FDA Releases New Chemical Hazards Guidance and Will Host a Webinar on November 16th

On October 22nd FDA released a new draft guidance on how food companies should find and control chemical hazards, plus draft limits for cadmium in foods for babies and young children. FDA will walk through both in a webinar on Monday, Nov. 16, from 10 am to 11 am CA Time, 11 am to 12 pm Arizona Time

Register: FDA webinar registration

What Is This, In Simple Terms?

Food facilities must write a food safety plan that starts with a hazard analysis: what could happen with each food they make, pack, or hold. Chapter 12, is FDA's new how-to for the chemical hazards, covering which chemicals are a concern and what to do about them.

Separately, FDA proposed cadmium action levels, which are benchmarks for how much cadmium in processed baby and toddler foods is a concern. FDA considers them achievable with control measures. Both are part of Closer to Zero, FDA's effort to reduce children's exposure to heavy metals (arsenic, cadmium, lead, and mercury).

Where It Stands and How to Comment

Both documents are drafts. Neither is final or carries out the force of a requirement, and FDA says its inspectors are not yet using Chapter 12 for enforcement. Comments go to regulations.gov:

• Chapter 12: due Jan. 21, 2027, docket FDA-2016-D-2343

• Cadmium action levels: due Dec. 22, 2026, docket FDA-2025-D-4023

Western Growers will be preparing comments for both documents. If you have any inquiries, please reach out to the science team [email protected]

What Does This Mean For Growers?

These draft documents do not directly affect farms. The food safety plan requirement applies to registered food facilities, not farms, and the cadmium levels are for manufacturers of processed baby foods. But the buyers of your crops must evaluate chemical hazards in raw ingredients, and FDA notes that crops can absorb trace heavy metals from where they are grown. Growers may see:

• Buyer questions about the soil, water, and inputs behind a crop, especially for infant and toddler products (carrots, spinach)

• Supplier specifications or testing requests tied to contaminant levels

• Uncertainty about what level to meet when FDA has not set one

More Detail on the Drafts

Chemical hazards guidance (Chapter 12)

Chapter 12 explains how food facilities should find and control chemical hazards under the preventive controls rule, with practical examples across many hazards.

• Which chemicals: environmental contaminants (arsenic, cadmium, lead, dioxins, PFAS), natural toxins such as mycotoxins, pesticide and animal drug residues, unapproved additives, and economically motivated adulteration. The FDA says contamination can happen at any stage.

• Deciding if a control is needed: facilities look to FDA contaminant and action levels, then weigh what is known about the hazard, the food and its ingredient sources, and how likely and serious the harm would be. When FDA has no level, the international Codex standard (CXS 193-1995) can serve as a guide.

• Example controls: sorting out affected material (mycotoxins in nuts and grains) or extra processing (glycidyl esters in refined oils).

• Supply-chain controls: when a hazard is present before an ingredient reaches the facility, the facility can control it through its suppliers.

• Proving that controls work: the chapter covers validating a control (using credible scientific information and, where needed, data from actual operations) and verifying it over time, such as calibrating monitoring instruments, product testing, and regular record review by a qualified person.

Cadmium action levels (baby and toddler foods)

• What it is: draft guidance proposing action levels for cadmium in processed foods for babies and young children (under 2). It is meant to help manufacturers lower cadmium in these products.

• Proposed levels: 10 ppb for most fruits, vegetables, and mixtures, and 45 ppb for dry infant cereals. FDA considers the levels achievable when manufacturers use control measures.

• How it connects: FDA says Chapter 12, once final, may help companies reduce heavy metal levels and better meet Closer to Zero action levels.

Resources

• FDA: Webinar on Closer to Zero Updates Including Cadmium Action Levels

• FDA Constituent Update: FDA Advances Closer to Zero Initiative

• FDA: PCHF Draft Guidance, Chapter 12 (Control of Chemical Hazards)

• FDA: Closer to Zero

• Guidance for Developing Best Management Practices to Reduce Cadmium Uptake by Spinach

• WGA: Cadmium and Fresh Produce Fact Sheet

• Research Article Reviews Cadmium Mitigation Strategies in Spinach and Carrots