The short answer
On October 22, 2026, FDA released Chapter 12 of its draft guidance Hazard Analysis and Risk-Based Preventive Controls for Human Food. It explains how food facilities should identify and control chemical hazards — heavy metals, PFAS, mycotoxins, pesticide residues, drug residues, unapproved additives and economic adulteration. Comments are due January 21, 2027 (docket FDA-2016-D-2343).
It is draft guidance, so it does not create new legal requirements. But it shows what FDA investigators will expect to see in a food safety plan — including at foreign facilities — and what FSVP importers will look for in their suppliers’ hazard analyses.
| Item | Detail |
|---|---|
| Document | Chapter 12, “Chemical Hazards”, of the Preventive Controls for Human Food draft guidance |
| Released | October 22, 2026 (Federal Register notice October 23, 2026) |
| Comment deadline | January 21, 2027 — docket FDA-2016-D-2343 on regulations.gov |
| Who it applies to | Facilities covered by the Preventive Controls for Human Food rule (21 CFR part 117), including foreign facilities that export to the U.S. |
Which chemical hazards FDA lists
- Environmental contaminants — heavy metals such as lead, arsenic and cadmium, and PFAS
- Natural toxins — mycotoxins (such as aflatoxin and DON) and plant toxins
- Unlawful pesticide residues
- Drug residues in foods from animals
- Unapproved food or color additives
- Chemicals added for economic gain (economic adulteration)
- Process- and facility-related chemicals
What FDA recommends
- 1Decide which hazards need a preventive controlConsider the food’s link to illness or recalls, your suppliers’ history, the formula, who eats the food (including babies and other vulnerable groups), past test results and how severe the hazard is.
- 2Avoid contaminated sourcesFor heavy metals, FDA recommends avoiding raw materials from areas known to be contaminated, where possible.
- 3Use supply-chain controlsFor baby and young-children foods where heavy metals are a hazard, FDA advises treating them as needing a supply-chain program as a preventive control.
- 4Test and monitorUse FDA pesticide monitoring data and pesticide import alerts; control mycotoxins through good farming, storage and processing, backed by testing.
- 5Check the legal status of every ingredientIncluding GRAS status and approved conditions of use for additives and colors.
The chapter includes worked examples for shelf-stable baby foods and dry infant rice cereal (heavy metals) and for a bakery controlling DON in wheat flour. On the same day, FDA also proposed cadmium action levels for processed foods for babies and young children.
Example: a rice cereal maker in Vietnam
A Vietnamese factory makes infant rice cereal for a U.S. brand. Under the draft guidance, its hazard analysis should identify arsenic, lead and cadmium as hazards, apply a supply-chain program for its rice suppliers (approved farms or regions, certificates of analysis, verification testing), and keep the records. The U.S. importer’s FSVP would then verify that program.
What exporters should do now
- Review your food safety plan against the hazard list above — especially heavy metals and pesticide residues, which are common causes of import alerts.
- Strengthen supplier controls for raw materials from regions with known contamination.
- Check every additive and color is permitted in the U.S. for your use. See the Red No. 3 ban and the GRAS proposal.
- Consider commenting by January 21, 2027 if the guidance would affect your products — for example if testing expectations are not practical for your supply chain.
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Frequently asked questions
When is the deadline to comment on FDA’s chemical hazards guidance?
January 21, 2027. Comments go to docket FDA-2016-D-2343 on regulations.gov.
Is the chemical hazards chapter mandatory?
No. It is draft guidance that describes FDA’s current thinking. The legal requirements remain in the Preventive Controls rule (21 CFR part 117), which already requires a hazard analysis that covers chemical hazards.
Does it apply to foreign food facilities?
Yes, to the extent those facilities are covered by the Preventive Controls rule. U.S. importers will also use it when reviewing foreign suppliers under FSVP.
Which chemical hazards get the most attention?
Heavy metals (especially in foods for babies and young children), PFAS, mycotoxins, pesticide and drug residues, unapproved additives and economic adulteration.
Sources
- Federal Register — Draft guidance availability notice, FR Doc. 2026-21669 (October 23, 2026)
- Covington — FDA releases Chapter 12 of draft guidance on preventive controls for chemical hazards (October 2026)
Dates and docket checked on November 11, 2026. This article is general information, not legal advice.