TOR-exempt chemicals, or vulnerable populations like children. The perchlorate case is the precedent that makes advocates' alarm concrete. In 2005, BASF used TOR to exempt perchlorate — a rocket fuel chemical — for use in polypropylene grain storage bags. The FDA's own 2017 data showed perchlorate contamination in kids' cereal increased after the exemption, both in the number of contaminated samples and in concentration levels. Perchlorate suppresses thyroid function and iodine absorption, which are essential for brain development. Lower T4 production is linked to lower IQ scores in children. The FDA reapproved the exemption six months after publishing its own data showing the contamination increase. The proposed expansion creates a compounding problem. One TOR-exempt chemical at sub-0.5ppb may not trigger acute harm. But ultra-processed foods routinely contain dozens of additives, and the rule has no mechanism for assessing cumulative exposure. The rule also creates a secondary loophole: carcinogens can qualify if they appear as impurities in a non-carcinogenic substance. And consumers have no way to identify TOR-exempt chemicals on labels. The regulatory architecture here is familiar: announce a visible reform while quietly expanding an adjacent pathway that serves the same industry interests. The GRAS tightening — which critics note only requires voluntary compliance — gets the press release. The TOR expansion gets a Federal Register filing. Either the White House or the Office of Management and Budget was involved in the rule negotiations, though it remains unclear who added the TOR language. Independent food consultant Maricel Maffini, who has worked on TOR issues, summarized the broader pattern: "This administration is not keen on regulating anything." The structural outcome is a food safety regime that increasingly relies on industry self-certification at thresholds that do not reflect current science on endocrine disruption, cumulative exposure, or pediatric vulnerability. A 2026 review by Maffini and the Environmental Working Group found at least 111 food chemicals exploited the existing GRAS standard across thousands of products. TOR expansion gives industry a second, parallel track to avoid review — one with even less visibility and no public notification requirement.
