FDA adds a chemical-hazards chapter to its food-safety guidance

The Food and Drug Administration has released a new draft chapter of its long-running guidance on how food manufacturers should keep hazards out of the human food supply. In a Federal Register notice published on 23 October 2026, the agency announced the availability of "one additional draft chapter of a multichapter draft guidance for industry titled 'Hazard Analysis and Risk-Based Preventive Controls for Human Food'" [s1]. The new material is "Chapter 12: Control of Chemical Hazards" [s1].

The guidance supports a rule at the heart of the modern US food-safety system. It explains the agency's current thinking on how to comply with the regulation titled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food," codified at 21 CFR part 117 [s1]. That rule, one of the foundational regulations issued under the FDA Food Safety Modernization Act, requires many food facilities to analyse the hazards in their products and put written preventive controls in place to manage them.

What a preventive-controls framework requires

The preventive-controls approach shifted US food safety from reacting to contamination after the fact toward preventing it. Under part 117, a covered facility must identify the hazards that could occur in its food, decide which require a preventive control, and then design, monitor and verify controls to keep those hazards in check. The hazards fall into broad families — biological, physical and chemical — and the multichapter guidance walks manufacturers through each piece of that system.

Chemical hazards, the subject of the new chapter, are a distinct category from the microbes that cause foodborne illness. They include substances such as environmental contaminants, residues and other chemical agents that can end up in food during growing, processing, packing or holding. The draft Chapter 12 is titled "Control of Chemical Hazards" and is meant to help facilities work out when a chemical hazard requires a preventive control and how to manage it within the part 117 framework [s1].

A guidance built chapter by chapter over a decade

FDA has assembled this guidance gradually rather than publishing it all at once. The notice lists the chapters already made available, which span most of the past decade [s1]. The introduction and the first five chapters — covering the food safety plan, conducting a hazard analysis, potential hazards, preventive controls, and the application of preventive controls — were published in 2016, with the introduction later revised in 2024 [s1].

Other chapters followed over the years: a chapter on heat treatments as a process control in 2017, the supply-chain program chapter in 2018, a recall-plan chapter in 2019, and chapters on the food allergen program and on acidified foods in 2023 [s1]. The chemical-hazards chapter now joins that sequence, filling in another part of the compliance picture for a rule that has been in force for years but whose accompanying guidance is still being completed.

Draft status and comment period

The new chapter is a draft, not a finished document. FDA states plainly that "this draft guidance is not final nor is it in effect at this time" [s1]. As with its other guidance, the chapter, when finalised, would represent the agency's current thinking and would not be binding on FDA or industry; a facility may use an alternate approach that still satisfies the applicable statutes and regulations [s1].

FDA is taking public comment. The agency asks for comments by 21 January 2027 "to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance" [s1]. Comments may be submitted through the rulemaking docket, FDA-2016-D-2343, the same docket under which the earlier chapters were released [s2].

Why it matters

The audience for Chapter 12 is primarily the food industry and the professionals who design food safety plans, not consumers directly. But the guidance shapes the everyday machinery that keeps chemical contaminants out of packaged food. By spelling out how manufacturers should treat chemical hazards under the preventive-controls rule, FDA is trying to make the analysis more consistent across facilities — so that a chemical risk is identified and controlled during production rather than discovered later in a finished product.

The fixed points are modest but concrete: a new draft Chapter 12 on controlling chemical hazards, added to the human-food preventive-controls guidance under 21 CFR part 117, open for comment until 21 January 2027.