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Hazard Analysis and Risk-Based 

Preventive Controls for Human Food: 

Draft Guidance for Industry1

This draft guidance, when finalized, will represent the current thinking of the Food and Drug 

Administration (FDA or we) on this topic. It does not establish any rights for any person and is 

not binding on FDA or the public. You can use an alternative approach if it satisfies the 

requirements of the applicable statutes and regulations. To discuss an alternative approach, 

contact FDA’s Technical Assistance Network by submitting your question at 

https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistancenetwork-tan. 

Appendix 1: Known or Reasonably Foreseeable Hazards 

(“Potential Hazards”) 

Table of Contents

A1.1 Purpose of Appendix 1

A1.2 Terms, Abbreviations, and Resources

A1.3 Requirement for a Hazard Analysis

A1.4 How We Developed Appendix 1

A1.5 Organization of Appendix 1

A1.5.1 Food Groups Addressed by Appendix 1

A1.5.2 Tables of Known or Reasonably Foreseeable Hazards (“Potential Hazards”)

A1.5.3 Organization of Each Table in Appendix 1

A1.5.4 The Food Subcategories in the Tables in Appendix 1 Address Raw Materials, 

Other Ingredients, and Multi-Component Foods

A1.5.5 Food Categories/Food Subcategories that Are LACF

A1.5.6 Infant Formula and Other Foods for Infants and Toddlers

1 This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and 

Applied Nutrition at the U.S. Food and Drug Administration. 
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A1.6 Tables of Known or Reasonably Foreseeable Hazards (“Potential 

Hazards”) in Appendix 1

A1.6.1 Food-Related Biological Hazards

A1.6.1.1 The most relevant food-related biological hazards

A1.6.1.2 Note about viruses, parasites, and Shigella spp.

A1.6.1.2.1 Viruses and parasites

A1.6.1.2.2 Shigella spp.

A1.6.1.3 Note about biological hazards in food subcategories manufactured using 

exceptionally lethal processes

A1.6.1.4 Note about biological hazards in products produced in establishments that are 

under the jurisdiction of USDA

A1.6.1.5 Note about biological hazards in infant formula and other foods for infants and 

toddlers

A1.6.1.6 Note about biological hazards in food products produced using ingredients that 

are pasteurized or otherwise treated to control biological hazards

A1.6.1.7 Note about biological hazards in food products that consumers cook

A1.6.2 Food-Related Chemical Hazards

A1.6.2.1 The most relevant food-related chemical hazards

A1.6.2.2 Note about food allergen hazards and substances associated with a food 

intolerance or food-related disease

A1.6.2.3 Note about radiological hazards, dioxins, PCBs, and toxic elements

A1.6.2.4 Note about unapproved food and color additives

A1.6.2.5 Note about toxic element hazards in foods for infants and toddlers, including 

infant formula

A1.6.2.6 Note about mycotoxin hazards

A1.7 Process-related Hazards and Facility-related Hazards

A1.7.1 The Most Relevant Process-related and Facility-related Biological Hazards

A1.7.2 The Most Relevant Process-related Chemical Hazards

A1.7.3 The Most Relevant Process-related Physical Hazards

A1.8 How to Use the Tables in Appendix 1

A1.8.1Appendix 1 Reflects a Tiered Approach to the Requirements for Hazard 

Analysis

A1.8.2Hazards that SMEs Recommended Be Identified as Known or Reasonably 

Foreseeable Hazards (“Potential Hazards”) Might Not Apply to All Food 

Products in a Food Subcategory
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A1.8.3Each Facility Determines, Through Its Hazard Analysis, Those Known or 

Reasonably Foreseeable Hazards (“Potential Hazards”) That Require a 

Preventive Control

A1.9 References

A1.10 Tables of Known or Reasonably Foreseeable (“Potential”) FoodRelated Biological Hazards

Table 1A: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Bakery Items

Table 1B: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Beverage Items

Table 1C: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Miscellaneous Food Additives, Color Additives, and GRAS 

Substances

Table 1D: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Chocolate and Candy

Table 1E: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Dairy

Table 1F: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Dressings, Condiments, and Dips

Table 1G: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Egg and Egg Products

Table 1H: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Fruits and Vegetables

Table 1I: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Game Meat Products1

Table 1J: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Grains, Pulses, Flours, and Starches

Table 1K: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Nuts and Seeds

Table 1L: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Oils and Oil Products

Table 1M: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Snack Foods1

Table 1N: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Soups and Sauces

Table 1O: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Spices and Herbs
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Table 1P: Known or reasonably foreseeable (“potential”) food-related biological 

hazards for Food Sweeteners (Nutritive and Non-Nutritive)

A1.11 Tables of Potential Food-Related Chemical Hazards

Food Group 2A: Known or reasonably foreseeable (“potential”) food-related 

chemical hazards for Bakery Items

Table 2B: Known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Beverage Items

Table 2C: Food Additives, Color Additives, and GRAS Substances

Table 2D: Known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Chocolate and Candy

Table 2E: Known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Dairy

Food Group 2F: Dressings, Condiments, and Dips

Table 2G: Known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Egg and Egg Products

Table 2H: Known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Fruits and Vegetables1

Table 2I: Known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Game Meat Products

Table 2J: Known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Grains, Pulses, Flours, and Starches

Table 2K: Known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Nuts and Seeds

Table 2L: Known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Oils and Oil Products

Food Group 2M: Known or reasonably foreseeable (“potential”) food-related 

chemical hazards for Snack Foods

Food Group 2N: Known or reasonably foreseeable (“potential”) food-related 

chemical hazards for Soups and Sauces

Table 2O: Known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Spices and Herbs

Table 2P: Known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Food Sweeteners (Nutritive and Non-Nutritive)
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A1.1 Purpose of Appendix 1

The guidance in Appendix 1 is intended to help you identify known or reasonably foreseeable 

biological, chemical, and physical hazards for each type of food manufactured, processed, 

packed, or held at your facility. Identifying known or reasonably foreseeable hazards is one step 

in determining, through your hazard analysis, which hazards require a preventive control. (See 

21 CFR 117.130(a)(1).) Throughout this guidance:

• We use the term “potential hazard” as a synonym for “known or reasonably foreseeable 

hazard” for the following reasons:

o Some users of this Appendix 1 could be more familiar with the term “potential hazard” 

because “potential hazard” is used in food safety systems such as HACCP that are 

similar to, but not the same as, the system of hazard analysis and risk-based preventive 

controls in part 117; 

o “Potential hazard” is a term that is used in some training materials to help emphasize 

during training that a known or reasonably foreseeable hazard is still being evaluated to 

determine whether it is a hazard requiring a preventive control for a food; and

o Form 2-B in Appendix 2 of this guidance (Hazard Analysis) uses the term “potential 

hazard” as a shorthand for “known or reasonably foreseeable hazard” due to space 

limitations.2

• With the exception of Form 2-B, when appropriate, in this guidance we use3 the combined 

term “known or reasonably foreseeable hazard (“potential hazard”)” (or, depending on 

context, “known or reasonably foreseeable (“potential”) hazard”) so that this guidance:

o consistently uses the term used in the regulatory text of part 117 to unambiguously direct 

you to the regulatory requirements that are the subject of this guidance; 

o consistently uses a term that could be more familiar to some users of this guidance; and

o consistently reminds you that a known or reasonably foreseeable hazard is still being 

evaluated to determine whether it is a hazard requiring a preventive control for a food.

A1.2 Terms, Abbreviations, and Resources

See the following sections in the Introduction of this guidance for terms, abbreviations, and 

resources as follows:

• Section III.A: Glossary of terms that are used in this guidance and are defined in 21 CFR 

117.3;

• Section III.B: Glossary of terms that are defined for use in this guidance but are not defined 

in 21 CFR 117.3;

• Section IV: Table of Abbreviations that are used in this guidance; and

2 We intend to modify Form 2-B to explain that it uses “potential hazard” as a synonym for “known or 

reasonably foreseeable hazard.” 

3 We intend to modify chapters already available as draft guidance to consistently use both terms.
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• Section VI: Resources that could be useful in developing and implementing your food safety 

plan.

We organized the resources in section VI in the Introduction of this guidance in a series of 

tables as shown in Table A1-1: 

Table A1-1 Resource Tables in Section VI in the Introduction of This Guidance 

Table No. in 

Section VI of the 

Introduction

Table Title

3 FDA Compliance Policy Guides Cited as a Resource in this Guidance

4 FDA Guidance for Industry Cited as a Resource in this Guidance

5 FDA Compliance Programs and Import Alerts Cited as a Resource in 

this Guidance

6 Codex Standards, Codes of Practice, and Guidelines Cited as a 

Resource in this Guidance

7 Resources for Designing Validation Studies

8 Additional Resources Cited in this Guidance

When we cite a resource that is listed in one of the tables in section VI of the Introduction of this 

guidance, we refer you to the applicable Table in the Introduction for information on how to 

access the resource. For example, if we cite to “CPG Sec. 555.400 Aflatoxins in Human Food: 

Guidance for FDA Staff,” we refer you to Table 3 in section VI of the Introduction.

These resources are available as of the date that we make this guidance available. We have 

verified the website addresses listed for these resources, as of the date that we make the 

Introduction of this guidance available, but websites are subject to change over time. In addition, 

the policies, recommendations, and information in these resources can change over time. We 

recommend that you periodically review websites listing FDA’s CPGs, FDA’s Guidance for 

Industry, FDA’s Compliance Programs and Import Alerts, and Codex Standards, Codes of 

Practice, and Guidelines for new or modified policies, recommendations, and information. 

A1.3 Requirement for a Hazard Analysis 

Part 117 defines and uses three terms (i.e., “hazard,” “known or reasonably foreseeable 

hazard,” and “hazard requiring a preventive control”) to establish a tiered approach to the 

requirements for hazard analysis and risk-based preventive controls. The term “hazard’ is the 

broadest of these three terms – e.g., any biological, chemical (including radiological), or physical 

agent that has the potential to cause illness or injury. To conduct your hazard analysis:

• You start with the universe of all hazards that are relevant to food safety. 

• Through the “hazard identification” phase of your hazard analysis, you then narrow this 

universe of all hazards relevant to food safety to those hazards that are “known or 

reasonably foreseeable hazards” (“potential hazards”) for each type of food manufactured, 

processed, packed, or held at your facility – i.e., those biological, chemical (including 
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radiological), and physical hazards that are known to be, or have the potential to be, 

associated with your facility or your food. These “known or reasonably foreseeable hazards” 

(“potential hazards”) are the hazards that you evaluate in your hazard analysis.

• Through the “hazard evaluation” phase of your hazard analysis, you then determine the 

subset of those known or reasonably foreseeable hazards (“potential hazards”) that are 

hazards requiring a preventive control – i.e., those known or reasonably foreseeable 

hazards for which a person knowledgeable about the safe manufacturing, processing, 

packing, or holding of food would, based on the outcome of a hazard analysis (which 

includes an assessment of the severity of the illness or injury if the hazard were to occur and 

the probability that the hazard will occur in the absence of preventive controls), establish 

one or more preventive controls to significantly minimize or prevent the hazard in a food and 

components to manage those controls (such as monitoring, corrections or corrective actions, 

verification, and records) as appropriate to the food, the facility, and the nature of the 

preventive control and its role in the facility's food safety system. 

(See the definitions of “hazard,” “known or reasonably foreseeable hazard,” and “hazard 

requiring a preventive control” in 21 CFR 117.3 and the discussion of the term “potential hazard” 

in section A1.1 of this Appendix 1. See the requirement for a hazard analysis in 21 CFR 

117.130.)

Chapter 2 of this guidance:

• provides an overview of the requirements for hazard analysis and recommendations for 

steps to take before beginning a hazard analysis; 

• describes a “Hazard Analysis Worksheet” that is a resource that you can use in conducting 

your hazard analysis; and

• provides recommendations for a step-by-step approach to conducting the hazard 

identification and hazard evaluation phases of the hazard analysis to determine those 

known or reasonably foreseeable hazards (“potential hazards”) requiring a preventive 

control. To do so, Chapter 2:

o includes a series of questions you can ask during the hazard identification phase 

required by 21 CFR 117.130(b) to help narrow the universe of hazards that are relevant 

to your facility and your food products to the known or reasonably foreseeable hazards 

(“potential hazards”); 

o provides recommendations for conducting the hazard evaluation phase required by 21 

CFR 117.130(c) to determine which known or reasonably foreseeable hazards 

(“potential hazards”) require a preventive control through consideration of the severity of 

the illness or injury if the hazard were to occur, an evaluation of environmental 

pathogens in certain circumstances, and an evaluation of a series of factors and their 

effects on the safety of the finished food for the intended consumer; and

o briefly discusses the types of preventive controls (e.g., process controls, food allergen 

controls, sanitation controls, and supply-chain controls) that could be applied when the 

outcome of the hazard evaluation phase of the hazard analysis is that a known or 

reasonably foreseeable hazard (“potential hazard”) requires a preventive control. 

Chapter 3 of this guidance is an in-depth resource that provides background information about 

the most relevant biological, chemical, and physical hazards that could be associated with a 

facility or a food. For example, Chapter 3 includes several “Quick Reference Guides” that help 
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you to identify common sources of biological, chemical, and physical hazards. However, 

Chapter 3 does not provide an exhaustive compendium of biological, chemical, and physical 

hazards or all known details about each biological, chemical, or physical hazard that Chapter 3 

discusses.

We recommend that you use the information in Chapters 2 and 3 to help you determine which 

hazards that we identify in the Tables in this Appendix as known or reasonably foreseeable 

hazards (“potential hazards”) for specific types of food products are hazards requiring a 

preventive control for your food products. See also the notes in sections A1.6.1 (regarding foodrelated biological hazards), A1.6.2 (regarding food-related chemical hazards), and A1.7

(regarding process-related hazards and facility-related hazards).

A1.4 How We Developed Appendix 1

The PCHF requirements apply to a broad array of food products. To develop guidance on 

hazards that could be known or reasonably foreseeable hazards (“potential hazards”) for 

specific types of food products, we consulted subject matter experts (SMEs) within CFSAN. We 

also contracted with a third-party consultant tasked to identify and retain recognized SMEs 

within the food industry and academia to provide input during this process. 

We consulted with CFSAN’s SMEs, and the consultant worked with its SMEs to identify 16 

Food Groups and Food Categories and Food Subcategories within each Food Group. The 

consultations with these SMEs included their recommendations on the most relevant hazards 

that should be identified as known or reasonably foreseeable hazards (“potential hazards”) for 

subsequent hazard evaluation by each facility that produces food products in the Food 

Subcategories to determine which hazards require a preventive control as appropriate to the 

facility and its food products. Resources that SMEs used for this purpose included scientific 

publications (including information from the books of the International Commission on 

Microbiological Specifications for Foods and publications from the Centers for Disease Control 

and Prevention), published data from the FDA Recalls, Market Withdrawals, & Safety Alerts 

Website (Table 8 in section VI of the Introduction of this guidance), published FDA databases 

(such as the Pesticide Residue Monitoring Program Reports and Data (Table 8 in section VI of 

the Introduction of this guidance)) and unpublished FDA databases (such as the database used 

to store reports to the Reportable Food Registry4 and FDA surveillance databases) available to 

CFSAN SMEs.

In 2016, we first made Appendix 1 available as draft guidance for public comment (81 FR 

57816, August 24, 2016). The 2016 draft Appendix 1 included three sets of Tables of known or 

reasonably foreseeable hazards (“potential hazards”) – one for biological hazards, one for 

chemical hazards, and one for process-related biological, chemical, and physical hazards. After 

considering public comments, we revised Appendix 1 and are making this revised Appendix 1 

available as a revised draft guidance for public comment. This revised Appendix 1 only includes 

two sets of Tables of known or reasonably foreseeable hazards (“potential hazards”) – one for 

biological hazards and one for chemical hazards. This revised Appendix 1 no longer includes a 

table of known or reasonably foreseeable hazards (“potential hazards”) for process-related 

biological, chemical, and physical hazards, because process-related hazards generally are 

unique to each facility based on its operations and processes. Instead, section A1.7

recommends that each facility identify known or reasonably foreseeable (“potential”) process4 Aggregate information is available to the public from the FDA-TRACK: Reportable Food Registry Data 

Dashboard (Table 8 in section VI of the Introduction of this guidance).
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related hazards for its products based on its knowledge, experience, and history of hazards 

associated with its operations, using the recommendations provided in Chapter 2 of this 

guidance in combination with the information provided in Chapter 3 of this guidance. Similarly, 

section A1.7 recommends that each facility identify known or reasonably foreseeable 

(“potential”) facility-related hazards for its products based on its knowledge, experience, and 

history of hazards associated with its facility, using the recommendations provided in Chapter 2 

of this guidance in combination with the information provided in Chapter 3 of this guidance.

Although Appendix 1 is comprehensive, it is not exhaustive and only reflects data and 

information available as of 2022. New information about hazards that could be associated with 

certain types of food products could become available in the future. In addition, Appendix 1 

does not address specialty ingredients such as seaweed (other than seaweed extracts such as 

carrageenan), proteins extracted from plants (e.g., protein extracted from peas), proteins 

produced through microbial fermentation (e.g., egg-white protein produced through yeast 

fermentation), and microorganisms (e.g., Bifidobacterium spp. and Lactobacillus spp.). 

Information that you could use to evaluate known or reasonably foreseeable (“potential”) 

hazards in such ingredients includes technical data sheets provided by the supplier, and 

specifications that are established in the Food Chemicals Codex or an FDA regulation or that 

are described in FDA’s response to a GRAS notice.5 If you do not find readily available 

information about known or reasonably foreseeable (“potential”) hazards in an ingredient, you 

could check with the supplier of the ingredient.

While Appendix 1 is a comprehensive starting point, each facility has the ultimate responsibility 

to identify the hazards relevant to food manufactured, processed, packed, or held at that facility, 

such as hazards that are associated with its facility-specific history even though they are not 

identified as known or reasonably foreseeable (“potential”) hazards in the tables.

A1.5 Organization of Appendix 1

A1.5.1 Food Groups Addressed by Appendix 1

We organized Appendix 1 around 16 Food Groups, identified as Food Groups A through P:

• Food Group A: Bakery Items

• Food Group B: Beverage items

• Food Group C: Food Additives, Color Additives, and GRAS Substances

• Food Group D: Chocolate and Candy

• Food Group E: Dairy

• Food Group F: Dressings, Condiments, and Dips

• Food Group G: Egg and Egg Products

• Food Group H: Fruits and Vegetables

• Food Group I: Game Meat Products

5 For information about GRAS notices and FDA’s response to GRAS notices, see our website (Table 8 in 

section VI of the Introduction of this guidance).
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• Food Group J: Grains, Pulses, Flours, and Starches

• Food Group K: Nuts and Seeds

• Food Group L: Oils and Oil Products

• Food Group M: Snack Foods

• Food Group N: Soups and Sauces

• Food Group O: Spices and Herbs

• Food Group P: Food Sweeteners (Nutritive and Non-Nutritive)

A1.5.2 Tables of Known or Reasonably Foreseeable Hazards (“Potential 

Hazards”)

We organized the information regarding known or reasonably foreseeable hazards (“potential 

hazards”) in Appendix 1 as follows:

• Section A1.10 includes Tables 1A through 1P, which list the most relevant6 food-related 

biological hazards in Food Subcategories in the 16 Food Groups. These Tables are 

marked (with an “X”) for those food-related biological hazards that SMEs recommended be 

identified as known or reasonably foreseeable hazards (“potential hazards”) for subsequent 

hazard evaluation by a facility that produces food products in those Food Subcategories to 

determine which hazards require a preventive control, as appropriate to the facility and its 

food products. 

• Section A1.11, which lists the most relevant food-related chemical hazards, is organized 

around the same 16 Food Groups as those addressed in section A.1.10. 

o In 12 of these 16 Food Groups, Tables 2B, 2C, 2D, 2E, 2G, 2H, 2I, 2J, 2K, 2L, 2O, 

and 2P list the most relevant food-related chemical hazards in Food Subcategories. 

These Tables are marked (with an “X”) for the most relevant7 food-related chemical 

hazards that SMEs recommended be identified as known or reasonably foreseeable 

hazards (“potential hazards”) for subsequent hazard evaluation by a facility that 

produces food products in those Food Subcategories to determine which hazards 

require a preventive control as appropriate to the facility and its food products.

o In four of these 16 Food Groups (i.e., Bakery Items; Dressings, Condiments, and Dips; 

Snack Foods; and Soups and Sauces), the known or reasonably foreseeable 

(“potential”) chemical hazards depend on the ingredients used. To maintain the overall 

organization associated with the 16 Food Groups, section A1.11 includes an entry for 

that Food Group (i.e., Food Groups 2A, 2F, 2M, and 2N) and recommends that you 

refer to the Tables most applicable to the ingredients you use. 

6 In determining the most relevant biological hazards to list in the Tables, we first selected 12 of the major 

pathogens identified as being associated with foodborne illness in the United States. (Scallan et al., 

2011.) As discussed in section A1.6.1.2.2, we subsequently deleted Shigella spp. from the relevant 

biological hazards listed in the Tables. 7 For information on factors that we considered in determining the most relevant chemical hazards to list 

in the Tables, see section A1.6.2. 
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For more information about the hazards in these Tables, see chapter 3 and section A1.6.

A1.5.3 Organization of Each Table in Appendix 1

Each Table in Appendix 1 represents one Food Group, which is identified in the title of the 

Table. Below, we describe the elements of these Tables.

• Food Category: The main subdivision within each of the 16 individual Food Groups

• #: A code (with a number or a number/letter combination) assigned to each Food 

Subcategory

• Food Subcategory: Descriptive details to distinguish food items within the Food Category. 

See section A1.5.4 for more information about the Food Subcategories. The Food 

Subcategories may not include “niche” food products, raw materials, or ingredients that 

result from an evolution of food products over time.

• Storage Conditions: The Tables for most (but not all) Food Groups specify storage 

conditions for Food Subcategories in that Food Group. For example, the Tables for Bakery 

Items identify three storage conditions (e.g., refrigerated storage, frozen storage, and 

ambient storage) that apply to specific subcategories of Bakery Items. 

• Hazards: See Chapter 3 for detailed information about the hazards that are most relevant to 

food safety. An “X” marks those hazards that SMEs recommended be identified as known or 

reasonably foreseeable hazards ("potential hazards") for subsequent hazard evaluation by a 

facility that produces food products in those Food Subcategories to determine whether these 

are hazards that require a preventive control as appropriate to the facility and its food 

products. For help in determining which of these recommendations apply to your food 

product and might be hazards requiring a preventive control as appropriate to your facility 

and your food, see Chapter 2 and Chapter 3 and the discussion in section A1.8.

• Comments: In general, your knowledge of your food product (e.g., ingredients, intended use, 

and storage conditions) should enable you to identify the Food Category and Food 

Subcategory that best represents it. However, although some products obviously fall into a 

Food Category and Subcategory, others may not. For example, “chocolate chip cookies” 

obviously fall into the Food Category Brownies/Cookies, but it may not be obvious that the 

Tables consider biscotti to be a “cookie.” Therefore, the Comments provide examples of 

products that may not obviously fall into a Food Category and Subcategory. 

Importantly, the food products in a Food Subcategory, and the sources of food ingredients in the 

Food Subcategories, are diverse. As a result, the recommendations of SMEs in the Tables in 

Appendix 1 may not always apply to all food products in that Food Subcategory. See the 

recommendations in section A1.8 regarding how to use the Tables in this Appendix, including 

discussion that hazards that SMEs recommended be identified as known or reasonably 

foreseeable hazards (“potential hazards”) might not apply to all food products in a Food 

Subcategory; each facility determines, through its hazard analysis, those known or reasonably 

foreseeable hazards (“potential hazards”) that require a preventive control.

Food products evolve and, thus, over time there will be food products that are not addressed in 

the Tables of potential hazards. If you identify a Food Subcategory that has characteristics of 

your food product, you may still be able to use the Tables in Appendix 1 to help you identify 

known or reasonably foreseeable hazards (“potential hazards”) that warrant evaluation to 

determine whether they are hazards requiring a preventive control for your food product.
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A1.5.4 The Food Subcategories in the Tables in Appendix 1 Address Raw 

Materials, Other Ingredients, and Multi-Component Foods 

Most foods contain multiple raw materials and other ingredients. Although many of the foods in 

the Tables are multi-component foods, it is not practical to include all multi-component foods in 

the tables, because the ingredients and processing methods can vary widely (e.g., entrées, side 

dishes, sandwiches). To assess the biological and chemical hazards for these multi-component 

foods, 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. 

Some Tables, such as the “Food Additives, Color Additives, and GRAS Substances” Food 

Group Table, address food materials that are almost exclusively used as ingredients in the 

production of other foods. Examples of foods in the “Food Additives, Color Additives, and GRAS 

Substances” Food Group are emulsifiers, stabilizers and thickeners, enzymes, colors, flavors, 

and other ingredients (such as antimicrobials and preservatives). 

Other Tables address Food Groups with Food Categories and Food Subcategories that are 

both commonly used as raw materials or other ingredients in the production of multicomponent foods and commonly consumed as finished foods. When using these Tables, the 

known or reasonably foreseeable hazards (“potential hazards”) that you should consider for an 

ingredient that you use in manufacturing/processing one of these food products could depend 

on how you use the ingredient. For example:

• Food products that are in the “Whole, Grains” Food Subcategory in Table 1J (e.g., barley, 

quinoa) are commonly sold both to manufacturers/processors for use as an ingredient in 

multi-component foods and to consumers. Multi-component foods manufactured/processed 

using whole grains as an ingredient can be dry foods (such as dry mixes that consumers 

use in cooking) or high-moisture foods (such as cooked grain bowls and cooked grain-based 

side dishes) in which the whole grains are hydrated during manufacturing/processing. You 

should consider Bacillus cereus as a known or reasonably foreseeable hazard (“potential 

hazard”) when you use the whole grains to manufacture/process a cooked high-moisture 

product (where B. cereus could grow), but not when you distribute dry whole grains to 

consumers or use the dry whole grains to manufacture/process a dry mix that consumers 

will cook.

• Food products that are in the “Dry Mixes, Powders” Food Subcategory in the “Soups, 

Sauces, Gravies” Food Category in Table 1N are commonly sold both to 

manufacturers/processors for use as an ingredient in multi-component foods (such as 

refrigerated or frozen meals) and to consumers (e.g., for use in an entrée prepared at home 

by rehydration followed by cooking). You should consider pathogenic sporeformers such as 

B. cereus and C. perfringens as known or reasonably foreseeable hazards (“potential 

hazards”) when you use a dry mix or powder as an ingredient of a sauce that you use to 

manufacture/process a frozen meal, but not when you use the dry mix or powder to 

manufacture/process a dry sauce mix packaged for retail sale to consumers.

• Food products that are in the “Dried, Ground, Cracked, or Whole” Food Subcategory in the 

“Spices” Food Category in Table 1O are commonly sold both to manufacturers/processors 

for use as an ingredient in multi-component foods (such as high-moisture dips, sauces, and 

refrigerated and frozen meals) and to consumers (e.g., for use in an entrée prepared at 

home). You should consider pathogenic sporeformers such as B. cereus and C. perfringens

as known or reasonably foreseeable hazards (“potential hazards”) when you use a product 
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in this Food Subcategory to manufacture/process high-moisture foods such as dips, sauces, 

and refrigerated and frozen meals (where high moisture could allow growth of pathogenic 

sporeformers), but not when you use a dry product in this Food Subcategory to 

manufacture/process a dry spice mix.

Some Food Categories and Food Subcategories could apply to more than one Table. For 

example, oil-based flavor extracts from plants appear in the oil-based liquid Subcategory of the 

Flavor Category in Table 1C (Miscellaneous Food Additives, Color Additives, and GRAS 

Substances) as well as in the essential oil Subcategory in the Seasonings Category in Table 1O

(Spices and Herbs). As another example, the category/subcategory of dairy-based ready-todrink beverages appear in Table 1B (Beverage Items) as well as in the cultured milk products 

subcategory of the milk and butter category in Table 1E (Dairy Products).

A1.5.5 Food Categories/Food Subcategories that Are LACF 

The PCHF requirements do not apply with respect to activities that are subject to the LACF 

regulations (21 CFR part 113) for the control of biological hazards and, thus, LACF foods are 

not covered by the Food Categories/Food Subcategories in Tables 1A through 1P (FoodRelated Biological Hazards). (See 21 CFR 117.5(d).) C. botulinum would be the biological 

hazard associated with an LACF used as an ingredient; the hazard would be controlled by the 

supplier. 

The PCHF requirements do apply to chemical and physical hazards that could be associated 

with an LACF food. The Tables in section A1.11 address chemical hazards that you should 

consider for LACF. For example, for the known or reasonably foreseeable (“potential”) chemical 

hazards associated with a canned vegetable, you should look at Table 2H, which addresses the 

Food Group Fruits and Vegetables. 

A1.5.6 Infant Formula and Other Foods for Infants and Toddlers

Infant formula is a specialized, multi-component food. The Food Categories/Food Subcategories 

in the Tables in Appendix 1 do not list infant formula. When you manufacture/process an infant 

formula, you should consider whether there are known or reasonably foreseeable biological or 

chemical hazards (“potential biological or chemical hazards”) associated with the ingredients of 

that infant formula. 

The Food Categories/Food Subcategories in the Tables in Appendix 1 do not specifically 

identify “baby food,” such as pureed fruits and vegetables intended for consumption by infants 

and toddlers. When you manufacture/process a food intended for consumption by infants or 

toddlers, you should look for a broader term applicable to that food. For example, for “baby 

food” that contains fruit, you could look at the Heat-Treated Fruit Products Subcategory or any 

of the other fruit-related Subcategories in Tables 1H and 2H. For “baby food” that contains a 

vegetable, you could look at any of the vegetable-related Subcategories in Tables 1H and 2H. 

See also the discussion of known or reasonably foreseeable (“potential”) biological hazards in 

infant formula and other foods for infants and toddlers in section A1.6.1.5 and the discussion of 

known or reasonably foreseeable (“potential”) chemical hazards in infant formula and other 

foods for infants and toddlers in section A1.6.2.5.
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A1.6 Tables of Known or Reasonably Foreseeable Hazards (“Potential 

Hazards”) in Appendix 1

A1.6.1 Food-Related Biological Hazards 

A1.6.1.1 The most relevant food-related biological hazards

Chapter 3 of this guidance provides background information (e.g., characteristics of 

microorganisms that can contaminate food and potential sources of these microbial 

contaminants) for the following food-related biological hazards that are most relevant to food 

safety: 

• Bacillus cereus

• Clostridium botulinum

• Clostridium perfringens

• Brucella spp.

• Campylobacter spp.

• Pathogenic E. coli

• Salmonella spp.

• Listeria monocytogenes

• Shigella spp.

• Staphylococcus aureus

• Parasites

• Viruses

As discussed in section A1.3, Chapter 3 does not provide an exhaustive compendium of 

biological, chemical, and physical hazards. Likewise, Tables 1A through 1P do not include an 

exhaustive list of known or reasonably foreseeable (“potential”) biological hazards. For example, 

Tables 1A through 1P do not list the biological hazard Cronobacter spp. (including C. sakazakii) 

because Cronobacter spp. (including C. sakazakii) is largely a hazard for powdered infant 

formula rather than a hazard applicable to foods for the general population.

8 However, Table 1E

(for the Food Category Dairy) notes that the SMEs recommend considering Cronobacter spp. 

(including C. sakazakii) as a known or reasonably foreseeable (“potential”) biological hazard in 

powdered milk intended for use in infant formula. 

Many RACS that are raw materials or ingredients in food products could be contaminated with 

multiple known or reasonably foreseeable (“potential”) biological hazards. In many cases, 

processing to control the most common of these known or reasonably foreseeable (“potential”) 

biological hazards for a Food Subcategory would also control biological hazards that are less 

common. For example, the most common known or reasonably foreseeable (“potential”) 

8 The draft Chapter 3 that we made available for public comment in 2016 did not discuss Cronobacter

spp. When we finalize that chapter, we intend to add a discussion of Cronobacter spp. and applicable 

references.
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biological hazard for raw cocoa beans is Salmonella. Processing to control Salmonella would 

also control less common known or reasonably foreseeable (“potential”) biological hazards for 

raw cocoa beans (such as L. monocytogenes and pathogenic E. coli). Therefore, Table 1D only 

identifies Salmonella as a known or reasonably foreseeable (“potential”) biological hazard for 

raw cocoa beans.

A1.6.1.2 Note about viruses, parasites, and Shigella spp. 

In food establishments subject to part 117, contamination of food with biological hazards that 

are viruses (e.g., norovirus and hepatitis A virus), parasites (e.g., Cryptosporidium spp., 

Cyclospora cayetanensis, and Giardia intestinalis) or the bacterial pathogen Shigella spp. by 

food handlers generally is addressed by following the CGMPs such as those relevant to worker 

hygiene and disease control. (See 21 CFR 117.10.) Likewise, when an entity that supplies 

produce to a food facility for use as an ingredient in a food product is subject to our produce 

safety regulation entitled “Standards for the Growing, Harvesting, Packing, and Holding of 

Produce for Human Consumption” (21 CFR part 112), that supplier addresses biological 

hazards that are viruses, parasites, or Shigella spp. by following provisions such as the 

standards for Health and Hygiene in part 112, subpart D. For waterborne viruses and parasites 

and for Shigella spp. (which can be present due to fecal contamination), a supplier of produce 

that is subject to 21 CFR part 112 would also follow the standards for Agricultural Water in part 

112, subpart E9

. 

A1.6.1.2.1 Viruses and parasites

There are very few Food Subcategories in which the SMEs identified viruses or parasites as 

known or reasonably foreseeable (“potential”) biological hazards for subsequent hazard 

evaluation to determine whether they are hazards requiring a preventive control. In the “Fruits 

and Vegetables” Food Group (see Table 1H), these Food Subcategories are:

• “Whole RAC” Food Subcategory in the “Fruits” Food Category; 

• “Fresh-cut” Food Subcategory in the “Processed Fruits” Food Category; 

• “Whole or Cut” (Frozen) Food Subcategory in the “Processed Fruits” Food Category; and 

• “Whole RAC” Food Subcategory in the “Vegetables” Food Category. 

Note that footnotes in Table 1H identify specific foods for which the SMEs identified viruses or 

parasites as known or reasonably foreseeable (“potential”) biological hazards for subsequent 

hazard evaluation within the Food Category. 

In the “Game Meat” Food Group (see Table 1I), the SMEs identified the parasite Toxoplasma 

gondii as associated with wild boar, deer and elk and considered that Trichinella spp. is 

primarily a problem with wild game such as wild boar, bear and walrus. This guidance does not 

address hazards associated with wild game meat, only farm-raised game meat. Thus, Table 1I

9 In 2019, FDA extended the dates for compliance with the provisions of part 112, subpart E for covered 

produce other than sprouts (84 FR 9706, March 18, 2019). The compliance dates range from January 26, 

2022, through January 26, 2024, depending on the size of a covered farm. In 2021, FDA proposed to 

amend the agricultural water provisions of the produce safety regulation that covered farms have found 

complex and challenging to implement (86 FR 69120, December 6, 2021). In that proposed rule, FDA 

announced its intent to exercise enforcement discretion for these subpart E requirements while pursuing 

a targeted compliance date rulemaking, with the goal of completing the rulemaking as quickly as possible.
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only identifies Toxoplasma gondii as a known or reasonably foreseeable (“potential”) biological 

hazard for deer and elk that are farmed for commercial meat distribution.

A1.6.1.2.2 Shigella spp.

Outbreaks of foodborne shigellosis have been associated with contaminated raw vegetables 

such as lettuce salads, shredded cabbage, green onions and parsley (Beuchat, 1996; Long et 

al., 2002; Naimi et al., 2003), and the SMEs identified Shigella spp. as known or reasonably 

foreseeable (“potential”) biological hazards for subsequent hazard evaluation for these raw 

vegetables in the “Fruits and Vegetables” Food Group. The SMEs also identified Salmonella

and/or pathogenic E. coli as known or reasonably foreseeable (“potential”) biological hazards for 

these raw vegetables in the “Fruits and Vegetables” Food Group. If you identify Salmonella

and/or pathogenic E. coli as a hazard requiring a preventive control, a preventive control that 

you establish and implement to significantly minimize or prevent Salmonella or pathogenic E. 

coli generally would also significantly minimize or prevent Shigella spp. Therefore, we decided 

that it was not necessary to separately identify Shigella spp. as a known or reasonably 

foreseeable (“potential”) biological hazard for subsequent hazard evaluation in any Food 

Group, and none of the Tables in section A1.10 list Shigella spp. as a known or reasonably 

foreseeable (“potential”) biological hazard.

A1.6.1.3 Note about biological hazards in food subcategories manufactured 

using exceptionally lethal processes 

Some food products can only be produced using exceptionally lethal processes that adequately 

control biological hazards. If the processing is not conducted in a way that adequately controls 

biological hazards, the product would not be suitable for distribution. Due to the exceptional 

lethality of the processes used to manufacture these food products, in some instances the 

SMEs did not identify any known or reasonably foreseeable (“potential”) biological hazards for 

these foods (e.g., sugar confections in Table 1D and crackers in Table 1M). In other instances, 

the tables indicate known or reasonably foreseeable (“potential”) biological hazards, but a 

facility could determine these are not hazards requiring a preventive control because they are 

produced using an exceptionally lethal process (e.g., soups, sauces and gravies, where some of 

the products receive an exceptionally lethal process but other products do not). 

For example:

• A process of making caramel by boiling ingredients such as sugar, butter, and sweetened 

condensed milk for several minutes to about 240oF (116oC) would provide exceptional 

lethality for biological hazards (e.g., Listeria monocytogenes); without boiling for several 

minutes, the ingredients will not result in a chewy caramel when cooled. Thus, the SMEs did 

not identify any known or reasonably foreseeable (“potential”) biological hazards associated 

with the “Sugar Confections” Food Subcategory (e.g., caramels) in the “Chocolate and 

Confectionery Products” Food Category (Table 1D).

• A process of making jam, jelly, or chutney by a process that includes boiling would provide 

exceptional lethality for biological hazards (e.g., pathogenic E. coli, Salmonella species 

(spp.), and Listeria monocytogenes); without boiling these products will not thicken to the 

desired consistency. Thus, the SMEs did not identify any known or reasonably foreseeable 

(“potential”) biological hazards associated with the “Jams, Jellies, Chutneys” Food 

Subcategory in the “Processed Fruits” Food Category (Table 1H). 
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• A process of making a shelf-stable acid or acidified fruit cocktail would provide exceptional 

lethality for biological hazards (e.g., pathogenic E. coli, Salmonella spp., and Listeria 

monocytogenes). The process for making the fruit cocktail that can be stored at ambient 

temperatures is designed to inactivate certain non-pathogenic sporeformers that could 

cause spoilage; these sporeformers have much greater heat resistance than the vegetative 

pathogens that are the biological hazards in the ingredients. The SMEs identified several 

known or reasonably foreseeable (“potential”) biological hazards associated with the 

Subcategory “Heat-Treated Fruit Products” in the “Processed Fruits” Food Category (Table 

1H) but noted that some of these foods may receive an exceptionally lethal process.

• A process of making a gravy by boiling or cooking down a liquid sauce to thicken it would 

provide exceptional lethality for vegetative pathogens such as E. coli O157:H7, Salmonella

spp. and Listeria monocytogenes, and, if one of these is the pertinent pathogen in an 

ingredient, you may not need to consider it as a known or reasonably foreseeable 

(“potential”) biological hazard. (Alternatively, your PCQI could identify vegetative pathogens 

such as E. coli O157:H7, Salmonella spp. or Listeria monocytogenes, as known or 

reasonably foreseeable (“potential”) biological hazards for ingredients used in making gravy, 

but determine that they do not require a preventive control because the process is 

exceptionally lethal.) The SMEs identified several known or reasonably foreseeable 

(“potential”) biological hazards associated with the Subcategories in the “Soups, Sauces, 

Gravies” Food Category (Table 1N) but noted that some of these foods may receive an 

exceptionally lethal process. 

• A baking process (e.g., 482oF (250oC) for 4.5 min.) used in the manufacture of snack 

crackers would provide exceptional lethality for vegetative pathogens such as E. 

coli O157:H7, Salmonella spp. and Listeria monocytogenes; without this high temperature 

process, the baked and cooled product would not have or retain the characteristic texture 

desired for this snack item. Thus, the SMEs did not identify any known or reasonably 

foreseeable (“potential”) biological hazards associated with the “Baked, Unfilled, 

Unseasoned or Seasoned” Food Subcategory in the “Crackers” Food Category (Table 1M).

A1.6.1.4 Note about biological hazards in products produced in 

establishments that are under the jurisdiction of USDA 

The production of certain meat products (but not game meat products), poultry products, and 

processed egg products (e.g., pasteurized liquid whole egg) is subject to regulation by USDA’s 

FSIS under the statutes it administers (i.e., the Federal Meat Inspection Act (21 U.S.C. 601 et 

seq.), the Poultry Products Inspection Act (21 U.S.C 451 et seq.), and the Egg Products 

Inspection Act (21 U.S.C. 1031 et seq.). None of the Food Groups in Appendix 1 is directed to 

products while under the sole jurisdiction of USDA’s FSIS. However, some FSIS-regulated

products are sometimes used as ingredients in food products that are subject to our regulation 

under the FD&C Act and produced in accordance with the requirements of part 117. For 

example, in the Food Group “Egg and Egg Products” the Food Category “Further Processed 

Egg Products” subcategory “Cooked Egg Products” includes products such as egg patties 

(which can be an ingredient in breakfast sandwiches) that can be made with liquid whole egg, 

an FSIS-regulated food. If you use a food product that is produced under the jurisdiction of 

USDA’s FSIS as an ingredient in your food product, you should determine, through your hazard 

analysis, whether a hazard you identify as a known or reasonably foreseeable (“potential”) 

biological hazard in that ingredient is a hazard requiring a preventive control. 
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In the Federal Register of October 29, 2020 (85 FR 68640), FSIS published a final rule to apply 

the egg products regulations to egg substitutes (e.g., egg whites) and freeze-dried products 

(e.g., freeze-dried breakfast items for outdoor recreation) and require inspection of these 

products. The final rule is effective October 30, 2023. The Food Group “Egg and Egg Products”

no longer includes egg substitutes and freeze-dried products.

A1.6.1.5 Note about biological hazards in infant formula and other foods for 

infants and toddlers

As discussed in section A1.5.6, the Food Categories/Food Subcategories in the Tables in 

Appendix 1 do not list infant formula or other foods for infants or toddlers. When you 

manufacture/process an infant formula or other food for infants or toddlers, you should consider 

whether there are known or reasonably foreseeable (“potential”) biological hazards associated 

with the ingredients in that infant formula or other food for infants and toddlers. 

Importantly, the controls to prevent adulteration from microorganisms in our infant formula 

regulations in 21 CFR part 10610 specify criteria for when a powdered infant formula that 

contains Cronobacter spp. or Salmonella spp. will be deemed adulterated under sections 

402(a)(1), 402(a)(4), and 412(a)(3) of the FD&C Act. You must comply with these 

microbiological criteria when you manufacture/process powdered infant formula. (See 21 CFR 

106.55(e).)

A1.6.1.6 Note about biological hazards in food products produced using 

ingredients that are pasteurized or otherwise treated to control biological 

hazards

Many biological hazards that could be in ingredients are controlled by pasteurization or other 

treatment that is performed by the supplier of those ingredients. For example, in many 

circumstances your supplier would control known or reasonably foreseeable (“potential”) 

biological hazards in milk-based ingredients used to make products such as dairy-based 

beverages, cream, cultured milk products, and cheese, or in egg-based ingredients used to 

make products such as some condiments. Tables 1A through 1P list the known or reasonably 

foreseeable (“potential”) biological hazards that could be in a food product due to the ingredients 

in the food product regardless of whether the outcome of the hazard analysis is that a hazard 

that requires a preventive control is controlled by you (e.g., by a process control) or by your 

supplier. 

A1.6.1.7 Note about biological hazards in food products that consumers 

cook

In some cases, the outcome of your hazard analysis for foods such as uncooked fruit pies could 

be that known or reasonably foreseeable (“potential”) biological hazards will be controlled by 

consumer cooking rather than by a preventive control. 

10 Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control 

Procedures, Quality Factors, Records and Reports, and Notifications
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A1.6.2 Food-Related Chemical Hazards

A1.6.2.1 The most relevant food-related chemical hazards

Chapter 3 of this guidance provides background information11 (e.g., characteristics of chemicals 

that can contaminate food and potential sources of these chemical contaminants) for the 

following food-related chemical hazards that are most relevant to food safety: 

• drug residues in milk, honey, and game meat; 

• environmental contaminants (e.g., dioxins and PCBs);

• food allergens and substances associated with a food intolerance or food-related disease 

(e.g., sulfites, gluten);

• toxic elements12 in or on produce ingredients;

• mycotoxins13 in commodities such as grains, apples, peanuts, and tree nuts;

• natural toxins (such as hypoglycin A in ackee and cyanogenic glycosides in cassava 

(yuca)14);

• pesticides in or on produce RACs15;

• radiological hazards; and

• unapproved food or color additives.

The Tables in section A1.11 address drug residues, toxic elements, mycotoxins/natural toxins, 

and pesticides. As discussed in sections A1.6.2.2 through A1.6.2.4, these Tables do not 

11 A reference that we did not include in draft Chapter 3 of this guidance is the European Union's Rapid 

Alert System for Food and Feed (RASFF) (Table 8 in section VI of the Introduction of this guidance). 

RASFF enables information to be shared efficiently between its members when risks to public health are 

detected in the food chain. The RASFF portal features an interactive searchable online database. It gives 

public access to summary information about the most recently transmitted RASFF notifications as well as 

the ability to search for information on any notification issued in the past. When we finalize Chapter 3, we 

intend to identify RASFF as a resource for you to use in determining whether a chemical hazard is a 

known or reasonably foreseeable (“potential”) hazard requiring a preventive control. 12 The discussion in the draft Chapter 3 that we made available for public comment in 2016 focused on 

the toxic elements that are heavy metals. When we finalize that chapter, we intend to discuss toxic 

elements more broadly, consistent with the discussions of toxic elements in FDA’s “Closer to Zero” action 

plan (Table 8 in section VI of the Introduction of this guidance). Import Alert 99-42 (Table 5 in section VI

of the Introduction of this guidance) covers specific firms that have offered foods with levels of heavy 

metals that may render a product injurious to health and that may be detained without physical 

examination in accordance with the guidance in FDA's Regulatory Procedures Manual Chapter 9-8 (Table 

8 in section VI of the Introduction of this guidance). 13 FDA’s Import Alert 23-14 identifies mycotoxins associated with certain food types (Table 5 in section VI

of the Introduction of this guidance). 14 The draft Chapter 3 that we made available for public comment in 2016 did not identify cyanogenic 

glycosides as a natural toxin. When we finalize that chapter, we intend to include cyanogenic glycosides 

as a natural toxin.

15 See Liang et al., 2021 and FDA’s Pesticide Residue Monitoring Program Reports and Data for 

commodities associated with pesticides (Table 8 in section VI of the Introduction of this guidance).
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address food allergens, substances associated with a food intolerance or food-related disease, 

radiological hazards, dioxins, and unapproved food or color additives. 

As discussed in Chapter 3, the PCHF requirements specify that you must consider, as part of 

your hazard identification, known or reasonably foreseeable hazards that may be intentionally 

introduced for purposes of economic gain (21 CFR 117.130(b)(2)(iii)) and recommends that you 

focus on circumstances where there has been a pattern of such adulteration in the past. 

Chapter 3 includes a quick reference guide (Table 3-8) that lists circumstances where there has 

been a pattern of such adulteration in the past and identifies additional resources that you can 

use for this purpose. The Tables in section A1.11 do not further address known or reasonably 

foreseeable hazards that may be intentionally introduced for purposes of economic gain.

A1.6.2.2 Note about food allergen hazards and substances associated with 

a food intolerance or food-related disease 

See the discussion of food allergen hazards in Chapter 3.16 The Food Allergen Labeling and 

Consumer Protection Act of 2004 (FALCPA) amended the FD&C Act and defined the following 

eight foods and any ingredients that contain protein derived from these eight foods (with certain 

exemptions noted in section 201(qq)(2) of the FD&C Act (21 U.S.C. 321(qq)(2)), including highly 

refined oils) as major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, 

wheat, and soybeans. In 2021, the Food Allergy Safety, Treatment, Education, and Research 

Act of 2021 (FASTER) amended the definition of "major food allergen" to add sesame to that 

definition, effective for food that is introduced or delivered for introduction into interstate 

commerce on or after January 1, 2023.

A food allergen hazard can occur due to an undeclared food allergen in your food product or in 

raw materials or other ingredients that you receive from a supplier. A food allergen hazard also 

can occur due to unintended allergen presence17 that can occur during production of your food 

product or during production of raw materials or other ingredients that you receive from a 

supplier. As a result, a food allergen hazard could be identified as a known or reasonably 

foreseeable (“potential”) chemical hazard for a majority of food products. Rather than identifying 

food allergen hazards as known or reasonably foreseeable (“potential”) chemical hazards for 

most food subcategories, the Tables of food-related chemical hazards do not address food 

allergen hazards. 

As discussed in Chapter 3, for some consumers, certain substances can cause hypersensitivity 

reactions. Like food allergens, these substances are lawfully used in food. Also, like food 

allergens, some of these substances are subject to labeling requirements. For example, some 

sulfiting agents must be listed on the ingredient label unless they are added to food as an 

“incidental substance”; sulfiting agents are considered to be incidental only if they have no 

technical effect in the finished food and are present at less than 10 parts per million (ppm) (21 

CFR 101.100(a)(4)). Because such substances generally are intentionally added to food (rather 

than be contaminants that could be unintentionally added to food), the Tables of food-related 

chemical hazards do not address these substances. 

16 For information on controlling food allergen hazards, see Chapter 11 of this guidance. 17 We use the term “unintended allergen presence” to mean the presence of an allergen due to allergen 

cross-contact.
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A1.6.2.3 Note about radiological hazards, dioxins, PCBs, and toxic 

elements 

See the discussion of radiological hazards in Chapter 3. Radiological hazards rarely occur in the 

food supply. There are two primary sources of radiological hazards:

• water: the primary source of water that could be contaminated with radiological hazards is 

well water in specific areas in the United States where high concentrations of some 

radionuclides, such as radium-226, radium-228, and uranium, have been detected in well 

water; and

• accidental contamination, e.g., contamination arising from accidental release from a nuclear 

facility or from damage to a nuclear facility from a natural disaster.

Radiological hazards that result from contaminated well water or from accidental contamination 

can affect almost any Food Subcategory. Rather than identify radiological hazards as known or 

reasonably foreseeable (“potential”) chemical hazards for all food subcategories, the Tables of 

food-related chemical hazards do not address radiological hazards. We recommend that you 

consider the information in Chapter 3 regarding radiological hazards when conducting your 

hazard analysis for your food products.

See also the discussion of dioxins and PCBs, which are environmental contaminants18, in 

Chapter 3. Because dioxins and PCBs rarely occur in the food supply and are largely 

associated with accidental contamination, the Tables of food-related chemical hazards do not 

address dioxins or PCBs.

Table 3-1 in Chapter 3 identifies four heavy metals (which we now refer to as “toxic elements”)

as chemical hazards that can contaminate food: arsenic, cadmium, lead, and mercury. This 

Appendix does not address mercury, which is principally a hazard in seafood products that are 

not covered by this guidance.

Water is an ingredient in many food products. If you source a water-containing food from a 

geographic area in which water has been contaminated with toxic elements, you may need to 

consider whether a toxic element is a known or reasonably foreseeable (“potential”) hazard for 

your food product (Keurig Dr Pepper, 2019; see also FDA Import Alert 99-42 in Table 5 in 

section VI of the Introduction of this guidance).

A1.6.2.4 Note about unapproved food and color additives 

See the discussion of food additives, color additives, and GRAS substances in Chapter 3, 

including the statutory framework applicable to substances that are added to food. An 

unapproved food or color additive that results from use of a substance that is not lawful for use 

in food can affect almost any Food Subcategory. Rather than identify unapproved food or color 

additives as known or reasonably foreseeable (“potential”) chemical hazards for all food 

18 The draft Chapter 3 that we made available for public comment in 2016 did not discuss perchlorates 

and per- and polyfluoroalkyl substances (PFAS), which can result from industrial contamination. When we 

finalize that chapter, we intend to include perchlorates and PFAS as examples of environmental 

contaminants.
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subcategories, the Tables of food-related chemical hazards do not address unapproved food 

and color additive hazards. 

A substance that is GRAS under the conditions of its intended use is not subject to the 

premarket review and approval requirements applicable to food and color additives. Although 

some GRAS substances are listed in our regulations, other GRAS substances are lawfully used 

in food without being listed in our regulations.

Some food and color additives are specifically prohibited from use in food because we have 

determined that the chemical additive poses a potential risk to public health (see 21 CFR part 

189 and 21 CFR 81.10). Examples of such food and color additives are coumarin (21 CFR 

189.130), safrole (21 CFR 189.180), and FD&C Red No. 4 (“Red No. 4”) (21 CFR 81.10(d)). We 

consider a prohibited food additive or color additive to be an unapproved food additive or color 

additive for the purposes of the PCHF requirements and, thus, to be a chemical hazard. 

We recommend that you consider the information in Chapter 3 to reduce the potential for an 

unapproved food or color additive in your food products. We intend to update Chapter 3 to 

highlight the following resources:

• Food and color additive regulations. The most relevant regulations are in:

o 21 CFR part 73: Listing of Color Additives Exempt from Certification

o 21 CFR part 74: Listing of Color Additives Subject to Certification

o 21 CFR part 172: Food Additives Permitted for Direct Addition to Food for Human 

Consumption

o 21 CFR part 173: Secondary Direct Food Additives Permitted in Food for Human 

Consumption

• The Color Additive Status List and the Food Additive Status List (Table 8 in section VI of the 

Introduction of this guidance)

• Lists of substances that are used in food under the GRAS provisions of the FD&C Act, 

including:

o 21 CFR part 182: Substances Generally Recognized as Safe

o 21 CFR part 184: Direct Food Substances Affirmed as Generally Recognized as Safe

o GRAS Notice Inventory (Table 8 in section VI of the Introduction of this guidance)

A1.6.2.5 Note about toxic element hazards in foods for infants and toddlers, 

including infant formula

As discussed in section A1.5.6, the Food Categories/Food Subcategories in the Tables in 

Appendix 1 do not list infant formula or other foods for infants and toddlers. When you 

manufacture/process an infant formula or other food for infants or toddlers, you should consider 

whether there are known or reasonably foreseeable (“potential”) chemical hazards associated 

with the ingredients in that infant formula or other food for infants or toddlers. 

FDA’s “Closer to Zero” action plan (Table 8 in section VI of the Introduction of this guidance) 

identifies actions we will take to reduce exposure to toxic elements from foods eaten by babies 
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and young children. We have prioritized babies and young children because their smaller body 

sizes and metabolism make them more vulnerable to the harmful effects of these contaminants. 

The “Closer to Zero” action plan follows a four-stage iterative approach that includes research, 

regulatory, and outreach efforts to lead to the development of action levels for certain toxic 

elements in categories of baby foods (e.g., cereals, pureed fruits and vegetables) and other 

foods commonly eaten by babies and young children. 

This guidance does not identify specific action levels for any toxic element hazards in foods for 

infants and toddlers. Instead, we identify action levels or other recommendations for reducing 

toxic elements in foods for infants and toddlers in more specific guidance such as Compliance 

Policy Guides (Table 3 in section VI of the Introduction of this guidance) and Guidance for 

Industry (Table 4 in section VI of the Introduction of this guidance). For example, as of the date 

of publication of this Appendix, our Guidance for Industry addresses arsenic in rice cereal, 

arsenic in juice, lead in juice, lead in food intended for babies and young children, and lead in 

candy likely to be consumed frequently by small children (Table 4 in section VI of the 

Introduction of this guidance). You should check our "Closer to Zero: Action Plan for Baby 

Foods” website (Table 8 in section VI of the Introduction of this guidance), and our websites 

listing Compliance Policy Guides and Guidance for Industry, for such action levels on a regular 

basis, because the action plan’s iterative approach can lead to adjustments in any announced 

action levels on an ongoing basis.

A1.6.2.6 Note about mycotoxin hazards 

As discussed in Chapter 3 and in our Compliance Program19 7307.001 (Mycotoxins in Domestic 

and Imported Foods) (Table 5 in section VI of the Introduction of this guidance), mycotoxins are 

a common group of natural toxins that include aflatoxin, fumonisin, deoxynivalenol (vomitoxin), 

ochratoxin, and patulin. Mycotoxins are toxic metabolites produced by certain fungi (i.e., molds) 

that can infect and proliferate on agricultural commodities (e.g., grains such as wheat and corn, 

peanuts, fruits, and tree nuts) in the field and during storage. Specific mycotoxins are most 

commonly associated with certain commodities as follows:

• aflatoxin: peanuts, dried corn, tree nuts, and some edible seeds20 (melon seeds, pumpkin 

seeds, and sunflower seeds);

• ochratoxin: cocoa, coffee, raisins, dried figs, cereal grains;

• fumonisins: dried corn;

• deoxynivalenol (vomitoxin): wheat, barley; and

• patulin: apples 

19 FDA's Compliance Programs (Table 5 in section VI of the Introduction of this guidance) provide 

instructions to FDA personnel for conducting activities to evaluate industry compliance with the FD&C Act 

and other laws administered by FDA. Compliance Programs are made available to the public under the 

Freedom of Information Act.

20 The draft Chapter 3 that we made available for public comment in 2016 did not discuss aflatoxins in

edible seeds. When we finalize that chapter, we intend to reference the information in our Compliance 

Program 7307.001 (Mycotoxins in Domestic and Imported Foods; Table 5 in section VI of the Introduction 

of this guidance).
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When a Table of known or reasonably foreseeable (“potential”) chemical hazards broadly 

identifies the chemical hazard “mycotoxin,” a footnote in the Table also identifies the applicable 

mycotoxin. 

A1.7 Process-related Hazards and Facility-related Hazards 

As discussed in Chapter 2 of this guidance, when conducting your hazard analysis, you 

consider those known or reasonably foreseeable hazards (“potential hazards”) originating from 

processes (process-related hazards), and the food-production environment (facility-related 

hazards) (21 CFR 117.130(c)(2)). Because each facility is unique in its products, operations, 

processes, and physical plant, process-related hazards and facility-related hazards can be 

specific to each facility. Therefore, this Appendix 1 does not identify known or reasonably 

foreseeable (“potential”) process-related hazards or facility-related hazards. Instead, we 

recommend that each facility identify known or reasonably foreseeable (“potential”) processrelated hazards or facility-related hazards for its products based on its knowledge, experience, 

and history of hazards associated with its operations. The recommendations provided in 

Chapter 2 of this guidance and the information provided in Chapter 3 of this guidance are 

resources for facilities to do so. For your convenience, we list the most relevant biological, 

chemical, and physical hazards that are process-related or facility-related (as discussed in 

Chapter 3) in sections A1.7.1 and A1.7.2.

For examples of known or reasonably foreseeable (“potential”) process-related hazards and 

facility-related hazards that could be associated with certain operations, see sections A1.7.1 

through A1.7.3. 

A1.7.1 The Most Relevant Process-related and Facility-related Biological 

Hazards

Sections 3.3.4 and 3.3.5 in Chapter 3 of this guidance provide background information for the 

following process-related and facility-related biological hazards that are most relevant to food 

safety:

• Bacterial Pathogens – Presence / growth / toxin production due to survival of a lethal 

treatment. (Section 3.3.4.1)

o For example, a heat treatment that is not properly delivered (e.g., the temperature is too 

low, or the heating time is insufficient) could allow a pathogen to survive; in some cases,

the surviving pathogens could subsequently grow and produce toxin. 

• Bacterial Pathogens - Growth and/or toxin production due to poor time/temperature control. 

(Sections 3.3.4.2.1 and 3.3.4.2.2)

o For example, a cooling mechanism that does not function as intended could allow a 

small number of microbial pathogens to increase in number.

• Bacterial Pathogens - Growth and/or toxin production due to poor formulation control. 

(Section 3.3.4.2.3)

o For example, if insufficient acid is added to reduce the pH sufficiently in an acidified 

food, pathogenic sporeformers could grow and produce toxin.

• Bacterial Pathogens - Growth and/or toxin production due to reduced oxygen packaging 

(ROP). (Section 3.3.4.2.4)
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o For example, reduced oxygen packaging that is used to increase shelf life could create 

an environment that supports the growth of C. botulinum.

• Bacterial pathogens - Presence due to ingredients added after process controls. (Section 

3.3.4.3)

• Bacterial Pathogens – Presence, growth, or growth with toxin production due to 

recontamination due to lack of container integrity. (Section 3.3.4.4)

o For example, if a container is not properly sealed and it is cooled in water, water 

containing pathogens can be drawn into the container. 

• Environmental Pathogens – Presence due to recontamination from the processing 

environment. (Section 3.3.5.1)

o For example, equipment that is difficult to clean or is prone to damage could increase 

the risk for environmental pathogens to contaminate the product post-processing.

o As another example, facility traffic patterns can transfer environmental pathogens from 

one process area to another.

See also Chapters 6 through 10 of this guidance. These chapters address process controls that 

are heat treatments, time/temperature controls, formulation, drying/dehydrating, and sanitation 

controls, respectively, applicable to process-related and facility-related biological hazards that 

require a preventive control.

A1.7.2 The Most Relevant Process-related Chemical Hazards

Section 3.4.2 in Chapter 3 of this guidance provides background information for the following 

process-related chemical hazards that are most relevant to food safety:

• Undeclared food allergens – Incorrect label (Sections 3.4.2.1.2 and 3.4.2.1.3). For example:

o An incorrect label can result if you change the product formulation to include a food 

allergen but do not update the product label to declare that food allergen.

o If the product label is pre-printed on the product package, an incorrect label can result if 

the wrong packaging is brought to the production line.

o If you apply the product label to the package after the package has been filled, an 

incorrect label can result if the wrong label is brought to the production line.

• Unintended food allergen presence – allergen cross-contact (Section 3.4.2.1.4). For 

example:

o Allergen cross-contact can result if equipment that is difficult to clean or is prone to 

damage is used to produce foods that contain ingredients from different food allergen 

sources. 

o Allergen cross-contact can result from the unintentional addition of the wrong ingredient 

to a food.

• Chemical hazards due to mis-formulation (e.g., sulfites, yellow #5) (Section 3.4.2.2.2)

o For example, mis-formulation can occur if you manufacture/process some products with 

added sulfites and other products without sulfites, and if you unintentionally add sulfites 

to a product that does not include sulfites in the product recipe. 

• Process-contaminant hazards in certain plant-based foods (Section 3.4.2.3)
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o For example, some chemical hazards (such as acrylamide in certain plant-based foods 

and 3-monochloropropane-1,2-diol esters (3-MCPDEs) and glycidyl esters (GEs) 

(developed in some refined oils)) have the potential to form during food production, 

particularly at high temperature.21 See our website regarding 3-MCPDEs and GEs (Table 

8 in section VI of the Introduction of this guidance) and the Codex Code of Practice CXC 

79-2019 in Table 6 in section VI of the Introduction of this guidance.

22

See also Chapters 11 and 12 of this guidance; these chapters address food allergen controls 

and preventive controls for chemical hazards, respectively, applicable to process-related 

chemical hazards that require a preventive control.

As discussed in section 3.4.3 of Chapter 3 of this guidance, this guidance does not discuss 

preventive controls for facility-related chemical hazards such as cleaning chemicals and the 

leaching of heavy metals from containers or utensils, because such hazards are usually 

addressed through CGMPs.

A1.7.3 The Most Relevant Process-related Physical Hazards 

Section 3.5 in Chapter 3 of this guidance provides background information for the following 

process-related and facility-related physical hazards that are most relevant to food safety: 

• Metal (Section 3.5)

o For example, a process that uses a metal chopping blade could introduce metal 

fragments if the blade breaks.

• Glass (when product is packed in glass) (Section 3.5)

o For example, a product packaged in glass containers could introduce glass fragments if 

a container breaks.

• Hard plastic (Section 3.5)

o For example, hard plastic can be introduced into food when tools and equipment such as 

scoops, paddles, buckets or other containers develop fatigue, crack, and break as they 

wear, or when plastic sieves and screens deteriorate.

As discussed in section 3.5 in Chapter 3 of this guidance, in general there is overlap between 

facility-related physical hazards and process-related physical hazards and, in evaluating the 

potential for physical hazards in your food products, it does not matter whether you consider 

physical hazards to be facility-related or process-related. 

21 The Codex Alimentarius Commission, in which FDA participates, has developed recommendations for 

industry on reducing 3-MCPDE and GE in refined oils and foods, particularly when a refined oil is used in 

infant formula (Codex Code of Practice CXC 79-2019, Table 6 in section VI of the Introduction of this 

guidance). FDA has focused its testing efforts on infant formula because infants are a vulnerable 

population, infant formula contains relatively large amounts of oil (about 25-30%) to support infants’ 

nutritional needs, and, for some infants, infant formula is a sole food source. Because of the combined 

efforts of industry and FDA, average 3-MCPDE and GE levels in infant formula in the U.S. have declined 

over the last several years.

22 The draft Chapter 3 that we made available for public comment in 2016 did not discuss 3-MCPDE and 

GE that can form during the production of refined oils. When we finalize that chapter, we intend to include 

information about these process-related chemical hazards.
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See also Chapter 13 of this guidance, applicable to process-related and facility-related physical 

hazards that require a preventive control.

A1.8 How to Use the Tables in Appendix 1

A1.8.1 Appendix 1 Reflects a Tiered Approach to the Requirements for 

Hazard Analysis 

As discussed in section A1.3, part 117 establishes a tiered approach to the requirements for 

hazard analysis. This tiered approach considers three levels of hazards: 

• The universe of hazards most relevant to food safety; 

• Known or reasonably foreseeable hazards (“potential hazards”); and 

• Hazards requiring a preventive control.

Under this tiered approach, you conduct your hazard analysis by first broadly considering the 

universe of all hazards relevant to food safety and then, through the process of hazard 

identification, narrowing that broad list of hazards to those hazards that are known or 

reasonably foreseeable hazards (“potential hazards”) for your food products. You then 

determine, through the process of hazard evaluation, the subset of those known or reasonably 

foreseeable hazards (“potential hazards”) that are hazards requiring a preventive control. For 

additional help in determining which known or reasonably foreseeable hazards (“potential 

hazards”) require a preventive control, see Chapters 2 and 3.

The columns in the Tables in Appendix 1 list the most relevant hazards23, among the universe 

of hazards for food safety, for 16 Food Groups. Hazards marked with an X for a Food 

Subcategory are hazards that SMEs recommended be identified as known or reasonably 

foreseeable hazards ("potential hazards") for subsequent hazard evaluation by each facility that 

produces food products in those Food Subcategories. 

A1.8.2 Hazards that SMEs Recommended Be Identified as Known or 

Reasonably Foreseeable Hazards (“Potential Hazards”) Might Not Apply to All 

Food Products in a Food Subcategory 

The food products in a Food Subcategory, and the sources of food ingredients in the Food 

Subcategories, are diverse. As a result, the recommendations of SMEs in the Tables in 

Appendix 1 may not always apply to all food products in that Food Subcategory. For example, a 

hazard marked with an X could:

• Be a known or reasonably foreseeable (“potential”) hazard only for some products in a Food 

Subcategory. For example:

o Table 1O (Spices and Herbs) identifies Cyclospora as a known or reasonably 

foreseeable (“potential”) biological hazard for some, but not all, herbs in two Food 

Subcategories (2b and 3a).

23 For information on how we identified the most relevant biological and chemical hazards to address in 

this Appendix, see sections A1.5.2, A1.6.1, and A1.6.2.
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o Table 1C (Food Additives, Color Additives, and GRAS Substances) identifies

Salmonella as a known or reasonably foreseeable (“potential”) biological hazard for 

Flavors in Subcategory 5e (Ambient or Refrigerated Other Flavor Enhancer) because 

the SMEs recommended that Salmonella be considered for one food product in this 

subcategory (i.e., hydrolyzed vegetable protein), even though other food products in this 

subcategory (such as monosodium glutamate) do not have a known or reasonably 

foreseeable (“potential”) Salmonella hazard;

• Only be a known or reasonably foreseeable (“potential”) hazard when a food ingredient is 

sourced from a specific geographic location (e.g., for chemical hazards such as toxic 

elements and pesticides sourced from locations where there has been a history of such 

contamination); or

• Only be a known or reasonably foreseeable (“potential”) hazard when a food ingredient is 

used in a food that changes its characteristics (e.g., B. cereus in cooked (hydrated) rice but 

not dried rice). 

See the recommendation in Chapter 2 for you to record the reasons that led to the conclusions 

of your hazard evaluation (i.e., the Yes/No conclusions listed in column 3 of Form 2-B). 

Explaining your reasons for a “No” conclusion can be just as important as explaining your 

reasons for a “Yes” conclusion. To be thorough and to have readily available answers to 

questions about your hazard analysis, you may find it useful to take a conservative approach by 

listing in Column 2 several known or reasonably foreseeable (“potential”) hazards even though 

they clearly do not require a preventive control (especially when there has been significant 

debate over whether something is actually a known or reasonably foreseeable (“potential”)

hazard for the facility), and explain the reasons for your “No” conclusion. This can be useful both 

during your own review of your food safety plan and during review of your food safety plan by 

others – e.g., if an inspector or auditor questions whether a particular hazard was considered. 

A1.8.3 Each Facility Determines, Through Its Hazard Analysis, Those 

Known or Reasonably Foreseeable Hazards (“Potential Hazards”) That 

Require a Preventive Control

Each facility has the responsibility to determine, through its complete hazard analysis, whether 

known or reasonably foreseeable hazards ("potential hazards") are hazards that require a 

preventive control as appropriate to the facility and its food products. For example, a hazard 

marked with an X in the Tables could be a hazard that does not require a preventive control if it 

has a low probability of occurring in your food product in light of your facility and your food due 

to:

• a process control that has exceptional lethality24 for biological pathogens (e.g., when your 

food product is caramel); 

• the effectiveness of your CGMP practices in addressing the hazard (such as the 

effectiveness of your CGMP hygiene procedures and policies in reducing the potential for 

sick or infected employees to contaminate food); or

24 We intend to discuss processes that have “exceptional lethality” in our discussion of process validation 

(Chapter 9). For example, processes that include boiling for several minutes might be considered 

processes that provide “exceptional lethality” in that such boiling can provide a high level of reduction of 

vegetative pathogens such as E. coli O157:H7, Salmonella spp. and L. monocytogenes. 
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• likely preparation and handling steps before consumption (e.g., if your product is not an RTE 

food (as defined in 21 CFR 117.3) and your product label provides the end user with 

cooking instructions adequate to significantly minimize biological hazards). 

A1.9 References

Section VII in the Introduction of this guidance includes all references cited in this guidance, 

including any references cited in this Appendix. When a reference listed in section VII of the 

Introduction of this guidance includes a website address, FDA has verified the website address, 

as of the date that the Notice of Availability for the Introduction of this guidance publishes in the 

Federal Register, but websites are subject to change over time.
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A1.10 Tables of Known or Reasonably Foreseeable (“Potential”) Food-Related Biological Hazards 

Tables 1A through 1P list the most relevant food-related biological hazards for 16 Food Groups. The food-related biological hazards marked with 

an X for a Food Subcategory are the food-related biological hazards that SMEs recommended be identified as known or reasonably foreseeable 

("potential") biological hazards for subsequent hazard evaluation by each facility that produces food products in those Food Subcategories to 

determine which of these biological hazards require a preventive control as appropriate to the facility and its food products. As discussed in section 

A1.1 of this Appendix, this guidance, including Tables 1A through 1P, consistently uses a combined term (e.g., “known or reasonably foreseeable 

(“potential”) biological hazard”) to describe the output of the Tables to consistently use both the term used in the regulatory text of part 117 and a 

term that could be more familiar to some users of this guidance.

Tables 1A through 1P 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 hazard identified in Tables 1A through 

1P as a known or reasonably foreseeable (“potential”) biological hazard is a hazard requiring a preventive control in the facility’s food product.
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Table 1A: Known or reasonably foreseeable (“potential”) food-related biological hazards for Bakery Items

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Bread, Biscuits, 

Rolls, Brownies, 

Cookies, Pizza, 

Pie Crust

1 

- Unbaked Bakery 

Items 

- Ready-To-Bake 

(RTB) Dough

- RTB Crust

- With or Without 

Inclusions1

Refrigerated or 

Frozen X X X 

Includes bagels, 

croissants, puff pastry, 

phyllo 

Bread, 

Whole/Pre-sliced 2a

- Fully-Baked

- With or without 

Pre-Bake Added 

Filling or 

Inclusions1

- Without PostBake Added 

Frosting/Topping 

Ambient, 

Refrigerated or 

Frozen

X X X Includes biscuits, 

bagels, rolls, croissants

Bread, 

Whole/Pre-sliced 2b

- Fully-Baked 

- With or without 

Pre-Bake Added 

Filling or 

Inclusions1

- With Post-Bake 

Added Filling, 

Frosting, and/or 

Topping

Ambient, 

Refrigerated or 

Frozen

X X X X Includes bread with 

drizzles/ frosting
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Brownies / 

Cookies 3a

- Fully-Baked 

- With or without 

Pre-Bake Added 

Filling or 

Inclusions1

- Without PostBake Added 

Frosting/ Topping

Ambient X X X Includes biscotti; fruit 

filled bars/wafers 

Brownies / 

Cookies 3b

- Fully-Baked

- With or without 

Pre-Bake Added 

Filling or

Inclusions1 

- With Post-Bake 

Added Filling, 

Frosting, and/or 

Topping

Ambient X X X X 

Includes fruit-, creamor chocolate-filled bars/ 

wafers

Cakes/Muffins/ 

Quick Breads 4a

- Fully-Baked

- With or without 

Pre-Bake Added 

Filling or 

Inclusions1

- Without PostBake Added 

Frosting/ Topping

Ambient, 

Refrigerated, or 

Frozen

X X X 

- Includes all flavors 

and densities 

- Includes all fillings 

added before baking 
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Cakes/Muffins/ 

Quick Breads 4b

- Fully-Baked 

- With or without 

Pre-Bake Added 

Filling or 

Inclusions1

- With Post-Bake 

Added Filling, 

Frosting, and/or 

Topping

Ambient, 

Refrigerated or 

Frozen

X X X X 

Includes tortes and 

products with postbake added cream, 

nuts, confectionery and 

dried fruits and layer 

cakes with fillings or 

frosting

Croutons/Bread 

Crumbs 5 Other Bakery Products Ambient X X X Includes unseasoned and seasoned products

Custard Pies 6 

- Unbaked Bakery 

Items

- Ready-To-Bake 

(RTB) Crust and 

Filling

Frozen X X X 

Includes pies with eggand milk-derived 

ingredients

Custard/Cream2/

Crème Pie/ 

Cheesecake

7a

- Fully-Baked/ 

Cooked 

- With or Without 

Pre-Cook Added 

Fillings 

- Without PostBake Added 

Frosting/Topping

Ambient, 

Refrigerated or 

Frozen

X3 X3 X X X 

Includes cheesecake 

and pies with egg- and 

milk-derived 

ingredients
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Custard/Cream2/

Crème Pie/ 

Cheesecake

7b

- Fully-Baked/ 

Cooked 

- With Post-Bake 

Added Frosting/ 

Topping

Ambient, 

Refrigerated or 

Frozen

X3 X3 X X X X 

Includes cheesecake 

and pies with whipped 

cream topping

Dry Mixes 8 Other Bakery 

Products Ambient X X X 

Includes mixes for 

breads, quick breads, 

pancakes, cookies, 

cakes, brownies, 

biscuits, breading, pie 

crust 

Fruit 

Pies/Cobblers 9a Unbaked Bakery Items Frozen X X X Includes all fruits and 

fruit mixtures 

Fruit 

Pies/Cobblers 9b

- Fully-Baked 

- With or Without 

Pre-or Post- Bake 

Added Fillings, 

Frosting, and/or 

Topping

Ambient, 

Refrigerated, or 

Frozen

X X X Includes all fruits and 

fruit mixtures 

Ice Cream 

Cones 10 Other Bakery Products Ambient X X X Includes plain and sugar cones
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Liquid Batter 11 Unbaked Bakery 

Items Refrigerated X3 X3 X X X X

Includes batters for 

pancakes, brownies, 

waffles, doughnut 

Other Pastry 

Products 12a

- Fully-Baked 

- With or Without 

Pre-Bake Added 

Filling 

- Without PostBake Added 

Frosting/Topping

Refrigerated or 

Frozen X X X 

Includes several 

breakfast items, such 

as French toast, 

pancakes, waffles 

Other Pastry 

Products 12b

- Fully-Baked 

- With Post-Bake 

Added Filling, 

Frosting and/or 

Topping

Ambient, 

Refrigerated or 

Frozen

X X X X 

Includes Danishes, 

éclairs, cream puffs, 

cannoli, doughnuts, 

toaster pastries, 

turnovers 

Tortillas, Soft 

Shell/Hard Shell 13 Other Bakery Products

Ambient or 

Refrigerated X X X 

Includes tortillas made 

with corn, wheat, rice, 

quinoa

1 If your food product includes an inclusion, your hazard analysis should also consider known or reasonably foreseeable (“potential”) biological hazards 

associated with the inclusion (e.g., hazards for nuts, chocolate chips, fruit). The other tables in section A1.10 are resources that could be applicable to the 

inclusion. 

2 In a cream/crème pie, the crust is baked and then a cooked filling is added to the baked crust. In a custard pie, the filling is poured into the crust and then the 

filling and crust are baked at the same time. 
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3 The SMEs noted that whether these pathogenic sporeformers are known or reasonably foreseeable (“potential”) biological hazards that could require 

time/temperature controls depends on the product (e.g., pH, water activity) and the process used to make the product. 
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Table 1B: Known or reasonably foreseeable (“potential”) food-related biological hazards for Beverage Items

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Non-dairy 

Cocoa/ 

Chocolate

1a Ready-to-Drink Refrigerated X1 X1 X 

Includes plantbased 

chocolate/ 

cocoa-flavored 

drinks

Non-dairy 

Cocoa/ 

Chocolate

1b Powdered 

Beverages Ambient X 

Includes plantbased 

chocolate/ 

cocoa-flavored 

products

Coffee 2a

- Roasted Beans

- Whole or 

Ground 

Ambient X 

Includes 

flavored, nonflavored, and 

single serve 

Coffee 2b

- Ready-to-Drink

- Unflavored and 

Flavored

Refrigerated X1 X1 X 

Includes 

brewed coffee 

and espressostyle coffee 

Coffee 2c - Powdered 

- Freeze Dried Ambient X 

Includes instant 

coffees, 

cappuccino mix

Coffee 2d

Concentrated 

Liquid Base 

Mixes

Refrigerated X1 X1 X Includes plain 

and flavored
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 38 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Dairy-Based 3 Ready-to-Drink Refrigerated X1 X1 X X X 

Includes

flavored and 

unflavored fluid 

milk from 

multiple 

species, yogurt 

drinks, kefir

Non-Dairy2 4a

- Ready-to-Drink 

Milk Substitutes

- Plain and 

Flavored

Refrigerated X1 X1 X X X 

Includes plantbased 

beverages and 

non-dairy liquid 

creamer

Non-Dairy 4b Powdered Coffee 

Creamer Ambient X Includes plain and flavored

Juice-Based2 5 Ready-to-Drink 

(not 100% juice)

Ambient3 or 

Refrigerated X1 X1 X X 

All fruit drinks 

with some juice

content

Tea and Tea 

Substitutes 6a Loose Leaf and Bagged Ambient X X 

Includes 

flavored and 

non-flavored 

teas and herbal 

teas 
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 39 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Tea and Tea 

Substitutes 6b - Instant - Powdered Ambient X X 

Includes 

flavored and 

non-flavored 

teas and herbal 

teas

Tea and Tea 

Substitutes 6c Ready-to-Drink Ambient3 or Refrigerated X X 

Includes 

flavored and 

non-flavored 

teas and herbal 

teas

Tea and Tea 

Substitutes 6d

Concentrated 

Liquid Base 

Mixes

Ambient3 or 

Refrigerated X X 

Includes plain 

and flavored 

and herbal teas

Carbonated 

Beverages 7 - Ready-to-Drink- Carbonated Ambient

Bottled drinking 

water is subject 

to the 

processing and 

bottling 

requirements of 

21 CFR part 

129 and the 

microbiological 

criteria in 21 

CFR 165.110(b)
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 40 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Uncarbonated 

Beverages 8 

- Ready-to-Drink 

- Uncarbonated 

Waters

Ambient

Bottled drinking 

water is subject 

to the 

processing and 

bottling 

requirements of 

21 CFR part 

129 and the 

microbiological 

criteria in 21 

CFR 165.110(b)

Sports and 

Energy 

Beverages

9 Ready-to-Drink Ambient3 or 

Refrigerated X3 All varieties

Beverage 

Concentrates/

Base Mixes2 

10a Liquid Ambient3 or 

Refrigerated

Includes bases 

for carbonated 

beverages and 

syrups for 

flavored drinks 
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 41 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Beverage 

Concentrates/

Base Mixes

10b Dry Powdered Ambient

Includes 

powdered 

flavors 

Adult 

Beverage 

Mixers2 

11

Mixes intended 

for alcoholic 

beverages (liquid 

and powders)

Ambient3 or 

Refrigerated X1 X1 X All varieties

Ground 

Coffee 

Substitutes

12 Dry Powdered Ambient X4 X4

Includes chicory 

root powder, 

roasted grains 1 The SMEs noted that whether these pathogenic sporeformers are known or reasonably foreseeable (“potential”) biological hazards that could require 

time/temperature controls depends on the product (e.g., pH, water activity) and the process used to make the product. 2 Depending on the ingredients there could be other hazards. Refer to other tables for the ingredients.

3 There may not be any known or reasonably foreseeable (“potential”) biological hazard applicable to shelf-stable products. Shelf-stable products that are LACF 

products are not subject to the requirements for biological hazards in 21 CFR Part 117. Shelf-stable non-LACF products generally are produced using an 

exceptionally lethal process. (See the discussion of exceptionally lethal processes in section A1.6.1.3.) 4 The SMEs identified this as a known or reasonably foreseeable (“potential”) biological hazard applicable only when the beverage includes an herb. 5

 See Table 1J for the known or reasonably foreseeable (“potential”) biological hazards associated with the applicable roasted grain. 
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 42 

Table 1C: Known or reasonably foreseeable (“potential”) food-related biological hazards for Miscellaneous Food Additives, 

Color Additives, and GRAS Substances

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Emulsifiers 1 Emulsifiers Ambient or 

Refrigerated

 X3 

Includes substances 

such as lecithin (from 

soy, safflower, or 

corn oil or from egg) 

mono- and 

diglycerides, 

polysorbates, 

sorbitan 

monostearate

Stabilizers and 

Thickeners 2a Firming Agents Ambient 

Includes substances 

such as calcium 

chloride, calcium 

lactate

Stabilizers and 

Thickeners 2b Humectants Ambient 

Includes substances 

such as glycerin, 

sorbitol

Stabilizers and 

Thickeners 2c Leavening Agents Ambient X3 

Includes substances 

such as baking soda, 

monocalcium 

phosphate, calcium 

carbonate, dried 

yeast
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 43

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Stabilizers and 

Thickeners 2d

Stabilizers, 

Thickeners, 

Binders, 

Texturizers

Ambient X 

Includes substances 

such as gelatin, 

pectin, carrageenan, 

modified starches, 

acacia gum, guar 

gum, xanthan gum 

Stabilizers and 

Thickeners 2e

Dough 

Strengtheners 

and 

Conditioner

Ambient

Includes substances 

such as ammonium 

sulfate, 

azodicarbonamide, 

and l-cysteine

Stabilizers and 

Thickeners 2f Anti-caking Agents Ambient

Includes substances 

such as calcium 

silicate, iron 

ammonium citrate, 

silicon dioxide

Enzymes 3 

Bakery, 

Proteolytic, 

Starch/Sugar 

Liquefication,

Cheesemaking

Refrigerated X 

Includes substances

such as amylases, 

chymosin, lactase, 

lipase, papain, 

proteases, xylanase 
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 44 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Colors 4a Certified Colors Ambient 

Includes FD&C 

colors listed in 21 

CFR part 74, subpart 

A 

Colors 4b

Colors Exempt 

from 

Certification

Ambient or 

Refrigerated 

Includes colors listed 

in 21 CFR part 73, 

subpart A 

Flavors 5a Liquid: OilBased1, 2 Ambient or 

Refrigerated

 

Includes a variety of 

oil-based flavor 

extracts from plants

Flavors 5b Liquid: 

Aqueous Ambient 

Includes a variety of 

non-oil-based flavor 

extracts from plants 

Flavors 5c Powdered: 

Natural Flavor

Ambient or 

Refrigerated 

Includes a variety of 

powdered flavor 

extracts from plants 

Flavors 5d

Artificial: 

Synthetic 

Flavor

Ambient or 

Refrigerated Includes a variety of synthetic flavors 
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 45 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Flavors 5e Other: Flavor 

Enhancer

Ambient or 

Refrigerated X 

Includes substances 

such as monosodium 

glutamate, autolyzed 

yeast extract, 

hydrolyzed vegetable 

proteins, disodium 

guanylate, inosinate

Flavors 5f Flavor Paste Ambient or 

Refrigerated X X X 

Includes a variety of 

plant-based flavor 

pastes 

Other Chemical 

Ingredients 6a Processing Chemicals Ambient 

Includes substances 

such as potassium 

hydroxide, potassium 

bicarbonate, sodium 

chloride, hydrochloric 

acid, sodium 

hydroxide, calcium 

carbonate, calcium 

lactate, mineral oil

Other Chemical 

Ingredients 6b Organic Acids Ambient 

Includes substances 

such as acetic acid, 

citric acid, lactic acid, 

fumaric acid
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 46 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Other Chemical 

Ingredients 6c Antioxidants Ambient or Refrigerated 

Includes substances 

such as butylated 

hydroxy toluene 

(BHT), d-alphatocopherol acetate 

(TOCO)

Other Chemical 

Ingredients 6d

Antimicrobials 

and 

Preservatives

Ambient or 

Refrigerated 

Includes substances 

such as nisin, 

potassium sorbate

Other Chemical 

Ingredients 6e Processing Aid Gases Ambient 

Includes gases such 

as nitrogen, carbon 

dioxide

Other Chemical 

Ingredients 6f Soluble Fiber Ambient

Includes substances 

such as inulin, 

fructan
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 47 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Nutrients 7 

Vitamins, 

Minerals, and 

Vitamin/Mineral 

Premixes 

Ambient or 

Refrigerated

Includes substances 

such as thiamine 

hydrochloride, 

riboflavin, niacin, 

niacinamide, folate or 

folic acid, beta 

carotene, potassium 

iodide, iron or ferrous 

sulfate, alpha 

tocopherols, ascorbic 

acid, Vitamin D, 

magnesium sulfate

1 Although the SMEs identified known or reasonably foreseeable (“potential”) biological hazards in the source plant of some of these oils (e.g., 

sesame, almond), such hazards have not been found in the oils. 2 See also Category 3b (Essential oils) in Table 1O (Spices and Herbs).

3 Salmonella has been isolated from soy lecithin (Food Navigator.co, 2006; and The Brussels Times, 2022a and b) and dried yeast (Wilson et al., 

1975).
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 48 

Table 1D: Known or reasonably foreseeable (“potential”) food-related biological hazards for Chocolate and Candy

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Chocolate 

Industrial 

Products

1a Raw Cocoa 

Beans Ambient X Cocoa Beans

Chocolate 

Industrial 

Products

1b Roasted Cocoa 

Beans and Nibs Ambient X Beans and Nibs

Chocolate 

Industrial 

Products

1c

Chocolate/Cocoa 

Products for 

Baking 

Ambient X 

Includes chocolate products 

with varying sweetness and 

includes bulk solid (blocks), 

bulk molded (chips), 

bulk powder, and bulk liquid

Confectionary 

Industrial 

Products

2a Other Products 

for Baking Ambient X 

Includes bulk molded (e.g., 

peanut butter chips, caramel 

chip) and bulk liquid

Confectionary 

Industrial 

Products

2b

Chocolate 

Coating for 

Enrobing 

Ambient X Includes bulk solid and bulk 

liquid products 

Chocolate and 

Confectionery 

Products

3a Chocolate 

Confections Ambient X Includes bars, chips, morsels, 

fudge, bonbons
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 49 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Chocolate and 

Confectionery 

Products 

3b

Chocolate 

Confections - 

With Inclusions1

Ambient 

Includes chocolate covered 

nuts/ fruit/ caramel/ mints, 

biscuits, nougats; chocolate 

candy bar with nuts or fruit; 

chocolate with crisped rice; 

fudge with nuts 

Confectionery 

Products 3c Sugar Confections2 Ambient 

Includes caramels, gummy gel 

candies, fruit chews, licorice, 

marshmallows, soft jellied 

candy, gel cups candy, maple 

creams, fondant, pastilles, rock 

candy, hard candy

Confectionery 

Products 3d

Sugar 

Confections with 

inclusions1 

Ambient 

Includes nut brittles (peanut 

brittle, almond brittle), nut 

clusters, candy with fruit pieces

Confectionery 

Products 3e

Sugar 

Confections 

Specialties 

Ambient X 

Includes candy coated 

popcorn, cereal confection, 

marzipan, coconut roll, peanut 

butter fudge, cotton candy2, 

pastes
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 50 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Toppings/ 

Frosting 4 

Toppings and 

Frosting (NonFruit/Nut)Ambient X3 All flavors and varieties

1 With the exception of inclusions (e.g., nuts, chocolate chips, fruit) added after the cooking process for the chocolate confection is complete, the SMEs did not 

identify any known or reasonably foreseeable (“potential”) biological hazards for products found in this Food Subcategory because the products are processed 

by an “exceptionally lethal process.” (See the discussion of exceptionally lethal processes in section A1.6.1.3.) If your food product includes an inclusion added 

after the cooking process for the chocolate confection, your hazard analysis should also consider known or reasonably foreseeable (“potential”) biological 

hazards associated with the inclusion (e.g., hazards for nuts, chocolate chips, fruit). The other tables in section A1.10 are resources that could be applicable to 

the inclusion.

2 The SMEs did not identify any known or reasonably foreseeable (“potential”) biological hazards for products found in this Food Subcategory or identified in the 

comment box because the products are processed by an “exceptionally lethal process.” (See the discussion of exceptionally lethal processes in section A1.6.1.3.)

3 The SMEs identified a known or reasonably foreseeable (“potential”) Salmonella hazard only if the product contains ingredients for which Salmonella is a 

known or reasonably foreseeable (“potential”) hazard. See the applicable Table for any known or reasonably foreseeable (“potential”) hazards associated with 

the ingredients of your food product. 
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 51 

Table 1E: Known or reasonably foreseeable (“potential”) food-related biological hazards for Dairy

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Raw1 Milk 1 Liquid Milk for 

Processing Refrigerated X2 X2 X X X X X X Raw fluid milk

Milk and Butter 2a Liquid Milk 

products

Ambient3 or 

Refrigerated X2 X2 X X X 

Includes flavored and 

unflavored fluid milk 

from multiple species 

(cow, goat, sheep), 

ultra-pasteurized 

milks, milk-based 

creamer 

Milk and Butter 2b Cream products Refrigerated X2 X2 X X X 

Includes heavy, light, 

whipping creams and 

half-and-half

Milk and Butter 2c Butter products Refrigerated X X X X Includes butter 

spreads and blends

Milk and Butter 2d Cultured milk 

products Refrigerated X X X 

Includes buttermilk, 

sour cream, yogurt, 

yogurt drinks, kefir

Milk and Butter 2e Dry milk 

products4 Ambient X5 X X X 

Includes dried 

products extracted 

from milk, such as 

whey powder and 

dried milk products 

used in dried dips
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 52 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Milk-Based 

Products 3a

Ice cream, 

regular and low 

fat (with and 

without 

inclusions)6 

Frozen X X X All flavors

Milk-Based 

Products 3b Sherbets Frozen X X X All flavors 

Milk-Based 

Products 3c Frozen Novelty Items Frozen X X X 

Includes ice cream 

cakes/bars/ 

sandwiches, frozen 

yogurt

Cheese and 

Cheese Products – 

Whole

4a

Extra Hard 

Cheese (low pH, 

low water activity) 

Ambient or 

Refrigerated X X X X 

Includes Parmesan, 

Asiago, Romano, 

Sbrinz 

Cheese and 

Cheese Products – 

Whole

4b Hard Cheese Refrigerated X X X X Includes Cheddar, 

Colby, Swiss, Gruyere

Cheese and 

Cheese Products – 

Whole

4c Semi-soft Cheese Refrigerated X X X X 

Includes Monterey, 

Provolone, Oaxaca, 

Monterey Jack, Edam, 

Havarti, Paneer, 

Raclette
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 53 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Cheese and 

Cheese Products – 

Whole

4d Soft, Ripened 

Cheese Refrigerated X X X X Includes Brie, Camembert, Taleggio 

Cheese and 

Cheese Products – 

Whole

4e

Soft, Unripen 

Cheese/ Fresh 

Cheese

Refrigerated X X X X 

Includes Cottage 

Cheese, Cream 

Cheese, Ricotta, 

Queso Fresco, 

Cheese Curd, 

Mozzarella

Cheese and 

Cheese Products - 

Sliced, Shredded, 

or Grated

5a Hard and Extra 

Hard Cheese 

Ambient or 

Refrigerated X X X X 

Includes Parmesan, 

Asiago, Romano, 

Cheddar

Cheese and 

Cheese Products - 

Sliced, Shredded, 

or Grated

5b Semi-soft Cheese Refrigerated X X X X 

Includes Monterey, 

Provolone, Oaxaca, 

Monterey Jack 

Cheese and 

Cheese Products - 

Sliced, Shredded, 

or Grated

5c Pasteurized 

Process Cheese

Ambient7 or 

Refrigerated

Includes Process 

American Cheese
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 54

1 Milk and cream, and butter made from them, in this Table are considered “pasteurized” under 21 CFR 1240.61 and the Pasteurized Milk Ordinance. Raw milk is 

only used in certain cheeses that are aged for at least 60 days. Brucella spp. and Campylobacter spp. are not identified as known or reasonably foreseeable 

(“potential”) hazards for Food Categories other than Raw Milk because processes targeting the principal pathogens associated with dairy products will also 

address these pathogens and they generally are not reintroduced into milk after it has been pasteurized. 2 The SMEs noted that whether these pathogenic sporeformers are known or reasonably foreseeable (“potential”) biological hazards that could require 

time/temperature controls depends on the product (e.g., pH, water activity) and the process used to make the product.

3 Excludes LACF (shelf-stable) products (including evaporated and sweetened and condensed milk products), which are not subject to the requirements for 

biological hazards in 21 CFR Part 117. 4 We recommend that you also consider Cronobacter spp. (including C. sakazakii) as a known or reasonably foreseeable (“potential”) biological hazard when milk 

powders are destined for use in dry blended powdered infant formula products. A facility that manufactures/processes powdered infant formula is subject to 

the microbiological criteria in 21 CFR 106.55(e) for when a powdered infant formula that contains Cronobacter spp. will be deemed adulterated under sections 

402(a)(1), 402(a)(4), and 412(a)(3) of the FD&C Act.

5 The SMEs identified this as a known or reasonably foreseeable (“potential”) biological hazard applicable only when the food is used as an ingredient in another 

product where the dried milk becomes hydrated. 

6 If your food product includes an inclusion, your hazard analysis should also consider known or reasonably foreseeable (“potential”) biological hazards 

associated with the inclusion (e.g., hazards for nuts, chocolate chips, fruit). The other tables in section A1.10 are resources that could be applicable to the 

inclusion. 

7 Excludes LACF (shelf-stable) pasteurized process cheese products (e.g., jars of cheese spreads), which are not subject to the requirements for biological hazards 

in 21 CFR Part 117.
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 55 

Table 1F: Known or reasonably foreseeable (“potential”) food-related biological hazards for Dressings, Condiments, and Dips

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Condiments 1a Mayonnaise Ambient or 

Refrigerated X X X 

Includes regular and 

“lite” products and 

flavored products 

Condiments 1b Mustard Ambient or 

Refrigerated X X X Includes all varieties 

Condiments 1c Ketchup Ambient X X X Includes all varieties

Condiments 1d Vinegar Ambient Includes all varieties 

Condiments 1e Other 

Condiments Ambient 

Includes soy sauce, 

Worcestershire sauce, 

prepared horseradish, 

steak sauce, Tabasco 

sauce

Salad 

Dressings 2a

Dressings, 

salad 

(prepared)

Ambient or 

Refrigerated X X X 

Includes all varieties 

Salad 

Dressings 2b Dry mixes Ambient X X Includes all varieties 
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 56 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Dips 3a Dips and 

spreads

Ambient1 or 

Refrigerated X X X X X X 

Includes dips and 

spreads such as 

guacamole, salsa, 

dairy-based dips, 

bean dips, sesamebased dips (e.g., 

hummus, tahini, 

vegetable dips, taco 

Dip, 7-layer dip

Dips 3b Dips and 

spreads, dry Ambient X2 X2 X X X 

Dry dips, dry dairybased dips (e.g., 

vegetable dip 

seasoning, toasted 

onion dip mix) 1 Excludes LACF (shelf-stable) products which are not subject to the requirements for biological hazards in 21 CFR Part 117. 2 The SMEs identified known or reasonably foreseeable (“potential) biological hazards for sporeformers that would apply only when these products are 

rehydrated and/or used as an ingredient in a product where pH would permit growth. 
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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 57 

Table 1G: Known or reasonably foreseeable (“potential”) food-related biological hazards for Egg and Egg Products

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Shell Eggs 1 Shell Eggs Refrigerated X 

Includes raw and 

pasteurized inshell 

Further 

Processed Egg 

Products 

2a Eggs Hard 

Cooked Refrigerated X X Includes eggs in shell or shelled

Further 

Processed Egg 

Products 

2b Cooked Egg 

Products 

Refrigerated or 

Frozen X X 

Includes cooked 

products such as 

omelets, egg 

patties, scrambled 

eggs

Further 

Processed Egg 

Products 

3 

Egg-based 

products and egg 

substitutes (not 

fully cooked)1

Refrigerated or 

Frozen X For use as an ingredient

1 As discussed in section A1.6.1.4, the production of certain processed egg products (e.g., pasteurized liquid whole egg) is subject to regulation by USDA’s FSIS

under the Egg Products Inspection Act. However, these processed egg products could be used as ingredients in foods subject to FDA’s jurisdiction. 

 
Contains Non-binding Recommendations

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Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 58 

Table 1H: Known or reasonably foreseeable (“potential”) food-related biological hazards for Fruits and Vegetables

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Fruits 1 Whole RAC Ambient or 

Refrigerated X X X X1 X2 All whole RAC fruits 

Processed 

Fruits 2a Fresh-cut Refrigerated X X X X1 X2

All fresh-cut fruit, 

including 

individual fruit 

and mixed fruit

Processed 

Fruits 2b Whole or Cut Frozen X X X X1 X2 All frozen fruit

Processed 

Fruits 2c Heat Treated Fruit Products

Ambient3,4 or 

Refrigerated X X X

Includes 

individual and 

mixed fruit (e.g., 

fruit and mixed 

fruit in juice or 

syrup)

Processed 

Fruits 2d

Dried/ 

Dehydrated Fruit 

Products

Ambient X X X All dried/ 

dehydrated fruits

Processed 

Fruits 2e Jams, Jellies, Chutneys4 Ambient All varieties
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Processed 

Fruits 2f Coated Fruits5 Refrigerated X

All coated fruits 

(e.g., caramel 

apples with 

inserted stick, 

chocolate 

covered 

strawberries)

Vegetables 3 Whole RAC Ambient or 

Refrigerated X6 X X X X X7 All whole RAC vegetables

Processed 

Vegetables 4a Fresh-cut Refrigerated X6 X X X X All fresh-cut vegetables

Processed 

Vegetables 4b Whole or Cut Frozen X X X All frozen vegetables

Processed 

Vegetables 4c Whole or cut, Heat treated Refrigerated X X X X X

All heat-treated, 

refrigerated 

vegetables, such 

as mashed 

potatoes and 

roasted 

vegetables

Processed 

Vegetables 4d Acidified Products Ambient X X X X X

All ambient 

acidified 

vegetables and 

vegetable 

mixtures (such 

as in salsas)
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Processed 

Vegetables 4e

Dried/ 

Dehydrated 

Products

Ambient X8 X8 X X X

All dried/ 

dehydrated 

vegetables

Processed 

Vegetables 4f Fermented Products Ambient X X X X X

Includes 

sauerkraut, 

pickles, kimchi

Processed 

Fruits or 

Vegetables

5 Acid Pureed 

Products Ambient X X X

Includes 

applesauce, 

apple butter, 

tomato paste 1 The SME identification of the parasite Cyclospora as a known or reasonably foreseeable (“potential”) biological hazard in this subcategory primarily applies to 

berries and berry-containing products that have not been heat treated sufficiently to inactivate Cyclospora, but could also apply to other produce from areas 

where Cyclospora has been determined to be present, e.g., in the water supply. 2 The SME identification of viruses (such as norovirus and hepatitis A) as known or reasonably foreseeable (“potential”) biological hazards is limited to berries, 

pomegranates (the arils), and any fresh, refrigerated, or frozen products containing berries or pomegranate.

3 Excludes LACF (shelf-stable) products such as heat-treated canned mangoes, which are not subject to the requirements for biological hazards in 21 CFR Part 

117.

4 The SMEs did not identify any known or reasonably foreseeable (“potential”) biological hazards forshelf-stable products found in this Food Subcategory 

because the products are processed by an “exceptionally lethal process.” (See the discussion of exceptionally lethal processes in section A1.6.1.3.) 5

 Your hazard analysis should also consider known or reasonably foreseeable (“potential”) biological hazards associated with the coating (e.g., hazards for 

chocolate) and the specific fruits being coated. The other tables in section A1.10 are resources that could be applicable to the coating. 6 See the discussion, in Chapter 3 of this guidance, of the potential for reduced oxygen packaging (ROP) to create a process-related biological hazard. When we 

finalize Chapter 3, we intend to emphasize that this risk may not apply to all fresh and fresh-cut produce RACs (e.g., we are not aware of reports of botulism 

associated with commercially available fresh-cut leafy greens packaged in ROP). We also intend to emphasize the importance of evaluating whether ROP 

presents an increased risk from sporeforming pathogens in your specific food product when deciding whether to use ROP. 
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7 The SME identification of parasites (such as Cyclospora) as a known or reasonably foreseeable (“potential”) biological hazard in this subcategory primarily 

applies to fresh herbs (such as basil and cilantro) and uncooked foods containing these herbs, but could also apply to other produce from areas where 

Cyclospora has been determined to be present, e.g., in the water supply.

8 The SMEs identified known or reasonably foreseeable (“potential”) biological hazards only when the food is used as an ingredient in another product where the 

dehydrated vegetable becomes hydrated. 
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Table 1I: Known or reasonably foreseeable (“potential”) food-related biological hazards for Game Meat Products1 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Raw Game 

Meat 1a

Intact (Not 

Ground) Game 

Meat

Refrigerated or 

Frozen X X X X X2 

Intact meat from 

all game species 

(e.g., bison, 

deer, elk, rabbit, 

and birds (such 

as pheasant, 

grouse, quail)) 

Raw Game 

Meat 1b Ground Game Meat

Refrigerated or 

Frozen X X X X X X2 

Ground meat 

from all game 

species 

Game Meat 

Products 2a

Processed 

Game Meat 

Products

Ambient X X X X X 

Processed 

products such 

as jerky 

Game Meat 

Products 2b

Processed 

Game Meat 

Products

Refrigerated X X X X X 

Processed 

products such 

as sausages, 

patties, 

frankfurters, 

salami
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Game Meat 

Products 2c

Processed 

Game Meat 

Products

Frozen X X X X X 

Processed 

products such 

as sausages, 

patties, 

frankfurters, 

salami 

1 The SMEs identified known or reasonably foreseeable (“potential”) biological hazards in the broad category “Game Meat Products” but did not 

differentiate between species (e.g., bison, deer, rabbit). 

2 Toxoplasma gondii is associated with deer and elk. 
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Table 1J: Known or reasonably foreseeable (“potential”) food-related biological hazards for Grains, Pulses, Flours, and 

Starches 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Grains 1 Whole, grains Ambient X1 X1 X X X All whole grains 

Grains, Milled 

Products 2a

Flours (other 

than rice flour, 

corn flour, and 

root flour)

Ambient X1 X1 X X X

All flours from grains 

(except as noted in the 

subcategory); includes 

gluten

Grains, Milled 

Products 2b Rice and rice products Ambient X1 X1 X

Includes all varieties of 

rice and rice-based 

noodles

Grains, Milled 

Products 2c Malt Ambient X Includes all malted grain products

Grains, Milled 

Products 2d Corn Ambient X1 X Cornmeal, corn flour

Grain-based 

Cereal 

Products

3a

Cereal 

Product: 

Ready-to-Eat

Ambient X

Includes cereal products 

with and without 

inclusions2 

Grain-based 

Cereal 

Products

3b Breakfast 

food, dried Ambient X1 X

Includes products such as 

oatmeal, farina, oat bran, 

cream of wheat, grits

Grain-based 

Pasta 

Products

4a Unfilled Pasta Refrigerated 

or Frozen X1 X1 X X X All varieties 
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp. 

Campylobacter spp. 

Pathogenic E. coli

Salmonella spp. 

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Grain-based 

Pasta 

Products

4b Filled Parboiled Pasta

Refrigerated 

or Frozen X1 X1 X X X All varieties 

Grain-based 

Pasta 

Products

4c Dried Pasta Ambient X1 X1 X1 X All varieties

Other Milled 

Products 5a Root flours Ambient X1 X All root flours (e.g., from potatoes, cassava)

Other Milled 

Products 5b Starch products Ambient X1 X Cornstarch, Potato Starch, Wheat Starch

Pulses3 6a Whole, dried Ambient X1 X1 X1 X X Includes all pulses 

Pulses3 6b Cooked 

pulses

Ambient,4 

Refrigerated 

or Frozen

X X X X X X Includes bean paste

1 The SMEs identified this as a known or reasonably foreseeable (“potential”) biological hazard applicable only when the food becomes hydrated to an aw that 

allows growth or is used as an ingredient in another product where the grains/pulse/flour/starch become hydrated to an aw that allows growth. 2 If a cereal product contains one or more inclusions (such as nuts or chocolate), your hazard analysis should also consider known or reasonably foreseeable 

(“potential”) biological hazards associated with the inclusion (e.g., hazards for nuts, chocolate chips, fruit). The other tables in section A1.10 are resources that 

could be applicable to the inclusion. 

3 Pulses are the dried, edible, pod-grown seed from produce (such as peas, beans, or lentils) within the legume family. Pulses include commodities such as 

bambara beans; chickpeas; cowpeas; dry beans (such as adzuki, black, flageolet, great northern, kidney, lima, mung, navy, pink, pinto, and tepary beans); dry 

broad beans; dry peas; lentils; and pigeon peas. 4 Excludes LACF (shelf-stable) products such as canned pulses or bean pastes, which are not subject to the requirements for biological hazards in 21 CFR Part 117.
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Table 1K: Known or reasonably foreseeable (“potential”) food-related biological hazards for Nuts and Seeds

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Nuts 1a Peanuts, Raw Ambient X X X Peanuts

Nuts 1b Peanuts Roasted 

or Boiled Ambient X X X Peanuts 

Nuts 1c Tree Nuts, Raw Ambient X X X Includes all tree nuts

Nuts 1d Tree Nuts, 

Roasted Ambient X X X Includes all tree nuts

Nuts 1e Nut Butters Ambient X X X Includes product from 

peanuts and tree nuts 

Edible Seeds 2a Raw Ambient X X X 

Includes edible seeds 

from flax, melon, 

pumpkin, sesame, 

sunflower

Edible Seeds 2b Roasted Ambient X X X 

Includes edible seeds 

from flax, melon, 

pumpkin, 

sesame, sunflower

Other Nut and 

Seed Products 3a Nut and Seed Pastes Ambient X X X 

Includes pastes from 

peanuts, tree nuts, and 

seeds, seeds 

Other Nut and 

Seed Products 3b Nut and Seed 

Flours Ambient X X X 

Includes flour from 

peanuts, tree nuts, and 

seeds 
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Other Nut and 

Seed Products 3c Coconut Products

Ambient, 

Refrigerated, 

or Frozen

 X X X 

Includes shredded, 

flaked, and toasted 

products
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Table 1L: Known or reasonably foreseeable (“potential”) food-related biological hazards for Oils and Oil Products

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Oil Products 1a Cooking Oils Ambient Includes single oils and oil 

blends

Oil Products 1b Margarines and 

other spreads

Ambient or 

Refrigerated Includes all varieties

Oil Products 1c Shortening Ambient

Includes varieties 

considered as imitation/ 

substitute and includes 

partially and fully 

hydrogenated vegetable 

oils

Oil Products 1d Infused Oils Ambient X1 

Includes oils infused with 

acidified or non-acidified 

ingredients

Oil Products 1e

Cocoa Butter 

and Cocoa 

Butter 

Substitutes

Ambient

Includes cocoa butter and 

cocoa butter substitutes 

(e.g., from coconut oil, 

palm kernel oil, or both 

oils (21 CFR 172.861) or 

primarily from palm oil or 

primarily from high-oleic 

safflower or sunflower oil 

(21 CFR 184.1259) 1 The SMEs only identified C. botulinum as a known or reasonably foreseeable (“potential”) hazard for oils infused with an ingredient that has not been acidified. 
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Table 1M: Known or reasonably foreseeable (“potential”) food-related biological hazards for Snack Foods1 

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Bread Snacks 1a Baked or Fried Ambient X X 

Includes 

unseasoned and 

seasoned2

varieties 

Bread Snacks 1b Baked with Filling Ambient X X 

Includes 

unseasoned and 

seasoned2

varieties

Chips and 

Crisps 2a Fried Fruit/ Vegetable Ambient X X 

Includes 

unseasoned3 and 

seasoned2

varieties 

Chips and 

Crisps 2b Baked Fruit/ Vegetable Ambient X X 

Includes 

unseasoned3 and 

seasoned2

varieties 

Chips and 

Crisps 2c

Dehydrated Fruit/ 

Vegetable Ambient X X 

Includes 

unseasoned3 and 

seasoned2

varieties

Crackers and 

Biscuits 3a - Baked - Unfilled Ambient3 

Includes 

unseasoned and 

seasoned2

varieties 
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Crackers and 

Biscuits 3b - Baked - Filled4 Ambient

Includes 

unseasoned and 

seasoned2

varieties

Puffed Snacks 4 Baked or Fried Ambient X X 

Includes 

unseasoned3 and 

seasoned2

varieties 

Snack Food 

Bars 5 

- Cold Pressed/ 

Formed 

- With or without 

coating

Ambient or 

Refrigerated X X 

Includes bars 

made with nuts, 

fruit, seeds, 

chocolate chips4

Snack Mix 6 

Mixed/ Coated 

Fruits, Nuts, and 

Pretzels 

Ambient X X 

Includes all 

varieties and 

coatings4

Pudding and 

Gelatin 

Products

7a Dry Mixes Ambient X X Includes all 

varieties4

Pudding and 

Gelatin 

Products

7b Prepared Ambient5 or 

Refrigerated X X X X X Includes all 

varieties4

Frozen 

Novelties 8a Non-Dairy Frozen X X 

Includes all 

varieties and 

coatings4
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Frozen 

Novelties 8b Flavored Ices Frozen

Includes all 

varieties and 

flavors 1 See other Food Groups such as Bakery, Confectionary, Dairy, Grains, Pulses, Flours, and Starches, and Nuts and Seeds for additional Snack Categories such as 

cookies, candy, ice cream dairy novelties, mixed nuts, sunflower seeds, and instant noodles.

2 If the product is seasoned after baking or frying, see also Table 1O for known or reasonably foreseeable (“potential”) hazards in spices and herbs that could be 

used in the seasoning. 3 The SMEs did not identify any known or reasonably foreseeable (“potential”) biological hazards forshelf-stable products found in this Food Subcategory 

because the products are processed by an “exceptionally lethal process.” (See the discussion of exceptionally lethal processes in section A1.6.1.3.) 4 If the product contains ingredients addressed by other Tables, see the applicable Table as well. 5 Excludes LACF (shelf-stable) products, which are not subject to the requirements for biological hazards in 21 CFR Part 117.
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. 

Table 1N: Known or reasonably foreseeable (“potential”) food-related biological hazards for Soups and Sauces

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Soups, 

Sauces, 

Gravies

1a Dry Mixes, 

Powders Ambient X1 X1 X1 X2

 X2 X2 Includes all varieties

Soups, 

Sauces, 

Gravies

1b Base pastes Ambient X1 X1 X1 X2 X2 X2 Includes all varieties

Soups, 

Sauces, 

Gravies

1c

Full Strength 

Liquid or 

Condensed

Refrigerated 

or Frozen X X X X2

 X2 X2 Includes all varieties

1 The SMEs identified known or reasonably foreseeable (“potential”) biological hazards for sporeformers that would apply only when these products 

are rehydrated and/or used as an ingredient in a high-moisture food. 

2 In some cases, for vegetative cells of pathogens the cooking step for a product in this Food Subcategory is an exceptionally lethal process. (See 

the discussion of exceptionally lethal processes in section A1.6.1.3.) Because some products in this Food Subcategory are produced using 

processing that is not an exceptionally lethal process, the SMEs recommended that the vegetative pathogen hazards marked with an X be identified 

as known or reasonably foreseeable (“potential”) biological hazards. If the processing step is an exceptionally lethal process, the outcome of the 

hazard analysis could be that the listed known or reasonably foreseeable (“potential”) biological hazard does not require a preventive control. Check 
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other tables for the major ingredients, because, depending on the ingredients, there may be other hazards, and some of the hazards listed here 

may not apply to all products in a Food Subcategory. 
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Table 1O: Known or reasonably foreseeable (“potential”) food-related biological hazards for Spices and Herbs

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

 Spices 1 

Dried, Ground, 

Cracked, or 

Whole

Ambient X1 X1 X1 X2 

Includes cinnamon, 

cardamom, turmeric, 

paprika, pepper (black, 

white, red), cayenne 

powder, paprika, chili 

powder, cumin, coriander, 

mustard, fenugreek, 

horseradish, fennel seeds, 

caraway, allspice, nutmeg, 

ginger, garlic (minced or 

powder), onion (minced or 

powder), oregano, celery 

seed 

Herbs 2a Dried Ambient X1 X1 X1 X2 

Includes basil, oregano, 

thyme, sage, parsley, bay 

leaf, dill, rosemary, 

cilantro, mint, kaffir lime, 

chives, peppermint

Herbs 2b Fresh Ambient or 

Refrigerated X2 X3 

Includes basil, oregano, 

thyme, sage, parsley, bay 

leaf, dill, rosemary, 

cilantro, mint, kaffir lime, 

chives, peppermint
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Seasonings 3a Pastes Ambient or 

Refrigerated X1 X1 X1 X2 X3 

Includes varieties made 

from a single spice or herb 

or from multiple spices or 

herbs 

Seasonings 3b Essential Oils Ambient 

Includes essential oil 

extracted from any spice or 

herb

Seasonings 3c

Spice and 

seasoning 

mixtures, Dry 

or Liquid 

Blends 

Ambient X1 X1 X1 X2 Includes all varieties

Seasonings 4 Salt Ambient Includes all varieties

1 The SMEs identified this as a known or reasonably foreseeable (“potential”) biological hazard applicable only when these products are rehydrated 

and/or used as an ingredient in a high-moisture food. 2 The SMEs identified Salmonella spp., but not pathogenic E. coli, as a known or reasonably foreseeable (“potential”) biological hazard in this 

subcategory based on a 2022 FAO/WHO report (FAO/WHO 2022b).

3 The SME identification of the parasite Cyclospora as a known or reasonably foreseeable (“potential”) biological hazard in this subcategory 

primarily applies only to certain herbs (e.g., basil and cilantro), but could also apply to other herbs from areas where Cyclospora has been 

determined to be present, e.g., in the water supply. 
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Table 1P: Known or reasonably foreseeable (“potential”) food-related biological hazards for Food Sweeteners (Nutritive and 

Non-Nutritive)

Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Food Sweeteners 

(Nutritive and 

Non-Nutritive)

1a Sugars (Dry) Ambient Includes all varieties 

Food Sweeteners 

(Nutritive and 

Non-Nutritive)

1b Syrup/Molasses 

(Liquid) Ambient Includes all varieties 

Food Sweeteners 

(Nutritive and 

Non-Nutritive)

1c Honey (Liquid) Ambient X1 

Includes all varieties 

and forms (e.g., 

comb, strained, 

whipped)

Food Sweeteners 

(Nutritive and 

Non-Nutritive)

1d

Imitation 

Syrup/Molasses 

(Liquid)

Ambient Includes all flavors/ 

varieties 

Food Sweeteners 

(Nutritive and 

Non-Nutritive)

1e Sugar Substitutes 

(Nutritive) Ambient 

Includes sugar 

alcohols, isomalt, 

tagatose 
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Category # Subcategory Storage 

Conditions

Bacillus cereus

Clostridium botulinum

C. perfringens

Brucella spp.

Campylobacter spp.

Pathogenic E. coli

Salmonella spp.

L. monocytogenes

S. aureus

Parasites

Viruses

Comments

Food Sweeteners 

(Nutritive and 

Non-Nutritive)

1f Sugar Substitutes 

(Non-nutritive) Ambient 

Includes aspartame, 

saccharin, 

acesulfame K, 

neotame, stevia, 

sucralose

1 The SMEs identified this as a known or reasonably foreseeable (“potential”) biological hazard applicable only if honey is used as an ingredient in 

infant foods.
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A1.11 Tables of Potential Food-Related Chemical Hazards 

For consistency with the Tables of Known or Reasonably Foreseeable (“Potential”) Food-Related Biological Hazards (Tables 1A through 1P), we 

organized this section around the same 16 Food Groups as those addressed by Tables 1A through 1P. However, in most circumstances a 

chemical hazard requiring a preventive control is addressed through a supply-chain program on ingredients used in a food product rather than 

through process controls applied during production of the food product. Therefore, we focused the Tables in this section on the food categories and 

subcategories containing food products that could be consumed as an ingredient of other food products; in some cases (e.g., Fruits and 

Vegetables) these food products also might be consumed as a finished food product. For example, for the purpose of considering biological 

hazards, Table 1G (Known or reasonably foreseeable (“potential”) food-related biological hazards for Egg and Egg Products) lists 5 food categories, 

including shell eggs. However, for the purpose of considering chemical hazards Table 2G (Known or reasonably foreseeable (“potential”) foodrelated chemical hazards for Egg and Egg Products) lists only one of those 5 food categories – i.e., shell eggs; shell eggs would be the source 

ingredient of the remaining 4 food categories that are listed in Table 1G for food-related biological hazards. 

For 12 of the 16 Food Groups, Tables 2B, 2D, 2E, 2G, 2H, 2I, 2J, 2K, 2O, and 2P list the most relevant food-related chemical hazards and mark 

with an X for a Food Subcategory the most relevant food-related chemical hazards that SMEs recommended be identified as known or reasonably 

foreseeable hazards ("potential hazards") for subsequent hazard evaluation by each facility that produces food products in those Food

Subcategories to determine which hazards require a preventive control as appropriate to the facility and its food products. As discussed in section 

A1.1 of this Appendix, this guidance, including the Tables of Known or Reasonably Foreseeable (“Potential”) Food-Related Chemical Hazards, 

consistently uses the combined term “known or reasonably foreseeable hazard (“potential hazard”)” to describe the output of the Tables to 

consistently use both the term used in the regulatory text of part 117 and a term that could be more familiar to some users of this guidance.

For four of the 16 Food Groups (i.e., Bakery Items; Dressings, Condiments, and Dips; Snack Foods; and Soups and Sauces) the chemical hazards 

depend on the ingredients used. To maintain the overall organization associated with the 16 Food Groups, for these Food Groups we include an 

entry for that “Food Group” (i.e., Food Groups 2A, 2F, 2M, and 2N) and advise you to address known or reasonably foreseeable chemical 

hazards (“potential chemical hazards”) that might be in the ingredients you use to produce foods in that Food Group.

For three Food Groups (i.e., Tables 2H, 2L, and 2O for Fruits and Vegetables, Oils and Oil Products, and Spices and Herbs, respectively), we 

organized the information in the Table around the hazards rather than around the food categories and food subcategories. For example, Table 2H 

for Fruits and Vegetables has separate rows directed to pesticides, cadmium, lead, and mycotoxins/other natural toxins. We organized the 

information this way because some chemical hazards (such as pesticides in the Fruits and Vegetables Food Group) broadly apply to many foods in 

a Food Group, whereas other chemical hazards (such as toxic elements and mycotoxins) more narrowly apply to a subset of foods in a Food 

Group.

The Tables of Known or Reasonably Foreseeable (“Potential”) Food-Related Chemical Hazards 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 
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analysis, whether a chemical hazard identified in these Tables as a known or reasonably foreseeable (“potential”) chemical hazard is a hazard 

requiring a preventive control for the facility’s food product.
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Food Group 2A: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Bakery Items

This Appendix does not include a Table of known or reasonably foreseeable (“potential”) food-related chemical hazards for Bakery Items. Instead, 

for known or reasonably foreseeable (“potential”) food-related chemical hazards for Bakery Items, you should see the Table(s) associated with the 

ingredients in your Bakery Item. For example: 

• If your Bakery Item contains chocolate, you should consult Table 2D regarding known or reasonably foreseeable (“potential”) food-related 

chemical hazards for Chocolate and Candy.

• If your Bakery Item contains eggs, you should consult Table 2G regarding known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Egg and Egg Products.

• If your Bakery Item contains wheat flour, you should consult Table 2J regarding known or reasonably foreseeable (“potential”) food-related 

chemical hazards for Grains, Pulses, Flours, and Starches.

• If your Bakery Item contains fruit, you should consult Table 2H regarding known or reasonably foreseeable (“potential”) food-related chemical 

hazards for Fruits and Vegetables.
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Table 2B: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Beverage Items

Category # Subcategory Storage 

Conditions

Drug residues

Arsenic

cadmium

Lead

Mycotoxins/

Natural toxins

Pesticides

Comments

Non-dairy 

Cocoa/ 

Chocolate

1 - Ready-to-Drink

- Powdered 

Ambient and 

Refrigerated X X X1

Includes plant-based 

chocolate/ cocoa 

flavored products

Coffee 2 

- Raw and Roasted 

Beans/ Whole or 

Ground 

- Single Serve

- Ready-to-Drink

- Powdered

- Freeze-Dried

Ambient X1 Includes flavored and 

unflavored varieties

Tea 6 

- Loose Leaf and 

Bagged 

- Tea and Tea 

Substitutes

Ambient X 

Includes plain and 

flavored teas and herbal 

teas

Carbonated 

Beverages 7 

Ready-to-Drink / 

Carbonated Plain 

and Flavored

Ambient X Includes plain and 

flavored varieties

Ground 

Coffee 

Substitutes

12 Dry Powdered Ambient X2 Includes chicory root 

powder, roasted grains

1 The applicable mycotoxin is ochratoxin. (See FDA Compliance Program 7307.001 (in Table 5 in section VI of the Introduction of this guidance) and Codex Code 

of Practice CAC/RCP 69-2009 and CAC/RCP 72-2013 (in Table 6 in section VI of the Introduction of this guidance).) 2 The applicable mycotoxin depends on the grain. For the applicable mycotoxin for a specific grain, see Table 1J. 
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Table 2C: Food Additives, Color Additives, and GRAS Substances 

Category # Subcategory Storage 

Conditions

Drug residues

Arsenic

Cadmium

Lead

Mycotoxins/

Natural toxins

Pesticides

Comments

Nutrients 7 

Vitamins, 

Minerals, and 

Vitamin/Mineral 

Premixes

Ambient or 

Refrigerated X1 X1

The specific vitamin or 

mineral that could be 

contaminated with arsenic 

or lead is not yet identified. 1 Bair, EC, 2022. 
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Table 2D: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Chocolate and Candy 

Category # Subcategory Storage 

Conditions

Drug residues

Arsenic

Cadmium

Lead

Mycotoxins/

Natural toxins

Pesticides

Comments

Chocolate 

Industrial Products 1a Raw Cocoa Beans Ambient X X X1 Cocoa Beans

Chocolate 

Industrial Products 1b

Roasted Cocoa 

Beans and Nibs, 

Cocoa Butter, 

Cocoa Powder

Ambient X X X1 Beans and Nibs

1 The applicable mycotoxin is ochratoxin. (See FDA Compliance Program 7307.001 (in Table 5 in section VI of the Introduction of this guidance) and Codex Code 

of Practice CAC/RCP 72-2013 (in Table 6 in section VI of the Introduction of this guidance).)
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Table 2E: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Dairy

Category # Subcategory Storage 

Conditions

Drug residues

Arsenic

Cadmium

Lead

Mycotoxins/

Natural toxins

Pesticides

Comments

All 1, 2, 3, 4, 5 All 

Ambient, 

Refrigerated, 

and Frozen

X 

Includes all products 

described in Table 1E, as 

well as shelf stable and 

aseptically processed and 

packaged milk and milk 

products that are 

produced in accordance 

with our LACF regulation 

in 21 CFR part 113
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Food Group 2F: Dressings, Condiments, and Dips

This Appendix does not include a Table of known or reasonably foreseeable (“potential”) food-related chemical hazards for Dressings, Condiments, 

and Dips. Instead, for known or reasonably foreseeable (“potential”) food-related chemical hazards for Dressings, Condiments, and Dips, you 

should see the Table(s) associated with the ingredients in your Dressing, Condiment or Dip Item. For example: 

• If your Dressing, Condiment, or Dip contains dairy ingredients, you should consult Table 2D regarding known or reasonably foreseeable 

(“potential”) food-related chemical hazards for Dairy.

• If your Dressing, Condiment, or Dip contains eggs, you should consult Table 2G regarding known or reasonably foreseeable (“potential”) foodrelated chemical hazards for Egg and Egg Products.

• If your Dressing, Condiment, or Dip contains flour or a pulse such as chickpeas, you should consult Table 2J regarding known or reasonably 

foreseeable (“potential”) food-related chemical hazards for Grains, Pulses, Flours, and Starches.

• If your Dressing, Condiment, or Dip contains a fruit or vegetable, you should consult Table 2H regarding known or reasonably foreseeable 

(“potential”) food-related chemical hazards for Fruits and Vegetables.
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Table 2G: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Egg and Egg Products

Category # Subcategory Storage 

Conditions

Drug residues

Arsenic

Cadmium

Lead

Mycotoxins/

Natural toxins

Pesticides

Comments

Shell Eggs 1 

Shell Eggs - Raw 

and Pasteurized 

in Shell

Refrigerated X Includes all shell eggs 
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Table 2H: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Fruits and Vegetables1

Category #1 Subcategory Storage 

Conditions

Drug residues

Arsenic

Cadmium

Lead

Mycotoxins/

Natural toxins

Pesticides

Comments

Fruits and 

vegetables All Whole RAC or processed

Ambient or 

Refrigerated X All fruits and vegetables

Fruits and 

vegetables All Whole RAC or processed

Ambient or 

Refrigerated X Includes spinach, lettuce, potatoes, beets 

Fruits and 

vegetables All Whole RAC or processed

Ambient or 

Refrigerated X 

Includes sweet potatoes, 

carrots, spinach, dried 

plums (prunes), potatoes, 

mushrooms, garlic

Fruits and 

vegetables All Whole RAC or processed

Ambient or 

Refrigerated X2

Includes apple products, 

dried fruits, dried beans and 

peas

1 Known or reasonably foreseeable (“potential”) chemical hazards generally apply to a raw agricultural commodity regardless of whether and how it 

is processed. Therefore, each row in Table 2H applies to “fruits and vegetables,” regardless of whether they are whole RACs or processed as 

described in Table 1H regarding known or reasonably foreseeable (“potential”) biological hazards. The difference between each row is the chemical 

hazard that is listed as a known or reasonably foreseeable (“potential”) chemical hazard. 

2 For apples and apple products, the applicable mycotoxin is patulin. For dried fruits the applicable mycotoxins are aflatoxin (dried figs) (FDA Import 

Alert 23-14; see Table 5 in section VI of the Introduction of this guidance) or ochratoxin A (raisins, dried figs) (FDA Compliance Program 7307.001; 

see Table 5 in section VI of the Introduction of this guidance). For dried vegetable (beans and peas) the applicable mycotoxin is ochratoxin A (FDA 

Compliance Program 7307.001; see Table 5 in section VI of the Introduction of this guidance). 
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Table 2I: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Game Meat Products

Category # Subcategory Storage 

Conditions

Drug residues

Arsenic

Cadmium

Lead

Mycotoxins/

Natural toxins

Pesticides

Comments

Raw Game Meat All 

Ground and Not 

Ground Game 

Meat

Refrigerated or 

Frozen X1

Bison Steak, Deer 

Shoulder, Rabbit, and Birds 

(Pheasant, Grouse, Quail)

1 The SMEs identified known or reasonably foreseeable (“potential”) drug residue hazards in the broad category “Game Meat Products” but did not 

differentiate between species (e.g., bison, deer, rabbit). You can search for drug approvals by species using the advanced search feature on our 

website at https://animaldrugsatfda.fda.gov/. (See Table 8 in section VI of the Introduction of this guidance.) You can find tolerances for approved 

animal drugs in 21 CFR Part 556.
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Table 2J: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Grains, Pulses, Flours, and 

Starches

Category # Subcategory Storage 

Conditions

Drug residues

Arsenic

Cadmium

Lead

Mycotoxins/

Natural toxins

Pesticides

Comments

Grains, 

Non-Rice 1 

Whole and 

milled grains 

(e.g., flour and 

bran)

Ambient X1 X 

Wheat, Rye, Sorghum, Oats, Barley, Triticale, 

Buckwheat, Corn, Amaranth, Millet, Quinoa 

(RACs and milled grain products)

Rice, 

Milled Rice 

Products

2b

Rice (whole 

and milled) 

and rice 

products

Ambient X X X2 X 

White or Brown Rice, Rice protein,

Sticky/sweet Rice, Basmati Rice, Jasmine 

Rice, Arborio rice, Rice-based noodles, Ricebased cereal

Other 

Milled 

Products

5a Root flours Ambient X3 Potato flour, Cassava flour

Other 

Milled 

Products

5a Root flours Ambient X Sweet potato flour, yam flour

Pulses 6a Whole (dried) 

or processed Ambient X4 X 

Soybean, Kidney, Pinto, Navy, Azuki, Mung, 

Black Gram, Dried Peas; Chickpea; 

Cowpea/Black-eyed Pea; Lentil; Winged Bean 1 The applicable mycotoxins are ochratoxin A (oats, wheat, barley), aflatoxin (dried corn), fumonisins (dried corn), and deoxynivalenol/ vomitoxin (wheat, barley)

(See CPG Sec. 555.400 (in Table 3 in section VI of the Introduction of this guidance); Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for 

Human Consumption and Grains and Grain By-Products used for Animal Feed (in Table 4 in section VI of the Introduction of this guidance); FDA Compliance 

Program 7307.001 (in Table 5 in section VI of the Introduction of this guidance); and Import Alert 23-14 (in Table 5 in section VI of the Introduction of this 

guidance).) 2 Aflatoxin is the applicable mycotoxin (only for raw brown rice). 

3 Cassava contains cyanogenic glycosides that produce cyanide. Depending on the level of cyanogenic glycosides, cassava is detoxified by heat processing alone, 

or by a combination of heat processing and food preparation techniques such as peeling, soaking, sun-drying, and scraping off the outer layer to leach out the 

cyanide (Canadian Food Inspection Agency, 2019). 
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4 The applicable mycotoxin is ochratoxin A for dried peas and beans. (See FDA Compliance Program 7307.001 (in Table 5 in section VI of the Introduction of this 

guidance).)
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Table 2K: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Nuts and Seeds

Category # Subcategory Storage 

Conditions

Drug residues

Arsenic

Cadmium

Lead

Mycotoxins/

Natural toxins

Pesticides

Comments

Nuts 1a Peanuts, Raw 

and treated Ambient X1 X Peanuts

Nuts 1c Tree Nuts, Raw 

and treated Ambient X1 All tree nuts

Nuts 1c Tree Nuts, Raw 

and treated Ambient X Cashews and pecans

Edible Seeds 2a Raw and treated Ambient X1 X Melon, Pumpkin, Sunflower

Edible Seeds 2a Raw and treated Ambient X Sunflower

1 The applicable mycotoxin is aflatoxin. (See CPG Sec. 570.200, CPG Sec. 570.375, and CPG Sec. 570.500 in Table 3 in section VI of the Introduction of this 

guidance.)
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Table 2L: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Oils and Oil Products

Category # Subcategory Storage 

Conditions

Drug residues

Arsenic

Cadmium

Lead

Mycotoxins/

Natural toxins

Pesticides

Comments

Oil products 1a

1d

Highly refined cooking 

oils and infused oils Ambient

See the discussion in section 

A1.7.2 that the chemical 

hazards 3-monochloropropane1,2-diol esters (3-MCPDEs) and 

glycidyl esters (GEs) have the 

potential to form in refined oils 

during food production, 

particularly at high temperature.

Oil products 1a

Cooking oils that are 

not highly refined 

(e.g., produced 

through cold pressing)

Ambient X Includes olive oil

Oil products 1a

1d

Cooking oils and 

infused oils that are 

not highly refined 

(e.g., produced 

through cold pressing)

Ambient X1

Includes cold-pressed oil and 

flavored oils from peanuts, tree 

nuts, sesame, sunflower, and 

melon

1 The applicable mycotoxin is aflatoxin (Einolghozati et al., 2021; Sahin et al., 2022; and Table 2K). 
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Food Group 2M: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Snack Foods

This Appendix does not include a Table of known or reasonably foreseeable (“potential”) food-related chemical hazards for Snack Foods. Instead, 

for known or reasonably foreseeable (“potential”) food-related chemical hazards for Snack Foods, you should see the Table(s) associated with the 

ingredients in your Snack Food. For example: 

• If your Snack Food contains chocolate, you should consult Table 2D regarding known or reasonably foreseeable (“potential”) food-related 

chemical hazards for Chocolate and Candy.

• If your Snack Food contains a fruit or vegetable, you should consult Table 2H regarding known or reasonably foreseeable (“potential”) foodrelated chemical hazards for Fruits and Vegetables.

• If your Snack Food contains wheat flour, you should consult Table 2J regarding known or reasonably foreseeable (“potential”) food-related 

chemical hazards for Grains, Pulses, Flours, and Starches.

• If your Snack Food contains peanuts or tree nuts, you should consult Table 2K regarding known or reasonably foreseeable (“potential”) foodrelated chemical hazards for Nuts and Seeds.
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Food Group 2N: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Soups and Sauces

This Appendix does not include a Table of known or reasonably foreseeable (“potential”) food-related chemical hazards for Soups and Sauces. 

Instead, for known or reasonably foreseeable (“potential”) food-related chemical hazards for Soups and Sauces, you should see the Table(s) 

associated with the ingredients in your Soup or Sauce. For example: 

• If your Soup or Sauce contains a dairy item, you should consult Table 2E regarding known or reasonably foreseeable (“potential”) food-related 

chemical hazards for Dairy.

• If your Soup or Sauce contains a fruit or vegetable, you should consult Table 2H regarding known or reasonably foreseeable (“potential”) foodrelated chemical hazards for Fruits and Vegetables.

• If your Soup or Sauce contains wheat flour, you should consult Table 2J regarding known or reasonably foreseeable (“potential”) food-related 

chemical hazards for Grains, Pulses, Flours, and Starches.
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Table 2O: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Spices and Herbs

Category # Subcategory Storage 

Conditions

Drug residues

Arsenic

Cadmium

Lead

Mycotoxins/

Natural toxins

Pesticides

Comments

Spices 1 Dried, Ground, 

Cracked, or Whole Ambient X Includes capsicums (which include cayenne, chili, paprika), cumin 

Spices 1 Dried, Ground, 

Cracked, or Whole Ambient X Includes chili powder, cumin, oregano

Spices 1 Dried, Ground, 

Cracked, or Whole Ambient X Includes chilis/chili powder, cumin, oregano

Spices 1 Dried, Ground, 

Cracked, or Whole Ambient X1

Includes aniseed, chili powder, 

cinnamon, coriander, cumin, curry, 

ginger, five spice, red hot pepper,

turmeric

Spices 1 Dried, Ground, 

Cracked, or Whole Ambient X2 

Includes capsicums (which include 

cayenne, chili, paprika), ginger, 

nutmeg, turmeric 

Herbs 2a Fresh and Dried Ambient X Includes basil, bay leaves, 

tarragon, thyme

1 See Ishida et al. 2022. 2 The applicable mycotoxins are aflatoxin and ochratoxin A. (See Compliance Program 7307.001 in Table 5 in section VI of the Introduction of this guidance; Iha 

and Truckness, 2019; and Kabak and Dobson, 2017.) 
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Table 2P: Known or reasonably foreseeable (“potential”) food-related chemical hazards for Food Sweeteners (Nutritive and 

Non-Nutritive)

Category # Subcategory Storage 

Conditions

Drug residues

Arsenic

Cadmium

Lead

Mercury

Mycotoxins/

Natural toxins

Pesticides

Comments

Food Sweeteners 

(Nutritive and 

Non-Nutritive)

1c Honey (Liquid) Ambient X X 

Includes all 

varieties and forms 

(e.g., comb, 

strained, whipped)
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