A regulatory agency created to protect Americans from unsafe food is now moving in the opposite direction. The US Food and Drug Administration has put forward a proposal that would expand an existing loophole, allowing some of the most dangerous chemical compounds ever identified to be incorporated into the food supply without any formal safety review. For the millions of Americans who assume that what reaches their dinner table has been vetted by federal scientists, the proposal raises fundamental questions about who, exactly, the agency is protecting.
FDA Proposes Expanding Loophole for Toxic Chemicals in Food
At the center of the controversy is a regulatory mechanism called the "threshold of regulation," or TOR, exemption. As it currently stands, this provision allows dangerous compounds — chemicals that would otherwise require rigorous pre-market safety review — to be used in food contact materials such as packaging films, storage containers, and food processing equipment. The exemption applies so long as two conditions are met: the substance in question is not classified as a carcinogen, and it is present at or below a concentration of 0.5 parts per billion.
To understand what 0.5 parts per billion actually represents, consider this: one part per billion is roughly equivalent to a single drop of water dissolved in an Olympic-size swimming pool. The threshold sounds vanishingly small. But in the world of FDA toxic chemicals food safety regulation, concentration alone does not determine risk. Certain classes of compounds — endocrine disruptors, neurotoxicants, and persistent organic pollutants — can trigger measurable biological effects at concentrations far lower than what the TOR exemption currently permits. The emerging science of low-dose toxicology has, over the past two decades, repeatedly challenged the traditional assumption that "the dose makes the poison."
The FDA's new proposal would push this further. Rather than limiting the exemption to food contact materials, the agency is seeking to extend it to chemicals added directly to food itself. That is a categorical shift. A substance migrating in trace amounts from a plastic wrapper into food is a different regulatory problem than a substance intentionally introduced into the food supply at the point of manufacture.
Which Chemicals Could Enter the Food Supply Under This Rule
The scope of the proposed expansion is not limited to obscure industrial compounds. The TOR exemption, as currently written, already covers substances that independent toxicologists describe as among the most hazardous ever synthesized. Heavy metals, halogenated organic compounds, and certain pesticide-adjacent chemicals fall within the categories that could, in principle, qualify for the exemption as long as they clear the non-carcinogenic and sub-0.5-ppb hurdles.
Read next Medicaid Work Requirements Strand Cancer SurvivorsThe non-carcinogenicity requirement sounds like a meaningful filter. It is not. The FDA's classification of a substance as non-carcinogenic does not mean it is safe. Thousands of industrial chemicals affect neurological development, disrupt hormone systems, impair immune function, or accumulate in body tissue over time — none of which are captured by a cancer-only screening criterion. Under the proposed expansion, a compound with well-documented neurotoxic or reproductive toxicity could still qualify for the exemption, provided it does not cause tumors in animal studies.
What makes this particularly consequential is the question of aggregate exposure. A single food product with a chemical present at 0.4 ppb may seem inconsequential in isolation. Americans, however, consume dozens of processed and packaged products daily across a lifetime. Regulatory analyses that examine chemicals in isolation consistently underestimate cumulative body burden — the total load that accumulates from multiple simultaneous exposures across food, water, and consumer products.
Public Health Implications of Bypassing Safety Reviews
The formal safety review process that the TOR exemption sidesteps is not bureaucratic theater. It requires manufacturers to submit toxicological data, exposure estimates, and scientific literature for independent evaluation by FDA scientists. That review — imperfect as critics rightly note it to be — creates a public record, allows third-party scrutiny, and can be revisited as new science emerges. Bypassing it eliminates all of those safeguards simultaneously.
Children, pregnant women, and immunocompromised individuals represent populations for whom chemical exposure at any level carries elevated risk. The National Toxicology Program and peer-reviewed research published in journals including Environmental Health Perspectives have documented that early-life exposures to even low concentrations of certain synthetic chemicals can alter developmental trajectories in ways that do not manifest until years or decades later. Standard toxicological screening, which evaluates acute effects in adult animal models, is poorly designed to capture these outcomes.
The FDA's own docket data over the past fifteen years reflects hundreds of substances that were initially deemed safe under existing loopholes and later required re-evaluation as evidence of harm emerged. Bisphenol A, phthalates, and perfluoroalkyl substances — the so-called PFAS "forever chemicals" — all entered the food system under regulatory frameworks that prioritized manufacturer convenience over precautionary principle. Each required years of advocacy and litigation before the FDA took corrective action.
Criticism From Scientists and Consumer Advocates
The scientific community's response to the proposed TOR expansion has been pointed. Toxicologists who specialize in environmental health have long argued that the existing TOR exemption represented the outer boundary of defensible regulatory risk tolerance — not a starting point for further loosening. Expanding it to cover direct food additives, in the view of many researchers, crosses a line that the original framework was never designed to approach.
Food safety attorneys and public health advocates have drawn attention to the structural problem underlying the proposal: the FDA, like many regulatory agencies, does not conduct its own independent chemical safety testing. It evaluates data submitted by manufacturers seeking approval. When an exemption eliminates the submission requirement entirely, the agency loses its primary mechanism for identifying hazards before they reach consumers. The burden of proof, effectively, shifts from industry to the public — harm must be demonstrated after the fact rather than prevented in advance.
Consumer advocacy organizations have noted that the proposed expansion arrives at a moment of broader deregulatory pressure on federal food oversight. The FDA's Generally Recognized as Safe, or GRAS, designation — which allows companies to self-certify that their ingredients are safe without mandatory FDA notification — has been criticized by the Government Accountability Office and academic researchers for creating systematic gaps in oversight. The TOR expansion, critics argue, compounds those gaps rather than addressing them.
Environmental health scientists have also flagged the enforcement challenge. At concentrations below 0.5 ppb, independent verification of compliance is analytically difficult and expensive. Routine food safety monitoring programs are not calibrated to detect substances at sub-ppb levels across a broad range of chemical classes, meaning the exemption would be largely self-policing.
What This Means for Food Regulation in the US
The FDA's proposal reflects a structural tension that has defined American food regulation for decades: the agency is simultaneously responsible for facilitating commerce and protecting public health, and those mandates do not always align. The TOR expansion is, at its core, a concession to the second mandate in favor of the first.
What is unusual about this particular moment is the breadth of the proposed change. Previous expansions of regulatory exemptions have typically been incremental, limited to specific chemical classes or end-use categories. Extending TOR to cover direct food additives is qualitatively different — it signals a willingness to treat the food supply itself as a domain where pre-market safety review is optional.
For American consumers, the practical implication is a food system in which an expanded category of toxic compounds can enter products on grocery store shelves without any federal scientist having reviewed the evidence, without any public docket where that review could be scrutinized, and without any requirement that manufacturers disclose which substances they are using or at what concentrations. The 0.5 ppb threshold will remain the nominal ceiling. But a ceiling only matters when someone is measuring.
Whether the FDA proceeds with the proposal will depend on the outcome of the public comment period and the political calculus of an agency navigating competing pressures. What is already clear is that the proposal has fundamentally altered the terms of the debate about FDA toxic chemicals food safety oversight — and that the outcome will have consequences for every American who eats.
Source: Society | The Guardian
