In September 2023, FDA released two new chapters to its Hazard Analysis and Risk-Based Preventive Controls for Human Food (PCHF) Draft Guidance (Draft Guidance). New draft Chapter 11 is focused on food allergen programs, and new draft Chapter 16 is focused on acidified foods. Following publication of FDA’s 2015 final rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” at 21 CFR Part 117 (“Part 117”), the agency has periodically released chapters to its PCHF Draft Guidance to help industry comply with the rule.
Comments on the Draft Guidance should be submitted by March 25, 2024, to ensure FDA’s consideration in preparing the final guidance (though FDA accepts comments on guidance at any time).1
PCHF Draft Guidance Chapter 16, Acidified Foods
The new draft chapter on acidified foods helps manufacturers understand how the requirements in Part 117 that apply to all registered food facilities complement the requirements specific to manufacturers of acidified foods, including the production and process controls in 21 CFR Part 114 and emergency permit control regulations in 21 CFR § 108.25 (collectively, the “acidified foods regulations”). FDA notes that while Parts 114 and 117 have some overlapping requirements for acidified foods manufacturers, this will not always be the case. Manufacturers should carefully evaluate their procedures and filings to ensure they comply with both the requirements of Part 117 and the acidified foods regulations.
The Draft Guidance highlights the following areas of note.
- Personnel Qualifications, Supervision, Oversight: The acidified foods regulations have requirements for personnel training and oversight that go beyond the requirements of Part 117. For example, a Preventive Controls Qualified Individual (PCQI) satisfying the requirements of Part 117 would require additional training to be qualified to supervise the processing and packaging of acidified foods.
- Food Safety Plans and Hazard Analyses: Part 117 requires a written hazard analysis that must consider reasonably foreseeable biological, chemical, or physical hazards that have the potential to cause illness or injury. The acidified foods regulations do not require a food safety plan or hazard analysis. Acidified food manufacturers must establish a food safety plan and conduct a hazard analysis consistent with the requirements of Part 117. The draft guidance makes clear FDA expects acidified food manufacturers to conduct a hazard analysis that considers hazards other than those controlled by the acidified foods regulation. FDA does not provide examples of hazards that should be considered and refers the acidified food manufacturer to other chapters of the guidance on hazard analysis (chapter 2), hazards associated with manufacturing, processing, packing, and holding of human food (chapter 3), Appendix 1, and section 6.16 regarding heat treatments as a process control. The draft guidance focuses on the interplay between the hazard analysis and the requirements of the acidified foods regulations. The acidified foods regulations require implementing and monitoring controls for C. botulinum and implementing a scheduled process that effectively controls other microorganisms of public health significance. Manufacturers may be able to incorporate these procedures and processes into components of their food safety plan. The Draft Guidance provides several examples to this effect, including that a hazard analysis can reference the acidified foods regulations as the basis for concluding that C. botulinum is a hazard requiring a preventive control in shelf-stable acidified foods, rather than pointing to published scientific literature. It also notes that the controls a manufacturer identifies in its scheduled process for controlling pathogens could inform the preventive controls included in a manufacturer’s food safety plan.
- Preventive Controls: The Draft Guidance explains that certain components of the form to file a schedule process require identifying information about proper parameters for the acidified food (e.g., pH, process time and temperature, preservatives), which may help identify process preventive controls for biological hazards under Part 117. The Draft Guidance also highlights components of Part 117 that go beyond the acidified foods requirements in Part 114, including the requirement to address preventive controls for physical and chemical hazards (including allergens), and the requirement to include sanitation controls. The draft guidance notes the hazard analysis could identify a need for a preventive control during seaming/sealing after filling the container to prevent recontamination. FDA notes the requirement in 114.80(a)(4) for testing and examination of containers to ensure the container suitably protects the food from leakage or contamination could satisfy the requirements of the PCHF rule. Regarding sanitation controls, the Draft Guidance notes that complying with the thermal processing requirement in Part 114 should make sanitation controls for environmental pathogens unnecessary, except in the case that a ready-to-eat acidified food is exposed to the environment before packaging and does not receive a treatment or other control measure (such as a formulation lethal to the environmental pathogen).
- Supply-Chain Controls: The recordkeeping requirements in the acidified foods regulations that require supplier guarantees or certifications could be used to comply with correlating supply-chain-applied controls identified in the manufacturer’s hazard analysis when the hazard analysis reveals testing is the appropriate supplier verification activity for the hazard.
- Recall Plan: A recall plan established to comply with Part 117 may fulfill similar requirements to maintain a recall procedure under the acidified foods regulations if it includes procedures to notify FDA about any recall (a requirement in 21 CFR § 108.25(e).
- Preventive Controls Management: The Draft Guidance notes several aspects of monitoring the effectiveness of preventive controls that could be helpful in complying with the acidified foods regulations and vice versa. In addition, both regulations have components that require validation of the preventive controls/scheduled process.
- Recordkeeping: Several recordkeeping requirements in Part 117 may be useful in meeting the recordkeeping requirements under the acidified foods regulations, including for supply-chain programs, monitoring records, and corrective actions. But, the acidified foods regulations require unique requirements, including a component to maintain records regarding distribution and maintaining records for three years (more than the two-year retention period required in Part 117).
The Draft Guidance includes an appendix listing additional requirements specific to acidified foods that have no corresponding requirement in Part 117. These include registering as a food canning establishment and submitting a scheduled process, heightened reporting requirements when food in commerce has potential health concerns, date coding on product containers, and more.
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The draft guidance serves as a helpful reference to manufacturers of acidified foods in identifying where there is overlap between the two regulatory programs and, particularly with the acidified foods regulations, what unique complexities must be separately addressed. The draft guidance contains many tables and charts that clearly identify FDA’s expectations under the acidified foods requirements and Parts 117. Manufacturers of acidified foods should review the draft guidance in detail to make certain their food safety plan captures the relevant requirements of both of these comprehensive programs.