FDA Releases Chapter 12 of Draft Guidance on Preventive Controls, for Chemical Hazards

On October 22, 2026, FDA released Chapter 12 of its draft guidance, Hazard Analysis and Risk-Based Preventive Controls for Human Food, which is intended to help industry comply with FDA’s final rule for preventive controls for human food (PC Rule) under the Food Safety Modernization Act (FSMA). FDA has issued chapters on a rolling basis since 2016; the new chapter addresses preventive controls for chemical hazards. The same day, FDA proposed new cadmium action levels as part of its “Closer to Zero Initiative to Safeguard Food for Children.”

Below, we highlight key aspects of Chapter 12, including the types of chemical hazards to consider and FDA’s guidance on evaluating whether a chemical hazard requires a preventive control. Manufacturers and their preventive controls qualified individuals (PCQIs) should review the draft guidance to benchmark their practices against FDA’s expectations.

• Known or Reasonably Foreseeable (“Potential”) Chemical Hazards. Section 12.3.1 lists types of chemical hazards that are known or reasonably foreseeable in food production, including environmental contaminants (such as heavy metals and PFAS), natural toxins (such as mycotoxins), unlawful pesticide residues, drug residues in food derived from animals, unapproved food or color additives, chemicals intentionally introduced for economic gain, and process- and facility-related chemical hazards.
• Factors for Managing Chemical Hazards. Section 12.3.4 sets out the factors a facility should consider in evaluating whether a chemical hazard can be adequately managed through current good manufacturing practices (CGMPs) and other prerequisite programs or instead requires a preventive control. Many of the chapter’s hazard-specific discussions refer back to these factors, which include (i) the association of the type of food with illness or injury (e.g., outbreaks or recalls); (ii) the sources of raw materials and a supplier’s history and performance; (iii) the formulation of the food, facility and equipment design, and the reasonably foreseeable use of the food, including consumption by vulnerable populations; (iv) the probability that a hazard will occur absent preventive controls, informed by past lapses and testing results; and (v) the severity of the resulting illness or injury.
• Evaluating Environmental Contaminants. Section 12.3.5 addresses environmental contaminants, especially heavy metals such as arsenic, cadmium, and lead, which FDA notes are generally concentrated in certain locations, whether naturally or because of industrial contamination or a disaster. The agency recommends addressing environmental contaminants through avoidance where possible (i.e., not sourcing ingredients from areas known to be contaminated). Where environmental contaminants may be present over a relatively wide geographic area, such as may be the case for heavy metals in some areas where raw agricultural commodities are grown, FDA recommends considering the factors identified in section 12.3.4 as well as the intended consumer. Given FDA’s priority focus on foods intended for babies and young children, the agency advises that manufacturers of such foods who identify heavy metals as potential hazards in their ingredients should consider such hazards to require a supply-chain program as a preventive control.
• Evaluating Natural Toxins. Mycotoxins can form on many raw agricultural commodities and are generally managed through agricultural, processing, and storage practices, supported by existing USDA marketing orders, grain grading, and testing programs. Natural toxins also include plant-produced toxins, such as hypoglycin A in unripe ackee fruit, which FDA’s existing Compliance Policy Guide addresses through proper fruit selection and processing. As with many other chemical hazards, FDA also recommends considering the section 12.3.4 factors in determining whether natural toxins require a preventive control.
• Evaluating Pesticide Residues. Facilities must consider pesticide residues as part of their hazard identification under the PC Rule. In evaluating whether a pesticide residue is a hazard requiring a preventive control, FDA recommends that manufacturers consider the section 12.3.4 factors, as well as whether the food has previously been found with residues exceeding established tolerances. To help identify such commodities, FDA points to its Pesticide Residue Monitoring Program reports and data and to several pesticide-related import alerts, which apply variously to specific growers, commercial entities, and countries.
• Evaluating Unapproved Food Additives or Color Additives. While the safety of food and color additives and generally recognized as safe (GRAS) substances has drawn significant FDA attention in recent years, section 12.3.9 reminds industry that assessing the legal status of ingredients and their intended uses is part of a manufacturer’s obligations under the PC Rule. Because ingredient safety is established under specific conditions of use, uses outside the parameters of FDA regulations or GRAS determinations may constitute unapproved food or color additives, which are chemical hazards. FDA recommends that manufacturers evaluate these hazards using the resources listed in section 12.3.2 (including FDA’s food additive, color additive, and GRAS regulations and related resources) and the section 12.3.4 factors.
• Evaluating Process-Related Contaminants. Process-related contaminants, such as 4-methylimidazole (4-MEI) and acrylamide, may form during production. In evaluating whether such a contaminant requires a preventive control, FDA recommends that manufacturers consider the section 12.3.4 factors, any agency guidance on the particular substance, and current industry practices to mitigate formation and consumer exposure. 

Chapter 12 includes illustrative examples of chemical hazard programs, including for manufacturers of shelf-stable baby foods and dry infant rice cereal controlling heavy metals and for a baker controlling the mycotoxin deoxynivalenol (DON) in bread made with wheat flour. The examples detail the production, procedures, hazard analysis, supply-chain program, verification, and records processes, as relevant.

FDA requests comments on the draft guidance by January 21, 2027, at www.regulations.gov (docket number FDA-2016-D-2343).

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.