The FDA Wants to Let Toxic Chemicals Into Food Without Safety Review — As Long As They Don't Cause Cancer

The carcinogen test was always the wrong question. Cancer is one category of harm. The human body has others.

The U.S. Food and Drug Administration is proposing to expand what it calls the "threshold of regulation" (TOR) exemption — a rule that already allows certain dangerous compounds to be used in food contact materials, such as packaging and processing equipment, without a safety review, provided they are not carcinogenic and appear at levels below 0.5 parts per billion. According to reporting by The Guardian US, the agency is now considering extending that exemption to allow some of the world's most toxic chemicals to be added directly to food itself — bypassing the review process entirely, so long as they clear the cancer bar.

The FDA is not merely expanding a loophole. It is institutionalizing a philosophy — that the only harm worth regulating is the one we can most easily measure. Cancer is a documented, litigable, politically legible harm. Neurological damage, endocrine disruption, reproductive toxicity, immunosuppression — these are harder to see in a courtroom, harder to trace to a single source, and, under this proposal, no longer the FDA's problem before a substance reaches your food.

The structure of the exemption matters. At 0.5 parts per billion, a chemical's concentration may sound negligible. But parts-per-billion thresholds are not reassuring for compounds that accumulate in tissue, that act on hormone receptors at vanishingly small doses, or that interact synergistically with other chemicals already present in a processed food supply. The science on low-dose effects in endocrine-disrupting compounds — a category that includes many industrial chemicals — has been unsettled and contested for decades, in part because the industries producing those compounds have funded the unsettling. A safety review would force that science into the open. The TOR exemption makes the review unnecessary.

That distinction — between a substance that has been reviewed and found safe, and a substance that has simply not been reviewed — is precisely what the FDA's credibility is supposed to rest on. The agency's foundational mandate, under the Federal Food, Drug, and Cosmetic Act, places the burden of demonstrating safety on the manufacturer before a substance enters the food supply. The TOR exemption inverts that burden. It creates a category of compounds that are presumed safe unless they cause cancer, without requiring the manufacturer to demonstrate anything else. Expanding that category to include substances added directly to food — not just materials that incidentally contact it — is a structural departure from the framework the agency was built on.

Food safety experts and public health advocates have raised alarms precisely because the non-carcinogenicity standard is not a safety standard — it is a single-axis exclusion. A compound can be highly toxic to developing nervous systems, disruptive to thyroid function, harmful to fetal development, and immunosuppressive while passing the cancer screen without difficulty. The history of chemical regulation in the United States is littered with substances that were declared safe under one criterion and later found to cause serious harm under criteria that weren't asked. PFAS compounds — now the subject of their own regulatory rollback at the EPA — were not initially flagged as carcinogens. They were flagged for other things, later, after decades of exposure.

Who benefits from a rule that eliminates pre-market safety review for chemicals added to food? Not consumers. Not the communities — disproportionately low-income and communities of color — who bear the highest body burdens of industrial chemical exposure because they live near production facilities, because they rely more heavily on packaged and processed foods, and because they have less access to healthcare that might catch the downstream effects. The beneficiaries of the TOR expansion are the chemical manufacturers and food producers who currently bear the cost, in time and money, of the review process the exemption would eliminate.

This is also a story about what gets defined as a food safety problem in the first place. The FDA's current framework draws a line between substances that contact food and substances that are added to it — a line that reflects both scientific judgment and legal architecture built up over decades. Erasing that line through an exemption expansion, rather than through rulemaking that would require full public comment, scientific review, and legal scrutiny, is a procedural choice as well as a substantive one. It is the kind of change that arrives quietly, gets noticed by specialists, and becomes embedded in the regulatory structure before the public understands what shifted.

The pattern is not new. Industry lobbying has repeatedly delayed or diluted FDA food safety rules, from traceability requirements to produce contamination standards, with the same basic argument: that the cost of compliance outweighs the risk of harm. That argument has a consistent flaw. It prices compliance costs in dollars and prices harm in uncertainty — and uncertainty, in regulatory capture, always wins. The TOR expansion operationalizes that logic by removing the review that would generate the data to resolve the uncertainty.

There is also a global dimension that domestic coverage of this proposal has largely missed. The United States is not an island in the global food system. American food safety standards — or the absence of them — affect what is exported, what trading partners accept, and what regulatory floor multinational food producers are held to internationally. The European Union operates under a precautionary principle that places the burden of proof on the producer to demonstrate safety before market entry, not after harm is documented. A U.S. rule that moves in the opposite direction — expanding categories of chemicals that require no review — creates downward pressure on international standards and gives global producers a regulatory arbitrage opportunity. What gets approved for the American market does not stay in the American market.

The people most exposed to the consequences of this proposal are not the people with the most power to contest it. Processed and packaged food consumption is highest among lower-income populations. Chemical exposure from food contact materials and additives accumulates unevenly across race and class lines, as documented in the environmental justice literature on body burden disparities. A rule that eliminates safety review does not eliminate harm — it eliminates the mechanism for detecting and preventing it before it reaches the people least equipped to absorb it.

The FDA's proposal is, in the agency's own framing, an efficiency measure. Reviews take time. Resources are constrained. The TOR exemption, extended, would reduce the regulatory burden on manufacturers and speed the path to market for compounds the agency has decided are probably fine.

That word — probably — is doing a great deal of work. The FDA was not built to decide that things are probably fine. It was built to decide that they are safe. Those are not the same standard, and the distance between them is where people get hurt.