Hazard Analysis and Risk-Based 

Preventive Controls for Human Food: 

Guidance for Industry

Draft Guidance

This guidance is being distributed for comment purposes only.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure

that FDA considers your comment on this draft guidance before we begin work on the final

version of the guidance, submit either electronic or written comments on the draft guidance

within 180 days of publication in the Federal Register of the notice announcing the availability of

the draft guidance. Submit electronic comments to https://www.regulations.gov. Submit written 

comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630

Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the 

docket number FDA–2016–D–2343 listed in the notice of availability that publishes in the 

Federal Register. 

For questions regarding this draft document 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. 

U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Food Safety and Applied Nutrition 

January 2024
Table of Contents 

Introduction and General Information Applicable to This Guidance

Chapter 1: The Food Safety Plan 

Chapter 2: Conducting a Hazard Analysis

Chapter 3: Potential Hazards Associated with the Manufacturing, Processing, Packing, and

Holding of Human Food

Chapter 4: Preventive Controls

Chapter 5: Application of Preventive Controls and Preventive Control Management Components

Chapter 6: Use of Heat Treatments as a Process Control

Chapter 7: Use of Time/Temperature as a Process Control (Coming Soon)

Chapter 8: Use of Product Formulation or Drying/Dehydrating as a Process Control for Biological 

Hazards (Coming Soon)

Chapter 9: Validation of a Process Control for a Bacterial Pathogen (Coming Soon)

Chapter 10: Sanitation Program (Coming Soon)

Chapter 11: Food Allergen Program

Chapter 12: Preventive Controls for Chemical Hazards (Coming Soon)

Chapter 13: Preventive Controls for Physical Hazards (Coming Soon)

Chapter 14: Recall Plan

Chapter 15: Supply-Chain Program for Human Food Products

Chapter 16: Acidified Foods

Chapter 17: Classification of Food as Ready to Eat or Not Ready to Eat (Coming Soon)

Appendix 1: Known or Reasonably Foreseeable Hazards ("Potential Hazards")

Appendix 2: Food Safety Plan Forms

Appendix 3: Bacterial Pathogen Growth and Inactivation
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Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 1 

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. 

Introduction and General Information Applicable to This Guidance

Table of Contents

I. Introduction

II. Purpose of This Guidance

III. Glossary of Terms Used in This Guidance

A. Definitions Established in 21 CFR 117.3

B. Other Terms that FDA Uses in This Guidance

IV. Abbreviations

V. Training

VI. Resources

VII. References

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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Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 2 

I. Introduction

In part 117 of 21 CFR, we have established our regulation titled “Current Good Manufacturing 

Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food.” We published 

the final rule establishing part 117 in the Federal Register of September 17, 2015 (80 FR 55908). 

Part 117 includes current good manufacturing practice (CGMP) requirements (primarily in 

subpart B, with associated requirements in subparts A and F) that generally apply to 

manufacturing, processing, packing, and holding human food. Part 117 also includes 

requirements (primarily in subparts C and G, with associated requirements in subparts A, D, E, 

and F) to establish and implement preventive controls for human food. 

The preventive controls for human foods (PCHF) requirements implement the provisions of the 

FDA Food Safety Modernization Act (FSMA), established in section 418 of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g). The PCHF requirements generally apply 

to those domestic and foreign facilities that manufacture, process, pack, or hold human food and 

are required to register under section 415 of the FD&C Act (21 U.S.C. 350d; 21 CFR part 1, 

subpart H). This registration requirement applies to facilities engaged in the 

manufacturing/processing, packing, or holding of food for consumption in the United States. 

(See the definition of “facility” in 21 CFR 1.227 and the registration requirement in 21 CFR 

1.225(a).) The PCHF requirements apply to the owner, operator, or agent in charge of a facility. 

See Table 1 for a list of the subparts established in part 117. 

Table 1. Subparts Established in 21 CFR Part 117 

Subpart Title

A General Provisions 

B Current Good Manufacturing Practice 

C Hazard Analysis and Risk-Based Preventive Controls 

D Modified Requirements 

E Withdrawal of a Qualified Facility Exemption

F Requirements Applying to Records That Must be Established and 

Maintained

G Supply-Chain Program 
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Part 117 includes several complete or partial exemptions from the PCHF requirements. See 21 

CFR 117.5 for a list and description of these exemptions. See 21 CFR 117.7 for the applicability 

of subparts C, D, and G to a facility solely engaged in the storage of unexposed packaged food, 

including the applicability of 21 CFR 117.206 (in subpart D) to unexposed packaged food that 

requires time/temperature control to significantly minimize or prevent the growth of, or toxin 

production by, pathogens. 

This document is directed to those persons (you) who are subject to the PCHF requirements of 

part 117. This guidance is not directed to persons who are exempt from PCHF requirements 

under 21 CFR 117.5 or are subject to the modified requirements in 21 CFR 117.206 for any 

unexposed packaged food that requires time/temperature control to significantly minimize or 

prevent the growth of, or toxin production by, pathogens. However, such persons may find some 

of the principles and recommendations in this guidance helpful in manufacturing, processing, 

packing, and holding human food. 

In general, FDA's guidance documents do not establish legally enforceable responsibilities. 

Instead, guidances describe FDA's current thinking on a topic and should be viewed only as 

recommendations, unless specific regulatory or statutory requirements are cited. The use of the 

word should in FDA guidances means that something is suggested or recommended, but not 

required. 

II. Purpose of This Guidance

The purpose of this guidance is to help you comply with the following specific PCHF 

requirements established in subparts C and G of part 117: 

• A written food safety plan (FSP);

• Hazard analysis;

• Preventive controls;

• Monitoring;

• Corrective actions;

• Verification; and

• Associated records.

Specifically, this document provides guidance on: 

• the components of an FSP and the importance of each component;

• the biological, chemical (including radiological) and physical hazards that are most relevant

to manufacturing, processing, packing, and holding FDA-regulated human food products;

• how to conduct a hazard analysis and develop an FSP for the products that you process;
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• how to identify preventive controls for common biological (specifically bacterial pathogens),

chemical, and physical hazards most relevant to the production of many processed foods so

you can apply those preventive controls to the hazards identified in your hazard analysis;

• how to identify and apply the preventive control management components (i.e., monitoring,

corrective actions and corrections, verification, and associated records); and

• the recordkeeping requirements associated with the FSP and implementation of the FSP.

We intend this guidance to include multiple chapters. When we develop each chapter, we 

announce its availability for public comment as the chapter becomes available. In the Table of 

Contents for this guidance, we list chapters that are not yet available as “coming soon.” 

We recommend that you consider how this guidance relates to each of your operations and tailor 

your FSP to the specific circumstances for the foods you process. 

III. Glossary of Terms Used in This Guidance

A. Definitions Established in 21 CFR 117.3

For the convenience of the reader, we are reproducing the definitions that are codified in 21 CFR 

117.3. These definitions were established through rulemaking that culminated in a final rule 

published on September 17, 2015 (80 FR 55908). They remain current as of the date of this 

guidance. Because these definitions could change through future rulemaking, you should check 

for the latest definitions at 21 CFR 117.3. 

Acid foods or Acidified foods: Foods that have an equilibrium pH of 4.6 or below. 

Adequate: That which is needed to accomplish the intended purpose in keeping with good 

public health practice.

Affiliate: Any facility that controls, is controlled by, or is under common control with another 

facility. 

Allergen cross-contact: The unintentional incorporation of a food allergen into a food. 

Audit: The systematic, independent, and documented examination (through observation, 

investigation, records review, discussions with employees of the audited entity, and, as 

appropriate, sampling and laboratory analysis) to assess an audited entity’s food safety processes 

and procedures. 

Batter: A semifluid substance, usually composed of flour and other ingredients, into which 

principal components of food are dipped or with which they are coated, or which may be used 

directly to form bakery foods. 
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Blanching (except for tree nuts and peanuts): A prepackaging heat treatment of foodstuffs for 

an adequate time and at an adequate temperature to partially or completely inactivate the 

naturally occurring enzymes and to effect other physical or biochemical changes in the food. 

Calendar day: Every day shown on the calendar. 

Correction: An action to identify and correct a problem that occurred during the production of 

food, without other actions associated with a corrective action procedure (such as actions to 

reduce the likelihood that the problem will recur, evaluate all affected food for safety, and 

prevent affected food from entering commerce).

Critical control point (CCP): A point, step, or procedure in a food process at which control can 

be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to 

an acceptable level.

Defect action level: A level of a non-hazardous, naturally occurring, unavoidable defect at 

which FDA may regard a food product “adulterated” and subject to enforcement action under 

section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act. 

Environmental pathogen: A pathogen capable of surviving and persisting with the 

manufacturing processing, packing, or holding environment such that food may be contaminated 

and may result in foodborne illness if that food is consumed without treatment to significantly 

minimize the environmental pathogen. Examples of environmental pathogens include Listeria 

monocytogenes and Salmonella spp. but do not include the spores of pathogenic sporeforming 

bacteria.

Facility: A domestic facility or foreign facility that is required to register under section 415 of 

the Federal Food, Drug, and Cosmetic Act, in accordance with the requirements of 21 CFR part 

1, subpart H. 

Farm: Farm as defined in 21 CFR 1.227. 

FDA: Food and Drug Administration. 

Food: Includes (1) articles used for food or drink for man or other animals, (2) chewing gum, 

and (3) articles used for components of any such article and includes raw materials and 

ingredients. 

Food allergen: A major food allergen as defined in section 201(qq) of the Federal Food, Drug, 

and Cosmetic Act.

2

Food-contact surfaces: Those surfaces that contact human food and those surfaces from which 

drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs 

2 Section 201(qq) of the FD&C Act defines the term ‘‘major food allergen,’’ in part, to mean any of the following:

Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., 

almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame or a food ingredient that contains protein 

derived from one of these foods, with certain exceptions regarding highly refined oils. 
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during the normal course of operation. “Food contact surfaces” includes utensils and foodcontact surfaces of equipment.

Full-time equivalent employee: A term used to represent the number of employees of a 

business entity for the purpose of determining whether the business qualifies for the small 

business exemption. The number of full-time equivalent employees is determined by dividing the 

total number of hours of salary or wages paid directly to employees of the business entity and of 

all of its affiliates and subsidiaries by the number of hours of work in 1 year, 2,080 hours (i.e., 40 

hours × 52 weeks). If the result is not a whole number, round down to the next lowest whole 

number. 

Harvesting: Applies to farms and farm mixed-type facilities and means activities that are 

traditionally performed on farms for the purpose of removing raw agricultural commodities from 

the place they were grown or raised and preparing them for use as food. Harvesting is limited to 

activities performed on raw agricultural commodities, or on processed foods created by 

drying/dehydrating a raw agricultural commodity without additional manufacturing/processing, 

on a farm. Harvesting does not include activities that transform a raw agricultural commodity 

into a processed food as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. 

Examples of harvesting include cutting (or otherwise separating) the edible portion of the raw 

agricultural commodity from the crop plant and removing or trimming part of the raw 

agricultural commodity (e.g., foliage, husks, roots or stems). Examples of harvesting also include 

cooling, field coring, filtering, gathering, hulling, shelling, sifting, threshing, trimming of outer 

leaves of, and washing raw agricultural commodities grown on a farm. 

Hazard: Any biological, chemical (including radiological), or physical agent that has the 

potential to cause illness or injury. 

Hazard requiring a preventive control: A known or reasonably foreseeable hazard 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 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. 

Holding: storage of food and also includes activities performed incidental to storage of a food 

(e.g., activities performed for the safe or effective storage of that food, such as fumigating food 

during storage, and drying/dehydrating raw agricultural commodities when the 

drying/dehydrating does not create a distinct commodity (such as drying/dehydrating hay or 

alfalfa)). Holding also includes activities performed as a practical necessity for the distribution of 

that food (such as blending of the same raw agricultural commodity and breaking down pallets), 

but does not include activities that transform a raw agricultural commodity into a processed food 

as defined in section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding facilities 

could include warehouses, cold storage facilities, storage silos, grain elevators, and liquid storage 

tanks. 
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Known or reasonably foreseeable hazard: A potential biological, chemical (including 

radiological), or physical hazard that is known to be, or has the potential to be, associated with 

the facility or the food. 

Lot: The food produced during a period of time and identified by an establishment’s specific 

code. 

Manufacturing/processing: Making food from one or more ingredients, or synthesizing, 

preparing, treating, modifying or manipulating food, including food crops or ingredients. 

Examples of manufacturing/processing activities include: Baking, boiling, bottling, canning, 

cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to create a 

distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating, 

eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, 

labeling, milling, mixing, packaging (including modified atmosphere packaging), pasteurizing, 

peeling, rendering, treating to manipulate ripening, trimming, washing, or waxing. For farms and 

farm mixed-type facilities, manufacturing/processing does not include activities that are part of 

harvesting, packing, or holding. 

Microorganisms: Yeast, molds, bacteria, viruses, protozoa, and microscopic parasites and 

includes species that are pathogens. The term “undesirable microorganisms” includes those 

microorganisms that are pathogens, that subject food to decomposition, that indicate that food is 

contaminated with filth, or that otherwise may cause food to be adulterated. 

Mixed-type facility: An establishment that engages in both activities that are exempt from 

registration under section 415 of the Federal Food, Drug, and Cosmetic Act and activities that 

require the establishment to be registered. An example of such a facility is a “farm mixed-type 

facility,” which is an establishment that is a farm, but also conducts activities outside the farm 

definition that require the establishment to be registered.

Monitor: To conduct a planned sequence of observations or measurements to assess whether 

control measures are operating as intended. 

Packing: Placing food into a container other than packaging the food and also includes repacking and activities performed incidental to packing or re-packing a food (e.g., activities 

performed for the safe or effective packing or re-packing of that food (such as sorting, culling, 

grading, and weighing or conveying incidental to packing or re-packing)), but does not include 

activities that transform a raw agricultural commodity into a processed food as defined in section 

201(gg) of the Federal Food, Drug, and Cosmetic Act.

Pathogen: A microorganism of public health significance. 

Pest: Any objectionable animals or insects including birds, rodents, flies, and larvae. 

Plant: The building or structure or parts thereof, used for or in connection with the 

manufacturing, processing, packing, or holding of human food. 

Preventive controls: Those risk-based, reasonably appropriate procedures, practices, and 

processes that a person knowledgeable about the safe manufacturing, processing, packing, or 

holding of food would employ to significantly minimize or prevent the hazards identified under 
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the hazard analysis that are consistent with the current scientific understanding of safe food 

manufacturing, processing, packaging, or holding at the time of the analysis. 

Preventive controls qualified individual (PCQI): A qualified individual who has successfully 

completed training in the development and application of risk-based preventive controls at least 

equivalent to that received under a standardized curriculum recognized as adequate by FDA or is 

otherwise qualified through job experience to develop and apply a food safety system. 

Qualified auditor: A person who is a qualified individual as defined in this part and has 

technical expertise obtained through education, training, or experience (or a combination thereof) 

necessary to perform the auditing function as required by 21 CFR 117.180(c)(2). Examples of 

potential qualified auditors include: (1) A government employee, including a foreign government 

employee; and (2) An audit agent of a certification body that is accredited in accordance with 

regulations in 21 CFR part 1, subpart M. 

Qualified end-user, with respect to a food: The consumer of the food (where the term 

consumer does not include a business); or a restaurant or retail food establishment (as those 

terms are defined in 21 CFR 1.227) that: (1) Is located: (i) In the same State or the same Indian 

reservation as the qualified facility that sold the food to such restaurant or establishment; or (ii) 

Not more than 275 miles from such facility; and (2) Is purchasing the food for sale directly to 

consumers at such restaurant or retail food establishment. 

Qualified facility (when including the sales by any subsidiary; affiliate; or subsidiaries or 

affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate): A 

facility that is a very small business as defined in this part, or a facility to which both of the 

following apply: (1) During the 3-year period preceding the applicable calendar year, the average 

annual monetary value of the food manufactured, processed, packed or held at such facility that 

is sold directly to qualified end-users (as defined in this part) during such period exceeded the 

average annual monetary value of the food sold by such facility to all other purchasers; and (2) 

The average annual monetary value of all food sold during the 3-year period preceding the 

applicable calendar year was less than $500,000, adjusted for inflation. 

Qualified facility exemption: An exemption applicable to a qualified facility under 21 CFR 

117.5(a). 

Qualified individual: A person who has the education, training, or experience (or a combination 

thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to 

the individual’s assigned duties. A qualified individual may be, but is not required to be, an 

employee of the establishment. 

Quality control operation: A planned and systematic procedure for taking all actions necessary 

to prevent food from being adulterated. 
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Raw agricultural commodity: Has the meaning given in section 201(r) of the Federal Food, 

Drug, and Cosmetic Act3. 

Ready-to-eat (RTE) food: Any food that is normally eaten in its raw state or any other food, 

including a processed food, for which it is reasonably foreseeable that the food will be eaten 

without further processing that would significantly minimize biological hazards.

Receiving facility: A facility that is subject to subparts C and G of this part and that 

manufactures/processes a raw material or other ingredient that it receives from a supplier. 

Rework: Clean, unadulterated food that has been removed from processing for reasons other 

than insanitary conditions or that has been successfully reconditioned by reprocessing and that is 

suitable for use as food. 

Safe-moisture level: A level of moisture low enough to prevent the growth of undesirable 

microorganisms in the finished product under the intended conditions of manufacturing, 

processing, packing, and holding. The safe moisture level for a food is related to its water 

activity (aw). An aw will be considered safe for a food if adequate data are available that 

demonstrate that the food at or below the given aw will not support the growth of undesirable 

microorganisms. 

Sanitize: To adequately treat cleaned surfaces by a process that is effective in destroying 

vegetative cells of pathogens, and in substantially reducing numbers of other undesirable 

microorganisms, but without adversely affecting the product or its safety for the consumer. 

Significantly minimize: To reduce to an acceptable level, including to eliminate.

Small business (for purposes of this part): A business (including any subsidiaries and 

affiliates) employing fewer than 500 full-time equivalent employees. 

Subsidiary: Any company which is owned or controlled directly or indirectly by another 

company. 

Supplier: The establishment that manufactures/processes the food, raises the animal, or grows 

the food that is provided to a receiving facility without further manufacturing/processing by 

another establishment, except for further manufacturing/processing that consists solely of the 

addition of labeling or similar activity of a de minimis nature. 

Supply-chain-applied control: A preventive control for a hazard in a raw material or other 

ingredient when the hazard in the raw material or other ingredient is controlled before its receipt. 

Unexposed packaged food: Packaged food that is not exposed to the environment. 

Validation: Obtaining and evaluating scientific and technical evidence that a control measure, 

combination of control measures, or the food safety plan as a whole, when properly 

implemented, is capable of effectively controlling the identified hazards. 

3 Any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their 

unpeeled natural form prior to marketing.
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Verification: The application of methods, procedures, tests and other evaluations, in addition to 

monitoring, to determine whether a control measure or combination of control measures is or has 

been operating as intended and to establish the validity of the food safety plan. 

Very small business (for purposes of this part): A business (including any subsidiaries and 

affiliates) averaging less than $1,000,000, adjusted for inflation, per year, during the 3-year 

period preceding the applicable calendar year in sales of human food plus the market value of 

human food manufactured, processed, packed, or held without sale (e.g., held for a fee). 

Water activity (aw): A measure of the free moisture in a food and is the quotient of the water 

vapor pressure of the substance divided by the vapor pressure of pure water at the same 

temperature. 

Written procedures for receiving raw materials and other ingredients: Written procedures to 

ensure that raw materials and other ingredients are received only from suppliers approved by the 

receiving facility (or, when necessary and appropriate, on a temporary basis from unapproved 

suppliers whose raw materials or other ingredients are subjected to adequate verification 

activities before acceptance for use). 

You, for purposes of this part: The owner, operator, or agent in charge of a facility. 

B. Other Terms that FDA Uses in This Guidance

The following definitions in this guidance are intended to help you comply with the PCHF 

requirements established in subparts C and G of part 117. These terms may be used differently 

elsewhere. 

Adequate cooking instructions: Cooking instructions that are adequate to significantly 

minimize biological hazards. 

Adequately reduce: Capable of reducing the presence of pathogens to an extent sufficient to 

prevent illness. 

Adjustment: An intervention that you take if you determine that there is a deviation from an 

operating limit, without a deviation from a critical value/critical limit. 

Allergen cleaning procedure: Procedures, practices, and processes for cleaning food-contact 

surfaces of equipment and utensils that are used for foods with different food allergen profiles. 

Allergen cross-contact control: Procedures, practices, and processes employed for ensuring 

protection of food from allergen cross-contact, including during storage, handling, and use. 

Allergenic component: A food allergen (i.e., a major food allergen as defined in section 201(qq) 

of the FD&C Act) that is a component of an ingredient (e.g., the food allergen “milk” in a spice 

blend). 
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Allergenic ingredient: A food allergen (i.e., a major food allergen as defined in section 201(qq) 

of the FD&C Act) that is an ingredient of another food product (e.g., the food allergen “peanuts” 

added to cookies). 

Allergen labeling guidance: Questions and Answers Regarding Food Allergens, Including the 

Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): 

Guidance for Industry. 

Allergen labeling requirements of the FD&C Act: Requirements (in section 403(w) of the 

FD&C Act (21 U.S.C 343(w))) that apply to certain foods that are, or contain, a major food 

allergen. 

Approved supplier: A supplier that has met the criteria of the receiving facility’s supply chain 

program, is controlling a hazard identified by the receiving facility as requiring a supply-chainapplied control, and has been approved by the receiving facility in accordance with the 

requirements of part 117, subpart G. 

Certificate of analysis: A document, provided by the supplier of a food prior to or upon receipt 

of the food, that documents the analysis of certain characteristics and attributes of the food. 

Certificate of Conformance: A document, provided by the supplier of a food prior to or upon 

receipt of the food, that states that the processing of the food and/or the food itself conform to 

certain specifications. 

Changeover: Procedures used to prepare the processing line when different products are 

produced on the same processing line. 

Cleaning: The removal of soil, including food residue, dirt, grease or other objectionable matter, 

from a surface. 

Clean in place (CIP): A system used to clean process piping, bins, tanks, mixing equipment, or 

larger pieces of equipment without disassembly, where interior product zones are fully exposed 

and soil can be readily washed away by the flow of the cleaning solution. 

Clean out of place (COP): A method (e.g., using cleaning tanks) used to clean equipment parts, 

and ancillary items including piping and valves after disassembly by taking them from the 

production area to a designated cleaning area. 

Codex validation guidelines: Codex publication titled “Guidelines for the Validation of Food 

Safety Control Measures (CXG 69-2008).” 

Commercial entity provisions: Provisions of 21 CFR 117.136. 

Compositing: Combining analytical portions from more than one collected sample into a 

mixture in preparation for analytical testing of the mixture.

Consignee: The term defined in 21 CFR part 7 to mean anyone who received, purchased, or used 

the product being recalled. (See 21 CFR 7.3(n).)

Controlled wet cleaning: The removal of soil, including food residues, dirt, grease, or other 

objectionable matter, from a surface, using a limited amount of water and detergents and 

controlling the spread of the water used. 
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Control point (CP): Any step at which biological, physical, or chemical factors can be 

controlled. 

Cooking instructions: Instructions to heat-process food using a kill step (e.g., by baking, 

boiling, or microwave cooking).

Corrective action: An action to identify and correct a food safety problem that occurred during 

the production of food, including actions associated with a corrective action procedure (such as 

actions to reduce the likelihood that the problem will recur, evaluate all affected food for safety, 

and prevent affected food from entering commerce). 

Covered produce: Produce, listed in 21 CFR 112.1(b), that is subject to the standards for 

growing, harvesting, packing, and holding of produce for human consumption in the produce 

safety regulation.

Critical parameter/critical factor: A parameter that could, if varied, affect the adequacy of a 

preventive control to significantly minimize or prevent a hazard requiring a preventive control.

Critical value/critical limit: A maximum and/or minimum value to which a biological, 

chemical, or physical parameter must be controlled to significantly minimize or prevent a hazard 

requiring a preventive control. 

Deviation: Failure to meet a critical value/critical limit or adhere to a critical parameter/critical 

factor.

Direct account: The term used in FDA’s recall policy in 21 CFR part 7, subpart C to mean the 

first consignee in a recalling firm’s distribution chain.

Direct consignee: The term used in 21 CFR 117.139 to mean the first consignee in a recalling 

firm’s distribution chain. Part 117 uses the term “direct consignee” to have the same meaning as 

“direct account” in 21 CFR part 7, subpart C.

Draft allergen labeling guidance: Questions and Answers Regarding Food Allergens, Including 

the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 

5): Guidance for Industry (Draft Guidance).

Dry cleaning: The physical removal of soil, including food residues, dirt, grease, or other 

objectionable matter, from a surface, by actions such as wiping, sweeping, brushing, scraping, or 

vacuuming the residues) without water.

End-Point Internal Product Temperature (EPIPT): A measurement of the internal 

temperature of the product at the end of the heat process.

Environmental sample: A sample that is collected from a surface or area of the plant for the 

purpose of testing the surface or area for the presence of microorganisms, such as an 

environmental pathogen or an appropriate indicator organism.

Exception record: A record that is created only when there is loss of control.

Food allergen label specification: All features of the product label that you will use to ensure 

that the finished food will not be misbranded under section 403(w) of the FD&C Act. Examples 

of such features are product name; the approach to naming the food source of all allergenic 
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ingredients (and allergenic components of ingredients) (e.g., within the ingredient statement or in 

a separate “Contains” statement); and any color coding or other distinctive features that you use 

to help production personnel select the correct label. 

Food allergen profile: The food allergen sources present or absent in a food. 

Food safety plan: A set of documents that contain the written hazard analysis, the written 

preventive controls, the written supply-chain program (when applicable), the written recall plan, 

and written preventive control management components (i.e., written procedures for monitoring, 

corrective action, and verification) as appropriate to ensure the effectiveness of the preventive 

controls, taking into account the nature of the preventive control and its role in the facility’s food 

safety system. See 21 CFR 117.126 and 117.140.

Food Safety System: The outcome of implementing the food safety plan and its supporting 

elements.

Fully cooked food: Food that a manufacturer/processor has heat-treated using a kill step. 

HACCP (Hazard Analysis and Critical Control Point): A systematic approach to the 

identification, evaluation, and control of food safety hazards. 

Hazard analysis: The process of identifying hazards, and evaluating information on those 

hazards (including the severity of the illness or injury if the hazard were to occur and the 

conditions that could lead to its presence), to determine which hazards require a preventive 

control and therefore should be addressed in a HACCP plan or a food safety plan.4

Heating instructions: Instructions for consumers to heat-process food without using a kill step 

(e.g., through warming or through surface heat treatments (such as toasting)). 

Import alert: An FDA document that informs FDA’s field staff and the public that the agency 

has enough evidence to allow for Detention Without Physical Examination (DWPE) of products 

that appear to be in violation of the FDA’s laws and regulations. These violations could be 

related to the product, manufacturer, shipper, importer, and/or other information. 

Intrinsic properties: Parameters inherent to a food. 

Kill step: Lethal processing to significantly minimize biological hazards. 

Knowledgeable person: A person who has knowledge about the safe manufacturing, 

processing, packing, or holding of food. 

Label: A display of written, printed, or graphic matter upon the immediate container of any 

article. See section 201(k) of the FD&C Act (21 U.S.C. 321(k)). 

4 Adapted from the Food Safety Preventive Controls Alliance (FSPCA) definition of hazard analysis, which is the 

process of collecting and evaluating information on hazards and the conditions leading to their presence to 

determine which hazards are significant for food safety and therefore should be addressed in a HACCP plan or food 

safety plan. 
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Labeling: All labels and other written, printed, or graphic matter (1) upon any article or any of 

its containers or wrappers, or (2) accompanying such article. See section 201(m) of the FD&C 

Act (21 U.S.C. 321(m)). 

Label control: Procedures, practices, and processes employed for labeling the finished food, 

including ensuring that the finished food is not misbranded under section 403(w) of the FD&C 

Act. 

Lethality treatment: A process that is used to significantly minimize (kill, destroy) viruses, 

parasites, or the vegetative cells of bacteria or to inactivate spores of sporeforming bacteria. 

Microbial challenge study: A study in which a preventive control is “challenged” by a pathogen 

or surrogate microorganism to determine the impact of the preventive control on the pathogen or 

its surrogate. 

NACMCF guidelines for conducting microbial challenge studies: National Advisory 

Committee on Microbiological Criteria for Foods publication titled “Parameters for Determining 

Inoculated Pack/Challenge Study Protocols,” J. Food Prot. 73:140-202. 

Non-lethality treatment: A process that is used to minimize or prevent the growth of 

microorganisms (e.g., time/temperature controls, most formulation controls, and 

dehydration/drying) rather than for the purpose of killing/destroying them. 

Operating limits: Criteria that could be more stringent than critical values/limits and are 

established for reasons other than food safety. 

Other risk-based mitigation measure: A measure, other than a “preventive control” as defined 

in 21 CFR 117.3, to reduce the risk of foodborne illness. 

Partially cooked food: Food that a manufacturer/processor has heat-treated without using a kill 

step. 

Pertinent pathogen: A known or reasonably foreseeable pathogen that requires a preventive 

control and is the most difficult to control by the process (e.g., the pathogen that has the greatest 

resistance to a lethality treatment or that is least impacted by a non-lethality treatment). 

Potential hazard: Synonym for “known or reasonably foreseeable hazard” as defined in 21 CFR 

117.3. (See section III.B.)

Prerequisite programs: Procedures, including Current Good Manufacturing Practices 

(CGMPs), that provide the basic environmental and operating conditions necessary to support 

the Food Safety Plan. 

Principal display panel: The part of a food label that is most likely to be displayed, presented, 

shown, or examined under customary conditions of display for retail sale and is often the front 

panel of a food product. See 21 CFR 101.1. 

Process parameter: A measurable or observable factor associated with the delivery of a process. 

Produce safety regulation: Our regulation, established in 21 CFR part 112, titled “Standards for 

the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” 
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Produce that is rarely consumed raw: Produce, listed in 21 CFR 112.2(a)(1), that is exempt 

from the standards for growing, harvesting, packing, and holding of produce for human 

consumption in the produce safety regulation. 

Recall: A firm's removal or correction of a marketed product that FDA considers to be in 

violation of the laws it administers and against which the Agency would initiate legal action, 

e.g., seizure. “Recall” does not include a market withdrawal or a stock recovery. (See 21 CFR

7.3(g).)

Recall classification: The numerical designation (i.e., I, II, or III) assigned by FDA to a 

particular product recall to indicate the relative degree of health hazard presented by the product 

being recalled. (1) Class I is a situation in which there is a reasonable probability that the use of, 

or exposure to, a violative product will cause serious adverse health consequences or death (21 

CFR 7.3(m)(1)); (2) Class II is a situation in which use of, or exposure to, a violative product 

may cause temporary or medically reversible adverse health consequences or where the 

probability of serious health consequences is remote (21 CFR 7.3(m)(2)); and (3) Class III is a 

situation in which use of, or exposure to, a violative product is not likely to cause illness or 

injury (21 CFR 7.3(m)(3)). (See 21 CFR 7.3(m).) 

Reduce to an acceptable level: See definition of “adequately reduce.”

Relevant hazards: Universe of all hazards that are most relevant to food safety and that are 

narrowed (through the hazard identification phase of a hazard analysis) to known or reasonably 

foreseeable (“potential”) hazards that are then evaluated (through the hazard evaluation phase of 

a hazard analysis) to determine the hazards requiring a preventive control. 

Risk management strategy: A combination of appropriate, risk-based preventive controls (and 

associated preventive control management components) and other risk-based mitigation 

measures that are not preventive controls. 

Root cause analysis: A retrospective evaluation of information from a root cause investigation 

of a contamination event5 to determine what actions can be taken to eliminate the root cause(s) 

and prevent a recurrence of the event.

Root cause investigation: A procedure used to attempt to determine the root cause(s) of a 

contamination event6

 by investigating all aspects of the manufacturing process, including the 

environment, and provide information for use in determining factors that may have contributed 

to the event, actions that can be taken to fix the problem that resulted in the event, and actions to 

prevent the problem from recurring.

5 Although most commonly associated with a pathogen contamination event, such evaluation could be adapated to 

identify and correct a problem related to any adulteration under section 402 or misbranding under section 403(w) of 

the FD&C Act. 

6 Although most commonly associated with a pathogen contamination event, such procedure could be adapated to 

identify and correct a problem related to any adulteration under section 402 or misbranding under section 403(w) of 

the FD&C Act.
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Safety factor: An increase in a process parameter so that it exceeds the minimum needed to 

achieve control. 

Sanitation break: Stopping production to clean and sanitize all food-contact surfaces (FCSs) in 

the production system. 

Sanitation cleaning procedures: Procedures, practices, and processes to clean (and, as 

applicable, sanitize) FCSs and non-FCSs. 

Second-party audit: An audit conducted by an employee of a receiving facility. 

Serious adverse health consequences or death to humans hazard: A hazard for which there is 

a reasonable probability that exposure to the hazard will result in serious adverse health 

consequences or death to humans. 

Severity: The seriousness of the effects of a hazard. 

Surrogate microorganism: A non-pathogenic microorganism that has survival and/or growth 

capabilities that are similar to, or more robust than, the pertinent pathogen under the conditions 

being evaluated. 

Target microorganism: The pertinent pathogen or its surrogate that will be evaluated in a 

validation study. 

Third-party audit: An audit conducted by a qualified auditor that is not an employee of either 

the receiving facility or the supplier. 

Time/temperature control for safety food (TCS food): A food that requires time/temperature 

control for safety to limit growth of, or toxin formation by, pathogens. 

Unintended allergen presence: The presence of an allergen due to allergen cross-contact. 

Visibly clean: Without visibly detectable material such as food residue, film, or protein sheen. 

We, our, and us: The U.S. Food and Drug Administration. 

Work-in-process (WIP): Partially finished products that are in between different production 

stages (e.g., batched or pre-processed ingredients that are transferred to totes and held until 

moved to another processing line to be incorporated into another product). 

IV. Abbreviations

Table 2: Abbreviations Used in This Guidance

Abbreviation What It Means 

ABC Almond Board of California 

aw Water activity
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Abbreviation What It Means 

BHA Butylated hydroxyanisole 

BHT Butylated hydroxytoluene 

CBA Consumer Brands Association (formerly Grocery Manufacturers 

Association) 

CBA LowMoisture Foods 

Guidelines

CBA “Control of Salmonella in Low-Moisture Foods Guidance 

Document” 

CCP Critical control point

CDC Centers for Disease Control and Prevention 

CIP Clean in place

CFIA Canadian Food Inspection Agency 

CFR Code of Federal Regulations 

CGMP Current good manufacturing practice 

CFSAN Center for Food Safety and Applied Nutrition 

CL Critical limit

COA Certificate of Analysis

Codex Codex Alimentarius Commission

COP Clean out of place 

CP Control point 

CPG Compliance Policy Guide 

D-value Decimal reduction time

DON Deoxynivalenol 

EDTA Ethylene-diaminetetraacetate
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Abbreviation What It Means 

EMP Environmental monitoring program 

EPIPT End-Point Internal Product Temperature 

EPA U.S. Environmental Protection Agency 

ECDPC European Centre for Disease Prevention and Control 

EFSA European Food Safety Authority 

FALCPA Food Allergen Labeling and Consumer Protection Act 

FAO Food and Agriculture Organization of the United Nations 

FCS Food-contact surface

FDA U.S. Food and Drug Administration 

FDA’s Listeria

guidance* 

Control of Listeria monocytogenes in Ready-To-Eat Foods: 

Guidance for Industry 

FD&C Act Federal Food, Drug, and Cosmetic Act 

FSIS Food Safety and Inspection Service of the U.S. Department of 

Agriculture

FSMA FDA Food Safety Modernization Act 

FSP Food safety plan 

FSPCA Food Safety Preventive Controls Alliance 

FSVP Foreign Supplier Verification Programs 

GE Glycidyl Esters

GMA Grocery Manufacturers Association (now Consumer Brands 

Association) 

HACCP Hazard Analysis and Critical Control Point 

HPP High Pressure Processing 
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Abbreviation What It Means 

ICMSF International Commission on Microbiological Specifications for 

Foods 

IFT Institute of Food Technologists 

ILSI International Life Sciences Institute 

ILSI Europe International Life Sciences Institute Europe 

IQF Individually quick frozen 

IRAC Interagency Risk Assessment Consortium 

ISO International Organization for Standardization 

JECFA Joint Food and Agriculture Organization/World Health 

Organization Expert Committee on Food Additives 

Juice HACCP 

guidance 

Guidance for Industry: Juice HACCP Hazards and Controls 

Guidance 

LACF Low-acid canned food

3-MCPD 3-Monochloropropane-1,2-Diol

3-MCPDE 3-Monochloropropane-1,2-Diol Esters

NACMCF National Advisory Committee on Microbiological Criteria for 

Foods 

NRTE food Not ready-to-eat food

Part 117 Current Good Manufacturing Practice, Hazard Analysis, and 

Risk-Based Preventive Controls for Human Food (21 CFR part 

117) 

PCBs Polychlorinated biphenyls 

PCHF “Preventive Controls for Human Food” (requirements in 21 CFR 

part 117 for hazard analysis and risk-based preventive controls 

for human food in accordance with section 418 of the FD&C 

Act) 
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Abbreviation What It Means 

PCQI Preventive controls qualified individual 

PDP Principal display panel on a food label 

PFAS Per- and polyfluoroalkyl substances 

ppb Parts per billion

ppm Parts per million

PPO Propylene oxide 

QC Quality control 

RAC Raw agricultural commodity

ROP Reduced oxygen packaging 

RPM FDA’s Regulatory Procedures Manual 

RTD Resistance temperature detector

RTE food Ready-to-eat food 

SAHCODH Serious adverse health consequences or death to humans

SAHCODH

hazard

Serious adverse health consequences or death to humans hazard

Seafood HACCP 

guidance 

Fish and Fishery Products Hazards and Controls Guidance 

SME Subject matter expert

STEC Shiga-toxin producing E. coli

TCS food Time/Temperature Control for Safety Food 

TDT Thermal Death Time

USDA U.S. Department of Agriculture 

WHO World Health Organization 
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Abbreviation What It Means 

WIP Work-in-process

z-value The degrees in Fahrenheit required for the thermal destruction 

curve to cross one log cycle (i.e., for reducing the D value by a 

factor of 10)

* In January 2017, we issued the draft guidance entitled “Control of Listeria monocytogenes in

Ready-to-Eat Foods.” When finalized, this guidance will reflect FDA’s current thinking on this

topic. In this document we simply refer to that guidance as “the Listeria guidance,” without

specifying its status as draft guidance or final guidance.

V. Training

This guidance generally does not address the requirements in part 117 applicable to the 

qualifications of individuals who manufacture, process, pack, or hold food. See 21 CFR 117.4, 

which establishes requirements for: 

• plant management and the owner, operator, or agent in charge of a facility to ensure that all

individuals who manufacture, process, pack, or hold food are qualified to perform their

assigned duties (21 CFR 117.4(a));

• qualifications of all individuals engaged in manufacturing, processing, packing, or holding

food to:

o be a qualified individual as that term is defined in § 117.3 - i.e., have the education,

training, or experience (or a combination thereof) necessary to manufacture, process, pack, or

hold clean and safe food as appropriate to the individual’s assigned duties (see 21 CFR

117.4(b)(1)); and

o receive training in the principles of food hygiene and food safety, including the

importance of employee health and personal hygiene, as appropriate to the food, the facility

and the individual’s assigned duties (see 21 CFR 117.4(b)(2));

• additional qualifications of supervisory personnel, such that responsibility for ensuring

compliance by individuals with the requirements of part 117 must be clearly assigned to

supervisory personnel who have the education, training, or experience (or a combination

thereof) necessary to supervise the production of clean and safe food (see 21 CFR 117.4(c));

and

• records that document training required by 21 CFR 117.4(b)(2) (see 21 CFR 117.4).

See also 21 CFR 117.180, which establishes additional requirements for: 
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• a PCQI to have successfully completed training in the development and application of riskbased preventive controls at least equivalent to that received under a standardized curriculum

recognized as adequate by FDA or be otherwise qualified through job experience to develop

and apply a food safety system (see 21 CFR 117.180(c)(1));

• a qualified auditor to have technical expertise obtained through education, training, or

experience (or a combination thereof) necessary to perform the auditing function (see 21

CFR 117.180(c)(2)); and

• records documenting all applicable training in the development and application of risk-based

preventive controls (see 21 CFR 117.180(d)).

The standardized curriculum recognized as adequate by FDA has been developed by the Food 

Safety Preventive Controls Alliance (FSPCA). The first edition of the the FSPCA Preventive 

Controls for Human Food training curriculum (“participant manual”) was published in 2016; the 

participant manual is available on the FSPCA website (see Table 8 in section VI). The FSPCA

manual contains an appendix with food safety plan “worksheets” or “forms” that are used in the 

training; these forms can also be used in or adapted for documenting various aspects of a food 

safety plan (e.g., the hazard analysis, process preventive controls, corrective actions). Appendix 

2 of this guidance contains Food Safety Plan Forms that we adapted from the FSPCA forms 

published in the FSPCA participant manual. Although we recommend using these forms, there is 

no standardized or mandated format for documenting the food safety plan; you can use other 

formats that provide all of the information that 21 CFR part 117 requires for each required 

component of the food safety plan. 

Training topics for personnel other than a PCQI and a qualified auditor vary as appropriate to an 

individual’s assigned duties. For example:

• All personnel who enter production areas should have adequate training about the importance

of health and hygiene in preventing contamination of food and food production areas;

• Human resource personnel should have training adequate to enable them to ensure that all

personnel receive training necessary to perform their assigned functions;

• Personnel with responsibilities for purchasing should have adequate training regarding the

importance of applicable food safety specifications and supply-chain controls (with

associated supplier approval and verification activities) for the raw materials and other

ingredients that they purchase;

• Personnel with responsibilities for receiving raw materials and other ingredients should have

adequate training regarding the importance of inspecting shipments at receipt and using

proper storage conditions, including when applicable refrigeration and segregation (e.g.,

when applicable, segregation of raw foods from RTE foods and segregation of foods with

different food allergen profiles);
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• Personnel with responsibilities for maintenance should have adequate training regarding the 

potential for maintenance activities to introduce contamination or lead to allergen crosscontact;

• Personnel with responsibilities for cleaning and sanitizing the plant, including food-contact 

surfaces, should have adequate training regarding each step in the cleaning/sanitizing process 

and actions to take if there are visual observations or other indication that a step was not 

performed correctly or was not effective; 

• Personnel with responsibilities for food production should have adequate training in the 

procedures for food production, including the importance of each step in production and 

actions to take if there is a problem during production; 

• Personnel with responsibilities for sampling surfaces for environmental pathogens should 

have adequate training in the procedures for collecting the samples;

• Personnel with responsibilities for laboratory testing of food or environmental samples 

should have adequate training in conducting that laboratory testing; 

• Supervisory personnel should have adequate training in the procedures, included in the food 

safety plan, applicable to their supervisory responsibilities; and

• Plant management should have adequate training in the food safety plan as a whole. 

VI. Resources 

The tables in this section are a compilation of resources that could be useful in developing and 

implementing your food safety plan. 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 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. 

Table 3. FDA Compliance Policy Guides Cited as a Resource in This Guidance* 

Topic CPG Link 

Aflatoxin M1 CPG Sec 527.400 Whole Milk, Lowfat Milk, 

Skim Milk - Aflatoxin M1. November 2005. 

https://www.fda.gov/regulatory-information/search-fdaguidance-documents/cpg-sec-527400-whole-milk-lowfatmilk-skim-milk-aflatoxin-m1

Aflatoxins CPG Sec. 555.400 Aflatoxins in Human Food: 

Guidance for FDA Staff. June 2021. 

https://www.fda.gov/media/149666/download
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Topic CPG Link 

Aflatoxins – Brazil 

nuts

CPG Sec. 570.200 Aflatoxins in Brazil Nuts: 

Guidance for FDA Staff. June 2021

https://www.fda.gov/media/72053/download

Aflatoxins – 

Pistachio nuts

CPG Sec. 570.500 Aflatoxins in Pistachio Nuts: 

Guidance for FDA Staff. June 2021. 

https://www.fda.gov/media/72084/download

Aflatoxins - Peanuts CPG Sec. 570.375 Aflatoxins in Peanuts and 

Peanut Products: Guidance for FDA Staff. June 

2021. 

https://www.fda.gov/media/72073/download

Aflatoxins – Animal 

food

CPG Sec. 683.100 Action Levels for Aflatoxins 

in Animal Food: Guidance for FDA Staff. 

March 2019. 

https://www.fda.gov/media/121202/download

Food allergens CPG Sec. 555.250 Statement of Policy for 

Labeling and Preventing Cross-contact of 

Common Food Allergens. 2005. 

https://www.fda.gov/regulatory-information/search-fdaguidance-documents/cpg-sec-555250-statement-policylabeling-and-preventing-cross-contact-common-foodallergens-new

Food allergens CPG Sec 555.250 DRAFT: Major Food 

Allergen Labeling and Cross-contact. 2023.**

https://www.fda.gov/regulatory-information/search-fdaguidance-documents/cpg-sec-555250-draft-major-foodallergen-labeling-and-cross-contact

Hard or sharp foreign 

objects

CPG Sec. 555.425 Foods, Adulteration 

Involving Hard or Sharp Foreign Objects. May 

2005. 

https://www.fda.gov/media/71953/download

Hypoglycin A Toxin CPG Sec. 550.050 Canned Ackee, Frozen 

Ackee, and Other Ackee Products - Hypoglycin 

A Toxin. April 2014. 

https://www.fda.gov/media/88521/download

3-MCPD CPG Sec. 500.500 Guidance Levels for 3-

MCPD (3-chloro-1,2-propanediol) in AcidHydrolyzed Protein and Asian-Style Sauces. 

March 2008. 

https://www.fda.gov/media/71760/download

Mercury - Grain CPG Sec. 578.400 Treated Grain Seed - 

Mercury Residue. October 1980. 

https://www.fda.gov/media/72102/download

Microbiological 

hazards – Dairy 

products

CPG Sec. 527.300 Dairy Products - Microbial 

Contaminants and Alkaline Phosphatase 

Activity. December 2010.

https://www.fda.gov/regulatory-information/search-fdaguidance-documents/cpg-sec-527300-microbialcontaminants-alkaline-phosphatase-activity

Patulin – Apple juice CPG Sec 510.150 Apple Juice, Apple Juice 

Concentrates, and Apple Juice Products - 

Adulteration with Patulin. November 2005. 

https://www.fda.gov/regulatory-information/search-fdaguidance-documents/cpg-sec-510150-apple-juice-applejuice-concentrates-and-apple-juice-products-adulterationpatulin

PCBs CPG Sec. 565.200 Red meat adulterated with 

PCBs. November 1987. 

https://www.FDA.gov/ICECI/ComplianceManuals/

CompliancePolicyGuidanceManual/ucm074589.htm

Pesticides CPG Sec. 575.100 Pesticide Residues in Food 

and Feed - Enforcement Criteria. March 1995.

https://www.fda.gov/media/75151/download

Pesticides CPG Sec. 575.100 Pesticide Chemical Residues 

in Food - Enforcement Criteria (CPG 7141.01) 

(Draft Guidance)*** January 2008. 

https://www.fda.gov/media/77986/download
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Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 25 

Topic CPG Link 

Pits - Dates CPG Sec. 550.300 Dates and Date Material; 

Imported and Domestic - Adulteration Involving 

Mold, Insect Excreta, Sour, Dirty, Worthless and 

Pits. 2005. 

https://www.fda.gov/media/71813/download

Pits - Olives CPG Sec. 550.600 Olives - Adulteration 

Involving Pits; Rot; Insect Infestation. 2005. 

https://www.fda.gov/media/71862/download

Pits and pit fragments

- Prunes

CPG Sec. 550.700 Dried Prunes, Dehydrated 

Low Moisture Prunes, and Pitted Prunes - 

Adulteration Involving Insects; Decomposition; 

Dirt; Pits; and Pit Fragments. 2005. 

https://www.fda.gov/media/71909/download

Radionuclides CPG Sec. 555.880 Guidance Levels for 

Radionuclides in Domestic and Imported Foods. 

2005. 

https://www.fda.gov/regulatory-information/search-fdaguidance-documents/cpg-sec-555880-guidance-levelsradionuclides-domestic-and-imported-foods

Salmonella spp. CPG Sec. 555.300 Foods, Except Dairy Products 

- Adulteration with Salmonella. March 1995.

https://www.fda.gov/regulatory-information/search-fdaguidance-documents/cpg-sec-555300-foods-except-dairyproducts-adulteration-salmonella

*In addition to the specific link we provided, you can access FDA’s Compliance Policy Guides at

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/manualcompliance-policy-guides.

** In 2023, FDA issued for public comment a draft compliance policy guide entitled “CPG Sec 555.250 DRAFT: 

Major Food Allergen Labeling and Cross-contact” (88 FR 31507, May 17, 2023). When finalized, this draft CPG 

will replace existing guidance, in CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact 

of Common Food Allergens, for FDA staff on FDA’s enforcement policy regarding major food allergen labeling and 

cross-contact.

*** The regulation of food containing pesticide chemical residues is governed by sections 201, 402 and 408 of the 

Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321, 342, and 346a). These sections of the 

FD&C Act were amended by the passage of the Food Quality Protection Act of 1996 (FQPA). In 2008, FDA issued 

as draft guidance a revised CPG Sec. 575.100 that, when finalized, will represent FDA’s current thinking on 

enforcement criteria for pesticide residues in food and feed, taking into account the provisions of the FQPA.

Table 4. FDA Guidance for Industry Cited as a Resource in This Guidance* 

Topic Guidance Link 

Acidified foods Guidance for Industry: Submitting Form 

FDA 2541 (Food Canning Establishment 

Registration) and Forms FDA 2541d, 

FDA 2541e, FDA 2541f, and FDA 2541g 

(Food Process Filing Forms) to FDA in 

Electronic or Paper Format. November 

2016.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-submittingforms-food-canning-establishmentregistration-and-food-process-filing

Acrylamide Guidance for Industry. Acrylamide in 

Foods. March 2016.

https://www.fda.gov/media/87150/download
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 26 

Topic Guidance Link 

Antimicrobial substances Guidance for Industry: Antimicrobial 

food additives. 1999.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-antimicrobialfood-additives 

Arsenic – Cereals for infants Guidance for Industry: Action level for 

inorganic arsenic in rice cereals for 

infants. August 2020. 

https://www.fda.gov/media/97234/download

Arsenic – Apple juice Guidance for Industry: Action Level for 

Inorganic Arsenic in Apple Juice. 2023.

https://www.fda.gov/media/86110/download 

Bottled water (Allowable 

levels for inorganic substances

in accordance with 21 CFR 

165.110(b)(4)(iii)(A)***

Small Entity Compliance Guide: Bottled 

Water and Arsenic. April 2009.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/small-entity-compliance-guidebottled-water-and-arsenic 

Chemical hazards Guidance for Industry: Action Levels for 

Poisonous or Deleterious Substances in 

Human Food and Animal Feed. August 

2000.

https://www.fda.gov/FoodGuidances

Cochineal extract and carmine Cochineal extract and carmine: 

Declaration by name on the label of all 

foods and cosmetic products that contain 

these color additives; Small Entity 

Compliance Guide. April 2009.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/small-entity-compliance-guidedeclaration-name-label-all-foods-andcosmetic-products-contain

Enforcement policy Policy Regarding Certain Entities Subject 

to the Current Good Manufacturing 

Practice and Preventive Controls, 

Produce Safety, and/or Foreign Supplier 

Verification Programs: Guidance for 

Industry. 2018.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-policyregarding-certain-entities-subject-currentgood-manufacturing-practice-and 

Enforcement policy Current Good Manufacturing Practice 

and Preventive Controls, Foreign 

Supplier Verification Programs, 

Intentional Adulteration, and Produce 

Safety Regulations: Enforcement Policy 

Regarding Certain Provisions. 2022.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-current-goodmanufacturing-practice-and-preventivecontrols-foreign-supplier 

Food allergens Guidance for Industry: Questions and 

Answers Regarding Food Allergens, 

Including the Food Allergen Labeling 

and Consumer Protection Act of 2004. 

Edition 5. 2022. 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-questions-andanswers-regarding-food-allergen-labelingedition-5 

Food allergens Questions and Answers Regarding Food 

Allergens, Including the Food Allergen 

Labeling Requirements of the Federal 

Food, Drug, and Cosmetic Act (Edition 

5): Guidance for Industry (Draft 

Guidance). 2022.**

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/draft-guidance-industry-questionsand-answers-regarding-food-allergen-labelingedition-5 

Food labeling (refrigerated 

foods) 

Guidance on Labeling of Foods That 

Need Refrigeration by Consumers. 1997.

(Also available at 62 FR 8248, February 

24, 1997) 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-labeling-foods-needrefrigeration-consumers 
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 27 

Topic Guidance Link 

HACCP systems - Seafood Fish and Fishery Products Hazards and 

Controls Guidance. June 2022. 

https://www.fda.gov/food/seafood-guidancedocuments-regulatory-information/fish-andfishery-products-hazards-and-controls

HACCP systems - Juice Guidance for Industry: Juice HACCP 

Hazards and Controls Guidance. 

February 2004.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-juice-hazardanalysis-critical-control-point-hazards-andcontrols-guidance-first

Human Food By-Products Human Food By-Products For Use As 

Animal Food: Draft Guidance for 

Industry #239**

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/cvm-gfi-239-human-food-productsuse-animal-food

Lead - Candy Guidance for Industry: Lead in Candy 

Likely To Be Consumed Frequently by 

Small Children: Recommended 

Maximum Level and Enforcement 

Policy. November 2006.

https://www.fda.gov/food/guidancedocuments-regulatory-informationtopic/guidance-industry-lead-candy-likely-beconsumed-frequently-small-children

Lead - Juice Draft** Guidance for Industry: Action 

Levels for Lead in Juice. April 2022.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/draft-guidance-industry-actionlevels-lead-juice

Lead – Food for babies and 

young children

Draft** Guidance for Industry: Action 

Levels for Lead in Food Intended for 

Babies and Young Children

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/draft-guidance-industry-actionlevels-lead-food-intended-babies-and-youngchildren

Microbiological hazards – 

Fresh-cut produce

Guidance for Industry: Guide to 

Minimize Microbial Food Safety Hazards 

of Fresh-cut Fruits and Vegetables. 2008.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-guide-minimizemicrobial-food-safety-hazards-fresh-cut-fruitsand-vegetables

Microbiological hazards – 

Fresh-cut produce

Draft** Guidance for Industry: Guide to 

Minimize Food Safety Hazards of Freshcut Produce. 2018.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/draft-guidance-industry-guideminimize-food-safety-hazards-fresh-cutproduce

Microbiological hazards - 

LACF

Guide to Inspections of Low Acid 

Canned Food Manufacturers Part 1 - 

Adminstrative Procedures/Scheduled 

Processes

https://www.fda.gov/low-acid-canned-foodmanufacturers-part-1-adminstrativeproceduresscheduled-processes

Listeria monocytogenes Control of Listeria monocytogenes in 

Ready-To-Eat Foods: Guidance for 

Industry (Draft Guidance). 2017.**

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/draft-guidance-industry-controllisteria-monocytogenes-ready-eat-foods

Mycotoxins - Fumonisin Guidance for Industry: Fumonisin Levels 

in Human Foods and Animal Feeds. 

November 2001.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-fumonisinlevels-human-foods-and-animal-feeds
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 28 

Topic Guidance Link 

Mycotoxins - DON Guidance for Industry and FDA: 

Advisory Levels for Deoxynivalenol 

(DON) in Finished Wheat Products for 

Human Consumption and Grains and 

Grain By-Products used for Animal Feed. 

July 2010.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-and-fdaadvisory-levels-deoxynivalenol-don-finishedwheat-products-human

Recalls Index of Model Press Releases. https://www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts/industry-guidancerecalls

Recalls Industry Guidance For Recalls.**** https://www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts/industry-guidancerecalls

Recalls Initiation of Voluntary Recalls Under 21 

CFR Part 7, Subpart C. Guidance for 

Industry and FDA Staff. 2022. 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/initiation-voluntary-recalls-under21-cfr-part-7-subpart-c

Recalls Product Recalls, Including Removals and 

Corrections. Guidance for Industry. 2020.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/product-recalls-includingremovals-and-corrections

Recalls Public Availability of Lists of Retail 

Consignees to Effectuate Certain Human 

and Animal Food Recalls Guidance for 

Industry and FDA Staff. 2020.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/public-availability-lists-retailconsignees-effectuate-certain-human-andanimal-food-recalls

Recalls Public Warning and Notification of 

Recalls Under 21 CFR Part 7, Subpart C. 

Guidance for Industry and FDA Staff. 

2019.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/public-warning-notification-recallsunder-21-cfr-part-7-subpart-c

Recalls Questions and Answers Regarding 

Mandatory Food Recalls: Guidance for 

Industry and FDA Staff. 2018.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-and-fda-staffquestions-and-answers-regarding-mandatoryfood-recalls

Recordkeeping required by 21 

CFR part 1, subpart J

Guidance for Industry: Questions and 

Answers Regarding Establishment and 

Maintenance of Records By Persons Who 

Manufacture, Process, Pack, Transport, 

Distribute, Receive, Hold, or Import 

Food (Edition 5). February, 2012.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-questions-andanswers-regarding-establishment-andmaintenance-records-persons-who

Registration of food facilities Guidance for Industry: Questions and 

Answers Regarding Food Facility 

Registration (Seventh Edition). August 

2018.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-questions-andanswers-regarding-food-facility-registrationseventh-edition
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 29 

Topic Guidance Link 

Reportable Food Registry Guidance for Industry: Questions and 

Answers Regarding the Reportable Food 

Registry As Established by the Food and 

Drug Administration Amendments Act of 

2007. 2009.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-questions-andanswers-regarding-reportable-food-registryestablished-food-and-drug

Reportable Food Registry Draft Guidance for Industry: Questions 

and Answers Regarding the Reportable 

Food Registry As Established by the 

Food and Drug Administration 

Amendments Act of 2007 (Edition 2). 

2010.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/draft-guidance-industry-questionsand-answers-regarding-reportable-foodregistry-established-food

Salmonella spp. - Peanutderived productGuidance for Industry: Measures to 

Address the Risk for Contamination by 

Salmonella Species in Food Containing a 

Peanut-Derived Product as an Ingredient. 

March 2009.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-measuresaddress-risk-contamination-salmonellaspecies-food-containing-peanut

Salmonella spp. - Pistachioderived productGuidance for Industry: Measures to 

Address the Risk for Contamination by 

Salmonella Species in Food Containing a 

Pistachio-Derived Product as an 

Ingredient. September 2011.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-measuresaddress-risk-contamination-salmonellaspecies-food-containing-pistachio

Salmonella spp. - Testing Guidance for Industry Testing for 

Salmonella Species in Human Foods and 

Direct-Human-Contact Animal Foods. 

March 2012.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-testingsalmonella-species-human-foods-and-directhuman-contact-animal-foods

Third-party certification Guidance for Industry and FDA Staff: 

Model Accreditation Standards for ThirdParty Certification Body Accreditation 

for Food Safety Audits. 2022.

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-and-fda-staffmodel-accreditation-standards-third-partycertification-body

* In addition to the specific link we provided, or if that link is no longer operative, you can access most of FDA’s

Guidance for Industry applicable to human food at https://www.fda.gov/FoodGuidances.

** A draft guidance, when finalized, will represent FDA’s current thinking on the specified topic.

*** See 21 CFR 165.110 for allowable levels for contaminants and toxic elements other than arsenic.

**** FDA website with links to specific guidance. 
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 30 

Table 5. FDA Compliance Programs* and Import Alerts Cited as a Resource in This 

Guidance** 

Topic Title and Link

Drug residues Import Alert 36-04. Detention without physical examination of honey and blended syrup due to unsafe drug 

residues

https://www.accessdata.fda.gov/cms_ia/importalert_111.html

Mycotoxins Import Alert 23-14, Detention Without Physical Examination of Food Products Due to the Presence of 

Mycotoxins Published Date: 06/06/2022 

https://www.accessdata.fda.gov/CMS_IA/importalert_581.html

Mycotoxins Compliance Program 7307.001 Mycotoxins in Domestic and Imported Foods

https://www.fda.gov/media/140749/download

Toxic 

elements

Import Alert 99-42 Detention Without Physical Examination of Foods Due to Heavy Metal Contamination

https://www.accessdata.fda.gov/cms_ia/importalert_1167.html

Various Food Compliance Programs. https://www.fda.gov/food/compliance-enforcement-food/foodcompliance-programs

*For a complete list of our Food Compliance Programs, including those for biological hazards, see

https://www.fda.gov/food/compliance-enforcement-food/food-compliance-programs#food_ds

**For a searchable database of our Import alerts, including those for biological hazards, see 

https://www.accessdata.fda.gov/CMS_IA/default.htm
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 31 

Table 6. Codex Standards, Codes of Practice, and Guidelines Cited as a Resource in This 

Guidance*, ** 

Topic Title Link 

Acrylamide Code of Practice for 

the Reduction of 

Acrylamide in Foods. 

CXC 67-2009.

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B67-2009%252FCXP_067e.pdf

Aflatoxin – 

Tree Nuts

Code of Practice for 

the Prevention and 

Reduction of 

Aflatoxin 

Contamination in 

Tree Nuts. CAC/RCP 

59-2005.

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B59-2005%252FCXP_059e.pdf

Aflatoxin - 

Peanuts

Code of Practice for 

the Prevention and 

Reduction of 

Aflatoxin 

Contamination in 

Peanuts. CAC/RCP 

55-2004.

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B55-2004%252FCXP_055e.pdf

Aflatoxin – 

Dried Figs

Code of Practice for 

the Prevention and 

Reduction of 

Aflatoxin 

Contamination in 

Dried Figs. CAC/RCP 

65-2008.

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B65-2008%252FCXP_065e.pdf

Arsenic - Rice Code of Practice for 

the Prevention and 

Reduction of Arsenic 

Contamination in 

Rice. CXC 77-2017.

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1%E2%80%8C&url=https%253A%252F%252Fworkspace.fao.org%2

52Fsites%252Fcodex%252FStandards%252FCXC%2B77-2017%252FCXC_077e.pdf

Cadmium – 

Cocoa Beans

Codex Code of 

Practice for the 

Prevention and 

Reduction of 

Cadmium 

Contamination in 

Cocoa. CXC 81-2022

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B81-2022%252FCXC_081e.pdf 

Contaminants 

and toxins

General Standard for 

Contaminants and 

Toxins in Food and 

Feed. CXS 193-1995. 

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf

Food allergens Codex Code of 

Practice on Food 

Allergen Management 

for Food Business 

Operators. CXC 80-

2020

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B80-2020%252FCXC_080e.pdf 
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 32 

Topic Title Link 

HACCP 

systems

General Principles of 

Food Hygiene. CXC

1-1969.

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf

Lead Code of Practice for 

the Prevention and 

Reduction of Lead 

Contamination in 

Foods. CXC 56-2004

https://www.fao.org/3/cc0579en/cc0579en.pdf

3-

Monochloropr

opane-1,2- 

Diol (3-

MCPD) 

Code of Practice for 

the Reduction of 3-

Monochloropropane1,2- Diol During the 

Production of AcidHVPs and Products 

That Contain AcidHVPs. CXC 64-2008

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B64-2008%252FCXP_064e.pdf

3-

Monochloropr

opane-1,2- 

Diol Esters (3-

MCPDEs) and 

Glycidyl 

Esters (GEs)

Code of Practice for 

the Reduction of 3-

Monochloropropane1,2- Diol Esters (3-

MCPDEs) and 

Glycidyl Esters (GEs) 

In Refined Oils and 

Food Products Made 

with Refined Oils. 

CXC 79-2019.

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B79-2019%252FCXC_079e.pdf

Mycotoxin Code of Practice for 

the Prevention and 

Reduction of 

Mycotoxin 

Contamination in 

Cereals. CXC 51-

2003. 

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B51-2003%252FCXC_051e.pdf

Mycotoxins Code of Practice for 

the Prevention and 

Reduction of 

Mycotoxins in Spices. 

CXC 78-2017.

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B78-2017%252FCXC_078e.pdf

Ochratoxin A - 

Coffee 

Code of Practice for 

the Prevention and 

Reduction of 

Ochratoxin A

Contamination in 

Coffee. CAC/RCP 

69-2009. (CXC-69-

2009)

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B69-2009%252FCXP_069e.pdf
Contains Non-binding Recommendations 

Draft-Not for Implementation

Topic Title Link 

Ochratoxin A - 

Cocoa

Code of Practice for 

the Prevention and 

Reduction of 

Ochratoxin A 

Contamination in 

Cocoa. CAC/RCP 72-

2013. (CXC 72-2013)

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B72-2013%252FCXP_072e.pdf

Pits (stones) - 

Olives

Standard for Table 

Olives. CXS 66-1981.

https://www.fao.org/fao-who-codexalimentarius/shproxy/pt/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252F

codex%252FStandards%252FCXS%2B66-1981%252FCXS_066e.pdf

Pits (stones) - 

Dates

Standard for Dates. 

CXS 143-1985. 

https://www.fao.org/fao-who-codexalimentarius/shproxy/pt/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252F

codex%252FStandards%252FCXS%2B143-1985%252FCXS_143e.pdf

Pits (stones) – 

Stone fruits

Standard for Canned 

Stone Fruits. CXS 

242-2003. 2017.

(Applies to stone

fruits of the genus

Prunus)

https://www.fao.org/fao-who-codexalimentarius/shproxy/pt/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252F

codex%252FStandards%252FCXS%2B242-2003%252FCXS_242e.pdf

Salmonella

spp.

Codex Code of 

Hygienic Practice for 

Low-Moisture Foods. 

CXC 75-2015. 

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B75-2015%252FCXC_075e.pdf 

Salmonella

spp. and 

Cronobacter

spp. 

Codex Code of 

Hygienic Practice for 

Powdered Formulae 

for Infants and Young 

Children. CAC/RCP 

66-2008. (CXC 66-

2008)

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252

Fcodex%252FStandards%252FCXC%2B66-2008%252FCXP_066e.pdf

Validation Guidelines for the 

validation of food 

safety control 

measures. CXG 69-

2008. 

https://www.fao.org/fao-who-codexalimentarius/shproxy/pt/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252F

codex%252FStandards%252FCXG%2B69-2008%252FCXG_069e.pdf 

*Codex Standards in this table, and other Codex Standards applicable to food safety, are available at

https://www.fao.org/fao-who-codexalimentarius/codex-texts/list-standards/pt/. Codex Codes of Practice in this table,

and other Codex codes of Practice applicable to food safety, are available at https://www.fao.org/fao-whocodexalimentarius/codex-texts/codes-of-practice/en/. Codex guidelines listed in this table, and other Codex

guidelines, are available at https://www.fao.org/fao-who-codexalimentarius/codex-texts/guidelines/en/. Codex

Standards, Codes of Practice, and Guidelines are available in several languages. To obtain a specific Standard, Code

of Practice, or Guideline in a specific language, select the check mark for that language for that Standard, Code of

Practice, or Guideline.

** Codex standards for chemical contaminants in food could be helpful for use as a guide for levels of chemical

contaminants in foods when FDA has not established a maximum level for a particular chemical hazard in a 

particular food or group of foods. 

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 33 
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 34 

Table 7. Resources for Designing Validation Studies

Organization Document How to Access Applicability

Alliance for Innovation 

& Operational 

Excellence (AIOE)

Anderson, D and LA Lucore. 2020.

Validating the reduction of Salmonella

and other pathogens in heat processed 

low-moisture foods

Available from the OpX website by 

registering (free):

https://www.opxleadershipnetwork.org/qu

ality/download/pathogen-reductionvalidation

Thermal processes

Low moisture foods

American Frozen Foods 

Institute (AFFI)

Process validation 

- Considerations for In-Plant 

Blanching Study

- Considerations for Lab-Scale

Blanching Study

- How to Validate Your Blancher 

https://affi.org/safety/validation/ Frozen vegetables

Almond Board of 

California

- Guidelines for Validation of

Blanching Processes, v1.0, April 13,

2007.

- Guidelines for Validation of Oil

Roasting Processes, v1.0, April 13,

2007. 

- Guidelines for Validation of Dry 

Roasting Processes, v1.2, October

23, 2007. 

- Guidelines for Process Validation 

Using Enterococcus faecium NRRLB-2345, v1.2, October 24, 2007.

- Guidelines for Validation of

Propylene Oxide Pasteurization,

v3.0, October 1, 2008.

- Guidelines for Validation of

Propylene Oxide Treatment for Inshell Almonds, v2.0, October 1, 

2008.

- Guidelines for Process Validation 

Using Enterococcus faecium NRRLB-2354 as a Surrogate 

Microorganism in Almond Process

Validation, 2014.

https://www.almonds.com/almondindustry/processors-andsuppliers/processing-safeproduct/pasteurization-program 

Tree nuts and other 

low moisture foods (as 

appropriate)

Chilled Foods 

Association 

Guidelines for setting shelf life of 

chilled foods in relation to nonproteolytic Clostridium botulinum. 

2018.

https://www.chilledfood.org/product/guide

lines-for-setting-shelf-life-of-chilledfoods-in-relation-to-non-proteolyticclostridium-botulinum/ 

Chilled foods

Codex Alimentarius 

Commission (Codex)

Codex. Guidelines for the validation of 

food safety control measures (CXG 

69-2008)

https://www.fao.org/fao-whocodexalimentarius/codextexts/guidelines/en/

https://www.fao.org/fao-whocodexalimentarius/shproxy/pt/?lnk=1&url=https%253A%252F

%252Fworkspace.fao.org%252Fsites%25

2Fcodex%252FStandards%252FCXG%2

B69-2008%252FCXG_069e.pdf 

General applicability
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 35 

Organization Document How to Access Applicability

European branch of the 

International Life 

Sciences Institute, ILSI 

Europe

Ceylan, E., A Amezquita, N. 

Anderson, R. Betts, L. Blayo, F. 

Garces-Vega, E. Gkogka, L.J. Harris, 

P. McClure, A Winkler, and H. M. W.

den Besten. 2021. Guidance on 

validation of lethal control measures

for foodborne pathogens in foods.

Compr. Rev. Food Sci. Food Saf. 

20:2825–2881. DOI: 10.1111/1541-

4337.12746. Available at: 

https://ift.onlinelibrary.wiley.com/doi/full/

10.1111/1541-4337.12746

General applicability; 

describes product and 

process factors 

essential in designing 

a validation study, 

selection criteria for 

identifying an 

appropriate target 

pathogen or surrogate 

organism. 

Institute for Food 

Safety and Health 

(IFSH)

Gombas, D.; Y. Luo; J. Brennan; G. 

Shergill; R. Petran; R. Walsh; H. Hau; 

K. Khurana; B. Zomorodi; J. Rosen; R. 

Varley; K. Deng. 2017.Guidelines to

validate control of cross-contamination

during washing of fresh-cut leafy 

vegetables.

J. of Food Prot. 80:312-330. 2017

https://doi.org/10.4315/0362-028X.JFP16-258

Commercial 

packinghouse and 

fresh-cut wash 

systems

Institute for Food 

Safety and Health 

(IFSH) 

Shazer, A.; D. Stewart; K. Deng; M. 

Tortorello. 2017. Approaches toward 

identification of surrogates to validate 

antimicrobial washes as preventive 

controls for fresh-cut leafy greens.

J. of Food Prot. 80:1600-1604. 2017

https://doi.org/10.4315/0362-028X.JFP17-069

Commercial 

packinghouse and 

fresh-cut wash 

systems

International 

Commission on 

Microbiological 

Specifications for 

Foods (ICMSF)

ICMSF. 2011. Microorganisms in 

Foods 8, Use of Data for Assessing 

Process Control and Product 

Acceptance. Chapter 2-Validation of 

Control Measures

https://www.springer.com/gp/book/97814

41993731

Book and individual chapters can be 

purchased.

General applicability

International 

Association for Food 

Protection (IAFP)

Consortium of Food Process 

Validation Experts. Validation of 

Antimicrobial Interventions for Small 

and Very Small Processors: A How-to 

Guide to Develop and Conduct 

Validations

Food Prot Trends, Vol. 22, No. 2, p. 95-

104.

General Applicability

National Advisory 

Committee on the 

Microbiological 

Criteria for Foods 

(NACMCF)

NACMCF. 2010. Parameters for 

determining inoculated pack/challenge 

study protocols. 

J Food Prot 73:140-202. 2010. General applicability 

for studies that 

involve inoculation of 

product.

PMMI OpX Leadership 

Network Products 

Safety Solutions Group 

Validating the Reduction of 

Salmonella and Other Pathogens in 

Heat Processed Low-Moisture Foods: 

Spotlight on Baking

https://www.opxleadershipnetwork.org/qu

ality/download/spotlight-baking

Baking Processes

University of 

California, Davis

Theofel, C, S Yada, and LJ Harris. 

Surrogate organisms for low moisture 

foods – published treatments [tables 

and references]

https://ucfoodsafety.ucdavis.edu/sites/g/fil

es/dgvnsk7366/files/inlinefiles/303737.pdf 

Low-moisture foods 
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 36 

Table 8. Additional Resources Cited in this Guidance

Topic Source Resource Title Resource Link

Animal drugs FDA 

website

Search animal 

drugs

https://animaldrugsatfda.fda.gov/

Audits International 

Featured 

Standards 

(IFS) 

website

IFS Food 7 – 

English* 

https://www.ifs-certification.com/index.php/en/standards/4128-ifs-food-standard-en

CGMP Eastern 

Research 

Group. 

2004.

Good 

Manufacturing 

Practices (GMPs) 

for the 21st 

Century - Food 

Processing. 

Section Four. 

Common Food 

Safety Problems 

in the U.S. Food 

Processing 

Industry: A 

Delphi Study. 

2004.

https://www.fda.gov/food/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements/goodmanufacturing-practices-21st-century-food-processing-2004-study-section-4-common-food-safety

Chemical 

contaminants

FDA 

website

Chemical 

Contaminants & 

Pesticides

https://www.fda.gov/food/chemical-contaminants-pesticides

Chemical 

contaminants

FDA 

website

FDA Total Diet 

Study (TDS)

https://www.fda.gov/food/science-research-food/fda-total-diet-study-tds

Color additives FDA 

website

Color additive 

status list 

https://www.fda.gov/industry/color-additive-inventories/color-additive-status-list
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 37 

Topic Source Resource Title Resource Link

Data and tools in 

support of food 

safety risk 

assessment 

efforts 

Foodrisk.org

website

Open Data & 

Tools

https://www.foodrisk.org/irac/open-data-tools/

Environmental 

contaminants

Code of 

Federal 

Regulations

21 CFR 109.30 

Tolerances for 

polychlorinated 

biphenyls (PCBs)

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-109/subpart-B/section-109.30

Environmental 

contaminants

FDA 

website

Dioxins and PCBs https://www.fda.gov/food/chemical-contaminants-food/dioxins-pcbs

Environmental 

contaminants

FDA 

website

Per- and 

Polyfluoroalkyl 

Substances 

(PFAS) 

https://www.fda.gov/food/chemical-contaminants-food/and-polyfluoroalkyl-substances-pfas

Food additives FDA 

website

Food additive 

status list 

https://www.fda.gov/food/food-additives-petitions/food-additive-status-list

Food allergens FDA 

website

Food 

Allergens/GlutenFree Guidance 

Documents & 

Regulatory 

Information 

https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foodallergens-and-gluten-free-guidance-documents-and-regulatory-information

Food allergens FDA 

website

Label Declaration 

of Allergenic 

Substances in 

Foods; Notice to 

Manufacturers.

1996

http://wayback.archiveit.org/7993/20171114013857/https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio

n/Allergens/ucm106546.htm

Food allergens GMA (now 

Consumer 

Brands 

Association)

Managing 

allergens in food 

processing 

establishments

Available for purchase at https://forms.consumerbrandsassociation.org/forms/store/ProductFormPublic/managingallergens-in-food-processing-establishments 
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 38 

Topic Source Resource Title Resource Link

Food Code FDA 

website

Food Code https://www.fda.gov/food/retail-food-protection/fda-food-code

Food fraud United 

States 

Pharmacopei

al 

Convention 

website

Food fraud 

mitigation 

guidance

https://www.usp.org/sites/default/files/usp/document/our-work/Foods/food-fraud-mitigation-guidance.pdf

Food fraud Food Fraud 

Advisors 

website

Food Fraud 

Databases 

Compared

https://foodfraudadvisors.com/list-of-food-fraud-databases/

Food safety FAO 

website

Food safety & 

quality

https://www.fao.org/food/food-safety-quality/home-page/en/

Food safety WHO 

website

Food Safety https://www.who.int/health-topics/food-safety/

Food safety

forms and 

training manual

FSPCA 

website

Food Safety 

Preventive 

Controls Alliance

https://www.fspca.net

Food ingredient 

standards

Food 

Chemicals 

Codex

Food Chemicals 

Codex

Available for purchase at https://www.foodchemicalscodex.org/

Foreign material U.S. 

Department 

of 

Agriculture, 

Agricultural 

Marketing 

Service

Foreign Material 

Manual

https://www.ams.usda.gov/publications/content/foreign-material-manual
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 39 

Topic Source Resource Title Resource Link

Game meat FSIS 

website

FSIS Cooking 

Guideline for 

Meat and Poultry 

Products (Revised 

Appendix A).

2021.

https://www.fsis.usda.gov/guidelines/2021-0014

Game meat FSIS 

website

FSIS Stabilization 

Guideline for 

Meat and Poultry 

Products (Revised 

Appendix B).

2021.

https://www.fsis.usda.gov/guidelines/2021-0013

GRAS 

substances

FDA 

website 

Generally 

Recognized as 

Safe (GRAS)

https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras

HACCP systems FSIS 

website

Meat and Poultry 

Hazards and 

Controls Guide. 

2018.

https://www.fsis.usda.gov/guidelines/2018-0005

HACCP systems FSIS 

website

FSIS compliance 

guideline HACCP 

systems 

validation. 2015.

https://www.fsis.usda.gov/guidelines/2015-0011

HACCP systems Codex 

website

Hazard analysis 

and critical 

control point 

(HACCP) system 

and guidelines for 

its application. 

Chapter Two in 

CXC 1-1969. 

https://www.fao.org/fao-who-codexalimentarius/shproxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCX

C%2B1-1969%252FCXC_001e.pdf

Information for 

consumers

FDA 

website

Consumers https://www.fda.gov/food/resources-you-food/consumers
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 40 

Topic Source Resource Title Resource Link

Information for 

consumers

FDA 

website

Raw Dough's a 

Raw Deal and 

Could Make You 

Sick

https://www.fda.gov/consumers/consumer-updates/raw-doughs-raw-deal-and-could-make-you-sick

International & 

Interagency 

Coordination

FDA 

website

International & 

Interagency 

Coordination

https://www.fda.gov/food/international-interagency-coordination

International & 

Interagency 

Coordination

FDA 

website

International 

Arrangements

https://www.fda.gov/international-programs/international-arrangements

International & 

Interagency 

Coordination

FDA 

website

International 

Cooperation on 

Food Safety

https://www.fda.gov/food/international-interagency-coordination/international-cooperation-food-safety

International & 

Interagency 

Coordination

FDA 

website

Systems 

Recognition 

(Food)

https://www.fda.gov/food/international-cooperation-food-safety/systems-recognition-food

Irradiation FDA 

website

Irradiation of 

Food & Packaging

https://www.fda.gov/food/food-ingredients-packaging/irradiation-food-packaging

Irradiation FDA 

website

Understanding 

food irradiation: 

What industry 

needs to know

https://www.fda.gov/food/irradiation-food-packaging/understanding-food-irradiation-what-industry-needs-know

Metal detection Loma 

Systems 

website

Guide to Metal 

Detection

https://www.loma.com/en-us/industry-guides/guide-to-metal-detection
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 41 

Topic Source Resource Title Resource Link

Metal detection Mettler 

Toledo 

website

- The Metal

Detection Guide.

Building an

Effective

Programme

- Understanding

Sensitivity In

Metal Detection

-How to Correctly

Test Your

Industrial Metal

Detector

https://www.mt.com/us/en/home/products/Product-Inspection_1/safeline-metal-detection.html

Microbiological 

hazards

Combase 

website

A Web Resource 

for Quantitative 

and Predictive 

Food 

Microbiology

https://www.combase.cc/index.php/en/

Microbiological 

hazards

FDA 

website

Bad Bug Book. 

2012.

https://www.fda.gov/media/83271/download
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 42 

Topic Source Resource Title Resource Link

Microbiological 

hazards

FDA 

website (A 

Report of the 

Institute of 

Food 

Technologist

s for the 

Food and 

Drug 

Administrati

on of the 

United 

States 

Department 

of Health 

and Human 

Services.

IFT/FDA 

Contract No. 

223-98-

2333; Task

Order No. 4)

Evaluation and 

definition of 

potentially 

hazardous foods: 

Chapter 3 Factors 

that influence 

microbial growth

https://www.fda.gov/files/food/published/Evaluation-and-Definition-of-Potentially-Hazardous-Foods.pdf

Microbiological 

hazards

USDA/ ARS 

website

Pathogen 

Modeling 

Program 

https://www.ars.usda.gov/northeast-area/wyndmoor-pa/eastern-regional-research-center/residue-chemistryand-predictive-microbiology-research/docs/pathogen-modeling-program/

Microbiological 

hazards - LACF

FDA 

website

Guide to 

Inspections of 

Low Acid Canned 

Food 

Manufacturers 

Part 1 - 

Administrative 

Procedures/Sched

uled Processes

https://www.fda.gov/low-acid-canned-food-manufacturers-part-1-adminstrative-proceduresscheduled-processes

Outbreaks CDC 

website

Estimates of 

Foodborne Illness

https://www.cdc.gov/foodborneburden/index.html
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 43 

Topic Source Resource Title Resource Link

Outbreaks CDC 

website

Foodborne 

outbreaks

https://www.cdc.gov/foodsafety/outbreaks/

Outbreaks European 

Food Safety 

Authority

website

Monitoring of 

foodborne 

diseases

https://www.efsa.europa.eu/en/topics/topic/monitoring-foodborne-diseases

Outbreaks and 

Recalls

FDA 

website

Recalls, 

Outbreaks & 

Emergencies

https://www.fda.gov/food/recalls-outbreaks-emergencies

Outbreaks and 

Recalls

Food 

Safety.gov 

website

Recalls and 

Outbreaks

https://www.foodsafety.gov/recalls-and-outbreaks

Pasteurization of 

milk

FDA 

website

Grade "A" 

Pasteurized Milk 

Ordinance

https://www.fda.gov/food/milk-guidance-documents-regulatory-information/national-conference-interstate-milkshipments-ncims-model-documents; see also 21 CFR 1240.61 (Mandatory pasteurization for all milk and milk products 

in final package form intended for direct human consumption at https://www.ecfr.gov/current/title-21/chapterI/subchapter-L/part-1240/subpart-D/section-1240.61) 

Pesticides FDA 

website

Pesticides https://www.fda.gov/food/chemicals-metals-pesticides-food/pesticides

Pesticides FDA 

website

Pesticide Residue 

Monitoring 

Program Reports 

and Data

https://www.fda.gov/food/pesticides/pesticide-residue-monitoring-program-reports-and-data

Pesticides Code of 

Federal 

Regulations 

(e-CFR) 

website

40 CFR Part 180 - 

Tolerances and 

Exemptions for 

Pesticide 

Chemical 

Residues in Food

https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 44 

Topic Source Resource Title Resource Link

Pesticides EPA website Indexes to Part 

180 Tolerance 

Information for 

Pesticide 

Chemicals in 

Food and Feed 

Commodities

https://www.epa.gov/pesticide-tolerances/indexes-part-180-tolerance-information-pesticide-chemicals-food-and-feed

Pesticides EPA website Regulation of 

pesticide residues 

on food

https://www.epa.gov/pesticide-tolerances

Physical hazards 

(glass 

fragments)

News 

website

Seavin voluntarily 

recalls select 

wines due to 

potential small 

pieces of glass in 

bottles

https://www.clickorlando.com/consumer/2018/05/26/seavin-voluntarily-recalls-select-wines-due-to-potential-smallpieces-of-glass-in-bottles/

Process 

contaminants

FDA 

website

3-

Monochloropropa

ne-1,2-diol 

(MCPD) Esters 

and Glycidyl 

Esters

https://www.fda.gov/food/chemical-contaminants-food/3-monochloropropane-12-diol-mcpd-esters-and-glycidyl-esters

Process 

contaminants

FDA 

website

Acrylamide https://www.fda.gov/food/chemical-contaminants-food/acrylamide

Recalls FDA 

website

Recalls, Market 

Withdrawals, & 

Safety Alerts

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 7

https://www.fda.gov/media/71814/download
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 45 

Topic Source Resource Title Resource Link

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 

7, Exhibit 7-1, 

Model 

Effectiveness 

Check Letter 

(Industry). 

https://www.fda.gov/media/71814/download

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 

7, Exhibit 7-2, 

Model 

Effectiveness 

Check Response 

Format (Industry).

https://www.fda.gov/media/71814/download

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 

7, Exhibit 7-3, 

Model 

Effectiveness 

Check 

Questionnaire for 

Telephone or 

Personal Visits 

(Industry). 

https://www.fda.gov/media/71814/download

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 

7, Exhibit 7-4, 

Model Recall 

Letter (Generic, 

All Centers).

https://www.fda.gov/media/71814/download
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 46 

Topic Source Resource Title Resource Link

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 

7, Exhibit 7-5, 

Model Recall 

Response Form.

https://www.fda.gov/media/71814/download

Recalls FDA 

website

Office of 

Regulatory Affairs 

(ORA) Recall 

Coordinators

https://www.fda.gov/safety/industry-guidance-recalls/ora-recall-coordinators

Recalls FSIS 

website

Food Safety https://www.fsis.usda.gov/food-safety

Recalls New 

Zealand 

Food Safety, 

Ministry for 

Primary 

Industries 

website

Food recall 

documents

https://www.mpi.govt.nz/food-business/food-recalls/food-recall-documents/

Reportable food FDA 

website

FDA-TRACK: 

Reportable Food 

Registry Data 

Dashboard

https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-reportable-food-registry-datadashboard

Sanitary 

transportation of 

food

FDA 

website

FSMA Final Rule 

on Sanitary 

Transportation of 

Human and 

Animal Food

https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-transportation-human-andanimal-food

Sanitation 3-A Sanitary

Standards,

Inc. website

3-A Sanitary

Standards and

Accepted

Practices*

https://www.3-a.org/
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 47 

Topic Source Resource Title Resource Link

Sanitation American 

Meat 

Institute

website

Food Safety 

Equipment Design 

Principles 

CHECKLIST & 

GLOSSARY. 

2021. 

https://www.meatinstitute.org/sites/default/files/original%20documents/Sanitation%20booklet%202021.pdf

Sanitation GMA (now 

Consumer 

Brands 

Association) 

Control of 

Salmonella in 

Low-Moisture 

Foods Guidance 

Document.**

https://graphics8.nytimes.com/packages/pdf/business/20090515_moss_ingredients/SalmonellaControlGuidance.pdf

Sanitation European 

Hygienic 

Engineering 

and Design 

Group 

(EHEDG)

website

EHEDG 

Guidelines Doc 8. 

Hygienic Design 

Principles. Third 

Edition. 2018.

https://www.ehedg.org/guidelines/

Sanitation Lelieveld, 

HLM, 

Holah, JT 

and Napper, 

D (Eds.) 

(Elsevier 

Publishing) 

Hygiene in Food 

Processing: 

Principles and 

Practices. 2014.*

N/A

Sanitation Marriott, 

NG, 

Schilling, 

MW, and 

Gravani, 

RB. 

(Springer 

International

) 

Principles of Food 

Sanitation, Sixth 

Ed. 2018.*

https://doi.org/10.1007/978-3-319-67166-6
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 48 

Topic Source Resource Title Resource Link

Sanitation Schmidt, RH 

and DJ 

Erickson, 

Food 

Science and 

Human 

Nutrition 

Department, 

Florida 

Cooperative 

Extension 

Service, 

Institute of 

Food and 

Agricultural 

Sciences, 

University 

of Florida

Sanitary Design 

and Construction 

of Food 

Equipment. 2005.

https://ucfoodsafety.ucdavis.edu/sites/g/files/dgvnsk7366/files/inline-files/26502.pdf

Spices American 

Spice Trade 

Association 

(ASTA)

website

Clean, Safe Spices 

Guidance 

Document

https://www.astaspice.org/food-safety-technical-guidance/best-practices-and-guidance/clean-safe-spices-guidancedocument/

Spices FDA 

website

Risk Profile: 

Pathogens and 

Filth in Spices

https://www.fda.gov/food/cfsan-risk-safety-assessments/risk-profile-pathogen-and-filth-spices

Supplier 

evaluation

FDA 

website

Firm/Supplier 

Evaluation 

Resources for 

FSMA Rules

https://www.fda.gov/food/food-safety-modernization-act-fsma/firmsupplier-evaluation-resources-fsma-rules

Substance 

intentionally 

introduced for 

purposes of 

economic gain

FDA 

website

Melamine https://www.fda.gov/food/chemical-contaminants-food/melamine
Contains Non-binding Recommendations 

Draft-Not for Implementation

Topic Source Resource Title Resource Link

Toxic elements FDA 

website

Metals and Your 

Food

https://www.fda.gov/food/chemical-contaminants-metals-pesticides-food/metals-and-your-food

Toxic elements FDA 

website 

Closer to Zero: 

Reducing 

Childhood 

Exposure to 

Contaminants 

from Foods

https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminantsfoods

Validation FSIS 

website

FSIS compliance 

guideline HACCP 

systems 

validation. 2015.

https://www.fsis.usda.gov/guidelines/2015-0011

Various European 

Union 

website

Rapid Alert 

System for Food 

and Feed 

(RASFF)

https://food.ec.europa.eu/safety/rasff-food-and-feed-safety-alerts_en

Various FDA 

website

Food Defect 

Levels Handbook

https://www.fda.gov/food/ingredients-additives-gras-packaging-guidance-documents-regulatory-information/fooddefect-levels-handbook

Various FDA 

website

Food Code https://www.fda.gov/food/retail-food-protection/fda-food-code

Various FDA 

website

Regulatory 

Procedures 

Manual

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/regulatoryprocedures-manual

X-ray detection Loma 

systems 

website

Guide to X-Ray 

Inspection

https://www.loma.com/en-us/industry-guides/guide-to-x-ray-inspection

*Available for purchase.

** This industry guidance document is also available as a series of three publications in the journal Food Production Trends:

Scott, VN., C Yuhuan, TA Freier, et al. 2009. Control of Salmonella in Low-Moisture Foods I: Minimizing Entry of Salmonella into a Processing Facility, Food 

Prot Trends, 29:342–353.

Chen, Y, VN Scott, TA Freier, et al. 2009a. Control of Salmonella in Low-moisture Foods II: Hygiene Practices to Minimize Salmonella Contamination and

Growth, Food Prot Trends, 29:435–445. 

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 49 
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 50 

Chen, Y, VN Scott, TA Freier, et al. 2009b. Control of Salmonella in Low-moisture Foods III: Process Validation and Environmental Monitoring, Food Prot 

Trends, vol. 29, no. 8, pp. 493-508.
Contains Non-binding Recommendations 

Draft-Not for Implementation

VII. References

In this section, we list all references cited in the chapters in this guidance. When a reference 

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.

See section VI of this Introduction for information that we list as a “Resource” rather than a 

“Reference.” The Resources included in section VI often are available on websites rather than in 

publications such as scientific journals or books. 

See Appendix 3 of this guidance for references applicable to Appendix 3. 

Ahamad, N and EM Marth. 1989. Behavior of Listeria monocytogenes at 7, 13, 21, and 35°C in 

tryptose broth acidified with acetic, citric, or lactic Acid. J Food Prot 52: 688–695 

Al Dujaili J and RE Anderson, 1991. Aciduric, pH-Elevating Bacillus which cause 

noneffervescent spoilage of underprocessed tomatoes. J Food Sci 56 (6): 1611-1613. 

Almond Board of California (ABC). 2008. Guidelines for validation of propylene oxide 

pasteurization. Available at

https://www.almonds.com/sites/default/files/content/attachments/ppo-validationguidelines.pdf. 

Almond Board of California. 2014. Guidelines for Process Validation Using Enterococcus 

faecium NRRL-B-2354 as a Surrogate Microorganism in Almond Process Validation. 

Available at https://www.almonds.com/almond-industry/processors-andsuppliers/processing-safe-product/pasteurization-program. 

Alzamora, SM, MS Tapia, and J Welti-Chanes. 2003. Chapter 8: The control of water activity. In 

Food Preservation Techniques, edited by Zeuthen, P and L Bøgh-Sørensen. Woodhead 

Publishing. 

Ayotte, JD, SM Flanagan, and WS Morrow. 2007. Occurrence of uranium and 222 radon in 

glacial and bedrock aquifers in the northern United States, 1993-2003. U.S. Geological 

Survey Scientific Investigations Report 2007-5037. Available at

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1001. Available at https://doi.org/10.4315/0362-028X-70.4.997

Zaura, 2005. Effective Supplier Program. Food Quality Magazine, December/January, 86-88. 

Zink, D. 2007. The return of Salmonella: IAFP special interest session on Salmonella growth, 

persistence and survival in low-moisture foods and their environment - strategies for control. 

IAFP Annual Meeting, Buena Vista, FL. 
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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-assistance-network-tan.

Chapter 1: The Food Safety Plan 

Table of Contents

1.1 Purpose of this Chapter

1.2 What is a Food Safety Plan?

1.3 Who Develops the Food Safety Plan for a Facility?

1.4 What are the Differences Between a HACCP Plan and a Food Safety 

Plan?

1.4.1 Hazard Analysis and Controls to Address the Hazards

1.4.2 Monitoring

1.4.3 Corrective Actions and Corrections

1.4.4 Verification

1.4.5 Validation

1.4.6 Recall plan

1.5 What if a Facility Already Has a HACCP Plan?

1.6 What Format Is Required for a Food Safety Plan?

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. Underlined text in yellow highlights 

represents a correction from the draft Chapter 1 that we issued for public comment in August 2016. 
Contains Non-binding Recommendations

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Chapter 1 (Food Safety Plan) - Page 2

1.7 When Are Changes Needed for a Food Safety Plan?

1.8 References

1.1 Purpose of this Chapter

The guidance provided in this chapter is intended to help you understand what a food safety 

plan is and how it differs from a HACCP plan. The PCHF requirements specify that a facility 

must prepare, or have prepared, and implement a written food safety plan. See 21 CFR 

117.126.

1.2 What is a Food Safety Plan?

A Food Safety Plan (FSP) consists of the primary documents in a preventive controls food 

safety system that provides a systematic approach to the identification of food safety hazards 

that must be controlled to prevent or minimize the likelihood of foodborne illness or injury. It 

contains a collection of written documents that describes activities that ensure the safety of food 

during manufacturing, processing, packing, and holding. See 21 CFR 117.126.

Below, we describe the written documents that make up the FSP (see 21 CFR 117.126(b)). 

• Hazard analysis to identify whether there are hazards requiring a preventive control. This hazard 

analysis must be written, regardless of whether any hazards requiring a preventive control are 

identified. (Some facilities may not identify any hazards requiring a preventive control.) 

• When the hazard analysis identifies hazards requiring a preventive control, the FSP also includes the 

following written documents:

o Preventive controls (see 21 CFR 117.135), as appropriate to the facility and the food,

to ensure safe food is produced, including:

 Process controls

 Food allergen controls

 Sanitation controls

 Supply-chain controls

 Recall plan

 Other controls

o Procedures for monitoring the implementation of the preventive controls, as 

appropriate to the nature of the preventive control and its role in the facility’s food 

safety system

o Corrective action procedures, as appropriate to the nature of the hazard and the 

nature of the preventive control

o Verification procedures, as appropriate to the nature of the preventive control and its 

role in the facility’s food safety system 

This written FSP is a record that you must maintain. See 21 CFR 117.126(c) and 21 CFR part 

117, subpart F, particularly 21 CFR 117.310. In addition, you must maintain records to 

document that you are implementing the FSP. (See 21 CFR 117.190.) 
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The FSP starts with a hazard analysis of all ingredients and process or manufacturing steps 

(see Chapter 2 of this guidance). A “hazard” is any biological, chemical (including radiological), 

or physical agent that has the potential to cause illness or injury. It is important to understand 

that for the purposes of food safety, the term “hazard” refers only to the conditions or 

contaminants in food that are capable of causing illness or injury to people. These include 

hazards that occur naturally, that are unintentionally added or that may be intentionally added to 

a food for purposes of economic gain (i.e., economic adulteration). Many conditions are highly 

undesirable in food, such as the presence of insects, hair, filth or spoilage, and violations of 

regulatory food standards. All of these defects should be controlled in food processing; often, 

however, these defects do not directly affect the safety of the product. Unless these conditions 

directly affect food safety, documents addressing these issues are not included in an FSP. If 

the hazard analysis does not identify any hazards requiring a preventive control, the only 

document in the FSP would be the hazard analysis. 

1.3 Who Develops the Food Safety Plan for a Facility?

A “preventive controls qualified individual” (PCQI) must develop (or oversee the development of) 

the FSP. A PCQI is a person with the education, training, or experience (or a combination of 

these) to develop and apply a food safety system. A PCQI can be qualified through job 

experience or by completing training equivalent to the standardized curriculum recognized as 

adequate by FDA (e.g., the Food Safety Preventive Controls Alliance (FSPCA) training). The 

PCQI does not need to be an employee of the facility. See 21 CFR 117.126(a) and the 

definition of PCQI in 21 CFR 117.3.

The FSP must be signed and dated by the owner, operator or agent in charge of the facility 

when it is first completed and whenever the plan is modified (See 21 CFR 117.310.). See 

section 1.6 of this document for information on signing an FSP that consists of multiple 

components such as HACCP plans, prerequisite programs, a recall plan and a variety of 

procedures. 

1.4 What are the Differences Between a HACCP Plan and a Food 

Safety Plan?

Hazard Analysis and Critical Control Points (HACCP) is a preventive food safety strategy that is 

a systematic approach to the identification and assessment of the risk of hazards from a 

particular food or food production process or practice and the control of those hazards that are 

reasonably likely to occur. HACCP systems have been mandated by U.S. Federal regulations 

issued by the Food and Drug Administration (FDA) for seafood and juice and by the Food 

Safety and Inspection Service (FSIS) for meat and poultry. 

The preventive controls approach to controlling hazards used in an FSP incorporates the use of 

risk-based HACCP principles in its development. (See the HACCP principles and their 

application as described by the National Advisory Committee on Microbiological Criteria for 

Foods.) Although an FSP and a HACCP plan are similar, they are not identical. Table 1-1

compares what is required for the elements of each type of plan. In the following paragraphs, 

we briefly discuss each of these elements. 
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Table 1-1 Comparison of Elements of a HACCP Plan and a Food Safety Plan 

Element HACCP Plan Different in Food Safety Plan

Hazard Analysis Biological, chemical, 

physical hazards

Chemical hazards include radiological

hazards, consideration of economically 

motivated adulteration (21 CFR 

117.130(b)(1)(ii))

Preventive Controls CCPs for processes Process CCPs + controls at other 

points that are not CCPs (21 CFR 

117.135(a)(2))

Parameters and values Critical limits at CCPs Parameters and minimum/maximum 

values (equivalent to critical limits for 

process controls) (21 CFR 

117.135(c)(1))

Monitoring Required for CCPs Required as appropriate for preventive 

controls (21 CFR 117.145)

Corrective actions and 

Corrections

Corrective actions Corrective actions or corrections as 

appropriate (21 CFR 117.150(a))

Verification (including 

validation)

For process controls Verification as appropriate for all 

preventive controls; validation for 

process controls; supplier verification 

required when supplier controls a 

hazard (21 CFR 117.155, 117.160)

Records For process controls As appropriate for all preventive 

controls (21 CFR 117.190)

Recall plan Not required in the plan Required when a hazard requiring a 

preventive control is identified (21 CFR 

117.139)

1.4.1 Hazard Analysis and Controls to Address the Hazards 

In developing a HACCP plan, the hazard analysis leads to the identification of critical control 

points (CCPs) where essential process controls are needed to prevent a foodborne hazard from 

causing illness or injury. Once CCPs are identified, critical limits are established that define the 

operating conditions in the process that must be effectively managed and monitored to control 

the hazard. When critical limits are not met, predefined corrective actions are taken. All of the 

steps in a HACCP plan are recorded and verified to ensure the system is operating as intended. 

The FSP also begins with a hazard analysis, which includes consideration of radiological 

hazards as chemical hazards, as well as hazards due to economically motivated adulteration, 

such as addition of dyes containing lead to spices to enhance color. The outcome of the hazard 
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Chapter 1 (Food Safety Plan) - Page 5

analysis is the facility’s determination of whether there are any known or reasonably foreseeable 

hazards that require a preventive control. In an FSP, preventive controls may be applied at 

CCPs, but also at points other than at CCPs. The FSP includes control measures that, under 

the HACCP approach, may have been included in prerequisite programs or CGMPs. For 

example, supplier controls and food allergen controls have often been addressed through 

prerequisite programs, and sanitation controls have often been addressed through CGMPs. 

Process controls in an FSP will have parameters with minimum or maximum values, which are 

equivalent to the critical limits for HACCP CCPs. The use of preventive controls in an FSP may 

expand beyond CCPs by identifying and providing controls that may not be process-related, but

are still important in the control of a hazard. Critical limits (minimum or maximum values) may

not be practical or needed for non-process-related preventive controls, such as using hygienic 

zoning controls to prevent cross-contact and cross-contamination or ensuring that suppliers 

have adequately controlled hazards in the foods they are providing a manufacturer/processor. 

1.4.2 Monitoring 

In a HACCP plan, the CCPs are always monitored. In an FSP, preventive controls are only 

monitored as appropriate to the nature of the preventive control and its role in the facility’s food 

safety system, and some preventive controls that are not applied at CCPs may not be 

monitored. 

1.4.3 Corrective Actions and Corrections 

In a HACCP plan, corrective actions are taken for deviations from a critical limit at a CCP. An 

FSP also provides for facilities to take corrective actions. However, immediate corrections (e.g., 

re-cleaning and sanitizing a line before start-up of production when food residue remains after 

cleaning) may be more appropriate for some preventive controls than a specific corrective 

action involving product risk evaluations of product safety for some preventive controls. The 

requirements for an FSP provide this flexibility. 

1.4.4 Verification 

In a HACCP plan, verification activities take place for process controls to ensure the process 

can control the hazards and the HACCP plan is being followed. In an FSP, verification activities 

will also be applied to preventive controls, but because preventive controls are not just process 

controls, there is flexibility to conduct verification activities as appropriate to the food, the facility 

and the nature of the preventive control and its role in the food safety system. 

1.4.5 Validation 

Some HACCP systems (e.g., for juice, and for meat and poultry products) require validation of 

the HACCP plan as a whole. In an FSP, validation means obtaining and evaluating scientific 

and technical evidence that a control measure, combination of control measures, or the food 

safety plan as a whole, when properly implemented, is capable of effectively controlling the 

identified hazards. The extent of validation activities may be less rigorous for some preventive 

controls than others, or may not be required (e.g., sanitation controls). 

1.4.6 Recall plan 

In a HACCP plan, recall plans have not been included. In an FSP, a Recall Plan must be 

prepared for each product for which a hazard requiring a preventive control has been identified. 
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1.5 What if a Facility Already Has a HACCP Plan?

If you have an existing HACCP plan, you should determine if it satisfies all the PCHF 

requirements in part 117. You can use existing programs, procedures, and records and 

supplement these with any additional information required, such as a supply-chain program. 

1.6 What Format Is Required for a Food Safety Plan?

There is no standardized or required format for an FSP. This guidance provides flexibility in its 

approach to guide you in identifying and establishing preventive controls for different types of 

hazards identified in your hazard analysis. You can use whatever format works best for your 

facility, provided that the FSP includes all the required information. The formats shown in this 

guidance are for illustrative purposes only and may not be complete. The FSPCA training 

materials have FSP worksheets and teaching example model FSPs that may be helpful. 

The FSP may consist of one or more existing HACCP plans, one or more prerequisite programs 

that include food safety controls, a recall plan, a written supply-chain program, written 

verification procedures such as environmental monitoring, and any other components specified 

in the PCHF requirements. You have flexibility in how to organize these documents within your 

FSP. One approach for organizing the FSP to allow for signing and dating it is to collect all 

these documents in a single location (e.g., a binder or folder) with a cover page containing the 

signature of the owner, operator, or agent in charge of the facility and the date on which the

cover page was signed. However, because the FSP also could be a set of documents kept in 

different locations within the facility, another approach is for the owner, operator, or agent in 

charge of the facility to sign and date a list of the relevant documents (e.g., as in a Table of

Contents).

1.7 When Are Changes Needed for a Food Safety Plan?

The FSP is a dynamic document that reflects your current hazard analysis, preventive controls, 

and applicable procedures. The FSP as a whole must be reanalyzed at least every 3 years. The 

reanalysis may be limited to the applicable portion of the FSP when you make changes to your 

system or equipment, when you become aware of new information about potential hazards 

associated with the food or your facility, when there is an unanticipated food safety problem, or 

when you find that a preventive control, combination of preventive controls, or the FSP itself is 

ineffective. See 21 CFR 117.170. 

1.8 References

National Advisory Committee on Microbiological Criteria for Foods (NACMCF). 1998. “Hazard 

Analysis and Critical Control Point Principles and Application Guidelines.” J Food Protect 61: 

1246-1259.
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Chapter 2 (Hazard Analysis) - Page 1 

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-assistance-network-tan. 

Chapter 2: Conducting a Hazard Analysis

Table of Contents 

2.1 Purpose of this Chapter

2.2 Overview of a Hazard Analysis

2.3 Recommended Activities Prior to Conducting a Hazard Analysis

2.3.1 Conduct Preliminary Steps

2.3.2 Set Up the Hazard Analysis Worksheet

2.4 Conducting a Hazard Analysis

2.4.1 Identify Potential Hazards (Ingredient-Related Hazards, Process-Related 

Hazards, and Hazards that May Be Introduced from the Environment 

(Hazard Identification)

2.4.2 Evaluate Potential Hazards to Determine Whether the Hazard Requires a 

Preventive Control (Hazard Evaluation)

2.4.2.1 Evaluating severity

2.4.2.2 Estimating the likely occurrence

2.4.2.3. Evaluating environmental pathogens whenever a ready-to-eat food is 

exposed to the environment

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. Underlined text in yellow highlights 

represents a correction from the draft Chapter 2 that we issued for public comment in August 2016. 
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Chapter 2 (Hazard Analysis) - Page 2

2.4.2.4. Evaluation factors

2.5 Identify Preventive Control Measures

2.6 References

2.1 Purpose of this Chapter

The guidance provided in this chapter is intended to help you conduct a hazard analysis in 

accordance with the PCHF requirements. The hazard analysis must be written, regardless of 

the results of the analysis, and must include two elements: (1) a hazard identification and (2) a 

hazard evaluation. You conduct a hazard analysis to identify and evaluate, based on 

experience, illness data, scientific reports, and other information, known or reasonably 

foreseeable hazards for each type of food manufactured, processed, packed, or held at your 

facility to determine whether there are hazards requiring preventive controls. See 21 CFR 

117.130.

2.2 Overview of a Hazard Analysis

Part 117 does not define the term “hazard analysis.” See Box 2-1 for a definition of “hazard 

analysis” that was developed by the Food Safety Preventive Controls Alliance (FSPCA).

Box 2-1. A Definition for “Hazard Analysis”

Hazard Analysis

The process of collecting and evaluating information on hazards and the conditions leading to 

their presence to determine which hazards are significant for food safety and therefore should 

be addressed in a HACCP plan or food safety plan (FSP).

Food Safety Preventive Controls Alliance

This section will guide you through the steps involved in conducting a hazard analysis. The 

PCHF requirements do not specify that you must use a “Hazard Analysis Worksheet” to conduct 

your hazard analysis. However, you may find it useful to use such a worksheet. See Form 2-B 

in Appendix 2 of this guidance and Box 2-3 in this chapter. 

The PCHF requirements do not specify that you must use a certain format for conducting a 

hazard analysis. You may use formats other than the Hazard Analysis Worksheet that we 

provide in this guidance (including the use of a written narrative) as long as your hazard 

analysis contains the elements of hazard identification and hazard evaluation. 

You use the hazard analysis to determine appropriate preventive controls. Your hazard analysis 

should provide justification for your decisions. You may group products together in a single 

hazard analysis worksheet if the food safety hazards and controls are essentially the same for 

all products in the group, but you should clearly identify any product or process differences. 

Keep in mind that you will need to refer to your written hazard analysis when you reanalyze or 
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Chapter 2 (Hazard Analysis) - Page 3

modify your FSP and that it can be a resource for you when you are asked by inspectors or 

auditors to justify why certain hazards were or were not included in your FSP.

The hazard analysis helps you to focus resources on the most important controls applied to 

provide safe food. If you do not conduct the hazard analysis correctly, and do not identify all 

hazards warranting preventive controls within the food safety plan, the food safety plan will not 

be effective in protecting consumers and preventing food safety issues, no matter how well your 

facility follows the plan. A proper analysis of biological, chemical (including radiological), and 

physical hazards associated with food ingredients, finished products, and the processes used

calls for good judgment, detailed knowledge of the properties of the raw materials/other 

ingredients and manufacturing processes, and access to appropriate scientific expertise. 

2.3 Recommended Activities Prior to Conducting a Hazard Analysis

Although the PCHF requirements do not specify that you must do so, we recommend that you 

conduct certain preliminary steps, and set up a Hazard Analysis Worksheet, as a useful 

framework for organizing and documenting your hazard analysis. 

2.3.1 Conduct Preliminary Steps

Box 1-2. Preliminary Steps

1. Assemble a Food Safety Team

2. Describe the product, its distribution, intended use, and consumer or end user of the product

3. Develop a process flow diagram and verify it on site

4. Describe the process 

Your written hazard analysis is part of your food safety plan, which must be prepared, or its 

preparation overseen, by one or more preventive controls qualified individuals (21 CFR

117.126(a)(2)). Although the PCHF requirements do not specify that you must do so, we 

recommend that a Food Safety Team of individuals with expertise in the day-to-day operations 

of your facility conduct your hazard analysis under the oversight of a Preventive Controls 

Qualified Individual. The individuals may include personnel from production, sanitation, quality 

control, laboratory, and maintenance. Using people from different functions within the facility 

can help provide a complete understanding of the process and things that can go wrong. You 

can supplement the expertise of the Food Safety Team by competent technical experts from 

other off-site functions within the firm (where applicable), such as research and development 

(R&D), technical applications groups, and quality management, as well as from outside experts 

from universities, cooperative extension services, trade associations, private consulting firms, or 

other sources.

The effectiveness of your Food Safety Team will be impacted by the quality and completeness 

of the information provided to them about the facility and food product(s) to be evaluated. 

Therefore, in order for your Food Safety Team to conduct the hazard analysis, we recommend 

that you define and document the following details for the facility:
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• Product description, including its distribution, intended use, and identification of consumer or end 

user;

• Process flow diagram; and

• Detailed process description to supplement the process flow diagram.

A product description and how the product will be distributed helps team members understand 

elements of the product that may impact food safety, such as whether temperature controls are 

needed during distribution. The description should include the full name of the finished product, 

including descriptors such as ready-to-eat (RTE), frozen; the packaging type and material; and 

storage and distribution details. Understanding how the product will be used by the consumer 

(e.g., consumed with or without further processing, such as cooking) and knowing the intended 

consumer of the product (e.g., whether the food is intended for general public or specifically 

intended for a more susceptible population such as infants and young children (e.g., infant 

formula), the elderly (e.g., foods manufactured for nursing homes), or immunocompromised 

persons (e.g., foods manufactured for hospitals) helps to identify hazards of particular concern

and the need for more stringent controls or verification activities.

The purpose of a process flow diagram is to provide a clear, simple description of the steps 

involved in the processing of your food product and its associated ingredients as they “flow” 

from receipt to distribution. The process flow diagram should cover all steps in the process that 

the facility performs, including receiving and storage steps for each raw material or other 

ingredient, preparation, processing, packaging, storage and distribution of the product. 

Additionally the process flow diagram should identify the equipment (e.g., pumps, surge tanks, 

hoppers, fillers) used in the operations. An accurate process flow diagram serves as a useful 

organizational format for elements of the food safety plan, because it identifies each of the steps 

that must be evaluated in the hazard analysis. You should verify the process flow diagram onsite in order to ensure no steps have been overlooked.

The purpose of a detailed process description is to explain what happens at each of the process 

steps. Information such as the maximum length of time a food is exposed to ambient 

temperature during processing, whether a food is handled manually, and whether rework is 

incorporated into product can be important for an accurate hazard analysis.

2.3.2 Set Up the Hazard Analysis Worksheet

Once you have assembled the Food Safety Team and started gathering the information you will 

use in your hazard analysis, we recommend that you set up a document that you will use to 

organize the hazard analysis. In this guidance, we describe how to set up an adaptation of the 

“Hazard Analysis Worksheet” used in HACCP systems to organize your hazard analysis. In this 

section of this chapter, we discuss how to set-up this worksheet (see Box 2-3, which shows a 

form adapted from a form used by the FSPCA). In the next section of this chapter, we provide 

details that will help you use the worksheet to conduct your analysis. 

• Column 1: Here, you will list (1) receipt of ingredients used in the process as a means of identifying 

hazards associated with an ingredient (you may group some ingredients, e.g., “spices”); and (2) 

processing steps. The process flow diagram recommended as a preliminary step (see Box 1-2) can 

help you to identify the processing steps that are included in the hazard analysis. 

• Column 2: Here, you will list the results of your hazard identification – i.e., the food safety hazards 

that potentially could be introduced, controlled, or enhanced at this step (known or reasonably 

foreseeable hazards). Include all ingredient-related hazards, process-related hazards, and hazards 

that may be introduced from the environment. 
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• Column 3: Here, you will record the conclusions of your hazard evaluation – i.e., the determinations 

you make of whether each listed food safety hazard requires a preventive control (Yes or No).

• Column 4: Here, you will record the reasons that led to the conclusions of your hazard evaluation 

(i.e., the Yes/No conclusions listed in column 3). 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 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 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.

• Column 5: Here, you will identify preventive controls that will significantly minimize or prevent the food 

safety hazard (e.g., process, allergen, sanitation, supply-chain or other) for those hazards you 

identified as requiring a preventive control (i.e., a “Yes” in column 3).

• Column 6: Because the worksheet breaks your production process into multiple steps, and the 

preventive control may be applied at a step in the process other than the step where you listed the 

hazard, you specify whether the preventive control will be applied at this particular step (Yes/No). It is 

important to note that identifying a hazard at a processing step as one that requires a preventive 

control does not mean that the hazard must be controlled at that processing step.
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Box 2-3. Example Hazard Analysis Work Sheet (Also see Form 2-B, Appendix 2)2

(1)

Ingredient / 

Processing 

Step

(2)

Identify potential

food safety 

hazards 

introduced, 

controlled or 

enhanced at this 

step

B = biological 

C = chemical, 

including 

radiological 

P = physical

(3)

Are 

any potential

food safety

hazards 

requiring 

preventive 

control?

(Yes/No)

(4)

Justify your 

decision for 

column 3

(5) 

What preventive 

control measure(s) 

can be applied to 

significantly 

minimize or 

prevent the food 

safety hazard?

Process including 

CCPs, Allergen, 

Sanitation, Supplier, 

other preventive 

control

(6)

Is the 

preventive 

control applied 

at this step?

(Yes/No)

2.4 Conducting a Hazard Analysis

2.4.1 Identify Potential Hazards (Ingredient-Related Hazards, Process-Related

Hazards, and Hazards that May Be Introduced from the Environment (Hazard 

Identification)

See 21 CFR 117.130(b).

We recommend that you start your identification of hazards potentially associated with a food or 

process (the “known or reasonably foreseeable hazards") with a brainstorming session to 

generate a list of biological, chemical, and physical hazards. Consider the following as you work 

through this process:

• Information about the product description, intended use, and distribution. 

• In-plant experience regarding the likelihood of hazards being associated with the finished products. 

This may include information from product testing results, consumer complaints, or knowledge of 

 2 Adapted from a form available from the FSPCA in “FSPCA Preventive Controls for Human Food 

Training Curriculum, First Edition – 2016.” The 2016 FSPCA form includes some additional features, 

such as a separate column for “Yes” and “No” responses and a separate row at each step for biological, 

chemical, and physical hazards (labeled B, C, and P, respectively). You can obtain the FSPCA form, 

including any later version if the form changes, from the FSPCA website 

(https://www.ifsh.iit.edu/sites/ifsh/files/departments/fspca/pdfs/FSPCA_Ap2_Worksheets__V1.1_Fillable.p

df)
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Chapter 2 (Hazard Analysis) - Page 7

facility personnel about the condition, function, and design of the facility that may be relevant to 

contamination.

• Raw materials and ingredients used in the product. Hazards, such as food allergen hazards or 

pathogens known to be associated with specific types of foods, may be introduced during product 

formulation. For example, mayonnaise is formulated with egg, which is a food allergen; “egg” must be 

included on the label and the mayonnaise may be a source of allergen cross-contact in your facility.

• Activities conducted at each step in the manufacturing process. Some processes may introduce 

hazards (e.g., a broken chopping blade can introduce metal fragments; a broken glass container can 

introduce glass fragments; improper cooling can allow low numbers of microbial pathogens to 

increase).

• Equipment used to make the product. Some types of equipment are more difficult to clean than others 

or are more prone to damage, which may increase the risk of hazards (e.g., biological or physical) 

being introduced into the product. 

• Types of packaging and packaging materials. Reduced oxygen packaging, used to increase shelf life

(e.g., potato salad packaged in a plastic container with a snap lid), may create an environment that 

supports the growth of Clostridium botulinum (C. botulinum). 

• Sanitary practices. You should consider the sanitary conditions within the processing facility (e.g., 

cleanliness of equipment and processing environment) and employee hygiene when identifying 

hazards. Hard-to-clean equipment may result in pathogen harborage sites. Producing foods with 

different food allergens on the same line may result in allergen cross-contact. 

• External information. Sources may include scientific papers, epidemiological studies (e.g., data from 

previous outbreaks associated with ingredients or processes relevant to a product), information from 

applicable government or industry food safety guidance documents, and historical data for similar 

products, if available.

After reviewing all the relevant information, the Food Safety Team can then develop a list of 

biological, chemical, and physical hazards that may be introduced, increased (e.g., due to 

pathogen growth), or controlled at each step described on the flow diagram. Enter those in 

column 2 of the Hazard Analysis Worksheet. 

We recommend that you consult Chapter 3 and Appendix 1 of this guidance to help you identify 

potential hazards. Chapter 3 of this guidance provides a review of biological, chemical, and 

physical hazards and Appendix 1 of this guidance provides tables describing potential 

ingredient-related hazards and process-related hazards. The hazards identified in Chapter 3 

and in Appendix 1 do not represent an exhaustive list of hazards potentially associated with a 

food facility or food. You are responsible for identifying any hazard that may be associated with 

your process or product, even if it is not listed in Chapter 3. 

You may find the following list of questions helpful during the hazard identification process. We 

adapted this list from Hazard Analysis and Critical Control Point Principles and Application 

Guidelines published by the National Advisory Committee on Microbiological Criteria for Foods. 

Examples of questions to be considered when identifying potential hazards

1. Ingredients

a. Does the food contain any ingredients that may present microbiological hazards, 

chemical hazards, or physical hazards?
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b. Is all the water used at any point in the manufacturing process of the appropriate 

quality standard?

c. What are the sources of the ingredients (geographical regions, specific supplier 

details)?

2. Intrinsic Factors – physical characteristics and composition of the product during and 

after processing

a. What hazards may result if the food composition is not controlled?

b. Does the food permit survival or promote pathogen growth and/or toxin formation 

during subsequent steps in the manufacturing process or distribution/storage?

c. Are there similar products already in the marketplace, and if so, which hazards 

have been associated with those products? What is the food safety record of 

those products?

3. Processing procedures

a. Does the process include a controllable processing step that destroys 

pathogens? If so, which pathogens? Consider not only vegetative cells but also 

spores, which are typically more resistant to inactivation treatments compared to 

their vegetative counterparts.

b. Is the product susceptible to recontamination between processing and 

packaging? If so, what are the biological, chemical (including radiological), or 

physical hazards potentially associated with the process environment?

4. Microbial content of the food

a. What is the baseline microbial content of the food?

b. Does the microbial population change during the normal storage time of the food 

prior to consumption?

c. Do changes in the microbial population affect the safety of the food?

d. Based on the answers to the above questions, is there a significant likelihood of 

any biological hazards?

5. Facility design

a. Does the layout of the facility provide an adequate separation of raw materials 

from RTE foods when this is necessary for food safety? If not, what are the 

hazards that could contaminate the RTE product?
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b. Is positive air pressure maintained in product packaging areas? Is this required 

for product safety?

c. Is the traffic pattern for people and moving equipment a significant source of 

contamination?

6. Equipment design and use

a. Will the equipment provide the necessary time-temperature control to ensure a 

safe product?

b. Can the equipment be sufficiently controlled so that the variation in performance 

will be within the tolerances required to produce a safe product?

c. Is the equipment reliable and maintained in good repair?

d. Is the equipment easy to clean and sanitize?

e. Can parts of the equipment contaminate the product and thereby introduce 

physical hazards? 

f. What product safety devices are used to control the potential for physical 

hazards to contaminate the product? Examples include: metal detectors, 

magnets, sifters, filters, screens, thermometers, bone removal devices, dud 

detectors

g. Are allergen protocols needed for using the same equipment for different 

products?

7. Packaging

a. Does the method of packaging affect the rate of growth of microbial pathogens 

and/or the formation of toxins?

b. Is the package clearly labeled with the appropriate storage instructions, e.g.,

“Keep refrigerated,” if required for safety?

c. Does the package include instructions for the safe handling and preparation of 

the food by the end user?

d. Is the packaging material resistant to damage and effective in preventing postpackaging microbial contamination?

e. Are tamper-evident packaging features used?

f. Is each package and case legibly and accurately coded?
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g. Does each package contain the proper label?

h. Are allergenic ingredients included in the list of ingredients on the label?

8. Employee health, hygiene, and education

a. Can employee health or personal hygiene practices impact the safety of the food 

being processed, and in what way(s)?

b. Do the employees understand the process and the factors they must control to 

assure the preparation of safe foods?

c. Will the employees inform management of a problem that could impact food 

safety?

9. Storage conditions between packaging and the end user

a. What is the likelihood that the food will be improperly stored at the wrong 

temperature?

b. Would an error in storage lead to a microbiologically unsafe food?

10. Intended use and user

a. Will the food be heated by the consumer?

b. Will there likely be leftovers? If so, how and maximally for how long should they 

be stored? How should they be re-heated?

c. Is the food intended for the general public?

d. Is the food intended for consumption by a population with increased susceptibility 

to illness or a particular hazard (e.g., Infants, the elderly, the immunocompromised, or pregnant women)?

e. Is the food intended to be used for institutional feeding (e.g., in school cafeterias, 

hospitals) or in private homes?

2.4.2 Evaluate Potential Hazards to Determine Whether the Hazard Requires a 

Preventive Control (Hazard Evaluation)

See 21 CFR 117.130(c).

• Under 21 CFR 117.130(c)(1)(i), you must assess 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.

• Under 21 CFR 117.130(c)(1)(ii), you must include an evaluation of environmental pathogens 

whenever an RTE food is exposed to the environment prior to packaging and the packaged food does 
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not receive a treatment or otherwise include a control measure (such as a formulation lethal to the 

pathogen) that would significantly minimize the pathogen.

• Under 21 CFR 117.130(c)(2), you must consider the effect of certain factors on the safety of the 

finished food for the intended consumer.

We discuss each of these points in the remainder of this section.

Consult the hazards in Chapter 3 and controls in Chapters 4 and 5 of this guidance document 

for each of the potential hazards that you entered in Column 2 of the Hazard Analysis 

Worksheet. These chapters offer guidance for completing your hazard analysis and developing 

your FSP. Chapters 6-13 each contain a section “Understand the Potential Hazard” that 

provides information about the significance of the hazard, the conditions under which it may 

develop in a processed product, and methods available to control the hazard.

Once you have identified all potential hazards, the next step is to evaluate each hazard and 

determine whether the hazard poses a significant risk to the end user or consumers in the 

absence of a preventive control. Narrow the list of potential hazards that you entered in column 

2 to those that require a preventive control. 

For example, at the receiving step for ingredients, you may identify soy as an allergen in your 

product because soy protein is one of the ingredients. Because it is an allergen, you would mark 

“Yes” in column 3 and explain that soy may cause allergic reactions in some consumers in 

column 4.

For each hazard also consider the following: 

• Seriousness of the potential illness or injury resulting from exposure to the hazard, and 

• The likelihood of occurrence in the absence of a preventive control. 

2.4.2.1 Evaluating severity 

To evaluate the severity of a potential hazard, you should consider certain factors, including 

• susceptibility of intended consumers to foodborne illness (e.g., infants, children, and 

immunocompromised persons may be more susceptible to certain foodborne illnesses), 

• the potential magnitude and duration of the illness or injury (e.g., how long an individual may be sick, 

and whether hospitalization or death is common), and 

• the possible impact of secondary problems (e.g., chronic sequelae such as kidney damage or 

reactive arthritis). 

If your facility does not have the expertise to evaluate the severity of a potential hazard, you 

should consult with outside experts.

2.4.2.2 Estimating the likely occurrence 

The likelihood of occurrence of a particular food hazard in the food when consumed can be 

influenced by:

• Frequency of association of the hazard with the food or facility

• Effectiveness of facility programs such as CGMPs

• Method of preparation in the establishment
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• Conditions during transportation

• Expected storage conditions

• Likely preparation and handling steps before consumption

Knowing your product, ingredients, processes, preparation methods, packaging, transportation, 

distribution, and likely use of the product will be helpful in estimating the likely occurrence of 

potential hazards. Hazards identified in one operation or facility may not be significant in another 

operation or facility producing the same or similar products because different equipment and 

processes may be used, the ingredients and their source may be different, or for other reasons. 

For example, one facility may package a beverage in glass and another may package the same 

product in plastic. You should consider each operation and facility location individually when 

estimating the likely occurrence of a food safety hazard. 

When estimating likely occurrence, you should consider information from several sources, such 

as the following:

• Data from outbreaks of foodborne illness, 

• Data from recalls,

• Information in the scientific literature, and 

• Experience and historical information gathered by your facility. 

2.4.2.2.1 Data from outbreaks 

Your Food Safety Team should consider foodborne illness outbreaks in the same or similar 

products, as well as data on foodborne illness outbreaks provided from other product types that 

may be relevant, or from foods prepared in retail food establishments rather than in 

manufacturing facilities. Several publicly available resources can provide such information. For 

example, we provide information on our findings related to outbreaks, including a discussion, 

whenever possible, of factors that would have contributed to the outbreak at the processing or 

production site for the foods we regulate. Moreover, the Centers for Disease Control and 

Prevention (CDC) provides considerable information on outbreaks that occurred from processed 

foods, as well as from foods prepared in restaurants, retail establishments, and other locations. 

See Box 2-4 for a list of useful reports and the list of references in section 2.6 of this chapter for 

how to access these reports. Information may also be available on outbreaks from similar foods 

that occur in other countries. For example, the European Food Safety Authority (EFSA) 

publishes summaries of foodborne disease outbreaks in European countries. 
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Box 2-4. Sources of Data about Outbreaks 3

Food and Drug Administration (FDA)

• Outbreak investigations – reports for FDA regulated foods

Centers for Disease Control and Prevention (CDC)

• Foodborne Outbreaks (including links to the List of Selected Multistate Foodborne Outbreak 

Investigations (see below) and Morbidity and Mortality Weekly Report reports on foodborne 

outbreaks)

• List of Selected Multistate Foodborne Outbreak Investigations - searchable database for selected 

U.S. outbreaks by year and by pathogen

• Attribution of Foodborne Illness – reports on foods associated with illness

Center for Science in the Public Interest (CSPI)

• Outbreaks & Recalls 

2.4.2.2.2 Data from recalls 

Recalls provide useful information in understanding the likely occurrence of potential hazards 

and the foods in which they occur. We categorize recalls as specified in 21 CFR 7.3(m):

Recall classification means the numerical designation, i.e., I, II, or III, assigned by the Food and 

Drug Administration to a particular product recall to indicate the relative degree of health hazard 

presented by the product being recalled.

• Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a 

violative product will cause serious adverse health consequences or death (21 CFR 7.3(m)(1);

• Class II is a situation in which use of, or exposure to, a violative product may cause temporary or 

medically reversible adverse health consequences or where the probability of serious health 

consequences is remote (21 CFR 7.3(m)(2); and

• Class III is a situation in which use of, or exposure to, a violative product is not likely to cause illness 

or injury (21 CFR 7.3(m)(3).

Federal and state websites post information on food recalls. See Box 2-5 for a list of some 

helpful federal websites that provide data about recalls. See the list of references in section 2.6 

of this chapter for the links to access this information.

 3 See section 2.6 of this chapter for information on how to access these sources of data about outbreaks.
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Box 2-5. Sources of Data About Recalls4

• Food and Drug Administration (FDA) Recalls, Market Withdrawals, & Safety Alerts

• U.S. Department of Agriculture (USDA) Food Safety and Inspection Service Recall 

Archive

• Foodsafety.gov (Gateway to Federal Food Safety Information), Recalls & Alerts

2.4.2.2.3 Information in the scientific literature 

Peer-reviewed scientific journals and other sources of technical literature (e.g., Codex 

Alimentarius Commission (Codex), the Food and Agriculture Organization and the World Health 

Organization) provide considerable information on foodborne hazards, including their 

occurrence, their potential growth in foods (e.g., for biological hazards), and their control. A 

useful search engine is Google Scholar. USDA provides a microbial modeling program that is 

available online and can be used to evaluate potential growth of pathogens under a variety of 

conditions. ComBase is an online tool for quantitative food microbiology. It contains the 

ComBase database of microbial growth and survival curves and the ComBase Predictor that 

uses the data to predict growth or inactivation of microorganisms. Keep in mind that modeling 

programs may not reflect exactly what will occur in a particular food, but they can provide an 

estimate of relative risk of different scenarios. Codex maintains internationally recognized codes 

of practice that are based on scientific literature and are available in several languages. Trade 

associations also provide food safety recommendations for specific types of foods and industry 

needs. 

We provide other guidance documents that contain product-specific food safety information 

(e.g., on shell eggs, cheese, fruits, vegetables, and milk). These guidance documents, which

represent FDA's current thinking on a topic, are organized by topic and by year of publication, 

with recently added guidance documents at the top of the page. 

2.4.2.2.4 Establishment’s historical information 

You may already have considerable information on your products from various laboratory tests 

on finished products, ingredients, in-process materials, or environmental monitoring. In addition, 

you may have experienced a contamination problem in the past that suggests a hazard is 

reasonably foreseeable, or received consumer complaints about certain hazards, such as 

physical hazards. 

You should evaluate the potential hazards independently at each processing step to determine 

whether you should identify that hazard as one requiring a preventive control. For example, you 

would identify a hazard as one requiring a preventive control if: 

• it is reasonably likely that the hazard can be introduced at an unsafe level at that processing step; or 

• it is reasonably likely that the hazard can increase to an unsafe level at that processing step; or 

 4 See section 2.6 of this chapter for information on how to access these sources of data about recalls.
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• the hazard was identified in an ingredient or at another processing or handling step and it can be 

controlled (i.e., significantly minimized or prevented) at the current processing step. 

When evaluating whether a hazard requires a preventive control, you should consider the 

method of distribution and storage and the intended use and consumer of the product 

(information which you developed as part of your preliminary steps in conducting a hazard 

analysis).

If you determine that a potential hazard requires a preventive control, you should answer “Yes” 

in column 3 of the Hazard Analysis Worksheet. If you determine that it does not require a 

preventive control, you should answer “No” in that column. In column 4, record your reason for 

your “Yes” or “No” answer. If the hazard does not require a preventive control, you would not 

complete columns 5 and 6.

2.4.2.3. Evaluating environmental pathogens whenever a ready-to-eat 

food is exposed to the environment 

If the food you make is ready-to-eat (see the definition in 21 CFR 117.3, which we included in 

the Glossary in section III of the Introduction of this guidance), the food could be contaminated 

with environmental pathogens such as Listeria monocytogenes (L. monocytogenes) or 

Salmonella. See 21 CFR 117.130(c)(1)(ii) for when the PCHF requirements specify that you 

must consider environmental pathogens in your hazard analysis. 

2.4.2.4. Evaluation factors 

When evaluating hazards, you must consider the effect of the following on the safety of the 

finished food for the consumer (21 CFR 117.130(c)(2)):

• The formulation of the food: The addition of certain ingredients such as acids and preservatives may 

be critical to the safety of the food, because they may inhibit growth of, or kill, microorganisms of 

public health significance. This could impact the evaluation at steps during production and storage 

with respect to the hazard of ‘‘pathogen growth.’’ A multicomponent food may have individual 

ingredients that do not support growth of undesirable microorganisms (e.g., because of pH or aw), but 

when put together there may be an interface where the pH and aw change (e.g., pies, layered 

breads). The formulation may contain an ingredient (e.g., a flavoring, coloring, or incidental additive) 

that is (or contains) an allergen that requires label control and possibly controls to prevent crosscontact.

• The condition, function, and design of the facility and equipment: The condition, function, or design of 

a facility or its equipment could potentially result in the introduction of hazards into foods. For 

example, older equipment (e.g., older slicing, rolling and conveying equipment) may be more difficult

to clean (e.g., because of close fitting components or hollow parts) and, thus, provide more 

opportunities for pathogens to become established in a niche environment than modern equipment 

designed to address the problem of pathogen harborage in niche environments; in such instances 

enhanced sanitation controls may be appropriate. Equipment designed such that there is metal-tometal contact may generate metal fragments; a preventive control such as metal detectors may be 

appropriate. A facility that manufactures, processes, or packs an RTE product such as fresh soft 

cheese may have cold, moist conditions that are conducive to the development of a niche where the 

pathogen L. monocytogenes can become established and contaminate food-contact surfaces and, 

eventually, foods; enhanced sanitation controls may be appropriate for such facilities. Facilities with 

closely spaced equipment should consider the impact of the close spacing on the potential for 

allergen cross-contact to be a hazard; targeted food allergen controls may be appropriate.

• Raw materials and other ingredients: A food can become contaminated through the use of 

contaminated food ingredients. Ingredients such as flavorings, colorings, or incidental additives may 
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contain ‘‘hidden’’ allergens. Machinery-harvested produce may be contaminated with physical 

hazards, because the machinery can pick up foreign material from the field.

• Transportation practices: The safety of a food can be affected by transportation practices for incoming 

raw materials and ingredients or for outgoing finished product. For example, when a food requires 

time/temperature control for safety, time/temperature controls would be important during 

transportation. Distributing a food in bulk without adequate protective packaging makes the product 

susceptible to contamination during transportation—e.g., from pathogens or chemicals present in an 

inadequately cleaned vehicle or from other inadequately protected foods that are being cotransported and are potential sources of contamination.

• Manufacturing/processing procedures: Hazards may arise from manufacturing/processing processes 

such as cooling or holding of certain foods due to the potential for germination of pathogenic 

sporeforming bacteria such as Clostridium perfringens (C. perfringens) and Bacillus cereus (B. 

cereus) (which may be present in food ingredients) as a cooked product is cooled and reaches a 

temperature that will allow germination of the spores and outgrowth. Hazards also may arise from 

manufacturing/processing processes such as acidification due to the potential for germination of 

spores of C. botulinum, with subsequent production of botulinum toxin, if the acidification is not done 

correctly. Toxins can be produced by the bacteria Staphylococcus aureus (S. aureus) or B. cereus in 

a product that has been heated and held at room temperature during the manufacturing process if the 

product formulation supports growth and toxin formation by the bacteria and S. aureus or B. cereus is 

present in the ingredients of the product or is introduced by poor employee hygiene (e.g., S. aureus). 

Physical hazards may occur from metal fragments generated during the manufacture of food on 

equipment in which metal (e.g., wires, saw blades or knives) is used to cut products during 

manufacturing.

• Packaging activities and labeling activities: Preventive controls for glass may be needed for products 

packed in glass. Preventive controls for C. botulinum may be needed when packing certain foods in 

modified atmosphere packaging. Label controls may be needed to ensure all food allergens are listed 

on the label of packaged foods that contain allergens.

• Storage and distribution: Biological hazards are more likely to require a preventive control during 

storage and distribution in foods that require refrigerated storage to maintain safety than in shelfstable foods.

• Intended or reasonably foreseeable use: Some foods that are intended to be cooked by the consumer 

may also have uses that do not include cooking, such as soup mixes used to make dips. Whenever 

an RTE food is exposed to the environment prior to packaging and the packaged food does not 

receive a treatment or otherwise include a control measure (such as a formulation lethal to the 

pathogen) that would significantly minimize the pathogen, hazards such as Salmonella spp., L. 

monocytogenes, and Escherichia coli O157:H7 (E. coli O157:H7) must be considered to determine if 

they require a preventive control. (See 21 CFR 117.130(c)(1)(ii).)

• Sanitation, including employee hygiene: Sanitation measures and practices can impact the likelihood 

of a hazard being introduced into a food. For example, the frequency with which a production line is 

shut down for a complete cleaning can impact the potential for food residues to transfer pathogens 

from equipment to foods (e.g., pathogens present on raw produce that could carry over into the next 

production cycle on a line). Practices directed at worker health and hygiene can reduce the potential 

for transfer of pathogens such as Salmonella spp., hepatitis A, and norovirus.

• Any other relevant factors, such as the temporal (e.g., weather-related) nature of some hazards (e.g., 

levels of some natural toxins): Hazards such as aflatoxin are subject to a weather-dependent effect in 

that aflatoxin levels in some raw agricultural commodities are more of a problem in some years than 

in others.

As noted earlier, identifying a hazard at a processing step as one that requires a preventive 

control does not mean that the hazard must be controlled at that processing step. Once you 

determine that a hazard requires a preventive control, the next step is to identify control 

measures to control the hazard.
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2.5 Identify Preventive Control Measures

Box 2-6. Definition of “Preventive Controls” in Part 117

Preventive Controls

Those risk-based, reasonably appropriate procedures, practices, and processes that a person 

knowledgeable about the safe manufacturing, processing, packing, or holding of food would 

employ to significantly minimize or prevent the hazards identified under the hazard analysis that 

are consistent with the current scientific understanding of safe food manufacturing, processing, 

packaging, or holding at the time of the analysis.

21 CFR 117.3

For each hazard that your Food Safety Team first identified in Column 2 as potentially 

associated with an ingredient, processing step, or the environment, and then identified in 

Column 3 as requiring a preventive control, you must identify and implement preventive controls 

to provide assurances that any hazards requiring a preventive control will be significantly 

minimized or prevented. See 21 CFR 117.135. If a process control can be applied at a point or

step in the food production process to prevent or eliminate the food safety hazard, or reduce it 

to an acceptable level, you should classify the point or step as a Critical Control Point (CCP). 

There are several control approaches, which may or may not include CCPs, that you can 

consider, depending on the potential hazard and where in the process flow diagram you 

determine the control measure should be applied. These include:

• Supply-chain controls

• Food allergen controls

• Sanitation controls

• Process controls

Supply-chain controls involve verification of controls used by suppliers to control hazards in raw 

materials or other ingredients before receipt by a manufacturer/processor. Food allergen 

controls include labeling and controls to prevent cross-contact, such as product sequencing, in 

addition to sanitation controls (i.e., to prevent cross-contact with allergens from other foods 

produced on the same line). Sanitation controls may be important to prevent contamination with 

microbial pathogens, especially for RTE foods that are exposed to the environment. Process 

controls are applied at specific processing steps, where critical parameters such as time and 

temperature may be identified to control the hazard of concern. See Box 2-7 for some 

examples of in-process controls.
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Box 2-7. Examples of In-Process Controls

Examples of In-Process Controls

• Acidification 

• Cooking 

• Drying 

• Fermentation 

• Filtering 

• Freezing 

• High pressure processing 

• Irradiation 

• Metal detection 

• Pasteurization 

• Refrigeration 

• Retort processing 

• Use of x-ray area

For every hazard you identify as requiring a preventive control, you must identify and implement 

at least one preventive control measure. See 21 CFR 117.135. Importantly, remember that 

more than one hazard may be addressed by a specific control measure. For example, several 

vegetative pathogens, such as Salmonella, L. monocytogenes, and E. coli O157:H7, are killed 

by cooking. Several chapters in this guidance provide one or more control strategy examples for 

how one or more hazards can be controlled, because there are often more ways than one to 

control a hazard. The control strategy examples also contain control measure information. 

Record the control measure(s) that you choose in column 5 of the Hazard Analysis Worksheet 

for each “Yes” answer in column 3.

When identifying preventive controls for your food process, your Food Safety Team should also 

consider 

• The effect of the control on identified potential food safety hazards (e.g., Does the preventive control 

significantly minimize or prevent the potential food safety hazards identified? Is the preventive control 

hazard-specific or does it control more than one hazard? Does the control effectiveness depend upon 

other controls? Can the preventive control be validated and verified?)

• The feasibility of monitoring those controls (e.g., Are the critical limits (minimum or maximum values) 

and, if appropriate, operating limits, for the preventive control measureable and practical? Can you 

obtain the results of monitoring quickly (i.e., real-time) to determine if the process is in control? Are 

you monitoring a batch or continuous process? Are you monitoring continuously or doing spot 

checks? Can the parameters be monitored in-line or must the product be sampled? Will the 

monitored parameters be indirectly linked to the critical limit (i.e., belt speed or pump flow rate for 

time of process)? Who will perform the monitoring or checks and what are the required qualifications? 

How is the monitoring to be verified?)
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• The location of the control with respect to other processing control measures (e.g., Is the application 

of the control measure at the last point in the process to ensure control of the targeted potential food 

safety hazard? Will the failure of an upstream control result in failure of downstream controls (i.e., 

acidification failure impacting thermal process efficacy for an acidified food)? Are monitoring activities 

appropriate to ensure control at this step?) 

• Corrective actions that will be needed in the event of a failure of a control measure or a significant 

processing variability (e.g., Can the process control and critical parameter be brought quickly back 

into control? How will you determine if the control measure is once again under control? Can the 

implicated product be identified and its safety evaluated? Can the cause of the loss of control be 

identified and corrected? What actions would be needed to reduce the likelihood of the failure to 

recur? Can the product be reprocessed? What actions would be necessary to prevent unsafe product 

from entering commerce (e.g., can product be diverted to animal food or does the product need to be 

destroyed)?)

• The severity of the consequences in case of a failure of a control measure (e.g., Is it reasonably likely 

that unsafe food would be produced as a result of the control measure failure? Is the hazard that 

could occur reasonably likely to cause serious adverse health consequences or death?) 

• Whether the control measure is applied to eliminate or significantly reduce the level of the hazard 

(e.g., Will the control measure eliminate the hazard, or is the control measure only able to minimize 

the hazard?)

• Synergistic effects between control measures (e.g., Consider whether one control measure can 

enhance the efficacy of another control measure. For example, formulation process controls may 

combine the use of preservatives, acidification, and water activity at levels that individually will not 

control pathogen growth, but they work together to do so.) 

You use your written hazard analysis to design the approaches you will use to control the 

hazards. The more thorough the hazard analysis, the more targeted your controls will be to 

ensure hazards are significantly minimized or prevented, and the more effective your food 

safety program will be in preventing illness or injury to consumers.

In the chapters that follow we address managing food safety hazards through heat treatments, 

time/temperature control, product formulation, sanitation controls, and food allergen controls. 

We address supply-chain controls in “Chapter 15 – Supply-Chain Program for Human Food 

Products.”

2.6 References

Center for Science in the Public Interest (CSPI). 2016. "Outbreaks & recalls." Accessed April 15, 

2016. http://www.cspinet.org/foodsafety/outbreak_report.html.

Centers for Disease Control and Prevention (CDCP). 2014. "Estimates of foodborne illness in 

the United States." Accessed April 15, 

2016. http://www.cdc.gov/foodborneburden/attribution/index.html.

Centers for Disease Control and Prevention (CDCP). 2016a. "Foodborne outbreaks." Accessed 

April 15, 2016. http://www.cdc.gov/foodsafety/outbreaks/index.html.

Centers for Disease Control and Prevention (CDCP). 2016b. "List of selected multistate 

foodborne outbreak investigations." Accessed April 15, 

2016. http://www.cdc.gov/foodsafety/outbreaks/multistate-outbreaks/outbreaks-list.html.

ComBase. 2016. "Combase homepage." http://www.combase.cc/index.php/en/.
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European Food Safety Authority. 2015. "The European Union summary report on trends and 

sources of zoonoses, zoonotic agents and food-borne outbreaks in 2014." EFSA 

Journal 13 (12): 4329, 191 pages. http://www.efsa.europa.eu/en/efsajournal/pub/4329

Food and Agriculture Organization of the United Nations (FAO). 2016. "Food safety & quality 

homepage." Accessed June 21, 2016. http://www.fao.org/food/food-safety-quality/homepage/en/.

Food and Drug Administration (FDA). 2015. "Recalls, market withdrawals, & safety alerts (FDA 

email sign-up webpage)." Accessed June 3, 

2015. https://service.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFD

A_48.

Food and Drug Administration (FDA). 2016a. "Food guidance documents." Accessed June 24, 

2016. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfo

rmation/default.htm.

Food and Drug Administration (FDA). 2016b. "Outbreak investigations." Accessed April 15, 

2016. http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm272351.ht

m.

Food Safety and Inspection Service (FSIS). 2016. "Recall case archive." Accessed April 15, 

2016. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-healthalerts/recall-case-archive.

Google. 2016. "Google scholar homepage." Accessed June 16, 

2016. https://scholar.google.com/.

National Advisory Committee on Microbiological Criteria for Foods (NACMCF). 1998. "Hazard 

analysis and critical control point principles and application guidelines." Journal of Food 

Protection 61 (9):1246-1259.

United States Department of Agriculture (USDA)-Microbial Food Safety Research Unit. 2005. 

"Pathogen modeling program 7.0 version 1.1.1433.15425." Accessed June 1, 

2016. http://www.ars.usda.gov/Services/docs.htm?docid=6788.

United States Department of Health and Human Services (HHS). "Recalls and alerts." Accessed 

July 15, 2016. http://www.foodsafety.gov/recalls/index.html.

World Health Organization (WHO). 2016. "Food safety." Accessed April 15, 

2016. http://www.who.int/foodsafety/en/.
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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-assistance-network-tan.

Chapter 3: Potential Hazards Associated with the 

Manufacturing, Processing, Packing, and Holding of Human 

Food 

Table of Contents

3.1 Purpose of this Chapter

3.2 Potential Hazards

3.3 Biological Hazards

3.3.1 Characteristics of Vegetative Foodborne Pathogens

3.3.2 Characteristics of Spore-Forming Foodborne Pathogens

3.3.3 Potential Ingredient-Related Biological Hazards

3.3.4 Potential Process-Related Biological Hazards

3.3.4.1 Bacterial pathogens (vegetative and sporeforming) that survive after 

treatment

3.3.4.2 Bacterial pathogens that grow and/or produce toxin

3.3.4.3 Bacterial pathogens in ingredients added after process controls

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. Underlined text in yellow highlights 

represents a correction from the draft Chapter 3 that we issued for public comment in August 2016. 
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3.3.4.4 Bacterial pathogens introduced after packaging due to lack of container 

integrity

3.3.5 Potential Facility-Related Biological Hazards

3.3.5.1 Sources of facility-related biological hazards

3.3.5.2 Transient vs. resident facility-related environmental pathogens

3.3.5.3 Facility-related environmental pathogens associated with wet vs. dry 

processing environments

3.4 Chemical Hazards

3.4.1 Ingredient-Related Chemical Hazards

3.4.1.1 Pesticides

3.4.1.2 Animal drug residues

3.4.1.3 Heavy metals

3.4.1.4 Environmental contaminants

3.4.1.5 Mycotoxins and other natural toxins

3.4.1.6 Chemical hazards that may be intentionally introduced for purposes of 

economic gain

3.4.2 Chemical Hazards That Can Be Either Ingredient-Related or ProcessRelated

3.4.2.1 Food allergens

3.4.2.2 Food additives, color additives, and GRAS substances, including 

substances associated with food intolerance or food disorder

3.4.2.3 Process contaminants produced during heating

3.4.2.4 Radiological hazards

3.4.3 Facility-Related Chemical Hazards

3.5 Physical Hazards

3.6 References

3.1 Purpose of this Chapter

The guidance in this chapter is intended to help you consider the biological, chemical, and 

physical hazards that are commonly of concern in food plants and that should be addressed in a 

hazard analysis. It addresses ingredient-related hazards, process-related hazards, and hazards 

that may be introduced from the food-production environment (facility-related hazards). It does 

not provide an exhaustive compendium of hazards or details about each hazard. Where 

possible, we cite scientific literature, regulations, and/or guidance (issued by FDA or our food 

safety regulatory partners) that may provide useful detailed discussion or analysis of hazards of 

concern. See the definition of “hazard” in 21 CFR 117.3. 
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It is important for you to understand the potential hazards that may be associated with your 

products using the raw materials and other ingredients, processes, and equipment specific for 

those products, as well as the environment of your specific facility. If you identify hazards 

requiring a preventive control, you will then have to determine what preventive controls are 

needed to reduce food safety risks and ensure the safety of your products for human 

consumption. See 21 CFR 117.130 and 117.135. Although this chapter briefly describes the 

types of preventive controls that may be appropriate for you to implement to control certain 

hazards, see Chapter 4 and Chapters 6 through 13 of this guidance for more detailed 

discussion of applicable preventive controls. 

3.2 Potential Hazards 

Food products can become contaminated with biological, chemical (including radiological), or 

physical hazards. Table 3-1 provides examples of potential hazards and is not exhaustive. 

Table 3-1 Examples of Potential Hazards 

Hazard Category Hazard Sub-category Examples

Biological Bacteria • Bacillus cereus (B. cereus)

• Campylobacter jejuni (C. jejuni)

• Clostridium botulinum (C. botulinum)

• Clostridium perfringens (C. perfringens)

• Shiga-toxin producing Escherichia coli

such as O157:H7 (E. coli O157:H7)

• Listeria monocytogenes (L. 

monocytogenes)

• Salmonella spp.

• Shigella spp.

• Staphylococcus aureus (S. aureus)

Biological Protozoa and Parasites • Cryptosporidium parvum

• Cyclospora cayetanensis

• Giardia lamblia (G. intestinalis)

• Trichinella spiralis

Biological Viruses • Norovirus

• Hepatitis A

• Rotavirus

Chemical Pesticide residues • Organophosphates

• Carbamates 

• Chlorinated hydrocarbons

• Pyrethroids

Chemical Heavy Metals • Lead

• Arsenic

• Cadmium

• Mercury

Chemical Drug residues (veterinary 

antibiotics)

• Chloramphenicol

• Beta- Lactams
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Hazard Category Hazard Sub-category Examples

Chemical Industrial chemicals • Ammonia

Chemical Environmental contaminants • Dioxins

Chemical Mycotoxins • Aflatoxin

• Patulin

• Ochratoxin

• Fumonisin

• Deoxynivalenol

Chemical Allergens • Milk, eggs, fish, crustacean shellfish, tree 

nuts, peanuts, wheat, and soybeans

(commonly called “the Big 8”)

Chemical Unapproved colors and 

additives

• FD&C Red #4

• Melamine

Chemical Substances associated with a 

food intolerance or food 

disorder

• Lactose

• Yellow #5

• Sulfites

• Carmine and Cochineal

• Gluten

Chemical Radionuclides • Radium 226 and 228

• Uranium 235 and 238

• Strontium 90

• Cesium 137

• Iodine 131

Physical N/A • Metal

• Glass

• Hard plastic

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

consider the potential for biological, chemical, and physical hazards to be related to raw 

materials and other ingredients (ingredient-related hazards), processes (process-related 

hazards), and the food-production environment (facility-related hazards) (21 CFR 117.130). In 

Chapter 2 we also provide examples of questions to be considered when identifying potential 

hazards in the following areas:

• Ingredients;

• Intrinsic factors; 

• Processing procedures; 

• Microbial content of the food; 

• Facility design; 

• Equipment design and use; 

• Packaging; 
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• Employee health, hygiene, and education; and

• Storage conditions between packaging and the end user.

Throughout this chapter, we discuss potential biological, chemical, and physical hazards from 

the perspective of ingredient-related hazards, process-related hazards, and facility-related 

hazards, considering the issues and factors listed immediately above.

3.3 Biological Hazards

You must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable 

biological hazards, including microbiological hazards such as parasites, environmental 

pathogens, and other pathogens. See 21 CFR 117.130(b)(1)(i). When your hazard analysis 

identifies a known or reasonably foreseeable biological hazard that requires a preventive 

control, you must identify and implement a preventive control for the biological hazard. See 21 

CFR 117.135(a)(1). 

The biological hazards that are the focus of this guidance are bacterial pathogens (e.g., 

Salmonella spp., Listeria monocytogenes, Clostridium botulinum, and Shiga-toxin producing 

Escherichia coli (STEC) such as O157:H7) that may be associated with foods or food 

processing operations and can cause consumer illness or disease. The other biological 

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

Giardia intestinalis), are also known to cause illness or disease, but these would generally be 

addressed by following Current Good Manufacturing Practice (e.g., worker hygiene and disease 

control) in facilities and our regulation entitled “Standards for the Growing, Harvesting, Packing, 

and Holding of Produce for Human Consumption” (21 CFR part 112) (e.g., worker hygiene and 

disease control, water safety) on farms that supply raw agricultural commodities to facilities. 

Food products can become contaminated with bacterial pathogens that can be:

• Ingredient-related hazards - i.e., introduced from raw materials and other ingredients; 

• Process-related hazards - e.g., if the pathogens:

o Survive processing that was intended to significantly minimize the pathogen;

o Increase in number due to lack of time/temperature control or due to the food’s 

formulation; or

o Selectively grow, and/or produce toxin, in a food as a result of using reduced oxygen 

packaging; 

• Facility-related hazards – e.g., if the pathogens are introduced from:

o Food processing equipment (e.g., insanitary equipment and utensils);

o Cross-contamination between raw and cooked products; 

o Air; or

o Contaminated water or sewage; or

• People-related hazards – e.g., due to people handling the product during packing or 

processing. (Such people-related hazards are sometimes controlled by following Current 

Good Manufacturing Practice (e.g., worker hygiene and disease control)).
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For further details on the sources of biological hazards that can be introduced into food 

products, see Tables 1A through1Q and Tables 3A through 3Q of Appendix 1 of this guidance.

Bacterial pathogens can be classified based on whether they form spores (“sporeformers”) or 

whether they only exist as vegetative cells and do not form spores (“non-sporeformers”). Spores 

are not hazardous as long as they remain in the spore state. Unfortunately, spores are very 

resistant to heat, chemicals, and other treatments that would normally kill vegetative cells of 

both sporeformers and non-sporeformers. As a result, when spores are a concern, the process 

steps used to kill them are often much more severe than those necessary to kill vegetative cells.

When spores survive a processing step designed to kill vegetative bacteria, they may become a 

hazard in the food if they are exposed to conditions that allow germination and growth as 

vegetative cells. This can be particularly serious when a processing step has removed most of 

their competition. Thus, other controls such as reduced pH or water activity (aw) or temperature 

control (refrigeration or freezing) may be needed to control sporeformers that remain after a kill 

step. 

Because the characteristics of foodborne pathogens differ, the preventive controls that you 

identify and implement to control specific pathogens should be based on the characteristics of 

those specific pathogens. In the remainder of this section on biological hazards, we briefly

review characteristics of common vegetative and sporeforming foodborne pathogens. For more 

detailed information, see FDA’s Bad Bug Book (FDA 2012c).

Table 3-2 is a Quick Reference Guide to help you identify potential pathogens by biological 

classification and potential sources or entry points in your facility. The potential hazards listed in 

Table 3-2 will not apply to all facilities. 

Table 3-2 Quick Reference Guide for Common Sources of Biological Hazards

Primary Source Bacteria Parasites Viruses

Ingredient-related (e.g., 

contamination of raw 

materials and other 

ingredients)

• Salmonella spp. (e.g., 

poultry, produce, nuts)

• E. coli O157:H7 & similar 

STEC (e.g., ruminant 

animals, dropped fruit, 

sprouts)

• Campylobacter spp. (e.g., 

poultry and raw milk)

• B. cereus (e.g., rice and 

other grains)

• C. botulinum (spores may 

be found in soil and on 

certain root crops.)

• C. perfringens (e.g., 

spices, may come in soil 

on produce)

• L. monocytogenes (e.g., 

raw agricultural 

commodities, other 

contaminated products

used as ingredients)

• Cryptosporidium 

parvum (contaminated 

water used as an 

ingredient)

• Cyclospora 

cayetanensis (berries)

• Toxoplasma gondii

(meat)

• Norovirus 

(produce, 

shellfish)

• Hepatitis A virus 

(produce, fruits)
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Primary Source Bacteria Parasites Viruses

Process-related (e.g., 

poor or ineffective 

process controls, 

including by a supplier)

• Salmonella spp. survive 

inadequate heat 

treatment

• C. perfringens (improperly 

cooled cooked foods)

• L. monocytogenes (raw 

agricultural commodities, 

contaminated products)

Cryptosporidium parvum

(contaminated water 

source)

N/A

Facility-related (may be 

caused by poor 

sanitation practices (e.g., 

inadequate cleaning and 

sanitizing of potential 

harborage sites), poor 

plant and equipment 

design, and poor pest 

management practices)

• L. monocytogenes (e.g., 

reservoirs include floors, 

cold wet areas, 

equipment, drains, 

condensate, coolers, and 

soil)

• Salmonella spp. (pests)

N/A Norovirus (only 

when active 

shedding occurs in 

facility through 

vomiting and 

diarrhea)

People-related 

(individuals who are 

carriers, showing no 

signs of disease, who 

are shedding the hazard, 

or who are infected and 

are actively ill)

• S. aureus 

• Shigella spp.

• Salmonella spp.

Cryptosporidium parvum • Hepatitis A virus 

• Norovirus

• Rotavirus

3.3.1 Characteristics of Vegetative Foodborne Pathogens 

Table 3-A in Appendix 3 of this guidance contains information on the physical conditions (i.e., 

aw, acidity (pH), temperature, and oxygen requirements) that will limit growth for most of the 

vegetative pathogens that are of greatest concern in food processing. Data shown are the 

minimum or maximum values - i.e., the extreme limits reported among the references cited. 

These values may have been obtained in laboratory media, which may be more favorable to 

growth than many foods. These values may not apply to your specific processing conditions.

Brucella spp. is the bacterium responsible for brucellosis. An estimated 840 foodborne cases 

of brucellosis occur annually in the United States (Scallan et al., 2011) When sheep, goats, 

cows, or camels are infected with the pathogen, their milk becomes contaminated with the 

bacteria. The most common way for humans to be infected is by eating or drinking 

unpasteurized/raw dairy products from infected animals. Brucella can also enter the body 

through skin wounds or mucous membranes following contact with infected animals. Symptoms 

include: fever; sweats; malaise; anorexia; headache; pain in muscles, joints and/or back; and 

fatigue. Some signs and symptoms may persist for prolonged periods of time or may never go 

away.

Campylobacter jejuni (C. jejuni) is the bacterium responsible for campylobacteriosis. An 

estimated 845,000 foodborne cases of campylobacteriosis occur annually in the United States

(Scallan et al., 2011). Symptoms include diarrhea, fever, abdominal pain, nausea, headache, 

and muscle pain. Symptoms start from 2 to 5 days after consumption of contaminated food and 

last from 7 to 10 days. A small percentage of patients develop complications that may be 
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severe. These include bacteremia and infection of various organ systems, such as meningitis, 

hepatitis, cholecystitis, and pancreatitis. Autoimmune disorders are another potential long-term 

complication associated with campylobacteriosis; for example, Guillain-Barré syndrome (GBS).

Everyone is susceptible to infection by C. jejuni. Campylobacteriosis occurs more frequently in 

the summer months than in the winter.

Pathogenic strains of Escherichia coli (E. coli) are responsible for four types of illness: 

gastroenteritis or infantile diarrhea, caused by enteropathogenic E. coli (EPEC); travelers’ 

diarrhea, caused by enterotoxigenic E. coli (ETEC); bacillary dysentery, caused by 

enteroinvasive E. coli (EIEC); and hemorrhagic colitis, caused by enterohemorrhagic E. coli

(EHEC). EHEC is the most severe, with potential for serious consequences such as hemolytic 

uremic syndrome, particularly in young children. An estimated 205,800 foodborne cases from 

all four types of E. coli occur annually in the United States (Scallan et al., 2011). Symptoms vary 

for the different forms of illness, but include abdominal pain, diarrhea, vomiting, fever, chills, 

dehydration, electrolyte imbalance, high body fluid acidity, and general discomfort. Symptoms 

start from 8 hours to 9 days after consumption of contaminated food and last from 6 hours to 19 

days, with both periods varying significantly between the illness types. Everyone is susceptible 

to all forms of infection from E. coli, but EPEC is most commonly associated with infants, and all 

types tend to result in more severe symptoms in the very young and elderly. 

Listeria monocytogenes (L. monocytogenes) is the bacterium responsible for listeriosis. An 

estimated 1,600 foodborne cases of listeriosis occur annually in the United States (Scallan et 

al., 2011). L. monocytogenes produces mild flu-like symptoms in many individuals. However, in 

susceptible individuals, including pregnant women, newborns, and the immunocompromised, it 

can result in more severe symptoms, including septicemia, meningitis, encephalitis, 

spontaneous abortion, and stillbirth. Symptoms start from 3 days to 3 weeks after consumption

of contaminated food. Mortality is high (approximately 25%) in those that display the more 

severe symptoms.

Salmonella spp. is the bacterium responsible for salmonellosis. An estimated 1,029,000 cases 

of foodborne salmonellosis occur annually in the United States (Scallan et al., 2011). Symptoms 

include: nausea, vomiting, abdominal cramps, diarrhea, fever, and headache. Symptoms start 

from 6 hours to 2 days after consumption of contaminated food and generally last from 4 to 7

days. The most severe form, typhoid fever, is caused by Salmonella Typhi. Everyone is 

susceptible to infection by Salmonella spp., but symptoms are most severe in the elderly, 

infants, and the infirmed. Infections by Salmonella spp. and other closely related bacterial 

pathogens, such as Shigella spp., E. coli, and Yersinia enterocolitica, can lead to chronic 

reactive arthritic symptoms in pre-disposed individuals.

Shigella spp. is the bacterium responsible for shigellosis. Shigella infections may be acquired 

from eating contaminated food. Foods may become contaminated by infected food handlers 

who do not wash their hands before handling food. An estimated 131,000 foodborne cases of 

shigellosis occur annually in the United States (Scallan et al., 2011). Symptoms include: 

abdominal pain; cramps; diarrhea; fever; vomiting; blood, pus, or mucus in stools; continuous or 

frequent urges for bowel movement; and death. Symptoms start from 12 hours to 2 days after 

consumption of contaminated food and last from 1 to 2 weeks. Everyone is susceptible to 

infection by Shigella spp.

Staphylococcus aureus (S. aureus) is a common bacterium found on the skin and in the 

noses of many healthy people and animals. The bacterium is responsible for producing toxins 

as it grows in foods, causing staphylococcal food poisoning. An estimated 241,000 foodborne 
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cases of staphylococcal food poisoning occur annually in the United States (Scallan et al., 

2011). Symptoms include: nausea, vomiting, diarrhea, abdominal pain, and weakness. 

Staphylococcal toxins are fast acting and can cause illness in as little as 30 minutes. Symptoms 

usually start within one to six hours after eating contaminated food. Everyone is susceptible to 

intoxication by S. aureus toxin, with more severe symptoms, including occasional death, 

occurring in infants, the elderly and debilitated persons. 

3.3.2 Characteristics of Spore-Forming Foodborne Pathogens 

Table 3-A in Appendix 3 contains information on the conditions that will limit growth for most of 

the spore-forming pathogens that are of greatest concern in food processing. Data shown are 

the minimum or maximum values – i.e., the extreme limits reported among the references cited. 

These values may have been obtained in laboratory media, which may be more favorable to 

growth than many foods. These values may not apply to your processing conditions.

Bacillus cereus (B. cereus) is the bacterium responsible for B. cereus food poisoning. An 

estimated 63,400 foodborne cases of B. cereus food poisoning occur annually in the United 

States (Scallan et al., 2011). There are two forms of illness, associated with two different toxins.

In one form of illness, B. cereus produces an emetic toxin in the contaminated food; the emetic 

toxin causes nausea and vomiting, starting from 30 minutes to 6 hours after consumption of the 

food. In the other form of illness, associated with an infection due to high numbers of B. cereus

in the contaminated food, B. cereus produces a diarrheal toxin in the intestines of the affected 

consumer after the consumer ingests food; the diarrheal toxin causes diarrhea, starting from 6 

to 15 hours after consumption. Symptoms in both forms of illness last about 24 hours. Everyone 

is susceptible to B. cereus food poisoning.

Clostridium botulinum (C. botulinum) toxin is the toxin responsible for a severe paralytic 

illness called botulism. C. botulinum is found in soil and grows best in low oxygen conditions. 

The bacteria form spores that can survive in a dormant state until exposed to conditions that 

support their germination and growth, such as in inadequately processed low-acid canned 

foods. Foodborne botulism is caused by eating foods that contain the botulinum toxin, which is 

formed during growth of C. botulinum. There are seven types of botulism toxin designated by 

letters A through G; only types A, B, E and F have caused botulism in humans. An estimated 55

foodborne cases of botulism occur annually in the United States (Scallan et al., 2011). 

Symptoms include: weakness; vertigo; double vision; difficulty in speaking, swallowing, and 

breathing; abdominal swelling; constipation; paralysis; and, possibly, death. Symptoms start 

from 18 to 36 hours after eating a contaminated food, but can occur as early as 6 hours or as 

late as 10 days after exposure. Everyone is susceptible to intoxication by C. botulinum toxin; 

only a few micrograms of the toxin can cause illness. Mortality is high; without the antitoxin and 

respiratory support, death is likely. 

Clostridium perfringens (C. perfringens) is the bacterium responsible for perfringens food 

poisoning. C. perfringens causes illness when large numbers of the bacteria are consumed in

contaminated food. The bacterium then produces enough toxin in the intestines to cause illness. 

C. perfringens spores can survive high temperatures. During cooling and holding of food at 

warm temperatures, the spores germinate and the resulting vegetative cells of the bacteria 

grow. An estimated 966,000 foodborne cases of perfringens food poisoning occur annually in 

the United States (Scallan et al., 2011). Symptoms include: abdominal cramps and diarrhea. 

Symptoms typically start from 8 to 12 hours after eating a contaminated food, but can occur as 

early as 6 hours after exposure and last for about a day. Everyone is susceptible to perfringens 
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food poisoning, but it is more common in the young and elderly, who may experience more 

severe symptoms lasting for one to two weeks.

3.3.3 Potential Ingredient-Related Biological Hazards 

See Table 3-2 in this chapter and Tables 1A through 1Q in Appendix 1 of this guidance for 

information that can help you identify potential ingredient-related biological hazards that may be 

associated with specific food products. See Chapter 4 – Preventive Controls, as well as 

Chapters 6 through 13, for recommendations on control of some specific ingredient-related 

biological hazards. 

3.3.4 Potential Process-Related Biological Hazards

The purpose of this section is to help you identify potential process-related biological hazards 

for the foods that you produce. See Chapter 4 – Preventive Controls, as well as Chapters 6 

through 13, for recommendations on control of some specific process-related biological 

hazards.

Some process-related biological hazards can occur if something goes wrong with a process 

control. For example, pathogens that you intend to control by cooking could survive if your 

product is undercooked during application of a heat treatment; pathogens that you intend to 

control by refrigeration could multiply and/or produce toxin if there is a lack of proper 

refrigerated holding during product assembly; and pathogens that you intend to control by aw

could multiply and/or produce toxin if the product is not properly formulated (e.g., too little sugar 

is used, resulting in an increase in the aw). Other process-related biological hazards are not 

related to something going wrong with a process control. For example, if you plan to use 

reduced oxygen packaging (ROP) to prevent the growth of spoilage organisms and extend the 

shelf life of the product, the extended shelf life provides more time for toxin production or 

pathogen growth if pathogens are present and temperatures are suitable for growth. As another 

example, if you manufacture a product by adding spices after a process control that would 

significantly minimize pathogens, pathogens in the added spices could introduce pathogens to 

the treated product. As yet another example, pathogens could be introduced to a treated 

product after packaging if there is a lack of container integrity.

In the following sections on process-related biological hazards, we describe examples of these 

kinds of process-related biological hazards.

3.3.4.1 Bacterial pathogens (vegetative and sporeforming) that survive 

after treatment 

If a process that you design to kill bacterial pathogens and/or their spores does not work as 

intended, the bacterial pathogens and/or their spores that you intended to control can be 

present in your food product. The primary pathogens of concern are L. monocytogenes, 

Salmonella spp., S. aureus and C. jejuni, pathogenic strains of E. coli, Yersinia enterocolitica (Y. 

enterocolitica), B. cereus C. perfringens, and C. botulinum. See Appendix 3 of this guidance for 

limiting conditions for growth of bacterial pathogens. 

See Chapter 4 of this guidance for an overview of recognized and established processing 

conditions to control pathogens and for factors to consider when designing your process to 

prevent problems. For example:
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• Some foods heat faster than others. Bacterial pathogens in the cold spot of the food will be 

inactivated more slowly than those at the surface because those in the cold spot are 

subjected to less heat. If the minimum process for lethality is not achieved at the cold spot, 

pathogens may survive the treatment.

• Certain characteristics of food make it either easier or harder to destroy bacterial pathogens, 

if present. For example, pathogens are more easily destroyed in foods with an acidic pH; 

sugars and oils tend to shield pathogens from the effects of heat; and the presence of 

moisture, both in and surrounding the food, make destruction easier. If these have not been 

taken into account in designing the process, pathogens may survive the treatment.

• Spores of bacterial pathogens are more heat tolerant than the vegetative cells of the same 

pathogen and different bacterial pathogens have different heat resistances (see Appendix 3 

of this guidance). If the process is not designed to control the most resistant pathogen of 

concern in the food, pathogens may survive the treatment.

See also Chapter 6 – Use of Heat Treatments as a Preventive Control for more detailed 

recommendations to control process-related biological hazards through heat treatments.

3.3.4.2 Bacterial pathogens that grow and/or produce toxin

3.3.4.2.1 Due to lack of proper time/temperature control

Bacterial pathogens that are introduced from contaminated ingredients into a product that does 

not undergo a lethality process, or that survive a lethality process as a result of a problem with a 

process control, can multiply (“grow”) and, depending on the pathogen, produce toxin as a result 

of time and temperature abuse of food products. Certain bacterial pathogens (e.g., E. coli

O157:H7, S. aureus, and L. monocytogenes) grow well in time- and temperature-abused food.

Time and temperature abuse occurs when a product is allowed to remain at temperatures 

favorable to bacterial pathogen growth for sufficient time to result in unsafe levels of the 

pathogens or their toxins in the product. Most bacterial pathogens will grow well in cooked foods 

that are temperature-abused if their growth is not otherwise controlled by means such as drying, 

salting, or acidification, because competing bacteria are significantly reduced by the cooking 

process. Uncooked foods that have high water activities and pH, such as batters, which are 

subjected to time/temperature abuse (e.g., using room-temperature batter for several hours), 

can support growth and toxin production by pathogens such as S. aureus. 

Vegetative pathogens may grow in products during processing steps and may be ultimately 

destroyed by a lethal step such as cooking. However, too much bacterial growth before the 

lethal step may render the lethal process inadequate. Moreover, if the time and temperature 

abuse allows production of toxin, such as toxin production from S. aureus in temperatureabused custard pies, this toxin will not be destroyed by a heat step later in the process.

In evaluating the potential for bacterial pathogens to grow and/or produce toxin in your food 

products, you should consider the following factors: 

• The types of pathogenic bacteria that are known or reasonably likely to be present; 

• Whether those pathogens can grow in the food; 

• The infective dose of the pathogenic bacteria;

• The expected initial level of the pathogenic bacteria in the food.
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See Chapter 4 of this guidance for an overview of processing conditions to minimize pathogen 

growth by controlling temperatures to prevent pathogen growth and time of exposure to 

temperatures at which growth can occur. See also Chapter 7 – Use of Time/Temperature 

Control as a Process Control for more detailed recommendations to control process-related 

biological hazards through time/temperature controls. Tables 3-A and 3-B (Appendix 3 of this 

guidance) provide the limiting temperature conditions for growth of vegetative and sporeforming 

bacterial pathogens. 

3.3.4.2.2 Due to lack of proper cooling after heat treatments

Depending upon the food and ingredients, heat treated foods can still possibly have viable 

forms (i.e., spores) of pathogenic bacteria present. Sometimes, vegetative cells that are 

particularly heat tolerant, (like Listeria monocytogenes) survive the cooking process; however, 

this should not be the case if the appropriate target pathogen was selected to be controlled by 

the applied process. More often, it is spores that survive the cooking process if they are present, 

and they begin to germinate when the product temperature begins to drop below 140°F. In 

addition, they will be present in the food during storage. Some spores such as those from 

pathogens such as non-proteolytic C. botulinum and some strains of B. cereus have the ability 

to germinate and grow at refrigeration temperatures, although long times are required. Other 

spores that remain in the food remain dormant until the product is temperature abused. In such 

an event, pathogenic spores that may be present are able to germinate, grow and possibly 

produce toxin due to the fact that most spoilage bacteria have been eliminated by the reduction 

step.

See Chapter 4 of this guidance for an overview of processing conditions to minimize pathogen 

growth by controlling temperatures during cooling after cooking. See also Chapter 7 – Use of 

Time/Temperature Control as a Process Control for more detailed recommendations to control 

process-related biological hazards through time/temperature controls.

3.3.4.2.3 Due to poor formulation control

Products most susceptible to biological hazards due to problems with formulation are RTE 

products that either do not receive a kill step in their process or that receive a kill step for 

vegetative pathogens but not spores and that may require refrigeration for safety during their 

manufacture and shelf life. For this category of products, product formulation can play a 

significant role in significantly minimizing or preventing hazards. For example, a naturally acidic 

product with a pH below 4.6 may rule out C. botulinum as a hazard requiring a preventive 

control, since this pH will prevent spore germination, growth, and toxin production. Formulation 

parameters such as pH, aw, use of preservatives, and oxygen availability, can work in concert to 

establish an ecosystem that is designed to inhibit the growth of the pathogens that may be 

present. If not, just as described for foods that have been time and temperature abused, 

bacterial pathogen growth and toxin formation can result due to this lack of inhibition and 

control.

In determining the potential for a process-related hazard due to poor formulation control, we 

recommend that you know the formulations or ingredient lists of your incoming products, as well 

as the equilibrated pH, titratable acidity, aw, percent moisture, percent sodium and percent

sugar, as appropriate, of the finished combined product. Many of the products susceptible to 

biological hazards due to problems with formulation are made up of multiple ingredients, each 

with their own specific set of formulation parameters. Any one individual component not 

meeting the required formulation criteria to ensure that the designed preventive control system 
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is achieved may result in a food that does not inhibit the growth or toxin formation of a pathogen 

that may be present in the food. 

In determining the potential for a process-related biological hazard due to poor formulation 

control, we also recommend that you consider the interactions that may occur among the 

various products, raw materials, and other ingredients when combined. Layering product 

components of significantly different pH or aw values alters the microenvironments at the 

interfaces of the components. A simple example is an éclair filled with a cream filling. The pH 

and aw at the interface of the pastry and the filling will be affected by the difference between the 

higher pH and lower aw of the pastry and the potentially lower pH and higher moisture content of 

the filling, potentially resulting in an environment favorable to microbial growth. A microorganism 

that is in the filling may not grow due to the pH, but the pH of the pastry may favor growth of a 

microorganism at the interface during the product’s shelf life. Characteristics such as oxygenreduction (redox) potential and the effectiveness of antimicrobials are also likely to differ at 

component interfaces and may impact pathogen survival and growth.

In determining the potential for a process-related hazard due to poor formulation control, we 

also recommend that you consider how the equilibrium pH and aw of the finished product 

compares to that of the individual components. If a finished formulated product is a more 

homogeneous mixture of the components, then the resulting final equilibrium pH and aw may be 

significantly different from that of the individual components. A good example is hummus, which 

is typically made from chick peas (garbanzo beans), which may be rehydrated from a dry state,

blended with acidifying agents, oils and spices and then pureed. The final product with a smooth

texture will have an equilibrium pH, and possibly aw, different from the original ingredients. If a 

topping of pine nuts, or oil, or diced red peppers is added to the top in the container as 

“decoration” then those additions could then significantly change the microenvironment at the 

interface and may require a control (such as acidification).

See Chapter 4 of this guidance for an overview of formulation-based controls. See Chapter 8 –

Use of Formulation as a Preventive Control for more detailed recommendations to control 

process-related biological hazards through product formulation.

3.3.4.2.4 Due to reduced oxygen packaging (ROP)

From a food safety standpoint, packaging serves two functions: (1) It prevents contamination of 

the food; and (2) it makes possible, or extends the effectiveness of, food preservation methods. 

For example, packaging can maintain the atmosphere in a controlled or modified atmosphere 

package or a vacuum package, or it can prevent rehydration of a dried food. All of these 

different packaging methods are grouped into a category that we call ROP. ROP is used to 

prevent the growth of spoilage organisms, thereby extending the shelf life of the product. There 

are some other product quality benefits as well, such as reductions in rancidity, shrinkage, and

color loss.

However, ROP does not control the growth of all bacterial pathogens and can create a processrelated biological hazard. The extended shelf life provides more time for toxin production or 

pathogen growth if pathogens are present and temperatures are suitable for growth. Lower 

oxygen levels favor pathogens that can grow in the absence of oxygen over the aerobic 

spoilage organisms that require oxygen for growth. For this reason, you may get toxin 

production before you get spoilage - something that is less likely to happen in traditional 

packaging.
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The major concern with ROP is C. botulinum, although there may also be concerns with other 

pathogens such as L. monocytogenes, particularly in refrigerated RTE foods. You should not 

use ROP unless barriers for C. botulinum are present. These barriers include: aw below 0.93; 

pH below 4.6; salt above 10%; thermal processing in the final container; and freezing with 

frozen storage and distribution. Each of these barriers by itself can be effective in the control of 

C. botulinum growth. Refrigeration below 38°F (3.33°C) can prevent growth of all strains of C. 

botulinum, but because temperatures above this are commonly employed for refrigeration, 

temperature should not be relied on as the only control. Combinations of barriers that 

individually would not control growth of C. botulinum can work together to prevent growth.

For a further discussion on the potential for ROP to create a process-related biological hazard, 

see Annex 6 of the 2013 Food Code (FDA, 2013b).

3.3.4.3 Bacterial pathogens in ingredients added after process controls 

The manufacture of certain RTE products involves, by design, the addition of ingredients after 

any process controls are applied. For example, the production of some fresh vegetable salad 

kits includes the addition to the final product, prior to packaging, of various ingredients such as 

nuts, dried berries, and seeds. The process control for the salad components (e.g., chlorine 

wash) is applied to the various fresh cut vegetables that are mixed in preparation for packaging, 

while the nuts, berries, and seeds are added just prior to packaging. As another example, the 

production of some fresh-baked pastry products includes the addition of toppings, such as 

frostings, nuts, dried fruit, confections (e.g., sprinkles). A facility that produces products 

containing ingredients added after a process control should consider the potential for the added 

components to be a process-related biological hazard as part of its hazard analysis.

3.3.4.4 Bacterial pathogens introduced after packaging due to lack of 

container integrity

Food manufactured and processed (e.g., heat treated) in a container and/or clean-filled after 

treatment can become contaminated if its container forms a leak or loses seal integrity, thereby 

exposing the processed food to a variety of biological hazards. The primary pathogens of 

concern include C. botulinum, L. monocytogenes, pathogenic strains of E. coli, Salmonella spp., 

S. aureus, and B. cereus.

The primary causes of recontamination of foods after a process control step and packaging are 

defective container closures and contaminated cooling water. Poorly formed or defective 

container closures can increase the risk of bacterial pathogens entering the container through 

container handling that occurs after the product has been filled and the container has been 

sealed. This risk is a particular concern during container cooling performed in a water bath. As 

the product cools, a vacuum is drawn in the container. Contaminated cooling water can enter 

through the container closure, especially if the closure is defective. 

3.3.5 Potential Facility-Related Biological Hazards

Foodborne illnesses due to commercially produced foods have been traced to post-process 

contamination due to the poor implementation of CGMPs, such as by exposure or contact with 

contaminated equipment during processing such as conveying, holding, chilling or packaging. 

Examples of events and foodborne illness outbreaks due to contamination of RTE foods are 

quite extensive and readily available in scientific literature. Typically in these events, foods that 

were processed by some means (e.g., cooked, pasteurized, dried) to reduce the presence of 
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microorganisms, in particular pathogens identified as hazards requiring a preventive control, 

were subsequently exposed to the environment where they were recontaminated with 

pathogens. As discussed in the following sections on facility-related biological hazards, there 

are challenges to prevent this from happening.

Table 3-3 provides a list of examples, adapted in part from ICMSF Book 7, Chapter 11 (ICMSF, 

2002) and from FDA documents that highlight the public health impact of contamination of RTE 

foods with environmental pathogens.

Table 3-3. Examples of Pathogens Identified from Outbreaks Attributed to Contamination 

with Environmental Pathogens 

Product Environmental 

Pathogen Details Reference

Chocolate S. Napoli Possibly contaminated water used 

in double-walled pipes, tanks and 

other equipment

Gill, et. al. (1983)

Chocolate S. Eastbourne From processing environment Craven, et. al.

(1975)

Butter (from 

pasteurized cream)

L. monocytogenes From processing environment Lyytikainen et. al.

(2000)

Peanut butter S. Tennessee From processing environment FDA (2007a, 

2007b)

Peanut butter Salmonella spp. From processing environment Cavallaro et al. 

(2011); FDA 

(2009b, 2009c)

Whole white pepper S. Rissen From processing environment FDA (2009d)

Cantaloupes L. monocytogenes From processing environment FDA (2012a)

Peanut butter S. Bredeney From processing environment FDA (2012b)

Soft cheeses (from 

pasteurized milk)

L. monocytogenes From processing environment FDA (2013c)

Soft cheese (from 

pasteurized milk)

L. monocytogenes From processing environment FDA (2014a)

The PCHF requirements specify that your hazard evaluation must include an evaluation of 

environmental pathogens whenever a ready-to-eat food is exposed to the environment prior to

packaging and the packaged food does not receive a treatment or otherwise include a control 

measure (such as a formulation lethal to the pathogen) that would significantly minimize the

pathogen. (See 21 CFR 117.130(c)(1)(ii).) Effectively designed and implemented CGMPs are 

key to keeping biological hazards out of your food products. However, experience has shown 

that application of CGMPs – even in combination with a HACCP plan - cannot guarantee that 
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contamination of a processed food from the environment will not occur. This is one reason why 

the PCHF requirements specify that sanitation controls include procedures, practices, and 

processes to ensure that the facility is maintained in a sanitary condition adequate to 

significantly minimize or prevent hazards such as environmental pathogens (21 CFR 

117.135(c)(3)). In addition, the PCHF requirements specify that, as appropriate to the facility, 

the food, and the nature of the preventive control and its role in the facility’s food safety system, 

you must conduct activities that include environmental monitoring, for an environmental 

pathogen or for an appropriate indicator organism, if contamination of an RTE food with an 

environmental pathogen is a hazard requiring a preventive control, by collecting and testing 

environmental samples.

In the following sections, we provide information to help you determine whether an 

environmental pathogen is a hazard requiring a preventive control in your facility. Although 

Table 3-3 includes some examples of outbreaks of foodborne illness caused by facility-related 

biological hazards other than environmental pathogens, we do not discuss those other facilityrelated biological hazards in this chapter.

3.3.5.1 Sources of facility-related biological hazards

The likelihood of product contamination with a facility-related environmental pathogen increases 

as the prevalence of the environmental pathogens in the processing environment increases. 

The prevalence of the environmental pathogens in the processing environment can be 

influenced by the raw materials used in the process, the type of process, and the hygienic 

practices applied to keep to keep the processing area clean and hygienic. Table 3-4 is a quick 

reference guide to help you identify some of the most common sources for facility-related 

hazards that can contaminate the food processing environment; Table 3-4 does not provide an 

exhaustive list of such pathogens.

Table 3-4. Quick Reference Guide for Common Sources of Facility-Related Biological 

Hazards

Source Examples

Raw agricultural commodities • Raw milk

• Cocoa beans

• Fruits and vegetables

• Nuts

• Unprocessed spices

Food handlers and maintenance 

personnel

• Transfer of biological hazards from one point to another 

on, for example, shoes and other clothing

• Improper hand washing 

• Transfer of biological hazards to foods through improper 

handling or maintenance practices

Air and water • Lack of appropriate air filtration for cooling, drying, air 

conveying

• Improper air flow from “raw” to RTE areas

• Aerosols from improper cleaning practices

Insects and pests • Flies

• Cockroaches

• Rodents
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Source Examples

Transport equipment • Forklifts

• Trolleys

• Racks 

• Carts

With these varied sources for potential contamination, it is easy to understand how a failure of 

one or more steps in your CGMPs can lead to contamination of the processing environment 

and, ultimately, your food products with facility-related biological hazards.

3.3.5.2 Transient vs. resident facility-related environmental pathogens

Once bacterial pathogens have been introduced into the processing environment, experience 

has shown that pathogens may be present as “transient” contamination or “resident” 

contamination within the facility.

3.3.5.2.1 Transient contamination 

Bacterial pathogens, including environmental pathogens, are typically introduced into the 

processing facility through, for example, incoming raw materials, personnel, or pests. It is 

important to ensure that these microorganisms remain transient and do not become established 

in the environment where they can grow and multiply. Transient contaminants can, however, 

result in a diversity of pathogens in the processing environment that can show up in the 

processing lines and finished product. This phenomenon is typical for food operations using a 

wide variety of ingredients, in particular raw commodities, because these materials can contain 

very diverse microflora. Generally though, the proper application of cleaning and sanitizing in 

accordance with CGMPs is adequate to control the transient bacteria in the processing facility. 

So, contamination detected from day-to-day may be found to be quite diverse.

3.3.5.2.2 Resident contamination

Bacterial pathogens causing resident contamination can also be introduced into the processing 

facility, where the pathogens then become established in a harborage site, multiply, and persist 

for extended periods of time, even years. A harborage site, or niche, is a site in the environment 

or on equipment (e.g., junctions, cracks, holes, and dead-end areas) that enables the 

accumulation of residues (food debris, dust, and water) and permits the growth of 

microorganisms such as L. monocytogenes and Salmonella. These sites may be difficult to 

inspect or access and therefore can protect environmental pathogens during routine cleaning 

and sanitizing. Thus, while common cleaning and sanitation practices are adequate to control 

the presence of transient contaminants, such practices do not control the presence of resident 

contaminants once they have become established. Sanitation controls, including proper 

personnel practices and equipment and facility design, are key to preventing transient bacterial 

pathogens from becoming resident strains. Once an environmental pathogen has become 

established as a “resident strain,” there is a persistent contamination risk for foods processed in 

that facility. The facility will need to use intensified sanitation procedures to eliminate the 

contamination. Of all the bacterial pathogens, Salmonella and L. monocytogenes have the most 

extensive history of being able to set up residence in a processing facility. Although not as likely, 

the potential exists for the other pathogens discussed previously in this chapter to become 

established as resident contaminants. 
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Key determinants for the pathogens to become established in a food processing environment 

are: 1) The temperature at which the food processing environment is maintained; 2) the

available moisture in the food processing environment; and 3) the availability of nutrients for 

growth. For processed foods, this typically translates into two primary categories of food 

processing environments by the nature of the products that are manufactured and packaged in 

a facility:

• Frozen/refrigerated and wet 

• Warm/ambient and dry

In both cases, proper cleaning is needed to minimize nutrient availability. The pathogen most 

often associated with cold and wet processing environments is L. monocytogenes, and the 

pathogen most often associated with warm and dry processing environments is Salmonella

(Scott et. al., 2009; ICMSF, 2005).

3.3.5.3 Facility-related environmental pathogens associated with wet vs. 

dry processing environments 

Food processing operations can typically be classified into one of two simple categories – wet 

processing environments or dry processing environments (Table 3-5). This very simple 

distinction has significant implications for the strategy that must be applied to control food 

contamination from environmental pathogens. 

Table 3-5. Some Examples of Foods Processed in Wet and Dry Processing 

Environments

Processing Environment 

Conditions

Examples of Foods

Wet • Ice Cream

• Refrigerated Dairy Products

• Refrigerated Deli Salads

• Refrigerated and Frozen Meals

• Refrigerated Beverages (non-juice)

Dry • Chocolate and Confections

• Milk Powders

• Baked Goods

• Dehydrated Soups

• Powdered Beverages

• Nut/nut products

3.3.5.3.1 Wet process environments

The most effective strategy to prevent the contamination of finished products with L. 

monocytogenes is to maintain an environment as dry as possible. Wet environments have some 

very obvious characteristics that lead to problems with contamination by L. monocytogenes, 

such as:
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• Wet floors due to constant wet cleaning will facilitate the transfer of Listeria spp., including L. 

monocytogenes, from an environmental source to food contact surfaces;

• Wet floors can create harborage sites if they are not well maintained and have 

broken/cracked grout or tiles. These structures may provide protected harborage to 

environmental pathogens even when the floors are cleaned and sanitized.

• Condensation on overhead structures as a result of air temperature and humidity control 

issues and from use of water in cooking and cooling operations creates a means of transfer 

of Listeria spp., including L. monocytogenes, from non-food-contact surfaces to exposed 

product and equipment food-contact surfaces. 

• Frost formation due to condensation at freezer entry and exit points provides an opportunity 

for moisture accumulation and a constant source of water for Listeria spp. to multiply.

• Inadequate sanitation practices on floor freezer and cooler units may provide the moisture to 

support Listeria spp., including L. monocytogenes, if water sources are not properly 

plumbed to hygienically designed drains.

Wet floors can serve as vectors for spreading Listeria spp. via the movement of people and 

equipment and material handling items such as totes and pallets. Wet floors can also serve as 

vectors for pathogen transfer when personnel walk through standing water on poorly designed 

floors and drains and during cleaning. L. monocytogenes does not spread alone through the air; 

however, in wet environments, aerosols from high pressure water hoses used during cleaning 

operations help spread L. monocytogenes throughout the environment and from one surface 

(e.g., floors) to another surface (e.g., food contact surfaces, such as conveyors, tables, and 

product containers). In many facilities, certain processing operations are inherently wet, such as 

product debagging, raw material preparation, mixing and formulation of liquid product 

components, cooking, and blanching. In these cases, the best that can be done is to control the 

personnel, equipment traffic, and cleaning practices that are involved with the specific operation. 

The intent is to minimize water accumulation and aerosol formation to prevent in-process and 

finished product recontamination.

We recommend that wet processing areas be dried out as much as possible. This continues to 

be an ongoing challenge for the food industry that has for many years depended upon the 

unlimited use of water for equipment and facility cleaning practices.

3.3.5.3.2 Dry process environments

Moisture control is critically important in preventing Salmonella contamination in low-moisture 

products (ICMSF, 2005). Water in the dry processing environment is one of the most significant 

risk factors (perhaps the single most important factor) for Salmonella contamination, because

water allows for pathogen growth, significantly increasing the risk for product contamination. 

Water, present even in very small amounts for short, sporadic time periods, may allow 

Salmonella to grow in the environment. At times, moisture is obvious in the form of water 

droplets or puddles from wet cleaning or from other not-so-apparent sources such as high 

relative humidity or moisture accumulating inside of equipment. 

Salmonella can, to varying degrees, be introduced into low-moisture product manufacturing 

facilities and become established in those environments. Harborage sites may develop and 

become a source of product contamination, unless the sites are identified and eliminated (CAC, 

2008). 
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Growth of Salmonella is only possible in the presence of water. Because food particles and dust 

are normally expected to be present in processing areas, adequate nutrients are always 

available to microorganisms. Growth cannot occur, however, if the plant environment is 

sufficiently dry. The potential Salmonella harborage sites become more important when water is 

present for a sufficient period of time. The presence of water in the dry processing environment 

can result from improper use of water during cleaning, which has been linked to the occurrence 

and spread of Salmonella (CAC, 2008). Other events resulting in the presence of water in a dry 

area include condensate formation, leaking water or steam valves, infiltration of water following 

heavy rains (e.g., leaky roofs) and the use of water showers in the case of fire emergencies. 

(CAC, 2008). We recommend that you remove water immediately from the primary Salmonellacontrolled hygiene areas (areas where RTE food is exposed to the environment) following such 

events in order to keep the plant environment as dry as possible. 

You should maintain dry conditions at all times in primary Salmonella-controlled hygiene areas, 

except for the occasions when you have determined that controlled wet cleaning is necessary. 

Potential problems arise when there is visible water present in the dry areas or when there are 

areas in which standing water has dried out. Salmonella may be found both in wet spots and in 

spots where standing water has dried (Zink, 2007). The latter situation may present an 

additional risk of spread via the generation of airborne contaminated dust.

3.4 Chemical Hazards

You must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable 

chemical hazards. See 21 CFR 117.130(b)(1)(ii). When your hazard analysis identifies a known 

or reasonably foreseeable chemical hazard that requires a preventive control, you must identify 

and implement a preventive control for the chemical hazard. See 21 CFR 117.135(a)(1).

The chemical hazards that are the focus of this section of this chapter include ingredient-related 

chemical hazards (i.e., pesticide and drug residues, heavy metals, environmental contaminants,

histamine due to decomposition, natural toxins (e.g., mycotoxins), radiological hazards, 

unapproved food and color additives, food allergens, and substances associated with a food 

intolerance or food disorder) and process-related chemical hazards (i.e., food allergens, 

substances introduced by misformulation and the introduction of industrial chemicals or other 

contaminants from the food processing environment). 

Food products can become contaminated with chemical hazards that are introduced at any 

stage in food production and processing. Some ingredient-related chemical hazards are natural 

components of food, such as food allergens, or are produced in the natural environment, such 

as mycotoxins, whereas other ingredient-related hazards (e.g., pesticides, drug residues, heavy 

metals, environmental contaminants) are contaminants of raw materials and other ingredients. 

Some process-related chemical hazards may be included in product formulation (e.g., sulfites 

that are a hazard for those consumers who are sensitive to them), whereas other processrelated chemical hazards may be unintentionally introduced into food, such as industrial 

chemicals that are used in a facility for purposes other than food production. Process 

contaminants may also form during heating (e.g., acrylamide).

2

 For further details on the 

 2 Some processing contaminants are formed during the heating of certain ingredients or finished foods 

(e.g., acrylamide). We have not included such contaminants in Table 3-6 as potential process-related 

chemical hazards that may require a preventive control as part of a food safety plan under part 117 

because we believe that more information is needed regarding appropriate levels and effective controls. 

As stated in our “Guidance for Industry: Acrylamide in Foods” (FDA, 2016a), we recommend that 
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sources of ingredient-related and process-related chemical hazards, see Tables 2A through 2Q 

and Tables 3A through 3Q of Appendix 1 of this guidance.

A chemical hazard may cause immediate effects, or may be associated with potential long-term 

effects after chronic exposure to the chemical. One example of an immediate effect is 

gastrointestinal illness such as nausea, which can be caused by elevated levels of industrial 

chemicals (such as caustic cleaning compounds). Caustic cleaning compounds can also cause 

burning of the mouth and esophagus. Ammonia in food contaminated by a refrigerant leak has 

caused gastrointestinal illness (stomachache and nausea) and headaches (Dworkin, et al. 

2004). Sulfites have resulted in diarrhea, headache, difficulty breathing, vomiting, nausea, 

abdominal pain and cramps in sulfite-sensitive individuals (Timbo et al. 2004). Examples of 

long-term effects include impaired cognitive development in children chronically exposed to 

relatively low levels of lead (e.g., in contaminated candy) (FDA, 2006a) and liver cancer

resulting from chronic exposure to the mycotoxin, aflatoxin (Williams et. al, 2004 and Shephard, 

2008).

FDA has set action levels and tolerances for some contaminants (FDA, 2015f). They represent 

limits at or above which FDA will take legal action to remove products from the market. Where 

no established action level or tolerance exists, FDA may take legal action against the product at 

the minimal detectable level of the contaminant. Action levels and tolerances are established 

based on the unavoidability of the poisonous or deleterious substances and do not represent 

permissible levels of contamination where it is avoidable. For example, FDA has established an 

action level of 3 ppm polychlorinated biphenyl (PCB) residues in red meat on a fat basis (FDA, 

1987). FDA also has issued for public comment a draft guidance for industry that would, when 

finalized, establish an action level of 100 ppb for inorganic arsenic in infant rice cereal (FDA 

2016). FDA has established tolerances for polychlorinated biphenyls (PCB's) in foods such as 

milk and other dairy products, poultry, eggs, and infant and junior foods (see 21 CFR 109.30).

Further, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), certain substances, such 

as food additives, color additives, new animal drugs, and pesticides require premarket approval 

before they may be legally used. 

FDA also has issued guidances to provide information to industry on methods to reduce levels 

of specific chemicals in foods. For example, FDA has issued guidance providing information to 

help growers, manufacturers, and food service operators reduce acrylamide levels in certain 

foods (FDA, 2016a). Similarly, the Codex Alimentarius Commission has established a number 

of codes of practice for controlling mycotoxins, heavy metals, and other chemicals in foods 

(CAC, 2012).

Chemical residues in a food are not always considered hazards and their occurrence may be 

unavoidable. Because the particular chemical and its levels in the food determine whether it is a 

hazard, and because mechanisms whereby a chemical hazard can be introduced into a food 

product are both varied and dependent on the nature of the chemical, the preventive controls 

that you identify and implement to control specific chemical hazards should be based on the 

characteristics of those chemicals and the mechanisms whereby they could be introduced into 

your food product. In the following sections on chemical hazards, we describe some common 

preventive controls for controlling chemical hazards. For additional information on the control of 

 

manufacturers evaluate approaches to acrylamide reduction that may be relevant to their particular 

processes and consider adopting approaches, if feasible, that reduce acrylamide levels in their products.
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chemical hazards, see Chapter 4 – Preventive Controls and Chapter 12 – Preventive Controls 

for Chemical Hazards.

In the remainder of this section on chemical hazards, we briefly describe characteristics of some 

chemical hazards that are of concern in foods and processing environments, including 

mechanisms whereby they can be introduced into a food product. We do not discuss seafood 

toxins in this guidance because seafood is exempt from the PCHF requirements; for a 

discussion of seafood toxins see our Fish and Fishery Products Hazards and Controls Guidance 

(FDA, 2011). 

Table 3-6 is a quick reference guide to help you identify some of the most common sources of 

chemical hazards; Table 3-6 does not provide an exhaustive list of such hazards

Table 3-6. Quick Reference Guide for Common Sources of Chemical Hazards

Source Examples

Ingredient-related chemical hazards • Pesticide residues on produce raw agricultural 

commodities

• Drug residues in milk

• Heavy metals in or on produce raw agricultural 

commodities

• Environmental contaminants (e.g., dioxins)

• Mycotoxins in grains

• Histamine in some aged cheeses

• Radiological hazards in foods from areas after a nuclear 

accident

• Unapproved food or color additives

• Food allergens and substances associated with a food 

intolerance or food disorder (e.g., sulfites, gluten)

Process-related chemical hazards • Undeclared food allergens due to mislabeling or crosscontact

• Improper addition of substances associated with a food 

intolerance (e.g., sulfites) 

• Improper use of a color additive such as Yellow No. 5

• Contamination with industrial chemicals such as cleaners 

or sanitizers

• Radiological hazards from use of contaminated water 

supply

Facility-related chemical hazards • Heavy metals due to leaching from equipment, containers,

or utensils 

3.4.1 Ingredient-Related Chemical Hazards

3.4.1.1 Pesticides 

Pesticide residues may be of concern in food crops and in foods of animal origin (as a result of 

pesticide residues in animal food). The term pesticide is used for products such as insecticides, 

fungicides, rodenticides, insect repellants, herbicides or weed killers, and some antimicrobials 

that are designed to prevent, destroy, repel, or reduce all types of pests (See EPA “Setting 
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Tolerances for Pesticide Residues in Foods”) (EPA, 2015). Three federal government agencies 

share responsibility for the regulation of pesticides. Pesticides that have been registered (i.e., 

approved) with the U.S. Environmental Protection Agency (EPA) may be applied according to 

label directions directly to raw agricultural commodities or food (see 40 CFR 180). For a 

registered pesticide that could potentially result in residues in or on food, the EPA establishes a 

tolerance, which is the maximum amount of residue that is permitted in or on a food. FDA is 

responsible for enforcing pesticide tolerances for foods other than meat, poultry, and certain egg 

products, which are the responsibility of the U.S. Department of Agriculture Food Safety and 

Inspection Service (USDA FSIS) (FDA, 2012d). A detailed description of how FDA enforces 

pesticide residues in animal food is available in CPG Sec. 575.100 Pesticide Residues in Food 

and Feed – Enforcement Criteria (FDA, 2015e). If pesticide residues are present in food in the 

absence of, or in excess of, a tolerance, the food is deemed adulterated under section 

402(a)(2)(B) of the FD&C Act (21 U.S.C. 342(a)(2)(B)). The most common reasons for 

adulteration of food products with pesticide residues are the improper treatment of raw materials 

with registered pesticides, and raw materials being exposed to prohibited pesticides. 

Fruits and vegetables that have been grown in the United States usually are in compliance with 

EPA’s pesticide tolerance regulations. If you obtain produce from a foreign country you should 

take steps to ensure that the imported produce will be in compliance with U.S. pesticide 

tolerance regulations, such as by considering pesticide residues to be chemical hazards that 

warrant preventive controls, such as supply-chain controls with a supplier verification program. 

3.4.1.2 Animal drug residues

Animal drug residues may be of concern for foods of animal origin, including muscle meat, 

organ meat, fat/skin, eggs, honey, and milk. In the United States, animal drugs require approval 

by FDA before they can be administered to food-producing animals. Depending on the 

chemical property of the drug, residues of certain drugs can become concentrated during food 

manufacturing and processing. For example, if a fat-soluble, heat-stable drug residue is present 

in raw milk, the drug can get concentrated when the milk is converted to full fat cheese

(Cerkvenik et al., 2004; Imperiale et al., 2004). Potential effects of drug residues range from 

short-term effects as a result of acute allergic reactions (e.g., penicillin) to long-term effects from 

drug resistant bacteria (Dayan, 1993). An example of an unapproved drug residue that has 

adulterated food is fluoroquinolone, which is an antibiotic that has not been approved for use on 

honey bees in the United States and has been detected in honey products from certain regions 

outside the United States (FDA, 2015a).

Drug residues in a food derived from an animal (such as milk) are considered a hazard if a 

tolerance has not been established for the particular drug-food combination, or if the tolerance 

level has been exceeded. Animal drugs used according to labeled directions should not result in 

residues in meat, poultry, milk, or egg products. When your hazard analysis identifies drug 

residues that require a preventive control, supply-chain controls with a supplier verification 

program could be an appropriate preventive control to manage the potential risk.

3.4.1.3 Heavy metals

Heavy metals, including lead, cadmium, arsenic, and mercury, may be of concern in certain 

foods as a result of agricultural practices (e.g., use of pesticides containing heavy metals or 

because crops are grown in soil containing elevated levels of heavy metals due to industrial 

waste), or the leaching of heavy metals from equipment, containers or utensils that come in 

contact with foods. Consumption of heavy metals in foods can lead to adverse health 
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consequences. For example, lead exposure can impair cognitive development in children (FDA, 

2006a). Consumption of inorganic arsenic has been associated with cancer, skin lesions, 

developmental effects, cardiovascular disease, neurotoxicity, and diabetes in humans (JEFCA, 

2010). 

When your hazard analysis identifies a heavy metal that requires a preventive control, the type 

of control would depend on how the heavy metal could get into your food product. In some 

cases, high levels of heavy metals may result from the environment (e.g., high lead levels in 

carrots that were grown in lead-contaminated soil). If your food product contains a food crop that 

is known to have been contaminated with a heavy metal through contaminated soil, a preventive 

control such as a supply-chain control with a verification program to ensure that the grower 

conducts an assessment of the growing region prior to its use for agriculture may be 

appropriate. In other cases, an unsafe level of a heavy metal such as lead could be introduced 

into a food product as a result of a food-contact surface constructed with lead solder. CGMP 

controls, such as the controls on equipment and utensils in 21 CFR 117.40, generally can 

control chemical hazards such as heavy metals that can leach from food-contact surfaces. 

3.4.1.4 Environmental contaminants 

Environmental contaminants may be of concern in certain foods as a result of their presence in 

the environment. When your hazard analysis identifies an environmental contaminant that 

requires a preventive control, the type of control would depend on how the environmental 

contaminant could get into your food product. In some cases, high levels of environmental 

contaminants (e.g., dioxin) may result from accidental contamination of animal feed (WHO, 

2014). In 2008, pork meat and pork products were recalled in Ireland when up to 200 times the 

safe limit of dioxins were detected in samples of pork, although risk assessments indicated no 

public health concern. The contamination was traced back to contaminated feed. In 1999, high 

levels of dioxins were found in poultry and eggs from Belgium and in several other countries. 

The cause was traced to animal feed contaminated with illegally disposed PCB-based waste 

industrial oil. Because dioxins tend to accumulate in the fat of food-producing animals, 

consumption of animal-derived foods (e.g., meat, poultry, eggs, fish, and dairy products) is 

considered to be the major route of human exposure, and FDA has developed a strategy for 

monitoring, method development, and reducing human exposure (FDA, 2002). 

3.4.1.5 Mycotoxins and other natural toxins

Natural toxins, such as mycotoxins, histamines and other biogenic amines, and plant-produced 

substances (such as the toxin hypoglycin A found in the tropical fruit ackee) are well recognized 

as hazards in raw or processed agricultural commodities (FDA, 2005a; FDA 2005b; FDA, 

2005c; FDA, 2005d).

Mycotoxins are a common group of natural toxins that include aflatoxin, fumonisin, 

deoxynivalenol (vomitoxin), ochratoxin, and patulin (see Table 3-7). 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. Mycotoxins may produce various toxicological effects. Some mycotoxins are 

teratogenic, mutagenic, or carcinogenic in susceptible animal species and are associated with 

various diseases in domestic animals, livestock, and humans in many parts of the world. The 

occurrence of mycotoxins in human and animal foods is not entirely avoidable; small amounts of 

these toxins may be found on agricultural commodities. Occurrence of these toxins on 

commodities susceptible to mold infestation is influenced by environmental factors such as 
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temperature, humidity, and the extent of rainfall during the pre-harvesting, harvesting, and postharvesting periods. The molds that produce mycotoxins typically grow and become established 

in the agricultural commodity during stressful growing and holding conditions, such as insect 

damage to the crop, drought stress, and wet storage (e.g., from condensation). Although 

mycotoxins are not a hazard requiring a preventive control during times and locations with good 

growing and harvest conditions, a preventive control such as supply-chain controls with a 

supplier verification program may be appropriate if you use agricultural commodities susceptible 

to mycotoxin formation, because growing and harvest conditions vary from year to year. 

Table 3-7 Common Mycotoxins Associated with Commodities

Mycotoxins Commodities Associated with Mycotoxins

Aflatoxin Peanuts, dried corn, tree nuts

Ochratoxin Coffee, raisins, cereal grains

Fumonisins Dried corn

Deoxynivalenol Wheat, barley

Patulin Apples

Histamines and other biogenic amines are produced from the breakdown of amino acids by 

bacteria in animal-derived foods (e.g., histamine is produced from the amino acid histidine). 

Effects of foodborne histamines or other biogenic amines generally are acute effects, including 

headache, nausea, heart palpitations, facial flushing, itching, urticaria (hives), and 

gastrointestinal upset. Consumption of certain cheeses, especially aged cheeses, has been 

associated with illness from histamines (Taylor and WHO, 1985; Stratton et. al, 1991). If you 

determine that cheeses you use as a raw material present a histamine hazard, you must identify 

and implement a preventive control (see 21 CFR 117.135(a)). If you purchase such cheeses, 

we recommend a supply-chain control with a supplier verification program as well as 

temperature controls to minimize growth of histamine-producing microorganisms. 

An example of a natural toxin produced by a plant is hypoglycin A, a heat stable toxin found in 

the tropical fruit ackee. The level of hypoglycin A in the edible portion of the ackee fruit 

decreases as the fruit ripens. Only properly ripened and processed ackee products with 

hypoglycin A at negligible levels are safe for consumption (FDA, 2015f). Although some persons 

consume unripe ackee with no adverse effects, other persons who consume unripe ackee with 

hypoglycin A exhibit symptoms that range from mild (e.g., vomiting) to severe (e.g., vomiting 

with profound hypoglycemia, drowsiness, muscular exhaustion, and possibly coma and death). 

3.4.1.6 Chemical hazards that may be intentionally introduced for 

purposes of economic gain 

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)). We recommend that you focus on circumstances 

where there has been a pattern of such adulteration in the past, suggesting a potential for 
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intentional adulteration even though the past occurrences may not be associated with the 

specific supplier or the specific food product. Table 3-8 is a quick reference guide listing 

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

resources include a free on-line food fraud database made available by the U.S. Pharmacopeial 

Convention (USP)3 (USP, 2014 and USP, 2016), a report from the Congressional Research 

Service (Congressional Research Service, 2014), and a report that identifies 137 unique 

incidents in 11 food categories (Everstine et al., 2013).

Table 3-8. Quick Reference Guide for Hazards That May Be Intentionally Introduced for 

Purposes of Economic Gain

Food Containing the 

Hazard Hazard Details Reference

Milk Melamine Milk firms in one country added 

melamine, a nitrogen-rich industrial 

by-product, to diluted dairy 

products to increase the apparent 

protein content

FDA, 2008

Turmeric Lead chromate A chemical with a vibrant yellow 

color that has been used as an 

adulterant in turmeric to change 

the color of the spice to suggest 

that it is of a higher quality

FDA, 2013d

Paprika Lead oxide A red chemical that has been used 

as an adulterant in paprika to 

change the color of the spice to 

suggest that it is of a higher quality

Lead Action 

News, 1995

Chili powder Sudan I An orange-red powder that had 

been added to chili powder as a 

coloring agent, but is now banned 

in many countries because the 

International Agency for Research 

on Cancer has classified it as a 

category 3 carcinogen (not 

classifiable as to its carcinogenicity 

to humans)

United Kingdom 

Food Standards 

Agency, 2005

In determining whether a hazard that may be intentionally introduced for purposes of economic 

gain is a hazard requiring a preventive control, we recommend that your hazard analysis 

consider both the country of origin of an ingredient that may contain the hazard and any specific 

supplier associated with an ingredient containing that hazard. For example, one example listed 

 3 USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity 

of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed 

worldwide. 
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in Table 3-8 is a widespread incident of economically motivated adulteration in which some milk 

firms in one country added melamine, a nitrogen-rich industrial by-product, to diluted dairy 

products to increase the apparent protein content (FDA, 2008). This adulteration resulted in 

significant public health consequences, with more than 290,000 ill infants and 6 deaths in that 

country. In light of this incident, we recommend that you include in your hazard analysis the 

potential for melamine to be an economically motivated adulterant in your food products when 

using milk products from a country where melamine adulteration has occurred and, based on 

the outcome of that hazard analysis, determine whether melamine is a hazard that must be 

addressed in your food safety plan. At present, we do not expect you to consider the potential 

for melamine to be a significant hazard when using domestic milk products, or milk products 

from other countries when there is no history of melamine adulteration associated with those 

countries.

If you determine through your hazard analysis that a hazard that may be intentionally introduced 

for purposes of economic gain is a hazard requiring a preventive control, we recommend that 

you address that hazard through your supply-chain program. 

3.4.2 Chemical Hazards That Can Be Either Ingredient-Related or ProcessRelated 

3.4.2.1 Food allergens

Researchers estimate that up to 15 million Americans and more than 17 million Europeans have 

food allergies (FARE, 2015). A number of foods contain allergenic proteins, which are natural 

constituents of the food that can pose a health risk to certain sensitive individuals. The 

symptoms of food allergies can include a tingling sensation in the mouth, swelling of the tongue 

and throat, nausea, difficulty in breathing, chest pain, hives, rash, itchy skin, vomiting, 

abdominal cramps, diarrhea, sudden drop in blood pressure, loss of consciousness, and, in 

severe cases, death. Symptoms of a food allergy usually come on suddenly, can be triggered by 

a small amount of food, and happen every time the food is eaten. The symptoms are the result 

of the body’s immune system reacting to a specific food or an ingredient in the food. 

Allergic consumers must avoid allergens to prevent potentially life threatening reactions. 

Undeclared food allergens are chemical hazards that can get into food because either: (1) The 

food manufacturer did not properly declare a food allergen ingredient on the product label; or (2) 

unintended (and, thus, undeclared) food allergens are present in a food due to incorrect labeling 

or due to allergen cross-contact. 

This section of this chapter provides a general discussion of food allergen hazards and common 

mechanisms to control them. For more detailed information, see Chapter 11 – Food Allergen 

Controls, which provides a comprehensive guide to food allergen control. An additional 

resource is “Managing Allergens in Food Processing Environments,” a publication of the 

Grocery Manufacturer’s Association (GMA, 2009). 

3.4.2.1.1 The “Big Eight” food allergens

The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 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 
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U.S.C. 321(qq)(2)) as major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, 

peanuts, wheat, and soybeans. The eight foods or food groups cause more than 90% of the 

food allergies in the United States (FDA, 2015c) and are commonly referred to as “the big eight” 

food allergens. FDA has published guidance on labeling the food allergens identified in 

FALCPA – See “Guidance for Industry: Questions and Answers Regarding Food Allergens, 

including the Food Allergen Labeling and Consumer Protection Act of 2004” (FDA, 2006b). 

Immediately below, we provide more information about each of “the big eight food allergens.”

• Crustacea: The class of Crustacea, or shellfish, includes shrimp, crab, lobster, and crayfish. 

Crab and shrimp are the most commonly consumed shellfish in the United States. The major 

shellfish allergen is tropomyosin, a muscle protein that accounts for 20% of the dry weight of 

shrimp (GMA, 2009).

• Egg: Most egg allergic proteins are found in the egg white (albumin) rather than the yolk.

• Fish: Different fish species (e.g., bass, cod, and flounder) have been found to have 

structurally-related proteins, and this may explain why individuals with a fish allergy are 

allergic to multiple types of fish. Cooking may reduce the allergenicity of fish, but it does not 

eliminate it.

• Milk (Dairy): Cow’s milk contains a number of different proteins that are grouped into two 

categories: caseins, which constitute 80% of the total protein, and whey proteins, which 

make up 20%. 

• Peanut: Peanut seeds contain an average of about 29% protein, classified as albumins or 

globulins. 

• Soy: Globulins are the major proteins in soybeans. 

• Tree Nuts: Tree nuts include almonds, Brazil nuts, cashews, filberts/hazelnuts, macadamia 

nuts, pecans, pine nuts, pistachios, and walnuts. FDA lists the nuts considered “tree nuts” 

in its 2006 “Guidance for Industry: Questions and Answers Regarding Food Allergens, 

including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4)”

(FDA, 2006b) and its 2013 Guidance for Industry: A Food Labeling Guide (FDA, 2013a).

• Wheat: Wheat proteins include the globulins, prolamins (i.e., glutenin and gliadin), and 

glutelins. About 25% of wheat-allergic children react to other cereal grains (i.e., barley, oats, 

or rye). Gluten is a mixture of proteins that occur naturally in wheat, rye, barley and 

crossbreeds of these grains. It is associated with celiac disease, which affects as many as 3 

million people in the United States by the body's natural defense system attacking the lining 

of the small intestine and preventing the proper absorption of nutrients (FDA, 2015(d)). 

3.4.2.1.2 Undeclared food allergen hazards due to incorrect label design

FALCPA also amended section 403 of the FD&C Act (21 U.S.C. 343) to prescribe certain 

requirements for what you must declare on the product label for any food product that contains 

any of the “big eight allergens,” including allergenic whole foods (such as milk) and any 

ingredients that contain protein derived from these foods (such as casein derived from milk). 

See section 403(w) of the FD&C Act (21 U.S.C. 343(w)) and our guidance entitled “Guidance for 

Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen 

Labeling and Consumer Protection Act of 2004” (FDA, 2006b). 
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An undeclared food allergen (including a food allergen contained in flavorings, colorings, and 

incidental additives) due to an incorrect label design that does not address all of the labeling 

requirements of FALCPA is a chemical hazard. See 21 CFR 117.130(b)(1)(ii).

3.4.2.1.3 Undeclared food allergen hazards due to incorrect application or 

use of a product label

If you apply the wrong label to a food, or use the wrong packaging (e.g., using packaging for 

“chocolate ice cream” rather than for “chocolate ice cream with almonds”), consumers who have 

a food allergy could purchase a food that would cause an allergic reaction. An undeclared food 

allergen due to applying the incorrect food label to a product, or using the wrong packaging, is a 

chemical hazard. See 21 CFR 117.130(b)(1)(ii).

3.4.2.1.4 Undeclared food allergen hazards due to allergen cross-contact

Cross-contact results from the unintentional incorporation of undeclared allergens into foods 

that are not intended to include those allergens. Cross-contact can occur either between foods 

that contain different food allergens or between foods with and without food allergens. 

Introduction of an allergen through cross-contact may occur during receiving, handling, 

processing and storage of ingredients and foods, utensils, and packaging; through improper 

handling and cleaning of equipment, utensils, and facilities; and through improper facility design. 

An undeclared food allergen due to allergen cross-contact is a chemical hazard. See 21 CFR 

117.130(b)(1)(ii). Allergen cross-contact can result from: 

• Failure to schedule the production of two different products appropriately, resulting in an 

allergen-containing product contaminating a product without food allergens.

• Failure to adequately clean between two different formulations of a product that do and do 

not contain allergens, resulting in an allergen-containing product contaminating a product 

without the allergen. 

• Failure to store allergen-containing ingredients separately from ingredients that do not 

contain allergens, where leakage of allergen-containing materials results in contamination of 

the non-allergen containing product.

• Failure to handle powdered allergens in a way that prevents particles from blowing onto 

foods or food contact surfaces for foods that do not contain that allergen. 

3.4.2.2 Food additives, color additives, and GRAS substances, including 

substances associated with food intolerance or food disorder

Under sections 201(s) and 409 of the FD&C Act (21 U.S.C 321(s) and 348, respectively), a 

substance that is added to food requires premarket review and approval as a food additive 

unless it satisfies the statutory exclusion from the definition of "food additive" for a substance 

that is generally recognized as safe (GRAS) under the conditions of its intended use (section 

201(s) of the FD&C Act or is otherwise excepted from the statutory definition of food additive 

(e.g., as a color additive, as a dietary ingredient intended for use in a dietary supplement, or as 

a new animal drug).

Under sections 201(t) and 721 of the FD&C Act (21 U.S.C 321(t) and 379(e), respectively), a 

color additive requires premarket review and approval; there is no statutory GRAS exclusion 

applicable to a color additive.
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Generally, a food additive, color additive, or GRAS substance is known to be safe for use in 

food only under specific conditions of use, such as a maximum level of use or use only in 

certain food categories. The potential risk to consumers increases when these substances are 

not properly controlled, such as exceeding the usage rates or accidentally introducing an

additive into a food for which it was not approved.

For some consumers, certain substances (including substances that are lawfully used in food as 

food additives, color additives, GRAS substances, and components of whole foods such as 

milk) can cause hypersensitivity reactions because the substance irritates the stomach, or the 

body cannot properly digest it. The symptoms include nausea, abdominal pain, diarrhea, 

vomiting, gas, cramps or bloating, heartburn, headaches, irritability, or nervousness. Symptoms 

of food intolerance usually occur gradually, in comparison with the sudden onset from an 

allergic reaction, and may only occur when a lot of a food is consumed or the food is consumed 

often. 

• Lactose: Some people are intolerant to lactose, a sugar that is a component of milk, 

because they lack the enzyme to digest lactose. The symptoms include abdominal pain, 

diarrhea, vomiting, gas, cramps or bloating. People who have a lactose intolerance avoid 

milk or milk products and rely on the allergen labeling for milk to identify the types of 

products that may cause them problems. 

• Sulfiting agents: Sulfiting agents are used as chemical preservatives in various products. 

People sensitive to sulfiting agents can experience symptoms that range from mild to lifethreatening reactions. As noted previously, sulfites have resulted in diarrhea, headache, 

difficulty breathing, vomiting, nausea, abdominal pain and cramps in sulfite-sensitive 

individuals (Timbo et al. 2004). 

• The sulfiting agents permitted in foods that must be listed on the ingredient label, unless 

they are added to food as an “incidental substance,” are: sulfur dioxide (21 CFR 182.3862), 

sodium sulfite (21 CFR 182.3798), sodium bisulfite (21 CFR 182.3739), sodium metabisulfite 

(21 CFR 182.3766), potassium bisulfite (21 CFR 182.3616), and potassium metabisulfite (21 

CFR 182.3637). 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)). The quantity of sulfiting agents added to food should not exceed 

the amount necessary to achieve the intended technical effect(s).

• Yellow No. 5: Yellow No. 5 (tartrazine) is a color additive subject to color certification under 

section 721(c) of the FD&C Act. (21 U.S.C. 379e) People sensitive to Yellow No. 5 can 

experience symptoms that range from mild to moderately severe. For example hives occur 

in some intolerant individuals, but in asthmatic individuals Yellow No.5 can trigger allergictype reactions (including bronchial asthma). To help protect people who are sensitive to 

Yellow No. 5, FDA’s regulation for Yellow No. 5 states that any food for human use that 

contains Yellow No. 5 must specifically declare the presence of the color additive by listing it 

as an ingredient (21 CFR 74.705(d)(2)). If Yellow No. 5 is added but is not declared, the 

product would be both misbranded under section 403(m) of the FD&C Act (21 U.S.C. 

343(m) and adulterated under section 402(c) of the FD&C Act (21 U.S.C 342(c)). 

• Cochineal extract and carmine: Cochineal extract and carmine are color additives 

permitted for use in foods in the United States under conditions of safe use listed in 21 CFR 

73.100. For sensitive consumers, cochineal extract and carmine can cause severe allergic 

reactions, including anaphylaxis (74 FR 207, January 5, 2009). Although the color additives 

cochineal extract and carmine cause allergic reactions, they are not included in the eight 
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major food allergens identified in FALCPA. As a result, the color additives cochineal extract 

and carmine are not included in the definition of “food allergen” in part 117 and are not 

subject to the food allergen controls specified in the PCHF requirements. In addition, FDA’s 

specific labeling requirement in the color additive listing for cochineal extract and carmine 

(21 CFR 73.100(d)(2)), rather than the more general labeling requirements of FALCPA, 

govern the food labeling requirements cochineal extract and carmine. All human foods 

containing cochineal extract or carmine are required to declare the presence of the color 

additive by listing its respective common or usual name, “cochineal extract” or “carmine,” in 

the statement of ingredients ((21 CFR 73.100(d)(2)). Additional information on the labeling 

requirements for these two color additives can be found in FDA industry guidance, 

Cochineal Extract and Carmine: Declaration by Name on the Label of All Foods and 

Cosmetic Products That Contain These Color Additives; Small Entity Compliance Guide

(FDA, 2009a). Control strategies for cochineal extract and carmine are similar to those 

applied to food allergen labeling controls.

In addition, some consumers have celiac disease, which is a hereditary, chronic inflammatory 

disorder of the small intestine triggered by the ingestion of certain storage proteins (referred to 

as gluten) occurring in wheat, rye, barley, and crossbreeds of these grains. As discussed in 

section 3.4.2.1.1 of this chapter, celiac disease affects as many as 3 million people in the United 

States (FDA, 2015(d)).

3.4.2.2.1 Unapproved food additives and color additives 

A substance (other than a food contact substance subject to a notification under section 409(h)) 

that is a food additive or a color additive must be used in accordance with a food additive 

regulation permitting that specific use or a color additive listing. Otherwise, the presence of that 

substance in food would make the food adulterated under section 402(a)(2)(C) of the FD&C Act

(21 U.S.C. 342(a)(2)(C)). Under the PCHF requirements, an unapproved food or color additive 

is a chemical hazard (see 21 CFR 117.130(b)(1)(ii)). 

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, safrole, and 

FD&C Red No. 4 (Red No. 4) (FDA, 2015b). 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. You should consult 21 CFR if you have 

questions about the regulatory status or safety of a particular additive when formulating your 

food products. An additional resource for you is the Food Additive Status List on our website 

(FDA, 2014b).

3.4.2.2.2 Chemical hazards due to misformulation 

A food ingredient can be a chemical hazard if it is added in excess of a maximum use level, 

regardless of whether the maximum use level is established due to food intolerance (such as for 

sulfites) or is otherwise a condition of safe use of a food additive, color additive, or GRAS 

substance. Control strategies to prevent misformulation of substances generally include 

process controls to ensure that excessive amounts are not added. 
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3.4.2.2.3 Chemical hazards due to incorrect labeling of substances 

associated with food intolerance or food disorder

Although the mechanisms whereby persons experience food intolerance or food disorder are 

different from the mechanisms that cause food allergy, reactions due to food intolerance or food 

disorder can cause significant health problems for those affected, and the principal means that 

consumers have to avoid the symptoms of food intolerance are the same means that 

consumers use to avoid symptoms of food allergy – i.e., avoid foods containing the substance 

that causes the problem. For example, people who are intolerant to lactose, a sugar that is a 

component of milk, avoid food products containing milk to avoid the symptoms associated with 

lactose intolerance. In addition, people who have celiac disease avoid food products containing 

wheat and other sources of gluten.

Undeclared substances associated with a food intolerance or food disorder are chemical 

hazards that can get into food because either: (1) The food manufacturer did not properly 

declare the substance on the product label; (2) unintended (and, thus, undeclared) substances 

are present in a food due to incorrect labeling. Control strategies to prevent incorrect labeling of 

substances associated with a food intolerance or food disorder are analogous to those used to 

prevent incorrect labeling of food allergens and, thus, you may find Chapter 11—Food Allergen 

Controls helpful in preventing incorrect labeling of substances associated with a food 

intolerance or food disorder. The preventive controls in that comprehensive guide to food 

allergen control do not explicitly address substances associated with food intolerance or food 

disorder, but may nonetheless be useful in addressing chemical hazards due to incorrect 

labeling of such substances.

3.4.2.3 Process contaminants produced during heating

There are several process-related contaminants that are produced during heating of specific 

ingredients or finished foods that may be a health (e.g., cancer) concern. For example, 

acrylamide is formed during high-temperature cooking processes (including frying, roasting, or 

baking) due to interaction between sugars and amino acids that are naturally present in foods. 

Acrylamide is found mainly in foods made from plants, including potato products, grain products, 

and coffee. 

As noted in footnote 8, we have not included such contaminants in Table 3-6 as potential 

process-related chemical hazards that may require a preventive control as part of a food safety 

plan under part 117 because we believe that more information is needed regarding appropriate 

levels and effective controls. We have published a guidance document, Guidance for Industry: 

Acrylamide in Foods (FDA, 2016a) to help growers, manufacturers, and food service operators 

reduce acrylamide levels in certain foods. Control strategies to reduce acrylamide in food may

include controlling temperatures during cooking and ingredient substitution.

3.4.2.4 Radiological hazards

Radiological hazards rarely occur in the food supply; however, when they do occur, these 

hazards can present a significant risk when exposures occur over a period of time (WHO, 

2011). Consuming food contaminated with radionuclides will increase the amount of 

radioactivity a person is exposed to, which could have adverse health effects. The health effect 

depends on the radionuclide and the amount of radiation to which a person is exposed. For 

instance, exposure to certain levels of radioactive iodine is associated with increased risk of 

thyroid cancer (WHO, 2011).
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Radiological hazards can become incorporated into food through the use of water that contains 

the radionuclides during food production or manufacture. There are areas in the United States 

where high concentrations of some radionuclides, such as radium-226, radium-228, and 

uranium, can be detected in well water (Ayotte et al., 2007; Focazio et al., 2001). You should be 

aware of the condition of the water used for production and manufacture in your facilities. For 

example, if your facility uses well water and there are elevated levels of radionuclides in the well 

water, you should not use the water. The CGMPs require that water that contacts food, foodcontact surfaces, or food-packaging materials be safe and of adequate sanitary quality (see 21 

CFR 117.37(a)).

Radiological hazards also may result from accidental contamination, e.g., contamination arising 

from accidental release from a nuclear facility or from damage to a nuclear facility from a natural 

disaster. In 2011, following damage to a nuclear power plant during an earthquake and tsunami 

in Japan, radioactivity was subsequently detected in foods, particularly milk, vegetables, and 

seafood produced in areas neighboring the plant (WHO, 2011). You should be vigilant 

regarding accidental releases of radiological hazards and their potential to contaminate your 

food product, either directly due to contamination of natural resources near your facility or as a 

result of raw materials and other ingredients that you obtain from a region that has experienced 

an accidental release of radiation. 

3.4.3 Facility-Related Chemical Hazards 

Industrial chemicals or other contaminants from the food processing environment can 

contaminate food during production – e.g., if chemicals used to clean a production line are not 

adequately removed from the production line or if heavy metals are leaching from containers or 

utensils. In this guidance, we do 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. 

3.5 Physical Hazards 

You must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable 

physical hazards (such as stones, glass, and metal fragments). See 21 CFR 117.130(b)(1)(iii).

When your hazard analysis identifies a known or reasonably foreseeable physical hazard that 

requires a preventive control, you must identify and implement a preventive control for the 

physical hazard. See 21 CFR 117.135(a)(1).

Physical hazards are broadly classified as “hard/sharp” physical hazards and “choking” hazards. 

Both categories can cause injury to the consumer. These injuries may include dental damage, 

laceration of the mouth or throat, laceration or perforation of the intestine, and choking and may 

even lead to the death. Because physical hazards cover a broad range of contaminants, such 

as glass, metal, plastic, wood, and stones, such contamination can occur throughout the 

processing facility, including the receiving dock for ingredients and supplies. 

In this section of this guidance we describe common physical hazards – i.e., metal, glass, and 

hard plastic physical hazards. 

• Metal: Metal-to-metal contact during processing can introduce metal fragments into 

products. For example, metal fragments can break off during mechanical cutting and 

blending operations, and some metal equipment has parts that can break or fall off, such as 

wire-mesh belts. FDA’s Health Hazard Evaluation Board (FDA, 2005e; Olsen, 1998) has 
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supported regulatory action against products with metal fragments of 0.3 inches (7 mm) to 

1.0 inches (25 mm) in length. Such fragments have been shown to be a hazard to 

consumers. Metal hazards can be controlled by the use of metal detection devices or by 

regular inspection of at-risk equipment for signs of damage.

• Glass: Glass fragments can be introduced into food whenever processing involves the use 

of glass containers. Normal handling and packaging methods, especially mechanized 

methods, can result in breakage. Ingesting glass fragments can cause injury to the 

consumer. FDA’s Health Hazard Evaluation Board has supported regulatory action against 

products with glass fragments of the same size noted for metal. Most products packed in 

glass containers are intended to be a ready-to-eat (RTE) commodity. In your hazard 

analysis, you should consider the potential for glass fragments to originate from sources 

other than glass containers used in packaging. For example, some facilities that do not 

pack in glass prohibit the presence of glass in the production environment to reduce the risk 

of glass getting into the product. You can address glass fragments originating from sources 

such as overhead light fixtures through CGMPs.

• Hard Plastic: 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. Hard plastic also can be introduced into food when plastic sieves and screens 

deteriorate. You should examine items to determine whether they are worn and remove

worn items before they break, especially if they cannot be effectively cleaned (e.g., because 

of small cracks). 

In general, there is overlap between facility-related physical hazards and process-related 

physical hazards. For example, equipment that has food-contact surfaces that break during 

food processing and result in physical debris being deposited in the food product can be 

considered a facility-related physical hazard (because the equipment is part of the facility) or a 

process-related physical hazard (because the equipment broke during processing). In general, 

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. However, a few physical 

hazards can readily be classified as facility-related or process-related. For example, nuts and 

bolts used during maintenance procedures would be a facility-related hazard, but production 

equipment that has nuts and bolts that could fall out during production would be a processrelated hazard. 

Table 3-9 is a Quick Reference Guide to help you identify common sources of these physical 

hazards. See Chapter 13 – Preventive Controls for Physical Hazards for more detailed 

recommendations on control measures for physical hazards. In this guidance, we do not 

discuss ingredient-related physical hazards such as wood and stone, which are usually 

addressed through CGMPs or as a supply-chain control through your supplier program. 
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Table 3-9. Quick Reference Guide for Common Sources of Physical Hazards

Source Metal – Ferrous & NonferrousPlastic, Ceramic, and 

Glass

Other

Ingredient-related • Farm field debris

• Precut, ground, 

injected, sliced, items, 

where metal was not 

properly controlled by 

supplier. 

• Farm field debris, 

• Packaging materials

• Pits or pit fragments, 

shells

Facility-related and processrelated (processing/production 

environment, equipment, and 

pests (insects, birds, rodents, 

reptiles))

 

• Equipment

• Grinders, slicers, 

knives

• Sieves, screens, wiremesh belts

• Mixing paddles 

• Metal cans (shavings, 

lids) 

• Pumps

• Cook Kettles with 

swept surface 

paddles

• Drop buckets 

• Equipment (inspection 

belts, small wares, 

buckets)

• Facility (glass light 

fixtures, glass 

windows in doors, 

plastic strip curtains)

• Glass containers

• Scoops 

• Mixing paddles

• Buckets

• Incomplete removal 

of pits or pit 

fragments, shells

• Poor Design --

Particle size of food 

inappropriate for 

consumer –

choking hazard

People-related (actions or 

behaviors)

• Jewelry 

• Hair pins 

• Buttons 

• Zipper pulls

N/A

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2016. http://apps.who.int/iris/bitstream/10665/44520/1/9789241660631_eng.pdf.
Contains Non-binding Recommendations

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Chapter 3 (Potential Hazards) - Page 42

Zink, D. 2007. "The return of Salmonella: IAFP special interest session on Salmonella growth, 

persistence and survival in low-moisture foods and their environment - strategies for 

control." IAFP Annual Meeting, Buena Vista, FL.
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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-assistance-network-tan.

Chapter 4: Preventive Controls

Table of Contents

4.1 Purpose of this Chapter

4.2 Overview of Preventive Controls

4.3 Process Controls

4.3.1 Treatments lethal to biological hazards

4.3.1.1 Use of Heat Treatment (Thermal Processing) as a Lethality Process 

Control

4.3.1.2 Use of High Pressure Processing (HPP) as a Lethality Process Control

4.3.1.3 Use of Irradiation as a Lethality Process Control

4.3.1.4 Use of Antimicrobial Fumigation as a Lethality Process Control

4.3.2 Use of Time-Temperature as a Process Control

4.3.2.1 Use of Refrigeration as a Time-Temperature Process Control

4.3.2.2 Use of Freezing as a Time-Temperature Process Control

4.3.3 Use of Product Formulation as a Process Control

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. Underlined text in yellow highlights 

represents a correction from the draft Chapter 4 that we issued for public comment in August 2016. 
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4.3.3.1 Use of Water activity (aw) as a Formulation Process Control

4.3.3.2 Use of Acidity (pH) as a Formulation Process Control

4.3.3.3 Use of Preservatives as a Formulation Process Control

4.3.4 Use of Dehydration/Drying as a Process Control

4.3.5 Use of Recipe Management as a Process Control for Food Ingredients

4.3.6 Use of Storage Conditions as a Process Control for Mycotoxins

4.3.7 Use of Physical Sorting as a Process Control for Mycotoxins

4.3.8 Use of Exclusion Strategies as a Process Control for Physical Hazards

4.3.8.1 Exclusion Strategies as a Process Control for Metal Hazards

4.3.8.2 Exclusion Strategies as a Process Control for Glass Hazards

4.4 Sanitation Controls

4.4.1 Use of Sanitation Controls for the Cleanliness of Food-Contact Surfaces

4.4.2 Use of Sanitation Controls to Prevent Allergen Cross-contact and Crosscontamination

4.5 Food Allergen Controls

4.6 Supply-chain Controls

4.6.1 Supply-chain Controls for Pesticides

4.6.2 Supply-chain Controls for Drug Residues

4.6.3 Heavy Metals

4.6.4 Supply-chain Controls for Mycotoxins

4.7 Recall Plan

4.8 References

4.1 Purpose of this Chapter

The guidance provided in this chapter is intended to help you identify and implement preventive 

controls. The PCHF requirements specify that you must identify and implement preventive 

controls to provide assurances that any hazards requiring a preventive control will be 

significantly minimized or prevented and the food manufactured, processed, packed, or held by 

your facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C 342) or misbranded under section 403(w) of the FD&C Act (21 U.S.C. 

343(w)). (See 21 CFR 117.135(a)(1)). This chapter provides an overview of common

preventive controls that you could use to significantly minimize or prevent the occurrence of 

biological, chemical, and physical hazards in food products and the food production 

environment when the outcome of your hazard analysis is that one or more of these hazards 

requires a preventive control. 
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The guidance in this chapter also is intended to help you monitor the preventive controls that 

you identify and implement. As appropriate to the nature of the preventive control and its role in 

the facility’s food safety system, the PCHF requirements specify that you must establish and 

implement written procedures, including the frequency with which they are to be performed, for 

monitoring the preventive control, and to monitor the preventive controls with adequate 

frequency to provide assurance that they are consistently performed. (See 21 CFR 117.145.)

This chapter does not provide all the details needed for identifying and implementing preventive 

controls. You have the flexibility to identify and implement preventive controls from among all 

procedures, practices, and processes that are available to you and that would provide 

assurances that the hazard is controlled (i.e., significantly minimized or prevented).

4.2 Overview of Preventive Controls 

Part 117 defines “preventive controls” as those risk-based, reasonably appropriate procedures, 

practices, and processes that a person knowledgeable about the safe manufacturing, 

processing, packing, or holding of food would employ to significantly minimize or prevent the 

hazards identified by the hazard analysis that are consistent with the current scientific 

understanding of safe food manufacturing, processing, packing, or holding at the time of the 

analysis. (See 21 CFR 117.3.) Preventive controls include: (1) Controls at critical control points 

(CCPs), if there are any CCPs; and (2) controls, other than those at CCPs, that are also 

appropriate for food safety (See 21 CFR 117.135(a)(2)). The PCHF requirements specify that 

preventive controls must be written. (See 21 CFR 117.135(b)).The PCHF requirements also 

specify that preventive controls must include, as appropriate to the facility and the food: (1) 

Process controls; (2) Food allergen controls; (3) Sanitation controls; (4) Supply-chain controls; 

(5) Recall plan; and (6) Other controls. (See 21 CFR 117.135(c)). 

Table 4-1 lists the sections in this chapter in which we address process controls, sanitation 

controls, food allergen controls, supply-chain controls, and recall plans. Although Table 4-1 

includes supply-chain controls, we intend to provide more information in our forthcoming 

“Chapter 15 - Supply-Chain Program for Human Food Products.” See Chapters 6 through 14 of 

this guidance for more detailed discussion of applicable preventive controls.

Table 4-1. Preventive Controls Addressed in this Chapter

Preventive Control Chapter Section

Process Controls 4.3

Sanitation Controls 4.4

Food Allergen Controls 4.5

Supply-chain Controls 4.6

Recall Plans 4.7

Table 4-2 lists the chapters in this guidance in which we provide additional details regarding 

certain preventive controls.

Table 4-2. Other Chapters in the Guidance With Additional Information About Specific 

Preventive Controls 

Preventive Control Chapter 
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Preventive Control Chapter 

Heat Treatment Process Control 6

Time/Temperature Control Process Control 7

Formulation Process Control (e.g., water 

activity, pH, and chemical preservatives)

8

Dehydration/Drying Process Control 9

Sanitation Controls 10

Food Allergen Controls 11

Preventive Controls for Chemical Hazards 12

Preventive Controls for Physical Hazards 13

Recall Plan 14

The PCHF requirements specify that you must validate that the preventive controls that you 

identify and implement are adequate to control the hazard as appropriate to the nature of the 

preventive control and its role in the facility’s food safety system. (See 21 CFR 117.160(a)).

The PCHF requirements also specify that validation of the preventive controls must be 

performed (or overseen) by a preventive controls qualified individual. (See 21 CFR 117.160(b) 

and the definition of a preventive controls qualified individual in 21 CFR 117.3.) You do not 

need to validate: (1) Food allergen controls; (2) sanitation controls; (3) the recall plan; and (4) 

the supply-chain program. You also do not need to validate other preventive controls, if the 

preventive controls qualified individual prepares (or oversees the preparation of) a written 

justification that validation of the other control is not applicable based on factors such as the 

nature of the hazard, and the nature of the preventive control and its role in the facility’s food 

safety system. (See 21 CFR 117.160(c).) We intend to discuss validation in “Chapter 16: 

Validation of a Process Control.”

4.3 Process Controls

Process controls include procedures, practices, and processes to ensure the control of 

parameters during operations such as heat processing, acidifying, irradiating, and refrigerating 

foods. Process controls must include, as appropriate to the nature of the applicable control and 

its role in the facility’s food safety system: (1) Parameters associated with the control of the 

hazard; and (2) the maximum or minimum value, or combination of values, to which any 

biological, chemical, or physical parameter must be controlled to significantly minimize or 

prevent a hazard requiring a process control. (See 21 CFR 117.135(c)(1).) Process controls do 

not include those procedures, practices, and processes that are not applied to the food itself, 

e.g., controls of personnel or the environment that may be used to significantly minimize or 

prevent hazards.
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Examples of processing parameters that can have a minimum or maximum value (or

combination of values) include time, temperature, flow rate, line speed, product bed depth, 

weight, product thickness or size, viscosity, moisture level, water activity, salt concentration, pH 

and others, depending upon the process. If a process parameter does not meet a minimum or 

maximum value (or critical limit), the process is not in control (i.e., a deviation has occurred) and 

the potential for producing a product that presents a consumer-health risk exists.

Many process controls, such as the application of heat to a food to adequately reduce 

pathogens, are applied in the same manner and for the same purpose as control measures 

established within HACCP plans and applied at CCPs as recommended by the National 

Advisory Committee on Microbiological Criteria for Foods (NACMCF, 1998) and the Codex 

Alimentarius Commission (CAC, 2003). When a process control is applied to a CCP in a 

HACCP plan, the maximum or minimum values (or combination of values) for the parameters 

associated with the control of the hazard are called “critical limits.” Critical limits have been 

defined by the NACMCF as a maximum and/or minimum value to which a biological, chemical 

or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an 

acceptable level the occurrence of a food safety hazard (NACMCF, 1998). 

In addition to this guidance, a number of sources of scientific and technical information can be 

useful in establishing process parameters or critical limits. Our guidance documents entitled 

“Fish and Fishery Products Hazards and Controls Guidance” and “Juice HACCP Hazards and 

Controls Guidance” each have information that can be broadly applied to food products. Other 

government agencies may also provide information through technical staff, regulations, 

guidelines, directives, performance standards, tolerances, and action levels. For example, the 

guidance documents entitled “Meat and Poultry Hazards and Controls Guide” (FSIS, 2005) and 

FSIS Compliance Guideline HACCP Systems Validation (FSIS, 2015), provided by the Food 

Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture, has information that 

can broadly be applied to food products, not just meat and poultry products subject to FSIS’ 

jurisdiction. As another example, EPA lists maximum pesticide residues limits (MRLs) and

tolerances in 40 CFR Part 180. (EPA, 2015) and provides Indexes to Part 180 Tolerance 

Information for Pesticide Chemicals in Food and Feed Commodities on its website (EPA, 2016). 

Trade associations, process authorities, industry scientists, university and extension scientists, 

and consultants can provide expertise and guidance. For example, the Grocery Manufacturer’s 

Association (GMA) has provided guidance on Control of Salmonella in Low-Moisture Foods 

(GMA, 2009). Information can also be obtained from peer reviewed scientific literature. For a 

more comprehensive list of resources, see the training materials provided by the Food Safety 

Preventive Controls Alliance (FSPCA, 2016) In addition to (or in place of) information from such 

resources, you also can conduct scientific studies for specific products in-house, at a contract 

laboratory, or at a university to establish appropriate process parameters and associated 

values.

You should use care when applying information from any of these sources to processing 

parameters for a specific product and process. Among other reasons, there may be important 

differences between the application of processing parameters as discussed in these sources 

how you would apply the processing parameters to your specific product and process. The 

processing parameters and/or minimum or maximum values may need to be adjusted to 

account for those differences. For example, the temperature (and time at that temperature) 

necessary to kill microorganisms in a food product can depend on the fat level in that food 

product. 
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Table 4-3 lists examples of the application of process controls to significantly minimize or 

prevent ingredient-related and process-related biological, chemical, and physical hazards and 

the section in this chapter that addresses each listed example. 

Table 4-3 Common Process Controls 

Process Control 

Subcategory

Hazard 

Category

Examples Chapter 

Section

Lethal Treatments Biological • Heat treatments (also called thermal 

treatments) (e.g., cooking, roasting, 

baking)

• High Pressure Processing (HPP)

• Irradiation 

• Antimicrobial fumigation (e.g., with 

polypropylene oxide (PPO))

4.3.1

Time/Temperature 

of Holding

Biological • Refrigeration 

• Freezing 

4.3.2

Formulation Biological • Reducing the water activity

• Reducing the pH

• Adding preservatives

4.3.3

Dehydration/Drying Biological • Air-drying (forced air and heating) 

• Freeze drying 

• Spray drying 

4.3.4

Recipe 

Management

Chemical • Controlling the maximum level of food 

ingredients

4.3.5

Storage Conditions Chemical • Controlling moisture during storage of 

raw agricultural commodities 

4.3.6

Physical Sorting Chemical • Reducing mycotoxin content through 

sorting by color and physical damage in 

raw agricultural commodities

4.3.7

Exclusion of Metal 

and Glass

Physical • Using magnets

• Using metal detectors

• Using sieves, screens

• Using X-ray systems

4.3.8

4.3.1 Treatments lethal to biological hazards

We use the term “lethality treatment” when referring to a treatment that is used to kill/destroy or 

inactivate microorganisms. In general, when discussing bacterial pathogens in this document 

we use the terms “kill” or “destroy” when discussing treatments lethal to vegetative cells and we 

use the term “inactivate” when discussing treatments lethal to spores. Common lethality 

treatments include: (1) Heat treatments (e.g., cooking, boiling, pasteurizing, baking, frying); (2) 
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HPP; (3) irradiation; and (4) antimicrobial fumigation. We discuss each of these in the following 

sections of this chapter.

4.3.1.1 Use of Heat Treatment (Thermal Processing) as a Lethality 

Process Control 

Heat treatment is a common lethality process control. Heat treatments generally fall into into the 

following two categories:

• Heat treatment that leads to commercial sterility: heat processing at high temperatures (> 212oF

(100°C)) under presssure with the objective of killing all forms of microorganisms, including the 

spores of bacteria. The treated products are shelf-stable without refrigeration. (Lower temperatures 

can lead to products that are shelf-stable in some cases, e.g., when the pH is low enough to prevent 

growth of surviving sporeformers.)

• Heat treatment that reduces microbial pathogens but does not lead to commercial sterility: heat 

processing at lower temperatures (e.g., 158°F (70°C) to 212°F (100°C)), with the processes designed 

to kill the vegetative forms of microorganisms with little to no effect on the spores of bacteria. The 

treated products are not shelf-stable and require controls such as refrigeration to control spores of 

bacterial pathogens.

This chapter does not address heat treatments that lead to commercial sterility of “low-acid 

canned foods.” Such treatments are subject to the requirements of 21 CFR part 113 (Thermally 

Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; commonly called 

“Low-Acid Canned Foods (LACF)) because the microbial hazards in LACF are not subject to the 

requirements for hazard analysis and risk-based preventive controls. Note that although some 

hermetically sealed containers (e.g., pouches and glass bottles) used to package thermally 

processed low-acid foods generally would not be viewed as “cans,” the term “low-acid canned 

foods” has been used for decades as a shorthand description for “thermally processed low-acid 

foods packaged in hermetically sealed containers,” and we continue to use that term (and its 

abbreviation, LACF) for the purposes of this guidance.

Pasteurization is an example of a lethal heat treatment that reduces microbial pathogens but 

does not lead to a shelf stable product. Pasteurization typically is applied to foods to kill nonsporeforming pathogens such as Salmonella, Listeria monocytogenes, and pathogenic strains 

of E. coli. One example is the pasteurization of grade “A” milk and milk products that is covered 

by the 2015 Pasteurized Milk Ordinance (PMO) (FDA, 2015a). This chapter does not address 

pasteurization of milk; if you pasteurize milk, you should refer to 21 CFR 1240.61 and the 

specific requirements in your jurisdiction.

Thermal Destruction of Microorganisms

To design a lethal heat treatment for use as a preventive control, you should have a basic 

understanding of thermobacteriology (i.e., the relationship between bacteria and heat), including 

two key types of data and information: 

• The kinetics of thermal inactivation or destruction of microorganisms, known as thermal death time 

data and;

• The rate at which heating occurs within the food material, also known as heat transfer or heat 

penetration.

Immediately below, we describe basic concepts associated with thermal death time data and 

heat transfer/heat penetration. For a more extensive review of thermobacteriology, including 
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graphical representations of the relationship of D values and z values to Thermal Death Time, 

refer to Stumbo, Chapter 7 (1973). 

Some terms and concepts used to describe the thermal destruction of microorganisms include:

• TDT (Thermal Death Time) is the time necessary to kill a given number of microorganisms at a 

specified temperature. The TDT is obtained by keeping temperature constant and measuring the time 

necessary to kill the amount of cells specified. 

• D Value (the decimal reduction time) is the time required to kill 90% of the microorganisms. Another 

way of expressing this is the time required at a specific temperature and under specified conditions to 

reduce a microbial population by one decimal (see discussion below).

• z Value refers to the degrees in Farhenheit required for the thermal destruction curve to cross one log 

cycle (i.e., for reducing the D value by a factor of 10).

Food processing experts evaluate treatments intended to kill or inactivate pathogens in food in 

terms of “logs” of kill, where the term “log” is a shorthand expression of the mathematical term 

logarithm. A logarithm is the exponent of the power to which a base number must be raised to 

equal a given number. In thermobacteriology, the base number is usually 10. As an example, 

the number 100 = 102 where the base number is 10 and the exponent is 2. Because the 

exponent is 2, the number 100 = log 2. Likewise, the number 1000 = 103 = log 3. The important 

thing to understand is that each “log” of kill is capable of causing a tenfold reduction in the 

number of microorganisms that the treatment is designed to kill, i.e., the most resistant 

microorganism of public health significance. 

The decimal reduction time (D) is used synonymously with “log” in the context of 

thermobacteriology. A 1-log or 1D process would be one that is capable of reducing the level of 

the most resistant pathogen of concern in the food by 10 fold, e.g., from 10,000 cells of the 

microorganism per gram of food to 1,000 cells of the microorganism per gram of food. 

Importantly, it is not possible to technically achieve a level of reduction to zero, or “no 

microorganisms”; instead, as a technical matter the probability of finding the organism becomes 

less likely as the magnitude of reduction increases. Thus, a 5-log reduction process would be 

one that is capable of reducing the level of the most resistant pathogen of concern in the food 

by 100,000 fold, e.g., from 10,000 cells of the microorganism per gram of food to a probability of 

1 cell in 10 g of food. 

Table 4-4 provides examples of how food processing experts would describe the effect of lethal 

heat treatments on microorganisms in foods using terms commonly associated with 

thermobacteriology.

Table 4-4. The concept of log reductions of microorganisms in foods

Initial number of the 

most resistant 

microorganism of 

public health 

significance per 

gram of food

Log 

reduction 

(also 

known as 

D)

Decrease in most resistant 

microorganism of public 

health significance per gram 

of food

Percent 

of change

Final number of 

bacteria per 

gram of food

10,000 or log 41 1 10-fold 90% 1,000 or log 3

10,000 or log 4 2 10 X 10 = 100 fold 99% 100 or log 2

10,000 or log 4 3 10 X 10 X 10 = 1000-fold 99.9% 10 or log 1

10,000 or log 4 4 10 X 10 X 10 X 10 = 10,000-fold 99.99% 1 or log 0
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Initial number of the 

most resistant 

microorganism of 

public health 

significance per 

gram of food

Log 

reduction 

(also 

known as 

D)

Decrease in most resistant 

microorganism of public 

health significance per gram 

of food

Percent 

of change

Final number of 

bacteria per 

gram of food

10,000 or log 4 5 10 X 10 X 10 X 10 X 10 = 

100,000-fold

99.999% 0.1 or log -12

10,000 or log 4 6 10 X 10 X 10 X 10 X 10 = 

1,000,000-fold

99.9999% 0.01 or log -2

1 Additional equivalent ways to express 10,000 include 104

, 10^4, and 10E4 

2 Additional equivalent ways to express 0.1 include 10-1 or 1 in 10.

Relative Heat Resistance of Microorganisms

Some microorganisms are more resistant to heat than other microorganisms and, thus, the 

require more stringent heating conditions to kill or inactivate them. Table 4-5 shows the relative 

heat resistance of common types of microorganisms.

Table 4-5. Relative Heat Resistance of Microbial Forms

Resistance to Heat Microbial Form

Highest Bacterial Spores

Moderate • Some Vegetative bacterial cells

• Cysts of Parasites

• Fungi, including fungal spores

Least • Some vegetative bacterial cells

• Viruses

As already noted, this chapter addresses relatively mild heat treatments that reduce microbial 

pathogens but do not lead to commercial sterility. These relatively mild heat treatments are 

used to reduce the number of vegetative cells of bacterial pathogens such as Listeria 

monocytogenes (L. monocytogenes), Salmonella, and enteropathogenic E. coli, and the spores 

of non-proteolytic strains of Clostridium botulinum (C. botulinum) and Bacillus cereus (B. 

cereus). These processes are designed to ensure product safety by achieving a 6-log reduction 

(6D). For a more detailed review of the relative heat resistance of food pathogens in mildly heat 

processed foods, see Jay (1996), FDA (2000), and Farkas (2007).

Factors Affecting the Heat Resistance of Microorganisms

In addition to the inherent heat resistance of specific microorganisms (or life stages of 

microorganisms, such as the spore stage), other factors associated with foods (such as water 

activity, pH, salt content, fat, and protein) can affect the heat resistance of microorganisms. 

Table 4-6 lists the most common factors that you should consider when designing a heat 

treatment as a process preventive control.

Table 4-6. Factors That Influence the Heat Resistance of Microorganisms in Foods

Factor Effect on Microbial Heat Resistance
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Factor Effect on Microbial Heat Resistance

Water As the humidity or moisture goes down, in general the heat 

resistance increases

Fat As the fat content increases, there is a general increase in heat 

resistance of some microorganisms

Salts The effect of salt varies and depends on the kind of salt and 

concentration. Some salts that decease water activity appear to 

increase heat resistance of microorganisms while other salts that may 

increase water activity (e.g., Ca2+ and Mg2+) appear to decrease heat 

resistance.

Carbohydrates The presence of sugars can increase the heat resistance of 

microorganisms due in part to the decrease in water activity. 

However, the impact can be variable, particularly among sugars and 

sugar alcohols.

pH Most microorganisms are more heat resistant near their optimum pH 

for growth. Generally, as the pH increases or decreases relative to 

this optimum pH, the microorganisms become more sensitive to heat.

Proteins Proteins have a protective effect and, thus, increase the heat 

resistance of microorganisms.

Other factors that can influence the heat resistance of microorganisms include the numbers of 

organisms, the age of the microorganisms, the temperatures at which microbial growth occurs, 

the presence of inhibitory compounds, and the time-temperature combination utilized. For a 

comprehensive compilation of data and research on the effect of food factors on the heat 

resistance of food pathogens of public health concern, see ICMSF (1996).

Lethal Heat Treatments 

Cooking:

Baking, boiling, roasting, steaming, and frying are conventional heating methods used for 

cooking a wide variety of foods (e.g., cereal-grain products, vegetables, soups, sauces, 

legumes, and assembled multi-component meals). Cooking is performed for two primary 

reasons: to make food palatable and to make it safe by eliminating vegetative pathogens such 

as Salmonella, L. monocytogenes, and enteropathogenic E. coli. This discussion focuses on the 

food safety aspects of the cooking methods.

You should design a cooking process to target heat resistant vegetative pathogens, such as L. 

monocytogenes. Typically, we recommend a thermal process that achieves a 5D to 7D 

reduction for most cooking treatments. However, if the expected initial microbial load is low, a 

less severe thermal process may be adequate. For cooking processes that target pathogenic 

sporeformers such as C. botulinum type E and non-proteolytic types B and F (i.e., 194°F (90o

C)) 

for 10 min), generally a 6D reduction in the level of contamination is suitable. 

Table 3-D in Appendix 3 of this document provides 6D process times for a range of cooking 

temperatures, with L. monocytogenes as the target pathogen. It is possible that higher levels of 

destruction may be necessary in some foods, e.g., if you expect especially high initial levels of 

the target pathogen.

Table 3-E in Appendix 3 of this document provides 6D process times for a range of heating 

temperatures, with non-proteolytic C. botulinum type B (the most heat-resistant form of nonproteolytic C. botulinum) as the target pathogen. 
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There are a variety of ways to control the application of these cooking processes depending 

upon the type of food and the method of delivery (e.g., boiling, steaming). For example, for 

liquid and semi-liquid food products that are batch-cooked in a cooking vessel such as a kettle 

agitated during the thermal process, the simplest way to control the process is to check the 

internal temperature of the product at the end of the designated cooking time (i.e., check the 

time-temperature parameters of the treatment). A dial thermometer with a long probe works 

quite well. If the temperature is taken at or near the center of the cooking vessel, it is reasonable 

to assume that all product in the cooking vessel is at or above that temperature, because foods 

processed in this manner generally heat by convection or forced convection. You can monitor a 

simple boiling heat process by visually observing and timing the boil. Usually, a temperature 

distribution study is performed to ensure that no point in the cooking vessel is at a lower 

temperature than the minimum value (or critical limit) for temperature required during the 

process. 

Heating food with large particles, like vegetables in stews and some soups, occurs primarily by

conduction, rather than by convection. Particle size and consistency can greatly affect the rate 

of heating at the center of the particle. You cannot control cooking processes for products with 

large particles by periodically checking the internal temperature of some of the product particles

as they leave the cooker because you cannot verify that each particle reached the appropriate 

temperature for adequate time. Therefore, you should establish the process scientifically and 

validate it through a scientific study demonstrating that if the minimum/maximum values are met 

for all the critical factors (e.g., cooking temperature, time, particle size) all particles will receive 

an adequate heat treatment.

Normally, a study to validate a cooking process is performed by a person or group 

knowledgeable in the design of thermal processes to determine the critical parameters required 

for the heat process being applied to ensure that it delivers the desired reduction level (logs of 

kill, as described in section 4.3.1.1 of this chapter). A preventive controls qualified individual 

must conduct (or oversee) such a study. See 21 CFR 117.180(a). (Because it is common 

practice for these studies to be conducted by entities with special expertise in the area, the 

preventive controls qualified individual likely will oversee, rather than conduct, the study.) Once 

that study has been completed, the person conducting the study will provide a time and 

temperature for the processor to monitor during processing, as well as any other parameters 

that are critical to delivery of an adequate heat treatment, such as maximum particle size). You 

can then monitor the time and temperature of the heat process to effectively ensure that all 

product particles have achieved the desired internal temperature. It may also be necessary to 

monitor other factors of the product or the process, such as the internal temperature of the 

product before the start of the process--called the initial temperature (IT), particle size, or 

relative humidity, where they affect the rate of heating. These factors, and their limits, will be 

determined by the process design study.

For some products, such as soups or sauces, you may be able to monitor End-Point Internal 

Product Temperature (EPIPT), a measurement of the internal temperature of the product at the 

end of the heat process, instead of performing continuous time and temperature monitoring. 

This approach is suitable if you have conducted a scientific study to validate that the EPIPT that 

you have selected will provide an appropriate reduction (e.g., 6D) in the numbers of the target 

pathogen in the slowest heating unit or portion of product under the worst set of heating 

conditions covered by the scientific study. If you want to monitor EPIPT, you should:

• Conduct a temperature distribution study within the heating system to identify any cold spots; 
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• Conduct a heat penetration study that accounts for the slowest heating product under the worst case 

heating conditions covered by the scientific study; and 

• Identify other critical factors of processing and/or packaging that affect the rate of product heating 

when scientifically establishing a heat process. 

You should use the EPIPT as a monitoring technique only under those conditions that were 

evaluated by the scientific study, with those conditions identified as process parameters with 

minimum/maximum values (or critical limits) that are monitored as part of your process controls.

See “Chapter 6 – Use of Heat Treatments as a Process Control” in this guidance for additional 

information about the EPIPT monitoring technique.

Other common forms of cooking that are used to produce commercially manufactured foods are 

baking and roasting. These are essentially the same unit operation because they both use 

heated air to alter the eating quality of foods. However, the term “baking” is usually used when 

heated air is applied to flour-based foods or fruits, and the term “roasting” is usually used when 

heated air is applied to meats, nuts, or vegetables. Baking and roasting operations use dry heat 

in gas-fired or electric ovens. For some products such as bakery products, the effectiveness of 

the dry heat in ovens is increased by the addition of steam for various cooking purposes.

Cooking equipment may be batch-type or continuous. In a continuous system the food is moved 

through the cooking equipment by conveyor or auger systems. The methods of controlling and 

monitoring the time-temperature parameters of these types of cooking processes will vary 

depending upon whether it is batch-type or continuous process. See “Chapter 6 – Use of Heat 

Treatments as a Process Control” for an example using baking as a preventive control. 

Emerging Technologies Based on Thermal Effects

Microwave, radio frequency, ohmic heating, and inductive heating are heat-based processes 

that can kill microorganisms by thermal effects. Microwave and radio frequency heating are 

based on the use of electromagnetic waves of certain frequencies to generate heat in a material 

through two mechanisms - dielectric and ionic. Ohmic heating is the process of passing electric 

currents (primarily alternating) through foods or other materials to heat them. The heating 

occurs in the form of internal energy generation within the material. Ohmic heating is 

distinguished from other electrical heating methods either by the presence of electrodes 

contacting the food (as opposed to microwave heating, where electrodes are absent), and 

depends on frequency of the current and waveform (typically sinusoidal). Inductive heating is a 

process of inducing electric currents within the food due to oscillating electromagnetic fields 

generated by electric coils. 

For any of these heat-based processes, the magnitude of time/temperature history and the 

location of the cold points will determine the effect on microorganisms. The effectiveness of 

these processes also depends on water activity and pH of the product. Although the shape of 

the destruction or inactivation curves is expected to be similar to those in conventional heating, 

the intricacies of each of the technologies need special attention if you plan to use them for 

microbial destruction or inactivation. For instance, in microwave heating a number of factors 

influence the location of the cold points, such as the composition, shape, and size of the food, 

the microwave frequency, and the applicator design. The location of the coldest-point and 

time/temperature history can be predicted through simulation software, and we expect that food 

processors may be able to use these emerging technologies in the future. 

For a detailed overview of these processing technologies, as well as alternative thermal 

processing techniques, see Sun (2005).
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4.3.1.2 Use of High Pressure Processing (HPP) as a Lethality Process 

Control

The pressure processing of foods for preservation was studied as early as the end of the 19th 

century and the beginning of the 20th century in the United States by people like Hite (1899) 

and Bridgman (1912). However the potential microbiological effects of HPP were not recognized 

by the food industry until around 1985. HPP has recently received a great deal of attention in 

the food, pharmaceutical, and biotechnology industries. Japan has been a leader in this 

technology, producing products such as jams, jellies, fruit juices, and yogurt.

Microorganisms vary in their sensitivity to high pressure. If you plan to use HPP, you should 

consider the organism of concern, product characteristics and, whether the process is to result 

in product that is to be refrigerated or that will be shelf stable. Destruction of the microorganism 

is primarily caused by changes in the structure and permeability of the cell wall which causes 

fluids to be forced into the cell. 

Bacterial spores are well established as the most pressure-resistant biological forms known. 

Spores resist inactivation by high pressure alone and most require the addition of heat or some 

other mechanism to achieve appropriate levels of destruction. C. botulinum is one of the most 

pressure-resistant and hazardous microorganisms, which is a challenge in the design of highpressure processes. Because of this, the best candidates for HPP continue to be acid foods and 

foods that will be refrigerated following processing (which provide control of sporeformers). 

High pressure processing of foods requires pressures of 400 to 700 MPa, or 4000 - 7000 bars 

(58,000 - 101,000 psig). The unit of measure frequently used for HPP in the food industry is the 

pascal (Pa) or megapascal (MPa, 1,000,000 Pa). Most commercial food industry applications 

use pressures in the range of 600 to 700 MPa. 

High pressure processing requires very specialized and costly equipment. Currently foods using 

HPP are being processed by batch systems. For batch processing, the food is packaged in a 

flexible or semi-flexible package, prior to placing the product in the HPP system, where the 

product is placed into a chamber and immersed in water or some other pressurizing fluid, then

subjected to the high pressure for a time of 1 - 20 minutes, depending on the temperature and 

pressure. The chamber would then be depressurized and the product removed. Applications 

and the feasibility for commercialization for other HPP systems such as semi-continuous, 

continuous, and pulsed HPP have been described elsewhere (FDA, 2000; Indrawati et al. 2003; 

Z. Berk, 2009).

For a detailed review of the application and use of HPP as a process control, see FDA (2000

and 2001) and Hogan et al. (2005).

4.3.1.3 Use of Irradiation as a Lethality Process Control

The application of radiation treatments to food for the purpose of improving safety (e.g. by 

reducing or eliminating pathogenic bacteria) or extending shelf life by (e.g. by reducing or 

eliminating spoilage microorganisms and insects) can use sources that have high enough 

energy levels to cause ionization (the creation of ions by expulsion of orbital electrons from 

atoms) or have lower energy levels that will not cause ionization. These are known as ionizing 

and non-ionizing radiation, respectively. The most commonly used form of radiation to treat 

foods as a lethality process control is ionizing radiation and the discussion in this section of this 

chapter focuses on ionizing radiation. Non-ionizing radiation in the form of lower energy 
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electromagnetic waves such as UV light and infrared heating can be used to treat foods similar 

to that described for microwaves, radio frequency, and ohmic heating in the section of this 

chapter entitled “Emerging Technologies Based on Thermal Effects” and will not be addressed 

here. For more information on the application of infrared (IR) radiation in food processing 

operations, see the review by Krishnamurthy et al. (2008). For more information on the 

application and use of UV light in food processing, see the discussion by FDA (2000, 2001). 

FDA is responsible for regulating the sources of radiation that are used to irradiate food (21 

CFR Part 179 Subpart B). Irradiation is considered a food additive in the United States and, as

such, its use in foods requires premarket approval by FDA (21 CFR Part 179). There are three 

sources of ionizing radiation approved for use on foods (21 CFR 179.26):

• Gamma rays – emitted from radioactive forms of the element cobalt (Cobalt 60) or the element 

cesium (Cesium 137). Gamma radiation is also used routinely in medicine to sterilize medical and

dental products and for the radiation treatment of cancer.

• X-rays – produced by reflecting a high-energy stream of electrons into food off a target substance 

(usually one of the heavy metals) using electron accelerators. X-rays are also widely used in 

medicine and industry to produce images of internal structures.

• Electron beam – (or e-beam) is similar to X-rays and is a stream of high-energy electrons propelled 

from an electron accelerator into food.

Some common terms that are used when describing the application of ionizing radiation in the 

treatment of foods are:

• Dose (absorbed) – The amount of energy absorbed per unit mass of irradiated material.

• D10 value – Amount of radiation required to reduce the population of a specific microorganism by 90% 

(one log10 cycle) under the stated conditions.

• Gray (Gy) - A unit of absorbed dose of ionizing radiation, equal to 1 joule/kg of absorbed energy. 

• Electron volt (eV) – A unit of energy. One electron volt is the kinetic energy acquired by an electron in 

passing through a potential difference of one volt in a vacuum.

The primary reason food irradiation is used as a lethal process control is to inactivate pathogens

and microorganisms that cause food spoilage (Farkas et al., 2014). The application of ionizing 

radiation damages DNA and very effectively inhibits DNA synthesis and further cell division in 

microorganisms that are exposed to these forms and levels of energy. The amount of radiation 

energy used to bring about the control of microorganisms varies according to the radiation 

resistance of the particular organism, which is often specific to the species level and the number 

or load of the microorganisms present. 

Radiation treatment at doses of 2–7 kiloGray (kGy), depending on the source of radiation and 

the food, have been reported to effectively eliminate potentially pathogenic non-sporeforming 

bacteria, including both long-time recognized pathogens such as Salmonella and S. aureus, as 

well as more recently emerged pathogens such as Campylobacter, L. monocytogenes or E. coli 

O157:H7, from suspected food products (Farkas, 1998). As an example, Table 4-7 provides a 

summary of compiled data on the ranges of decimal reduction doses (D10 values) for the most 

important non-sporeforming pathogenic bacteria determined in various foods under various 

conditions.
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Table 4-7. D10 Values (kGy) for Some Foodborne Non-sporeforming Pathogenic Bacteria

Bacteria Non-frozen food Frozen food

Vibrio spp. 0.02-0.14 0.04-0.44

Yersinia enterocolitica 0.04-0.21 0.20-0.39

Campylobacter jejuni 0.08-0.20 0.18-0.32

Aeromonas hydrophila 0.11-0.19 0.21-0.34

Shigella spp. 0.22-0.40 0.22-0.41

Escherichia coli O157:H7 0.24-0.43 0.30-0.98

Staphylococcus aureus 0.26-0.57 0.29-0.45

Salmonella spp. 0.18-0.92 0.37-1.28

Listeria monocytogenes 0.20-1.0 0.52-1.4

Adapted from Farkas et al., 2014

Bacterial spores are more resistant to irradiation than non-sporeforming bacteria. The spores of 

C. botulinum types A and B are particularly resistant.

For illustrative purposes, Table 4-8 lists the approved uses of ionizing radiation for application 

as a process control in food processing as of April, 2016. We adapted Table 4-8 from 21 CFR 

179.26(b), which specifies the limitations on the approved uses of ionizing radiation for the 

treatment of food and includes uses for purposes other than as a process control. For example, 

21 CFR 179.26(b) also specifies limitations on the use of ionizing radiation for use in 

disinfestation of arthropod pests in food. You should refer to 21 CFR 179.26 for the most 

current limitations on the approved uses for the treatment of food using ionizing radiation. 

Table 4-8. Approved Uses for the Treatment of Food Using Ionizing Radiation

Use Limitations

For control of Trichinella spiralis in pork carcasses or fresh, 

non-heat-processed cuts of pork carcasses

Minimum dose 0.3 kiloGray (kGy) (30 

kilorad (krad)); maximum dose not to 

exceed 1 kGy (100 krad).

For microbial disinfection of dry or dehydrated enzyme 

preparations (including immobilized enzymes)

Not to exceed 10 kGy (1 megarad 

(Mrad)).

For microbial disinfection of the following dry or dehydrated 

aromatic vegetable substances when used as ingredients in 

small amounts solely for flavoring or aroma: culinary herbs, 

seeds, spices, vegetable seasonings that are used to impart 

flavor but that are not either represented as, or appear to be, a 

vegetable that is eaten for its own sake, and blends of these 

aromatic vegetable substances. Turmeric and paprika may also 

be irradiated when they are to be used as color additives. The 

blends may contain sodium chloride and minor amounts of dry 

food ingredients ordinarily used in such blends

Not to exceed 30 kGy (3 Mrad).
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Use Limitations

For control of food-borne pathogens in fresh (refrigerated or 

unrefrigerated) or frozen, uncooked poultry products that are: 

(1) Whole carcasses or disjointed portions (or other parts) of 

such carcasses that are “ready-to-cook poultry” within the 

meaning of 9 CFR 381.l(b) (with or without non-fluid seasoning; 

includes, e.g., ground poultry), or (2) mechanically separated 

poultry product (a finely comminuted ingredient produced by the 

mechanical deboning of poultry carcasses or parts of 

carcasses)

Not to exceed 4.5 kGy for non-frozen 

products; not to exceed 7.0 kGy for 

frozen products.

For the sterilization of frozen, packaged meats used solely in 

the National Aeronautics and Space Administration space flight 

programs

Minimum dose 44 kGy (4.4 Mrad). 

Packaging materials used need not 

comply with §179.25(c) provided that 

their use is otherwise permitted by 

applicable regulations in 21 CFR parts 

174 through 186.

For control of foodborne pathogens in, and extension of the 

shelf-life of, refrigerated or frozen, uncooked products that are 

meat within the meaning of 9 CFR 301.2(rr), meat byproducts 

within the meaning of 9 CFR 301.2(tt), or meat food products 

within the meaning of 9 CFR 301.2(uu), with or without non-fluid 

seasoning, that are otherwise composed solely of intact or 

ground meat, meat byproducts, or both meat and meat 

byproducts

Not to exceed 4.5 kGy maximum for 

refrigerated products; not to exceed 7.0 

kGy maximum for frozen products.

For control of Salmonella in fresh shell eggs. Not to exceed 3.0 kGy.

For control of microbial pathogens on seeds for sprouting. Not to exceed 8.0 kGy.

For the control of Vibrio bacteria and other foodborne 

microorganisms in or on fresh or frozen molluscan shellfish.

Not to exceed 5.5 kGy.

For control of food-borne pathogens and extension of shelf-life 

in fresh iceberg lettuce and fresh spinach.

Not to exceed 4.0 kGy.

For control of foodborne pathogens, and extension of shelf-life, 

in unrefrigerated (as well as refrigerated) uncooked meat, meat 

byproducts, and certain meat food products

Not to exceed 4.5 kGy.

For control of food-borne pathogens in, and extension of the 

shelf-life of, chilled or frozen raw, cooked, or partially cooked 

crustaceans or dried crustaceans (water activity less than 0.85), 

with or without spices, minerals, inorganic salts, citrates, citric 

acid, and/or calcium disodium EDTA

Not to exceed 6.0 kGy.

Adapted from 21 CFR Part 179.26(b)

For additional information on processes, application, and equipment used in the ionizing 

radiation treatment of foods see FDA (2004), Lacroix (2005), Fellows (2009a), Farkas and 

Mohacsi-Farkas (2011) and FDA (2015b).

4.3.1.4 Use of Antimicrobial Fumigation as a Lethality Process Control

In California, treatment processes for almonds must use technologies that have been 

determined to achieve a minimum 4-log reduction of Salmonella in almonds (see 7 CFR part 

981, Almonds Grown in California). The Almond Board of California (ABC) has processes in 

place to review treatment processes for scientific adequacy. ABC has funded research projects 

demonstrating that fumigation with propylene oxide (PPO) (a registered fumigant in the United

States for the reduction of bacteria, yeasts, and mold on raw nut meats) is an effective 

treatment for achieving a minimum 4-log reduction of Salmonella in almonds (ABC, 2008). 
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4.3.2 Use of Time-Temperature as a Process Control

Temperature is an essential factor that affects the growth of bacteria. Bacterial growth can occur 

over a wide range of temperatures from about 23°F (-5°C) to 194°F (90° C). Table 4-9 lists four 

types of bacteria based on their temperature growth ranges.

Table 4-9. Temperature Ranges for the Growth of Microorganisms

Group Minimum Temperature 

°C (°F)

Optimum Temperature 

°C (°F)

Maximum Temperature 

°C (°F)

Thermophiles 40 - 45 (104 - 113) 55 - 75 (131 - 167) 60 - 90 (140 - 194)

Mesophiles 5 - 15 (41 - 59) 30 - 45 (86 - 113) 35 - 47 (95 - 117)

Psychrophiles -5 - +5 (23 - 41) 12 - 15 (54 - 59) 15 - 20 (59 - 68)

Psychrotrophs -5 - +5 (23 – 41) 25 - 30 (77 - 86) 30 - 35 (86 - 95)

Thermophiles grow at hot temperatures above 131°F (55°C). Mesophiles grow at or near room 

temperatures. Psychrophiles grow at or near refrigeration temperatures. Psychrotrophs are 

capable of growth at refrigeration temperatures, but their optimal growth temperature is in the 

mesophilic range.

Most pathogenic bacteria are mesophiles and their optimum growth temperature corresponds to 

human body temperature (see Table 3-A of Appendix 3 of this guidance). Typically, the higher 

the temperature (within the normal growth range), the more rapid the growth of the

microorganism.

It is not only the temperature that is of concern; it is the total time of exposure at temperatures

that allow growth that needs to be controlled. The most general recommendation is to hold cold 

foods below 41°F (5°C) and to keep hot foods above 135°F (57°C). However, in some situations 

it may not be possible to completely avoid product exposure to mesophilic temperatures.

4.3.2.1 Use of Refrigeration as a Time-Temperature Process Control

Refrigeration works well for controlling the growth of most pathogenic bacteria. However, some 

pathogens, like L. monocytogenes and Yersinia enterocolitica, can grow at temperatures close 

to freezing. Refrigeration has the added advantage of slowing down biological and chemical 

processes that result in spoilage, oxidative rancidity, and other quality defects. 

Control of temperature during storage can be accomplished in several ways, such as ice, 

chemical coolant gel packs, and mechanical dry refrigeration (e.g., in a cooler). 

Controlling temperature with ice or gel packs can be effective if there is an adequate amount of 

ice or gel packs. Therefore, you should monitor the control by checking whether an adequate 

amount of coolant is present on the product at all times, including when it is shipped and when it 

is received and checking the temperature of the food with a thermometer or temperature 

recording device. 

For mechanical dry refrigerated storage in a cooler, if the ambient temperature can be related to 

the product temperature, monitoring the temperature of the storage area will ensure that the 

product temperature is under control. Ordinarily monitoring of the cooler requires use of 

continuous monitoring instruments such as recorder thermometer charts, maximum-indicating 

thermometers, and high temperature alarms.
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Time/Temperature

When food is removed from refrigeration, the temperature of the food gradually increases and 

can reach the temperature associated with the growth range specific to particular pathogens. 

Bacterial pathogens go through a lag phase, where little or no growth occurs as the 

microorganisms adjust to their new environment. Depending upon the ambient temperature, it is 

possible that food can stay out of refrigeration for at least a couple of hours with no risk of 

significant pathogen growth. As the product temperature approaches the growth range, 

pathogens enter what is called the “log phase” (because they grow logarithmically). The object 

is to prevent that from happening, ideally keeping pathogens in their lag phase. We call the 

temperature range of concern (41°F (5°C) to 135°F (57°C)) the “danger zone.”

Traditionally, the rule of thumb for foods that will support microbial growth has been no more 

than 4 hours in the danger zone (41°F (5°C) to 135°F (57°C)). Different pathogens have 

different rates of growth at different temperatures, and the rate of growth will be affected by the 

type of food and its inherent properties. Therefore, the actual maximum time that a product may 

be safely held in the danger zone depends on a number of factors, including the type of 

pathogens that are present and the ability of the food to support their growth. Guidance on this 

issue is available in the US Food Code2 (FDA, 2013) and in Table 3-B in Appendix 3 of this 

document. You may set limits based on these factors or based on studies done on your own 

specific food products, rather than relying on the 4-hour rule of thumb. Food inspectors should 

also use these factors when they evaluate the significance of time - temperature abuse.

Control of time and temperature during processing may be more complicated than during

storage, because it involves information about the time and temperature exposure of the

product during production. You can obtain this information in a variety of ways, such as marking 

units of product and tracking how long they remain at unrefrigerated temperatures; monitoring

the ambient temperature in a chill room operation; or monitoring product temperatures during

different phases of production. See “Chapter 7 – Use of Time/Temperature Control as a 

Process Control” of this guidance for additional information about the application of timetemperature holding conditions.

Cooling after Cooking

Cooling after cooking can be a critical function influencing the safety of a food (FDA, 2013). 

Depending upon the food and ingredients, cooked foods can still have viable pathogenic 

bacteria present. For example, the spores of sporeforming pathogens such as C. botulinum can 

survive cooking processes. For non-sporeforming pathogens that are particularly heat tolerant 

(such as L. monocytogenes), vegetative cells can sometimes survive the cooking process; 

however, this should not be the case if you selected the appropriate target pathogen for control 

by the applied process and you validated the control. More often, it is the spores of 

 2 The U.S. Food Code (FDA, 2013) is a model that assists food control jurisdictions at all levels of 

government by providing them with a scientifically sound technical and legal basis for regulating the retail 

and food service segment of the industry (restaurants and grocery stores and institutions such as nursing 

homes). Local, state, tribal, and federal regulators use the FDA Food Code as a model to develop or 

update their own food safety rules and to be consistent with national food regulatory policy. Although the 

target audience for the U.S. Food Code does not include most food processing facilities, the U.S. Food 

Code nonetheless contains scientifically-based information that you can use as a resource where 

appropriate in establishing some preventive controls particularly regarding use of refrigeration to control 

the growth of microbial pathogens.
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sporeforming pathogens (such as C. botulinum) that survive the cooking process if they are 

present because temperatures that can only be achieved under pressure are usually needed to 

inactivate spores. These spores will begin to germinate when the product temperature drops to 

a temperature at which they can grow (usually below 135°F (57°C)) and will be present in the 

food during storage. Some spores, such as those from non-proteolytic C. botulinum and some 

strains of B. cereus, have the ability to germinate and grow at refrigeration temperatures, 

although long times are required. Other spores that may be present in the food remain dormant 

until the product is temperature-abused (i.e., held in the temperature range at which these 

pathogens can grow). In such an event, pathogenic spores are able to germinate, grow, and 

the resulting cells can possibly produce toxin due to the fact that most spoilage bacteria (which 

may otherwise compete for growth) have been eliminated by the cooking process. For further 

discussion on the importance of cooling food after cooking see Factors that Influence Microbial 

Growth (Chapter 3 in the Evaluation and Definition of Potentially Hazardous Foods) (FDA, 

2001).

If the cooking process is adequate to inactivate spores and the product is protected from 

recontamination during cooling, the cooling step will not be critical. Situations where these 

conditions exist are probably limited to certain pressurized steam processes.

Simply putting food in a refrigerator is not adequate to prevent microbiological growth. When 

large volumes of hot food are cooled, it can take a long time, sometimes as long as 36 hours, to 

chill the food to a point where pathogen growth is inhibited. The U.S. Food Code specifies the 

application of a two part cooling protocol In order to cool foods safely and keep bacteria in the 

lag phase. First, drop the temperature from 135°F (57°C) to 70°F (21°C) within two hours. The

temperature must be lowered through this range quickly because foodborne pathogens multiply 

most rapidly between these temperatures. Second, after dropping the initial temperature to 70°F 

(21°C), you can take up to additional 4 hours to get the product down to 41°F (5°C). FSIS also 

recommends a two part cooling for meat and poultry, but uses slightly different temperatures: 

“temperature should not remain between 130°F (54°C) and 80°F (27°C) for more than 1.5 hours 

nor between 80°F (27°C) and 40°F (4°C) for more than 5 hours” (FSIS, 1999). Both these 

protocols are adequate to minimize the potential for growth of foodborne pathogens.

A blast freezer is one of the best cooling methods. High velocity cold air can drop the

temperature of large volumes of hot food in less than an hour. The containers of food that have 

been chilled can then be shifted to a holding cooler. 

Cooling tunnels and spiral freezers are similar to blast freezers but are more compatible with 

moving production lines. They use high velocity cold air, or liquid carbon dioxide or nitrogen for

rapid cooling. Products may be frozen before or after packaging depending upon the product 

and package size.

Heat exchangers are used for cooling liquids like milk and juice after pasteurization. Lines 

containing a coolant such as water or cold, raw product run adjacent to lines of hot, pasteurized 

product. No actual exchange or co-mingling of coolant or raw product with heat-treated product 

occurs. However, the cold raw liquid, for example, picks up heat from the hot, pasteurized juice. 

This helps preheat the raw product and also helps precool the heat-treated liquid. See “Chapter 

6 – Use of Heat Treatments as a Process Control” in this guidance for additional information 

about heat exchangers.

Cook-chill operations are typically used in large institutional settings such as prisons, hospitals,

and schools as well as in food processing plants. Food is cooked in nylon reinforced plastic 
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bags or is cooked and then pumped into these bags. The bags are chilled in a tumble chiller that 

tumbles the bags in ice water. This drops the temperature of large volumes of hot food quickly. 

Typically, an ice tank where coils of refrigerant are run through the tank of water provides the 

large volume of cold water needed. 

Be advised that food can be recontaminated during the cooling process as a result of hand

contact, condensate drip, or contact with other foods. See “Chapter 10 – Sanitation Controls” in 

this guidance for additional information about controlling the risk of recontamination.

4.3.2.2 Use of Freezing as a Time-Temperature Process Control

Foods are microbiologically stable when held at temperatures below 17.6oF (-8oC). During 

frozen storage, populations of viable microorganisms in most foods will decrease; however, 

some microorganisms remain viable for long periods of time during frozen storage. Most

viruses, bacterial spores, and some bacterial vegetative cells survive freezing unchanged.

Some of the other microorganisms are sensitive to the freezing and thawing process (i.e.,

freezing, frozen storage, or thawing). Since multi-celled organisms (such as such as parasitic 

protozoa, nematodes, and trematodes) are generally more sensitive to low temperatures than 

are bacteria; freezing and frozen storage are good methods for killing these organisms in 

various foods. This is especially important if consumers are likely to eat the foods raw or

undercooked. See Kennedy (2003) and Fellows (2009b) for a detailed review on the use of 

freezing technologies in the preservation of foods.

4.3.3 Use of Product Formulation as a Process Control

Most food preservation techniques used by processors employ knowledge of factors (such as 

water activity, pH, temperature, nutrients, chemical inhibitors, competitive microflora, and 

atmosphere) that affect the growth of bacteria. For more information on how these factors affect 

microbial growth, see International Commission on Microbiological Specifications for Foods 

(ICMSF) (1996, 2002), Jay (1996), and Zeuthen and Bogh-Sorensen (2003).

In this section of this chapter, we discuss two key factors that are frequently used as a 

formulation process control – i.e., water activity and pH. We also discuss the use of 

preservatives as a formulation process control. 

4.3.3.1 Use of Water activity (aw) as a Formulation Process Control

Microorganisms need water to survive as well as to grow. Water activity (aw) refers to the 

availability of water to the organism. In general, microorganisms survive and grow better when 

the water activity is high than when the water activity is low. 

If you have a closed container of water, the air over the water becomes saturated with water. 

The relative humidity is 100%, which equals a water activity of 1.0. Thus, water has a water 

activity of 1.0. Foods are more complex systems than water, and the water can bind to 

components of the food so not all the water in the food is available to microorganisms; thus, the 

water activity of most food products is less than 1.0. 

Water activity is directly related to the vapor pressure of the water in a solution. You can 

determine water activity by measuring the equilibrium relative humidity of the air over the 

solution in a closed container. Relative humidity divided by 100 equals the water activity:
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(aw) = RH/100

or

aw = p/po

Foods vary in their water activity as shown in Table 4-10. Although you can measure the water 

activity of your specific food if you have the appropriate equipment, for many purposes you can 

rely on the water activity values shown in Table 4-10.
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Table 4-10. Principal Groups of Foods Based on Water Activity (aw) (ICMSF, 1980)

Water Activity Food Groups

0.98 and above • Fresh meats and fish

• Fresh fruits and vegetables 

• Milk and other beverages

• Canned vegetables in brine

• Canned fruit in light syrup

Below 0.98 to 0.93 • Evaporated milk

• Tomato paste

• Lightly salted pork and beef products

• Canned cured meats

• Fermented sausages (not dried)

• Cooked sausages

• Processed cheese

• Gouda cheese

• Canned fruits in heavy syrup

• Bread

Below 0.93 to 0.85 • Dry or fermented sausage

• Dried venison

• Cheddar cheese

• Sweetened condensed milk

Below 0.85 to 0.60 • Intermediate moisture foods

• Dried fruits

• Flour

• Cereals

• Jam and jellies

• Molasses

• Heavily salted fish

• Meat extract

• Nuts

Below 0.60 • Confectionery

• Chocolate

• Honey

• Dried Noodles

• Crackers

• Potato Chips

• Dried egg, milk and vegetables

Table 4-10 organizes the foods into five categories, based on their water activity. Table 4-11 

further classifies these five categories into three categories – i.e., moist foods, intermediatemoisture foods (often included in the low-moisture foods category), and low-moisture foods. 

Moist foods (i.e., foods with water activity above 0.85) require refrigeration or another barrier to 

control the growth of pathogens (see Table 4-11). Intermediate-moisture foods (i.e., foods with 

water activities between 0.60 and 0.85) do not require refrigeration to control pathogens, but

they may have a limited shelf life because of spoilage, primarily by yeast and mold. The 

microbiological stability of intermediate-moisture foods may depend on factors other than water 

activity, such as reduced pH, chemical preservatives, heat treatments, or combinations of these, 

even though the reduced water activity is of major importance. Low-moisture foods (i.e., foods 

with a water activity below 0.60) have an extended shelf life, even without refrigeration.
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Table 4-11. Classification of Foods and Control Requirements Based on Water 

Activity

Water Activity Classification Requirements for Control

Above 0.85 Moist Foods Require refrigeration or another barrier to control the

growth of pathogens

0.60 and 0.85

IntermediateMoisture Foods

• Do not require refrigeration to control pathogens 

• Limited shelf life because of spoilage, primarily by

yeast & mold

Below 0.60 Low-Moisture

Foods

Extended shelf life, even without refrigeration

See Table 4-12 for some examples of moist foods (water activities above 0.85). Most fresh 

meats, fruits, and vegetables, and many dairy products, fall into this category. The big surprise 

here is probably the bread. Most of us tend to think it is a dry, shelf-stable product. Actually, the 

“crumb” (interior) has a relatively high water activity. It is safe because of the multiple barriers of 

pH, water activity (the crust has a low water activity), and preferential growth by mold rather 

than pathogens. In other words, the bread spoils before it becomes hazardous.

Table 4-12. Examples of High Moisture (High Water Activity (aw)) Foods

Moist Foods Water Activity (aw)

Lettuce 0.99

Apples 0.99

Milk 0.98

Bread 0.95

See Table 4-13 for some examples of intermediate-moisture foods (water activity between 0.60 

and 0.85). Some unique products like soy sauce appear to be a high moisture product, but 

actually are in the intermediate-moisture category because salt, sugars or other ingredients bind 

the moisture. Because jams and jellies have a water activity that will support the growth of yeast 

and mold, they are mildly heat-treated immediately before packaging to prevent spoilage.

Table 4-13. Examples of Intermediate Moisture Foods

Intermediate Moisture Foods Water Activity (aw)

Soy sauce 0.80

Jams 0.80

Molasses 0.76

Honey 0.75

Flour 0.70

Dried fruit 0.70

Candies 0.65

See Table 4-14 for some examples of low-moisture foods (water activity below 0.60).
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Table 4-14. Examples of Low-Moisture Foods

Low-Moisture Foods Water Activity (aw)

Dried noodles 0.50

Cookies 0.30

RTE Cereals 0.20

Crackers 0.10

Some of the intermediate and low water activity foods have naturally low water activity (e.g.,

molasses and flour). We do not discuss those foods because water activity does not have to be 

controlled during processing.

Other intermediate and low water activity foods, like dried fruit, strawberry jam, crackers, soy 

sauce, and dried noodles, start with a high water activity and, through processing, end up with a 

reduced water activity. This section of this chapter focuses on these types of foods.

Control of Water Activity

Some products require careful control of water activity for food safety, while others do not. For 

example, the production of jam does not need careful control of water activity for food safety 

because the food would not thicken (and, thus, become jam) unless the water activity was 

reduced through the addition of the necessary amount of sugar. On the other hand, dried fruit 

products need careful control of water activity for food safety, because fruit products with a 

variety of moisture levels could still appear to be “dried fruit.”

There are two primary ways of reducing water activity in foods: (1) product formulation (such as 

by adding salt or sugar); and (2) dehydration (drying). In this section of this chapter, we discuss 

reducing water activity by product formulation. In section 4.3.4 of this document, we discuss 

reducing water activity by dehydration. 

Every organism has a minimum, optimum, and maximum water activity for growth (see Table 3-

A in Appendix 3 of this document). Yeasts and molds can grow at low water activity; however 

0.85 is considered the safe cutoff level for pathogen growth. Water activity of 0.85 is based on 

the minimum water activity for S. aureus growth. For a detailed discussion and listing of the 

minimal water activities for microorganisms of public health concern, see ICMSF (1996).

There are two basic ways for how you can approach product formulation that uses control of

water activity for food safety. One approach is to closely follow a scientifically established 

process for formulation that ensures a water activity of 0.85 or below. The other approach is to 

develop your own process for formulation and to validate it by taking finished product samples 

and testing them for water activity.

4.3.3.2 Use of Acidity (pH) as a Formulation Process Control

The term “pH” refers to a numeric scale used to describe acidity and alkalinity. The pH reflects 

the concentration of hydrogen ions and is expressed mathematically as the negative logarithm 

of the hydrogen ion concentration. The pH scale ranges from 0 to 14, with 7 being neutral.

pH = (-log of the [H+])
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Microorganisms can only grow at certain pH levels (Table 4-15). Table 4-15 shows that mold 

and yeast can grow over a broad range of pH, including very low pH. Table 4-15 also shows 

that the pH range where bacteria can grow is more restricted in that bacteria don’t grow at very 

low pH.

Table 4-15. Growth Limiting pH Ranges for Microorganisms

Type of Microorganism pH Range for Growth

Bacteria (Gram+) 4.0 to 8.5

Bacteria (Gram -) 4.5 to 9.0

Molds 1.5 to 9.0

Yeast 2.0 to 8.5

Table 4-15 classifies bacteria as “Gram positive” and “Gram negative.” In general, “Gram 

positive” and “Gram negative” are designations associated with the cell walls of bacteria, and 

how the bacterial cell walls appear under a microscope when a stain is used to see them. Gram 

positive bacteria appear blue, and gram negative bacteria appear red.

Lowering the pH is considered primarily a method of inhibiting the growth of bacteria rather than

a method for killing bacteria. Although many microorganisms held at low pH for an extended

time will be killed, keep in mind that some pathogenic bacteria, and in particular E. coli 

O157:H7, can survive acidic conditions for extended periods of time, even if their growth is 

inhibited. For details on the minimum and maximum pH limits for bacterial pathogens, see Table 

3-A of Appendix 3 of this document.

Foods with a natural pH of 4.6 and below are considered acid foods. Some foods are naturally 

acidic, including most fruits (e.g., many peaches, pH 4.0; apples, pH 3.5). However, some 

tropical fruits, including some pineapple, may fall in the pH range above 4.6, depending in part 

on variety and growing conditions. Foods with a pH above 4.6 are said to be low-acid foods. 

Examples of low-acid foods include protein foods (such as milk and eggs), most vegetables, 

and starch based foods (such as bread and crackers).

Acidification

Because an acid pH can inhibit the growth of many bacteria, acidification of foods is a common 

formulation process control. Acidification is the direct addition of acid to a low-acid food. 

Examples of foods that are acidified as a process control include pickled beets and peppers. 

There are a variety of acids (such as acetic acid, lactic acid, and citric acid) that can be used to 

acidify foods, depending on the desired attributes of the finished product. 

We have established specific CGMP requirements for thermally processed low-acid foods 

packaged in hermetically sealed containers (commonly called “low-acid canned foods” or LACF 

(21 CFR part 113). We also have established requirements for acidified foods (21 CFR part 

114). At the time when we established these regulations, the focus of these CGMP 

requirements was the control of C. botulinum; when the pH of a food is 4.6 or below, spores of 

C. botulinum will not germinate and grow. As a result, the pH of 4.6 is a dividing line for the 

purpose of determining whether a food other than an acid food is subject to part 113 as an 

LACF or part 114 as an acidified food. See 21 CFR 114.3. 
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An acid food, such as tomatoes with a pH of 4.2, is not subject to either the LACF regulations or 

the acidified foods regulations. Under the acidified foods regulations, “acidified foods” are lowacid foods to which acid(s) or acid food(s) are added; they have a water activity greater than 

0.85 and have a finished equilibrium pH of 4.6 or below (21 CFR 114.3(b)). The definition of 

acidified foods provides that carbonated beverages, foods that are stored, distributed, and 

retailed under refrigeration, and certain other foods are excluded from the coverage of 21 CFR 

part 114 (21 CFR 114.3(b)).

Processors of acidified foods must register with FDA to obtain a Food Canning Establishment 

number (21 CFR 108.25(c)(1)). Processors of acidified foods also must file a scheduled process 

with FDA (21 CFR 108.25(c)(2)); the scheduled process is the process selected by a processor 

as adequate for use under the conditions of manufacture for a food in achieving and maintaining 

a food that will not permit the growth of pathogens. The scheduled process includes control of 

pH and other critical factors equivalent to the process established by a competent processing 

authority (21 CFR 114.3). Acidified foods must be so manufactured, processed, and packaged 

that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the 

scheduled process and maintained in all finished foods; manufacturing must be in accordance 

with the scheduled process (21 CFR 114.80(a)(1)). Sufficient control, including frequent testing 

and recording of results, must be exercised so that the finished equilibrium pH values for 

acidified foods are not higher than 4.6 (21 CFR 114.80(a)(2)). An equilibrium pH is achieved 

when a natural pH balance has been reached by all ingredients - which can take several days in 

foods with very large particulates (National Canners Association, 1968). You should refrigerate 

products that require several days to reach equilibrium pH to prevent the growth of C. botulinum 

or other pathogens.

There are several different methods of adding the acid to the product. One method is called 

direct acidification, where predetermined amounts of acid and the low-acid foods are added to 

individual finished product containers during production. With this method, it is important that the 

processor control the acid-to-food ratio. This is probably the most common method used for 

acidified vegetables. Another method of acidification is batch acidification. As the name implies, 

acid and food are combined in large batches and allowed to equilibrate. The acidified food is 

then packaged.

Acidified foods must be treated sufficiently to control spoilage microorganisms in addition to 

vegetative pathogens. Although one reason is to prevent spoilage triggering economic loss, the 

food safety reason is that the action of the spoilage organisms can raise the pH, compromising 

the safety of the product because any spores of C. botulinum that are in the food can germinate, 

grow, and produce botulinum toxin. The acidified foods regulation requires that you thermally 

process the food to an extent that is sufficient to destroy the vegetative cells of pathogenic and 

non-pathogenic microorganisms capable of reproducing in the food under the conditions in 

which the food is stored, distributed, retailed and held by the user. However, you may use 

permitted preservatives to inhibit reproduction of non-pathogenic microorganisms in lieu of 

thermal processing. (21 CFR 114.80(a)(1))

For further information on the use of acidification of foods as a process control, see 21 CFR part 

114. The regulation provides detailed information on appropriate procedures to measure pH for 

foods.
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Fermentation

During bacterial fermentation, acid-producing bacteria produce lactic acid, which reduces the 

pH. Because the reduced pH can inhibit the growth of many bacteria, bacterial fermentation of 

foods is a common formulation process control. Examples of low-acid foods fermented by 

bacterial fermentation to a pH below 4.6 include fermented olives, fermented cucumber pickles, 

cheeses, and sauerkraut. Molds are used to ferment some foods such as soy sauce, tamari 

sauce, and other oriental foods, mainly for taste and other characteristics.

In practice, fermentation is an art. You need to encourage growth of favorable organisms and 

discourage the growth of organisms that can cause spoilage. This is usually accomplished by 

adding salt or a starter culture to the food, or in some cases slightly acidifying it. A starter culture 

can be either yeast or bacteria.

In many fermented products, there is no process to eliminate the acid-producing bacteria. These 

fermented products are kept refrigerated so that the culture bacteria and bacteria not killed 

during the fermentation process do not spoil the product.

4.3.3.3 Use of Preservatives as a Formulation Process Control

Preservatives can be used to prevent the growth of microorganisms – e.g., if a food product is 

not thermally processed (or not thermally processed to an extent that is sufficient to kill the 

vegetative cells of non-pathogenic microorganisms (such as spoilage microorganisms) that are 

capable of reproducing in the food under the conditions in which the food is stored, distributed, 

retailed and held by the user). Preservatives work by denaturing protein, inhibiting enzymes, or

altering or destroying the cell walls or cell membranes of microorganisms. Examples of products 

that use preservatives as a formulation process control include acidified foods that are either not 

thermally processed or only minimally thermally processed, hummus (which uses sodium 

benzoate to inhibit yeast and mold), and many breads (which use calcium propionate to inhibit 

mold). 

Some of the more commonly used preservatives are:

• Acetic acid and its salts (e.g., sodium acetate, sodium diacetate), which is added to reduce bacterial 

growth. 

• Benzoates, which include benzoic acid, sodium benzoate and potassium benzoate. Benzoates are 

used primarily to inhibit yeast or mold. Also can inhibit bacterial pathogens (e.g., S. aureus, L. 

monocytogenes).

• Natamycin is applied on cheese to inhibit the growth of fungi. 

• Nisin is used as an antimicrobial agent to inhibit the outgrowth of C. botulinum spores and toxin 

formation in a variety of pasteurized process cheese spreads. 

• Propionates, which include propionic acid, and sodium, potassium and calcium propionates, are

used in breads, cakes, and cheeses to inhibit mold. Also can inhibit bacterial pathogens (e.g., S. 

aureus, Salmonella).

• Sorbates, which include sorbic acid, and sodium and potassium sorbates. Sorbates are primarily 

used to inhibit yeast and mold. Also can inhibit bacterial pathogens (e.g., E. coli O157:H7, L. 

monocytogenes).
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• Sulfites, such as sulfur dioxide, are used in a variety of products including lemon juice, seafood, 

vegetables, molasses, wines, dried fruit, and fruit juices. Sulfites are used primarily as an antioxidant 

but also have antimicrobial properties.

Table 4-16 provides examples of how some of these commonly used preservatives are used. 

Table 4-16. Preservatives Commonly Used in Conjunction with Main Groups of Foods in 

the United States

Foodstuff Acetic 

Acid

Benzoates Natamycin Nisin Propionates Sorbates Sulfites

Fat Emulsions + + - - - ++ -

Cheese - (+) + + + ++ -

Vegetable 

Products

++ ++ - - - ++ +

Fruit products + ++ - - - ++ ++

Beverages - ++ - - - ++ (+)

Baked goods + - - - ++ ++ -

Confectionery - (+) - - - ++ -

Source: Adapted from Davidson and Branen 1993; Table 11 in Lück and Jager 1997, p 61

++ used frequently

+ used occasionally

(+) used in exceptional cases only

 - not used

A food category that may benefit from the use of preservatives as a formulation process control 

is fresh, refrigerated, RTE deli salads. This category of food, which is typically formulated with 

multiple components, including spices and fresh vegetables, may experience a high bio-load at 

the time of preparation if treated ingredients are not used. Maintaining quality (e.g., by 

preventing spoilage by yeasts and molds) and ensuring product safety cannot always be 

achieved by reducing pH (e.g., by using an acidified food as a salad dressing (such as 

mayonnaise) or an acid food as a salad dressing (such as vinegar)). Antimicrobial substances 

such as potassium sorbate and propionic acid are commonly used for a variety of RTE deli 

salads to inhibit bacteria, yeast, and mold, extending the product shelf-life. 

For further regulatory guidance on the use of antimicrobial substances, see FDA (1999). For a 

comprehensive review on the application of antimicrobials, see Davidson, et al. (2005).

4.3.4 Use of Dehydration/Drying as a Process Control

Dehydration (which reduces water activity) is one of the oldest methods of food preservation. In 

the United States, there are three primary methods of dehydration as a process control. 

• Freeze-drying - used for a variety of products

• Forced air drying - used for solid foods like vegetables and fruit 

• Spray drying - used for liquids and semi-liquids like milk
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Dehydrated/dried products are usually considered shelf stable due to their low water activity 

(aw) and, therefore, are often stored and distributed unrefrigerated. Examples of shelf-stable 

dehydrated/dried food products include milk powders, powdered beverages, pasta, and dried 

peas and beans. 

If you use dehydration/drying as a process control, you should select a packaging material that 

will prevent rehydration of the product under the expected conditions of storage and distribution. 

Additionally, finished product package closures should be free of gross defects that could 

expose the product to moisture during storage and distribution. 

See “Chapter 9 – Use of Dehydration/Drying as a Process Control” of this guidance for 

additional information on the use of dehydration/drying as a process control. For a detailed 

overview of dehydration/drying technologies commonly used in the United States (including 

freeze drying, forced air drying, and spray drying), as well as other dehydration technologies 

such as drum drying and fluid bed drying, see Greensmith (1998) and Heldman and Lund 

(2007). For a discussion on the effects of drying on microorganisms, see Jay (1996).

4.3.5 Use of Recipe Management as a Process Control for Food Ingredients 

A food ingredient (such as a food additive, color additive, or GRAS substance) can be a 

chemical hazard if it is added in excess of a maximum use level, regardless of whether the 

maximum use level is established due to food intolerance (such as for sulfites) or is otherwise a 

condition of safe use of a food additive, color additive, or GRAS substance. Control strategies to 

prevent misformulation of food ingredients generally include recipe management to ensure that 

excessive amounts are not added. 

4.3.6 Use of Storage Conditions as a Process Control for Mycotoxins

Mycotoxins are toxic metabolites produced by certain fungi (i.e., molds) that can infect and 

proliferate on raw agricultural commodities (e.g., grains such as wheat and corn, peanuts, fruits,

and tree nuts) in the field and during storage. Contamination by toxigenic fungi during storage 

and transportation is caused by improper drying or re-wetting of the crop from rain or 

condensation. Thus, effective process controls involve correct drying and storage.

By far the most critical environmental factors determining whether a raw agricultural commodity 

will support mold growth are temperature, moisture content, and time, and each of these 

parameters can be manipulated and controlled to manage the prevention of mold growth in a 

raw agricultural commodity. The principal process control for prevention of mold growth in 

storage conditions is the control of moisture. Although low-temperature storage can help control 

mold growth in some conditions, large-scale storage of raw agricultural commodities generally 

takes place in structures that do not provide for low-temperature and, thus, low-temperature 

storage generally is not a control measure for mold during the storage of raw agricultural 

commodities.

4.3.7 Use of Physical Sorting as a Process Control for Mycotoxins

In most cases, mycotoxins in raw agricultural commodities are present in a very small proportion 

of individual seeds or kernels. As a result, removing the contaminated seeds or kernels 

mechanically is a practical and effective process control to reduce the mycotoxin content of the 

bulk raw agricultural commodity (West and Bullerman, 1991). Various techniques have been 

devised, based on color and visual appearance of decay or damage, to separate out 
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contaminated seeds during inspection processes. This may be manual or by more advanced 

electronic instrumental selection.

4.3.8 Use of Exclusion Strategies as a Process Control for Physical Hazards

 4.3.8.1 Exclusion Strategies as a Process Control for Metal Hazards

Metal-to-metal contact during processing can introduce metal fragments into products. For 

example, metal fragments can break off during mechanical cutting and blending operations, and 

some metal equipment has parts that can break or fall off, such as wire-mesh belts. You can 

control metal hazards by using physical separation techniques (such as magnets, sieves, 

screens, or flotation tanks), by using electronic or X-ray metal detection devices, and by 

regularly inspecting at-risk equipment for signs of damage.

The effectiveness of physical separation techniques depends on the nature of the product. 

These measures are more likely to be effective in liquids, powders, and similar products in 

which the metal fragment will not become imbedded.

The use of electronic metal detectors is complex, especially with regard to stainless steel, which 

is difficult to detect. The orientation of the metal object in the food affects the ability of the 

equipment to detect it. For example, if a detector is not properly calibrated and is set to detect a 

sphere 0.08 inch (2 mm) in diameter, it may fail to detect a stainless steel wire that is smaller in 

diameter but up to 0.9 inch (24 mm) long, depending on the orientation of the wire as it travels 

through the detector. Processing factors, such as ambient humidity or product acidity, may 

affect the conductivity of the product and create an interference signal that may mask metal 

inclusion unless the detector is properly calibrated. You should consider these factors when 

calibrating and using this equipment.

X-ray devices can also be used for metal detection. One advantage in using such a device is 

that X-rays can detect non-metal foreign objects that may also be hazardous, such as glass 

fragments. 

Preventive maintenance of equipment and periodically examining your processing equipment 

for damage that can contribute metal fragments can be a useful control measure, particularly 

when you have a piece of equipment that is prone to break, such as saw blades, or equipment 

that has metal-to-metal contact. The success of this strategy depends in large part on the nature 

of the equipment inspected and the frequency of the inspection. However, this approach will not 

necessarily prevent metal fragments from being incorporated into the product in all cases, but 

may enable you to separate products that may have been exposed to metal fragments. Visually 

inspecting equipment for damaged or missing parts may only be feasible with relatively simple 

equipment, such as band saws, small orbital blenders, and wire mesh belts. More complex 

equipment that contains many parts, some of which may not be readily visible, may not be 

suitable for visual inspection and may require controls such as metal detection or physical 

separation techniques.

See “Chapter 13-- Preventive Controls for Physical Hazards” of this guidance for additional 

information on the control of metal hazards.
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 4.3.8.2 Exclusion Strategies as a Process Control for Glass Hazards

Glass fragments can be introduced into food whenever processing involves the use of glass 

containers. Normal handling and packaging methods, especially mechanized methods, can 

result in breakage. Ingesting glass fragments can cause injury to the consumer. Most products 

packed in glass containers are intended to be a ready-to-eat (RTE) commodity that requires 

minimal handling on the part of the consumer before eating, so that consumers have little 

opportunity to detect glass inclusion. 

This chapter addresses the hazard of glass fragments that may occur from the use of glass 

containers. You should address the hazard of glass fragments originating from sources such as 

overhead light fixtures through CGMPs. 

You can help prevent glass from getting into your food products by periodically checking the 

processing areas and equipment for glass breakage. In addition, the line operator can listen for 

breakage and can look for broken glass on the floor. (You can enhance the utility of these 

controls by painting the floor under the processing line in a color that highlights the container 

glass.) These types of controls will not necessarily prevent glass fragments from being 

incorporated into your product, but they can enable you to separate products that may have 

been exposed to glass fragments from those that have not. 

You also can help prevent glass fragments from getting into your food products by cleaning 

empty containers before filling into the product package. You can do so by using water or 

compressed air and inverting the container during or after cleaning. You should be mindful that 

container cleaning may not fully control glass hazards in some processes that use automated 

filling systems because this equipment can result in glass breakage during the filling and

capping process. 

See “Chapter 13--Preventive Controls for Physical Hazards” of this guidance for additional 

information on the control of glass hazards.

4.4 Sanitation Controls 

CGMPs require sanitary operations (21 CFR 117.35) and sanitary facilities and controls (21 

CFR 117.37). There are requirements applicable to the cleanliness of equipment and utensils, 

including food-contact surfaces (21 CFR 117.40), and plant construction and design (21 CFR 

117.20(b)). To comply with these CGMP requirements, sanitation procedures, practices, and 

processes should take place every day in your facility. 

Sanitation controls include procedures, practices, and processes to ensure that the facility is 

maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as 

environmental pathogens, biological hazards due to employee handling, and food allergen 

hazards. Sanitation controls must include, as appropriate to the facility and the food, 

procedures, practices, and processes for the: (1) Cleanliness of food-contact surfaces, including 

food-contact surfaces of utensils and equipment; and (2) prevention of allergen cross-contact 

and cross-contamination from insanitary objects and from personnel to food, food packaging 

material, and other food-contact surfaces and from raw product to processed product. (See 21 

CFR 117.135(c)(3).) 

You determine which hazards require a sanitation control, rather than CGMPs, through your

hazard analysis. Thus, some – but not all - of your sanitation procedures, practices, and 
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processes will be “sanitation controls”; other sanitation procedures, practices, and processes 

will be CGMPs. For your sanitation controls to be effective, you should first assess the 

sanitation procedures, practices, and processes that you will have in place to comply with the 

CGMP requirements. For example, equipment design that ensures that all surfaces can be 

accessed and cleaned is essential for the effective application of sanitation controls. Effective 

sanitary design should consider factors such as whether equipment includes hollow bodies or 

poorly developed welds and seams, as well as whether ease of disassembly allows adequate 

access to all food-contact surfaces to ensure thorough cleaning and sanitation. Sanitary design 

also applies to food facility structures (e.g., floors, walls, piping, and ceilings) to ensure effective 

cleaning and sanitation practices. The required elements for cleaning – time, temperature, 

mechanical force and chemical concentration – simply cannot be reliably applied if the 

equipment and facility structural design does not allow adequate access (Marriott and Gravani, 

2010). Due to this link between your CGMP procedures, practices, and processes and your 

sanitation controls, your CGMP procedures, practices, and processes are sometimes called 

“prerequisite programs.”

The nature of the processing conditions (i.e., wet or dry) required for the manufacture of a 

particular product (such as a dry processing environment for spray dried milk powder, and a wet 

processing environment for soft cheese) impacts the selection of the appropriate CGMP 

sanitation procedures, practices, and processes or the appropriate sanitation control. For 

example, moisture control is critically important in preventing contamination by an environmental 

pathogen, such as Salmonella, in low-moisture products. Water in a dry processing 

environment is one of the most significant risk factors for Salmonella contamination, because 

the presence of water allows for pathogen growth leading to product contamination from the 

environment or from insanitary food contact surfaces. Therefore, dry cleaning or controlled wet 

cleaning practices should be considered for use as sanitation control measures in a dry 

processing environment. Any time water is used for cleaning, the equipment should be 

thoroughly dried before use. Wet processing operations are subject to wet cleaning. However, 

water, in particular standing water, should be minimized even if facilities are wet cleaned. This 

is particularly true for facilities that need to control L. monocytogenes because they are 

producing RTE products exposed to the environment.

The nature of a bacterial pathogen (e.g., whether it is a transient or a resident strain of an 

environmental pathogen) also impacts the selection of the appropriate CGMP sanitation 

procedures, practices, and processes, or the appropriate sanitation control. (See section 

3.2.5.2 (Transient vs. resident facility-related environmental pathogens) in “Chapter 3-- Potential 

Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food” 

in this guidance for additional information about transient and resident strains of environmental 

pathogens. 

Table 4-17 lists examples of the application of sanitation controls to significantly minimize or 

prevent biological and chemical hazards and the section in this chapter that addresses each 

listed example. 
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Table 4-17. Examples of Sanitation Controls 

Sanitation Control 

Subcategory

Examples Chapter Section

Cleaning food-contact 

surfaces

• Applying a full wet clean with detergents 

and sanitizers for Clean in Place and Clean 

out of Place (CIP/COP)

• Applying controlled wet clean with minimum 

water usage and wipe down (COP)

• Dry cleaning with vacuums, brushes, wipes

4.4.1

Control cross-contact / crosscontamination

• Using hygienic zoning for separation of 

process operations such as raw vs. Workin-Process (WIP) vs. finished product; wet 

vs. dry; personnel and materials flow; air 

balance

• Using dedicated cleaning / sanitation 

practices in designated hygiene zones (see 

cleaning food-contact surfaces)

• Cleaning between different products 

containing different allergens

4.4.2

See “Chapter 10 – Sanitation Controls” of this guidance for additional information about 

sanitation controls. In addition to this guidance, a number of sources of scientific and technical 

information can be useful in establishing sanitation controls. See Holah, 2014 and Marriott and 

Gravani, 2010. 

4.4.1 Use of Sanitation Controls for the Cleanliness of Food-Contact Surfaces

The CGMP requirements for sanitary operations include specific requirements for cleaning foodcontact surfaces. See 21 CFR 117.35(d). All food-contact surfaces, including utensils and 

food-contact surfaces of equipment, must be cleaned as frequently as necessary to protect 

against allergen cross-contact and against contamination of food (21 CFR 117.35(d)). Foodcontact surfaces used for manufacturing/processing, packing, or holding low-moisture food must 

be in a clean, dry, sanitary condition before use (21 CFR 117.35(d)(1)). When the surfaces are 

wet-cleaned, they must, when necessary, be sanitized and thoroughly dried before subsequent 

use (21 CFR 117.35(d)(1)). In wet processing, when cleaning is necessary to protect against 

allergen cross-contact or the introduction of microorganisms into food, all food-contact surfaces 

must be cleaned and sanitized before use and after any interruption during which the foodcontact surfaces may have become contaminated (21 CFR 117.35(d)(2)). Where equipment 

and utensils are used in a continuous production operation, the utensils and food-contact 

surfaces of the equipment must be cleaned and sanitized as necessary (21 CFR 117.35(d)(2). 

Part 117 does not define the term “cleaning.” In this guidance, we use the term “cleaning” to 

mean removing the “soil”– i.e., bacteriological nutrients, such as fats, carbohydrates, proteins,
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and minerals”– that can build up on food-contact surfaces in the plant and processing 

equipment. Part 117 defines “sanitize” to mean to adequately treat cleaned surfaces by a 

process that is effective in destroying vegetative cells of pathogens, and in substantially 

reducing numbers of other undesirable microorganisms, but without adversely affecting the 

product or its safety for the consumer. (21 CFR 117.3) Although cleaning operations and 

sanitizing operations often are conducted separately – and sequentially – some systems (such 

as steam systems) both clean and sanitize the surfaces; we consider that such systems satisfy 

the definition of ‘‘sanitize.’’ (See 80 FR 55908 at 55956.)

Table 4-16 describes three types of cleaning strategies that you can use to remove soil, 

depending upon the processing conditions (wet or dry). Table 4-16 includes our 

recommendations for using these cleaning strategies. See Appendix 4 of this guidance for more 

details about these cleaning strategies.

Table 4-18. Types of Cleaning Strategies

Cleaning Strategy Description and Recommendations

Wet Cleaning Uses water-based and/or wet chemical cleaning solutions. When using 

wet cleaning, you should avoid certain practices, e.g., excessive use of 

water (e.g., floor is flooded with water), high pressure hoses. Instead, 

you should use water on an as-needed basis. You also should

minimize and isolate your use of water to specific areas where possible. 

Drying after wet cleaning helps to minimize growth of remaining 

microorganisms. 

Dry Cleaning Does not use any water. Dry cleaning is the physical removal of 

residues (e.g., food particles and dust) without water. You should 

remove food residues by actions such as sweeping, brushing, scraping, 

or vacuuming the residues from equipment surfaces and the facility 

environment. Be careful to not distribute food particles to other 

equipment or areas during removal. 

Controlled Wet 

Cleaning

Uses a limited amount of water, generally for dry operations. Complete 

drying should follow immediately after the controlled wet cleaning. You 

can move specific pieces of equipment out of the area to be wet 

cleaned, sanitized, and dried and then return the equipment after the 

area is cleaned.

After the surfaces are cleaned and rinsed you should sanitize food contact surfaces and other 

areas as appropriate. You should use all sanitizers in accordance with the EPA-registered (or 

similar registration in other countries) label use instructions, including approval for use in food 

establishments. 

As noted in section 4.4, sanitation controls must include, as appropriate to the facility and the 

food, procedures, practices, and processes for the cleanliness of food-contact surfaces, 

including food-contact surfaces of utensils and equipment. (See 21 CFR 117.135(c)(3).)

Examples of sanitation controls related to the cleanliness of food-contact surfaces include 

cleaning and sanitizing procedures, practices, and processes (including appropriate frequencies 

for these procedures, concentrations of cleaning and sanitizing compounds, method of 

application, and contact time) (Holah, 2014). See “Chapter 10 – Sanitation Controls” of this 

guidance for a practical example of the application of cleaning and sanitizing of food-contact 

surfaces as a preventive control for bacterial contamination.
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4.4.2 Use of Sanitation Controls to Prevent Allergen Cross-contact and 

Cross-contamination

As noted in section 4.4, sanitation controls must include, as appropriate to the facility and the 

food, procedures, practices, and processes for the prevention of allergen cross-contact and 

cross-contamination from insanitary objects and from personnel to food, food packaging 

material, and other food-contact surfaces and from raw product to processed product. (See 21 

CFR 117.135(c)(3).) 

Table 4-19 describes three common practices that you can use to prevent allergen crosscontact and to prevent cross-contamination of foods from insanitary objects, poor hygienic 

practices, different processing operations, and environmental pathogens. 

Table 4-19. Common Practices to Prevent Allergen Cross-contact and Crosscontamination 

Practice Description

Hygienic Zoning Hygienic zoning for separation and segregation of process operations such 

as raw vs. work-in-process vs. finished product; wet vs. dry; personnel and 

materials traffic flow; air balance

Hygienic Zone 

Specific Cleaning

Dedicated cleaning / sanitation practices within hygiene zones 

Allergen Specific 

Cleaning

Cleaning between different products containing different allergens

The objective of hygienic zoning is to reduce the potential for transient pathogens to enter 

sensitive areas in the facility, such as packing areas where an RTE product is exposed to the 

processing environment. Typically, this type of sanitation control is applied in facilities that 

make RTE products. 

You should determine the need for, and scope of, a hygienic zoning program based on your 

facility, the products you make, and the outcome of your hazard analysis. For example, the 

need for, and scope of, a hygienic zoning program are likely to be very different for a flour mill, 

a facility that makes RTE refrigerated food, and a facility that makes canned acidified foods. In 

determining the need for, and scope of, a hygienic zoning program, you should take into 

account the structure of your plant, packaging, personnel and ingredient traffic flows, and any 

cross over areas. You also should consider potential contaminants from raw materials, air flow, 

support areas, and other activities taking place in the facility. 

Some facilities implement hygienic zoning for quality reasons (e.g., to control mold 

contamination); however, the sanitation controls that are the subject of this guidance need only 

address food safety. See “Chapter 10 – Sanitation Controls” of this guidance for a practical 

example for the application of hygienic zoning to prevent recontamination by environmental 

pathogens.

4.5 Food Allergen Controls

Food allergen controls include procedures, practices, and processes to control food allergens. 

Food allergen controls must include those procedures, practices, and processes employed for: 

(1) Ensuring protection of food from allergen cross-contact, including during storage, handling, 
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and use; and (2) labeling the finished food, including ensuring that the finished food is not 

misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)). See 21 CFR 

117.135(c)(2).

Examples of procedures, practices, and processes to ensure protection of food from allergen 

cross-contact are:

• Identifying and marking allergen-containing ingredients at receiving;

• Segregating and storing allergen-containing materials at receiving and warehousing;

• Scheduling production of products based on allergen-containing recipes;

• Physical separation of processes for non-allergen-containing and allergen-containing products;

• Sanitation and cleaning practices;

• Using full wet cleaning to remove allergenic materials prior to producing a non-allergen-containing 

product on the same line;

• Using dedicated cleaning utensils and equipment for removing allergenic materials from food 

processing equipment. 

Examples of procedures, practices, and processes to label the finished food are:

• Performing label review for each new batch of labels received at the facility;

• Implementing procedures for application of correct label to product.

See “Chapter 11 - Food Allergen Controls” of this guidance for in-depth guidance on preventive 

control strategies for food allergen hazards.

4.6 Supply-chain Controls

Supply-chain controls include the supply-chain program required by 21 CFR part 117, subpart G

(21 CFR 117.135(c)(4)). Subpart G specifies:

• The requirement to establish and implement a supply-chain program (21 CFR 117.405); 

• General requirements applicable to a supply-chain program (21 CFR 117.410); 

• Responsibilities of the receiving facility (21 CFR 117.415); 

• Requirements for using approved suppliers (21 CFR 117.420); 

• Requirements for determining appropriate supplier verification activities (including determining the 

frequency of conducting the activity) (21 CFR 117.425); 

• Requirements for conducting supplier verification activities for raw materials and other ingredients (21 

CFR 117.430); 

• Requirements for an onsite audit (21 CFR 117.435); and 

• Requirements for records documenting the supply-chain program (21 CFR 117.475). 

In this section of this guidance, we discuss the use of ingredient specifications as a supply-chain 

control for several chemical hazards – i.e., pesticides, drug residues, heavy metals, and 

mycotoxins. See our forthcoming “Chapter 15: Supply-Chain Program for Human Food 

Products” for in-depth guidance on supply-chain controls.
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4.6.1 Supply-chain Controls for Pesticides

Pesticides used in the growing of vegetables fruits, and grain crops include fungicides, 

insecticides, and rodenticides that control pests found in growing environments. These may also 

be used in manufacturing environments. If you determine through your hazard analysis that a 

pesticide hazard requires a preventive control (e.g., due to residual pesticide level violations in a 

particular raw agricultural commodity), and that control is applied by your supplier, you would 

have a supply-chain program in which you would verify that your supplier controls pesticides. 

You could have specifications for your supplier that pesticide levels in raw materials and other 

ingredients must be within permitted levels and you could ask to review your supplier’s pesticide 

control program. Your program could have verification activities such as periodic testing by you 

or your supplier for pesticide residues.

4.6.2 Supply-chain Controls for Drug Residues

Drug residues due to the use of antibiotics or related drugs in livestock are principally a potential 

concern for milk-based products. If you determine through your hazard analysis that a drug 

residue hazard requires a preventive control, and that control is applied by your supplier, you 

would have a supply-chain program in which you would verify that your supplier controls drug 

residues to ensure that drug residues in raw materials and other ingredients are within permitted 

levels.

4.6.3 Heavy Metals

Heavy metals are principally a concern in raw agricultural commodities grown in soils that are

contaminated either naturally or through industrial activity. If you determine through your hazard 

analysis that a heavy metal hazard requires a preventive control, and that control is applied by 

your supplier, you would have a supply-chain program in which you would verify that suppliers 

source raw agricultural commodities from regions that do not have high levels of heavy metal 

contamination in soil, and specifications that heavy metals in raw materials and other 

ingredients will be within permitted levels.

4.6.4 Supply-chain Controls for Mycotoxins

Mycotoxins are toxic metabolites produced by certain fungi (i.e., molds) that can infect and 

proliferate on raw agricultural commodities (e.g., grains such as wheat and corn, peanuts, fruits,

and tree nuts) in the field and during storage. Critical environmental factors determining whether 

a raw agricultural commodity will support mold growth are temperature, moisture content, and 

time, and each of these parameters can be manipulated and controlled to manage the 

prevention of mold growth in a raw agricultural commodity. As noted in section 4.3.7 of this 

chapter, effective process controls for mycotoxins involve correct drying and storage as well as 

physical sorting techniques to remove damaged or moldy raw agricultural commodities. 

If you determine through your hazard analysis that a mycotoxin hazard requires a preventive 

control, and that control is applied by your supplier, you would have a supply-chain program in 

which you would verify that your supplier controls mycotoxins. You could have specifications

that mycotoxins in raw materials and other ingredients will be within permitted levels. 
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4.7 Recall Plan

For food with a hazard requiring a preventive control, you must establish a written recall plan for 

the food. The written recall plan must include procedures that describe the steps to be taken, 

and assign responsibility for taking those steps, to perform the following actions as appropriate 

to the facility: (1) Directly notify the direct consignees of the food being recalled, including how 

to return or dispose of the affected food; (2) Notify the public about any hazard presented by the 

food when appropriate to protect public health; (3) Conduct effectiveness checks to verify that 

the recall is carried out; and (4) Appropriately dispose of recalled food—e.g., through 

reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying 

the food. See 21 CFR 117.139.

We recommend that you consult our general guidance on policy, procedures, and industry 

responsibilities regarding recalls in 21 CFR part 7, subpart C (§§ 7.40 through 7.59) and FDA’s 

Guidance for Industry: Product Recalls, Including Removals and Corrections (FDA, 2015c).

A recall can be disruptive to your operation and business, but there are several steps you can 

take in advance to minimize this disruptive effect:

• Adequately code products to make possible positive lot identification and to facilitate effective recall of 

all violative lots.

• Maintain such product distribution records as are necessary to facilitate location of products that are 

being recalled. You should maintain such records for a period of time that exceeds the shelf life and 

expected use of the product.

4.8 References

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Codex Alimentarius Commission (CAC). 2003. "Hazard analysis and critical control point 

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Davidson, P. M., and A. L. Branen. 1993. Antimicrobials in Foods, 2nd edition. 
Contains Non-binding Recommendations

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Davidson, P. M., J. N. Sofos, and A. L. Branen. 2005. Antimicrobials in Foods. 3rd Edition: CRC 

Press.

Environmental Protection Agency (EPA). 2015. "Regulation of pesticide residues on food." 

Accessed June 23, 2016. https://www.epa.gov/pesticide-tolerances.

Environmental Protection Agency (EPA). 2016. "Indexes to Part 180 tolerance information for 

pesticide chemicals in food and feed commodities." Accessed May 31, 2016. 

https://www.epa.gov/pesticide-tolerances/indexes-part-180-tolerance-informationpesticide-chemicals-food-and-feed.

Farkas, J. 2007. "Chapter 32: Physical methods of food preservation." In Food Microbiology: 

Fundamentals and Frontiers, third edition, edited by Doyle, M. P., Beauchat, L. R., 685-

712. Washington, DC: American Society of Microbiology.

Farkas, J., D. A. E. Ehlermann, and C. Mohacsi-Farkas. 1998. "Irradiation as a method for 

decontaminating food - a review." Int J Food Micro 44:189-204.

Farkas, J., D. A. E. Ehlermann, and C. Mohacsi-Farkas. 2014. "Chapter 27: Food Technologies: 

Food irradiation." In Encyclopedia of Food Safety, edited by Motarjemi, Y., Moy, G., 

Todd, E., Elsevier Publishing.

Farkas, J., and C. Mohacsi-Farkas. 2011. "History and future of food irradiation." Trends in 

Food Science and Technology 22:121-126.

Fellows, P. J. 2009a. "Chapter 7: Irradiation." In Food Processing and Technology - Principles 

and Practices, 271-289. Woodhead Publishing.

Fellows, P. J. 2009b. "Chapter 22: Freezing." In Food Processing and Technology - Principles 

and Practices, 650-686. Woodhead Publishing.

Food and Drug Administration (FDA). 1999. "Guidance for industry: Antimicrobial food 

additives." Accessed June 14, 2016. 

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n/IngredientsAdditivesGRASPackaging/ucm077256.htm.

Food and Drug Administration (FDA). 2000. "Kinetics of microbial inactivation for alternative 

food processing technologies - overarching principles: Kinetics and pathogens of 

concern for all technologies." Accessed May 31, 2016. 

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0198.htm.

Food and Drug Administration (FDA). 2001. "Evaluation and definition of potentially hazardous 

foods: Chapter 3 Factors that influence microbial growth." Accessed 05/31/2016. 

http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/ucm09

4145.htm.
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Food and Drug Administration (FDA). 2003. "Guidance for industry: Product recalls, including 

removals and corrections." Accessed February 19, 2015. 

http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm.

Food and Drug Administration (FDA). 2004. "Irradiation of food and packaging: An overview." 

http://www.fda.gov/Food/IngredientsPackagingLabeling/IrradiatedFoodPackaging/ucm08

1050.htm.

Food and Drug Administration (FDA). 2013. "Food Code." Accessed July 26, 2016. 

http://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodCod

e/UCM374510.pdf.

Food and Drug Administration (FDA). 2015a. "Grade "A" Pasteurized Milk Ordinance, 2015 

revision."

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio

n/Milk/ucm2007966.htm.

Food and Drug Administration (FDA). 2015b. "Understanding food irradiation: What industry 

needs to know." Accessed May 31, 2016. 

http://www.fda.gov/food/ingredientspackaginglabeling/irradiatedfoodpackaging/ucm2420

21.htm.

Food Safety and Inspection Service (FSIS). 1999. "Compliance guidelines for cooling heattreated meat and poultry products (stabilization)." 

http://www.fsis.usda.gov/wps/wcm/connect/a3165415-09ef-4b7f-8123-

93bea41a7688/95-033F-Appendix-B.pdf?MOD=AJPERES.

Food Safety and Inspection Service (FSIS). 2005. "Meat and poultry hazards and controls 

guide." http://www.fsis.usda.gov/wps/wcm/connect/3cd0a6a5-fcff-4809-a298-

030f3cd711a9/Meat_and_Poultry_Hazards_Controls_Guide_10042005.pdf?MOD=AJPE

RES.

Food Safety and Inspection Service (FSIS). 2013. "FSIS compliance guideline HACCP systems 

validation." Accessed March 13, 2015. 

http://www.fsis.usda.gov/shared/PDF/HACCP_Systems_Validation.pdf.

Food Safety Preventive Controls Alliance (FSPCA). 2016. "Chapter 7: Resources for preparing 

food safety plans." In Preventive Controls for Human Food Participant Manual, First 

Edition v. 1.2.

Goullieux, A., and J. P. Pain. 2005. "Chapter 18: Ohmic heating." In Emerging Technologies in 

Food Processing, edited by Sun, D., 469-505. London: Elsevier Academic Press.

Greensmith, M. 1998. “Chapter 4: Dryers”. In Practical Dehydration. 2nd ed. Cambridge, 

England: Woodhead Publishing.

Grocery Manufacturers Association (GMA). 2009. "Control of Salmonella in low-moisture foods." 

http://www.gmaonline.org/downloads/technical-guidance-andtools/SalmonellaControlGuidance.pdf.
Contains Non-binding Recommendations

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Hite, B. H. 1899. The effect of pressure in the preservation of milk. In West Virginia Agricultural 

Experiment Station. Morgantown, WV.

Hogan, E., A. L. Kelly, and D. Sun. 2005. "Chapter 1: High pressure processing of foods: An 

overview." In Emerging Technologies in Food Processing, edited by Sun, D., 3-33. 

London: Elsevier Academic Press.

Holah, J. T. 2014. "Cleaning and disinfection practices in food processing." In Hygiene in Food 

Processing - Principles and Practices, edited by Lelieveld, H. L. M., Holah, J. T., Napper, 

D., Elsevier Publishing.

Indrawati, A. Van Loey, C. Smout, and M. H. Katholieke. 2003. "Chapter 19: Hydrostatic 

pressure technology in food preservation." In Food Preservation Techniques, edited by 

Zeuthen, P., Bøgh-Sørensen, L., 428-448. Cambridge, England: Woodhead Publishing.

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Ecology of Foods 1: Factors affecting life and death of microorganisms, 88-89. Orlando: 

Academic Press.

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Professional.

Jay, J. M. 1996. "Intrinsic and extrinsic parameters of foods that affect microbial growth." In 

Modern Food Microbiology, 38-66. Chapman & Hall.

Kennedy, C. 2003. "Developments in freezing." In Food Preservation Techniques, edited by 

Zeuthen, P., Bøgh-Sørensen, L., 228-240. Cambridge, England: Woodhead Publishing.

Krishnamurthy, K., H. K. Khurana, S. Jun, J. Irudayaraj, and A. Demirci. 2008. "Infrared heating

in food processing: An overview." Comprehensive Reviews in Food Science and Food 

Safety 7:2-13.

LaCroix, M. 2005. "Irradiation of foods." In Emerging Technologies for Food Processing, edited 

by Sun, D., 353-386. Elsevier.

Luck, E., and M. Jager. 1997. Antimicrobial Food Additives: Characteristics, Uses, Effects, 61. 

Berlin: Springer.

Lucke, F. K. 2003. "Chapter 7: The control of pH." In Food Preservation Techniques, edited by 

Zeuthen, P., 61. Bøgh-Sørensen, L., Woodhead Publishing.

Marriott, N. G., and R. B. Gravani. 2010a. "Chapter 8: Quality assurance for sanitation." In 

Principles of Food Sanitation, 116-140. Aspen Publications.

Marriott, N. G., and R. B. Gravani. 2010b. "Chapter 9: Cleaning compounds." In Principles of 

Food Sanitation, 141-164. Aspen Publications.
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National Advisory Committee on Microbiological Criteria for Foods (NACMCF). 1998. "Hazard 

analysis and critical control point principles and application guidelines." Journal of Food 

Protection 61 (9):1246-1259.

National Canners Association. 1968. Laboratory Manual for Food Canners and Processors: 

Chapter 9 Process Calculations Vol. 1., p 220. Westport, CT: The AVI Publishing 

Company, Inc.

Okos, M. R., O. Campanella, G. Narsimhan, R. K. Singh, and A. C. Weitnauer. 2007. "Chapter 

10: Food dehydration." In Handbook of Food Engineering (2nd edition), edited by 

Heldman, D. R. and D. B. Lund. Taylor & Francis.

Orsat, V., and G. Vijaya Raghavan. 2005. "Chapter 17: Radio-frequency processing." In 

Emerging Technologies in Food Processing, edited by Sun, D., 445-468. London: 

Elsevier Academic Press.

Stumbo, C. R. 1973. "Death of bacteria subjected to moist heat." In Thermobacteriology in Food 

Processing. New York, NY: Academic Press.

Sumnu, G., and S. Sahin. 2005. "Chapter 16: Recent developments in microwave heating." In 

Emerging Technologies in Food Processing, edited by Sun, D., 419-444. London: 

Elsevier Academic Press.

West, D. I., and L. B. Bullerman. 1991. "Physical and chemical separation of mycotoxins from 

agricultural products." In Mycotoxins and Animal Foods, edited by Smith, J. E., 

Henderson, R. S., 777-784. Boca Raton: CRC Press.
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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's (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-assistance-network-tan.

Chapter 5: Application of Preventive Controls and Preventive 

Control Management Components

Table of Contents

5.1 Purpose of this Chapter

5.2 Overview of the Application of Preventive Controls for Biological 

Hazards

5.3 Overview of the Application of Preventive Controls for Chemical 

Hazards

5.3.1 Examples of the Application of Preventive Controls for Chemical Hazards

5.3.2 Considerations Applicable to Radiological Hazards

5.3.3 Examples of the Control of Food Allergen Hazards

5.4 Overview of the Application of Preventive Controls for Physical 

Hazards

5.5 Preventive Control Management Components

5.5.1 Overview of Preventive Control Management Components

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. Underlined text in yellow highlights 

represents a correction from the draft Chapter 5 that we issued for public comment in August 2016. 
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5.5.2 Monitoring

5.5.3 Corrective Actions and Corrections

5.5.4 Verification

5.5.5 Records

5.6 References

5.1 Purpose of this Chapter

The guidance provided in this chapter is intended to help you identify and implement preventive 

controls, and associated preventive control management components, as a part of your food 

safety plan. See 21 CFR 117.135 and 117.140. Note that if you determine through your hazard 

analysis that there are no hazards requiring preventive controls, you must still document that 

determination in your written hazard analysis (see 21 CFR 117.130(a)(2)). However, you would 

not need to establish preventive controls and associated preventive control management 

components.

This chapter provides an overview of the application of preventive controls to significantly 

minimize or prevent the occurrence of biological, chemical, and physical hazards in finished 

foods and the food production environment. This chapter also provides an overview of 

preventive control management components (i.e., monitoring, corrective actions, and 

corrections, and verification activities (and their associated records)). Chapters 6 through 13 of 

this guidance provide more detailed examples of the application of preventive controls and

associated preventive control management components. 

This chapter does not provide all the details needed for complete programs. You have the 

flexibility to identify and implement preventive controls, and associated preventive control 

management components, from among all procedures, practices, and processes that are 

available to you and that would provide assurances that the hazard is controlled (i.e., 

significantly minimized or prevented).

5.2 Overview of the Application of Preventive Controls for Biological 

Hazards

Table 5-1 provides examples of the application of preventive controls to significantly minimize or 

prevent the occurrence of ingredient-related and process-related biological hazards.

Table 5-1 provides general information about the effects of the listed preventive controls but is 

not intended to imply that a particular preventive control has been validated for control of 

specific pathogens in specific foods. You are responsible for validating specific preventive 

controls as appropriate to the nature of the preventive control and its role in your facility’s food 

safety system (see 21 CFR 117.160(a)). 

Table 5-1 does not address the application of preventive controls to facility-related hazards. 

See “Chapter 10 – Sanitation Controls” of this guidance for additional information on the 

application of sanitation controls to address facility-related hazards. 
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Table 5-1 Application of Common Preventive Controls to Ingredient-Related and ProcessRelated Biological Hazards 

Preventive 

Control 

Common 

Procedures, 

Practices, 

and 

Processes

Applicability 

to SporeForming 

Bacterial 

Pathogens

Applicability 

to 

Vegetative 

Bacterial 

Pathogens

Applicability to 

Bacterial Toxins

Applicability to 

Parasites

Process

Control –

Lethal 

Treatments

Heat (e.g., 

cooking, 

roasting, 

baking)

In general,

heat 

processes 

will not 

eliminate 

spores of 

bacterial 

pathogens 

Eliminates 

vegetative 

cells of 

pathogens

Will not eliminate 

preformed toxins 

of S. aureus and 

B. cereus emetic 

toxin

Heat processing 

will inactivate 

parasites found 

in foods; specific 

times and 

temperatures 

are dependent 

on the parasite, 

food matrix, and 

process used

Process

Control –

Lethal 

Treatments

Irradiation, 

ionizing

The doses 

approved in 

the U.S. will 

not eliminate 

spores of 

bacterial 

pathogens in 

most foods

Eliminates 

vegetative 

cells of 

pathogens

Will not eliminate 

preformed toxins 

of S. aureus and 

B. cereus emetic 

toxin

Limited uses for 

parasite control; 

depending on 

dose, approved 

uses for 

foodborne 

pathogens may 

inactivate 

parasites found 

in foods 

Process

Control –

Lethal 

Treatments

Antimicrobial 

Fumigation, 

e.g., 

Propylene 

Oxide (PPO) 

or Ethylene 

Oxide (ETO)

Will not 

eliminate 

spores of 

bacterial 

pathogens

Defined PPO 

processes 

have been 

shown to 

reduce 

Salmonella

by 5 logs in 

certain foods

Unknown, but 

unlikely to have 

an effect on 

preformed toxins 

of S. aureus and 

B. cereus emetic 

toxin

Ozone has been 

found to 

inactivate select 

parasites (e.g., 

C. parvum

oocysts) 
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Preventive 

Control 

Common 

Procedures, 

Practices, 

and 

Processes

Applicability 

to SporeForming 

Bacterial 

Pathogens

Applicability 

to 

Vegetative 

Bacterial 

Pathogens

Applicability to 

Bacterial Toxins

Applicability to 

Parasites

Process

Control –

Lethal 

Treatments

High Pressure 

Processing 

(HPP)

In general,

HPP will not 

eliminate 

spores of 

bacterial 

pathogens 

(FDA, 2000)

Eliminates 

vegetative 

cells of 

pathogens

(FDA, 2000)

Will not eliminate 

preformed toxins 

of S. aureus and 

B. cereus

• Will 

eliminate 

parasitic 

worms of 

Trichinella 

spiralis at >

200 MPa for 

10 min 

• No 

infectivity of 

Cryptospori

dium

oocysts 

when 

treated by 

HPP at 

5.5X108 Pa 

(80,000 psi) 

for 60 sec in 

apple and 

orange juice 

• Information 

is lacking on 

the pressure 

resistances 

of other 

parasites

Process

Control –

Time / 

Temperature 

of Holding

Refrigeration Used to 

control 

growth of 

sporeforming 

bacterial 

pathogens

Depending 

on the 

temperature, 

refrigeration 

will inhibit 

growth of 

many 

pathogens. 

However, 

pathogens 

such as L. 

monocytogen

es and some 

strains of B. 

cereus may 

grow at 

refrigeration 

temperatures

Will prevent the 

formation of

toxins of S. 

aureus.

Depending on 

the temperature, 

will prevent 

formation of B. 

cereus toxins. 

Will have no 

effect on 

preformed toxins

Limited 

information; 

generally not 

applicable to 

parasites 

because 

parasites do not 

grow in food
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Preventive 

Control 

Common 

Procedures, 

Practices, 

and 

Processes

Applicability 

to SporeForming 

Bacterial 

Pathogens

Applicability 

to 

Vegetative 

Bacterial 

Pathogens

Applicability to 

Bacterial Toxins

Applicability to 

Parasites

Process

Control –

Time / 

Temperature 

of Holding

Freezing Used to 

control 

growth of 

spore 

forming 

bacterial 

pathogens, 

but the 

spores will 

survive 

freezing well

Freezing 

prevents 

growth of 

vegetative 

cells of 

pathogens. 

Depending 

on the 

temperature, 

the numbers 

of some 

pathogens 

may be 

reduced over 

time;

however you 

cannot count 

on freezing 

to eliminate 

pathogens, 

and many 

can survive 

for an 

extended 

time 

Freezing that 

prevents growth 

will prevent 

formation of 

toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxins 

There are 

specific 

schedules of 

time and 

temperature 

shown to 

inactivate 

parasites; 

Cyclospora is 

known to be at 

least somewhat 

resistant to 

freezing 

because an 

outbreak 

occurred 

attributed to 

raspberries in 

cake that was 

previously 

frozen at about 

26°F (–3.3° C) 

Process

Control –

Formulation

Water activity 

control

Reducing the 

water activity 

(e.g., by 

adding 

solutes such 

as sugar and 

salt) to 0.92 

or below will

inhibit 

outgrowth of 

spores

Reducing the 

water activity 

(e.g., by 

adding 

solutes such 

as sugar and 

salt) to 0.85 

or below will 

inhibit growth 

of vegetative 

cells of 

pathogens 

Water activity 

that prevents 

growth will 

prevent formation 

of toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxins

Limited 

information; 

generally not 

applicable to 

parasites 

because they do 

not grow in food
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Preventive 

Control 

Common 

Procedures, 

Practices, 

and 

Processes

Applicability 

to SporeForming 

Bacterial 

Pathogens

Applicability 

to 

Vegetative 

Bacterial 

Pathogens

Applicability to 

Bacterial Toxins

Applicability to 

Parasites

Process

Control –

Formulation

Acidification Lowering the 

pH by the 

addition of 

acid can 

inhibit spores 

from 

germinating, 

will not 

eliminate the 

spores

In, general, 

you can rely

on added 

acid to 

prevent 

growth of 

vegetative 

bacterial 

pathogens, 

but you 

cannot rely 

on added 

acid to 

eliminate 

vegetative

cells of 

bacterial 

pathogens

A pH that 

prevents growth 

will prevent 

formation of 

toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxins

No information 

for use as 

control in foods

Process

Control –

Formulation

Adding 

preservatives

Will not 

eliminate 

spores of 

bacterial 

pathogens, 

but can 

prevent

germination 

of spores of 

certain 

species 

Various 

preservative 

chemicals 

have specific 

action 

against some 

vegetative 

cells of 

bacterial 

pathogens 

and/or fungi

that prevent 

growth

Formulations 

that prevent 

growth will 

prevent formation 

of toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxin

No information 

for use as 

control in foods

Process

Control –

Dehydration

Air drying Will not 

eliminate 

spores of 

bacterial 

pathogens, 

but limits or 

inhibits 

outgrowth

While drying 

may 

inactivate 

some 

pathogens, 

others (e.g.,

Salmonella) 

may survive 

drying for 

fairly long 

times 

Drying that 

prevents growth 

will prevent 

formation of 

toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxin

No information 

on effect on 

parasites in 

foods
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Preventive 

Control 

Common 

Procedures, 

Practices, 

and 

Processes

Applicability 

to SporeForming 

Bacterial 

Pathogens

Applicability 

to 

Vegetative 

Bacterial 

Pathogens

Applicability to 

Bacterial Toxins

Applicability to 

Parasites

Process

Control –

Dehydration

Freeze drying In general, 

serves to 

preserve 

microorganis

ms, but 

inhibits 

outgrowth

In general, 

serves to 

preserve 

microorganis

ms, but 

inhibits 

growth

Drying that 

prevents growth 

will prevent 

formation of 

toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxin

No information 

on effect on 

parasites in 

foods

Process

Control –

Dehydration

Spray drying In general,

spores of 

bacterial 

pathogens 

will not be 

eliminated, 

but inhibits 

outgrowth

Some 

pathogens 

may survive 

spray drying 

depending 

upon the 

product 

formulation. 

Growth will 

be inhibited

Drying that 

prevents growth 

will prevent 

formation of 

toxins of S. 

aureus and B. 

cereus but have 

no effect on 

preformed toxin

No information 

on effect on 

parasites in 

foods 

Chapters 6 through 9 of this guidance provide specific examples of the application of some of 

these preventive controls. Table 5-2 lists these chapters and the examples covered in these 

chapters. Table 5-2 also lists examples of sanitation controls, which are covered in Chapter 10.

Table 5-2 Chapters in this Guidance that Provide Examples of the Application of 

Common Preventive Controls for Ingredient-Related and Process-Related Biological 

Hazards

Hazard Preventive 

Control Examples of Preventive Controls Chapter

Bacterial 

pathogens that 

survive the lethal 

treatment

Process Control –

Lethal Treatments

• Cooking of RTE soups (frozen and 

refrigerated)

• Baking of RTE cookies 

6

Bacterial 

pathogens that

grow, including 

those that produce 

toxin, due to time/ 

temperature 

abuse

Process Control –

Time / 

Temperature of 

Holding

• Refrigeration of fresh fruit salads 

• Control of temperature during 

thawing to prevent microbial growth

7

Bacterial 

pathogens that

grow, including 

those that produce 

toxin, due to poor 

formulation control

Process Control -

Formulation

• Acidification of prepared vegetable 

salads 

• Water activity control in refrigerated 

cookie dough

8
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Hazard Preventive 

Control Examples of Preventive Controls Chapter

Bacterial 

pathogens that 

grow, including 

those that produce 

toxin, due to 

inadequate drying

Process Control –

Drying/dehydration

• Drying of milk to produce spraydried milk powder 9

Bacterial 

pathogens that 

contaminate 

product due to

poor sanitation

Sanitation Control 

– Cleaning / 

sanitizing food 

contact surfaces

• Controlling presence of bacterial 

pathogens in RTE prepared 

sandwiches by sanitation

10

Recontamination 

of an RTE product 

with an 

environmental 

pathogen 

Sanitation –

Prevention of 

recontamination 

from the 

environment

• Use of hygienic zoning as a 

component of a program for 

prevention of recontamination of ice 

cream with environmental 

pathogens 

10

5.3 Overview of the Application of Preventive Controls for Chemical 

Hazards

5.3.1 Examples of the Application of Preventive Controls for Chemical 

Hazards

Table 5-3 provides examples of the application of preventive controls to significantly minimize or 

prevent the occurrence of ingredient-related chemical hazards in finished foods. See “Chapter 

12 – Preventive Controls for Chemical Hazards” of this guidance for further examples of the 

implementation of preventive controls for chemical hazards. 
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Table 5-3 Examples of the Control of Ingredient-Related Chemical Hazards

Preventive 

Control

Common Procedures, 

Practices, and Processes

Examples of Applicability to Chemical Hazards

Supply-Chain 

Program

Establish and implement a riskbased supply-chain program 

with supplier approval and 

verification activities (as a 

means of ensuring that raw 

materials and other ingredients 

are procured from those 

suppliers that can meet 

company specifications and 

have appropriate programs in 

place)

• Applicability to heavy metals: approved 

suppliers control arsenic and lead in raw 

agricultural commodities such as rice and 

carrots 

• Applicability to naturally occurring toxins: 

approved suppliers control growth of 

mycotoxin-forming fungi in stored raw 

agricultural commodities that are purchased 

by the facility as raw materials

• Applicability to food and color additives and 

substances associated with a food 

intolerance: approved suppliers control 

presence of or use of identified substances 

and ensure safe levels are not exceeded

Supply-Chain 

Program

Conduct verification activities 

appropriate to the hazard

• Sampling and testing (by supplier or receiving 

facility) to verify supplier control for chemical 

hazards such as pesticides, drug residues, 

heavy metals, and mycotoxins, when a 

supply-chain-applied control has been applied 

for such hazards 

• On-site audit to verify control of food 

allergens, such as when purchasing roasted 

almonds from a facility that handles multiple 

tree nuts

Process Controls Recipe management 

procedures as appropriate 

Facility programs to control product formulation to 

ensure that safe levels are not exceeded

Process Controls Storage conditions Control of moisture in stored raw agricultural 

commodities to prevent formation of mold

Process Controls Physical sorting Facility processing practices to sort (e.g., based 

on color, physical damage, or presence of mold) 

raw agricultural commodities to reduce levels of 

mycotoxins in processed foods

5.3.2 Considerations Applicable to Radiological Hazards

Contamination of foods by radionuclides (a radiological hazard) is a rare event. The most 

common way these radionuclides are incorporated into foods is through use of water that 

contains a radionuclide during the manufacture of a food. For example, in certain locations in 

the United States, high concentrations of radium-226, radium-228 and uranium have been 

detected in private wells (Ayotte et al., 200; Focazio et al., 2001). The most relevant information 

that would lead you to consider and evaluate a specific radiological hazard to determine 

whether it is a hazard requiring a preventive control would be publicly disseminated information 

following a particular event, such as contamination arising from accidental release from a 
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nuclear facility or from damage to a nuclear facility from a natural disaster. For example, in 

2011, radioactivity was detected in milk, vegetables and seafood produced in areas neighboring 

a nuclear power plant damaged during an earthquake and tsunami in Japan. We have issued 

guidance on levels of concern for radionuclides that could be a known or reasonably 

foreseeably hazard in certain circumstances, such as after an accident at a nuclear facility 

(FDA, 2001).

Your hazard analysis does not need to consider sources of radiation used in accordance with a 

food additive regulation. Such sources are safe for their intended use. As with any other 

equipment and substances used in the manufacture of food, you must comply with all applicable 

safety requirements established either under the terms of a food additive regulation or by an 

authority such as the Occupational Safety and Health Administration. Although the two most 

likely sources of radiological hazards that you would need to address are water used in the 

production of foods (as an ingredient or cleaning aid), and accidental contamination of your food 

product (or its ingredients) from accidental release of radionuclides from a nuclear facility, the 

PCHF requirements do not limit your responsibilities to these two sources, because we cannot

anticipate what might be a source in the future.

5.3.3 Examples of the Control of Food Allergen Hazards

Table 5-4 provides examples of the application of preventive controls to significantly minimize or 

prevent the occurrence of the ingredient-related and process-related undeclared food allergen 

hazards within finished foods. See “Chapter 11 – Food Allergen Controls” of this guidance for 

additional information on the application of food allergen controls.

Table 5-4 Application of Common Preventive Controls to Ingredient-Related and ProcessRelated Food Allergen Hazards

Preventive

Control 

Common Procedures, 

Practices, and Processes

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to 

Incorrect Product Label

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to CrossContact

Allergen 

Control –

Labelling

Perform label design and 

review during product 

development prior to 

commercialization and 

label review for each new 

batch of labels received.

Label design and review 

minimize the potential for 

the label to not identify all 

of the food allergens 

present in the food

N/A

Allergen 

Control –

Labelling

Implement procedures for 

application of correct label 

to product. 

Label application 

procedures can help 

minimize the potential for 

an incorrect label to be

applied to an allergencontaining food

N/A
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Preventive

Control 

Common Procedures, 

Practices, and Processes

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to 

Incorrect Product Label

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to CrossContact

Allergen 

Control –

Allergen 

cross-contact

Identify and mark food 

allergen-containing 

ingredients (e.g., by color 

coding or with food 

allergen icons) at 

receiving.

N/A Clearly identifying food 

allergens associated with 

raw materials or other 

ingredients simplifies 

handling practices to 

prevent allergen crosscontact

Allergen 

Control –

Allergen 

cross-contact

Segregate and store food 

allergen-containing

materials at receiving and 

warehousing.

N/A Segregation of different 

food allergens can

minimize the potential for 

allergen cross-contact

during storage

Allergen 

Control –

Allergen 

Cross-contact

Open and handle food 

allergen-containing 

ingredients at separate 

times / contain by using 

separate rooms, or by 

scheduling use of the 

same rooms at different 

times.

N/A Handling food allergens 

separately can minimize 

the potential for inadvertent 

incorporation of a food 

allergen into a product for 

which it is not an ingredient

Allergen 

Control –

Allergen 

Cross-contact

Schedule production of 

products based on food 

allergen-containing 

recipes. Schedule 

production of products that 

do not contain food 

allergens before production 

of products that do contain 

food allergens or schedule 

production of products with 

a unique food allergen last.

N/A Production scheduling can 

minimize the potential for

inadvertent incorporation of 

food allergen into a product 

for which it is not an 

ingredient

Allergen 

Control –

Allergen 

cross-contact

Physically separate 

processes for products that 

do not contain food 

allergens from products

that do contain food 

allergens or separate 

processes for products that 

do not contain the same 

food allergens

N/A Separating processes 

containing different food 

allergens can minimize the 

potential for inadvertent 

incorporation of food 

allergen into a product for 

which it is not an ingredient

Allergen 

Control –

Allergen 

cross-contact

Implement production 

procedures for rework and 

work-in-process (WIP): 

using “like into like,”

appropriate storage and 

handling, tracking

N/A Control of rework can

minimize the potential for

inadvertent incorporation of 

food allergen into a product 

for which it is not an 

ingredient
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Preventive

Control 

Common Procedures, 

Practices, and Processes

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to 

Incorrect Product Label

How the Preventive 

Control Can Significantly 

Minimize or Prevent 

Undeclared Food 

Allergens due to CrossContact

Sanitation

Control –

Cleaning food 

contact 

surfaces

Use full wet cleaning to 

remove food allergen 

residues prior to producing 

a product that does not 

contain that food allergen 

on the same line.

N/A Cleaning can minimize the 

presence of food allergen 

residues, preventing 

inadvertent incorporation of 

food allergen into a product 

for which it is not an 

ingredient

Sanitation 

Control –

Cross-contact

Use hygienic zoning for 

physical separation of 

process operations, 

including personnel, that 

involve foods with and 

without a specific food 

allergen

N/A Hygienic zoning can help 

prevent inadvertent 

incorporation of food 

allergen into a product for 

which it is not an ingredient 

Sanitation 

Control - 

Cross-contact

Use dedicated cleaning

utensils and equipment for 

removing food allergen 

residues from food 

processing equipment

N/A Use of dedicated cleaning 

utensils/equipment can 

prevent transfer of food 

allergen residues, thereby

preventing inadvertent 

incorporation of food 

allergen into a product for 

which it is not an ingredient

5.4 Overview of the Application of Preventive Controls for Physical 

Hazards

Table 5-5 provides an overview of the application of preventive controls to significantly minimize 

or prevent the occurrence of physical hazards in finished foods. See “Chapter 13 – Preventive 

Controls for Physical Hazards” of this guidance for further examples for the implementation of 

preventive controls for physical hazards.

Table 5-5 Applicability of Preventive Controls to Physical Hazards 

Preventive

Control 

Category

Common 

Procedures, 

Practices, and 

Processes

Applicability 

to Metal

Hazards

Applicability to Glass

Hazards (Products 

Packed in Glass)

Applicability to Other 

Hard/Sharp Physical 

Hazards

Process

Control –

Exclusion

Use screens, 

flotation tanks, 

riffle board, 

sifters, magnets, 

inversion/air to 

exclude metal 

and glass

Physically 

removes metal 

fragments 

Physically removes

glass 

Physically removes hard 

plastic, wood, stones
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Preventive

Control 

Category

Common 

Procedures, 

Practices, and 

Processes

Applicability 

to Metal

Hazards

Applicability to Glass

Hazards (Products 

Packed in Glass)

Applicability to Other 

Hard/Sharp Physical 

Hazards

Process 

Control –

Detection

Use metal or Xray detectors to 

detect and divert 

foods containing 

metal and glass

Metal and Xray detectors 

detect metal

pieces, which 

generally 

allows for 

exclusion of 

foods 

containing 

metal

X-ray detectors detect 

glass pieces, which 

generally allows for 

exclusion of foods 

containing glass

X-rays can often detect 

hazardous objects such 

as hard plastic, stones, 

bones, pits

5.5 Preventive Control Management Components

5.5.1 Overview of Preventive Control Management Components

Preventive control management components include monitoring, corrective actions and 

corrections, and verification activities (and their associated records). You must apply 

appropriate preventive control management components by considering the nature of the 

preventive control and its role in the facility’s food safety system to ensure the effectiveness of 

the preventive control. For example, monitoring may be limited for certain control measures 

such as preventive maintenance for equipment to prevent metal hazards (although you should 

have a record that the activity took place). When sanitation controls are required for 

environmental pathogens, little or no monitoring may be needed when cleaning and sanitation 

are conducted in accordance with established written protocols. Occasional verification that 

procedures are being followed may suffice. See 21 CFR 117.140.

5.5.2 Monitoring

You must establish and implement written procedures, including the frequency they are to be 

performed, for monitoring preventive controls (as appropriate to the nature of the preventive 

control and its role in your food safety system). See 21 CFR 117.145. Chapters 6 through 13 of 

this guidance provide examples of the application of preventive controls. Each of these 

chapters contains a section, “Establish Monitoring Procedures,” that provides information about 

appropriate monitoring procedures for each control strategy example discussed.

To fully describe your monitoring program, the procedures should answer four questions: (1) 

What will be monitored? (2) How will monitoring be done? (3) How often will monitoring be done 

(frequency)? and (4) Who will do the monitoring?

What you monitor should be directly related to control of the hazard. For example, for process 

controls you would monitor parameters to ensure the minimum/maximum values are met. For 

other preventive controls, you could monitor that the activity has been conducted consistent with 

a defined procedure. 
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The frequency of monitoring depends upon the circumstances. Continuous monitoring is always 

desirable, and in some cases necessary. In other cases, it may not be necessary or practical. 

You should monitor often enough that the normal variability in the values you are measuring can 

be determined and a deviation from normal will be detected. This is especially true if these 

values are typically close to the control values. Even with continuous monitoring, you should 

periodically check the paper or electronic record of the continuous monitoring to determine 

whether deviations from the control value have occurred. The frequency of that check should be 

at least daily.

If a measurement shows that a deviation from the control value has occurred, you should 

assume that the control value had not been met since the last check in which the value was 

acceptable. As a result, the greater the time span between measurements, the more products 

you are putting at risk.

You should specify in the written procedures the position of the employee who will do the 

monitoring and describe how they are to perform the monitoring procedure. See Chapters 6 

through 13 of this guidance for monitoring examples that include “who” and “how.” 

You must document your monitoring of preventive controls. See 21 CFR 117.145(c)(1). 

Although, as noted above, continuous monitoring (with associated records) is desirable, in some 

circumstances the monitoring records may be “exception records” that document loss of control. 

See 21 CFR 117.145(c)(2). 

5.5.3 Corrective Actions and Corrections

You must establish and implement corrective action procedures that would apply if preventive 

controls are not properly implemented, as appropriate to the nature of the hazard and the nature 

of the preventive control. These include corrective action procedures that must be taken if you

detect the presence of a pathogen or appropriate indicator organism in a ready-to-eat product 

as a result of product testing or if you detect the presence of an environmental pathogen or 

appropriate indicator organism through your environmental monitoring activities. See 21 CFR 

117.150(a) and (a)(1). 

A predetermined corrective action procedure has the following advantages: (1) It provides 

detailed instructions for an employee to follow in the event of a deviation in applying a 

preventive control; (2) it can be prepared at a time when an emergency situation is not calling 

for an immediate decision; and (3) it removes the obligation to reassess the food safety plan in 

response to a deviation.

Chapters 6 through 13 of this guidance provide examples of the application of preventive

controls. Each of these chapters contains a section, “Establish Corrective Action Procedures,” 

that provides information about appropriate corrective action procedures for each control 

strategy example discussed. An appropriate corrective action procedure must accomplish the 

following goals: (1) Ensure that the appropriate action is taken to identify and correct the 

problem that has occurred with the implementation of a preventive control; (2) ensure that the 

appropriate action is taken when necessary to reduce the likelihood that the problem will recur; 

(3) ensure that all affected food is evaluated for safety; and (4) ensure that all affected food is 

prevented from entering into commerce unless an evaluation has determined that the product is 

not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 342) or misbranded under 21 section 403(w) of the FD&C Act (21 U.S.C. 343(w)). See 

21 CFR 117.150(a)(2). 
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You must document your corrective actions. See 21 CFR 117.150(d). For example, when 

documenting a decision that affected product is released into commerce, your documentation 

should explain how your decision was based on sound evidence that the deviation did not 

create a food safety hazard. As another example, you should document all product dispositions, 

including dispositions to reject or destroy the product.

If you have not established a written corrective action procedure for a preventive control, you 

still must take appropriate corrective actions when an unanticipated food safety problem 

indicates that a preventive control may not have been properly implemented. See 21 CFR 

117.150(b)(1)(i). For example, you would take appropriate corrective actions if you detected a 

pathogen in a product when your production process should have controlled the pathogen. 

Although it may not be possible to anticipate all the problems that could happen, corrective 

actions need to be taken and fully documented when an unanticipated situation occurs. The 

corrective actions for the unanticipated problems would include standard corrective action 

procedures (e.g. identify and correct an implementation problem, take steps to reduce the 

likelihood it will recur, evaluate all implicated product for safety, and prevent adulterated or 

misbranded product from entering commerce). See 21 CFR 117.150(b)(2)(i). In addition when 

appropriate you must reanalyze the food safety plan (or the applicable portion of the food safety 

plan) to determine whether you need to modify the plan. See 21 CFR 117.150(b)(2)(ii). 

A correction is an action to identify and correct a problem that occurred during the production of 

food, without other actions associated with a corrective action procedure. See the definition of 

“correction” in 21 CFR 117.3. The term ‘‘correction’’ focuses on the first step in a ‘‘corrective 

action procedure’’ (i.e., identify and correct the problem). Corrections may be appropriate 

instead of corrective actions when minor, isolated problems occur that do not directly impact 

product safety. 

Here is an example of corrections vs. corrective actions. If you observe food residue on ‘‘clean’’ 

equipment prior to production, corrections would involve re-cleaning and sanitizing the 

equipment before it is used. Because you observed the food residue prior to production of food, 

and you corrected the problem in a timely manner, no food is affected and no actions are 

needed with respect to food. You are not required to record the correction because this isolated 

incident does not directly impact product safety, and you made the corrections in a timely 

manner (i.e., before the production starts). On the other hand, if you make an RTE creamed 

vegetable soup using a continuous heat exchanger and hot-fill process, and after packaging the 

soup your review of temperature records of the processed soup at the discharge end of the hold 

tube shows that the soup did not reach the temperature you identified as a critical limit, 

corrective actions would involve destroying the product, reheating it or sending it to animal food 

as appropriate,2 investigating the cause of the problem, and taking the actions needed to reduce 

the likelihood that the problem will recur based on the root cause of the problem. (Using an 

automatic flow diversion valve that diverts low-temperature product at the end of the hold tube 

back to the pre-heat kettle to be re-processed would avoid the need for taking corrective actions 

on product, although you would still investigate the cause and correct the problem.)

You must document all corrective actions in records that are subject to verification records 

review. When appropriate, you also must document corrections. See 21 CFR 117.150(d). You 

are not required to document corrections in records that are subject to verification records 

 2 For more information on sending human food to animal food use, refer to Draft Guidance for Industry: 

Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug 

Administration Amendments Act of 2007, Section III.L (FDA, 2010).
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review when the corrections are taken in a timely manner and you identify and correct a minor 

and isolated problem that does not directly impact product safety. See 21 CFR 117.150(c)(2). 

However, we recommend that you document corrections such as re-running product through a 

functioning metal detector when the one used on the production line did not reject the test 

pieces used to verify that the metal detector was operating correctly, because it provides a 

record of both the problem and the steps you took to correct the problem. If the problem recurs 

on a frequent basis, such documentation also can alert you that equipment may need to be 

repaired or replaced. We also recommend that you record corrections taken when equipment is 

adjusted because, for example, temperature does not meet an operating limit (although the 

critical limit has not been violated); such information can be useful to identify trends that indicate 

equipment repairs may be needed.

The record of corrective actions should include information on the following four elements:

First, document the actions taken to identify and correct the problem with implementation of the 

preventive control. For example, explain how you identified what went wrong with a process 

control and how you restored process control.

Second, explain what you did to reduce the likelihood that the problem will recur. Evaluation of 

historical corrective action records can help to identify recurring problems. When critical limit 

deviations frequently reoccur, the process and the Food Safety Plan may need reanalysis and 

modification. A formal process may be needed to manage major changes that need to be 

implemented. This may include reissuing forms, retraining employees, phasing in changes, 

managing label information, informing suppliers, and other tasks, depending on the nature of the 

change.

Third, explain how you evaluated the safety of all affected food. Specific technical expertise may 

be required for this evaluation, depending on the nature of the deviation. 

Fourth, explain what you did with any affected food, including identifying the amount of product 

involved and disposition of the affected product.

5.5.4 Verification

Chapters 6 through 13 of this guidance provide examples of the application of preventive

controls. Each of these chapters contains a section, “Establish Verification Procedures,” that 

provides information about appropriate verification activities for each control strategy example 

discussed. The information covers validation of the adequacy of control measure (e.g., process 

establishment); evidence that monitoring is being conducted as required; evidence that 

appropriate decisions about corrective actions are being made as required; evidence of 

verification of the implementation and effectiveness of controls (such as product testing or

environmental monitoring when appropriate); calibration of instruments, when appropriate, and 

review of records. See 21 CFR 117.155, 117.160 and 117.165. When calibration or an accuracy 

check of a preventive control monitoring instrument shows that the instrument is not accurate, 

you should evaluate the monitoring records since the last instrument calibration to determine 

whether the inaccuracy would have contributed to a deviation. For this reason, food safety plans 

with infrequent calibration or accuracy checks can place more products at risk than those with 

more frequent checks if a problem with instrument accuracy occurs.
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5.5.5 Records

Chapters 6 through 13 of this guidance provide examples of the application of preventive 

controls. Each of these chapters contains a section, “Establish a Recordkeeping System,” that 

provides information about appropriate records for each control strategy example discussed. 

Types and frequency of records vary, depending on factors such as the nature of the hazard 

and the nature of the control measure and its role in the food safety system. 

5.6 References

Ayotte, J. D., S. M. Flanagan, and W. S. Morrow. 2007. "Occurrence of Uranium and 222Radon 

in glacial and bedrock aquifers in the northern United States, 1993-2003." U.S. 

Geological Survey Scientific Investigations Report 2007-5037. Accessed April 18, 

2016. http://pubs.usgs.gov/sir/2007/5037/. 

Cama, V. A., and Y. R. Ortega. 2014. “Cyclospora cayetanensis.” In Encyclopedia of Food 

Safety, edited by Motarjemi, Y., Moy, G., Todd, E., Elsevier.

Dawson, D. J. 2005. "Foodborne protozoan parasites." Int J Food Micro 103:201-227.

Dawson, D. J., C. M. Samuel, V. Scrannage, and C. J. Atherton. 2004. "Survival of 

Cryptosporidium species in environments relevant to foods and beverages." J Appl 

Microbiol 96 (6).

Deng, M. Q., and D. O. Cliver. 1999. "Cryptosporidium parvum studies with dairy products." Int J

Food Micro 46:113-121.

Dixon, B. R. 2014. "Protozoa: Cryptosporidium spp. ." In Encyclopedia of Food Safety, edited by 

Motarjemi, Y., Moy, G., Todd, E., 18-22. Waltham: Academic Press.

Erickson, M. C., and Y. R. Ortega. 2006. "Inactivation of protozoan parasites in food, water, and 

environmental systems." J Food Protect 69:2786-2808.

Fayer, R. 1994. "Effect of high-temperature on infectivity of Cryptosporidium parvum oocysts in 

water." Appl Environ Microb 60:2732-2735.

Fayer, R., and T. Nerad. 1996. "Effect of low temperatures on viability of Cryptosporidium 

parvum oocysts." Appl Environ Microb 62:1431-1433.

Focazio, M. J., Z. Szabo, T. F. Kraemer, A. H. Mullin, T. H. Barringer, and V. T. dePaul. 2001. 

“Occurrence of selected radionuclides in ground water used for drinking water in the 

United States: A targeted reconnaissance survey, 1998.” U.S. Geological Survey WaterResources Investigations Report 00-4273. Accessed October 14, 

2011. http://pubs.usgs.gov/wri/wri004273/pdf/wri004273.pdf.

Food and Drug Administration (FDA). 2000. "Kinetics of microbial inactivation for alternative 

food processing technologies - overarching principles: Kinetics and pathogens of 

concern for all technologies." Accessed May 31, 

2016. http://www.fda.gov/Food/FoodScienceResearch/SafePracticesforFoodProcesses/

ucm100198.htm.
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Chapter 5 (Preventive Control Management Components) - Page 18

Food and Drug Administration (FDA). 2005. "CPG Sec. 560.750 Radionucleotides in imported 

foods - levels of concern." Accessed October 14, 

2011. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfo

rmation/ucm212793.htm.

Food and Drug Administration (FDA). 2010. “Draft Guidance for Industry: Questions and 

Answers Regarding the Reportable Food Registry as Established by the Food and Drug 

Administration Amendments Act of 2007,” Section III.L. Accessed August 17, 

2016. http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInfo

rmation/ucm212793.htm.

Friedman, D. E., K. A. Patten, J. B. Rose, and M. C. Barney. 1997. "The potential for C. parvum

oocyst survival in beverages associated with contaminated tap water." J Food Safety

17:125-132.

Gamble, H. R. 2014. Trichinella spiralis and other Trichinella species. In Encyclopedia of Food 

Safety, edited by Motarjemi, Y., Moy, G., Todd, E., Elsevier.

Harp, J. A., R. Fayer, B. A. Pesch, and G. J. Jackson. 1996. "Effect of pasteurization on 

infectivity of Cryptosporidium parvum oocysts in water and milk." Appl Environ Microb

62.

Ho, A. Y., A. S. Lopez, M. G. Eberhart, R. Levenson, B. S. Finkel, and A. J. da Silva. 2002. 

"Outbreak of cyclosporiasis associated with imported raspberries, Philadelphia, 

Pennsylvania, 2000." Emerg Infect Dis 8:783-788.

Kniel, K. E., S. S. Sumner, D. S. Lindsay, C. R. Hackney, M. D. Pierson, A. M. Zajac, D. A. 

Golden, and R. Fayer. 2003. "Effect of organic acids and hydrogen peroxide on 

Cryptosporidium parvum viability in fruit juices." J Food Protect 66:1650-1657.

Korich, D. G., J. R. Mead, M. S. Madore, N. A. Sinclair, and C. R. Sterling. 1990. "Effects of 

ozone, chlorine dioxide, chlorine, and monochloramine on Cryptosporidium parvum

oocyst viability." Appl Environ Microb 56 (5):1423-1428.

Mahbubani, M. H., A. K. Bej, M. Perlin, F. W. Schaefer III, W. Jakubowski, and R. M. Atlas. 

1991. "Detection of Giardia cysts by using the polymerase chain reaction and 

distinguishing live from dead cysts." Appl Environ Microb 57:3456-3461.

Ortega, Y. R. 2013. "Chapter 28: Protozoa." In Food Microbiology - Fundamentals and 

Frontiers, edited by Doyle, M., Buchanan, R. L.

Robertson, L. J., A. T. Campbell, and H. V. Smith. 1992. "Survival of Cryptosporidium parvum

oocysts under various environmental pressures." Appl Environ Microb 58:3494-3500.

Rose, J. B., and T. R. Slifko. 1999. "Giardia, Cryptosporidium, and Cyclospora and their impact 

on foods: A review." J Food Prot 62 (1059-1070).

Slifko, T. R., E. Raghubeer, and J. B. Rose. 2000. "Effect of high hydrostatic pressure on 

Cryptosporidium parvum infectivity." J Food Prot 63 (9):1262-7.
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Sterling, C. R., and Y. R. Ortega. 1999. "Cyclospora: An enigma worth unraveling." Emerg 

Infect Dis 5 (1):48-53.

World Health Organization (WHO). 2004. Guidelines for drinking-water quality. 3rd Edition. 

Geneva, Switzerland. Accessed May 20, 

2016. http://www.who.int/water_sanitation_health/dwq/gdwq3rev/en/

and http://www.who.int/water_sanitation_health/dwq/en/waterforhealth.pdf. 
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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-assistance-network-tan. 

Chapter 6: Use of Heat Treatments as a Process Control 

Table of Contents

6.1 Purpose of this Chapter

6.2 Considerations to Keep in Mind If You Use a Heat Treatment as a 

Process Control

6.3 Examples Used in this Chapter

6.4 Understand the Potential Hazard

6.5 Terms Used in This Chapter

6.6 Design and Validation of the Heat Treatment

6.7 Develop a Strategy for Preventive Control Management Components

6.8 Establish and Implement Monitoring Procedures

6.8.1 What to Monitor

6.8.2 How to Monitor

6.8.2.1 How to monitor batch heating equipment

6.8.2.2 How to monitor continuous heating equipment

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. Underlined text in yellow highlights 

represents a correction from the draft Chapter 6 that we issued for public comment in August 2017.
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6.8.3 How Often to Monitor (Frequency of Monitoring)

6.8.3.1 How often to monitor batch heating equipment

6.8.3.2 How often to monitor continuous heating equipment

6.8.4 Who performs the monitoring

6.9 Establish and Implement Corrective Action Procedures

6.10 Determine Verification Procedures

6.11 Establish and Maintain Records

6.11.1 Records of Monitoring Activities

6.11.1.1 Records of monitoring activities for batch heating equipment

6.11.1.2 Records of monitoring activities for continuous heating equipment

6.11.2 Records of Corrective Actions

6.11.3 Record of On-going Verification Activities

6.12 Example of Cookie Processor A’s Heat Treatment

6.12.1 Cookie Processor A’s Product, Hazard Analysis, and Batch Heat Treatment

6.12.2 Cookie Processor A’s Process Design and Validation

6.12.3 Cookie Processor A’s Monitoring

6.12.3.1 What Cookie Processor A monitors

6.12.3.2 How Cookie Processor A monitors

6.12.3.3 How often Cookie Processor A monitors

6.12.3.4 Who monitors critical factors for Cookie Processor A’s heat treatment

6.12.4 Cookie Processor A’s Corrective Action Procedures

6.12.5 Cookie Processor A’s Verification Procedures

6.12.6 Cookie Processor A’s Monitoring Records

6.12.7 Cookie Processor A’s Records of Corrective Actions

6.12.8 Cookie Processor A’s Verification Records

6.12.9 Summary Process Control Table for Cookie Processor A

6.13 Example of Cookie Processor B’s Heat Treatment

6.13.1 Cookie Processor B’s Product, Hazard Analysis, and Continuous Heat 

Treatment

6.13.2 Cookie Processor B’s Process Design and Validation

6.13.3 Cookie Processor B’s Monitoring
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6.13.3.1 What Cookie Processor B monitors

6.13.3.2 How Cookie Processor B monitors

6.13.3.3 How often Cookie Processor B monitors

6.13.3.4 Who monitors critical factors for Cookie Processor B’s heat treatment

6.13.4 Cookie Processor B’s Corrective Action Procedures

6.13.5 Cookie Processor B’s Verification Procedures

6.13.6 Cookie Processor B’s Monitoring Records

6.13.7 Cookie Processor B’s Records of Corrective Actions

6.13.8 Cookie Processor B’s Verification Records

6.13.9 Summary Process Control Table for Cookie Processor B

6.14 Example of Soup Processor A’s Heat Treatment

6.14.1 Soup Processor A’s Product, Hazard Analysis, and Batch Heat Treatment

6.14.2 Soup Processor A’s Process Design and Validation

6.14.3 Soup Processor A’s Monitoring

6.14.3.1 What Soup Processor A monitors

6.14.3.2 How Soup Processor A monitors

6.14.3.3 How often Soup Processor A monitors

6.14.3.4 Who monitors critical factors for Soup Processor A’s heat treatment

6.14.4 Soup Processor A’s Corrective Action Procedures

6.14.5 Soup Processor A’s Verification Procedures

6.14.6 Soup Processor A’s Monitoring Records

6.14.7 Soup Processor A’s Records of Corrective Actions

6.14.8 Soup Processor A’s Verification Records

6.14.9 Summary Process Control Table for Soup Processor A

6.15 Example of Soup Processor B’s Heat Treatment

6.15.1 Soup Processor B’s Product, Hazard Analysis, and Continuous Heat Treatment

6.15.2 Soup Processor B’s Process Design and Validation

6.15.3 Soup Processor B’s Monitoring

6.15.3.1 What Soup Processor B monitors

6.15.3.2 How Soup Processor B monitors

6.15.3.3 How often Soup Processor B monitors
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6.15.3.4 Who monitors critical factors for Soup Processor B’s heat treatment

6.15.4 Soup Processor B’s Corrective Action Procedures

6.15.5 Soup Processor B’s Verification Procedures

6.15.6 Soup Processor B’s Monitoring Records

6.15.7 Soup Processor B’s Records of Corrective Actions

6.15.8 Soup Processor B’s Verification Records

6.15.9 Summary Process Control Table of Soup Processor B

6.16 Example of Salsa Processor A’s Heat Treatment

6.16.1 Salsa Processor A’s Product, Hazard Analysis, and Heat Treatment

6.16.2 Salsa Processor A’s Process Design and Validation

6.16.3 Salsa Processor A’s Monitoring

6.16.3.1 What Salsa Processor A monitors

6.16.3.2 How Salsa Processor A monitors

6.16.3.3 How often Salsa Processor A monitors

6.16.3.4 Who monitors critical factors for Salsa Processor A’s heat treatment

6.16.4 Salsa Processor A’s Corrective Action Procedures

6.16.5 Salsa Processor A’s Verification Procedures

6.16.6 Salsa Processor A’s Monitoring Records

6.16.7 Salsa Processor A’s Records of Corrective Actions

6.16.8 Salsa Processor A’s Verification Records

6.16.9 Summary Process Control Table for Salsa Processor A

6.17 References

Appendix 6. Summary Process Control Tables for the Examples in 

Chapter 6

Appendix 6-A: Summary Process Control Table for Baking; Cookie Processor A

Appendix 6-B: Summary Process Control Table for Baking; Cookie Processor B

Appendix 6-C: Summary Process Control Table for Cooking; Soup Processor A

Appendix 6-D: Summary Process Control Table for Cooking; Soup Processor B

Appendix 6-E: Summary Process Control Table for Heat Treatment; Salsa 

Processor A
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6.1 Purpose of this Chapter

The purpose of this chapter is to explain how to establish and implement a heat treatment (e.g., 

baking or cooking) as a process control for bacterial pathogens. See Chapter 4 – Preventive 

Controls for additional detail on heat and other lethal treatments. 

This chapter does not address controlling bacterial pathogens by those heat treatments, such 

as retort processes, that are subject to 21 CFR part 113 (Thermally Processed Low-Acid Foods 

Packaged in Hermetically Sealed Containers; commonly called “Low-Acid Canned Foods”

(LACF)) because the microbial hazards in LACF are not subject to the requirements for hazard 

analysis and risk-based preventive controls. 

6.2 Considerations to Keep in Mind If You Use a Heat Treatment as a 

Process Control

Heating is only one of the process controls that you may choose to use to produce a safe 

product. Based on your hazard analysis, there may be other process controls to consider. In 

addition, the heat treatments discussed in this chapter are designed to kill/destroy vegetative 

cells of bacterial pathogens (e.g., Salmonella), but are not adequate to inactivate spores of 

sporeforming bacteria (e.g., all strains of C. botulinum). Therefore, if you use one of the heat 

treatments described in this chapter, you may need to establish and implement additional 

preventive controls to control spores. See Chapter 4 for further information regarding additional 

process controls for pathogenic sporeformers. See Table 6-1 for additional strategies for 

controlling bacterial pathogens.

Table 6-1 Strategies Other than Heat Treatment for Controlling Bacterial Pathogens

Preventive Control Chapter 

Time/Temperature Control 7

Formulation Control (e.g., water activity, pH, 

and chemical preservatives)

8

Dehydration/Drying 9

Sanitation Controls 10

6.3 Examples Used in this Chapter

Sections 6.12 through 6.16 of this chapter provide examples to illustrate how to properly apply 

heat treatments as a process control and to establish and implement preventive control 

management components (i.e., monitoring, corrective actions and corrections, and verification)

for those heat treatments. These examples are:
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• Cookie Processor A: Cookies baked using a batch process (in batches on trays in 

convection ovens), wrapped by twos in plastic (Section 6.12) 

• Cookie Processor B: Cookies baked using a continuous process (in a continuous band 

oven), packaged in boxes of 24 cookies (Section 6.13)

• Soup Processor A: Ready-to-Eat (RTE) soups containing vegetable particles, cooked using 

a batch process (in a kettle), packaged in 8 ounce plastic bowls, and frozen (Section 6.14)

• Soup Processor B: RTE soups (clear broths and creamed vegetable soups, without 

vegetable particles) cooked using a continuous process (in a continuous flow heat 

exchanger), packaged in 5 gallon bags, and refrigerated (Section 6.15)

• Salsa Processor A: Chopped mixed vegetable salsa (an acidified food) that is directly 

acidified, cooked in a kettle, and hot-filled into glass jars (Section 6.16)2

Each of these examples describes certain activities that must be either performed, or overseen 

by, a preventive controls qualified individual (PCQI). When a PCQI oversees (rather than 

performs) these activities, the activity could be performed by a designee of the PCQI. For 

simplicity, we describe the activity as performed by a PCQI, without specifying each time that 

the activity could be performed by a designee of a PCQI.

6.4 Understand the Potential Hazard

Heat is known to be effective against bacterial pathogens and is a common process control for 

these hazards. However, if heat treatments are not properly designed and implemented, the 

pathogens of concern may survive the process and cause illness. See Chapter 3 for more 

information on bacterial pathogens.

6.5 Terms Used in This Chapter 

Part 117 specifies that process controls include procedures, practices, and processes to ensure 

the control of parameters during operations such as heat processing, acidifying, irradiating, and 

refrigerating foods. Process controls must include, as appropriate to the nature of the applicable 

control and its role in the facility’s food safety system: (1) Parameters associated with the 

control of the hazard; and (2) the maximum or minimum value, or combination of values, to 

which any biological, chemical, or physical parameter must be controlled to significantly 

minimize or prevent a hazard requiring a process control. (See 21 CFR 117.135(c)(1).)

The examples in this chapter describe:

• Process parameters such as baking/cooking time, baking/cooking temperature, dough 

weight, particle size, belt speed, and pump speed;

• Maximum values for some of these process parameters (e.g., 28 g portion of dough); and

 2 In forthcoming chapters, we will provide an example of formulation control for this acidified food

(Chapter 8 – Use of Formulation as a Process Control) and an example of control of glass hazards 

(Chapter 13 – Preventive Controls for Physical Hazards).
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• Minimum values for some of these process parameters (e.g., 350°F (177°C) minimum 

baking temperature, 13 minutes minimum baking time).

Process controls typically are established at “critical control points” (CCPs). “CCP” is a term 

commonly used in HACCP systems. In HACCP systems, the maximum or minimum values for a 

process parameter established at a CCP are called “critical limits.” Our HACCP regulation for 

juice (21 CFR part 120) defines “critical limit” as the maximum or minimum value to which a 

physical, biological, or chemical parameter must be controlled at a critical control point to 

prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.

Part 117 does not preclude the use of terms (such as “critical limits” and “critical factors”) that 

are associated with HACCP systems. Because the maximum or minimum values for the 

process parameters described in the examples in this chapter are established at CCPs, we see 

no meaningful difference between the terms “maximum value” and “minimum value” used in part 

117 for a process control and the term “critical limit” used in HACCP systems for controls 

established at CCPs. Therefore, in this chapter we use the term “critical limit” when referring to 

a maximum or minimum value established for a process control parameter. Because part 117 

specifies that preventive controls include controls, other than those at CCPs, that are also 

appropriate for food safety (21 CFR 117.135(a)(2)(ii)), in this chapter we use the more general 

term “process parameter” (rather than “critical factor”) when referring to parameters other than 

those specified in the examples with critical limits. 

Part 117 does not define the term “operating limit.” In this guidance, we use the term “operating 

limit” to mean criteria that may be more stringent than critical limits and are established for 

reasons other than food safety. For example, if you bake cookies and establish 13 minutes as 

the critical limit for the minimum baking time to control bacterial pathogens, you could establish 

15 minutes as an operating limit for the baking time and assess the cookies for quality if the 

baking time is less than 15 minutes, but still exceeds the critical limit of 13 minutes (e.g., if the 

baking time was 14 minutes). 

Part 117 does not define the term “adjustment.” In this guidance, we use the term “adjustment” 

when referring to an intervention that you take if you determine that there is a deviation from an 

operating limit, without a deviation from a critical limit. For example, if you bake cookies,

establish 28 g as the maximum value (critical limit) for the weight of cookie dough deposited by 

an automatic dough depositor, and establish 27 g as the operating limit for the weight of cookie 

dough, you could make an adjustment to the dough depositor if you observe that the amount of 

dough deposited exceeds the operating limit of 27 g, but does not exceed the critical limit of 28 

g. 

6.6 Design and Validation of the Heat Treatment

The heat treatments discussed in this chapter are designed to significantly minimize (eliminate 

or reduce to an acceptable level) vegetative cells of bacterial pathogens that may have been 

introduced into the food by raw materials or during processing steps that occur before the heat 

step. With few exceptions, the PCHF requirements specify that you must validate that the 

preventive controls are adequate to control the hazard as appropriate to the nature of the 

preventive control and its role in your food safety system. The validation of the preventive 

controls must be performed (or overseen) by a PCQI. (See 21 CFR 117.160.)
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To control bacterial pathogens using a heat treatment adequate to ensure that the pathogens do 

not survive the process, you should:

• Scientifically establish a heat treatment that will significantly minimize the target bacterial 

pathogens (eliminate them or reduce their numbers to acceptable levels); 

• Design and operate the heat treatment equipment so that every unit of product receives at 

least the established minimum heat treatment; and

• Monitor the established process parameters to verify achievement of the scientifically 

established heat treatment (e.g., time and temperature).

You could establish process parameters and the critical limits for the process parameters based 

on scientific information, usually obtained by a scientific study (often from studies in the 

literature). You also could obtain this information from a process authority that has knowledge 

about process parameters and minimum/maximum values (e.g., critical limits) for the product 

being produced. A process authority could also conduct the studies that would establish a valid 

heat treatment. 

For heat treatments, examples of process parameters include:

• Amount of time for the heat treatment (e.g., the amount of time exposed to heat as 

determined by the speed of the belt through a continuous oven, or observed number of 

minutes at a boil for some cooking processes)3

; 

• Temperature of the heating medium (e.g., temperature of oven or steam or water used for 

cooking); 

• Internal Temperature (IT) of the product; 

• Final temperature of the product; 

• Particle size (e.g., when heat must penetrate particles such as chopped vegetables so that 

the interior of the particles receives a complete heat treatment); 

• Depth of product on a conveyor belt; 

• Container size (e.g., can dimensions when products are heated in containers); and 

• Product formulation. 

When a study is conducted to establish a valid heat treatment, that study could identify other 

process parameters that affect the rate of heating of the product. 

 3 When an End-Point Internal Product Temperature (EPIPT) has been determined by a study, there is no 

time associated with the heat treatment.
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6.7 Develop a Strategy for Preventive Control Management 

Components 

With few exceptions, part 117 specifies that preventive controls are subject to the following 

preventive control management components as appropriate to ensure the effectiveness of the 

preventive controls, taking into account the nature of the preventive control and its role in the 

facility’s food safety system: (1) Monitoring; (2) corrective actions and corrections; and (3) 

verification. (See 21 CFR 117.140.) In the remainder of this chapter, we discuss each of these 

preventive control management components when the process control is a heat treatment. See 

Sections 6.12 through 6.16 for examples that provide more detail about how to apply each of 

these preventive control management components to specific types of heat treatments. 

6.8 Establish and Implement Monitoring Procedures

Part 117 requires that, as appropriate to the nature of the preventive control and its role in your 

food safety system, you establish and implement written procedures, including the frequency 

with which they are to be performed, for monitoring the preventive control. You must monitor the 

preventive controls with adequate frequency to provide assurance that they are consistently 

performed. (See 21 CFR 117.145.)

6.8.1 What to Monitor

Heat treatments designed to significantly minimize pathogens play a key role in your food safety 

system. When a heat treatment is your preventive control and you have established critical 

factors for the heat treatment (e.g., as identified by a scientific study or provided by an expert in 

thermal processing, such as a process authority), you would monitor those critical factors. 

Exceptions to such monitoring include heat treatments that are designed such that a process 

parameter is automatically controlled, e.g., when a bar is placed at a specified height above a 

conveyor belt to ensure that the bed depth of product being heat treated cannot exceed the 

depth determined to be the critical limit for the depth of product. 

6.8.2 How to Monitor

6.8.2.1 How to monitor batch heating equipment

For most temperature determinations in batch heating equipment, you should use a continuous 

temperature-recording device (e.g., a recording thermometer). You should install the device 

where it measures the coldest temperature of the cooking equipment (the cold spot determined 

by a study). In some instances (e.g., to determine the IT prior to heating or to determine the 

EPIPT), you could use a temperature-indicating device (e.g., a thermometer). Where cooking is 

performed at the boiling point, you could visually observe minutes at a boil.

For the heating time of a batch process, you should record the times of the start and the end of 

the cooking or baking cycle and calculate the heating time from this information. To help you do 

so, you could set timers to give an audible or visible indication that the cooking or baking time 

has been completed.
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For most heat treatments, you should monitor both temperature and time. However, when an 

EPIPT has been scientifically established, you could monitor only the finished product 

temperature, because there is no time associated with the heat treatment.

For other process parameters, use appropriate equipment to monitor the parameter, e.g., scales 

when you establish a critical limit for a weight; rulers or calipers when you establish a critical

limit for size.

6.8.2.2 How to monitor continuous heating equipment 

For monitoring temperature in continuous heating equipment, you should use a continuous 

temperature-recording device (e.g., a recording thermometer). You should install the device 

where it measures the coldest temperature of the cooking equipment (the cold spot determined 

by a study). For larger heating chambers such as continuous baking or roasting ovens, you 

should install temperature recording devices in multiple locations, e.g., the top, middle, and 

bottom baking areas of the oven. For continuous monitoring of the temperature of continuous 

flow heated liquids, you could use a resistance temperature detector (RTD) placed in line.

For monitoring time (e.g., cooking or baking times) in continuous heating equipment, you could

use a stopwatch or tachometer to monitor the speed of the belt drive wheel, or use a stopwatch 

to monitor the time it takes for a test unit or a belt mark to pass through the equipment. In other 

systems, you could determine time by the flow rate of a fluid product pumped through a 

continuous heating system. (In simple terms, the heating time is determined by the speed with 

which a food flows through the heating system. Determining the appropriate flow rate can be 

complicated – we recommend you use an expert in thermal processing to establish processes 

for such continuous heating systems.) To achieve a process-specific flow rate, you could 

calibrate the pump to a set RPM, mark a set point on the pump, and visually observe the pump 

setting (i.e., speed measured in RPM). Some systems provide a mechanism whereby you could

lock the pump to prevent a change in the pump speed that would affect the product flow rate. 

For other process parameters, you should use appropriate equipment to monitor the factor, e.g., 

scales when you establish a critical limit for a weight; rulers or calipers when you establish a 

critical limit for size.

6.8.3 How Often to Monitor (Frequency of Monitoring)

6.8.3.1 How often to monitor batch heating equipment

If you use a continuous temperature-recording device (e.g., a recording thermometer) for 

monitoring, you should do a visual check of the recorded data at least once per batch. If you 

establish an EPIPT, you should monitor the EPIPT for each batch.

For the heating time of a batch process, you should monitor the recorded start and end times for 

each batch unless you are using an EPIPT. (When using an EPIPT, the frequency of checking 

temperature is often designed to minimize exposure to heat once the EPIPT is reached, and it is 

product quality, rather than product safety, that generally would be negatively impacted.)

You should monitor other process parameters with sufficient frequency to achieve control. 
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6.8.3.2 How often to monitor continuous heating equipment 

If you use a continuous temperature-recording device (e.g., a recording thermometer) for 

monitoring, you should do a visual check of the recorded data at least once per day. 

For the heating time of a continuous process, you should monitor the automated timers at least 

once per day or pump speed setting at least twice per shift, and whenever you make any 

changes in the automated timer or pump speed setting.

You should monitor other process parameters with sufficient frequency to achieve control.

6.8.4 Who performs the monitoring

When a person (rather than a machine) is assigned to perform monitoring, that person must 

have the education, training, or experience (or a combination of these) necessary to perform the 

individual’s assigned duties. (See 21 CFR 117.4(b)(1).)

Examples of who performs the monitoring, or devices that perform monitoring, include:

• A continuous monitoring thermometer measures the product IT or the oven temperature;

• The person who puts ingredients together before they are taken to the line determines the 

weight of ingredients critical to the formulation of the product or determines that particle size 

is within specifications;

• The line operator (e.g., kettle cook, bakers), Quality Control (QC) personnel, or any other 

person who has an understanding of the nature of the preventive controls;

o Visually checks data generated by a continuous monitoring device to ensure that the 

critical limits have consistently been met4

;

o Monitors the temperature for manual (non-automated or non-continuous) devices; 

and

o Performs other monitoring activities that occur on the processing line.

6.9 Establish and Implement Corrective Action Procedures

Part 117 requires that, as appropriate to the nature of the hazard and the nature of the 

preventive control, you must establish and implement written corrective action procedures that 

must be taken if preventive controls are not properly implemented, including procedures to 

address, as appropriate: (1) The presence of a pathogen or appropriate indicator organism in a 

ready-to-eat product detected as a result of product testing; and (2) The presence of an 

environmental pathogen or appropriate indicator organism detected through environmental 

monitoring. The corrective action procedures must describe the steps to be taken to ensure that: 

(1) Appropriate action is taken to identify and correct a problem that has occurred with 

implementation of a preventive control; (2) Appropriate action is taken, when necessary, to 

reduce the likelihood that the problem will recur; (3) All affected food is evaluated for safety; and 

 4 This is sometimes considered a verification activity.
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(4) All affected food is prevented from entering into commerce, if you cannot ensure that the 

affected food is not adulterated or misbranded. (See 21 CFR 117.150(a).)

When your preventive control is a heat treatment, your corrective action procedures would

describe the steps you will take when the heat treatment does not achieve the process-specified 

temperature or time (as well as any other critical limits established for the heat treatment). 

Examples of steps identified in corrective action procedures applicable to a heat treatment 

include:

• Continue heating a product that has not reached the specified temperature after the 

specified number of minutes;

• Extend the length of the heat cycle to compensate for a temperature drop (e.g., by 

continuing to heat the product for a longer time; by slowing the belt speed or flow rate to 

increase time of exposure to heat), using an alternate process developed by a process 

authority; 

• Process at a higher temperature or longer time to compensate for a low IT, using an 

alternate process developed by a process authority;

• Reprocess the product (deliver the full process as if no heating had already occurred);

• Chill and hold the product for an evaluation of the adequacy of the heat treatment that has 

been delivered, and stipulate the disposition of the product if the product has not received 

an adequate process (e.g., destroy the product, divert it to a non-food use, or reheat it); 

• Divert the product to a use in which the critical limits for the parameter are not applicable 

(e.g., an RTE product may become a not-RTE product or may become an ingredient for 

further processing by you or another manufacturer/processor);

• Divert the product to animal food (usually for animals other than pets);

5 and

• Destroy the product.

Although part 117 establishes requirements applicable to your corrective action procedures, it 

neither establishes requirements for other procedures, such as for adjustments, you might 

establish in your plant nor precludes you from establishing such procedures. Likewise, part 117 

neither establishes requirements applicable to any assessment that you do for food quality if a 

process parameter deviates from an operating limit but does not deviate from a critical limit 

(e.g., if you have a procedure to assess food quality if the baking temperature for cookies is 

more than 5-10 degrees above the temperature set as a critical limit). 

 5 FDA is developing guidance on the use of human food by-products in animal food, including diversion of 

human food products to animal food use. In 2016, FDA issued for public comment a draft guidance for 

industry entitled “Human Food By-Products For Use As Animal Food” (FDA, 2016 and 81 FR 58521, 

August 25, 2016). In determining whether it is appropriate to divert a food product to animal food use, we 

recommend that you consult the final guidance on this subject when it becomes available.
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6.10 Determine Verification Procedures

Part 117 requires that verification activities include, as appropriate to the nature of the 

preventive control and its role in your food safety system: (1) Validation; (2) Verification that 

monitoring is being conducted; (3) Verification that appropriate decisions about corrective 

actions are being made; (4) Verification of implementation and effectiveness; and (5) reanalysis.

(See 21 CFR 117.155.) For a discussion of validating a heat treatment, see section 6.6 of this 

chapter.

Part 117 also requires that you verify that the preventive controls are consistently implemented 

and are effectively and significantly minimizing or preventing the hazards. To do so you must 

conduct activities that include the following, as appropriate to the facility, the food, and the 

nature of the preventive control and its role in the facility’s food safety system: 

• Calibration of process monitoring instruments and verification instruments (or checking them 

for accuracy) (21 CFR 117.165(a)(1)); 

• Product testing, for a pathogen (or appropriate indicator organism) or other hazard (21 CFR 

117.165(a)(2)); 

• Environmental monitoring, for an environmental pathogen or for an appropriate indicator 

organism, if contamination of a ready-to-eat food with an environmental pathogen is a 

hazard requiring a preventive control, by collecting and testing environmental samples (21 

CFR 117.165(a)(3)); and

• Review of certain records by (or under the oversight of) a PCQI, to ensure that the records 

are complete, the activities reflected in the records occurred in accordance with the food 

safety plan, the preventive controls are effective, and appropriate decisions were made 

about corrective actions (21 CFR 117.165(a)(4)).

Part 117 also requires, as appropriate to the facility, the food, the nature of the preventive 

control, and the role of the preventive control in the facility’s food safety system, that you 

establish and implement written procedures for: (1) The method and frequency of calibrating 

process monitoring instruments and verification instruments (or checking them for accuracy); (2) 

Product testing; and (3) Environmental monitoring. (See 21 CFR 117.165(b).)

Examples of verification activities applicable to heat treatments include:

• Calibrating devices used for monitoring (and for verification), such as thermometers, RTDs,

timers, and scales, before use (or verifying their accuracy); 

• Reviewing monitoring records (e.g., process logs) to confirm that the heat treatment was 

performed at the proper temperature and for the appropriate amount of time (sometimes 

also called “batch records review”);

• Performing measurements at the monitoring points independent of the routine monitoring 

activity or observing line operators performing measurements;

• Verifying that appropriate decisions about corrective actions are being made when there are 

process deviations from critical limits; and
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• Conducting, when appropriate, product testing to confirm that the heat treatment has 

adequately controlled bacterial pathogens that are relevant to the product.

This chapter does not discuss verification activities that are not directly related to heat 

treatments. For example, this chapter does not discuss environmental monitoring for an 

environmental pathogen as verification of sanitation controls. Likewise, this chapter does not 

discuss corrective action procedures that could be associated with such verification activities, 

such as product testing if the results of environmental monitoring for an environmental pathogen 

are positive.

6.11 Establish and Maintain Records

Part 117 requires that you document the preventive control management components as 

follows: (1) The monitoring of preventive controls in records that are subject to verification and 

records review; (2) all corrective actions (and, when appropriate, corrections) in records that are 

subject to verification and records review; and (3) all verification activities. (See 21 CFR 

117.145(b)-(c), 117.150(d), and 117.155(b).)

Examples of what to document in records applicable to a heat treatment include:

• Monitoring activities of the process parameters that were established by a scientific study or 

provided by a process authority;

• Corrective actions that you take when a heat treatment does not achieve the processspecified temperature or time or when other critical limits are not met;

• Verification activities for implementation of the heat treatment such as:

o Calibration records for monitoring/measuring devices, and a review of the calibration 

records;

o Review of process records (e.g., logs of IT, process temperatures, process times, 

temperature charts);

o Review of any corrective actions taken as a result of a deviation from any of the 

critical limits for the heat treatment; and

o Any other verification activities conducted, including any product testing used to 

verify the adequacy of the heat treatment.

6.11.1 Records of Monitoring Activities

6.11.1.1 Records of monitoring activities for batch heating equipment

Examples of what to document in records of monitoring activities for batch heating equipment 

include:

• Records of temperature and time, if you monitor both temperature and time;
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• Records of the finished product temperature, if you establish an EPIPT (where there is no 

time associated with the heat treatment); 

• Records applicable to a continuous temperature recording device (e.g., a recording 

thermometer), if you use one, such as:

o Recorder charts;

o When applicable, records documenting the visual checks of recorded data (e.g., a 

hand written note on the recorder charts); and

o When applicable, records noting the start time and end time of the cooking or baking 

periods;

• Records of monitoring of critical limits for other process parameters for your heat treatment 

(e.g., weight or size).

You should keep these records in a “process log” for each production line, with information to 

identify the plant or facility, dates (and when appropriate, the time) of monitoring, the signature 

or initials of the person performing the monitoring (e.g., operator initials) and evidence of review 

(i.e., the initials of the PCQI or designee). 

6.11.1.2 Records of monitoring activities for continuous heating 

equipment 

Examples of what to document in records of monitoring activities for batch heating equipment 

include:

• Records of any continuous temperature-recording device (e.g., a recording thermometer) 

(When applicable, this would include records of each temperature-recording device installed 

for each heating area in an oven with multiple temperature recording devices); 

• Records of the time interval (in minutes) determined by a stopwatch and automated timer if 

you use a stopwatch to monitor the time interval of an automated timer;

• Records of the pump speed (RPM) in the line process log every time you do a visual check

(if you determine time by the flow rate of a fluid product through a continuous heating 

system and you visually monitor the pump setting); and

• Records of monitoring of critical limits for other process parameters for your heat treatment 

(e.g., weights, size, thickness, etc.). 

You should keep these records in a “process log” for each production line (or other forms of 

documentation), with information to identify the plant or facility, dates (and when appropriate, 

the time) of monitoring, the signature or initials of the person performing the monitoring (e.g., 

operator initials) and evidence of review (i.e., the initials of the PCQI or designee).

6.11.2 Records of Corrective Actions

Examples of what to document in records of corrective actions that you take when a heat 

treatment is not properly implemented include records of corrective actions if your heat 
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treatment does not achieve the process-specified temperature or time established for your food 

product, or any other critical limit you established for a process parameter for your heat 

treatment. 

6.11.3 Record of On-going Verification Activities

Examples of what to document in records of verification activities applicable to your heat 

treatment include:

• Records (e.g., a log) documenting:

o The calibration of measuring devices (such as thermometers, RTDs, timers, and 

scales);

o Who conducted the calibration; 

o The method of calibration (which could be a Standard Operating Procedure); 

o The date of calibration; 

o Whether the device was in or out of specification; and 

o Adjustments needed and performed;

• A record of the process logs review, by whom, and date of review;

• A report of reviewing corrective actions taken when there are process deviations, including 

initials of the reviewer and the date of review; and

• A report of product testing (when determined appropriate) to verify that the heat treatment 

has adequately controlled bacterial pathogens that are relevant to the product.

6.12 Example of Cookie Processor A’s Heat Treatment 

6.12.1 Cookie Processor A’s Product, Hazard Analysis, and Batch Heat 

Treatment

Cookie Processor A bakes cookies in batches on trays in convection ovens and packages them

by wrapping the cookies by twos in plastic. Cookie dough is made and deposited on trays in the 

dough preparation room and racks of trays are moved to the baking room. Trays are removed 

from the convection oven after baking, placed on clean racks, and moved to the packaging 

room. 

Cookie Processor A’s PCQI identified Salmonella as the hazard associated with the ingredients 

(e.g., flour, eggs, peanut butter) used in making the cookies and determined that baking the 

cookies was the preventive control that would address this hazard. However, to ensure the

adequacy of the baking process used as the preventive control in Cookie Processor A’s food 

safety plan, Cookie Processor A’s PCQI needed to determine the appropriate processing 

parameters, including any critical limits, that would provide adequate lethality for Salmonella

during a batch baking process in a convection oven. To do so, Cookie Processor A’s PCQI 
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consulted with a local university’s extension specialist in process design and validation of heat 

treatments. Cookie Processor A’s PCQI asked the extension specialist to:

• Identify processing parameters that need critical limits for food safety; and

• Determine critical limits for those processing parameters. 

6.12.2 Cookie Processor A’s Process Design and Validation

The extension specialist provided Cookie Processor A’s PCQI with a published study by Lathrop 

et al., (2014) on survival of Salmonella during baking of peanut butter cookies. The published 

study showed that peanut butter cookie dough made with peanut butter inoculated with high 

levels of Salmonella (28 g portions of dough, water activity (aw) of 0.82) and baked at 350°F 

(177°C) for 15 minutes had no detectable Salmonella. Cookies baked for 13 minutes showed at 

least a 5.2 log reduction in Salmonella. In that published study, the cookie temperature at the 

end of 15 minutes was 229°F (109°C). 

The extension specialist identified the following processing parameters that need critical limits 

for food safety in Cookie Processor A’s heat treatment:

• Convection oven temperature (°F) to achieve specified minimum product temperature; 

• Baking time in oven (minutes); and

• Dough delivery process resulting in the specified cookie portion weight (g).

To determine critical limits for those processing parameters when baking cookies in batches in 

Cookie Processor A’s convection oven, and demonstrate that these critical limits can be 

achieved in Cookie Processor A’s convection oven, the extension specialist conducted in-house 

heat distribution tests on Cookie Processor A’s ovens and heat penetration tests on the cookies 

using a fully loaded oven (each oven rack contained a full tray of cookies, deposited in 28 g 

portions using a dough depositor). These in-house heat distribution and heat penetration tests

showed that all parts of each of Cookie Processor A’s oven were at or above 350°F (177°C) 

when the ovens were set at that temperature and that the coldest cookie temperature was 

above 230°F (110°C) after 13 minutes. In addition, aw determinations by an outside laboratory 

on the cookie dough were equal to or greater than 0.82 using Cookie Processor A’s recipes. 

Based on the in-house tests, and the published study by Lathrop et al. (Lathrop, 2014), the 

extension specialist determined that the baking process of 350°F or greater for a minimum of 13 

minutes (operating limit of 15 minutes) would provide adequate lethality for Salmonella for the 

recipe tested, so long as cookie dough portions did not exceed 28 g. The extension specialist 

informed Cookie Processor A that any subsequent change to the cookie recipe should be 

evaluated to determine whether it would impact these determinations.

Based on the information obtained from the extension specialist, Cookie Processor A’s PCQI

established three critical limits for the production of the cookies to ensure adequate lethality: 

• The critical limit (minimum value) for the baking temperature is 350°F (177°C); 

• The critical limit (minimum value) for the baking time is 13 minutes; and
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• The critical limit (maximum value) for the cookie dough portion size is 28 g.

Based on the information obtained from the extension specialist, Cookie Processor A’s PCQI

also established three operating limits for the production of the cookies: 

• The operating limit for the baking temperature is 352°F (178°C); 

• The operating limit for the baking time is 15 minutes; and 

• The operating limit for cookie dough portion size is 27 g.

Cookie Processor A calibrated a dough depositor to deliver 27 g portions of dough onto cookie 

sheets and produces cookies according to the established operating limits by baking 27 g 

portions of cookie dough in 352°F (178°C) ovens for 15 minutes.

6.12.3 Cookie Processor A’s Monitoring

6.12.3.1 What Cookie Processor A monitors 

Cookie Processor A monitors oven temperature, baking time, the dough depositor setting, and 

the weight of dough deposited. 

6.12.3.2 How Cookie Processor A monitors 

Cookie Processor A: 

• Uses a recording thermometer with recording chart to continuously monitor oven 

temperature; 

• Manually checks the temperature recorder chart and marks it with the batch number;

records time when the cookies enter the oven and the oven temperature, calculates and 

records the time cookies should be removed, records the time the cookies are removed from 

the oven on baking record sheets, and calculates and records the elapsed baking time;

• Checks the set point of the dough depositor that controls the weight of dough portions 

deposited; and 

• Periodically checks the weight of a few individual raw cookie dough portions using a 

calibrated scale located near the depositor.

6.12.3.3 How often Cookie Processor A monitors 

Cookie Processor A:

• Checks the oven temperature (continuously recorded) before putting each batch of cookies 

into the oven to ensure it is reading at the minimum specified set point (i.e., at least 350°F 

(177°C);

• Records the start and end baking times of each batch of cookies;

• Checks the set point of the dough depositor every 2 hours; and
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• Checks the weight of a few deposited cookie portions twice per shift.

6.12.3.4 Who monitors critical factors for Cookie Processor A’s heat 

treatment

At Cookie Processor A:

• The baker checks the oven temperature before putting each batch of cookies into the oven 

and notes and records the start and end times of the baking cycle for each batch of cookies. 

• A QC technician checks the set point of the dough depositor and the weight of the raw 

cookie dough portions. 

6.12.4 Cookie Processor A’s Corrective Action Procedures

Cookie Processor A’s corrective action procedures specify that:

• If cookies were baked in an oven that was not at least 350°F (177°C), the cookies will be 

diverted to animal food (non-pet food) and employees will be retrained on the importance of 

ensuring that the oven temperature has reached the set point;

• If the bake time calculated from the start and end times is less than the critical limit of 13 

minutes, the cookies will be diverted to animal food (non-pet food) and the PCQI will 

determine why the bake time was not met to prevent this from happening in the future;

• If the dough depositor is depositing a dough weight that exceeds the critical limit of 28 g: 

o The cookies will be diverted to animal food (non-pet food);

o The PCQI will take steps to determine (if possible) what caused the depositor to 

deliver an incorrect weight so that actions can be taken to prevent such occurrences; 

and

o The dough depositor will be adjusted to deliver the correct weight.

Cookie Processor A also has adjustment procedures that provide for:

• An assessment of product quality if the bake time is less than the operating limit of 15 

minutes but more than the critical limit of 13 minutes, with an investigation of why the bake 

time was less than the operating limit to prevent this from happening in the future; and

• An adjustment of the dough depositor if the cookie dough weight exceeds the operating limit 

of 27 g but does not exceed the critical limit of 28 g.

6.12.5 Cookie Processor A’s Verification Procedures

At Cookie Processor A:

• The following are calibrated at least annually:

o The recording thermometer that monitors oven temperature; 
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o The dough depositor; and 

o The scales used to check the weights of cookie portions. 

• Within a week of their creation, the PCQI:

o Reviews calibration logs (records of calibrating monitoring equipment) to make sure 

that the devices are properly calibrated using the appropriate methods and at the 

appropriate frequencies as specified in the calibration procedures;

o Checks the baking record sheets and the temperature recording chart for monitoring 

records for temperature and time (i.e., time when the cookies enter the oven, 

calculated time for removal, and time the cookies were removed from the oven) to 

verify that the oven temperature was at least at the critical limit of 350°F (177°C) and 

that the cookies were baked for 15 minutes;

o Checks the dough weight logs for the cookie dough portion weighing records to verify 

that none of the dough portions exceeded 28 g in weight; and

o Initials and dates each of the records reviewed in the place marked “Verified by.”

• The PCQI reviews the corrective action records within a week of a deviation, and initials and 

dates each of the records reviewed in the place marked “Verified by.”

6.12.6 Cookie Processor A’s Monitoring Records

Cookie Processor A keeps:

• The recording charts of the recording thermometer as a record of monitoring the oven 

temperature; 

• The baking record sheets as a record of monitoring the baking times; and 

• A dough weight log as a record of the dough depositor setting and the dough portioning 

weight. 

6.12.7 Cookie Processor A’s Records of Corrective Actions

Cookie Processor A keeps records:

• Documenting that cookies placed in an oven that was not at least 350°F (177°C) or cookies 

baked for less than 13 minutes were diverted to animal food (non-pet food);

• Of any investigations of the cause of any deviations;

• Of all changes made to correct a problem and to prevent reoccurrence of deviations; and

• Documenting any retraining.
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Cookie Processor A also keeps records of adjustments, because such records could be useful 

in identifying ongoing production problems that could demonstrate a need to review and change 

applicable production procedures. 

6.12.8 Cookie Processor A’s Verification Records 

Cookie Processor A maintains records, initialed and dated by the PCQI, of the PCQI’s review of:

• The calibration logs; 

• The monitoring records (such as the oven temperature recording chart, records containing 

the bake time for cookies, and dough weight log); and

• The corrective action log.

6.12.9 Summary Process Control Table for Cookie Processor A

Appendix 6-A summarizes the above information for Cookie Processor A on the FSPCA’s 

Process Control Form (Form 2-C (Modified) from Appendix 2).

6.13 Example of Cookie Processor B’s Heat Treatment 

6.13.1 Cookie Processor B’s Product, Hazard Analysis, and Continuous 

Heat Treatment

Cookie Processor B bakes cookies in a continuous band oven and packages them in boxes of 

24 cookies. Cookie dough is made in the dough preparation room and placed in totes that are 

taken to the dough hopper of an extruder at the front of the continuous band oven in the baking 

room. The dough extruder automatically deposits the dough across the oven band (solid 

conveyor), where the cookie dough is conveyed through the heating tunnel (oven). After baking, 

the band drops the cookies onto a conveyor that cools them and moves them to the packaging 

room.

Cookie Processor B’s PCQI identified Salmonella as the hazard associated with the ingredients 

(e.g., flour, eggs, peanut butter) used in making cookies and determined that baking the cookies 

was the preventive control that would address this hazard. However, to ensure the adequacy of 

the baking process used as the preventive control in Cookie Processor B’s food safety plan,

Cookie Processor B’s PCQI needed to determine the appropriate processing parameters, 

including any critical limits, that would provide adequate lethality for Salmonella for a continuous 

baking process using a band oven. To do so, Cookie Processor B’s PCQI consulted with a 

process design specialist at a food research consulting firm regarding the process design and 

validation of the heat treatment. Cookie Processor B’s PCQI asked the process design 

specialist to:

• Identify processing parameters that need critical limits for food safety; and

• Determine critical limits for those processing parameters. 
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6.13.2 Cookie Processor B’s Process Design and Validation 

The process design specialist provided Cookie Processor B’s PCQI with a published study by 

Lathrop, et al., (2014) on survival of Salmonella during baking of peanut butter cookies. The 

published study showed that peanut butter cookie dough made with peanut butter inoculated 

with high levels of Salmonella (28 g portions of dough, aw of 0.82) and baked at 350o

F (177°C) 

for 15 minutes had no detectable Salmonella. Cookies baked for 13 minutes showed at least a

5.2 log reduction in Salmonella. In that published study, the cookie temperature at the end of 15 

minutes was 229°F (109°C). 

The process design specialist identified the following processing parameters that need critical 

limits for food safety in Cookie Processor B’s heat treatment:

• Band oven temperature (o

F) to achieve specified minimum product temperature; 

• Baking time in oven (minutes) controlled by the speed of the conveyor belt through the 

continuous band oven; and

• Dough extrusion process resulting in the specified cookie portion weight (g).

To determine the critical limits for these processing parameters for baking cookies in Cookie 

Processor B’s continuous band oven, and demonstrate that these critical limits can be achieved 

in Cookie Processor B’s continuous band oven, the process design specialist conducted inhouse oven temperature mapping (heat distribution) studies on the continuous band oven and 

heat penetration studies on the cookies. The results of these studies, and the recommendations

of the process design specialist after conducting these studies, were as follows:

• Results of the in-house oven temperature mapping (heat distribution) study confirmed that 

the continuous band oven achieved and maintained the desired minimum temperature of 

350o

F (177°C) at the coldest spot in the oven at a set point temperature of 350oF (177°C) (or 

higher).

• The in-house heat penetration studies for the baking process used thermocouples with the 

sensors placed in the geometric center of the cookie dough portions (in 16 cookie dough 

portions deposited in 28 g portions at different points across the width of the oven band, in 

each of 3 trials conducted over 3 days). The speed of the conveyor belt in the band oven 

was set to result in a residence time of cookies in the oven of 13.0 minutes (as a worst case, 

or conservative, speed setting). Results from the heat penetration study demonstrated that 

all 28 g cookie dough portions achieved a minimum internal temperature of 231o

F at the end 

of a 13.0-minute baking time.6

• Because the operating limit for Cookie Processor B’s baking process is 15 minutes, the 

process design specialist also established the tachometer RPM reading that would result in

a residence time of cookies in the continuous band oven of 15-minutes.

 6 Note that these data demonstrate that if a deviation results in a baking time less than 15 minutes but 13 

or more minutes, the cookies receive more than a 5-log reduction for Salmonella (they reach a 

temperature of 231o

F) and are safe for consumption.
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• To ensure that the nominal weight of each raw cookie dough portion does not exceed the 

established process critical parameter weight of 28 g, the process design specialist specified 

that the cookie dough extruder should be calibrated to deliver 27 g raw cookie dough 

portions as an operating limit, and that the delivery should be verified by performing weight 

measurements at startup of the dough extruder each day.

Based on the information derived from this in-house validation study, in combination with the 

study published by Lathrop et al. (Lathrop, 2014), the process design specialist determined that 

Cookie Processor B’s band oven would provide adequate lethality for Salmonella for the specific 

recipe tested, so long as the weight of the raw cookie dough portion did not exceed 28 g and the 

cookies were baked for at least 13 minutes at a 350°F (177°C) oven setting.

Based on the information obtained from the process design specialist, Cookie Processor B’s 

PCQI, established three critical limits for the production of the cookies to ensure adequate 

lethality: 

• The critical limit (minimum value) for the baking temperature is 350°F (177°C);

• The critical limit (minimum value) for the baking time is 13 minutes; and

• The critical limit (maximum value) for the cookie dough portion size is 28 g.

Based on the information obtained from the process design specialist, Cookie Processor B’s 

PCQI also established three operating limits for the production of the cookies: 

• The operating limit for the baking temperature is 352°F (178°C);

• The operating limit for the baking time is 15 minutes; and

• The operating limit for cookie dough portion size is 27 g.

Cookie Processor B calibrated a dough depositor to deliver 27 g portions of dough onto cookie 

sheets and produces cookies according to the established operating limits by baking 27 g 

portions of cookie dough in a 352°F (178°C) band oven for 15 minutes.

6.13.3 Cookie Processor B’s Monitoring

6.13.3.1 What Cookie Processor B monitors

Cookie Processor B monitors oven temperature (at the identified cold spot), belt speed as 

indicated by tachometer RPM (for control of baking time), the dough depositor setting, and the 

weight of dough deposited.

6.13.3.2 How Cookie Processor B monitors

Cookie Processor B: 

• Uses a recording thermometer with recording chart to continuously monitor oven 

temperature at the cold spot; conducts a visual check of the chart and records the check in 

the operator’s baking log; 
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• Uses an automated tachometer with recorder chart to monitor the speed of the conveyor 

belt through the band oven (which is tied to the baking time) and conducts a visual check of 

the tachometer RPM; 

• Checks the set point of the dough depositor that controls the weight of the raw cookie dough 

portions deposited; and

• Periodically checks the weight of a few individual cookie dough portions using a calibrated 

scale located near the depositor.

6.13.3.3 How often Cookie Processor B monitors

Cookie Processor B:

• Checks the oven continuous temperature-recording device every hour to ensure it is reading 

at a minimum the specified set point (i.e., at least 350o

F) (177°C);

• Monitors the automated tachometer recording (RPM) at start up and twice per shift;

• Checks the set point of the dough depositor at start up and every 2 hours; and

• Checks the weight of deposited cookie portions at least twice per shift.

6.13.3.4 Who monitors critical factors for Cookie Processor B’s heat 

treatment

At Cookie Processor B:

• The baker checks the oven temperatures and monitors the automated tachometer 

recording; and

• A dough preparer checks the set point of the dough depositor and the weight of the raw 

cookie dough portions.

6.13.4 Cookie Processor B’s Corrective Action Procedures

Cookie Processor B’s corrective action procedures specify that:

• If cookies were baked in an oven that was not at least 350°F (177°C):

o The cookies will be diverted to further processing (e.g., baking for cookie crumbles 

ingredient production) or to animal food (non-pet food);

o Maintenance will determine the cause of the low temperature and fix the oven so the 

temperature is reset to the operating limit of 352°F (178°C) before more cookies are 

baked; and 

o Employees will be retrained, if necessary, on the importance of ensuring that the 

oven temperature has reached the set point before allowing the line to run. 

• If the tachometer RPM recording indicates that the baking time is less than 13 minutes: 
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o The cookies will be put on QC hold. The PCQI will determine whether the product will 

be diverted to further processing (e.g., baking) to make cookie crumbles as a baking 

ingredient or to animal food (non-pet food); and 

o The PCQI will conduct an investigation to determine why the bake time was not met 

and will inform plant management of actions they need to take to prevent this from 

happening in the future. 

If the dough depositor is depositing a dough weight that exceeds the maximum 28 g: 

o The PCQI will determine whether the product will be further processed into 

alternative products or be diverted to animal food (non-pet food), and (if possible) 

determine what caused the depositor to deliver an incorrect weight so that actions 

can be taken to prevent such occurrences; and

o The dough depositor will be adjusted by maintenance or by the equipment 

manufacturer to deliver the correct weight.

Cookie Processor B also has adjustment procedures that provide for:

• An assessment of product quality if the bake time is less than the operating limit of 15 

minutes but more than the critical limit of 13 minutes, with an investigation of why the bake 

time was less than the operating limit to prevent this from happening in the future; and

• An adjustment of the dough depositor if the cookie dough weight exceeds the operating limit 

of 27 g but does not exceed the critical limit of 28 g.

6.13.5 Cookie Processor B’s Verification Procedures

At Cookie Processor B: 

• The following are calibrated at least annually: 

o Recording thermometer and chart that monitors oven temperature; 

o The automated tachometer and recorder chart that monitors belt speed (baking 

time); 

o The dough depositor; and 

o The scales used to check the weights of cookie portions. 

• A QC technician checks the recorder charts twice per shift to confirm that the oven is 

maintained at the specified baking temperature of at least 350°F (177°C) and the 

tachometer RPM resulted in baking times of 15 minutes; the QC technician writes the date 

and time on the recorder charts, and initials the recorder charts. 

• A QC technician checks the raw cookie dough portion weighing records (dough weight logs)

twice per shift to verify that none of the dough portions exceeded 28 g in weight; the QC 

technician writes the date and time on the dough weight log and initials the dough weight 

log. 
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• The PCQI collects the oven recording thermometer charts, operator’s baking log, 

tachometer charts, and dough weight sheets daily for subsequent review within 7 days of 

their creation.

• Within 7 days of their creation the PCQI reviews the following records, dates and initials the 

records or a verification cover sheet to document that review, and then files the records:

o The calibration logs to make sure that the devices are properly calibrated using the 

appropriate methods and at the appropriate frequencies as specified in the 

calibration procedures; and

o The oven recording thermometer charts, operator’s baking log, tachometer charts,

and dough weight sheets for accuracy and to ensure the parameter values were met.

• The PCQI reviews corrective action records at the end of each week, initials and dates them 

to document that review, and files them chronologically (based on the date of the deviation)

in a folder with other corrective actions.

6.13.6 Cookie Processor B’s Monitoring Records

Cookie Processor B keeps:

• The recording charts of the recording thermometer and the operator’s baking log as a record 

of monitoring temperature in the oven;

• The recording charts of the recording tachometer with the visual observation noted on the 

chart as a record of monitoring the RPMs that achieve the baking time; and 

• A dough weight record sheet as a record of monitoring the check of the dough depositor 

setting and the check of the weight of the raw dough portions deposited. 

6.13.7 Cookie Processor B’s Records of Corrective Actions

Cookie Processor B keeps records:

• Of any lot of cookies diverted to further processing (e.g., baking for cookie crumbles) or to

animal food (non-pet food);

• Of any investigation of the cause of any deviations;

• Of all changes made to correct a problem and to prevent reoccurrence of deviations; and

• Documenting any retraining.

Cookie Processor B also keeps records of adjustments, because such records could be useful 

in identifying ongoing production problems that could demonstrate a need to review and change 

applicable production procedures.

6.13.8 Cookie Processor B’s Verification Records

Cookie Processor B maintains records initialed and dated by the PCQI, of the review of: 
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• Calibration logs;

• Oven recording thermometer charts;

• Operator’s baking log with the hourly checks of the temperature chart and the twice-per-shift 

tachometer RPM reading;

• Tachometer charts;

• Dough weight logs; and

• Corrective action logs. 

6.13.9 Summary Process Control Table for Cookie Processor B

Appendix 6-B summarizes the above information for Cookie Processor B on the FSPCA’s 

Process Control Form (Form 2-C (Modified) from Appendix 2).

6.14 Example of Soup Processor A’s Heat Treatment 

6.14.1 Soup Processor A’s Product, Hazard Analysis, and Batch Heat 

Treatment

Soup Processor A makes cooked, frozen RTE vegetable soups containing vegetable particles 

as ingredients. Soup Processor A cooks the soups to a minimum of 180°F (82°C) using a batch 

process in a 150 gallon steam-jacketed kettle, packages the soups in 8 ounce plastic bowls, and 

freezes the bowls of soup.

Soup Processor A’s PCQI identified L. monocytogenes as the hazard associated with the RTE 

vegetable soups and determined that cooking the soup using a batch process in a steamjacketed kettle maintained at a minimum of 180°F (82°C) was the preventive control to address 

this hazard. Soup Processor A’s PCQI identified cooking time and vegetable particle size as 

processing parameters that needed critical limits to provide adequate lethality for L. 

monocytogenes during the batch kettle-cooking process. Soup Processor A’s PCQI used Table 

3-D in Appendix 3 of this guidance to determine process times for a range of cooking 

temperatures with L. monocytogenes as the target pathogen and arranged for food scientists at 

Soup Processor A to conduct in-house studies that could be used to determine the critical limits 

for vegetable particle size.

6.14.2 Soup Processor A’s Process Design and Validation 

Using Table 3-D in Appendix 3 of this guidance, Soup Processor A’s PCQI determined that 0.05 

minutes (3 seconds) at 180°F achieves an acceptable 6-log (i.e., 6 logarithm) reduction, 

typically called a 6D (6 decimal reduction) process. (See Chapter 4 for further details.) Because 

of the additional lethality during the heating time needed for the soup to reach 180°F (82°C), 

and because more than 3 seconds would elapse before cooling from 180°F could begin, Soup 

Processor A’s PCQI decided to use an EPIPT and cook the soups until the temperature reaches 

180°F rather than to continuously monitor temperature during cooking.
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Food scientists at Soup Processor A conducted in-house studies to determine the critical limit 

for vegetable particle size. Based on those studies, Soup Processor A’s PCQI determined that 

as long as vegetable particles in the soup did not exceed 1⁄2 inch (13 mm) square, the particles 

would also be at 180°F when the liquid portion of the soup reached that temperature, provided 

that the particles were stored refrigerated (i.e., at least 33°F) (0.6 °C) and not frozen. (Soup 

Processor A’s SOPs specify that vegetable particles are stored refrigerated at a temperature of 

33 - 40°F (0.6 - 4 °C).) 

Soup Processor A established two critical limits for the production of the soup to ensure 

adequate lethality: 

• Minimum EPIPT of 180°F (82°C); and

• Maximum size of vegetable particles (1⁄2 inch (13 mm)).

Soup Processor A determined that a critical limit for the temperature of the particles in the soup 

is not necessary as long as the production line follows the SOP to store the particles 

refrigerated.

6.14.3 Soup Processor A’s Monitoring

6.14.3.1 What Soup Processor A monitors

Soup Processor A monitors the temperature of soup in the kettle and the size of any particles.

6.14.3.2 How Soup Processor A monitors

Soup Processor A:

• Uses a thermometer to periodically determine the temperature of soup in the top inch (2.5 

cm) of the kettle (where it is coldest) until the EPIPT is reached and records the measured 

temperature in a cook log; and

• Collects a statistically-based sample of vegetable particles (e.g., diced carrots, potatoes, 

onions), uses digital calipers to ensure they do not exceed 1⁄2 inch (13 mm) in any direction, 

and records the measured size of the vegetable particles in a log.

6.14.3.3 How often Soup Processor A monitors

Soup Processor A:

• Begins measuring the temperature of the soup after approximately 30 minutes of heating; 

• Measures the temperature approximately every 10 minutes after the temperature of the 

soup reaches approximately 170°F (77°C), until the temperature reaches 180°F (82°C); and

• Checks the particle size of every third lot of vegetable particles used as an ingredient in 

production upon receipt of the ingredient. 
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6.14.3.4 Who monitors critical factors for Soup Processor A’s heat 

treatment

At Soup Processor A: 

• The kettle cook operator measures the temperature of the soup during processing; and

• A formulation control operator checks the vegetable particle size.

6.14.4 Soup Processor A’s Corrective Action Procedures

Soup Processor A’s corrective action procedures specify that:

• If it is determined that the EPIPT did not reach 180°F (82°C) while the soup is being 

packaged but has not been frozen, packaging will be stopped and the remaining soup, 

including soup returned to the kettle from packages that have been filled but not frozen, will 

be reprocessed until the EPIPT reaches 180°F. Any packages that have already been 

frozen will be destroyed;

• If it is determined that the EPIPT did not reach 180°F (82°C) after the soup is packaged and 

frozen, the PCQI will assess the safety of the product to determine appropriate disposition. If 

the PCQI determines that the process delivered was inadequate to ensure product safety, 

the soup will be diverted to animal food (non-pet food) or destroyed;

• When soup is packaged before the EPIPT reaches 180°F (82°C) due to operator error, the 

kettle cook operator will be retrained, as appropriate, in proper procedures for, and the 

importance of, ensuring the product is not packaged before the EPIPT reaches 180°F; and

• If it is determined that the mean plus 2.5 standard deviation of the vegetable particle sizes 

exceeds 1⁄2 inch (13 mm) the lot of vegetables is rejected. The unopened packages will be 

returned to the supplier, and the PCQI will discuss the issue with the supplier so the supplier 

can investigate the root cause for incorrect particle size. The formulation control operator will 

check the vegetable particle size of every lot for the next 15 lots to verify particle sizes meet 

specification. If all 15 lots meet specification, the formulation control operator will return to 

monitoring every third lot.

6.14.5 Soup Processor A’s Verification Procedures

At Soup Processor A:

• The thermometers used to measure soup temperature are:

o Checked for accuracy at least daily by the QC technician; and

o Calibrated by the QC technician against a NIST-calibrated reference thermometer at 

least annually or whenever an accuracy check shows that recalibration is needed. 

The PCQI reviews, dates, and initials the calibration log within a week of the 

calibration.
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• The accuracy of digital calipers is checked by the QC technician before use by verifying that 

when fully closed the caliper reads zero (if not, the caliper is sent for repair or replaced);

• When calibration and accuracy checks of the thermometers and calipers are performed, the 

date and time are recorded in a log;

• On a weekly basis, the PCQI:

o Reviews monitoring records (cook logs) to confirm that all soups were cooked to a 

minimum temperature of 180°F (82°C) as indicated by the records of the EPIPT 

readings; 

o Reviews the accuracy checks of the thermometers and the digital calipers;

o Reviews the particle measurement logs to verify that vegetable particles used in the 

soup did not exceed 1⁄2 inch (13 mm) in size; and

• Before a lot of soup is released, the PCQI reviews corrective action records as part of a preshipment review to ensure all lot records are in order. (Because Soup Processor A uses an 

EPIPT and employees have been with Soup Processor A for many years, Soup Processor A

experiences few deviations, so the PCQI has determined and documented that this 

timeframe, rather than 7 working days, is reasonable.)

6.14.6 Soup Processor A’s Monitoring Records

Soup Processor A keeps:

• A production line cook log as a record of monitoring the temperatures; and

• A log of the size of vegetable particles checked upon receipt for the lots of raw materials 

used in production. 

6.14.7 Soup Processor A’s Records of Corrective Actions

Soup Processor A keeps records:

• Of the reprocessing of product (e.g., recooked to 180o

F) (82°C) if a soup was filled before 

the process-specified EPIPT was achieved and had not been frozen;

• Of any product safety assessment by the PCQI (e.g., soup that had been filled before 

reaching the EPIPT but that had been frozen) and the disposition of such product;

• Of any investigations of the cause of any deviations (including investigation into the 

supplier’s procedures for control of particle size); 

• Of all changes made to correct a problem and to prevent reoccurrence of deviations; and

• Documenting any retraining.
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6.14.8 Soup Processor A’s Verification Records

Soup Processor A maintains records with the date and initials of the PCQI for the review of:

• The log of the accuracy checks and calibration of the thermometer; 

• The cook log for monitoring the soup temperatures; 

• The log of the accuracy checks of the digital calipers; and

• The log of vegetable particle size; 

• Corrective action records.

6.14.9 Summary Process Control Table for Soup Processor A

Appendix 6-C summarizes the above information for Soup Processor A on the FSPCA’s 

Process Control Form (Form 2-C (Modified) from Appendix 2).

6.15 Example of Soup Processor B’s Heat Treatment 

6.15.1 Soup Processor B’s Product, Hazard Analysis, and Continuous Heat 

Treatment

Soup Processor B makes RTE clear broths and RTE creamed vegetable soups (with no 

particles) that are cooked using a continuous process (in a continuous flow heat exchanger), 

hot-filled into 5 gallon bags, and refrigerated. The ingredients include dehydrated vegetable 

powders, pasteurized liquid fresh cream, spice blends, starch, and other thickeners.

Soup Processor B’s PCQI, a food scientist/food engineer who functions as the facility’s food 

processing expert7

, identified Salmonella, L. monocytogenes, C. botulinum type A, C. botulinum

proteolytic type B, and C. botulinum non-proteolytic type B as hazards associated with the 

soups. Soup Processor B’s PCQI determined that cooking the soups using a continuous 

process (in a continuous flow heat exchanger) was a preventive control to address most of

these hazards. (Refrigeration will be needed to control C. botulinum type A and C. botulinum

proteolytic type B in the heat-treated soups.) In identifying the processing parameters and 

determining the critical limits for these processing parameters, Soup Processor B’s PCQI/food 

processing expert needed to evaluate which of the potential hazards would be the target 

organism.

 7 The individual who identifies critical limits, and establishes a heat treatment in a continuous flow system, 

for a product such as Soup Processor B’s soup, should have specialized experience adequate to 

evaluate processing parameters, establish appropriate minimum/maximum values (e.g., the residence 

time in the hold tube based on flow characteristics of the product and the length and diameter of the hold 

tube) and ensure the safety of an RTE product packaged in reduced oxygen packaging. When the 

regulatory framework does not require that the individual be a “process authority,” individuals with a 

variety of backgrounds (in this case, a food engineering background) could have such specialized 

experience.
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Because hot-filling into 5-gallon bags would result in reduced oxygen packaging, and because 

the soups will be distributed refrigerated, Soup Processor B’s PCQI/food processing expert

determined that C. botulinum non-proteolytic type B is an appropriate target organism for the 

soup heat treatment.8

6.15.2 Soup Processor B’s Process Design and Validation 

Using Table 3-E of Appendix 3 of this guidance, Soup Processor B’s PCQI/food processing

expert determined that a heat treatment that targeted C. botulinum non-proteolytic type B as the 

most heat resistant pathogen would also address Salmonella and L. monocytogenes and that 

hot-filling at 185°F (85°C) would minimize risk of recontamination after the heat treatment.

Based on an assessment and review of the scientific literature, Soup Processor B’s PCQI/ food 

processing expert decided to use a process of 205°F (96°C) for 2.5 minutes (equivalent to a 

minimum temperature of 194°F (90°C) for a minimum of 10 minutes) based on Table 3-E of in 

Appendix 3 of this guidance. This time and temperature combination will deliver a 6D process 

for the most heat resistant spores for strains of C. botulinum non-proteolytic type B.

Briefly, the procedure for the continuous heat and hot-fill process for clear broths and creamed 

vegetable soups is as follows:

• Add the dry ingredients to the blend tank with the volume of water specified in the 

formulation and mix at a high speed (> 2000 rpm) for 30 minutes to ensure all dry materials 

are wetted and in solution (no clumps), and then blend in fresh cream that has been 

refrigerated to 40o

F - 45oF (4°C- 7°C);

• Pump the untreated soup from the blend tank to the pre-process agitated surge tank (which 

is water jacketed to control the contents at the set process Initial Temperature (IT) (between 

40o

F and 45oF) (4°C- 7°C)) through in-line sieves to ensure no mix particles larger than 0.1 

inch (2.5 mm) pass to the pre-process agitated surge tank;

• Pump the untreated soup via a metering pump (at a flow rate specified in gal/min) from the 

pre-process agitated surge tank to the indirect continuous heat exchanger (scraped surface) 

and then to the hold tube (which is sized to ensure the soup mix is held at the process 

temperature for a minimum of 2.5 minutes);

• The heat-treated soup flows from the hold tube into an agitated hot-holding surge tank that 

keeps the soup at > 185o

F (85°C); the heat-treated soup is then pumped to the filling hopper 

for the hot-fill process;

• Hot fill the heat-treated soup into 5-gallon pre-labeled bags and seal the bags; and

• Cool the sealed, hot-filled soup bags, pack them in a carton, and store the carton under 

refrigeration prior to distribution.

 8 Annex 6 of the Food Code (FDA, 2013) is a source of additional information about selection of the target 

organism.
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Soup Processor B’s PCQI/ food processing expert determined that five process parameters are 

critical to the safety of the food product and established critical limits for each of these process 

parameters:

• IT of product held in the pre-process agitated surge tank (between 40o

F and 45°F) (4°C7°C);

• Metering pump speed (RPM) to deliver process-specified flow rate (gal/min);

• Hold tube size (must deliver a minimum 2.5 minute product hold time prior to hot-filling);

• Temperature of the heat-treated soup at discharge end of hold tube (minimum value of 

205o

F) (96°C); and

• Temperature of the heat-treated soup in the agitated hot-holding surge tank (minimum value 

of 185o

F) (85°C).

6.15.3 Soup Processor B’s Monitoring

6.15.3.1 What Soup Processor B monitors

Soup Processor B:

• Monitors the IT in the surge tank;

• Checks the pump speed RPM setting;

• Checks that the correct hold tube is in place prior to production;

• Checks the temperature of the heat-treated soup exiting the hold tube using an RTD probe 

connected to a recording device; and

• Monitors the temperature of the heat-treated soup held in the agitated hot-holding surge 

tank prior to final packaging (i.e., hot fill).

6.15.3.2 How Soup Processor B monitors

Soup Processor B:

• Uses a Resistance Temperature Detector (RTD) probe attached to a recording chart to 

monitor the IT of the untreated soup in the pre-processing surge tank; 

• Visually observes that the RPM dial setting on the pump (i.e., pump speed in RPM) is 

appropriate to achieve the process-specified flow rate of the soup;

• Visually observes that the correct hold tube is in place (hold tubes are numbered and each 

numbered hold tube is assigned to specific soup recipes);

• Uses an RTD probe attached to a recording chart to monitor the temperature of the heattreated soup exiting the hold tube; and
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• Uses another RTD probe attached to a recording chart to monitor the temperature of the 

heat-treated soup in the hot-holding surge tank. 

6.15.3.3 How often Soup Processor B monitors

Soup Processor B:

• Checks the continuously recorded IT (RTD chart recorder) of the untreated soup in the preprocess surge tank twice per shift;

• Checks and records the pump speed setting (flow rate) at the beginning of production and 

twice per shift; 

• Notes the hold tube used on the pump speed log at the beginning of production and 

whenever the variety of soup being produced changes; 

• Checks the continuously recorded temperature (RTD chart recorder) of the heat-treated 

soup at the exit of the hold tube twice per shift; and

• Checks the continuously recorded temperature (RTD chart recorder) of the heat-treated 

soup in the filling surge tank twice per shift. 

6.15.3.4 Who monitors critical factors for Soup Processor B’s heat 

treatment

At Soup Processor B, the line operator monitors the recorded temperature data (IT of the 

untreated soup, temperature of the heat-treated soup exiting the hold tube, and temperature of 

the heat-treated soup in the agitated hot-holding surge tank), the pump speed setting, and the 

hold tube identification. 

6.15.4 Soup Processor B’s Corrective Action Procedures

Soup Processor B’s corrective action procedures specify:

• A list of:

o Those soups that can be fully reprocessed in instances where soup was underprocessed; and 

o Those soups that cannot be fully reprocessed and therefore will be diverted to animal 

food (non-pet food) or destroyed if the PCQI determines that the process delivered 

was inadequate to ensure product safety. 

• If the IT of the untreated soup was too low during the production of that soup:

o The product will be held until the PCQI determines whether the process was 

adequate or if the soup can be reprocessed; and

o The production manager will investigate why the IT was too low and take appropriate 

actions to prevent the situation from reoccurring.
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• If the metering pump speed during production of the soup was too fast:

o Any ongoing production will be stopped and affected product will be held until the 

PCQI evaluates the safety of the product; 

o The PCQI will assess the safety of the product and determine whether it will be 

released, re-processed, diverted to animal food (non-pet food), or destroyed; and

o The production manager will investigate why the pump speed was too fast and take 

appropriate actions to prevent the situation from reoccurring.

• If the incorrect hold tube was used: 

o The PCQI will assess the safety of the product to determine appropriate disposition;

o The production manager will investigate why the incorrect hold tube was used; and

o Employees will be retrained if necessary in light of the reason the incorrect hold tube 

was used. 

• If the RTD at the end of the hold tube recorded a low temperature and the soup was not 

diverted to the batch tank for automatic reprocessing:

o The PCQI will assess the safety of the product to determine appropriate disposition; 

and

o The production manager will investigate the low temperature and the diversion failure 

and take appropriate action to fix the problem. 

• If the temperature of the heat-treated soup in the agitated hot-holding surge tank is below 

the process set point: 

o The product will be held until the PCQI determines whether the temperature was 

adequate for safety or if the soup should be reprocessed, diverted to animal food

(non-pet food), or destroyed. 

o The production manager will investigate why the temperature was too low and take 

appropriate actions to prevent the situation from reoccurring.

6.15.5 Soup Processor B’s Verification Procedures

At Soup Processor B: 

• An outside calibration service annually performs on-site calibration of the RTDs and 

recording devices used to measure IT of the untreated soup, the temperature of the heattreated soup at the exit of the hold tube, and the hot-fill temperature. A sticker with the 

calibration date is affixed to each recording device and the date and results are recorded in 

a calibration log. Soup Processor B’s PCQI also reviews, initials, and dates the monitoring 

device calibration logs within a week of their creation;
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• The Quality Assurance Manager or designee verifies twice a year that the pump speed 

provides the correct flow rate for the hold tubes used for the different soups, and the PCQI 

reviews this within one week;

• On a daily basis, the PCQI :

o Reviews recorder charts and pump speed log with the hold tube identification to 

confirm that the soup was cooked at the specified temperature of 205°F (96°C) for a 

minimum of 2.5 minutes; and

o Checks the other process logs to confirm that the soup in the pre-process agitated 

surge tank was maintained at an IT between 40°F and 45°F (4°C- 7°C), that the 

temperature of the heat-treated soup at hold tube exit was at least 205 °F (96°C),

and that the temperature of the heat-treated soup held in the agitated hot-holding 

surge tank prior to hot-filling was maintained at the specified process temperature of 

> 185o

F (852°C), and also checks that process log temperatures agree with the 

recorder charts;

• The PCQI reviews corrective action records within one week of when the deviation occurred;

and

• Soup Processor B does not conduct product testing for pathogens or environmental 

monitoring because the product, which is subjected to a heat treatment validated to be 

highly lethal to vegetative pathogens and filled hot, is not exposed to the environment after 

the heat treatment.

6.15.6 Soup Processor B’s Monitoring Records

Soup Processor B keeps:

• The recording charts from the RTDs used to monitor the IT of the untreated soup exiting the 

pre-process agitated surge tank, the temperature of heat-treated soup exiting the hold tube,

and the temperature at the agitated hot-holding surge tank; 

• The process logs for the temperature checks (IT of the untreated soup, temperature of the 

heat-treated soup exiting the hold tube, and temperature at the agitated hot-holding surge 

tank); and

• A process log for each line to record pump speeds and hold tube number for the product 

being processed.

6.15.7 Soup Processor B’s Records of Corrective Actions

Soup Processor B keeps records:

• Of any product safety assessment by the PCQI of the safety of product to determine 

appropriate disposition if:

o The IT of the untreated soup was too low; 

o The metering pump speed was too fast; 
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o An incorrect hold tube was used;

o The RTD at the end of the hold tube recorded a low temperature and the heattreated soup was not diverted to the batch tank for automatic reprocessing; or

o The temperature for the heat-treated soup held in the agitated hot-holding surge tank 

prior to hot-filling was too low.

• Of the reprocessing of a soup that can be reprocessed if the RTD at the end of the hold tube 

recorded a low temperature and the soup was not diverted to the batch tank for automatic 

reprocessing;

• Of any soup that cannot be reprocessed and thus is sent to animal food (non-pet food) or 

destroyed;

• Of any investigations of the cause of any deviations;

• Of all changes made to correct a problem and to prevent reoccurrence of deviations; and

• Documenting any retraining.

6.15.8 Soup Processor B’s Verification Records

Soup Processor B maintains the following records with the date and initials of the PCQI for the 

review of:

• The monitoring records - i.e.: 

o The temperature recording chart for all RTD probes (IT of the untreated soup exiting 

the pre-process agitated surge tank, the temperature of heat-treated soup exiting the 

hold tube, and the temperature at the agitated hot-holding surge tank);

o The process logs for the temperature checks (IT of the untreated soup exiting the 

blend tank, the temperature of heat-treated soup exiting the hold tube, and 

temperature at the agitated hot-holding surge tank); and 

o The process logs for each line with pump speeds and hold tube number for the 

product being processed;

• The calibration logs, including notes of the actions taken when any adjustments were 

needed;

• The semi-annual verification tests that the pump speed provides the correct flow rate for the 

hold tubes used for the different soups, including notes of when any adjustments to the 

pump speed were needed; and

• The corrective action records. 
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6.15.9 Summary Process Control Table of Soup Processor B

Appendix 6-D summarizes the above information for Soup Processor B on the FSPCA’s 

Process Control Form (Form 2-C (Modified) from Appendix 2).

6.16 Example of Salsa Processor A’s Heat Treatment 

6.16.1 Salsa Processor A’s Product, Hazard Analysis, and Heat Treatment

Salsa Processor A manufactures a shelf-stable chopped mixed vegetable salsa product that is 

an acidified food subject to the requirements of 21 CFR part 114 (part 114). Our regulations for 

acidified foods in part 114 require that an acidified food be manufactured, processed, and 

packaged so that the finished equilibrium pH value of 4.6 or lower is achieved within the time 

designated in the scheduled process and maintained in all finished products. (See 21 CFR 

114.80(a)(1).) Acidified foods are shelf-stable foods and must be thermally processed to an 

extent that is sufficient to destroy the vegetative cells of microorganisms of public health 

significance and those of non-health significance capable of reproducing in the food under the 

conditions in which the food is stored, distributed, retailed and held by the user. (See 21 CFR 

114.80(a)(1).) The “scheduled process” (i.e., the process selected by a processor as adequate 

for use under the conditions of manufacture for a food in achieving and maintaining a food that 

will not permit the growth of microorganisms having public health significance) includes control 

of pH and other critical factors equivalent to the process established by a competent processing 

authority (21 CFR 114.3). Salsa Processor A’s PCQI is also a thermal process authority for the 

purpose of establishing a scheduled process in accordance with part 114.9

Salsa Processor A’s product consists of chopped vegetables (i.e., tomatoes, long green chilies, 

onions, jalapeño peppers, and garlic), salt, spices, and vinegar. Each batch is directly acidified, 

cooked in a kettle, and then hot-filled into glass jars. The hermetically sealed jars are shelf 

stable under ambient storage temperatures.

Salsa Processor A’s PCQI/process authority identified Salmonella, E. coli O157:H7, Listeria 

monocytogenes and Clostridium botulinum as hazards associated with the salsa because these 

pathogenic bacteria can be present on some of the ingredients and can be a hazard if the salsa 

is not properly acidified to a pH that is low enough to prevent the germination of spores of C. 

botulinum and if the heat treatment is not adequate to kill vegetative cells of the pathogenic 

bacteria. 

Salsa Processor A’s PCQI/process authority consulted the scientific literature and found that 

some sporeforming microorganisms that are generally associated with spoilage (such as 

Bacillus subtilis (B. subtilis), and B. licheniformis) could potentially affect the safety of an 

acidified food if spores that are not destroyed during the product heat treatment germinate, 

grow, and cause the pH to increase above 4.6 such that spores of C. botulinum could 

 9 Our regulations require that a commercial processor engaged in the processing of acidified foods 

provide us with information, submitted on Form FDA 2541e, on the scheduled processes for each 

acidified food in each container size. (See 21 CFR 108.25(c)(2).) For additional information about 

submitting a “process filing” for an acidified food using Form FDA 2541e, see our guidance for industry 

entitled “Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, 

FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper 

Format” (FDA, 2015).
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germinate, grow and produce toxin (Rodriguez et al, 1992). However, the scientific literature 

indicated that these sporeformers do not grow at pH 4.2 or less and require oxygen for growth 

at pH 4.4 (Rodriguez et al, 1992). Salsa Processor A’s salsa is acidified to pH 4.1; thus Salsa 

Processor A’s PCQI/process authority determined that the heat treatment should target 

vegetative pathogens such as Salmonella, E. coli O157:H7, and Listeria monocytogenes. Salsa 

Processor A’s PCQI/process authority also determined that there were non-pathogenic 

sporeformers that would survive a heat treatment designed for vegetative pathogens that could 

spoil the product under ambient conditions. 

6.16.2 Salsa Processor A’s Process Design and Validation 

Based on an assessment and review of scientific literature, Salsa Processor A’s PCQI/ process 

authority selected a process (158°F (70°C) for 1.5 minutes) that will deliver a 5D process for 

Salmonella, E. coli O157:H7, and Listeria monocytogenes at a product pH of no higher than 4.1

(Breidt et al., 2010). Salsa Processor A’s PCQI/process authority also determined that the pH of 

4.1 would control sporeforming pathogens such as C. botulinum, as well as sporeformers that 

could potentially grow and raise the pH of the salsa. (See Chapter 8 – “Use of Formulation as a 

Process Control” for information on the use of acidification to control C. botulinum.) Salsa 

Processor A’s PCQI/process authority also determined that a process that delivers 200°F (93°C) 

for 2 minutes is adequate to destroy any other sporeformers that could survive the process and 

potentially spoil the product, and thus achieve a shelf-stable product.

In-house studies determined that as long as the chopped vegetable particles in the salsa did not 

exceed 1.0 cm (0.4 inch) square, the particles would also be at 158°F (70°C) when the liquid 

portion of the salsa reached that temperature, provided that the particles were stored 

refrigerated (i.e., at least 33°F (0.6°C)) and not frozen. (Salsa Processor A’s SOPs specify that 

vegetables to be chopped are stored refrigerated (at a temperature of 33 - 40°F (0.6 - 4 °C)) 

until used.) Salsa Processor A determined that the size of the particles in the vegetable salsa is 

a parameter requiring a critical limit (i.e., a maximum value of 1.0 cm square). However, Salsa 

Processor A’s PCQI/process authority determined that a critical limit for the temperature of the 

particles in the vegetable salsa is not necessary as long as the production line follows the SOP 

to store the particles refrigerated.

Briefly, the procedure for the production of the mixed vegetable salsa is as follows:

• All vegetables, which have been held refrigerated, are washed and or peeled, cored or 

seeded, and chopped;

• Vinegar (5 percent acetic acid), salt, and spices are prepped and weighed per recipe;

• Salsa is made by combining all ingredients in an agitated 150 gallon steam-jacketed cook 

kettle that heats the salsa to 200°F (93°C); the salsa is then held for at least 2 minutes;

• Heat-treated salsa is pumped from the cook kettle to a temperature-controlled filling surge 

tank and equilibrated to 200°F (93°C);

• The heat-treated salsa is then hot-filled into clean pint glass jars via a volumetric filler. Jars 

are capped under flowing steam, then inverted and conveyed for one minute (to kill 

microorganisms on the container) prior to being re-inverted, and conveyed through a cold 

water shower for cooling; and
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• Cooled and sealed jars are then dried prior to being labelled, packed 12 to a carton, and 

stored on pallets.

Salsa Processor A’s PCQI/ process authority determined that the following process parameters 

related to the heat treatment are critical to the safety of the chopped vegetable salsa10 and 

established critical limits for each of these process parameters:

• Maximum particle size of chopped vegetables (1.0 cm) (0.4 inch);

• Minimum process temperature for the salsa (158°F) (70°C)11;

• Minimum process time for the salsa (1.5 minutes);

• Minimum temperature of the heat-treated salsa in the filling surge tank (158°F) (70°C); and

• Minimum inverted jar hold time (1 minute).

Because Salsa Processor A needs to make a shelf-stable food, Salsa Processor A treats the 

operating limits established for shelf-stability as if they were the critical limits established for 

food safety. 

6.16.3 Salsa Processor A’s Monitoring

6.16.3.1 What Salsa Processor A monitors

Salsa Processor A:

• Monitors the particle size of the chopped vegetables;

• Monitors the temperature of the in-process salsa in the cook kettle;

• Monitors the time that the in-process salsa is at the process temperature (operating limit) of 

200°F (93°C) or higher in the cook kettle (which ensures that the critical limit of 158°F (70°C) 

will be met); 

• Monitors the temperature of the heat-treated salsa held in the filling surge tank prior to final 

packaging (i.e., hot fill); and

• Checks conveyor belt speed as indicated by automated tachometer RPM (for control of 

inversion time) for inverted jars.

6.16.3.2 How Salsa Processor A monitors

Salsa Processor A:

 10 See Chapter 8 – Use of Formulation as a Process Control – for additional information about pH as a 

critical factor in the production of an acidified food, including the preventive control management 

components.

11 This is the process for safety. However, the acidified foods regulation requires the destruction of 

spoilage organisms such that the food is shelf-stable. Thus the operating limits are actually 200°F (93°C) 

for 2 minutes.
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• Collects a statistically-based sample of vegetable particles (e.g., chopped tomatoes, green 

chilies, onions, jalapeño peppers), uses digital calipers to ensure they do not exceed 1 cm 

(0.4 inch) in any direction, and records the results in the process log;

• Uses an RTD probe attached to a recording chart to monitor the temperature of the inprocess salsa at the cold point in the cook kettle (in top inch (2.5 cm) of kettle), visually

checks the chart and records the observed temperature in the process log;

• Visually checks the temperature recorder chart and marks it with the batch number, records 

the time when the in-process salsa reaches the process temperature in the process log, 

calculates the processing time, records the processing time on the recorder chart and in the 

process log, notes when product should be transferred from cook kettle in the process log,

and records the time when product is transferred from the cook kettle to the filling surge tank

in the process log; 

• Uses another RTD probe attached to a recording chart to monitor the temperature of the 

heat-treated salsa in the filling surge tank, visually checks the chart, and records the 

temperature in the process log; and

• Uses an automated tachometer with recorder chart to monitor the conveyor speed (which is 

tied to the jar inversion time), visually checks the tachometer RPM, and records the RPM in 

the process log.

6.16.3.3 How often Salsa Processor A monitors

Salsa Processor A:

• Checks the particle size of one in-process lot of each chopped vegetable once per 

production shift;

• Checks the continuously recorded temperature (RTD chart recorder) of the in-process salsa 

in the cook kettle once for each batch;

• Checks the processing time once for each batch;

• Checks the continuously recorded temperature (RTD chart recorder) of the in-process salsa 

in the filling surge tank twice per shift; and

• Monitors the automated tachometer RPM (inversion conveyor belt speed) at the beginning 

of production and twice per shift.

6.16.3.4 Who monitors critical factors for Salsa Processor A’s heat 

treatment

At Salsa Processor A:

• A formulation control operator checks the particle size of the chopped vegetables; and
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• The line operator monitors the recorded temperature and time data (in-process salsa in 

cook kettle and filling surge tank, and the automated tachometer RPM (conveyor belt 

speed) for jar inversion. 

6.16.4 Salsa Processor A’s Corrective Action Procedures

Salsa Processor A’s corrective action procedures specify:

• If it is determined that the mean plus 2.5 standard deviation of the vegetable particle sizes 

exceeds 1 cm (0.4 inch), the in-process lot of chopped vegetables is rejected and will be 

reworked for a different recipe. The PQCI will check with the vegetable processing operator 

to investigate the root cause of the incorrect particle size and, when applicable, notify 

maintenance to reset the vegetable chopper operation to specification. The formulation 

control operator will check the vegetable particle size of every in-process lot for the next 15 

in-process lots to verify particle sizes meet specification. If all 15 lots meet specification, the 

formulation control operator will return to monitoring one in-process lot of each chopped 

vegetable once per production shift;

• If the RTD at the cook kettle records a low temperature or a shortened process time: 

o The product will be held until the PCQI determines whether the process was 

adequate for safety or if the product should be reprocessed or destroyed; 

o The production manager will investigate why the under-processing occurred and take 

appropriate actions to prevent the situation from reoccurring; and

o Employees will be retrained if necessary in light of the reason for the underprocessing;

• If the temperature at the filling surge tank is below the process set point:

o The product will be held until the PCQI determines whether the fill temperature was 

adequate for safety or if the product should be reprocessed or destroyed; 

o The production manager will investigate why the fill temperature was too low and 

take appropriate actions to prevent the situation from reoccurring; and

o Employees will be retrained if necessary; and

• If it is determined that the jar inversion time is below the process set point:

o The product will be held until the PCQI determines whether the process was

adequate or if the product can be reprocessed; 

o The production manager will investigate why the belt speed deviated from the 

process set point and take appropriate actions to prevent the situation from 

reoccurring; and

o Employees will be retrained if necessary in light of the reason for the belt speed 

deviation.
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6.16.5 Salsa Processor A’s Verification Procedures

At Salsa Processor A: 

• An outside calibration service annually performs on-site calibration of the RTDs, tachometer, 

and recording charts used to measure the temperature at the cook kettle and the hot-fill 

surge tank, and the belt speed of the jar inversion conveyor. A sticker with the calibration 

date is affixed to each recording device and the date and results are recorded in a 

calibration log. The PCQI reviews, initials, and dates the monitoring device calibration logs 

within a week of their creation;

• The Quality Assurance Manager or designee verifies the jar inversion belt speed and time

twice each year, and the PCQI reviews this within one week;

• On a daily basis, the PCQI :

o Checks process logs to confirm that the particle size of the chopped vegetables was 

at the specified value of < 1 cm (0.4 inch);

o Reviews process logs and recorder charts to confirm that the in-process salsa was 

cooked to 200°F (93°C) for a minimum of 2.0 minutes, and checks that process log 

temperatures agree with the recorder;

o Reviews process logs and recorder charts to confirm that the jars were filled at the 

specified temperature of >200°F (93°C), and checks that process log temperatures 

agree with the recorder charts; and

o Reviews the recorded RPM for the conveyor belt to confirm that the jars were 

inverted for the minimum specified time of 1 minute;

• The PCQI reviews corrective action records within one week of when the deviation occurred

and

• Salsa Processor A does not conduct product testing for pathogens or environmental 

monitoring because the product, which is acidified and subjected to a heat treatment 

validated to be highly lethal to vegetative pathogens and filled hot, is not exposed to the 

environment after the heat treatment.

6.16.6 Salsa Processor A’s Monitoring Records

Salsa Processor A keeps:

• The process logs for checks of the particle size of the chopped vegetables;

• The recording charts from the RTDs used to monitor the temperature and time of the inprocess salsa in the cook kettle and in the filling surge tank;

• The recording chart from the automated tachometer used to monitor the jar inversion 

conveyor belt speed; 
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• The process logs for temperature checks (cook kettle and filling surge tank) and process 

times in the cook kettle; and 

• The process logs for the belt speed for the jar inversion conveyor belt. 

6.16.7 Salsa Processor A’s Records of Corrective Actions

Salsa Processor A keeps records:

• Of any product safety assessment by the PCQI of the safety of product to determine 

appropriate disposition if:

o The RTD at the cook kettle recorded a low temperature;

o The cooking process time was less than the minimum specified time;

o The product temperature in the filling surge tank was too low; or

o The jar inversion time was too short;

• Of the reprocessing of a product that can be reprocessed if:

o Particle size of the chopped vegetables exceeded process set point;

o The process temperature of the in-process salsa in the cook kettle was too low; 

o The process time was less than the minimum specified time;

o The temperature of the heat-treated salsa in the filling surge tank was too low; or 

o The jar inversion time was too short;

• Of any product that cannot be reprocessed and thus is destroyed;

• Of any investigations of the cause of any deviations;

• Of all changes made to correct problems and to prevent reoccurrence of deviations; and

• Documenting any retraining.

6.16.8 Salsa Processor A’s Verification Records

Salsa Processor A maintains the following verification records:

• The date and initials of the PCQI on the monitoring record (e.g., on the charts or in the logs) 

for the review of: 

o Each temperature recording chart for all RTD probes (cook kettle and filling surge 

tank);

o The process logs for the temperature checks (cook kettle and filling surge tank); 
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o The recording charts for the automated tachometer on the jar inversion conveyor 

belt; 

o The process logs for checks of the particle size of the chopped vegetables and belt 

speed of the jar inversion conveyor belt; and

• The date and initials in the calibration log of the PCQI’s review of the results of the outside 

calibration service’s calibration of the RTDs and automated tachometer, as well as any 

notes by the PCQI of the actions taken when any adjustments were needed;

• The date and initials of the PCQI’s review of the results of the semi-annual verification tests 

that the jar inversion conveyor belt speed is correct, as well as any notes by the PCQI when 

any adjustments to the conveyor belt were needed; and

• The date and initials of the PCQI’s review of corrective action records.

6.16.9 Summary Process Control Table for Salsa Processor A

Appendix 6-E summarizes the above information for Salsa Processor A on the FSPCA’s 

Process Control Form (Form 2-C (Modified) from Appendix 2).

6.17 References

FDA. 2013. FDA Food Code 2013: Annex 6 Food processing 

criteria. http://www.FDA.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodC

ode/UCM374510.pdf.

FDA. 2015. Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment 

Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process 

Filing Forms) to FDA in Electronic or Paper 

Format http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio

n/ucm309376.htm.

FDA. 2016. Guidance for Industry #239: Human Food By-Products For Use As Animal Food. 

Draft 

Guidance. https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/Guidancefo

rIndustry/default.htm.

Lathrop, A.A., T. Taylor, and J. Schenpf. 2014. Survival of Salmonella during Baking of Peanut 

Butter Cookies. Journal of Food Protection 77: 635–639.

Rodriguez J, Cousin M, and Nelson P. 1992. Evaluation of anaerobic growth of Bacillus 

licheniformis and Bacillus subtilis in tomato juice. Journal of Food Protection 55: 672-677.
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Appendix 6. Summary Process Control Tables for the Examples in Chapter 6

Appendix 6-A: Summary Process Control Table for Baking; Cookie Processor A

FORM 2-C (Modified)12 PROCESS CONTROLS

PAGE _________

PRODUCTS: Cookies baked in batches on trays in ovens and packaged by wrapping the cookies by twos in plastic 

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)___________________________________________________

PROCESS CONTROL STEP: __Baking__________________________________________

HAZARD(S): ___Salmonella___________________________________________________

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records13

Minimum 

oven 

temperature 

of 350°F 

(177°C) 

(operating 

limit is 352°F 

(178°C))

Temperature 

of oven

• Recording 

thermometer in 

oven 

• Manual check 

of recording chart 

and mark the 

recording with the 

batch number

• Record 

temperature on 

baking record 

sheet

Continuous 

recording 

during each 

batch; manual 

check before 

putting cookies 

in oven 

Baker If oven was not at least 350°F

(177°C):

• Cookies will be diverted to 

cattle feed; and 

• Employees will be retrained 

on the importance of ensuring 

that the oven temperature has 

reached the set point.

• Annual calibration of 

thermometer

• Records review by PCQI 

within one week of record 

creation (baking sheets, 

temperature recording chart, 

calibration logs)

• Review of corrective action 

records within one week of a 

deviation

• Baking record 

sheets

• Temperature 

recording charts

• Calibration records

• Corrective action 

records

 12 Modified from Form 2-C in Appendix 2 to address a single process control step. Form 2-C in Appendix 2 can be used to list multiple process control steps. 13 Records include the date and initials of the PCQI (or designee) as verification.
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Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records13

Minimum 

process time 

of 13 minutes 

(operating 

limit is 15 

minutes)

Time in oven On baking record 

sheets:

• Record time 

that cookies are 

placed in the 

oven

• Calculate and 

record the time 

when the cookies 

should be 

removed from 

oven

• Record time 

that cookies are 

removed from the 

oven

• Calculate the 

elapsed baking 

time 

Each batch Baker If the bake time is less than 13 

minutes: 

• Cookies will be diverted to 

cattle feed; and

• PCQI determines why the 

bake time was not met to 

prevent this from happening in 

the future.

• Records review by PCQI 

within one week of record 

creation (Baking record 

sheets)

• Review of corrective action 

records within one week of a 

deviation

• Baking record 

sheets

• Corrective action 

records

Dough 

weight ≤28 g 

(operating 

limit is ≤27 g)

• Dough 

depositor 

setting

• Dough 

weight

• Check set 

point of depositor

• Weigh dough 

portions

• Check set 

point every 2 

hours

• Weigh 

dough 

portions twice 

per shift

QC 

technician

If dough weight exceeds 28 g:

• Product will be diverted to 

cattle feed;

• PCQI will determine (if 

possible) what caused the 

depositor to deliver an incorrect 

weight; and. 

• Dough depositor adjusted to 

deliver correct weight.

• Annual calibration of dough 

depositor and scales

• Records review by PCQI 

within one week of record 

creation (calibration logs, 

dough weight logs)

• Review of corrective action 

records within one week of a 

deviation

• Dough weight log 

• Calibration records 

• Corrective action 

records
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Appendix 6-B: Summary Process Control Table for Baking; Cookie Processor B

FORM 2-C (Modified)14 PROCESS CONTROLS

PAGE _________

PRODUCTS: Cookies baked in a continuous band oven and packaged in boxes of 24 cookies 

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

PROCESS CONTROL STEP: __Baking___________________________________________

HAZARD(S): ___Salmonella____________________________________________________

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records15

Minimum 

oven 

temperature 

of 350°F 

(177°C) 

(operating 

limit is 352°F 

(178°C))

Temperature 

of oven at the 

identified cold 

spot

Recording 

thermometer in 

oven, visual check 

of recording chart, 

with a note of the 

check in the 

operator’s baking 

log

Continuous 

recording during 

each batch with 

visual check 

every hour

Baker If oven was not at least 350°F

(177°C):

• Cookies will be diverted to 

further processing (baking for 

cookie crumbles) or cattle feed; 

• Maintenance will determine 

the cause of the low temperature 

and fix the oven so the 

temperature is at least 350 °F 

(177°C) before more cookies are 

baked; and

• Employees will be retrained if 

necessary.

• Annual calibration of 

oven thermometer and 

temperature recording 

chart

• QC technician check of 

thermometer recording 

chart

• Records review by 

PCQI within 7 days of 

record creation (operator’s 

baking log, temperature 

recording chart, calibration 

log)

• Review of corrective 

action records at the end 

of each week

• Operator’s baking 

log

• Temperature 

recording chart

• Calibration records 

for thermometer and 

temperature recording 

chart 

• Corrective action 

records

 14 Modified from Form 2-C in Appendix 2 to address a single process control step. Form 2-C in Appendix 2 can be used to list multiple process control steps. 15 Records include the date and initials of the PCQI (or designee) as verification.
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Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records15

Maximum 

belt speed 

(tachometer 

RPM) to 

achieve a 

minimum 

process time 

of 13 minutes 

(operating 

limit is 

maximum 

tachometer 

RPM to 

achieve a 

process time 

of 15 

minutes)

Belt speed 

(tachometer 

RPM)

Automated 

tachometer with 

recorder chart and 

visual observation 

of tachometer 

RPM

Continuous 

recording during 

each batch with 

visual check at 

start-up and twice 

per shift

Baker If the tachometer reading 

indicates that the baking time is 

less than 13 minutes:

• The cookies are placed on 

hold;

• The PCQI assesses whether 

the cookies will be diverted to 

bake as cookie crumbles or 

diverted to cattle feed; and 

• The PCQI determines why the 

bake time was not met and 

informs management of actions 

they need to take to prevent this 

from happening.

• Annual calibration of 

tachometer and its 

recorder chart

• QC technician check of 

tachometer recording chart

• Records review by 

PCQI within 7 days of 

record creation 

(tachometer chart, 

calibration logs)

• Review of corrective 

action records at the end 

of each week 

• Recording chart for 

automated tachometer

• Calibration records 

for tachometer and its 

recording chart

• Corrective action 

records

Dough 

weight ≤28 g 

(operating 

limit is ≤27 g)

• Dough 

depositor 

setting

• Dough 

weight

• Check set 

point of depositor

• Weigh dough 

portions

• Check set 

point at start-up 

and every 2 

hours

• Weigh dough 

portions twice 

per shift

Dough 

preparer

If dough weight exceeds 28 g:

• PCQI will determine whether 

the product will be further 

processed or diverted to cattle 

feed; and 

• PCQI will determine (if 

possible) what caused the 

depositor to deliver an incorrect 

weight. 

• Dough depositor adjusted to 

deliver correct weight.

• Annual calibration of 

dough depositor and 

scales

• QC technician check of 

dough weight log twice per 

shift

• Records review by 

PCQI within 7 days of 

record creation (calibration 

logs, dough weight logs)

• Review of corrective 

action at the end of each 

week

• Dough weight 

record sheets

• Calibration records 

for dough depositor 

and scales

• Corrective action 

records
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 50

Appendix 6-C: Summary Process Control Table for Cooking; Soup Processor A

FORM 2-C (Modified)16 PROCESS CONTROLS

PAGE _________

PRODUCTS: Soup cooked in a kettle, packaged in 8 ounce plastic bowls, and frozen _____

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

PROCESS CONTROL STEP: ___Cooking________________________________________

HAZARD(S): __Listeria monocytogenes__________________________________________

 16 Modified from Form 2-C in Appendix 2 to address a single process control step. Form 2-C in Appendix 2 can be used to list multiple process control steps.
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 51

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records17

Minimum soup 

temperature of 

180°F (82°C) 

(EPIPT)

Temperature of 

soup in kettle 

Thermometer 

inserted into 

soup in top inch 

(2,5 cm) of 

kettle; 

measured 

temperature is 

recorded in the 

cook log

Begin after 30 

min; then 

every 10 min 

after reaching 

170°F (77°C) 

until the EPIPT 

is reached 

(180°F (82°C))

Kettle cook 

operator

• If EPIPT did not reach 180°F 

(82°C) and soup is being 

packaged but has not been 

frozen: stop packaging and 

reprocess soup until the EPIPT 

reaches 180°F. Packages that 

have been frozen will be 

destroyed. 

• If EPIPT did not reach 180°F 

(82°C) and soup has been 

packaged and frozen, the PCQI 

will assess the safety of the 

product to determine appropriate 

disposition. If process delivered 

was inadequate to ensure product 

safety, soup will be diverted to 

animal food or destroyed.

• If soup is packaged before the 

EPIPT reaches 180°F (82°C) due 

to operator error, the kettle cook 

operator will be retrained.

• PCQI reviews cook 

log weekly.

• QC technician 

calibrates thermometers 

against NIST reference 

thermometer at least

annually; PCQI reviews 

the calibration log within 

a week of the calibration.

• QC technician checks 

accuracy of 

thermometers daily; 

PCQI reviews these 

accuracy checks on a 

weekly basis.

• PCQI reviews

corrective action records

before shipment of each 

lot of soup.

• Cook log of 

monitoring 

temperature 

• Thermometer 

calibration and 

accuracy checks log 

• Corrective action 

records 

Maximum 

particle size 

no greater 

than 1⁄2 inch

(13 mm) in 

any direction

Size of diced 

carrots, 

potatoes, onions

Collect a 

statisticallybased sample of 

vegetable 

particles and 

then use digital 

calipers to 

ensure they do 

not exceed 1⁄2 

inch (13 mm) in 

any direction; 

record the 

measurement in 

a log

Every third lot 

on receipt

Formulation 

control 

operator

If vegetable particle sizes exceed 

1⁄2 inch (13 mm): 

• The lot of vegetables is 

rejected and unopened packages 

are returned to the supplier; 

• PCQI discusses with the 

supplier so the supplier can 

investigate the root cause for 

incorrect particle size; and

• Formulation control operator 

checks vegetable particle size of 

every lot for the next 15 lots. If all 

15 lots meet specification, the 

formulation control operator will 

return to monitoring every third lot.

• QC technician checks 

accuracy of digital 

calipers before use.

• PCQI reviews particle 

measurement log and 

accuracy checks of the 

digital calipers weekly.

• PCQI reviews 

corrective action records

before shipment of each 

lot of soup

• Vegetable particle 

size log 

• Digital caliper 

accuracy check logs 

• Corrective action 

records 

 17 Records include the date and initials of the PCQI (or designee) as verification.
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 52

Appendix 6-D: Summary Process Control Table for Cooking; Soup Processor B

FORM 2-C (Modified)18 PROCESS CONTROLS

PAGE _________

PRODUCTS: Soup cooked in a continuous flow heat exchanger, packaged in 5 gallon bag, and refrigerated 

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

PROCESS CONTROL STEP: Cooking 

HAZARD(S): Vegetative pathogens such as Salmonella and Listeria monocytogenes; and

Clostridium botulinum (especially non-proteolytic type B)

 18 Modified from Form 2-C in Appendix 2 to address a single process control step. Form 2-C in Appendix 2 can be used to list multiple process control steps.
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 53 

Critical What to Frequency of Who How to Monitor Corrective Action Verification Records19

Limits Monitor Monitoring Monitors

Minimum IT in pre- RTD probe with Continuous Line operator If the IT of a batch of soup was too • Outside service • Process logs for

soup IT of process recording chart recording of IT low during the processing of that calibrates RTDs and temperature checks of

40°F (4°C) agitated monitors IT checked twice soup: recorder charts IT

surge tank per shift • annually. Product will be held until the • Recording charts of

PCQI determines whether the • PCQI reviews IT

process was adequate or if the soup calibration logs within 1 • Calibration records can be reprocessed; and week of creation. for RTDs and recorder

• Production manager will • PCQI reviews charts

investigate why the IT was too low recorder charts and the • Corrective action and take appropriate actions to process logs containing records

prevent the situation from IT daily.

reoccurring. • PCQI reviews

corrective action 

records within one week

of when deviation 

occurs.

Metering Pump RPM Visual observation At beginning of Line operator If the metering pump speed during • QA manager verifies • Process logs for 

pump setting of RPM dial setting production and production of the soup was too fast: pump speed provides pump speeds

speed to twice per shift • correct flow rate for the Any ongoing production will be • Calibration records deliver hold tubes twice a year stopped and affected product will be for flow rates process- and PCQI reviews this held until the PCQI evaluates the specified within 1 week. • Corrective action safety of the product; and flow rate records • • PCQI reviews pump (gal/min) The PCQI will assess the safety speed log daily. of the product and determine 

whether it will be released, re- • PCQI reviews

processed, diverted to animal food, corrective action 

or destroyed. records within one week

• of when deviation Production manager will occurs. investigate why the pump speed was

too fast and take appropriate actions

to prevent the situation from

reoccurring

 

19 Records include the date and initials of the PCQI (or designee) as verification. 
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 54 

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records19

Correct hold 

tube to 

deliver 2.5 

minute hold 

time at 

specified

pump 

speed

Correct hold 

tube in place

Visual observation 

that hold tube 

number is correct

for the specific 

soup recipe

At beginning of 

production and 

when soup 

variety changes

Line operator If the incorrect hold tube was used:

• PCQI will assess the safety and 

determine disposition of the product; 

• Production manager will 

investigate why the incorrect hold 

tube was used; and

• Employees will be retrained if 

necessary

• PCQI reviews pump 

speed log with hold tube 

identification daily. 

• PCQI reviews 

corrective action 

records within one week 

of when deviation 

occurs.

• Process logs 

containing hold tube 

number for the product 

being processed (i.e., 

the pump speed log) 

• Corrective action 

records

Minimum 

product 

temperature 

at end of 

hold tube of 

205°F

(96°C)

Temperature 

at end of hold 

tube

RTD probe with 

recording chart 

monitors 

temperature at 

hold tube exit

Continuous 

recording of 

product at hold 

tube exit 

checked twice 

per shift

Line operator If soup is not automatically diverted 

for reprocessing when the 

temperature at the end of the hold 

tube is low: 

• PCQI will assess the safety of the 

product and determine appropriate 

disposition; and 

• Production manager will 

investigate the low temperature and 

the diversion failure and take 

appropriate action to fix the problem.

• Outside service 

calibrates RTDs and 

recorder charts 

annually. 

• PCQI reviews 

calibration logs within 1 

week of creation.

• PCQI reviews 

recorder charts and the 

process logs containing 

temperature at hold 

tube exit daily. 

• PCQI reviews 

corrective action 

records within one week 

of when deviation 

occurs.

• Process logs for 

temperature checks of 

hold tube exit 

temperature

• Recording charts of 

product exiting hold 

tube

• Calibration records 

for RTDs and recorder 

charts

• Corrective action 

records
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 55

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records19

Minimum 

product 

temperature 

in agitated 

hot holding 

surge tank 

of 185°F 

(85°C)

Temperature 

in agitated 

hot holding 

surge tank

RTD probe with 

recording chart 

monitors 

temperature of 

product in agitated 

hot-holding surge 

tank

Continuous 

recording of fill 

temperature 

checked twice 

per shift

Line operator If the temperature in the agitated hotholding surge tank was below the 

process set point:

• Product will be held until the 

PCQI determines whether the 

temperature was adequate for safety 

or if the soup should be reprocessed 

or destroyed; and

• Production manager will 

investigate why the temperature in 

the agitated hot-holding surge tank

was too low and take appropriate 

actions to prevent the situation from 

reoccurring.

• Outside service 

calibrates RTDs and 

recorder charts 

annually. 

• PCQI reviews 

calibration logs within 1 

week of creation.

• PCQI reviews 

recorder charts and the 

process logs containing 

temperature in the 

agitated hot-holding 

surge tank daily.

• PCQI reviews 

corrective action 

records within one week 

of when deviation 

occurs.

• Process logs for 

temperature checks of 

filling temperature

• Recording charts of 

filling temperature

• Calibration records 

for RTDs and recorder 

charts

• Corrective action 

records
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 56

Appendix 6-E: Summary Process Control Table for Heat Treatment; Salsa Processor A

FORM 2-C (Modified)20 PROCESS CONTROLS

PAGE _________

PRODUCTS: Chopped mixed vegetable salsa that is an acidified food _________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

PROCESS CONTROL STEP: Heat 

treatment____________________________________ HAZARD(S): Salmonella, E. coli O157:H7, Listeria monocytogenes and Clostridium botulinum _____________

 20 Modified from Form 2-C in Appendix 2 to address a single process control step. Form 2-C in Appendix 2 can be used to list multiple process control steps.
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 57

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records21

Maximum 

particle size of 

chopped 

vegetables 

(1.0 cm) (0.4 

inch)

Particle size of 

the chopped 

vegetables

• Collect 

statisticallybased sample 

of vegetable 

particles;

• Use digital 

calipers to

measure 

particle size; 

and

• Record 

results in the 

process log

Check one inprocess lot of 

each chopped 

vegetable once 

per production 

shift

Formulation 

control 

operator

If the mean plus 2.5 standard deviation of 

the vegetable particle sizes exceeds 1 cm 

(0.4 inch):

• The in-process lot of chopped 

vegetables is rejected and will be 

reworked for a different recipe.

• The PQCI will check with the vegetable 

processing operator to investigate the root 

cause of the incorrect particle size and, 

when applicable, notify maintenance to 

reset the vegetable chopper operation to 

specification. 

• The formulation control operator will 

check the vegetable particle size of every 

in-process lot for the next 15 in-process 

lots to verify particle sizes meet 

specification. If all 15 lots meet 

specification, the formulation control 

operator will return to monitoring every 

one lot per vegetable per production shift.

On a daily basis, 

the PCQI checks 

process logs to 

confirm that the 

particle size of the 

chopped vegetables 

was at the specified 

value 

• The process logs 

for checks of the 

particle size of the 

chopped vegetables

• Corrective action 

records

 21 Records include the date and initials of the PCQI (or designee) as verification.
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 58

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records21

Minimum 

process 

temperature 

for the salsa 

(200°F) (93°C)

Temperature 

of the inprocess salsa 

in the cook 

kettle

• RTD probe 

with recording 

chart monitors 

temperature of 

the in-process 

salsa (in top 

inch (2.5 cm) of 

kettle);

• Visual 

check of the 

chart;

• Record 

temperature in 

process log

Once for each 

batch

Line operator If the RTD at the cook kettle records a low 

temperature: 

• The product will be held until the PCQI 

determines whether the process was 

adequate for safety or if the product 

should be reprocessed or destroyed. 

• The production manager will 

investigate why the under-processing 

occurred and take appropriate actions to 

prevent the situation from reoccurring.

• Employees will be retrained if 

necessary in light of the reason for the 

under-processing.

• Annual 

calibration of the 

RTDs and 

recording chart 

used to measure 

temperature at the 

cook kettle, with 

the date and 

results recorded in 

a calibration log. 

The PCQI reviews, 

initials, and dates 

the calibration logs 

within a week of 

their creation.

• On a daily 

basis, the PCQI 

reviews recorder 

charts and process 

logs to confirm that 

the in-process 

salsa was cooked 

at the specified 

temperature, and 

checks that 

process log 

temperatures 

agree with the 

recorder charts. 

• The recording 

charts from the RTDs 

used to monitor the 

temperature of the inprocess salsa in the 

cook kettle 

• The process logs 

for temperature checks 

of the cook kettle 

• Corrective action 

records

• Of calibration of the 

RTDs and recording 

charts, with any notes 

by the PCQI about 

adjustments
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 59

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records21

Minimum 

process time 

at 200°F

(93°C) for the 

salsa (2

minutes)

Time that the 

in-process 

salsa is at the 

process 

temperature

• Visual 

checks of 

recorder chart;

• Mark chart

with batch 

number;

• Record time

when inprocess salsa 

reaches 

process 

temperature in 

process log;

• Calculate 

processing 

time;

• Record 

processing

time on the 

recorder chart 

and in the 

process log;

• Note when 

product should 

be transferred 

to filling surge 

tank in the 

process log;

• Record the 

time when 

product is 

transferred 

from to the 

filling surge 

tank in the 

process log

Once for each 

batch

Line operator If the RTD at the cook kettle records a 

shortened process time: 

• The product will be held until the PCQI 

determines whether the process was 

adequate for safety or if the product 

should be reprocessed or destroyed. 

• The production manager will 

investigate why the under-processing 

occurred and take appropriate actions to 

prevent the situation from reoccurring.

• Employees will be retrained if 

necessary in light of the reason for the 

under-processing.

On a daily basis, 

the PCQI reviews 

recorder charts and 

process logs to 

confirm that the inprocess salsa was 

cooked for the 

specified time 

• Of the temperature 

recording chart marked 

with various times, and 

the process log, 

• Corrective action 

records
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 60

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records21

Minimum 

temperature of 

the heattreated salsa 

in the filling 

surge tank 

(200°F) (93°C)

Temperature 

of the heattreated salsa 

held in the 

filling surge 

tank

• RTD probe 

with recording 

chart monitors

temperature of 

heat-treated 

salsa in filling 

surge tank;

• Visual 

check of chart; 

• Record 

temperature in 

process log

Twice per shift Line operator If the temperature at the filling surge tank 

is below the process set point:

• The product will be held until the PCQI 

determines whether the fill temperature 

was adequate for safety or if the product 

should be reprocessed or destroyed. 

• The production manager will 

investigate why the fill temperature was 

too low and take appropriate actions to 

prevent the situation from reoccurring.

• Employees will be retrained if 

necessary

• Annual 

calibration of the 

RTDs and 

recording chart 

used to measure 

the temperature at 

the filling surge 

tank, with the date 

and results 

recorded in a 

calibration log. The 

PCQI reviews, 

initials, and dates 

the calibration logs 

within a week of 

their creation

• On a daily 

basis, the PCQI 

reviews process 

logs and recorder 

charts to confirm 

that the jars were 

filled at the 

specified 

temperature, and 

checks that 

process log 

temperatures 

agree with the 

recorder charts.

• The recording 

charts from the RTDs 

used to monitor the 

temperature of the 

filling surge tank

• The process logs 

for temperature checks 

of the filling surge tank

• Corrective action 

records

• Of calibration of the 

RTDs and recording 

charts, with any notes 

by the PCQI about 

adjustments
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 6 (Heat Treatments) - Page 61

Critical 

Limits

What to 

Monitor How to Monitor Frequency of Monitoring

Who

Monitors Corrective Action Verification Records21

Minimum 

inverted jar 

hold time (1 

minute)

Conveyor belt 

speed as 

indicated by 

automated 

tachometer 

RPM

• Automated 

tachometer 

with recorder 

chart monitors

conveyor 

speed;

• Visual

check of chart

• Record 

RPM in 

process log

At the 

beginning of 

production and 

twice per shift

Line operator If it is determined that the jar inversion time 

is below the process set point:

• The product will be held until the PCQI 

determines whether the process was 

adequate or if the product can be 

reprocessed.

• The production manager will 

investigate why the belt speed deviated 

from the process set point and take 

appropriate actions to prevent the 

situation from reoccurring. 

• Employees will be retrained if 

necessary in light of the reason for the 

belt speed deviation

• Annual 

calibration of the 

tachometer and 

recording chart 

used to measure 

belt speed of the 

jar inversion 

conveyor, with the 

date and results 

recorded in a 

calibration log. The 

PCQI reviews, 

initials, and dates 

the calibration logs 

within a week of 

their creation.

• The QA

Manager verifies 

the jar inversion 

belt speed and 

time twice each 

year, and the PCQI 

reviews this within 

one week.

• On a daily 

basis, the PCQI 

reviews the 

recorded RPM for 

the conveyor belt

• The recording chart 

from the automated 

tachometer used to 

monitor the jar 

inversion conveyor belt 

speed

• The process logs 

for checks of the belt 

speed for the jar 

inversion conveyor belt

• Corrective action 

records

• Of calibration of the 

tachometer and 

recording charts, and 

verification tests that 

the jar inversion time is 

correct, with any notes 

by the PCQI about 

adjustments
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 7 (Time-Temperature Control) - Page 1

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-assistance-network-tan.

Chapter 7: Use of Time/Temperature as a Process Control 

(Coming Soon)

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. 
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 8 (Formulation or Drying) - Page 1

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-assistance-network-tan.

Chapter 8: Use of Product Formulation or Drying/Dehydrating

as a Process Control for Biological Hazards (Coming Soon)

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. 
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 9 (Validation) - Page 1

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-assistance-network-tan.

Chapter 9: Validation of a Process Control for a Bacterial 

Pathogen (Coming Soon)

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. 
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 10 (Sanitation Program) - Page 1

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-assistance-network-tan.

Chapter 10: Sanitation Program (Coming Soon)

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. 
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 1 

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. 

Chapter 11: Food Allergen Program

Table of Contents

11.1. Purpose of This Chapter

11.2 Terms Used in This Chapter

11.2.1 Definitions Established in 21 CFR 117.3

11.2.2 Other Terms That FDA Uses in This Chapter

11.2.3 Abbreviations Used in This Chapter

11.3 Understand the Hazard Requiring a Preventive Control

11.4 Considerations If You Establish and Implement a Food Allergen 

Program

11.4.1 Preventive Controls for Allergen Cross-Contact Enhance the CGMP Control 

Measures in Your Food Allergen Program

11.4.2 Foods That Contain a Major Food Allergen Are Subject to the Allergen 

Labeling Requirements of the FD&C Act

11.4.3 Policy Statements and Other Guidance Regarding Allergen Labeling

11.5 Develop a Strategy for Preventive Control Management Components

11.5.1 Overview of Preventive Control Management Components

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.
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 2

11.5.2 Monitoring and Verification

11.5.2.1 Requirements for monitoring

11.5.2.2 Requirements for verification

11.5.2.3 Flexibility in complying with the requirements for monitoring and 

verification for allergen cross-contact controls and label controls

11.5.3 Corrective Actions and Corrections

11.5.4 Applying Preventive Control Management Components to Supply-Chain 

Controls

11.5.5 Reanalysis

11.5.6 Records Documenting the Preventive Control Management Components

11.6 Allergen Cross-contact Controls

11.6.1 Allergen Cleaning Procedures

11.6.1.1 Monitoring and Verification for Allergen Cleaning Procedures

11.6.1.2 Corrective Actions and Corrections for Allergen Cleaning Procedures

11.6.1.3 Reanalysis of Your Allergen Cleaning Procedures

11.6.1.4 Records Documenting Allergen Cleaning Procedures and Applicable 

Preventive Control Management Components

11.6.2 Allergen Ingredient Procedures

11.7 Label Controls

11.7.1 Preventive Controls for the Content of the Product Label and for Managing 

Labels

11.7.1.1 Label controls for the content of the product label

11.7.1.2 Label controls for managing product labels/packages

11.7.2 Monitoring and Verification for Label Controls

11.7.2.1 What to monitor or verify for a label control

11.7.2.2 How to monitor or verify a label control

11.7.2.3 How often to monitor or verify a label control

11.7.2.4 Who monitors or verifies a label control

11.7.3 Corrective Actions/Corrections for Label Controls

11.7.4 Reanalysis for Label Controls

11.7.5 Records Documenting the Label Controls and Applicable Preventive 

Control Management Components

11.8 Supply-Chain Program

11.8.1 Regulatory Framework for the Supply-Chain Program
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11.8.2 When to Establish and Implement a Supply-chain Program as a Preventive 

Control for a Food Allergen Hazard

11.8.3 Supplier Approval and Supplier Verification Activities in a Supply-Chain 

Program for the Control of Food Allergen Hazards

11.8.3.1 Evaluating whether a potential supplier provides allergen advisory 

statements for raw materials or other ingredients that you would receive 

from the supplier before approving the supplier

11.8.3.2 Determining the appropriate supplier approval and verification activities

11.8.3.3 Conducting an audit of a supplier when the hazard requiring a supplychain applied control is a food allergen hazard

11.8.4 Receiving a Raw Material or Other Ingredient From a Supplier That 

Provides Allergen Advisory Statements

11.8.5 Corrective Actions and Corrections in the Event of Supplier Nonconformance

11.8.6 Reanalysis in the Event of Ongoing Supplier Nonconformance

11.8.7 Records Documenting the Supply-Chain Program

11.8.8 Review of Records for the Supply-Chain Program

11.9 Allergen Advisory Statements

11.9.1 How the 1996 Food Allergen Notice Applies to CGMP Measures and PCHF 

Requirements

11.9.2 Justification by Your Preventive Controls Qualified Individual That an 

Allergen Advisory Statement Is Necessary and Appropriate

11.9.3 Suppliers That Use Allergen Advisory Statements

11.9.4 Reanalysis of Your Determination That Allergen Advisory Statements Are 

Appropriate If You Experience Ongoing Problems with Your Allergen CrossContact Controls or Your Supply-Chain Program

11.10 Training

11.11 Examples Used in this Chapter

11.12 Example of a Food Allergen Program Established and Implemented 

by Dessert Manufacturer A for the Production of Ice Cream and Other 

Frozen Dessert Products

11.12.1 Dessert Manufacturer A’s Products and Hazard Analysis

11.12.2 Dessert Manufacturer A’s Food Allergen Program

11.12.2.1 Dessert Manufacturer A’s CGMP measures in its food allergen program

11.12.2.2 Dessert Manufacturer A’s food allergen controls
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11.12.2.3 Dessert Manufacturer A’s assessment of supply-chain controls related to 

food allergens

11.12.3 Dessert Manufacturer A’s Allergen Cross-Contact Control

11.12.3.1 Dessert Manufacturer A’s allergen cleaning procedures

11.12.3.2 Dessert Manufacturer A’s monitoring/verification of allergen cleaning 

procedures

11.12.3.3 Dessert Manufacturer A’s corrective actions/corrections for allergen 

cleaning procedures

11.12.3.4 Dessert Manufacturer A’s records for allergen cleaning procedures and 

associated preventive control management components

11.12.4 Dessert Manufacturer A’s Label Controls

11.12.4.1 Dessert Manufacturer A’s label content controls and label management 

controls

11.12.4.2 Dessert Manufacturer A’s monitoring/verification of label controls

11.12.4.3 Dessert Manufacturer A’s corrective actions/corrections for label controls

11.12.4.4 Dessert Manufacturer A’s records for label controls and associated 

preventive control management components

11.12.5 Summary of Dessert Manufacturer A’s Food Allergen Program

11.13 Example of Food Allergen Program Established and Implemented by 

Bakery B for the Production of a Variety of Cookie Products

11.13.1 Bakery B’s Products and Hazard Analysis

11.13.2 Bakery B’s Food Allergen Program

11.13.2.1 Bakery B’s CGMP measures in its food allergen program

11.13.2.2 Bakery B’s food allergen controls

11.13.2.3 Bakery B’s assessment of supply-chain controls related to food allergens

11.13.3 Bakery B’s Allergen Cross-contact Controls

11.13.3.1 Bakery B’s allergen cross-contact controls on utensils, tools, apparel, and 

movement of personnel

11.13.3.2 Bakery B’s monitoring/verification of allergen cross-contact controls

11.13.3.3 Bakery B’s corrective actions/corrections for allergen cross-contact 

controls

11.13.3.4 Bakery B’s records for allergen cross-contact controls and associated 

preventive control management components

11.13.4 Bakery B’s Label Controls

11.13.4.1 Bakery B’s label content controls and label management controls
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11.13.4.2 Bakery B’s monitoring/verification of label controls

11.13.4.3 Bakery B’s corrective actions/corrections for label controls

11.13.4.4 Bakery B’s records for label controls and associated preventive control 

management components

11.13.5 Bakery B’s Supply-chain Controls

11.13.5.1 The ingredient with a food allergen hazard that requires a supply-chainapplied control

11.13.5.2 The two vegan caramel chip processors that Bakery B evaluates as 

potential suppliers

11.13.5.3 Bakery B’s supplier approval and verification activities

11.13.5.4 Bakery B’s corrective actions/corrections in the event of supplier nonconformance

11.13.5.5 Bakery B’s records documenting its supply-chain controls

11.13.6 Summary of Bakery B’s Food Allergen Program

11.14 References

11.15 Resources

Appendix 11-1 CGMP Measures to Prevent Allergen Cross-Contact

11-1.A CGMP Measures Are Part of Your Food Allergen Program

11-1.B CGMP Measures to Prevent Allergen Cross-Contact by Personnel

11-1.C CGMP Measures for the Design and Construction of the Plant to Prevent 

Allergen Cross-Contact

11-1.D CGMP Measures for Sanitary Operations to Prevent Allergen CrossContact

11-1.E CGMP Measures on Equipment and Utensils to Prevent Allergen CrossContact

11-1.F CGMP Measures for Raw Materials and Other Ingredients, and for 

Manufacturing Operations, to Prevent Allergen Cross-Contact

11-1.F.1 CGMP measures for raw materials and other ingredients to prevent 

allergen cross-contact

11-1.F.2 CGMP measures for manufacturing operations to prevent allergen crosscontact

11-1.G CGMP Measures for Warehousing and Distribution to Prevent Allergen 

Cross-contact

Appendix 11-2 Summary of Dessert Manufacturer A’s Food Allergen 

Controls and Associated Preventive Control Management 

Components
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FORM 2-D (Modified) Allergen Cleaning Procedures

FORM 2-E (Modified) FOOD ALLERGEN INGREDIENT ANALYSIS

FORM 2-F (Modified) FOOD ALLERGEN LABEL VERIFICATION LIST

FORM 2-G (Modified) PRODUCTION LINE FOOD ALLERGEN ASSESSMENT

Appendix 11-3 Summary of Bakery B’s Food Allergen Controls and 

Associated Preventive Control Management Components

FORM 2-E (Modified) FOOD ALLERGEN INGREDIENT ANALYSIS

FORM 2-F (Modified) FOOD ALLERGEN LABEL VERIFICATION LIST

FORM 2-G (Modified) PRODUCTION LINE FOOD ALLERGEN ASSESSMENT

11.1. Purpose of this Chapter

The purpose of this chapter is to explain how to establish and implement a food allergen

program. Part 117 defines “food allergen” as a major food allergen as defined in section 201(qq) 

of the FD&C Act (21 CFR 117.3). Section 201(qq) of the FD&C Act defines the term ‘‘major food 

allergen,’’ in part, to mean any of the following: Milk, egg, fish (e.g., bass, flounder, or cod), 

Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or 

walnuts), wheat, peanuts, soybeans, and sesame2 or a food ingredient that contains protein 

derived from one of these foods, with certain exceptions regarding highly refined oils.

A food allergen program could include, as appropriate to the facility and its food products: 

• CGMP measures that you take to comply with the requirements of part 117, subpart B, to 

prevent allergen cross-contact3 due to personnel, design and construction of the plant, 

sanitary operations, equipment and utensils, raw materials and other ingredients,

manufacturing operations, and warehousing and distribution. Your hazard analysis should 

consider how your CGMP measures prevent allergen cross-contact, and the preventive 

controls that you establish and implement to address a food allergen hazard should 

complement and enhance your CGMP measures for preventing allergen cross-contact. 

2 In 2004, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amended the 

FD&C Act to provide FDA with additional, specific authority regarding the labeling of a food (other than a 

raw agricultural commodity) that bears or contains a “major food allergen.” Under section 403(w) of the 

FD&C Act (21 U.S.C. 343(w)), a food is misbranded if it contains a major food allergen and fails to declare 

that major food allergen on its label in the manner specified using the major food allergen’s common or 

usual name, including the name of the food source from which the major food allergen is derived. Section 

201(qq)(1) of the FD&C Act (21 U.S.C. 321(qq)(1)) defined a “major food allergen,” in part, as any of the 

following: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. The specified 

labeling requirements became effective on January 1, 2006, for packaged foods. In April 2021, the Food 

Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) amended section 201(qq) 

of the FD&C Act to add sesame to the definition of “major food allergen.” This amendment applies to “any 

food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023”

(Public Law 117-11).

3 Part 117 defines “allergen cross-contact” as the unintentional incorporation of a food allergen into a 

food. (See 21 CFR 117.3.)
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• Food allergen controls to provide assurances that any food allergen hazards requiring a 

preventive control will be significantly minimized or prevented. (See 21 CFR 117.135(a) and 

(c)(2).) Food allergen controls include procedures, processes, and practices that are:

o Allergen cross-contact controls – i.e., procedures, practices, and processes employed 

for ensuring protection of food from allergen cross-contact, including during storage, 

handling, and use (21 CFR 117.135(c)(2)(i)); and 

o Label controls – i.e., procedures, practices, and processes employed for labeling the 

finished food, including ensuring that the finished food is not misbranded under section 

403(w) of the FD&C Act (21 U.S.C. 343(w)). (21 CFR 117.135(c)(2)(ii).)

• A supply-chain program as required by part 117, subpart G for those raw materials and 

other ingredients for which a manufacturing/processing facility has identified a food allergen 

hazard that is controlled before its receipt. (See 21 CFR 117.405(a)(1).) See Chapter 15 for 

comprehensive guidance on how to comply with the requirements of part 117, subpart G for 

all hazards, not just food allergen hazards.

In this chapter, we provide multiple, detailed recommendations for each of these aspects of a 

food allergen program. Our purpose is to provide as many examples as possible so that you can 

develop your own food allergen program as appropriate to your operations, not to imply that a 

food allergen program should have all the CGMP measures, preventive controls (including 

supply-chain controls), monitoring/verification activities, corrective action procedures, and 

records that we describe for illustrative purposes. 

For background and details about food allergen hazards, see section 3.4.2.1 of Chapter 3. For a 

preliminary discussion of food allergen controls, see section 4.5 of Chapter 4. For an overview 

of the application of preventive control management components to food allergen controls, see 

section 5.3.3 of Chapter 5. For the definitions of terms used in this chapter, see section III in the 

Introduction of this guidance and section 11.3 in this chapter.

This chapter does not address substances that are associated with food allergy but are not 

major food allergens defined in section 201(qq) of the FD&C Act. However, you may find the 

recommendations in this chapter for food allergen controls to be useful for such substances if 

appropriate for your food and facility. This document also does not address substances (e.g., 

sulfites and yellow No. 5) that are associated with food intolerance or substances (e.g., gluten) 

that are associated with food-related disease (e.g., celiac disease) as discussed in section 

3.4.2.2 of Chapter 3 of this guidance. However, you may find the recommendations in this 

chapter for label controls for food allergens to be a useful tool for developing your strategy for 

complying with any regulatory requirements for labeling such substances, even though the 

labeling requirements for such substances are different from the labeling requirements for the 

major food allergens.

4

In a 1996 notice to manufacturers entitled “Label Declaration of Allergenic Substances in Foods” 

(the 1996 food allergen notice) (see Table 11-8), we advised the food industry that we were 

aware that some manufacturers are voluntarily labeling their products with statements such as 

4 For example, sulfiting agents permitted in foods must be listed on the ingredient label, unless they are 

added to food as an “incidental substance” (i.e., because they have no technical effect in the finished food 

and are present at less than 10 parts per million (ppm)). (See 21 CFR 101.100(a)(4).) As a second 

example, our regulation for the color additive Yellow No. 5 states that any food for human use that 

contains Yellow No. 5 must specifically declare the presence of the color additive by listing it as an 

ingredient. (See 21 CFR 74.705(d)(2).) 
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"may contain (insert name of allergenic ingredient)." In the 1996 food allergen notice and in our 

allergen labeling guidance (see Table 11-7), we advised that labeling such as “may contain 

[allergen]” is not a substitute for, and should not be used in lieu of, adherence to CGMPs. Our 

allergen labeling guidance also advises that labeling such as “may contain [allergen]” is not a 

substitute for adherence to food allergen preventive controls and that any such statement must 

be truthful and not misleading. In the 1996 food allergen notice, we also urged manufacturers to 

“take all steps necessary to eliminate cross-contamination and to ensure the absence of the 

identified food.” Consistent with the 1996 food allergen notice and our allergen labeling 

guidance, in section 11.9 of this chapter we advise that:

• You should not use allergen advisory statements (formerly called allergen precautionary 

labeling) in lieu of adherence to CGMPs or in lieu of the requirements for allergen crosscontact controls;

• If you use allergen advisory statements, they must be truthful and not misleading;

• If you use allergen advisory statements, your preventive controls qualified individual (PCQI)

should provide a written justification, in your food safety plan, for why allergen cross-contact 

controls cannot ensure protection of food from allergen cross-contact;

• Your supplier approval and verification activities should include an evaluation of whether a 

potential supplier provides allergen advisory statements for raw materials and other 

ingredients that you would receive from the potential supplier. When a potential supplier 

would provide an allergen advisory statement on the applicable raw materials or other 

ingredients, you should discuss the reasons for the allergen advisory statements with the 

potential supplier. You should approve such suppliers only if you determine, through your 

supplier approval and verification activities, that such statements are not being used in lieu 

of adherence to CGMPs or in lieu of adherence to the requirements for allergen crosscontact controls; and

• Reanalysis of your determination regarding using allergen advisory statements is 

appropriate if you experience ongoing problems with your allergen cross-contact controls or 

your supply-chain controls. 

This chapter does not broadly discuss other issues associated with allergen advisory

statements. See the discussion of labeling policy statements and other guidance regarding 

allergen labeling in section 11.4.3 and our web page providing guidance documents and 

regulatory information regarding food allergens (see Table 11-8) for the most current policy 

statements and other guidance relevant to allergen advisory statements. You should periodically 

check that web page for updates to these policy statements and other guidance.

11.2 Terms Used in This Chapter

11.2.1 Definitions Established in 21 CFR 117.3

Section III.A in the Introduction of this guidance includes a glossary of terms that are used in 

this guidance and are defined in 21 CFR 117.3. At this time, that glossary does not include all 

terms that are used in this chapter. See Table 11-1 for additional terms that are defined in 21 

CFR 117.3. We intend to include these terms in the glossary in section III.A in the Introduction 

of this guidance when we update the Introduction. When we do so, we intend to delete Table 

11-1 from this chapter, because it would be duplicative.
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Table 11-1 Applicable Terms Defined in Part 117 (See 21 CFR 117.3.)

Term What the Term Means

Allergen cross-contact The unintentional incorporation of a food allergen into a food.

Audit The systematic, independent, and documented examination (through observation, 

investigation, records review, discussions with employees of the audited entity, and, 

as appropriate, sampling and laboratory analysis) to assess a supplier’s food safety 

processes and procedures.

Food allergen A major food allergen as defined in section 201(qq) of the FD&C Act.

Lot The food produced during a period of time and identified by an establishment’s 

specific code.

Manufacturing/ 

processing

Making food from one or more ingredients, or synthesizing, preparing, treating, 

modifying or manipulating food, including food crops or ingredients. Examples of 

manufacturing/processing activities include: Baking, boiling, bottling, canning, 

cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to 

create a distinct commodity (such as drying/dehydrating grapes to produce raisins), 

evaporating, eviscerating, extracting juice, formulating, freezing, grinding, 

homogenizing, irradiating, labeling, milling, mixing, packaging (including modified 

atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate 

ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, 

manufacturing/processing does not include activities that are part of harvesting, 

packing, or holding.

Qualified auditor A person who is a qualified individual as defined in part 117 and has technical 

expertise obtained through education, training, or experience (or a combination 

thereof) necessary to perform the auditing function as required by § 117.180(c)(2). 

Examples of potential qualified auditors include: (1) A government employee, 

including a foreign government employee; and (2) An audit agent of a certification 

body that is accredited in accordance with regulations in 21 CFR part 1, subpart M 

(Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and 

To Issue Certifications).

Receiving facility A facility that is subject to subparts C and G of part 117 and that 

manufactures/processes a raw material or other ingredient that it receives from a 

supplier.

Rework Clean, unadulterated food that has been removed from processing for reasons other 

than insanitary conditions or that has been successfully reconditioned by 

reprocessing and that is suitable for use as food.

Supplier The establishment that manufactures/processes the food, raises the animal, or grows 

the food that is provided to a receiving facility without further 

manufacturing/processing by another establishment, except for further 

manufacturing/processing that consists solely of the addition of labeling or similar 

activity of a de minimis nature.

Supply-chain-applied 

control

A preventive control for a hazard in a raw material or other ingredient when the 

hazard in the raw material or other ingredient is controlled before its receipt.

Written procedures for 

receiving raw materials 

and other ingredients

Written procedures to ensure that raw materials and other ingredients are received 

only from suppliers approved by the receiving facility (or, when necessary and 

appropriate, on a temporary basis from unapproved suppliers whose raw materials or 

other ingredients are subjected to adequate verification activities before acceptance 

for use).

11.2.2 Other Terms That FDA Uses in This Chapter

Section III.B in the Introduction of this guidance includes a glossary of terms that are used in 

this guidance but are not defined in 21 CFR 117.3. At this time, that glossary does not include 
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all terms that are used in this chapter. See Table 11-2 for additional terms that we use in this 

chapter. We intend to include these terms in the glossary in the Introduction of this guidance 

when we update the Introduction. When we do so, we will delete Table 11-2 from this chapter.

Table 11-2 Terms Used in This Chapter

Term What the Term Means

Allergen cleaning 

procedure

Procedures, practices, and processes for cleaning food-contact surfaces of 

equipment and utensils that are used for foods with different food allergen 

profiles 

Allergen cross-contact 

control

Procedures, practices, and processes employed for ensuring protection of 

food from allergen cross-contact, including during storage, handling, and 

use

Allergenic component A food allergen (i.e., a major food allergen as defined in section 201(qq) of 

the FD&C Act) that is a component of an ingredient (e.g., the food allergen 

“milk” in a spice blend)

Allergenic ingredient A food allergen (i.e., a major food allergen as defined in section 201(qq) of 

the FD&C Act) that is an ingredient of another food product (e.g., the food 

allergen “peanuts” added to cookies)

Allergen labeling guidance Questions and Answers Regarding Food Allergens, Including the Food 

Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic 

Act (Edition 5): Guidance for Industry

Approved supplier A supplier that has met the criteria of the receiving facility’s supply chain 

program, is controlling the identified hazard, and has been approved by the 

receiving facility

Certificate of analysis 

(COA) 

A document, provided by the supplier of a food prior to or upon receipt of the 

food, that documents the analysis of certain characteristics and attributes of 

the food

Changeover Procedures used to prepare the processing line when different products are 

produced on the same processing line

Draft allergen labeling 

guidance5

Questions and Answers Regarding Food Allergens, Including the Food 

Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic 

Act (Edition 5): Guidance for Industry (Draft Guidance)

Exception record A record that you establish only when there is loss of control

Food allergen label 

specification

All features of the product label that you will use to ensure that the finished 

food will not be misbranded under section 403(w) of the FD&C Act. 

Examples of such features are product name; the approach to naming the 

food source of all allergenic ingredients (and allergenic components of 

ingredients) (e.g., within the ingredient statement6 or in a separate 

“Contains” statement); and any color coding or other distinctive features that 

you use to help production personnel select the correct label. 

Food allergen profile The food allergen sources present or absent in a food 

Label7 A display of written, printed, or graphic matter upon the immediate container 

of a food article. (See the definition of “label” in section 201(k) of the FD&C 

Act ((21 U.S.C. 321(k))

5 The draft guidance, when finalized, will explain FDA’s current thinking on a number of issues related to 

the labeling of food allergens, including requirements in both FALCPA and the FASTER Act.

6 See 21 CFR 101.4 Food; designation of ingredients.

7 Note that the definition of “label” in section 201(k) of the FD&C Act specifies that a requirement that any 

word, statement, or other information appear on the label shall not be considered to be complied with 

unless such word, statement, or other information also appears on the outside container or wrapper, if 

any there be, of the retail package of such article, or is easily legible through the outside container or 

wrapper. 
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Term What the Term Means

Label control Procedures, practices, and processes employed for labeling the finished 

food, including ensuring that the finished food is not misbranded under 

section 403(w) of the FD&C Act

SAHCODH (Serious 

adverse health 

consequences or death to 

humans) hazard 

A hazard for which there is a reasonable probability that exposure to the 

hazard will result in serious adverse health consequences or death to 

humans.

Third-party audit An audit conducted by a qualified auditor that is not an employee of either 

the receiving facility or the supplier.

Unintended allergen 

presence8

The presence of an allergen due to allergen cross-contact

Visibly clean Without visibly detectable material such as food residue, film, or protein 

sheen

Work-in-process (WIP) Partially finished products that are in between different production stages 

(e.g., batched or pre-processed ingredients that are transferred to totes and 

held until moved to another processing line to be incorporated into another 

product).

11.2.3 Abbreviations Used in This Chapter

Section IV in the Introduction of this guidance includes a list of abbreviations that are used in 

this guidance. At this time, that list of abbreviations does not include all abbreviations that are 

used in this chapter. See Table 11-3 for additional abbreviations that are used in this chapter. 

We intend to include these abbreviations in section IV in the Introduction of this guidance when 

we update the Introduction. When we do so, we will delete Table 11-3 from this chapter. For 

your convenience, Table 11-3 includes some abbreviations, already included in section IV of the 

Introduction of this guidance, that are commonly used in this chapter. 

Table 11-3 Common Abbreviations Used in This Chapter

Abbreviation What It Means

CIP Clean in place

CFR Code of Federal Regulations

CGMP Current good manufacturing practice

FALCPA Food Allergen Labeling and Consumer Protection Act

FAO Food and Agriculture Organization of the United Nations

FCS Food-contact surface

FD&C Act Federal Food, Drug, and Cosmetic Act

FSPCA Food Safety Preventive Controls Alliance

PCHF “Preventive Controls for Human Food” (requirements in 21 CFR part 117 for hazard 

analysis and risk-based preventive controls for human food in accordance with 

section 418 of the FD&C Act)

PCQI Preventive controls qualified individual

8 In the draft Chapter 3 that we made available for comment on August 24, 2016 (81 FR 57816), we used 

the terminology “undeclared allergen” rather than “unintended allergen presence,” when an allergen is 

present due to cross-contact. When we finalize that chapter, we intend to use the terminology 

“unintended allergen presence.”
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Abbreviation What It Means

WHO World Health Organization

11.3 Understand the Hazard Requiring a Preventive Control

Section 3.4.2.1 of Chapter 3 includes food allergen information such as:

• The prevalence and symptoms of food allergies; 

• The importance of susceptible consumers avoiding foods that are or contain food allergens; 

• The “major food allergens” subject to the allergen labeling requirements of the FD&C Act9

(i.e., milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and 

sesame10); 

• The presence of gluten (i.e., a mixture of proteins associated with celiac disease) in one of 

the major food allergens (i.e., wheat); and

• The classification of unintended allergen presence11 as a “chemical hazard”; and 

• The classification of an undeclared12 food allergen due to applying a label that does not 

declare all allergenic ingredients, applying the incorrect food label to a product, or using the 

wrong packaging, as a “chemical hazard.” 

Unintended allergen presence can occur through failure to prevent allergen cross-contact. 

Depending on your plant, the food products you produce, and the nature of the ingredients that 

you use, you should design your food allergen program to prevent allergen cross-contact 

between foods with different “food allergen profiles” – i.e., to prevent allergen cross-contact: 

• Between foods that contain different food allergens; and

9 For additional information about allergen labeling requirements of the FD&C Act, see section 403(w) of 

the FD&C Act (21 U.S.C. 343(w)), the definition of “major food allergen” in section 201(qq) of the FD&C 

Act (21 U.S.C. 321(qq)), our guidance regarding the allergen labeling requirements of the FD&C Act (see 

Table 11-7), and section 11.4.2. Additional regulatory information and guidance documents applicable to 

food allergens are available on our website (see Table 11-8). 

10 The allergen labeling requirements of the FD&C Act for sesame are effective for food that is introduced 

or delivered for introduction into interstate commerce on or after January 1, 2023. 11 In the draft Chapter 3 that we made available for comment on August 24, 2016 (81 FR 57816), we used 

the terminology “undeclared allergen” rather than “unintended allergen presence,” when an allergen is 

present due to cross-contact. When we finalize that chapter, we intend to use the terminology 

“unintended allergen presence” when an allergen is present due to cross-contact. 12 In contrast to “unintended allergen presence,” which we use when an allergen is present due to crosscontact, we use variations of the term “declare” when that term is used in the FD&C Act, our regulations, 

or an FDA guidance document to describe information that is present on a food label. For example, the 

label requirements in 21 CFR 101.4 for the designation of ingredients and our guidance regarding the 

allergen labeling requirements of the FD&C Act (the allergen labeling guidance; see Table 11-7 and the 

discussion in section 11.4.2) both use variations of the term “declare” when describing information 

presented on a food label. Likewise, we use variations of the term “undeclared” when describing a label 

that does not comply with label requirements in the FD&C Act or our food labeling regulations. When we 

finalize Chapter 3, we intend to explain how we use variations of the term “declare” to describe 

information that is present on a food label.
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• Between foods that contain certain food allergens and foods that do not contain any food 

allergens. 

Without such controls the food is likely to present a hazard to a consumer who has a food 

allergy. For example:

o If one beverage that you produce contains milk-derived ingredients, and a different 

beverage that you produce in that same establishment contains soy-derived ingredients, 

a food allergen program could help to prevent allergen cross-contact between the 

beverage containing milk-derived ingredients and the beverage containing soy-derived 

ingredients. Otherwise, the milk beverage could have unintended soy protein, and the 

soy beverage could have unintended milk protein. 

o If you produce some chocolate candy that contains almonds and other chocolate candy 

that does not contain almonds, a food allergen program could help to prevent allergen 

cross-contact between the chocolate candy that contains almonds and the chocolate 

candy that does not contain almonds. Otherwise, the chocolate candy that is formulated 

to not contain almonds could have unintended almonds.

o If a milk-derived food ingredient (such as whey protein powder) has the potential to 

spread to foods that do not contain milk due to the powder-based nature of the 

ingredient, a food allergen program to reduce the potential for transmission of the 

powdered ingredient (e.g., as dust) could help to prevent allergen cross-contact in foods 

that do not contain milk.

As discussed in section 3.4.2.1 of Chapter 3, food allergen hazards are a potential hazard 

regardless of whether a food allergen is present in a major ingredient (such as peanuts and tree 

nuts that are allergenic ingredients of products such as cookies and trail mix) or is an allergenic

component of a minor ingredient (such as milk that is a component of a spice blend). Therefore, 

the recommendations in this chapter apply to all raw materials and other ingredients used in the 

production of a food product, regardless of whether an allergenic ingredient is a major or minor

ingredient and regardless of whether an allergenic component is a major or minor component of 

a major of minor raw material or other ingredient in a food product.

FDA has not established a maximum amount of food allergen that may be present in labeled 

food products without need for declaration. However, FDA recognizes that published data on 

population threshold dose responses to various food allergens are becoming increasingly 

available (Remington et al., 2020; FAO/WHO, 2021 and 2022). These published data raise the 

possibility that some low-level exposures to food allergens, and the presence of certain 

allergen-derived ingredients, may not cause allergic reactions in most consumers who have that 

food allergy. Food manufacturers/processors could evaluate such data in light of their specific 

products, such as through risk assessments or other scientifically valid assessments, in making 

decisions on appropriate food allergen controls. As discussed in sections 11.8.4 and 11.9.2, 

your PCQI has the responsibility to determine the appropriate approach to the potential for 

untended allergen presence in your food product (i.e., the potential for the presence in your food 

product, due to allergen cross-contact, of a food allergen from a food source that is not already 

an ingredient in that food product).
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11.4 Considerations If You Establish and Implement a Food Allergen 

Program

11.4.1 Preventive Controls for Allergen Cross-Contact Enhance the CGMP 

Control Measures in Your Food Allergen Program

The CGMPs in part 117, subpart B specify several requirements to prevent allergen crosscontact. CGMP requirements are sometimes called a “prerequisite program” (NACMCF, 1998) 

to signify that the measures that you take to comply with the CGMP requirements should be in 

place before you conduct your hazard analysis and identify risk-based preventive controls to 

address specific hazards, such as the food allergen hazards that are the subject of this chapter. 

The allergen cross-contact controls that you establish and implement as preventive controls 

should complement and enhance the measures you have in place to comply with the CGMP 

requirements to prevent allergen cross-contact. In developing your allergen cross-contact 

controls, we recommend that you consider adapting one or more of the measures for complying 

with the CGMP requirements to function as a preventive control by combining a CGMP measure 

with one or more preventive control management components such as monitoring or verifying 

through, e.g., visual observation, after considering the nature of your food products and the role 

of a CGMP measure in your food safety system. For example:

• Section 11.6.1 of this chapter provides our recommendations for allergen cleaning 

procedures (i.e., cleaning of FCSs of equipment and utensils that are used for foods with 

different food allergen profiles), and section 11.12 of this chapter provides an example in 

which a manufacturer of frozen desserts establishes and implements allergen cleaning 

procedures as an allergen cross-contact control. Such cleaning complements and enhances

the CGMP requirements in 21 CFR 117.35 for preventing allergen cross-contact through 

sanitary operations.

• Section 11.13 of this chapter provides an example in which a bakery that produces cookies 

with and without peanuts establishes and implements allergen cross-contact controls on 

apparel, movement of personnel, utensils, and tools. These allergen cross-contact controls 

complement and enhance the CGMP requirements in 21 CFR 117.10, 117.20, and 117.40 

for preventing allergen cross-contact due to personnel, plant construction and design, and 

equipment.

• Section 11.6.2 of this chapter provides our recommendations for allergen ingredient 

procedures that you could use to complement the CGMP requirement that raw materials 

and other ingredients that are food allergens, and rework that contains food allergens, be 

identified and held in a manner that prevents allergen cross-contact. (See 21 CFR 

117.80(b)(8).) There are several ways by which you could adapt the measures you take to 

comply with this CGMP requirement to function as an allergen cross-contact control, such 

as:

o Clearly identify allergen-containing raw materials and other ingredients using a system 

that adequately distinguishes between raw materials and other ingredients with different 

food allergen profiles to alert personnel that these materials are subject to special 

precautions and handling procedures throughout the plant. An example of such a system 

is color-coding – e.g., through use of color-coded stickers/tags, placards, or shrink-wrap, 

with a specific color dedicated to each of the major food allergens and a system (such as 
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a chart displayed at multiple locations in the plant) for alerting personnel to the assigned 

colors.

o Conduct periodic verification through visual observation of the identification and storage 

of raw materials, ingredients, and rework, document the results of your visual 

observations, and document corrective actions (or, when applicable, corrections) that 

you take if your observations indicate that food allergens in raw materials or other 

ingredients have not been identified (e.g., if a color-coding system that you establish was 

not properly implemented) or that these materials are not stored properly (e.g., if bags 

containing soy protein are not completely closed or if there is spillage of powder in the 

storage area).

o Monitor or verify that the allergenic ingredients brought to the staging area for the recipe 

or formulation of the scheduled product match the product label content by inspecting 

the ingredient labels (or stickers/tags on ingredients if, for example, you have used colorcoded stickers/tags to identify allergenic-containing ingredients) and reconciling allergenrelated information on the ingredient labels (or stickers/tags) with the product label or the 

product specifications (i.e., in the recipe or formulation).

• The CGMPs require that WIP and rework be handled in a manner that protects against 

allergen cross-contact. (See 21 CFR 117.80(c)(5).) One way to adapt the measures you 

take to comply with this CGMP requirement to function as an allergen cross-contact control 

is to establish and implement written procedures to manage re-entry of WIP and rework 

(e.g., during release of WIP and rework from storage areas, during the staging and transfer 

of WIP and rework, and at the re-entry points for WIP and rework in the production process). 

You then could monitor activities such as re-entry of rework and WIP (e.g., by recording the 

amount used, the product in which the WIP or rework was used, the lot number, and 

reconciliation of the amount used with the total amount produced), and document any 

corrective actions (or, when applicable, corrections) if a problem occurs.

Importantly, a food allergen program generally is used in combination with the sanitation 

controls required by 21 CFR 117.135(c)(3). The allergen cleaning procedures that we 

recommend in section 11.6.1 are similar to the sanitation controls that are the subject of 

Chapter 10, with targeted recommendations specific to the removal of allergenic residues and, 

thus, the prevention of allergen cross-contact.

11.4.2 Foods That Contain a Major Food Allergen Are Subject to the 

Allergen Labeling Requirements of the FD&C Act

Section 403(w) of the FD&C Act (21 U.S.C 343(w)) contains requirements (the “allergen labeling 

requirements of the FD&C Act”) that apply to certain foods that are, or contain, a major food 

allergen. Our guidance regarding the allergen labeling requirements of the FD&C Act (the 

allergen labeling guidance; see Table 11-7) provides information to help you comply with the 

allergen labeling requirements of the FD&C Act. One such labeling requirement is to name the 

food source of all major food allergens used as ingredients in the packaged food. As discussed 

in the allergen labeling guidance, this can be done in one of two ways. The first option is for you 

to include the name of the food source in parentheses following the common or usual name of 

the major food allergen in the list of ingredients in instances when the name of the food source 

of the major allergen does not appear elsewhere in the ingredient statement (e.g., Sugar, whey 

(milk), eggs). The second option is to use a “Contains” statement followed by the names of the 

food sources from which all major food allergens are derived (e.g., “Contains egg and milk”,

“Contains egg”) immediately after or adjacent to the list of ingredients. Importantly, a “Contains” 

statement includes the names of the food sources of all major food allergens used as 
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ingredients in the packaged food. See the allergen labeling guidance for more details about how 

to meet the allergen labeling requirements of the FD&C Act.

13

11.4.3 Policy Statements and Other Guidance Regarding Allergen Labeling

Our web page providing guidance documents and regulatory information regarding food 

allergens (see Table 11-8) provides policy statements and other guidance issued by FDA 

regarding allergen labeling. For example:

• The 1996 food allergen notice (see Table 11-8) advised the food industry that, because 

adhering to CGMPs is essential for effective reduction of adverse reactions by consumers, 

labeling such as “may contain [allergen]” should not be used in lieu of adherence to CGMPs 

and urged manufacturers to take all steps necessary to eliminate cross-contamination and 

to ensure the absence of the identified food. 

• Question/Answer D.14 in our allergen labeling guidance advises that:

o Labeling such as “may contain [allergen]” is not a substitute for adherence to CGMPs 

and food allergen preventive controls; and

o Any statement such as “may contain [allergen]” must be truthful and not misleading; 

• Question/Answer D.13 in our draft allergen labeling guidance14 advises that the food 

allergen labeling requirements of the FD&C Act do not apply to a major food allergen that is 

unintentionally incorporated in a food as a result of cross-contact; and

• Our Compliance Policy Guide (CPG) entitled “CPG Sec. 555.250 Statement of Policy for 

Labeling and Preventing Cross-contact of Common Food Allergens” (see Table 11-6)

describes various labeling requirements and policies15,16.

You should periodically check FDA’s website for updates to our policy statements and other 

guidance regarding allergen labeling. 

13 Note that our regulation in 21 CFR 101.91 defines the term ‘‘gluten-free’’ for voluntary use in the 

labeling of foods. A food label that includes the term ‘‘wheat’’ in the ingredient list or in a separate 

‘‘Contains wheat’’ statement as required by the allergen labeling requirements of the FD&C Act and also 

bears the claim ‘‘gluten-free’’ will be deemed to be misbranded unless its labeling also bears additional 

language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a 

‘‘gluten-free’’ claim.

14 The draft allergen labeling guidance, when finalized, will explain FDA’s current thinking on a number of 

issues related to the labeling of food allergens, including requirements in both FALCPA and the FASTER 

Act.

15 CPG Sec. 555.250 also discusses practices used to prevent potential allergen cross-contact. 16 In 2023, FDA issued for public comment a draft compliance policy guide entitled “CPG Sec. 555.250 

DRAFT: Major Food Allergen Labeling and Cross-contact” (88 FR 31507, May 17, 2023). When finalized, 

this draft CPG will replace existing guidance, in CPG Sec. 555.250 Statement of Policy for Labeling and 

Preventing Cross-contact of Common Food Allergens, for FDA staff on FDA’s enforcement policy 

regarding major food allergen labeling and cross-contact.
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11.5 Develop a Strategy for Preventive Control Management 

Components

11.5.1 Overview of Preventive Control Management Components

With few exceptions, part 117 specifies that preventive controls are subject to the following 

preventive control management components as appropriate to ensure the effectiveness of the 

preventive controls, taking into account the nature of the preventive control and its role in the 

facility’s food safety system: (1) Monitoring; (2) corrective actions and corrections; and (3) 

verification. (See 21 CFR 117.140.)

This chapter describes our recommendations for three types of preventive controls that are 

subject to preventive control management components:

• Allergen cross-contact controls; 

• Label controls17; and

• Supply-chain controls for raw materials and other ingredients when a food allergen hazard in 

the raw material or other ingredient is controlled before its receipt. 

Our recommended CGMP measures in Appendix 11-1 to prevent allergen cross-contact are not 

subject to preventive control management components. However, as discussed in section

11.4.1, you could develop and implement appropriate preventive control management 

components for any CGMP measure that you adapt to function as a preventive control.

11.5.2 Monitoring and Verification

11.5.2.1 Requirements for monitoring

Part 117 requires that, as appropriate to the nature of the preventive control and its role in your 

food safety system, you establish and implement written procedures, including the frequency 

with which they are to be performed, for monitoring the preventive control. (See 21 CFR 

117.145(a).) You must monitor the preventive controls with adequate frequency to provide 

assurance that they are consistently performed. (See 21 CFR 117.145(b).) See section 11.5.6

for a discussion of the requirements of part 117 for records of monitoring activities.

11.5.2.2 Requirements for verification

Part 117 requires that verification activities include, as appropriate to the nature of the 

preventive control and its role in your food safety system: (1) Validation18; (2) Verification that 

17 Section 11.7 provides separate recommendations for “label content controls” and “label management 

controls.” However, we do so solely as an organizational tool for presenting our recommendations for how 

to use label controls to prevent food from being misbranded under section 403(w) of the FD&C Act. In 

your food safety plan, it makes no difference whether you classify your label control as a control on label 

content or a control on managing your labels. Thus, when you tailor this guidance for your operations you 

may find it more useful to classify a label control in a different manner than we do in this chapter. 18 During the rulemaking to establish part 117, we acknowledged that it is premature to require validation 

of food allergen controls (see the discussion in the proposed rule (78 FR 3646 at 3755, January 16, 2013) 

and Response 515 in the final rule (80 FR 55908 at 56058)). As a result, part 117 does not require 
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monitoring is being conducted; (3) Verification that appropriate decisions about corrective 

actions are being made; (4) Verification of implementation and effectiveness; and (5) 

Reanalysis. (See 21 CFR 117.155.)

Part 117 requires that you verify that the preventive controls are consistently implemented and 

are effectively and significantly minimizing or preventing the hazards. To do so you must 

conduct activities that include the following, as appropriate to the facility, the food, and the 

nature of the preventive control and its role in the facility’s food safety system: (1) Calibration of 

process monitoring instruments and verification instruments (or checking them for accuracy); 

and (2) Review of certain records by (or under the oversight of) a PCQI, to ensure that the 

records are complete, the activities reflected in the records occurred in accordance with the food 

safety plan, the preventive controls are effective, and appropriate decisions were made about 

corrective actions. (See 21 CFR 117.165(a)(1) and (4).)

Part 117 also requires, as appropriate to the facility, the food, the nature of the preventive 

control, and the role of the preventive control in the facility’s food safety system, that you 

establish and implement written procedures for the method and frequency of calibrating process 

monitoring instruments and verification instruments (or checking them for accuracy). (See 21 

CFR 117.165(b)(1).)

See section 11.5.5 for a discussion of reanalysis. See section 11.5.6 for a discussion of the 

requirements of part 117 for records of verification activities.

11.5.2.3 Flexibility in complying with the requirements for monitoring 

and verification for allergen cross-contact controls and label controls

The requirements for monitoring provide flexibility for you to establish and implement written 

procedures for monitoring preventive controls as appropriate to the nature of the preventive 

control and its role in your food safety system. (See 21 CFR 117.145.) Likewise, the 

requirements for verification provide flexibility for you to conduct verification activities that are 

appropriate to the facility, the food, and the nature of the preventive control and its role in the 

facility’s food safety system. (See 21 CFR 117.165.) In many cases, the nature of an activity 

(such as visual observation) conducted as a preventive control management component for an 

allergen cross-contact control or a label control could be classified as either monitoring or as 

verification. In light of the flexibility that part 117 provides for monitoring and verification, it 

generally makes little difference whether you consider such an activity to be monitoring or 

verification for the purposes of your allergen program as long as you comply with requirements 

applicable to monitoring or verification; part 117 does not require that you establish and 

implement both a monitoring activity and a verification activity if the same activity (such as visual 

observation) would be used as both a monitoring activity and a verification activity. Regardless 

of what you call them, you must have procedures that are adequate to ensure the effectiveness 

of the preventive controls.

validation of food allergen controls (see 21 CFR 117.160(c)(1)). Therefore, this guidance does not provide 

recommendations for validation of food allergen controls. However, nothing in part 117 would prevent you 

from validating a food allergen control, if you choose to do so (see Response 513, 80 FR 55908 at 

56057), and some verification procedures that we describe in this chapter could, with minimal 

modification, be part of a validation study. (See the discussion in Response 515, 80 FR 55908 at 56058.)
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11.5.3 Corrective Actions and Corrections

Part 117 includes requirements, as appropriate to the nature of the hazard and the nature of the 

preventive control, for corrective action procedures that must be taken if a preventive control is 

not properly implemented. (See 21 CFR 117.150(a)(1).) The corrective action procedures must 

describe the steps to be taken to ensure that: (1) Appropriate action is taken to identify and 

correct the problem; (2) appropriate action is taken, when necessary, to reduce the likelihood 

that the problem will recur; (3) all affected food is evaluated for safety; and (4) all affected food 

is prevented from entering into commerce, if you cannot ensure that the affected food is not 

adulterated or misbranded. (See 21 CFR 117.150(a)(2).)

However, you do not need to take corrective actions if you take action, in a timely manner, to 

identify and correct conditions and practices that are not consistent with the food allergen 

controls in 21 CFR 117.135(c)(2)(i) (ensuring protection of food from allergen cross-contact), or 

if you take action, in a timely manner, to identify and correct a minor and isolated problem that 

does not directly impact product safety (i.e., make corrections). (See 21 CFR 117.150(c).) For 

example, if you observe that a CIP system failed to maintain its target temperature, and you 

correct the problem by determining the root cause of the problem, adjusting the temperature 

and running a complete CIP at the appropriate temperature before beginning production, you 

could consider that your prompt action corrects conditions and practices that are not consistent 

with your allergen cross-contact controls. As another example, if a problem occurs with a label 

control before a product label is applied or used in food production and you fix the problem so 

that only correct labels are used, you could consider the problem to be a minor problem that 

does not directly impact product safety.

See section 11.5.6 for a discussion of the requirements of part 117 for records of corrective 

actions and corrections.

11.5.4 Applying Preventive Control Management Components to SupplyChain Controls 

The supply-chain program required by part 117, subpart G includes specific requirements 

applicable to supplier verification activities, and the supply-chain program as a whole is subject 

to a subset of preventive control management components – i.e., corrective actions and 

corrections, review of records, and reanalysis. (See 21 CFR 117.140(b).)

11.5.5 Reanalysis

Part 117 includes requirements for you to conduct a reanalysis of the food safety plan as a 

whole at least once every 3 years. (See 21 CFR 117.170(a).) Part 117 also includes 

requirements for you to conduct a reanalysis of the food safety plan as a whole, or the 

applicable portion of the food safety plan: (1) Whenever a significant change in the activities 

conducted at your facility creates a reasonable potential for a new hazard or creates a 

significant increase in a previously identified hazard; (2) whenever you become aware of new 

information about potential hazards associated with the food; (3) whenever appropriate after an 

unanticipated food safety problem; and (4) whenever you find that a preventive control, 

combination of preventive controls, or the food safety plan as a whole is ineffective. (See 21 

CFR 117.170(b).)

See the discussions in sections 11.6.1.3, 11.6.2, 11.7.4, and 11.8.6 regarding circumstances in 

which reanalysis of your food safety plan is warranted in light of ongoing problems with your 
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allergen cross-contact controls, label controls, or supply-chain program, respectively. See the 

discussion in section 11.9.5 regarding reanalysis of your determination regarding allergen 

advisory statements.

11.5.6 Records Documenting the Preventive Control Management 

Components

Part 117 requires that you document the preventive control management components as 

follows: 

• The monitoring of preventive controls in records that are subject to verification and records 

review. (See 21 CFR 117.145(c)(1).) However, part 117 provides flexibility for records of 

monitoring to be “exception records” - i.e., records that you establish only when there is loss 

of control. (See 21 CFR 117.145(c)(2).) See the discussion in section 11.7.5 of an example 

of exception records relevant to a label control.

• All corrective actions (and, when appropriate, corrections) in records that are subject to 

verification and records review. (See 21 CFR 117.150(d).)

• All verification activities in records that are subject to records review. (See 21 CFR 

117.155(b) and 117.165(a)(4).)

11.6 Allergen Cross-contact Controls

11.6.1 Allergen Cleaning Procedures

As discussed in section 11.4.1, your allergen cross-contact controls should complement the 

measures you take to comply with the CGMP requirements of part 117, subpart B for preventing 

allergen cross-contact. In this chapter, we discuss allergen cleaning procedures as an allergen 

cross-contact control19 that can complement the measures that you take to comply with the 

CGMP requirement that all FCSs, including utensils and FCSs of equipment, must be cleaned 

as frequently as necessary to protect against allergen cross-contact. (See 21 CFR 117.35(d).) 

As with all preventive controls, the allergen cleaning procedures must be written. (See 21 CFR 

117.135(b).)

Procedures for monitoring preventive controls also must be written. (See 21 CFR 117.145(a).)

Note that a form that you would use to document a monitoring activity could function as a written 

procedure for the monitoring activity, because the person who conducts the monitoring could 

use the form as a guide for what to monitor. Likewise, if you will establish any written verification 

or corrective action procedures, a form that you would use to document the verification activity 

or corrective actions could function as a written procedure for the verification activity or the 

corrective actions, because the person who conducts the verification activity or is responsible 

19 Alternatively, you could consider such cleaning to be a sanitation control established to satisfy the 

requirements of 21 CFR 117.135(c)(3)(ii). In addition, as already discussed in section 11.4, you could 

consider adapting one or more of the measures for complying with the CGMP requirements to prevent 

allergen cross-contact (e.g., the measures discussed in Appendix 11-1) to function as a preventive control 

by combining a CGMP measure to prevent allergen cross-contact with one or more preventive control 

management components such as monitoring or verifying through, e.g., visual observation, and 

appropriate records.
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for the corrective actions could use the form as a guide for what to verify and the steps to take 

to comply with the requirements for corrective actions.

We recommend that you keep the required written procedures for monitoring the allergen 

cleaning procedures, and any written verification or corrective action procedures that you 

establish for the allergen cleaning procedures, together with your allergen cleaning procedures, 

because doing so would help communicate the overall framework and goals of the allergen 

cleaning procedures. In the remainder of this document, we use the term sanitation standard 

operating procedure (SSOP) to refer to a document that includes all procedures and forms 

applicable to allergen cleaning procedures that you establish and implement as a preventive 

control. 

We recommend that your SSOP for allergen cleaning procedures include the following as 

appropriate to the type of cleaning process (e.g., dry cleaning or wet cleaning) and the design of 

the equipment or utensil to be cleaned:

• The purpose of the cleaning procedure (e.g., its role in preventing allergen cross-contact);

• The frequency of cleaning (e.g., how often the cleaning is to be conducted and the temporal 

relationship to changeover of a production line);

• Who is responsible for performing the cleaning procedure;

• Instructions to perform the specific cleaning procedure, including:

o Types of cleaning agents to be used for specific equipment and utensils;

o Concentration of cleaning agents used in wet cleaning;

o Equipment and tools to be used during the cleaning procedure; and

o Specific instructions for cleaning, such as the sequence of steps and whether 

disassembly of equipment is required;20

• A list of monitoring/verification activities that will be performed and any written procedures 

that you establish for those activities;

• Corrections or corrective actions to take when the cleaning procedure is not properly 

implemented; and 

• Any forms that you will use to document monitoring/verification of the cleaning procedure,

corrections, or corrective actions.

11.6.1.1 Monitoring and Verification for Allergen Cleaning Procedures

As discussed in section 11.5, you have flexibility to apply preventive control management 

components as appropriate to ensure the effectiveness of the preventive controls, and the 

nature of an allergen cross-contact control is such that in some cases an activity could be 

classified as either a monitoring activity or a verification activity, as long as you comply with 

20 For example, in wet cleaning operations a common sequence of operations is Pre-clean (e.g., scraping 

to remove foods), Pre-rinse, Apply detergent and Scour, Post-Rinse, Prepare for Inspection, Pre-op 

Inspection, Sanitize, and Assemble. In dry cleaning operations, where the objective is to minimize the use 

of water in the area to prevent the growth of microorganisms such as Salmonella, tools such as vacuum 

cleaners, brooms, brushes, and wipes are commonly used.
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requirements applicable to monitoring or verification. For example, observing whether an FCS is 

visibly clean generally could be classified as either a monitoring activity or a verification activity.

In other cases, a preventive control management activity for an allergen cross-contact control 

would commonly be considered a monitoring activity rather than a verification activity. For 

example, checking the temperature of water used during a wet cleaning operation generally is 

classified as monitoring. Likewise, in some cases a preventive control management activity for 

an allergen cross-contact control would commonly be considered a verification activity rather 

than a monitoring activity. For example, part 117 classifies calibration as a verification activity

(see 21 CFR 117.165(a)(1)).

You have flexibility to determine what monitoring/verification activities, and how many 

monitoring/verification activities, are appropriate for your operation to ensure the effectiveness 

of the preventive control. (See 21 CFR 117.140(a).) For example, in some cases you could 

determine to monitor the steps of a cleaning process but not verify the cleaning process by 

swabbing surfaces to detect food residues that remain after cleaning. In addition, you can 

classify observations of steps in the cleaning process to be either monitoring or verification. 

However, regardless of whether you classify a specific activity as monitoring or as verification, 

the nature and number of activities you conduct must be adequate to ensure the effectiveness 

of the preventive control. (See 21 CFR 117.140(a)). In addition, you must verify the results of 

that activity by reviewing applicable records. (See 21 CFR 117.165(a)(4).)

In this section of this chapter, we provide a combined list of examples of monitoring and 

verification activities without classifying the activities as either monitoring or verification. See 

section 11.12 for an example of how a manufacturer that establishes and implements an 

allergen cross-contact control could classify specific activities as monitoring or verification 

activities.

The specific activity to be monitored or verified depends on the type of cleaning procedure

(e.g., wet cleaning or dry cleaning). Examples of monitoring and verification activities are:

• Checking the makeup of a cleaning solution (e.g., the amount of cleaning chemical added to 

a specified amount of water or the presence of active ingredient of a cleaning chemical in a 

specified amount of water) in a wet-cleaning operation;

• Recording the date and time of cleaning of equipment during a changeover from an 

allergen-containing product to a product that does not contain that food allergen; 

• Using a checklist to document each step of the cleaning procedure as it is performed;

• Observing each step in the cleaning process as it is being conducted (e.g., by a sanitation 

supervisor);

• Observing that an automatic cycle begins and ends (e.g., when using automatic equipment 

such as a clean-in-place (CIP) system);

• Calibrating an automated cleaning system to ensure appropriate temperatures and cleaning 

agent concentrations if these are critical to removal of the food allergen;

• Observing that the production equipment is visibly clean (e.g., at the end of cleaning or as 

part of a pre-operational inspection just prior to production), taking into account the nature of 

the FCSs (e.g., materials from which the FCSs are constructed);
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• Using rapid ATP (adenosine triphosphate) swabs, protein swabs, or allergen-specific test 

kits to detect food residues that remain after cleaning;21

• Periodically using an allergen‐specific test kit (if one is available for the food allergen(s) of 

interest in the matrix of your food product) to detect the presence of food allergens 

remaining on food‐contact surfaces after cleaning by using swabs or testing final rinse water 

(e.g., the final rinse of a CIP cycle for equipment that is wet cleaned). If your production 

procedure includes a “push-through” technique in which the subsequent product, an inert 

ingredient (such as sugar or salt), or an allergen-containing ingredient (such as flour) that 

will be an ingredient in the subsequent product is pushed through the system to remove 

traces of food residue, you could use test kits to evaluate “push-through” material, or the first 

product through the line, to demonstrate that a food allergen from a previous production run 

has been removed; and

• Reviewing the monitoring/verification records in accordance with 21 CFR 117.165(a)(4).

11.6.1.2 Corrective Actions and Corrections for Allergen Cleaning

Procedures

When cleaning procedures used to control allergen cross-contact have not been properly 

implemented, you must implement corrections or take corrective actions in accordance with 

your corrective action procedures. (See 21 CFR 117.150.) 

• An example of when a correction can suffice is an observation that a CIP system failed to 

maintain its target temperature, if you correct the problem by adjusting the temperature and 

running a complete CIP at the appropriate temperature before beginning production. (See 

21 CFR 117.150(c)(1), which provides that you do not need to take corrective actions if you 

take action, in a timely manner, to identify and correct conditions and practices that are not 

consistent with the allergen cross-contact controls.) 

• An example of when a corrective action is warranted is finding the presence of a food 

allergen during periodic testing of FCSs using an allergen test kit. The detection of the food 

allergen could be an indication either that the cleaning procedure was not properly 

implemented or that the cleaning procedure is not effective at removing the food allergen. In 

such a situation, corrective actions would include:

o Identifying the problem (e.g., determining whether the food residue was detected 

because the cleaning procedure was not properly implemented or because the cleaning 

procedure was not effective);

o Correcting the problem and reducing the likelihood that the problem will recur (e.g., by 

re-training employees in how to use the cleaning procedure or by revising the cleaning 

procedure to improve its effectiveness); and

o Determining whether food is affected and, if so, evaluating that food for safety, and 

ensuring that the food with an unintended allergen does not enter commerce (or that any 

21 Note that ATP tests are considered “non-specific” tests for cleanliness because ATP is found in all 

living cells and its presence could reflect diverse sources such as food, microorganisms, or even human 

skin. ATP tests and other “non-specific” tests (such as tests that would detect any protein rather than a 

specific protein) have the potential to be more sensitive than visual observation but may not be sensitive 

enough to detect levels of a particular allergenic protein.
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such food that has entered commerce is recalled). In determining which food is affected, 

we recommend that you consider all food lots produced from cleanup to cleanup.

We recommend that your corrective action procedures distinguish between those corrective 

actions you would take if you determine that the problem was due to improper implementation of 

the allergen cleaning procedure and those corrective actions you would take if you determine 

that the allergen cleaning procedure is not effective. For example, if an occasional finding of 

product residue on a cleaned FCS leads you to determine that the allergen cleaning procedure 

was not properly implemented, you could limit your corrective action procedures to retraining the 

personnel who conduct the cleaning. However, if repeated findings of product residue on a 

cleaned FCS lead you to determine that the cleaning procedure is not effective, your corrective 

action procedures should include reanalysis of your food safety plan to determine whether to 

revise your allergen cleaning procedures. (See the discussion of reanalysis in section 11.6.1.3.)

11.6.1.3 Reanalysis of Your Allergen Cleaning Procedures

As discussed in section 11.5.5, part 117 includes requirements for you to conduct a reanalysis 

of the food safety plan as a whole, or the applicable portion of the food safety plan, whenever 

you find that a preventive control, combination of preventive controls, or the food safety plan as 

a whole is ineffective, or at least every 3 years. (See 21 CFR 117.170(b)(4).) Reanalysis of your 

allergen cleaning procedures is appropriate if, for example, repeated findings of product residue 

on a cleaned FCS lead you to determine that the cleaning procedure is not effective. 

See the discussions of allergen advisory statements in section 11.9. In some circumstances, 

reanalysis of your allergen cleaning procedures could lead you to conclude that allergen 

advisory statements are appropriate because, despite using appropriate CGMPs and preventive 

controls, residues or allergen cross-contact cannot be avoided.

11.6.1.4 Records Documenting Allergen Cleaning Procedures and 

Applicable Preventive Control Management Components

Your allergen cross-contact controls for cleaning are preventive controls and, thus, you must 

have a record of the allergen cleaning procedures (such as in the SSOP discussed in this

chapter). (See 21 CFR 117.135(b) and 117.126(b)(2).)

Records of monitoring and verification activities may be created manually or automatically (e.g., 

if a computer record is generated automatically when a CIP system is used). For manual 

records, we recommend that you use standardized forms and checklists, as appropriate to the 

activity being monitored or verified, because such forms can help ensure that the activities are 

conducted in a consistent manner.

As noted in section 11.5.6, exception records for monitoring may be adequate in some 

circumstances. (See 21 CFR 117.145(c)(2)(ii).) 

You must document all corrective actions and, as appropriate, corrections. (See 21 CFR 

117.150(d).) To document corrective actions, you would describe the problem, how it was 

corrected (including steps you will take to prevent it from happening again, and the evaluation 

and disposition of any affected food). An example of when it would be appropriate to document 

corrections is when you want to be able to determine patterns that could suggest improvements 

to your procedures. For example, if you use a checklist to monitor whether equipment is clean

during a pre-operational inspection before beginning production, a review of corrections noted 
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on the checklists could help to identify a pattern of problems such that a change to the cleaning 

procedure would be warranted.

All verification activities must be documented. (See 21 CFR 117.155(b).) One way to document

a record review that you conduct to satisfy the requirements of 21 CFR 117.165(a)(4) is for your 

PCQI (or designee) to sign or initial, and date, the primary monitoring, corrective action, and 

verification records.

11.6.2 Allergen Ingredient Procedures

As discussed in section 11.4.1, your allergen cross-contact controls should complement the 

measures you take to comply with the CGMP requirements of part 117, subpart B for preventing 

allergen cross-contact. In this chapter, we discuss allergen ingredient procedures as an allergen 

cross-contact control that can complement the measures that you take to comply with the 

CGMP requirement that raw materials and other ingredients that are food allergens, and rework 

that contains food allergens, be identified and held in a manner that prevents allergen crosscontact. (See 21 CFR 117.80(b)(8).) Allergen cross-contact can result from the unintentional 

addition of the wrong ingredient to a food; allergen ingredient procedures can prevent such 

unintentional addition.

Allergen ingredient procedures could be particularly useful when it is not readily apparent, to 

production personnel or to consumers, that an ingredient is or contains a food allergen. In some 

food products, production personnel add a flavor ingredient such as a seasoning mix to the food 

based on the recipe or formulation of the finished food (e.g., a flavor added to chips), whereas in 

other food products a consumer adds a flavor packet that is provided separately in a packaged 

food product during preparation of that food product. It may not be readily apparent to 

production personnel and consumers in such circumstances that the seasoning mix contains a 

flavor ingredient such as soy.

If your PCQI determines that you must identify and implement allergen ingredient procedures to 

provide assurances that food allergen hazards requiring a preventive control will be significantly 

minimized or prevented and the food manufactured, processed, packed, or held by your facility 

will not be adulterated under section 402 of the FD&C Act, we recommend that you tailor those 

procedures to your facility and your operations. For example, the preventive control, and 

associated monitoring or verification activities, would depend on factors such as where and 

when you transfer ingredients from their original packaging to containers used in production, 

and how you identify ingredients after you have transferred them from their original packaging.

As with allergen cleaning procedures, when allergen ingredient procedures have not been 

properly implemented, you must implement corrections or take corrective actions in accordance 

with your corrective action procedures. (See 21 CFR 117.150).) 

• An example of when a correction can suffice is an observation that the wrong ingredient has 

been brought to the staging or production area before that ingredient is used in production.

(See 21 CFR 117.150(c)(1), which provides that you do not need to take corrective actions if 

you take action, in a timely manner, to identify and correct conditions and practices that are 

not consistent with the allergen cross-contact controls.) 

• An example of when a corrective action is warranted is a determination that an incorrect 

ingredient, containing an allergen not otherwise included as an ingredient of the food, was 

added to the food during production. In such a situation, corrective actions would include:
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o Identifying the problem (e.g., determining whether the allergenic ingredient was added 

because the allergen ingredient procedures were not properly implemented or because 

the allergen ingredient procedures were not effective); 

o Correcting the problem and reducing the likelihood that the problem will recur (e.g., by 

re-training employees in how to use the allergen ingredient procedures or by revising the 

allergen ingredient procedures to improve their effectiveness); and

o Determining whether food is affected and, if so, evaluating that food for safety, and 

ensuring that food with unintended allergen presence (which would not be listed on the 

label) does not enter commerce (or that any such food that has entered commerce is 

recalled).

Reanalysis of your allergen ingredient procedures is appropriate if, for example, repeated 

findings that an allergenic ingredient was unintentionally added to your food product lead you to 

determine that the allergen ingredient procedures are not effective.

As with all preventive controls, the allergen ingredient procedures and any associated 

monitoring procedures must be written. (See 21 CFR 117.135(b) and 117.145(a).)

11.7 Label Controls

11.7.1 Preventive Controls for the Content of the Product Label and for 

Managing Labels

To ensure that a finished food is not misbranded under section 403(w) of the FD&C Act, we 

recommend that your label controls provide assurance that:

• The product label correctly names the food source of all ingredients that are, or contain, a 

major food allergen in the manner described by the allergen labeling requirements of the 

FD&C Act and includes all ingredients that are, or contain, a major food allergen; and

• The correct label is applied to the correct product in that the label applied to the product 

during production matches the ingredient specifications (i.e., in the recipe or formulation) of 

the product being manufactured/processed.

To do so, we recommend that you establish and implement label controls and associated 

preventive control management components for:

• The content of the product label at the following stages:

o Development of labels; 

o Ordering labels; 

o Production of labels; and

o Receipt of labels.

22

• Managing printed labels, including storage, use, and disposition of product labels at the 

following stages:

o Storage of labels; 

22 At some stages, such as receipt of labels, it is likely that you would monitor or verify a label control 

established at an earlier stage, e.g., production of labels, rather than establish a label control.
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o Food production (including staging and packaging/labeling); and

o Post-production. 

In this chapter, we provide separate recommendations for “label content controls” and “label 

management controls.” However, we do so solely as an organizational tool for presenting our 

recommendations for how to use label controls to prevent food from being misbranded under 

section 403(w). In your food safety plan, label content controls and label management controls 

will be very inter-related, and it makes no difference whether you classify your label control as a 

label content control or a label management control. In addition, in some cases you could have 

two label controls (i.e., one for label content and another for label management), with a single 

monitoring/verification activity, documented by a single record, for both label controls. Thus, 

when you tailor this guidance for your operations you may find it more useful to classify a label 

control in a different manner than we do in this chapter, and to have fewer 

monitoring/verification activities, and fewer records, than the activities and records that we 

describe in this chapter. Our purpose is to provide as many examples as possible so that you 

can develop your own food allergen program as appropriate to your operations, not to imply that 

a food allergen program should have all the controls, monitoring/verification activities, and 

records that we describe for illustrative purposes.

We recommend that you apply such label controls to pre-printed labels that you receive, as well 

as to labels that you generate yourself, regardless of whether the product label is a label that 

you would apply to the packaged food product or is pre-printed on the package itself.

You are required to have written procedures for your label controls23 and for monitoring your 

label controls. (21 CFR 117.135(b) and 117.145(a).) We recommend that you organize any 

written procedures for controls on the content of the product label in a manner that will help 

communicate the overall framework and goals of these controls. For example, you could 

organize your procedures that address development of labels, ordering labels, production of 

labels, and receipt of labels, and associated preventive control management components (such 

as monitoring procedures), in a single document, or collect them in one file or folder. In this 

document, we refer to such procedures as the “Label Content Procedures.”

Likewise, we recommend that you organize any written procedures for controls for the 

management of product labels/packages, and for associated preventive control management 

components (such as monitoring procedures), in a single document, file or folder, because 

doing so will help communicate the overall framework and goals of these controls. In this 

document, we refer to such procedures as the "Label Management Procedures.”

As with allergen cross-contact controls, a form that you would use to document a monitoring 

activity could function as a written procedure for the monitoring activity, because the person who 

conducts the monitoring could use the form as a guide for what to monitor. Likewise, if you will 

establish any written verification or corrective action procedures, a form that you would use to 

document the verification activity or corrective actions could function as a written procedure for 

the verification activity or the corrective actions, because the person who conducts the 

verification activity or is responsible for the corrective actions could use the form as a guide for 

what to verify and the steps to take to comply with the requirements for corrective actions.

23 The requirement for you to have written procedures for your preventive controls applies even if a third 

party helps you to establish and implement those written procedures.
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11.7.1.1 Label controls for the content of the product label

11.7.1.1.1 Label development stage

You can develop the product label yourself or you can arrange for a third party (e.g., a label 

design specialist or company) to develop the product label. Complete label content 

requirements are beyond the scope of this chapter; the focus here is the labeling related to food 

allergens. Examples of what your Label Content Procedures could address at the label 

development stage are:

• Procedures for developing the food allergen label specification for the product label to 

ensure that the finished food will not be misbranded under section 403(w) of the FD&C Act, 

such as:

o Identifying the allergenic ingredients (e.g., peanuts) in the product specification (i.e., the 

recipe or formulation);

o Identifying any allergenic components in the raw materials and other ingredients 

obtained from a supplier, e.g.:

 If a spice blend you will add as an ingredient has a milk-derived component; or 

 If your supplier provides an allergen advisory statement for an ingredient you receive 

from that supplier and your PCQI determines and documents that an allergen 

advisory statement should be carried through on any of your own products; and

o Your approach (e.g., through the ingredient statement or through a “Contains”

statement) to satisfying the allergen labeling requirements of the FD&C Act to name the 

food source of any major food allergen that is:

 An ingredient of your food product; or 

 An allergenic component of an ingredient in your food product; and

o When applicable, your PCQI’s:

 Written justification for why allergen cross-contact controls cannot ensure protection 

of food from allergen cross-contact during manufacture of your food product and, 

thus, that allergen advisory statements are appropriate (see section 11.9.2); and 

 Written determination regarding your approach to allergen advisory statements when 

a supplier provides an allergen advisory statement for an ingredient that you use in a 

food product (see section 11.9.3).

• When useful for your operation, the use of an identity coding system for printed labels and 

packages (e.g., color codes that are easy to visualize, such as colored striping on labels that 

will be stacked flat in packaging machines). The utility of such an identity coding system 

largely depends on the nature of the package/label and the packaging/labeling operation. 

11.7.1.1.2 Ordering stage for labels

If you will order pre-printed product labels (or packages that contain pre-printed product labels) 

from a vendor, examples of what your Label Content Procedures could address at the ordering 

stage are:
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• Specifying in the written purchase document the specific text of the food allergen label

specification to satisfy the allergen labeling requirements of the FD&C Act to name the food 

source of any ingredients that are, or contain, a major food allergen; 

• Specifying in the written purchase document that “proofs” or samples of product labels need 

to be provided for your review before you authorize the initial production run of pre-printed 

product labels; and

• Specifying in the written purchase document any necessary procedures to minimize the 

potential for commingling product labels for different products. For example, one such 

procedure is to use separate pallets for labels for different products, where practical.

Alternatively, a copy of the label could be pasted on the outside of each box of labels or 

packages. 

11.7.1.1.3 Label production stage for labels that you generate 

If you will use computer-generated product labels that you print yourself, examples of what your 

Label Content Procedures could address at the label production stage for the computergenerated labels are procedures for:

• Checking that the correct electronic file for the label is used; and 

• Limiting the number of personnel who are authorized to edit electronic files for product 

labels.

11.7.1.2 Label controls for managing product labels/packages

11.7.1.2.1 Storage stage

Examples of what your Label Management Procedures could address at the storage stage are 

procedures for:

• Avoiding commingling of product labels/packages for different products (e.g., on pallets or 

shelves where you store labels that you receive or that you generate yourself); 

• Posting a copy of the product labels on the storage bins or shelves where they are stored; 

and

• Timely disposal of out-of-date product labels/packages. 

11.7.1.2.2 Production (staging) stage

Examples of what your Label Management Procedures could address at the production 

(staging) stage are procedures for:

• Checking a sample of the product label (or product package, if the label is pre-printed on the 

product package) to ensure that it is the correct label/package for the product before placing 

a roll or stack of labels or packaging with pre-printed labels in the staging area; and
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• Ensuring that either the only labels in the product labeling/packaging area are for the 

product being placed in a package at that time, or that the labels/packaging are 

appropriately identified or aligned so they will only be transferred to the appropriate 

production line.

11.7.1.2.3 Post-production stage

Examples of what your Label Management Procedures could address at the post-production 

stage are procedures for removing from the packaging line and appropriately storing unused 

packaging and labels after a production run is complete, including ensuring that product 

labels/packages are switched appropriately at product changeover.

11.7.2 Monitoring and Verification for Label Controls

As with an allergen cross-contact control, you have flexibility to apply preventive control 

management components as appropriate to ensure the effectiveness of the preventive controls, 

and the nature of a label control is such that in some cases a preventive control management 

component for a label control could be classified as either a monitoring activity or a verification

activity, as long as you comply with requirements applicable to monitoring or verification. For 

example, checking a product label/package that you receive from a supplier against your food 

allergen label specification generally could be classified as either a monitoring activity or a 

verification activity. Thus, if you conduct such a check you could classify this check as 

“monitoring” the content of the product label, or you could classify this check as “verifying” the 

content of the product label. 

In other cases, a preventive control management activity for a label control would commonly be 

considered a monitoring activity rather than as a verification activity. For example, checking that 

the correct label/package is being applied/used during a production run generally is classified as 

a monitoring activity. In some cases a preventive control management activity for a label control 

would commonly be considered a verification activity rather than a monitoring activity. For 

example, part 117 classifies review of records as a verification activity (see 21 CFR 

117.165(a)(4)).

You have flexibility to determine what monitoring/verification activities, and how many

monitoring/verification activities, are appropriate for your operation to ensure the effectiveness 

of the preventive control. (See 21 CFR 117.140(a).). For example, in some cases you could 

determine to monitor that labels/packages brought to the staging area are the correct 

labels/packages for the product by visually checking the labels/packages, but not verify this 

label control (such as by using a barcode scanner to confirm that the correct label/package is 

applied to/used for the correct product). In addition, you could classify visual checks and use of 

a barcode scanner to be either monitoring or verification as long as you comply with 

requirements applicable to monitoring or verification. However, regardless of whether you 

classify a specific activity as monitoring or as verification, the nature and number of activities

you conduct must be adequate to ensure the effectiveness of the preventive control. (See 21 

CFR 117.140(a)). In addition, you must verify the results of that activity by reviewing applicable 

records. (See 21 CFR 117.165(a)(4).)

In this section of this chapter, we provide a combined list of examples of monitoring and 

verification activities without classifying the activities as either monitoring or verification. See

sections 11.12.3.2 and 11.13.3.2 for examples of how manufacturers that establish and 

implement label controls could classify specific activities as monitoring or verification.
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11.7.2.1 What to monitor or verify for a label control

11.7.2.1.1 Label content

To monitor or verify the content of the product label, we recommend that you confirm that a 

product label/package that you receive from a label supplier, or that you generate yourself:

• Satisfies the food allergen label specification that you developed for the product; and

• Is the correct label/package for a particular product with a particular ingredient specification 

(i.e., recipe or formulation).

11.7.2.1.2 Label management

To monitor or verify the management of product labels/packages, we recommend that you 

confirm that the correct label/package is applied to/used for the correct product. 

11.7.2.2 How to monitor or verify a label control

11.7.2.2.1 Label content

To monitor or verify the content of the product label/package, we recommend that you put a 

hold on product labels/packages that you receive, or the product labels that you generate 

yourself, until you compare them to your food allergen label specification by manually inspecting

product labels/packages to:

• Reconcile allergen-related label information on the product label (i.e., declaration of 

ingredients and name of the food source of allergenic ingredients and allergenic 

components of ingredients) with the food allergen label specification; and

• Determine whether other specifications (e.g., for color coding related to allergen control) are

satisfied.

11.7.2.2.2 Label management

To monitor or verify the management of product labels/packages, we recommend that you:

• Visually check that labels/packages brought to the staging area are the correct 

labels/packages for the product; and

• Use a barcode scanner to confirm that the correct label/package is applied to/used for the 

correct product when doing so is practical for your operation. Alternatively, you could 

manually confirm that the correct label/package is applied to/used for the correct product. 
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11.7.2.3 How often to monitor or verify a label control

11.7.2.3.1 Label content

We recommend that you monitor or verify the content of the product label before you use it for 

production by comparing the product labels/packages to your food allergen label specification at 

one or more of the following stages24: 

• Upon receipt of the label (or, for labels that you generate yourself, soon after you print the 

labels); 

• Before new batches of labels are released for use during production; or

• Immediately prior to production.

11.7.2.3.2 Label management

• We recommend that you visually check that labels/packages brought to the staging area (or 

directly to the processing line) are the correct labels/packages for the product during staging 

or immediately prior to production.

• When confirming that the correct label is applied to/used for the correct product, we 

recommend that you:

o Do so at the beginning of production, and each time that new labels/packages are 

brought to the production line, if you monitor or verify by manual inspection; or

o Monitor or verify continuously during production if the barcode scanner scans 

continuously, or at regular intervals if you manually operate the barcode scanner or 

manually confirm that the correct label/package is applied to/used for the correct product

(e.g., 1-, 2-, or 4-hour intervals).

11.7.2.4 Who monitors or verifies a label control

11.7.2.4.1 Label content

• The personnel who compare the product labels/packages to your food allergen label 

specification depend, in part, on when the confirmation takes place (e.g., upon 

receipt/printing; before new batches of labels are released for production; or immediately 

prior to production) (see section 11.7.2.3). Note that individuals who manufacture, process, 

pack, or hold food must be qualified to perform their assigned duties (21 CFR 117.4).

Immediately below, we list some examples of personnel positions that could conduct 

monitoring/verification activities; this list is not exhaustive. Although a supervisor could be 

appropriate (e.g., for a large operation), non-supervisory personnel with appropriate 

qualifications could also be appropriate. In addition, when we identify a “team” we do so for 

illustrative purposes rather than to recommend that you organize your personnel into such 

teams.

24 The action of confirming the content of the product label before you use it for production is more 

important than the timeframe of when you confirm the content of the product label. We note that

confirming the content of the product label upon receipt/printing can save you down time if you discover a 

problem before you are ready to use the labels in a production run.
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o Personnel who have responsibility for operations such as receiving, quality assurance, 

or regulatory affairs (e.g., for label compliance) could confirm the food allergen 

specification of the product label/package upon receipt from the supplier of the 

labels/packages. 

o Personnel such as the supervisor (or other qualified representative) of the Label 

Production Team, and personnel with responsibility for operations such as quality 

assurance or regulatory affairs (e.g., for label compliance) could confirm the food 

allergen specification of a product label that you generate yourself after printing 

production labels. 

o Personnel such as the supervisor (or other qualified representative) of the Label 

Production Team, or personnel with responsibility for operations such as quality 

assurance or regulatory affairs (e.g., for label compliance) could confirm the food 

allergen specification of the product label/package before new batches of labels are 

released for production. 

o Personnel such as the line operator could confirm the food allergen specification of the 

product label/package immediately prior to production. 

11.7.2.4.2 Label management 

• Personnel such as the line operator or supervisor, the production supervisor, and quality 

control personnel could confirm the check of the product labels/packages. 

• When confirming that the correct label is applied to/used for the correct product: 

o Personnel such as the line operator or supervisor, the production supervisor, and quality 

control personnel could conduct the monitoring or verification activity if you confirm by 

manual inspection or manual operation of a barcode scanner. 

o The scanner does the monitoring or verification activity if you confirm using a continuous

barcode scanner. 

11.7.3 Corrective Actions/Corrections for Label Controls

When a label control has not been properly implemented, you must implement corrections or 

take corrective actions in accordance with your corrective action procedures. (See 21 CFR 

117.150.) 

• Examples of when a correction can suffice are:

o Label content. Determining that the content of a product label/package is incorrect with 

respect to the allergen labeling requirements of the FD&C Act before using the 

label/package in production. If you correct the label before using it such that no food is 

affected, you could consider the problem to be a minor and isolated problem that does 

not directly impact product safety as specified by 21 CFR 117.150(c)(2). 

o Label management. An observation that the incorrect label/package was brought to the 

staging area. If you correct the problem by returning the incorrect label/package to 

storage so that it is not used to label/package food, and bringing the correct 

label/package to the staging area before production begins, you could consider that the 

problem is a minor problem that does not directly impact product safety as specified in 

21 CFR 117.150(c)(2), unless the problem is a recurring problem. The provisions of 21 
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CFR 117.150(c)(2) for corrections apply to isolated problems rather than recurring 

problems; in contrast, corrective actions are appropriate for problems that affect food 

safety or recur frequently and include identifying the cause of the problem and taking

steps to prevent the problem from happening in the future. 

• Examples of when a corrective action is warranted are:

o Label content. Determining that the content of a product label/package is incorrect with 

respect to the allergen labeling requirements of the FD&C Act after using the 

label/package in production. Because an incorrect label with respect to the allergen 

labeling requirements of the FD&C Act would misbrand the food under section 403(w) of 

the FD&C Act, the incorrect label content is not a minor problem as specified by 21 CFR 

117.150(c)(2). In such a situation, corrective actions would include:

 Identifying the problem (e.g., by asking the label supplier (or, for labels generated inhouse by talking to the person who generated the labels) to determine what went 

wrong); 

 Correcting the problem and reducing the likelihood that the problem will recur (e.g., 

by reviewing the supplier’s corrective actions and by making appropriate changes to 

your Label Content Procedures25); and 

 Evaluating the product for safety in the same manner as for a corrective action for a 

problem with the label management control. (See corrective actions for a problem 

with label management immediately below.)

o Label management. Determining that an incorrect label (with respect to the allergen 

labeling requirements of the FD&C Act) was applied to a food product (e.g., a label for a 

different product, with a different food allergen profile, was applied), or that food was 

placed in an incorrect package (in that the product label on the package does not satisfy 

the allergen labeling requirements of the FD&C Act), during a production run. Because 

an incorrect label would misbrand the food under section 403(w) of the FD&C Act, the 

problem would not be a minor problem as specified in 21 CFR 117 117.150(c)(2). In 

such a situation, corrective actions would include:

 Identifying the problem (e.g., by determining whether the incorrect label was brought 

to the production line); 

 Correcting the problem and reducing the likelihood that the problem will recur (e.g., 

by revising the procedure for checking that the correct label/package has been 

brought to the staging area, or re-training personnel); 

 Ensuring that any food with an incorrect label does not enter commerce – e.g., by reworking the food product, re-labeling the food product, re-packaging the food product

with a correct label, diverting the food product to animal food (usually for animals 

other than pets)26, or destroying the food product; and

 Recalling food with an incorrect label if the food has already entered commerce. 

25 If you fail to identify an incorrect label until after it is used in production, you should also review your 

Label Management Procedures. 26 FDA is developing guidance on the use of human food by-products in animal food, including diversion 

of human food products to animal food use. In 2016, FDA issued for public comment a draft guidance for 

industry entitled “Human Food By-Products For Use As Animal Food” (see Table 11-7 and 81 FR 58521, 

August 25, 2016). In determining whether it is appropriate to divert a food product to animal food use, we 

recommend that you consult the final guidance on this subject when it becomes available.
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11.7.4 Reanalysis for Label Controls

As discussed in section 11.5.5, part 117 includes requirements for you to conduct a reanalysis 

of the food safety plan as a whole, or the applicable portion of the food safety plan, whenever 

you find that a preventive control, combination of preventive controls, or the food safety plan as 

a whole is ineffective. (See 21 CFR 117.170(b)(4).) Reanalysis of your label controls is 

appropriate if, for example, you have recurring problems with your label content controls or label 

management controls.

11.7.5 Records Documenting the Label Controls and Applicable Preventive 

Control Management Components

Your Label Content Procedure and Label Management Procedure are preventive controls and, 

thus, you must have a record of those procedures. (See 21 CFR 117.135(b) and 21 CFR 

117.126(b)(2).)

Records of monitoring and verification activities may be created manually or automatically (e.g., 

if a computer record is generated automatically when you use a barcode scanner). For manual 

records, we recommend you use standardized forms and checklists, as appropriate to the 

activity being monitored or verified, because such forms can help ensure that the activities are 

conducted in a consistent manner.

As noted in section 11.5.6, exception records for monitoring may be adequate in some 

circumstances. (See 21 CFR 117.145(c)(2)(ii).) For example, if you use an automated barcode 

scanner to monitor that the correct label is applied to/used for the correct product, it may be 

adequate to generate exception records when the scanner detects that the wrong label is 

applied to the product. Alternatively, a checklist that you include in a production record could 

document that you conducted the monitoring, with exception records for any observed

nonconformance. For example, you could use a checklist to document that you monitor product 

labels to reconcile allergen-related label information on the product label with the ingredient 

specifications (i.e., the recipe or formulation) of the food product and generate exception 

records for those instances when you determine that the label content was incorrect with 

respect to the label specification.

You must document all corrective actions and, as appropriate, corrections. (See 21 CFR 

117.150(d).) If an incorrect label is applied to a product, you would document the corrective 

actions you take. An example of when it could be appropriate to document corrections is when 

you notify a supplier that a “proof” of a product label does not match the food allergen label 

specification, because review of such records could demonstrate whether a particular supplier 

has consistent problems in satisfying the food allergen label specification during label 

development.

All verification activities must be documented. (See 21 CFR 117.155(b).) One way to document

your record review is for your PCQI (or designee) to sign or initial, and date, the primary 

monitoring, corrective action, and verification records.
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11.8 Supply-Chain Program

11.8.1 Regulatory Framework for the Supply-Chain Program

A receiving facility must establish and implement a risk-based supply-chain program for those 

raw materials and other ingredients for which the receiving facility has identified a hazard 

requiring a supply-chain-applied control. (See 21 CFR 117.405(a)(1).) A supply-chain program 

must include using approved suppliers and conducting appropriate supplier verification 

activities.27 (See 21 CFR 117.410.) When a hazard that requires a supply-chain applied control 

is a SAHCODH hazard (i.e., a hazard for which there is a reasonable probability that exposure 

to the hazard will result in serious adverse health consequences or death to humans (e.g., when 

a recall of a violative product is designated as “Class 1” under 21 CFR 7.3(m)(1))), an audit is 

required as a supplier verification activity in most circumstances, before using the raw material 

or other ingredient from the supplier and at least annually thereafter. (See 21 CFR 

117.430(b)(1).)28 Reactions to a food allergen can be severe (e.g., anaphylaxis that can lead to

cardiovascular collapse and death) (Taylor and Hefle, 2001; Boyce et al., 2010) and, thus, there 

is a reasonable probability that exposure to a food allergen hazard will result in serious adverse 

health consequences or death to humans. Therefore, in most circumstances29, a food allergen 

hazard will be a SAHCODH hazard and generally an annual audit will be required as a supplier 

verification activity. However, see the discussion in section 11.8.3.2 regarding circumstances 

when it might be appropriate for your PCQI to use the flexibility provided in 21 CFR 

117.430(b)(2) to make a written determination that other verification activities and/or less 

frequent onsite auditing of the supplier provide adequate assurance that the hazards are 

controlled.

In some cases, a supplier of a raw material or other ingredient that is, or contains, a food 

allergen would also be controlling other hazards that require a supply-chain applied control. For 

example, if your supplier dry roasts tree nuts, including almonds that you would use to make 

trail mix, your supplier would be controlling the biological hazard Salmonella in the almonds. In 

such a circumstance, your supply-chain program would address Salmonella hazards as well as 

food allergen hazards. See part 117, subpart G for the complete requirements for a supplychain program and Chapter 15 for comprehensive guidance on how to comply with the 

requirements of part 117, subpart G. 

11.8.2 When to Establish and Implement a Supply-chain Program as a 

Preventive Control for a Food Allergen Hazard 

We recommend that you:

• Discuss the food allergen profile of a potential supplier’s products during your initial 

consultation with the potential supplier (e.g., during a telephone conversation, or as part of 

any questionnaire that you use for initial consultations with potential suppliers); and 

27 See Table 11-8 for our website “Firm/Supplier Evaluation Resources for FSMA Rules.”

28 The requirement for an annual onsite audit does not apply if there is a written determination by the 

PCQI that other verification activities and/or less frequent onsite auditing of the supplier provide adequate 

assurance that the hazards are controlled. (See 21 CFR 117.430(b)(2).)

29 Undeclared major food allergens that have been known to cause fatal reactions are generally classified 

as Class I recalls. FDA considers each situation on a case-by-case basis when determining the 

appropriate recall classification.
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• Establish and implement a supply-chain program for the control of food allergen hazards if it 

is reasonably foreseeable that the food allergen profile(s) of food products produced by a 

potential supplier could lead to allergen cross-contact in raw materials or other ingredients 

that you would receive from that supplier. 

The nature and extent of your supply-chain program would depend on the food allergen profile 

of the potential supplier’s products (e.g., the severity of the hazard if allergen cross-contact were 

to occur, and whether the allergen cross-contact is likely to be extensive (such as when an

allergen present due to cross-contact could be distributed homogeneously in the product30) or 

limited (such as when an allergen present due to cross-contact is more likely to be distributed 

non-homogeneously31)) and the food allergen program in place at the supplier (including CGMP 

measures and preventive controls for allergen cross-contact). See the discussion in section

11.8.3 of examples of supplier approval and verification activities in supply-chain programs that 

depend on such factors. 

In general, we see no reason for you to establish and implement a supply-chain program for the 

control of food allergen hazards if:

• You will receive a raw material or other ingredient from a supplier that does not 

manufacture, process, or pack any food allergens; or

• You will receive a raw material or other ingredient that is (or contains) a food allergen from a 

supplier, and that food allergen is the only food allergen that the supplier 

manufactures/processes. For example, if the supplier is an almond handler that 

manufactures/processes almonds, but does not manufacture/process other tree nuts, or 

other foods (such as milk products, soy products, or peanut butter) that are, or contain, a 

food allergen, there would be no need to evaluate whether the supplier has appropriate 

procedures in place to prevent allergen cross-contact between foods with different food 

allergen profiles.

11.8.3 Supplier Approval and Supplier Verification Activities in a SupplyChain Program for the Control of Food Allergen Hazards

11.8.3.1 Evaluating whether a potential supplier provides allergen 

advisory statements for raw materials or other ingredients that you would 

receive from the supplier before approving the supplier

As discussed in section 11.9.3, we recommend that your supplier approval and verification 

activities include an evaluation of whether a potential supplier provides allergen advisory 

statements for raw materials and other ingredients that you would receive from the potential 

supplier. When a potential supplier would provide an allergen advisory statement on the 

applicable raw materials or other ingredients, we recommend that you discuss the reasons for 

the allergen advisory statement with the potential supplier before approving the supplier. You 

should approve a supplier that provides allergen advisory statements for its products only if you 

30 Liquid milk and liquid soy (such as in a soy beverage) are examples of allergens that could be 

distributed homogeneously. 

31 Pieces of tree nuts and peanuts are examples of allergens likely to be distributed non-homogeneously.
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determine that such statements are not being used in lieu of adherence to CGMPs or in lieu of 

adherence to the requirements for allergen cross-contact controls.

11.8.3.2 Determining the appropriate supplier approval and verification 

activities

As noted in section 11.8.1, most food allergen hazards are SAHCODH hazards and, thus, an 

annual audit will be the appropriate supplier approval and verification activity in most 

circumstances when you establish and implement a supply-chain program for a food allergen 

hazard. (See 21 CFR 117.430(b)). However, the PCHF requirements provide flexibility for your 

PCQI to provide a written determination that other verification activities and/or less frequent

onsite auditing of the supplier provide adequate assurance that the hazards are controlled. (See 

21 CFR 117.430(b)(2).) See Table 11-4 for some examples of appropriate supplier approval and 

verification activities in various circumstances. 

If your supplier provides allergen advisory statements for the raw materials or other ingredients 

that you receive from the supplier, product testing for the food source that is the subject of the 

allergen advisory statements can provide you with information about the frequency with which 

the applicable food allergen is present in the raw materials or other ingredients that you receive 

and, when the food allergen is present, about the levels of the applicable food allergen. If your 

PCQI will use the results of product testing as part of a determination of whether to carry an 

allergen advisory statement forward to your own food products, we recommend that you 

conduct such testing on multiple lots of the applicable raw material or other ingredient as part of 

your supplier approval process, and then periodically as an ongoing supplier verification activity 

to confirm the PCQI’s determination about whether to carry a supplier’s allergen advisory 

statement forward to your own food products. In developing your sampling plan for testing an 

individual lot, you should consider factors such as whether the food being sampled is 

homogeneous or non-homogeneous and whether a food allergen that is present due to allergen 

cross-contact is likely to be distributed homogeneously or non-homogeneously. 

If your supplier does not provide allergen advisory statements for the raw materials or other 

ingredients that you receive from the supplier, but the information you obtain, through your 

supply chain program, about your supplier’s food allergen program suggests that the potential 

for allergen cross-contact in raw materials or other ingredients obtained from that supplier is 

moderate or high, then periodic testing of the applicable raw material or other ingredient is an 

example of an ongoing supplier verification activity to verify that food from a supplier producing 

foods with different food allergen profiles has been protected from allergen cross-contact. Due 

to limitations in product testing, testing that you conduct as a supplier approval or verification 

activity should be in addition to other supplier approval and verification activities rather than the 

sole supplier approval and verification activity. You could conduct this testing yourself or request 

that your supplier have such testing conducted and provide you with a Certificate of Analysis 

(COA). The frequency of such testing could vary with the potential that the ingredient would not 

be protected from allergen cross-contact. For example, if a supplier that processes food 

products with different food allergen profiles on the same processing line combines scheduling, 

allergen cleaning procedures, and frequent verification testing in its food safety plan, your PCQI 

could determine that annual testing is appropriate. However, if a supplier that processes food 

products with different food allergen profiles on the same processing line does not do 

verification testing, more frequent testing (such as monthly or quarterly) could be appropriate. 

As discussed in section 11.3, FDA has not established a maximum amount of food allergen that 

may be present in labeled food products without need for declaration. However, FDA recognizes 
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that published data on population threshold dose responses to various food allergens are 

becoming increasingly available. These published data raise the possibility that some low-level 

exposures to certain food allergens, and the presence of certain allergen-derived ingredients, 

may not cause allergic reactions in most consumers who have that food allergy. Because food 

manufacturers/processors could evaluate such data in light of their specific products, such as 

through risk assessments or other scientifically valid scientific assessments, in making decisions 

on appropriate food allergen controls, where Table 11-4 mentions the results of testing we are 

referring merely to the detection of unintended allergen presence and not the level of the 

unintended food allergen. As discussed in sections 11.8.4 and 11.9.2, your PCQI has the 

responsibility to determine the appropriate approach to the potential presence in your food 

product of a food allergen from a food source that is not already an ingredient in that food 

product. 
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Table 11-4 Examples of Supplier Approval Activities and Ongoing Supplier Verification Activities

Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Vegan caramel 

chips that do not 

have any 

allergenic 

ingredients

Milk The supplier uses separate processing lines for vegan caramel

chips and caramel (or other) chips that contain milk. 

Low, because the supplier 

uses different processing 

lines for vegan caramel

chips and caramel (and 

other) chips that contain 

milk. Therefore, the 

supplier does not use 

allergen advisory

statements. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s 

“Firm/Supplier Evaluation 

Resources” web page

(see Table 11-8)

- Onsite audit 

- Annual Certificate of 

Conformance that the supplier 

continues to use separate 

processing lines for vegan 

caramel chips and caramel 

(and other) chips that contain 

milk. 

- Supplier audit every 3 years.

Vegan caramel

chips that do not 

have any 

allergenic 

ingredients

Milk - The supplier uses the same processing line for vegan 

caramel chips and caramel (and other) chips that contain milk. 

- Supplier’s allergen cross-contact controls and verification 

testing:

- The supplier schedules production of vegan caramel 

chips before production of caramel (and other) chips that 

contain milk.

- Before production of vegan caramel chips, the supplier’s 

allergen cleaning procedures include scrape-down of 

accessible surfaces and push-through (e.g., in piping) 

with vegan caramel, with the push-through material used 

as re-work in the production of caramel products that 

contain milk. 

- During development of the food safety plan, verification 

testing of vegan caramel chips consistently is negative 

whenever verification testing of FCSs of the chip 

depositor is negative.

- During production, the supplier routinely verifies the 

allergen cleaning by testing FCSs of the chip depositor 

for the presence of milk allergen, with repeat cleaning if 

necessary. 

Moderate, because the 

supplier uses the same 

processing line for vegan 

caramel chips and caramel 

(and other) chips that 

contain milk. However, the 

supplier combines 

scheduling, allergen 

cleaning procedures, 

verification testing, and 

repeat cleaning in its food 

safety plan. The supplier 

does not use advisory 

labeling because the 

verification testing during 

development of its food 

safety plan demonstrates 

that vegan caramel chips 

do not contain milk allergen 

whenever verification 

testing of the chip depositor 

is negative, and the 

supplier routinely verifies 

the cleaning by testing the 

chip depositor, with repeat 

cleaning as necessary.

- Questionnaire about 

food allergen control 

practices

- Search FDA’s 

“Firm/Supplier Evaluation

Resources” web page

(see Table 11-8)

- Onsite audit

- Test several shipments 

of vegan caramel chips

- Annual onsite audit

- Periodic testing of shipments 

of vegan caramel chips (e.g., 

quarterly or every 5th lot) 
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Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Vegan caramel

chips that do not 

have any 

allergenic 

ingredients

Milk - The supplier uses the same processing line for vegan 

caramel chips and caramel (and other) chips that contain milk. 

- Supplier’s allergen cross-contact controls and verification 

testing:

- The supplier schedules production of vegan caramel 

chips before production of caramel (and other) chips that 

contain milk.

- Before production of vegan caramel chips, the supplier’s 

allergen cleaning procedures include scrape-down of 

accessible surfaces and push-through (e.g., in piping) 

with vegan caramel, with the push-through material used 

as re-work in the production of caramel products that 

contain milk.

- During development of the food safety plan, verification 

testing of vegan caramel chips periodically is positive.

- The supplier samples and tests every lot for milk allergen 

and discards or reworks any lots of vegan caramel chips 

that contain milk into caramel products that contain milk.

- The supplier provides customers with a COA 

documenting negative test results for every lot. 

Moderate, because the 

supplier uses the same 

processing line for vegan 

caramel chips and caramel 

(and other) chips that 

contain milk. However, the 

supplier combines 

scheduling, allergen 

cleaning procedures, and 

verification testing of every 

lot in its food safety plan. 

The supplier does not use 

allergen advisory 

statements because only 

those lots of vegan caramel 

chips that are negative for

milk allergen are 

distributed. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s 

“Firm/Supplier Evaluation 

Resources” web page

(see Table 11-8)

- Onsite audit

- Test several shipments 

of vegan caramel chips

for milk

- Annual onsite audit

- Annual sampling and testing 

(as verification of the supplier’s 

sampling and testing of every 

lot)
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Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Vegan caramel

chips that do not 

have any 

allergenic 

ingredients

Milk - The supplier uses the same processing line for vegan 

caramel chips and caramel (and other) chips that contain milk. 

- Supplier’s allergen cross-contact controls and verification 

testing:

- During development of the food safety plan, the supplier 

assessed multiple cleaning practices for efficacy in 

preventing allergen cross-contact, but regardless of 

which cleaning practice was used verification test results 

were periodically positive for unintended milk presence 

on FCSs on the chip depositor and in vegan caramel

chips. 

- The supplier concludes that its verification testing during 

development of the food safety plan demonstrates that 

its cleaning is not always able to protect the vegan 

caramel chips from allergen cross-contact. 

- The supplier’s PCQI provides a written justification, in the 

supplier’s food safety plan, for why allergen crosscontact controls are not always able to ensure protection 

of food from allergen cross-contact; 

- The supplier’s labeling for the applicable food product(s) 

includes allergen advisory statements that disclose the 

possible unintended allergen presence in the food; and, 

- Because the supplier provides allergen advisory 

statements, the supplier does not routinely do 

verification testing of either the FCSs on the chip 

depositor or the vegan caramel chips.

High. The supplier uses 

allergen advisory 

statements because it uses 

the same processing line 

for vegan caramel chips 

and non-vegan caramel 

(and other) chips that 

contain milk, and its 

verification testing during 

development of the food 

safety plan demonstrates 

that its cleaning is not 

always able to protect the 

vegan caramel chips from 

allergen cross-contact. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s 

“Firm/Supplier Evaluation 

Resources” web page

(see Table 11-8)

- Onsite audit

- Test multiple lots for the 

frequency and level of 

detectable milk as part of 

the PCQI’s determination 

of whether to carry an 

allergen advisory 

statement forward 

- Annual onsite audit

- If an allergen advisory 

statement is carried forward,

annual sampling and testing of 

vegan caramel chips for the 

frequency and level of 

detectable milk to confirm the 

results obtained during supplier 

approval and determine 

whether to conduct reanalysis: 

- Of the PCQI’s 

determination to carry 

forward an allergen 

advisory statement, and

- To re-evaluate the 

supplier. 

- If an allergen advisory 

statement is not carried 

forward, monthly sampling and 

testing of vegan caramel chips 

for the frequency and level of 

detectable milk to confirm the 

results obtained during supplier 

approval and determine 

whether to conduct reanalysis: 

- Of the PCQI’s 

determination to not carry 

forward an allergen 

advisory statement; and

- To-re-evaluate the 

supplier. 
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Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Almond-based 

beverage

Soy - The supplier uses the same processing line for almondbased beverages and soy-based beverages.

- Supplier’s allergen cross-contact controls and verification 

testing:

- The supplier develops allergen cleaning procedures for 

use when changing from one beverage type to the other.

- During development of the food safety plan, verification 

testing of FCSs on the processing line and in the 

almond-based beverage is consistently negative for the 

presence of soy allergen. 

- During routine production, the supplier monitors the 

cleaning procedures and conducts sampling and 

analytical testing for residues of soy as verification, at 

least quarterly or more frequently as requested by the 

customer. 

Moderate, because the 

supplier uses the same 

processing line for almondbased and soy-based 

beverages. However, the 

supplier does not use 

allergen advisory

statements due to the liquid 

nature of the food products 

and consistently negative 

test results from verification 

testing of its cleaning 

procedures during 

development of the food 

safety plan.

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Test several shipments 

for soy

- Annual onsite audit

- Receive COAs with every 

shipment for the first 6 months

- Receive quarterly COAs after 

the first 6 months

- Annual sampling and testing 

(as verification of the supplier’s 

quarterly sampling and testing)

Dry-roasted 

almonds

Dry-roasted 

peanuts

- Supplier’s CGMP measures for separation in space:

- The supplier has separate storage areas in separate 

buildings for almonds and peanuts.

- The supplier has separate processing lines in separate 

buildings for almonds and peanuts. 

Low, because the supplier 

stores and processes 

almonds and peanuts in 

separate buildings. 

Therefore, the supplier 

does not use allergen 

advisory statements. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Annual Certificate of 

Conformance that the supplier 

continues to use separate 

buildings for storing and 

processing almonds and 

peanuts. 

- Supplier audit every three 

years.

Dry-roasted 

almonds

Dry-roasted 

peanuts

- Supplier’s CGMP measures for separation in space:

- The supplier stores almonds and peanuts in separate 

rooms of the same building. 

- The supplier has separate processing lines in separate 

rooms of the same building for almonds and peanuts.

- The supplier has dedicated apparel, portable equipment, 

utensils, and tools for almonds and peanuts. 

- Supplier’s allergen cross-contact controls, subject to 

monitoring:

- Almonds and peanuts are color-coded upon receipt. 

- Apparel, portable equipment, utensils, and tools are 

color-coded or tagged.

- Traffic patterns restrict movement of personnel, portable 

equipment, utensils, and tools.

Low, because the supplier 

stores and processes 

almonds and peanuts in 

separate rooms, and has 

allergen cross-contact 

controls for ingredients, 

apparel, portable 

equipment, utensils, and 

tools. Therefore, the 

supplier does not use 

allergen advisory

statements. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Annual Certificate of 

Conformance that the supplier 

continues to use separate 

rooms for storing and 

processing almonds and 

peanuts and continues to 

implement its allergen crosscontact controls for ingredients, 

apparel, portable equipment, 

utensils and tools

- Supplier audit every other 

year.
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Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Dry-roasted 

almonds

Dry-roasted 

peanuts

- Supplier’s CGMP measures for separation in space and time:

- The supplier stores shelled almonds and shelled peanuts 

in covered containers in separate storage areas, 

separated by plastic curtains, in the same storage room.

- The supplier has separate processing lines, separated by 

plastic curtains, in the same room, for almonds and 

peanuts. 

- The supplier schedules production of roasted almonds 

and roasted peanuts at different times.

- Supplier’s allergen cross-contact controls and verification

testing: 

- Almonds and peanuts are color-coded upon receipt to 

facilitate storing in the correct area and ingredient 

identification when bringing shelled almonds and shelled 

peanuts to the production line. 

- Apparel, portable equipment, utensils, and tools are 

dedicated and color-coded or tagged for use with either 

almonds or peanuts. 

- Traffic patterns restrict movement of personnel, portable 

equipment, utensils, and tools.

- During the development of the food safety plan, conducts 

verification procedures by sampling and sorting almonds 

to look for peanuts, or by analytical testing for peanut 

residue, is consistently negative.

- During routine production, when the supplier does its 

quality control (QC) checks on samples of almonds for 

color and size, it also sorts the sample and looks for 

peanuts. 

Low, because the supplier 

has CGMP measures for 

separation in both space 

and time, has allergen 

cross-contact controls for 

ingredients, apparel, 

portable equipment, 

utensils, and tools, and 

during development of the 

food safety plan verification 

testing for peanuts and 

peanut residue is 

consistently negative. 

Therefore, the supplier 

does not use allergen 

advisory statements. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Sample and sort 

almonds from several 

shipments to look for 

peanuts 

- Annual onsite audit

- Periodic (e.g., semi-annually

checking shipments of almonds

by sampling and sorting to look 

for peanuts
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Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Dry-roasted 

almonds

Dry-roasted 

cashews 

- The supplier uses the same production line for almonds and 

cashews.

- Supplier’s CGMP measures for separation in space: 

- Separate storage areas, in different rooms, for shelled 

almonds and shelled cashews.

- Supplier’s allergen cross-contact controls and verification 

testing:

- Almonds and cashews are color-coded upon receipt to 

facilitate storing in the correct area and ingredient 

identification when bringing shelled almonds and shelled 

cashews to the production line. 

- Apparel, portable equipment, utensils, and tools are 

dedicated and color-coded or tagged for either almonds 

or cashews. 

- The supplier consults with an expert in dry cleaning 

techniques to develop cleaning procedures for use when 

changing from one nut to the other.

- During development of the food safety plan, verification 

testing by sampling and sorting almonds to look for 

cashews, or by analytical testing for cashew residue, is 

rarely positive. 

- During routine production, the supplier monitors the 

cleaning procedure and conducts analytical tests of 

FCSs for cashew residue before beginning production of 

almonds, with repeat cleaning if necessary.

- During routine production, the supplier holds each lot 

until receiving the results of verification procedures

(sampling and sorting almonds to look for cashews) and 

analytical testing for cashew residue. The supplier

reworks any lots of almonds that contain cashews in a 

mixed nuts product. 

- The supplier provides a COA with the results of its 

verification testing for each shipment of almonds.

Moderate, because the 

supplier uses the same 

processing line for almonds 

and cashews. However, the 

supplier does not use 

allergen advisory

statements because the 

verification testing of its 

allergen cross-contact 

controls during 

development of its food 

safety plan demonstrates 

that the frequency of 

allergen cross-contact is 

low, it routinely monitors 

the cleaning during 

production, it follows “hold 

and test” procedures before 

distributing almonds, and it 

provides a COA with the 

results of verification 

testing for every lot of 

almonds. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Sample and sort 

almonds from several 

shipments to look for 

cashews 

- Test several shipments 

for cashew residue

- Annual onsite audit

- Supplier COA for each 

shipment

- Periodic (e.g., semi-annually 

or every 6th lot) checking 

shipments of almonds by 

sampling and sorting to look for 

cashews and testing for 

cashew residue (as verification 

of the supplier’s sampling and 

testing of every lot)
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Ingredient Potential 

Unintended 

Allergen 

Presence Due 

to Allergen 

Cross-Contact 

at the Supplier

Food Allergen Program at the Supplier Potential for Allergen 

Cross-Contact at the 

Supplier and Supplier’s 

Decision Regarding 

Allergen Advisory 

Statements

Examples of Supplier 

Approval Activities

Examples of Ongoing 

Supplier Verification 

Activities

Dry-roasted 

almonds

Dry-roasted 

cashews 

- The supplier uses the same production line for almonds and 

cashews.

- Supplier’s CGMP measures for separation in space: 

- Separate storage areas, in the same room, for almonds 

and cashews.

- Supplier’s allergen cross-contact controls and verification

testing: 

- Almonds and cashews are color-coded upon receipt.

- Apparel, portable equipment, utensils, and tools are 

dedicated and color-coded or tagged for either almonds 

or cashews. 

- The supplier develops cleaning procedures for use when 

changing from one nut to the other.

- During development of the food safety plan, assessed

multiple cleaning practices for efficacy in preventing 

allergen cross-contact, but regardless of which cleaning 

practice was used verification testing by sampling and 

sorting almonds to look for cashews, or by analytical 

testing for cashew residue, is frequently positive. 

- The supplier concludes that its verification testing during 

development of the food safety plan demonstrates that 

its cleaning is not always able to protect the almonds 

from allergen cross-contact. 

- The supplier’s PCQI provides a written justification, in the 

supplier’s food safety plan, for why allergen crosscontact controls are not always able to ensure protection 

of food from allergen cross-contact. 

- The supplier’s labeling for the applicable food product(s) 

includes allergen advisory statements that disclose the 

possible unintended allergen presence in the food. 

 - Because the supplier provides allergen advisory 

labeling, the supplier does not routinely do verification 

testing of either the FCSs on the processing line or the 

almonds.

High. The supplier uses 

allergen advisory labeling 

because it uses the same 

production line for almonds 

and cashews and 

verification testing during 

development of the food

safety plan demonstrates 

that its cleaning is not 

always able to protect the 

almonds from allergen 

cross-contact. 

- Questionnaire about 

food allergen control 

practices

- Search FDA’s “Supplier 

Evaluation Resources” 

web page (see Table 11-

8)

- Onsite audit

- Sample and sort 

almonds from several 

shipments to look for 

cashews, and test several 

shipments for the 

presence of cashew

residue, as part of the 

PCQI’s determination of 

whether to carry the 

allergen advisory labeling 

forward 

- Annual onsite audit

- If allergen advisory labeling is 

carried forward, periodic 

checking shipments of almonds 

by sampling and sorting to 

confirm the results obtained 

during supplier approval

- If allergen advisory labeling is 

not carried forward, periodic 

checking shipments of almonds 

by sampling and sorting, and by 

testing for cashew residue, to 

confirm the results obtained 

during supplier approval and 

determine whether to conduct 

reanalysis:

- Of the PCQI’s 

determination to not carry 

forward allergen advisory 

labeling; and

- To-re-evaluate the 

supplier.

- Frequency of sampling and 

sorting (and, when applicable, 

analytical testing) varies 

depending on whether allergen 

advisory labeling is carried 

forward (e.g., monthly if 

allergen advisory labeling is not 

carried forward; semi-annually 

or every 6th lot if allergen 

advisory labeling is carried 

forward)
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11.8.3.3 Conducting an audit of a supplier when the hazard requiring a 

supply-chain applied control is a food allergen hazard

If you will conduct an onsite audit of a supplier, the onsite audit must be performed by a 

qualified auditor. (See 21 CFR 117.435 and the definition of a qualified auditor in 21 CFR 

117.3.) Specifically, the auditor that conducts audits to verify food allergen controls must have 

technical expertise obtained through education, training, or experience (or a combination of 

these) necessary to verify that a supplier is implementing measures adequate to control food 

allergens. 

When you conduct an audit for a supplier that is subject to the requirements of part 117,32

examples of activities to evaluate during the audit are33:

• Storage and handling practices for ingredients, WIP, rework, and finished goods;

• Methods used for physical separation, product containment, and product identification; 

• Production practices, including procedures for use of rework and WIP;

• Production scheduling; 

• Movement of raw materials and other ingredients that are, or contain, a food allergen;

• Use and segregation of specific utensils, implements, and tools;

• Procedures for the approval of labels and of packaging that contains pre-printed labels;

• Procedures for assuring that the correct label is applied to the correct food product; 

• Handling of obsolete labels/packaging;

• Sanitation procedures;

• Post-cleaning verification to ensure the absence of food allergens prior to processing a 

product with a different food allergen profile; 

• Procedures for monitoring food allergen controls; and

• Review of records, such as cleaning procedures, monitoring records, corrective action 

records, verification records, incoming inspection records of labels/packaging, training 

records, label/packaging approval records, and previous allergen audit reports and follow up 

reports to correct deficiencies, if any, found in those reports.

32 If your supplier is a facility that is not subject to the requirements for hazard analysis and risk-based 

preventive controls because it satisfies one of the criteria in 21 CFR 117.5 for an exemption, you would 

evaluate the supplier’s CGMP measures to prevent allergen cross-contact.

33 Adapted from “Managing Allergens in Food Processing Establishments” (GMA, 2009).
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11.8.4 Receiving a Raw Material or Other Ingredient From a Supplier That 

Provides Allergen Advisory Statements

As discussed in section 11.9.3, if you approve a supplier that provides an allergen advisory 

statement for a raw material or other ingredient, your supply-chain program should include a 

written determination by the PCQI of whether to carry an allergen advisory statement forward to 

any of your own products. For example:

• If your supplier provides an allergen advisory statement for vegan caramel chips (e.g., about 

the potential for unintended milk presence), and you will use the vegan caramel chips in a 

food product that contains an ingredient that is (or contains) milk (such as milk powder), your 

product label would already declare the food source “milk,” and there would be no need for 

an additional allergen advisory statement on your food product.

• If your supplier provides an allergen advisory statement for vegan caramel chips (e.g., about 

the potential for unintended milk presence), and you will use the vegan caramel chips in a 

food product that is not formulated to contain any other ingredient that is (or contains) milk, 

you should either:

o Carry such an allergen advisory statement forward to the product label on your food 

products, and specify in your Label Content Procedures for receiving the vegan caramel

chips that you treat the vegan caramel chips in the same manner as you treat other 

ingredients that are or contain a major food allergen;

34 or 

o Rely on a scientifically valid determination (which you include in your food safety plan) 

that the amount35 of milk allergen that may be present in labeled food products produced 

using that supplier’s ingredient is low enough such that the presence may not cause 

allergic reactions in most consumers who have that food allergy.

11.8.5 Corrective Actions and Corrections in the Event of Supplier Nonconformance

If you determine (e.g., through your supplier verification audit, periodic testing, or consumer 

complaints) that the supplier is not adequately controlling food allergen hazards, the 

requirements for a supply-chain program specify that you must take corrective action or 

corrections to ensure that raw materials or other ingredients from the supplier do not cause the 

food that you manufacture or process to be adulterated under section 402 of the FD&C Act.

(See 21 CFR 117.410(e) and 117.150.) 

Corrections could be appropriate if, for example, you find (through your ongoing supplier 

verification activities) that a supplier has an implementation issue with certain allergen controls, 

(e.g., an audit indicates that some of the procedures to control the movement of employees and 

mobile equipment to prevent cross contact have not been followed) but the observations 

indicate that cross-contact was unlikely. You could consider that non-compliance to be a minor 

problem that would not directly impact the safety of the food product that you purchase from that 

supplier. In such circumstances, corrections could include assessing the supplier’s explanation 

34 See the discussions in section 11.7.1.1.4 regarding Label Content Procedures for receipt of raw 

materials and other ingredients. 35 See discussion in section 11.3 regarding published data on population threshold dose responses to 

various food allergens. 
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of what went wrong and the steps that the supplier is taking to prevent the problem from 

recurring.

See 21 CFR 117.410(e) and 117.150 for the requirements applicable to corrective actions if you 

determine that the supplier is not controlling hazards that you have identified as requiring a food 

allergen control applied by the supplier. Corrective actions (rather than corrections) are 

appropriate when the problem with a supplier’s control of food allergen hazards impacts (or has 

the potential to impact) the safety of your product. For example, if your supplier recalls a 

powdered milk product due to unintended soy presence, and you had purchased that powdered 

milk product, you would follow the supplier’s instructions regarding powdered milk that you have 

not already used. However, the problem that led to the recall of the powdered milk product could 

directly impact the safety of food that you manufactured/processed before becoming aware of 

the recall as well as the safety of milk powder that you purchase from that supplier in the future. 

In such circumstances, corrective actions would include: 

• Identifying the problem (e.g., by determining why your supplier’s food allergen program

failed);

• Correcting the problem and reducing the likelihood that the problem will recur (e.g., by 

working with the supplier to ensure appropriate implementation of a food allergen program in 

the future or by changing suppliers); and

• Evaluating all affected food for safety (e.g., by evaluating the food you manufactured or 

processed for unintended allergen presence) and ensuring that any food with unintended

allergen presence does not enter commerce (or is removed from commerce if it has been 

shipped).

11.8.6 Reanalysis in the Event of Ongoing Supplier Nonconformance

As discussed in section 11.5.5, part 117 includes requirements for you to conduct a reanalysis 

of the food safety plan as a whole, or the applicable portion of the food safety plan, whenever 

you find that a preventive control, combination of preventive controls, or the food safety plan as 

a whole is ineffective. (See 21 CFR 117.170(b)(4).) Reanalysis of your supply chain program is 

appropriate if, for example:

• A supplier of raw materials or other ingredients that are at high risk for a food allergen 

hazard due to allergen cross-contact does not provide allergen advisory statements for 

those raw materials or other ingredients, but you repeatedly detect an unintended allergen 

presence during routine sampling and testing of those raw materials or other ingredients. 

Reanalysis to address the unintended allergen presence could include discussions with the 

supplier about the CGMP measures and allergen cross-contact controls used by the 

supplier to prevent allergen cross to help determine whether modifications are needed for 

your food safety plan.

• A supplier of raw materials or other ingredients that are at high risk for a food allergen 

hazard due to allergen cross-contact provides allergen advisory statements for those raw 

materials or other ingredients, and the detected levels of the unintended allergen presence

in raw materials or other ingredients during routine sampling and testing are sufficiently high 

to warrant discussion with the supplier about the CGMP measures and allergen crosscontact controls used by the supplier to prevent allergen cross-contact. 
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During reanalysis, your PCQI would determine whether to discontinue use of such suppliers. 

See also the discussions of reanalysis of allergen advisory labeling in section 11.9.5. In some 

circumstances, reanalysis of your supply-chain program could lead you to conclude that an 

allergen advisory statement for your product has become appropriate because you are not 

always able to assure, through your supply-chain controls, that the ingredient you receive will be 

protected from allergen cross-contact.

11.8.7 Records Documenting the Supply-Chain Program

See 21 CFR 117.475 for a list of records required to document a supply-chain program. See 

Chapter 15 for a comprehensive discussion of those records. 

11.8.8 Review of Records for the Supply-Chain Program

As specified in 21 CFR 117.475(b), you must review the records for your supply-chain program 

in accordance with §117.165(a)(4), which requires that a PCQI review (or oversee the review of)

your supply-chain records within a reasonable time after the records were created to ensure that 

the records are complete, the activities reflected in the records occurred in accordance with the 

food safety plan, the preventive controls are effective, and appropriate decisions were made 

about corrective actions. 

11.9 Allergen Advisory Statements

11.9.1 How the 1996 Food Allergen Notice Applies to CGMP Measures and 

PCHF Requirements

In the 1996 food allergen notice (see Table 11-8), we advised that, “because adhering to 

CGMPs is essential for effective reduction of adverse reactions by consumers, such 

precautionary labeling should not be used in lieu of adherence to CGMPs.” We also urged

manufacturers to “take all steps necessary to eliminate allergen cross-contamination and to 

ensure the absence of the identified food.”

When we issued the 1996 food allergen notice, your responsibility to prevent allergen crosscontact was solely addressed through CGMP requirements to prevent contamination and 

adulteration of food. In 2015 (80 FR 55908, September 17, 2015), we revised those CGMP 

requirements to more explicitly require that you use CGMP measures to prevent allergen crosscontact36. We also added new requirements for allergen cross-contact preventive controls to:

• Provide assurance that any food allergen hazards requiring a preventive control will be 

significantly minimized or prevented and the food manufactured, processed, packed, or held 

by your facility will not be adulterated under section 402 of the FD&C Act (21 CFR 

117.135(a)); and

• Ensure protection of food from allergen cross-contact (21 CFR 117.135(c)(2)(i)).

36 As noted in section 11.1, our more recent allergen labeling guidance also advises that labeling such as 

“may contain [allergen]” is not a substitute for adherence to either CGMPs or food allergen preventive 

controls.
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Consistent with the 1996 food allergen notice and our allergen labeling guidance:

• You should not use allergen advisory statements in lieu of adherence to the CGMP 

requirements to prevent allergen cross-contact; and

• You should not use allergen advisory statements in lieu of adherence to the requirements 

for allergen cross-contact controls. 

As discussed in section 11.1, this chapter does not broadly discuss other issues associated with 

allergen advisory statements. See our web page providing guidance documents and regulatory 

information regarding food allergens (Table 11-8) for our policy statements and other guidance 

relevant to allergen advisory statements. You should periodically check that web page for 

updates to these policy statements and other guidance.

11.9.2 Justification by Your Preventive Controls Qualified Individual That an 

Allergen Advisory Statement Is Appropriate

We realize that there may be circumstances in which you are not always able to provide 

assurance, even after implementation of appropriate CGMP measures and allergen crosscontact controls, that food can be protected from allergen cross-contact. If so:

o Your PCQI should provide a written justification, in your food safety plan, for why 

allergen cross-contact controls cannot ensure protection of food from allergen crosscontact; and

o Your labeling for the applicable food product(s) could include information that discloses 

the possible unintended allergen presence in the food.

The allergen labeling guidance (see Table 11-7) reiterates the statement in the 1996 food 

allergen notice that that allergen advisory statements such as "may contain [allergen]" should 

not be used as a substitute for adherence to CGMPs and adds that any allergen advisory 

statement such as "may contain [allergen]" must be truthful and not misleading. In developing 

information that is truthful and not misleading and discloses the possible unintended allergen 

presence in the food, you should carefully consider how to design and place the information so 

that it will be easily seen by consumers looking for this additional information on the label.

11.9.3 Suppliers That Use Allergen Advisory Statements

We realize that there may be circumstances in which a supplier that produces some ingredients 

that contain a food allergen, and other ingredients that do not contain a food allergen, may not 

be able to provide assurance that its food products have been protected from allergen crosscontact, even after implementation of appropriate CGMP measures and allergen cross-contact 

controls, and therefore provides allergen advisory statements for the raw materials and other 

ingredients that you would receive from that supplier. We recommend that your supplier 

approval and verification activities include an evaluation of whether a potential supplier provides 

allergen advisory statements for raw materials and other ingredients that you would receive 

from the potential supplier before approving the supplier. When a potential supplier would 

provide allergen advisory statements on the applicable raw materials or other ingredients, we 

recommend that you discuss the reasons for the allergen advisory statements with the potential 

supplier. You should approve a supplier that provides allergen advisory statements for its 

products only if you determine that such statements are not being used in lieu of adherence to 

CGMPs or in lieu of adherence to the requirements for allergen cross-contact controls. 
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If you approve a supplier that provides allergen advisory statements for food products that you 

would receive from that supplier, your PCQI should provide, in your food safety plan, a written 

determination of whether:

• The allergen advisory statement has no impact on the food allergen profile of your products, 

because all products that would contain the affected ingredient also include an ingredient 

that is (or contains) the food allergen that could be present in the ingredient due to allergen 

cross-contact at the supplier and, thus, your product labels already declare the food source 

of that food allergen;

• You will carry an allergen advisory statement forward to one or more of your food products

produced using those raw materials and other ingredients. If so, your Label Content 

Procedures for receiving these ingredients should specify that you treat these ingredients in 

the same manner as you treat ingredients that are or contain a major food allergen37; or

• You will rely on a scientifically valid determination (which you include in your food safety 

plan) that the amount of food allergen that may be present in labeled food products 

produced using that supplier’s ingredient is low enough such that its presence may not 

cause allergic reactions in most consumers who have that food allergy. 

11.9.4 Reanalysis of Your Determination That Allergen Advisory Statements

Are Appropriate If You Experience Ongoing Problems with Your Allergen 

Cross-Contact Controls or Your Supply-Chain Program

The requirements of part 117 for reanalysis specify that you must conduct a reanalysis of the 

food safety plan as a whole, or the applicable portion of the food safety plan whenever you find 

that a preventive control, combination of preventive controls, or the food safety plan as a whole 

is ineffective. (See 21 CFR 117.170(b)(4).) Reanalysis of your allergen cross-contact controls, 

including your determination of whether allergen advisory statements are appropriate, is 

appropriate if you experience ongoing problems with implementation of those controls. Likewise, 

reanalysis of your supply-chain program is appropriate if you experience ongoing supplier 

nonconformance with respect to allergen cross-contact. If your food safety plan does not 

provide for the use of allergen advisory statements, reanalysis of your allergen cross-contact 

controls or your supply-chain program could lead you determine that you are not always able to 

provide assurance, through your allergen cross-contact controls or your supply-chain program, 

that food can be protected from allergen cross-contact, despite using appropriate CGMPs and 

preventive controls. If so:

• You should revise your food safety plan to include a written justification for why allergen 

cross-contact controls or your supply-chain program cannot ensure protection of food from 

allergen cross-contact;

• Your labeling for the applicable food product(s) should include information that discloses the 

possible unintended allergen presence in the food and must be truthful and not misleading; 

and

• In developing allergen advisory statements following reanalysis, you should carefully 

consider how to design and place an allergen advisory statement to call it to the attention of 

a consumer who is allergic to a major food allergen and checks the ingredient statements 

and “Contains” statements on a product label for the food source of all ingredients that are, 

37 See the discussion in section 11.7.1.1.4 regarding Label Content Procedures for receipt of raw 

materials and other ingredients.
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or contain, that major food allergen when first making a purchase selection but may not 

continue to check the ingredient statements and “Contains” statements on that product label 

when purchasing the same product on multiple occasions.

11.10 Training

As required by 21 CFR 117.4(b), each individual engaged in manufacturing, processing, 

packing, or holding food (including temporary and seasonal personnel) or in the supervision 

thereof must:

• Be a qualified individual as that term is defined in 21 CFR 117.3—i.e., have the education, 

training, or experience (or a combination thereof) necessary to manufacture, process, pack, 

or hold clean and safe food as appropriate to the individual's assigned duties; and

• Receive training in the principles of food hygiene and food safety, including the importance 

of employee health and personal hygiene, as appropriate to the food, the facility and the 

individual's assigned duties. (See 21 CFR 117.4(b).)

In addition, supervisory personnel who are responsible for ensuring compliance by individuals 

with the requirements of part 117 must have the education, training, or experience (or a 

combination of these) necessary to supervise the production of clean and safe food. (See 21 

CFR 117.4(c).) Records that document required training must be established and maintained.

(See 21 CFR 117.4(d).)

The successful control of food allergens depends on the involvement of all personnel in all 

phases of product development, ingredient procurement/sourcing, receiving, production and 

distribution of foods, and proper action by employees to control food allergens depends on their 

understanding of their responsibilities (GMA, 2009). Therefore, we recommend that all 

individuals (including individuals with responsibility for management, research and development, 

marketing, procurement, legal/regulatory issues, auditing, product development, design 

engineering, production, quality assurance, consumer complaints, and warehousing and 

distribution) receive general allergen awareness training. Such training should include 

information on the significance of food allergens, proper control of product labeling, and the 

prevention of allergen cross-contact, including the specific practices and procedures employed 

by your establishment.

Examples of training topics for all personnel are:

• Awareness of those raw materials and other ingredients that contain food allergens and that 

should be the subject of a food allergen program; 

• How the design of your plant and equipment helps to prevent allergen cross-contact;

• Procedures that you use to prevent allergen cross-contact – e.g., procedures for storage (of 

raw materials and other ingredients, WIP, rework, and finished products), production 

scheduling, cleaning, rework, packaging products, labeling products, and waste 

management;
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• CGMP measures to prevent allergen cross-contact due to personnel practices, including 

hand washing, use of protective clothing, proper disposal and cleaning of soiled clothing and 

protective gear, and traffic patterns for personnel to move through the plant;

• CGMP measures to prevent allergen cross-contact when moving equipment, maintenance 

tools, and utensils throughout the plant; and

• Actions to take when unintended allergen presence is suspected. 

 

See Table 11-5 for examples of training topics appropriate to an individual’s assigned duties. 

Table 11-5 Examples of Training Topics Appropriate to an Individual’s Assigned Duties

Personnel Function Training Topics 

Purchasing Awareness that food allergen hazards may require supply-chain controls

with associated supplier approval and verification activities

Receiving Procedures for receipt, handling, and storage of allergen-containing raw 

materials and other ingredients to ensure that they are appropriately 

identified and stored

Production operations The food allergen control measures employed during production, including 

the preventive measures, corrective actions, and records applicable to each 

employee’s position

Management of WIP and 

rework 

Awareness of the importance of controlling WIP and rework to prevent 

allergen cross-contact

Maintenance Measures to prevent allergen cross-contact (e.g., through maintenance

tools) between production lines 

Cleaning operations Awareness of the key role of cleaning procedures in preventing allergen 

cross-contact

Supervision The plant’s food allergen program applicable to the supervisory 

responsibilities

11.11 Examples Used in this Chapter

Sections 11.12 and 11.13 of this chapter provide examples to illustrate how to establish and 

implement a food allergen program. These examples are:

• Food Allergen Program Established and Implemented by Dessert Manufacturer A for the 

Production of Ice Cream and Other Frozen Dessert Products; and

• Food Allergen Program Established and Implemented by Bakery B for the Production of a 

Variety of Cookie Products.

In reviewing these examples, keep in mind that: 

• Our purpose in providing multiple, detailed recommendations in each example is to provide 

as many examples as possible so that you can develop your own food allergen program as 
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appropriate to your operations, not to imply that a food allergen program should have all the 

CGMP measures, preventive controls (including supply-chain controls), 

monitoring/verification activities, corrective action procedures, and records that we describe 

in each example for illustrative purposes.

• Label controls have a role in ensuring that the finished food will not be misbranded under 

section 403(w) of the FD&C Act. Putting a label control in place to prevent such misbranding 

is more important than classifying that control in a particular way (e.g., as a label content 

control or a label management control). 

• You have flexibility to determine what monitoring/verification activities, and how many 

monitoring/verification activities, are appropriate for your operation to ensure the 

effectiveness of the preventive control. (See 21 CFR 117.140(a).) For the purpose of these 

examples, we specified how Dessert Manufacturer A or Bakery B classified an activity as 

either monitoring or verification and retained that classification throughout the examples. 

• Regardless of whether you identify a label control as a label content control or a label 

management control, you have flexibility to conduct a single activity as 

monitoring/verification for either type of label control, and you also have flexibility to use a 

single record to document either type of label controls.

As noted in sections 11.1 and 11.4.3, this chapter does not broadly discuss issues associated 

with allergen advisory statements. Accordingly, the examples in sections 11.12 and 11.13 do 

not discuss whether and how a manufacturer/processor would determine that allergen advisory 

statements are, or are not, appropriate.

11.12 Example of a Food Allergen Program Established and 

Implemented by Dessert Manufacturer A for the Production of Ice 

Cream and Other Frozen Dessert Products

11.12.1 Dessert Manufacturer A’s Products and Hazard Analysis

Dessert Manufacturer A produces four frozen dessert products on the same processing line:

• Raspberry sorbet, which contains no ingredients that are, or contain, a food allergen;

• Vanilla ice cream, which contains two ingredients that are, or contain, a food allergen (i.e., 

cream and milk powder);

• Vanilla frozen custard, which contains three ingredients that are, or contain, a food allergen 

(i.e., cream, milk powder, and pasteurized liquid eggs); and 

• Vanilla frozen custard with almonds, which contains four ingredients that are, or contain, a 

food allergen (i.e., cream; milk powder; pasteurized liquid eggs; and dry-roasted, chopped 

almonds).

The manufacturing process is as follows:

• Mix ingredients (except for almonds added to vanilla frozen custard with almonds) to form a 

dessert mix;

• Homogenize the dessert mix (for the ice cream and custard mixes);
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• Heat process (i.e., pasteurize) the dessert mix in a high-temperature-short-time (HTST) 

pasteurizer;

• Partially freeze the heat-treated dessert mix in a scraped-surface freezer; and

• Pump the partially frozen heat-treated dessert mix into 56-ounce plastic-coated paperboard 

tubs that are the product packaging; for the vanilla frozen custard containing almonds, the 

almonds are added during this step.

o The tubs have a pre-printed product label, including the product name and ingredient 

statement. The tubs also have a barcode that is used for multiple purposes, such as 

inventory management.

o The lids are pre-printed with the product name.

Through the hazard analysis, Dessert Manufacturer A’s PCQI determines that a food allergen 

program, with one or more preventive controls, is necessary to ensure protection of the frozen 

desserts from allergen cross-contact and to ensure that the finished frozen desserts are not 

misbranded under section 403(w) of the FD&C Act.

11.12.2 Dessert Manufacturer A’s Food Allergen Program

11.12.2.1 Dessert Manufacturer A’s CGMP measures in its food allergen 

program

In determining the appropriate preventive controls, Dessert Manufacturer A first considers the 

measures that it has established to satisfy the CGMP requirements to prevent allergen crosscontact. Dessert Manufacturer A has CGMP measures in place at the following operational 

stages:

• Receipt of ingredients: Dessert Manufacturer A uses color-coded stickers/tags to designate 

totes/containers of allergenic ingredients – cream and milk powder have white stickers/tags, 

pasteurized liquid eggs have yellow stickers/tags, and almonds have brown stickers/tags.

• Storage of ingredients: Dessert Manufacturer A:

o Segregates (i.e. stores in a different area) allergenic ingredients (cream, milk powder, 

pasteurized liquid eggs, and almonds) from non-allergenic ingredients (e.g., sugar, 

flavorings, and coloring).

o Dedicates one cold storage unit to allergens, with closed, clearly marked, plastic totes of 

cream and plastic bags (in boxes) of pasteurized liquid eggs segregated on separate 

sides of the unit.

o Stores almond pieces (in boxes with liners) and milk powder (in plastic bags) in 

dedicated bays in the warehouse. 

o Specifies in production procedures that partially-used containers be closed before they 

are returned to the cooler or warehouse.

• Scheduling: Dessert Manufacturer A produces the frozen products in a sequence whereby 

the product with no allergens (i.e., raspberry sorbet) is produced first and the product with 

the most allergens (i.e., vanilla frozen custard with almonds) is produced last. The complete 

sequence of products manufactured on the line is as follows: raspberry sorbet, vanilla ice 

cream, vanilla frozen custard, and vanilla frozen custard with almonds.

• Staging: Dessert Manufacturer A:
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o Uses separate areas to weigh or measure out non-allergenic ingredients (e.g., sugar, 

flavoring, and colors) and allergenic ingredients (cream, milk powder, pasteurized liquid 

eggs, and almonds) before staging the ingredients next to the line. Only one allergenic 

ingredient is weighed/measured at a time, the area is cleaned, and any partially-used 

containers are closed and returned to the cooler or warehouse before another ingredient 

is weighed/measured to prevent cross-contact of any partially-used ingredients. 

o Dedicates (i.e., to a specific food allergen or to non-allergenic ingredients) tools, 

containers, and equipment used to measure ingredients, using the same color-coding 

used on the containers of allergen-containing ingredients.

o Prepares the weighed/measured ingredients as needed, identifies them on a sticker 

(name and amount), and takes them directly to the production line. 

• Processing: Dessert Manufacturer A adds the almonds at the end of the production process

to minimize the number of pieces of processing equipment that contact the almonds.

• Cleaning: Dessert Manufacturer A uses freshly prepared cleaning solutions to clean all 

equipment and utensils in the production line immediately after production of each product is 

complete.

11.12.2.2 Dessert Manufacturer A’s food allergen controls

Because Dessert Manufacturer A processes foods with different allergen profiles on the same 

processing line, Dessert Manufacturer A’s PCQI determined that an allergen cross-contact 

control during its production of frozen desserts is necessary to ensure protection of the frozen 

desserts from allergen cross-contact.

Because three of Dessert Manufacturer A’s dessert products contain ingredients that are or 

contain a food allergen, Dessert Manufacturer A’s PCQI determined that label controls are 

necessary to ensure that its frozen dessert products are not misbranded under section 403(w) 

of the FD&C Act.

11.12.2.3 Dessert Manufacturer A’s assessment of supply-chain 

controls related to food allergens

Dessert Manufacturer A’s PCQI assessed whether Dessert Manufacturer A needs to establish 

and implement a supply-chain control to ensure that the plants that supply cream, milk powder, 

liquid pasteurized eggs, and dry-roasted, chopped almonds significantly minimize or prevent 

allergen cross-contact. 

o Through its supply-chain programs for the control of biological hazards in cream, milk 

powder, and pasteurized liquid eggs, Dessert Manufacturer A has determined that the 

suppliers of cream, milk powder, and pasteurized liquid eggs do not process other food 

allergens. Therefore, Dessert Manufacturer A’s PCQI determined that Manufacturer A 

does not need to assess the potential for allergen cross-contact at the suppliers for the 

cream, milk powder, and pasteurized liquid eggs.

o Through its supply-chain program for the supplier’s dry-roasting process for the control 

of Salmonella hazards in the dry-roasted, chopped almonds, Dessert Manufacturer A 

has determined that the almond handlers that dry roast and chop the almonds do not 

handle other tree nuts or other food allergens. Therefore, Dessert Manufacturer A’s 
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PCQI determined that Dessert Manufacturer A’s supply-chain program for the receipt of 

dry-roasted, chopped almonds does not need to assess the potential for allergen crosscontact at the almond handlers’ plants. 

11.12.3 Dessert Manufacturer A’s Allergen Cross-Contact Control

11.12.3.1 Dessert Manufacturer A’s allergen cleaning procedures

Under the production sequence established by Dessert Manufacturer A, the first product in the 

production sequence contains no allergenic ingredients. After that first product, each successive 

dessert on the production line contains allergenic ingredients, including allergenic ingredients

that were in the previous dessert processed on the production line as well as one additional 

allergenic ingredient, until all four products have been processed and the production sequence 

starts again. After processing the final product in the production sequence (i.e., the vanilla 

custard with almonds, which contains four allergenic ingredients) the next product to be 

processed contains no food allergens (i.e., raspberry sorbet). Therefore, Dessert Manufacturer 

A’s PCQI determined that:

• The production sequence, coupled with general cleaning measures established in 

accordance with the CGMP requirements of 21 CFR 117.35, is adequate to prevent allergen 

cross-contact after the processing of each of the first three products in the production 

sequence (i.e., after the processing of raspberry sorbet, vanilla ice cream, and vanilla 

custard without almonds); 

• General cleaning measures established in accordance with the CGMP requirements of 21 

CFR 117.35 alone are not adequate to prevent allergen cross-contact after the processing

of the final product in the production sequence (i.e., after processing of vanilla almond 

custard with almonds), because the production sequence begins again with raspberry 

sorbet, which contains no allergenic ingredients. Thus, allergen cleaning procedures that are

targeted to the removal of all allergenic food residues from FCSs are needed as a 

preventive control to prevent allergen cross-contact after the production of vanilla custard 

with almonds; and 

• If circumstances arise in which the customary production sequence is altered, the allergen

cleaning procedures (rather the general cleaning measures) are needed between production 

runs when a previous dessert product on the production line contains at least one allergenic 

ingredient not present in the subsequent production run. 

Dessert Manufacturer A develops its allergen cleaning procedures in consultation with its 

provider of food hygiene services and cleaning compounds and with the Quality Assurance 

supervisor who will oversee periodic analytical tests to verify the results of visual inspection after 

a cleaning cycle.

11.12.3.2 Dessert Manufacturer A’s monitoring/verification of allergen 

cleaning procedures

Dessert Manufacturer A conducts the following activities to monitor/verify that its allergen 

cleaning procedures are preventing allergen cross-contact: 
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• During each cleaning procedure to remove allergenic food residues, the Sanitation 

Supervisor uses a checklist (the “allergen cleaning checklist”) to monitor each step in the 

allergen cleaning procedure and note any corrections taken during the cleaning procedure.

After the equipment has been cleaned and visually inspected, the Sanitation Supervisor 

uses an ATP bioluminescence swab test or a protein swab test to verify that the line is 

clean. The Sanitation Supervisor notes the monitoring and results of the ATP swab test or 

protein swab test on the allergen cleaning checklist.

• Before each production run of raspberry sorbet (or before running any product that does not 

contain an allergenic ingredient present in the previous run), the Sanitation Supervisor 

conducts and documents a pre-operational visual inspection of applicable processing 

equipment and utensils as monitoring that they are visibly clean and notes if the visual 

inspection demonstrates that the allergen cleaning procedure needs to be repeated (the 

“pre-operational visual inspection record”).

• On a quarterly basis, and whenever there is a change in the cleaning procedure, a Quality 

Assurance technician verifies the visual inspection by conducting allergen-specific analytical 

tests before a production run of raspberry sorbet that follows a run of vanilla custard with 

almonds and keeps the analytical test results as a record.

• On a weekly basis, Dessert Manufacturer A’s PCQI reviews the allergen cleaning checklists 

as verification that all equipment and utensils have been cleaned prior to production, and 

documents that record review by initialing and dating the allergen cleaning checklists. 

• On a weekly basis, Dessert Manufacturer A’s PCQI reviews the pre-operational visual 

inspection records and documents that record review by initialing and dating the preoperational visual inspection records.

• Within a week of any allergen-specific analytical tests to verify the visual inspection, Dessert 

Manufacturer A’s PCQI reviews the results of the analytical tests as verification, and 

documents that record review by initialing and dating the results. 

• Within a week of a problem that requires corrective action, Dessert Manufacturer A’s PCQI 

reviews the corrective action records, and initials and dates each of the records reviewed in 

the place marked “Verified by.”

11.12.3.3 Dessert Manufacturer A’s corrective actions/corrections for 

allergen cleaning procedures

• Corrections. If the Sanitation Supervisor observes, during monitoring, that a step in the 

allergen cleaning procedure has not been properly implemented, the Sanitation Supervisor 

directs personnel to repeat the full cleaning procedure before beginning the next production 

run and notes this action on the allergen cleaning checklist. Similarly, if the ATP or protein 

swab tests indicate that the equipment has not been adequately cleaned, the Sanitation 

Supervisor directs personnel to repeat the full cleaning procedure, verifies the cleaning with 

an ATP or protein swab test, and notes this action on the allergen cleaning checklist. 

• Corrective actions. If a routine analytical test detects unintended allergen presence in 

raspberry sorbet, or if a consumer who has an allergy to egg, milk, or almonds reports an 

allergic reaction to raspberry sorbet:

o If the problem was identified through a consumer report of an allergic reaction, 

Manufacturer A investigates whether there were production issues that could have 

contributed to unintended allergen presence, conducts product testing on samples that it 

retained of the applicable lot to confirm the unintended allergen presence and, if there is 
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unintended allergen presence, determine the extent of the problem (e.g., number of 

affected lots).

o The Production Manager conducts a root cause investigation to try to determine 

whether:

 Allergen cleaning procedures were not properly implemented (e.g., a complete clean 

was not conducted during an out-of-sequence changeover to raspberry sorbet to 

fulfill an order); or 

 The allergen cleaning procedures are not effective (e.g., if it is determined that there 

is a place where a particle can get hung up on the equipment, thus requiring 

disassembly of that part of the equipment for cleaning before a production run for 

raspberry sorbet);

o When appropriate based on the root cause of the problem, the Production Supervisor:

 Re-trains sanitation managers/personnel (e.g., if it is determined that the allergen 

cleaning procedures were not properly implemented);

 Revises the allergen cleaning procedures (e.g., if it is determined that the allergen 

cleaning procedures are not effective); 

 Appropriately disposes of impacted lots of raspberry sorbet that have not yet been 

distributed; and

 Arranges for recalls of affected lots of raspberry sorbet that are in commerce and are 

adulterated under section 402(a)(4) of the FD&C Act due to allergen cross-contact. 

11.12.3.4 Dessert Manufacturer A’s records for allergen cleaning

procedures and associated preventive control management components

Dessert Manufacturer A maintains the following records:

• Its SSOP, which includes:

o Procedures for cleaning FCSs to remove all allergenic food residues; and

o Forms it will use for documentation of carrying out the written procedures, for monitoring 

and verification activities and for corrections and corrective actions (the forms may serve 

the dual purpose of written procedures and documentation) and; 

• The following records that are dated and initialed by the PCQI to document review of the 

records:

o The allergen cleaning checklists for each cleaning cycle;

o Pre-operation visual inspection records of the production line; 

o Results of any analytical test conducted to verify the results of visual inspection; and

o Any corrective action records.

11.12.4 Dessert Manufacturer A’s Label Controls

11.12.4.1 Dessert Manufacturer A’s label content controls and label 

management controls

11.12.4.1.1 Label content

Dessert Manufacturer A applies the following Label Content Procedures during the development 

and production of product packaging:
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• Label development stage: The product development specialist develops a food allergen 

label specification by reviewing the ingredients listed in the recipe or formulation, and the 

components listed by suppliers for all ingredients, to identify all food allergens in each 

product and the food source of each allergenic ingredient or component.

o The product development specialist notes that the food allergens in the ingredients are 

as follows:

 Raspberry sorbet: There are no allergenic ingredients. 

 Vanilla ice cream: The allergenic ingredients are cream and milk powder. The name 

of the food source for both ingredients is milk. 

 Vanilla frozen custard: The allergenic ingredients are cream, milk powder, and 

pasteurized liquid eggs. The names of the food sources are milk and eggs.

 Vanilla frozen custard with almonds. The allergenic ingredients are cream, milk 

powder, pasteurized liquid eggs, and dry-roasted, chopped almonds. The names of 

the food sources are milk, eggs, and almonds.

o The product development specialist notes that the name of the food source of all

allergenic ingredients is included as a part of the common or usual name of at least one

ingredient38 that contains the allergen, i.e., “milk powder,” “eggs,” and “almonds” and 

that there are no additional allergenic components in other ingredients.

o The product development specialist decides that the label specification for naming the 

food sources of the major food allergens that are ingredients in the dessert products is 

the ingredient statement declaring the allergenic ingredients as follows:

 Vanilla ice cream: The ingredient statement declares milk powder.

 Vanilla custard: The ingredient statement declares milk powder and eggs.

 Vanilla custard with almonds: The ingredient statement declares milk powder, eggs, 

and almonds.

o The food allergen label specification includes a requirement for each tub to be colorcoded through a different colored band on the top edge of the tub (red for the raspberry 

sorbet, blue for the vanilla ice cream, yellow for the custard without almonds, and brown 

for the custard with almonds).

o The product development specialist decides that the product name39 will be pre-printed 

on the lid for the tub and, thus, that the food allergen label specification will include a 

requirement for each lid to be color-coded, on a band surrounding the edge of the lid, 

using the same color-coding as for the tubs (red for the raspberry sorbet, blue for the 

vanilla ice cream, yellow for the custard without almonds, and brown for the custard with 

almonds). 

o The Label Coordinator reviews the food allergen label specification and documents 

approval by signing and dating it.

• Ordering stage: 

38 The food source of the allergenic ingredient “cream” is declared as part of the common or usual name 

of another ingredient (i.e., milk powder). 

39 Note that a label management control applies to labeling associated with food allergens. If the lid does 

not provide any label information (such as the product name, the ingredient statement, or a “Contains”

statement) applicable to the food allergen profile of the product, a color code for a lid (e.g., to complement 

the color code on the tub) would not be a label management control, because the wrong color of lid would 

not be relevant to the question of whether the product is misbranded under section 403(w) of the FD&C 

Act.
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o The Label Coordinator reviews a mock-up of the product label, provided by the 

manufacturer of the tubs and lids, and confirms that the mock-up matches the food 

allergen label specification before authorizing a production run of the tubs and lids.

o The purchase order for the product tubs and lids specifies that the product tubs/lids for 

the different products be shipped on different pallets.

11.12.4.1.2 Label management

Dessert Manufacturer A applies Label Management Procedures during storage, staging, 

production, and post-production. Dessert Manufacturer A stores tubs and lids in boxes on 

pallets with a sticker containing the product name and carton size on the outside of the box.

When tubs and lids are brought to the staging area for packaging, production personnel check 

product name and the ingredient statement printed on the tub, and the color on the top edge of 

the tub, as well as the product name on the lid and the color of the band of the lid, to confirm 

that the correct tub and lid have been brought to the staging area for packaging. At the end of 

production, Dessert Manufacturer A places unused tubs and lids in the appropriate boxes

containing the product name and carton size and returns them to the warehouse.

11.12.4.2 Dessert Manufacturer A’s monitoring/verification of label 

controls 

Dessert Manufacturer A conducts the activities described in sections 11.12.4.2.1 and 

11.12.4.2.2 to monitor/verify that its label controls are ensuring that its finished frozen dessert 

products are not misbranded under section 403(w) of the FD&C Act.

11.12.4.2.1 Monitoring/verification of label content controls

• Receipt of product packaging (tubs and lids): After the tubs and lids are manufactured and 

delivered to Dessert Manufacturer A, quality assurance personnel verify that the tubs and 

lids match the approved food allergen specification for the product label (including the 

product name and ingredient statement on the tubs and the color of the tubs, as well as the 

product name on the lid and the color of the band of the lid). Quality assurance personnel 

document this review on a Label Review Form included in the Label Content Procedures

and sign and date the form.

• On a weekly basis, Dessert Manufacturer A’s PCQI reviews, initials, and dates the records 

documenting the verification by quality assurance personnel that the tubs and lids match the 

approved food allergen label specification.

• Within a week of a problem that requires corrective action, Dessert Manufacturer A’s PCQI 

reviews the corrective action records, and initials and dates each of the records reviewed in 

the place marked “Verified by.”

11.12.4.2.2 Monitoring/verification of label management controls

• Storage of product packaging (tubs and lids): On a weekly basis, quality assurance 

personnel use a checklist to monitor that the tubs and lids are stored appropriately at receipt 

and following production by observation in the storage area for the tubs and lids and 
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document any incorrect storage on a “Storage Record for Label Controls” form included in 

the Label Management Procedures, and sign and date the form.

• Production (packaging): The line operator monitors and documents the staging check of the 

tubs and lids by observing the stacks of tubs and lids placed on the line at the beginning of 

packaging (and each time new tubs and lids are brought to the packaging line) to confirm 

that the top edge of the tub, and the band on the lid, have the proper color for the product 

being produced (red for the raspberry sorbet, blue for the vanilla ice cream, yellow for the 

custard without almonds, and brown for the custard with almonds). If the monitoring 

demonstrates that the tub or lid is incorrect, the line operator obtains the correct tub or lid

and notes the problem on the production sheet and initialing and dating that note.

• Production (from packaging and code dating through case packing): The line operator 

manually uses a UPC barcode scanner to monitor that the correct tub is being used for the 

various products. This monitoring occurs when the line is initially set up and at hourly 

intervals throughout the production run. The line operator records and initials the results of 

the barcode scanner on the production sheet, along with the date and time of each check.

40

• Post-production: At the end of each production run, the line operator verifies that any 

unused tubs and lids have been placed in the appropriately stickered boxes for return to the 

storage area and notes this post-production verification check on the production sheet. 

• On a weekly basis, Dessert Manufacturer A’s PCQI reviews, initials, and dates:

o Storage Record for Label Controls for monitoring the correct storage of tubs and lids by 

quality assurance personnel.

o The production sheet with:

 Staging checks of the tubs and lids brought to the packaging line; 

 The records documenting the results of the barcode scanning of the production tubs 

when the packaging line is initially set up and at hourly intervals during production; 

and

 The post-production verification check that unused tubs and lids have been placed in 

appropriately stickered boxes for return to storage.

• Within a week of a problem that requires corrective action, Dessert Manufacturer A’s PCQI 

reviews the corrective action records, and initials and dates each of the records reviewed in 

the place marked “Verified by.”

11.12.4.3 Dessert Manufacturer A’s corrective actions/corrections for 

label controls

11.12.4.3.1 Corrective actions/corrections for label content controls

• Corrections: Receiving personnel reject lots of inaccurate/wrong tubs or lids that are sent 

from the packaging manufacturer. Procurement personnel follow up with the packaging 

manufacturer as to the cause of the problem and the steps the packaging manufacturer will 

take to correct the problem and prevent it in the future.

• Corrective actions: If the inaccurate label content is not discovered until after the product is 

packaged, Dessert Manufacturer A takes and documents the following corrective actions:

40In this example, the tub has a bar code but the lid does not. Therefore, the monitoring that the line 

operator conducts using a barcode scanner only applies to the tubs. 
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o Segregation of any incorrectly labeled/packaged products. 

 Mislabeled vanilla ice cream is used as rework in the vanilla ice cream and the 

vanilla custards. 

 Any mislabeled raspberry sorbet or vanilla frozen custard with or without almonds is 

either reworked into the same product during the next production run or discarded. 

o Investigation by the Production Manager of the root cause of incorrectly labeled 

products. The Production Supervisor arranges for modification of the label content

procedures, re-training of personnel, or both as appropriate.

o Initiation of a recall of any product in commerce that is misbranded under section 403(w) 

of the FD&C Act.

11.12.4.3.2 Corrective actions/corrections for label management controls

• Corrections: Dessert Manufacturer A:

o Returns any incorrectly stored tubs or lids to the correct storage location and documents 

the correction on the Storage Record for Label Controls; and

o Removes any tubs from the line if they have the wrong color of band at the top and 

removes any lids from the line if they have the incorrect color of band on the edge and

returns them to storage without documenting the correction.

• Corrective actions: If product is packaged using an incorrect tub or lid, Dessert Manufacturer 

A takes and documents the same corrective actions as for a problem with a label content 

control, except that modifications to the preventive control procedures would affect Label 

Management Procedures rather than Label Content Procedures. (See section 11.12.4.3.1.)

11.12.4.4 Dessert Manufacturer A’s records for label controls and 

associated preventive control management components

11.12.4.4.1 Records for label content controls

Dessert Manufacturer A maintains the following records:

• The Label Content Procedures;

• The approved food allergen label specification, dated and signed by the Label Coordinator.

• The following records, initialed and dated by the PCQI to document review of the records:

o The Label Review Forms, signed and dated by quality assurance personnel, 

documenting that the final packaging (tubs and lids) has been reviewed after receipt 

from the packaging manufacturer and that the product name and ingredient statement 

on the product label, and the color on the top edge of the tubs, as well as the product 

name on the lid and the color of the band of the lid, match the food allergen label 

specification for the product; and

o Any corrective action records.
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11.12.4.4.2 Records for label management controls

Dessert Manufacturer A maintains the following records:

• The Label Management Procedures, including monitoring procedures for checking the color 

of the product tub and lid at staging and the Storage Record for Label Controls form.

• The following records, initialed and dated by the PCQI to document review of the records:

o The Storage Record for Label Controls; 

o The production sheet on which the line operator notes:

 Results of staging checks including any instance in which monitoring demonstrates 

that the wrong tubs or lids were brought to the staging area; and 

 The results of the UPC barcode scanner at the beginning of the production run and 

every hour during the production run; and

 The post-production verification check that any unused tubs and lids have been 

placed in the appropriately stickered box for return to storage; and

o Any corrective action records.

11.12.5 Summary of Dessert Manufacturer A’s Food Allergen Program

Appendix 11-2 summarizes Dessert Manufacturer A’s:

• Allergen cross-contact control on the FSPCA’s Sanitation Control Form (Form 2-D from 

Appendix 2 of this guidance); and

• Label controls on the FSPCA’s Food Allergen Control Form (Form 2-H (modified) from 

Appendix 2 of this guidance).

Appendix 11-2 also provides Dessert Manufacturer A’s:

• Ingredient analysis to support both allergen cross-contact controls and label controls (Form 

2E (Modified) from Appendix 2 of this guidance);

• Food allergen verification list to support label controls (Form 2F (Modified) from Appendix 2

of this guidance); and 

• Production line food allergen assessment to support allergen cross-contact controls (Form

2G (Modified) from Appendix 2 of this guidance). 

11.13 Example of Food Allergen Program Established and 

Implemented by Bakery B for the Production of a Variety of Cookie 

Products

11.13.1 Bakery B’s Products and Hazard Analysis

Bakery B produces three types of cookies, for milk allergic-consumers, that have no ingredients 

containing milk:
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• Oatmeal cookies, which contain two ingredients that are, or contain, a food allergen: flour 

(wheat) and pasteurized liquid eggs;

• Caramel chip cookies, which contain:

o Two ingredients that are, or contain a food allergen: flour (wheat) and pasteurized liquid 

eggs; and

o One ingredient (i.e., vegan caramel chips) that does not contain a food allergen but has

the potential to contain a food allergen (i.e., milk) as a result of allergen cross-contact by 

suppliers that produce non-vegan caramel, milk chocolate, and butterscotch chips that 

contain milk; and

• Peanut butter cookies, which contain three ingredients that are, or contain, food allergens: 

flour (wheat), pasteurized liquid eggs, and peanut butter (peanuts).

All three cookies contain vegetable shortening, which contains soy. However, Bakery B sources 

its vegetable shortening from suppliers that produce vegetable shortening from highly refined 

soybean oil, which is exempt from the allergen labeling requirements of the FD&C Act. (See 

section 201(qq)(2)(A) of the FD&C Act.)

The manufacturing process is as follows:

• Dough preparation: 

o For oatmeal cookies: Mix the base ingredients (wheat flour, eggs, vegetable shortening, 

vanilla extract, salt, baking soda, brown sugar, and granulated sugar) in a spiral mixer,

then add oatmeal and raisins. 

o For caramel chip cookies: Mix the same base ingredients as used for the oatmeal 

cookies in a spiral mixer, then add caramel chips. 

o For peanut butter cookies: Mix the same base ingredients as used for the oatmeal 

cookies in a spiral mixer, then add peanut butter. 

• Dough depositing and baking: Form cookies using a dough depositor and bake them on 

parchment-lined aluminum cookie sheets in a rotating rack oven.

• Packaging: After baking, hand-pack cookies into plastic trays that are placed in in plasticlined paper pouches.

• Labeling: Label the plastic-lined paper pouches, already filled with cookies, with labels that

are computer-generated in-house. The labels are printed and applied during production 

(rather than printed in advance of production and stored until needed).

Through its hazard analysis, Bakery B’s PCQI determines that a food allergen program, with

one or more preventive controls, is necessary to ensure protection of the cookies from allergen 

cross-contact and ensure that the finished cookies are not misbranded under section 403(w) of 

the FD&C Act.
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11.13.2 Bakery B’s Food Allergen Program

11.13.2.1 Bakery B’s CGMP measures in its food allergen program

In determining the appropriate preventive controls, Bakery B first considers the measures that it 

has established to satisfy the CGMP requirements to prevent allergen cross-contact. Bakery B 

has CGMP measures in place at the following operational stages:

• Storage of ingredients: The peanut-containing ingredient (peanut butter) is segregated from 

other ingredients in a separate warehouse bay that has signs “Only for Peanut Butter.”

• Separation in space. Although all cookie products are produced in the same plant:

o The peanut butter cookies are produced and packaged on a different processing line 

(with different equipment, utensils and tools) than the oatmeal cookies and caramel chip 

cookies.

o The production areas for weighing the peanut butter and for staging the peanut butter 

cookie ingredients are physically separated by a wall and door from the rest of the 

production areas – next to the peanut butter cookie line but away from the production 

area for the oatmeal cookies and caramel chip cookies.

11.13.2.2 Bakery B’s food allergen controls

Bakery B’s CGMP measures segregate the processing line for cookies containing peanuts from 

the processing line for cookies that do not contain peanuts. Although Bakery B processes two 

different cookies (i.e., oatmeal cookies and caramel chip cookies) on the same production line, 

these cookies have the same food allergen profile. Therefore, Bakery B’s PCQI determined that 

general cleaning measures established in accordance with the CGMP requirements of 21 CFR 

117.35 for cleaning FCSs, coupled with its segregation of processing lines, are adequate to 

clean its production lines and sanitation controls to prevent allergen cross-contact are not 

needed for the production line equipment. However, due to the severity of allergic reactions in 

consumers who are allergic to peanuts, Bakery B’s PCQI determined that allergen cross-contact 

controls on utensils, tools, apparel, and movement of personnel are necessary to ensure 

protection of the oatmeal cookies and caramel chip cookies from allergen cross-contact with 

peanut protein.

Because all of Bakery B’s cookies contain ingredients that are or contain a food allergen,

Bakery B’s PCQI determined that label controls are necessary to ensure that its cookies are not 

misbranded under section 403(w) of the FD&C Act.

11.13.2.3 Bakery B’s assessment of supply-chain controls related to 

food allergens

Bakery B’s PCQI assessed whether Bakery B needs to establish and implement a supply-chain 

control to ensure that the plants that supply caramel chips, flour, eggs, vegetable shortening,

and peanut butter significantly minimize or prevent allergen cross-contact.

• Bakery B’s PCQI determined that the vegan caramel chips have the potential for unintended 

milk presence as a result of allergen cross-contact by both potential suppliers, because 
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each potential supplier produces non-vegan chips (caramel, milk chocolate, and 

butterscotch chips that contain milk) in addition to vegan caramel chips. Therefore, Bakery 

B’s PCQI determined that supply-chain controls are necessary to ensure that the caramel 

chips are protected from allergen cross-contact.

• Through its initial discussions with potential suppliers of flour, Bakery B has determined that 

the suppliers of flour do not handle food allergens other than wheat. Therefore, Bakery B’s 

PCQI determined that Bakery B’s supply-chain program for the receipt of flour does not 

need to assess the potential for allergen cross-contact at the suppliers’ plants. 

• Through its initial discussions with potential suppliers of pasteurized liquid eggs, Bakery B 

has determined that the suppliers of pasteurized liquid eggs do not handle other food 

allergens. Therefore, Bakery B’s PCQI determined that Bakery B does not need to assess 

the potential for allergen cross-contact at the suppliers for pasteurized liquid eggs. 

• Through its initial discussions with potential suppliers of vegetable shortening, Bakery B has 

determined that the suppliers of vegetable shortening do not handle food allergens other 

than soy and all suppliers produce vegetable shortening from highly refined soybean oil, 

which is exempt from the allergen labeling requirements of the FD&C Act. (See section 

201(qq)(2)(A) of the FD&C Act.) Therefore, Bakery B’s PCQI determined that Bakery B does 

not need to assess the potential for allergen cross-contact at the suppliers for vegetable 

shortening.

• Through its initial discussions with potential suppliers of peanut butter, Bakery B has 

determined that the suppliers of peanut butter do not handle food allergens other than 

peanuts. Therefore, Bakery B’s PCQI determined that Bakery B does not need to assess the 

potential for allergen cross-contact at the suppliers for peanut butter.

11.13.3 Bakery B’s Allergen Cross-contact Controls 

11.13.3.1 Bakery B’s allergen cross-contact controls on utensils, tools, 

apparel, and movement of personnel

Bakery B establishes and implements allergen cross-contact controls on utensils, tools, and 

apparel and on the movement of personnel as follows:

• Dedicated utensils, tools, and apparel:

o Bakery B dedicates all utensils (e.g., scoops, spatulas) and tools (e.g., scrapers, 

brushes) used in the production of the peanut butter cookies so that they are not used 

for the production of oatmeal cookies or caramel chip cookies. Bakery B color-codes all 

utensils and tools (peanut - blue; non-peanut - white) to make it visibly obvious if the

incorrect utensil or tool is brought into the production area.

o Bakery B dedicates all apparel (e.g., smocks, hairnets) used in the production of the 

peanut butter cookies so that they are not used for the production of oatmeal cookies or 

caramel chip cookies. Bakery B color-codes all apparel (peanut - blue; non-peanut -

white) to make it visibly obvious if the incorrect apparel is brought into the production 

area.

• Restricted personnel movement in the plant: Bakery B restricts the movement of personnel 

in the plant by assigning personnel to work exclusively on the peanut butter cookie line or 
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the production line used for oatmeal cookies and caramel chip cookies during any given 

production shift.

11.13.3.2 Bakery B’s monitoring/verification of allergen cross-contact 

controls 

Bakery B conducts the following activities to monitor/verify that its allergen cross-contact 

controls are preventing allergen cross-contact: 

• During each shift, the Production Supervisor for each cookie processing area monitors the 

utensils and tools in the area for the correct color (peanut - blue; non-peanut - white) by 

visual observation. The Production Supervisor documents the monitoring and any nonconformance on a “Checklist for Allergen Cross-Contact Controls.”

• During each shift, the Production Supervisor for each cookie processing area monitors

personnel for the appropriate color smocks and hairnets by visual observation and 

documents the monitoring on a “Checklist for Allergen Cross-Contact Controls.”

• On a weekly basis, Bakery B’s PCQI reviews the Checklist for Allergen Cross-Contact 

Controls (including corrective actions when applicable) and documents that verification 

review by initialing and dating the record in the place marked “Verified by.”

11.13.3.3 Bakery B’s corrective actions/corrections for allergen crosscontact controls

• If a Production Supervisor finds utensils or tools in the wrong production area, the 

Production Supervisor removes the item and takes it to the cleaning room for washing 

before it is returned to the correct production area. The Production Supervisor determines, if 

possible, how the utensil or tool was brought into the wrong processing area and ensures 

that personnel are re-trained as appropriate based on the determination of the root cause of 

the problem.

o Corrections: If production has not begun, these activities are corrections and the 

Production Supervisor does not document the correction on the Checklist for Allergen 

Cross-Contact Controls. 

o Corrective actions: If production has begun, these activities are corrective actions and 

are documented on the Checklist for Allergen Cross-Contact Controls. The Production 

Supervisor determines whether product may have been affected (i.e. whether product 

may have come in contact with peanut protein), and, if so, evaluates any affected 

cookies for safety and prevents affected food from entering commerce by re-processing 

affected oatmeal or caramel chip cookie dough base (prior to addition of oatmeal and 

raisins or caramel chips) as peanut butter cookies or diverting the affected oatmeal 

cookies or affected caramel chip cookies or dough to animal food.

• If a Production Supervisor finds personnel wearing the incorrect color of smock or hairnet, 

the Production Supervisor determines whether the incorrect color was due to putting on the 

wrong item(s) (and, if so, why) or due to a violation of the plant traffic pattern procedures 

such that personnel from the peanut butter cookie area entered the oatmeal/caramel chip 
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cookie production area. The Production Supervisor ensures that personnel are re-trained as 

appropriate based on the determination of the root cause of the problem.

o Corrections: If the employee put on the wrong-colored item, the employee is required to 

leave the area and apply the correct apparel. The Production Supervisor makes this 

correction but does not document it.

o Corrective actions: If the problem was due to personnel from the peanut butter cookie 

production area entering the oatmeal/caramel chip cookie production area, these 

activities are corrective actions and are documented on the Checklist for Allergen CrossContact Controls. The Production Supervisor determines whether product may have 

been affected (i.e., whether product may have come in contact with peanut protein), and, 

if so, evaluates any affected dough and/or cookies for safety and prevents affected 

cookies from entering commerce by re-processing affected oatmeal or caramel chip 

cookie dough base as peanut butter cookies or diverting the affected oatmeal cookies or 

affected caramel chip cookies and/or dough to animal food.

11.13.3.4 Bakery B’s records for allergen cross-contact controls and 

associated preventive control management components

Bakery B maintains the following records:

• The written procedures for the allergen cross-contact controls, with the color-code 

designation for utensils, tools, and apparel; and

• The Checklist for Allergen Cross-Contact Controls used for documenting monitoring of 

utensils, tools, and apparel for the correct colors for the specific processing area. This 

“Checklist for Allergen Cross-Contact Controls” record also lists the specific nonconformances, if any, describes the corrective actions, and is initialed and dated by Bakery 

B’s PCQI to document the PCQI’s review of the record. 

11.13.4 Bakery B’s Label Controls

11.13.4.1 Bakery B’s label content controls and label management 

controls

In this example, Bakery B generates the labels for its cookies during production from an 

electronic file. As a result, Bakery B’s label content controls and label management controls are 

so inter-related that some records document monitoring/verification activities for both label 

content controls and label management controls.

11.13.4.1.1 Label content

Bakery B applies the following Label Content Procedures during development and production of 

product labels and receipt of ingredients:

• Label development stage: The Label Team develops a food allergen label specification by 

reviewing the ingredients listed in the recipe or formulation, and the components listed by 

suppliers for all ingredients, to identify all food allergens in each product and the food source 

of each allergenic ingredient or component.
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o The Label Team notes that the allergens contained in the ingredients are as follows:

 Oatmeal cookies: The allergenic ingredients are flour (wheat) and pasteurized liquid 

eggs. The names of the food sources are wheat and egg.

 Caramel chip cookies: The allergenic ingredients are flour (wheat) and pasteurized 

liquid eggs. The names of the food sources are wheat and egg.

 Peanut butter cookies. The allergenic ingredients are flour (wheat), pasteurized liquid 

eggs, and peanut butter (peanuts). The names of the food sources are wheat, egg, 

and peanuts.

o The Label Team notes that there are no additional allergenic components in other 

ingredients.

o An individual in the Label Team has responsibility for the food allergen label specification 

for the cookies. Because the labels are printed and applied during production (rather 

than printed in advance of production and stored until needed), that individual 

determines that the food allergen label specification does not need to include a feature 

such as color coding to help ensure that the correct labels are retrieved from storage. 

Therefore, the key label content features included in the food allergen label specification 

are the product name and the approach to naming the food sources of the ingredients 

that are (or contain) a food allergen. In choosing how to comply with the allergen labeling 

requirements of the FD&C Act, the individual considers that the name of the ingredient 

“flour” does not identify the food source of the allergen (i.e., wheat) and decides that the 

food allergen label specification for naming the food sources of the major food allergens 

that are ingredients in the cookies is to place a “Contains” statement for the food sources 

of all the food allergens in the cookies after the ingredient statement on the product label 

as follows:

 Oatmeal cookies: “Contains wheat and egg.”

 Caramel chip cookies: “Contains wheat and egg.”

 Peanut butter cookies: “Contains wheat, egg, and peanuts.”

o The Label Team Supervisor prints a sample of the product label to review the food 

allergen label specification for the product and documents approval by signing and 

dating the printed label. 

11.13.4.1.2 Label management

Production (staging): When a production run is scheduled, one individual in the Label Team 

selects the electronic file to be printed and sends the file to the Label Team Supervisor. The 

Label Team Supervisor confirms that the electronic file is the correct file for the product and 

then sends the file to the production printer where the labels will be generated when they are 

applied to the packages.

11.13.4.2 Bakery B’s monitoring/verification of label controls

Bakery B conducts the following activities to monitor/verify that its label controls are ensuring 

that its cookies are not misbranded under section 403(w) of the FD&C Act:
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11.13.4.2.1 Label content

• Before sending the electronic file for the production label to the production printer, the Label 

Team Supervisor verifies the content of the production label by reviewing the electronic file 

for the product label, to confirm that the product name and “Contains” statement in the 

electronic file match the approved food allergen label specification. The Label Team 

Supervisor sends the electronic file to the production printer, where the Production 

Supervisor will print a production label from the printer on the production line, paste that 

printed label onto the production sheet, and sign and date the production sheet next to the 

printed label.

41

• On a weekly basis, Bakery B’s PCQI reviews, initials, and dates the production sheets 

documenting the verification review of the content of the production label.

• Within a week of a problem that requires corrective action, Bakery B’s PCQI reviews the 

corrective action records, and initials and dates each of the records reviewed in the place 

marked “Verified by.”

11.13.4.2.2 Label management

• Electronic label generation during production: After the electronic file for production labels is 

sent to the printer on the production line, the Production Supervisor prints a label from the 

production printer, verifies that the product name and “Contains” statement on the labels 

match the approved food allergen label specification for the product, and documents this 

review by pasting the printed label onto the production sheet for cookies, signing and dating 

the production sheet next to the label. 

• Production of cookies (from packaging and code dating through case packing): The line 

operator verifies that the correct label is applied to each product through a visual check. This 

visual check occurs when the line is initially set up and each time newly printed labels are 

added to the line throughout the production run. The line operator records and initials the 

results of this visual check on the production sheet, along with the date and time of the 

check.

• On a weekly basis, Bakery B’s PCQI reviews, initials, and dates the records documenting:

o The verification that the correct electronic file has been sent to production; and

o The results of the visual check that the correct label is applied to each product.

• Within a week of a problem that requires a corrective action, Bakery B’s PCQI reviews the 

corrective action records, and initials and dates each of the records reviewed in the place 

marked “Verified by.”

41 In this example, a single record (i.e., the label printed from the production printer) documents 

verification activities for both the content of the product label and the selection of the correct electronic file 

for production. 
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11.13.4.3 Bakery B’s corrective actions/corrections for label controls

11.13.4.3.1 Corrective actions/corrections for label content controls

• Corrections: If the Label Team Supervisor determines that the label content (product name 

and/or “Contains” statement) does not match the approved food allergen label specification

before the electronic file is sent to the production printer, the Label Team Supervisor 

corrects the label content in the electronic file without creating a record of the correction.

• Corrective Actions: If the label content of production labels does not match the approved 

food allergen label specification and the problem is discovered only after packaged cookies 

have been labeled, Bakery B takes and documents the following corrective actions:

o Segregation of any affected products;

o Rework of affected products by manually transferring the trays of incorrectly labeled 

cookies to plastic-lined paper pouches and applying the correct label; 

o Investigation by the Production Manager and Label Team Supervisor to determine the 

root cause of the problem. As necessary to correct the problem and prevent it in the 

future, the Label Team modifies its procedures and arranges for re-training as 

appropriate; and

o Initiation of a recall of any product in commerce that is misbranded under section 403(w) 

of the FD&C Act.

11.13.4.3.2 Corrective actions/corrections for label management controls

• Corrections: If the Production Supervisor determines that an electronic file for the wrong 

label was sent to the production printer but the label has not been applied to product, the 

Production Supervisor follows up with the Label Team Supervisor to obtain the correct 

electronic file without creating a record of the correction.

• Corrective actions: If the wrong label is applied to any products, Bakery B takes and 

documents the following corrective actions:

o Segregation of any products that have the wrong label;

o Rework of affected products by manually transferring the trays of incorrectly labeled 

cookies to plastic-lined paper pouches and applying the correct label;

o Investigation by the Production Manager of the root cause of the problem. The 

Production Supervisor arranges for modification of the label management procedures, 

re-training of personnel, or both as appropriate; and

o Initiation of a recall of any product in commerce that is misbranded under section 403(w) 

of the FD&C Act.

11.13.4.4 Bakery B’s records for label controls and associated 

preventive control management components

11.13.4.4.1 Records for label content controls

Bakery B maintains the following records:

• Label Content Procedures.
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• The approved food allergen label specification, signed and dated by the Label Development 

Team Supervisor.

• The following records that are initialed and dated by the PCQI to document review of the 

records:

o The production label that is pasted onto the production sheet and signed and dated by 

the Production Supervisor; and

o Any corrective action records.

11.13.4.4.2 Records for label management controls

Bakery B maintains the following records:

• Label Management Procedures.

• The following records that are initialed and dated by the PCQI to document review of the 

records:

o The production label that is pasted onto the production sheet and signed and dated by 

the Production Supervisor; 

o The production sheet on which the line operator documents the results of the verification 

check that the correct label is being applied to the correct product at the beginning of 

each production run and each time newly printed labels are brought to the line during 

production; and

o The corrective action records.

11.13.5 Bakery B’s Supply-chain Controls

11.13.5.1 The ingredient with a food allergen hazard that requires a 

supply-chain-applied control

As discussed in section 11.13.2.3, based on initial discussions with potential suppliers of vegan 

caramel chips, Bakery B’s PCQI determined that the caramel chips have the potential for 

unintended milk presence as a result of allergen cross-contact by potential suppliers, because 

the potential suppliers produce non-vegan caramel, milk chocolate, and butterscotch chips that 

contain milk. 

11.13.5.2 The two vegan caramel chip processors that Bakery B 

evaluates as potential suppliers

Bakery B evaluates two vegan caramel chip processors as potential suppliers. The 

characteristics of these caramel chip processors are as follows:

• Caramel Chip Processor A uses dedicated processing lines (i.e., one processing line for 

production of caramel (and other) chips that contains milk and a different processing line for 

production of caramel (and other) chips that do not contain milk). Caramel Chip Processor A 
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does not provide an allergen advisory statement for caramel chips that it supplies as an 

ingredient to receiving facilities. 

• Caramel Chip Processor B uses product scheduling, scraping, and push-through cleaning of 

a processing line used to produce caramel chips containing milk before using that 

processing line to produce caramel chips that do not contain milk. Caramel Chip Processor 

B uses the push-through material as re-work in the production of caramel chip products that 

contain milk. During production, Caramel Chip Processor B routinely verifies the allergen 

cleaning by testing FCSs of the chip depositor for the presence of milk allergen, with repeat 

cleaning if necessary. Caramel Chip Processor B does not provide an allergen advisory 

statement for caramel chips that it supplies as an ingredient to receiving facilities. 

In this example, Bakery B will approve Caramel Chip Processor A and Caramel Chip Processor 

B as suppliers. In the remainder of this example, we refer to these processors as Supplier A and 

Supplier B, respectively.

11.13.5.3 Bakery B’s supplier approval and verification activities

To approve its suppliers, Bakery B:

• Asked each potential supplier to fill out a questionnaire related to:

o The supplier’s food allergen program (including the supplier’s CGMP measures, allergen 

cross-contact controls, and label controls); and 

o Whether the supplier provides an allergen advisory statement for the potential 

unintended milk presence in vegan caramel chips.

42

• Searched FDA’s “Supplier Evaluation Resources” web page (see Table 11-8) for information 

relevant to each supplier's compliance with applicable food safety regulations; 

• Reviewed a third-party audit provided by each supplier; and

• Tested several lots of vegan caramel chips from each potential supplier to confirm that the

caramel chips do not contain milk.

For ongoing verification of each approved supplier, Bakery B:

• Requires Supplier A to provide a Certificate of Conformance that the caramel chips are 

produced on a dedicated processing line each year and a third-party audit every three

years;

• Requires Supplier B to provide a third-party audit each year; and

• Samples and tests caramel chips from Supplier B quarterly. 

Bakery B’s PCQI reviews the Certificate of Conformance and the results of the audit and the 

analytical tests for the presence of milk in the caramel chips within a week of receipt and 

documents this review by signing and dating the Certificate of Conformance, results of the audit,

and the analytical tests.

42 In this example, neither supplier provides allergen advisory statements for its products. Bakery B’s 

supply-chain program specifies that Bakery B would ask any supplier that provides allergen advisory 

statements to provide the rationale for doing so.
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11.13.5.4 Bakery B’s corrective actions/corrections in the event of 

supplier non-conformance

• Corrections: If the results of an onsite audit raise questions about whether a supplier is 

controlling for unintended milk presence in the caramel chips, but it seems unlikely that

allergen cross-contact has occurred, Bakery B temporarily stops using the caramel chips 

from that supplier until the supplier addresses the questions raised by the audit. If it appears 

that the supplier is not able to address the questions in a timely fashion, Bakery B takes 

steps to approve a new supplier, relying in the meantime on the remaining supplier.

• Corrective actions: If the results of an onsite audit indicate that cross-contact is likely to have 

occurred or if the results of Bakery B’s sampling and testing demonstrate unintended milk 

presence in one or more lots of caramel chips: 

o Bakery B temporarily stops using the caramel chips from that supplier until the supplier 

can provide evidence that the problem has been corrected. If it appears that the supplier 

is not able to solve the problem in a timely fashion, Bakery B takes steps to approve a 

new supplier, relying in the meantime on the remaining supplier; and

o Bakery B’s PCQI evaluates caramel chip cookies that have been manufactured using 

caramel chips from the supplier for unintended milk presence, and evaluates whether 

cookies that have been released into commerce need to be recalled.

11.13.5.5 Bakery B’s records documenting its supply-chain controls 

Bakery B maintains the following records:

• The written supply-chain program required by 21 CFR 117.475(c)(1);

• Written procedures for the receipt of caramel chips (see 21 CFR 117.475(c)(4)), and a 

checklist documenting implementation of those procedures (see 21 CFR 117.475(c)(5));

• The following records that are initialed and dated by the PCQI to document review of the 

records:

o Documentation of the determination of the appropriate supplier verification activities for 

raw materials and other ingredients (see 21 CFR 117.475(c)(6)); 

o Documentation of the results of its search of FDA’s “Supplier Evaluation Resources” web

page (see Table 11-8) for each supplier as a supplier approval activity (see 21 CFR 

117.475(c)(3) and (6));

o The results of third-party audits for each supplier of caramel chips (see 21 CFR 

117.475(c)(7));

o The results of quarterly sampling and testing by Bakery B of caramel chips provided by 

Supplier B; and

o Records of any corrective actions (see 21 CFR 117.475(c)(16)).
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11.13.6 Summary of Bakery B’s Food Allergen Program

Appendix 11-3 summarizes Bakery B’s allergen cross-contact controls and label controls on the 

FSPCA’s Food Allergen Control Form (Form 2-H (Modified) from Appendix 2 of this guidance).

Appendix 11-3 also provides Bakery B’s: 

• Ingredient analysis to support both allergen cross-contact controls and label controls (Form 

2E (Modified) from Appendix 2 of this guidance); 

• Food allergen verification list to support label controls (Form 2F (Modified) from Appendix 2

of this guidance); and 

• Production line food allergen assessment to support allergen cross-contact controls (Form 

2G (Modified) from Appendix 2 of this guidance). 

11.14 References

Some of these references include a website address. FDA has verified these website 

addresses, as of the date the notice of availability for this document publishes in the Federal 

Register, but websites are subject to change over time.

Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, 

Fenton MJ, Arshad SH, Bahna SL, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, 

Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli 

S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger 

JM. 2010. Guidelines for the diagnosis and management of food allergy in the United 

States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol.126(6 

Suppl):S1-58.

Food and Agriculture Organization of the United Nations and World Health Organization. 2021. 

Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. 

Part 2: Review and establish threshold levels in foods of the priority allergens. Virtual 

meeting, 15 March – 2 April 2021. Summary and Conclusions. Available at 

https://www.who.int/news-room/events/detail/2021/03/15/default-calendar/ad-hoc-jointfao-who-expert-consultation-on-risk-assessment-of-food-allergens-part2-review-andestablish-threshold-levels-in-foods-of-the-priority-allergens 

Food and Agriculture Organization of the United Nations and World Health Organization. 2022. 

Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. 

Part 2: Review and establish threshold levels in foods of the priority allergens. Virtual 

follow-up meeting on milk and sesame. Summary and Conclusions. Available at 

https://www.who.int/news-room/events/detail/2021/03/15/default-calendar/ad-hoc-jointfao-who-expert-consultation-on-risk-assessment-of-food-allergens-part2-review-andestablish-threshold-levels-in-foods-of-the-priority-allergens

Grocery Manufacturers Association (GMA). 2009. Managing Allergens in Food Processing 

Establishments. Fourth Edition. Edited by WE Stone and KE Stevenson.

National Advisory Committee on Microbiological Criteria for Foods (NACMCF). 1998. Hazard 

Analysis and Critical Control Point Principles and Application Guidelines, Journal of 

Food Protection, 61: 1246-1259.
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Remington, BC, J Westerhout, MY Meima, WM Bloma, AG Kruizinga, MW Wheeler, SL Taylor, 

GF Houben, JL Baumert. 2020. Updated population minimal eliciting dose distributions 

for use in risk assessment of 14 priority food allergens. Food and Chemical Toxicology 

139: 111259. (https://doi.org/10.1016/j.fct.2020.111259) 

Taylor, SL and SL Hefle. 2001. Food Allergies and Other Food Sensitivities. Food Technology

55(9): 68-83.

11.15 Resources

The tables in this section are a compilation of resources that 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 this guidance available, but websites are subject to 

change over time. In addition, the policies and recommendations in these resources can change 

over time. We recommend that you periodically review websites listing FDA’s CPGs, FDA’s 

Guidance for Industry, and the resources listed in Table 11-8 for new or modified policies and 

recommendations.

Table 11-6. Applicable FDA Compliance Policy Guides* 

CPG Link

CPG Sec. 555.250 Statement of Policy for 

Labeling and Preventing Cross-contact of 

Common Food Allergens. 2001

https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/cpg-sec-555250-statement-policy-labeling-andpreventing-cross-contact-common-food-allergens-new

CPG Sec 555.250 DRAFT: Major Food 

Allergen Labeling and Cross-contact. 

202343

https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/cpg-sec-555250-draft-major-food-allergen-labelingand-cross-contact 

*In addition to the specific link we provided, you can access FDA’s Manual of Compliance Policy Guides 

at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliancemanuals/manual-compliance-policy-guides. Chapter 5 addresses Food, Colors, and Cosmetics and is 

available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/manualcompliance-policy-guides/chapter-5-food-colors-and-cosmetics.

43 In 2023, FDA issued for public comment a draft compliance policy guide entitled “CPG Sec. 555.250 

DRAFT: Major Food Allergen Labeling and Cross-contact” (88 FR 31507, May 17, 2023). When finalized, 

this draft CPG will replace existing guidance, in CPG Sec. 555.250 Statement of Policy for Labeling and 

Preventing Cross-contact of Common Food Allergens, for FDA staff on FDA’s enforcement policy 

regarding major food allergen labeling and cross-contact.
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Table 11-7. Applicable FDA Guidance for Industry* 

Guidance Link

Questions and Answers Regarding 

Food Allergens, Including the Food 

Allergen Labeling Requirements of 

the Federal Food, Drug, and 

Cosmetic Act (Edition 5). 2022. 

Guidance for Industry**

https://www.fda.gov/media/117410/download

Questions and Answers Regarding 

Food Allergens, Including the Food 

Allergen Labeling Requirements of 

the Federal Food, Drug, and 

Cosmetic Act (Edition 5). 2022. 

Draft Guidance for Industry*** 

https://www.fda.gov/media/163454/download

Human Food By-Products For Use 

As Animal Food: Draft Guidance 

for Industry #239*** 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-239-human-food-products-use-animal-food

*In addition to the specific link we provided, or if that link is no longer operative, you can access most of FDA’s Guidance for Industry applicable to 

human food at https://www.fda.gov/FoodGuidances. 

** In 2022, we announced the availability of both draft and final guidance for industry entitled “Questions and Answers Regarding Food Allergens, 

Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5) (87 FR 73561, November 30, 2022). 

These guidances are revisions of a currently issued guidance, entitled “Questions and Answers Regarding Food Allergens, Including the Food 

Allergen Labeling and Consumer Protection Act of 2004 (Edition 4).” The final guidance includes the questions and answers from the currently 

issued guidance that remain substantively unchanged. The draft guidance, when finalized, will explain FDA’s current thinking on a number of 

issues related to the labeling of food allergens, including requirements in both FALCPA and the FASTER Act. 

*** A draft guidance, when finalized, will represent FDA’s current thinking on the specified topic.

Table 11-8. Additional Resources 

Source Resource Title Resource Link

3-A Sanitary 

Standards, 

Inc.

3-A Sanitary 

Standards and 

Accepted 

Practices* 

https://www.3-a.org/
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Source Resource Title Resource Link

American 

Meat 

Institute

AMI Fact Sheet. 

Sanitary 

Equipment 

Design. 2014.

https://www.meatinstitute.org/index.php?ht=a/GetDocumentAction/i/11006

European 

Hygienic 

Engineering 

and Design 

Group 

(EHEDG) 

EHEDG 

Guidelines Doc 

8. Hygienic 

Design

Principles. Third 

Edition. 2018.

https://www.ehedg.org/guidelines/

FDA Firm/Supplier 

Evaluation 

Resources for 

FSMA Rules

https://www.fda.gov/food/food-safety-modernization-act-fsma/firmsupplier-evaluation-resources-fsma-rules

FDA Food 

Allergens/GlutenFree Guidance 

Documents & 

Regulatory 

Information

https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/food-allergens-and-glutenfree-guidance-documents-and-regulatory-information

FDA Industry 

Guidance For 

Recalls

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls

FDA Label 

Declaration of 

Allergenic 

Substances in 

Foods; Notice to 

Manufacturers. 

1996

http://wayback.archiveit.org/7993/20171114013857/https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106546.htm

FDA FSMA Final Rule 

on Sanitary 

Transportation of 

Human and 

Animal Food

https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-transportation-human-and-animal-food
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Source Resource Title Resource Link

Schmidt, RH 

and DJ 

Erickson, 

Food 

Science and 

Human 

Nutrition 

Department, 

Florida 

Cooperative 

Extension 

Service, 

Institute of 

Food and 

Agricultural 

Sciences, 

University of 

Florida

Sanitary Design 

and Construction 

of Food 

Equipment. 

2005.

https://ucfoodsafety.ucdavis.edu/sites/g/files/dgvnsk7366/files/inline-files/26502.pdf

*Available for purchase.
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Appendix 11-1 CGMP Measures to Prevent Allergen Cross-Contact

11-1.A CGMP Measures Are Part of Your Food Allergen Program

As noted in section 11.1, your hazard analysis should consider how your CGMP measures 

prevent allergen cross-contact, and the preventive controls that you establish and implement to 

address a food allergen hazard should complement and enhance your CGMP measures for 

preventing allergen cross-contact. To help you do so, in this Appendix we provide 

recommendations for measures you can take to comply with the CGMP requirements in 21 CFR 

part 117, subpart B, to prevent allergen cross-contact. As noted in section 11.3, you should 

design your food allergen program to prevent allergen cross-contact between foods with 

different food allergen profiles. 

Although the CGMPs do not specify that you take corrective actions if you identify a failure of 

your CGMP measures to prevent allergen cross-contact, we recommend that you implement 

corrections or corrective actions as necessary and appropriate to ensure that the CGMP 

measures that are part of your food allergen program are operating as intended to prevent 

allergen cross-contact. An example of a correction is re-cleaning equipment that is not visibly 

clean before beginning production. Examples of corrective actions are re-training personnel who 

implement the CGMP measures and revising applicable procedures if the procedures do not 

prevent allergen cross-contact as intended.

11-1.B CGMP Measures to Prevent Allergen Cross-Contact by Personnel

Examples of CGMP measures that you can implement to prevent allergen cross-contact by 

personnel are:

• Provide personnel who work in direct contact with raw materials or other ingredients that are 

(or contain) a food allergen, or who work on a production line for a food product that 

contains a food allergen, with aprons, smocks, uniforms, or other appropriate types of clean,

washable outer garments. When practical for your operation, an additional CGMP measure 

is for these outer garments and other apparel (such as hairnets) to be dedicated (e.g., to the 

production of products with distinct food allergen profiles) and distinguishable (e.g., through

a color-coding system).

• Assign employees to work exclusively with foods containing the same food allergen profile. 

Alternatively, establish procedures for employees to change apparel when they move 

between areas that are processing foods with different food allergen profiles. When practical

for your operation, an additional CGMP measure is to avoid production assignments that 

would require personnel to move back and forth, during the same shift, between a 

processing line that contains a food allergen and a different processing line for food that has 

a different food allergen profile. 

• Provide disposable gloves for use by personnel who directly handle foods containing food 

allergens and direct those personnel to discard the gloves in a covered waste bin

immediately after use. Alternatively, emphasize the importance of washing hands after 

working with foods that are, or contain, a food allergen and of maintaining reusable gloves in 

an intact, clean, and sanitary condition.
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• Develop traffic patterns that restrict the movement of personnel (including personnel with 

responsibilities for production, maintenance, and clerical activities) between areas that are 

processing foods with different food allergen profiles.

• Provide separate break areas for use by personnel who work in processing areas with 

different food allergen profiles when doing so is practical for your operation. Alternatively, 

provide an apparel area, at the entrance to the processing area for foods that are, or 

contain, food allergens, where personnel obtain outer garments to be worn in the processing 

area and return the outer garments when they leave the area (e.g., for breaks or at the end 

of the shift), or instruct personnel on where to leave outer garments when they leave the 

production area.

In addition to these CGMP measures to prevent allergen cross-contact by personnel, we 

recommend that you make visitors aware of food allergen practices in the plant to prevent 

allergen cross-contact due to the actions of the visitors.

The sections of part 117 that are relevant to the recommendations in this chapter regarding 

personnel are 21 CFR 117.10(b)(1), 117.10(b)(3), 117.10(b)(5), and 117.10(b)(9).

11-1.C CGMP Measures for the Design and Construction of the Plant to 

Prevent Allergen Cross-Contact

When building a new plant or remodeling an existing plant, we recommend that you incorporate 

features in overall plant layout and design that will minimize the potential for allergen crosscontact and facilitate cleaning of equipment. When doing so is not practical (e.g., due to 

limitations in the design of an existing plant), we recommend that you place increased emphasis 

on CGMP measures for sanitary operations, equipment and utensils, storage and handling of 

raw materials and other ingredients, and processing operations.

Examples of features that you can incorporate in the design and construction of the plant to 

prevent allergen cross-contact are:

• Separation in space between areas processing foods with different food allergen profiles, 

such as by a dedicated plant, section of a plant, or processing line (e.g., separated by 

permanent or temporary doors and full or partial walls);

• Use of enclosed equipment or processing lines (e.g., closed pipes, tanks, pumps, heat 

exchangers, and fillers) when practical and appropriate. Alternatively, configuration of open 

production lines so they do not cross over to minimize the potential for an allergencontaining food to fall onto a line containing food with a different food allergen profile. 

Another alternative is to install barriers such as pans and shields at the crossover points.

• Use of valves to physically separate ingredients with different food allergen profiles in 

processing equipment or lines. When using valves, we recommend that you:

o Ensure that all valves are clearly marked; and

o Clean and inspect valves routinely for potential leaks.

• Use of air flow controls to prevent airborne particulate matter that is, or contains, a food 

allergen from being brought into areas that do not use that food allergen. Examples of such 

air flow controls are a microbiological air filtration system and a positive air pressure 

environment in the packaging area.
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• Use of traffic patterns that that do not cross over open production lines and that restrict the 

movement of equipment, raw materials and other ingredients, WIP, rework, and finished 

product between areas in which foods with different food allergen profiles are exposed to the 

environment in the plant. 

• Creation of a buffer room or clean area between areas handling foods with different food 

allergen profiles.

The sections of part 117 that are relevant to the recommendations in this chapter regarding the 

design and construction of the plant are 21 CFR 117.20(b)(2), 117.20(b)(4), and 117.20(b)(6).

11-1.D CGMP Measures for Sanitary Operations to Prevent Allergen CrossContact

Examples of CGMP measures that you can implement to prevent allergen cross-contact during 

cleaning operations are:

• Establish and implement cleaning procedures that are tailored to the removal of allergenic 

food residues from your equipment and utensils based on the:

o Nature of the food or ingredient; 

o Type of food residue that is being removed (e.g., liquid, paste, or powders); 

o Type of FCS (e.g., stainless steel, rubber, or plastic);

o Nature of the cleaning equipment (e.g., CIP or manual); and 

o Cleaning options (detergents for wet operations, vacuums and brushes for dry 

operations).

• Clean equipment and utensils in a manner that protects against allergen cross-contact.

Examples of how to do so are:

o Using freshly prepared cleaning solutions (rather than reusing cleaning solutions that

could cause recontamination of surfaces with allergenic food residue);

o Using vacuums, rather than compressed air or grit blasting, for removing dry food 

residue from difficult-to-clean areas, because compressed air and grit blasting can 

disperse food allergen residues from one area to another. Alternatively, if vacuums 

cannot remove such residues, you could disassemble the equipment to enable you to 

remove such residues. If you need to use compressed air or grit blasting (e.g., if 

vacuums cannot remove such residues and it is not practical to disassemble equipment 

for cleaning food residue), you should take precautions to contain food residues that are 

forcefully removed by the compressed air or grit blasting; and

o Using low pressure water hoses, rather than high pressure water hoses, for removing 

food residues from wet processing areas, because high pressure water hoses could 

spread and aerosolize food allergen residues during cleaning.

• Clean bins, totes, and containers used for ingredients that are, or contain, a food allergen as 

soon as possible after being emptied.

• Dismantle equipment, as appropriate, to allow for manual cleaning.

• Inspect equipment after each cleaning to determine whether it is visibly clean, and 

periodically confirm the results of the visible inspection through periodic (e.g., quarterly) 
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analytical tests (whether general tests for any food residue, or specific tests for residues of 

food allergens).

The sections of part 117 that are relevant to the recommendations in this chapter regarding

sanitary operations are 21 CFR 117.35(a), 117.35(c), and 117.35(d). 

11-1.E CGMP Measures on Equipment and Utensils to Prevent Allergen 

Cross-Contact

Examples of CGMP measures that you can implement to prevent allergen cross-contact from 

equipment and utensils are:

• Purchase or design equipment with hygienic design features to prevent the accumulation of 

food residues, to allow easy access for dismantling, cleaning, and inspecting equipment, 

and (for liquid transfer systems) to minimize the potential for allergen cross-contact through 

cross connections or pressure differentials (e.g., through use of “make or break” 

connections to facilitate disconnecting CIP lines during production). Resources that you 

could adapt to help you do so are available online or are available for purchase (see Table 

11-8). Although these publications are directed to sanitary design of equipment to prevent 

contamination of food from pathogenic microorganisms, the same principles generally apply 

to the prevention of allergen cross-contact. 

• When repairing or maintaining equipment, ensure that welds are smooth; replacement 

materials are easily cleanable; seals and hoses do not contain cracks; and “dead ends” or 

other areas where pockets of materials can accumulate are eliminated.

• Provide shielding, permanent and/or temporary partitions, covers, and catch pans to protect 

exposed unpacked product from allergen cross-contact.

• Provide physical containment of dry ingredients by partially or completely covering specific 

equipment, such as conveying equipment, hoppers, storage silos, shakers, and size 

graders.

• Dedicate distinguishable (e.g., through color-coding) utensils and tools for processing lines 

with different food allergen profiles, when practical for your operation. Alternatively, place 

increased emphasis on sanitary operations, such as by visually inspecting equipment and 

tools that are shared between processing lines for products with different food allergen 

profiles for food residues that could contain food allergens.

The sections of part 117 that are relevant to the recommendations in this chapter regarding 

equipment and utensils are 21 CFR 117.40(a)(1) and (6) and 117.40(b).

11-1.F CGMP Measures for Raw Materials and Other Ingredients, and for 

Manufacturing Operations, to Prevent Allergen Cross-Contact

11-1.F.1 CGMP measures for raw materials and other ingredients to 

prevent allergen cross-contact

Examples of CGMP measures that you can implement to prevent allergen cross-contact during 

receipt and storage of raw materials and other ingredients are:
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• Review all labels on, and documents accompanying, shipments of raw materials or other 

ingredients (including minor ingredients such as spice blends) to confirm that the raw 

material or other ingredient contains only the expected food allergen(s).

• Inspect allergen-containing raw materials and other ingredients upon receipt to ensure that 

the containers are intact and that the contents have not leaked or spread. If containers have 

leaks, tears, or other defects, inspect nearby containers for evidence of allergen crosscontact. Either reject (or properly dispose of) raw materials and other ingredients when a 

container is not intact or there is evidence of allergen cross-contact, or handle damaged 

containers in a manner that prevents allergen cross-contact. For example, you could store 

damaged containers in a separate location, place a damaged container inside another 

container, or move the contents of the damaged container to a different container, with 

appropriate identification of any new containers that you use. You should not move 

damaged containers into a production area unless leakage of allergen-containing raw 

materials and other ingredients has been contained.

• Clearly identify allergen-containing raw materials and other ingredients using a system that 

adequately distinguishes between raw materials and other ingredients with different food 

allergen profiles to alert personnel that these materials are subject to special precautions 

and handling procedures throughout the plant. An example of such a system is color-coding 

– e.g., through use of color-coded stickers/tags, placards, or shrink-wrap, with a specific 

color dedicated to each of the major food allergens and a system (such as a chart displayed 

at multiple locations in the plant) for alerting personnel to the assigned colors.

44 Another 

example of such a system is the use of distinctive pallets, totes, or bins dedicated to specific 

food allergens. 

• Establish and implement measures to ensure that raw materials and other ingredients that 

are received in bulk or food not completely enclosed by a container, including those 

delivered by railcar or tanker, have been transported and are being transferred in a manner 

that does not result in allergen cross-contact.

45 Examples of such measures are verification 

of tanker and/or railcar cleaning (e.g., hopper, boxcar, tanker, wash-tags), prior load 

information, and cleaning and sanitizing vehicles and transportation equipment. You should 

reject the shipment if there is evidence that food has not been protected from allergen crosscontact.

• Segregate allergen-containing raw materials and other ingredients from raw materials and 

other ingredients that do not contain allergens – e.g., in a dedicated storage room or area of 

the plant, or in separate bays or areas of a storage room. If a dedicated storage room or 

area is not available, we recommend that you store raw materials and other ingredients that 

contain allergens below those that do not contain allergens to prevent allergen cross-contact 

in the event of a spill or leak.

44 If your plant uses a color-coding system for purposes other than identification of food allergens, you 

should take steps to prevent confusion between the color-coding systems.

45 Our regulations (in 21 CFR Part 1, Subpart O) for Sanitary Transportation of Human and Animal Food

establish requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in 

transporting human and animal food to use sanitary practices to ensure the safety of the food. The goal of 

the regulations is to prevent practices during transportation that create food safety risks, such as failure to 

properly refrigerate food requiring temperature control for safety, inadequate cleaning of vehicles between 

loads, and failure to properly protect food. For more information see our webpage “FSMA Final Rule on 

Sanitary Transportation of Human and Animal Food” (see Table 11-8). 
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• Use secure, closable containers to store allergen-containing raw materials and other 

ingredients.

• When receiving or using bulk storage tanks or silos:

o Use techniques such as visual identifiers (e.g., stickers or tags), computerized 

verification checks, lockouts over valve openings, and employee inspection and sign-off 

on a valve and tank set-up to prevent mix-ups that could result in allergen cross-contact; 

and

o Clean bulk storage tanks or silos used to store an allergen-containing raw material or 

other ingredient before using the bulk storage tanks or silos for a raw material or other 

ingredient that has a different food allergen profile.

• Use containers that are movable on their own, rather than containers that need to be moved 

with handling equipment such as dollies, forklifts, or pallet jacks, for allergen-containing raw 

materials and other ingredients, whenever practical. Alternatively, clean the handling 

equipment after moving allergen-containing raw materials and other ingredients. You should 

take care to avoid damage to containers or the spread of allergens within your plant from 

transporting or lifting devices.

The sections of part 117 that are relevant to the recommendations in this chapter regarding raw 

materials and other ingredients are 21 CFR 117.80(b)(1), 117.80(b)(5), 117.80(b)(7), and 

117.80(b)(8).

11-1.F.2 CGMP measures for manufacturing operations to prevent 

allergen cross-contact

Examples of CGMP measures that you can implement to prevent allergen cross-contact during 

manufacturing operations are:

• Implement production scheduling to separate by time the manufacture of products with 

different food allergen profiles. For example, you could produce the foods in a sequence 

whereby the food with no allergen or the fewest allergens is produced first and the food with 

the most allergens is produced last. As another example, you could cluster runs of products 

containing the same food allergen profile to reduce the number of changeovers.

• Add allergenic ingredients as late in the production process as possible, and as far 

downstream as possible in the processing line (e.g., closest to the filling and packaging 

equipment), to minimize the amount of equipment in the production area that comes in 

contact with the allergen.

• Stage allergen-containing raw materials and other ingredients in designated areas as close 

as possible to the production area before opening, weighing, or transferring them in covered 

or closed containers to the processing line.

• Add raw materials and other ingredients that are, or contain, a food allergen in a manner 

that minimizes the potential for unintentional dispersion by dust. For example, you could 

minimize the formation and dispersion of dust by adding liquid ingredients to mixers at the 

same time as powders, using dust collection systems (e.g., local exhaust, ventilation 

systems and/or vacuum systems), controlling surrounding dust sources, and/or covering 

equipment.

• Immediately clean up spills that contain food allergens. 
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• Place special emphasis on the control of WIP and re-work that contain food allergens. 

Examples of how to control WIP and rework to prevent allergen cross-contact are:

o Clearly identify WIP and rework (including the name of the WIP/rework, all food 

allergens present in the WIP/rework, the date of manufacture, which production line the 

materials will be added to and, where known, the date the rework is to be used) and

store them in sturdy containers with secure covers in designated, clearly marked areas. 

Use interior disposable plastic liners where appropriate.

o Assemble all WIP and rework for a specific batch of product in a dedicated staging area 

before transferring the WIP/rework to the processing line.

o Implement a rework policy for rework to be added back to same finished product (i.e., 

“exact into exact”) whenever practical. Alternatively, add rework to another product with 

the same food allergen profile.

o Use allergen-containing WIP and rework as soon as possible to minimize the potential 

for the rework to be incorporated into the wrong product.

• Use allergen-specific testing procedures where necessary and when possible to identify 

sanitation failures or possible allergen cross-contact.

• Place waste materials that contain food allergens (e.g., spills, defective and unusable 

products, used ingredient packaging) in covered collection bins, totes, or containers that are 

identified as holding allergen-containing waste.

The sections of part 117 that are relevant to the recommendations in this chapter regarding 

manufacturing operations are 21 CFR 117.80(a)(5), 117.80(c)(1), 117.80(c)(5), 117.80(c)(6), 

117.80(c)(7), 117.80(c)(10), 117.80(c)(12), and 117.80(c)(13).

11-1.G CGMP Measures for Warehousing and Distribution to Prevent 

Allergen Cross-contact

Examples of CGMP measures that you can implement to prevent allergen cross-contact during 

warehousing and distribution are:

• Hold food in sealed packages or closed containers.

• When moving containers of allergen-containing products using handling equipment such as 

dollies, forklifts, or pallet jacks, take care to avoid damage to packaging that could result in 

food allergen residues on packages of foods that do not contain that food allergen. (Opening 

the package could result in transfer of food allergens on the package exterior to the food 

inside.)

• Clean up spills or leaks from damaged containers of allergen-containing products as soon 

as they occur.

The section of part 117 that is relevant to the recommendations in this chapter regarding 

warehousing and distribution is 21 CFR 117.93.
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Appendix 11-2 Summary of Dessert Manufacturer A’s Food Allergen 

Controls and Associated Preventive Control Management 

Components

FORM 2-D (Modified) Allergen Cleaning Procedures

PAGE _________

PRODUCTS: Raspberry sorbet, vanilla ice cream, vanilla frozen custard, and vanilla frozen 

custard with almonds

PLANT NAME: _Dessert Manufacturer A __ADDRESS: _______________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Allergen Cleaning

Item Applicable Information

Location Production Line

Purpose Remove all residues of allergen-containing food and ingredients

Frequency - After production of vanilla frozen custard with almonds, when production sequence is 

normal as follows: (1) raspberry sorbet; (2) vanilla ice cream; (3) vanilla frozen custard; (4) 

vanilla frozen custard with almonds; and

- Any time the production sequence does not follow the normal sequence 

Who Provider of food hygiene services and Sanitation Supervisor

Procedure Allergen cleaning procedure

Monitoring - During each cleaning procedure, the Sanitation Supervisor uses the allergen cleaning 

checklist to document monitoring of each step in the cleaning procedure and note any 

corrections.

- Before each production run of raspberry sorbet, the Sanitation Supervisor conducts and 

documents a pre-operational visual inspection of applicable equipment and utensils as 

monitoring that they are visibly clean.

Verification - After the equipment has been cleaned and visually inspected, the Sanitation Supervisor 

uses an ATP bioluminescence swab test or a protein swab test to verify that the line is clean

and notes the results on the allergen cleaning checklist. 

- On a quarterly basis, and whenever there is a change in the cleaning procedure, a QA 

technician verifies the visual inspection by conducting allergen-specific analytical tests before 

a production run of raspberry sorbet that follows a run of vanilla frozen custard with almonds

and keeps the analytical test results as a record. 

- On a weekly basis, the PCQI reviews the allergen cleaning checklists, including results of 

ATP bioluminescence swab tests or protein swab tests, as verification that all equipment and 

utensils have been cleaned prior to production, and documents that record review by 

initialing and dating the allergen cleaning checklists. 

- On a weekly basis, the PCQI reviews pre-operational visual inspection records and 

documents that record review by initialing and dating the records. 

- Within a week of any allergen-specific analytical tests to verify the visual inspection, the 

PCQI reviews the results of the analytical tests as verification, and documents that record 

review by initialing and dating the results. 

- Within a week of a problem that requires corrective action, the PCQI reviews the corrective 

action records, and initials and dates each of the records reviewed in the place marked 

“Verified by.”
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Item Applicable Information

Corrections - If the Sanitation Supervisor observes, during monitoring, that a step in the allergen cleaning 

procedure has not been properly implemented, the Sanitation Supervisor directs personnel to 

repeat the full cleaning procedure before beginning the next production run and notes this 

action on the allergen cleaning checklist. 

- If the ATP or protein swab tests indicate that the equipment has not been adequately 

cleaned, the Sanitation Supervisor directs personnel to repeat the full cleaning procedure 

and notes this action on the allergen cleaning checklist. 

Corrective actions If a routine analytical test detects unintended allergen presence in raspberry sorbet, or if a 

consumer who has an allergy to egg, milk, or almonds reports an allergic reaction to 

raspberry sorbet:

- If the problem was identified through a consumer report of an allergic reaction, 

Manufacturer A conducts product testing to confirm the unintended allergen and, if allergen 

cross-contact has occurred, determine the extent of the problem (e.g., number of affected 

lots). 

- The Production Manager conducts a root cause investigation to try to determine whether:

- Allergen cleaning procedures were not properly implemented; or 

- The allergen cleaning procedures are not effective.

- When appropriate based on the root cause of the problem, the Production Supervisor:

- Re-trains sanitation managers/personnel;

- Revises the allergen cleaning procedures; 

- Appropriately disposes of impacted lots of raspberry sorbet that have not yet been 

distributed; and

- Recalls affected lots of raspberry sorbet that are in commerce and are adulterated 

under section 402(a)(4) of the FD&C Act due to allergen cross-contact.

Records - An SSOP (with procedures for cleaning food-contact surfaces and forms to communicate 

the written procedures and document their use, for monitoring/verification and for 

corrections/corrective actions); 

- The following records that are dated and initialed by the PCQI:

- The allergen cleaning checklist for each cleaning cycle;

- Pre-operational visual inspection records 

- A record of the results of any analytical test conducted to confirm the results of visual

inspection; and

- Any corrective action records.

Verification: (signature or initials)_____________________Date: ________________________
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 91

FORM 2-E (Modified) FOOD ALLERGEN INGREDIENT ANALYSIS

PAGE _________

PRODUCTS: Raspberry sorbet, vanilla ice cream, vanilla frozen custard, and vanilla frozen 

custard with almonds

PLANT NAME: _Dessert Manufacturer A __ADDRESS: _______________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Vanilla ice 

cream

Raw Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (almond)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in 

Allergen Advisory

Statements

Cream Creamery A 

and Creamery 

B 

X 

Milk powder Powdered Milk 

Manufacturer C 

and Powdered 

Milk 

Manufacturer D

X 

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Vanilla 

frozen custard

Raw 

Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (almond)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in 

Allergen Advisory

Statements

Cream Creamery A and 

Creamery B X 

Milk powder Powdered Milk 

Manufacturer C 

and Powdered 

Milk Manufacturer 

D 

X 
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 92

Raw 

Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (almond)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in 

Allergen Advisory

Statements

Pasteurized 

liquid eggs

Egg 

Establishment E 

and Egg 

Establishment F

x 

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Vanilla 

frozen custard with almonds

Raw 

Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (almond)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in 

Allergen Advisory

Statements

Cream Creamery A and 

Creamery B X 

Milk powder Powdered Milk 

Manufacturer C 

and Powdered Milk 

Manufacturer D

X 

Pasteurized 

liquid eggs

Egg Establishment 

E and Egg 

Establishment F

x 

Roasted, 

chopped 

almonds

Almond Handler G 

and Almond 

Handler H

x 
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 93

FORM 2-F (Modified) FOOD ALLERGEN LABEL VERIFICATION LIST

PAGE _________

PRODUCTS: Raspberry Sorbet, vanilla ice cream, vanilla frozen custard, and vanilla frozen 

custard with almonds

PLANT NAME: _Dessert Manufacturer A __ADDRESS: _______________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Product Allergen Statement [In Ingredient List]

Raspberry sorbet Not applicable

Vanilla ice cream Milk powder

Vanilla frozen custard Milk powder, eggs

Vanilla frozen custard with almonds Milk powder, eggs, almonds
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 94

FORM 2-G (Modified) PRODUCTION LINE FOOD ALLERGEN ASSESSMENT

PAGE _________

PRODUCTS: Raspberry Sorbet, vanilla ice cream, vanilla frozen custard, and vanilla frozen 

custard with almonds

PLANT NAME: _Dessert Manufacturer A __ADDRESS: _______________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Production Line Assessment

Product Name

Production 

Line 

Egg

Milk

Soy

Wheat

Tree Nut (almond)

Peanut

Fish (market 

name)

Shellfish (market 

name)

Sesame

Raspberry sorbet Line A

Vanilla ice cream Line A x

Vanilla frozen custard Line A X x

Vanilla frozen custard with 

almonds

Line A X x x
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 95

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Frozen desserts________________________________________________

PLANT NAME: _Dessert Manufacturer A__ADDRESS: _____________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

ALLERGEN CONTROL STEP: _Label content: Correct food allergen label specification____

HAZARD(S): __Food allergens (milk, eggs, almonds)________________________________

Criterion

What to 

Monitor

How to 

Monitor

Frequency of 

Monitoring

Who 

Monitors

Corrective Action/ 

Corrections Verification Records

Correct food 

allergen label 

specification 

for:

- The product 

name and 

Ingredient 

statement on 

tubs of frozen 

dessert; 

- The product 

name on lids 

for frozen 

dessert; and

- The color on 

the edge of 

the product 

tubs and lids

N/A – Dessert 

Manufacturer 

A classifies 

its activity as 

verification

N/A N/A N/A - Correction (not 

documented): Reject lots 

of incorrect tubs and lids 

and follow up with tub/lid 

manufacturer

- Corrective action 

(documented): If the 

inaccurate label content is 

not discovered until after 

the product is packaged: 

- Segregate incorrectly 

packaged products; 

- Rework or discard 

product as 

applicable; 

- Investigate root 

cause and modify 

procedures or retrain personnel as 

applicable; and 

- Recall if necessary

- Upon receipt of the tubs and lids, QA 

personnel:

 - Check that the product name and 

ingredient statement on the label 

pre-printed on the tubs, the

product name on the label preprinted on the lids, and the color 

on the edges of the tubs and lids, 

match the approved food allergen 

label specification;

- Document this verification review 

on a Label Review Form included 

in the Label Content Procedures 

and sign and date the form.

- On a weekly basis, the PCQI reviews, 

initials, and dates the Label Review 

Forms documenting the verification 

review of the product tubs and lids.

- Within a week of any corrective 

actions, the PCQI reviews, initials, and 

dates the corrective action records.

- Label Content Procedures

- The approved food 

allergen label specification, 

signed and dated by the 

Label Coordinator 

- The following records, 

initialed and dated by the 

PCQI:

- Label Review Forms 

documenting the 

verification review of 

the product tubs and 

lids; and

- Any corrective action 

records.
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 96

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Frozen desserts________________________________________________

PLANT NAME: _Dessert Manufacturer A___ADDRESS: ____________________________

ISSUE DATE: (mm/dd/yy)__________SUPERSEDES: (mm/dd/yy)_____________________

ALLERGEN CONTROL STEP: _Label management: Correct tub/lid brought to staging and correct tub/lid used in packaging

HAZARD(S): __Food allergens (milk, eggs, almonds)________________________________

Criterion

What to 

Monitor How to Monitor Frequency of Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Storage of 

tubs and lids 

in boxes on 

pallets with a 

sticker 

containing the 

product name 

and carton 

size on the 

outside of the 

box

Storage of 

tubs and lids 

at receipt and 

following 

production

Visual observation Weekly QA 

personnel

Corrections (documented on a 

Storage Record for Label 

Controls): Return any 

incorrectly stored tubs or lids to 

the correct storage location

On a weekly basis, 

the PCQI reviews, 

initials, and dates 

Storage Record for 

Label Controls 

documenting 

monitoring storage 

of tubs or lids and 

associated 

corrections

- Storage Record for 

Label Controls

 

Check that tub 

brought to the 

staging area 

has the 

correct color 

on the edge of 

the tub, and 

that the lid 

brought to the 

staging area 

has the 

correct 

product name 

and color

The staging 

check of the 

product tub 

and lid

- Visually observe that the 

top edge of the tub and lid 

have the correct color 

At the beginning 

of packaging and 

when new tubs or 

lids are brought 

to the line

Line 

operator

Correction (documented): 

Remove incorrect tubs or lids 

from the line, return to storage, 

and obtain the correct tub and 

lid. 

On a weekly basis, 

the PCQI reviews, 

initials, and dates 

any production 

sheets 

documenting the 

staging checks, 

including when an 

incorrect tub or lid 

is on the line at the 

beginning of 

production 

- Label Management 

Procedures, including 

the procedures for 

monitoring the staging 

check of the product 

tub and lid

- The production 

sheets documenting 

the staging checks, 

initialed and dated by 

the line operator (and 

the PCQI). 
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 97

Criterion

What to 

Monitor How to Monitor Frequency of Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Use of the 

correct tub 

during 

packaging

That the 

correct tub is 

being used 

during 

packaging

- Manually use a barcode 

scanner

When the line is 

set up and at 

hourly intervals 

throughout the 

production run

Line 

operator

Corrective action

(documented): 

- Segregate incorrectly 

packaged products; 

- Rework or discard product 

as applicable; 

- Investigate root cause 

and modify procedures or 

re-train personnel as 

applicable; and 

- Recall if necessary

- On a weekly 

basis, the PCQI 

reviews, initials, 

and dates 

production sheets 

documenting 

results of the 

barcode scanning 

of the tubs

- Within a week of 

any corrective 

actions, the PCQI 

reviews, initials, 

and dates the 

corrective action 

records.

The following records, 

initialed and dated by 

the PCQI:

- The production 

sheets with the 

results of the 

barcode scanner 

and verification 

check that 

unused tubs and 

lids are put in 

appropriately 

stickered boxes; 

and

- Any corrective 

actions
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 98

Appendix 11-3 Summary of Bakery B’s Food Allergen Controls and 

Associated Preventive Control Management Components

FORM 2-E (Modified) FOOD ALLERGEN INGREDIENT ANALYSIS

PAGE _________

PRODUCTS: Oatmeal cookies, caramel chip cookies, and peanut butter cookies

PLANT NAME: _Bakery B ____ADDRESS: _____________________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Oatmeal 

cookies

Raw Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (market 

name) 

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in 

Allergen Advisory

Statements

Flour Miller C and Miller 

D X 

Pasteurized 

liquid eggs

Egg Establishment 

E and Egg 

Establishment F

X 
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 99

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Caramel 

chip cookies

Raw 

Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (market 

name)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in

Allergen Advisory

Statements

Vegan 

caramel 

chips

Carmel chip 

Processor A X*

Vegan 

caramel 

chips

Caramel chip 

Processor B X**

Flour Miller C and Miller 

D X

Pasteurized 

liquid eggs

Egg 

Establishment E 

and Egg 

Establishment F

X

* Low potential for unintended milk presence at Caramel Chip Processor A, because Caramel Chip 

Processor A uses different processing lines for the production of vegan caramel chips and non-vegan 

caramel (and other) chips that contain milk.

** Moderate potential for unintended milk presence at Caramel Chip Processor B, because Caramel Chip 

Processor B uses the same processing line for the production of vegan caramel chips and non-vegan 

caramel (and other) chips that contain milk. However, Caramel Chip Processor B routinely verifies its 

allergen cleaning procedures by testing food-contact surfaces of the chip depositor for the presence of 

milk allergen, with repeat cleaning if necessary.
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 100

Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Peanut 

butter cookies

Raw 

Material 

Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut (market 

name)

Peanut

Fish (market name)

Shellfish (market 

name)

Sesame

Food Allergens in

Allergen Advisory

Statements

Peanut 

butter

Peanut Processor A 

and Peanut 

Processor B

X

Flour Miller C and Miller D

X

Pasteurized 

liquid eggs

Egg Establishment 

E and Egg 

Establishment F

X
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 101

FORM 2-F (Modified) FOOD ALLERGEN LABEL VERIFICATION LIST

PAGE _________

PRODUCTS: Oatmeal cookies, caramel chip cookies, and peanut butter cookies

PLANT NAME: _Bakery B ____ADDRESS: _____________________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Product Allergen Statement

Oatmeal cookies Contains: Wheat and egg

Caramel chip cookies Contains: Wheat and egg

Peanut butter cookies Contains: Wheat, egg, and peanuts
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 102

FORM 2-G (Modified) PRODUCTION LINE FOOD ALLERGEN ASSESSMENT

PAGE _________

PRODUCTS: Oatmeal cookies, caramel chip cookies, and peanut butter cookies

PLANT NAME: _Bakery B ____ADDRESS: _____________________________________

ISSUE DATE: (mm/dd/yy)____________SUPERSEDES: (mm/dd/yy)__________________

Production Line Assessment

Product Name

Production 

Line 

Egg

Milk

Soy

Wheat

Tree Nut

(almonds)

Peanut

Fish (market 

name)

Shellfish (market 

name)

Sesame

Oatmeal cookies Line A X X

Caramel chip cookies Line A X X

Peanut butter cookies Line B X X X
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 103 

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Cookies______ ________________________________________________

PLANT NAME: _Bakery B______ADDRESS: _____________________________________

ISSUE DATE: (mm/dd/yy)________________SUPERSEDES: (mm/dd/yy)________________

ALLERGEN CONTROL STEP: _ Allergen cross-contact: correct color of utensils and tools____

HAZARD(S): __Food allergens (wheat, egg, peanuts)________________________________

Criterion What to 

Monitor How to Monitor

Frequency 

of 

Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Correct Color of - Visual During each Production Remove incorrect utensil/tool for On a weekly basis, the - Allergen cross-contact 

color of the utensils observation shift Supervisor cleaning, and then return them to the PCQI reviews the Checklist control procedures for the 

utensils and 

tools

and tools for each 

cookie 

correct area. Determine, if possible, how 

the problem arose and re-train personnel 

for Allergen Cross-Contact 

Controls records (including 

color of utensils and tools, 

including monitoring 

processing as appropriate. corrective actions when procedures

area - Correction (not documented): If the 

problem is before production, this is 

correction.

- Corrective action (documented): If the 

applicable) and documents 

that verification review by 

initialing and dating the 

record. 

- Checklist for Allergen 

Cross-Contact Controls, 

initialed and dated by the 

PCQI, documenting:

problem is during production, this is - Results of 

corrective action, with documentation of monitoring, 

the following on the non-conformance including nonrecord: conformance; and

- Determination of whether dough - When applicable, 

and/or cookies are affected; associated 

- Evaluation of affected dough and/or corrective actions.

cookies for safety; 

- Prevention of affected cookies from 

entering commerce (re-processing 

or diverting the affected dough 

and/or cookies); and

- Recall of cookies if necessary 
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 104 

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Cookies______ ________________________________________________

PLANT NAME: _Bakery B______ADDRESS: _____________________________________

ISSUE DATE: (mm/dd/yy)________________SUPERSEDES: (mm/dd/yy)________________

ALLERGEN CONTROL STEP: _ Allergen cross-contact: correct color of apparel and movement of personnel_

HAZARD(S): __Food allergens (wheat, egg, peanuts)________________________________

Criterion

What to 

Monitor How to Monitor

Frequency 

of 

Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Correct Color of - Visual During each Production Determine whether incorrect color On a weekly basis, the - Allergen cross-contact 

color of the apparel observation shift Supervisor apparel was due to putting on the wrong PCQI reviews the Checklist control procedures for the 

apparel and 

movement 

for each 

cookie 

item(s) (and, if so, why) or due to a 

violation of the plant traffic pattern 

for Allergen Cross-Contact 

Controls records (including 

color of apparel and 

movement of personnel, 

of processing procedures such that personnel from the corrective actions when including monitoring 

personnel area peanut butter cookie area entered the applicable) and documents procedures

oatmeal/caramel chip cookie production 

area. Re-train personnel as appropriate 

- Correction (not documented): If the 

that verification review by 

initialing and dating the 

record. 

- Checklist for Allergen 

Cross-Contact Controls, 

initialed and dated by the 

employee put on the wrong colored item, PCQI, documenting:

the employee leaves the area and applies

the correct apparel. - Results of 

monitoring, 

- Corrective action (documented): If the including any nonproblem was due to personnel from the conformance; and

peanut butter cookie production area 

entering the oatmeal/caramel chip cookie 

production area, with documentation of 

the following on the non-conformance 

- When applicable, 

associated 

corrective actions

record:

- Determination of whether dough 

and/or cookies are affected;

- Evaluation of affected dough and/or 

cookies for safety; 

- Prevention of affected cookies from 

entering commerce (re-processing 

or diverting the affected dough 

and/or cookies); and

- Recall of cookies if necessary.
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 105 

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Cookies______ ________________________________________________

PLANT NAME: _Bakery B__________ADDRESS: ________________________________

ISSUE DATE: (mm/dd/yy)________________SUPERSEDES: (mm/dd/yy)______________

ALLERGEN CONTROL STEP: _Label content: Correct food allergen label specification _________

HAZARD(S): __Food allergens (wheat, egg, peanuts)__________________________

Criterion

What to 

Monitor

How to 

Monitor

Frequency 

of 

Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Correct food N/A – N/A N/A N/A - Correction (not documented): If the - Before sending the file to the - Label Content Procedures

allergen label 

specification 

for the 

product 

name and 

the 

“Contains” 

statement on 

product 

labels

Bakery B 

classifies 

its activity 

as 

verification

label content does not match the 

approved food allergen label 

specification before the file is sent to 

the production printer, the Label 

Team Supervisor corrects the label 

content in the file.

- Corrective action (documented): If 

the problem is discovered only after 

packaged cookies have been labeled: 

- Segregate affected product;

- Rework cookies by manually 

transferring the trays of 

incorrectly labeled cookies to 

pouches with the correct label; 

- Investigate root cause and 

modify procedures or re-train 

personnel as applicable; and 

production printer, the Label 

Team Supervisor checks that the 

product name and “Contains” 

statement on the production label 

matches the approved food 

allergen label specification.

- The Production Supervisor prints 

a production label from the 

production printer, pastes that 

printed label onto the production 

sheet, and signs and dates the 

production sheet next to the 

printed label. 

- On a weekly basis, the PCQI 

reviews, initials, and dates the 

records documenting the 

verification review of the 

production labels.

- The approved food 

allergen label specification, 

signed and dated by the 

Label Team Supervisor

- The following records, 

initialed and dated by the 

PCQI: 

- The production sheet 

containing the label 

from the production 

printer, signed and 

dated by the 

Production 

Supervisor; and. 

- Any corrective action 

records.

- Recall any product if necessary. - Within a week of a problem that 

requires corrective action, the 

PCQI reviews, initials, and dates 

the corrective action records
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 106 

FORM 2-H (Modified) FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: Cookies______ ________________________________________________

PLANT NAME: _Bakery B_________ADDRESS: __________________________________

ISSUE DATE: (mm/dd/yy)_________________SUPERSEDES: (mm/dd/yy)_______________

ALLERGEN CONTROL STEP: _Label management_________________________________

HAZARD(S): __Food allergens (wheat, egg, peanuts)________________________________

Criterion

What to 

Monitor

How to 

Monitor

Frequency of 

Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Selection of 

the correct 

electronic file 

for the label

N/A –

Bakery B 

classifies its 

activity as 

verification

N/A N/A N/A - Correction (not documented): If the 

Production Supervisor determines that 

a file for the wrong label was sent to 

the production printer but the label has 

not been applied to product, the 

Production Supervisor follows up with 

the Label Team Supervisor to obtain 

the correct file. 

- Corrective action (documented): If the 

problem is discovered only after 

packaged cookies have been labeled: 

- Segregate affected product;

- Rework cookies by manually 

transferring the trays of 

incorrectly labeled cookies to 

pouches with the correct label; 

- Investigate root cause and modify 

procedures or re-train personnel 

as applicable; and 

- Recall any product if necessary.

- The Production Supervisor 

prints a production label from 

the production printer, pastes 

that printed label onto the 

production sheet, and signs 

and dates the production 

sheet next to the printed label

- On a weekly basis, the PCQI 

reviews, initials, and dates the 

records documenting the 

verification review of the 

production labels.

- Within a week of a problem 

that requires corrective action, 

the PCQI reviews, initials, and 

dates the corrective action 

records

- Label Management 

Procedures

- The following 

records, initialed and 

dated by the PCQI:

- The production 

sheet containing 

the label from 

the production 

printer, signed 

and dated by the 

Production 

Supervisor; and

- Any corrective 

actions
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 107

Criterion

What to 

Monitor

How to 

Monitor

Frequency of 

Monitoring

Who 

Monitors Corrective Action/ Correction Verification Records

Application of 

the correct 

label

N/A –

Bakery B 

classifies its 

activity as 

verification

N/A N/A N/A Corrective action (documented): 

- Segregate incorrectly packaged 

products; 

- Rework cookies by manually 

transferring the trays of incorrectly 

labeled cookies to pouches with the 

correct label; 

- Investigate root cause and modify 

procedures or re-train personnel as 

applicable; and 

- Recall any product if necessary

- The line operator:

- Visually checks that the 

correct label is applied; 

and 

- Records, initials, and 

dates the results of the 

visual check on the 

production sheet

- On a weekly basis, the PCQI 

reviews, initials, and dates the 

production sheets with the 

results of the visual check for 

the correct application of the 

product label.

- Within a week of any 

corrective actions, the PCQI 

review, initials, and dates the 

corrective action records.

- Label Management 

Procedures

- The following 

records, initialed and 

dated by the PCQI:

- The production 

sheets 

documenting the 

results of the 

visual check for 

the application 

of the correct 

label; and

- Any corrective 

actions
Contains Nonbinding Recommendations

Draft – Not for Implementation

Chapter 11 (Food Allergen Program) - Page 108

This page intentionally left blank
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 12 (Preventive Controls for Chemical Hazards) - Page 1 

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-assistance-network-tan. 

Chapter 12: Preventive Controls for Chemical Hazards 

(Coming Soon)

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. 
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 13 (Preventive Controls for Physical Hazards) - Page 1 

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-assistance-network-tan. 

Chapter 13: Preventive Controls for Physical Hazards 

(Coming Soon)

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. 
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 14 (Recall Plan) - Page 1

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.

Chapter 14: Recall Plan

Table of Contents

14.1 Purpose of This Chapter

14.2 Terms Used in This Chapter

14.2.1 Definitions Established in 21 CFR 117.3

14.2.2 Other Terms That FDA Uses in This Chapter

14.3 Overview of the Requirements for a Recall Plan

14.4 Resources That Can Help You Prepare a Recall Plan

14.5 Procedures That Describe the Steps to be Taken to Perform Recall 

Actions

14.5.1 Notify Direct Consignees

14.5.1.1 Identify the food

14.5.1.2 Explain the reason for the recall

14.5.1.3 Specify the depth of the recall

 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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14.5.1.4 Provide instructions for what consignees should do with respect to the recalled 

food

14.5.1.5 Make it easy for recipients to communicate with you

14.5.1.6 Include model letters in your recall plan

14.5.2 Notify the Public When Appropriate

14.5.3 Conduct an Effectiveness Check

14.5.4 Decide What to Do with the Recalled Food

14.6 Procedures That Assign Responsibility to Perform Recall Actions

14.7 Procedures for Notifying FDA

14.7.1 Procedures for Notifying FDA About a Reportable Food

14.7.2 Procedures for Notifying the Appropriate FDA Recall Coordinator

14.8 References

14.1 Purpose of This Chapter

The purpose of this chapter is to help you establish and implement a written recall plan as 

required by 21 CFR 117.139. Although the written recall plan is a type of preventive control (see 

21 CFR 117.135(c)(5)), the PCHF requirements specify that the written recall plan is not subject 

to the preventive control management components specified in 21 CFR 117.140 (i.e., 

monitoring, corrective actions and corrections, and verification.) (See 21 CFR 117.140(c).)

Therefore, this chapter does not discuss the application of preventive control management 

components to your written recall plan.

14.2 Terms Used in This Chapter 

14.2.1 Definitions Established in 21 CFR 117.3

See section III.A in the Introduction of this guidance for a glossary of terms that are used in this 

guidance and are defined in 21 CFR 117.3.

14.2.2 Other Terms That FDA Uses in This Chapter

Section III.B in the Introduction of this guidance includes a glossary of terms that are used in 

this guidance but are not defined in 21 CFR 117.3. At this time, that glossary does not include 

all terms that are used in this chapter. See Table 14-1 for additional terms that we use in this 

chapter. We intend to include these terms in the glossary in the Introduction of this guidance 

when we update the Introduction. When we do so, we will delete Table 14-1 from this chapter.
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Table 14-1 Terms Used in this Chapter

Term What the Term Means

Consignee The term defined in 21 CFR part 7 to mean anyone who received, 

purchased, or used the product being recalled. (See 21 CFR 7.3(m).)

Direct account The term used in FDA’s recall policy in 21 CFR part 7, subpart C to mean 

the first consignee in a recalling firm’s distribution chain.

Direct consignee The term used in 21 CFR 117.139 to mean the first consignee in a recalling 

firm’s distribution chain. Part 117 uses the term “direct consignee” to have 

the same meaning as “direct account” in 21 CFR part 7, subpart C.

Recall A firm's removal or correction of a marketed product that FDA considers to 

be in violation of the laws it administers and against which the agency would 

initiate legal action, e.g., seizure. Recall does not include a market 

withdrawal or a stock recovery. (See 21 CFR 7.3(g).)

Recall classification The numerical designation (i.e., I, II, or III) assigned by FDA to a particular 

product recall to indicate the relative degree of health hazard presented by 

the product being recalled.

(1) Class I is a situation in which there is a reasonable probability that the 

use of, or exposure to, a violative product will cause serious adverse health 

consequences or death (21 CFR 7.3(m)(1));

(2) Class II is a situation in which use of, or exposure to, a violative product 

may cause temporary or medically reversible adverse health consequences 

or where the probability of serious health consequences is remote (21 CFR 

7.3(m)(2)); and

(3) Class III is a situation in which use of, or exposure to, a violative product 

is not likely to cause illness or injury (21 CFR 7.3(m)(3)).

(See 21 CFR 7.3(m).) 

14.3 Overview of the Requirements for a Recall Plan

The PCHF requirements specify that you must establish a written recall plan for food that 

requires a preventive control (21 CFR 117.139(a)). The PCHF requirements also specify that 

the written recall plan must include procedures that describe the steps to be taken, and assign 

responsibility for taking those steps, to perform the following actions as appropriate to the facility 

(21 CFR 117.139(b)):

• Directly notify the direct consignees of the food being recalled, including how to return or 

dispose of the affected food (21 CFR 117.139(b)(1)); 

• Notify the public about any hazard presented by the food when appropriate to protect public 

health (21 CFR 117.139(b)(2)); 

• Conduct effectiveness checks to verify that the recall is carried out (21 CFR 117.139(b)(3)); 

and

• Appropriately dispose of recalled food—e.g., through reprocessing, reworking, diverting to a 

use that does not present a safety concern, or destroying the food (21 CFR 117.139(b)(4)). 
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14.4 Resources That Can Help You Prepare a Recall Plan

The following resources are available to help you prepare a recall plan:

• Our general guidance on policy, procedures, and industry responsibilities regarding recalls 

in subpart C of 21 CFR part 7 (21 CFR 7.40 through 7.59; FDA’s recall guidance); 

• Our guidances for industry, available from our Web site entitled “Industry Guidance for 

Recalls: Information on Recalls of FDA Regulated Products”

(https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidancerecalls):

o “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. Guidance for Industry 

and FDA Staff. Draft Guidance” (FDA, 2019a; the draft initiation of voluntary recalls 

guidance)

o “Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. Guidance 

for Industry and FDA Staff” (FDA, 2019c; FDA’s public warning and notification 

guidance); 

o “Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal 

Food Recalls Guidance for Industry and FDA Staff. Draft Guidance” (FDA, 2018b); 

o “Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and 

FDA Staff” (FDA, 2018c);

o “Guidance for Industry: Product Recalls, Including Removals and Corrections" (FDA, 

2014; the industry recall guidance); and

• Index of Model Press Releases (available at https://www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts/industry-guidance-recalls); and

• Chapter 7 of FDA’s Regulatory Procedures Manual (FDA, 2019d), including:

o Exhibit 7-1 – Model Effectiveness Check Letter (Industry) (FDA, 2019e); 

o Exhibit 7-2 – Model Effectiveness Check Response Format (Industry) (FDA, 2019f); 

o Exhibit 7-3 – Model Effectiveness Check Questionnaire for Telephone or Personal Visits

(Industry) (FDA, 2019g); 

o Exhibit 7-4 - Model Recall Letter (Generic, All Centers) (FDA, 2019h); and

o Exhibit 7-5 - Model Recall Response Form (FDA, 2019i).

Throughout this chapter we refer you to specific recommendations in these guidances and our 

Regulatory Procedures Manual.
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14.5 Procedures That Describe the Steps to be Taken to Perform 

Recall Actions

The goal of procedures that describe the steps to be taken to perform recall actions is to help 

you to act promptly when you determine that a recall is warranted by following your plan.

14.5.1 Notify Direct Consignees

We recommend that your recall plan describe a written recall communication that you will use to 

notify your direct consignees about the recall. (See 21 CFR 7.49.) A written recall 

communication should provide direct consignees with the specific information that they need to 

conduct the recall and be a reference for direct consignees to consult on an ongoing basis 

throughout the recall procedure. 

A written recall communication can be through any effective means (e.g., through letters, email, 

telefax, or text messaging). If your recall plan specifies that you will contact your direct 

consignees by phone, we recommend that your recall plan also specify that you will confirm that 

phone communication in writing (e.g., follow up the phone call with a written communication 

such as a letter, email, telefax, or text message) and/or document your phone communication in 

an appropriate manner. (See 21 CFR 7.49(b)). 

As discussed in sections 14.5.1.1 through 14.5.1.6, we recommend that your recall plan:

• Proactively address the questions that direct consignees are likely to have by describing in 

detail the components to be included in your written recall communication (e.g., identify the 

food, explain the reason for the recall, specify the depth of the recall, provide instructions for 

what direct consignees should do with the food, and make it easy for recipients to 

communicate with you); and

• Include model letters that you would modify based on the specific situation that warranted 

the recall. See our recommendation in section 14.5.1.6 for you to include a model recall 

letter(s) in your recall plan. 

14.5.1.1 Identify the food

We recommend that your recall plan describe how your written recall communication will clearly 

provide pertinent, descriptive information to enable accurate and immediate identification of the 

food being recalled (e.g., identify the product name, size, lot number(s), code(s), expiration 

dates, and any other pertinent descriptive information (such as UPC codes and shipping 

dates)). (See the Model Recall Letter (FDA, 2019h) and 21 CFR 7.49(c)(1)(ii)). To help direct 

consignees identify the recalled product, we recommend that your plan specify that the written 

recall communication will include a product label. (See the Model Recall Letter (FDA, 2019h).)

14.5.1.2 Explain the reason for the recall

We recommend that your recall plan describe the information that your written recall 

communication will use to concisely explain the reason for the recall and the health hazard(s) 

involved. (See the Model Recall Letter (FDA, 2019h) and 21 CFR 7.49(c)(1)(iii)). 
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14.5.1.3 Specify the depth of the recall 

We recommend that your recall plan describe how your written recall communication will specify 

the depth to which the recall will extend (e.g., wholesale, retail, or consumer level). (See the 

Model Recall Letter (FDA, 2019h) and 21 CFR 7.42(b)(1)). If you have reason to believe that 

your direct consignees have further distributed the food (e.g., if your direct consignees include 

distributors who would in turn sell to retail food establishments), then your recall plan should 

specify that the written recall communication will instruct your direct consignees to in turn notify 

their customers about the recall. (See the Model Recall Letter (FDA, 2019h), 21 CFR 7.49(a)(3), 

and section 14.5.1.4 of this chapter). 

14.5.1.4 Provide instructions for what consignees should do with 

respect to the recalled food 

We recommend that your recall plan describe how your written recall communication will 

provide specific instructions on what consignees who receive the recall communication should 

do with respect to the recalled food. (See the Model Recall Letter (FDA, 2019h) and 21 CFR 

7.49(c)(1)(iv)). For example, your recall plan could describe how your written recall 

communication will instruct consignees to:

• Remove food from sale;

• Cease distribution of food;

• Notify their customers (e.g., to the wholesale or retail level as appropriate) about the recall;

• Return food to you or to another location specified in the recall communication; and/or

• Explain what to do with any food that is not returned (e.g., whether and how to destroy the

food).

If your recall plan will describe how your written recall communication will ask direct consignees 

to notify their customers, we recommend that it specify that recipients of the written recall 

communication do so by sending a copy of the written recall communication to their customers. 

Alternatively, your recall plan could specify that you give your direct consignees a modified 

recall communication to use for this purpose, provided that the modified recall communication 

includes all pertinent information (e.g., accurate and complete information about the food, the 

reason for the recall, the depth of the recall, instructions for what to do with the food, and an 

easy way for recipients to communicate with you).

14.5.1.5 Make it easy for recipients to communicate with you

We recommend that your recall plan describe how your written recall communication will inform 

recipients (i.e., any consignees that receive a recall communication) about any information that 

they should send you (e.g., whether the recipient has any of the applicable food), explain how 

recipients will do so, and make it easy for recipients to do so. For example, your recall plan 

could specify that your written communication will provide recipients with a toll-free phone 

number where they can call you, or a response form that they can send you (e.g., using a 
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postage-paid, self-addressed postcard or envelope, an email, or an online submission). (See 

the Model Recall Letter (FDA, 2019h) and 21 CFR 7.49(c)(1)(v)). If your recall plan will specify 

that you will use a response form, we recommend that the form include all instructions from your 

recall letter to make it easy for recipients to indicate that they followed each instruction. See our 

Web site entitled “Industry Guidance for Recalls: Information on Recalls of FDA Regulated 

Products” (available at https://www.fda.gov/safety/recalls-market-withdrawals-safetyalerts/industry-guidance-recalls) for access to an example of a model recall response form

(FDA, 2019i). Your plan should also include procedures to follow up with consignees who do 

not respond to your written recall communication.

14.5.1.6 Include model letters in your recall plan

We recommend that your recall plan include one or more model recall letters that you would 

modify based on the specific situation that warranted the recall and use as your written recall 

communication. Including model recall letters in your recall plan will facilitate the rapid 

preparation of such letters when needed and can prompt you to include all the information 

described in your recall plan (e.g., identify the food, explain the reason for the recall, specify the 

depth of the recall, provide instructions for what consignees should do with the food, and make 

it easy for recipients to communicate with you). See the Model Recall Letter (FDA, 2019h). 

14.5.2 Notify the Public When Appropriate

Your recall plan must include procedures to notify the public about any hazard presented by the 

food when appropriate to protect public health (See 21 CFR 117.139(b)(2).) For example, 

public warnings are used to alert the public that a food being recalled presents a serious hazard 

to health. A public warning is reserved for urgent situations where other means of preventing 

use of the recalled product appear inadequate. Depending on the circumstances, a public 

warning is issued through the general news media or through specialized news media (such as 

professional or trade press, or communications to medical professionals). (See 21 CFR

7.42(b)(2).) 

FDA provides public access to information on recalls by posting a listing of recalls according to 

their classification in the FDA Enforcement Report, whether they were requested by FDA or 

firm-initiated, and the specific action taken by the recalling firm. (See 21 CFR 7.50.) The FDA 

Enforcement Report is designed to provide a public listing of products in the marketplace that 

are being recalled. Unlike with public warnings, the recalls listed in the FDA Enforcement Report 

are not limited to urgent situations that present serious hazards to health and are not 

necessarily used to alert the public about the risk or hazard of a product under recall. 

Currently, FDA also provides information gathered from press releases and other public notices 

about certain recalls of FDA-regulated products on its Web page entitled “Recalls, Market 

Withdrawals, & Safety Alerts” (available at https://www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts). When FDA posts removal or correction information that has been 

publicized by a firm, we do so as a public service and it does not necessarily mean that the 

situation is urgent or that the product presents a serious hazard to health, such that it would be 

considered a “public warning” as the term is used in this chapter.

Your recall plan should describe your criteria for determining whether a public warning is 

appropriate. See the public warning and notification guidance (FDA, 2019c) for 
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recommendations regarding the circumstances for issuance of public warnings, including a

discussion of the parties responsible for issuing a public warning. 

Your recall plan also should describe the steps you will take when you determine that a public 

warning is appropriate. See the public warning and notification guidance for recommendations 

regarding the use, content, and distribution of public warnings, including a discussion of what 

information should be included in a public warning. (See 21 CFR 7.42(b)(2) and the public 

warning and notification guidance (FDA, 2019c).)

See model press releases for recalls related to food allergens and some pathogens (e.g., 

Listeria monocytogenes, Clostridium botulinum, Salmonella, and E. coli O157:H7), which are 

available from the Index of Model Press Releases on our Web site entitled “Industry Guidance 

for Recalls: Information on Recalls of FDA Regulated Products” 

(https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls). 

We recommend that your recall plan include one or more of these model press releases (or 

other model press releases that you prepare), which you would modify based on the specific 

situation that warranted the recall. Including model recall press releases in your recall plan will 

facilitate the rapid preparation of such press releases when needed.

14.5.3 Conduct an Effectiveness Check

The purpose of an effectiveness check is to verify that all consignees at the specified recall 

depth have received notification about the recall and have taken appropriate action. (See 21 

CFR 7.42(b)(3).) See the Index of Generic Model Letter Exhibits, in the FDA Regulatory 

Procedures Manual available from our Web site entitled “Industry Guidance for Recalls: 

Information on Recalls of FDA Regulated Products” (https://www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts/industry-guidance-recalls), for model documents (i.e., an Effectiveness 

Check Letter (FDA, 2019e), an Effectiveness Check Response Format (FDA, 2019f), and an 

Effectiveness Check Questionnaire for Telephone or Personal Visits (FDA, 2019g)) that you can 

use to conduct an effectiveness check. We recommend that your recall plan include one or 

more of these model documents, which you would modify based on the specific situation that 

warranted the recall. Including such model documents in your recall plan will facilitate the rapid 

preparation of such documents when needed. 

14.5.4 Decide What to Do with the Recalled Food

We recommend that your recall plan describe the options that you will consider to appropriately 

dispose of recalled food (e.g., through reprocessing, reworking, diverting to a use that does not 

present a safety concern, or destroying the food) and the factors that you will use to determine 

the appropriate disposition of recalled food. 

14.6 Procedures in Which You Assign Responsibility to Perform 

Recall Actions

In the procedures in your recall plan, you must assign responsibility for taking the steps to notify 

the direct consignees, notify the public, conduct effectiveness checks, and appropriately dispose 

of recalled food. (See 21 CFR 117.139(b).) The goal of such procedures is to save time during a 
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recall and help you to clearly communicate responsibilities to applicable managers and staff so 

that they can act as soon as the decision to conduct a recall is made.

We recommend that the procedures in your recall plan:

• Identify members (and alternate members2

) of a recall management team, headed by a 

recall coordinator. The members (and alternate members) assigned to the recall 

management team could include, as applicable to your facility, those with responsibilities for 

distribution, production and quality assurance, consumer affairs, accounting, legal counsel, 

public relations, technical, marketing, and regional sales managers and staffs as shown in 

Table 14-2 (New Zealand Ministry of Agriculture and Forestry, 2012). 

• Provide the following information about each member (and alternate member) of your recall 

management team:

o Name and job position/title; 

o Business phone number (including cell phone number when applicable) and email 

address; 

o After-hours phone number (e.g., home or cell phone number); and

o Responsibilities; and

• Specify who is responsible for the decision to conduct a recall.

Table 14-2 Examples of Some Roles and Responsibilities for Members of a Recall 

Management Team*

Role Responsibility

Recall coordinator Coordinate and document all recall activities 

Distribution Stop distribution and arrange for return of recalled food; 

prepare inventory and distribution status of affected food

Production and 

quality assurance

Prepare batch identification; stop production of food if related 

to the problem; investigate the cause of the problem and 

check records to determine whether other product lots should 

also be recalled

Consumer affairs Prepare response to consumers; answer consumer inquiries

 2 The alternate members would replace team members who are not available when the facility is 

considering or implementing a recall.
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Role Responsibility

Public relations Handle press release; manage media contacts

Marketing Notify sales managers and brokers; arrange for pick-up at 

retail levels 

Regional sales 

manager

Help contact customers; assist in product pick-up as needed

*Adapted from Recall Guidance Material available from the New Zealand Ministry of Agriculture 

and Forestry (New Zealand Ministry of Agriculture and Forestry, 2012).

14.7 Procedures for Notifying FDA

14.7.1 Procedures for Notifying FDA About a Reportable Food

Section 417 of the FD&C Act (21 U.S.C. 350f) requires FDA to establish a Reportable Food 

Registry (RFR). A ‘‘reportable food’’ is an article of food (other than dietary supplements or 

infant formula) for which there is a reasonable probability that the use of, or exposure to, such 

article of food will cause serious adverse health consequences or death to humans or animals 

(Section 417(a)(2) of the FD&C Act). Under section 417(d)(1) of the FD&C Act, food firms that 

are ‘‘responsible parties’’ as defined in the statute are required to notify FDA electronically with 

certain information within 24 hours of determining that a food they manufactured, processed, 

packed, or held is a reportable food. We have issued guidance regarding the RFR (FDA, 2009 

and FDA, 2010). That guidance includes examples of circumstances under which food might be 

reportable. 

We recommend that your recall plan include any procedures you have to comply with the RFR,

or a cross-reference to such procedures, so that the procedures will be readily available to your 

recall management team. Doing so may save time, which is critical during a recall. 

14.7.2 Procedures for Notifying the Appropriate FDA Recall Coordinator

The industry recall guidance recommends that you notify the appropriate FDA Recall 

Coordinator as soon as a decision is made that a recall is appropriate and prior to the issuance 

of press or written notification to customers (FDA, 2014). The industry recall guidance also 

provides our recommendations for what to send to the appropriate FDA Recall Coordinator 

about your recall. In addition, the draft initiation of voluntary recalls guidance encourages firms

to consult with FDA while its own investigation is ongoing if the firm has questions about its 

examination of a product problem (FDA, 2019a). See “ORA Recall Coordinators” for a current 

list of FDA Recall Coordinators (FDA, 2019b).

We recommend that your recall plan include the guidances and exhibits listed in section 14.4 so

that they will be readily available to your recall management team.
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14.8 References

FDA, 2009. "Guidance for Industry: Questions and Answers Regarding the Reportable Food 

Registry As Established by the Food and Drug Administration Amendments Act of 2007," 

(https://www.fda.gov/FoodGuidances)

FDA, 2010. "Draft Guidance for Industry: Questions and Answers Regarding the Reportable 

Food Registry As Established by the Food and Drug Administration Amendments Act of 2007 

(Edition 2)," (https://www.fda.gov/FoodGuidances)

FDA, 2014. "Guidance for Industry: Product Recalls, Including Removals and Corrections," 

(https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls)

FDA, 2018a. Index of Model Press Releases," (https://www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts/industry-guidance-recalls)

FDA, 2018b. “Public Availability of Lists of Retail Consignees to Effectuate Certain Human and 

Animal Food Recalls Guidance for Industry and FDA Staff. Draft Guidance,” 

(https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls)

FDA, 2018c. “Questions and Answers Regarding Mandatory Food Recalls: Guidance for 

Industry and FDA Staff,” (https://www.fda.gov/safety/recalls-market-withdrawals-safetyalerts/industry-guidance-recalls) 

FDA, 2019a. “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. Guidance for 

Industry and FDA Staff. Draft Guidance,” (https://www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts/industry-guidance-recalls) 

FDA, 2019b. Office of Regulatory Affairs (ORA) Recall Coordinators, 

(https://www.fda.gov/safety/industry-guidance-recalls/ora-recall-coordinators)

FDA, 2019c, "Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. 

Guidance for Industry and FDA Staff," (https://www.fda.gov/safety/recalls-market-withdrawalssafety-alerts/industry-guidance-recalls)

FDA, 2019d, Regulatory Procedures Manual, Chapter 7, 

(https://www.fda.gov/media/71814/download)

FDA, 2019e, Regulatory Procedures Manual, Chapter 7, Exhibit 7-1, “Model Effectiveness 

Check Letter (Industry),” (https://www.fda.gov/media/71814/download)

FDA, 2019f, Regulatory Procedures Manual, Chapter 7, Exhibit 7-2, “Model Effectiveness

Check Response Format (Industry),” (https://www.fda.gov/media/71814/download)

FDA, 2019g, Regulatory Procedures Manual, Chapter 7, Exhibit 7-3, “Model Effectiveness

Check Questionnaire for Telephone or Personal Visits (Industry),” 

(https://www.fda.gov/media/71814/download)
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FDA, 2019h, Regulatory Procedures Manual, Chapter 7, Exhibit 7-4, “Model Recall Letter 

(Generic, All Centers),” (https://www.fda.gov/media/71814/download)

FDA, 2019i Regulatory Procedures Manual, Chapter 7, Exhibit 7-5, “Model Recall Response 

Form,” (https://www.fda.gov/media/71814/download)

Ministry of Agriculture and Forestry (New Zealand), 2012. Recall Guidance Material, 

(https://www.mpi.govt.nz/food-safety/food-recalls/developing-your-food-recall-plan/)
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Chapter 15 (Supply-Chain Program) - Page 1 

Hazard Analysis and Risk-Based 

Preventive Controls for Human Food: 

Draft Guidance for Industry 1

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-assistance-network-tan. 

Chapter 15: Supply-Chain Program for Human Food Products

Table of Contents

15.1 Purpose of this Chapter

15.2 Considerations to Keep in Mind if You Establish and Implement a 

Supply-Chain Program

15.3 Overview of the Requirements for a Supply-Chain Program

15.3.1 Applicable Requirements of Part 117

15.3.2 “Receiving Facilities” and “Suppliers”

15.3.3 Produce Safety Regulation

15.3.4 Foreign Supplier Verification Program Regulation

15.3.5 Accredited Third-Party Certification Regulation

15.3.6 How We Use the Term “You” in This Chapter

15.4 Understand the Potential Hazard

15.5 Terms Used in This Chapter

15.5.1 Definitions Established in 21 CFR 117.3

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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15.5.2 Other Terms That FDA Uses in This Chapter

15.6 Requirement to Establish and Implement a Supply-Chain Program 

(21 CFR 117.405)

15.6.1 Requirement to Establish and Implement a Supply-chain Program

15.6.2 How Your Corporate Parent Can Participate in Establishing and 

Implementing Your Supply-chain Program

15.6.3 Exceptions to the Requirement to Establish and Implement a Supply-chain 

Program

15.6.3.1 Exception for importers

15.6.3.2 Exception for food supplied for research or evaluation use

15.6.4 Requirement When a Supply-Chain-Applied Control Is Applied by an Entity 

Other than the Receiving Facility’s Supplier

15.6.5 Role of the Preventive Controls Qualified Individual in the Supply-Chain 

Program

15.7 General Requirements Applicable to a Supply-Chain Program (21 

CFR 117.410)

15.7.1 What the Supply-Chain Program Must Include

15.7.2 Appropriate Supplier Verification Activities

15.7.2.1 Onsite audits (21 CFR 117.410(b)(1))

15.7.2.2 Sampling and testing of the raw material or other ingredient (21 CFR 

117.410(b)(2))

15.7.2.3 Review of the supplier’s relevant food safety records (21 CFR 

117.410(b)(3))

15.7.2.4 Other appropriate supplier verification activities based on supplier 

performance and the risk associated with the raw material or other 

ingredient (21 CFR 117.410(b)(4))

15.7.3 Assurance that a Hazard Has Been Significantly Minimized or Prevented

15.7.4 Considerations in Approving Suppliers and Determining the Appropriate 

Supplier Verification Activities and the Frequency with Which They Are 

Conducted

15.7.4.1 Hazard analysis

15.7.4.2 Entity controlling the hazard

15.7.4.3 Supplier performance

15.7.4.4 Other factors

15.7.4.5 Exception to the full requirements for considerations for approving 

suppliers and determining appropriate supplier verification activities
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15.7.5 Supplier Nonconformance

15.8 Responsibilities of the Receiving Facility (21 CFR 117.415)

15.8.1 Your Responsibility to Approve Suppliers

15.8.2 Your Responsibility to Determine and Conduct Appropriate Supplier 

Verification Activities

15.8.2.1 Flexibility for another entity to determine, conduct, and document 

appropriate supplier verification activities

15.8.2.2 Supplier verification activities that the supplier can conduct and document

15.8.3 What You May Not Accept from a Supplier as a Supplier Verification 

Activity

15.8.4 Audit Provided by the Supplier

15.9 Using Approved Suppliers (21 CFR 117.420)

15.9.1 Approving Suppliers

15.9.2 Written Procedures for Receiving Raw materials and Other Ingredients

15.10 Determining Appropriate Supplier Verification Activities (Including 

Determining the Frequency of Conducting the Activity) (21 CFR 

117.425)

15.11 Conducting Supplier Verification Activities for Raw Materials and 

Other Ingredients (21 CFR 117.430)

15.11.1 Requirement to Conduct Supplier Verification Activities

15.11.2 Specific Requirements When the Hazard Requiring a Preventive Control is 

a SAHCODH Hazard

15.11.2.1 Requirement for an onsite audit when the hazard requiring a preventive 

control is a SAHCODH hazard

15.11.2.2 Exception to the requirement for an onsite audit when the hazard 

requiring a preventive control is a SAHCODH hazard

15.11.3 Alternative Supplier Verification Activity If the Supplier Is a “Qualified 

Facility”

15.11.4 Alternative Supplier Verification Activity If the Supplier is a Certain Type of 

Produce Farm

15.11.5 Alternative Supplier Verification Activity If the Supplier Is a Shell Egg 

Producer That Is Not Subject to the Requirements of 21 CFR Part 118

15.11.6 Financial Conflict of Interest

15.12 Onsite Audit (21 CFR 117.435)

15.12.1 Who Conducts an Onsite Audit
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15.12.2 Consideration of Food Safety Regulations

15.12.3 Substitution of an Inspection for an Audit

15.12.4 Audits Conducted to Meet the Requirements of Subpart G Do Not Have to 

Comply with the Requirements of the Accredited Third-Party Regulation

15.13 Records Documenting the Supply-Chain Program

15.14 Compliance Dates

15.15 Table of Abbreviations

15.16 References

15.1 Purpose of this Chapter

The purpose of this chapter is to help a receiving facility comply with the requirements of 

subpart G for establishing and implementing a supply-chain program for its suppliers. (See 

section 15.3.2 and the list of terms in section 15.5.1 for the definition of “receiving facility.”) This 

chapter also is intended to help an entity other than the receiving facility conduct certain 

activities on behalf of a receiving facility, provided that the receiving facility complies with 

applicable requirements in subpart G to review and assess the entity’s applicable 

documentation, and document that review and assessment.

15.2 Considerations to Keep in Mind if You Establish and Implement 

a Supply-Chain Program

If you are an importer, see section 15.6.2.1 for a discussion of how we have aligned the 

provisions for supplier verification in our regulation entitled “Foreign Supplier Verification 

Programs for Importers of Food for Humans and Animals” (21 CFR part 1, subpart L; the FSVP 

regulation) with the provisions for a supply-chain program in subpart G such that importers and 

receiving facilities do not have to duplicate verification activities. Importantly, this chapter of this

guidance does not address the responsibilities of receiving facilities that import raw materials or 

other ingredients to comply with applicable requirements of the FSVP regulation. If you are a 

receiving facility that is also a food importer, and you choose to comply with the FSVP 

regulation rather than conduct supplier verification activities in accordance with subpart G (see 

21 CFR 117.405(a)(2)), you should refer to our guidance on the FSVP regulation.

15.3 Overview of the Requirements for a Supply-Chain Program

15.3.1 Applicable Requirements of Part 117

Subpart C requires a facility to conduct a hazard analysis to determine whether there are any 

hazards that require a preventive control (21 CFR 117.130) and identifies several types of 

possible preventive controls, including process controls (21 CFR 117.135(c)(1)), food allergen 

controls (21 CFR 117.135(c)(2)), sanitation controls (21 CFR 117.135(c)(3)), and supply-chain 

controls (21 CFR 117.135(c)(4)). The requirements for supply-chain controls are established in 

subpart G (Supply-Chain Program). We list the requirements of subpart G in Table 15-1. In the 
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remainder of this chapter, we provide recommendations for how you can comply with each of 

these requirements.

Table 15-1 Requirements for a Supply-Chain Program in Subpart G

Section Description

117.405 Requirement to establish and implement a supply-chain program

117.410 General requirements applicable to a supply-chain program

117.415 Responsibilities of the receiving facility

117.420 Using approved suppliers

117.425 Determining appropriate supplier verification activities (including 

determining the frequency of conducting the activity)

117.430 Conducting supplier verification activities for raw materials and other 

ingredients

117.435 Onsite audit

117.475 Records documenting the supply-chain program

15.3.2 “Receiving Facilities” and “Suppliers”

Subpart G applies to a “receiving facility.” Part 117 defines a “receiving facility” as a facility that 

is subject to subparts C and G of part 117 and that manufactures/processes a raw material or 

other ingredient that it receives from a supplier. (See 21 CFR 117.3.) Part 117 defines a 

“supplier” as the establishment that manufactures/processes the food, raises the animal, or 

grows the food that is provided to a receiving facility without further manufacturing/processing 

by another establishment, except for further manufacturing/processing that consists solely of the 

addition of labeling or similar activity of a de minimis nature. (See 21 CFR 117.3.)

Under subpart G, entities such as brokers, produce aggregators, food distributors, and cold 

storage facilities are neither receiving facilities that are required to establish a supply-chain 

program nor suppliers, because such entities are not manufacturers/processors. However, part 

117 provides that such entities can conduct certain activities specified in subpart G on behalf of 

a receiving facility. (See 21 CFR 117.415.)

Examples of receiving facilities are:

• A facility that manufactures/processes produce raw agricultural commodities (RACs) into 

bagged salads;

• A facility that mills grains such as wheat to make flour; and

• A facility that manufactures cookies using flour, sugar and other ingredients.

Examples of suppliers are:

• A farm that grows RACs such as lettuce that are supplied to a bagged salad manufacturer;

• A farm that grows wheat that is supplied to a miller; and

• A facility that mills grains and manufactures flour that is supplied to a cookie manufacturer.
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See also section 15.6.4 for a discussion of the special circumstance of when a preventive 

control is applied by an entity other than the receiving facility’s supplier (e.g., when a harvesting 

or packing operation applies controls to certain produce (i.e., produce covered by part 112), 

because growing, harvesting, and packing activities are under different management).

15.3.3 Produce Safety Regulation

In part 112 (21 CFR part 112), we have established our regulation entitled “Standards for the 

Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (the produce 

safety regulation; 80 FR 74354, November 27, 2015). The produce safety regulation sets forth 

in a new part 112 procedures, processes, and practices that minimize the risk of serious 

adverse health consequences or death, including those reasonably necessary to prevent the 

introduction of known or reasonably foreseeable biological hazards into or onto produce and to 

provide reasonable assurances that the produce is not adulterated on account of such hazards. 

The produce safety regulation applies to certain produce farms, and does not apply to activities 

of facilities that are subject to part 117. 

Some provisions of subpart G (i.e., 21 CFR 117.405(c), 117.410(d)(2)(ii), 117.430(d), and 

117.475(c)(13)) refer to the provisions of the produce safety regulation.

15.3.4 Foreign Supplier Verification Program Regulation

In part 1, subpart L (21 CFR part 1, subpart L), we have established our regulation entitled 

“Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (the 

FSVP regulation; 80 FR 74226, November 27, 2015). The FSVP regulation requires importers 

to establish foreign supplier verification programs to verify that their foreign suppliers are using 

processes and procedures that provide the same level of public health protection as those 

required under the provisions on hazard analysis and risk-based preventive controls and 

standards for produce safety in the FD&C Act, that the imported food is not adulterated, and that 

food is not misbranded with respect to food allergen labeling. 

Some provisions of subpart G (i.e., 21 CFR 117.405(a)(2) and 117.475(c)(2)) refer to the 

provisions of the FSVP regulation. 

15.3.5 Accredited Third-Party Certification Regulation

In part 1, subpart M (21 CFR part 1, subpart M), we have established our regulation entitled 

“Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue 

Certifications” (the accredited third-party certification regulation; 80 FR 74570, November 27, 

2015). The accredited third-party certification regulation provides for accreditation of third-party 

certification bodies to conduct food safety audits and to certify that eligible foreign entities 

(including registered foreign food facilities) and food produced by such entities meet applicable 

FDA requirements for purposes of sections 801(q)2 and 8063 of the FD&C Act.

 2 Section 801(q) of the FD&C Act gives FDA the authority to make a risk-based determination to require, 

as a condition of admissibility, that a food imported or offered for import into the United States be 

accompanied by a certification or other assurance that the food meets the applicable requirements of the 

FD&C Act.

3 Section 302 of FSMA (Voluntary qualified importer program) amended the FD&C Act to create a new 

section 806 with the same name. Section 806 of the FD&C Act describes a voluntary, fee-based program 

for the expedited review and importation of foods from importers who achieve and maintain a high level of 
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Some provisions of part 117 (i.e., the definition of “qualified auditor” in 21 CFR 117.3 and the 

requirements for onsite audits in 21 CFR 117.435(d)) refer to the provisions of the accredited 

third-party certification regulation.

15.3.6 How We Use the Term “You” in This Chapter

In this guidance, we use the term “you” to refer to a “receiving facility,” rather than to all facilities 

subject to the PCHF requirements, because the requirements of subpart G apply only to 

receiving facilities.

15.4 Understand the Potential Hazard

Part 117 defines “supply-chain-applied control” as a preventive control for a hazard in a raw 

material or other ingredient when the hazard in the raw material or other ingredient is controlled 

before its receipt. (See 21 CFR 117.3 and the list of terms in section 15.5.1.) For background 

and details about hazards, including hazards that could require a supply-chain-applied control, 

see Chapter 3 – Potential Hazards Associated with the Manufacturing, Processing, Packing, 

and Holding of Human Food.

15.5 Terms Used in This Chapter

15.5.1 Definitions Established in 21 CFR 117.3

Section III.A in the Introduction of this guidance includes a glossary of terms that are used in 

this guidance and that are defined in 21 CFR 117.3. At this time, that glossary does not include 

all terms that are used in this chapter. See Table 15-2 for additional terms that are defined in 21 

CFR 117.3. We intend to include these terms in the glossary in section III.A in the Introduction 

of this guidance when we update the Introduction. When we do so, we intend to delete Table 

15-2 from this chapter, because it would be duplicative.

Table 15-2 Applicable Terms Defined in Part 117 (See 21 CFR 117.3.)

Term What the Term Means

Audit The systematic, independent, and documented examination (through observation, 

investigation, records review, discussions with employees of the audited entity, and, 

as appropriate, sampling and laboratory analysis) to assess a supplier’s food safety 

processes and procedures.

Manufacturing/ 

processing

Making food from one or more ingredients, or synthesizing, preparing, treating, 

modifying or manipulating food, including food crops or ingredients. Examples of 

manufacturing/processing activities include: Baking, boiling, bottling, canning, 

cooking, cooling, cutting, distilling, drying/dehydrating raw agricultural commodities to 

create a distinct commodity (such as drying/dehydrating grapes to produce raisins), 

evaporating, eviscerating, extracting juice, formulating, freezing, grinding, 

homogenizing, irradiating, labeling, milling, mixing, packaging (including modified 

atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate 

ripening, trimming, washing, or waxing. For farms and farm mixed-type facilities, 

manufacturing/processing does not include activities that are part of harvesting, 

packing, or holding.

 

control over the safety and security of their supply chains. This control includes importation of food from 

facilities that have been certified under FDA’s third-party certification rule.
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Term What the Term Means

Qualified auditor A person who is a qualified individual as defined in this part and has technical 

expertise obtained through education, training, or experience (or a combination 

thereof) necessary to perform the auditing function as required by § 117.180(c)(2). 

Examples of potential qualified auditors include: (1) A government employee, 

including a foreign government employee; and (2) An audit agent of a certification 

body that is accredited in accordance with regulations in 21 CFR part 1, subpart M 

(Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and 

To Issue Certifications).

Qualified facility A facility (when including the sales by any subsidiary; affiliate; or subsidiaries or 

affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) that 

is a very small business, or a facility to which both of the following apply: (1) During 

the 3-year period preceding the applicable calendar year, the average annual 

monetary value of the food manufactured, processed, packed or held at such facility 

that is sold directly to qualified end-users (as defined in this part) during such period 

exceeded the average annual monetary value of the food sold by such facility to all 

other purchasers; and (2) The average annual monetary value of all food sold during 

the 3-year period preceding the applicable calendar year was less than $500,000, 

adjusted for inflation.

Raw agricultural 

commodity (RAC)

Any food in its raw or natural state, including all fruits that are washed, colored, or 

otherwise treated in their unpeeled natural form prior to marketing. 

Receiving facility A facility that is subject to subparts C and G of part 117 and that 

manufactures/processes a raw material or other ingredient that it receives from a 

supplier.

Supplier The establishment that manufactures/processes the food, raises the animal, or grows 

the food that is provided to a receiving facility without further 

manufacturing/processing by another establishment, except for further 

manufacturing/processing that consists solely of the addition of labeling or similar 

activity of a de minimis nature.

Supply-chain-applied 

control

A preventive control for a hazard in a raw material or other ingredient when the 

hazard in the raw material or other ingredient is controlled before its receipt.

Very small business A business (including any subsidiaries and affiliates) averaging less than $1,000,000, 

adjusted for inflation, per year, during the 3-year period preceding the applicable 

calendar year in sales of human food plus the market value of human food 

manufactured, processed, packed, or held without sale (e.g., held for a fee).

Written procedures for 

receiving raw materials 

and other ingredients

Written procedures to ensure that raw materials and other ingredients are received 

only from suppliers approved by the receiving facility (or, when necessary and 

appropriate, on a temporary basis from unapproved suppliers whose raw materials or 

other ingredients are subjected to adequate verification activities before acceptance 

for use).

15.5.2 Other Terms That FDA Uses in This Chapter

Section III.B in the Introduction of this guidance includes a glossary of terms that are used in 

this guidance but are not defined in 21 CFR 117.3. At this time, that glossary does not include 

all terms that are used in this chapter. See Table 15-3 for additional terms that we use in this 

chapter. We intend to include these terms in the glossary in section III.B in the Introduction of 

this guidance when we update the Introduction. When we do so, we intend to delete Table 15-3

from this chapter, because it would be duplicative.

Table 15-3 Terms Used in this Chapter

Term What the Term Means
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Term What the Term Means

Approved supplier A supplier that has met the criteria of the receiving facility’s supply chain 

program, is controlling the identified hazard, and has been approved by the 

receiving facility.

Certificate of analysis (CoA) A document, provided by the supplier of a food prior to or upon receipt of the 

food, that documents certain characteristics and attributes of the food.

Customer An entity that receives a product, raw material, or ingredient from a receiving 

facility.

Identified hazard A hazard identified by the receiving facility as requiring a supply-chainapplied control.

Second-party audit An audit conducted by an employee of a receiving facility.

SAHCODH hazard A hazard for which there is a reasonable probability that exposure to the 

hazard will result in serious adverse health consequences or death to 

humans.

Third-party audit An audit conducted by a qualified auditor that is not an employee of either 

the receiving facility or the supplier.

15.6 Requirement to Establish and Implement a Supply-Chain 

Program (21 CFR 117.405)

15.6.1 Requirement to Establish and Implement a Supply-chain Program 

With some exceptions (see 21 CFR 117.405(a)(2) and (a)(3)), subpart G requires a receiving 

facility to establish and implement a risk-based supply-chain program for those raw materials 

and other ingredients for which the receiving facility has identified a hazard requiring a supplychain-applied control. (See 21 CFR 117.405(a)(1).)

The supply-chain program must be written. (See 21 CFR 117.405(b).) There is no standardized 

or required format for the written supply-chain program or its records. You can use whatever 

format works best for your facility, provided that the records include all the required information.

You are not required to establish and implement a supply-chain program for a particular raw 

material or other ingredient if you will control the hazard at your own facility, regardless of 

whether your supplier has also applied one or more preventive controls for that hazard to raw 

materials and other ingredients that your supplier provides to you. (See 21 CFR 117.405(a)(1).)

In addition, you are not required to implement a preventive control if you comply with certain 

requirements for ensuring a hazard will be controlled by your customer or subsequent entity in 

the distribution chain. (See 21 CFR 117.136.) 

Subpart G does not require you to establish and implement a supply-chain program to control 

potential hazards associated with food contact substances. A long-standing CGMP provision 

requires that appropriate quality control operations be employed to ensure that food is suitable 

for human consumption and that food-packaging materials are safe and suitable. (See 21 CFR 

117.80(a)(2).) Similar provisions address other circumstances where food contact substances 

may migrate to the raw materials and other ingredients obtained by a receiving facility from 

suppliers (e.g., 21 CFR 117.40 regarding food-contact surfaces). FDA has extensive premarket 

review processes for food contact substances under the food contact notification process (21 

CFR part 170, subpart D) and the food additive petition process (21 CFR part 171). In light of 

FDA’s premarket oversight of food contact substances and our experience with regulatory 
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oversight of food-packaging material as a matter of CGMP, we consider following CGMPs by a 

receiving facility to be sufficient to address the safety of food contact substances in raw 

materials and other ingredients it obtains. Therefore, there are no hazards associated with food 

contact substances that are hazards requiring a supply-chain applied control under 21 CFR 

117.405(a)(1).

15.6.2 How Your Corporate Parent Can Participate in Establishing and 

Implementing Your Supply-chain Program 

As discussed in the final rule establishing part 117, your corporate parent (as the owner, 

operator, or agent in charge) can be active in developing and implementing your food safety 

plan (see Response 371, Response 668, and Response 690 at 80 FR 56022, 56100, and 

56111, respectively). For example, an individual at the corporate level may be the preventive 

controls qualified individual (PCQI). Further, the responsibilities of the receiving facility (such as 

approving suppliers) could be handled at the corporate level. For example, your corporate 

parent could have a team that establishes written procedures for supplier approval, determines

supplier verification activities, conducts supplier verification activities, and maintains required 

documentation. In addition, your corporate parent could establish and implement a supply-chain 

program that takes into consideration its knowledge of the food safety programs in place at all of 

the facilities under its ownership. See also the example in section 15.11.2.2 in which a facility 

that is part of a larger corporation determines an alternative to an onsite audit when the supplier 

is a subsidiary of the same corporation. The records documenting the supply-chain program are 

subject to the requirements, in subpart F, applying to records that must be established and 

maintained. Under 21 CFR 117.315, offsite storage of records (such as storage at the place of 

business of your corporate parent of records documenting the supply-chain program) is 

permitted if such records can be retrieved and provided onsite within 24 hours of request for 

official review. If your corporate parent establishes and maintains the records for the supplychain program electronically and you can access applicable records maintained at the corporate 

level electronically, we consider the records to be onsite.

15.6.3 Exceptions to the Requirement to Establish and Implement a Supplychain Program

Subpart G provides for two exceptions to the requirement to establish and implement a supplychain program. 

15.6.3.1 Exception for importers

We have aligned the provisions for supplier verification in the FSVP regulation with the 

provisions for a supply-chain program in part 117. A receiving facility that is an importer, is in 

compliance with the FSVP regulation, and has documentation of verification activities conducted 

under 21 CFR 1.506(e) (which provides assurance that the hazards to be controlled before 

importation for the raw material or other ingredient have been significantly minimized or 

prevented) need not conduct supplier verification activities for that raw material or other 

ingredient. (See 21 CFR 117.405(a)(2).) We are providing separate guidance to help importers 
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who are subject to the FSVP regulation to comply with the requirements of the FSVP 

regulation.

4

15.6.3.2 Exception for food supplied for research or evaluation use

The requirements for a supply-chain program do not apply to food that is supplied for research 

or evaluation use, provided that such food:

• Is not intended for retail sale and is not sold or distributed to the public (21 CFR 

117.405(a)(3)(i));

• Is labeled with the statement “Food for research or evaluation use” (21 CFR 

117.405(a)(3)(ii));

• Is supplied in a small quantity that is consistent with a research, analysis, or quality 

assurance purpose, the food is used only for this purpose, and any unused quantity is 

properly disposed of (21 CFR 117.405(a)(3)(iii)); and 

• Is accompanied with documents, in accordance with the practice of the trade, stating that 

the food will be used for research or evaluation purposes and cannot be sold or distributed 

to the public (21 CFR 117.405(a)(3)(iv)).

You should take steps to ensure that the label statement “Food for research or evaluation use” 

remains securely attached to the food until the food is used for research or evaluation.

The quantity of the food should be limited to the amount anticipated to be needed to perform the 

research, analysis, or quality assurance procedures, and any unused portion should be properly 

disposed of. The amount of food used in research or for evaluation can vary based on the type 

of food, the nature of the research or evaluation, and other factors such as the number of 

repetitions required for the research or evaluation process. For example, 10 pounds of a food 

could be a small quantity consistent with the amount needed to perform a laboratory analysis for 

pesticides, and 50 pounds of the food could be a small quantity consistent with the amount 

needed for a mycotoxin analysis. On the other hand, only a few ounces of a color additive might 

be needed for research.

The exemption for food for research or evaluation does not apply to food for consumption at 

trade shows, because such food would be “distributed to the public” (i.e., attendees of the trade 

show). (See 21 CFR 117.405(a)(3)(i).) This is the case regardless of whether it is a “Research 

and Development” (R&D) facility that directly provides the food for consumption to a trade show, 

or it is the R&D facility’s customer that provides the food for consumption to a trade show. 

However, the exemption for research or evaluation would apply to food used in a defined study, 

conducted during a trade show, of a food involving a discrete set of test subjects who have 

agreed to participate in the study, because it does not appear that such food would be sold or 

distributed to the general public. When the exemption does not apply, you must comply with the 

requirements of subpart G when your supplier applies a supply-chain-applied control even if you 

consider yourself an “R&D facility.”

 4 Even if you implement a supply-chain program in accordance with subpart G for a raw material or other 

ingredient you import, you will need to ensure that you are identified as the FSVP importer of the raw 

material or other ingredient in accordance with 21 CFR 1.509.
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15.6.4 Requirement When a Supply-Chain-Applied Control Is Applied by an 

Entity Other than the Receiving Facility’s Supplier

When a supply-chain-applied control is applied by an entity other than the receiving facility’s 

supplier (e.g., when such an entity applies controls to certain produce (i.e., produce covered by 

part 112)), because growing, harvesting, and packing activities are under different 

management), the receiving facility must: (1) Verify the supply-chain-applied control; or (2) 

obtain documentation of an appropriate verification activity from another entity, review and 

assess the entity’s applicable documentation, and document that review and assessment. (See 

21 CFR 117.405(c).)

The most likely circumstance where this requirement applies is included as an example in the 

requirement – i.e., when the supplier is a farm and growing, harvesting, and packing activities 

are under different management. The definition of supplier specifies that the supplier is the 

establishment that grows the food. However, harvesting and packing operations that are 

conducted by a business entity separate from the grower do not fall within the definition of 

“supplier,” even though harvesting and packing operations include some supply-chain-applied 

controls, such as maintaining wash water temperature adequate to minimize infiltration of 

microorganisms and establishing and following water-change schedules for recirculated water.

A receiving facility has an obligation to identify and implement preventive controls to provide 

assurances that any hazards requiring a preventive control will be significantly minimized or 

prevented and the food manufactured, processed, packed, or held by the facility will not be 

adulterated under section 402 of the FD&C Act (21 U.S.C. 342) or misbranded under section 

403(w) of the FD&C Act (21 U.S.C. 343(w)). That obligation includes responsibilities for raw 

materials and other ingredients when a supply-chain-applied control is applied by an entity 

(such as a harvesting or packing operation) other than the receiving facility’s supplier (the 

grower).

We do not expect the receiving facility to follow all of the requirements of subpart G applicable 

to “suppliers” when verifying control by another entity in the supply chain (e.g., a harvesting or 

packing operation). Instead, we expect the receiving facility will take steps such as a review of 

that entity’s applicable food safety records. For example, if a receiving facility receives produce 

from a supply chain that includes a separate grower, harvester, and packer, the grower is the 

supplier and the requirements of subpart G applicable to “suppliers” apply to the grower. To 

verify controls applied by the harvester, the receiving facility could review the harvester’s 

records, such as records of training for workers who hand harvest RTE produce. To verify 

controls applied by the packer, the receiving facility could review the packer’s records, such as 

water-change schedules for recirculated water used in packing operations.

See also the discussion in sections 15.8.1 and 15.8.2 of provisions of part 117 that allow entities 

such as distributors, brokers, and aggregators to determine, conduct, and document verification 

activities that apply to suppliers as a service to you, provided that you review and assess 

applicable documentation provided by the other entity and document your review and 

assessment. (See 21 CFR 117.415(a)(3).) If a harvester determines, conducts, and documents

verification activities that apply to the grower (your supplier), you could review and assess the 

harvester’s documentation. Likewise, you could obtain documentation of review of applicable 

records maintained by the harvester or packer from another entity, review and assess the 

entity’s applicable documentation, and document that review and assessment.
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15.6.5 Role of the Preventive Controls Qualified Individual in the SupplyChain Program

The preventive controls are part of your food safety plan, and your food safety plan must be 

prepared, or its preparation overseen by, your PCQI. (See 21 CFR 117.126(a)(2), 21 CFR 

117.126(b)(2), and 117.180(a)(1).) (See 21 CFR 117.3 and the Glossary in section III of the 

Introduction of this guidance for the definition of “PCQI.”)

15.7 General Requirements Applicable to a Supply-Chain Program 

(21 CFR 117.410)

15.7.1 What the Supply-Chain Program Must Include

Subpart G includes a list of the general requirements for what the supply-chain program must 

include, and provides a cross-reference to where you can find the specific requirements. As 

specified in 21 CFR 117.410(a), the general requirements are:

• Using approved suppliers as required by § 117.420 (21 CFR 117.410(a)(1)); 

• Determining appropriate supplier verification activities (including determining the frequency 

of conducting the activity) as required by § 117.425 (21 CFR 117.410(a)(2)); 

• Conducting supplier verification activities as required by §§ 117.430 and 117.435 (21 CFR 

117.410(a)(3));

• Documenting supplier verification activities as required by § 117.475 (21 CFR 

117.410(a)(4)); and

• When applicable, verifying a supply-chain-applied control applied by an entity other than the 

receiving facility’s supplier and documenting that verification as required by § 117.475, or 

obtaining documentation of an appropriate verification activity from another entity, reviewing 

and assessing that documentation, and documenting the review and assessment as 

required by § 117.475 (21 CFR 117.410(a)(5)).

See the discussion of the specific requirements of 21 CFR 117.405(c), 117.420, 117.425, 

117.430, 117.435, and 117.475 in sections 15.6.4, 15.9, 15.10, 15.11, 15.12, and 15.13, 

respectively.

15.7.2 Appropriate Supplier Verification Activities

Section 21 CFR 117.410(b) of subpart G specifies four appropriate supplier verification activities 

for raw materials and other ingredients. We discuss these in sections 15.7.2.1 through 15.7.2.4.

15.7.2.1 Onsite audits (21 CFR 117.410(b)(1))

See 21 CFR 117.430(b), 21 CFR 117.435, 21 CFR 117.475(c)(7), and sections 15.11.2, 15.12, 

and 15.13 for details about the requirements for onsite audits and our recommendations for how 

to comply with those requirements.
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15.7.2.2 Sampling and testing of the raw material or other ingredient 

(21 CFR 117.410(b)(2))

Subpart G provides that sampling and testing of a raw material or other ingredient is an 

appropriate supplier verification activity. (See 21 CFR 117.410(b)(2).) Such sampling and 

testing can be on a periodic basis or on a lot-by-lot basis. We recommend that you establish the 

frequency of such testing by first conducting the sampling and testing on a relatively frequent 

basis (e.g., monthly) until the supplier establishes a good history of supplying an acceptable raw 

material or other ingredient, after which time you could sample and test less frequently, such as 

quarterly.

If you choose to use sampling and testing as a supplier verification activity, you should use 

scientifically-based sampling plans that provide reasonable assurance that the hazard has been 

significantly minimized or prevented and that address known limitations of sampling and testing 

foods as a verification activity. For example, your sampling plan should take into consideration 

whether a hazard is homogeneously distributed throughout the lot, and your selection of an 

analytical method should consider whether food components could interfere with the method of 

analysis, as well as whether the method is sensitive enough to detect a hazard that is present at 

low concentrations. To address such limitations, we recommend that you obtain samples that 

are representative of the lot, use a testing method that has been shown to provide reliable 

results when the analyte of interest is within the food matrix you will be testing, and use a 

method that has a sensitivity appropriate to detect that hazard.

See 21 CFR 117.475(c)(8) and section 15.13 for a list of required documentation when you 

conduct sampling and testing as a supplier verification activity. See section 15.8.2.2 for a 

discussion of the flexibility the rule provides for your supplier to conduct and document sampling 

and testing of raw materials and other ingredients, for the hazard it controls, and provide such 

documentation (such as in a Certificate of Analysis (COA)) to you in lieu of you conducting such 

sampling and testing yourself.

15.7.2.3 Review of the supplier’s relevant food safety records (21 CFR 

117.410(b)(3))

In general, by “relevant food safety records” we mean any records that will provide sufficient 

documentation that your supplier is following the procedures your supplier established to control 

a hazard and that the hazard has been controlled. Many such records relate to a particular lot of 

a raw material or other ingredient provided to you, such as the record created when a 

preventive control measure was applied. For example, if you produce frozen mixed vegetables

and rely on your supplier (the farm that grows the vegetables) to control pesticide residues in 

the raw vegetables that you will use to produce the frozen mixed vegetables, and you determine 

through supplier verification activities (e.g., periodic testing for pesticides) that your supplier 

provided a vegetable with a pesticide level in excess of the approved tolerance for that 

pesticide, you could obtain a copy of the pesticide application records from the farm that grows 

the vegetables for a period of time adequate to demonstrate that problems that could lead to 

excess pesticide levels have been resolved. 

Relevant food safety records also include, when applicable, records demonstrating that your 

supplier has verified control of a hazard by its own supplier. Such records could relate more 

broadly to a supplier’s food safety procedures, such as records of your supplier’s audit of its 

supplier’s food safety activities. For example, if you produce deli salads and obtain chopped 
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fresh vegetables from your supplier, you could obtain a copy of your supplier’s records 

documenting his audits of the farms growing the vegetables.

Figure 1 shows an example of using relevant food safety records when the hazard requiring a 

supply-chain-applied control is Salmonella that could contaminate black pepper and your 

supplier (Supplier A) provides you with a spice mix containing black pepper that has been 

steam-treated by Establishment B (earlier in the supply chain) to control Salmonella. One 

relevant food safety record could be the applicable audit records resulting from an onsite audit 

of Establishment B, which you could obtain from Supplier A.5 The applicable audit records could 

include copies of audit procedures, dates, conclusions of the audits, and any corrective actions 

taken in response to significant deficiencies identified during the audit of Establishment B. If 

Supplier A conducts additional verification activities such as periodic testing of the steamtreated black pepper, you could also ask Supplier A to provide records of those activities to you 

for your review. If you want to see documentation of the applicable parameters for the steam 

treatment that Establishment B delivered to a lot of black pepper, you could obtain these 

records either directly from Establishment B or from Supplier A.

 5 Alternatively, Supplier A may request that Establishment B obtain a third-party audit. Thus, 

Establishment B may also be able to provide applicable audit records for you to review.
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Figure 1. Applicable Records When Supplier A Provides You With a Spice Mix Containing Black 

Pepper That Has Been Steam-treated by Establishment B

See 21 CFR 117.475(c)(9) and section 15.13 for a list of required documentation when you 

conduct a review of the supplier’s relevant food safety records as a supplier verification activity.

15.7.2.4 Other appropriate supplier verification activities based on 

supplier performance and the risk associated with the raw material or other 

ingredient (21 CFR 117.410(b)(4))

Subpart G provides that you could conduct (and document) or obtain documentation of other 

supplier verification activities that are appropriate based on your supplier’s performance and the 

risk posed by the raw material or other ingredient. This means that you could specify and design 

risk-based activities (other than an onsite audit, sampling and testing, and review of relevant 

food safety records) that can provide effective supplier verification.

As one example, you could develop and use a fact-specific questionnaire or consider 

information applicable to a supplier’s certification to a specific audit scheme, and you could use 

such activities alone or in combination with other supplier verification activities. As another 

example, if you determine and document that you would audit a supplier on a biennial rather 

spice mix with 

black pepper black pepper

Establishment B

Steam treats black 

pepper to control for 

Salmonella

Supplier A

Creates spice mix with 

treated black pepper

Your Facility

Identifies Salmonella 

hazard in black pepper

Establishment B

Identification 

and control of 

hazard

Supplier A

Conducts and documents the 

following supplier verification 

activities of Establishment B:

Supplier A's onsite audit of 

Establishment B 

Other supplier verification activities 

conducted by Supplier A of 

Establishment B (such as periodic 

testing of steam-treated black 

pepper)

Your Facility

Supplier Verification of 

hazard control through 

review of supplier's 

relevant food safety 

records:

or

Review Supplier A's 

records of other activities 

- Review audit records of 

Establishment B

OR

- Review documentation 

of applicable parameters 

for the steam treatment 

done by Establishment B

(obtain from Supplier A 

or Establishment B 

directly)

Supplier 

verification

activities by 

Supplier A and 

Your Facility
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than annual basis as provided by 21 CFR 117.430(b)(2), you could review the records 

demonstrating the results of the supplier’s environmental monitoring program during the year 

that you do not conduct an audit.

See 21 CFR 117.475(c)(10) and section 15.13 for recommended documentation when you 

conduct a supplier verification activity other than an onsite audit, sampling and testing, or review 

of the supplier’s relevant food safety records.

15.7.3 Assurance that a Hazard Has Been Significantly Minimized or 

Prevented

The supply-chain program in subpart G is a type of preventive control and, thus, must comply 

with the requirements applicable to preventive controls in 21 CFR 117.135. Under 21 CFR 

117.135(a), a preventive control provides assurance that any hazards requiring a preventive 

control will be significantly minimized or prevented. To make this clear, 21 CFR 117.410(c) 

specifies that the supply-chain program must provide assurance that a hazard requiring a 

supply-chain-applied control has been significantly minimized or prevented. Suppliers that are 

subject to the PCHF requirements in part 117 are required to develop and implement a food 

safety plan that will significantly minimize or prevent hazards associated with the food

manufactured, processed, packed or held by the facility (21 CFR 117.126) and to document

they are following their plan (21 CFR 117.190). Suppliers subject to the produce safety 

requirements in part 112 must take appropriate measures to minimize the risk of serious 

adverse health consequences or death from the use of, or exposure to, covered produce, 

including those measures reasonably necessary to prevent the introduction of known or 

reasonably foreseeable hazards into covered produce, and to provide reasonable assurances 

that the produce is not adulterated under section 402 of the FD&C Act on account of such 

hazards. (See 21 CFR 112.11.)

15.7.4 Considerations in Approving Suppliers and Determining the 

Appropriate Supplier Verification Activities and the Frequency with Which 

They Are Conducted 

As noted in section 15.7.1, subpart G specifies that you must approve suppliers and determine 

appropriate supplier verification activities (including determining the frequency of conducting the 

activity). (See 21 CFR 117.410(a)(1) and (a)(2).) Section 21 CFR 117.410(d)(1) specifies factors 

that you must consider in approving suppliers and determining appropriate supplier verification 

activities (including determining the frequency of conducting the activity). We discuss these 

factors in sections 15.7.4.1 through 15.7.4.4. With one exception, the requirement to consider 

each of these factors applies every time you approve a supplier for a raw material or other 

ingredient, and every time that you determine the appropriate supplier verification activity for a 

food received from that supplier. See a discussion of the exception, in 21 CFR 117.410(d)(2), in 

section 15.7.4.5.

As noted in sections 15.8.1 and 15.8.2, only you can approve suppliers, but subpart G provides

some flexibility for another entity in the distribution chain to conduct certain other activities 

related to supplier verification, and to provide you with applicable documentation of those 

activities, to help you do so.
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15.7.4.1 Hazard analysis

The first factor that you must consider in (1) approving suppliers, (2) determining appropriate 

supplier verification activities, and (3) determining the frequency of conducting those activities is 

the hazard analysis of the food, conducted in accordance with 21 CFR 117.130. (See 21 CFR 

117.410(d)(1)(i).) To do so, you must consider the nature of the hazard controlled before receipt 

of the raw material or other ingredient. (See 21 CFR 117.410(d)(1)(i).) Immediately below, we 

explain the requirements of part 117 for a hazard analysis and provide recommendations for 

how to consider the hazard analysis in approving suppliers, determining appropriate supplier 

verification activities, and determining the frequency of those activities.

Part 117 requires that you conduct a hazard analysis to identify and evaluate, based on 

experience, illness data, scientific reports, and other information, known or reasonably 

foreseeable hazards for each type of food manufactured, processed, packed, or held at your 

facility to determine whether there are any hazards requiring a preventive control. (See 21 CFR 

117.130(a).) If you determine that there are any hazards that require a preventive control, with 

few exceptions Part 117 further requires that you must identify and implement a preventive 

control. (See 21 CFR 117.135(a).) When the preventive control will be applied to a raw material 

or other ingredient before receipt, part 117 requires that you establish and implement a riskbased supply-chain program for that raw material or other ingredient. (See 21 CFR 117.405.)

As part of your hazard analysis, you would evaluate the hazard to assess 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. (See 21 CFR 117.130(c)(1)(i).) The outcome of this aspect of 

the hazard evaluation impacts the type of verification activity you use (as well as the frequency 

of conducting the activity). For example, when the hazard is one for which there is a reasonable 

probability that exposure to the hazard will cause serious adverse health consequences or 

death, in general you must conduct an annual onsite audit before using the raw material or other 

ingredient from the supplier and at least annually thereafter. (See 21 CFR 117.430(b) and the 

discussion in section 15.11.2.) For other hazards, the determination of supplier verification 

activities, and the frequency of conducting those activities, also should be risk-based – i.e., the 

greater the risk presented by the hazard, the more robust the verification activity, and the 

greater the frequency of the verification.

As part of your hazard analysis, you also would evaluate environmental pathogens whenever a 

ready-to-eat food is exposed to the environment prior to packaging and the packaged food does 

not receive a treatment or otherwise include a control measure (such as a formulation lethal to 

the pathogen) that would significantly minimize the pathogen. (See 21 CFR 117.130(c)(1)(ii).) If, 

for example, you are purchasing a cheese to be used in an RTE product you make, and you 

expect that a sanitation control will be applied to address the environmental pathogen Listeria 

monocytogenes, you could ask to review the cheese producer’s written procedures for the 

environmental monitoring it does to verify the sanitation controls. (See 21 CFR 117.165(b)(3).)

You also could periodically verify your supplier’s controls by sampling and testing the cheese for 

L. monocytogenes. Because L. monocytogenes is a hazard for which there is a reasonable 

probability that exposure to the hazard will cause serious adverse health consequences or 

death, you also would conduct an annual onsite audit to verify that your supplier controls L.

monocytogenes when it manufactures the cheese by using a “kill step” such as pasteurization of 

the milk used to make the cheese and sanitation controls to significantly minimize contamination 

from L. monocytogenes in the environment, with environmental monitoring to verify controls for 

L. monocytogenes. 
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For all hazards that require a supply-chain-applied control, we recommend that you use the 

outcome of your hazard analysis to help you determine the extent of what you do to consider 

supplier performance as required by 21 CFR 117.117.410(d)(1)(iii) (see the discussion in 

section 15.7.4.3). The greater the risk presented by the hazard, the more stringently you should 

assess supplier performance as a mechanism to reduce the risk presented by the hazard.

15.7.4.2 Entity controlling the hazard

The second factor that you must consider in (1) approving suppliers, (2) determining appropriate 

supplier verification activities, and (3) determining the frequency of conducting those activities is 

the entity or entities that will be applying controls for the hazards requiring a supply-chainapplied control. (See 21 CFR 117.410(d)(1)(ii).) For example, the entity that applies the 

appropriate preventive control could be your direct supplier or your supplier’s supplier. If the 

control is not applied by your direct supplier, you would direct your supplier verification activities 

to your supplier’s supplier, but there is some flexibility in how you could do this.

Figure 2 shows an example in which you obtain a seasoning mix from Supplier X. Supplier X 

made the seasoning mix by blending milk powder (produced by Establishment Y) and a spice

blend (produced by Establishment Z). You identify Salmonella as a hazard in the seasoning mix, 

and you learn from Supplier X (your direct supplier) that it does not apply a control for 

Salmonella in its blending operation. Instead, Establishment Y applies a process control for 

Salmonella in the milk powder and Establishment Z applies a process control for Salmonella in 

the spice blend. Although Supplier X is your “supplier,” Supplier X also is a receiving facility 

(because Supplier X is a manufacturer) and, thus, would have conducted appropriate supplier 

verification activities, such as auditing its suppliers (or obtaining audits) and sampling and 

testing the milk and the spices, to ensure that they have used proper controls. (See section 

15.11.1 for a discussion of when an audit is required for certain hazards and the exception to 

that requirement.) With respect to supplier verification activities for Establishments Y and Z, 

Subpart G provides that you could rely on documentation provided by Supplier X to you 

regarding Supplier X’s supplier verification activities. (See 21 CFR 117.415(a)(3).) Alternatively,

you could conduct the appropriate supplier verification activities with respect to Establishments 

Y and Z yourself, or you could rely on documentation from Supplier X for some supplier 

verification activities with respect to Establishments Y and Z and conduct other supplier 

verification activities with respect to Establishments Y and Z yourself. You also would determine 

an appropriate supplier verification activity and associated frequency for Supplier X.
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Figure 2. Supplier X makes a seasoning mix by blending milk powder (produced by Establishment 

Y) and a spice blend (produced by Establishment Z)

In determining whether to approve a supplier that relies on its own supplier to control the hazard

requiring a supply-chain-applied control, we recommend you consider the robustness of the 

entity’s supplier approval process and supplier verification activities.

15.7.4.3 Supplier performance

The third factor that you must consider in approving suppliers, determining appropriate supplier 

verification activities, and determining the frequency of conducting those activities is supplier 

performance. (See 21 CFR 117.410(d)(1)(iii).) Considering supplier performance includes:

• The supplier’s procedures, processes, and practices related to the safety of the raw material 

and other ingredients (21 CFR 117.410(d)(1)(iii)(A)); 

• Applicable FDA food safety regulations and information relevant to the supplier’s compliance 

with those regulations, including an FDA warning letter or import alert relating to the safety 

of food and other FDA compliance actions related to food safety (or, when applicable, 

relevant laws and regulations of a country whose food safety system FDA has officially 

seasoning mix

Establishment Y

Process control for 

Salmonella during 

manufacture of milk 

powder

Establishment Z

Process control for 

Salmonella applied to 

spice blend 

Supplier X

Creates seasoning mix with 

processed milk powder and 

spice blend; identifies 

hazard, but does not apply 

its own controls

Your Facility

Identifies Salmonella 

hazard in seasoning mix

milk powder

spice blend

Identification 

and control of 

hazard

Establishment Z

Establishment Y

Supplier X

Does not apply its own 

controls, but does conduct 

and document supplier 

verification of

Establishments Y and Z:

Appropriate supplier 

verification activities could 

include auditing or 

obtaining an audit of 

Establishments Y and Z and 

sampling and testing the 

milk and spices to ensure 

that suppliers used proper 

Your Facility

Supplier verification of hazard 

control through:

Alternatively

Review Supplier X 

documention of its supplier 

verification activities of 

Establishments Y and Z

- Conduct appropriate 

supplier verification 

actitivites of Establishments 

Y and Z directly (e.g., audit). 

OR

- Conduct some supplier 

verification activities of 

Establishments Y and Z 

yourself and rely on 

documentation from Supplier 

X for others.

Establishments Yand Z

Supplier 

verification

activities by 

Supplier X and 

Your Facility
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recognized as comparable or has determined to be equivalent to that of the United States, 

and information relevant to the supplier’s compliance with those laws and regulations) (21 

CFR 117.410(d)(1)(iii)(B)); and 

• The supplier’s food safety history relevant to the raw materials or other ingredients that the 

receiving facility receives from the supplier, including available information about results 

from testing raw materials or other ingredients for hazards, audit results relating to the safety 

of the food, and responsiveness of the supplier in correcting problems (21 CFR 

117.410(d)(1)(iii)(C)). 

As noted in section 15.7.4.1 regarding your hazard analysis as the first factor to consider, the 

greater the risk presented by the hazard, the more stringently you should assess supplier 

performance as a mechanism to reduce the risk presented by the hazard.

15.7.4.3.1 Supplier’s procedures, processes, and practices

Understanding the supplier’s procedures, processes, and practices related to the safety of the 

raw material and other ingredients can help you understand the supplier’s strengths and 

weaknesses. Mechanisms to do so include:

• Conducting a supplier “pre-assessment” questionnaire or survey to gather information about 

the supplier’s operation, covering topics such as product information (e.g., regulatory 

compliance information and allergen information) and the supplier’s food safety programs 

(e.g., a Hazard Analysis and Critical Control Point (HACCP) program, a sanitation control 

program, and an allergen control program);

• Asking the supplier to provide documents such as a food safety plan or HACCP plan (if 

applicable) and third-party food safety and good manufacturing practice audit results; 

• Conducting a pre-approval site visit to assess programs and process capabilities; and

• Using a system with defined metrics to evaluate supplier performance, including compliance 

to specifications, third-party audit scores, number of recalls, mock recall performance, 

material rejections/complaints, and issue response time (e.g., the supplier’s timeframe for 

resolving a food safety issue).

15.7.4.3.2 Applicable food safety regulations

You should determine what FDA food safety regulations a potential supplier is subject to, such 

as the CGMP and PCHF requirements (21 CFR part 117), the produce safety regulation (21 

CFR part 112), the requirements applicable to low-acid canned foods (21 CFR parts 108 and 

113), the requirements applicable to acidified foods (21 CFR parts 108 and 114), or other 

relevant food safety provisions. In evaluating the supplier’s compliance with the relevant 

regulations, you should consider whether the supplier is the subject of an FDA warning letter, 

import alert, or other FDA compliance action related to food safety (e.g., mandatory recall). See 

our Web site “Supplier Evaluation Resources” (FDA, 2016d) for resources that are available to 

help you evaluate the supplier’s compliance with relevant FDA regulations.

Having an understanding of applicable FDA food safety regulations and information relevant to 

the supplier’s compliance with those regulations can help you determine whether the supplier 

has a demonstrable history of supplying acceptable products and meeting all industry and 

regulatory requirements. Mechanisms to do so include:

• Asking the supplier to provide documentation of any recent regulatory inspections on file; 
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• Searching our online databases for warning letters, import alerts, import refusals, recalls, 

and inspections. All of these databases are available to the public from our Web site 

“Supplier Evaluation Resources” (FDA, 2016d).

• Searching for actions that we publicize, such as food outbreak investigations and 

suspension of a facility’s registration. We generally make these available from the

homepage for our human food program at http://www.fda.gov/Food/default.htm.

You should use this information to inform your decisions about whether you will approve a 

supplier, the type of verification activity you would use if you do approve the supplier, and the 

frequency of conducting the verification activity. Being subject to an FDA enforcement action 

such as a warning letter or an import alert should not necessarily disqualify a supplier. However, 

you should consider carefully the actions a supplier has taken as a result of regulatory 

compliance issues along with how it impacts your approval of that supplier and your verification 

activities.

Part 117 includes several provisions that reflect that some suppliers operate in a foreign 

country. (See, e.g., the definition of “qualified auditor in 21 CFR 117.3 and the provisions of 21 

CFR 117.405(a)(2), 117.430(c), 117.435(c)(1)(ii), 117.435(c)(2), and 117.475(c)(15).) When the 

supplier is in a foreign country whose food safety system FDA has officially recognized as 

comparable or determined to be equivalent to that of the United States, you may consider 

relevant laws and regulations of that country, and information relevant to the supplier’s 

compliance with those laws and regulations. (See 21 CFR 117.410(d)(1)(iii)(B).) Thus, having 

an understanding of applicable laws and regulations in a foreign country can help you consider 

supplier performance when FDA has officially recognized that country’s food safety system as 

comparable or determined it is equivalent to that of the United States. For example, just as you 

could ask a domestic supplier to provide documentation of any recent regulatory inspections on 

file, you could ask a foreign supplier that is in a foreign country whose food safety system FDA 

has officially recognized as comparable or determined to be equivalent to that of the United 

States to provide documentation of an inspection conducted by the applicable food safety 

authority. As of the date of this guidance, FDA has a Food Safety Systems Recognition 

Arrangement with Australia (FDA, 2017), Canada (FDA, 2016b), and New Zealand (FDA, 

2015a). To determine whether we have a Food Safety Systems Recognition Arrangement or 

other cooperative arrangement with a foreign country, you can search the “Cooperative 

Arrangements” Web page (FDA, 2016a) of our “International Arrangements” Web page (FDA, 

2015b) of our internet site directed to International Programs (FDA, 2016c). 

15.7.4.3.3 Supplier’s food safety history

Before you became subject to the requirements of subpart G, you could already have 

established a relationship with your suppliers and have information related to audits or have the 

results of sampling and testing that provide a history of how the supplier has met your 

specifications. If so, you already could be aware of past problems with raw materials or other 

ingredients provided by the supplier, and the steps the supplier took to address such problems.

You may consider such prior relationships as part of your consideration of the supplier’s food 

safety history. Likewise, as time goes on and you conduct appropriate supplier verification 

activities to comply with the requirements of subpart G, you would consider this same type of 

information for suppliers that you approve in compliance with subpart G.

You should focus your consideration of the supplier’s food safety history on the hazard that the 

supplier is controlling because that is the most relevant information. However, you should also 

consider other information about the supplier, e.g., information regarding recalls or regulatory 
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actions. For example, if you are obtaining a product from a supplier that is controlling a microbial 

hazard (e.g., Salmonella in a spice blend) and food from this supplier has been associated with 

a chemical hazard (e.g., excess sulfites in another spice blend it produces), you should consider 

whether you should implement verification activities related to control of sulfites to prevent 

excess sulfites in the spice blend you receive for a period of time adequate to demonstrate that 

problems that could lead to excess sulfites levels have been resolved.

15.7.4.4 Other factors

Section 117.410(d)(1)(iv) specifies that you must consider any other factors as appropriate and 

necessary, such as storage and transportation practices, in approving suppliers, determining 

appropriate supplier verification activities, and determining the frequency of conducting those 

activities. For example, if you are receiving raw materials or other ingredients that support the 

growth of mold that could produce mycotoxins during storage if temperature and moisture are 

not controlled, you should consider the procedures that the supplier uses to control factors 

impacting growth of mold during the time the supplier stores the raw materials or other 

ingredients being supplied. As another example, if you are receiving raw materials or other 

ingredients that need temperature control during transportation to ensure their safety, you 

should consider the ability of the supplier to ensure control of temperature during transportation 

if the supplier will be responsible for that activity. As another example, if you are obtaining a raw 

material or other ingredient from a facility that is owned by your corporate parent you may 

consider your knowledge of corporate-wide food safety procedures, processes, and practices in 

determining the type of supplier verification activity and the frequency with which it is conducted.

See also the discussion in section 15.6.2 of a circumstance where an individual at the corporate 

level is the PCQI for the purposes of the supply-chain program.

15.7.4.5 Exception to the full requirements for considerations for 

approving suppliers and determining appropriate supplier verification 

activities

Section 117.410(d)(2) provides that considering supplier performance can be limited to the 

supplier’s compliance history (as required by 21 CFR 117.410(d)(1)(iii)(B)), if the supplier is: (i) 

A qualified facility as defined by 21 CFR 117.3; (ii) a farm that grows produce and is not a 

covered farm under 21 CFR part 112 in accordance with 21 CFR 112.4(a), or in accordance 

with 21 CFR 112.4(b) and 112.5; or (iii) a shell egg producer that is not subject to the 

requirements of 21 CFR part 118 because it has less than 3,000 laying hens.

15.7.5 Supplier Nonconformance

Section 117.410(e) specifies that if you determine through auditing; verification testing;

document review; relevant consumer, customer or other complaints; or otherwise that the 

supplier is not controlling hazards that you have identified as requiring a supply-chain-applied 

control, you must take and document prompt action in accordance with 21 CFR 117.150 

(Corrective actions and corrections) to ensure that raw materials or other ingredients from the 

supplier do not cause food that you manufacture or process to be adulterated under section 402 

of the FD&C Act or misbranded under section 403(w) of the FD&C Act. 

We recommend that you establish processes and procedures to handle supplier 

nonconformance situations. The appropriate actions you take in response to nonconformance

will depend on the circumstances and the specific root cause of the nonconformance and could

include:
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• Discontinuing use of the supplier until the cause or causes of nonconformance, adulteration, 

or misbranding are adequately addressed;

• Notifying the supplier of the problem and requesting documentation of corrective actions 

taken by the supplier;

• Assisting the supplier’s efforts to correct and prevent recurrence of the problem;

• Revising your supply-chain program; and

• Conducting, or working with your supplier to conduct, a recall of an adulterated or 

misbranded food.

15.8 Responsibilities of the Receiving Facility (21 CFR 117.415)

Section 117.415 describes your responsibilities as a receiving facility. As noted in section 

15.3.2, subpart G includes provisions that provide for an entity other than you to conduct certain 

activities, provided that you review and assess the entity’s applicable documentation, and 

document that review and assessment. Section 117.415 both specifies this flexibility provided 

by subpart G and places some bounds on that flexibility. We discuss this flexibility and its 

bounds in sections 15.8.1 through 15.8.4.

15.8.1 Your Responsibility to Approve Suppliers 

Section 117.415(a)(1) specifies that the receiving facility must approve suppliers. Although 21 

CFR 117.415(a)(2) through (a)(4) provide some flexibility for other entities to determine and 

conduct appropriate supplier verification activities (see section 15.8.2), ultimately the receiving 

facility is responsible for its supply-chain program (see the discussion in the final rule 

establishing part 117, 80 FR 55908 at 56097). See section 15.7.4 for considerations in 

approving suppliers and section 15.9 for the requirements to approve suppliers before receiving 

raw materials and other ingredients from those suppliers and have written procedures for 

receiving raw materials and other ingredients.

As noted in section 15.6.1, the definition of “supplier” in part 117 means that a broker or 

distributor is not a supplier; the supplier is the establishment that manufactures/processes the 

food, raises the animal, or grows the food. Thus, if you buy raw materials or other ingredients 

from a broker or distributor, you should ask the broker or distributor to provide you with 

information that allows you to approve the establishment that manufactures/processes the food, 

raises the animal, or grows the food as a supplier of the food that you purchase from that broker 

or distributor. Likewise, if you purchase raw materials or other ingredients from a retail 

establishment (e.g., a warehouse-style establishment that sells to consumers), some applicable 

information (e.g., name and place of business of the manufacturer, packer, or distributor) would 

be on the product label as required by food labeling regulations. (See 21 CFR 101.5.) Also, you 

could ask the retail establishment to provide you with information that allows you to evaluate the 

establishment that manufactures/processes the food, raises the animal, or grows the food. 

15.8.2 Your Responsibility to Determine and Conduct Appropriate Supplier 

Verification Activities

Section 117.415(a)(2) specifies that the receiving facility must determine and conduct 

appropriate supplier verification activities, and satisfy all documentation requirements of subpart 
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G. However, sections 117.415(a)(3) and (4) provide some flexibility for other entities to 

determine and conduct supplier verification activities on behalf of the receiving facility. See 

section 15.7.4 for considerations in determining appropriate supplier verification activities and 

the frequency of conducting them.

15.8.2.1 Flexibility for another entity to determine, conduct, and 

document appropriate supplier verification activities

Under 21 CFR 117.415(a)(3), an entity other than the receiving facility may do any of the 

following, provided that the receiving facility reviews and assesses the entity’s applicable 

documentation, and documents that review and assessment:

• Establish written procedures for receiving raw materials and other ingredients by the entity

(21 CFR 117.415(a)(3)(i));

• Document that written procedures for receiving raw materials and other ingredients are 

being followed by the entity (21 CFR 117.415(a)(3)(ii)); and 

• Determine, conduct, or both determine and conduct the appropriate supplier verification 

activities (21 CFR 117.415(a)(3)(iii)), with appropriate documentation.

Although we specify that these activities are your responsibility, subpart G accounts for one or 

more entities in the supply chain between you and “the supplier” by providing some flexibility for 

these entities to perform certain activities.

15.8.2.2 Supplier verification activities that the supplier can conduct 

and document 

Under 21 CFR 117.415(a)(4), the supplier may conduct and document sampling and testing of 

raw materials and other ingredients, for the hazard controlled by the supplier, as a supplier 

verification activity for a particular lot of product and provide such documentation to the 

receiving facility. However, 21 CFR 117.415(a)(4) also requires that you review and assess that 

documentation, and document that review and assessment. An example of documentation of 

the results of sampling and testing is a COA, whether of periodic testing or lot-by-lot testing of 

the raw material or ingredient. 

We recommend that a COA document that major analytical parameters for the specific foods, or 

lots, contained in a specific shipment have been met (see, e.g., GMA, 2008). Testing can be 

performed by the supplier’s in-house laboratory or contracted to an outside testing laboratory.

The laboratory conducting the testing should use scientifically valid laboratory methods and 

procedures that can provide reliable, accurate test results.

15.8.3 What You May Not Accept from a Supplier as a Supplier Verification 

Activity

Section 117.415(b) specifies that a receiving facility may not accept any of the following as a 

supplier verification activity from its supplier:

• A determination by its supplier of the appropriate supplier verification activities for that 

supplier (21 CFR 117.415(b)(1)); 

• An audit conducted by its supplier of that supplier (21 CFR 117.415(b)(2)); 
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• A review by its supplier of that supplier’s own relevant food safety records (21 CFR 

117.415(b)(3)); or 

• The conduct by its supplier of other appropriate supplier verification activities for that 

supplier (21 CFR 117.415(b)(4)).

The only supplier verification activities in which the supplier can play a role are sampling and 

testing (see section 15.8.2.2) and providing an audit of the supplier conducted by a third party 

(see section 15.8.4).

15.8.4 Audit Provided by the Supplier

Under 21 CFR 117.415(c), your responsibilities as a receiving facility do not prohibit you from 

relying on an audit provided by your supplier when the audit of the supplier was conducted by a 

third-party qualified auditor in accordance with the requirements of subpart G applicable to 

audits (i.e., 21 CFR 117.430(f) and 117.435). We discuss these requirements applicable to 

audits in sections 15.11.6 and 15.12, respectively.

15.9 Using Approved Suppliers (21 CFR 117.420)

As noted in sections 15.7.1 and 15.8.1, subpart G requires that a receiving facility approve 

suppliers. (See 21 CFR 117.410(a)(1) and 117.415(a)(1).) 

15.9.1 Approving Suppliers

Section 117.420(a) specifies that the receiving facility must approve suppliers in accordance 

with the requirements of 21 CFR 117.410(d), and document that approval, before receiving raw 

materials and other ingredients from those suppliers. As discussed in section 15.7.4, 21 CFR 

117.410(d) both specifies factors that you must consider in approving suppliers and determining 

appropriate supplier verification activities and provides for an exception to the full requirements 

for considering these factors.

15.9.2 Written Procedures for Receiving Raw materials and Other 

Ingredients

Section 117.420(b) specifies that:

• Written procedures for receiving raw materials and other ingredients6 must be established 

and followed (21 CFR 117.420(b)(1)); 

• The written procedures for receiving raw materials and other ingredients must ensure that 

raw materials and other ingredients are received only from approved suppliers (or, when 

necessary and appropriate, on a temporary basis from unapproved suppliers whose raw 

materials or other ingredients are subjected to adequate verification activities before 

acceptance for use) (21 CFR 117.420(b)(2)); and 

 6 As noted in the list of terms in section 15.5, part 117 defines the term “written procedures for receiving 

raw materials and other ingredients” to mean written procedures to ensure that raw materials and other 

ingredients are received only from suppliers approved by the receiving facility (or, when necessary and 

appropriate, on a temporary basis from unapproved suppliers whose raw materials or other ingredients 

are subjected to adequate verification activities before acceptance for use). We defined this term to 

simplify the provisions discussing these procedures.
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• Use of the written procedures for receiving raw materials and other ingredients must be 

documented (21 CFR 117.420(b)(3)).

You have flexibility to design appropriate written procedures that are tailored to your facility and 

operations for receiving raw materials and other ingredients. The goal of these written

procedures is to ensure that you can accurately identify approved suppliers and incorporate 

changes to your suppliers in a timely and accurate way (e.g., addition of new approved 

suppliers, deletion of suppliers no longer deemed approved, criteria for approving temporary 

suppliers). Procedures to ensure that raw materials or other ingredients are only received from 

approved suppliers allow consistent implementation of the supplier program by personnel who 

order raw materials and other ingredients, personnel who receive raw materials and other 

ingredients, and personnel who conduct supplier verification activities. Such procedures also 

can be part of training of personnel who will have responsibility for receiving raw materials and 

other ingredients. 

The use of written procedures for receiving raw materials and other ingredients is particularly 

important in light of the flexibility subpart G provides for an entity other than you (such as an 

entity in the supply chain between you and the supplier) to conduct this activity. (See 21 CFR 

117.415(a)(2).) Although such an entity can do this as a service to you, a written procedure is 

appropriate to ensure a robust and meaningful verification. If you purchase from a broker or 

distributor, you must approve the suppliers of the raw materials or other ingredients you buy 

from the broker/distributor (see sections 15.8.1 and 15.9.1), but the broker/distributor could 

document that written procedures are being followed to ensure that the raw materials and other 

ingredients provided to you only come from suppliers that you have approved. The 

broker/distributor would provide this documentation to you (e.g., in documents accompanying 

the shipment) for you to review and assess. Thus, if you rely on a broker/distributor to ensure 

that the raw materials and other ingredients provided to you only come from suppliers that you 

have approved, you and the broker/distributor you buy from should agree on the written 

procedures for how the broker/distributor will document that raw materials or other ingredients 

are received only from suppliers approved by you. For example, the broker/distributor could 

have a checklist that an employee dates and initials after reviewing the invoice from the 

supplier, and send a copy of that dated checklist to you together with the invoice for the raw 

materials or other ingredients. You could use an electronic system or specific supply chain 

management software to document receipt of the raw material or other ingredient and review of 

checklist from the broker/distributor at the time of receipt. Below, we discuss the use of 

checklists and computer systems in more detail.

One approach to a written procedure for ensuring that raw materials and other ingredients are 

only received from approved suppliers is to maintain and use an actual “approved supplier list” 

to ensure that only suppliers from the lists are used for the purchase of raw materials or other 

ingredients (Zaura, 2005). One example of this approach is a simple paper system where the 

receiving personnel or quality control/assurance personnel check the origin of the purchased 

materials (IFS, 2012) and refer to a list of approved suppliers to verify that the raw material or 

ingredient is received from an approved supplier (SQFI, 2014) (e.g., put a check mark on the 

receiving document if the supplier is an approved supplier).

Another approach to a written procedure for ensuring that raw materials and other ingredients 

are only received from approved suppliers is a computer system or specific supply chain 

management software that manages the procurement, receipt, and usage of raw materials and 
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other ingredients. An example of this approach is for authorized personnel from the receiving 

facility or its corporate headquarters to enter approved suppliers and approved raw materials 

and other ingredients into the computerized system. When raw materials and other ingredients 

are delivered to a facility, the receiving personnel cross reference the purchase order number, 

supplier name, and material received with the information previously entered into the computer 

system to verify the materials are from an approved supplier and the order is correct. Typically 

the computer system would also have a safeguard mechanism to prevent the acceptance of a 

raw material or other ingredient from an unapproved supplier. On an as needed basis, a facility 

or its corporate headquarters can use the computer system to generate a list of the approved 

suppliers and approved raw materials or ingredients in real time.

Another approach to a written procedure for ensuring that raw materials and other ingredients 

are only received from approved suppliers is use of computer programs that link inputs on items 

received with the list of approved suppliers for that item and flag discrepancies. You could either 

use your existing receiving record system or modify your existing receiving record system to 

record information regarding receipt from approved suppliers. 

Subpart G accounts for emergency situations in which you would need to receive raw materials 

or other ingredients on a temporary basis from an unapproved supplier (See 21 CFR 

117.420(b)(2) and SQFI, 2014.) Examples of such situations are disruptions in delivery of raw 

materials and other ingredients from approved suppliers due to:

• An environmental incident (e.g., an earthquake) or weather-related incident (e.g., a tornado

or severe drought or flooding in the area where the supplier is located);

• A major equipment breakdown at the facility of a sole supplier of a food;

• The emergence of a contamination problem at your supplier’s facility; or

• Your supplier ceases operations without giving you advance notification.

For an unapproved supplier that you plan to use on a temporary basis, we recommend that you 

conduct at least a minimal review of the supplier. For example, we suggest that you review 

FDA’s Web site to determine whether the potential supplier has received a warning letter or is 

listed on an import alert. In addition, if you need to use an unapproved supplier under such 

unexpected circumstances, you must subject the applicable raw materials or other ingredients 

to adequate verification activities before acceptance for use. (See 21 CFR 117.420(b)(2).) For 

example, if you are receiving a raw material or ingredient such as black pepper and your 

supplier controls Salmonella, you could sample and test each shipment of food from the supplier

for Salmonella using a statistically-based sampling plan. Alternatively, you could obtain and 

review records of the process that the temporary supplier uses to kill Salmonella in the black 

pepper. 

You should use unapproved suppliers only on a temporary basis until you are able to fully 

evaluate and approve a new supplier, or until the problem with your previously approved 

supplier has been corrected and, as appropriate, you reevaluate your approval of that supplier.

An appropriate time period for use of an unapproved supplier on a temporary basis might vary, 

depending on the circumstances, from a few weeks to a few months. For example, if your 

approved supplier ceases operations and you intend to continue to use a temporary supplier, 

you should promptly evaluate the new supplier and revise your supply-chain program 

accordingly. If you are considering multiple new suppliers to replace your approved supplier, 
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you may need some additional time to evaluate and approve the additional suppliers. As 

another example, it could be the case that you expect to be able to obtain the food from the 

approved supplier in a few weeks, but you subsequently determine that it may take several 

months or an indefinite period of time before you can obtain the food from the approved supplier

because of an equipment breakdown or a weather-related incident. In that circumstance, you 

may determine that you want to use your temporary supplier or another supplier on a more 

permanent basis. If that occurs, you should promptly evaluate and approve the new supplier 

and revise your supply-chain program to reflect this. Having multiple suppliers approved for 

each raw material or ingredient you receive can reduce the use of temporary suppliers when 

one supplier becomes unavailable.

How you document use of the written procedures for receiving raw materials and other 

ingredients depends on what your procedures are and how you implement them. For example, if 

you use a checklist, or put a check mark on the receiving document if the supplier is an 

approved supplier, then the checklist or receiving document would be your documentation. If 

you use a computerized system, you can generate records, such as a list of approved suppliers 

and a list of approved raw materials and other ingredients received from those suppliers on an 

as needed basis. If you receive documentation from another entity that has documented the 

receipt of raw materials or other ingredients from suppliers you have approved, you would 

review that documentation to verify that it is correct and document your assessment (e.g., with a 

notation on the documentation you received or in a computerized receiving log). 

If you receive raw materials or other ingredients on a temporary basis from an unapproved 

supplier, remember that subpart G requires you to subject raw materials or other ingredients 

from that unapproved supplier to adequate verification activities before you accept the raw 

materials or other ingredients for use. (See 21 CFR 117.420(b)(3).) To satisfy this requirement, 

you should document the verification activities that you conducted before accepting raw 

materials or other ingredients from a temporary supplier. 

15.10 Determining Appropriate Supplier Verification Activities 

(Including Determining the Frequency of Conducting the Activity) (21 

CFR 117.425)

Section 21 CFR 117.425 requires that appropriate supplier verification activities (including the 

frequency of conducting the activity) be determined in accordance with the requirements of 21 

CFR 117.410(d). Section 21 CFR 117.410(d) specifies the considerations in approving suppliers 

and determining the appropriate supplier verification activities and the frequency with which they 

are conducted. For details about the requirements of 21 CFR 117.410(d) and our 

recommendations for complying with those requirements, see section 15.7.4.

15.11 Conducting Supplier Verification Activities for Raw Materials 

and Other Ingredients (21 CFR 117.430)

Section 21 CFR 117.430 specifies requirements to conduct one or more of the supplier 

verification activities specified in 21 CFR 117.410(b), provides for alternative supplier verification 

activities in certain circumstances, and prohibits certain financial conflicts of interest. We 

discuss these provisions in sections 15.11.1 through 15.11.6.
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15.11.1 Requirement to Conduct Supplier Verification Activities

With some exceptions, 21 CFR 117.430(a) requires that one or more supplier verification 

activities (i.e., onsite audit, sampling and testing, review of food safety records, and other 

supplier verification activities)7 must be conducted for each supplier before using the raw 

material or other ingredient from that supplier and periodically thereafter. The exceptions to this 

requirement are specified in 21 CFR 117.430(c), (d), and (e). See the discussion of the 

exceptions to this requirement in sections 15.11.3 through 15.11.5.

A successful supplier program includes supplier verification activities both before the use of the 

raw material or other ingredient and periodically thereafter to evaluate ongoing compliance 

(ASTA, 2011; Edleman, 2012; Eldridge, 2012; ERG, 2004; Neumann, 2009; Zaura, 2005). 

Periodic verification provides routine feedback on the supplier’s performance, rather than only 

when a problem arises (Zaura, 2005). 

Subpart G includes specific requirements for conducting onsite audits (21 CFR 117.435) and for 

documenting the conduct of supplier verification activities (21 CFR 117.475). See sections 

15.11.2 and 15.12 for discussions of conducting an onsite audit as a supplier verification 

activity. See section 15.13 for a discussion of documenting of supplier verification activities.

15.11.2 Specific Requirements When the Hazard Requiring a Preventive 

Control is a SAHCODH Hazard

15.11.2.1 Requirement for an onsite audit when the hazard requiring a 

preventive control is a SAHCODH hazard

With one exception (see section 15.11.2), 21 CFR 117.430(b)(1) requires that when a hazard in 

a raw material or other ingredient will be controlled by the supplier and is one for which there is 

a reasonable probability that exposure to the hazard will result in serious adverse health 

consequences or death to humans (SAHCODH hazard): 

• The appropriate supplier verification activity is an onsite audit of the supplier (21 CFR 

117.430(b)(1)(i)); and 

• The audit must be conducted before using the raw material or other ingredient from the 

supplier and at least annually thereafter (21 CFR 117.430(b)(1)(ii)).

SAHCODH hazards are those for which a recall of a violative product posing such a hazard is 

designated as “Class 1” under 21 CFR 7.3(m)(1) (i.e., a situation in which there is a reasonable 

probability that the use of, or exposure to, a violative product will cause serious adverse health 

consequences or death). Examples of such hazards that, in some circumstances, have resulted 

in serious adverse health consequences or death to humans include pathogens or their toxins in 

RTE foods and undeclared food allergens. Foods (other than dietary supplements or infant 

formula) containing a SAHCODH hazard are considered “reportable foods,” subject to the 

Reportable Food Registry requirements prescribed by the Food and Drug Administration 

Amendments Act of 2007. See our “Guidance for Industry: Questions and Answers Regarding 

the Reportable Food Registry as Established by the Food and Drug Administration 

 7 The list of appropriate supplier verification activities is specified in 21 CFR 117.410(b). The receiving 

facility determines which activity to conduct in accordance with 21 CFR 117.410(d). See the discussion of 

the appropriate supplier verification activities in section 15.4.2. See the discussion of determining 

appropriate supplier verification activities in section 15.4.4.
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Amendments Act of 2007” (FDA, 2009 and FDA, 2010), and the annual reports of the 

Reportable Food Registry (e.g., FDA, 2016e.) for examples of foods that we have considered to 

be SAHCODH hazards. 

Onsite audits provide the opportunity to review the food safety plan and written procedures and 

to observe the implementation of food safety procedures, as well as to review the records 

related to the past application of control measures, including laboratory test results. Audits also 

provide the opportunity to interview employees to assess their understanding of the food safety 

measures for which they are responsible.

The goal of conducting an audit “at least annually thereafter” is to receive the results of an audit 

with sufficient frequency to provide assurance that a hazard requiring a supply-chain-applied 

control has been significantly minimized or prevented. We realize there could be practical 

reasons which preclude meeting this timeframe, e.g., if a third-party auditor needs to delay a 

previously scheduled audit. We do not expect to take action if the timeframe between annual 

audits is reasonably close to one year (e.g., within 13-14 months).

For specific requirements that apply to an audit, see 21 CFR 117.435 and section 15.12. For a 

discussion of documentation associated with an audit, see section 15.13.

15.11.2.2 Exception to the requirement for an onsite audit when the 

hazard requiring a preventive control is a SAHCODH hazard

The exception to the requirement to conduct an annual onsite audit when the hazard requiring a 

preventive control is a SAHCODH hazard is when there is a written determination that other 

verification activities and/or less frequent onsite auditing of the supplier provide adequate 

assurance that the hazards are controlled. (See 21 CFR 117.430(b)(2).) The written 

determination is part of your food safety plan and, thus, must be prepared by (or under the 

oversight of) your PCQI (see the discussion in section 15.6.5).

As an example of using an alternative approach to an annual onsite audit, consider the situation 

in which you are part of a larger corporation, are making trail mix, and obtain roasted peanuts 

from a supplier that is a subsidiary of the corporation and is operating under the same food 

safety system as you. You could determine that the food safety requirements established by the 

parent company and applied at the subsidiary provide the needed assurance that Salmonella in 

raw peanuts is adequately controlled. You could support your decision by documenting this 

determination, including the supplier’s procedures and the corporation’s activities to verify that 

the subsidiary operates in accordance with corporate food safety policies to ensure that hazards 

are adequately controlled. See also the discussion in section 15.6.2 of a circumstance where an 

individual at the corporate level is the PCQI for the purposes of the supply-chain program.

However, if a SAHCODH hazard is identified for the food and you conclude that annual onsite 

auditing is not required, we recommend that your supplier verification activities generally include 

some frequency of onsite auditing, such as every 2 or 3 years for most suppliers not in your 

same corporate structure. For example, consider the situation in which you have many years of 

experience with the same supplier. You could document the history of the supplier’s compliance

with control of the hazard (including summarizing test results, audit findings and other 

information) to support your decision that an annual onsite audit is not needed. You would

identify appropriate supplier verification activities and document these in your supply-chain 

program, e.g., you could determine and describe in your written program that you will require an 

audit every two years and sample and test for the hazard each quarter in the intervening year.
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15.11.3 Alternative Supplier Verification Activity If the Supplier Is a 

“Qualified Facility” 

Section 21 CFR 117.430(c) provides for an alternative supplier verification activity if a supplier is 

a qualified facility as defined by 21 CFR 117.3. If this is the case, you do not need to comply 

with the requirements to conduct one of the supplier verification activities specified in 21 CFR 

117.410(b) (i.e., audit, sampling and testing, review of the supplier’s relevant food safety 

records, or other appropriate supplier verification activity), or conduct an annual onsite audit if 

the hazard requiring a preventive control is a SAHCODH hazard, if you:

• Obtain written assurance that the supplier is a qualified facility as defined by § 117.3: 

o Before first approving the supplier for an applicable calendar year; and 

o On an annual basis thereafter, by December 31 of each calendar year, for the 

following calendar year; and 

• Obtain written assurance, at least every 2 years, that the supplier is producing the raw 

material or other ingredient in compliance with applicable FDA food safety regulations (or, 

when applicable, relevant laws and regulations of a country whose food safety system FDA 

has officially recognized as comparable or has determined to be equivalent to that of the 

United States). The written assurance must include either: 

o A brief description of the preventive controls that the supplier is implementing to 

control the applicable hazard in the food; or

o A statement that the facility is in compliance with State, local, county, tribal, or other 

applicable non-Federal food safety law, including relevant laws and regulations of 

foreign countries.

A facility is a qualified facility if it is a very small business as that term is defined in part 117. See 

the definitions for “qualified facility” and “very small business” in 21 CFR 117.3 and in the list of 

terms in section 15.5. A qualified facility is not subject to the PCHF requirements for hazard 

analysis and risk-based preventive controls, including the requirement to have a supply-chain 

program. It is the responsibility of the supplier to determine whether it is a qualified facility; it is 

your responsibility to obtain written assurance from the supplier that it is a qualified facility.

By specifying “by December 31” for the annual written assurance that the supplier is a qualified 

facility, the provision provides some flexibility for you to work with each applicable supplier to 

determine the specific date within a calendar year for that supplier to annually notify you about 

its status. You and your suppliers have some flexibility to approach the potential for the status of 

a facility to shift between “qualified facility” and “not a qualified facility” (or vice versa) in a way 

that works best for your specific business relationship.

The biennial written assurance aligns with the responsibilities of a qualified facility to submit an 

attestation to FDA every two years.

8 (See 21 CFR 117.201(a).) In its attestation, the qualified 

facility attests that: (1) It meets the definition of a qualified facility; and (2) either it has 

established and is following certain food safety practices, or it is in compliance with State, local, 

county, tribal, or other applicable non-Federal food safety law, including relevant laws and 

 8 For a facility that begins manufacturing, processing, packing or holding food before September 17, 2018, 

the facility must make its first submission by December 17, 2018. For a facility that begins manufacturing, 

processing, packing or holding food after September 17, 2018, the facility must make its first submission 

before beginning operations. 
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regulations of foreign countries. See section 15.7.4.3 for a discussion of the applicability of 

relevant laws and regulations of a country whose food safety system FDA has officially 

recognized as comparable or has determined to be equivalent to that of the United States. A

qualified facility submits its attestation to FDA on Form FDA 3942a. A supplier that is a qualified 

facility could provide a copy of that form to its customers to help them comply with 21 CFR 

117.430(c)(1). (A qualified facility that submits the attestation electronically could print a copy for 

this purpose.) Subpart G also requires that a receiving facility obtain a written assurance that 

includes a brief written description of the preventive controls that the qualified facility is 

implementing to control the applicable hazard in the food, or a statement that the qualified 

facility is in compliance with an applicable non-Federal food safety law. For example, a qualified 

facility that supplies honey-roasted pecans could include a brief written description of its 

preventive controls to control Salmonella on the pecans (e.g., roasting the pecans at a specified 

temperature for a specified time period); alternatively, a qualified facility that supplies honeyroasted pecans could provide a statement that it complies with the food safety laws of the state 

in which it is located. 

15.11.4 Alternative Supplier Verification Activity If the Supplier is a Certain 

Type of Produce Farm

Section 21 CFR 117.430(d) provides for an alternative supplier verification activity if a supplier is 

a farm that grows produce and is not a covered farm under the produce safety regulation in 21 

CFR part 112 in accordance with 21 CFR 112.4(a), or in accordance with 21 CFR 112.4(b) and 

112.5. If this is the case, you do not need to comply with the requirements to conduct one of the 

supplier verification activities specified in 21 CFR 117.410(b), or conduct an annual onsite audit 

if the hazard requiring a preventive control is a SAHCODH hazard, for produce that the 

receiving facility receives from the farm as a raw material or other ingredient if you: 

• Obtain written assurance that the raw material or other ingredient provided by the supplier is 

not subject to the produce safety regulation in 21 CFR part 112 in accordance with 21 CFR

112.4(a), or in accordance with 21 CFR 112.4(b) and 112.5: 

o Before first approving the supplier for an applicable calendar year; and 

o On an annual basis thereafter, by December 31 of each calendar year, for the 

following calendar year; and 

• Obtain written assurance, at least every 2 years, that the farm acknowledges that its food is 

subject to section 402 of the FD&C Act (or, when applicable, that its food is subject to 

relevant laws and regulations of a country whose food safety system FDA has officially 

recognized as comparable or has determined to be equivalent to that of the United States).

Under 21 CFR 112.4(a), a farm or farm mixed-type facility that has less than $25,000 in annual 

sales of produce averaged over the previous 3-year period is not a covered farm under the 

produce safety regulation. Under 21 CFR 112.4(b) and 112.5, a farm is not a covered farm if the 

farm is eligible for a qualified exemption and associated modified requirements based on the 

average monetary value of all food sold and the relative value of food sold directly to qualified 

end users as compared to all other buyers9

, and FDA has not withdrawn the farm’s exemption.

It is the responsibility of the supplier to determine whether it is not subject to the produce safety 

regulation; it is your responsibility to obtain written assurance from the supplier that it is not 

subject to the produce safety regulation.

 9 See 21 CFR 112.5(a) for the requirements of the qualified exemption and 21 CFR 112.3 for the 

definition of “qualified end users.”
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By specifying “by December 31” for the annual written assurance that the supplier is a farm that 

grows produce and is not a covered farm under the produce safety regulation, the provision 

provides some flexibility for you to work with each applicable supplier to determine the specific 

date within a calendar year for that supplier to annually notify you about its status. You and your

suppliers have some flexibility to approach the potential for the status of a facility to shift 

between “not a covered farm” and “covered farm” (or vice versa) in a way that works best for 

your specific business relationship.

See section 15.7.4.3 for a discussion of the applicability of relevant laws and regulations of a 

country whose food safety system FDA has officially recognized as comparable or has 

determined to be equivalent to that of the United States.

15.11.5 Alternative Supplier Verification Activity If the Supplier Is a Shell Egg 

Producer That Is Not Subject to the Requirements of 21 CFR Part 118

Section 21 CFR 117.430(e) provides for an alternative supplier verification activity if a supplier is 

a shell egg producer that is not subject to the requirements of 21 CFR part 118 for the 

production, storage, and transportation of shell eggs because it has less than 3,000 laying hens.

If this is the case, you do not need to comply with the requirements to conduct one of the 

supplier verification activities specified in 21 CFR 117.410(b), or conduct an annual onsite audit 

if the hazard requiring a preventive control is a SAHCODH hazard, if you: 

• Obtain written assurance that the shell eggs produced by the supplier are not subject to 21 

CFR part 118 because the shell egg producer has less than 3,000 laying hens: 

o Before first approving the supplier for an applicable calendar year; and 

o On an annual basis thereafter, by December 31 of each calendar year, for the 

following calendar year; and

• Obtain written assurance, at least every 2 years, that the shell egg producer acknowledges 

that its food is subject to section 402 of the FD&C Act (or, when applicable, that its food is 

subject to relevant laws and regulations of a country whose food safety system FDA has 

officially recognized as comparable or has determined to be equivalent to that of the United 

States).

A shell egg producer is not subject to the requirements for the production, storage, and 

transportation of shell eggs if it has less than 3,000 laying hens. It is the responsibility of the 

supplier to determine whether it is not subject to the requirements for the production, storage, 

and transportation of shell eggs; it is your responsibility to obtain written assurance from the 

supplier that it is not subject to those requirements. 

By specifying “by December 31” for the annual written assurance that the supplier is a shell egg 

producer that is not subject to 21 CFR part 118, the provision provides some flexibility for you to 

work with each applicable supplier to determine the specific date within a calendar year for that 

supplier to annually notify the receiving facility about its status. You and your suppliers have 

some flexibility to approach the potential for the status of a facility to shift between “not subject 

to 21 CFR part 118” and “subject to 21 CFR part 118” (or vice versa) in a way that works best 

for your specific business relationship.

See section 15.7.4.3 for a discussion of the applicability of relevant laws and regulations of a 

country whose food safety system FDA has officially recognized as comparable or has 

determined to be equivalent to that of the United States.
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15.11.6 Financial Conflict of Interest

Section 21 CFR 117.430(f) specifies that there must not be any financial conflicts of interests 

that influence the results of the verification activities listed in 21 CFR 117.410(b). For example, if 

a qualified individual has a financial conflict of interest that influences the results of supplier 

verification activities, the qualified individual would be precluded from being able to 

independently conduct supplier verification activities. You can avoid this possibility when 

conducting supplier verification activities by only using individuals or firms that do not have 

conflicts of interest.

In addition, 21 CFR 117.430(f) specifies that payment must not be related to the results of the 

activity. For example, you may not give a qualified auditor who conducts an onsite audit, or a 

qualified individual who reviews supplier food safety records, greater compensation for 

determining that a supplier is in compliance with applicable FDA requirements. Also, you may 

not reduce the compensation of a qualified auditor or qualified individual or assess financial 

penalties because the qualified auditor or qualified individual identified areas of supplier noncompliance. Similarly, a supplier may not make such payments.

The requirements of 21 CFR 117.430(f) do not prohibit employees of a supplier from performing 

the functions specified in 21 CFR 117.415 in accordance with 21 CFR 117.415. (See the 

discussion of functions that a supplier can perform in accordance with 21 CFR 117.415(a)(4) in 

section 15.8.2.2). For example, this provision would not prohibit an employee of a supplier from 

conducting sampling and testing so that the supplier could provide the results in documentation 

provided to the receiving facility; it is common for suppliers to include COAs for tests conducted 

on specific lots of product along with the shipment to the receiving facility. The requirements of 

21 CFR 117.430(f) also do not prohibit you from relying on an audit provided by your supplier 

when the audit of the supplier was conducted by a third-party qualified auditor. (See the 

discussion of 21 CFR 117.415(c) in section 15.8.4.)

15.12 Onsite Audit (21 CFR 117.435)

Section 21 CFR 117.435 specifies requirements applicable to onsite audits, including who must 

conduct an onsite audit; consideration of applicable food safety regulations; and when the 

written results of an inspection can be substituted for an audit. We discuss these provisions in 

sections 15.12.1 through 15.12.3.

15.12.1 Who Conducts an Onsite Audit

Section 21 CFR 117.435(a) requires that an onsite audit of a supplier be performed by a 

qualified auditor. Part 117 defines “qualified auditor” as a person who is a qualified individual as 

defined in part 117 and has technical expertise obtained through education, training, or 

experience (or a combination thereof) necessary to perform the auditing function as required by 

21 CFR 117.180(c)(2). Examples of potential qualified auditors include: 

• A government employee, including a foreign government employee; and 

• An audit agent of a certification body that is accredited in accordance with the accredited 

third-party certification regulation.

Part 117 defines “qualified individual” as a person who has the education, training, or 

experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean 
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and safe food as appropriate to the individual’s assigned duties. A qualified individual may be, 

but is not required to be, an employee of the establishment.

See the definitions of “qualified auditor” and “qualified individual” in 21 CFR 117.3 and in the list 

of terms in section 15.5.) The requirements applicable to a qualified auditor are set forth in 21 

CFR 117.180(c)(2), which specifies that to be a qualified auditor, a qualified individual must 

have technical expertise obtained through education, training, or experience (or a combination 

thereof) necessary to perform the auditing function. A qualified auditor may be, but is not 

required to be, an employee of the receiving facility.

We have not established specific courses, programs, or certifications, or defined the type of 

experiences that would be required to satisfy the requirements applicable to a qualified auditor

as defined in part 117. However, consistent with the requirements for competent audit agents in 

21 CFR 1.650 and the guidance entitled “Third-Party Certification Body Accreditation for Food 

Safety Audits: Model Accreditation Standards: Guidance for Industry and FDA Staff” (Guidance 

on Accredited Third-Party Certification) (FDA, 2016f), we expect a qualified auditor to have 

education, training, or experience that provides the person with knowledge and skills necessary 

to evaluate whether the equipment, processes, and procedures in a food facility or on a farm 

ensure that the hazards associated with the food have been controlled. For example, an 

individual who has previously conducted food safety inspections for a food safety authority may 

be a qualified auditor, provided that the individual has the knowledge and experience to assess 

compliance with the applicable provisions of the FD&C Act. A person should have at least some 

actual experience in auditing (including assisting in audits or observing audits) to meet the 

definition of a qualified auditor, because the necessary technical expertise likely cannot be 

obtained solely through education and/or training that does not involve assisting or observing 

others in the performance of an audit.

The example of an audit agent of a certification body that has been accredited in accordance 

with regulations in our accredited third-party certification regulation (21 CFR part 1, subpart M) 

adds context about the standard for such individuals. The requirements in 21 CFR 1.650

address how an accredited third-party certification body must ensure its audit agents are 

competent and objective. Although an onsite audit that is solely conducted to meet the 

requirements of part 117 by an audit agent of a certification body that is accredited in 

accordance with regulations in part 1, subpart M, is not subject to the requirements in those 

regulations (see section 15.12.4), the requirements for audit agents and the Guidance on 

Accredited Third-Party Certification with respect to competency are useful in determining 

appropriate education, training, or experience for a qualified auditor. For example, competency 

requirements for audit agents in the accredited third-party certification regulation include that 

they:

• Have relevant knowledge and experience that provides an adequate basis for the audit 

agent to evaluate compliance with applicable food safety requirements of the FD&C Act and 

FDA regulations;

• Be competent to conduct food safety audits; and

• Have completed annual food safety training (FDA 2016f). 

The Guidance on Accredited Third-Party Certification (FDA 2016f) further recommends 

education and/or experience for entry level auditors and lead auditors, as well as auditor skills 

such as observational, reasoning, analytical and communication skills (FDA 2016f). Auditors 

should be trained to understand and properly apply FDA’s food safety requirements under the 
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FD&C Act and FDA regulations for purposes of auditing (FDA 2016f). Technical training may 

vary depending on the processes and products being audited (FDA 2016f). Training methods 

may include classroom training, annual food safety training, and joint audits with a qualified 

trainer to help the audit agent apply classroom learning (FDA 2016f).

The GFSI provisions for auditor competency in ‘‘GFSI Food Safety Auditor Competencies’’ 

(GFSI, 2013) are also useful in determining the knowledge, experience, and skills for a qualified 

auditor. The GFSI’s auditor competency model lists three main components for auditor 

competencies: (1) Auditing skills and knowledge; (2) technical skills and knowledge; and (3) 

behavior and systems thinking (GFSI, 2013). Within each main component, GFSI provides 

details of specific tasks and the required auditor knowledge and skills to perform the specific 

tasks (GFSI, 2013).

You or one of your employees may conduct the audit as long as you are or your employee is a 

qualified auditor, based on education, training, or experience, or a combination thereof.

15.12.2 Consideration of Food Safety Regulations

Section 21 CFR 117.435(b) requires that if the raw material or other ingredient at the supplier is 

subject to one or more FDA food safety regulations, an onsite audit must consider such 

regulations and include a review of the supplier's written plan (e.g., HACCP plan or other food 

safety plan), if any, and its implementation, for the hazard being controlled (or, when applicable, 

an onsite audit may consider relevant laws and regulations of a country whose food safety 

system FDA has officially recognized as comparable or has determined to be equivalent to that 

of the United States).

The qualified auditor who audits your supplier may be your own employee (“second-party audit”) 

or an independent third party (i.e., a qualified auditor who is neither your employee nor an 

employee or the supplier) (third-party audit). Both second-party audits and third-party audits 

allow first-hand review of the critical food safety programs in place at a supplier’s establishment

and can help you to obtain a sense of how effective programs are by diligently reviewing 

program records, observing activities, and interviewing workers.

Because FDA food safety regulations vary in scope and detail, the parameters and key 

components of an onsite audit conducted under section 21 CFR 117.435(a) would vary 

depending on what regulations apply to the supplier.

A supplier that is subject to the PCHF requirements must have a food safety plan. (See 21 CFR 

117.126.) If your supplier is subject to the PCHF requirements, the onsite audit would focus on 

the supplier’s food safety plan and assess the implementation of the preventive controls applied 

by the supplier to address the known or reasonably foreseeable hazards that you have 

determined to require a supply-chain-applied control. For example, before you obtain roasted 

peanuts for which you had identified Salmonella as a hazard from a supplier subject to the 

PCHF requirements, you would audit the supplier (or obtain documentation of an audit 

performed by a third party) to determine whether the supplier’s roasting process adequately 

controlled the Salmonella. Because the supplier was subject to the PCHF requirements, the 

audit should include a review of the supplier’s food safety plan. The auditor should review 

whether the roasting process had been validated to significantly minimize Salmonella in peanuts 

and should examine whether the supplier had implemented the roasting procedures in 

accordance with its food safety plan (e.g., through observing the establishment’s procedures 

and reviewing records).
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A supplier that is not subject to the PCHF requirements, but is subject to HACCP requirements, 

would have a “HACCP plan” rather than a “food safety plan.” If, for example, you use juice as an 

ingredient in a refrigerated fruit salad, and your supplier is subject to the process control 

requirements in 21 CFR 120.24, the onsite audit of the juice supplier would assess the 

validation and implementation of the process controls in your supplier’s HACCP plan. 

The produce safety regulation in 21 CFR part 112 does not require farms that are subject to that 

regulation to have food safety plans. However, in some cases, a supplier (such as a large 

farming operation) might voluntarily elect to establish a food safety plan. In that case, the onsite 

audit of the supplier should include a review of the supplier’s written plan, and its 

implementation of the plan, to ensure that identified hazards are being adequately controlled.

An audit of your supplier should include both records review and observation of practices to 

obtain a complete picture of the safety of your supplier’s operations. Comprehensive systems 

audits that include records reviews are more likely to reflect conditions throughout the year than 

an audit focused only on the state of the facility at the time of the audit. An audit of a 

manufacturing/processing facility subject to the PCHF requirements should address process, 

allergen, sanitation, and supply-chain-applied controls (if any), as well as CGMPs (if applicable) 

and the specific hazards identified in your hazard analysis of the food.

There are several national and international auditing schemes widely used to assess food safety 

practices in manufacturing facilities and on farms. You could rely on the results of audits 

conducted in accordance with such schemes provided that the audits evaluate the farm or 

facility’s compliance with applicable FDA regulations, review the supplier’s food safety plan (if 

any) and its implementation, and otherwise meet the requirements for onsite audits in 21 CFR 

117.435. Before relying on the results of a third-party onsite audit, you should determine 

whether the auditing scheme used can help you to conclude whether the supplier uses 

processes and procedures that comply with applicable regulations. Audit schemes that consider 

FDA food safety regulations and include a review of the supplier’s written food safety plan

(including a HACCP plan), if any, and its implementation, with respect to the hazard being 

controlled are likely to satisfy the requirements for an onsite audit.

15.12.3 Substitution of an Inspection for an Audit

Section 21 CFR 117.435(c) allows for the following inspections to substitute for an onsite audit, 

provided that the inspection was conducted within 1 year of the date that the onsite audit would 

have been required to be conducted:

• The written results of an appropriate inspection of the supplier for compliance with 

applicable FDA food safety regulations by FDA, by representatives of other Federal 

Agencies (such as the United States Department of Agriculture (USDA)), or by 

representatives of State, local, tribal, or territorial agencies (21 CFR 117.435(c)(1)(i)); or

• For a foreign supplier, the written results of an inspection by FDA or the food safety authority 

of a country whose food safety system FDA has officially recognized as comparable or has 

determined to be equivalent to that of the United States. (See 21 CFR 117.435(c)(1)(ii).) For 

inspections conducted by the food safety authority of a country whose food safety system 

FDA has officially recognized as comparable or determined to be equivalent, the food that is 

the subject of the onsite audit must be within the scope of the official recognition or 

equivalence determination, and the foreign supplier must be in, and under the regulatory 

oversight of, such country. (See 21 CFR 117.435(c)(2).)
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For an inspection conducted by FDA, other Federal Agencies, or State, local, tribal, or territorial 

agencies, an ‘‘appropriate’’ inspection conducted for compliance ‘‘with applicable FDA 

regulations’’ means that the inspection must be sufficiently relevant to compliance with 

applicable FDA food safety regulations to credibly substitute for an onsite audit. For example, 

inspection by USDA to determine whether a farm satisfies the requirements of the produce 

safety regulation could constitute an appropriate inspection that could substitute for an audit, but 

an inspection by USDA to determine whether a farm satisfies the requirements of the National 

Organic Program could not.

In the case of a foreign supplier, a country whose food safety system FDA has officially 

recognized as ‘‘comparable’’ to that of the United States would be one for which there is a 

signed systems recognition arrangement or other agreement between FDA and the country 

establishing official recognition of the foreign food safety system. See section 15.7.4.3.2 for 

information on countries for which we have a Food Safety Systems Recognition Arrangement or 

other cooperative arrangement with a foreign country.

Some countries issue certifications or recognitions to facilities for compliance with certain 

requirements such as for HACCP systems. We would not accept a HACCP certificate issued by 

a foreign government as a substitute for an onsite audit because HACCP requirements are not 

identical to the PCHF requirements, and it would not be clear as to what basis was used to 

issue a HACCP certificate. However, a receiving facility could consider whether such a 

certificate could be part of its justification for conducting another supplier verification activity in 

lieu of an annual onsite audit, or for conducting an audit on a less frequent basis than annually

(see section 15.11.2.2).

15.12.4 Audits Conducted to Meet the Requirements of Subpart G Do Not 

Have to Comply with the Requirements of the Accredited Third-Party 

Regulation

Section 21 CFR 117.435(d) specifies that if an onsite audit is solely conducted to meet the 

requirements of part 117 by an audit agent of a certification body that is accredited in 

accordance with regulations in part 1, subpart M, the audit is not subject to the requirements in 

those regulations.

Audits conducted under the accredited third-party certification regulation are done for specific 

purposes, e.g., for compliance with the requirements of the Voluntary Qualified Importer 

Program. Audits conducted to meet the requirements of 21 CFR 117.435 may be conducted by 

a person who had been accredited under these provisions; however, the requirements for audits 

conducted under the accredited third-party certification regulation (e.g., specific information that 

must be included in an audit and submission of regulatory audit reports to FDA under 21 CFR 

1.652) would not apply to an audit even when the auditor is accredited to do such audits unless 

they are also conducted for purposes under the accredited third-party certification regulation. 

15.13 Records Documenting the Supply-Chain Program

Section 21 CFR 117.475 specifies that the records documenting the supply-chain program are 

subject to the requirements of subpart F of part 117. (See 21 CFR 117.475(a).) Subpart F sets 

forth general requirements applicable to all records, such as the use of either paper or electronic 

records and the need for records to be accurate, indelible, and legible. Subpart F also sets forth 

requirements for record retention and official review. Section 117.330 in subpart F explains how 

you can use existing records to satisfy the recordkeeping requirements of part 117. 
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Section 21 CFR 117.475 requires that you must review the records of the supply-chain program 

in accordance with § 117.165(a)(4). (See 21 CFR 117.475(b).) Under 21 CFR 117.165(a)(4(ii)),

records of the supply-chain program must be reviewed within a reasonable time after the 

records are made by (or under the oversight of) a PCQl to ensure that the records are complete, 

the activities reflected in the records occurred in accordance with the food safety plan, the 

preventive controls are effective, and appropriate decisions were made about corrective actions.

Table 15-4 lists the records required (as applicable) for the supply-chain program. (See 21 CFR 

117.475(c).) 

Table 15-4 List of Records Required for the Supply-Chain Program

Section Description Discussion

117.475(c)(1) The written supply-chain program There is no standardized or 

required format for the written 

supply chain program or its 

records. You can use whatever 

format works best for your facility, 

provided that the records include 

all the required information. Also,

the written supply-chain program is 

part of the food safety plan, which

must be signed and dated by the 

owner, operator, or agent in charge 

of the facility upon initial 

completion and upon any 

modification. (See 21 CFR

117.310.) 

117.475(c)(2) If you are an importer, documentation 

that you are in compliance with the FSVP 

requirements under part 1, subpart L, 

including documentation of verification 

activities conducted under §1.506(e) 

If you are an importer, and you 

have records documenting the 

supplier verification activities you 

conducted to comply with the 

FSVP regulation, you can rely on 

those records as documentation of 

verification activities to comply with 

the supply-chain program 

requirements of subpart G. 

117.475(c)(3) Documentation of the approval of a 

supplier

• Your written determination of the basis 

for approving the supplier; and

• The approved suppliers – e.g., a paper 

list of approved suppliers or an electronic 

system that can generate a list of 

approved suppliers as needed
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Section Description Discussion

17.475(c)(4) Written procedures for receiving raw 

materials and other ingredients

Examples are a paper checklist 

and a computer system that 

manages the procurement, receipt, 

and usage of raw materials and

other ingredients.

117.475(c)(5) Documentation demonstrating use of the 

written procedures for receiving raw 

materials and other ingredients

Examples are a paper checklist 

that was marked to demonstrate

receipt and electronic records 

produced by a computer system 

that manages the procurement, 

receipt, and usage of raw materials 

and other ingredients.

117.475(c)(6) Documentation of the determination of 

the appropriate supplier verification 

activities for raw materials and other 

ingredients

Your written determination should 

explain why you chose your 

particular supplier verification 

activities. See the discussion in 

section 15.7.4.

117.475(c)(7) Documentation of the conduct of an 

onsite audit, including (i) The name of the 

supplier subject to the onsite audit; (ii) 

Documentation of audit procedures; (iii) 

The dates the audit was conducted; (iv) 

The conclusions of the audit; (v) 

Corrective actions taken in response to 

significant deficiencies identified during 

the audit; and (vi) Documentation that the

audit was conducted by a qualified 

auditor

Examples of documentation of 

audit procedures include the 

process(es) and food(s) observed, 

types of records reviewed, and 

whether the audit included 

interviews or laboratory testing. 

Examples of the conclusions of an 

audit include whether the audit did, 

or did not, result in any significant 

deficiencies. 

You have some flexibility to work 

with the qualified auditor, or with a 

supplier who arranges for a thirdparty audit, on appropriate 

documentation that the auditor has 

technical expertise obtained 

through education, training, or 

experience (or a combination 

thereof) necessary to perform the 

auditing function. Examples of 

such documentation are a list of 

applicable training and examples 

of relevant audits conducted by the 

auditor.
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Section Description Discussion

117.475(c)(8) Documentation of sampling and testing 

conducted as a supplier verification 

activity. This documentation must 

include: (i) Identification of the raw 

material or other ingredient tested 

(including lot number, as appropriate) 

and the number of samples tested; (ii) 

Identification of the test(s) conducted, 

including the analytical method(s) used; 

(iii) The date(s) on which the test(s) were 

conducted and the date of the report; (iv) 

The results of the testing; (v) Corrective 

actions taken in response to detection of 

hazards; and (vi) Information identifying 

the laboratory conducting the testing

You have some flexibility in the 

format of appropriate 

documentation of sampling and 

testing, such as on a CoA. 

Documentation of corrective 

actions would apply to the steps 

you take when you (or a third party

acting on your behalf) detect the 

hazard in raw materials or other 

ingredients that you received, 

including what you do with the raw 

material or other ingredient and the 

steps you take to address the 

problem with the supplier.

117.475(c)(9) Documentation of the review of the 

supplier's relevant food safety records. 

This documentation must include: (i) The 

name of the supplier whose records were 

reviewed; (ii) The date(s) of review; (iii) 

The general nature of the records 

reviewed; (iv) The conclusions of the 

review; and (v) Corrective actions taken 

in response to significant deficiencies 

identified during the review

Records of the supply-chain 

program must be reviewed within a 

reasonable time after the records 

are made by (or under the 

oversight of) a PCQl to ensure that 

the records are complete, the 

activities reflected in the records 

occurred in accordance with the 

food safety plan, the supplier’s

preventive controls are effective, 

and appropriate decisions were 

made about corrective actions.

(See 21 CFR 117.165(a)(4).)

117.475(c)(10) Documentation of other appropriate 

supplier verification activities based on 

the supplier performance and the risk 

associated with the raw material or other 

ingredient

Your documentation of other 

appropriate supplier verification 

activities would depend on the 

nature of the activity. For example, 

if you use a fact-specific 

questionnaire you would have a 

record of the questionnaire applied 

to a particular supplier. If you 

considered information applicable 

to a supplier’s certification to a 

specific audit scheme, you would 

have a record of the information 

you considered.
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Section Description Discussion

117.475(c)(11) Documentation of any determination that 

verification activities other than an onsite 

audit, and/or less frequent onsite auditing 

of a supplier, provide adequate 

assurance that the hazards are 

controlled when a hazard in a raw 

material or other ingredient will be 

controlled by the supplier and is one for 

which there is a reasonable probability 

that exposure to the hazard will result in 

serious adverse health consequences or 

death to humans

Because your written supply-chain 

program is part of your food safety 

plan, the written determination 

must be prepared by (or under the 

oversight of) your PCQI. See the 

discussion in section 15.11.2.2 for 

examples of what such a written 

determination could address.

117.475(c)(12) The following documentation of an 

alternative verification activity for a 

supplier that is a qualified facility: (i) The 

written assurance that the supplier is a 

qualified facility as defined by §117.3, 

before approving the supplier and on an 

annual basis thereafter; and (ii) The 

written assurance that the supplier is 

producing the raw material or other 

ingredient in compliance with applicable 

FDA food safety regulations (or, when 

applicable, relevant laws and regulations 

of a country whose food safety system 

FDA has officially recognized as 

comparable or has determined to be 

equivalent to that of the United States)

You and your suppliers have some 

flexibility to determine the 

appropriate documentation in a 

way that works best for your 

specific business relationship. For 

example, for documentation of its 

status, a qualified facility could 

provide you with documentation of 

its submission of the qualified 

facilities form (Form FDA 3942a). 

For the other assurance, you and 

your supplier can choose which of 

two options to use, based on the 

specific circumstances of the 

supplier. See the discussion in 

section 15.11.3 of the two different 

types of attestation.
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Section Description Discussion

117.475(c)(13) The following documentation of an 

alternative verification activity for a 

supplier that is a farm that supplies a raw 

material or other ingredient and is not a 

covered farm under part 112 of this 

chapter: (i) The written assurance that

the supplier is not a covered farm under 

part 112 of this chapter in accordance 

with §112.4(a), or in accordance with 

§§112.4(b) and 112.5, before approving 

the supplier and on an annual basis 

thereafter; and (ii) The written assurance 

that the farm acknowledges that its food 

is subject to section 402 of the FD&C Act 

(or, when applicable, that its food is 

subject to relevant laws and regulations 

of a country whose food safety system 

FDA has officially recognized as 

comparable or has determined to be 

equivalent to that of the United States)

You and your suppliers have some 

flexibility to determine the 

appropriate documentation in a 

way that works best for your 

specific business relationship.

117.475(c)(14) The following documentation of an 

alternative verification activity for a 

supplier that is a shell egg producer that 

is not subject to the requirements 

established in part 118 of this chapter 

because it has less than 3,000 laying 

hens: (i) The written assurance that the 

shell eggs provided by the supplier are 

not subject to part 118 of this chapter 

because the supplier has less than 3,000 

laying hens, before approving the 

supplier and on an annual basis 

thereafter; and (ii) The written assurance 

that the shell egg producer 

acknowledges that its food is subject to 

section 402 of the FD&C Act (or, when 

applicable, that its food is subject to 

relevant laws and regulations of a 

country whose safety system FDA has 

officially recognized as comparable or 

has determined to be equivalent to that 

of the United States)

You and your suppliers have some 

flexibility to determine the 

appropriate documentation in a 

way that works best for your 

specific business relationship.
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Section Description Discussion

117.475(c)(15) The written results of an appropriate 

inspection of the supplier for compliance 

with applicable FDA food safety 

regulations by FDA, by representatives of 

other Federal Agencies (such as the U.S.

Department of Agriculture), or by 

representatives from State, local, tribal, 

or territorial agencies, or the food safety 

authority of another country when the 

results of such an inspection are

substituted for an onsite audit

The written results of an 

appropriate inspection would 

depend on the inspection and how 

the entity conducting the inspection 

reports its results.

117.475(c)(16) Documentation of actions taken with 

respect to supplier nonconformance

Your documentation of supplier 

nonconformance would depend on 

the nature of the nonconformance.

See the examples of potential 

supplier nonconformance in 

section 15.7.5.

117.475(c)(17) Documentation of verification of a supplychain-applied control applied by an entity 

other than the receiving facility's supplier

The documentation you receive 

from another entity should be 

similar to the documentation you 

would have if you had conducted 

the activity yourself.
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Section Description Discussion

117.475(c)(18) When applicable, documentation of the 

receiving facility's review and 

assessment of: (i) Applicable 

documentation from an entity other than 

the receiving facility that written 

procedures for receiving raw materials 

and other ingredients are being followed;

(ii) Applicable documentation, from an 

entity other than the receiving facility, of 

the determination of the appropriate 

supplier verification activities for raw 

materials and other ingredients; (iii) 

Applicable documentation, from an entity 

other than the receiving facility, of 

conducting the appropriate supplier 

verification activities for raw materials 

and other ingredients; (iv) Applicable 

documentation, from its supplier, of: (A) 

The results of sampling and testing 

conducted by the supplier; or (B) The 

results of an audit conducted by a thirdparty qualified auditor in accordance with 

21 CFR 117.430(f) and 117.435; and (v) 

Applicable documentation, from an entity 

other than the receiving facility, of 

verification activities when a supplychain-applied control is applied by an 

entity other than the receiving facility's 

supplier

You have some flexibility for how 

to appropriately document that you 

reviewed and assessed the 

documentation from another entity.

For example, appropriate staff in 

your facility could date and sign the 

documentation received from the 

other entity, or you could attach a 

signed, dated statement, from 

appropriate staff in your facility, 

specifying that the documentation 

had been reviewed and assessed.

15.14 Compliance Dates

In the preamble of the final rule establishing part 117, we provided compliance dates for the 

requirements of the supply-chain program in subpart G. (See Table 54 in the final rule, 80 FR 

55908 at 56128). The compliance dates for implementing your supply-chain program apply with 

respect to each of your suppliers, not to your supply-chain program as a whole, because the 

compliance dates depend on whether your suppliers will be subject to part 117, the produce 

safety regulation, or neither regulation. For those suppliers subject to part 117 or the produce 

safety regulation, you are not required to conduct supplier verification activities until after your

supplier’s compliance date is reached. 

For your convenience, Table 15-5 provides the information from Table 54 in the preamble of the 

final rule establishing part 117. 
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Chapter 15 (Supply-Chain Program) - Page 47

Table 15-5 Compliance Dates for the Requirements of the Supply-Chain Program 

Situation Compliance date:

You are a small business and your supplier will not 

be subject to the PCHF requirements of part 117 or 

the produce safety regulation

September 18, 2017

You are a small business and your supplier is 

subject to the PCHF requirements of part 117 or 

the produce safety regulation

The later of September 18, 2017, or 6 months after 

your supplier of that raw material or other 

ingredient is required to comply with the applicable 

requirements

You are neither a small business nor a very small 

business and your supplier will not be subject to the 

PCHF requirements of part 117 or the produce 

safety regulation

March 17, 2017

You are neither a small business nor a very small 

business and your supplier will be subject to the 

PCHF requirements of part 117 or the produce 

safety regulation

6 months after your supplier of that raw material or 

other ingredient is required to comply with the 

applicable requirements

15.15 Table of Abbreviations

Section IV in the Introduction of this guidance includes a table of abbreviations that are used in 

this guidance. At this time, that Table of Abbreviations does not include all abbreviations that 

are used in this chapter. See Table 15-6 for an additional abbreviation that we use in this 

chapter. For the convenience of the reader, Table 15-6 also describes what we mean by 

“PCHF,” even though this abbreviation is already in section IV in the Introduction of this 

guidance. We intend to compile all abbreviations in section IV in the Introduction of this 

guidance when we update the Introduction. When we do so, we intend to delete Table 15-6 from 

this chapter, because it would be duplicative.

Table 15-6 Table of Abbreviations

Abbreviation What It Means

PCHF “Preventive Controls for Human Food” (requirements in 21 CFR 

part 117 for hazard analysis and risk-based preventive controls 

for human food in accordance with section 418 of the FD&C Act) 

SAHCODH 

Hazard

Hazard for which there is a reasonable probability that exposure 

to the hazard will result in serious adverse health consequences 

or death to humans

15.16 References 

American Spice Trade Association (ASTA). 2011. Clean, Safe Spices.
Contains Nonbinding Recommendations

Draft-Not for Implementation

Chapter 15 (Supply-Chain Program) - Page 48

Eastern Research Group, Inc. (ERG). 2004. Good Manufacturing Practices (GMPs) for the 21st 

Century - Food Processing. Section Four. Common Food Safety Problems in the U.S. Food 

Processing Industry: A Delphi Study. 

Edleman, V. 2012. The Supplier Approval Process. The Manufacturing Confectioner, 92(11):60-

67.

Eldridge, B., 2012. Supplier Management: Six Steps to Selecting the Right Supplier. Food 

Safety Magazine, 18 (4): 30-31. 

FDA. 2009. “Guidance for Industry: Questions and Answers Regarding the Reportable Food 

Registry As Established by the Food and Drug Administration Amendments Act of 2007.” 

(http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/RFR/

ucm180761.htm)

FDA. 2010. “Draft Guidance for Industry: Questions and Answers Regarding the Reportable 

Food Registry As Established by the Food and Drug Administration Amendments Act of 2007 

(Edition 2).” (http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM213214.pdf) 

FDA Memorandum. 2014. “Supplier Programs.” See Reference 24 to the 2014 supplemental 

human preventive controls notice. 

FDA. 2015a. FDA - New Zealand MPI, Food Safety Systems Recognition Arrangement. 

(http://www.fda.gov/internationalprograms/agreements/memorandaofunderstanding/ucm331907

.htm).

FDA. 2015b. International Arrangements.

(http://www.fda.gov/internationalprograms/agreements/) 

FDA. 2016a. Cooperative Arrangements. 

(http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/default.htm

) 

FDA. 2016b. FDA - CFIA and Health Canada, Food Safety Systems Recognition Arrangement.

(http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/ucm49819

7.htm) 

FDA. 2016c. International Programs. (http://www.fda.gov/InternationalPrograms/default.htm). 

FDA. 2016d. Supplier Evaluation Resources. 

(https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm516330.htm) 

FDA. 2016e. The Reportable Food Registry: A Five Year Overview of Targeting Inspection 

Resources and Identifying Patterns of Adulteration, September 8, 2009 – September 7, 2014. 

(http://www.fda.gov/downloads/food/complianceenforcement/rfr/ucm502117.pdf)

FDA. 2016f. Third-Party Certification Body Accreditation for Food Safety Audits: Model 

Accreditation Standards: Guidance for Industry and FDA Staff. 

(https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/uc

m455328.htm)
Contains Nonbinding Recommendations

Draft-Not for Implementation

Chapter 15 (Supply-Chain Program) - Page 49

FDA. 2017. Report of the Systems Recognition Review of Australia by the U.S. FDA. 

(https://www.fda.gov/downloads/Food/InternationalInteragencyCoordination/InternationalCooper

ation/UCM553393.pdf)

Global Food Safety Initiative & The Consumer Goods Forum 2013. “GFSI Food Safety Auditor 

Competencies, Edition 1.” (http://www.mygfsi.com/images/mygfsi/gfsifiles/informationkit/GFSI_Food_Safety_Auditor_Competencies_-_Edition_1_October_2013.pdf)

International Featured Standards (IFS). 2012. IFS Food: Standard for auditing quality and food 

safety of food products, Version 6. (http://www.ifs-certification.com/index.php/en/certificationbodies-en/ifs-standards/ifs-food)

Neumann, M. 2009. Benefits of a supplier approval program. Crisis Control Newsletter, 

U0109(1):1-2.

Safe Quality Food Institute (SQFI). 2014. SQF Code 7.2. A HACCP-Based Supplier Assurance 

Code for the Food Industry. (http://www.sqfi.com/wp-content/uploads/SQF-Code_Ed-7.2-

July.pdf)

Zaura, 2005. Effective Supplier Program. Food Quality Magazine, December/January, 86-88.
Contains Non-binding Recommendations

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Chapter 16 (Acidified Foods) - Page 1 

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-assistance-network-tan. 

Chapter 16: Acidified Foods 

Table of Contents

16.1 Purpose of This Chapter

16.2 Considerations to Keep in Mind If You Manufacture/Process an 

Acidified Food

16.2.1 Background on Specific Acidified Food Requirements

16.2.2 Relationship Between the Requirements in the PCHF Rule and the Specific 

Acidified Food Requirements

16.2.3 Developing a Strategy to Comply with the PCHF Rule, Emergency Permit 

Control Regulations, and Part 114

16.2.4 You Must Comply with the Specific Acidified Food Requirements Even If 

There Is No Corresponding Requirement in the PCHF Rule

16.3 Understand the Hazard Requiring a Preventive Control

16.4 Terms Used in This Chapter

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. 
Contains Non-binding Recommendations

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Chapter 16 (Acidified Foods) - Page 2

16.5 Quick Reference Guide

16.6 Requirements for Qualifications of Personnel with Responsibility for 

Supervision or Other Oversight

16.7 Requirements for Oversight

16.8 Requirements for a Written Food Safety Plan

16.9 Requirements for Hazard Analysis

16.10 Requirements for Preventive Controls

16.10.1 Identifying and Implementing Preventive Controls That Are Process 

Controls for Biological Hazards Requiring a Preventive Control

16.10.2 Preventive Controls That Have No Corresponding Requirements in 21 CFR 

108.25 or Part 114

16.10.2.1 Identifying and Implementing Preventive Controls for Chemical Hazards 

or Physical Hazards Requiring a Preventive Control

16.10.2.2 Identifying and Implementing Preventive Controls That Are Sanitation 

Controls

16.10.3 Supply-chain Controls

16.10.4 Recall Plan

16.11 Requirements for Preventive Control Management Components

16.12 Requirements for Records

16.13 Requirements for Coding

16.14 References

Appendix 16-1 Key Specific Acidified Food Requirements

16.1 Purpose of this Chapter

The guidance in this chapter is intended for persons who:

• Are subject to the PCHF requirements; and

• Manufacture, process, or pack acidified foods.

If you are subject to PCHF requirements and manufacture, process, or pack acidified foods, the 

guidance provided in this chapter is intended to explain:
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• How you can leverage procedures, practices, and processes that you establish and 

implement to comply with the requirements prescribed by 21 CFR 108.25 and 21 CFR part 

114, and records that you establish and keep to comply with those requirements, to address

corresponding requirements of the PCHF rule; and

• How you can leverage the procedures, practices, and processes that you establish and 

implement to comply with the requirements of the PCHF rule, and the records that you 

establish and keep to comply with those requirements, to address corresponding

requirements of 21 CFR 108.25 and 21 CFR part 114. 

This guidance is not intended for persons that manufacture, process, or pack acidified foods, 

but are exempt from PCHF requirements in accordance with 21 CFR 117.5(a) as a “qualified 

facility.” Qualified facilities that manufacture, process, or pack acidified foods remain subject to 

21 CFR 108.25 and part 114 and are subject to modified requirements under 21 CFR 117.201. 

16.2 Considerations to Keep in Mind If You Manufacture/Process an 

Acidified Food

16.2.1 Background on Specific Acidified Food Requirements

FDA has established specific CGMP requirements for thermally processed low-acid foods 

packaged in hermetically sealed containers (i.e., “low-acid canned foods,” or “LACF”) (21 CFR 

part 113; the LACF regulations2

) and acidified foods (21 CFR part 114 (“part 114”). In the 

proposed and final rulemakings for LACF3 and acidified foods,

4 FDA discussed the need for 

CGMP requirements to control Clostridium botulinum (C. botulinum). C. botulinum is a 

bacterium commonly found in soil. It can produce a nerve toxin (botulinum toxin) under 

anaerobic conditions such as those in canned foods. Botulinum toxin can cause botulism, a rare 

but serious paralytic illness that can be fatal and is considered a medical emergency. For 

additional information about C. botulinum and botulinum toxin, see Chapter 3 of this guidance 

and the references provided in that chapter.

Part 114 defines a scheduled process as the “process selected by a processor as adequate for 

use under the conditions of manufacture for a food in achieving and maintaining a food that will 

not permit the growth of microorganisms having public health significance. It includes control of 

pH and other critical factors equivalent to the process established by a competent processing 

authority” (21 CFR 114.3(e)). Because the pH of acidified foods is sufficiently low to prevent the 

germination of spores of C. botulinum, acidified foods may be held at ambient temperature 

without a heat treatment comparable to that required in the scheduled process for LACF (41 FR 

30442 at 30442; see 21 CFR 113.3(r)). 

2 Note that there is a partial exemption from the PCHF requirements for food subject to part 113 in 21 

CFR 117.5(d).

3 Proposed rule, 41 FR 30444, July 23, 1976; final rule, 44 FR 16209, March 16, 1979.

4 Proposed rule, 41 FR 30457, July 23, 1976; final rule, 44 FR 16230, March 16, 1979.
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FDA also has established emergency permit control requirements, under section 404 of the 

FD&C Act, for acidified foods (21 CFR 108.25; the emergency permit control regulations). FDA 

established these requirements, in part, because of the importance of controlling the pH of 

acidified foods. The emergency permit control regulations are intended to ensure safe 

manufacturing, processing, and packing processes and to permit FDA to verify that these 

processes are being followed. The emergency permit control regulations require commercial 

processors of acidified foods to register and file with FDA information, submitted on Form FDA 

2541, that includes the name of the establishment, principal place of business, location of each 

establishment in which that processing is carried on, the processing method in terms of acidity 

and pH control, and a list of foods so processed in each establishment (21 CFR 108.25(c)(1)). 

The emergency permit control regulations also require commercial processors of acidified foods 

to provide FDA with information, submitted on Form FDA 2541e, on the scheduled processes 

including, as applicable, information about the product, the container type and size, pH, method 

of acidification, microbial preservatives critical to the scheduled process, process source, 

process mode, the container and container closure treatment, and details of the scheduled 

process (e.g., process time and temperature) for each acidified food in each container size (21 

CFR 108.25(c)(2)). All plant personnel involved in acidification, pH control, heat treatment, or 

other critical factors of the operation must be under the operating supervision of a person who 

has attended a school5 approved by the Commissioner for giving instruction in food-handling 

techniques, food protection principles, personal hygiene, plant sanitation practices, pH controls, 

and critical factors in acidification, and who has satisfactorily completed the prescribed course of 

instruction (21 CFR 108.25(f)).

16.2.2 Relationship Between the Requirements in the PCHF Rule and the 

Specific Acidified Food Requirements

Some requirements of the PCHF rule have corresponding requirements in the emergency 

permit control regulations, part 114, or both, but other requirements of the PCHF rule do not. 

For example:

• The requirement of the PCHF rule for process controls for biological hazards requiring a 

preventive control has corresponding requirements for a scheduled process for an acidified 

food under the emergency permit control regulations and part 114; but

• Neither the emergency permit control regulations nor part 114 requires a hazard analysis.

Likewise, some requirements in the emergency permit control regulations, part 114, or both

have corresponding requirements in the PCHF rule, but other requirements in the emergency 

permit control regulations, part 114, or both do not. For example:

5 Often referred to as “Better Process Control School.”
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• The requirements in part 114 for frequent testing of pH, and recording the results of that 

testing, have a corresponding requirement in the PCHF rule for monitoring and for 

establishing and keeping records of monitoring; but

• The requirement of the emergency permit control regulations to submit the scheduled 

process to FDA on Form FDA 2541e has no corresponding requirement in the PCHF rule, 

and the requirement of part 114 for marking each container or product with an identifying 

code permanently visible to the naked eye has no corresponding requirement in the PCHF 

rule.

16.2.3 Developing a Strategy to Comply with the PCHF Rule, Emergency 

Permit Control Regulations, and Part 114 

Sections 16.6 through 16.13 of this chapter compare the specific requirements of the 

emergency permit control regulations, part 114, and the PCHF rule to help you comply with all 

applicable requirements by explaining:

• How you can leverage procedures, practices, and processes that you establish and 

implement to comply with the requirements prescribed by 21 CFR 108.25 and part 114, and 

records that you establish and keep to comply with those requirements, to address

corresponding requirements of the PCHF rule; and

• How you can leverage the procedures, practices, and processes that you establish and 

implement to comply with the requirements of the PCHF rule, and the records that you 

establish and keep to comply with those requirements, to address corresponding 

requirements of 21 CFR 108.25 and part 114.

Importantly, the procedures, practices, and processes that you establish and implement to 

comply with the requirements prescribed by 21 CFR 108.25 and part 114, and records that you 

establish and keep to comply with those requirements, could partially but not fully satisfy 

corresponding requirements of the PCHF rule. Likewise, the procedures, practices, and 

processes that you establish and implement to comply with the requirements of the PCHF rule, 

and the records that you establish and keep to comply with those requirements, could partially 

but not fully satisfy corresponding requirements of 21 CFR 108.25 and part 114. Sections 16.6 

through 16.13 of this chapter provide details about the extent to which complying with the 

requirements prescribed by 21 CFR 108.25 and part 114 can address the corresponding PCHF 

requirements and vice versa.

In some cases, the simplest approach to complying with both sets of requirements could be to 

use procedures, practices, processes, or records associated with the specific acidified food

requirements to address the corresponding requirements of the PCHF rule. For example, see 

the discussion in section 16.10.1 regarding process controls. Because process controls for 

acidified foods must address all parameters specified on Form FDA 2541e, a simple approach 

to complying with the requirement to identify and implement preventive controls that are process 

controls could be to complete Form FDA 2541e and include it in your food safety plan as a 

written process control. 
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In other cases, the simplest approach to complying with both sets of requirements could be to 

use procedures, practices, processes, or records associated with the specific requirements of

the PCHF rule to address the corresponding requirements specific to acidified foods. For 

examples, see the discussions in:

• Section 16.10.4 regarding the recall plan required by the PCHF rule for foods with hazards 

that require a preventive control and the recall procedures required by 21 CFR 108.25(e);

• Section 16.11 regarding preventive control management components required by the PCHF 

rule and corresponding requirements in part 114; and

• Section 16.12 regarding the recordkeeping requirements of part 117 and the corresponding 

recordkeeping requirements of part 114. 

This chapter provides you with information to help you choose an approach for complying with 

the PCHF rule, emergency permit control regulations, and part 114, in a way that works best for 

your facility and your acidified food product. 

16.2.4 You Must Comply with the Specific Acidified Food Requirements Even If 

There Is No Corresponding Requirement in the PCHF Rule

Appendix 16-1 in this chapter summarizes key specific acidified food requirements under the 

emergency permit control regulations, part 114, or both that either:

• Have no explicitly corresponding requirement under the PCHF rule; or

• Exceed the corresponding requirements of the PCHF rule. 

Sections 16.6 through 16.13 of this chapter provide suggestions for how you can address some

of the key specific acidified food requirements (see Appendix 16-1) by complying with the PCHF 

rule. For example, part 114 requires that the scheduled process for an acidified food control 

microorganisms of non-health significance in addition to pathogens (see 21 CFR 114.80(a)(1) 

and Appendix 16-1), and section 16.9 explains how your hazard analysis could identify 

microorganisms of non-health significance as a biological hazard requiring a preventive control, 

even though microorganisms of non-health significance, by themselves, are not “hazards” as 

that term is defined in part 117. However, sections 16.6 through 16.13 of this chapter also clarify 

that none of the PCHF requirements address the submission of a food canning establishment 

registration on Form FDA 2541 as required by 21 CFR 108.25(c)(1) or suggest any way to 

comply with the requirement to submit Form FDA 2541e other than the mechanism specified in 

21 CFR 108.25(c)(2).

If a specific acidified food requirement exceeds the corresponding requirement of the PCHF 

rule, you must comply with the specific acidified food requirement. As discussed in section 

16.12, part 114 requires that you keep records required by part 114 for 3 years, which exceeds 

the 2-year record retention requirement in part 117 for records documenting the food safety plan 

and implementation of the food safety plan. (See 21 CFR 114.100(e) and 21 CFR 117.315.) 
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16.3 Understand the Hazard Requiring a Preventive Control

The PCHF rule requires a hazard analysis to determine whether there are any hazards requiring 

a preventive control. (See 21 CFR 117.130(a)(1).) Part 114 includes requirements to control 

hazards associated with C. botulinum and other microorganisms of public health significance. 

Thus, understanding the hazards that can be controlled by complying with part 114 can help to 

understand which known or reasonably foreseeable (potential) hazards require a preventive 

control under the PCHF rule. Below, we discuss the hazards that part 114 controls, as well as 

the importance of controlling some microorganisms of non-health significance6 (which are not 

“hazards” as that term is defined in part 117). 

When conditions are not conducive to growth of vegetative cells (e.g., when the availability of 

nutrients is limited), C. botulinum can form spores that are adapted for prolonged survival under 

adverse conditions (Larousse and Brown, 1997). Thermal processes using temperatures such 

as 212 °F (100°C) (i.e., the temperature of boiling water) or even lower (e.g., 150 °F (65.6°C) in 

some circumstances) can destroy the vegetative cells of C. botulinum, but do not destroy the 

spores of C. botulinum (see 41 FR 30442 at 30442, July 23, 1976). 

When the pH of a food is 4.6 or below, spores of C. botulinum will not germinate and grow (41 

FR 30442 at 30442). However, an acidified food can pose a risk of botulism if pH and other 

critical factors are not carefully controlled during processing to prevent the germination and 

growth of viable spores of C. botulinum (44 FR 16204 at 16204, March 16, 1979). When critical 

factors are not carefully controlled, the vegetative cells of some microorganisms of non-health 

significance (such as some spoilage bacteria, yeasts, and molds) can grow in an acid 

environment and, in so doing, cause the pH of the food to increase (Fields, Zamora, and 

Bradsher, 1977; Odlaug and Pflug, 1978; and Institute of Food Technologists, 2001). In 

addition, some spoilage microorganisms (such as Bacillus licheniformis (B. licheniformis)) 

produce heat-resistant, acid-tolerant spores that, when critical factors are not properly 

controlled, can germinate, grow, and cause the pH to increase; thermal processing that is 

sufficient to destroy vegetative cells of such microorganisms may not be sufficient to destroy 

their spores (Fields, Zamora, and Bradsher, 1977; Montville, 1982; Al Dujaili and Anderson, 

1991; and Rodriguez, Cousin, and Nelson, 1992). 

16.4 Terms Used in This Chapter

Section III.B in the Introduction of this guidance includes a glossary of terms that are used in 

this guidance but are not defined in 21 CFR 117.3. At this time, that glossary does not include 

all terms that are used in this chapter. See Table 16-1 for additional terms that we use in this 

chapter. We intend to include these terms in the glossary in the Introduction of this guidance 

when we update the Introduction. When we do so, we will delete Table 16-1 from this chapter.

6 See section 16.9 for additional discussion of microorganisms of non-health significance.
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Table 16-1 Terms Used in this Chapter

Term What the Term Means

Emergency permit control 

regulations

Emergency permit control requirements in 21 CFR 108.25 for acidified 

foods

Part 114 Requirements in 21 CFR part 114, Acidified Foods

Potential hazard Known or reasonably foreseeable hazard (which is defined in 21 CFR 

117.3)

16.5 Quick Reference Guide 

Table 16-2 is a quick reference guide to help you see at a glance the relationship between the 

specific acidified food requirements and corresponding PCHF requirements. 

Table 16-2 Quick Reference Guide Listing the Specific Acidified Food Requirements and 

Corresponding PCHF Requirements

Description of Requirement Applicable 

Requirements in 21 

CFR 108.25 or Part 

114 (21 CFR)

Applicable 

Requirements in Part 

117 (21 CFR)

Applicable 

Section in This 

Chapter

Applicable 

Chapters in This 

Guidance

Qualifications of personnel with 

responsibility for supervision or 

other oversight

• 108.25(f)

• 114.10

• 117.4(c) 

• 117.180(c)(1)

16.6 N/A

Oversight • 108.25(f)

• 114.10

• 114.83

• 117.126(a)(2)

• 117.160(b)(1)

• 117.160(c)(5)

• 117.165(a)(4)

• 117.170(c)(2)(ii)

• 117.180(a)

16.7 Chapter 1

Written food safety plan N/A 117.126 16.8 Chapter 1

Hazard analysis N/A 117.130 16.9 • Chapters 2, 3, 

and 6 

• Appendix 1

• Appendix 3
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Description of Requirement Applicable 

Requirements in 21 

CFR 108.25 or Part 

114 (21 CFR)

Applicable 

Requirements in Part 

117 (21 CFR)

Applicable 

Section in This 

Chapter

Applicable 

Chapters in This 

Guidance

Identifying and implementing 

preventive controls that are 

process controls for biological 

hazards requiring a preventive 

control

• 108.25(c)(2)

• 108.25(c)(3)

• 114.80(a)(1)

• 114.80(a)(3)

• 114.80(a)(4)

• 117.126(b)(2)

• 117.135(a)

• 117.135(b)

• 117.135(c)(1)

16.10.1 Chapters 4 and 6 

Identifying and implementing 

preventive controls for chemical 

or physical hazards requiring a 

preventive control

N/A • 117.126(b)(2)

• 117.135(a)

• 117.135(b)

• 117.135(c)(1)

• 117.135(c)(2)

16.10.2.1 Chapters 4, 11, 

12, and 13

Identifying and implementing 

preventive controls that are 

sanitation controls

N/A • 117.126(b)(2)

• 117.135(a)

• 117.135(b)

• 117.135(c)(3)

16.10.2.2 Chapter 10

Supply-chain controls 114.100(a) • 117.126(b)(3)

• 117.135(a)

• 117.135(c)(4)

• Subpart G

16.10.3 Chapters 4 and 

15

Recall plan 108.25(e) • 117.126(b)(4)

• 117.135(a)

• 117.135(b)

• 117.135(c)(5)

• 117.139

16.10.4 Chapters 4 and 

14

Preventive control management 

components

• 108.25(c)(3)(ii)

• 114.3

• 114.80(a)(2)

• 114.80(a)(4)

• 114.89

• 114.90

• 117.126(b)(5)

• 117.126(b)(6)

• 117.126(b)(7)

• 117.140

• 117.145

• 117.150

• 117.155

• 117.160

• 117.165

16.11 Chapters 5 and 6
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Description of Requirement Applicable 

Requirements in 21 

CFR 108.25 or Part 

114 (21 CFR)

Applicable 

Requirements in Part 

117 (21 CFR)

Applicable 

Section in This 

Chapter

Applicable 

Chapters in This 

Guidance

Records • 108.25(g)

• 114.100

• 117.9

• 117.126(c)

• 117.145(c)

• 117.150(d)

• 117.155(b)

• 117.180(d)

• 117.190(a)

• 117.475(c)

• Subpart F

16.12 Chapter 6

Coding 114.80(b) N/A 16.13 N/A

16.6 Requirements for Qualifications of Personnel with 

Responsibility for Supervision or Other Oversight

Part 117 includes requirements for qualifications of personnel, including supervisory personnel 

(see 21 CFR 117.4). Table 16-3 shows how you can leverage compliance with corresponding 

training requirements in 21 CFR 108.25(f) and 114.10 to address the requirement of 21 CFR 

117.4(c) to provide supervisory oversight for the production of an acidified food product. Note 

that, in general, satisfying the training requirements of 21 CFR 117.4 would not satisfy the 

specialized training requirements of 21 CFR 108.25(f) and 114.10. 
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Chapter 16 (Acidified Foods) - Page 11 

Table 16-3 Qualifications of Personnel with Responsibility for Supervision or Other 

Oversight 

Requirements in Part 117

(21 CFR)

Requirements in 21 

CFR 108.25 or Part 

114 (21 CFR)

How You Can Leverage 

Compliance with 

Requirements in 21 CFR

108.25 or Part 114 to 

Address Requirements in 

Part 117

117.4(c): Responsibility for ensuring 

compliance by individuals with the 

requirements of this part must be clearly 

assigned to supervisory personnel who 

have the education, training, or 

experience (or a combination thereof) 

necessary to supervise the production 

of clean and safe food.

108.25(f) and 114.10: All 

operators of processing 

and packaging systems 

shall be under the 

operating supervision of a 

person who has attended a 

school approved by the 

Commissioner for giving 

instruction in food-handling 

techniques, food-protection 

principles, personal 

hygiene and plant 

sanitation practices, pH 

controls and critical factors 

in acidification, and who 

has been identified by that 

school as having 

satisfactorily completed the 

prescribed course of 

instruction.

Satisfactorily completing the 

prescribed course of instruction in a 

school specified in 21 CFR 108.25(f) 

and 114.10 provides an individual 

with the qualifications necessary to

provide supervisory oversight for the 

production of an acidified food 

product as required by 21 CFR

117.4(c). 

16.7 Requirements for Oversight 

The PCHF rule requires preparation or oversight of the food safety plan, and performance or 

oversight of implementation of certain activities related to the food safety plan, by one or more 

PCQIs. (See 21 CFR 117.126(a)(2) and 117.180(a).) Table 16-4 shows how you can leverage 

compliance with corresponding requirements in 21 CFR 108.25(f), 114.10, and 114.83 to 

address these requirements of the PCHF rule as they relate to acidification. 

See Appendix 16-1 in this chapter and the discussion in section 16.6 regarding the specialized 

training requirements of 21 CFR 108.25(f) and 114.10 for supervisory oversight of processing 

and packaging of acidified foods. In general, a person who satisfies the qualification 

requirements of the PCHF rule for a PCQI to prepare, or oversee the preparation of, the food 

safety plan and to conduct or oversee activities listed in 21 CFR 117.180(a) would not be 

qualified to supervise the processing and packaging of acidified foods unless that person also 

satisfies the specialized training requirements of 21 CFR 108.25(f) and 114.10.
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Chapter 16 (Acidified Foods) - Page 12 

Table 16-4 Requirements for Oversight 

Requirements in Part 

117

(21 CFR)

Requirements in 21 CFR

108.25 or Part 114

(21 CFR)

How You Can Leverage 

Compliance with 

Requirements in 21 CFR

108.25 or Part 114 to Address 

Requirements in Part 117

• 117.126(a)(2): The food 

safety plan must be 

prepared, or its preparation 

overseen, by one or more 

preventive controls qualified 

individuals.

• 117.180(a): One or more 

preventive controls qualified 

individuals must do or 

oversee certain activities

related to preparation and 

implementation of the food 

safety plan: 

o 117.160(b)(1)

(validation of preventive 

controls)

o 117.160(b)(1)(i)(B)(2) 

(justification for a 

validation timeframe that 

exceeds the first 90 

days of production) 

o 117.160(c)(5)

(justification that 

validation is not

applicable) 

o 117.165(a)(4) (review of 

records) 

o 117.165(a)(4)(i) 

(justification for a 

timeframe that exceeds 

7 days for review of 

certain records) 

o 117.170(c)(2)(ii)

(justification for the 

timeframe for 

completion of the 

reanalysis, and 

validation of additional 

preventive controls, if 

the timeframe exceeds 

90 days after 

production) 

• 108.25(f) and 114.10: All 

operators of processing and 

packaging systems shall be 

under the operating supervision 

of a person who has attended a 

school approved by the 

Commissioner for giving 

instruction in food-handling 

techniques, food-protection 

principles, personal hygiene 

and plant sanitation practices, 

pH controls and critical factors 

in acidification, and who has 

been identified by that school 

as having satisfactorily 

completed the prescribed 

course of instruction.

• 114.83 The scheduled process 

shall be established by a 

qualified person who has 

expert knowledge acquired 

through appropriate training 

and experience in the 

acidification and processing of 

acidified foods. Under 114.3(e), 

scheduled process means the 

process selected by a 

processor as adequate for use 

under the conditions of 

manufacture for a food in 

achieving and maintaining a

food that will not permit the 

growth of microorganisms 

having public health 

significance. It includes control 

of pH and other critical factors 

equivalent to the process 

established by a competent 

processing authority.

• A person who satisfactorily completes

the prescribed course of instruction 

specified in 21 CFR 108.25(f) and

114.10 could, through job experience, 

be qualified to conduct or oversee the 

following activities listed in 21 CFR

117.180(a) as they relate to 

acidification: 

o Review of records (21 CFR 

117.165(a)(4); and

o Justification for a timeframe that 

exceeds 7 days for review of 

certain records (21 CFR 

117.165(a)(4)(i))

• A person who is a competent 

processing authority and who 

establishes the scheduled process in 

accordance with 21 CFR 114.83 

could, through job experience, be 

qualified to conduct or oversee the 

following activities listed in 21 CFR 

117.180(a) as they relate to 

acidification and thermal processing 

of an acidified food: 

o 117.160(b)(1) (validation of 

preventive controls)

o 117.160(b)(1)(i)(B)(2) 

(justification for a validation 

timeframe that exceeds the first 

90 days of production)

o 117.160(c)(5) (justification that 

validation is not applicable)

o 117.165(a)(4) (review of records)

o 117.165(a)(4)(i) (justification for a 

timeframe that exceeds 7 days 

for review of certain records) 

o 117.170(c)(2)(ii) (justification for 

the timeframe for completion of 

the reanalysis, and validation of 

additional preventive controls, if 

the timeframe exceeds 90 days 

after production)
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16.8 Requirements for a Written Food Safety Plan

The PCHF rule requires that you prepare, or have prepared, and implement a written food 

safety plan (see 21 CFR 117.126). Neither 21 CFR 108.25 nor part 114 has a corresponding 

requirement to prepare, or have prepared, and implement a written food safety plan. However, 

in the remainder of this chapter we explain how you can leverage procedures, practices, and 

processes that you establish and implement to comply with the requirements of 21 CFR 108.25 

or part 114, and records that you establish and keep to comply with those requirements, to 

address requirements of the PCHF rule for a food safety plan.

16.9 Requirements for Hazard Analysis 

Part 117 defines hazard as any biological, chemical (including radiological), or physical agent 

that has the potential to cause illness or injury. (See 21 CFR 117.3.) The PCHF rule includes 

requirements:

• To conduct a hazard analysis, which must be written regardless of its outcome (see 21 CFR 

117.130(a));

• For a hazard identification that considers known or reasonably foreseeable hazards that 

include biological hazards, chemical hazards, and physical hazards, regardless of whether 

the hazard occurs naturally, is unintentionally introduced, or is intentionally introduced for 

purposes of economic gain (see 21 CFR 117.130(b)); and

• Applicable to the hazard evaluation (see 21 CFR 117.130(c)).

Neither 21 CFR 108.25 nor part 114 has a corresponding requirement for any requirement of 

the PCHF rule for hazard analysis. However, 21 CFR 108.25 and part 114 require specific 

controls for the biological hazard C. botulinum, monitoring of one of those controls (i.e., pH), and 

a basis for the adequacy of the process. (See 21 CFR 114.80(a)(1) and (2) and 21 CFR 

108.25(c)(3)(ii), respectively.) In addition, part 114 requires thermal processing to an extent that 

is sufficient to destroy the vegetative cells of microorganisms of public health significance. (See 

21 CFR 114.80(a)(1).) 

A hazard analysis that identifies and evaluates C. botulinum as a biological hazard requiring a 

preventive control can lead to appropriate preventive controls and associated preventive control 

management components that could address the corresponding requirements of part 114 as 

they relate to the biological hazard C. botulinum. In addition, a hazard analysis that identifies 

microorganisms (other than C. botulinum) of public health significance can lead to appropriate 

preventive controls and associated preventive control management components that could 

address the corresponding requirements of part 114 as they relate to the vegetative cells of 

microorganisms of public health significance other than C. botulinum. For example:

• As discussed in section 16.2.1, in the proposed and final rulemakings for LACF and acidified 

foods FDA discussed the need for CGMP requirements to control C. botulinum. Under part 
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117, a knowledgeable person would identify C. botulinum as a biological hazard requiring a 

preventive control to inactivate vegetative cells of C. botulinum and to prevent toxin 

formation due to germination and growth from spores of C. botulinum. A hazard analysis

could reference 21 CFR 108.25 and part 114, rather than citations to published scientific 

literature, as the basis for a conclusion that C. botulinum in shelf-stable acidified foods is a 

hazard requiring a preventive control. 

• Part 114 requires that acidified foods be thermally processed to an extent that is sufficient to 

destroy the vegetative cells of microorganisms of public health significance. (See 21 CFR 

114.80(a)(1).) Under part 117, a knowledgeable person could identify pathogenic bacteria 

such as Salmonella, Escherichia coli (E. coli) O157:H7 and Listeria monocytogenes (L. 

monocytogenes) as hazards associated with some acidified foods because these 

pathogenic bacteria can be present on some of the ingredients and can be a hazard if the 

heat treatment is not adequate to kill vegetative cells of the pathogenic bacteria. (See 

Appendix 1 of this guidance and the example of the heat processing for a salsa in Chapter 6

of this guidance.) 

• Part 114 requires that the scheduled process for an acidified food control microorganisms of 

non-health significance in addition to pathogens. (See 21 CFR 114.80(a)(1) and Appendix 

16-1.) Microorganisms of non-health significance, by themselves, are not “hazards” as that 

term is defined in part 117. However, as discussed in section 16.3, when critical factors are 

not carefully controlled, the vegetative cells of some microorganisms of non-health 

significance (such as some spoilage bacteria) can grow in an acid environment and, in so 

doing, cause the pH of the food to increase. Therefore, under part 117, a knowledgeable 

person could identify microorganisms of non-health significance in shelf-stable acidified 

foods as biological hazards requiring a preventive control. 

• The parameters that you submit to us on Form FDA 2541e address critical factors such as 

control of pH, process time and temperature, and preservatives. (See Form 2541e and 21 

CFR 114.80(a)(1).) As discussed in section 16.10.1, identifying pathogenic bacteria such as

C. botulinum, Salmonella, E. coli O157:H7, and L. monocytogenes as biological hazards

requiring a preventive control, and identifying microorganisms of non-health significance in 

shelf-stable acidified foods as biological hazards requiring a preventive control, could lead to 

identifying the parameters that you submit to us on Form FDA 2541e as the preventive 

controls. As discussed in section 16.11, these parameters for process controls could lead to 

preventive control management components (such as monitoring pH, and verification that 

includes validation to establish the adequacy of the process) to address the requirement of 

21 CFR 114.80(a)(2) for monitoring pH and the requirement of 21 CFR 108.25(c)(3)(ii) for 

adequacy of the scheduled process.

7

• Part 114 requires that testing and examination of containers shall occur often enough to 

ensure that the container suitably protects the food from leakage or contamination because 

there is a potential for recontamination with microorganisms (including pathogens and 

microorganisms of non-health significance that could raise the pH) if there is a loss of 

seam/seal integrity, especially during cooling of the sealed containers in water. (See 21 CFR 

114.80(a)(4).) The hazard evaluation must consider the effect of packaging activities on the 

7 Although not specified in part 114, preventive control management components for acidified foods 

generally would include monitoring the thermal process and other critical factors in addition to monitoring 

pH, and verification activities in addition to validation. See Section 6.16 in Chapter 6 of this for a 

comprehensive example of preventive control management components for an acidified food. 
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safety of the finished food for the intended consumer. (See 21 CFR 117.130(c)(2)(vi).) A 

knowledgeable person would identify microorganisms (including pathogens and 

microorganisms of non-health significance that could raise the pH) that could recontaminate

the food due to lack of container integrity as process-related biological hazards requiring a 

preventive control. As discussed in section 16.10.1, this outcome of the hazard analysis 

could lead to a preventive control during seaming/sealing after filling the container (i.e., 

applying a hermetic seal) to prevent recontamination. As discussed in section 16.11, this 

preventive control could lead to preventive control management components that include 

monitoring of seam/seal integrity to address the requirements of 21 CFR 114.80(a)(4).

For help in identifying other known or reasonably foreseeable biological, chemical, or physical 

hazards applicable to your product, see: 

• Chapter 2 of this guidance regarding the hazard analysis; 

• Chapter 3 of this guidance regarding hazards associated with the manufacturing, 

processing, packing, and holding of human food; 

• Appendix 1 of this guidance regarding known or reasonably foreseeable (potential) hazards 

and 

• Section 6.16 in Chapter 6 of this guidance regarding heat treatments as a process control, 

which provides an example of a hazard analysis for a salsa. In this example, a salsa 

manufacturer identified Salmonella, E. coli O157:H7, L. monocytogenes, and C. botulinum

as hazards associated with the salsa because these pathogenic bacteria can be present on 

some of the ingredients and can be a hazard if the salsa is not properly acidified to a pH that 

is low enough to prevent the germination of spores of C. botulinum and if the heat treatment 

is not adequate to kill vegetative cells of the pathogenic bacteria. In addition, the salsa 

manufacturer consulted the scientific literature and found that sporeforming bacteria that are 

generally associated with spoilage (such as Bacillus subtilis and B. licheniformis) could 

affect the safety of an acidified food if spores that are not destroyed during the product heat 

treatment germinate, grow, and cause the pH to increase above 4.6. 

16.10 Requirements for Preventive Controls

The PCHF rule includes requirements to identify and implement preventive controls to provide 

assurances that any hazards requiring a preventive control will be significantly minimized or 

prevented and the food manufactured, processed, packed, or held by your facility will not be 

adulterated under section 402 of the FD&C Act or misbranded under section 403(w) of the 

FD&C Act. (See 21 CFR 117.135(a).) Preventive controls must be written. (See 21 CFR 

117.135(b).)
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16.10.1 Identifying and Implementing Preventive Controls that Are Process 

Controls for Biological Hazards Requiring a Preventive Control

Table 16-5 shows how you can leverage the parameters that you submit on Form FDA 2541e to 

address the requirements of the PCHF rule for written preventive controls that are process 

controls for biological hazards requiring a preventive control. For example, Form FDA 2541e 

requires information about pH, process time and temperature, and preservatives.8

See Appendix 16-1 in this chapter for key additional requirements specific to acidified foods. 

Table 16-5 also shows how, with some limitations, you can leverage written process controls 

that you identify and implement for acidification to comply with the requirements of the PCHF 

rule to address the corresponding requirements in part 114 and Form FDA 2541e (e.g., for 

control of pH, process time and temperature, and preservatives). However, the requirement in 

21 CFR 108.25(c)(2) to submit Form FDA 2541e to FDA has no corresponding requirement in 

the PCHF rule. You must submit Form FDA 2541e to FDA as required by 21 CFR 108.25(c)(2)

even if you include Form FDA 2541e in your food safety plan. 

As discussed in section 16.9, one outcome of the hazard analysis could be a preventive control 

during seaming/sealing after filling the container (i.e., applying a hermetic seal) to prevent 

recontamination. Although this preventive control has no directly corresponding requirement in 

21 CFR 108.25(e) or part 114, there is a related requirement specific to acidified foods. As 

shown in Appendix 16-1 in this chapter, part 114 requires testing and examination of containers 

at a frequency that is often enough to ensure that the container suitably protects the food from 

leakage or contamination. (See 21 CFR 114.80(a)(4).) See the discussion in section 16.11 of 

how the requirement of part 114 for testing and examination of containers at a frequency that is 

often enough to ensure that the container suitably protects the food from leakage or 

contamination could satisfy the requirements of the PCHF rule for monitoring of seam/seal 

integrity as a preventive control management component for a process control of applying a 

hermetic seal.

For additional help regarding the requirements of the PCHF rule for process controls for 

biological hazards requiring a preventive control, see:

• Chapter 4 regarding preventive controls; and 

• Section 6.16 in Chapter 6 (regarding heat treatments as a process control), which provides 

an example of process controls for a salsa. 

8 Note that you must include your process controls in the food safety plan that you keep onsite even 

though you submit them to FDA on Form FDA 2541e, because the food safety plan must be kept onsite 

(see 21 CFR 117.315(d)). 
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Table 16-5 Identifying and Implementing Preventive Controls that Are Process Controls 

for Biological Hazards Requiring a Preventive Control

Requirements in Part 117

(21 CFR)

Corresponding Requirements in 21 

CFR 108.25 or Part 114

(21 CFR)

How You Can Leverage 

Compliance with 

Requirements in 21 

CFR 108.25 or Part 114 

to Address 

Corresponding 

Requirements in the 

PCHF Rule

How You Can 

Leverage 

Compliance with the 

Requirements of the 

PCHF Rule to 

Address 

Corresponding 

Requirements of 21 

CFR 108.25 and Part 

114

• Requirements to identify 

and implement 

preventive controls that 

are process controls:

o 117.135(a) (general 

requirement)

o 117.135(c)(1) Process 

controls. Process 

controls include 

procedures, practices, 

and processes to 

ensure the control of 

parameters during 

operations such as 

heat processing, 

acidifying, irradiating, 

and refrigerating 

foods. Process 

controls must include, 

as appropriate to the 

nature of the 

applicable control and 

its role in the facility’s 

food safety system: (i) 

Parameters associated 

with the control of the 

hazard; and (ii) The 

maximum or minimum 

value, or combination 

of values, to which any 

biological, chemical, or 

physical parameter 

must be controlled to 

significantly minimize 

or prevent a hazard 

requiring a process 

control.

• Requirement for written 

procedures for 

preventive controls that 

are process controls:

o 117.126(b)(2)

o 117.135(b)

• 108.25(c)(2): Requires the 

submission to FDA of Form FDA 

2541e. Form FDA 2541e requires, as 

applicable, information about the 

product, the container type and size, 

pH, method of acidification, microbial 

preservatives critical to the scheduled 

process, process source, process 

mode, the container and container 

closure treatment, and details of the 

scheduled process (e.g., process time 

and temperature), for each acidified 

food in each container size.

• 108.25(c)(3): Requires a commercial 

processor engaged in processing 

acidified foods to process each food 

in conformity with at least the 

scheduled processes filed under 21 

CFR 108.25(c)(2).

• 114.80(a)(1): Acidified foods shall be 

so manufactured, processed, and 

packaged that a finished equilibrium 

pH value of 4.6 or lower is achieved 

within the time designated in the 

scheduled process and maintained in 

all finished foods. Manufacturing shall 

be in accordance with the scheduled 

process. Acidified foods shall be 

thermally processed to an extent that 

is sufficient to destroy the vegetative 

cells of microorganisms of public 

health significance and those of nonhealth significance capable of 

reproducing in the food under the 

conditions in which the food is stored, 

distributed, retailed and held by the 

user. Permitted preservatives may be 

used to inhibit reproduction of 

microorganisms of non-health 

significance (in lieu of thermal 

processing).

• 114.80(a)(3): Lists acceptable 

procedures for acidification to attain 

acceptable equilibrium pH levels in 

the final food

• The parameters that 

you establish in 

accordance with 21 

CFR 114.80(a)(1) and 

submit on Form FDA 

2541e could satisfy 

the requirement for 

parameters associated 

with control of a 

hazard for process 

controls, and 

applicable maximum 

or minimum values in 

21 CFR 117.135(c)(1), 

as long as you include 

that scheduled 

process in the food 

safety plan that is 

signed and dated by 

the owner, operator, or 

agent in charge of the 

facility and kept onsite 

(see 21 CFR 117.310 

and 117.315(c)). 

• Compliance with the 

scheduled process 

submitted to FDA on 

Form FDA 2541e 

could satisfy the 

requirements in 21 

CFR 117.135(a) and 

(c) to implement 

preventive controls 

that are process 

controls for biological 

hazards that require a 

preventive control.

Complying with the 

PCHF requirements 

to identify and 

implement process 

controls, parameters 

associated with 

control of the hazard, 

and applicable 

maximum or 

minimum values that 

satisfy all 

requirements in 21 

CFR 114.80(a)(1) 

and all requirements 

on Form FDA 2541e 

could satisfy all 

requirements of 21 

CFR 108.25(c)(2) and 

(3) and part 114 (e.g., 

for control of pH, 

process time and 

temperature, and

preservatives), as 

long as you also 

submit Form FDA 

2541e to FDA. 
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16.10.2 Preventive Controls That Have No Corresponding Requirements 

in 21 CFR 108.25 or Part 114

As discussed in sections 16.10.2.1 and 16.10.2.2, the PCHF rule specifies some preventive 

control requirements that have no corresponding requirements in either 21 CFR 108.25 or part 

114.

16.10.2.1 Identifying and Implementing Preventive Controls for Chemical 

Hazards or Physical Hazards Requiring a Preventive Control 

When the hazard requiring a preventive control under part 117 is a chemical or physical hazard, 

neither 21 CFR 108.25 nor part 114 has a corresponding requirement to identify and implement 

a preventive control. Preventive controls for chemical or physical hazards could be a process 

control (see 21 CFR 117.135(c)(1)) or, in the case of a chemical hazard that is a food allergen 

hazard, a food allergen control (see 21 CFR 117.135(c)(2)).

For help in identifying and implementing preventive controls for known or reasonably 

foreseeable chemical and physical hazards applicable to acidified foods, see:

• Chapter 4 regarding preventive controls; 

• Chapter 11 regarding food allergen controls; 

• Chapter 12 regarding preventive controls for chemical hazards; and

• Chapter 13 regarding preventive controls for physical hazards.

16.10.2.2 Identifying and Implementing Preventive Controls That Are 

Sanitation Controls

Sanitation controls include procedures, practices, and processes to ensure that the facility is 

maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as 

environmental pathogens, biological hazards due to employee handling, and food allergen 

hazards. Sanitation controls must include, as appropriate to the facility and the food, 

procedures, practices, and processes for the: (1) Cleanliness of food-contact surfaces, including 

food-contact surfaces of utensils and equipment; and (2) prevention of allergen cross-contact 

and cross-contamination from insanitary objects and from personnel to food, food packaging 

material, and other food-contact surfaces and from raw product to processed product. (See 21 

CFR 117.135(c)(3).) Neither 21 CFR 108.25 nor part 114 has a corresponding requirement to 

identify and implement a sanitation control. 

Complying with part 114 should make it unnecessary to identify and implement sanitation 

controls for the control of environmental pathogens (such as L. monocytogenes or Salmonella) 

for many acidified foods because part 114 requires thermal processing to an extent that is 
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sufficient to destroy the vegetative cells of microorganisms of public health significance (see 21 

CFR 114.80(a)) and because many acidified foods are packaged (e.g., by hot filling) in a way 

that does not expose the thermally processed food to the environment at a temperature at which 

environmental pathogens would survive the filling. However, as part of the hazard analysis the 

PCQI would evaluate whether sanitation controls for the control of environmental pathogens are 

necessary if a ready-to-eat acidified food is exposed to the environment prior to packaging and 

the packaged food does not receive a treatment or otherwise include a control measure (such 

as a formulation lethal to the environmental pathogen) that would significantly minimize the 

environmental pathogen. (See 21 CFR 117.130(c)(1)(ii).)

Sanitation controls are one way to address food allergen hazards. You determine through your 

hazard analysis whether food allergen hazards require sanitation controls (which can also be 

considered food allergen controls, because sanitation controls are procedures to protect food 

from allergen cross-contact). 

For help in determining whether to identify and implement sanitation controls, see:

• Chapter 4 regarding preventive controls; and 

• Chapter 10 regarding sanitation controls. 

16.10.3 Supply-chain Controls

The PCHF rule requires that a receiving facility establish and implement a risk-based supplychain program for those raw materials and other ingredients for which the receiving facility has 

identified a hazard requiring a supply-chain-applied control. (See subpart G and 21 CFR 

117.405(a)(1).) Supply-chain controls are not required if the receiving facility (rather than a 

supplier) will control a hazard requiring a preventive control. For example, supply-chain controls 

are not required for biological hazards that are controlled by the process controls for an acidified 

food.

Part 114 requires that records shall be maintained of suppliers' guarantees or certifications that 

verify compliance with FDA regulations and guidance documents or action levels. (See 21 CFR

114.100(a).) If your hazard analysis for a raw material or other ingredient identifies any hazards 

requiring a supply-chain-applied control, and your supply-chain program for that raw material or 

other ingredient includes sampling and testing of that raw material or other ingredient with 

results reported in documentation such as a Certificate of Analysis, complying with the 

requirements for supply-chain controls could satisfy the corresponding requirement of 21 CFR 

114.100(a) for records of suppliers’ guarantees or certifications. (See 21 CFR 117.410(b)(2) 

(which identifies sampling and testing of raw materials or other ingredients as an appropriate 

supplier verification activity) and 21 CFR 117.475(c)(8) (which requires documentation of 

sampling and testing conducted as a supplier verification activity)).
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For help in determining whether to establish and implement a supply-chain program, see:

• Chapter 4 regarding preventive controls; and

• Chapter 15 regarding a supply-chain program.

16.10.4 Recall Plan

The PCHF rule requires a recall plan for food with a hazard requiring a preventive control. (See 

21 CFR 117.139.) Table 16-6 shows how you can leverage procedures, practices, and 

processes that you establish and implement to comply with corresponding requirements in 21 

CFR 108.25(e) to address the requirements of the PCHF rule for a recall plan. 

Table 16-6 also shows how, with one limitation, you can leverage a written recall plan that you 

establish and implement to comply with the requirements of the PCHF rule to address the 

corresponding requirements in 21 CFR 108.25(e) regarding recalls. However, the requirement 

in 21 CFR 108.25(e) for the recall procedures to include notifying FDA of any recalls has no 

corresponding requirement in the PCHF rule for a recall plan. Therefore, a written recall plan 

that you establish and implement to comply with the requirements of the PCHF rule could only 

satisfy all requirements of 21 CFR 108.25(e) regarding recalls if it also includes procedures for 

notifying FDA of any recalls.

For help regarding the recall plan, see:

• Chapter 4 regarding preventive controls; and

• Chapter 14 regarding the recall plan.
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Chapter 16 (Acidified Foods) - Page 21 

Table 16-6 Recall Plan

Requirements in Part 

117

(21 CFR)

Corresponding 

Requirements in 21 

CFR 108.25 or Part 114

(21 CFR)

How You Can Leverage 

Compliance with 

Requirements in 21 CFR 

108.25 or Part 114 to Address 

Corresponding Requirements 

in the PCHF Rule

How You Can 

Leverage 

Compliance with the 

Requirements of the 

PCHF Rule to 

Address 

Corresponding 

Requirements of 21 

CFR 108.25 and Part

114

• Requirements to 

identify and 

implement preventive 

controls:

o 117.135(a) 

(general 

requirement)

o 117.135(c)(5) 

(recall plan)

o 117.139 (recall 

plan)

• Requirement for 

written procedures for 

preventive controls:

o 117.126(b)(4)

o 117.135(b)

108.25(e): A commercial 

processor engaged in 

the processing of 

acidified foods shall 

prepare and maintain 

files on a current 

procedure for use for 

products under the 

processor's control, 

which that processor will 

ask the distributor to 

follow, including plans 

for recalling products 

that may be injurious to 

health; for identifying, 

collecting, warehousing, 

and controlling products; 

for determining the 

effectiveness of recalls; 

for notifying FDA of any 

recalls; and for 

implementing recall 

programs.

A written recall procedure that 

you establish and implement to 

comply with 21 CFR 108.25(e) 

could satisfy all requirements 

of the PCHF rule for a recall 

plan, as long as it includes 

procedures that describe the 

steps to be taken, and assign 

responsibility for taking those 

steps, to perform the following 

actions as appropriate to the 

facility:

• Directly notify the direct 

consignees of the food being 

recalled, including how to 

return or dispose of the 

affected food;

• Notify the public about any 

hazard presented by the 

food when appropriate to 

protect public health;

• Conduct effectiveness 

checks to verify that the 

recall is carried out; and

• Appropriately dispose of 

recalled food—e.g., through 

reprocessing, reworking, 

diverting to a use that does 

not present a safety concern, 

or destroying the food.

A written recall plan 

that you establish 

and implement to 

comply with 21 CFR 

117.139 could satisfy 

the requirements of 

21 CFR 108.25(e), 

as long as it includes 

procedures for 

notifying FDA about 

any recall.

16.11 Requirements for Preventive Control Management 

Components

With some exceptions, the preventive controls required by the PCHF rule are subject to the 

following preventive control management components as appropriate to ensure the 
Contains Non-binding Recommendations

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Chapter 16 (Acidified Foods) - Page 22

effectiveness of the preventive controls, taking into account the nature of the preventive control 

and its role in the facility's food safety system: 

• Monitoring in accordance with 21 CFR 117.145;

• Corrective actions and corrections in accordance with 21 CFR 117.150; and

• Verification in accordance with 21 CFR 117.155.

(See 21 CFR 117.140.) The exceptions to these requirements for preventive control 

management components are:

• The supply-chain program is subject to a subset of the preventive control management 

components (i.e., corrective actions and corrections in accordance with 21 CFR 117.150, 

review of records in accordance with 21 CFR 117.165(a)(4), and reanalysis in accordance 

with 21 CFR 117.170). (See 21 CFR 117.140(b).) 

• The recall plan is not subject to the requirements for preventive control management 

components. (See 21 CFR 117.140(c).)

Table 16-7 lists most9 of the specific provisions of the PCHF rule for establishing and 

implementing preventive control management components, including the requirements for 

written procedures for the preventive control management components. Table 16-7 also lists the 

corresponding requirements in part 114. Table 16-7 shows how you can leverage procedures, 

practices, and processes that you establish and implement to comply with 21 CFR 114.80(a)(2), 

114.80(a)(4), or 114.89, or that are listed in 21 CFR 114.90, to address the requirements of the 

PCHF rule for preventive control management components. To see how you can leverage 

records documenting compliance with recordkeeping requirements of part 114 to address the 

corresponding requirements for records documenting implementation of the preventive control 

management components, see Table 16-8.

Table 16-7 also shows how you can leverage the preventive control management components 

that you implement to satisfy the requirements of the PCHF rule to address the corresponding 

requirements in 21 CFR 114.80(a)(2), 114.80(a)(4), and 114.89. To see how you can leverage 

records documenting implementation of the preventive control management components to 

address corresponding recordkeeping requirements of part 114, see Table 16-8.

See also Appendix 16-1 in this chapter for key additional requirements specific to acidified 

foods. The emergency permit control regulations require that you provide FDA with any process 

and procedure information that we deem necessary to determine the adequacy of the process 

upon request. (See 21 CFR 108.25(c)(3)(ii).) The requirements of the PCHF rule applicable to 

validation of preventive controls correspond to the requirements of 21 CFR 108.25 and part 114 

for the adequacy of the scheduled process, and we ordinarily will review records applicable to 

9 See Table 16-8 for the records documenting implementation of the preventive control management 

components. 
Contains Non-binding Recommendations

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Chapter 16 (Acidified Foods) - Page 23

process validation during inspection. However, as required by 21 CFR 108.25(c)(3)(ii) you must 

send us any process and procedure information that we deem necessary to determine the 

adequacy of the process if we ask you to do so (e.g., as a follow-up to your submission of a 

scheduled process on Form FDA 2541e).

For help regarding preventive control management components, see:

• Chapter 5 regarding preventive control management components; and

• Chapter 6 regarding heat treatments as a process control.
Contains Non-binding Recommendations

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Chapter 16 (Acidified Foods) - Page 24 

Table 16-7 Preventive Control Management Components 

Requirements in Part 117

(21 CFR)

Corresponding 

Requirements in 21 

CFR 108.25 or Part 114

(21 CFR)

How You Can Leverage 

Compliance with Requirements 

in 21 CFR 108.25 or Part 114 to 

Address Corresponding 

Requirements in the PCHF Rule

How You Can Leverage 

Compliance with the 

Requirements of the 

PCHF Rule to Address 

Corresponding 

Requirements of 21 

CFR 108.25 and Part 

114

• Requirements to establish 

and implement preventive 

control management 

components:

o 117.140 

o 117.145 (monitoring)

o 117.150 (corrective 

actions and corrections)

o 117.155 (verification)

o 117.160 (validation)

o 117.165 (verification of 

implementation and 

effectiveness)

o 117.165(a)(1) 

(calibration)

o 117.165(a)(2) (product 

testing)

o 117.165(a)(3) 

(environmental 

monitoring)

o 117.165(a)(4) (review of 

records)

• Requirement for written 

procedures for preventive 

control management 

components:

o 117.126(b)(5) and 

117.145(a) (monitoring)

o 117.126(b)(6) and 

117.150(a)(1) (corrective 

action procedures)

o 117.126(b)(7) and 

117.165(b) (verification)

o 117.165(b)(1) 

(calibration)

o 117.165(b)(2) (product 

testing)

o 117.165(b)(3) 

(environmental 

monitoring)

• 108.25(c)(3)(ii) 

Provide us with any 

process and 

procedure information 

that we deem 

necessary to 

determine the 

adequacy of the 

process

• 114.3(e): Scheduled 

process means the 

process selected by a 

processor as 

adequate for use 

under the conditions 

of manufacture for a 

food in achieving and 

maintaining a food 

that will not permit the 

growth of 

microorganisms 

having public health 

significance.

• 114.80(a)(2) Exercise 

of sufficient control, 

including frequent 

testing and recording 

of results, so that the 

finished equilibrium 

pH values for 

acidified foods are 

not higher than 4.6

• 114.80(a)(4) Testing 

and examination of 

containers shall occur 

often enough to 

ensure that the 

container suitably 

protects the food from 

leakage or 

contamination. 

• 114.89 (deviations 

from scheduled 

processes)

• 114.90 (methodology)

• Complying with 21 CFR 

114.80(a)(2) could satisfy the 

requirements of the PCHF rule 

for monitoring pH as a 

preventive control management 

component for pH control as a 

process control.

• Complying with 21 CFR 

114.80(a)(4) could satisfy the 

requirements of the PCHF rule 

for monitoring seam/seal 

integrity of finished product as a 

preventive control management 

component when applying a 

hermetic seal is a process 

control.

• Written procedures that you 

establish and implement to 

comply with the requirements of 

21 CFR 114.80(a)(2) and (a)(4) 

could satisfy the requirements of 

21 CFR 117.126(b)(5) and 

117.145(a) for written monitoring 

procedures. 

• Written procedures that you 

establish and implement to 

comply with the requirements of 

21 CFR 114.89 could satisfy the 

requirements of 21 CFR 

117.126(b)(6) and 117.150(a)(1) 

for written corrective action 

procedures as appropriate to the 

nature of the hazard and the 

nature of the preventive control.

• Written procedures that you 

establish and implement to 

comply with 21 CFR 114.90 

could satisfy some requirements 

of the PCHF rule for written 

procedures for preventive 

control management 

components (e.g., written 

procedures for monitoring or 

calibration of equipment). 

• Complying with the 

requirements of 21 

CFR 117.145 for 

monitoring preventive 

controls for (1) pH and 

(2) applying a 

hermetic seal could 

satisfy the 

requirements of 21 

CFR 114.80(a)(2) and 

(a)(4), respectively.

• Complying with the 

requirements of 21 

CFR 117.150 to 

establish and 

implement corrective 

action procedures 

could satisfy the 

requirements of 21 

CFR 114.89 for 

deviations from 

scheduled processes. 

• Complying with the 

requirements of 21 

CFR 117.155 and 

117.160 for process 

validation would be 

consistent with the 

definition of 

“scheduled process” 

in 21 CFR 114.3, but 

you still must submit 

information about the 

adequacy of the 

process to FDA upon 

request as required by 

21 CFR 

108.25(c)(3)(ii).
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Chapter 16 (Acidified Foods) - Page 25

16.12 Requirements for Records

Subpart A of part 117 requires that food establishments establish and maintain records that 

document required training. (See 21 CFR 117.9.) Subparts C and G of part 117 require that you 

have a written food safety plan (see 21 CFR 117.126), records documenting implementation of 

the food safety plan (see 21 CFR 117.190), and records documenting the supply-chain program 

(see 21 CFR 117.475(c)).

Subpart F of part 117 includes requirements applicable to all records required by part 117. For 

example:

• The owner, operator, or agent in charge of the facility must sign and date the food safety 

plan (21 CFR 117.310);

• Part 117 allows you to use existing records, supplemented as necessary to include all 

required information (§ 117.330(a)); and

• Part 117 does not require that records be kept in one set of records. If existing records 

contain some of the required information, any new information required by the PCHF rule 

may be kept either separately or combined with the existing records (§ 117.330(a)).

Table 16-8 shows how you can leverage compliance with the recordkeeping requirements of 21 

CFR 108.25(g) and 114.100(a) through (c) to address the recordkeeping requirements of the 

PCHF rule. Table 16-8 also shows how you can leverage compliance with the recordkeeping 

requirements of the PCHF rule to address the corresponding requirements in 21 CFR 

114.100(a), (b), and (c).10

See Appendix 16-1 in this chapter for key additional requirements specific to acidified foods. 

Importantly: 

• The regulations in 21 CFR 108.25 and part 114 each have a recordkeeping requirement that 

exceeds the corresponding recordkeeping requirement in part 117. Specifically, the 

regulations in 21 CFR 108.25 and part 114 require that you keep records required by part 

114 for 3 years, which exceeds the maximum 2-year record retention requirement in part 

117. (See 21 CFR 108.25(g), 114.100(e), and 117.315.)

• Part 114 requires records of distribution. (See 21 CFR 114.100(d).) Part 117 does not have 

a corresponding recordkeeping requirement. However, compliance with 21 CFR 114.100(d) 

could satisfy some requirements of 21 CFR 1.345 in part 1, subpart J (Establishment, 

Maintenance, and Availability of Records) for the identity of the immediate, subsequent 

recipients of food; likewise, compliance with the requirements of 21 CFR 1.345 in part 1, 

subpart J for the identity of the immediate, subsequent recipients of food could satisfy the 

requirements in 21 CFR 114.100(d) for records of distribution of acidified foods.

10 See also the discussions in sections 16.6 through 16.10 for limitations on whether complying with the 

requirements of 21 CFR 108.25 and part 114 can address the requirements of part 117 and vice versa. 
Contains Non-binding Recommendations

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Chapter 16 (Acidified Foods) - Page 26

For help regarding the recordkeeping requirements of the PCHF rule for acidified foods, see 

section 6.16 in Chapter 6 regarding heat treatments as a process control, which provides an 

example of records documenting implementation of the food safety plan for a salsa.
Contains Non-binding Recommendations

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Chapter 16 (Acidified Foods) - Page 27 

Table 16-8 Records 

Requirements in Part 117

(21 CFR)

Corresponding 

Requirements in 21 CFR 108 

or Part 114

(21 CFR)

How You Can Leverage 

Compliance with 

Requirements in 21 CFR 

108.25 or Part 114 to Address 

Corresponding Requirements 

in the PCHF Rule

How You Can Leverage 

Compliance with the 

Requirements of the 

PCHF Rule to Address 

Corresponding 

Requirements of 21 

CFR 108.25 and Part 

114

• 117.9 (training)

• 117.126(c): Food safety 

plan

• 117.190(a): 

Implementation records, 

including records 

documenting:

o Basis for not 

establishing a 

preventive control 

(117.136(b)) 

o Monitoring 

(117.145(c))

o Corrective actions and 

corrections 

(117.150(d))

o Verification 

(117.155(b))

o Supply-chain program 

(117.475(c))

o Training of PCQI) 

(117.180(d))

• Subpart F:

o 117.301 (Applicability)

o 117.305 (General 

requirements) 

o 117.310 (Food safety 

plan)

o 117.315 (Record 

retention)

o 117.320 (Official 

review)

o 117.325 (Public 

disclosure)

o 117.330 (Use of 

existing records)

o 117.335 (Special 

requirements for 

written assurance)

• 114.100(a): Records of 

examinations of raw 

materials, packaging 

materials, and finished 

products, and of suppliers' 

guarantees or certifications

• 114.100(b): Processing and 

production records, 

including records of pH 

measurements and other 

critical factors intended to

ensure a safe product 

• 114.100(c): All departures 

from scheduled processes 

having a possible bearing 

on public health or the 

safety of the food

• 114.100(d): Records 

identifying initial distribution 

of the finished product to 

facilitate, when necessary, 

the segregation of specific 

food lots that may have 

become contaminated or 

otherwise unfit for their 

intended use

• 108.25(g) and 114.100(e): 

Records shall be retained at 

the processing plant or 

other reasonably accessible 

location for a period of 3 

years from the date of 

manufacture. 

• 108.25(f) and 114.10: All 

operators of processing and 

packaging systems shall be 

under the operating 

supervisions of a person 

who has attended a school 

approved by the 

Commissioner and who has 

been identified by that 

school as having 

satisfactorily completed the 

prescribed course of 

instruction.

• Records demonstrating 

compliance with 21 

114.100(a) could satisfy the 

requirements of 21 CFR 

117.475(c)(8) for sampling 

and testing records 

applicable to a supply-chain 

program, if your supply-chain 

program identifies any 

hazards requiring a supplychain applied control. 

• Records demonstrating 

compliance with 21 CFR 

114.100(b) could satisfy: 

o The requirements of 21 

CFR 117.145(c) for 

records of monitoring pH 

as a preventive control 

management component 

for pH control as a process 

control.

o The requirements of 21 

CFR 117.145(c) for 

records of monitoring when 

monitoring seam/seal 

integrity of finished product 

is a preventive control 

management component 

for the scheduled process.

• Records demonstrating 

compliance with 21 CFR 

114.100(c) could satisfy 

some requirements of 21 

CFR 117.150(d) for records 

of corrective actions and 

corrections.

• If your supply-chain 

program identifies any 

hazards requiring a 

supply-chain applied 

control, records that 

comply with 21 CFR 

117.475(c)(8) could 

satisfy corresponding 

requirements in 21 

CFR 114.100(a) for 

records of suppliers' 

guarantees or 

certifications. 

• Monitoring records 

that comply with 21 

CFR 117.145(c) could 

satisfy corresponding 

requirements in 21 

CFR 114.100(b) for 

records of pH 

measurements and 

other critical factors. 

• Corrective action

records that comply 

with 21 CFR 

117.150(d) could 

satisfy corresponding 

requirements in 21 

CFR 114.100(c) for 

records of all 

departures from 

scheduled processes 

having a possible 

bearing on public 

health or the safety of 

the food. 
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Chapter 16 (Acidified Foods) - Page 28 

16.13 Requirements for Coding

Part 114 requires that each container or product be marked with an identifying code 

permanently visible to the naked eye. (See 21 CFR 114.80(b) for the complete requirements.) 

There is no corresponding requirement for coding in the PCHF rule. You must comply with all 

requirements for coding in 21 CFR 114.80(b) even though there is no corresponding 

requirement for coding in the PCHF rule.

16.14 References

Al Dujaili J and RE Anderson, 1991. Aciduric, pH-Elevating Bacillus which cause 

noneffervescent spoilage of underprocessed tomatoes. Journal of Food Science 56 (6): 1611-

1613.

FDA, 2009. Guidance for Industry: Questions and Answers Regarding the Reportable Food 

Registry as Established by the Food and Drug Administration Amendments Act of 2007 

(https://www.fda.gov/FoodGuidances).

FDA, 2010. Draft Guidance for Industry: Questions and Answers Regarding the Reportable 

Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 

(Edition 2) (https://www.fda.gov/FoodGuidances). 

FDA, 2012. Guidance for Industry: Questions and Answers Regarding Establishment and 

Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, 

Receive, Hold, or Import Food (Edition 5) (https://www.fda.gov/FoodGuidances).

FDA, 2016. Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment 

Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process 

Filing Forms) to FDA in Electronic or Paper Format (https://www.fda.gov/FoodGuidances) 

FDA, 2018. Questions and Answers Regarding Food Facility Registration (Seventh Edition) 

(https://www.fda.gov/FoodGuidances). 

FDA, 2020. Guidance for Industry: Product Recalls, Including Removals and Corrections 

(https://www.fda.gov/safety/industry-guidance-recalls/guidance-industry-product-recallsincluding-removals-and-corrections).

Fields M, A Zamora, and M Bradsher. 1977. Microbiological analysis of home canned tomatoes 

and green beans. Journal of Food Science 42: 931-934.

Institute of Food Technologists. 2001. Evaluation and Definition of Potentially Hazardous Foods. 

Chapter 3. IFT/FDA Contract No. 223-98-2333 (https://www.fda.gov/media/103613/download). 
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 16 (Acidified Foods) - Page 29 

Larousse J and B Brown. 1997. Thermobacteriology. In Food Canning Technology, eds J 

Larousse and B Brown, pp.117-150. New York: Wiley-VCH

Montville T. 1982. Metabiotic effect of Bacillus licheniformis on Clostridium botulinum: 

Implications for home canned tomatoes. Applied and Environmental Microbiology 44 (2): 334-

338.

Odlaug TE, and IJ Pflug. 1978. Clostridium botulinum and acid foods. Journal of Food 

Protection 41 (7): 566-573.

Rodriguez J, M Cousin, and P Nelson. 1992. Evaluation of anaerobic growth of Bacillus 

licheniformis and Bacillus subtilis in tomato juice. Journal of Food Protection 9: 672-677.

Appendix 16-1 Key Specific Acidified Food Requirements 

The requirements of 21 CFR 108.25 and part 114 include some requirements that either have 

no explicitly corresponding requirement in part 117 or exceed the corresponding requirement in 

part 117. Appendix Table 16-1-1 lists the key additional requirements specific to acidified foods 

and, when applicable, resources that are available to help you comply with those additional 

requirements. 

Appendix Table 16-1-1 Key Specific Acidified Food Requirements 

Description of Specific 

Acidified Food

Requirement

Applicable 

Regulation(s)

Comments Resources

Submit food canning 

establishment registration to 

FDA using Form FDA 2541

21 CFR 108.25(c)(1) Registering your 

establishment as a food 

canning establishment 

using Form FDA 2541 (as 

required by 21 CFR 

108.25(c)(1)) is in addition 

to registering your food 

facility using Form FDA 

3537 (as required by 21 

CFR Part 1, Subpart H)

• FDA, 2016

• FDA, 2018 
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 16 (Acidified Foods) - Page 30 

Description of Specific 

Acidified Food

Requirement

Applicable 

Regulation(s)

Comments Resources

Submit scheduled process to 

FDA using Form FDA 2541e

21 CFR 108.25(c)(2) See the discussion in

section 16.10.1. Although 

you can leverage Form FDA 

2541e to address the 

requirements of the PCHF 

rule for written process 

controls for biological 

hazards requiring a 

preventive control, including 

Form FDA 2541e in the 

food safety plan that you 

keep onsite does not affect 

your responsibility to submit 

Form FDA 2541e to FDA.

FDA, 2016

Provide FDA with information 

about the scheduled process 

and procedure upon FDA’s 

request

21 CFR 108.25(c)(3)(ii) See the discussion in 

section 16.11. The 

requirements of the PCHF 

rule applicable to validation 

of preventive controls 

correspond to the 

requirements of 21 CFR 

108.25 and part 114 for the 

adequacy of the scheduled 

process, and we ordinarily 

will review records 

applicable to process 

validation during inspection. 

However, as required by 21 

CFR 108.25(c)(3)(ii), you 

must send us any process 

and procedure information 

that we deem necessary to 

determine the adequacy of 

the process if we ask you to 

do so (e.g., as a follow-up 

to your submission of a 

scheduled process on Form 

FDA 2541e).

N/A
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 16 (Acidified Foods) - Page 31 

Description of Specific 

Acidified Food

Requirement

Applicable 

Regulation(s)

Comments Resources

Notify FDA about problems 

when food is in commerce

21 CFR 108.25(d) 

(problems include 

spoilage, process 

deviation, or 

contamination with 

microorganisms, the 

nature of which has 

potential healthendangering significance)

Notifying FDA about 

problems when an acidified 

food is in commerce is in 

addition to your 

responsibility to report 

problems to the Reportable 

Food Registry (when there 

is a reasonable probability 

that the use of, or exposure 

to, an article of food will 

cause serious adverse 

health consequences or 

death to humans or 

animals) 

• FDA, 2009

• FDA, 2010

Recall procedure that incudes 

plans for notifying FDA of any 

recalls

21 CFR 108.25(e) See the discussion in 

section 16.10.4. Although a 

plan for notifying FDA of 

any recalls is not required 

by the PCHF rule, including 

a plan for notifying FDA of 

any recalls in the written 

recall plan that you 

establish in accordance with 

21 CFR 117.139 could also 

satisfy the requirements of 

21 CFR 108.25(e) for a 

recall procedure.

FDA, 2003

Satisfactory completion of the 

prescribed course of 

instruction in a school 

approved by the 

Commissioner for giving 

instruction in food-handling 

techniques, food-protection 

principles, personal hygiene 

and plant sanitation practices, 

pH controls and critical factors 

in acidification

• 21 CFR 108.25(f)

• 21 CFR 114.10

See the discussions in 

sections 16.6 and 16.7. 

Satisfactorily completing the 

prescribed course of 

instruction in a school 

specified in 21 CFR 

108.25(f) and 114.10 may 

not provide an individual 

with all qualifications 

applicable to supervisory 

personnel as required by 21 

CFR 117.4 or all 

qualifications applicable to a 

PCQI as required by 21 

CFR 117.180(c)(1).

N/A
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 16 (Acidified Foods) - Page 32 

Description of Specific 

Acidified Food

Requirement

Applicable 

Regulation(s)

Comments Resources

The scheduled process for an 

acidified food must control 

microorganisms of non-health 

significance in addition to 

pathogens.

21 CFR 114.80(a) See the discussion in 

sections 16.9 and 16.10.1, 

and 16.11. Microorganisms 

of non-health significance, 

by themselves, are not 

“hazards” as that term is 

defined in part 117. 

However, when critical 

factors are not carefully 

controlled, the vegetative 

cells of some 

microorganisms of nonhealth significance (such as 

some spoilage bacteria) can 

grow in an acid environment 

and, in so doing, cause the 

pH of the food to increase. 

Therefore:

• A knowledgeable person 

could identify 

microorganisms of nonhealth significance in 

shelf-stable acidified 

foods as biological 

hazards requiring a 

preventive control. 

• The preventive control 

could be the scheduled 

process that you submit 

to us on Form FDA 

2541e. 

• The preventive control 

management components 

could be monitoring pH 

and validation that 

establishes the adequacy 

of the process. 

N/A

Records of distribution 21 CFR 114.100(d) Compliance with 21 CFR 

114.100(d) could satisfy 

some requirements of 21 

CFR 1.345 in part 1, 

subpart J (Establishment, 

Maintenance, and 

Availability of Records) for 

the identity of the 

immediate, subsequent 

recipients of food

FDA, 2012
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 16 (Acidified Foods) - Page 33 

Description of Specific 

Acidified Food

Requirement

Applicable 

Regulation(s)

Comments Resources

Record retention for 3 years • 21 CFR 108.25(g)

• 21 CFR 114.100(e)

See the discussion in 

section 16.12. The 

regulations in 21 CFR 

108.25 and part 114 each 

have a recordkeeping 

requirement that exceeds 

the corresponding 

recordkeeping requirement 

in part 117. 

N/A

Coding 21 CFR 114.80(b) See the discussion in 

section 16.13. Part 114 

requires that each container 

or product be marked with 

an identifying code 

permanently visible to the 

naked eye; there is no 

corresponding requirement 

for coding in the PCHF rule.

N/A
Contains Non-binding Recommendations

Draft-Not for Implementation

Chapter 17 (Classification of Food) - Page 1

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-assistance-network-tan.

Chapter 17: Classification of Food as Ready to Eat or Not 

Ready to Eat (Coming Soon)

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. 
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 1 (Known or Reasonably Foreseeable Hazards (“Potential Hazards”)) - Page 1 

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
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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

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
Contains Non-binding Recommendations

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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.
Contains Non-binding Recommendations

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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. 
Contains Non-binding Recommendations

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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
Contains Non-binding Recommendations

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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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Appendix 2 (Food Safety Plan Forms) - Page 1 

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's (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-assistance-network-tan.

Appendix 2: Food Safety Plan Forms

Table of Contents

Introduction

Form 2-A: FSPCA Form for Product Description

Form 2-B: FSPCA Form for Hazard Analysis

Form 2-C: FSPCA Form for Process Controls

Form 2-D: FSPCA Form for Sanitation Controls

FSPCA Food Allergen Control Forms

Form 2-E: FSPCA Form for Food Allergen Ingredient Analysis

Form 2-F: FSPCA Form for Food Allergen Label Verification List

Form 2-G: FSPCA Form for Production Line Food Allergen Assessment

Form 2-H: FSPCA Form for Food Allergen Controls

Form 2-I: FSPCA Form for Supply-chain-applied Preventive Controls 

Program

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. Underlined text in yellow highlights 

represents a correction from the draft Appendix 2 that we issued for public comment in August 2016. 
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Introduction

We recommend that you use worksheets to document the: 

• Product description; 

• Hazard analysis; 

• Process controls; 

• Sanitation controls; and

• Food allergen controls.

There is no standardized or mandated format for documenting the food safety plan. However, 

in this appendix we refer you to worksheets that were developed by Food Safety Preventive 

Controls Alliance (FSPCA). We recommend that you use forms such as these for documenting 

your food safety plan for two reasons: (1) These worksheets are used in training by the FSPCA

and, thus, you will be familiar with these forms if you take this training; and (2) these worksheets 

are similar to forms used in documenting Hazard Analysis and Critical Control Point (HACCP) 

plans and prerequisite programs and, thus, these worksheets may be similar to forms you are 

already using. 

The FSPCA makes these forms available on its website 

at https://www.ifsh.iit.edu/sites/ifsh/files/departments/fspca/pdfs/FSPCA_Ap2_Worksheets__V1.

1_Fillable.pdf. In this Appendix, we have modified the format of FSPCA’s forms for consistency 

with the formats we use for making documents accessible for persons using assistive 

technology such as a screen reader. You may obtain the current copy of FSPCA’s forms from 

its website.

In general, regardless of whether you use these worksheets, we recommend that you arrange 

the information in your food safety plan in a progressive manner that clearly explains the 

thought process for the hazard analysis and the individual steps in the Food Safety Plan. For 

example:

• Your hazard analysis should contain information to justify:

o Your identification of each hazard requiring a preventive control; and 

o The types of preventive controls applied;

• You should explain the details for each preventive control.

Other formats are entirely acceptable if they work for your organization. If you use another 

format, you should ensure that your format provides all of the information that the preventive 

controls rule requires for each required component of the food safety plan. See 21 CFR 

117.126, 117.305, and 117.310. 

Each FSPCA form has a form name, but does not have an identifying number. In this Appendix, 

we number each FSPCA form (Form 2-A, Form 2-B, etc.) to have a concise identifier for each 

form. 
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Form 2-A: FSPCA Form for Product Description 

In Chapter 2 of this guidance, we recommend that you conduct certain preliminary steps before 

conducting your hazard analysis. One of these preliminary steps is to describe the product, its 

distribution, intended use, and consumer or end user of the product. The product description 

form that is commonly used in the development of HACCP plans can be used to do so. See 

Form 2-A. 

Below, we list the information that you will see on Form 2-A. When appropriate for clarity, we 

explain what type of information you would include for the listed information. Regardless of 

whether you use Form 2-A, we recommend that you include such information in any product 

description that you develop. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Product Name: i.e., the full name of the finished product. 

• Product Description, including Important food safety characteristics – i.e., descriptors such as readyto-eat (RTE), frozen; factors that can influence growth of pathogens, such as whether the food has a 

low pH or aw or contains preservatives. 

• Ingredients. 

• Packaging Used: e.g., type (bottle, box, can); material (plastic, glass, cardboard with liner); reduced 

oxygen packaging.

• Intended Use: e.g., intended for retail, foodservice, or further processing; whether the food is readyto-eat or ready-to-cook by the consumers; and what the potential is for mishandling or unintended 

use. 

• Intended Consumers: usually the general public; however, if a food product is intended specifically for 

susceptible populations such as hospitals, you should say so.

• Shelf Life. 

• Labeling Instructions Related to Safety: e.g., “keep refrigerated” or cooking instructions.

• Storage and Distribution: e.g., whether the food is stored and/or distributed refrigerated, frozen or at 

ambient temperatures. 
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FORM 2-A PRODUCT DESCRIPTION

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Product Name(s)

Product Description, 

including Important Food 

Safety Characteristics

Ingredients

Packaging Used

Intended Use

Intended Consumers

Shelf Life

Labeling Instructions 

related to Safety

Storage and Distribution

Approved: (signature or initials)____________________________________________

Date: ___________________________________________________________________
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Form 2-B: FSPCA Form for Hazard Analysis

In Chapter 2 of this guidance, we explain how to set up an adaptation of the “Hazard Analysis 

Worksheet” used in HACCP systems to organize your hazard analysis. See Form 2-B. Note that 

for brevity Form 2-B uses the term “potential hazard” rather than “known or reasonably 

foreseeable hazard.” 

See section 2.2.2 in Chapter 2 for an overview of how to set up columns 1-6 of Form 2-B. See 

the remainder of Chapter 2 for more detail about how to provide information on Form 2-B. 

Regardless of whether you use Form 2-B, we recommend that you include such information in 

your hazard analysis.
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FORM 2-B HAZARD ANALYSIS*

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

(1)

Ingredient / 

Processing 

Step

(2)

Identify potential

food safety 

hazards 

introduced, 

controlled or 

enhanced at this 

step

B = biological 

C = chemical, 

including 

radiological 

P = physical

(3)

Are 

any potent

ial

food 

safety

hazards 

requiring 

preventive 

control?

(Yes/No)

(4)

Justify your 

decision for 

column 3

(5) 

What preventive 

control measure(s) 

can be applied to 

significantly minimize 

or prevent the food 

safety hazard?

Process including CCPs, 

Allergen, Sanitation, 

Supplier, other preventive 

control

(6)

Is the 

preventive 

control applied 

at this step?

(Yes/No)

* The current FSPCA form includes some additional features, such as a separate column for “Yes” and 

“No” responses and a separate row at each step for biological, chemical, and physical hazards (labeled 

B, C, and P, respectively).
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Form 2-C: FSPCA Form for Process Controls

Chapter 5 of this guidance provides an overview of the application of preventive controls to 

significantly minimize or prevent the occurrence of biological, chemical, and physical hazards in 

finished foods and the food production environment. Chapter 5 also provides an overview of 

preventive control management components (i.e., monitoring, corrective actions and 

corrections, and verification activities (and their associated records)). When the preventive 

control that you identify is a process control, Form 2-C provides a format for you to specify the 

process control and the associated preventive control management components. 

Below, we list the information that you will see on Form 2-C. When appropriate for clarity, we 

explain what type of information you would include for the listed information. Regardless of 

whether you use Form 2-C, we recommend that you include such information in your food 

safety plan when you will implement a process control.

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Process Control: From the Hazard Analysis form, enter the steps identified as requiring a process 

control 

• Hazard(s): From the Hazard Analysis form, enter the hazard requiring a preventive control at each 

step listed in the “Process Control” column. 

• Parameters, values, or critical limits: Enter the parameters, and the associated minimum or 

maximum value (or critical limits) associated with the parameters. 

• Monitoring: In the columns provided, enter what will be monitored, how it will be monitored, the 

frequency that the monitoring will be done and who will do the monitoring (e.g., the position, such as 

“operator” or “QA technician”). 

• Corrective Actions: Describe the corrective actions that will be taken when deviations from the 

minimum/maximum values (or critical limits) for a parameter occur. 

• Verification: List the ongoing verification activities, including calibration (where appropriate) and 

records review. Although the form was designed to focus on ongoing verification activities, rather 

than data and information addressing validation, you also can list information such as a validation 

study on FSPCA Form 2-C if you find it useful to do so. 

• Records: List the names of the records that result from implementation of the process controls (e.g., 

cook log, cooling records, metal detector check log). 
8

FORM 2-C PROCESS CONTROLS

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Process 

Control 

Step

Hazard(s) Critical Limits What to Monitor How to Monitor

Frequency

of 

Monitoring

Who

Monitors

Corrective 

Action Verification Records
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 2 (Food Safety Plan Forms) - Page 9

Process 

Control 

Step

Hazard(s) Critical Limits What to Monitor How to Monitor

Frequency

of 

Monitoring

Who

Monitors

Corrective 

Action Verification Records
10

Form 2-D: FSPCA Form for Sanitation Controls

The forthcoming Chapter 10 of this guidance will address sanitation controls, which can vary 

substantially from facility to facility. When the preventive control that you identify is a sanitation 

control, Form 2-D provides a format for you to specify the sanitation control and the associated 

preventive control management components. Although Form 2-D may not always be the most 

effective way to describe the many sanitation controls that may be employed, you may find 

Form 2-D helpful to summarize cleaning and sanitizing of a particular piece of equipment or 

particular locations in your plant where product is exposed to the environment. 

Below, we list the information that you will see on Form 2-D. When appropriate for clarity, we 

explain what type of information you would include for the listed information. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Location: Enter the location(s) in the plant where the sanitation control described on Form 2-D will be 

used. 

• Purpose: e.g., to remove food allergens, to reduce contamination with environmental pathogens 

• Frequency: How often the procedure is used (e.g., daily; after each production run; weekly;)

• Who: i.e., the position, such as “sanitation technician” or “sanitation supervisor”

• Procedure: You can write the procedure on the form or refer to a specific Standard Operating 

Procedure (SOP). Procedures can include cleaning procedures and monitoring procedures, such as 

measuring sanitizer concentration. 

• Corrections (Corrective Actions Where Appropriate) - e.g., recleaning equipment that is not visibly 

clean prior to production. In most cases, corrections are appropriate. However, you may want to 

include circumstances that would trigger corrective actions. 

• Records: the type of records you will maintain.

• Verification activities (such as records review) and the type of records maintained are listed. 
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 2 (Food Safety Plan Forms) - Page 11

FORM 2-D SANITATION CONTROLS

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Location

Purpose

Frequency

Who

Procedure

Monitoring

Corrections

(Corrective 

actions where 

necessary)

Records

Verification: (signature or initials)____________________________________________

Date: ____________________________________________________________________
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 2 (Food Safety Plan Forms) - Page 12

FSPCA Food Allergen Control Forms

Chapter 5 of this guidance provides an overview of the application of preventive controls to 

significantly minimize or prevent the occurrence of biological, chemical, and physical hazards in 

finished foods and the food production environment. Chapter 5 also provides an overview of 

preventive control management components (i.e., monitoring, corrective actions and 

corrections, and verification activities (and their associated records)). Our forthcoming Chapter 

11 - Food Allergen Controls will provide a comprehensive guide to food allergen control.

When the preventive control that you identify is an allergen control, the FSPCA forms that we 

identify as Forms 2-E, 2-F, 2-G, and 2-H provide a format for you to specify the allergen control 

and the associated preventive control management components. 

• Form 2-E: FSPCA form for Food Allergen Ingredient Analysis. Use for conducting an allergen-specific 

hazard analysis of food ingredients.

• Form 2-F: FSPCA form for Food Allergen Label Verification List. Use to list the specific allergens to 

be listed in the “Contains” declaration on the product label.

• Form 2-G: FSPCA form for Production Line Food Allergen Assessment. Use to identify common and 

unique food allergens for products produced on a production line for the purpose of making decisions 

on scheduling (e.g., run unique allergens last) and allergen cleaning information (e.g., conduct a full 

allergen cleaning before running products without the allergen)

• Form 2-H: FSPCA form for Food Allergen Controls. Use to describe any food allergen controls and 

associated preventive control management components.

Regardless of whether you use these FSPCA Food Allergen forms, we recommend that you 

conduct a food allergen ingredient analysis and include information such as you see in Form 2-

E in your food safety plan. if your food allergen ingredient analysis identifies food allergens that 

will be (or may be) in your products, we recommend that you include information such as you 

see in the remaining FSPCA forms in your food safety plan.
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 2 (Food Safety Plan Forms) - Page 13

Form 2-E: FSPCA Form for Food Allergen Ingredient Analysis

Below, we list the information that you will see on Form 2-E. When appropriate for clarity, we 

explain what type of information you would include for the listed information. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Raw Material Name: List all raw materials received in the facility

• Supplier: Identify the supplier for each raw material

• Food Allergens in Ingredient Formulation: Identify any food allergens in each listed raw material –

e.g., by reviewing ingredient labels or contacting the manufacturer

• Food Allergens in Precautionary Labeling: List any allergens listed in precautionary labeling (such as 

a “May Contain” statement) in raw materials that you receive 
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 2 (Food Safety Plan Forms) - Page 14

FORM 2-E FOOD ALLERGEN INGREDIENT ANALYSIS

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Food Allergens in Ingredient Formulation or in Precautionary Labeling

Raw Material Name Supplier

Egg

Milk

Soy

Wheat

Tree Nut

(market name)

Peanut

Fish 

(market name)

Shellfish (market 

name)

Food Allergens 

in Precautionary 

Labeling
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 2 (Food Safety Plan Forms) - Page 15

Form 2-F: FSPCA Form for Food Allergen Label Verification List 

Below, we list the information that you will see on Form 2-F. When appropriate for clarity, we 

explain what type of information you would include for the listed information. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Product: List each product that will contain (or may contain) a major food allergen

• Allergen Statement: Specify the “Contains” statement that you will include on the product label for that 

product.

FORM 2-F FOOD ALLERGEN LABEL VERIFICATION LIST

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Product Allergen Statement

Contains:

Contains:

Contains:

Contains:
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 2 (Food Safety Plan Forms) - Page 16

Form 2-G: FSPCA Form for Production Line Food Allergen Assessment 

Below, we list the information that you will see on Form 2-G. When appropriate for clarity, we 

explain what type of information you would include for the listed information. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Product Name: List each product made in the plant

• Production Line: Identify the production line used for each listed product

• List the allergens that you will add to the listed product, including any allergens listed in precautionary 

labeling if you determine there is the potential for these to contaminate the line.

FORM 2-G PRODUCTION LINE FOOD ALLERGEN ASSESSMENT

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Product Name Production Line 

Egg

Milk

Soy

Wheat

Tree Nut

(market name)

Peanut

Fish

(market name)

Shellfish

(market name)
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 2 (Food Safety Plan Forms) - Page 17

Form 2-H: FSPCA Form for Food Allergen Controls

The FSPCA Food Allergen Control Form (Form 2-H) is modeled after the FSPCA Process 

Controls Form (Form 2-C). Below, we list the information that you will see on Form 2-H. When 

appropriate for clarity, we explain what type of information you would include for the listed 

information. 

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Allergen Control Step: Describe the step at which the allergen control is being applied e.g., at label 

receipt or label application for label controls; at post-production sanitation for equipment cleaning. 

• Hazard: e.g., undeclared allergen due to incorrect label; undeclared allergen due to cross-contact. 

• Criterion: Specify the criterion you are trying to meet, e.g., all finished product labels declare the 

allergens in the product. 

• Monitoring; In the columns provided, enter what will be monitored (e.g., the label ingredient 

declaration), how it will be monitored (e.g., the label will be visually checked and compared to the 

product formulation), the frequency that the monitoring will be done (e.g., each new order of labels 

before they are released to production), and who will do the monitoring (e.g., label coordinator). 

• Corrective Actions: In some cases, corrections will be appropriate. However, you should include 

circumstances that would trigger corrective actions. 

• Verification: List the verification activities, such as records review. 

• Records: List the names of the records that result from implementation of the food allergen controls 

(e.g., label review log).
18

FORM 2-H FOOD ALLERGEN CONTROLS

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Allergen

Control 

Step

Hazard(s) Criterion What to Monitor How to Monitor

Frequency

of 

Monitoring

Who

Monitors

Corrective 

Action Verification Records
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 2 (Food Safety Plan Forms) - Page 19

Allergen

Control 

Step

Hazard(s) Criterion What to Monitor How to Monitor

Frequency

of 

Monitoring

Who

Monitors

Corrective 

Action Verification Records
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 2 (Food Safety Plan Forms) - Page 20

Form 2-I: FSPCA Form for Supply-chain-applied Preventive Controls 

Program

Chapter 5 of this guidance provides an overview of the application of preventive controls to 

significantly minimize or prevent the occurrence of biological, chemical, and physical hazards in 

finished foods and the food production environment. Chapter 5 also provides an overview of 

preventive control management components (i.e., monitoring, corrective actions and 

corrections, and verification activities (and their associated records)). Our forthcoming 

Guidance for Industry, Supply-Chain Programs, Draft Guidance, will provide a comprehensive 

guide to supply-chain controls.

When the preventive control that you identify is a supply-chain control, Form 2-I provides a 

format for you to specify the preventive control and the associated preventive control 

management components appropriate for a supply-chain program. You would use a separate 

form for each ingredient that would have a supply-chain program control. Below, we list the 

information that you will see on Form 2-I. When appropriate for clarity, we explain what type of 

information you would include for the listed information. Regardless of whether you use Form 2-

I, we recommend that you include such information in your food safety plan when you will 

implement a supplier control.

• General information such as the name and address of the plant, the issue date of the form and the 

old version (“supersedes”), the page number (often “Page X of Y”). 

• Hazards requiring a supply-chain-applied control: List each hazard requiring a preventive control 

• Preventive controls applied by the supplier: When applicable, list any preventive controls applied by 

the supplier

• Verification activities: List the verification activities you will conduct – i.e., onsite audits; sampling and 

testing of the raw material or other ingredient; review of the supplier’s relevant food safety records; 

and other appropriate supplier verification activities based on supplier performance and the risk 

associated with the raw material or other ingredient.

• Verification procedures: e.g., procedures for receiving raw materials and other ingredients; audit 

procedures

• Records: e.g., records documenting receipt from an approved supplier, records documenting review 

of supplier verification activities
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 2 (Food Safety Plan Forms) - Page 21

Form 2-I: Supply-chain-applied Preventive Controls Program

PAGE _________

PRODUCTS: ______________________________________________________________

PLANT NAME: _____________________________________________________________

ADDRESS: ________________________________________________________________

ISSUE DATE: (mm/dd/yy)_____________________________________________________

SUPERSEDES: (mm/dd/yy)____________________________________________________

Determination of Verification Procedures

Ingredient:

Hazards requiring a 

supply-chain-applied 

control

Preventive controls applied 

by the supplier

Verification activities

Verification procedures

Records

Approved Suppliers for Ingredients Requiring a Supply-chain-applied Control

Ingredient 

(requiring 

supply-chainapplied control)

Approved 

Supplier

Hazard(s) requiring 

supply-chainapplied control

Date of 

Approval

Verification 

method

Verification 

records

Receiving Procedure for Ingredients Requiring a Supply-chain-applied 

Control 

[Document procedures used for receiving ingredients requiring a supply-chain-applied control.] 
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 1 

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-assistance-network-tan. 

Appendix 3: Bacterial Pathogen Growth and Inactivation 

This appendix contains information on the growth and inactivation of bacterial pathogens. The 

tables in this appendix derive from our guidance entitled “Fish and Fishery Products Hazards 

and Controls Guidance.” In these tables, and our discussion of these tables, we use the 

technical terms “D-value” and “z-value,” which we briefly describe immediately below. For 

additional information about what these terms mean and how you can use the information in 

these tables to determine appropriate processing conditions for your product, you should 

consult standard food processing books and technical information.

• D-value: The relationship between the duration of a thermal treatment and the percentage of

microorganisms surviving the treatment is generally logarithmic, and the results of such studies are

usually presented in a plot that represents the log of the percent of surviving vegetative cells or

spores versus time at a given temperature. The time required to destroy 90 percent of the vegetative

cells or spores at a given temperature is called the decimal reduction time, usually referred to as the

“D-value” (Larousse and Brown, 1997). The D-value usually varies inversely with temperature.

• z-value: In general, the slope of a plot of the log of the D-value versus temperature is approximately

linear. A “z-value” is derived from the reciprocal of the slope of the best straight line and is equal to

the increase in the number of degrees (from a given starting temperature) that results in a 90 percent

reduction in the D-value (Larousse and Brown, 1997). The D-value and z-value for the vegetative

cells or spores of a microbial strain at a specified temperature characterize its thermal resistance at

that temperature. Therefore, D-values and z-values provide a means to compare the thermal

resistance of different microorganisms, or different strains of the same microorganism, at one or more

temperatures.

Table 3-A contains information on the minimum water activity (aw), minimum and maximum pH, 

and minimum and maximum temperatures that limit growth for the bacterial pathogens that are 

of greatest concern in food processing. Table 3-A also provides data on the maximum water 

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. Underlined text in yellow highlights 

represents a correction from the draft Appendix 3 that we issued for public comment in August 2016. 
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 2

phase salt that limits growth and the oxygen requirements for the pathogens listed. The data 

shown in Table 3-A are the extreme limits reported among the references cited. These values 

may not apply to your food or processing conditions.

Table 3-B contains information on maximum cumulative exposure time at internal product 

temperature ranges for exposure of foods that, under ordinary circumstances, will be safe for 

the bacterial pathogens that are of greatest concern in food processing. These maximum, 

cumulative exposure times are derived from published scientific information. 

Table 3-C is a Quick Reference Guide based on Table 3-B.

Because the nature of bacterial growth is logarithmic, linear interpolation using the time and 

temperature guidance may not be appropriate. Furthermore, the food matrix affects bacterial 

growth (e.g., presence of competing microorganisms, available nutrients, growth-restrictive 

agents). You should consider such attributes when using the information in Tables 3-A, 3-B, 

and 3-C.

Table 3-D contains information on the destruction of Listeria monocytogenes (L. 

monocytogenes). Lethal rate, as used in Table 3-D, is the relative lethality of 1 minute at the 

designated internal product temperature as compared with the lethality of 1 minute at the 

reference internal product temperature of 158°F (70°C) (using a z = 13.5°F (7.5°C)). For 

example, 1 minute at 145°F (63°C) is 0.117 times as lethal as 1 minute at 158°F (70°C). The 

times provided are the length of time at the designated internal product temperature necessary 

to deliver a “6D” process for L. monocytogenes (i.e., a process that will accomplish a 6 

logarithm (factor of 1,000,000) reduction in the number of L. monocytogenes). 

The length of time at a particular internal product temperature needed to accomplish a 6D 

reduction in the number of L. monocytogenes depends, in part, upon the food that is being 

heated. The values in the table are generally conservative and apply to all foods. You may be 

able to establish a shorter process time for your food by conducting scientific thermal death time 

studies. Additionally, lower degrees of destruction may be acceptable in your food if supported 

by a scientific study of the normal initial levels in the food. It is also possible that higher levels of 

destruction may be necessary in some foods, if you anticipate relatively high initial levels in the 

food you are processing.

Table 3-E contains information on the destruction of Clostridium botulinum (C. botulinum) type 

B (the most heat- resistant form of non-proteolytic C. botulinum). (The non-proteolytic strains of 

C. botulinum can grow at refrigeration temperatures and may be a hazard requiring a preventive 

control in some foods intended to be held refrigerated for extended periods of time.) Lethal rate, 

as used in this table, is the relative lethality of 1 minute at the designated internal product 

temperature as compared with the lethality of 1 minute at the reference product internal 

temperature of 194°F (90°C) (for temperatures less than 194°F (90°C), z = 12.6°F (7.0°C); for 

temperatures above 194°F (90°C), z = 18°F (10°C)). The times provided are the length of time

at the designated internal product temperature necessary to deliver a 6D process for C. 

botulinum. The values in the table are generally conservative. You may be able to establish a 

shorter process time for your food by conducting scientific thermal death time studies. 
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 3

Table 3-A Limiting Conditions for Pathogen Growth

Pathogen

Min. aw

(using 

salt)

Min. 

pH

Max. 

pH

Max. % 

Water 

Phase 

Salt

Min. 

Temp.

Max. 

Temp.

Oxygen 

Requirement

Bacillus 

cereus

0.92 4.3 9.3 10 39.2°F 

4°C

131°F1

55°C

facultative 

anaerobe4

Campylobacter jejuni 0.987 4.9 9.5 1.7 86°F

30°C

113°F

45°C

microaerophile2

Clostridium 

botulinum, 

type A, and 

proteolytic 

types B and 

F

0.935 4.6 9 10 50°F 

10°C

118.4°F 

48°C anaerobe3

Clostridium 

botulinum, 

type E, and 

nonproteolytic 

types B and 

F

0.97 5 9 5 37.9°F 

3.3°C

113°F 

45°C anaerobe3

Clostridium 

perfringens 0.93 5 9 7 50°F 10°C

125.6°F 

52°C anaerobe3

Pathogenic 

strains of 

Escherichia 

coli

0.95 4 10 6.5 43.7°F 

6.5°C

120.9°F 

49.4°C

facultative 

anaerobe4

Listeria 

monocytogenes0.92 4.4 9.4 10 31.3°F 

-0.4°C

113°F 

45°C

facultative 

anaerobe4

Salmonella

spp. 0.94 3.7 9.5 8 41.4°F5.2°C

115.2°F 

46.2°C

facultative 

anaerobe4

Shigella spp. 0.96 4.8 9.3 5.2 43°F 

6.1°C

116.8°F

47.1°C

facultative 

anaerobe4

Staphylococcus 

aureus 

growth

0.83 4 10 20 44.6°F 

7°C

122°F 

50°C

facultative 

anaerobe4
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 4

Pathogen

Min. aw

(using 

salt)

Min. 

pH

Max. 

pH

Max. % 

Water 

Phase 

Salt

Min. 

Temp.

Max. 

Temp.

Oxygen 

Requirement

Staphylococcus 

aureus toxin 

formation

0.85 4 9.8 10 50°F 

10°C

118°F 

48°C

facultative 

anaerobe4

Vibrio 

cholerae 0.97 5 10 6 50°F 10°C

109.4°F

43°C

facultative 

anaerobe4

Vibrio 

parahaemolyticus0.94 4.8 11 10 41°F 

5°C

113.5°F 

45.3°C

facultative 

anaerobe4

Vibrio 

vulnificus 0.96 5 10 5 46.4°F 8°C

109.4°F 

43°C

facultative 

anaerobe4

Yersinia 

enterocolitica0.945 4.2 10 7 29.7°F 

-1.3°C

107.6°F 

42°C

facultative 

anaerobe4

1

Has significantly delayed growth (>24 hours) at 131°F (55°C).

2

Requires limited levels of oxygen.

3

Requires the absence of oxygen.

4

Grows either with or without oxygen.
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 5

Table 3-B. Time and Temperature Guidance for Controlling Pathogen Growth and Toxin 

Formation in Food Products

Potentially Hazardous Condition Product Temperature Maximum Cumulative 

Exposure Time

Growth and toxin formation by 

Bacillus cereus

39.2-43°F (4-6°C)

44-59°F (7-15°C)

60-70°F (16-21°C)

Above 70°F (21°C)

5 days

1 day

6 hours

3 hours

Growth of Campylobacter jejuni 86-93°F (30-34°C)

Above 93°F (34°C)

48 hours

12 hours

Germination, growth, and toxin 

formation by Clostridium 

botulinum type A, and proteolytic 

types B and F

50-70°F (10-21°C)

Above 70°F (21°C)

11 hours

2 hours

Germination, growth, and toxin 

formation by Clostridium 

botulinum type E, and nonproteolytic types B and F

37.9-41°F (3.3-5°C) 

42-50°F (6-10°C)

51-70°F (11-21°C)

Above 70°F (21°C)

7 days 

2 days

11 hours

6 hours

Growth of Clostridium 

perfringens

50-54°F (10-12°C) 

55-57°F (13-14 °C)

58-70°F (15-21°C)

Above 70°F (21°C)

21 days

1 day

6 hours1

2 hours

Growth of pathogenic strains of 

Escherichia coli

43.7-50°F (6.6-10°C)

51-70°F (11-21°C)

Above 70°F (21°C)

2 days 

5 hours

2 hours

Growth of Listeria 

monocytogenes

31.3-41°F (-0.4-5°C)

42-50°F (6-10°C)

51-70°F (11-21°C)

71-86°F (22-30°C)

Above 86°F (30°C)

7 days

1 day

7 hours

3 hours

1 hour

Growth of Salmonella species 41.4-50°F (5.2-10°C)

51-70°F (11-21°C)

Above 70°F (21°C)

2 days

5 hours

2 hours 

Growth of Shigella species 43-50°F (6.1-10°C)

51-70°F (11-21°C)

Above 70°F (21°C)

2 days

5 hours

2 hours

Growth and toxin formation by 

Staphylococcus aureus

50°F (7-10°C)

51-70°F (11-21°C)

Above 70°F (21°C)

14 days

12 hours1

3 hours
Contains Non-binding Recommendations

Draft-Not for Implementation

Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 6

Potentially Hazardous Condition Product Temperature Maximum Cumulative 

Exposure Time

Growth of Vibrio cholerae 50°F (10°C) 

51-70°F (11-21°C)

71-80°F (22-27°C) 

Above 80oF (27oC)

21 days

6 hours

2 hours

1 hour2

Growth of Vibrio 

parahaemolyticus

41-50°F (5-10°C)

51-70°F (11-21°C)

71-80°F (22-27°C) 

Above 80oF (27oC)

21 days 

6 hours

2 hours

1 hour2

Growth of Vibrio vulnificus 46.4-50°F (8-10°C) 

51-70°F (11-21°C)

71-80°F (22-27°C) 

Above 80oF (27oC)

21 days

6 hours

2 hours

1 hour2

Growth of Yersinia enterocolitica 29.7-50°F (-1.3-10°C)

51-70°F (11-21°C)

Above 70°F (21°C)

1 day

6 hours

2.5 hours

1 Additional data needed.

2

Applies to cooked, ready-to-eat foods only.

Table 3-C is a Quick Reference Guide derived from Table 3-B:

Table 3-C Quick Reference Guide for Time and Temperature Guidance for Controlling 

Pathogen Growth and Toxin Formation in Food Products (for Internal Temperatures 

above 50°F (10°C) but below 135oF (57.2oC))

If the food is a ... And the food is 

held at an internal 

temperature ...

Then you should 

limit the 

exposure time to 

...

Or, if 

Staphylococcus 

aureus (S. aureus) 

is the only 

pathogen of 

concern, then you 

should limit the 

exposure time to ...

As long as ...

Raw, RTE 

ingredient or food 

product 

Above 70°F 

(21.1°C)

2 hours 3 hours N/A

Raw, RTE 

ingredient or food 

product 

Above 70°F 

(21.1°C)

4 hours N/A No more than 2 

of those hours 

are between 70°F 

(21.1°C) and 

135oF (57.2oC)

Raw, RTE 

ingredient or food 

product

At any time above 

50°F (10°C) but 

never above 70°F 

(21.1°C)

5 hours 12 hours N/A
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Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 7

If the food is a ... And the food is 

held at an internal 

temperature ...

Then you should 

limit the 

exposure time to 

...

Or, if 

Staphylococcus 

aureus (S. aureus) 

is the only 

pathogen of 

concern, then you 

should limit the 

exposure time to ...

As long as ...

Raw, RTE 

ingredient or food 

product

At internal 

temperatures (or at 

ambient air 

temperatures)

below 50°F (10°C) 

throughout 

processing

N/A N/A N/A

Cooked, RTE 

ingredient or food 

product

At any time above 

80°F (26.7°C)

1 hour 3 hours N/A

Cooked, RTE 

ingredient or food 

product

At any time above 

80°F (26.7°C)

4 hours N/A No more than 1 

of those hours is 

above 70°F 

(21.1°C)

Cooked, RTE 

ingredient or food 

product

At any time above 

70°F (21.1°C) but 

never above 80°F 

(26.7°C)

2 hours 3 hours N/A

Cooked, RTE 

ingredient or food 

product

Never held above 

80°F (26.7°C)

4 hours N/A No more than 2 

of those hours 

are above 70°F 

(21.1°C)

Cooked, RTE 

ingredient or food 

product

At any time above 

50°F (10°C) but 

never above 70°F 

(21.1°C)

5 hours 12 hours N/A

Cooked, RTE 

ingredient or food 

product

At internal 

temperatures (or 

ambient air 

temperatures) 

below 50°F (10°C) 

throughout 

processing

N/A N/A N/A

Note that the preceding recommended critical limits do not address internal product 

temperatures between 40°F (4.4°C), which is the recommended maximum storage temperature 

for refrigerated food products, and 50°F (10°C). That is because growth of foodborne 

pathogenic bacteria is very slow at these temperatures and the time necessary for significant 

growth is longer than would be reasonably likely to occur in most food processing steps. 

However, if you have processing steps that occur at these temperatures that approach the 

maximum cumulative exposure times listed in Table 3-B for the pathogenic bacteria of concern 

in your product, you should consider development of a critical limit for control at these 

temperatures. 
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Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 8

It is not possible to furnish recommendations for each pathogenic bacterium, process, type of 

food product, and temperature or combination of temperatures. Programmable models to 

predict growth rates for certain pathogens associated with various foods under differing 

conditions have been developed by the U.S. Department of Agriculture’ (the Pathogen Modeling 

Program (PMP)) and by an international consortium of the Institute of Food Research (UK), the 

USDA Agricultural Research Service (USDA-ARS) and the University of Tasmania Food Safety 

Centre (CombBase database and Predictor). These programs can provide growth curves for 

selected pathogens. To use these models, you indicate the conditions, such as pH, 

temperature, and salt concentration that you are interested in and the models provide pathogen 

growth predictions (e.g., growth curve, time of doubling, time of lag phase, and generation time). 

FDA does not endorse or require the use of such modeling programs, but recognizes that the 

predictive growth information they provide may be helpful to some processors. However, you 

should be aware that significant deviations between actual microbiological data in specific 

products and the predictions may occur, including those for the lag phase of growth. Therefore, 

you should validate the time and temperature limits derived from such predictive models if 

growth of pathogens during processing requires a preventive control. 
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Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 9

Table 3-D Inactivation of Listeria monocytogenes

Internal Product 

Temperature (°F)

Internal Product 

Temperature (°C)

Lethal 

Rate

Time for 6D Process 

(minutes)

145 63 0.117 17.0

147 64 0.158 12.7

149 65 0.215 9.3

151 66 0.293 6.8

153 67 0.398 5.0

154 68 0.541 3.7

156 69 0.736 2.7

158 70 1.000 2.0

160 71 1.359 1.5

162 72 1.848 1.0

163 73 2.512 0.8

165 74 3.415 0.6

167 75 4.642 0.4

169 76 6.310 0.3

171 77 8.577 0.2

172 78 11.659 0.2

174 79 15.849 0.1

176 80 21.544 0.09

178 81 29.286 0.07

180 82 39.810 0.05

182 83 54.116 0.03

183 84 73.564 0.03

185 85 100.000 0.02

Note: z = 13.5°F (7.5°C). 
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Table 3-E Inactivation of Non-Proteolytic Clostridium botulinum Type B

Internal Product 

Temperature (°F)

Internal Product 

Temperature (°C)

Lethal 

Rate*

Time for 6D Process 

(minutes)

185 85 0.193 51.8

187 86 0.270 37.0

189 87 0.370 27.0

190 88 0.520 19.2

192 89 0.720 13.9

194 90 1.000 10.0

196 91 1.260 7.9

198 92 1.600 6.3

199 93 2.000 5.0

201 94 2.510 4.0

203 95 3.160 3.2

205 96 3.980 2.5

207 97 5.010 2.0

208 98 6.310 1.6

210 99 7.940 1.3

212 100 10.000 1.0

Note: For temperatures less than 194°F (90°C), z = 12.6°F (7.0°C); for temperatures above 

194°F (90°C), z = 18°F (10°C).
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Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 11

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