FDA May Allow Some Toxic Chemicals To Be Added To Food Without Safety Review

TL;DR

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An FDA proposal submitted to the Federal Register would expand the “threshold of regulation” exemption, potentially allowing some chemicals to be added directly to food without standard food-additive review. Health advocates say the proposal’s risk standard, treatment of cumulative exposure and lack of consumer disclosure could leave harmful substances unchecked; the FDA did not respond to The Guardian’s request for comment.

The Food and Drug Administration has proposed expanding a regulatory exemption that could allow some chemicals to be added directly to food without a food-additive safety review, according to a report by The Guardian. Public-health advocates warn that the proposal could cover chemicals they say may cause harm at very low exposures, while the FDA did not respond to the newspaper’s request for comment.

The exemption, known as the threshold of regulation (TOR), currently applies to certain substances used in food-contact materials, including packaging and processing equipment. Under the existing framework described in the report, a substance may qualify if it is not carcinogenic and its use results in exposure below 0.5 parts per billion. The proposed rule would extend the exemption to substances used directly in food, including as flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers and binders.

The proposal says a substance used directly or indirectly in food would be exempt from regulation as a food additive if there is “no appreciable risk to human health.” Advocates object to the proposal’s definition of “appreciable risk.” They also argue that a low level of exposure to one chemical may not account for repeated exposure to multiple substances, and that the proposal could allow certain carcinogens when they occur as impurities.

The Guardian reported that the TOR expansion was included in a proposed rule concerning the “generally regarded as safe” (GRAS) process. In August, Health Secretary Robert F. Kennedy Jr. and the FDA publicly described their efforts as “closing” a different regulatory loophole, but the report says their public statements did not mention the TOR provision. Advocates have criticized that omission; the source does not establish that officials intended to mislead the public.

Direct Ingredients Under the Exemption

The proposed expansion could change how some food chemicals reach the market: substances that now qualify for an exemption when used in packaging or equipment could potentially be used as ingredients in food. The report lists possible uses including flavorings, preservatives, emulsifiers and processing aids, but does not identify specific product categories that could be affected.

Advocates’ central concern is that the proposal’s “no appreciable risk” threshold may not capture every kind of harm. They point to possible effects on hormone systems, brain development, immunity and other bodily functions, and say a focus on individual exposure levels may miss the combined effects of several chemicals. Those are concerns raised by advocates, not findings established for every substance that might qualify.

The report also says consumers may have no way to identify products containing TOR-exempted chemicals. The practical impact will depend on the rule’s final wording, how the FDA applies it and which substances companies seek to use.

Perchlorate and the TOR Record

Advocates cite perchlorate, a chemical used in rocket fuel, as an example of concerns linked to the existing exemption. The report says that in 2005, BASF used TOR to exempt perchlorate for use in large polypropylene “super sacks” that store and transport grains. Advocates say material could break off as grain was loaded and emptied, contaminating food.

FDA data published in 2017 showed an increase in the number of sampled children’s cereals containing perchlorate after the exemption, as well as a broad increase in levels across samples, according to the report. The FDA later reapproved the use. The agency said there was no meaningful increase across the 250 foods it measured, while critics argued the cereal findings were not given adequate weight. The report says perchlorate can interfere with iodine uptake by the thyroid; it also cites research linking low exposure with reduced thyroid hormone production and lower IQ scores in children. Those links do not by themselves establish the effects of any particular exposure from cereal.

The TOR proposal surfaced alongside a separate effort to revise the GRAS process, under which ingredients can be treated as generally recognized as safe. The two processes are distinct. The news development is that the proposed GRAS rule reportedly also contains language that could broaden TOR; the source does not say the rule has been finalized.

““The FDA and industry have this position that if there’s only a little bit of something in the diet, then it’s not going to be problematic, but that isn’t supported by science of any kind.””

— Maricel Maffini, independent food consultant

How the Risk Test Would Work

The report does not provide the proposal’s complete text or a final decision. It does not give a public-comment deadline, so the timing of any comment period is not clear from the report.

It is also not clear which specific chemicals companies would seek to use under an expanded exemption, how the FDA would determine “no appreciable risk,” or what evidence it would require. Advocates list perchlorate, some phthalates, bisphenols, PFAS and flame retardants as substances of concern, but that does not establish that each would qualify under the proposal. The FDA did not respond to The Guardian’s request for comment, leaving the agency’s explanation of the proposal and its risk assessment unavailable in the supplied report.

Rulemaking and Agency Response

The source material does not specify the proposal’s procedural next steps or a timetable. It reports that the proposal could broaden the TOR exemption, but the rule’s status and any public-comment schedule are not stated.

Readers should watch for the full proposed text, the FDA’s explanation of its risk standard, and any response to concerns about cumulative exposure, impurities and consumer disclosure. Until the rule’s status and terms are confirmed, the proposal should not be treated as permission already granted for a particular chemical or product.

Key Questions

Has the FDA approved the expanded exemption?

The report describes a proposal, not a finalized rule. It does not provide a final approval or implementation date.

What does the threshold of regulation exemption cover now?

As described in the report, TOR currently applies to some substances used in food-contact materials, such as packaging and processing equipment, subject to specified conditions including low exposure and not being carcinogenic.

What would the proposed change allow?

It could extend the exemption to chemicals used directly in food, including as flavorings, preservatives, emulsifiers, processing aids and other ingredients, if they meet the proposed “no appreciable risk” standard.

Which chemicals are advocates worried about?

Advocates cited perchlorate, some phthalates, bisphenols, PFAS and flame retardants as examples of chemicals that may pose concerns at low exposure. The report does not establish that every listed chemical would qualify under the proposal.

Can consumers identify foods with TOR-exempted chemicals?

Advocates say there is no way for consumers to know whether a product contains a TOR-exempted chemical. The report does not describe a proposed labeling requirement.

Source: hn