FDA Releases Two New Chapters for its Draft Guidance on the Preventive Controls for Human Food Rule: Food Allergen Program & Acidified Foods

FDA Releases Two New Chapters for its Draft Guidance on the Preventive Controls for Human Food Rule: Food Allergen Program & Acidified Foods

September 27, 2023, Covington Alert

Yesterday, FDA released two new chapters to its draft guidance, Hazard Analysis and Risk-Based Preventive Controls for Human Food. The draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC Rule) under the Food Safety Modernization Act (FSMA). The first chapters were issued in 2016 and FDA has subsequently issued additional chapters on a rolling basis. The two chapters issued yesterday cover preventive controls (PCs) requirements for food allergens and acidified foods.

I. Chapter 11—Food Allergen Program

Chapter 11 of the draft guidance provides recommendations on how to establish and implement a food allergen program. Below, we highlight a few key aspects of the allergen chapter, including FDA guidance on the use of allergen advisory statements and supplier approval procedures; we note that this chapter is particularly detailed and worth reading in full.

• Allergen Advisory Statements. The allergen chapter reiterates FDA’s longstanding position that allergen advisory statements on product labels should not be used in lieu of adherence to the CGMP requirements and allergen cross-contact controls. Notably, FDA acknowledges that in some circumstances, allergen cross-contact may still occur even after implementation of appropriate CGMP measures and allergen cross-contact controls. In such a case, FDA explains that the PCQI should include a justification in the food safety plan for why cross-contact cannot be fully prevented, and should consider the use of an allergen advisory statement.

  For example, an allergen advisory statement may be appropriate where the same processing line is used for vegan caramel chips and non-vegan caramel chips that contain milk, and the manufacturer finds that during verification testing the cleaning is not always able to protect the vegan caramel chips from allergen cross-contact. The facility’s PCQI would provide a written justification in the food safety plan for why allergen cross-contact controls cannot ensure the absence of allergen cross-contact, and could implement an allergen advisory label statement to disclose possible unintended allergen presence in the food.

• Supplier Approval. Section 11.8 of the allergen chapter states that in most circumstances, a food allergen hazard will be a SAHCODH hazard (i.e., a hazard for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans) and therefore an annual supplier audit will be required as a verification activity. FDA notes that a manufacturer should approve a supplier that provides allergen advisory statements for its products only if the manufacturer determines that such statements are not being used in lieu of adherence to CGMPs and/or to the requirements for allergen cross-contact controls. The section also details ingredient testing recommendations. Table 11-4 provides examples of supplier approval activities and ongoing supplier verification activities for a couple of ingredient and risk scenarios.

• Allergen Thresholds. FDA states that it has not established a maximum amount of any major food allergen that may be unintentionally present in a food product. FDA recognizes, however, as it has in other recent publications, the potential relevance of published data on population threshold dose responses to various food allergens, which raises the possibility that some low-level exposures to food allergens, and the presence of certain allergen-derived ingredients, may not be expected to cause allergic reactions in most consumers who have that food allergy. FDA notes that such data could be useful to manufacturers in making decisions on appropriate food allergen controls.

• CGMP Requirements as Prerequisite to Allergen Cross-Contact Preventive Controls. FDA notes that allergen cross-contact preventive controls should complement and enhance measures taken to comply with the CGMP requirements (also known as prerequisite programs) to prevent or significantly minimize allergen cross-contact. FDA recommends that a manufacturer adapt measures for complying with the CGMP requirements to function as a PC by combining a CGMP measure with one or more PC management components. FDA provides a number of recommendations and examples of how to adapt such measures. For example, FDA explains that a manufacturer’s cleaning measure to comply with CGMP requirements could be coupled with observing whether the food contact surface is visibly clean, which is generally a monitoring or verifying activity for allergen cross-contact controls.

The allergen chapter provides two illustrative examples on how to establish and implement a food allergen program: Food Allergen Program Established and Implemented by Dessert Manufacturer A for the Production of Ice Cream and Other Frozen Dessert Products (section 11.12) and Food Allergen Program Established and Implemented by Bakery B for the Production of a Variety of Cookie Products (section 11.13). Each example details the hazard analysis, CGMP measures, food allergen controls, supply-chain controls, allergen cross-contact controls, allergen cleaning procedures, and label controls.

II. Chapter 16—Acidified Foods

Chapter 16 offers guidance on how manufacturers who are subject to the PC Rule and who manufacture, process, and pack acidified foods[1] can leverage the policies, procedures, and records they implement and maintain under FDA’s acidified food regulations to comply with the PC Rule, and vice versa. These acidified foods regulations include FDA’s emergency permit control regulations for acidified foods (21 C.F.R. § 108.25) and CGMP regulations for acidified foods (21 C.F.R. Part 114). Notably, because the primary focus of this chapter is on the overlap between the PC Rule and the acidified food regulations, the chapter does not offer significant standalone guidance on FDA’s approach to regulating acidified foods.

A key point conveyed throughout the chapter is that, while multiple requirements under the PC Rule have corresponding requirements under FDA’s acidified food regulations, others do not. So, while various instances may exist where manufacturers can leverage a single set of policies, procedures, and records to satisfy their obligations under both sets of requirements, this will not always be the case. Manufacturers should therefore always be careful to identify and ensure compliance with all applicable requirements under both frameworks.

Sections 16.6 through 16.13 of the chapter walk through key components of the PC Rule and acidified food regulations and identify areas of potential overlap. Key examples presented in these sections include:

• Personnel Qualifications and Oversight. The chapter notes that complying with the personnel training and oversight requirements under the acidified food regulations will generally be sufficient to satisfy the PC Rule’s personnel training and oversight requirements. But, because the acidified foods regulations establish more specialized personnel training and oversight requirements than the PC Rule, satisfying the PC Rule’s training requirements, alone, will generally not be sufficient to satisfy the acidified foods regulations. For example, while PCQIs are generally qualified to prepare and oversee implementation of food safety plans under the PC Rule, they are not qualified to supervise the processing and packaging of acidified foods unless they satisfy additional training requirements under the acidified foods regulations.
• Food Safety Plan and Hazard Analysis. The chapter notes that, while the acidified food regulations do not require manufacturers to develop a written food safety plan or conduct a hazard analysis (as required under the PC Rule), manufacturers can leverage these activities to identify controls required under the acidified food regulations. For example, the acidified food regulations require that manufacturers implement and monitor specific controls for C. botulinum. Thus, if a manufacturer conducts a hazard analysis under the PC Rule that identifies and evaluates C. botulinum as a hazard requiring a PC, the manufacturer could then develop and implement PCs that address the corresponding requirements under the acidified foods regulations. The manufacturer’s hazard analysis could, in turn, cite to the acidified foods regulations—rather than the published literature—as the basis for concluding that C. botulinum is a hazard requiring a PC.
• Preventive Controls. The chapter notes that manufacturers can leverage the processing parameters they are required to identify when submitting a process filing for acidified foods (i.e., through Form FDA 2541e) to fulfill the PC Rule’s requirements regarding identification of written PCs required for biological hazards, e.g., by including a completed Form FDA 2541e in their food safety plan as a written process control. Likewise, manufacturers could leverage PCs they implement under the PC Rule to satisfy requirements under the acidified foods regulations regarding controls for pH, process time, temperature, and preservatives. The chapter notes, however, that the PC Rule specifies some PC requirements that have no corresponding requirements under the acidified foods regulations, including those regarding chemical and physical hazards and sanitation controls (although the chapter notes that complying with the thermal processing requirements under the acidified foods regulations may, in many cases, make it unnecessary to implement sanitation controls).
• Recall Plans. The chapter notes that establishing and implementing a recall plan as required by the PC Rule could satisfy corresponding recall plan requirements under the acidified foods regulations, as long as the recall plan includes procedures for notifying FDA about any recall (which is required under the acidified foods regulations, but not under the PC Rule).
• Records Requirements. The chapter notes that maintaining various records required under the PC Rule could satisfy corresponding recordkeeping requirements under the acidified foods regulations, subject to some key differences. For example, the acidified foods regulations require manufacturers to retain required records for a longer period (3 years) than the PC Rule (2 years). Moreover, the acidified foods regulations require records of distribution, while the PC Rule does not.

The chapter concludes with an appendix (Appendix 16-1) that lists additional requirements under the acidified foods regulations that have no explicit corresponding requirement under the PC Rule or that exceed any corresponding requirements under the PC Rule. Manufacturers should carefully assess these requirements when developing their compliance programs.

FDA encourages comments on the draft guidance chapters within 180 days (i.e., by March 25, 2024), although the agency accepts comments on guidance documents at any time.

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.