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A proposed FDA rule would expand the threshold-of-regulation exemption, which can allow certain substances in food without the usual food-additive review, to include chemicals added directly to food. Public health advocates warn the proposal’s risk standard may not account for low-dose, cumulative or non-cancer harms; the FDA has not responded to a request for comment.
The Food and Drug Administration is proposing to expand a regulatory exemption that could let companies use some substances directly in food without the usual food-additive review, according to a Guardian report published October 10. Public health advocates say the proposal could cover chemicals that may cause harm at low doses, while the FDA’s proposal describes the exemption as applying where there is “no appreciable risk to human health.”
The exemption, called the threshold of regulation or TOR, currently applies to certain substances used in food-contact materials, such as packaging and processing equipment. The report says the existing pathway is available when a substance is not carcinogenic and is present at levels below 0.5 parts per billion. The proposed expansion would cover substances added directly to food, including as flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers and binders.
The FDA proposal states that a substance used directly or indirectly in food would be exempt from regulation as a food additive if it poses “no appreciable risk to human health.” Advocates question how that standard would be defined and say it may not capture harms that occur below the stated concentration threshold, including effects that are not cancer-related. The Guardian reported that the FDA did not respond to its request for comment.
The report identifies perchlorate, some phthalates, some bisphenols, some PFAS and some flame retardants as examples of chemicals advocates say could qualify in theory, depending on how the proposal is applied. That does not establish that these substances have been approved for direct addition to food under the proposed expansion. The rule’s scope and the substances that could ultimately use it remain subject to the regulatory process.
Direct-Addition Exemption Raises Safety Questions
The proposal could change the point at which a substance is subject to FDA review: instead of being limited to materials that contact food, the TOR pathway could cover substances used as ingredients or processing aids. That matters to consumers because the proposed categories include common functions in processed foods, while the report says there would be no way for shoppers to identify whether a product contains a TOR-exempted substance.
Advocates also argue that a low concentration does not by itself establish safety, especially where people may encounter multiple substances over time. They say the proposal does not adequately address cumulative exposure or non-cancer outcomes such as effects on the nervous system, immune system or hormone regulation. Those are concerns raised by critics, not findings established by the proposal itself.
The dispute is also relevant to the administration’s separate effort to change the “generally recognized as safe” (GRAS) process. The Guardian reports that public statements in August described the administration as closing a different regulatory loophole, while the proposed rule submitted to the Federal Register also included the TOR expansion. The difference between those public statements and the text of the proposal has prompted criticism from advocates.
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Perchlorate and the Existing TOR Pathway
The report points to perchlorate as an example of concerns about the existing, narrower exemption. In 2005, chemical company BASF used TOR to exempt perchlorate for use in large polypropylene “super sacks” used to store and move grains. Perchlorate prevents grains from sticking to the bags. Advocates say friction and handling could cause the chemical and plastic particles to break off and enter the grain.
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 the samples, according to the report. Six months after publishing that data, the agency reapproved the use in super sacks. The FDA’s position, as described in the report, was that it found no meaningful increase across the 250 foods it measured. Critics argued that this overall analysis obscured the cereal findings. The source does not provide enough detail to independently resolve that disagreement.
Perchlorate can interfere with the thyroid’s uptake of iodine, which is needed to produce thyroid hormone involved in brain development. Advocates cite potential developmental concerns from exposure. The report says litigation challenging the exemption was ultimately dismissed; it does not establish that the proposed direct-food expansion would itself authorize perchlorate as an ingredient.
“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 who has worked on TOR issues
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Scope and Risk Standard Remain Unclear
The report does not specify the proposal’s publication date in the Federal Register, the deadline for public comments, or the next step in the rulemaking. It is also unclear how FDA would define and measure “no appreciable risk”, which substances companies might seek to exempt, or what evidence would be required for an exemption.
Advocates say the proposal fails to account for combined exposure to multiple chemicals and for harms that are not classified as cancer. The source describes these as criticisms; it does not include a full FDA scientific assessment or enough detail to determine how the agency would evaluate those outcomes. It also reports that the proposal could create a secondary loophole for carcinogens formed as impurities, but provides no further detail about its scope or operation.
It remains uncertain whether the proposed rule will be finalized in its current form. The FDA’s response to the report’s request for comment was not available, and no agency explanation of the proposal’s scientific basis is included in the supplied material.
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Federal Rulemaking Will Set the Terms
The next developments depend on the formal rulemaking record: publication of the proposed rule, any public-comment period, FDA responses to comments and possible revisions before a final rule. The source material does not give a timetable, so no effective date or final decision can be confirmed.
Readers seeking to assess the proposal should watch for the rule’s exact definitions, the evidence FDA requires to show “no appreciable risk,” and whether the agency addresses low-dose and cumulative exposure. Any final decision on the exemption’s scope would clarify whether and how the pathway could apply to directly added food substances.
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Key Questions
What is the FDA proposing?
The reported proposal would expand the threshold-of-regulation exemption from certain food-contact uses to substances added directly to food, including some flavorings, preservatives and processing aids.
Does the proposal approve specific toxic chemicals for use in food?
The source does not say that specific chemicals have been approved for direct addition under the proposal. It says several chemical groups could qualify in theory, depending on how the exemption is applied.
What does “no appreciable risk” mean?
The proposal uses the phrase as its stated safety standard, but the supplied report does not explain how FDA would define or measure it. Advocates say its application to low-dose and non-cancer harms is unclear.
Can consumers tell whether food contains a TOR-exempted substance?
Advocates cited in the report say there is no way for consumers to know whether a product contains such a substance. The source does not provide details about any proposed disclosure or labeling requirements.
When will the FDA decide?
The supplied material gives no rulemaking timetable, comment deadline or final decision date. The proposal’s status and next milestones will depend on the formal federal rulemaking process.
Source: hn
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