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The FDA has proposed expanding a “threshold of regulation” exemption so some substances added directly to food could avoid the usual food-additive review if the agency finds no appreciable risk. Public health advocates say the standard may fail to account for low-dose effects and combined exposures; the agency did not respond to The Guardian’s request for comment.
The U.S. Food and Drug Administration is proposing to expand an exemption that could let some substances be added directly to food without the usual food-additive safety review, according to a report by The Guardian. The proposal would broaden the existing “threshold of regulation” pathway, prompting public health advocates to warn that chemicals harmful at low levels could reach consumers with limited scrutiny.
The proposed rule says a substance used in food, whether directly or indirectly added, would be exempt from regulation as a food additive if there is “no appreciable risk to human health.” The existing threshold-of-regulation exemption applies to certain food-contact materials, such as packaging and processing equipment, under specified conditions. The proposed expansion would cover direct uses including flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers and binders, The Guardian reported.
The report says the existing pathway applies to compounds that are not carcinogenic and are present below 0.5 parts per billion. Advocates argue that this threshold does not resolve concerns about chemicals that may cause harm at lower exposure levels. They cite perchlorate, some phthalates and bisphenols, some PFAS and some flame retardants as examples of substances that could raise concerns, depending on their use and exposure.
The FDA did not respond to The Guardian’s request for comment. The report does not establish that any particular chemical has already been authorized for direct addition to food under the proposed expansion. Its effects would depend on the final rule, the agency’s interpretation of “no appreciable risk,” and which substances companies seek to use.
How the Exemption Could Affect Food Oversight
If adopted as described, the proposal could change which substances receive a formal food-additive review before use. That matters because consumers may have little ability to identify chemicals covered by the exemption: advocates say products would not necessarily disclose whether they contain a threshold-of-regulation substance.
Public health groups also question whether the proposed standard would account for cumulative exposure—many small amounts of different substances from multiple foods—and harms that may occur below the stated threshold. Those are advocates’ concerns, not findings that every chemical covered by the proposal would cause harm. The practical level of risk would depend on the substance, dose, food use and evidence the FDA considers.
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A Prior Exemption Involving Perchlorate
The Guardian points to a 2005 exemption involving perchlorate, a chemical used in rocket fuel, as an example of the existing pathway’s possible consequences. Chemical company BASF received an exemption for perchlorate in large polypropylene “super sacks” used to store and move grain. Advocates say particles could detach during loading and unloading and contaminate grain products.
FDA data published in 2017 showed an increase in the number of sampled children’s cereals with perchlorate after the exemption, as well as a broad increase in levels in individual 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; critics argued that the cereal findings deserved greater weight. The report says very low perchlorate exposure has been linked to reduced thyroid hormone production, which is relevant to brain development. The dispute illustrates competing interpretations of the data; it does not establish that the proposed rule will produce the same outcome.
The proposal is linked to a separate FDA effort concerning the “generally recognized as safe” (GRAS) process. In August, Health and Human Services Secretary Robert F. Kennedy Jr. and the FDA publicly described their action on that issue as “closing” a loophole. The Guardian reported that the proposed rule submitted to the Federal Register also contained the threshold-of-regulation expansion, which advocates say was not highlighted in those public statements.
““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, an independent food consultant who has worked on threshold-of-regulation issues
The Scope and Safety Test Remain Open
The source material does not specify the proposal’s comment period, final decision date or whether the FDA has published additional implementation details. It is also unclear how the agency would define “no appreciable risk,” what evidence it would require, or how it would evaluate low-dose and combined exposures.
The proposal does not, on the information reported, identify particular ingredients newly approved for direct use. Advocates say some chemicals with non-cancer health effects could qualify in theory; that is a warning about the potential scope, not confirmation that those chemicals will be exempted. The agency’s response and any detailed risk assessment were not available in the report.
FDA Rulemaking and Public Response
The next steps depend on the FDA’s rulemaking process. Readers should look for the proposal’s Federal Register notice, any public comment deadline and the agency’s responses to comments or revisions. Until the FDA clarifies the risk standard and the substances and uses that could qualify, the proposal’s practical reach remains uncertain.
Public health advocates are likely to press the agency on low-dose effects, cumulative exposure and consumer disclosure, while companies and other stakeholders may address how the exemption would apply to food ingredients and processing. The source does not report a final rule or a timetable for one.
Key Questions
What is the FDA proposing?
The proposal would expand the threshold-of-regulation exemption so that some substances added directly to food, as well as indirectly, could avoid regulation as food additives if the FDA’s stated “no appreciable risk to human health” test is met.
Does the proposal mean toxic chemicals have already been approved for food?
No. The report describes a proposal, not a final rule or a list of newly authorized ingredients. Advocates say some chemicals could qualify in theory, but the source does not confirm that any specific substance has been approved for direct use under the proposed expansion.
Why are public health advocates concerned?
They say some substances may cause harm at levels below the existing 0.5-parts-per-billion threshold, and that the proposal may not adequately address combined exposures. These are concerns raised by advocates; the risk depends on the chemical and its use.
What is the perchlorate example?
In 2005, an exemption allowed perchlorate in large grain-storage bags. FDA sampling later showed increased detection in children’s cereal, according to The Guardian. The agency said there was no meaningful increase across the 250 foods it measured, while critics said the cereal results warranted more attention.
What happens next?
The FDA’s rulemaking process would determine whether the proposal changes, is finalized or is withdrawn. The proposal’s comment timetable, final schedule and detailed application of the “no appreciable risk” standard are not specified in the source material.
Source: hn
