The U.S. Food and Drug Administration has proposed new rules governing food additives. Some of the changes appear reasonable, but one provision could allow very small doses of toxic chemicals to be used in foods without a safety review. According to a report from The Guardian, the proposed regulation will “expand a controversial loophole to allow some of the world’s most toxic chemicals to be added directly to food without a safety review.” The agency’s document contains two other, seemingly sensible measures alongside the controversial addition, which appears to have been inserted with little explanation.
Expanding the Threshold of Regulation
The first of the reasonable changes adds a notice requirement. Companies must now notify the FDA when using an exemption from review known as GRAS, or Generally Regarded as Safe. The agency estimates that there may be around a thousand substances that companies are classifying as GRAS, yet it lacks a complete inventory of these items or the companies using them. Requiring notice would allow the FDA to monitor the situation and intervene when necessary. This step falls short of the stricter crackdown on GRAS additives promised during the last presidential campaign, but it represents a basic level of oversight.
The other two changes relate to the TOR, or Threshold of Regulation. Currently, the FDA considers any amount of a substance below 0.5 parts per billion to be harmless. The proposal lowers this threshold to an estimated daily intake of 0.025 micrograms per kilogram of body weight per day. Even if a substance falls below this level, the FDA retains the right to object if other health concerns exist. The agency argues that restating the standard in micrograms rather than parts per billion makes it more responsive to differences between population subgroups. On its face, this shift seems acceptable, provided the agency has performed the calculations correctly.
However, the third change—expanding the TOR exemption to cover food additives rather than just substances that merely contact food—raises more serious questions. The FDA offers no evidence to support the new numerical level or to prove that extending the exemption to food contents presents no risks. Experts quoted by The Guardian believe the proposed threshold is too high for certain substances.
Rather than extending the exemption to new uses, the agency should lower the threshold for some chemical types. The proposal also fails to explain why the previous TOR process was limited to incidental exposures like packaging. If the number of exempted substances increases from around 150 to 1500, the cumulative effect of a “toxic cocktail” could have a significant health impact, even if no single exemption poses a significant risk on its own.
Procedural Concerns Over Exemption Transparency
Under the draft rule, a company files a request for an exemption and, if granted, the agency posts a notice of that specific use. That notice becomes the de facto rule for any other producer wishing to employ the same substance.
Instead, the public would need to file a Freedom of Information Act request to see the supporting data. Agencies often redact trade-secret information, leaving only limited details accessible. This process can delay scrutiny for months, reducing the chance for timely objections.
Because the exemption list is posted online, opponents may eventually learn of a new use, but they would lack the background needed to assess safety. The draft rule therefore sidesteps standard rulemaking safeguards that normally ensure broader stakeholder input.
Potential Public Health Impact of Expanded Exemptions
Expanding the threshold exemption to cover food additives means that substances previously limited to packaging contact could now appear directly in consumable products. The agency has not presented data demonstrating that the proposed exposure level is safe for all chemical classes.