TL;DR
Get oils, diffusers and self-care delivered free with Prime
- Fast, free delivery on millions of items
- Prime Video, Amazon Music and more included
- Member-only deals all year
The FDA has proposed broadening its “threshold of regulation” exemption so certain substances could be added directly to food without the usual food-additive review if the agency finds no appreciable risk to human health. Public health advocates say the proposal’s risk standard may not address chemicals that can cause harm at very low doses or the combined effects of multiple exposures. The FDA did not respond to the Guardian’s request for comment, and the proposal’s final terms and fate are not established in the supplied reporting.
The Food and Drug Administration has proposed expanding an existing exemption that could allow some chemicals to be added directly to food without standard food-additive review, according to a Guardian report published October 10. The proposal would extend the “threshold of regulation” pathway to uses including flavorings, preservatives and processing aids; public health advocates warn that the approach may not account for chemicals that can have effects at very low doses.
Under the current threshold of regulation (TOR) exemption, certain compounds used in food-contact materials, such as packaging or processing equipment, may avoid food-additive regulation if they are not carcinogenic and are present below 0.5 parts per billion, the Guardian reported. The proposed expansion would cover substances used as ingredients added directly to food, including flavorings, preservatives, emulsifiers, processing aids, enzymes, stabilizers and binders.
The proposal’s stated test is whether use of a substance presents “no appreciable risk to human health,” according to language quoted in the report. The central dispute is how the FDA would define and assess that risk. Advocates say a threshold based on small quantities may miss hazards that occur below the existing concentration level, as well as the effects of repeated exposure to several different substances.
The proposal was included in a rulemaking package concerning the separate “generally recognized as safe” (GRAS) system, the report said. It was not mentioned in public materials issued by Health and Human Services Secretary Robert F. Kennedy Jr and the FDA in August when they said they were acting to close the GRAS loophole. The Guardian said the FDA did not respond to its request for comment. The supplied reporting does not establish that the proposed expansion has been adopted or that any specific new chemical use has been approved under it.
A Wider Route Around Additive Review
If adopted, the change could affect how some food ingredients reach the market by extending TOR beyond indirect contact through packaging or equipment to uses inside food itself. That could include substances serving functional roles such as preserving, binding or flavoring products. The proposal’s reach matters because consumers generally cannot identify a TOR-exempted substance from product labels, according to the report.
Advocates argue that the proposed standard may not adequately address low-dose effects and combined exposure. The report cites concern about endocrine-disrupting chemicals, which may affect hormone systems, as well as neurotoxic and immune-system effects. These are advocates’ warnings about potential hazards, not findings that every substance eligible for an exemption causes harm at the proposed levels.
The issue also bears on the administration’s food-safety claims. Critics say a public announcement about changes to GRAS could leave an incomplete impression if the same rule package expands another route for avoiding review. Whether the proposal changes consumer risk will depend on its final wording, the evidence used to evaluate each substance and how the FDA applies the “no appreciable risk” test.
As an affiliate, we earn on qualifying purchases.
The Perchlorate Exemption Dispute
The Guardian report describes a prior TOR exemption involving perchlorate, a chemical used in rocket fuel, in polypropylene “super sacks” used to transport grain. BASF obtained an exemption in 2005 for that use, the report said. Advocates contend that material could break off as grain was loaded and emptied, contributing to contamination of foods made from 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 among samples, according to the report. The FDA later reapproved the use. The agency’s stated conclusion, as described by the Guardian, was that there was no meaningful increase across the 250 foods measured. Critics said that overall result obscured the cereal findings.
Perchlorate can interfere with the thyroid’s uptake of iodine, which is needed to produce thyroid hormone involved in brain development. The report says low-level exposure has been linked to lower production of the hormone T4 and lower IQ scores in children. Those cited associations and the interpretation of the FDA data form part of the advocates’ case against the earlier exemption; they do not by themselves establish that the proposed rule will produce the same outcome.
“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 worked on TOR issues
As an affiliate, we earn on qualifying purchases.
How the FDA Would Define Risk
The report does not provide the complete proposed rule text, a full explanation of the scientific method the agency would use, or the exact substances and uses that would qualify. It is also unclear whether the exemption would apply automatically when companies meet a specified test or whether the FDA would evaluate individual cases, and what evidence companies would need to submit.
Advocates say the proposal does not adequately address cumulative exposure from multiple chemicals or a secondary pathway for carcinogens that arise as impurities. The supplied report presents those as concerns about how the proposal is written; it does not establish that such uses have been approved under an expanded exemption.
The current status also needs distinction: the reported development is a proposal, not a confirmed final rule. The article says the FDA did not respond to a request for comment. No final decision date, implementation schedule or outcome of public input is established in the supplied material.
As an affiliate, we earn on qualifying purchases.
Rulemaking and Public Response
The next clear milestone is the FDA’s handling of the proposed rule through the federal rulemaking process. Readers should look for the complete text, any public-comment period and the agency’s responses to concerns about low-dose effects, cumulative exposure and the treatment of impurities. The source material does not specify when those steps will occur.
Any final version could clarify which chemicals and food uses are eligible, what evidence is required, and how the FDA will interpret “no appreciable risk.” Until the agency issues a final decision or further details, the proposal should not be treated as a blanket authorization for toxic chemicals to be added to food.
As an affiliate, we earn on qualifying purchases.
Key Questions
What is the FDA proposing?
The proposal would expand the threshold of regulation exemption so some substances used directly in food could be exempt from food-additive regulation if the FDA’s stated “no appreciable risk to human health” condition is met. The Guardian report describes possible uses such as flavorings, preservatives and processing aids.
Does the proposal mean toxic chemicals are already being added to food under the expanded rule?
No. The supplied reporting describes a proposal, not a final rule or confirmed approvals under an expanded exemption. The substances and uses that could qualify have not been specified in the material provided.
What is the threshold of regulation exemption?
TOR is an existing pathway for some compounds used in food-contact materials, including packaging or processing equipment, to avoid food-additive regulation under specified conditions. The report says the proposal would extend that pathway to certain direct uses in food.
Why are public health advocates concerned?
Advocates say some chemicals may have health effects at very low doses, and that evaluating substances one at a time may overlook combined exposure. They also point to the perchlorate exemption as a warning, though the interpretation of the FDA’s data and the risks of the earlier use have been disputed.
When will the FDA make a final decision?
The supplied report does not give a final decision date or implementation schedule. The proposal’s status and next rulemaking steps remain unclear.
Source: hn
Columbus Day / Indigenous Peoples' Day Picks
long weekend sales
As an affiliate, we earn on qualifying purchases.
