FDA adds draft Chapter 12 on chemical hazards to its preventive controls guidance
Key facts
- Type / category
- Standard / Guidance
- Status
- Draft for comment
- Agency
- FDA
- Source date
- Comment deadline
- Sectors
- Food
- Standards
- Reference
- FR Doc 2026-21669
On October 23, 2026, FDA announced a new draft chapter of its multichapter draft guidance Hazard Analysis and Risk-Based Preventive Controls for Human Food (docket FDA-2016-D-2343). The new chapter, Chapter 12: Control of Chemical Hazards, applies to food facilities covered by the preventive controls requirements in 21 CFR part 117. FDA asks for comments by January 21, 2027 so they can be considered before work on the final version begins.
According to the notice, the chapter covers chemical hazards including radiological hazards, pesticide and drug residues, natural toxins, decomposition, unapproved food and color additives, environmental contaminants such as lead, cadmium, arsenic, dioxin and PFAS, and hazardous chemicals that can form during processing. It joins other chapters of the same draft guidance that FDA has released since 2016.
This is guidance, which isn't legally binding. It describes the agency's current thinking.
What it means for labs
This chapter is about chemical hazards, not microbiology, but food clients updating their hazard analysis may revisit their whole food safety plan, including testing and environmental monitoring. Facilities that want a say can comment by January 21, 2027.
Who it affects
Food facilities covered by FDA's preventive controls rule and the people who write their food safety plans
Sources
This summary is for general information and may not reflect later changes. Always check the official source linked above. It isn't legal or regulatory advice, and Micro-Core Consulting isn't affiliated with the agencies or standards bodies named.