What Happened?

If you make, process, or sell food, the U.S. Food and Drug Administration (FDA) wants your input on a new draft guidance chapter covering chemical hazards, including lead, PFAS, pesticide residues, and natural toxins, with public comments due Jan. 21, 2027. The draft chapter, called Chapter 12: Control of Chemical Hazards, was released Oct. 23, 2026, according to a Legis1 review of FDA's preventive controls guidance series. ​

The draft explains how food companies can comply with existing FDA rules on hazard analysis and preventive controls, and it does not change any existing regulation. It covers:

  • Environmental contaminants: lead, cadmium, arsenic, dioxin, and PFAS
  • Pesticide and drug residues
  • Natural toxins and decomposition
  • Process-related contaminants: hazardous chemicals that can form during production
  • Unapproved food or color additives
  • Radiological hazards

Why Does it Matter to Me?

Food manufacturers get concrete examples from the draft on how to evaluate chemical hazards and choose practices or controls to minimize or prevent them, including supply-chain controls, according to reporting by Cheese Reporter.

Farmers and growers are not directly covered, but the Western Growers Association warns that buyers who must assess chemical hazards in raw ingredients may start asking growers questions about soil, water, and crop inputs, or request supplier testing. The guidance could ripple beyond food processors to the farms that supply them.

Chapter 12 is the first new draft chapter added to the series since Sept. 27, 2023, and the overall series has been in development since Aug. 24, 2016.

Both Sides, Now

FDA connects the draft to Executive Order 14212, "Establishing the President's Make America Healthy Again Commission," signed Feb. 13, 2025, stating the chapter helps improve understanding of regulations on controlling chemical hazards in food. The President signed that order, and Congress has not taken a separate vote to authorize this guidance effort.

A CDC report in the Morbidity and Mortality Weekly Report (MMWR) documented 566 cases of elevated blood lead levels tied to contaminated cinnamon-containing applesauce between November 2023 and April 2024. The Western Growers Association says it plans to prepare comments on the draft.

What Happens Next?

Comments are due Jan. 21, 2027, and can be filed electronically at regulations.gov under Docket No. FDA-2016-D-2343.

FDA says it will consider comments on costs or cost savings before developing the final version, and it intends to release additional chapters for public comment as they are completed. On Feb. 2, 2024, the FDA revised and republished the series introduction and Appendix 1 to address comments on its 2016 drafts. It later extended the comment period for both through Aug. 2, 2024.

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