As explained in more detail in the update below, key changes include the following:

• Introduction: The 2016 version of the draft Introduction consisted of only a few pages limited to a brief introduction, statement of purpose, and definitions section.  The revised draft Introduction is 70 pages, including an expanded glossary of terms used and defined in later chapters and three new sections on training, references, and resources.²
• Appendix 1: FDA made several significant changes to Appendix 1 to address “stakeholder concerns over specific hazard-commodity associations and the Agency’s use of the Appendix during inspections.”³  Appendix 1 has historically included a series of tables identifying the most relevant food-related biological, chemical, and process-related hazards across various food groups, with a short introduction.  In the 2024 update, FDA has deleted the process-related hazard tables, revised the tables for biological and chemical-related hazards, and added nearly 30 pages of introductory text.  The substantive introduction to the Appendix 1 tables explains how to use the tables, with frequent references to other chapters of the PCHF Draft Guidance as well as other FDA guidance documents and reference materials.  Notably, although FDA removed “allergens” as a chemical hazard identified in the tables, careful consideration of allergens is still a key issue because, as FDA explains in the new introductory text, they are a known and reasonably foreseeable chemical hazard for a majority of foods.  When evaluating known or reasonably foreseeable hazards (“potential hazards”) as part of a hazard analysis, it is now necessary to both consider the narrative guidance and refer to the tables in Appendix 1.⁴

In this Hogan Lovells update, we first provide a brief overview of the purpose and history of the PCHF Draft Guidance, address the key changes to the draft Introduction, and then discuss some of the more significant changes to Appendix 1 in more detail.  This update is not an exhaustive summary of FDA’s revisions to Appendix 1, which are  substantial and nuanced.  We strongly encourage food companies to review the revised PCHF Draft Guidance Introduction and Appendix 1 carefully to determine whether updates to your food safety plans are warranted. 

Background

The multi-chapter PCHF Draft Guidance is designed to aid in developing food safety plans, including conducting a hazard analysis.  Appendix 1 is intended to help with identification of known or reasonably foreseeable biological, chemical, and physical hazards for each type of food manufactured, processed packed, or held at a food facility.  FDA has been releasing chapters of the PCHF Draft Guidance on a rolling basis and the draft Introduction and draft Appendix 1 were made available for the first time in 2016.  All chapters, including the draft Introduction and Appendix 1, remain in draft form.  

Key Changes – Introduction

The revised Introduction to the PCHF Draft Guidance includes an expanded glossary of terms that are used and defined in later chapters, as well as three new sections on training, references, and resources. 

• Glossary of Terms:  The expanded glossary found in Section III includes all terms that are defined in 21 CFR § 117.3, as well as new definitions for terms that FDA uses throughout the PCHF Draft Guidance (e.g., “critical parameter/critical factor”, “visibly clean,” and “root cause analysis”). FDA also includes a table of abbreviations used in the PCHF Draft Guidance as Section IV.
• Training: In Section V, FDA provides an overview of required training under the PCHF rule.  Section V summarizes the type of training needed for Preventive Controls Qualified Individuals (PCQI) and qualified auditors, as well as examples of training topics for personnel other than a PCQI or qualified auditor.
• Resources: The new Section VI is a compilation of resources that could be useful for developing and implementing a food safety plan.  The resources consist of Compliance Policy Guides (CPGs) (Table 3), FDA Guidance for Industry (Table 4), Import Alerts (Table 5), Codex Standards, Codes of Practice, Guidelines (Table 6), resources for designing validation studies (Table 7), and miscellaneous additional resources (Table 8).
• References: Section VII consists of a comprehensive bibliography of references that have been used in certain chapters of the PCHF Draft Guidance, as well as references FDA expects to include in future chapters of the PCHF Draft Guidance that will be released. 

Key Changes – Appendix 1

We summarize some of the key changes to the draft Appendix 1 below:

• Title and Terminology:  FDA updated the title of Appendix 1 from “Potential Hazards for Foods and Processes” to “Known or Reasonably Foreseeable Hazards (‘Potential Hazards’).”  FDA uses this combined term (or, alternatively, “Known or Reasonably Foreseeable Hazards (‘Potential’) Hazards”)  throughout the Appendix. This change helps clarify the scope of the guidance within the regulatory terminology. 

More substantively though, related to this change, FDA also takes steps in the revised draft to emphasize that although Appendix 1 should be used as a starting point for conducting a hazard analysis, it does not mean that the hazards identified in the Appendix are hazards requiring a preventive control in any particular food.  For example, before each hazard table FDA includes in the introductory text a disclaimer that the tables “do not identify any hazards requiring a preventive control in any Food Subcategory. It is the responsibility of the owner, operator, or agent in charge of each food facility to determine, through hazard analysis, whether a [biological/chemical] hazard identified in [the tables] as a known or reasonably foreseeable (“potential”) [biological/chemical] hazard is a hazard requiring a preventive control in the facility’s food product.”⁵

• Eliminated Process-Related Hazard Tables: The 2016 draft Appendix 1 included three sets of Tables of known or reasonably foreseeable (“potential”) hazards – for biological hazards, chemical hazards, and process-related hazards.  The revised draft Appendix 1 contains only two table categories – Table 1 for Biological Hazards and Table 2 for Chemical Hazards.  Appendix 1 no longer includes a table of potential hazards for “process-related” biological, chemical, and physical hazards (formerly Table 3) because, as FDA reasons, process and facility related hazards “generally are unique to each facility based on its operations and processes.” ⁶
  • New Discussion of Most Common Process-Related Hazards: In lieu of Table 3, FDA recommends that each facility “identify known or reasonably foreseeable (“potential”) process-related hazards for its products based on its knowledge, experience, and history of hazards associated with its operations,” using the recommendations and guidance in Chapters 2 and 3 of the PCHF Draft Guidance.⁷ In Section A1.7, FDA discusses the fourteen most common process-related hazards – organized by biological,⁸ chemical,⁹ and physical¹⁰ hazards ­– with cross references to other relevant Chapters in the PCHF Draft Guidance.
• Reorganized and Revised Food Groups, Categories, and Subcategories: Like the 2016 version of the draft Appendix 1, each table in the updated draft Appendix 1 represents one Food Group, which is identified in the title of the table.  The revised draft Appendix 1 lists sixteen Food Groups identified as Food Groups A through P.¹¹ Tables 1A through 1P list the most relevant food-related biological hazards and Tables 2A through 2P list the most relevant food-related chemical hazards.  Other elements of each table are the Food Category (the main subdivision within each of the sixteen Food Groups), Food Subcategory (descriptive details to distinguish food items within the Food Category, which are also identified by a number/letter code combination), Storage Conditions if applicable (e.g., frozen, refrigerated, self-stable), Hazards (discussed in more detail below), and Comments (examples of products that may not obviously fall into a Food Category and Subcategory).  Although these basic elements of the tables generally are consistent with the 2016 version of Appendix 1, FDA has made a handful of revisions to the organization of Food Groups, Categories, and Subcategories to emphasize the need to evaluate hazards of food ingredients, rather than finished products:
  • Eliminated “multi-component foods”: In the updated draft Appendix 1, FDA has eliminated the Food Group “multi-component foods” (formerly “Table K”), which included broad Subcategories such as lunch dishes, appetizers, and side dishes.  These categories are no longer included in the Tables.  When evaluating multi-component foods, FDA advises that “you should consider the hazards associated with the individual raw materials/ingredients as well as the hazards that may arise from the processing methods used in making them.”
  • Food Subcategories: FDA explains that many foods identified in the tables are multi-component foods with multiple raw materials. As FDA states in Section A1.5.4, the Food Groups and Food Subcategories have been revised to better reflect food ingredients rather than finished products, where possible. 
  • Placeholder Chemical Hazard Tables: FDA states that for certain Food Groups (2A – Bakery Items; 2F – Dressings, condiments, and Dips; 2M – Snack Foods; and 2N – Soups and Sauces), the known or reasonably foreseeable (“potential”) relevant chemical hazards depend on the ingredients used.  Therefore, the draft Appendix 1 identifies a placeholder entry for Tables 2A, 2F, 2M, and 2N, and recommends referring to the tables most applicable to the ingredients used in the product. 
• Revised Biological and Chemical Hazard Tables: On a Food Category and Subcategory basis, Tables 1A-1P (Biological Hazards) and Tables 2A-2P (Chemical Hazards) identify the known or reasonably foreseeable hazards (“potential hazards”) with an “X,” thus identifying that further evaluation is recommended in order to determine whether they are hazards that require a preventive control for a specific food.  As explained below, FDA has revised which chemical and biological hazards are identified in each table:
  • Key Revisions to Biological Hazards: Revised Table 1 identifies eleven biological hazards, most of which are the same as those listed in the 2016 draft Appendix 1.¹² The most notable changes from the 2016 version are the removal of shigella spp., Giardia lamblia, and Trichinella spiralis as potential hazards, and the addition of the broader categories of “Parasites” and “Viruses.”  FDA also provides additional guidance in Section A1.6.1 about particular concerns on a number of specific issues regarding biological hazards, including infant formula:
    • Infant Formula and Cronobacter: FDA explains that the tables in Appendix 1 do not list infant formula or other foods for infants or toddlers.¹³ The tables therefore do not list Cronobacter spp., “because Cronobacter spp. (including C. sakazakii) is largely a hazard for powdered infant formula rather than a hazard applicable to the general population.” However, FDA explains there may be instances where facilities should consider Cronobacter spp. as a known or reasonably foreseeable (“potential”) biological hazard, such as in powdered milk intended for use in infant formula.¹⁴
  • Key Revisions to Chemical Hazards: Revised Table 2 identifies six potential chemical hazards: drug residues, arsenic, cadmium, lead, mycotoxins/natural toxins, and pesticides. The changes from the chemical hazards identified in the 2016 draft Appendix 1, as well as added commentary from FDA include the following:
    • Allergens: In a significant departure from the 2016 draft Appendix 1, the tables of food-related chemical hazards no longer identify food allergen hazards.  FDA explains in Section A1.6.2.2 that a food allergen hazard can occur due to (1) an “undeclared food allergen” in your own products or ingredients or raw materials received from a supplier; or (2) “unintended allergen presence” (i.e., the presence of an allergen due to allergen cross-contact) that can occur in your own food production processes or during production of raw materials or ingredients received from a supplier. Therefore, because “a food allergen hazard could be identified as a known or reasonably foreseeable (“potential”) chemical hazard for a majority of food products,” the tables of food-related chemical hazards do not address food allergen hazards.  However, this change to the information in the chemical hazard tables does not reflect any change in FDA’s perspective on the importance of assessing food allergen hazards as part of a hazard analysis.  Indeed, allergens are front of mind for FDA, as the agency recently released Chapter 11 of the PCHF Draft Guidance, which provides detailed guidance on food allergen programs under the PCHF rule.¹⁵
    • Mycotoxins: In Section A1.6.2.6, FDA identifies the specific mycotoxins that are most commonly associated with certain commodities and explains that when a table of potential chemical hazards broadly identifies the chemical hazard “mycotoxin,” a footnote in the table identifies the applicable mycotoxin (e.g., ochratoxin in cocoa).
    • Radiological Hazards, Dioxins, PCBs, Unapproved Food or Color Additives:  The tables of food-related chemical hazards do not address food radiological hazards,¹⁶ dioxins, or unapproved food or color additives,¹⁷  all of which were previously included on the 2016 Appendix 1 Chemical Hazard Tables. 
    • Heavy Metals: While the 2016 draft Appendix 1 identified “Heavy Metals” generally, the updated draft Appendix 1 Tables provide more granularity, identifying the heavy metals arsenic, cadmium, and lead.
    • Closer to Zero: Relatedly, and as discussed in the previous section on biological hazards, the Appendix 1 tables do not list foods for infants and toddlers.  However, under section A1.6.2.5 – Note about toxic element hazards in foods for infants and toddlers including infant formula, FDA discusses its “Closer to Zero” action plan, which identifies actions FDA will take to reduce exposure to toxic elements from foods eaten by babies and young children.  FDA clarifies that the Appendix 1 guidance “does not identify specific action levels for any toxic element for hazards in foods for infants and toddlers,” and instructs readers to refer to FDA’s websites “on a regular basis,” for more information on the establishment of such action levels.

Conclusion

The updates to the Draft PCHF Guidance, and specifically to Appendix 1, are significant and should be carefully reviewed by all food companies.  Because the revisions reflect FDA’s current thinking about how food facilities should be evaluating hazards, they may result in the need to revise hazard analyses and food safety plans.  Importantly, the revised Appendix 1 will influence FDA investigators conducting inspections in the field, establishing the framework for what they expect to see in facility food safety plans and programs.  To the extent companies identify significant issues or concerns, we encourage companies to raise those in comments, either directly or via trade associations.  To ensure FDA considers those comments in formulating final guidance, the comments should be submitted by June 3.     

If you have any questions, please contact us.

Authored by: Elizabeth Fawell, Maile Gradison, Andrea Bruce, and Anneke Altieri.

References

1 89 Fed. Reg. 7315 (Feb. 2, 2024), FDA, Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability;  FDA, Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (January 2024), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-hazard-analysis-and-risk-based-preventive-controls-human-food.

2 FDA, Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry; Introduction and General Information Applicable to This Guidance (January 2024), available at https://www.fda.gov/media/99621/download.

3. FDA Constituent Update, FDA Publishes Revised Draft Introduction and Appendix to the Preventive Controls for Human Food Guidance (Jan. 30, 2024), https://www.fda.gov/food/cfsan-constituent-updates/fda-publishes-revised-draft-introduction-and-appendix-preventive-controls-human-food-guidance.

4. FDA, Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry; Appendix 1: Known or Reasonably Foreseeable Hazards (“Potential Hazards”);  (January 2024), available at https://www.fda.gov/media/99581/download.

5. See e.g., FDA Hazard Analysis and Risk-Base Preventive Controls for Human Food: Draft Guidance for Industry, Appendix 1, p. 30 (emphasis added).

6. Id. at A1.4.

7.  Id. at A1.7.  Chapter 2 addresses Conducting a Hazard Analysis. Chapter 3 addresses Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food.

8. The Process-Related Biological Hazards are: Bacterial Pathogens – (1) Presence/growth/toxin production due to survival of a lethal treatment; (2) Growth and/or toxin production due to poor time/temperature control; (3) Growth and/or toxin production due to poor formulation control; (4) Growth and/or toxin production due to reduced oxygen packaging (ROP); (5) Presence due to ingredients added after process controls; and (6) Presence, growth, or growth with toxin production due to recontamination due to lack of container integrity; Environmental Pathogens – Presence due to recontamination from the processing environment.

9. The Process-Related Chemical Hazards are: Undeclared food allergens – Incorrect label; Unintended food allergen presence – Allergen cross-contact; Chemical hazards due to mis-formulation (e.g., sulfites, yellow #5); and Process-contaminant hazards in certain plant-based foods.^[8]

10. The Process-Related Physical Hazards are: Metal; Hard plastic; and Glass.

11. The Food Groups are A - Bakery items, B - Beverage items, C - Food additives, color additives, and GRAS substances, D -Chocolate and Candy, E- Dairy, F - Dressings, Condiments and Dips, G - Egg and Egg Products, H - Fruits and Vegetables, I - Game Meat Products, J - Grains, Pulses, Flours, and Starches, K - Nuts and Seeds, L - Oils and Oil Products, M - Snack Foods, N - Soups and Sauces,  O - Spices and herbs, and P - Food Sweeteners (Nutritive and Non-Nutritive). 

12.  The Food Groups are A - Bakery items, B - Beverage items, C - Food additives, color additives, and GRAS substances, D -Chocolate and Candy, E- Dairy, F - Dressings, Condiments and Dips, G - Egg and Egg Products, H - Fruits and Vegetables, I - Game Meat Products, J - Grains, Pulses, Flours, and Starches, K - Nuts and Seeds, L - Oils and Oil Products, M - Snack Foods, N - Soups and Sauces,  O - Spices and herbs, and P - Food Sweeteners (Nutritive and Non-Nutritive). 

13. The potential biological hazards that are present in the 2024 version of Appendix 1 are Bacillus cereus, Clostridium botulinum, C. perfringens, Brucella spp., Campylobacter spp., Pathogenic E. coli, Salmonella spp., L. monocytogenes, S. aureus, Parasites, and Viruses.

14. Draft Appendix 1 at A1.6.1.5;  A1.6.1.1. 

15. Id. at A1.6.1.1.  Section A1.6.1 also includes discussions about the potential biological hazards identified for products subject to exceptionally lethal processes, products under the jurisdiction of the United States Department of Agriculture, products produced using pasteurized ingredients, and products consumers cook.

16. FDA, Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry; Chapter 11: Food Allergen Program;  (September 2024), available at https://www.fda.gov/media/172318/download?attachment; HL Update – FDA Releases Draft Guidance on Food Allergen Programs Under the Preventive Controls Rule; Nov. 27, 2023; available at https://www.engage.hoganlovells.com/knowledgeservices/news/fda-releases-draft-guidance-on-food-allergen-programs-under-the-preventive-controls-rule. 

17. FDA explains in Section A1.6.2.3 that radiological hazards, dioxins, and PCBs rarely occur in the food supply and are largely associated with accidental contamination (or contaminated well water for radiological hazards) and recommends that facilities consider discussions in Chapter 3 of the Draft PCHF Guidance for more information.

18. In Section A1.6.2.4, FDA confirms that it considers unapproved food additives or color additives to be a chemical hazard, and that it intends to update Chapter 3 to highlight food and color additive regulations, the Color Additive Status Lists, and lists of substances that are used in food under the Generally Recognized as Safe (GRAS) provisions of the Food, Drug, and Cosmetic Act.