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Draft Guidance
This guidance is being distributed for comment purposes only.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that FDA considers your comment on this draft guidance before we begin work on the final 
version of the guidance, submit either electronic or written comments on the draft guidance 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the draft guidance.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 FDA2016D2343 listed in the notice of availability that publishes in the 
Federal Register.  
For questions regarding this draft document contact FDAs Technical Assistance Network by 
submitting your question 
at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistance-
network-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 Contains Non-binding Recommendations 
Draft-Not for Implementation 
Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs Technical Assistance Network by submitting your question at 
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistance-
network-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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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 entitys 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 food-
contact 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 facilitys 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 establishments 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 re-
packing 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 individuals 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 (a ). An a  will be considered safe for a food if adequate data are available that 
w w
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 (a ): A measure of the free moisture in a food and is the quotient of the water 
w
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 facilitys supply chain 
program, is controlling a hazard identified by the receiving facility as requiring a supply-chain-
applied 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 FDAs recall policy in 21 CFR part 7, subpart C to mean the 
first consignee in a recalling firms distribution chain. 
Direct consignee: The term used in 21 CFR 117.139 to mean the first consignee in a recalling 
firms 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 facilitys 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 FDAs 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 FDAs 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 
a   Water activity 
w
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Abbreviation  What It Means 
BHA  Butylated hydroxyanisole 
BHT  Butylated hydroxytoluene 
CBA  Consumer Brands Association (formerly Grocery Manufacturers 
Association) 
CBA Low- CBA Control of Salmonella in Low-Moisture Foods Guidance 
Moisture Foods  Document 
Guidelines 
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 
FDAs Listeria  Control of Listeria monocytogenes in Ready-To-Eat Foods: 
guidance*  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 for Industry: Juice HACCP Hazards and Controls 
guidance  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  FDAs Regulatory Procedures Manual 
RTD  Resistance temperature detector 
RTE food  Ready-to-eat food 
SAHCODH  Serious adverse health consequences or death to humans 
SAHCODH  Serious adverse health consequences or death to humans hazard 
hazard 
Seafood HACCP  Fish and Fishery Products Hazards and Controls Guidance 
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 FDAs 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:
be a qualified individual as that term is defined in  117.3 - i.e., have the education,
o
training, or experience (or a combination thereof) necessary to manufacture, process, pack, or
hold clean and safe food as appropriate to the individuals assigned duties (see 21 CFR
117.4(b)(1)); and
receive training in the principles of food hygiene and food safety, including the
o
importance of employee health and personal hygiene, as appropriate to the food, the facility
and the individuals 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 risk-
based 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 
individuals 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 cross-
contact; 
  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 FDAs CPGs, FDAs 
Guidance for Industry, FDAs 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,  https://www.fda.gov/regulatory-information/search-fda-
Skim Milk - Aflatoxin M1. November 2005.  guidance-documents/cpg-sec-527400-whole-milk-lowfat-
milk-skim-milk-aflatoxin-m1 
Aflatoxins  CPG Sec. 555.400 Aflatoxins in Human Food:  https://www.fda.gov/media/149666/download 
Guidance for FDA Staff. June 2021. 
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Topic  CPG  Link 
Aflatoxins  Brazil  CPG Sec. 570.200 Aflatoxins in Brazil Nuts:  https://www.fda.gov/media/72053/download 
nuts  Guidance for FDA Staff. June 2021 
Aflatoxins   CPG Sec. 570.500 Aflatoxins in Pistachio Nuts:  https://www.fda.gov/media/72084/download 
Pistachio nuts  Guidance for FDA Staff. June 2021. 
Aflatoxins - Peanuts  CPG Sec. 570.375 Aflatoxins in Peanuts and  https://www.fda.gov/media/72073/download 
Peanut Products: Guidance for FDA Staff. June 
2021. 
Aflatoxins  Animal  CPG Sec. 683.100 Action Levels for Aflatoxins  https://www.fda.gov/media/121202/download 
food  in Animal Food: Guidance for FDA Staff. 
March 2019. 
Food allergens  CPG Sec. 555.250 Statement of Policy for  https://www.fda.gov/regulatory-information/search-fda-
Labeling and Preventing Cross-contact of  guidance-documents/cpg-sec-555250-statement-policy-
Common Food Allergens. 2005.  labeling-and-preventing-cross-contact-common-food-
allergens-new 
Food allergens  CPG Sec 555.250 DRAFT: Major Food  https://www.fda.gov/regulatory-information/search-fda-
Allergen Labeling and Cross-contact. 2023.**  guidance-documents/cpg-sec-555250-draft-major-food-
allergen-labeling-and-cross-contact 
Hard or sharp foreign  CPG Sec. 555.425 Foods, Adulteration  https://www.fda.gov/media/71953/download 
objects  Involving Hard or Sharp Foreign Objects. May 
2005. 
Hypoglycin A Toxin  CPG Sec. 550.050 Canned Ackee, Frozen  https://www.fda.gov/media/88521/download 
Ackee, and Other Ackee Products - Hypoglycin 
A Toxin. April 2014. 
3-MCPD CPG Sec. 500.500 Guidance Levels for 3- https://www.fda.gov/media/71760/download 
MCPD (3-chloro-1,2-propanediol) in Acid-
Hydrolyzed Protein and Asian-Style Sauces. 
March 2008. 
Mercury - Grain  CPG Sec. 578.400 Treated Grain Seed -  https://www.fda.gov/media/72102/download 
Mercury Residue. October 1980. 
Microbiological  CPG Sec. 527.300 Dairy Products - Microbial  https://www.fda.gov/regulatory-information/search-fda-
hazards  Dairy  Contaminants and Alkaline Phosphatase  guidance-documents/cpg-sec-527300-microbial-
products  Activity. December 2010.  contaminants-alkaline-phosphatase-activity 
Patulin  Apple juice  CPG Sec 510.150 Apple Juice, Apple Juice  https://www.fda.gov/regulatory-information/search-fda-
Concentrates, and Apple Juice Products -  guidance-documents/cpg-sec-510150-apple-juice-apple-
Adulteration with Patulin. November 2005.  juice-concentrates-and-apple-juice-products-adulteration-
patulin 
PCBs  CPG Sec. 565.200 Red meat adulterated with  https://www.FDA.gov/ICECI/ComplianceManuals/ 
PCBs. November 1987.  CompliancePolicyGuidanceManual/ucm074589.htm 
Pesticides  CPG Sec. 575.100 Pesticide Residues in Food  https://www.fda.gov/media/75151/download 
and Feed - Enforcement Criteria. March 1995. 
Pesticides  CPG Sec. 575.100 Pesticide Chemical Residues  https://www.fda.gov/media/77986/download 
in Food - Enforcement Criteria (CPG 7141.01) 
(Draft Guidance)*** January 2008. 
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Topic  CPG  Link 
Pits - Dates  CPG Sec. 550.300 Dates and Date Material;  https://www.fda.gov/media/71813/download 
Imported and Domestic - Adulteration Involving 
Mold, Insect Excreta, Sour, Dirty, Worthless and 
Pits. 2005. 
Pits - Olives  CPG Sec. 550.600 Olives - Adulteration  https://www.fda.gov/media/71862/download 
Involving Pits; Rot; Insect Infestation. 2005. 
Pits and pit fragments  CPG Sec. 550.700 Dried Prunes, Dehydrated  https://www.fda.gov/media/71909/download 
-Prunes Low Moisture Prunes, and Pitted Prunes - 
Adulteration Involving Insects; Decomposition; 
Dirt; Pits; and Pit Fragments. 2005. 
Radionuclides  CPG Sec. 555.880 Guidance Levels for  https://www.fda.gov/regulatory-information/search-fda-
Radionuclides in Domestic and Imported Foods.  guidance-documents/cpg-sec-555880-guidance-levels-
2005.  radionuclides-domestic-and-imported-foods 
Salmonella spp.  CPG Sec. 555.300 Foods, Except Dairy Products  https://www.fda.gov/regulatory-information/search-fda-
-Adulteration with Salmonella. March 1995. guidance-documents/cpg-sec-555300-foods-except-dairy-
products-adulteration-salmonella 
*In addition to the specific link we provided, you can access FDAs Compliance Policy Guides at
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/manual-
compliance-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 FDAs 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 FDAs 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  https://www.fda.gov/regulatory-
FDA 2541 (Food Canning Establishment  information/search-fda-guidance-
Registration) and Forms FDA 2541d,  documents/guidance-industry-submitting-
FDA 2541e, FDA 2541f, and FDA 2541g  forms-food-canning-establishment-
(Food Process Filing Forms) to FDA in  registration-and-food-process-filing 
Electronic or Paper Format. November 
2016. 
Acrylamide  Guidance for Industry. Acrylamide in  https://www.fda.gov/media/87150/download 
Foods. March 2016. 
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Topic  Guidance  Link 
Antimicrobial substances  Guidance for Industry: Antimicrobial  https://www.fda.gov/regulatory-
food additives. 1999.  information/search-fda-guidance-
documents/guidance-industry-antimicrobial-
food-additives  
Arsenic  Cereals for infants  Guidance for Industry: Action level for  https://www.fda.gov/media/97234/download 
inorganic arsenic in rice cereals for 
infants. August 2020.   
Arsenic  Apple juice  Guidance for Industry: Action Level for  https://www.fda.gov/media/86110/download  
Inorganic Arsenic in Apple Juice. 2023. 
Bottled water (Allowable  Small Entity Compliance Guide: Bottled  https://www.fda.gov/regulatory-
levels for inorganic substances  Water and Arsenic. April 2009.  information/search-fda-guidance-
in accordance with 21 CFR  documents/small-entity-compliance-guide-
165.110(b)(4)(iii)(A)***  bottled-water-and-arsenic  
Chemical hazards  Guidance for Industry: Action Levels for  https://www.fda.gov/FoodGuidances 
Poisonous or Deleterious Substances in 
Human Food and Animal Feed. August 
2000. 
Cochineal extract and carmine  Cochineal extract and carmine:  https://www.fda.gov/regulatory-
Declaration by name on the label of all  information/search-fda-guidance-
foods and cosmetic products that contain  documents/small-entity-compliance-guide-
these color additives; Small Entity  declaration-name-label-all-foods-and-
Compliance Guide. April 2009.  cosmetic-products-contain 
Enforcement policy  Policy Regarding Certain Entities Subject  https://www.fda.gov/regulatory-
to the Current Good Manufacturing  information/search-fda-guidance-
Practice and Preventive Controls,  documents/guidance-industry-policy-
Produce Safety, and/or Foreign Supplier  regarding-certain-entities-subject-current-
Verification Programs: Guidance for  good-manufacturing-practice-and   
Industry. 2018. 
Enforcement policy  Current Good Manufacturing Practice  https://www.fda.gov/regulatory-
and Preventive Controls, Foreign  information/search-fda-guidance-
Supplier Verification Programs,  documents/guidance-industry-current-good-
Intentional Adulteration, and Produce  manufacturing-practice-and-preventive-
Safety Regulations: Enforcement Policy  controls-foreign-supplier  
Regarding Certain Provisions. 2022. 
Food allergens  Guidance for Industry: Questions and  https://www.fda.gov/regulatory-
Answers Regarding Food Allergens,  information/search-fda-guidance-
Including the Food Allergen Labeling  documents/guidance-industry-questions-and-
and Consumer Protection Act of 2004.  answers-regarding-food-allergen-labeling-
Edition 5. 2022.  edition-5  
Food allergens  Questions and Answers Regarding Food  https://www.fda.gov/regulatory-
Allergens, Including the Food Allergen  information/search-fda-guidance-
Labeling Requirements of the Federal  documents/draft-guidance-industry-questions-
Food, Drug, and Cosmetic Act (Edition  and-answers-regarding-food-allergen-labeling-
5): Guidance for Industry (Draft  edition-5  
Guidance). 2022.** 
Food labeling (refrigerated  Guidance on Labeling of Foods That  https://www.fda.gov/regulatory-
foods)  Need Refrigeration by Consumers. 1997.  information/search-fda-guidance-
(Also available at 62 FR 8248, February  documents/guidance-labeling-foods-need-
24, 1997)  refrigeration-consumers  
Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 26 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Guidance  Link 
HACCP systems - Seafood  Fish and Fishery Products Hazards and  https://www.fda.gov/food/seafood-guidance-
Controls Guidance. June 2022.  documents-regulatory-information/fish-and-
fishery-products-hazards-and-controls 
HACCP systems - Juice  Guidance for Industry: Juice HACCP  https://www.fda.gov/regulatory-
Hazards and Controls Guidance.  information/search-fda-guidance-
February 2004.  documents/guidance-industry-juice-hazard-
analysis-critical-control-point-hazards-and-
controls-guidance-first 
Human Food By-Products  Human Food By-Products For Use As  https://www.fda.gov/regulatory-
Animal Food: Draft Guidance for  information/search-fda-guidance-
Industry #239**  documents/cvm-gfi-239-human-food-products-
use-animal-food 
Lead - Candy  Guidance for Industry: Lead in Candy  https://www.fda.gov/food/guidance-
Likely To Be Consumed Frequently by  documents-regulatory-information-
Small Children: Recommended  topic/guidance-industry-lead-candy-likely-be-
Maximum Level and Enforcement  consumed-frequently-small-children 
Policy. November 2006. 
Lead - Juice  Draft** Guidance for Industry: Action  https://www.fda.gov/regulatory-
Levels for Lead in Juice. April 2022.  information/search-fda-guidance-
documents/draft-guidance-industry-action-
levels-lead-juice 
Lead  Food for babies and  Draft** Guidance for Industry: Action  https://www.fda.gov/regulatory-
young children  Levels for Lead in Food Intended for  information/search-fda-guidance-
Babies and Young Children  documents/draft-guidance-industry-action-
levels-lead-food-intended-babies-and-young-
children 
Microbiological hazards   Guidance for Industry: Guide to  https://www.fda.gov/regulatory-
Fresh-cut produce  Minimize Microbial Food Safety Hazards  information/search-fda-guidance-
of Fresh-cut Fruits and Vegetables. 2008.  documents/guidance-industry-guide-minimize-
microbial-food-safety-hazards-fresh-cut-fruits-
and-vegetables 
Microbiological hazards   Draft** Guidance for Industry: Guide to  https://www.fda.gov/regulatory-
Fresh-cut produce  Minimize Food Safety Hazards of Fresh- information/search-fda-guidance-
cut Produce. 2018.  documents/draft-guidance-industry-guide-
minimize-food-safety-hazards-fresh-cut-
produce 
Microbiological hazards -  Guide to Inspections of Low Acid  https://www.fda.gov/low-acid-canned-food-
LACF  Canned Food Manufacturers Part 1 -  manufacturers-part-1-adminstrative-
Adminstrative Procedures/Scheduled  proceduresscheduled-processes 
Processes 
Listeria monocytogenes  Control of Listeria monocytogenes in  https://www.fda.gov/regulatory-
Ready-To-Eat Foods: Guidance for  information/search-fda-guidance-
Industry (Draft Guidance). 2017.**  documents/draft-guidance-industry-control-
listeria-monocytogenes-ready-eat-foods 
Mycotoxins - Fumonisin  Guidance for Industry: Fumonisin Levels  https://www.fda.gov/regulatory-
in Human Foods and Animal Feeds.  information/search-fda-guidance-
November 2001.  documents/guidance-industry-fumonisin-
levels-human-foods-and-animal-feeds 
Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 27  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Guidance  Link 
Mycotoxins - DON  Guidance for Industry and FDA:  https://www.fda.gov/regulatory-
Advisory Levels for Deoxynivalenol  information/search-fda-guidance-
(DON) in Finished Wheat Products for  documents/guidance-industry-and-fda-
Human Consumption and Grains and  advisory-levels-deoxynivalenol-don-finished-
Grain By-Products used for Animal Feed.  wheat-products-human 
July 2010. 
Recalls  Index of Model Press Releases.  https://www.fda.gov/safety/recalls-market-
withdrawals-safety-alerts/industry-guidance-
recalls 
Recalls  Industry Guidance For Recalls.****  https://www.fda.gov/safety/recalls-market-
withdrawals-safety-alerts/industry-guidance-
recalls 
Recalls  Initiation of Voluntary Recalls Under 21  https://www.fda.gov/regulatory-
CFR Part 7, Subpart C. Guidance for  information/search-fda-guidance-
Industry and FDA Staff. 2022.   documents/initiation-voluntary-recalls-under-
21-cfr-part-7-subpart-c
Recalls  Product Recalls, Including Removals and  https://www.fda.gov/regulatory-
Corrections. Guidance for Industry. 2020.  information/search-fda-guidance-
documents/product-recalls-including-
removals-and-corrections 
Recalls  Public Availability of Lists of Retail  https://www.fda.gov/regulatory-
Consignees to Effectuate Certain Human  information/search-fda-guidance-
and Animal Food Recalls Guidance for  documents/public-availability-lists-retail-
Industry and FDA Staff. 2020.  consignees-effectuate-certain-human-and-
animal-food-recalls 
Recalls  Public Warning and Notification of  https://www.fda.gov/regulatory-
Recalls Under 21 CFR Part 7, Subpart C.  information/search-fda-guidance-
Guidance for Industry and FDA Staff.  documents/public-warning-notification-recalls-
2019.  under-21-cfr-part-7-subpart-c 
Recalls  Questions and Answers Regarding  https://www.fda.gov/regulatory-
Mandatory Food Recalls: Guidance for  information/search-fda-guidance-
Industry and FDA Staff. 2018.  documents/guidance-industry-and-fda-staff-
questions-and-answers-regarding-mandatory-
food-recalls 
Recordkeeping required by 21  Guidance for Industry: Questions and  https://www.fda.gov/regulatory-
CFR part 1, subpart J  Answers Regarding Establishment and  information/search-fda-guidance-
Maintenance of Records By Persons Who  documents/guidance-industry-questions-and-
Manufacture, Process, Pack, Transport,  answers-regarding-establishment-and-
Distribute, Receive, Hold, or Import  maintenance-records-persons-who 
Food (Edition 5). February, 2012. 
Registration of food facilities  Guidance for Industry: Questions and  https://www.fda.gov/regulatory-
Answers Regarding Food Facility  information/search-fda-guidance-
Registration (Seventh Edition). August  documents/guidance-industry-questions-and-
2018.  answers-regarding-food-facility-registration-
seventh-edition 
Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 28  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Guidance  Link 
Reportable Food Registry  Guidance for Industry: Questions and  https://www.fda.gov/regulatory-
Answers Regarding the Reportable Food  information/search-fda-guidance-
Registry As Established by the Food and  documents/guidance-industry-questions-and-
Drug Administration Amendments Act of  answers-regarding-reportable-food-registry-
2007. 2009.  established-food-and-drug 
Reportable Food Registry  Draft Guidance for Industry: Questions  https://www.fda.gov/regulatory-
and Answers Regarding the Reportable  information/search-fda-guidance-
Food Registry As Established by the  documents/draft-guidance-industry-questions-
Food and Drug Administration  and-answers-regarding-reportable-food-
Amendments Act of 2007 (Edition 2).  registry-established-food 
2010. 
Salmonella spp. - Peanut- Guidance for Industry: Measures to  https://www.fda.gov/regulatory-
derived product  Address the Risk for Contamination by  information/search-fda-guidance-
Salmonella Species in Food Containing a  documents/guidance-industry-measures-
Peanut-Derived Product as an Ingredient.  address-risk-contamination-salmonella-
March 2009.  species-food-containing-peanut 
Salmonella spp. - Pistachio- Guidance for Industry: Measures to  https://www.fda.gov/regulatory-
derived product  Address the Risk for Contamination by  information/search-fda-guidance-
Salmonella Species in Food Containing a  documents/guidance-industry-measures-
Pistachio-Derived Product as an  address-risk-contamination-salmonella-
Ingredient. September 2011.  species-food-containing-pistachio 
Salmonella spp. - Testing  Guidance for Industry Testing for  https://www.fda.gov/regulatory-
Salmonella Species in Human Foods and  information/search-fda-guidance-
Direct-Human-Contact Animal Foods.  documents/guidance-industry-testing-
March 2012.  salmonella-species-human-foods-and-direct-
human-contact-animal-foods 
Third-party certification  Guidance for Industry and FDA Staff:  https://www.fda.gov/regulatory-
Model Accreditation Standards for Third- information/search-fda-guidance-
Party Certification Body Accreditation  documents/guidance-industry-and-fda-staff-
for Food Safety Audits. 2022.  model-accreditation-standards-third-party-
certification-body 
*In addition to the specific link we provided, or if that link is no longer operative, you can access most of FDAs
Guidance for Industry applicable to human food at https://www.fda.gov/FoodGuidances.
** A draft guidance, when finalized, will represent FDAs 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. 
Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 29  Contains Non-binding Recommendations 
Draft-Not for Implementation 
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  Import Alert 99-42 Detention Without Physical Examination of Foods Due to Heavy Metal Contamination 
elements  https://www.accessdata.fda.gov/cms_ia/importalert_1167.html 
Various  Food Compliance Programs. https://www.fda.gov/food/compliance-enforcement-food/food-
compliance-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
Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 30  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Table 6. Codex Standards, Codes of Practice, and Guidelines Cited as a Resource in This 
Guidance*, ** 
Topic  Title  Link 
Acrylamide  Code of Practice for  https://www.fao.org/fao-who-codexalimentarius/sh-
the Reduction of  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Acrylamide in Foods.  Fcodex%252FStandards%252FCXC%2B67-2009%252FCXP_067e.pdf 
CXC 67-2009. 
Aflatoxin   Code of Practice for  https://www.fao.org/fao-who-codexalimentarius/sh-
Tree Nuts  the Prevention and  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Reduction of  Fcodex%252FStandards%252FCXC%2B59-2005%252FCXP_059e.pdf 
Aflatoxin 
Contamination in 
Tree Nuts. CAC/RCP 
59-2005. 
Aflatoxin -  Code of Practice for  https://www.fao.org/fao-who-codexalimentarius/sh-
Peanuts  the Prevention and  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Reduction of  Fcodex%252FStandards%252FCXC%2B55-2004%252FCXP_055e.pdf 
Aflatoxin 
Contamination in 
Peanuts. CAC/RCP 
55-2004. 
Aflatoxin   Code of Practice for  https://www.fao.org/fao-who-codexalimentarius/sh-
Dried Figs  the Prevention and  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Reduction of  Fcodex%252FStandards%252FCXC%2B65-2008%252FCXP_065e.pdf 
Aflatoxin 
Contamination in 
Dried Figs. CAC/RCP 
65-2008. 
Arsenic - Rice  Code of Practice for  https://www.fao.org/fao-who-codexalimentarius/sh-
the Prevention and  proxy/en/?lnk=1%E2%80%8C&url=https%253A%252F%252Fworkspace.fao.org%2
Reduction of Arsenic  52Fsites%252Fcodex%252FStandards%252FCXC%2B77-2017%252FCXC_077e.pdf 
Contamination in 
Rice. CXC 77-2017. 
Cadmium   Codex Code of 
Cocoa Beans  Practice for the  https://www.fao.org/fao-who-codexalimentarius/sh-
Prevention and  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Reduction of  Fcodex%252FStandards%252FCXC%2B81-2022%252FCXC_081e.pdf  
Cadmium 
Contamination in 
Cocoa. CXC 81-2022 
Contaminants  General Standard for  https://www.fao.org/fao-who-codexalimentarius/sh-
and toxins  Contaminants and  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Toxins in Food and  Fcodex%252FStandards%252FCXS%2B193-1995%252FCXS_193e.pdf  
Feed. CXS 193-1995. 
Food allergens  Codex Code of  https://www.fao.org/fao-who-codexalimentarius/sh-
Practice on Food  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Allergen Management  Fcodex%252FStandards%252FCXC%2B80-2020%252FCXC_080e.pdf  
for Food Business 
Operators. CXC 80-
2020 
Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 31  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Title  Link 
HACCP  General Principles of  https://www.fao.org/fao-who-codexalimentarius/sh-
systems  Food Hygiene. CXC  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
1-1969. Fcodex%252FStandards%252FCXC%2B1-1969%252FCXC_001e.pdf 
Lead  Code of Practice for  https://www.fao.org/3/cc0579en/cc0579en.pdf 
the Prevention and 
Reduction of Lead 
Contamination in 
Foods. CXC 56-2004 
3- Code of Practice for  https://www.fao.org/fao-who-codexalimentarius/sh-
Monochloropr the Reduction of 3- proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
opane-1,2-  Monochloropropane- Fcodex%252FStandards%252FCXC%2B64-2008%252FCXP_064e.pdf 
Diol (3- 1,2- Diol During the 
MCPD)  Production of Acid-
HVPs and Products 
That Contain Acid-
HVPs. CXC 64-2008 
3- Code of Practice for  https://www.fao.org/fao-who-codexalimentarius/sh-
Monochloropr the Reduction of 3- proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
opane-1,2-  Monochloropropane- Fcodex%252FStandards%252FCXC%2B79-2019%252FCXC_079e.pdf 
Diol Esters (3- 1,2- Diol Esters (3-
MCPDEs) and  MCPDEs) and 
Glycidyl  Glycidyl Esters (GEs) 
Esters (GEs)  In Refined Oils and 
Food Products Made 
with Refined Oils. 
CXC 79-2019. 
Mycotoxin  Code of Practice for  https://www.fao.org/fao-who-codexalimentarius/sh-
the Prevention and  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Reduction of  Fcodex%252FStandards%252FCXC%2B51-2003%252FCXC_051e.pdf 
Mycotoxin 
Contamination in 
Cereals. CXC 51-
2003.  
Mycotoxins  Code of Practice for  https://www.fao.org/fao-who-codexalimentarius/sh-
the Prevention and  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Reduction of  Fcodex%252FStandards%252FCXC%2B78-2017%252FCXC_078e.pdf 
Mycotoxins in Spices. 
CXC 78-2017. 
Ochratoxin A -  Code of Practice for  https://www.fao.org/fao-who-codexalimentarius/sh-
Coffee  the Prevention and  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Reduction of  Fcodex%252FStandards%252FCXC%2B69-2009%252FCXP_069e.pdf 
Ochratoxin A 
Contamination in 
Coffee. CAC/RCP 
69-2009. (CXC-69-
2009) 
Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 32  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Title  Link 
Ochratoxin A -  Code of Practice for  https://www.fao.org/fao-who-codexalimentarius/sh-
Cocoa  the Prevention and  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Reduction of  Fcodex%252FStandards%252FCXC%2B72-2013%252FCXP_072e.pdf 
Ochratoxin A 
Contamination in 
Cocoa. CAC/RCP 72-
2013. (CXC 72-2013) 
Pits (stones) -  Standard for Table  https://www.fao.org/fao-who-codexalimentarius/sh-
Olives  Olives. CXS 66-1981.  proxy/pt/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252F
codex%252FStandards%252FCXS%2B66-1981%252FCXS_066e.pdf 
Pits (stones) -  Standard for Dates.  https://www.fao.org/fao-who-codexalimentarius/sh-
Dates  CXS 143-1985.   proxy/pt/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252F
codex%252FStandards%252FCXS%2B143-1985%252FCXS_143e.pdf 
Pits (stones)   Standard for Canned  https://www.fao.org/fao-who-codexalimentarius/sh-
Stone fruits  Stone Fruits. CXS  proxy/pt/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252F
242-2003. 2017. codex%252FStandards%252FCXS%2B242-2003%252FCXS_242e.pdf 
(Applies to stone
fruits of the genus
Prunus)
Salmonella  Codex Code of  https://www.fao.org/fao-who-codexalimentarius/sh-
spp.  Hygienic Practice for  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Low-Moisture Foods.  Fcodex%252FStandards%252FCXC%2B75-2015%252FCXC_075e.pdf  
CXC 75-2015. 
Salmonella  Codex Code of  https://www.fao.org/fao-who-codexalimentarius/sh-
spp. and  Hygienic Practice for  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252
Cronobacter  Powdered Formulae  Fcodex%252FStandards%252FCXC%2B66-2008%252FCXP_066e.pdf 
spp.  for Infants and Young 
Children. CAC/RCP 
66-2008. (CXC 66-
2008) 
Validation  Guidelines for the  https://www.fao.org/fao-who-codexalimentarius/sh-
validation of food  proxy/pt/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252F
safety control  codex%252FStandards%252FCXG%2B69-2008%252FCXG_069e.pdf  
measures. CXG 69-
2008. 
*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-who-
codexalimentarius/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 
Table 7. Resources for Designing Validation Studies 
Organization  Document  How to Access  Applicability 
Alliance for Innovation  Anderson, D and LA Lucore. 2020.  Available from the OpX website by  Thermal processes 
& Operational  Validating the reduction of Salmonella  registering (free): 
Low moisture foods 
Excellence (AIOE)  and other pathogens in heat processed 
https://www.opxleadershipnetwork.org/qu
low-moisture foods 
ality/download/pathogen-reduction-
validation 
American Frozen Foods  Process validation   https://affi.org/safety/validation/   Frozen vegetables 
Institute (AFFI) 
- Considerations for In-Plant 
Blanching Study 
- Considerations for Lab-Scale
Blanching Study 
- How to Validate Your Blancher 
Almond Board of  - Guidelines for Validation of https://www.almonds.com/almond- Tree nuts and other 
California  Blanching Processes, v1.0, April 13, industry/processors-and- low moisture foods (as 
2007. suppliers/processing-safe- appropriate) 
product/pasteurization-program  
- 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 NRRL-
B-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 In-
shell Almonds, v2.0, October 1, 
2008. 
- Guidelines for Process Validation 
Using Enterococcus faecium NRRL-
B-2354 as a Surrogate 
Microorganism in Almond Process
Validation, 2014. 
Chilled Foods  Guidelines for setting shelf life of  https://www.chilledfood.org/product/guide Chilled foods 
Association   chilled foods in relation to non- lines-for-setting-shelf-life-of-chilled-
proteolytic Clostridium botulinum.  foods-in-relation-to-non-proteolytic-
2018.  clostridium-botulinum/  
Codex Alimentarius  Codex. Guidelines for the validation of  https://www.fao.org/fao-who- General applicability 
Commission (Codex)  food safety control measures (CXG  codexalimentarius/codex-
69-2008)  texts/guidelines/en/ 
https://www.fao.org/fao-who-
codexalimentarius/sh-
proxy/pt/?lnk=1&url=https%253A%252F
%252Fworkspace.fao.org%252Fsites%25
2Fcodex%252FStandards%252FCXG%2
B69-2008%252FCXG_069e.pdf  
Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 34  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Organization  Document  How to Access  Applicability 
European branch of the  Ceylan, E., A Amezquita, N.  Compr. Rev. Food Sci. Food Saf.  General applicability; 
International Life  Anderson, R. Betts, L. Blayo, F.  20:28252881. DOI: 10.1111/1541- describes product and 
Sciences Institute, ILSI  Garces-Vega, E. Gkogka, L.J. Harris,  4337.12746. Available at:  process factors 
Europe  P.McClure, A Winkler, and H. M. W. https://ift.onlinelibrary.wiley.com/doi/full/ essential in designing 
den Besten. 2021. Guidance on  10.1111/1541-4337.12746  a validation study, 
validation of lethal control measures selection criteria for 
for foodborne pathogens in foods. identifying an 
appropriate target 
pathogen or surrogate 
organism. 
Institute for Food  Gombas, D.; Y. Luo; J. Brennan; G.  J.of Food Prot. 80:312-330. 2017  Commercial 
Safety and Health  Shergill; R. Petran; R. Walsh; H. Hau;  packinghouse and 
https://doi.org/10.4315/0362-028X.JFP-
(IFSH)  K. Khurana; B. Zomorodi; J. Rosen; R.  fresh-cut wash 
16-258 
Varley; K. Deng. 2017.Guidelines to systems 
validate control of cross-contamination
during washing of fresh-cut leafy 
vegetables. 
Institute for Food  Shazer, A.; D. Stewart; K. Deng; M.  J.of Food Prot. 80:1600-1604. 2017  Commercial 
Safety and Health  Tortorello. 2017. Approaches toward  packinghouse and 
https://doi.org/10.4315/0362-028X.JFP-
(IFSH)  identification of surrogates to validate  fresh-cut wash 
17-069 
antimicrobial washes as preventive  systems 
controls for fresh-cut leafy greens. 
International  ICMSF. 2011. Microorganisms in  https://www.springer.com/gp/book/97814 General applicability 
Commission on  Foods 8, Use of Data for Assessing  41993731 
Microbiological  Process Control and Product 
Book and individual chapters can be 
Specifications for  Acceptance. Chapter 2-Validation of 
purchased. 
Foods (ICMSF)  Control Measures 
International  Consortium of Food Process  Food Prot Trends, Vol. 22, No. 2, p. 95- General Applicability 
Association for Food  Validation Experts. Validation of  104. 
Protection (IAFP)  Antimicrobial Interventions for Small 
and Very Small Processors: A How-to 
Guide to Develop and Conduct 
Validations 
National Advisory  NACMCF. 2010. Parameters for  J Food Prot 73:140-202. 2010.  General applicability 
Committee on the  determining inoculated pack/challenge  for studies that 
Microbiological  study protocols.   involve inoculation of 
Criteria for Foods  product. 
(NACMCF) 
PMMI OpX Leadership  Validating the Reduction of  https://www.opxleadershipnetwork.org/qu Baking Processes 
Network Products  Salmonella and Other Pathogens in  ality/download/spotlight-baking 
Safety Solutions Group   Heat Processed Low-Moisture Foods: 
Spotlight on Baking 
University of  Theofel, C, S Yada, and LJ Harris.  https://ucfoodsafety.ucdavis.edu/sites/g/fil Low-moisture foods 
California, Davis  Surrogate organisms for low moisture  es/dgvnsk7366/files/inline-
foods  published treatments [tables  files/303737.pdf  
and references] 
Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 35  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Table 8. Additional Resources Cited in this Guidance 
Topic  Source  Resource Title  Resource Link 
Animal drugs  FDA  Search animal  https://animaldrugsatfda.fda.gov/ 
website  drugs 
Audits  International  IFS Food 7   https://www.ifs-certification.com/index.php/en/standards/4128-ifs-food-standard-en 
Featured  English* 
Standards 
(IFS) 
website 
CGMP  Eastern  Good  https://www.fda.gov/food/current-good-manufacturing-practices-cgmps-food-and-dietary-supplements/good-
Research  Manufacturing  manufacturing-practices-21st-century-food-processing-2004-study-section-4-common-food-safety 
Group.  Practices (GMPs) 
2004.  for the 21st 
Century - Food 
Processing. 
Section Four. 
Common Food 
Safety Problems 
in the U.S. Food 
Processing 
Industry: A 
Delphi Study. 
2004. 
Chemical  FDA  Chemical  https://www.fda.gov/food/chemical-contaminants-pesticides 
contaminants  website  Contaminants & 
Pesticides 
Chemical  FDA  FDA Total Diet  https://www.fda.gov/food/science-research-food/fda-total-diet-study-tds 
contaminants  website  Study (TDS) 
Color additives  FDA  Color additive  https://www.fda.gov/industry/color-additive-inventories/color-additive-status-list 
website  status list 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 36  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Data and tools in  Foodrisk.org  Open Data &  https://www.foodrisk.org/irac/open-data-tools/ 
support of food  website  Tools 
safety risk 
assessment 
efforts 
Environmental  Code of  21 CFR 109.30  https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-109/subpart-B/section-109.30 
contaminants  Federal  Tolerances for 
Regulations  polychlorinated 
biphenyls (PCBs) 
Environmental  FDA  Dioxins and PCBs  https://www.fda.gov/food/chemical-contaminants-food/dioxins-pcbs 
contaminants  website 
Environmental  FDA  Per- and  https://www.fda.gov/food/chemical-contaminants-food/and-polyfluoroalkyl-substances-pfas 
contaminants  website  Polyfluoroalkyl 
Substances 
(PFAS) 
Food additives  FDA  Food additive  https://www.fda.gov/food/food-additives-petitions/food-additive-status-list 
website  status list 
Food allergens  FDA  Food  https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/food-
website  Allergens/Gluten- allergens-and-gluten-free-guidance-documents-and-regulatory-information 
Free Guidance 
Documents & 
Regulatory 
Information 
Food allergens  FDA  Label Declaration  http://wayback.archive-
website  of Allergenic  it.org/7993/20171114013857/https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformatio
Substances in  n/Allergens/ucm106546.htm 
Foods; Notice to 
Manufacturers. 
1996 
Food allergens  GMA (now  Managing  Available for purchase at https://forms.consumerbrandsassociation.org/forms/store/ProductFormPublic/managing-
Consumer  allergens in food  allergens-in-food-processing-establishments  
Brands  processing 
Association)  establishments 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 37  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Food Code  FDA  Food Code  https://www.fda.gov/food/retail-food-protection/fda-food-code 
website 
Food fraud  United  Food fraud  https://www.usp.org/sites/default/files/usp/document/our-work/Foods/food-fraud-mitigation-guidance.pdf 
States  mitigation 
Pharmacopei guidance 
al 
Convention 
website 
Food fraud  Food Fraud  Food Fraud  https://foodfraudadvisors.com/list-of-food-fraud-databases/ 
Advisors  Databases 
website  Compared 
Food safety  FAO  Food safety &  https://www.fao.org/food/food-safety-quality/home-page/en/ 
website  quality 
Food safety  WHO  Food Safety  https://www.who.int/health-topics/food-safety/ 
website 
Food safety  FSPCA  Food Safety  https://www.fspca.net 
forms and  website  Preventive 
training manual  Controls Alliance 
Food ingredient  Food  Food Chemicals  Available for purchase at https://www.foodchemicalscodex.org/ 
standards  Chemicals  Codex 
Codex 
Foreign material  U.S.  Foreign Material  https://www.ams.usda.gov/publications/content/foreign-material-manual 
Department  Manual 
of 
Agriculture, 
Agricultural 
Marketing 
Service 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 38  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Game meat  FSIS  FSIS Cooking  https://www.fsis.usda.gov/guidelines/2021-0014 
website  Guideline for 
Meat and Poultry 
Products (Revised 
Appendix A). 
2021. 
Game meat  FSIS  FSIS Stabilization  https://www.fsis.usda.gov/guidelines/2021-0013 
website  Guideline for 
Meat and Poultry 
Products (Revised 
Appendix B). 
2021. 
GRAS  FDA  Generally  https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras 
substances  website  Recognized as 
Safe (GRAS) 
HACCP systems  FSIS  Meat and Poultry  https://www.fsis.usda.gov/guidelines/2018-0005 
website  Hazards and 
Controls Guide. 
2018. 
HACCP systems  FSIS  FSIS compliance  https://www.fsis.usda.gov/guidelines/2015-0011 
website  guideline HACCP 
systems 
validation. 2015. 
HACCP systems  Codex  Hazard analysis  https://www.fao.org/fao-who-codexalimentarius/sh-
website  and critical  proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCX
control point  C%2B1-1969%252FCXC_001e.pdf 
(HACCP) system 
and guidelines for 
its application. 
Chapter Two in 
CXC 1-1969.  
Information for  FDA  Consumers  https://www.fda.gov/food/resources-you-food/consumers 
consumers  website 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 39  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Information for  FDA  Raw Dough's a  https://www.fda.gov/consumers/consumer-updates/raw-doughs-raw-deal-and-could-make-you-sick 
consumers  website  Raw Deal and 
Could Make You 
Sick 
International &  FDA  International &  https://www.fda.gov/food/international-interagency-coordination 
Interagency  website  Interagency 
Coordination  Coordination 
International &  FDA  International  https://www.fda.gov/international-programs/international-arrangements 
Interagency  website  Arrangements 
Coordination 
International &  FDA  International  https://www.fda.gov/food/international-interagency-coordination/international-cooperation-food-safety 
Interagency  website  Cooperation on 
Coordination  Food Safety 
International &  FDA  Systems  https://www.fda.gov/food/international-cooperation-food-safety/systems-recognition-food 
Interagency  website  Recognition 
Coordination  (Food) 
Irradiation  FDA  Irradiation of  https://www.fda.gov/food/food-ingredients-packaging/irradiation-food-packaging 
website  Food & Packaging 
Irradiation  FDA  Understanding  https://www.fda.gov/food/irradiation-food-packaging/understanding-food-irradiation-what-industry-needs-know 
website  food irradiation: 
What industry 
needs to know 
Metal detection  Loma  Guide to Metal  https://www.loma.com/en-us/industry-guides/guide-to-metal-detection 
Systems  Detection 
website 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 40  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Metal detection  Mettler  -The Metal https://www.mt.com/us/en/home/products/Product-Inspection_1/safeline-metal-detection.html 
Toledo  Detection Guide.
website  Building an
Effective
Programme
-Understanding
Sensitivity In
Metal Detection
-How to Correctly
Test Your
Industrial Metal
Detector
Microbiological  Combase  A Web Resource  https://www.combase.cc/index.php/en/ 
hazards  website  for Quantitative 
and Predictive 
Food 
Microbiology 
Microbiological  FDA  Bad Bug Book.  https://www.fda.gov/media/83271/download 
hazards  website  2012. 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 41  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Microbiological  FDA  Evaluation and  https://www.fda.gov/files/food/published/Evaluation-and-Definition-of-Potentially-Hazardous-Foods.pdf 
hazards  website (A  definition of 
Report of the  potentially 
Institute of  hazardous foods: 
Food  Chapter 3 Factors 
Technologist that influence 
s for the  microbial growth 
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)
Microbiological  USDA/ ARS  Pathogen  https://www.ars.usda.gov/northeast-area/wyndmoor-pa/eastern-regional-research-center/residue-chemistry-
hazards  website  Modeling  and-predictive-microbiology-research/docs/pathogen-modeling-program/ 
Program 
Microbiological  FDA  Guide to  https://www.fda.gov/low-acid-canned-food-manufacturers-part-1-adminstrative-proceduresscheduled-processes 
hazards - LACF  website  Inspections of 
Low Acid Canned 
Food 
Manufacturers 
Part 1 - 
Administrative 
Procedures/Sched
uled Processes 
Outbreaks  CDC  Estimates of  https://www.cdc.gov/foodborneburden/index.html 
website  Foodborne Illness 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 42  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Outbreaks  CDC  Foodborne  https://www.cdc.gov/foodsafety/outbreaks/ 
website  outbreaks 
Outbreaks  European  Monitoring of  https://www.efsa.europa.eu/en/topics/topic/monitoring-foodborne-diseases 
Food Safety  foodborne 
Authority  diseases 
website 
Outbreaks and  FDA  Recalls,  https://www.fda.gov/food/recalls-outbreaks-emergencies 
Recalls  website  Outbreaks & 
Emergencies 
Outbreaks and  Food  Recalls and  https://www.foodsafety.gov/recalls-and-outbreaks 
Recalls  Safety.gov  Outbreaks 
website 
Pasteurization of  FDA  Grade "A"  https://www.fda.gov/food/milk-guidance-documents-regulatory-information/national-conference-interstate-milk-
milk  website  Pasteurized Milk  shipments-ncims-model-documents; see also 21 CFR 1240.61 (Mandatory pasteurization for all milk and milk products 
Ordinance  in final package form intended for direct human consumption at https://www.ecfr.gov/current/title-21/chapter-
I/subchapter-L/part-1240/subpart-D/section-1240.61)  
Pesticides  FDA  Pesticides  https://www.fda.gov/food/chemicals-metals-pesticides-food/pesticides 
website 
Pesticides  FDA  Pesticide Residue  https://www.fda.gov/food/pesticides/pesticide-residue-monitoring-program-reports-and-data 
website  Monitoring 
Program Reports 
and Data 
Pesticides  Code of  40 CFR Part 180 -  https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-180 
Federal  Tolerances and 
Regulations  Exemptions for 
(e-CFR)  Pesticide 
website  Chemical 
Residues in Food 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 43  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Pesticides  EPA website  Indexes to Part  https://www.epa.gov/pesticide-tolerances/indexes-part-180-tolerance-information-pesticide-chemicals-food-and-feed 
180 Tolerance 
Information for 
Pesticide 
Chemicals in 
Food and Feed 
Commodities 
Pesticides  EPA website  Regulation of  https://www.epa.gov/pesticide-tolerances 
pesticide residues 
on food 
Physical hazards  News  Seavin voluntarily  https://www.clickorlando.com/consumer/2018/05/26/seavin-voluntarily-recalls-select-wines-due-to-potential-small-
(glass  website  recalls select  pieces-of-glass-in-bottles/ 
fragments)  wines due to 
potential small 
pieces of glass in 
bottles 
Process  FDA  3- https://www.fda.gov/food/chemical-contaminants-food/3-monochloropropane-12-diol-mcpd-esters-and-glycidyl-esters 
contaminants  website  Monochloropropa
ne-1,2-diol 
(MCPD) Esters 
and Glycidyl 
Esters 
Process  FDA  Acrylamide  https://www.fda.gov/food/chemical-contaminants-food/acrylamide 
contaminants  website 
Recalls  FDA  Recalls, Market  https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts 
website  Withdrawals, & 
Safety Alerts 
Recalls  FDA  Regulatory  https://www.fda.gov/media/71814/download 
website  Procedures 
Manual, Chapter 7 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 44  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Recalls  FDA  Regulatory  https://www.fda.gov/media/71814/download 
website  Procedures 
Manual, Chapter 
7, Exhibit 7-1, 
Model 
Effectiveness 
Check Letter 
(Industry). 
Recalls  FDA  Regulatory  https://www.fda.gov/media/71814/download 
website  Procedures 
Manual, Chapter 
7, Exhibit 7-2, 
Model 
Effectiveness 
Check Response 
Format (Industry). 
Recalls  FDA  Regulatory  https://www.fda.gov/media/71814/download 
website  Procedures 
Manual, Chapter 
7, Exhibit 7-3, 
Model 
Effectiveness 
Check 
Questionnaire for 
Telephone or 
Personal Visits 
(Industry). 
Recalls  FDA  Regulatory  https://www.fda.gov/media/71814/download 
website  Procedures 
Manual, Chapter 
7, Exhibit 7-4, 
Model Recall 
Letter (Generic, 
All Centers). 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 45  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Recalls  FDA  Regulatory  https://www.fda.gov/media/71814/download 
website  Procedures 
Manual, Chapter 
7, Exhibit 7-5, 
Model Recall 
Response Form. 
Recalls  FDA  Office of  https://www.fda.gov/safety/industry-guidance-recalls/ora-recall-coordinators 
website  Regulatory Affairs 
(ORA) Recall 
Coordinators 
Recalls  FSIS  Food Safety  https://www.fsis.usda.gov/food-safety 
website 
Recalls  New  Food recall  https://www.mpi.govt.nz/food-business/food-recalls/food-recall-documents/ 
Zealand  documents 
Food Safety, 
Ministry for 
Primary 
Industries 
website 
Reportable food  FDA  FDA-TRACK:  https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-reportable-food-registry-data-
website  Reportable Food  dashboard 
Registry Data 
Dashboard 
Sanitary  FDA  FSMA Final Rule  https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-transportation-human-and-
transportation of  website  on Sanitary  animal-food 
food  Transportation of 
Human and 
Animal Food 
Sanitation  3-A Sanitary 3-A Sanitary https://www.3-a.org/ 
Standards, Standards and
Inc. website Accepted
Practices*
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 46  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Sanitation  American  Food Safety  https://www.meatinstitute.org/sites/default/files/original%20documents/Sanitation%20booklet%202021.pdf 
Meat  Equipment Design 
Institute  Principles 
website  CHECKLIST & 
GLOSSARY. 
2021. 
Sanitation  GMA (now  Control of  https://graphics8.nytimes.com/packages/pdf/business/20090515_moss_ingredients/SalmonellaControlGuidance.pdf 
Consumer  Salmonella in 
Brands  Low-Moisture 
Association)  Foods Guidance 
Document.** 
Sanitation  European  EHEDG  https://www.ehedg.org/guidelines/ 
Hygienic  Guidelines Doc 8. 
Engineering  Hygienic Design 
and Design  Principles. Third 
Group  Edition. 2018. 
(EHEDG) 
website 
Sanitation  Lelieveld,  Hygiene in Food  N/A 
HLM,  Processing: 
Holah, JT  Principles and 
and Napper,  Practices. 2014.* 
D (Eds.) 
(Elsevier 
Publishing) 
Sanitation  Marriott,  Principles of Food  https://doi.org/10.1007/978-3-319-67166-6 
NG,  Sanitation, Sixth 
Schilling,  Ed. 2018.* 
MW, and 
Gravani, 
RB. 
(Springer 
International
) 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 47  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Sanitation  Schmidt, RH  Sanitary Design  https://ucfoodsafety.ucdavis.edu/sites/g/files/dgvnsk7366/files/inline-files/26502.pdf 
and DJ  and Construction 
Erickson,  of Food 
Food  Equipment. 2005. 
Science and 
Human 
Nutrition 
Department, 
Florida 
Cooperative 
Extension 
Service, 
Institute of 
Food and 
Agricultural 
Sciences, 
University 
of Florida 
Spices  American  Clean, Safe Spices  https://www.astaspice.org/food-safety-technical-guidance/best-practices-and-guidance/clean-safe-spices-guidance-
Spice Trade  Guidance  document/ 
Association  Document 
(ASTA) 
website 
Spices  FDA  Risk Profile:  https://www.fda.gov/food/cfsan-risk-safety-assessments/risk-profile-pathogen-and-filth-spices 
website  Pathogens and 
Filth in Spices 
Supplier  FDA  Firm/Supplier  https://www.fda.gov/food/food-safety-modernization-act-fsma/firmsupplier-evaluation-resources-fsma-rules 
evaluation  website  Evaluation 
Resources for 
FSMA Rules 
Substance  FDA  Melamine  https://www.fda.gov/food/chemical-contaminants-food/melamine 
intentionally  website 
introduced for 
purposes of 
economic gain 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 48  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Topic  Source  Resource Title  Resource Link 
Toxic elements  FDA  Metals and Your  https://www.fda.gov/food/chemical-contaminants-metals-pesticides-food/metals-and-your-food 
website  Food 
Toxic elements  FDA  Closer to Zero:  https://www.fda.gov/food/environmental-contaminants-food/closer-zero-reducing-childhood-exposure-contaminants-
website  Reducing  foods 
Childhood 
Exposure to 
Contaminants 
from Foods 
Validation  FSIS  FSIS compliance  https://www.fsis.usda.gov/guidelines/2015-0011 
website  guideline HACCP 
systems 
validation. 2015. 
Various  European  Rapid Alert  https://food.ec.europa.eu/safety/rasff-food-and-feed-safety-alerts_en 
Union  System for Food 
website  and Feed 
(RASFF) 
Various  FDA  Food Defect  https://www.fda.gov/food/ingredients-additives-gras-packaging-guidance-documents-regulatory-information/food-
website  Levels Handbook  defect-levels-handbook 
Various  FDA  Food Code  https://www.fda.gov/food/retail-food-protection/fda-food-code 
website 
Various  FDA  Regulatory  https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/regulatory-
website  Procedures  procedures-manual 
Manual 
X-ray detection Loma  Guide to X-Ray  https://www.loma.com/en-us/industry-guides/guide-to-x-ray-inspection 
systems  Inspection 
website 
*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, 29:342353. 
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, 29:435445.  
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 49  Contains Non-binding Recommendations 
Draft-Not for Implementation 
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. 
Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 50  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 35C in 
tryptose broth acidified with acetic, citric, or lactic Acid. J Food Prot 52: 688695 
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-validation-
guidelines.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-and-
suppliers/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 Bgh-Srensen. Woodhead 
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Wilson, CR, WH Andrews, and PL Poelma. 1975. Evaluation of methods to isolate Salmonella 
from pressed yeast and dried inactive yeast. J Milk Food Technol 38:383-385. 
Zhang G, L Ma, N Patel, B Swaminathan, S Wedel, and MP Doyle. 2007. Isolation of 
Salmonella Typhimurium from Outbreak-Associated Cake Mix. J Food Prot 70 (4): 997
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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Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 70  Contains Non-binding Recommendations 
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Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs 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. 
Chapter 1 (Food Safety Plan) - Page 1  Contains Non-binding Recommendations 
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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: 
  Preventive controls (see 21 CFR 117.135), as appropriate to the facility and the food, 
o
to ensure safe food is produced, including: 
  Process controls 
  Food allergen controls 
  Sanitation controls 
  Supply-chain controls 
  Recall plan 
  Other controls 
  Procedures for monitoring the implementation of the preventive controls, as 
o
appropriate to the nature of the preventive control and its role in the facilitys food 
safety system  
  Corrective action procedures, as appropriate to the nature of the hazard and the 
o
nature of the preventive control  
  Verification procedures, as appropriate to the nature of the preventive control and its 
o
role in the facilitys 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,  Chemical hazards include radiological 
physical hazards  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  Corrective actions  Corrective actions or corrections as 
Corrections  appropriate (21 CFR 117.150(a)) 
Verification (including  For process controls  Verification as appropriate for all 
validation)  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 
Chapter 1 (Food Safety Plan) - Page 4 
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analysis is the facilitys 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 facilitys 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. 
Chapter 1 (Food Safety Plan) - Page 6 
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Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs 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. 
Chapter 2 (Hazard Analysis) - Page 1  Contains Non-binding Recommendations 
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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 
Chapter 2 (Hazard Analysis) - Page 2 
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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 on-
site 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)  (2)  (3)  (4)  (5)   (6) 
Ingredient /  Identify potential  Are  Justify your  What preventive  Is the 
Processing  food safety  any potential  decision for  control measure(s)  preventive 
Step  hazards  food safety  column 3  can be applied to  control applied 
introduced,  hazards  significantly  at this step? 
controlled or  requiring  minimize or  (Yes/No) 
enhanced at this  preventive  prevent the food 
step  control?  safety hazard? 
B = biological   (Yes/No)  Process including 
C = chemical,  CCPs, Allergen, 
including  Sanitation, Supplier, 
other preventive 
radiological  
control 
P = physical 
           
           
 
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)  
Chapter 2 (Hazard Analysis) - Page 6 
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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 post-
packaging 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 immuno-
compromised, 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  Establishments 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 a ), but 
w
when put together there may be an interface where the pH and a  change (e.g., pies, layered 
w
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 cross-
contact. 
  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-to-
metal 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 transportatione.g., from  pathogens or chemicals present in an 
inadequately cleaned vehicle or from other inadequately protected foods that are being co-
transported 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 shelf-
stable 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/. 
Chapter 2 (Hazard Analysis) - Page 19 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
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/home-
page/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-health-
alerts/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/. 
 
 
Chapter 2 (Hazard Analysis) - Page 20 
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Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs 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. 
Chapter 3  (Potential Hazards) - Page 1  Contains Non-binding Recommendations 
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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 Process-
Related 
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 
  Bacillus cereus (B. cereus) 
Biological  Bacteria 
  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) 
  Cryptosporidium parvum 
Biological  Protozoa and Parasites 
  Cyclospora cayetanensis 
  Giardia lamblia (G. intestinalis) 
  Trichinella spiralis 
  Norovirus 
Biological  Viruses 
  Hepatitis A 
  Rotavirus 
  Organophosphates 
Chemical  Pesticide residues 
  Carbamates  
  Chlorinated hydrocarbons 
  Pyrethroids  
  Lead 
Chemical  Heavy Metals 
  Arsenic 
  Cadmium 
  Mercury 
  Chloramphenicol 
Chemical  Drug residues (veterinary 
antibiotics)    Beta- Lactams 
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Hazard Category  Hazard Sub-category  Examples 
  Ammonia 
Chemical  Industrial chemicals 
  Dioxins 
Chemical  Environmental contaminants 
  Aflatoxin 
Chemical  Mycotoxins 
  Patulin 
  Ochratoxin 
  Fumonisin 
  Deoxynivalenol 
  Milk, eggs, fish, crustacean shellfish, tree 
Chemical  Allergens 
nuts, peanuts, wheat, and soybeans 
(commonly called the Big 8) 
  FD&C Red #4 
Chemical  Unapproved colors and 
additives    Melamine 
  Lactose 
Chemical  Substances associated with a 
food intolerance or food    Yellow #5 
disorder     Sulfites 
  Carmine and Cochineal 
  Gluten 
  Radium 226 and 228 
Chemical  Radionuclides 
  Uranium 235 and 238 
  Strontium 90 
  Cesium 137 
  Iodine 131 
  Metal 
Physical  N/A 
  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: 
  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 foods 
o
formulation; or 
  Selectively grow, and/or produce toxin, in a food as a result of using reduced oxygen 
o
packaging;  
  Facility-related hazards  e.g., if the pathogens are introduced from: 
  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  
o
  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 (a ) or temperature 
w
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 FDAs 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 
  Salmonella spp. (e.g.,    Cryptosporidium    Norovirus 
Ingredient-related (e.g., 
poultry, produce, nuts)  parvum (contaminated  (produce, 
contamination of raw 
materials and other    E. coli O157:H7 & similar  water used as an  shellfish) 
ingredients)  STEC (e.g., ruminant  ingredient)     Hepatitis A virus  
animals, dropped fruit,    Cyclospora  (produce, fruits) 
sprouts)  cayetanensis (berries) 
  Campylobacter spp. (e.g.,    Toxoplasma gondii 
poultry and raw milk)  (meat) 
  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) 
 
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Primary Source  Bacteria  Parasites  Viruses 
  Salmonella spp. survive 
Process-related (e.g.,  Cryptosporidium parvum  N/A 
inadequate heat 
poor or ineffective  (contaminated water 
treatment 
process controls,  source) 
including by a supplier)    C. perfringens (improperly 
cooled cooked foods) 
  L. monocytogenes (raw 
agricultural commodities, 
contaminated products) 
  L. monocytogenes (e.g., 
Facility-related (may be  N/A  Norovirus (only 
reservoirs include floors, 
caused by poor  when active 
cold wet areas, 
sanitation practices (e.g.,  shedding occurs in 
equipment, drains, 
inadequate cleaning and  facility through 
condensate, coolers, and 
sanitizing of potential  vomiting and 
soil) 
harborage sites), poor  diarrhea) 
plant and equipment    Salmonella spp.  (pests) 
design, and poor pest 
management practices) 
  S. aureus     Hepatitis A virus  
People-related  Cryptosporidium parvum   
(individuals who are    Shigella spp.     Norovirus 
 
carriers, showing no    Salmonella spp.    Rotavirus 
signs of disease, who 
are shedding the hazard, 
or who are infected and 
are actively ill) 
 
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., 
a , acidity (pH), temperature, and oxygen requirements) that will limit growth for most of the 
w
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-Barre 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 a  
w
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 a ).  Other process-related biological hazards are not 
w
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 temperature-
abused 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 140F.   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, a , use of preservatives, and oxygen availability, can work in concert to 
w
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, a , percent moisture, percent sodium and percent 
w
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 a  values alters the microenvironments at the 
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interfaces of the components. A simple example is an eclair filled with a cream filling. The pH 
and a  at the interface of the pastry and the filling will be affected by the difference between the 
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higher pH and lower a of the pastry and the potentially lower pH and higher moisture content of 
w 
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 products shelf life. Characteristics such as oxygen-
reduction (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 a  of the finished product 
w
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 a  may be 
w
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 a  different from the original ingredients. If a 
w,
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 process-
related 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: a  below 0.93; 
w
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 38F (3.33C) 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  
Environmental 
Product  Details  Reference 
Pathogen 
Chocolate  S. Napoli  Possibly contaminated water used  Gill, et. al. (1983) 
in double-walled pipes, tanks and 
other equipment 
Chocolate  S. Eastbourne  From processing environment  Craven, et. al. 
(1975) 
Butter (from  L. monocytogenes  From processing environment  Lyytikainen et. al. 
pasteurized cream)  (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  L. monocytogenes  From processing environment  FDA (2013c) 
pasteurized milk) 
Soft cheese (from  L. monocytogenes  From processing environment  FDA (2014a) 
pasteurized milk) 
  
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 facilitys 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 facility-
related 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 milk 
Raw agricultural commodities 
  Cocoa beans 
  Fruits and vegetables 
  Nuts 
  Unprocessed spices 
  Transfer of biological hazards from one point to another 
Food handlers and maintenance 
on, for example, shoes and other clothing 
personnel 
  Improper hand washing  
  Transfer of biological hazards to foods through improper 
handling or maintenance practices 
  Lack of appropriate air filtration for cooling, drying, air 
Air and water 
conveying 
  Improper air flow from raw to RTE areas 
  Aerosols from improper cleaning practices 
  Flies 
Insects and pests 
  Cockroaches 
  Rodents 
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Source  Examples 
  Forklifts 
Transport equipment 
  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  Examples of Foods 
Conditions 
  Ice Cream 
Wet 
  Refrigerated Dairy Products 
  Refrigerated Deli Salads 
  Refrigerated and Frozen Meals 
  Refrigerated Beverages (non-juice) 
  Chocolate and Confections 
Dry 
  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 Salmonella-
controlled 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 process-
related 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 
  Pesticide residues on produce raw agricultural 
Ingredient-related chemical hazards 
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) 
  Undeclared food allergens due to mislabeling or cross-
Process-related chemical hazards 
contact 
  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 
  Heavy metals due to leaching from equipment, containers, 
Facility-related chemical hazards 
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 
EPAs 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 post-
harvesting 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  Details  Reference 
Hazard 
Milk  Melamine  Milk firms in one country added  FDA, 2008 
melamine, a nitrogen-rich industrial 
by-product, to diluted dairy 
products to increase the apparent 
protein content 
Turmeric  Lead chromate  A chemical with a vibrant yellow  FDA, 2013d 
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 
Paprika  Lead oxide  A red chemical that has been used  Lead Action 
as an adulterant in paprika to  News, 1995 
change the color of the spice to 
suggest that it is of a higher quality 
Chili powder  Sudan I  An orange-red powder that had  United Kingdom 
been added to chili powder as a  Food Standards 
coloring agent, but is now banned  Agency, 2005 
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) 
  
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 Process-
Related   
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 bodys 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 Manufacturers 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): Cows 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 life-
threatening 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 allergic-
type reactions (including bronchial asthma).  To help protect people who are sensitive to 
Yellow No. 5, FDAs 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, FDAs 
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.   
Chapter 3  (Potential Hazards) - Page 31 
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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 11Food 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). 
Chapter 3  (Potential Hazards) - Page 32 
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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, food-
contact 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. FDAs Health Hazard Evaluation Board (FDA, 2005e; Olsen, 1998) has 
Chapter 3  (Potential Hazards) - Page 33 
  Contains Non-binding Recommendations 
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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. FDAs 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 process-
related 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.   
   
Chapter 3  (Potential Hazards) - Page 34 
  Contains Non-binding Recommendations 
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Table 3-9. Quick Reference Guide for Common Sources of Physical Hazards 
Source  Metal  Ferrous & Non- Plastic, Ceramic, and  Other 
ferrous  Glass 
  Farm field debris    Farm field debris,     Pits or pit fragments, 
Ingredient-related 
  Precut, ground,    Packaging materials  shells 
injected, sliced, items, 
where metal was not 
properly controlled by 
supplier.  
  Equipment    Equipment (inspection    Incomplete removal 
Facility-related and process-
related (processing/production    Grinders, slicers,  belts, small wares,  of pits or pit 
buckets)  fragments, shells 
environment, equipment, and  knives 
pests (insects, birds, rodents,    Sieves, screens, wire-   Facility (glass light    Poor Design --
reptiles))  mesh belts  fixtures, glass  Particle size of food 
windows in doors,  inappropriate for 
       Mixing paddles   plastic strip curtains)  consumer  
    Metal cans (shavings,    Glass containers  choking hazard   
lids)  
    Scoops  
  Pumps 
  Mixing paddles 
    Cook Kettles with 
  Buckets 
swept surface 
 
paddles 
 
  Drop buckets  
 
  Jewelry     Buttons  
People-related (actions or  N/A 
behaviors)    Hair pins     Zipper pulls 
 
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28 (3):181-9. doi: 10.1006/rtph.1998.1249. 
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Scallan, E., R. M. Hoekstra, F. J. Angulo, R. V. Tauxe, M. A. Widdowson, S. L. Roy, J. L. Jones, 
and P. M. Griffin. 2011. "Foodborne illness acquired in the United States--major 
pathogens."  Emerg Infect Dis 17 (1):7-15. doi: 10.3201/eid1701.091101p1. 
Scott, V. N., Y. Chen, T. A. Freier, J. Kuehm, M. Moorman, J. Meyer, T. Morille-Hinds, L. Post, 
L. Smoot, S. Hood, J. Shebuski, and J. Banks. 2009. "Control of Salmonella in low-
moisture foods i: Minimizing entry of Salmonella into a processing facility."  Food Prot 
Trends 29:342-353. 
Shephard, G. S. 2008. "Risk assessment of aflatoxins in food in Africa."  Food Addit Contam 
Part A Chem Anal Control Expo Risk Assess 25 (10):1246-56. doi: 
10.1080/02652030802036222. 
Stratton, J. E., R. W. Hutkins, and S. L. Taylor. 1991. "Biogenic amines in cheese and other 
fermented foods: A review."  J Food Prot 54:460-469. 
Taylor, S. L., and World Health Organization (WHO). 1985. "Histamine poisoning associated 
with fish, cheese, and other foods." Accessed April 22, 
2016. http://apps.who.int/iris/bitstream/10665/66407/1/VPH_FOS_85.1.pdf. 
Timbo, B., K. M. Koehler, C. Wolyniak, and K. C. Klontz. 2004. "Sulfites--a Food and Drug 
Administration review of recalls and reported adverse events."  J Food Prot 67 (8):1806-
11. 
United Kingdom Food Standards Agency. 2005. "Sudan | Timeline." Accessed July 19, 
2016. http://webarchive.nationalarchives.gov.uk/20111206002505/http:/www.food.gov.uk
/safereating/chemsafe/sudani/sudanitimeline. 
United States Pharmacopeial Convention. 2016a. "Food fraud mitigation guidance." Accessed 
July 19, 2016. http://www.usp.org/food-ingredients/food-fraud-mitigation-guidance. 
United States Pharmacopeial Convention. 2016b. "Us Pharmacopeial Convention (USP) Food 
Fraud Database." Accessed July 19, 2016. http://www.foodfraud.org/. 
Williams, J. H., T. D. Phillips, P. E. Jolly, J. K. Stiles, C. M. Jolly, and D. Aggarwal. 2004. 
"Human aflatoxicosis in developing countries: A review of toxicology, exposure, potential 
health consequences, and interventions."  Am J Clin Nutr 80 (5):1106-22. 
World Health Organization (WHO). 2011. "FAQs: Japan nuclear concerns." Accessed April 22, 
2016. http://www.who.int/hac/crises/jpn/faqs/en/. 
World Health Organization (WHO). 2014. "Dioxins and their effects on human health." Accessed 
June 24, 2016. http://www.who.int/mediacentre/factsheets/fs225/en/#. 
WHO/FAO Joint Expert Committee on Food Additives (JECFA). 2010. "Evaluation of certain 
contaminants in food, 72nd Report of the World Health Organization/Food and 
Agriculture Organization of the United Nations Joint Expert Committee on Food 
Additives." Accessed April 22, 
2016. http://apps.who.int/iris/bitstream/10665/44520/1/9789241660631_eng.pdf. 
Chapter 3  (Potential Hazards) - Page 41 
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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. 
 
Chapter 3  (Potential Hazards) - Page 42 
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Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs 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. 
Chapter 4 (Preventive Controls) - Page 1  Contains Non-binding Recommendations 
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4.3.3.1  Use of Water activity (a ) as a Formulation Process Control 
w
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 Cross-
contamination 
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 facilitys 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  8 
activity, pH, and chemical preservatives) 
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 facilitys 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 facilitys 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 facilitys 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 Manufacturers 
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  Hazard  Examples   Chapter 
Subcategory  Category  Section 
Lethal Treatments  Biological    Heat treatments (also called thermal  4.3.1 
treatments) (e.g.,  cooking, roasting, 
baking) 
  High Pressure Processing (HPP) 
  Irradiation  
  Antimicrobial fumigation (e.g., with 
polypropylene oxide (PPO)) 
Time/Temperature  Biological    Refrigeration   4.3.2 
of Holding 
  Freezing  
Formulation  Biological    Reducing the water activity  4.3.3 
  Reducing the pH 
  Adding preservatives 
Dehydration/Drying  Biological    Air-drying (forced air and heating)   4.3.4 
  Freeze drying  
  Spray drying  
Recipe  Chemical    Controlling the maximum level of food  4.3.5 
Management  ingredients 
Storage Conditions  Chemical    Controlling moisture during storage of  4.3.6 
raw agricultural commodities  
Physical Sorting  Chemical    Reducing mycotoxin content through  4.3.7 
sorting by color and physical damage in 
raw agricultural commodities 
Exclusion of Metal  Physical    Using magnets  4.3.8 
and Glass 
  Using metal detectors 
  Using sieves, screens 
  Using X-ray systems 
 
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 
(100C)) 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., 158F (70C) to 212F (100C)), 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 non-
sporeforming 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  Log  Decrease in most resistant  Percent  Final number of 
most resistant  reduction  microorganism of public  of change  bacteria per 
microorganism of  (also  health significance per gram  gram of food 
public health  known as  of food 
significance per  D) 
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  Log  Decrease in most resistant  Percent  Final number of 
most resistant  reduction  microorganism of public  of change  bacteria per 
microorganism of  (also  health significance per gram  gram of food 
public health  known as  of food 
significance per  D) 
gram of food 
10,000 or log 4  5  10 X 10 X 10 X 10 X 10 =  99.999%  0.1 or log -12 
100,000-fold 
10,000 or log 4  6  10 X 10 X 10 X 10 X 10 =  99.9999%  0.01 or log -2 
1,000,000-fold 
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., 194F (90oC)) 
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 non-
proteolytic 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 high-
pressure 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. 
  D  value  Amount of radiation required to reduce the population of a specific microorganism by 90% 
10
(one log  cycle) under the stated conditions. 
10
  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 27 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 (D  values) for the most 
10
important non-sporeforming pathogenic bacteria determined in various foods under various 
conditions. 
 
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Table 4-7. D  Values (kGy) for Some Foodborne Non-sporeforming Pathogenic Bacteria 
10
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,  Minimum dose 0.3 kiloGray (kGy) (30 
non-heat-processed cuts of pork carcasses  kilorad (krad)); maximum dose not to 
exceed 1 kGy (100 krad). 
For microbial disinfection of dry or dehydrated enzyme  Not to exceed 10 kGy (1 megarad 
preparations (including immobilized enzymes)  (Mrad)). 
For microbial disinfection of the following dry or dehydrated  Not to exceed 30 kGy (3 Mrad). 
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 
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Use  Limitations 
For control of food-borne pathogens in fresh (refrigerated or  Not to exceed 4.5 kGy for non-frozen 
unrefrigerated) or frozen, uncooked poultry products that are:  products; not to exceed 7.0 kGy for 
(1) Whole carcasses or disjointed portions (or other parts) of  frozen products. 
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) 
For the sterilization of frozen, packaged meats used solely in  Minimum dose 44 kGy (4.4 Mrad). 
the National Aeronautics and Space Administration space flight  Packaging materials used need not 
programs  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  Not to exceed 4.5 kGy maximum for 
shelf-life of, refrigerated or frozen, uncooked products that are  refrigerated products; not to exceed 7.0 
meat within the meaning of 9 CFR 301.2(rr), meat byproducts  kGy maximum for frozen products. 
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 
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  Not to exceed 5.5 kGy. 
microorganisms in or on fresh or frozen molluscan shellfish. 
For control of food-borne pathogens and extension of shelf-life  Not to exceed 4.0 kGy. 
in fresh iceberg lettuce and fresh spinach. 
For control of foodborne pathogens, and extension of shelf-life,  Not to exceed 4.5 kGy. 
in unrefrigerated (as well as refrigerated) uncooked meat, meat 
byproducts, and certain meat food products 
For control of food-borne pathogens in, and extension of the  Not to exceed 6.0 kGy. 
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 
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 23F (-5C) to 194F (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  Optimum Temperature  Maximum Temperature 
C (F)  C (F)  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 131F (55C). 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 41F (5C) and to keep hot foods above 135F (57C). 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 (41F (5C) to 135F (57C)) 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 (41F (5C) to 135F (57C)). 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 time-
temperature 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 135F (57C)) 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 135F (57C) to 70F (21C) 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 70F 
(21C), you can take up to additional 4 hours to get the product down to 41F (5C). FSIS also 
recommends a two part cooling for meat and poultry, but uses slightly different temperatures: 
temperature should not remain between 130F (54C) and 80F (27C) for more than 1.5 hours 
nor between 80F (27C) and 40F (4C) 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 (a ) as a Formulation Process Control 
w
Microorganisms need water to survive as well as to grow. Water activity (a ) refers to the 
w
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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(a ) = RH/100 
w
or 
a   = p/p  
w o
 
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, intermediate-
moisture 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 
  Intermediate-   Do not require refrigeration to control pathogens  
0.60 and 0.85  Moisture Foods 
  Limited shelf life because of spoilage, primarily by 
yeast & mold 
Below 0.60  Low-Moisture  Extended shelf life, even without refrigeration 
Foods 
 
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 (a ) 
w
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 (a ) 
w
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 (a ) 
w
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 dont 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 low-
acid 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  Benzoates  Natamycin  Nisin  Propionates  Sorbates  Sulfites 
Acid 
Fat Emulsions  +  +  -  -  -  ++  - 
Cheese  -  (+)  +  +  +  ++  - 
Vegetable  ++  ++  -  -  -  ++  + 
Products 
Fruit products  +  ++  -  -  -  ++  ++ 
Beverages  -  ++  -  -  -  ++  (+) 
Baked goods  +  -  -  -  ++  ++  - 
Confectionery  -  (+)  -  -  -  ++  - 
Source: Adapted from Davidson and Branen 1993; Table 11 in Luck 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 
(a ) and, therefore, are often stored and distributed unrefrigerated.  Examples of shelf-stable 
w
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  Examples   Chapter Section 
Subcategory 
Cleaning food-contact    Applying a full wet clean with detergents  4.4.1 
surfaces  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 
Control cross-contact / cross-   Using hygienic zoning for separation of  4.4.2 
contamination  process operations such as raw vs. Work-
in-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 
 
 
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 food-
contact 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)). Food-
contact 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 food-
contact 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  Uses a limited amount of water, generally for dry operations.  Complete 
Cleaning  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 cross-
contact 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 Cross-
contamination  
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  Dedicated cleaning / sanitation practices within hygiene zones  
Specific Cleaning 
Allergen Specific  Cleaning between different products containing different allergens 
Cleaning   
 
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 suppliers 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 foode.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 FDAs 
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. 
 
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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. 
Chapter 4 (Preventive Controls) - Page 42  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs 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. 
Chapter 5 (Preventive Control Management Components) - Page 1  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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 facilitys 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 Process-
Related Biological Hazards  
Preventive  Common  Applicability  Applicability  Applicability to  Applicability to 
Control   Procedures,  to Spore-  to  Bacterial Toxins  Parasites 
Practices,  Forming  Vegetative 
and  Bacterial  Bacterial 
Processes  Pathogens  Pathogens 
Process  Heat (e.g.,  In general,  Eliminates  Will not eliminate  Heat processing 
Control   cooking,  heat  vegetative  preformed toxins  will inactivate 
Lethal  roasting,  processes  cells of  of S. aureus and  parasites found 
Treatments  baking)  will not  pathogens  B. cereus emetic  in foods; specific 
eliminate  toxin  times and 
spores of  temperatures 
bacterial  are dependent 
pathogens   on the parasite, 
food matrix, and 
process used 
Process  Irradiation,  The doses  Eliminates  Will not eliminate  Limited uses for 
Control   ionizing  approved in  vegetative  preformed toxins  parasite control; 
Lethal  the U.S. will  cells of  of S. aureus and  depending on 
Treatments  not eliminate  pathogens  B. cereus emetic  dose, approved 
spores of  toxin  uses for 
bacterial  foodborne 
pathogens in  pathogens may 
most foods  inactivate 
parasites found 
in foods   
Process  Antimicrobial  Will not  Defined PPO  Unknown, but  Ozone has been 
Control   Fumigation,  eliminate  processes  unlikely to have  found to 
Lethal  e.g.,    spores of  have been  an effect on  inactivate select 
Treatments  Propylene  bacterial  shown to  preformed toxins  parasites (e.g., 
Oxide (PPO)  pathogens  reduce  of S. aureus and  C. parvum 
or Ethylene  Salmonella  B. cereus emetic  oocysts)  
Oxide (ETO)  by 5 logs in  toxin  
certain foods 
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Preventive  Common  Applicability  Applicability  Applicability to  Applicability to 
Control   Procedures,  to Spore-  to  Bacterial Toxins  Parasites 
Practices,  Forming  Vegetative 
and  Bacterial  Bacterial 
Processes  Pathogens  Pathogens 
Process  High Pressure  In general,  Eliminates  Will not eliminate    Will 
Control   Processing  HPP will not  vegetative  preformed toxins  eliminate 
Lethal  (HPP)  eliminate  cells of  of S. aureus and  parasitic 
Treatments  spores of  pathogens  B. cereus  worms of 
bacterial  (FDA, 2000)  Trichinella 
pathogens  spiralis at > 
(FDA, 2000)   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  Refrigeration  Used to  Depending  Will prevent the  Limited 
Control   control  on the  formation of  information; 
Time /  growth of  temperature,  toxins of S.  generally not 
Temperature  sporeforming   refrigeration  aureus.  applicable to 
of Holding  bacterial  will inhibit  Depending on  parasites 
pathogens  growth of  the temperature,  because 
many  will prevent  parasites do not 
pathogens.   formation of B.  grow in food 
However,  cereus toxins. 
pathogens  Will have no 
such as L.  effect on 
monocytogen preformed toxins  
es and some 
strains of B. 
cereus may 
grow at 
refrigeration 
temperatures 
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Preventive  Common  Applicability  Applicability  Applicability to  Applicability to 
Control   Procedures,  to Spore-  to  Bacterial Toxins  Parasites 
Practices,  Forming  Vegetative 
and  Bacterial  Bacterial 
Processes  Pathogens  Pathogens 
Process  Freezing  Used to  Freezing  Freezing that  There are 
Control   control  prevents  prevents growth  specific 
Time /  growth of  growth of  will prevent  schedules of 
Temperature  spore  vegetative  formation of  time and 
of Holding  forming  cells of  toxins of S.  temperature 
bacterial  pathogens.  aureus and B.  shown to 
pathogens,  Depending  cereus but have  inactivate 
but the  on the  no effect on  parasites; 
spores will  temperature,  preformed toxins   Cyclospora is 
survive  the numbers  known to be at 
freezing well  of some  least somewhat 
pathogens  resistant to 
may be  freezing 
reduced over  because an 
time;  outbreak 
however you  occurred 
cannot count  attributed to 
on freezing  raspberries in 
to eliminate  cake that was 
pathogens,  previously 
and many  frozen at about 
can survive  26F (3.3 C)  
for an 
extended 
time   
Process  Water activity  Reducing the  Reducing the  Water activity  Limited 
Control   control  water activity  water activity  that prevents  information; 
Formulation  (e.g., by  (e.g., by  growth will  generally not 
adding  adding  prevent formation  applicable to 
solutes such  solutes such  of toxins of S.  parasites 
as sugar and  as sugar and  aureus and B.  because they do 
salt) to 0.92  salt) to 0.85  cereus but have  not grow in food 
or below will  or below will  no effect on 
inhibit  inhibit growth  preformed toxins 
outgrowth of  of vegetative 
spores  cells of 
pathogens   
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Preventive  Common  Applicability  Applicability  Applicability to  Applicability to 
Control   Procedures,  to Spore-  to  Bacterial Toxins  Parasites 
Practices,  Forming  Vegetative 
and  Bacterial  Bacterial 
Processes  Pathogens  Pathogens 
Process  Acidification  Lowering the  In, general,  A pH that  No information 
Control   pH by the  you can rely  prevents growth  for use as 
Formulation  addition of  on added  will prevent  control in foods 
acid can  acid to  formation of 
inhibit spores  prevent  toxins of S. 
from  growth of  aureus and B. 
germinating,  vegetative  cereus but have 
will not  bacterial  no effect on 
eliminate the  pathogens,  preformed toxins 
spores  but you 
cannot rely 
on added 
acid to 
eliminate 
vegetative 
cells of 
bacterial 
pathogens 
Process  Adding  Will not  Various  Formulations   No information 
Control   preservatives  eliminate  preservative  that prevent  for use as 
Formulation  spores of  chemicals  growth will  control in foods 
bacterial  have specific  prevent formation 
pathogens,  action  of toxins of S. 
but  can  against some  aureus and B. 
prevent  vegetative  cereus but have 
germination  cells of  no effect on 
of spores of  bacterial  preformed toxin 
certain  pathogens 
species   and/or fungi 
that prevent 
growth 
Process  Air drying  Will not  While drying  Drying that  No information 
Control   eliminate  may  prevents growth  on effect on 
Dehydration  spores of  inactivate  will prevent  parasites in 
bacterial  some  formation of  foods  
pathogens,  pathogens,  toxins of S. 
but limits or  others (e.g.,  aureus and B. 
inhibits  Salmonella)  cereus but have 
outgrowth  may survive  no effect on 
drying for  preformed toxin 
fairly long 
times  
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Preventive  Common  Applicability  Applicability  Applicability to  Applicability to 
Control   Procedures,  to Spore-  to  Bacterial Toxins  Parasites 
Practices,  Forming  Vegetative 
and  Bacterial  Bacterial 
Processes  Pathogens  Pathogens 
Process  Freeze drying  In general,  In general,  Drying that  No information 
Control   serves to  serves to  prevents growth  on effect on 
Dehydration  preserve  preserve  will prevent  parasites in 
microorganis microorganis formation of  foods 
ms, but  ms, but  toxins of S. 
inhibits  inhibits  aureus and B. 
outgrowth  growth   cereus but have 
no effect on 
preformed toxin 
Process  Spray drying  In general,  Some  Drying that  No information 
Control   spores of  pathogens  prevents growth  on effect on 
Dehydration  bacterial  may survive  will prevent  parasites in 
pathogens  spray drying  formation of  foods  
will not be  depending  toxins of S. 
eliminated,  upon the  aureus and B. 
but inhibits  product  cereus but have 
outgrowth  formulation.  no effect on 
Growth will  preformed toxin 
be inhibited 
 
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 
Preventive 
Hazard  Examples of Preventive Controls   Chapter 
Control  
Bacterial   Process Control     Cooking of RTE soups (frozen and   
pathogens that  Lethal Treatments  refrigerated)  6 
survive the lethal 
  Baking of RTE cookies  
treatment 
Bacterial  Process Control     Refrigeration of fresh fruit salads    
pathogens that  Time /  7 
  Control of temperature during 
grow, including  Temperature of 
thawing to prevent microbial growth 
those that produce  Holding 
toxin, due to time/     
temperature 
abuse 
Bacterial  Process Control -    Acidification of prepared vegetable   
pathogens that  Formulation  salads   8 
grow, including   
  Water activity control in refrigerated 
those that produce 
cookie dough 
toxin, due to poor  
formulation control 
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Preventive 
Hazard  Examples of Preventive Controls   Chapter 
Control  
Bacterial  Process Control     Drying of milk to produce spray-  
pathogens that  Drying/dehydration  dried milk powder  9 
grow, including 
 
those that produce 
toxin, due to 
inadequate drying 
Bacterial  Sanitation Control    Controlling presence of bacterial   
pathogens that   Cleaning /  pathogens in RTE prepared  10 
contaminate  sanitizing food  sandwiches by sanitation 
product due to  contact surfaces 
poor sanitation 
Recontamination  Sanitation     Use of hygienic zoning as a  10 
of an RTE product  Prevention of  component of a program for 
with an  recontamination  prevention of recontamination of ice 
environmental  from the  cream with environmental 
pathogen   environment  pathogens  
 
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  Common Procedures,  Examples of Applicability to Chemical Hazards 
Control  Practices, and Processes 
Supply-Chain  Establish and implement a risk-   Applicability to heavy metals: approved 
Program  based supply-chain program  suppliers control arsenic and lead in raw 
with supplier approval and  agricultural commodities such as rice and 
verification activities (as a  carrots  
means of ensuring that raw 
  Applicability to naturally occurring toxins: 
materials and other ingredients 
approved suppliers control growth of 
are procured from those 
mycotoxin-forming fungi in stored raw 
suppliers that can meet 
agricultural commodities that are purchased 
company specifications and 
by the facility as raw materials 
have appropriate programs in 
place)    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  Conduct verification activities    Sampling and testing (by supplier or receiving 
Program  appropriate to the hazard  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  Facility programs to control product formulation to 
procedures as appropriate   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 Process-
Related Food Allergen Hazards 
Preventive  Common Procedures,  How the Preventive  How the Preventive 
Control   Practices, and Processes  Control Can Significantly  Control Can Significantly 
Minimize or Prevent  Minimize or Prevent 
Undeclared Food  Undeclared Food 
Allergens due to  Allergens due to Cross-
Incorrect Product Label  Contact 
Allergen  Perform label design and  Label design and review  N/A 
Control   review during product  minimize the potential for 
Labelling  development prior to  the label to not identify all 
commercialization and  of the food allergens 
label review for each new  present in the food 
batch of labels received.   
Allergen  Implement procedures for  Label application  N/A 
Control   application of correct label  procedures can help 
Labelling  to product.   minimize the potential for 
an incorrect label to be 
applied to an allergen- 
containing food 
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Preventive  Common Procedures,  How the Preventive  How the Preventive 
Control   Practices, and Processes  Control Can Significantly  Control Can Significantly 
Minimize or Prevent  Minimize or Prevent 
Undeclared Food  Undeclared Food 
Allergens due to  Allergens due to Cross-
Incorrect Product Label  Contact 
Allergen  Identify and mark food  N/A  Clearly identifying food 
Control   allergen-containing  allergens associated with 
Allergen  ingredients (e.g., by color  raw materials or other 
cross-contact  coding or with food  ingredients simplifies 
allergen icons) at  handling practices to 
receiving.   prevent allergen cross-
contact 
Allergen  Segregate and store food  N/A  Segregation of different 
Control   allergen-containing  food allergens can 
Allergen  materials at receiving and  minimize the potential for 
cross-contact  warehousing.  allergen cross-contact 
during storage 
Allergen  Open and handle food  N/A  Handling food allergens 
Control   allergen-containing  separately can minimize 
Allergen  ingredients at separate  the potential for inadvertent 
Cross-contact  times / contain by using  incorporation of a food 
separate rooms, or by  allergen into a product for 
scheduling use of the  which it is not an ingredient 
same rooms at different 
times. 
Allergen  Schedule production of  N/A  Production scheduling can 
Control   products based on food  minimize the potential for 
Allergen  allergen-containing  inadvertent incorporation of 
Cross-contact  recipes. Schedule  food allergen into a product 
production of products that  for which it is not an 
do not contain food  ingredient 
allergens before production 
of products that do contain 
food allergens or schedule 
production of products with 
a unique food allergen last. 
Allergen  Physically separate  N/A  Separating processes 
Control   processes for products that  containing different food 
Allergen  do not contain food  allergens can minimize the 
cross-contact  allergens from products  potential for inadvertent 
that do contain food  incorporation of food 
allergens or separate  allergen into a product for 
processes for products that  which it is not an ingredient 
do not contain the same 
food allergens 
Allergen  Implement production  N/A  Control of rework can 
Control   procedures for rework and  minimize the potential for 
Allergen  work-in-process (WIP):  inadvertent incorporation of 
cross-contact  using like into like,  food allergen into a product 
appropriate storage and  for which it is not an 
handling, tracking  ingredient 
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Preventive  Common Procedures,  How the Preventive  How the Preventive 
Control   Practices, and Processes  Control Can Significantly  Control Can Significantly 
Minimize or Prevent  Minimize or Prevent 
Undeclared Food  Undeclared Food 
Allergens due to  Allergens due to Cross-
Incorrect Product Label  Contact 
Sanitation  Use full wet cleaning to  N/A  Cleaning can minimize the 
Control   remove food allergen  presence of food allergen 
Cleaning food  residues prior to producing  residues, preventing 
contact  a product that does not  inadvertent incorporation of 
surfaces  contain that food allergen  food allergen into a product 
on the same line.  for which it is not an 
ingredient 
Sanitation  Use hygienic zoning for  N/A  Hygienic zoning can help 
Control   physical separation of  prevent inadvertent 
Cross-contact  process operations,  incorporation of food 
including personnel, that  allergen into a product for 
involve foods with and  which it is not an ingredient  
without a specific food 
allergen 
Sanitation  Use dedicated cleaning  N/A  Use of dedicated cleaning 
Control -   utensils and equipment for  utensils/equipment can 
Cross-contact  removing food allergen  prevent transfer of food 
residues from food  allergen residues, thereby 
processing equipment  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  Common  Applicability  Applicability to Glass  Applicability to Other 
Control  Procedures,  to Metal  Hazards (Products  Hard/Sharp Physical 
Category  Practices, and  Hazards  Packed in Glass)  Hazards 
Processes 
Process  Use screens,  Physically  Physically removes  Physically removes hard 
Control   flotation tanks,  removes metal  glass   plastic, wood, stones 
Exclusion  riffle board,  fragments  
sifters, magnets, 
inversion/air to 
exclude metal 
and glass 
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Preventive  Common  Applicability  Applicability to Glass  Applicability to Other 
Control  Procedures,  to Metal  Hazards (Products  Hard/Sharp Physical 
Category  Practices, and  Hazards  Packed in Glass)  Hazards 
Processes 
Process  Use metal or X- Metal and X- X-ray detectors detect  X-rays can often detect 
Control   ray detectors to  ray detectors  glass pieces, which  hazardous objects such 
Detection  detect and divert  detect metal  generally  allows for  as hard plastic, stones, 
foods containing  pieces, which  exclusion of foods  bones, pits 
metal and glass  generally   containing glass 
allows for   
exclusion of 
foods 
containing 
metal 
 
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 facilitys 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. 
Chapter 5 (Preventive Control Management Components) - Page 16  
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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 Water-
Resources 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. 
Chapter 5 (Preventive Control Management Components) - Page 17  
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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. 
Chapter 5 (Preventive Control Management Components) - Page 18  
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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: 
1
Draft Guidance for Industry  
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 FDAs 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. 
Chapter 6 (Heat Treatments) - Page 1  Contains Non-binding Recommendations 
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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 As Heat Treatment 
6.12.1 Cookie Processor As Product, Hazard Analysis, and Batch Heat Treatment 
6.12.2 Cookie Processor As Process Design and Validation 
6.12.3 Cookie Processor As 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 As heat treatment 
6.12.4 Cookie Processor As Corrective Action Procedures 
6.12.5 Cookie Processor As Verification Procedures 
6.12.6 Cookie Processor As Monitoring Records 
6.12.7 Cookie Processor As Records of Corrective Actions 
6.12.8 Cookie Processor As Verification Records 
6.12.9 Summary Process Control Table for Cookie Processor A 
6.13  Example of Cookie Processor Bs Heat Treatment 
6.13.1 Cookie Processor Bs Product, Hazard Analysis, and Continuous Heat 
Treatment 
6.13.2 Cookie Processor Bs Process Design and Validation 
6.13.3 Cookie Processor Bs 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 Bs heat treatment 
6.13.4 Cookie Processor Bs Corrective Action Procedures 
6.13.5 Cookie Processor Bs Verification Procedures 
6.13.6 Cookie Processor Bs Monitoring Records 
6.13.7 Cookie Processor Bs Records of Corrective Actions 
6.13.8 Cookie Processor Bs Verification Records 
6.13.9 Summary Process Control Table for Cookie Processor B 
6.14  Example of Soup Processor As Heat Treatment 
6.14.1 Soup Processor As Product, Hazard Analysis, and Batch Heat Treatment 
6.14.2 Soup Processor As Process Design and Validation 
6.14.3 Soup Processor As 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 As heat treatment 
6.14.4 Soup Processor As Corrective Action Procedures 
6.14.5 Soup Processor As Verification Procedures 
6.14.6 Soup Processor As Monitoring Records 
6.14.7 Soup Processor As Records of Corrective Actions 
6.14.8 Soup Processor As Verification Records 
6.14.9 Summary Process Control Table for Soup Processor A 
6.15  Example of Soup Processor Bs Heat Treatment 
6.15.1 Soup Processor Bs Product, Hazard Analysis, and Continuous Heat Treatment 
6.15.2 Soup Processor Bs Process Design and Validation 
6.15.3 Soup Processor Bs 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 Bs heat treatment 
6.15.4 Soup Processor Bs Corrective Action Procedures 
6.15.5 Soup Processor Bs Verification Procedures 
6.15.6 Soup Processor Bs Monitoring Records 
6.15.7 Soup Processor Bs Records of Corrective Actions 
6.15.8 Soup Processor Bs Verification Records 
6.15.9 Summary Process Control Table of Soup Processor B 
6.16  Example of Salsa Processor As Heat Treatment 
6.16.1 Salsa Processor As Product, Hazard Analysis, and Heat Treatment 
6.16.2 Salsa Processor As Process Design and Validation 
6.16.3 Salsa Processor As 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 As heat treatment 
6.16.4 Salsa Processor As Corrective Action Procedures 
6.16.5 Salsa Processor As Verification Procedures 
6.16.6 Salsa Processor As Monitoring Records 
6.16.7 Salsa Processor As Records of Corrective Actions 
6.16.8 Salsa Processor As 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,  8 
and chemical preservatives) 
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 facilitys 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., 350F (177C) 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 
facilitys 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 
individuals 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;  
  Visually checks data generated by a continuous monitoring device to ensure that the 
o
critical limits have consistently been met4;  
  Monitors the temperature for manual (non-automated or non-continuous) devices; 
o
and  
  Performs other monitoring activities that occur on the processing line. 
o
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 facilitys 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 facilitys 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 process-
specified temperature or time or when other critical limits are not met;  
  Verification activities for implementation of the heat treatment such as:  
  Calibration records for monitoring/measuring devices, and a review of the calibration 
o
records; 
  Review of process records (e.g., logs of IT, process temperatures, process times, 
o
temperature charts); 
  Review of any corrective actions taken as a result of a deviation from any of the 
o
critical limits for the heat treatment; and 
  Any other verification activities conducted, including any product testing used to 
o
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: 
  Recorder charts; 
o
  When applicable, records documenting the visual checks of recorded data (e.g., a 
o
hand written note on the recorder charts); and  
  When applicable, records noting the start time and end time of the cooking or baking 
o
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: 
  The calibration of measuring devices (such as thermometers, RTDs, timers, and 
o
scales); 
  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;  
o
  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 As Heat Treatment  
6.12.1  Cookie Processor As 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 As 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 As food 
safety plan, Cookie Processor As 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 As PCQI 
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consulted with a local universitys extension specialist in process design and validation of heat 
treatments. Cookie Processor As 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 As Process Design and Validation  
The extension specialist provided Cookie Processor As 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 (a ) of 0.82) and baked at 350F 
w
(177C) 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 229F (109C).  
The extension specialist identified the following processing parameters that need critical limits 
for food safety in Cookie Processor As 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 As convection oven, and demonstrate that these critical limits can be 
achieved in Cookie Processor As convection oven, the extension specialist conducted in-house 
heat distribution tests on Cookie Processor As 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 As oven were at or above 350F (177C) 
when the ovens were set at that temperature and that the coldest cookie temperature was 
above 230F (110C) after 13 minutes. In addition, a  determinations by an outside laboratory 
w
on the cookie dough were equal to or greater than 0.82 using Cookie Processor As 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 350F 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 As 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 350F (177C);  
  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 As PCQI 
also established three operating limits for the production of the cookies:  
  The operating limit for the baking temperature is 352F (178C);  
  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 352F (178C) ovens for 15 minutes.  
6.12.3  Cookie Processor As 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 350F 
(177C); 
  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 As 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 As Corrective Action Procedures 
Cookie Processor As corrective action procedures specify that: 
  If cookies were baked in an oven that was not at least 350F (177C), 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:  
  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 
o
deliver an incorrect weight so that actions can be taken to prevent such occurrences; 
and  
  The dough depositor will be adjusted to deliver the correct weight. 
o
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 As Verification Procedures 
At Cookie Processor A: 
  The following are calibrated at least annually: 
  The recording thermometer that monitors oven temperature;  
o
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  The dough depositor; and  
o
  The scales used to check the weights of cookie portions.  
o
  Within a week of their creation, the PCQI: 
  Reviews calibration logs (records of calibrating monitoring equipment) to make sure 
o
that the devices are properly calibrated using the appropriate methods and at the 
appropriate frequencies as specified in the calibration procedures;  
  Checks the baking record sheets and the temperature recording chart for monitoring 
o
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 350F (177C) and 
that the cookies were baked for 15 minutes; 
  Checks the dough weight logs for the cookie dough portion weighing records to verify 
o
that none of the dough portions exceeded 28 g in weight; and 
  Initials and dates each of the records reviewed in the place marked Verified by. 
o
  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 As 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 As Records of Corrective Actions 
Cookie Processor A keeps records: 
  Documenting that cookies placed in an oven that was not at least 350F (177C) 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 As Verification Records  
Cookie Processor A maintains records, initialed and dated by the PCQI, of the PCQIs 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 FSPCAs 
Process Control Form (Form 2-C (Modified) from Appendix 2). 
6.13  Example of Cookie Processor Bs Heat Treatment  
6.13.1  Cookie Processor Bs 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 Bs 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 Bs food safety plan, 
Cookie Processor Bs 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 Bs 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 Bs 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 Bs Process Design and Validation  
The process design specialist provided Cookie Processor Bs 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, a  of 0.82) and baked at 350oF (177C) 
w
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 229F (109C).  
The process design specialist identified the following processing parameters that need critical 
limits for food safety in Cookie Processor Bs heat treatment: 
  Band oven temperature (oF) 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 Bs continuous band oven, and demonstrate that these critical limits can be achieved 
in Cookie Processor Bs continuous band oven, the process design specialist conducted in-
house 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 
350oF (177C) at the coldest spot in the oven at a set point temperature of 350oF (177C) (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 231oF at the end 
of a 13.0-minute baking time.6  
  Because the operating limit for Cookie Processor Bs 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 231oF) 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 Bs 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 350F (177C) oven setting. 
Based on the information obtained from the process design specialist, Cookie Processor Bs 
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 350F (177C);  
  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 Bs 
PCQI also established three operating limits for the production of the cookies:  
  The operating limit for the baking temperature is 352F (178C);  
  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 352F (178C) band oven for 15 minutes. 
6.13.3  Cookie Processor Bs 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 operators 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 350oF) (177C);  
  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 Bs 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 Bs Corrective Action Procedures 
Cookie Processor Bs corrective action procedures specify that: 
  If cookies were baked in an oven that was not at least 350F (177C):  
  The cookies will be diverted to further processing (e.g., baking for cookie crumbles 
o
ingredient production) or to animal food (non-pet food);  
  Maintenance will determine the cause of the low temperature and fix the oven so the 
o
temperature is reset to the operating limit of 352F (178C) before more cookies are 
baked; and  
  Employees will be retrained, if necessary, on the importance of ensuring that the 
o
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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  The cookies will be put on QC hold. The PCQI will determine whether the product will 
o
be diverted to further processing (e.g., baking) to make cookie crumbles as a baking 
ingredient or to animal food (non-pet food); and  
  The PCQI will conduct an investigation to determine why the bake time was not met 
o
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:  
  The PCQI will determine whether the product will be further processed into 
o
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 
  The dough depositor will be adjusted by maintenance or by the equipment 
o
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 Bs Verification Procedures 
At Cookie Processor B:  
  The following are calibrated at least annually:  
  Recording thermometer and chart that monitors oven temperature;  
o
  The automated tachometer and recorder chart that monitors belt speed (baking 
o
time);  
  The dough depositor; and  
o
  The scales used to check the weights of cookie portions.  
o
  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 350F (177C) 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, operators 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: 
  The calibration logs to make sure that the devices are properly calibrated using the 
o
appropriate methods and at the appropriate frequencies as specified in the 
calibration procedures; and  
  The oven recording thermometer charts, operators baking log, tachometer charts, 
o
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 Bs Monitoring Records 
Cookie Processor B keeps: 
  The recording charts of the recording thermometer and the operators 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 Bs 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 Bs 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;  
  Operators 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 FSPCAs 
Process Control Form (Form 2-C (Modified) from Appendix 2). 
6.14  Example of Soup Processor As Heat Treatment  
6.14.1  Soup Processor As 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 180F (82C) 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 As 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 steam-
jacketed kettle maintained at a minimum of 180F (82C) was the preventive control to address 
this hazard. Soup Processor As 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 As 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 As Process Design and Validation  
Using Table 3-D in Appendix 3 of this guidance, Soup Processor As PCQI determined that 0.05 
minutes (3 seconds) at 180F 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 180F (82C), 
and because more than 3 seconds would elapse before cooling from 180F could begin, Soup 
Processor As PCQI decided to use an EPIPT and cook the soups until the temperature reaches 
180F 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 As PCQI determined that 
as long as vegetable particles in the soup did not exceed 12 inch (13 mm) square, the particles 
would also be at 180F when the liquid portion of the soup reached that temperature, provided 
that the particles were stored refrigerated (i.e., at least 33F) (0.6 C) and not frozen. (Soup 
Processor As SOPs specify that vegetable particles are stored refrigerated at a temperature of 
33 - 40F (0.6 - 4 C).)  
Soup Processor A established two critical limits for the production of the soup to ensure 
adequate lethality:  
  Minimum EPIPT of 180F (82C); and 
  Maximum size of vegetable particles (12 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 As 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 12 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 170F (77C), until the temperature reaches 180F (82C); 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 As 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 As Corrective Action Procedures 
Soup Processor As corrective action procedures specify that: 
  If it is determined that the EPIPT did not reach 180F (82C) 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 180F. Any packages that have already been 
frozen will be destroyed; 
  If it is determined that the EPIPT did not reach 180F (82C) 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 180F (82C) 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 180F; and 
  If it is determined that the mean plus 2.5 standard deviation of the vegetable particle sizes 
exceeds 12 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 As Verification Procedures 
At Soup Processor A: 
  The thermometers used to measure soup temperature are: 
  Checked for accuracy at least daily by the QC technician; and 
o
  Calibrated by the QC technician against a NIST-calibrated reference thermometer at 
o
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: 
  Reviews monitoring records (cook logs) to confirm that all soups were cooked to a 
o
minimum temperature of 180F (82C) as indicated by the records of the EPIPT 
readings;  
  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 
o
soup did not exceed 12 inch (13 mm) in size; and 
  Before a lot of soup is released, the PCQI reviews corrective action records as part of a pre-
shipment 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 As 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 As Records of Corrective Actions 
Soup Processor A keeps records: 
  Of the reprocessing of product (e.g., recooked to 180oF) (82C) 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 
suppliers 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 As 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 FSPCAs 
Process Control Form (Form 2-C (Modified) from Appendix 2). 
6.15  Example of Soup Processor Bs Heat Treatment  
6.15.1  Soup Processor Bs 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 Bs PCQI, a food scientist/food engineer who functions as the facilitys 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 Bs 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 Bs 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 Bs 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 Bs 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 Bs Process Design and Validation  
Using Table 3-E of Appendix 3 of this guidance, Soup Processor Bs 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 185F (85C) would minimize risk of recontamination after the heat treatment.  
Based on an assessment and review of the scientific literature, Soup Processor Bs PCQI/ food 
processing expert decided to use a process of 205F (96C) for 2.5 minutes (equivalent to a 
minimum temperature of 194F (90C) 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 40oF - 45oF (4C- 7C); 
  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 
40oF and 45oF) (4C- 7C)) 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 > 185oF (85C); 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 Bs 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 40oF and 45F) (4C- 
7C); 
  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 
205oF) (96C); and 
  Temperature of the heat-treated soup in the agitated hot-holding surge tank (minimum value 
of 185oF) (85C). 
6.15.3  Soup Processor Bs 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 heat-
treated 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 pre-
process 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 Bs 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 Bs Corrective Action Procedures 
Soup Processor Bs corrective action procedures specify: 
  A list of: 
  Those soups that can be fully reprocessed in instances where soup was under-
o
processed; and  
  Those soups that cannot be fully reprocessed and therefore will be diverted to animal 
o
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: 
  The product will be held until the PCQI determines whether the process was 
o
adequate or if the soup can be reprocessed; and 
  The production manager will investigate why the IT was too low and take appropriate 
o
actions to prevent the situation from reoccurring.  
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  If the metering pump speed during production of the soup was too fast: 
  Any ongoing production will be stopped and affected product will be held until the 
o
PCQI evaluates the safety of the product;  
  The PCQI will assess the safety of the product and determine whether it will be 
o
released, re-processed, diverted to animal food (non-pet food), or destroyed; and 
  The production manager will investigate why the pump speed was too fast and take 
o
appropriate actions to prevent the situation from reoccurring. 
  If the incorrect hold tube was used:  
  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 
o
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: 
  The PCQI will assess the safety of the product to determine appropriate disposition; 
o
and  
  The production manager will investigate the low temperature and the diversion failure 
o
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:  
  The product will be held until the PCQI determines whether the temperature was 
o
adequate for safety or if the soup should be reprocessed, diverted to animal food 
(non-pet food), or destroyed.  
  The production manager will investigate why the temperature was too low and take 
o
appropriate actions to prevent the situation from reoccurring. 
6.15.5  Soup Processor Bs 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 heat-
treated 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 Bs 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 : 
  Reviews recorder charts and pump speed log with the hold tube identification to 
o
confirm that the soup was cooked at the specified temperature of 205F (96C) for a 
minimum of 2.5 minutes; and 
  Checks the other process logs to confirm that the soup in the pre-process agitated 
o
surge tank was maintained at an IT between 40F and 45F (4C- 7C), that the 
temperature of the heat-treated soup at hold tube exit was at least 205 F (96C), 
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 
> 185oF (852C), 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 Bs 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 Bs 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: 
  The IT of the untreated soup was too low;  
o
  The metering pump speed was too fast;  
o
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  An incorrect hold tube was used;  
o
  The RTD at the end of the hold tube recorded a low temperature and the heat-
o
treated soup was not diverted to the batch tank for automatic reprocessing; or 
  The temperature for the heat-treated soup held in the agitated hot-holding surge tank 
o
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 Bs 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.:  
  The temperature recording chart for all RTD probes (IT of the untreated soup exiting 
o
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 exiting the 
o
blend tank, the temperature of heat-treated soup exiting the hold tube, and 
temperature at the agitated hot-holding surge tank); and  
  The process logs for each line with pump speeds and hold tube number for the 
o
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 FSPCAs 
Process Control Form (Form 2-C (Modified) from Appendix 2). 
6.16  Example of Salsa Processor As Heat Treatment  
6.16.1  Salsa Processor As 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 As PCQI is also a thermal process authority for the 
purpose of establishing a scheduled process in accordance with part 114.9 
Salsa Processor As product consists of chopped vegetables (i.e., tomatoes, long green chilies, 
onions, jalapeno 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 As 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 As 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 As salsa is acidified to pH 4.1; thus Salsa 
Processor As PCQI/process authority determined that the heat treatment should target 
vegetative pathogens such as Salmonella, E. coli O157:H7, and Listeria monocytogenes. Salsa 
Processor As 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 As Process Design and Validation  
Based on an assessment and review of scientific literature, Salsa Processor As PCQI/ process 
authority selected a process (158F (70C) 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 As 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 As PCQI/process authority also determined that a process that delivers 200F (93C) 
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 158F (70C) when the liquid 
portion of the salsa reached that temperature, provided that the particles were stored 
refrigerated (i.e., at least 33F (0.6C)) and not frozen. (Salsa Processor As SOPs specify that 
vegetables to be chopped are stored refrigerated (at a temperature of 33 - 40F (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 As 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 200F (93C); 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 200F (93C); 
  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 As 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 (158F) (70C)11; 
  Minimum process time for the salsa (1.5 minutes); 
  Minimum temperature of the heat-treated salsa in the filling surge tank (158F) (70C); 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 As 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 
200F (93C) or higher in the cook kettle (which ensures that the critical limit of 158F (70C) 
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 200F (93C) 
for 2 minutes. 
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  Collects a statistically-based sample of vegetable particles (e.g., chopped tomatoes, green 
chilies, onions, jalapeno 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 in-
process 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 As 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 As Corrective Action Procedures 
Salsa Processor As 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:  
  The product will be held until the PCQI determines whether the process was 
o
adequate for safety or if the product should be reprocessed or destroyed;  
  The production manager will investigate why the under-processing occurred and take 
o
appropriate actions to prevent the situation from reoccurring; and 
  Employees will be retrained if necessary in light of the reason for the under-
o
processing; 
  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 
o
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 
o
take appropriate actions to prevent the situation from reoccurring; and 
  Employees will be retrained if necessary; and 
o
  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 
o
adequate or if the product can be reprocessed;  
  The production manager will investigate why the belt speed deviated from the 
o
process set point and take appropriate actions to prevent the situation from 
reoccurring; and 
  Employees will be retrained if necessary in light of the reason for the belt speed 
o
deviation. 
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6.16.5  Salsa Processor As 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 : 
  Checks process logs to confirm that the particle size of the chopped vegetables was 
o
at the specified value of < 1 cm (0.4 inch); 
  Reviews process logs and recorder charts to confirm that the in-process salsa was 
o
cooked to 200F (93C) for a minimum of 2.0 minutes, and checks that process log 
temperatures agree with the recorder; 
  Reviews process logs and recorder charts to confirm that the jars were filled at the 
o
specified temperature of >200F (93C), and checks that process log temperatures 
agree with the recorder charts; and  
  Reviews the recorded RPM for the conveyor belt to confirm that the jars were 
o
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 As 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 in-
process 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 As 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: 
  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;  
o
  Of the reprocessing of a product that can be reprocessed if: 
  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; 
o
  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 As 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:  
  Each temperature recording chart for all RTD probes (cook kettle and filling surge 
o
tank); 
  The process logs for the temperature checks (cook kettle and filling surge tank);  
o
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  The recording charts for the automated tachometer on the jar inversion conveyor 
o
belt;  
  The process logs for checks of the particle size of the chopped vegetables and belt 
o
speed of the jar inversion conveyor belt; and 
  The date and initials in the calibration log of the PCQIs review of the results of the outside 
calibration services 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 PCQIs 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 PCQIs 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 FSPCAs 
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: 635639. 
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. 
 
Chapter 6 (Heat Treatments) - Page 45  
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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 
12
FORM 2-C (Modified)  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  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records13 
Limits  Monitor  Monitoring  Monitors 
Minimum  Temperature    Recording  Continuous  Baker  If oven was not at least 350F    Annual calibration of    Baking record 
oven  of oven  thermometer in  recording  (177C):  thermometer  sheets 
temperature  oven   during each    Cookies will be diverted to    Records review by PCQI    Temperature 
of 350F  batch; manual 
  Manual check  cattle feed; and   within one week of record  recording charts 
(177C)  check before 
(operating  of recording chart  putting cookies    Employees will be retrained  creation (baking sheets,    Calibration records 
l(i1m7i8t isC 3))5 2F  arbenacdtco hmrd nainurgkm  twbhieethr   the  in oven   otrhenaa ttc hthheee dim  otpvheoenr st aetent mcpeop ieonrft a.e tnusreu rhinags   tce amliRbpreeavrtaiieotwunr  eloo fgr ecsoc) orrredcintigve c haactrito, n  re cCorodrsre ctive action 
  Record  records within one week of a 
temperature on  deviation 
baking record 
sheet 
                                                
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. 
Chapter 6 (Heat Treatments) - Page 46  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Critical  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records13 
Limits  Monitor  Monitoring  Monitors 
Minimum  Time in oven  On baking record  Each batch  Baker  If the bake time is less than 13    Records review by PCQI    Baking record 
process time  sheets:  minutes:   within one week of record  sheets 
of 13 minutes    Record time    Cookies will be diverted to  creation (Baking record    Corrective action 
(operating  sheets) 
that cookies are  cattle feed; and  records 
limit is 15 
minutes)  placed in the    PCQI determines why the    Review of corrective action 
oven  bake time was not met to  records within one week of a 
  Calculate and  prevent this from happening in  deviation 
record the time  the future. 
when the cookies 
should be 
removed from 
oven 
  Record time 
that cookies are 
removed from the 
oven 
  Calculate the 
elapsed baking 
time  
Dough    Dough    Check set    Check set  QC  If dough weight exceeds 28 g:    Annual calibration of dough    Dough weight log  
weight 28 g  depositor  point of depositor  point every 2  technician    Product will be diverted to  depositor and scales    Calibration records  
(liompiet risa tin2g7  g)  setting    Weigh dough  hours  cattle feed;    Records review by PCQI    Corrective action 
  Dough  portions    Weigh    PCQI will determine (if  within one week of record  records 
weight  dough  possible) what caused the  creation (calibration logs, 
portions twice  depositor to deliver an incorrect  dough weight logs) 
per shift  weight; and.     Review of corrective action 
  Dough depositor adjusted to  records within one week of a 
deliver correct weight.  deviation 
 
   
Chapter 6 (Heat Treatments) - Page 47  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Appendix 6-B:  Summary Process Control Table for Baking; Cookie Processor B 
14
FORM 2-C (Modified)  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  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records15 
Limits  Monitor  Monitoring  Monitors 
Minimum  Temperature  Recording  Continuous  Baker  If oven was not at least 350F    Annual calibration of    Operators baking 
oven  of oven at the  thermometer in  recording during  (177C):  oven thermometer and  log 
temperature  identified cold  oven, visual check  each batch with    Cookies will be diverted to  temperature recording    Temperature 
of 350F  spot  of recording chart,  visual check  chart 
further processing (baking for  recording chart 
(177C)  with a note of the  every hour 
(operating  check in the  cookie crumbles) or cattle feed;     QC technician check of    Calibration records 
limit is 352F  operators baking    Maintenance will determine  thermometer recording  for thermometer and 
(178C))  log  the cause of the low temperature  chart  temperature recording 
and fix the oven so the    Records review by  chart  
temperature is at least 350 F  PCQI within 7 days of    Corrective action 
(177C) before more cookies are  record creation (operators 
records 
baked; and  baking log, temperature 
  Employees will be retrained if  recording chart, calibration 
necessary.  log) 
  Review of corrective 
action records at the end 
of each week 
                                                
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. 
Chapter 6 (Heat Treatments) - Page 48  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Critical  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records15 
Limits  Monitor  Monitoring  Monitors 
Maximum  Belt speed   Automated  Continuous  Baker  If the tachometer reading    Annual calibration of    Recording chart for 
belt speed  (tachometer  tachometer with  recording during  indicates that the baking time is  tachometer and its  automated tachometer 
(tachometer  RPM)  recorder chart and  each batch with  less than 13 minutes:  recorder chart    Calibration records 
RPM) to  visual observation  visual check at    The cookies  are placed on    QC technician check of  for tachometer and its 
achieve a  of tachometer  start-up and twice 
hold;  tachometer recording chart  recording chart 
minimum  RPM  per shift 
process time    The PCQI assesses whether    Records review by    Corrective action 
of 13 minutes  the cookies will be diverted to  PCQI within 7 days of  records 
(operating  bake as cookie crumbles or  record creation 
limit is  diverted to cattle feed; and   (tachometer chart, 
maximum    The PCQI determines why the  calibration logs) 
tachometer  bake time was not met and    Review of corrective 
RPM to  informs management of actions  action records at the end 
achieve a  they need to take to prevent this  of each week  
process time  from happening. 
of 15 
minutes) 
Dough    Dough    Check set    Check set  Dough  If dough weight exceeds 28 g:    Annual calibration of    Dough weight 
weight 28 g  depositor  point of depositor  point at start-up  preparer    PCQI will determine whether  dough depositor and  record sheets 
(operating  setting    Weigh dough  and every 2  the product will be further  scales    Calibration records 
limit is 27 g)    Dough  portions  hours  processed or diverted to cattle    QC technician check of  for dough depositor 
weight    Weigh dough  feed; and   dough weight log twice per  and scales 
portions twice    PCQI will determine (if  shift    Corrective action 
per shift  possible) what caused the    Records review by  records 
depositor to deliver an incorrect  PCQI within 7 days of 
weight.   record creation (calibration 
  Dough depositor adjusted to  logs, dough weight logs) 
deliver correct weight.    Review of corrective 
action at the end of each 
week 
 
   
Chapter 6 (Heat Treatments) - Page 49  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Appendix 6-C:  Summary Process Control Table for Cooking; Soup Processor A 
16
FORM 2-C (Modified)  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. 
Chapter 6 (Heat Treatments) - Page 50  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
 
Critical  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records17 
Limits  Monitor  Monitoring  Monitors 
Minimum soup  Temperature of  Thermometer  Begin after 30  Kettle cook    If EPIPT did not reach 180F    PCQI reviews cook    Cook log of 
temperature of  soup in kettle   inserted into  min; then  operator  (82C) and soup is being  log weekly.  monitoring 
180F (82C)  soup in top inch  every 10 min  packaged but has not been    QC technician  temperature  
(EPIPT)  (2,5 cm) of  after reaching  frozen: stop packaging and  calibrates thermometers    Thermometer 
kettle;  170F (77C)  reprocess soup until the EPIPT 
against NIST reference  calibration and 
measured  until the EPIPT  reaches 180F.  Packages that 
thermometer at least  accuracy checks log  
temperature is  is reached  have been frozen will be 
recorded in the  (180F (82C))  destroyed.   annually; PCQI reviews    Corrective action 
the calibration log within 
cook log  records  
  If EPIPT did not reach 180F  a week of the calibration. 
(82C) and soup has been    QC technician checks 
packaged and frozen, the PCQI 
accuracy of 
will assess the safety of the 
thermometers daily; 
product to determine appropriate 
PCQI reviews these 
disposition. If process delivered 
accuracy checks on a 
was inadequate to ensure product 
weekly basis. 
safety, soup will be diverted to 
animal food or destroyed.    PCQI reviews 
corrective action records 
  If soup is packaged before the 
before shipment of each 
EPIPT reaches 180F (82C) due 
lot of soup. 
to operator error, the kettle cook 
operator will be retrained. 
Maximum  Size of diced  Collect a  Every third lot  Formulation  If vegetable particle sizes exceed    QC technician checks    Vegetable particle 
particle size  carrots,  statistically- on receipt  control  12 inch (13 mm):   accuracy of digital  size log  
no greater  potatoes, onions  based sample of  operator    The lot of vegetables is  calipers before use.    Digital caliper 
than 12 inch  vegetable 
rejected and unopened packages    PCQI reviews particle  accuracy check logs  
(13 mm) in  particles and 
any direction  then use digital  are returned to the supplier;   measurement log and    Corrective action 
calipers to    PCQI discusses with the  accuracy checks of the  records  
ensure they do  supplier so the supplier can  digital calipers weekly. 
not exceed 12  investigate the root cause for    PCQI reviews  
inch (13 mm) in  incorrect particle size; and  corrective action records 
any direction;    Formulation control operator  before shipment of each 
record the  checks vegetable particle size of  lot of soup 
measurement in  every lot for the next 15 lots.  If all 
a log  15 lots meet specification, the 
formulation control operator will 
return to monitoring every third lot. 
                                                
17 Records include the date and initials of the PCQI (or designee) as verification. 
Chapter 6 (Heat Treatments) - Page 51  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Appendix 6-D:  Summary Process Control Table for Cooking; Soup Processor B 
18
FORM 2-C (Modified)  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. 
Chapter 6 (Heat Treatments) - Page 52  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
 
Critical  What to  How to Monitor  Frequency of  Who  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 
40F (4C)  agitated  monitors IT  checked twice  soup:  recorder charts  IT 
surge tank  per shift    Product will be held until the  annually.     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    Any ongoing production will be  correct flow rate for the    Calibration records 
deliver  stopped and affected product will be  hold tubes twice a year  for flow rates 
process- held until the PCQI evaluates the  and PCQI reviews this 
specified  safety of the product; and  within 1 week.    Corrective action 
flow rate  records 
(gal/min)    The PCQI will assess the safety    PCQI reviews pump 
of the product and determine  speed log daily. 
whether it will be released, re-   PCQI reviews 
processed, diverted to animal food,  corrective action 
or destroyed.  records within one week 
  Production manager will  of when deviation 
investigate why the pump speed was  occurs. 
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. 
Chapter 6 (Heat Treatments) - Page 53  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Critical  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records19 
Limits  Monitor  Monitoring  Monitors 
Correct hold  Correct hold  Visual observation  At beginning of  Line operator  If the incorrect hold tube was used:    PCQI reviews pump    Process logs 
tube to  tube in place  that hold tube  production and     PCQI will assess the safety and  speed log with hold tube  containing hold tube 
deliver 2.5  number is correct  when soup  determine disposition of the product;   identification daily.  number for the product 
tmimineu taet  hold   fsooru tph ere scpipeec ific  variety changes     Production manager will    PCQI reviews  btheein pgu pmropc sepseseedd  l(oi.ge). ,  
specified  investigate why the incorrect hold  corrective action 
pump  tube was used; and  records within one week    Corrective action 
of when deviation  records 
speed    Employees will be retrained if  occurs. 
necessary 
Minimum  Temperature  RTD probe with  Continuous  Line operator  If soup is not automatically diverted    Outside service    Process logs for 
product  at end of hold  recording chart  recording of  for reprocessing when the  calibrates RTDs and  temperature checks of 
temperature  tube  monitors  product at hold  temperature at the end of the hold  recorder charts  hold tube exit 
at end of  temperature at  tube exit  tube is low:  annually.   temperature 
hold tube of  hold tube exit  checked twice    PCQI will assess the safety of the    PCQI reviews    Recording charts of 
205F  per shift 
product and determine appropriate  calibration logs within 1  product exiting hold 
(96C) 
disposition; and   week of creation.  tube 
  Production manager will    PCQI reviews    Calibration records 
investigate the low temperature and  recorder charts and the  for RTDs and recorder 
the diversion failure and take  process logs containing  charts 
appropriate action to fix the problem.  temperature at hold    Corrective action 
tube exit daily. 
records 
  PCQI reviews 
corrective action 
records within one week 
of when deviation 
occurs. 
Chapter 6 (Heat Treatments) - Page 54  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Critical  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records19 
Limits  Monitor  Monitoring  Monitors 
Minimum  Temperature  RTD probe with  Continuous  Line operator  If the temperature in the agitated hot-   Outside service    Process logs for 
product  in  agitated  recording chart  recording of fill  holding surge tank was below the  calibrates RTDs and  temperature checks of 
temperature  hot holding  monitors  temperature  process set point:  recorder charts  filling temperature 
in agitated  surge tank  temperature of  checked twice    Product will be held until the  annually.     Recording charts of 
hot holding  product in agitated  per shift 
PCQI determines whether the    PCQI reviews  filling temperature 
surge tank  hot-holding surge 
of 185F  tank  temperature was adequate for safety  calibration logs within 1    Calibration records 
or if the soup should be reprocessed  week of creation. 
(85C)  for RTDs and recorder 
or destroyed; and 
  PCQI reviews  charts 
  Production manager will  recorder charts and the    Corrective action 
investigate why the temperature in  process logs containing 
records 
the agitated hot-holding surge tank  temperature in the 
was too low and take appropriate  agitated hot-holding 
actions to prevent the situation from  surge tank daily. 
reoccurring. 
  PCQI reviews 
corrective action 
records within one week 
of when deviation 
occurs. 
 
 
   
Chapter 6 (Heat Treatments) - Page 55  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Appendix 6-E:  Summary Process Control Table for Heat Treatment; Salsa Processor A 
20
FORM 2-C (Modified)  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 
t r  e  a  t m   e  n  t _  _ __________________________________                                                                                                                                                    
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. 
Chapter 6 (Heat Treatments) - Page 56  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
 
Critical  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records21 
Limits  Monitor  Monitoring  Monitors 
Maximum  Particle size of    Collect   Check one in- Formulation  If the mean plus 2.5 standard deviation of  On a daily basis,    The process logs 
particle size of  the chopped  statistically- process lot of  control  the vegetable particle sizes exceeds 1 cm  the PCQI checks  for checks of the 
chopped  vegetables  based sample  each chopped  operator  (0.4 inch):  process logs to  particle size of the 
vegetables  of vegetable  vegetable once    The in-process lot of chopped  confirm that the  chopped vegetables 
(1.0 cm) (0.4  particles;  per production  vegetables is rejected and will be  particle size of the    Corrective action 
inch)  shift  chopped vegetables 
  Use digital  reworked for a different recipe.  records 
was at the specified 
calipers to    The PQCI will check with the vegetable  value  
measure  processing operator to investigate the root 
particle size;  cause of the incorrect particle size and, 
and  when applicable, notify maintenance to 
  Record  reset the vegetable chopper operation to 
results in the  specification.  
process log    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. 
                                                
21 Records include the date and initials of the PCQI (or designee) as verification. 
Chapter 6 (Heat Treatments) - Page 57  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Critical  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records21 
Limits  Monitor  Monitoring  Monitors 
Minimum  Temperature    RTD probe  Once for each  Line operator  If the RTD at the cook kettle records a low    Annual    The recording 
process  of the in- with recording  batch  temperature:   calibration of the  charts from the RTDs 
temperature  process salsa  chart monitors    The product will be held until the PCQI  RTDs and  used to monitor the 
for the salsa  in the cook  temperature of  recording chart  temperature of the in-
determines whether the process was 
(200F) (93C)  kettle  the in-process  used to measure  process salsa in the 
adequate for safety or if the product 
salsa (in top  temperature at the  cook kettle  
should be reprocessed or destroyed.  
iknecthtl e()2; .5 cm) of    The production manager will  cthoeo kd akteet talen,d w ith    The process logs 
  Visual  oincvceusrtriegda taen wdh tya kthee a upnpdroepr-rpiartoec eacstsioinngs  to  rae csaullitbsr raeticoonr dloegd.  in  foofr t hteem cpoeorka tkuertetl ec h ecks 
check of the  prevent the situation from reoccurring.  The PCQI reviews,    Corrective action 
chart; 
  Employees will be retrained if  initials, and dates  records 
  Record  necessary in light of the reason for the  the calibration logs    Of calibration of the 
temperature in  under-processing.  within a week of  RTDs and recording 
process log  their creation.  charts, with any notes 
  On a daily  by the PCQI about 
basis, the PCQI  adjustments 
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.  
Chapter 6 (Heat Treatments) - Page 58  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Critical  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records21 
Limits  Monitor  Monitoring  Monitors 
Minimum  Time that the    Visual  Once for each  Line operator  If the RTD at the cook kettle records a  On a daily basis,    Of the temperature 
process time  in-process  checks of   batch  shortened process time:   the PCQI reviews  recording chart marked 
at 200F  salsa is at the  recorder chart;    The product will be held until the PCQI  recorder charts and  with various times, and 
(93C) for the  process    Mark chart  determines whether the process was  process logs to  the process log,  
salsa (2  temperature  confirm that the in-
with batch  adequate for safety or if the product    Corrective action 
minutes)  process salsa was 
number;  should be reprocessed or destroyed.   records 
cooked for the 
  Record time    The production manager will  specified time  
when in- investigate why the under-processing 
process salsa  occurred and take appropriate actions to 
reaches  prevent the situation from reoccurring. 
process    Employees will be retrained if 
temperature in  necessary in light of the reason for the 
process log;  under-processing. 
  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 
Chapter 6 (Heat Treatments) - Page 59  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Critical  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records21 
Limits  Monitor  Monitoring  Monitors 
Minimum  Temperature    RTD probe  Twice per shift  Line operator  If the temperature at the filling surge tank    Annual    The recording 
temperature of  of the heat- with recording  is below the process set point:  calibration of the  charts from the RTDs 
the heat- treated salsa  chart monitors    The product will be held until the PCQI  RTDs and  used to monitor the 
treated salsa  held in the  temperature of  recording chart  temperature of the 
determines whether the fill temperature 
in the filling  filling surge  heat-treated  used to measure  filling surge tank 
was adequate for safety or if the product 
surge tank  tank  salsa in filling  should be reprocessed or destroyed.   the temperature at    The process logs 
(200F) (93C)  surge tank;  the filling surge 
  Visual  in veTshteig parteo dwuhcyti othne m fialln taegmepre wrailtl ure was  taanndk ,r ewsiuthlt sth e date  foofr t hteem fiplleinrga tsuurerg ceh teacnkks  
check of chart;   too low and take appropriate actions to  recorded in a    Corrective action 
  Record  prevent the situation from reoccurring.  calibration log. The  records 
temperature in    Employees will be retrained if  PCQI reviews,    Of calibration of the 
process log  necessary  initials, and dates  RTDs and recording 
the calibration logs  charts, with any notes 
within a week of  by the PCQI about 
their creation  adjustments 
  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. 
Chapter 6 (Heat Treatments) - Page 60  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Critical  What to  How to Monitor  Frequency of  Who  Corrective Action  Verification  Records21 
Limits  Monitor  Monitoring  Monitors 
Minimum  Conveyor belt    Automated  At the  Line operator  If it is determined that the jar inversion time    Annual    The recording chart 
inverted jar  speed as  tachometer  beginning of  is below the process set point:  calibration of the  from the automated 
hold time (1  indicated by  with recorder  production and    The product will be held until the PCQI  tachometer and  tachometer used to 
minute)  automated  chart monitors  twice per shift  recording chart  monitor the jar 
determines whether the process was 
tachometer  conveyor  used to measure  inversion conveyor belt 
adequate or if the product can be 
RPM  speed;   belt speed of the  speed 
reprocessed. 
  Visual    The production manager will  jcaorn ivnevyeorsr,io wni th the    The process logs 
check of  chart  investigate why the belt speed deviated  date and results  for checks of the belt 
  Record  from the process set point and take  recorded in a  speed for the jar 
RPM in  appropriate actions to prevent the  calibration log. The  inversion conveyor belt 
process log  situation from reoccurring.    PCQI reviews,    Corrective action 
  Employees will be retrained if  initials, and dates  records 
necessary in light of the reason for the  the calibration logs    Of calibration of the 
belt speed deviation  within a week of  tachometer and 
their creation.  recording charts, and 
  The QA  verification tests that 
Manager verifies  the jar inversion time is 
the jar inversion  correct, with any notes 
belt speed and  by the PCQI about 
time twice each  adjustments 
year, and the PCQI 
reviews this within 
one week. 
  On a daily 
basis, the PCQI 
reviews the 
recorded RPM for 
the conveyor belt 
Chapter 6 (Heat Treatments) - Page 61  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
 
 
 
Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
 
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 FDAs 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.   
Chapter 7 (Time-Temperature Control) - Page 1  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
 
 
 
Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
 
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 FDAs 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.   
Chapter 8 (Formulation or Drying) - Page 1  
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Draft-Not for Implementation 
 
 
 
 
Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
 
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 FDAs 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.   
Chapter 9 (Validation) - Page 1  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
 
 
 
Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
 
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 FDAs 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.   
Chapter 10 (Sanitation Program) - Page 1  
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
 
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 FDAs Technical Assistance Network by submitting your question at 
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistance-
network-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.  
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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 supply-
chain 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 Non-
conformance 
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 Cross-
Contact 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 As Products and Hazard Analysis 
11.12.2  Dessert Manufacturer As Food Allergen Program 
11.12.2.1 Dessert Manufacturer As CGMP measures in its food allergen program 
11.12.2.2 Dessert Manufacturer As food allergen controls 
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11.12.2.3 Dessert Manufacturer As assessment of supply-chain controls related to 
food allergens 
11.12.3  Dessert Manufacturer As Allergen Cross-Contact Control 
11.12.3.1 Dessert Manufacturer As allergen cleaning procedures 
11.12.3.2 Dessert Manufacturer As monitoring/verification of allergen cleaning 
procedures 
11.12.3.3 Dessert Manufacturer As corrective actions/corrections for allergen 
cleaning procedures 
11.12.3.4 Dessert Manufacturer As records for allergen cleaning procedures and 
associated preventive control management components 
11.12.4  Dessert Manufacturer As Label Controls 
11.12.4.1 Dessert Manufacturer As label content controls and label management 
controls 
11.12.4.2 Dessert Manufacturer As monitoring/verification of label controls 
11.12.4.3 Dessert Manufacturer As corrective actions/corrections for label controls 
11.12.4.4 Dessert Manufacturer As records for label controls and associated 
preventive control management components 
11.12.5  Summary of Dessert Manufacturer As 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 Bs Products and Hazard Analysis 
11.13.2  Bakery Bs Food Allergen Program 
11.13.2.1 Bakery Bs CGMP measures in its food allergen program 
11.13.2.2 Bakery Bs food allergen controls 
11.13.2.3 Bakery Bs assessment of supply-chain controls related to food allergens 
11.13.3  Bakery Bs Allergen Cross-contact Controls 
11.13.3.1 Bakery Bs allergen cross-contact controls on utensils, tools, apparel, and 
movement of personnel 
11.13.3.2 Bakery Bs monitoring/verification of allergen cross-contact controls 
11.13.3.3 Bakery Bs corrective actions/corrections for allergen cross-contact 
controls 
11.13.3.4 Bakery Bs records for allergen cross-contact controls and associated 
preventive control management components 
11.13.4  Bakery Bs Label Controls 
11.13.4.1 Bakery Bs label content controls and label management controls 
Chapter 11 (Food Allergen Program) - Page 4  
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11.13.4.2 Bakery Bs monitoring/verification of label controls 
11.13.4.3 Bakery Bs corrective actions/corrections for label controls 
11.13.4.4 Bakery Bs records for label controls and associated preventive control 
management components 
11.13.5  Bakery Bs Supply-chain Controls 
11.13.5.1 The ingredient with a food allergen hazard that requires a supply-chain-
applied control 
11.13.5.2 The two vegan caramel chip processors that Bakery B evaluates as 
potential suppliers 
11.13.5.3 Bakery Bs supplier approval and verification activities 
11.13.5.4 Bakery Bs corrective actions/corrections in the event of supplier non-
conformance 
11.13.5.5 Bakery Bs records documenting its supply-chain controls 
11.13.6  Summary of Bakery Bs 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 Cross-
Contact 
11-1.E  CGMP Measures on Equipment and Utensils to Prevent Allergen Cross-
Contact 
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 cross-
contact 
11-1.G  CGMP Measures for Warehousing and Distribution to Prevent Allergen 
Cross-contact 
Appendix 11-2  Summary of Dessert Manufacturer As 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 Bs 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 allergens 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: 
  Allergen cross-contact controls  i.e., procedures, practices, and processes employed 
o
for ensuring protection of food from allergen cross-contact, including during storage, 
handling, and use (21 CFR 117.135(c)(2)(i)); and  
  Label controls  i.e., procedures, practices, and processes employed for labeling the 
o
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 cross-
contact 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 cross-
contact 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 suppliers 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 establishments 
specific code. 
Manufacturing/  Making food from one or more ingredients, or synthesizing, preparing, treating, 
processing  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  A preventive control for a hazard in a raw material or other ingredient when the 
control  hazard in the raw material or other ingredient is controlled before its receipt. 
Written procedures for  Written procedures to ensure that raw materials and other ingredients are received 
receiving raw materials  only from suppliers approved by the receiving facility (or, when necessary and 
and other ingredients  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  Procedures, practices, and processes for cleaning food-contact surfaces of 
procedure  equipment and utensils that are used for foods with different food allergen 
profiles  
Allergen cross-contact  Procedures, practices, and processes employed for ensuring protection of 
control  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 facilitys supply chain 
program, is controlling the identified hazard, and has been approved by the 
receiving facility 
Certificate of analysis  A document, provided by the supplier of a food prior to or upon receipt of the 
(COA)   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  Questions and Answers Regarding Food Allergens, Including the Food 
guidance5  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  All features of the product label that you will use to ensure that the finished 
specification  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 FDAs 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  A hazard for which there is a reasonable probability that exposure to the 
adverse health  hazard will result in serious adverse health consequences or death to 
consequences or death to  humans. 
humans) hazard  
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  The presence of an allergen due to allergen cross-contact 
presence8 
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 cross-
contact, 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: 
  If one beverage that you produce contains milk-derived ingredients, and a different 
o
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.  
  If you produce some chocolate candy that contains almonds and other chocolate candy 
o
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. 
  If a milk-derived food ingredient (such as whey protein powder) has the potential to 
o
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 cross-
contact. 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: 
  Clearly identify allergen-containing raw materials and other ingredients using a system 
o
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. 
  Conduct periodic verification through visual observation of the identification and storage 
o
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).  
  Monitor or verify that the allergenic ingredients brought to the staging area for the recipe 
o
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 color-
coded stickers/tags to identify allergenic-containing ingredients) and reconciling allergen-
related 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: 
  Labeling such as may contain [allergen] is not a substitute for adherence to CGMPs 
o
and food allergen preventive controls; and 
  Any statement such as may contain [allergen] must be truthful and not misleading;  
o
  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 FDAs 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 FDAs 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 FDAs 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 
facilitys 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 facilitys 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 facilitys 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 
facilitys 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 Supply-
Chain 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: 
  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 
o
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: 
  Identifying the problem (e.g., determining whether the food residue was detected 
o
because the cleaning procedure was not properly implemented or because the cleaning 
procedure was not effective);  
  Correcting the problem and reducing the likelihood that the problem will recur (e.g., by 
o
re-training employees in how to use the cleaning procedure or by revising the cleaning 
procedure to improve its effectiveness); and 
  Determining whether food is affected and, if so, evaluating that food for safety, and 
o
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 cross-
contact. (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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  Identifying the problem (e.g., determining whether the allergenic ingredient was added 
o
because the allergen ingredient procedures were not properly implemented or because 
the allergen ingredient procedures were not effective);  
  Correcting the problem and reducing the likelihood that the problem will recur (e.g., by 
o
re-training employees in how to use the allergen ingredient procedures or by revising the 
allergen ingredient procedures to improve their effectiveness); and 
  Determining whether food is affected and, if so, evaluating that food for safety, and 
o
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: 
  Development of labels;  
o
  Ordering labels;  
o
  Production of labels; and  
o
  Receipt of labels.22  
o
  Managing printed labels, including storage, use, and disposition of product labels at the 
following stages: 
  Storage of labels;  
o
 
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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  Food production (including staging and packaging/labeling); and 
o
  Post-production.  
o
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: 
  Identifying the allergenic ingredients (e.g., peanuts) in the product specification (i.e., the 
o
recipe or formulation); 
  Identifying any allergenic components in the raw materials and other ingredients 
o
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  
  Your approach (e.g., through the ingredient statement or through a Contains 
o
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 
  When applicable, your PCQIs: 
o
  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 computer-
generated 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: 
  Do so at the beginning of production, and each time that new labels/packages are 
o
brought to the production line, if you monitor or verify by manual inspection; or 
  Monitor or verify continuously during production if the barcode scanner scans 
o
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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  Personnel who have responsibility for operations such as receiving, quality assurance, 
o
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.  
  Personnel such as the supervisor (or other qualified representative) of the Label 
o
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.  
  Personnel such as the supervisor (or other qualified representative) of the Label 
o
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. 
  Personnel such as the line operator could confirm the food allergen specification of the 
o
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: 
  Personnel such as the line operator or supervisor, the production supervisor, and quality 
o
control personnel could conduct the monitoring or verification activity if you confirm by 
manual inspection or manual operation of a barcode scanner.  
  The scanner does the monitoring or verification activity if you confirm using a continuous 
o
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: 
  Label content. Determining that the content of a product label/package is incorrect with 
o
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).  
  Label management. An observation that the incorrect label/package was brought to the 
o
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 
Chapter 11 (Food Allergen Program) - Page 33  
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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: 
  Label content. Determining that the content of a product label/package is incorrect with 
o
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 in-
house 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 suppliers 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.) 
  Label management. Determining that an incorrect label (with respect to the allergen 
o
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 re-
working 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. 
Chapter 11 (Food Allergen Program) - Page 34  
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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 supply-
chain 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 suppliers 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 suppliers 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 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 
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. 
Chapter 11 (Food Allergen Program) - Page 37  
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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 PCQIs determination about whether to carry a suppliers 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 suppliers 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 
Chapter 11 (Food Allergen Program) - Page 38  
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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.  
Chapter 11 (Food Allergen Program) - Page 39  
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Table 11-4 Examples of Supplier Approval Activities and Ongoing Supplier Verification Activities 
Ingredient  Potential  Food Allergen Program at the Supplier  Potential for Allergen  Examples of Supplier  Examples of Ongoing 
Unintended  Cross-Contact at the  Approval Activities  Supplier Verification 
Allergen  Supplier and Suppliers  Activities 
Presence Due  Decision Regarding 
to Allergen  Allergen Advisory 
Cross-Contact  Statements 
at the Supplier 
Vegan caramel  Milk  The supplier uses separate processing lines for vegan caramel  Low, because the supplier  - Questionnaire about  - Annual Certificate of 
chips that do not  chips and caramel (or other) chips that contain milk.  uses different processing  food allergen control  Conformance that the supplier 
have any  lines for vegan caramel  practices  continues to use separate 
allergenic  chips and caramel (and  processing lines for vegan 
- Search FDAs 
ingredients  other) chips that contain  Firm/Supplier Evaluation  caramel chips and caramel 
milk. Therefore, the  (and other) chips that contain 
Resources web page 
supplier does not use  milk. 
(see Table 11-8) 
allergen advisory 
- Onsite audit   - Supplier audit every 3 years. 
statements. 
 
Vegan caramel  Milk  - The supplier uses the same processing line for vegan  Moderate, because the  - Questionnaire about  - Annual onsite audit 
chips that do not  caramel chips and caramel (and other) chips that contain milk.   supplier uses the same  food allergen control  - Periodic testing of shipments 
have any  - Suppliers allergen cross-contact controls and verification  processing line for vegan  practices  of vegan caramel chips (e.g., 
allergenic  testing:  caramel chips and caramel  - Search FDAs  quarterly or every 5th lot) 
ingredients  (and other) chips that 
- The supplier schedules production of vegan caramel  Firm/Supplier Evaluation 
contain milk. However, the 
chips before production of caramel (and other) chips that  Resources web page 
supplier combines 
contain milk.  (see Table 11-8) 
scheduling, allergen 
- Before production of vegan caramel chips, the suppliers  cleaning procedures,  - Onsite audit 
allergen cleaning procedures include scrape-down of  verification testing, and  - Test several shipments 
accessible surfaces and push-through (e.g., in piping)  repeat cleaning in its food  of vegan caramel chips 
with vegan caramel, with the push-through material used  safety plan. The supplier 
as re-work in the production of caramel products that  does not use advisory 
contain milk.   labeling because the 
- During development of the food safety plan, verification  verification testing during 
testing of vegan caramel chips consistently is negative  development of its food 
whenever verification testing of FCSs of the chip  safety plan demonstrates 
depositor is negative.  that vegan caramel chips 
do not contain milk allergen 
- During production, the supplier routinely verifies the 
whenever verification 
allergen cleaning by testing FCSs of the chip depositor 
testing of the chip depositor 
for the presence of milk allergen, with repeat cleaning if 
is negative, and the 
necessary.  
supplier routinely verifies 
the cleaning by testing the 
chip depositor, with repeat 
cleaning as necessary. 
Chapter 11 (Food Allergen Program) - Page 40  
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Ingredient  Potential  Food Allergen Program at the Supplier  Potential for Allergen  Examples of Supplier  Examples of Ongoing 
Unintended  Cross-Contact at the  Approval Activities  Supplier Verification 
Allergen  Supplier and Suppliers  Activities 
Presence Due  Decision Regarding 
to Allergen  Allergen Advisory 
Cross-Contact  Statements 
at the Supplier 
Vegan caramel  Milk  - The supplier uses the same processing line for vegan  Moderate, because the  - Questionnaire about  - Annual onsite audit 
chips that do not  caramel chips and caramel (and other) chips that contain milk.   supplier uses the same  food allergen control  - Annual sampling and testing 
have any  - Suppliers allergen cross-contact controls and verification  processing line for vegan  practices  (as verification of the suppliers 
allergenic  testing:  caramel chips and caramel  - Search FDAs  sampling and testing of every 
ingredients  - The supplier schedules production of vegan caramel  (and other) chips that  Firm/Supplier Evaluation  lot) 
contain milk. However, the 
chips before production of caramel (and other) chips that  Resources web page 
supplier combines 
contain milk.  (see Table 11-8) 
scheduling, allergen 
- Before production of vegan caramel chips, the suppliers  cleaning procedures, and  - Onsite audit 
allergen cleaning procedures include scrape-down of  verification testing of every  - Test several shipments 
accessible surfaces and push-through (e.g., in piping)  lot in its food safety plan.  of vegan caramel chips 
with vegan caramel, with the push-through material used  The supplier does not use  for milk 
as re-work in the production of caramel products that  allergen advisory 
contain milk.  statements because only 
- During development of the food safety plan, verification  those lots of vegan caramel 
testing of vegan caramel chips periodically is positive.  chips that are negative for 
milk allergen are 
- The supplier samples and tests every lot for milk allergen 
distributed.  
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. 
Chapter 11 (Food Allergen Program) - Page 41  
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Ingredient  Potential  Food Allergen Program at the Supplier  Potential for Allergen  Examples of Supplier  Examples of Ongoing 
Unintended  Cross-Contact at the  Approval Activities  Supplier Verification 
Allergen  Supplier and Suppliers  Activities 
Presence Due  Decision Regarding 
to Allergen  Allergen Advisory 
Cross-Contact  Statements 
at the Supplier 
Vegan caramel  Milk  - The supplier uses the same processing line for vegan  High. The supplier uses  - Questionnaire about  - Annual onsite audit 
chips that do not  caramel chips and caramel (and other) chips that contain milk.   allergen advisory  food allergen control  - If an allergen advisory 
have any  - Suppliers allergen cross-contact controls and verification  statements because it uses  practices  statement is carried forward, 
allergenic  testing:  the same processing line  - Search FDAs  annual sampling and testing of 
ingredients  - During development of the food safety plan, the supplier  for vegan caramel chips  Firm/Supplier Evaluation  vegan caramel chips for the 
assessed multiple cleaning practices for efficacy in  and non-vegan caramel  Resources web page  frequency and level of 
preventing allergen cross-contact, but regardless of  (and other) chips that  (see Table 11-8)  detectable milk to confirm the 
contain milk, and its  results obtained during supplier 
which cleaning practice was used verification test results  - Onsite audit 
verification testing during  approval and determine 
were periodically positive for unintended milk presence 
development of the food  - Test multiple lots for the  whether to conduct reanalysis: 
on FCSs on the chip depositor and in vegan caramel 
safety plan demonstrates  frequency and level of 
chips.   that its cleaning is not  detectable milk as part of  - Of the PCQIs 
determination to carry 
- The supplier concludes that its verification testing during  always able to protect the  the PCQIs determination 
forward an allergen 
development of the food safety plan demonstrates that  vegan caramel chips from  of whether to carry an 
its cleaning is not always able to protect the vegan  allergen cross-contact.   allergen advisory  advisory statement, and 
caramel chips from allergen cross-contact.   statement forward   - To re-evaluate the 
supplier. 
- The suppliers PCQI provides a written justification, in the 
suppliers food safety plan, for why allergen cross- - If an allergen advisory 
contact controls are not always able to ensure protection  statement is not carried 
of food from allergen cross-contact;   forward, monthly sampling and 
testing of vegan caramel chips 
- The suppliers labeling for the applicable food product(s) 
for the frequency and level of 
includes allergen advisory statements that disclose the 
detectable milk to confirm the 
possible unintended allergen presence in the food; and,  
results obtained during supplier 
- Because the supplier provides allergen advisory 
approval and determine 
statements, the supplier does not routinely do 
whether to conduct reanalysis: 
verification testing of either the FCSs on the chip 
- Of the PCQIs 
depositor or the vegan caramel chips. 
determination to not carry 
forward an allergen 
advisory statement; and 
- To-re-evaluate the 
supplier. 
Chapter 11 (Food Allergen Program) - Page 42  
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Ingredient  Potential  Food Allergen Program at the Supplier  Potential for Allergen  Examples of Supplier  Examples of Ongoing 
Unintended  Cross-Contact at the  Approval Activities  Supplier Verification 
Allergen  Supplier and Suppliers  Activities 
Presence Due  Decision Regarding 
to Allergen  Allergen Advisory 
Cross-Contact  Statements 
at the Supplier 
Almond-based  Soy  - The supplier uses the same processing line for almond- Moderate, because the  - Questionnaire about  - Annual onsite audit 
beverage  based beverages and soy-based beverages.  supplier uses the same  food allergen control  - Receive COAs with every 
- Suppliers allergen cross-contact controls and verification  processing line for almond- practices  shipment for the first 6 months 
based and soy-based 
testing:  - Search FDAs Supplier  - Receive quarterly COAs after 
beverages. However, the 
- The supplier develops allergen cleaning procedures for  Evaluation Resources  the first 6 months 
supplier does not use 
use when changing from one beverage type to the other.  allergen advisory  web page (see Table 11- - Annual sampling and testing 
8) 
- During development of the food safety plan, verification  statements due to the liquid  (as verification of the suppliers 
testing of FCSs on the processing line and in the  nature of the food products  - Onsite audit  quarterly sampling and testing) 
almond-based beverage is consistently negative for the  and consistently negative  - Test several shipments 
presence of soy allergen.   test results from verification  for soy 
- During routine production, the supplier monitors the  testing of its cleaning 
cleaning procedures and conducts sampling and  procedures during 
analytical testing for residues of soy as verification, at  development of the food 
least quarterly or more frequently as requested by the  safety plan. 
customer.  
Dry-roasted  Dry-roasted  - Suppliers CGMP measures for separation in space:  Low, because the supplier  - Questionnaire about  - Annual Certificate of 
almonds  peanuts  - The supplier has separate storage areas in separate  stores and processes  food allergen control  Conformance that the supplier 
buildings for almonds and peanuts.  almonds and peanuts in  practices  continues to use separate 
separate buildings.  buildings for storing and 
- The supplier has separate processing lines in separate  - Search FDAs Supplier 
Therefore, the supplier  processing almonds and 
buildings for almonds and peanuts.   Evaluation Resources 
does not use allergen  web page (see Table 11- peanuts.  
advisory statements. 
8)  - Supplier audit every three 
- Onsite audit  years. 
Dry-roasted  Dry-roasted  - Suppliers CGMP measures for separation in space:  Low, because the supplier  - Questionnaire about  - Annual Certificate of 
almonds  peanuts  - The supplier stores almonds and peanuts in separate  stores and processes  food allergen control  Conformance that the supplier 
rooms of the same building.   almonds and peanuts in  practices  continues to use separate 
separate rooms, and has  rooms for storing and 
- The supplier has separate processing lines in separate  - Search FDAs Supplier 
allergen cross-contact  processing almonds and 
rooms of the same building for almonds and peanuts.  Evaluation Resources 
controls for ingredients,  peanuts and continues to 
web page (see Table 11-
- The supplier has dedicated apparel, portable equipment,  apparel, portable  implement its allergen cross-
8) 
utensils, and tools for almonds and peanuts.   equipment, utensils, and  contact controls for ingredients, 
- Onsite audit 
- Suppliers allergen cross-contact controls, subject to  tools. Therefore, the  apparel, portable equipment, 
monitoring:  supplier does not use  utensils and tools 
allergen advisory 
- Almonds and peanuts are color-coded upon receipt.   - Supplier audit every other 
statements. 
year. 
- Apparel, portable equipment, utensils, and tools are 
color-coded or tagged. 
- Traffic patterns restrict movement of personnel, portable 
equipment, utensils, and tools. 
Chapter 11 (Food Allergen Program) - Page 43  
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Ingredient  Potential  Food Allergen Program at the Supplier  Potential for Allergen  Examples of Supplier  Examples of Ongoing 
Unintended  Cross-Contact at the  Approval Activities  Supplier Verification 
Allergen  Supplier and Suppliers  Activities 
Presence Due  Decision Regarding 
to Allergen  Allergen Advisory 
Cross-Contact  Statements 
at the Supplier 
Dry-roasted  Dry-roasted  - Suppliers CGMP measures for separation in space and time:  Low, because the supplier  - Questionnaire about  - Annual onsite audit 
almonds  peanuts  - The supplier stores shelled almonds and shelled peanuts  has CGMP measures for  food allergen control  - Periodic (e.g., semi-annually 
in covered containers in separate storage areas,  separation in both space  practices  checking shipments of almonds 
separated by plastic curtains, in the same storage room.  and time, has allergen  - Search FDAs Supplier  by sampling and sorting to look 
cross-contact controls for 
- The supplier has separate processing lines, separated by  Evaluation Resources  for peanuts 
ingredients, apparel, 
plastic curtains, in the same room, for almonds and  web page (see Table 11-
portable equipment, 
peanuts.   8) 
utensils, and tools, and 
- The supplier schedules production of roasted almonds  during development of the  - Onsite audit 
and roasted peanuts at different times.  food safety plan verification  - Sample and sort 
- Suppliers allergen cross-contact controls and verification  testing for peanuts and  almonds from several 
testing:   peanut residue is  shipments to look for 
consistently negative.  peanuts  
- Almonds and peanuts are color-coded upon receipt to 
Therefore, the supplier 
facilitate storing in the correct area and ingredient 
does not use allergen 
identification when bringing shelled almonds and shelled 
advisory statements. 
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.  
Chapter 11 (Food Allergen Program) - Page 44  
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Draft  Not for Implementation 
 
Ingredient  Potential  Food Allergen Program at the Supplier  Potential for Allergen  Examples of Supplier  Examples of Ongoing 
Unintended  Cross-Contact at the  Approval Activities  Supplier Verification 
Allergen  Supplier and Suppliers  Activities 
Presence Due  Decision Regarding 
to Allergen  Allergen Advisory 
Cross-Contact  Statements 
at the Supplier 
Dry-roasted  Dry-roasted  - The supplier uses the same production line for almonds and  Moderate, because the  - Questionnaire about  - Annual onsite audit 
almonds  cashews  cashews.  supplier uses the same  food allergen control  - Supplier COA for each 
- Suppliers CGMP measures for separation in space:   processing line for almonds  practices  shipment 
and cashews. However, the 
- Separate storage areas, in different rooms, for shelled  - Search FDAs Supplier  - Periodic (e.g., semi-annually 
supplier does not use 
almonds and shelled cashews.  Evaluation Resources  or every 6th lot) checking 
allergen advisory 
web page (see Table 11-
- Suppliers allergen cross-contact controls and verification  statements because the  shipments of almonds by 
8) 
testing:  verification testing of its  sampling and sorting to look for 
- Onsite audit  cashews and testing for 
- Almonds and cashews are color-coded upon receipt to  allergen cross-contact 
facilitate storing in the correct area and ingredient  controls during  - Sample and sort  cashew residue (as verification 
identification when bringing shelled almonds and shelled  development of its food  almonds from several  of the suppliers sampling and 
cashews to the production line.  safety plan demonstrates  shipments to look for  testing of every lot) 
that the frequency of  cashews 
- Apparel, portable equipment, utensils, and tools are 
dedicated and color-coded or tagged for either almonds  allergen cross-contact is  - Test several shipments 
or cashews.  low, it routinely monitors  for cashew residue 
the cleaning during 
- The supplier consults with an expert in dry cleaning  production, it follows hold 
techniques to develop cleaning procedures for use when  and test procedures before 
changing from one nut to the other.  distributing almonds, and it 
- During development of the food safety plan, verification  provides a COA with the 
testing by sampling and sorting almonds to look for  results of verification 
cashews, or by analytical testing for cashew residue, is  testing for every lot of 
rarely positive.   almonds.  
- 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. 
Chapter 11 (Food Allergen Program) - Page 45  
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Ingredient  Potential  Food Allergen Program at the Supplier  Potential for Allergen  Examples of Supplier  Examples of Ongoing 
Unintended  Cross-Contact at the  Approval Activities  Supplier Verification 
Allergen  Supplier and Suppliers  Activities 
Presence Due  Decision Regarding 
to Allergen  Allergen Advisory 
Cross-Contact  Statements 
at the Supplier 
Dry-roasted  Dry-roasted  - The supplier uses the same production line for almonds and  High. The supplier uses  - Questionnaire about  - Annual onsite audit 
almonds  cashews  cashews.  allergen advisory labeling  food allergen control  - If allergen advisory labeling is 
- Suppliers CGMP measures for separation in space:   because it uses the same  practices  carried forward, periodic 
- Separate storage areas, in the same room, for almonds  production line for almonds  - Search FDAs Supplier  checking shipments of almonds 
and cashews and  Evaluation Resources  by sampling and sorting to 
and cashews. 
verification testing during  web page (see Table 11- confirm the results obtained 
- Suppliers allergen cross-contact controls and verification  development of the food  8)  during supplier approval 
testing:   safety plan demonstrates 
- Onsite audit  - If allergen advisory labeling is 
- Almonds and cashews are color-coded upon receipt.  that its cleaning is not 
not carried forward, periodic 
always able to protect the  - Sample and sort 
- Apparel, portable equipment, utensils, and tools are  checking shipments of almonds 
almonds from allergen  almonds from several 
dedicated and color-coded or tagged for either almonds  by sampling and sorting, and by 
cross-contact.  shipments to look for 
or cashews.  testing for cashew residue, to 
cashews, and test several 
- The supplier develops cleaning procedures for use when  shipments for the  confirm the results obtained 
changing from one nut to the other.  presence of cashew  during supplier approval and 
determine whether to conduct 
- During development of the food safety plan, assessed  residue, as part of the 
reanalysis: 
multiple cleaning practices for efficacy in preventing  PCQIs determination of 
allergen cross-contact, but regardless of which cleaning  whether to carry the  - Of the PCQIs 
practice was used verification testing by sampling and  allergen advisory labeling  determination to not carry 
sorting almonds to look for cashews, or by analytical  forward   forward allergen advisory 
testing for cashew residue, is frequently positive.   labeling; and 
- The supplier concludes that its verification testing during  - To-re-evaluate the 
development of the food safety plan demonstrates that  supplier. 
its cleaning is not always able to protect the almonds  - Frequency of sampling and 
from allergen cross-contact.  sorting (and, when applicable, 
- The suppliers PCQI provides a written justification, in the  analytical testing) varies 
suppliers food safety plan, for why allergen cross- depending on whether allergen 
contact controls are not always able to ensure protection  advisory labeling is carried 
of food from allergen cross-contact.  forward (e.g., monthly if 
allergen advisory labeling is not 
- The suppliers labeling for the applicable food product(s) 
carried forward; semi-annually 
includes allergen advisory statements that disclose the  or every 6th lot if allergen 
possible unintended allergen presence in the food. 
advisory labeling is carried 
 - Because the supplier provides allergen advisory  forward) 
labeling, the supplier does not routinely do verification 
testing of either the FCSs on the processing line or the 
almonds. 
Chapter 11 (Food Allergen Program) - Page 46  
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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 suppliers CGMP measures to prevent allergen cross-contact. 
33 Adapted from Managing Allergens in Food Processing Establishments (GMA, 2009). 
Chapter 11 (Food Allergen Program) - Page 47 
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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: 
  Carry such an allergen advisory statement forward to the product label on your food 
o
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  
  Rely on a scientifically valid determination (which you include in your food safety plan) 
o
that the amount35 of milk allergen that may be present in labeled food products produced 
using that suppliers 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 Non-
conformance 
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 suppliers 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.  
Chapter 11 (Food Allergen Program) - Page 48 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
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 suppliers 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 suppliers 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 suppliers 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 cross-
contact controls used by the supplier to prevent allergen cross-contact.  
Chapter 11 (Food Allergen Program) - Page 49 
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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 cross-
contact 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 cross-
contact36. 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. 
Chapter 11 (Food Allergen Program) - Page 50 
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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 cross-
contact controls, that food can be protected from allergen cross-contact. If so: 
  Your PCQI should provide a written justification, in your food safety plan, for why 
o
allergen cross-contact controls cannot ensure protection of food from allergen cross-
contact; and 
  Your labeling for the applicable food product(s) could include information that discloses 
o
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 cross-
contact, 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.  
Chapter 11 (Food Allergen Program) - Page 51 
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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 suppliers 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. 
Chapter 11 (Food Allergen Program) - Page 52 
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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 117.3i.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 individuals assigned duties. 
 Table 11-5 Examples of Training Topics Appropriate to an Individuals 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 
employees position 
Management of WIP and  Awareness of the importance of controlling WIP and rework to prevent 
rework  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 plants 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 As 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.  
  The tubs have a pre-printed product label, including the product name and ingredient 
o
statement. The tubs also have a barcode that is used for multiple purposes, such as 
inventory management. 
  The lids are pre-printed with the product name. 
o
Through the hazard analysis, Dessert Manufacturer As 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 As Food Allergen Program  
11.12.2.1  Dessert Manufacturer As 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 cross-
contact. 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: 
  Segregates (i.e. stores in a different area) allergenic ingredients (cream, milk powder, 
o
pasteurized liquid eggs, and almonds) from non-allergenic ingredients (e.g., sugar, 
flavorings, and coloring).  
  Dedicates one cold storage unit to allergens, with closed, clearly marked, plastic totes of 
o
cream and plastic bags (in boxes) of pasteurized liquid eggs segregated on separate 
sides of the unit. 
  Stores almond pieces (in boxes with liners) and milk powder (in plastic bags) in 
o
dedicated bays in the warehouse.  
  Specifies in production procedures that partially-used containers be closed before they 
o
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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  Uses separate areas to weigh or measure out non-allergenic ingredients (e.g., sugar, 
o
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.  
  Dedicates (i.e., to a specific food allergen or to non-allergenic ingredients) tools, 
o
containers, and equipment used to measure ingredients, using the same color-coding 
used on the containers of allergen-containing ingredients.  
  Prepares the weighed/measured ingredients as needed, identifies them on a sticker 
o
(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 As food allergen controls 
Because Dessert Manufacturer A processes foods with different allergen profiles on the same 
processing line, Dessert Manufacturer As 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 As dessert products contain ingredients that are or 
contain a food allergen, Dessert Manufacturer As 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 As assessment of supply-chain 
controls related to food allergens 
Dessert Manufacturer As 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.  
  Through its supply-chain programs for the control of biological hazards in cream, milk 
o
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 As 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. 
  Through its supply-chain program for the suppliers dry-roasting process for the control 
o
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 As 
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PCQI determined that Dessert Manufacturer As supply-chain program for the receipt of 
dry-roasted, chopped almonds does not need to assess the potential for allergen cross-
contact at the almond handlers plants.  
 
11.12.3  Dessert Manufacturer As Allergen Cross-Contact Control 
11.12.3.1  Dessert Manufacturer As 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 
As 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 As 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 As 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 As PCQI reviews the pre-operational visual 
inspection records and documents that record review by initialing and dating the pre-
operational visual inspection records.  
  Within a week of any allergen-specific analytical tests to verify the visual inspection, Dessert 
Manufacturer As 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 As 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 As 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: 
  If the problem was identified through a consumer report of an allergic reaction, 
o
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).  
  The Production Manager conducts a root cause investigation to try to determine 
o
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);  
  When appropriate based on the root cause of the problem, the Production Supervisor: 
o
  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 As records for allergen cleaning 
procedures and associated preventive control management components 
Dessert Manufacturer A maintains the following records: 
  Its SSOP, which includes: 
  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 
o
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: 
  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. 
o
11.12.4  Dessert Manufacturer As Label Controls 
11.12.4.1  Dessert Manufacturer As 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.  
  The product development specialist notes that the food allergens in the ingredients are 
o
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. 
  The product development specialist notes that the name of the food source of all 
o
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. 
  The product development specialist decides that the label specification for naming the 
o
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.  
  The food allergen label specification includes a requirement for each tub to be color-
o
coded 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). 
  The product development specialist decides that the product name39 will be pre-printed 
o
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).  
  The Label Coordinator reviews the food allergen label specification and documents 
o
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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  The Label Coordinator reviews a mock-up of the product label, provided by the 
o
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. 
  The purchase order for the product tubs and lids specifies that the product tubs/lids for 
o
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 As 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 As 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 As 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 As PCQI reviews, initials, and dates: 
  Storage Record for Label Controls for monitoring the correct storage of tubs and lids by 
o
quality assurance personnel. 
  The production sheet with:  
o
  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 As 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 As 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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  Segregation of any incorrectly labeled/packaged products.  
o
  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.  
  Investigation by the Production Manager of the root cause of incorrectly labeled 
o
products. The Production Supervisor arranges for modification of the label content 
procedures, re-training of personnel, or both as appropriate. 
  Initiation of a recall of any product in commerce that is misbranded under section 403(w) 
o
of the FD&C Act. 
 
11.12.4.3.2  Corrective actions/corrections for label management controls 
  Corrections: Dessert Manufacturer A: 
  Returns any incorrectly stored tubs or lids to the correct storage location and documents 
o
the correction on the Storage Record for Label Controls; and 
  Removes any tubs from the line if they have the wrong color of band at the top and 
o
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 As 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: 
  The Label Review Forms, signed and dated by quality assurance personnel, 
o
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 
  Any corrective action records. 
o
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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: 
  The Storage Record for Label Controls;  
o
  The production sheet on which the line operator notes: 
o
  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  
  Any corrective action records. 
o
11.12.5  Summary of Dessert Manufacturer As Food Allergen Program 
Appendix 11-2 summarizes Dessert Manufacturer As: 
  Allergen cross-contact control on the FSPCAs Sanitation Control Form (Form 2-D from 
Appendix 2 of this guidance); and 
  Label controls on the FSPCAs Food Allergen Control Form (Form 2-H (modified) from 
Appendix 2 of this guidance). 
Appendix 11-2 also provides Dessert Manufacturer As:  
  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 Bs 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: 
  Two ingredients that are, or contain a food allergen: flour (wheat) and pasteurized liquid 
o
eggs; and 
  One ingredient (i.e., vegan caramel chips) that does not contain a food allergen but has 
o
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:  
  For oatmeal cookies: Mix the base ingredients (wheat flour, eggs, vegetable shortening, 
o
vanilla extract, salt, baking soda, brown sugar, and granulated sugar) in a spiral mixer, 
then add oatmeal and raisins.  
  For caramel chip cookies: Mix the same base ingredients as used for the oatmeal 
o
cookies in a spiral mixer, then add caramel chips.  
  For peanut butter cookies: Mix the same base ingredients as used for the oatmeal 
o
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 plastic-
lined 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 Bs 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 Bs Food Allergen Program 
11.13.2.1  Bakery Bs 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: 
  The peanut butter cookies are produced and packaged on a different processing line 
o
(with different equipment, utensils and tools) than the oatmeal cookies and caramel chip 
cookies. 
  The production areas for weighing the peanut butter and for staging the peanut butter 
o
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 Bs food allergen controls 
Bakery Bs 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 Bs 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 Bs 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 Bs cookies contain ingredients that are or contain a food allergen, 
Bakery Bs 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 Bs assessment of supply-chain controls related to 
food allergens 
Bakery Bs 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 Bs 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 
Bs 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 Bs 
PCQI determined that Bakery Bs 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 Bs 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 Bs 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 Bs 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 Bs Allergen Cross-contact Controls  
11.13.3.1  Bakery Bs 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:  
  Bakery B dedicates all utensils (e.g., scoops, spatulas) and tools (e.g., scrapers, 
o
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.  
  Bakery B dedicates all apparel (e.g., smocks, hairnets) used in the production of the 
o
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 Bs 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 non-
conformance 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 Bs 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 Bs corrective actions/corrections for allergen cross-
contact 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.  
  Corrections: If production has not begun, these activities are corrections and the 
o
Production Supervisor does not document the correction on the Checklist for Allergen 
Cross-Contact Controls.  
  Corrective actions: If production has begun, these activities are corrective actions and 
o
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. 
  Corrections: If the employee put on the wrong-colored item, the employee is required to 
o
leave the area and apply the correct apparel. The Production Supervisor makes this 
correction but does not document it. 
  Corrective actions: If the problem was due to personnel from the peanut butter cookie 
o
production area entering the oatmeal/caramel chip cookie production area, 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 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 Bs 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 non-
conformances, if any, describes the corrective actions, and is initialed and dated by Bakery 
Bs PCQI to document the PCQIs review of the record.  
 
11.13.4  Bakery Bs Label Controls 
11.13.4.1  Bakery Bs 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 Bs 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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  The Label Team notes that the allergens contained in the ingredients are as follows: 
o
  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. 
  The Label Team notes that there are no additional allergenic components in other 
o
ingredients. 
  An individual in the Label Team has responsibility for the food allergen label specification 
o
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.  
  The Label Team Supervisor prints a sample of the product label to review the food 
o
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 Bs 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 Bs 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 Bs 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 Bs PCQI reviews, initials, and dates the records documenting: 
  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. 
o
  Within a week of a problem that requires a corrective action, Bakery Bs 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 Bs 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:  
  Segregation of any affected products; 
o
  Rework of affected products by manually transferring the trays of incorrectly labeled 
o
cookies to plastic-lined paper pouches and applying the correct label;  
  Investigation by the Production Manager and Label Team Supervisor to determine the 
o
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 
  Initiation of a recall of any product in commerce that is misbranded under section 403(w) 
o
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: 
  Segregation of any products that have the wrong label; 
o
  Rework of affected products by manually transferring the trays of incorrectly labeled 
o
cookies to plastic-lined paper pouches and applying the correct label;  
  Investigation by the Production Manager of the root cause of the problem. The 
o
Production Supervisor arranges for modification of the label management procedures, 
re-training of personnel, or both as appropriate; and 
  Initiation of a recall of any product in commerce that is misbranded under section 403(w) 
o
of the FD&C Act. 
11.13.4.4  Bakery Bs 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: 
  The production label that is pasted onto the production sheet and signed and dated by 
o
the Production Supervisor; and  
  Any corrective action records. 
o
 
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: 
  The production label that is pasted onto the production sheet and signed and dated by 
o
the Production Supervisor;  
  The production sheet on which the line operator documents the results of the verification 
o
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 
  The corrective action records. 
o
 
11.13.5  Bakery Bs 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 Bs 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 Bs supplier approval and verification activities 
To approve its suppliers, Bakery B: 
  Asked each potential supplier to fill out a questionnaire related to: 
  The suppliers food allergen program (including the suppliers CGMP measures, allergen 
o
cross-contact controls, and label controls); and  
  Whether the supplier provides an allergen advisory statement for the potential 
o
unintended milk presence in vegan caramel chips.42  
  Searched FDAs 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 Bs 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 Bs 
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 Bs 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 Bs sampling and testing demonstrate unintended milk 
presence in one or more lots of caramel chips:  
  Bakery B temporarily stops using the caramel chips from that supplier until the supplier 
o
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 
  Bakery Bs PCQI evaluates caramel chip cookies that have been manufactured using 
o
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 Bs 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: 
  Documentation of the determination of the appropriate supplier verification activities for 
o
raw materials and other ingredients (see 21 CFR 117.475(c)(6));  
  Documentation of the results of its search of FDAs Supplier Evaluation Resources web 
o
page (see Table 11-8) for each supplier as a supplier approval activity (see 21 CFR 
117.475(c)(3) and (6)); 
  The results of third-party audits for each supplier of caramel chips (see 21 CFR 
o
117.475(c)(7)); 
  The results of quarterly sampling and testing by Bakery B of caramel chips provided by 
o
Supplier B; and 
  Records of any corrective actions (see 21 CFR 117.475(c)(16)).  
o
 
Chapter 11 (Food Allergen Program) - Page 76 
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11.13.6  Summary of Bakery Bs Food Allergen Program 
Appendix 11-3 summarizes Bakery Bs allergen cross-contact controls and label controls on the 
FSPCAs Food Allergen Control Form (Form 2-H (Modified) from Appendix 2 of this guidance). 
Appendix 11-3 also provides Bakery Bs:  
  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-joint-
fao-who-expert-consultation-on-risk-assessment-of-food-allergens-part2-review-and-
establish-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-joint-
fao-who-expert-consultation-on-risk-assessment-of-food-allergens-part2-review-and-
establish-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. 
Chapter 11 (Food Allergen Program) - Page 77 
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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 FDAs CPGs, FDAs 
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  https://www.fda.gov/regulatory-information/search-fda-guidance-
Labeling and Preventing Cross-contact of  documents/cpg-sec-555250-statement-policy-labeling-and-
Common Food Allergens. 2001  preventing-cross-contact-common-food-allergens-new 
CPG Sec 555.250 DRAFT: Major Food  https://www.fda.gov/regulatory-information/search-fda-guidance-
Allergen Labeling and Cross-contact.  documents/cpg-sec-555250-draft-major-food-allergen-labeling-
202343  and-cross-contact  
*In addition to the specific link we provided, you can access FDAs Manual of Compliance Policy Guides 
at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-
manuals/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/manual-
compliance-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 FDAs enforcement policy 
regarding major food allergen labeling and cross-contact. 
Chapter 11 (Food Allergen Program) - Page 78 
  Contains Nonbinding Recommendations 
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Table 11-7. Applicable FDA Guidance for Industry*  
Guidance  Link 
Questions and Answers Regarding  https://www.fda.gov/media/117410/download  
Food Allergens, Including the Food 
Allergen Labeling Requirements of 
the Federal Food, Drug, and 
Cosmetic Act (Edition 5). 2022. 
Guidance for Industry** 
Questions and Answers Regarding  https://www.fda.gov/media/163454/download  
Food Allergens, Including the Food 
Allergen Labeling Requirements of 
the Federal Food, Drug, and 
Cosmetic Act (Edition 5). 2022. 
Draft Guidance for Industry*** 
Human Food By-Products For Use  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-239-human-food-products-use-animal-food 
As Animal Food: Draft Guidance 
for Industry #239*** 
*In addition to the specific link we provided, or if that link is no longer operative, you can access most of FDAs 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 FDAs 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 FDAs current thinking on the specified topic. 
 
Table 11-8. Additional Resources  
Source  Resource Title  Resource Link 
3-A Sanitary  3-A Sanitary  https://www.3-a.org/ 
Standards,  Standards and 
Inc.  Accepted 
Practices* 
Chapter 11 (Food Allergen Program) - Page 79 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Source  Resource Title  Resource Link 
American  AMI Fact Sheet.  https://www.meatinstitute.org/index.php?ht=a/GetDocumentAction/i/11006 
Meat  Sanitary 
Institute  Equipment 
Design. 2014. 
European  EHEDG  https://www.ehedg.org/guidelines/ 
Hygienic  Guidelines Doc 
Engineering  8. Hygienic 
and Design  Design 
Group  Principles. Third 
(EHEDG)  Edition. 2018. 
FDA  Firm/Supplier  https://www.fda.gov/food/food-safety-modernization-act-fsma/firmsupplier-evaluation-resources-fsma-rules  
Evaluation 
Resources for 
FSMA Rules 
FDA  Food  https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/food-allergens-and-gluten-
Allergens/Gluten- free-guidance-documents-and-regulatory-information 
Free Guidance 
Documents & 
Regulatory 
Information 
FDA  Industry  https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls 
Guidance For 
Recalls 
FDA  Label  http://wayback.archive-
Declaration of  it.org/7993/20171114013857/https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106546.htm 
Allergenic 
Substances in 
Foods; Notice to 
Manufacturers. 
1996 
FDA  FSMA Final Rule  https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-sanitary-transportation-human-and-animal-food  
on Sanitary 
Transportation of 
Human and 
Animal Food 
Chapter 11 (Food Allergen Program) - Page 80 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Source  Resource Title  Resource Link 
Schmidt, RH  Sanitary Design  https://ucfoodsafety.ucdavis.edu/sites/g/files/dgvnsk7366/files/inline-files/26502.pdf 
and DJ  and Construction 
Erickson,  of Food 
Food  Equipment. 
Science and  2005. 
Human 
Nutrition 
Department, 
Florida 
Cooperative 
Extension 
Service, 
Institute of 
Food and 
Agricultural 
Sciences, 
University of 
Florida 
*Available for purchase. 
 
 
Chapter 11 (Food Allergen Program) - Page 81 
  Contains Nonbinding Recommendations 
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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. 
Chapter 11 (Food Allergen Program) - Page 82 
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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 cross-
contact 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 allergen-
containing 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: 
  Ensure that all valves are clearly marked; and 
o
  Clean and inspect valves routinely for potential leaks.  
o
  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.  
Chapter 11 (Food Allergen Program) - Page 83 
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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 Cross-
Contact 
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: 
  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 
o
operations).  
  Clean equipment and utensils in a manner that protects against allergen cross-contact. 
Examples of how to do so are: 
  Using freshly prepared cleaning solutions (rather than reusing cleaning solutions that 
o
could cause recontamination of surfaces with allergenic food residue);  
  Using vacuums, rather than compressed air or grit blasting, for removing dry food 
o
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  
  Using low pressure water hoses, rather than high pressure water hoses, for removing 
o
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) 
Chapter 11 (Food Allergen Program) - Page 84 
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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 cross-
contact. 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 cross-
contact. 
  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).  
Chapter 11 (Food Allergen Program) - Page 86 
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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: 
  Use techniques such as visual identifiers (e.g., stickers or tags), computerized 
o
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  
  Clean bulk storage tanks or silos used to store an allergen-containing raw material or 
o
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.  
Chapter 11 (Food Allergen Program) - Page 87 
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Draft  Not for Implementation 
 
  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: 
  Clearly identify WIP and rework (including the name of the WIP/rework, all food 
o
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. 
  Assemble all WIP and rework for a specific batch of product in a dedicated staging area 
o
before transferring the WIP/rework to the processing line.  
  Implement a rework policy for rework to be added back to same finished product (i.e., 
o
exact into exact) whenever practical. Alternatively, add rework to another product with 
the same food allergen profile. 
  Use allergen-containing WIP and rework as soon as possible to minimize the potential 
o
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.   
Chapter 11 (Food Allergen Program) - Page 88 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Appendix 11-2  Summary of Dessert Manufacturer As 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. 
Chapter 11 (Food Allergen Program) - Page 89 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
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: ________________________ 
   
Chapter 11 (Food Allergen Program) - Page 90 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
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 
RNaawm eM aterial  Supplier  Egg  Milk  Soy  Wheat  Tree Nut (almond)  Peanut  Fish (market name)  (Shellfish market name)  Sesame  Food Allergens in Allergen Advisory tatements S
Cream  Creamery A   
and Creamery    X               
B 
Milk powder  Powdered Milk   
Manufacturer C 
and Powdered    X               
Milk 
Manufacturer D 
 
Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Vanilla 
frozen custard 
RMNaaawmte eri al  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    X               
Milk Manufacturer 
D 
Chapter 11 (Food Allergen Program) - Page 91 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
RMNaaawmte eri al  Supplier  Egg  Milk  Soy  Wheat  Tree Nut (almond)  Peanut  Fish (market name)   Shellfish (market name)  Sesame  Food Allergens in Allergen Advisory Statements 
Pasteurized  Egg   
liquid eggs  Establishment E 
x                 
and Egg 
Establishment F 
 
Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Vanilla 
frozen custard with almonds 
RMNaaawmte eri al  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 
  X               
and Powdered Milk 
Manufacturer D 
Pasteurized  Egg Establishment   
liquid eggs  E and Egg  x                 
Establishment F 
Roasted,  Almond Handler G   
chopped  and Almond          x         
almonds  Handler H 
 
 
 
   
Chapter 11 (Food Allergen Program) - Page 92 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
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 
 
 
 
 
   
Chapter 11 (Food Allergen Program) - Page 93 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
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 
d)  et 
on et  rk
Egg  Milk  Soy  Wheat  e Nut (alm Peanut  Fish(mark name)  ellfish (maname)  Sesame 
Production  e h
r S
Product Name  Line   T
Raspberry sorbet  Line A                   
Vanilla ice cream  Line A    x               
Vanilla frozen custard  Line A  X  x               
Vanilla frozen custard with  Line A  X  x    x         
 
almonds 
 
 
Chapter 11 (Food Allergen Program) - Page 94 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
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)________________________________ 
 
What to  How to  Frequency of  Who  Corrective Action/ 
Criterion  Verification  Records 
Monitor  Monitor  Monitoring  Monitors  Corrections 
Correct food  N/A  Dessert  N/A  N/A  N/A  - Correction (not  - Upon receipt of the tubs and lids, QA  - Label Content Procedures 
allergen label  Manufacturer  documented): Reject lots  personnel:  - The approved food 
specification  A classifies  of incorrect tubs and lids   - Check that the product name and  allergen label specification, 
for:  its activity as  and follow up with tub/lid  ingredient statement on the label  signed and dated by the 
- The product  verification  manufacturer  pre-printed on the tubs, the  Label Coordinator  
name and  - Corrective action  product name on the label pre- - The following records, 
Ingredient  (documented): If the  printed on the lids, and the color  initialed and dated by the 
statement on  inaccurate label content is  on the edges of the tubs and lids,  PCQI: 
tubs of frozen  not discovered until after  match the approved food allergen 
- Label Review Forms 
dessert;   the product is packaged:  label specification; 
documenting the 
- The product  - Segregate incorrectly  - Document this verification review  verification review of 
name on lids  packaged products;   on a Label Review Form included  the product tubs and 
for frozen  - Rework or discard  in the Label Content Procedures  lids; and 
dessert; and  and sign and date the form. 
product as  - Any corrective action 
- The color on  applicable;   - On a weekly basis, the PCQI reviews,  records. 
the edge of  initials, and dates the Label Review 
- Investigate root 
the product  Forms documenting the verification 
cause and modify 
tubs and lids  procedures or re- review of the product tubs and lids. 
train personnel as  - Within a week of any corrective 
applicable; and   actions, the PCQI reviews, initials, and 
dates the corrective action records. 
- Recall if necessary 
   
Chapter 11 (Food Allergen Program) - Page 95 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
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)________________________________ 
 
What to  Frequency of  Who 
Criterion  How to Monitor  Corrective Action/ Correction  Verification  Records 
Monitor  Monitoring  Monitors 
Storage of  Storage of  Visual observation  Weekly  QA  Corrections (documented on a  On a weekly basis,  - Storage Record for 
tubs and lids  tubs and lids  personnel  Storage Record for Label  the PCQI reviews,  Label Controls 
in boxes on  at receipt and  Controls): Return any  initials, and dates 
 
pallets with a  following  incorrectly stored tubs or lids to  Storage Record for 
  
sticker  production  the correct storage location  Label Controls 
containing the  documenting 
product name  monitoring storage 
and carton  of tubs or lids and 
size on the  associated 
outside of the  corrections 
box 
Check that tub  The staging  - Visually observe that the  At the beginning  Line  Correction (documented):  On a weekly basis,  - Label Management 
brought to the  check of the  top edge of the tub and lid  of packaging and  operator  Remove incorrect tubs or lids  the PCQI reviews,  Procedures, including 
staging area  product tub  have the correct color   when new tubs or  from the line, return to storage,  initials, and dates  the procedures for 
has the  and lid  lids are brought  and obtain the correct tub and  any production  monitoring the staging 
 
correct color  to the line  lid.   sheets  check of the product 
on the edge of  documenting the  tub and lid 
the tub, and  staging checks, 
- The production 
that the lid  including when an 
sheets documenting 
brought to the  incorrect tub or lid 
the staging checks, 
staging area  is on the line at the 
initialed and dated by 
has the  beginning of 
the line operator (and 
correct  production  
the PCQI).  
product name 
 
and color 
Chapter 11 (Food Allergen Program) - Page 96 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
What to  Frequency of  Who 
Criterion  How to Monitor  Corrective Action/ Correction  Verification  Records 
Monitor  Monitoring  Monitors 
Use of the  That the  - Manually use a barcode  When the line is  Line  Corrective action  - On a weekly  The following records, 
correct tub  correct tub is  scanner  set up and at  operator  (documented):   basis, the PCQI  initialed and dated by 
during  being used  hourly intervals  reviews, initials,  the PCQI: 
  - Segregate incorrectly 
packaging  during  throughout the  packaged products;   and dates  - The production 
packaging  production run  production sheets 
- Rework or discard product  sheets with the 
documenting 
as applicable;   results of the 
results of the 
barcode scanner 
- Investigate root cause  barcode scanning 
and verification 
and modify procedures or  of the tubs  check that 
re-train personnel as 
- Within a week of  unused tubs and 
applicable; and  
any corrective  lids are put in 
- Recall if necessary  actions, the PCQI  appropriately 
reviews, initials,  stickered boxes; 
and dates the  and 
corrective action  - Any corrective 
records.  actions 
 
Chapter 11 (Food Allergen Program) - Page 97 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Appendix 11-3  Summary of Bakery Bs 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  
RNaawm eM aterial  Supplier  Egg  Milk  Soy  Wheat  market Tree Nut (name)  Peanut  Fish (market name)  Shellfish (market name)  Sesame  Food Allergens in Allergen Advisory Statements 
Flour   Miller C and Miller 
D        X             
Pasteurized  Egg Establishment 
liquid eggs  E and Egg  X                   
Establishment F 
 
   
Chapter 11 (Food Allergen Program) - Page 98 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
 
Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Caramel 
chip cookies 
RMNaaawmte eri al  Supplier  Egg  Milk  Soy  Wheat  market Tree Nut (name)  Peanut  Fish (market name)  Shellfish (market name)  Sesame  Food Allergens in Allergen Advisory Statements 
Vegan  Carmel chip   
caramel  Processor A     X*               
chips 
Vegan  Caramel chip   
caramel  Processor B    X**               
chips 
Flour   Miller C and Miller   
D        X           
Pasteurized  Egg   
liquid eggs  Establishment E 
X                 
and Egg 
Establishment F 
* 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. 
 
   
Chapter 11 (Food Allergen Program) - Page 99 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Food Allergens in Ingredient Formulation or in Allergen Advisory Statements: Peanut 
butter cookies 
RMNaaawmte eri al  Supplier  Egg  Milk  Soy  Wheat  market Tree Nut (name)  Peanut  Fish (market name)  Shellfish (market name)  Sesame  Food Allergens in Allergen Advisory Statements 
Peanut  Peanut Processor A   
butter  and Peanut            X       
Processor B 
Flour   Miller C and Miller D   
      X           
Pasteurized  Egg Establishment   
liquid eggs  E and Egg  X                 
Establishment F 
 
 
 
   
Chapter 11 (Food Allergen Program) - Page 100 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
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 
 
 
 
 
 
   
Chapter 11 (Food Allergen Program) - Page 101 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
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 
t 
e
t  k
Egg  Milk  Soy  Wheat  Tree Nut almonds)  Peanut  sh (markename)  lfish (marname)  Sesame 
( Fi el
Production  h
S
Product Name  Line  
Oatmeal cookies  Line A  X      X           
Caramel chip cookies  Line A  X      X           
Peanut butter cookies  Line B  X      X    X       
 
 
Chapter 11 (Food Allergen Program) - Page 102 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
 
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)________________________________ 
 
Frequency 
What to  Who 
Criterion  How to Monitor  of  Corrective Action/ Correction  Verification  Records 
Monitor  Monitors 
Monitoring 
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  and tools     for each  correct area. Determine, if possible, how  for Allergen Cross-Contact  color of utensils and tools, 
tools  cookie  the problem arose and re-train personnel  Controls records (including  including monitoring 
 
processing  as appropriate.   corrective actions when  procedures 
area  applicable) and documents 
- Correction (not documented): If the  - Checklist for Allergen 
that verification review by 
problem is before production, this is  Cross-Contact Controls, 
initialing and dating the 
correction.  initialed and dated by the 
record. 
- Corrective action (documented): If the  PCQI, documenting: 
problem is during production, this is  -  Results of 
corrective action, with documentation of  monitoring, 
the following on the non-conformance  including non-
record:  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  
   
Chapter 11 (Food Allergen Program) - Page 103  
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
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)________________________________ 
 
Frequency 
What to  Who 
Criterion  How to Monitor  of  Corrective Action/ Correction  Verification  Records 
Monitor  Monitors 
Monitoring 
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    for each  item(s) (and, if so, why) or due to a  for Allergen Cross-Contact  color of apparel and 
movement  cookie  violation of the plant traffic pattern  Controls records (including  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  that verification review by 
- Checklist for Allergen 
area. Re-train personnel as appropriate   initialing and dating the 
Cross-Contact Controls, 
record.  
- Correction (not documented): If the  initialed and dated by the 
employee put on the wrong colored item,  PCQI, documenting: 
the employee leaves the area and applies  - Results of 
the correct apparel.   monitoring, 
- Corrective action (documented): If the  including any non-
problem was due to personnel from the  conformance; and 
peanut butter cookie production area  - When applicable, 
entering the oatmeal/caramel chip cookie  associated 
production area, with documentation of  corrective actions 
the following on the non-conformance 
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. 
   
Chapter 11 (Food Allergen Program) - Page 104  
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
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)__________________________ 
Frequency 
What to  How to  Who 
Criterion  of  Corrective Action/ Correction  Verification  Records 
Monitor  Monitor  Monitors 
Monitoring 
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  Bakery B  label content does not match the  production printer, the Label  - The approved food 
specification  classifies  approved food allergen label  Team Supervisor checks that the  allergen label specification, 
for the  its activity  specification before the file is sent to  product name and Contains  signed and dated by the 
product  as  the production printer, the Label  statement on the production label 
Label Team Supervisor 
name and  verification  Team Supervisor corrects the label  matches the approved food 
- The following records, 
the  content in the file.  allergen label specification. 
initialed and dated by the 
Contains 
- Corrective action (documented): If  - The Production Supervisor prints 
PCQI:  
statement on 
the problem is discovered only after  a production label from the 
product  - The production sheet 
packaged cookies have been labeled:  production printer, pastes that 
labels  printed label onto the production  containing the label 
- Segregate affected product;  from the production 
sheet, and signs and dates the 
- Rework cookies by manually  printer, signed and 
production sheet next to the 
transferring the trays of  dated by the 
printed label.  
incorrectly labeled cookies to  Production 
pouches with the correct label;   - On a weekly basis, the PCQI  Supervisor; and. 
reviews, initials, and dates the 
- Investigate root cause and  - Any corrective action 
records documenting the 
modify procedures or re-train  records. 
verification review of the 
personnel as applicable; and  
production labels. 
- 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 
   
Chapter 11 (Food Allergen Program) - Page 105  
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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)________________________________ 
 
What to  How to  Frequency of  Who 
Criterion  Corrective Action/ Correction  Verification  Records 
Monitor  Monitor  Monitoring  Monitors 
Selection of  N/A    N/A  N/A  N/A  - Correction (not documented): If the  - The Production Supervisor  - Label Management 
the correct  Bakery B  Production Supervisor determines that  prints a production label from  Procedures 
electronic file  classifies its  a file for the wrong label was sent to  the production printer, pastes 
- The following 
for the label  activity as  the production printer but the label has  that printed label onto the  records, initialed and 
verification  not been applied to product, the  production sheet, and signs 
dated by the PCQI: 
Production Supervisor follows up with  and dates the production 
- The production 
the Label Team Supervisor to obtain  sheet next to the printed label 
sheet containing 
the correct file. 
- On a weekly basis, the PCQI  the label from 
- Corrective action (documented): If the  reviews, initials, and dates the  the production 
problem is discovered only after  records documenting the  printer, signed 
packaged cookies have been labeled:  verification review of the  and dated by the 
- Segregate affected product;  production labels.  Production 
- Within a week of a problem  Supervisor; and 
- Rework cookies by manually 
transferring the trays of  that requires corrective action,  - Any corrective 
the PCQI reviews, initials, and 
incorrectly labeled cookies to  actions 
dates the corrective action 
pouches with the correct label;  
records 
- Investigate root cause and modify 
procedures or re-train personnel 
as applicable; and  
- Recall any product if necessary. 
 
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What to  How to  Frequency of  Who 
Criterion  Corrective Action/ Correction  Verification  Records 
Monitor  Monitor  Monitoring  Monitors 
Application of  N/A    N/A  N/A  N/A  Corrective action (documented):   - The line operator:  - Label Management 
the correct  Bakery B  - Segregate incorrectly packaged   - Visually checks that the  Procedures 
label  classifies its  products;   correct label is applied;  - The following 
activity as 
- Rework cookies by manually  and   records, initialed and 
verification 
transferring the trays of incorrectly  - Records, initials, and  dated by the PCQI: 
labeled cookies to pouches with the  dates the results of the  - The production 
correct label;   visual check on the  sheets 
- Investigate root cause and modify  production sheet  documenting the 
procedures or re-train personnel as  - On a weekly basis, the PCQI  results of the 
applicable; and   reviews, initials, and dates the  visual check for 
- Recall any product if necessary  production sheets with the  the application 
results of the visual check for  of the correct 
the correct application of the  label; and 
product label.  - Any corrective 
- Within a week of any  actions 
corrective actions, the PCQI 
review, initials, and dates the 
corrective action records. 
 
 
 
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Chapter 11 (Food Allergen Program) - Page 108  
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Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs 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.   
Chapter 12 (Preventive Controls for Chemical Hazards) - Page 1  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs 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.   
Chapter 13 (Preventive Controls for Physical Hazards) - Page 1  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
 Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
 
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 FDAs Technical Assistance Network by submitting your question at 
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistance-
network-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.   
Chapter 14 (Recall Plan) - Page 1  
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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 FDAs recall policy in 21 CFR part 7, subpart C to mean 
the first consignee in a recalling firms distribution chain. 
Direct consignee  The term used in 21 CFR 117.139 to mean the first consignee in a recalling 
firms 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 foode.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; FDAs 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-guidance-
recalls): 
  Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. Guidance for Industry 
o
and FDA Staff. Draft Guidance (FDA, 2019a; the draft initiation of voluntary recalls 
guidance) 
  Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. Guidance 
o
for Industry and FDA Staff (FDA, 2019c; FDAs public warning and notification 
guidance);  
  Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal 
o
Food Recalls Guidance for Industry and FDA Staff. Draft Guidance (FDA, 2018b);  
  Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and 
o
FDA Staff (FDA, 2018c); 
  Guidance for Industry: Product Recalls, Including Removals and Corrections" (FDA, 
o
2014; the industry recall guidance); and  
  Index of Model Press Releases (available at https://www.fda.gov/safety/recalls-market-
withdrawals-safety-alerts/industry-guidance-recalls); and 
  Chapter 7 of FDAs Regulatory Procedures Manual (FDA, 2019d), including:  
  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 
o
(Industry) (FDA, 2019g);  
  Exhibit 7-4 - Model Recall Letter (Generic, All Centers) (FDA, 2019h); and 
o
  Exhibit 7-5 - Model Recall Response Form (FDA, 2019i).  
o
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-safety-
alerts/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-market-
withdrawals-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-market-
withdrawals-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: 
  Name and job position/title;  
o
  Business phone number (including cell phone number when applicable) and email 
o
address;  
  After-hours phone number (e.g., home or cell phone number); and 
o
  Responsibilities; and  
o
  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  Prepare batch identification; stop production of food if related 
quality assurance  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  Help contact customers; assist in product pick-up as needed 
manager 
*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.  
Chapter 14 (Recall Plan) - Page 10  
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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-market-
withdrawals-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-safety-
alerts/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-market-
withdrawals-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-withdrawals-
safety-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) 
Chapter 14 (Recall Plan) - Page 11  
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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/) 
 
Chapter 14 (Recall Plan) - Page 12  
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Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry   
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 FDAs 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 Facilitys 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 suppliers 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 entitys 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 facilitys 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 suppliers food safety 
processes and procedures. 
Manufacturing/  Making food from one or more ingredients, or synthesizing, preparing, treating, 
processing  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 FDAs 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  Any food in its raw or natural state, including all fruits that are washed, colored, or 
commodity (RAC)  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  A preventive control for a hazard in a raw material or other ingredient when the 
control  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  Written procedures to ensure that raw materials and other ingredients are received 
receiving raw materials  only from suppliers approved by the receiving facility (or, when necessary and 
and other ingredients  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 facilitys 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-chain-
applied 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 supply-
chain-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 
FDAs 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 supply-
chain 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 Supply-
chain Program 
Subpart G provides for two exceptions to the requirement to establish and implement a supply-
chain 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 f or 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 facilitys 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 Facilitys Supplier 
When a supply-chain-applied control is applied by an entity other than the receiving facilitys 
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 entitys 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 facilitys 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 entitys 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 harvesters 
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 packers 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 
harvesters documentation. Likewise, you could obtain documentation of review of applicable 
records maintained by the harvester or packer from another entity, review and assess the 
entitys applicable documentation, and document that review and assessment.  
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15.6.5  Role of the Preventive Controls Qualified Individual in the Supply-
Chain 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 facilitys 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 suppliers 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 suppliers food safety procedures, such as records of your suppliers audit of its 
suppliers food safety activities. For example, if you produce deli salads and obtain chopped 
Chapter 15 (Supply-Chain Program) - Page 14 
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fresh vegetables from your supplier, you could obtain a copy of your suppliers 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 steam-
treated 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  
 
Establishment B Supplier A Your Facility
spicemix with 
Identification  Steam treats black  black pepper Creates spice mix with  black pepper Identifies Salmonella 
and control of  pepper to control for  treated black pepper hazard in black pepper
hazard Salmonella
Your Facility
Supplier Verification of 
Supplier A
hazard control through 
Conducts and documents the 
review of supplier's 
following supplier verification 
relevant food safety 
activities of Establishment B:
Supplier  records:
verification Establishment B Supplier A's onsite audit of 
activities by  Establishment B  -Review audit records of 
Supplier A and  Establishment B
OR
Your Facility
Other supplier verification activities  -Review documentation 
conducted by Supplier A of  of applicable parameters 
Establishment B (such as periodic  for the steam treatment 
testing of steam-treated black  done by Establishment B
pepper)
(obtain from Supplier A 
or Establishment B 
directly)
or
Review Supplier A's 
records of other activities 
 
 
 
 
 
 
See 21 CFR 117.475(c)(9) and section 15.13 for a list of required documentation when you 
conduct a review of the suppliers 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 suppliers 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 suppliers 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 
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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 suppliers 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 suppliers 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 risk-
based 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 producers 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 suppliers 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-chain-
applied 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 suppliers supplier. If the 
control is not applied by your direct supplier, you would direct your supplier verification activities 
to your suppliers 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 Xs 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) 
 
Establishment Y
Process control for 
Salmonelladuring  milk powder Supplier X
manufacture of milk 
Your Facility
powder Creates seasoning mix with 
Identification  processed milk powder and  seasoning mix Identifies Salmonella 
spice blend; identifies 
and control of  hazard in seasoning mix
hazard Establishment Z hazard, but does not apply 
its own controls
Process control for 
Salmonella applied to 
spice blend  spice blend
Your Facility
Supplier X
Supplier verification of hazard 
Does not apply itsown 
control through:
controls, but does conduct 
and document supplier  Review Supplier X 
verification of documention of its supplier 
Establishment Y
Establishments Y and Z: verification activities of 
Establishments Y and Z
Supplier 
Appropriate supplier 
verification
verification activities could  Alternatively
activities by 
include auditing or 
Supplier X and  obtaining an audit of   -Conduct appropriate 
Your Facility Establishments Y and Z and  supplier verification  
sampling and testing the  actitivites of Establishments 
milk and spices to ensure  Y and Z directly (e.g., audit).  
Establishment Z
that suppliers used proper  OR
-Conduct some supplier 
verification activities of 
Establishments Y and Z 
yourself and rely on 
documentation from Supplier 
X for others.
Establishments Yand 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 
entitys 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 suppliers 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 suppliers 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 
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recognized as comparable or has determined to be equivalent to that of the United States, 
and information relevant to the suppliers compliance with those laws and regulations) (21 
CFR 117.410(d)(1)(iii)(B)); and  
  The suppliers 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 Suppliers procedures, processes, and practices 
Understanding the suppliers procedures, processes, and practices related to the safety of the 
raw material and other ingredients can help you understand the suppliers strengths and 
weaknesses. Mechanisms to do so include: 
  Conducting a supplier pre-assessment questionnaire or survey to gather information about 
the suppliers operation, covering topics such as product information (e.g., regulatory 
compliance information and allergen information) and the suppliers 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 suppliers 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 suppliers 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 suppliers compliance with relevant FDA regulations. 
Having an understanding of applicable FDA food safety regulations and information relevant to 
the suppliers 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 facilitys 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 suppliers 
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 countrys 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 Suppliers 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 suppliers 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 suppliers 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 
suppliers 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 suppliers 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 entitys 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 entitys 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 suppliers 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 suppliers 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 suppliers 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 
FDAs 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 suppliers 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 suppliers procedures and the corporations 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 suppliers 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.  
Chapter 15 (Supply-Chain Program) - Page 31 
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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 suppliers 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:  
  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 
o
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:  
  A brief description of the preventive controls that the supplier is implementing to 
o
control the applicable hazard in the food; or  
  A statement that the facility is in compliance with State, local, county, tribal, or other 
o
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 honey-
roasted 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:  
  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 
o
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 farms 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:  
  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 
o
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 non-
compliance. 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 individuals 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 FDAs 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 GFSIs 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 suppliers 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 suppliers 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 suppliers roasting process adequately 
controlled the Salmonella. Because the supplier was subject to the PCHF requirements, the 
audit should include a review of the suppliers 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 establishments 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 suppliers 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 suppliers 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 suppliers 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 
facilitys compliance with applicable FDA regulations, review the suppliers 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 suppliers 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  If you are an importer, and you 
that you are in compliance with the FSVP  have records documenting the 
requirements under part 1, subpart L,  supplier verification activities you 
including documentation of verification  conducted to comply with the 
activities conducted under 1.506(e)   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    Your written determination of the basis 
supplier  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  Examples are a paper checklist 
materials and other ingredients  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  Examples are a paper checklist 
written procedures for receiving raw  that was marked to demonstrate 
materials and other ingredients  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  Your written determination should 
the appropriate supplier verification  explain why you chose your 
activities for raw materials and other  particular supplier verification 
ingredients  activities. See the discussion in 
section 15.7.4. 
117.475(c)(7)  Documentation of the conduct of an  Examples of documentation of 
onsite audit, including (i) The name of the  audit procedures include the 
supplier subject to the onsite audit; (ii)  process(es) and food(s) observed, 
Documentation of audit procedures; (iii)  types of records reviewed, and 
The dates the audit was conducted; (iv)  whether the audit included 
The conclusions of the audit; (v)  interviews or laboratory testing. 
Corrective actions taken in response to  Examples of the conclusions of an 
significant deficiencies identified during  audit include whether the audit did, 
the audit; and (vi) Documentation that the  or did not, result in any significant 
audit was conducted by a qualified  deficiencies.  
auditor 
You have some flexibility to work 
with the qualified auditor, or with a 
supplier who arranges for a third-
party 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  You have some flexibility in the 
conducted as a supplier verification  format of appropriate 
activity. This documentation must  documentation of sampling and 
include: (i) Identification of the raw  testing, such as on a CoA. 
material or other ingredient tested  Documentation of corrective 
(including lot number, as appropriate)  actions would apply to the steps 
and the number of samples tested; (ii)  you take when you (or a third party 
Identification of the test(s) conducted,  acting on your behalf) detect the 
including the analytical method(s) used;  hazard in raw materials or other 
(iii) The date(s) on which the test(s) were  ingredients that you received, 
conducted and the date of the report; (iv)  including what you do with the raw 
The results of the testing; (v) Corrective  material or other ingredient and the 
actions taken in response to detection of  steps you take to address the 
hazards; and (vi) Information identifying  problem with the supplier. 
the laboratory conducting the testing 
117.475(c)(9)  Documentation of the review of the  Records of the supply-chain 
supplier's relevant food safety records.  program must be reviewed within a 
This documentation must include: (i) The  reasonable time after the records 
name of the supplier whose records were  are made by (or under the 
reviewed; (ii) The date(s) of review; (iii)  oversight of) a PCQl to ensure that 
The general nature of the records  the records are complete, the 
reviewed; (iv) The conclusions of the  activities reflected in the records 
review; and (v) Corrective actions taken  occurred in accordance with the 
in response to significant deficiencies  food safety plan, the suppliers 
identified during the review  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  Your documentation of other 
supplier verification activities based on  appropriate supplier verification 
the supplier performance and the risk  activities would depend on the 
associated with the raw material or other  nature of the activity. For example, 
ingredient  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 suppliers 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  Because your written supply-chain 
verification activities other than an onsite  program is part of your food safety 
audit, and/or less frequent onsite auditing  plan, the written determination 
of a supplier, provide adequate  must be prepared by (or under the 
assurance that the hazards are  oversight of) your PCQI. See the 
controlled when a hazard in a raw  discussion in section 15.11.2.2 for 
material or other ingredient will be  examples of what such a written 
controlled by the supplier and is one for  determination could address. 
which there is a reasonable probability 
that exposure to the hazard will result in 
serious adverse health consequences or 
death to humans 
117.475(c)(12)  The following documentation of an  You and your suppliers have some 
alternative verification activity for a  flexibility to determine the 
supplier that is a qualified facility: (i) The  appropriate documentation in a 
written assurance that the supplier is a  way that works best for your 
qualified facility as defined by 117.3,  specific business relationship. For 
before approving the supplier and on an  example, for documentation of its 
annual basis thereafter; and (ii) The  status, a qualified facility could 
written assurance that the supplier is  provide you with documentation of 
producing the raw material or other  its submission of the qualified 
ingredient in compliance with applicable  facilities form (Form FDA 3942a). 
FDA food safety regulations (or, when  For the other assurance, you and 
applicable, relevant laws and regulations  your supplier can choose which of 
of a country whose food safety system  two options to use, based on the 
FDA has officially recognized as  specific circumstances of the 
comparable or has determined to be  supplier. See the discussion in 
equivalent to that of the United States)  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  You and your suppliers have some 
alternative verification activity for a  flexibility to determine the 
supplier that is a farm that supplies a raw  appropriate documentation in a 
material or other ingredient and is not a  way that works best for your 
covered farm under part 112 of this  specific business relationship.  
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) 
117.475(c)(14)  The following documentation of an  You and your suppliers have some 
alternative verification activity for a  flexibility to determine the 
supplier that is a shell egg producer that  appropriate documentation in a 
is not subject to the requirements  way that works best for your 
established in part 118 of this chapter  specific business relationship.  
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) 
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Section  Description  Discussion 
117.475(c)(15)  The written results of an appropriate  The written results of an 
inspection of the supplier for compliance  appropriate inspection would 
with applicable FDA food safety  depend on the inspection and how 
regulations by FDA, by representatives of  the entity conducting the inspection 
other Federal Agencies (such as the U.S.  reports its results. 
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 
117.475(c)(16)  Documentation of actions taken with  Your documentation of supplier 
respect to supplier nonconformance  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 supply- The documentation you receive 
chain-applied control applied by an entity  from another entity should be 
other than the receiving facility's supplier  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  You have some flexibility for how 
receiving facility's review and  to appropriately document that you 
assessment of: (i) Applicable  reviewed and assessed the 
documentation from an entity other than  documentation from another entity. 
the receiving facility that written  For example, appropriate staff in 
procedures for receiving raw materials  your facility could date and sign the 
and other ingredients are being followed;  documentation received from the 
(ii) Applicable documentation, from an  other entity, or you could attach a 
entity other than the receiving facility, of  signed, dated statement, from 
the determination of the appropriate  appropriate staff in your facility, 
supplier verification activities for raw  specifying that the documentation 
materials and other ingredients; (iii)  had been reviewed and assessed.  
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 third-
party 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 supply-
chain-applied control is applied by an 
entity other than the receiving facility's 
supplier 
  
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 
suppliers 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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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  September 18, 2017 
be subject to the PCHF requirements of part 117 or 
the produce safety regulation 
You are a small business and your supplier is  The later of September 18, 2017, or 6 months after 
subject to the PCHF requirements of part 117 or  your supplier of that raw material or other 
the produce safety regulation  ingredient is required to comply with the applicable 
requirements 
You are neither a small business nor a very small  March 17, 2017 
business and your supplier will not be subject to the 
PCHF requirements of part 117 or the produce 
safety regulation 
You are neither a small business nor a very small  6 months after your supplier of that raw material or 
business and your supplier will be subject to the  other ingredient is required to comply with the 
PCHF requirements of part 117 or the produce  applicable requirements 
safety regulation 
 
 
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 for which there is a reasonable probability that exposure 
Hazard  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. 
Chapter 15 (Supply-Chain Program) - Page 47 
  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
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) 
Chapter 15 (Supply-Chain Program) - Page 48 
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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/information-
kit/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/certification-
bodies-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. 
 
 
Chapter 15 (Supply-Chain Program) - Page 49 
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Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs 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.   
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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 (100C) (i.e., the temperature of boiling water) or even lower (e.g., 150 F (65.6C) 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. 
Chapter 16 (Acidified Foods) - Page 7  
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Table 16-1 Terms Used in this Chapter 
Term  What the Term Means 
Emergency permit control  Emergency permit control requirements in 21 CFR 108.25 for acidified 
regulations  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  Applicable  Applicable  Applicable 
Requirements in 21  Requirements in Part  Section in This  Chapters in This 
CFR 108.25 or Part  117 (21 CFR)  Chapter  Guidance 
114 (21 CFR) 
Qualifications of personnel with   108.25(f)   117.4(c)   16.6  N/A 
responsibility for supervision or 
other oversight   114.10   117.180(c)(1) 
Oversight   108.25(f)   117.126(a)(2)  16.7  Chapter 1 
 114.10   117.160(b)(1) 
 114.83   117.160(c)(5) 
 117.165(a)(4) 
 117.170(c)(2)(ii) 
 117.180(a) 
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  Applicable  Applicable  Applicable 
Requirements in 21  Requirements in Part  Section in This  Chapters in This 
CFR 108.25 or Part  117 (21 CFR)  Chapter  Guidance 
114 (21 CFR) 
Identifying and implementing   108.25(c)(2)   117.126(b)(2)  16.10.1  Chapters 4 and 6  
preventive controls that are 
process controls for biological   108.25(c)(3)   117.135(a) 
hazards requiring a preventive 
 114.80(a)(1)   117.135(b) 
control 
 114.80(a)(3)   117.135(c)(1) 
 114.80(a)(4) 
Identifying and implementing  N/A   117.126(b)(2)  16.10.2.1  Chapters 4, 11, 
preventive controls for chemical  12, and 13 
or physical hazards requiring a   117.135(a) 
preventive control 
 117.135(b) 
 117.135(c)(1) 
 117.135(c)(2) 
Identifying and implementing  N/A   117.126(b)(2)  16.10.2.2  Chapter 10 
preventive controls that are 
sanitation controls   117.135(a) 
 117.135(b) 
 117.135(c)(3) 
Supply-chain controls  114.100(a)   117.126(b)(3)  16.10.3  Chapters 4 and 
15 
 117.135(a) 
 117.135(c)(4) 
 Subpart G 
Recall plan  108.25(e)   117.126(b)(4)  16.10.4  Chapters 4 and 
14 
 117.135(a) 
 117.135(b) 
 117.135(c)(5) 
 117.139 
Preventive control management   108.25(c)(3)(ii)   117.126(b)(5)  16.11  Chapters 5 and 6 
components 
 114.3   117.126(b)(6) 
 114.80(a)(2)   117.126(b)(7) 
 114.80(a)(4)   117.140 
 114.89   117.145 
 114.90   117.150 
 117.155 
 117.160 
 117.165 
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Description of Requirement  Applicable  Applicable  Applicable  Applicable 
Requirements in 21  Requirements in Part  Section in This  Chapters in This 
CFR 108.25 or Part  117 (21 CFR)  Chapter  Guidance 
114 (21 CFR) 
Records   108.25(g)   117.9  16.12  Chapter 6 
 114.100   117.126(c) 
 117.145(c) 
 117.150(d) 
 117.155(b) 
 117.180(d) 
 117.190(a) 
 117.475(c) 
 Subpart F 
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. 
Chapter 16 (Acidified Foods) - Page 10  
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Table 16-3 Qualifications of Personnel with Responsibility for Supervision or Other 
Oversight  
Requirements in Part 117  Requirements in 21  How You Can Leverage 
(21 CFR)  CFR 108.25 or Part  Compliance with 
114 (21 CFR)  Requirements in 21 CFR 
108.25 or Part 114 to 
Address Requirements in 
Part 117 
117.4(c): Responsibility for ensuring  108.25(f) and 114.10: All  Satisfactorily completing the 
compliance by individuals with the  operators of processing  prescribed course of instruction in a 
requirements of this part must be clearly  and packaging systems  school specified in 21 CFR 108.25(f) 
assigned to supervisory personnel who  shall be under the  and 114.10 provides an individual 
have the education, training, or  operating supervision of a  with the qualifications necessary to 
experience (or a combination thereof)  person who has attended a  provide supervisory oversight for the 
necessary to supervise the production  school approved by the  production of an acidified food 
of clean and safe food.  Commissioner for giving  product as required by 21 CFR 
instruction in food-handling  117.4(c). 
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. 
 
 
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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Table 16-4 Requirements for Oversight  
Requirements in Part  Requirements in 21 CFR  How You Can Leverage 
117  108.25 or Part 114  Compliance with 
(21 CFR)  (21 CFR)  Requirements in 21 CFR 
108.25 or Part 114 to Address 
Requirements in Part 117 
  117.126(a)(2): The food    108.25(f) and 114.10: All    A person who satisfactorily completes 
safety plan must be  operators of processing and  the prescribed course of instruction 
prepared, or its preparation  packaging systems shall be  specified in 21 CFR 108.25(f) and 
overseen, by one or more  under the operating supervision  114.10 could, through job experience, 
preventive controls qualified  of a person who has attended a  be qualified to conduct or oversee the 
individuals.  school approved by the  following activities listed in 21 CFR 
Commissioner for giving  117.180(a) as they relate to 
  117.180(a): One or more 
instruction in food-handling  acidification: 
preventive controls qualified 
techniques, food-protection 
individuals must do or  principles, personal hygiene  o Review of records (21 CFR 
oversee certain activities  117.165(a)(4); and 
and plant sanitation practices, 
related to preparation and 
pH controls and critical factors   Justification for a timeframe that 
implementation of the food  o
in acidification, and who has  exceeds 7 days for review of 
safety plan: 
been identified by that school  certain records (21 CFR 
 117.160(b)(1)  as having satisfactorily  117.165(a)(4)(i)) 
o
(validation of preventive  completed the prescribed 
controls)  course of instruction.    A person who is a competent 
processing authority and who 
 117.160(b)(1)(i)(B)(2)    114.83 The scheduled process  establishes the scheduled process in 
o
(justification for a  shall be established by a  accordance with 21 CFR 114.83 
validation timeframe that  qualified person who has  could, through job experience, be 
exceeds the first 90  expert knowledge acquired  qualified to conduct or oversee the 
days of production)  through appropriate training  following activities listed in 21 CFR 
and experience in the  117.180(a) as they relate to 
o 117.160(c)(5)  acidification and processing of  acidification and thermal processing 
(justification that  acidified foods. Under 114.3(e),  of an acidified food: 
validation is not  scheduled process means the 
applicable)  process selected by a  o 117.160(b)(1) (validation of 
processor as adequate for use  preventive controls) 
 117.165(a)(4) (review of 
o
under the conditions of 
records)   117.160(b)(1)(i)(B)(2) 
o
manufacture for a food in 
(justification for a validation 
o 117.165(a)(4)(i)  achieving and maintaining a  timeframe that exceeds the first 
(justification for a  food that will not permit the 
90 days of production) 
timeframe that exceeds  growth of microorganisms 
7 days for review of  having public health  o 117.160(c)(5) (justification that 
certain records)   significance. It includes control  validation is not applicable) 
of pH and other critical factors 
 117.170(c)(2)(ii)   117.165(a)(4) (review of records) 
o equivalent to the process  o
(justification for the 
established by a competent   117.165(a)(4)(i) (justification for a 
timeframe for  o
processing authority.  timeframe that exceeds 7 days 
completion of the 
for review of certain records)  
reanalysis, and 
validation of additional   117.170(c)(2)(ii) (justification for 
o
preventive controls, if  the timeframe for completion of 
the timeframe exceeds  the reanalysis, and validation of 
90 days after  additional preventive controls, if 
production)  the timeframe exceeds 90 days 
after production) 
 
 
Chapter 16 (Acidified Foods) - Page 12  
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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.  
Chapter 16 (Acidified Foods) - Page 14  
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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).) 
Chapter 16 (Acidified Foods) - Page 15  
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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)).   
Chapter 16 (Acidified Foods) - Page 16  
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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  Corresponding Requirements in 21  How You Can Leverage  How You Can 
(21 CFR)  CFR 108.25 or Part 114  Compliance with  Leverage 
(21 CFR)  Requirements in 21  Compliance with the 
CFR 108.25 or Part 114  Requirements of the 
to Address  PCHF Rule to 
Corresponding  Address 
Requirements in the  Corresponding 
PCHF Rule  Requirements of 21 
CFR 108.25 and Part 
114 
 Requirements to identify   108.25(c)(2): Requires the   The parameters that  Complying with the 
and implement  submission to FDA of Form FDA  you establish in  PCHF requirements 
preventive controls that  2541e. Form FDA 2541e requires, as  accordance with 21  to identify and 
are process controls:  applicable, information about the  CFR 114.80(a)(1) and  implement process 
product, the container type and size,  submit on Form FDA  controls, parameters 
o 117.135(a) (general  pH, method of acidification, microbial  2541e could satisfy  associated with 
requirement)  preservatives critical to the scheduled  the requirement for  control of the hazard, 
o 1co1n7t.r1o3ls5.( cP)r(o1c) ePsrso cess  pmroodcee,s sth, ep rcoocnetsasin seor uarncde ,c pornotcaeinsesr   pwaitrha mcoentetrrosl  aosf sao ciated  amnadx iampupmlic aobr le 
controls include  closure treatment, and details of the  hazard for process  minimum values that 
procedures, practices,  scheduled process (e.g., process time  controls, and  satisfy all 
and processes to  and temperature), for each acidified  applicable maximum  requirements in 21 
ensure the control of  food in each container size.  or minimum values in  CFR 114.80(a)(1) 
parameters during   108.25(c)(3): Requires a commercial  2a1s  lCoFngR  a1s1 7yo.1u3 i5n(ccl)u(d1e),   aonnd F aolrlm re FqDuiAre 2m5e4n1tes  
operations such as 
heat processing,  processor engaged in processing  that scheduled  could satisfy all 
acidifying, irradiating,  acidified foods to process each food  process in the food  requirements of 21 
in conformity with at least the  safety plan that is  CFR 108.25(c)(2) and 
and refrigerating 
foods. Process  scheduled processes filed under 21  signed and dated by  (3) and part 114 (e.g., 
CFR 108.25(c)(2).  the owner, operator, or  for control of pH, 
controls must include, 
as appropriate to the   114.80(a)(1): Acidified foods shall be  agent in charge of the  process time and 
nature of the  so manufactured, processed, and  facility and kept onsite  temperature, and 
(see 21 CFR 117.310  preservatives), as 
applicable control and  packaged that a finished equilibrium 
its role in the facilitys  pH value of 4.6 or lower is achieved  and 117.315(c)).   long as you also 
submit Form FDA 
food safety system: (i)  within the time designated in the   Compliance with the  2541e to FDA. 
Parameters associated  scheduled process and maintained in  scheduled process 
with the control of the  all finished foods. Manufacturing shall  submitted to FDA on   
hazard; and (ii) The  be in accordance with the scheduled  Form FDA 2541e 
maximum or minimum  process. Acidified foods shall be  could satisfy the 
value, or combination  thermally processed to an extent that  requirements in 21 
of values, to which any  is sufficient to destroy the vegetative  CFR 117.135(a) and 
biological, chemical, or  cells of microorganisms of public  (c) to implement 
physical parameter  health significance and those of non- preventive controls 
must be controlled to  health significance capable of  that are process 
significantly minimize  reproducing in the food under the  controls for biological 
or prevent a hazard  conditions in which the food is stored,  hazards that require a 
requiring a process  distributed, retailed and held by the  preventive control. 
control.  user. Permitted preservatives may be 
used to inhibit reproduction of 
 Requirement for written 
microorganisms of non-health 
procedures for 
significance (in lieu of thermal 
preventive controls that 
processing). 
are process controls: 
 114.80(a)(3): Lists acceptable 
o 117.126(b)(2)  procedures for acidification to attain 
o 117.135(b)  acceptable equilibrium pH levels in 
the final food 
 
 
 
Chapter 16 (Acidified Foods) - Page 17  
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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 
Chapter 16 (Acidified Foods) - Page 18  
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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 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 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)). 
Chapter 16 (Acidified Foods) - Page 19  
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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. 
 
Chapter 16 (Acidified Foods) - Page 20  
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Table 16-6 Recall Plan 
Requirements in Part  Corresponding  How You Can Leverage  How You Can 
117  Requirements in 21  Compliance with  Leverage 
(21 CFR)  CFR 108.25 or Part 114  Requirements in 21 CFR  Compliance with the 
(21 CFR)  108.25 or Part 114 to Address  Requirements of the 
Corresponding Requirements  PCHF Rule to 
in the PCHF Rule  Address 
Corresponding 
Requirements of 21 
CFR 108.25 and Part 
114 
  Requirements to  108.25(e): A commercial  A written recall procedure that  A written recall plan 
identify and  processor engaged in  you establish and implement to  that you establish 
implement preventive  the processing of  comply with 21 CFR 108.25(e)  and implement to 
controls:  acidified foods shall  could satisfy all requirements  comply with 21 CFR 
prepare and maintain  of the PCHF rule for a recall  117.139 could satisfy 
 117.135(a) 
o files on a current  plan, as long as it includes  the requirements of 
(general 
procedure for use for  procedures that describe the  21 CFR 108.25(e), 
requirement) 
products under the  steps to be taken, and assign  as long as it includes 
 117.135(c)(5)  processor's control,  responsibility for taking those  procedures for 
o
(recall plan)  which that processor will  steps, to perform the following  notifying FDA about 
ask the distributor to  actions as appropriate to the  any recall. 
o 117.139 (recall  follow, including plans  facility: 
plan)  for recalling products 
  Directly notify the direct 
that may be injurious to 
  Requirement for  consignees of the food being 
health; for identifying, 
written procedures for  recalled, including how to 
collecting, warehousing, 
preventive controls:  return or dispose of the 
and controlling products; 
affected food; 
 117.126(b)(4)  for determining the 
o
effectiveness of recalls;    Notify the public about any 
 117.135(b) 
o for notifying FDA of any  hazard presented by the 
recalls; and for  food when appropriate to 
implementing recall  protect public health; 
programs. 
  Conduct effectiveness 
checks to verify that the 
recall is carried out; and 
  Appropriately dispose of 
recalled foode.g., through 
reprocessing, reworking, 
diverting to a use that does 
not present a safety concern, 
or destroying the food. 
 
 
 
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 
Chapter 16 (Acidified Foods) - Page 21  
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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.  
Chapter 16 (Acidified Foods) - Page 22  
  Contains Non-binding Recommendations 
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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. 
Chapter 16 (Acidified Foods) - Page 23  
  Contains Non-binding Recommendations 
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Table 16-7 Preventive Control Management Components  
Requirements in Part 117  Corresponding  How You Can Leverage  How You Can Leverage 
(21 CFR)  Requirements in 21  Compliance with Requirements  Compliance with the 
CFR 108.25 or Part 114  in 21 CFR 108.25 or Part 114 to  Requirements of the 
(21 CFR)  Address Corresponding  PCHF Rule to Address 
Requirements in the PCHF Rule  Corresponding 
Requirements of 21 
CFR 108.25 and Part 
114 
 Requirements to establish   108.25(c)(3)(ii)   Complying with 21 CFR   Complying with the 
and implement preventive  Provide us with any  114.80(a)(2) could satisfy the  requirements of 21 
control management  process and  requirements of the PCHF rule  CFR 117.145 for 
components:  procedure information  for monitoring pH as a  monitoring preventive 
that we deem  preventive control management  controls for (1) pH and 
o 117.140   necessary to  component for pH control as a  (2) applying a 
o 117.145 (monitoring)  determine the  process control.  hermetic seal could 
adequacy of the  satisfy the 
o 117.150 (corrective  process   Complying with 21 CFR  requirements of 21 
actions and corrections)  114.80(a)(4) could satisfy the  CFR 114.80(a)(2) and 
 114.3(e): Scheduled  requirements of the PCHF rule  (a)(4), respectively. 
o 117.155 (verification)  process means the  for monitoring seam/seal 
process selected by a  integrity of finished product as a   Complying with the 
o 117.160 (validation)  processor as  preventive control management  requirements of 21 
o 117.165 (verification of  adequate for use  component when applying a  CFR 117.150 to 
implementation and  under the conditions  hermetic seal is a process  establish and 
effectiveness)  of manufacture for a  control.  implement corrective 
food in achieving and  action procedures 
o 117.165(a)(1)  maintaining a food   Written procedures that you  could satisfy the 
(calibration)  that will not permit the  establish and implement to  requirements of 21 
growth of  comply with the requirements of  CFR 114.89 for 
o 117.165(a)(2) (product  microorganisms  21 CFR 114.80(a)(2) and (a)(4)  deviations from 
testing)  having public health  could satisfy the requirements of  scheduled processes. 
o 117.165(a)(3)  significance.  2111 7C.1F4R5 (1a1) 7fo.1r2 w6r(ibtt)e(5n)  manodn itoring   Complying with the 
(environmental 
 114.80(a)(2) Exercise  procedures.  requirements of 21 
monitoring) 
of sufficient control,  CFR 117.155 and 
o 1re1c7o.1rd6s5)( a)(4) (review of  itnecsltuindgin agn fdre rqeuceonrdt ing   Wesrtiattbelnis hp raoncde dimurpelse mtheant ty toou   1va1l7id.1a6ti0o nfo wr opuroldc ebses  
of results, so that the  comply with the requirements of  consistent with the 
 Requirement for written  finished equilibrium  21 CFR 114.89 could satisfy the  definition of 
procedures for preventive  pH values for  requirements of 21 CFR  scheduled process 
control management  acidified foods are  117.126(b)(6) and 117.150(a)(1)  in 21 CFR 114.3, but 
components:  not higher than 4.6  for written corrective action  you still must submit 
procedures as appropriate to the  information about the 
o 117.126(b)(5) and   114.80(a)(4) Testing  nature of the hazard and the  adequacy of the 
117.145(a) (monitoring)  and examination of  nature of the preventive control.  process to FDA upon 
o 11a11ct77io..11n25 p60r((obac))((e61d))u  a(rcneodsr) r ective  coecoofntnnseuttnaar iieenn neetohrrs uas gtsu thhiht aateolb l  loy ccur   Wecosrtmiattbpellnyis  hpw riaothnc de2 d1imu CrpeFlseR mt h1ea1nt4 ty .to9ou0    r21e10q 8Cu.2eF5sRt( c a)s(3 r)e(iqi)u. ired by 
o 111177..112665((bb))( (7v)e arinfidc ation)  pleraokteacgtes  othr e food from  coof uthlde  sPaCtiHsfFy  sruolme efo rre wqruitirteenm ents 
contamination.  procedures for preventive 
o 117.165(b)(1)  control management 
(calibration)   114.89 (deviations  components (e.g., written 
from scheduled  procedures for monitoring or 
o 117.165(b)(2) (product  processes)  calibration of equipment). 
testing) 
 114.90 (methodology) 
o 117.165(b)(3) 
(environmental 
monitoring) 
 
 
Chapter 16 (Acidified Foods) - Page 24  
  Contains Non-binding Recommendations 
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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.  
Chapter 16 (Acidified Foods) - Page 25  
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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. 
Chapter 16 (Acidified Foods) - Page 26  
  Contains Non-binding Recommendations 
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Table 16-8 Records  
Requirements in Part 117  Corresponding  How You Can Leverage  How You Can Leverage 
(21 CFR)  Requirements in 21 CFR 108  Compliance with  Compliance with the 
or Part 114  Requirements in 21 CFR  Requirements of the 
(21 CFR)  108.25 or Part 114 to Address  PCHF Rule to Address 
Corresponding Requirements  Corresponding 
in the PCHF Rule  Requirements of 21 
CFR 108.25 and Part 
114 
 117.9 (training)   114.100(a): Records of   Records demonstrating   If your supply-chain 
examinations of raw  compliance with 21  program identifies any 
 117.126(c): Food safety  materials, packaging  114.100(a) could satisfy the  hazards requiring a 
plan  materials, and finished  requirements of 21 CFR  supply-chain applied 
 117.190(a):  products, and of suppliers'  117.475(c)(8) for sampling  control, records that 
guarantees or certifications  and testing records  comply with 21 CFR 
Implementation records, 
applicable to a supply-chain  117.475(c)(8) could 
including records   114.100(b): Processing and  program, if your supply-chain  satisfy corresponding 
documenting:  production records,  program identifies any  requirements in 21 
o Basis for not  including records of pH  hazards requiring a supply- CFR 114.100(a) for 
establishing a  measurements and other  chain applied control.  records of suppliers' 
preventive control  critical factors intended to  guarantees or 
(117.136(b))    ensure a safe product    Records demonstrating  certifications. 
compliance with 21 CFR 
o Monitoring   114.100(c): All departures  114.100(b) could satisfy:   Monitoring records 
(117.145(c))  from scheduled processes  that comply with 21 
having a possible bearing  o The requirements of 21  CFR 117.145(c) could 
o Corrective actions and  on public health or the  CFR 117.145(c) for  satisfy corresponding 
corrections  safety of the food  records of monitoring pH  requirements in 21 
(117.150(d))  as a preventive control  CFR 114.100(b) for 
 114.100(d): Records  management component 
records of pH 
o Verification  identifying initial distribution  for pH control as a process 
measurements and 
(117.155(b))  of the finished product to  control. 
other critical factors. 
facilitate, when necessary, 
o S(1u1p7p.4ly7-5ch(ca)i)n  program  tfhoeod s elogtsre tghaatti omna oyf  hsapveec ific  o TChFeR r e1q1u7i.r1e4m5(ecn)t sfo or f 21   Creocrorerdcsti vthea at cctoiomnp ly 
o Training of PCQI)  become contaminated or  records of monitoring when  with 21 CFR 
(117.180(d))  otherwise unfit for their  monitoring seam/seal  117.150(d) could 
intended use  integrity of finished product  satisfy corresponding 
 Subpart F:  is a preventive control 
requirements in 21 
 108.25(g) and 114.100(e):  management component 
o 117.301 (Applicability)  Records shall be retained at  for the scheduled process.  CFR 114.100(c) for 
records of all 
the processing plant or 
o 117.305 (General  other reasonably accessible   Records demonstrating  departures from 
requirements)   location for a period of 3  compliance with 21 CFR  scheduled processes 
o 1p1la7n.)3 10 (Food safety  ymeaanrus ffarcotmur eth. e date of  1so1m4.e1 0r0e(qcu)i rceomueldn stsa toisf f2y1   hbaevairningg a o pno psusbiblilce  
CFR 117.150(d) for records  health or the safety of 
o 117.315 (Record   108.25(f) and 114.10: All  of corrective actions and  the food.   
retention)  operators of processing and  corrections. 
packaging systems shall be 
o 117.320 (Official  under the operating 
review)  supervisions of a person 
who has attended a school 
o 117.325 (Public  approved by the 
disclosure) 
Commissioner and who has 
o 117.330 (Use of  been identified by that 
existing records)  school as having 
satisfactorily completed the 
o 117.335 (Special  prescribed course of 
requirements for  instruction. 
written assurance) 
 
 
Chapter 16 (Acidified Foods) - Page 27  
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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-recalls-
including-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).  
Chapter 16 (Acidified Foods) - Page 28  
  Contains Non-binding Recommendations 
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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  Applicable  Comments  Resources 
Acidified Food  Regulation(s) 
Requirement 
 
Submit food canning  21 CFR 108.25(c)(1)   Registering your    FDA, 2016 
establishment registration to  establishment as a food 
  FDA, 2018  
FDA using Form FDA 2541  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) 
Chapter 16 (Acidified Foods) - Page 29  
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Description of Specific  Applicable  Comments  Resources 
Acidified Food  Regulation(s) 
Requirement 
 
Submit scheduled process to  21 CFR 108.25(c)(2)  See the discussion in  FDA, 2016 
FDA using Form FDA 2541e  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. 
Provide FDA with information  21 CFR 108.25(c)(3)(ii)  See the discussion in  N/A 
about the scheduled process  section 16.11. The 
and procedure upon FDAs  requirements of the PCHF 
request  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). 
Chapter 16 (Acidified Foods) - Page 30  
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
 
 
Description of Specific  Applicable  Comments  Resources 
Acidified Food  Regulation(s) 
Requirement 
 
Notify FDA about problems  21 CFR 108.25(d)  Notifying FDA about    FDA, 2009 
when food is in commerce  (problems include  problems when an acidified 
  FDA, 2010 
spoilage, process  food is in commerce is in 
deviation, or  addition to your 
contamination with  responsibility to report 
microorganisms, the  problems to the Reportable 
nature of which has  Food Registry (when there 
potential health- is a reasonable probability 
endangering significance)  that the use of, or exposure 
to, an article of food will 
cause serious adverse 
health consequences or 
death to humans or 
animals) 
Recall procedure that incudes  21 CFR 108.25(e)  See the discussion in  FDA, 2003 
plans for notifying FDA of any  section 16.10.4. Although a 
recalls  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. 
Satisfactory completion of the    21 CFR 108.25(f)  See the discussions in  N/A 
prescribed course of  sections 16.6 and 16.7. 
  21 CFR 114.10 
instruction in a school  Satisfactorily completing the 
approved by the  prescribed course of 
Commissioner for giving  instruction in a school 
instruction in food-handling  specified in 21 CFR 
techniques, food-protection  108.25(f) and 114.10 may 
principles, personal hygiene  not provide an individual 
and plant sanitation practices,  with all qualifications 
pH controls and critical factors  applicable to supervisory 
in acidification  personnel as required by 21 
CFR 117.4 or all 
qualifications applicable to a 
PCQI as required by 21 
CFR 117.180(c)(1). 
Chapter 16 (Acidified Foods) - Page 31  
  Contains Non-binding Recommendations 
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Description of Specific  Applicable  Comments  Resources 
Acidified Food  Regulation(s) 
Requirement 
 
The scheduled process for an  21 CFR 114.80(a)  See the discussion in  N/A 
acidified food must control  sections 16.9 and 16.10.1, 
microorganisms of non-health  and 16.11. Microorganisms 
significance in addition to  of non-health significance, 
pathogens.  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 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: 
   A knowledgeable person 
could identify 
microorganisms of non-
health 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.  
Records of distribution  21 CFR 114.100(d)  Compliance with 21 CFR  FDA, 2012 
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 
Chapter 16 (Acidified Foods) - Page 32  
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Description of Specific  Applicable  Comments  Resources 
Acidified Food  Regulation(s) 
Requirement 
 
Record retention for 3 years    21 CFR 108.25(g)  See the discussion in  N/A 
section 16.12. The 
  21 CFR 114.100(e) 
regulations in 21 CFR 
108.25 and part 114 each 
have a recordkeeping 
requirement that exceeds 
the corresponding 
recordkeeping requirement 
in part 117.  
Coding  21 CFR 114.80(b)  See the discussion in  N/A 
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. 
 
 
 
 
Chapter 16 (Acidified Foods) - Page 33  
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Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
 
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 FDAs 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.   
Chapter 17 (Classification of Food) - Page 1  
  Contains Non-binding Recommendations 
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Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs Technical Assistance Network by submitting your question at 
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistance-
network-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.   
Appendix 1 (Known or Reasonably Foreseeable Hazards (Potential Hazards)) - Page 1  Contains Non-binding Recommendations 
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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 
A1.8.1 Appendix 1 Reflects a Tiered Approach to the Requirements for Hazard 
Analysis 
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 
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A1.8.3 Each 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) Food-
Related 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: 
  Some users of this Appendix 1 could be more familiar with the term potential hazard 
o
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;  
  Potential hazard is a term that is used in some training materials to help emphasize 
o
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 
  Form 2-B in Appendix 2 of this guidance (Hazard Analysis) uses the term potential 
o
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: 
  consistently uses the term used in the regulatory text of part 117 to unambiguously direct 
o
you to the regulatory requirements that are the subject of this guidance;  
  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 
o
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  Table Title 
Section VI of the 
Introduction 
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 FDAs CPGs, FDAs Guidance for 
Industry, FDAs 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 
Appendix 1 (Known or Reasonably Foreseeable Hazards (Potential Hazards)) - Page 6  
 
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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: 
  includes a series of questions you can ask during the hazard identification phase 
o
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);  
  provides recommendations for conducting the hazard evaluation phase required by 21 
o
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 
  briefly discusses the types of preventive controls (e.g., process controls, food allergen 
o
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 food-
related 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 CFSANs 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) process-
 
4 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 FDAs 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 FDAs 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.  
  In 12 of these 16 Food Groups, Tables 2B, 2C, 2D, 2E, 2G, 2H, 2I, 2J, 2K, 2L, 2O, 
o
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. 
  In four of these 16 Food Groups (i.e., Bakery Items; Dressings, Condiments, and Dips; 
o
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., entrees, 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 multi-
component 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 entree 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 entree 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-to-
drink 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 (Food-
Related 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 USDAs 
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 USDAs 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 
USDAs 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 FDAs 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 FDAs 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 FDAs 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. 
Appendix 1 (Known or Reasonably Foreseeable Hazards (Potential Hazards)) - Page 21  
 
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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: 
  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 
o
Consumption 
  21 CFR part 173: Secondary Direct Food Additives Permitted in Food for Human 
o
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: 
  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) 
o
 
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.  
FDAs 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 plans 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) process-
related 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) 
  For example, a heat treatment that is not properly delivered (e.g., the temperature is too 
o
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) 
  For example, a cooling mechanism that does not function as intended could allow a 
o
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) 
  For example, if insufficient acid is added to reduce the pH sufficiently in an acidified 
o
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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  For example, reduced oxygen packaging that is used to increase shelf life could create 
o
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) 
  For example, if a container is not properly sealed and it is cooled in water, water 
o
containing pathogens can be drawn into the container.  
  Environmental Pathogens  Presence due to recontamination from the processing 
environment. (Section 3.3.5.1) 
  For example, equipment that is difficult to clean or is prone to damage could increase 
o
the risk for environmental pathogens to contaminate the product post-processing. 
  As another example, facility traffic patterns can transfer environmental pathogens from 
o
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: 
  An incorrect label can result if you change the product formulation to include a food 
o
allergen but do not update the product label to declare that food allergen. 
  If the product label is pre-printed on the product package, an incorrect label can result if 
o
the wrong packaging is brought to the production line. 
  If you apply the product label to the package after the package has been filled, an 
o
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: 
  Allergen cross-contact can result if equipment that is difficult to clean or is prone to 
o
damage is used to produce foods that contain ingredients from different food allergen 
sources.  
  Allergen cross-contact can result from the unintentional addition of the wrong ingredient 
o
to a food. 
  Chemical hazards due to mis-formulation (e.g., sulfites, yellow #5) (Section 3.4.2.2.2) 
  For example, mis-formulation can occur if you manufacture/process some products with 
o
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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  For example, some chemical hazards (such as acrylamide in certain plant-based foods 
o
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) 
  For example, a process that uses a metal chopping blade could introduce metal 
o
fragments if the blade breaks. 
  Glass (when product is packed in glass) (Section 3.5) 
  For example, a product packaged in glass containers could introduce glass fragments if 
o
a container breaks. 
  Hard plastic (Section 3.5) 
  For example, hard plastic can be introduced into food when tools and equipment such as 
o
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: 
  Table 1O (Spices and Herbs) identifies Cyclospora as a known or reasonably 
o
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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  Table 1C (Food Additives, Color Additives, and GRAS Substances) identifies 
o
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 facilitys food product.
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Table 1A: Known or reasonably foreseeable (potential) food-related biological hazards for Bakery Items 
Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  Clostridium botulinum  C. perfringens  Brucella spp.  Campylobacter spp.  Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
- Unbaked Bakery 
Items  
Bread, Biscuits, 
- Ready-To-Bake  Includes bagels, 
Rolls, Brownies,  Refrigerated or 
1  (RTB) Dough            X  X  X        croissants, puff pastry, 
Cookies, Pizza,  Frozen 
- RTB Crust  phyllo  
Pie Crust 
- With or Without 
Inclusions1 
- Fully-Baked  
- With or without 
Pre-Bake Added 
Ambient, 
Bread,  Filling or  Includes biscuits, 
2a  Refrigerated or            X  X  X       
Whole/Pre-sliced  Inclusions1  bagels, rolls, croissants 
Frozen 
- Without Post- 
Bake Added 
Frosting/Topping  
- Fully-Baked  
- With or without 
Pre-Bake Added 
Filling or  Ambient, 
Bread,  Includes bread with 
2b  Inclusions1  Refrigerated or            X  X  X  X     
Whole/Pre-sliced  drizzles/ frosting 
- With Post-Bake  Frozen 
Added Filling, 
Frosting, and/or 
Topping 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  Clostridium botulinum  C. perfringens  Brucella spp.  Campylobacter spp.  Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
- Fully-Baked  
- With or without 
Pre-Bake Added 
Filling or 
Brownies /  Includes biscotti; fruit 
3a  Inclusions1  Ambient            X  X  X       
Cookies  filled bars/wafers  
- Without Post- 
Bake Added 
Frosting/ Topping 
 
- Fully-Baked 
- With or without 
Pre-Bake Added 
Filling or  Includes fruit-, cream- 
Brownies / 
3b  Inclusions1   Ambient            X  X  X  X      or chocolate-filled bars/ 
Cookies 
- With Post-Bake  wafers 
Added Filling, 
Frosting, and/or 
Topping 
- Fully-Baked 
- With or without 
Pre-Bake Added  - Includes all flavors 
Ambient, 
Cakes/Muffins/  Filling or  and densities  
4a  Refrigerated, or            X  X  X       
Quick Breads  Inclusions1  - Includes all fillings 
Frozen 
- Without Post- added before baking  
Bake Added 
Frosting/ Topping 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  Clostridium botulinum  C. perfringens  Brucella spp.  Campylobacter spp.  Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
- Fully-Baked  
- With or without  Includes tortes and 
Pre-Bake Added  products with post- 
Filling or  Ambient,  bake added cream, 
Cakes/Muffins/ 
4b  Inclusions1  Refrigerated or            X  X  X  X      nuts, confectionery and 
Quick Breads 
- With Post-Bake  Frozen  dried fruits and layer 
Added Filling,  cakes with fillings or 
Frosting, and/or  frosting 
Topping 
Croutons/Bread  Other Bakery  Includes unseasoned 
5  Ambient            X  X  X       
Crumbs  Products  and seasoned products 
- Unbaked Bakery 
Items  Includes pies with egg- 
Custard Pies  6  - Ready-To-Bake  Frozen            X  X  X        and milk-derived 
(RTB) Crust and  ingredients 
Filling 
- Fully-Baked/ 
Cooked  
- With or Without  Includes cheesecake 
Custard/Cream2/ Ambient, 
Pre-Cook Added  and pies with egg- and 
Creme Pie/  7a  Refrigerated or  X3  X3        X  X  X       
Fillings   milk-derived 
Cheesecake  Frozen 
- Without Post- ingredients 
Bake Added 
Frosting/Topping 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  Clostridium botulinum  C. perfringens  Brucella spp.  Campylobacter spp.  Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
- Fully-Baked/ 
Custard/Cream2/ Cooked   Ambient,  Includes cheesecake 
Creme Pie/  7b  - With Post-Bake  Refrigerated or  X3  X3        X  X  X  X      and pies with whipped 
Cheesecake  Added Frosting/  Frozen  cream topping 
Topping 
Includes mixes for 
breads, quick breads, 
Other Bakery  pancakes, cookies, 
Dry Mixes  8  Ambient            X  X  X       
Products  cakes, brownies, 
biscuits, breading, pie 
crust  
Fruit  Unbaked Bakery  Includes all fruits and 
9a  Frozen            X  X  X       
Pies/Cobblers  Items   fruit mixtures  
- Fully-Baked  
- With or Without 
Ambient, 
Fruit  Pre-or Post- Bake  Includes all fruits and 
9b  Refrigerated, or            X  X  X       
Pies/Cobblers  Added Fillings,  fruit mixtures  
Frozen 
Frosting, and/or 
Topping 
Ice Cream  Other Bakery  Includes plain and 
10  Ambient            X  X  X       
Cones  Products  sugar cones 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  Clostridium botulinum  C. perfringens  Brucella spp.  Campylobacter spp.  Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
Includes batters for 
Unbaked Bakery 
Liquid Batter  11  Refrigerated  X3  X3        X  X  X  X      pancakes, brownies, 
Items 
waffles, doughnut  
- Fully-Baked  
- With or Without 
Includes several 
Pre-Bake Added 
Other Pastry  Refrigerated or    breakfast items, such 
12a  Filling             X  X  X     
Products  Frozen  as French toast, 
- Without Post-
pancakes, waffles  
Bake Added 
Frosting/Topping 
- Fully-Baked   Includes Danishes, 
- With Post-Bake  Ambient,  eclairs, cream puffs, 
Other Pastry 
12b  Added Filling,  Refrigerated or            X  X  X  X      cannoli, doughnuts, 
Products 
Frosting and/or  Frozen  toaster pastries, 
Topping  turnovers  
Includes tortillas made 
Tortillas, Soft  Other Bakery  Ambient or 
13                 X  X  X            with corn, wheat, rice, 
Shell/Hard Shell  Products  Refrigerated 
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/creme 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 
 
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Includes plant-
Non-dairy  based 
Cocoa/  1a  Ready-to-Drink  Refrigerated  X1  X1          X          chocolate/ 
Chocolate  cocoa-flavored 
drinks 
Includes plant-
Non-dairy  based 
Powdered 
Cocoa/  1b  Ambient              X          chocolate/ 
Beverages 
Chocolate  cocoa-flavored 
products 
Includes 
- Roasted Beans 
flavored, non-
Coffee  2a  - Whole or  Ambient              X         
flavored, and 
Ground  
single serve  
Includes 
- Ready-to-Drink 
brewed coffee 
Coffee  2b  - Unflavored and  Refrigerated  X1  X1          X         
and espresso-
Flavored 
style coffee  
Includes instant 
- Powdered  
Coffee  2c  Ambient              X          coffees, 
- Freeze Dried 
cappuccino mix 
Concentrated 
Includes plain 
Coffee  2d  Liquid Base  Refrigerated  X1  X1          X         
and flavored 
Mixes 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Includes 
flavored and 
unflavored fluid 
Dairy-Based  3  Ready-to-Drink   Refrigerated  X1  X1        X  X  X        milk from 
multiple 
species, yogurt 
drinks, kefir 
Includes plant-
- Ready-to-Drink 
based 
Milk Substitutes 
Non-Dairy2  4a  Refrigerated  X1  X1        X  X  X        beverages and 
- Plain and 
non-dairy liquid 
Flavored 
creamer 
Powdered Coffee  Includes plain 
Non-Dairy  4b  Ambient              X         
Creamer    and flavored 
All fruit drinks 
Ready-to-Drink  Ambient3 or 
Juice-Based2  5  X1  X1        X  X          with some juice 
(not 100% juice)  Refrigerated 
content 
Includes 
flavored and 
Tea and Tea  Loose Leaf and 
6a  Ambient            X  X          non-flavored 
Substitutes  Bagged  
teas and herbal 
teas  
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Includes 
flavored and 
Tea and Tea  - Instant  
6b  Ambient            X  X          non-flavored 
Substitutes  - Powdered   
teas and herbal 
teas 
Includes 
flavored and 
Tea and Tea  Ambient3 or 
6c  Ready-to-Drink              X  X          non-flavored 
Substitutes  Refrigerated 
teas and herbal 
teas 
Concentrated  Includes plain 
Tea and Tea  Ambient3 or 
6d  Liquid Base            X  X          and flavored 
Substitutes  Refrigerated 
Mixes  and herbal teas  
Bottled drinking 
water is subject 
to the 
processing and 
bottling 
Carbonated  - Ready-to-Drink 
7  Ambient                        requirements of 
Beverages  - Carbonated  
21 CFR part 
129 and the 
microbiological 
criteria in 21 
CFR 165.110(b) 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Bottled drinking 
water is subject 
to the 
processing and 
- Ready-to-Drink   bottling 
Uncarbonated 
8  - Uncarbonated  Ambient                        requirements of 
Beverages 
Waters  21 CFR part 
129 and the 
microbiological 
criteria in 21 
CFR 165.110(b) 
Sports and 
Ambient3 or 
Energy  9  Ready-to-Drink               X3          All varieties 
Refrigerated 
Beverages 
Includes bases 
Beverage  for carbonated 
Ambient3 or 
Concentrates/ 10a    Liquid                        beverages and 
Refrigerated 
Base Mixes2  syrups for 
flavored drinks  
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Beverage  Includes 
Concentrates/ 10b  Dry Powdered  Ambient                        powdered 
Base Mixes  flavors  
Mixes intended 
Adult 
for alcoholic  Ambient3 or 
Beverage  11  X1  X1          X          All varieties 
beverages (liquid  Refrigerated 
Mixers2 
and powders) 
Ground  Includes chicory 
Coffee  12   Dry Powdered  Ambient            X4  X4          root powder, 
Substitutes  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.  
Appendix 1 (Known or Reasonably Foreseeable Hazards (Potential Hazards)) - Page 41  
 
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Table 1C: Known or reasonably foreseeable (potential) food-related biological hazards for Miscellaneous Food Additives, 
Color Additives, and GRAS Substances 
 
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Category  #  Subcategory  CoSntodri atigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Includes substances 
such as lecithin (from 
soy, safflower, or 
  corn oil or from egg) 
Emulsifiers  1  Emulsifiers  Ambient or                    X3              mono- and 
Refrigerated  diglycerides, 
polysorbates, 
sorbitan 
monostearate 
Includes substances 
Stabilizers and  such as calcium 
2a  Firming Agents  Ambient                                  
Thickeners  chloride, calcium 
lactate 
Includes substances 
Stabilizers and 
2b  Humectants  Ambient                                   such as glycerin, 
Thickeners 
sorbitol 
Includes substances 
such as baking soda, 
Stabilizers and  Leavening    monocalcium 
2c                     X3             
Thickeners  Agents  Ambient  phosphate, calcium 
carbonate, dried 
yeast 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  stridium botulinu C.perfringens Brucella spp.  mpylobacter spp. athogenic E. coli  Salmonella spp.  monocytogenes S.aureus Parasites  Viruses  Comments 
o Ca P L.
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Includes substances 
Stabilizers,  such as gelatin, 
Stabilizers and  Thickeners,  pectin, carrageenan, 
2d  X 
Thickeners  Binders,  Ambient  modified starches, 
Texturizers  acacia gum, guar 
gum, xanthan gum  
Includes substances 
Dough 
such as ammonium 
Stabilizers and  Strengtheners 
2e  Ambient  sulfate, 
Thickeners  and 
azodicarbonamide, 
Conditioner 
and l-cysteine 
Includes substances 
such as calcium 
Stabilizers and  Anti-caking 
2f  Ambient  silicate, iron 
Thickeners  Agents 
ammonium citrate, 
silicon dioxide 
Bakery,  Includes substances 
Proteolytic,  such as amylases, 
Starch/Sugar  chymosin, lactase, 
Enzymes  3  Refrigerated  X 
Liquefication, lipase, papain, 
Cheese- proteases, xylanase  
making 
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Category  #  Subcategory  CoSntodri atigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Includes FD&C 
colors listed in 21 
Colors  4a  Certified Colors  Ambient                                  
CFR part 74, subpart 
A 
Colors Exempt  Includes colors listed 
Ambient or 
Colors  4b  from                                   in 21 CFR part 73, 
Refrigerated 
Certification  subpart A  
  Includes a variety of 
Liquid: Oil-
Flavors  5a  Ambient or                                   oil-based flavor 
Based1, 2 
Refrigerated  extracts from plants 
Includes a variety of 
Liquid: 
Flavors  5b  Ambient                                   non-oil-based flavor 
Aqueous 
extracts from plants  
Includes a variety of 
Powdered:  Ambient or   
Flavors  5c                                powdered flavor 
Natural Flavor  Refrigerated 
extracts from plants  
Artificial: 
Ambient or    Includes a variety of 
Flavors  5d  Synthetic                               
Refrigerated  synthetic flavors  
Flavor 
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Includes substances 
such as monosodium 
glutamate, autolyzed 
Other: Flavor  Ambient or 
Flavors  5e                    X              yeast extract, 
Enhancer  Refrigerated 
hydrolyzed vegetable 
proteins, disodium 
guanylate, inosinate 
Includes a variety of 
Ambient or 
Flavors  5f  Flavor Paste                 X  X  X           plant-based flavor 
Refrigerated 
pastes  
Includes substances 
such as potassium 
hydroxide, potassium 
bicarbonate, sodium 
Other Chemical  Processing   
6a                                   chloride, hydrochloric 
Ingredients  Chemicals  Ambient 
acid, sodium 
hydroxide, calcium 
carbonate, calcium 
lactate, mineral oil 
Includes substances 
Other Chemical  such as acetic acid, 
6b  Organic Acids  Ambient                                  
Ingredients  citric acid, lactic acid, 
fumaric acid 
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Includes substances 
such as butylated 
Other Chemical  Ambient or  hydroxy toluene 
6c  Antioxidants                                  
Ingredients  Refrigerated  (BHT), d-alpha-
tocopherol acetate 
(TOCO) 
Antimicrobials  Includes substances 
Other Chemical  Ambient or 
6d  and                                   such as nisin, 
Ingredients  Refrigerated 
Preservatives  potassium sorbate 
Includes gases such 
Other Chemical  Processing Aid 
6e  Ambient                                   as nitrogen, carbon 
Ingredients  Gases 
dioxide 
Includes substances 
Other Chemical 
6f  Soluble Fiber  Ambient                        such as inulin, 
Ingredients 
fructan 
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Includes substances 
such as thiamine 
hydrochloride, 
riboflavin, niacin, 
Vitamins,  niacinamide, folate or 
Minerals, and  Ambient or  folic acid, beta 
 Nutrients  7                       
Vitamin/Mineral  Refrigerated  carotene, potassium 
Premixes  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). 
 
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Table 1D: Known or reasonably foreseeable (potential) food-related biological hazards for Chocolate and Candy 
 
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Chocolate 
Raw Cocoa 
Industrial  1a  Ambient              X          Cocoa Beans 
Beans 
Products 
Chocolate 
Roasted Cocoa 
Industrial  1b  Ambient              X          Beans and Nibs 
Beans and Nibs 
Products 
Includes chocolate products 
Chocolate  Chocolate/Cocoa  with varying sweetness and 
Industrial  1c  Products for  Ambient                    X              includes bulk solid (blocks), 
Products  Baking   bulk molded (chips),  
bulk powder, and bulk liquid 
Confectionary  Includes bulk molded (e.g., 
Other Products 
Industrial  2a  Ambient                    X              peanut butter chips, caramel 
for Baking  
Products  chip) and bulk liquid 
Confectionary  Chocolate 
Includes bulk solid and bulk 
Industrial  2b  Coating for  Ambient                    X             
liquid products  
Products  Enrobing  
Chocolate and 
Chocolate    Includes bars, chips, morsels, 
Confectionery  3a  Ambient                    X          
Confections  fudge, bonbons 
Products 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Includes chocolate covered 
nuts/ fruit/ caramel/ mints, 
Chocolate and  Chocolate 
    biscuits, nougats; chocolate 
Confectionery  3b  Confections -  Ambient                            
candy bar with nuts or fruit; 
Products   With Inclusions1 
chocolate with crisped rice; 
fudge with nuts  
Includes caramels, gummy gel 
candies, fruit chews, licorice, 
Confectionery  Sugar      marshmallows, soft jellied 
3c  Ambient                            
Products   Confections2  candy, gel cups candy, maple 
creams, fondant, pastilles, rock 
candy, hard candy 
Sugar  Includes nut brittles (peanut 
Confectionery     
3d  Confections with  Ambient                             brittle, almond brittle), nut 
Products  
inclusions1  clusters, candy with fruit pieces 
Includes candy coated 
Sugar  popcorn, cereal confection, 
Confectionery     
3e  Confections  Ambient                    X        marzipan, coconut roll, peanut 
Products  
Specialties   butter fudge, cotton candy2, 
pastes 
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Toppings and 
Toppings/  4  Frosting (Non-  Ambient                    X3             All flavors and varieties 
Frosting 
Fruit/Nut) 
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. 
 
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Table 1E: Known or reasonably foreseeable (potential) food-related biological hazards for Dairy 
 
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Liquid Milk for 
Raw1 Milk  1  Refrigerated  X2  X2    X  X  X  X  X  X      Raw fluid milk 
Processing 
Includes flavored and 
unflavored fluid milk 
from multiple species 
Liquid Milk  Ambient3 or 
Milk and Butter  2a  X2  X2        X  X  X        (cow, goat, sheep), 
products  Refrigerated 
ultra-pasteurized 
milks, milk-based 
creamer  
Includes heavy, light, 
Milk and Butter  2b  Cream products  Refrigerated  X2  X2        X  X  X        whipping creams and 
half-and-half 
Includes butter 
Milk and Butter  2c  Butter products  Refrigerated            X  X  X  X     
spreads and blends 
Includes buttermilk, 
Cultured milk 
Milk and Butter  2d  Refrigerated            X  X  X        sour cream, yogurt, 
products 
yogurt drinks, kefir 
Includes dried 
products extracted 
Milk and Butter  2e   Dry milk  Ambient  X5             X  X  X          from milk, such as 
products4  whey powder and 
dried milk products 
used in dried dips 
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Ice cream, 
regular and low 
Milk-Based   
3a  fat (with and  Frozen              X  X  X           All flavors 
Products  
without 
inclusions)6 
Milk-Based   
3b  Sherbets  Frozen              X  X  X           All flavors  
Products 
Includes ice cream 
Milk-Based  Frozen Novelty    cakes/bars/ 
3c  Frozen              X  X  X          
Products  Items  sandwiches, frozen 
yogurt 
Cheese and  Extra Hard  Includes Parmesan, 
Ambient or   
Cheese Products   4a  Cheese (low pH,              X  X  X  X        Asiago, Romano, 
Refrigerated 
Whole  low water activity)    Sbrinz 
Cheese and 
  Includes Cheddar, 
Cheese Products   4b  Hard Cheese   Refrigerated              X  X  X  X       
Colby, Swiss, Gruyere 
Whole 
Includes Monterey, 
Cheese and  Provolone, Oaxaca, 
 
Cheese Products   4c  Semi-soft Cheese  Refrigerated              X  X  X  X        Monterey Jack, Edam, 
Whole  Havarti, Paneer, 
Raclette 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Cheese and 
Soft, Ripened    Includes Brie, 
Cheese Products   4d  Refrigerated              X  X  X  X       
Cheese  Camembert, Taleggio  
Whole 
Includes Cottage 
Cheese, Cream 
Cheese and  Soft, Unripen 
  Cheese, Ricotta, 
Cheese Products   4e  Cheese/ Fresh  Refrigerated              X  X  X  X       
Queso Fresco, 
Whole  Cheese 
Cheese Curd, 
Mozzarella 
 Cheese and 
Includes Parmesan, 
Cheese Products -  Hard and Extra  Ambient or   
5a              X  X  X  X        Asiago, Romano, 
Sliced, Shredded,  Hard Cheese   Refrigerated 
Cheddar 
or Grated 
Cheese and 
Includes Monterey, 
Cheese Products -   
5b  Semi-soft Cheese  Refrigerated              X  X  X  X        Provolone, Oaxaca, 
Sliced, Shredded, 
Monterey Jack  
or Grated 
Cheese and 
Cheese Products -  Pasteurized  Ambient7 or  Includes Process 
5c                       
Sliced, Shredded,  Process Cheese  Refrigerated  American Cheese 
or Grated 
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1 Milk and cream, and butter made from them, in this Table are considered pasteurized under 21 CFR 1240.61 and the Pasteurized Milk Ordinance. Raw milk is 
only used in certain cheeses that are aged for at least 60 days. Brucella spp. and Campylobacter spp. are not identified as known or reasonably foreseeable 
(potential) hazards for Food Categories other than Raw Milk because processes targeting the principal pathogens associated with dairy products will also 
address these pathogens and they generally are not reintroduced into milk after it has been pasteurized. 
2 The SMEs noted that whether these pathogenic sporeformers are known or reasonably foreseeable (potential) biological hazards that could require 
time/temperature controls depends on the product (e.g., pH, water activity) and the process used to make the product. 
3 Excludes LACF (shelf-stable) products (including evaporated and sweetened and condensed milk products), which are not subject to the requirements for 
biological hazards in 21 CFR Part 117.  
4 We recommend that you also consider Cronobacter spp. (including C. sakazakii) as a known or reasonably foreseeable (potential) biological hazard when milk 
powders are destined for use in dry blended powdered infant formula products. A facility that manufactures/processes powdered infant formula is subject to 
the microbiological criteria in 21 CFR 106.55(e) for when a powdered infant formula that contains Cronobacter spp. will be deemed adulterated under sections 
402(a)(1), 402(a)(4), and 412(a)(3) of the FD&C Act. 
5 The SMEs identified this as a known or reasonably foreseeable (potential) biological hazard applicable only when the food is used as an ingredient in another 
product where the dried milk becomes hydrated.  
6 If your food product includes an inclusion, your hazard analysis should also consider known or reasonably foreseeable (potential) biological hazards 
associated with the inclusion (e.g., hazards for nuts, chocolate chips, fruit). The other tables in section A1.10 are resources that could be applicable to the 
inclusion.   
7 Excludes LACF (shelf-stable) pasteurized process cheese products (e.g., jars of cheese spreads), which are not subject to the requirements for biological hazards 
in 21 CFR Part 117. 
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Table 1F: Known or reasonably foreseeable (potential) food-related biological hazards for Dressings, Condiments, and Dips 
 
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Category  #  Subcategory  CoSntodri atigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Includes regular and 
Ambient or 
Condiments   1a  Mayonnaise                 X  X  X          lite products and 
Refrigerated 
flavored products  
Ambient or 
Condiments   1b  Mustard                 X  X  X          
Refrigerated  Includes all varieties  
Condiments   1c  Ketchup  Ambient                 X  X  X           Includes all varieties 
Condiments   1d  Vinegar  Ambient                                   Includes all varieties  
Includes soy sauce, 
Worcestershire sauce, 
Other 
Condiments   1e  Ambient                                  prepared horseradish, 
Condiments 
steak sauce, Tabasco 
sauce 
Dressings, 
Salad  Ambient or 
2a  salad                 X   X  X          
Dressings   Refrigerated 
(prepared)  Includes all varieties  
Salad 
2b  Dry mixes  Ambient              X  X            
Dressings   Includes all varieties  
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Category  #  Subcategory  CoSntodri atigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Includes dips and 
spreads such as  
guacamole, salsa, 
dairy-based dips, 
Dips and  Ambient1 or 
Dips  3a  X  X         X  X  X  X        bean dips, sesame-
spreads  Refrigerated 
based dips (e.g., 
hummus, tahini, 
vegetable dips, taco 
Dip, 7-layer dip 
Dry dips, dry dairy-
based dips (e.g., 
Dips and 
Dips  3b  Ambient  X2  X2          X  X     X       vegetable dip 
spreads, dry 
seasoning, toasted 
onion dip mix) 
1 Excludes LACF (shelf-stable) products which are not subject to the requirements for biological hazards in 21 CFR Part 117.  
2 The SMEs identified known or reasonably foreseeable (potential) biological hazards for sporeformers that would apply only when these products are 
rehydrated and/or used as an ingredient in a product where pH would permit growth. 
 
 
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Table 1G: Known or reasonably foreseeable (potential) food-related biological hazards for Egg and Egg Products 
 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Includes raw and 
 
Shell Eggs  1   Shell Eggs   Refrigerated                    X           pasteurized in-
shell   
Further 
Eggs Hard  Includes eggs in 
Processed Egg  2a  Refrigerated                    X  X          
Cooked   shell or shelled 
Products  
Includes cooked 
Further  products such as 
Cooked Egg  Refrigerated or         
Processed Egg  2b           X  X        omelets, egg 
Products   Frozen 
Products   patties, scrambled 
eggs 
Egg-based 
Further 
products and egg  Refrigerated or  For use as an 
Processed Egg  3                X       
substitutes (not  Frozen  ingredient 
Products  
fully cooked)1 
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 USDAs FSIS 
under the Egg Products Inspection Act. However, these processed egg products could be used as ingredients in foods subject to FDAs jurisdiction. 
    
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Table 1H: Known or reasonably foreseeable (potential) food-related biological hazards for Fruits and Vegetables 
 
 
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Category  #  Subcategory  CoSntodri atigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Ambient or  All whole RAC 
Fruits  1  Whole RAC            X  X  X    X1  X2 
Refrigerated  fruits  
All fresh-cut fruit, 
Processed  including 
2a  Fresh-cut  Refrigerated            X  X  X    X1  X2 
Fruits  individual fruit 
and mixed fruit 
Processed 
2b  Whole or Cut  Frozen            X  X  X    X1  X2  All frozen fruit 
Fruits 
Includes 
individual and 
Processed  Heat Treated  Ambient3,4 or  mixed fruit (e.g., 
2c            X  X  X       
Fruits  Fruit Products  Refrigerated    fruit and mixed 
fruit in juice or 
syrup) 
Dried/ 
Processed  All dried/ 
2d  Dehydrated Fruit  Ambient            X  X  X       
Fruits  dehydrated fruits 
Products 
Processed  Jams, Jellies, 
2e  Ambient                        All varieties 
Fruits  Chutneys4 
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Category  #  Subcategory  CoSntodri atigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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All coated fruits 
(e.g., caramel 
apples with 
Processed 
2f  Coated Fruits5  Refrigerated                X        inserted stick, 
Fruits 
chocolate 
covered 
strawberries) 
Ambient or  All whole RAC 
Vegetables  3  Whole RAC  X6  X        X  X  X    X7   
Refrigerated  vegetables 
Processed  All fresh-cut 
4a  Fresh-cut  Refrigerated  X6  X        X  X  X       
Vegetables  vegetables 
Processed  All frozen 
4b  Whole or Cut  Frozen            X  X  X       
Vegetables  vegetables 
All heat-treated, 
refrigerated 
vegetables, such 
Processed  Whole or cut, 
4c  Refrigerated  X  X        X  X  X        as mashed 
Vegetables  Heat treated 
potatoes and 
roasted 
vegetables 
All ambient 
acidified 
Processed  Acidified  vegetables and 
4d  Ambient  X  X        X  X  X       
Vegetables  Products  vegetable 
mixtures (such 
as in salsas) 
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Category  #  Subcategory  CoSntodri atigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Dried/  All dried/ 
Processed 
4e  Dehydrated  Ambient  X8  X8        X  X  X        dehydrated 
Vegetables 
Products  vegetables 
Includes 
Processed  Fermented 
4f  Ambient  X  X        X  X  X        sauerkraut, 
Vegetables  Products 
pickles, kimchi 
Includes 
Processed 
Acid Pureed  applesauce, 
Fruits or  5  Ambient            X  X  X       
Products  apple butter, 
Vegetables 
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 for shelf-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 
 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Intact meat from 
all game species 
Intact (Not  (e.g., bison, 
Raw Game  1a  Ground) Game  Refrigerated or         X     X  X  X         X2    deer, elk, rabbit, 
Meat  Frozen 
Meat  and birds (such 
as pheasant, 
grouse, quail))  
Ground meat 
Raw Game  1b  Ground Game  Refrigerated or         X     X  X  X   X      X2    from all game 
Meat  Meat  Frozen 
species  
Processed  Processed 
Game Meat     
2a  Game Meat  Ambient        X     X  X  X   X     products such 
Products 
Products  as jerky  
Processed 
products such 
Processed 
Game Meat      as sausages, 
2b  Game Meat  Refrigerated        X     X  X  X  X    
Products  patties, 
Products 
frankfurters, 
salami 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Processed 
products such 
Processed 
Game Meat      as sausages, 
2c  Game Meat  Frozen  X  X  X  X  X 
Products  patties, 
Products 
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   
 
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Category  #  Subcategory  CoSntodri atigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Grains   1  Whole, grains  Ambient  X1   X1           X  X   X           All whole grains  
Flours (other  All flours from grains 
Grains, Milled  than rice flour,  (except as noted in the 
2a  Ambient  X1  X1        X  X  X       
Products  corn flour, and  subcategory); includes 
root flour)  gluten 
Includes all varieties of 
Grains, Milled  Rice and rice 
2b  Ambient  X1    X1        X          rice and rice-based 
Products  products 
noodles 
Grains, Milled  Includes all malted grain 
2c  Malt  Ambient              X         
Products  products 
Grains, Milled 
2d  Corn  Ambient  X1            X          Cornmeal, corn flour 
Products 
Grain-based  Cereal  Includes cereal products 
Cereal  3a  Product:  Ambient              X          with and without 
Products  Ready-to-Eat  inclusions2  
Grain-based  Includes products such as 
Breakfast 
Cereal  3b  Ambient  X1            X          oatmeal, farina, oat bran, 
food, dried 
Products  cream of wheat, grits 
Grain-based 
Refrigerated 
Pasta  4a  Unfilled Pasta  X1  X1        X  X  X        All varieties  
or Frozen 
Products 
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Category  #  Subcategory  CoSntodri atigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Grain-based 
Filled Par- Refrigerated 
Pasta  4b  X1  X1        X  X  X        All varieties  
boiled Pasta  or Frozen 
Products 
Grain-based 
Pasta  4c  Dried Pasta  Ambient  X1  X1  X1        X          All varieties 
Products 
Other Milled  All root flours (e.g., from 
5a  Root flours  Ambient  X1            X         
Products  potatoes, cassava) 
Other Milled  Starch  Cornstarch, Potato 
5b  Ambient  X1            X         
Products  products  Starch, Wheat Starch 
Pulses3  6a  Whole, dried  Ambient  X1  X1  X1        X  X              Includes all pulses  
Ambient,4 
Cooked 
 Pulses3  6b  Refrigerated  X  X  X        X  X  X           Includes bean paste 
pulses 
or Frozen 
1 The SMEs identified this as a known or reasonably foreseeable (potential) biological hazard applicable only when the food becomes hydrated to an a  that 
w
allows growth or is used as an ingredient in another product where the grains/pulse/flour/starch become hydrated to an a  that allows growth.  
w
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 
 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Nuts   1a  Peanuts, Raw  Ambient                 X   X   X           Peanuts  
Peanuts Roasted 
Nuts   1b  Ambient                 X   X   X           Peanuts  
or Boiled 
Nuts   1c  Tree Nuts, Raw  Ambient                 X  X   X           Includes all tree nuts 
Tree Nuts, 
Nuts   1d  Ambient                 X  X   X           Includes all tree nuts 
Roasted 
Includes product from 
Nuts  1e  Nut Butters  Ambient            X  X  X       
peanuts and tree nuts   
Includes edible seeds 
from flax, melon, 
Edible Seeds  2a  Raw  Ambient                 X  X  X          
pumpkin, sesame, 
sunflower 
Includes edible seeds 
from flax, melon, 
Edible Seeds  2b  Roasted  Ambient                 X  X  X          
pumpkin,  
sesame, sunflower 
Includes pastes from 
Other Nut and  Nut and Seed 
3a  Ambient                 X   X  X           peanuts, tree nuts, and 
Seed Products  Pastes 
seeds, seeds  
Includes flour from 
Other Nut and  Nut and Seed 
3b  Ambient                 X  X  X           peanuts, tree nuts, and 
Seed Products  Flours 
seeds  
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Ambient,  Includes shredded, 
Other Nut and 
3c  Coconut Products  Refrigerated,                 X  X  X           flaked, and toasted 
Seed Products 
or Frozen  products 
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Table 1L: Known or reasonably foreseeable (potential) food-related biological hazards for Oils and Oil Products 
 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  stridium botulinu C.perfringens Brucella spp.  mpylobacter spp. athogenic E. coli  Salmonella spp.  monocytogenes S.aureus Parasites  Viruses  Comments 
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Includes single oils and oil 
Oil Products  1a  Cooking Oils  Ambient 
blends 
Margarines and  Ambient or 
Oil Products  1b  Includes all varieties 
other spreads  Refrigerated 
Includes varieties 
considered as imitation/ 
substitute and includes 
Oil Products  1c  Shortening  Ambient 
partially and fully 
hydrogenated vegetable 
oils 
Includes oils infused with 
Oil Products  1d  Infused Oils  Ambient  X1  acidified or non-acidified 
ingredients 
Includes cocoa butter and 
cocoa butter substitutes 
(e.g., from coconut oil, 
Cocoa Butter 
palm kernel oil, or both 
and Cocoa 
Oil Products  1e  Ambient  oils (21 CFR 172.861) or 
Butter 
primarily from palm oil or 
Substitutes 
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 
 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Includes 
unseasoned and 
Bread Snacks  1a  Baked or Fried   Ambient                 X  X             
seasoned2 
varieties  
Includes 
unseasoned and 
Bread Snacks  1b  Baked with Filling   Ambient                 X  X             
seasoned2 
varieties 
Includes 
Chips and  Fried Fruit/  unseasoned3 and 
2a  Ambient                  X  X             
Crisps  Vegetable  seasoned2 
varieties  
Includes 
Chips and  Baked Fruit/  unseasoned3 and 
2b  Ambient                  X  X             
Crisps  Vegetable  seasoned2 
varieties  
Includes 
Dehydrated Fruit/ 
Chips and  unseasoned3 and 
2c  Vegetable  Ambient            X  X         
Crisps  seasoned2 
 
varieties 
Includes 
Crackers and  - Baked   unseasoned and 
3a  Ambient3                       
Biscuits  - Unfilled  seasoned2 
varieties  
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Includes 
Crackers and  - Baked   unseasoned and 
3b  Ambient                       
Biscuits  - Filled4   seasoned2 
varieties 
Includes 
unseasoned3 and 
Puffed Snacks  4  Baked or Fried   Ambient            X  X         
seasoned2 
varieties  
- Cold Pressed/  Includes bars 
Snack Food  Formed   Ambient or  made with nuts, 
5                 X  X             
Bars  - With or without  Refrigerated  fruit, seeds, 
coating  chocolate chips4  
Mixed/ Coated  Includes all 
 
Snack Mix  6  Fruits, Nuts, and  Ambient                 X   X           varieties and 
Pretzels   coatings4 
Pudding and 
      Includes all 
Gelatin  7a   Dry Mixes  Ambient           X  X          
varieties4 
Products 
Pudding and 
Ambient5 or  Includes all 
Gelatin  7b  Prepared  X  X           X  X  X          
Refrigerated  varieties4 
Products 
Includes all 
Frozen 
8a  Non-Dairy   Frozen                    X  X           varieties and 
Novelties 
coatings4 
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Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
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Includes all 
Frozen 
8b  Flavored Ices  Frozen                        varieties and 
Novelties 
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 for shelf-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 
 
m
 
Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
l
C
Soups, 
Dry Mixes, 
Sauces,  1a  Ambient  X1  X1  X1        X2   X2   X2           Includes all varieties 
Powders 
Gravies 
Soups, 
Sauces,  1b  Base pastes  Ambient  X1  X1  X1        X2   X2  X2            Includes all varieties 
Gravies 
Soups,  Full Strength 
Refrigerated 
Sauces,  1c  Liquid or  X  X   X        X2   X2  X2           Includes all varieties 
or Frozen 
Gravies  Condensed 
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 
 
m
 
Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
l
C
Includes cinnamon, 
cardamom, turmeric, 
paprika, pepper (black, 
white, red), cayenne 
powder, paprika, chili 
Dried, Ground,  powder, cumin, coriander, 
  Spices   1  Cracked, or  Ambient  X1  X1  X1          X2              mustard, fenugreek, 
Whole  horseradish, fennel seeds, 
caraway, allspice, nutmeg, 
ginger, garlic (minced or 
powder), onion (minced or 
powder), oregano, celery 
seed  
Includes basil, oregano, 
thyme, sage, parsley, bay 
Herbs    2a  Dried   Ambient  X1  X1  X1          X2              leaf, dill, rosemary, 
cilantro, mint, kaffir lime, 
chives, peppermint 
Includes basil, oregano, 
thyme, sage, parsley, bay 
Ambient or 
Herbs  2b  Fresh              X2      X3    leaf, dill, rosemary, 
Refrigerated 
cilantro, mint, kaffir lime, 
chives, peppermint 
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m
 
Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
l
C
Includes varieties made 
Seasonings   3a  Pastes  Ambient or  X1  X1  X1          X2        X3     from a single spice or herb 
Refrigerated  or from multiple spices or 
herbs  
Includes essential oil 
Seasonings   3b  Essential Oils  Ambient                                   extracted from any spice or 
herb 
Spice and 
seasoning 
Seasonings   3c  mixtures, Dry  Ambient  X1  X1  X1          X2              Includes all varieties 
or Liquid 
Blends  
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) 
 
m
 
Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
l
C
Food Sweeteners 
(Nutritive and  1a  Sugars (Dry)  Ambient                                   Includes all varieties  
Non-Nutritive) 
Food Sweeteners 
Syrup/Molasses 
(Nutritive and  1b  Ambient                                   Includes all varieties  
(Liquid) 
Non-Nutritive) 
Includes all varieties 
Food Sweeteners 
and forms (e.g., 
(Nutritive and  1c  Honey (Liquid)  Ambient     X1                            
comb, strained, 
Non-Nutritive) 
whipped) 
Food Sweeteners  Imitation 
  Includes all flavors/ 
(Nutritive and  1d  Syrup/Molasses  Ambient                               
varieties   
Non-Nutritive)  (Liquid) 
Food Sweeteners  Includes sugar 
 Sugar Substitutes 
(Nutritive and  1e  Ambient                                   alcohols, isomalt, 
(Nutritive)  
Non-Nutritive)  tagatose  
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m
 
Category  #  Subcategory  CoSntodriatigoen s  Bacillus cereus  ostridium botulinu C. perfringens  Brucella spp.  Campylobacter spp. Pathogenic E. coli  Salmonella spp.  L. monocytogenes  S. aureus  Parasites  Viruses  Comments 
l
C
Includes aspartame, 
Food Sweeteners  saccharin, 
Sugar Substitutes 
(Nutritive and  1f  Ambient                                   acesulfame K, 
(Non-nutritive)  
Non-Nutritive)  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) food-
related 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 facilitys 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 
s   s 
Category  #  Subcategory  CoSntodriatigoen s  rug residue Arsenic  cadmium  Lead  Mycotoxins/atural toxin Pesticides  Comments 
D N
Non-dairy  Includes plant-based 
- Ready-to-Drink  Ambient and 
Cocoa/  1      X  X  X1    chocolate/ cocoa 
- Powdered   Refrigerated 
Chocolate  flavored products 
- Raw and Roasted 
Beans/ Whole or 
Ground  
Includes flavored and 
Coffee  2  - Single Serve  Ambient          X1   
unflavored varieties 
- Ready-to-Drink 
- Powdered 
- Freeze-Dried 
- Loose Leaf and 
Includes plain and 
Bagged  
Tea  6  Ambient            X  flavored teas and herbal 
- Tea and Tea 
teas 
Substitutes 
Ready-to-Drink / 
Carbonated  Includes plain and 
7  Carbonated Plain  Ambient    X         
Beverages  flavored varieties 
and Flavored 
Ground 
Includes chicory root 
Coffee  12  Dry Powdered  Ambient          X2   
powder, roasted grains 
Substitutes 
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  
s   s 
Category  #  Subcategory  CoSntodriatigoen s  rug residue Arsenic  Cadmium  Lead  Mycotoxins/atural toxin Pesticides  Comments 
D N
Vitamins,  The specific vitamin or 
Minerals, and  Ambient or  mineral that could be 
Nutrients  7    X1    X1     
Vitamin/Mineral  Refrigerated  contaminated with arsenic 
Premixes  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  
s   s 
Category  #  Subcategory  CoSntodriatigoen s  rug residue Arsenic  Cadmium  Lead  Mycotoxins/atural toxin Pesticides  Comments 
D N
Chocolate  Raw Cocoa 
1a  Ambient      X  X  X1    Cocoa Beans 
Industrial Products  Beans 
Roasted Cocoa 
Chocolate  Beans and Nibs, 
1b  Ambient      X  X  X1    Beans and Nibs 
Industrial Products  Cocoa Butter, 
Cocoa Powder 
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 
s   s 
Category  #  Subcategory  CoSntodriatigoen s  rug residue Arsenic  Cadmium  Lead  Mycotoxins/atural toxin Pesticides  Comments 
D N
Includes all products 
described in Table 1E, as 
well as shelf stable and 
Ambient,  aseptically processed and 
All   1, 2, 3, 4, 5  All  Refrigerated,  X            packaged milk and milk 
and Frozen  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) food-
related 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 
s   s 
Category  #  Subcategory  CoSntodriatigoen s  rug residue Arsenic  Cadmium  Lead  Mycotoxins/atural toxin Pesticides  Comments 
D N
Shell Eggs - Raw 
Shell Eggs  1  and Pasteurized  Refrigerated  X            Includes all shell eggs  
in Shell 
 
 
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Table 2H: Known or reasonably foreseeable (potential) food-related chemical hazards for Fruits and Vegetables1 
s   s 
Category  #1  Subcategory  CoSntodriatigoen s  rug residue Arsenic  Cadmium  Lead  Mycotoxins/atural toxin Pesticides  Comments 
D N
Fruits and  Whole RAC  Ambient or 
All            X  All fruits and vegetables 
vegetables  or processed  Refrigerated 
Fruits and  Whole RAC  Ambient or  Includes spinach, lettuce, 
All      X       
vegetables  or processed  Refrigerated  potatoes, beets  
Includes sweet potatoes, 
Fruits and  Whole RAC  Ambient or  carrots, spinach, dried 
All        X     
vegetables  or processed  Refrigerated  plums (prunes), potatoes, 
mushrooms, garlic 
Includes apple products, 
Fruits and  Whole RAC  Ambient or 
All          X2    dried fruits, dried beans and 
vegetables  or processed  Refrigerated 
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 
s   s 
Category  #  Subcategory  CoSntodriatigoen s  rug residue Arsenic  Cadmium  Lead  Mycotoxins/atural toxin Pesticides  Comments 
D N
Ground and Not  Bison Steak, Deer 
Refrigerated or 
Raw Game Meat  All  Ground Game  X1            Shoulder, Rabbit, and Birds 
Frozen 
Meat  (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 
s   s 
Category  #  Subcategory  CoSntodriatigoen s  rug residue Arsenic  Cadmium  Lead  Mycotoxins/atural toxin Pesticides  Comments 
D N
Whole and 
Wheat, Rye, Sorghum, Oats, Barley, Triticale, 
Grains,  milled grains 
1  Ambient          X1  X  Buckwheat, Corn, Amaranth, Millet, Quinoa 
Non-Rice  (e.g., flour and 
(RACs and milled grain products) 
bran) 
Rice (whole    White or Brown Rice, Rice protein, 
Rice, 
and milled)  Sticky/sweet Rice, Basmati Rice, Jasmine 
Milled Rice  2b  Ambient    X  X  X2  X 
and rice  Rice, Arborio rice, Rice-based noodles, Rice-
Products 
products  based cereal 
Other 
Milled  5a  Root flours  Ambient          X3    Potato flour, Cassava flour 
Products 
Other 
Milled  5a  Root flours  Ambient            X  Sweet potato flour, yam flour 
Products 
Soybean, Kidney, Pinto, Navy, Azuki, Mung, 
Whole (dried) 
Pulses  6a  Ambient          X4  X  Black Gram, Dried Peas; Chickpea; 
or processed 
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 
s   s 
Category  #  Subcategory  CoSntodriatigoen s  rug residue Arsenic  Cadmium  Lead  Mycotoxins/atural toxin Pesticides  Comments 
D N
Peanuts, Raw 
Nuts  1a  Ambient          X1  X  Peanuts 
and treated 
Tree Nuts, Raw 
Nuts  1c  Ambient          X1    All tree nuts 
and treated 
Tree Nuts, Raw 
Nuts  1c  Ambient            X  Cashews and pecans 
and treated 
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 
s   s 
Category  #  Subcategory  CoSntodriatigoen s  rug residue Arsenic  Cadmium  Lead  Mycotoxins/atural toxin Pesticides  Comments 
D N
See the discussion in section 
A1.7.2 that the chemical 
hazards 3-monochloropropane-
1a  Highly refined cooking  1,2-diol esters (3-MCPDEs) and 
Oil products  Ambient             
1d  oils and infused oils   glycidyl esters (GEs) have the 
potential to form in refined oils 
during food production, 
particularly at high temperature. 
Cooking oils that are 
not highly refined 
Oil products  1a  Ambient            X  Includes olive oil 
(e.g., produced 
through cold pressing) 
Cooking oils and 
Includes cold-pressed oil and 
infused oils that are 
1a  flavored oils from peanuts, tree 
Oil products  not highly refined  Ambient          X1   
1d  nuts, sesame, sunflower, and 
(e.g., produced 
melon 
through cold pressing) 
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) food-
related 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) food-
related 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) food-
related 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. 
 
 
Appendix 1 (Known or Reasonably Foreseeable Hazards (Potential Hazards)) - Page 94  
 
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Table 2O: Known or reasonably foreseeable (potential) food-related chemical hazards for Spices and Herbs 
s   s 
Category  #  Subcategory  CoSntodriatigoen s  rug residue Arsenic  Cadmium  Lead  Mycotoxins/atural toxin Pesticides  Comments 
D N
Dried, Ground,  Includes capsicums (which include 
Spices  1  Ambient            X 
Cracked, or Whole  cayenne, chili, paprika), cumin  
Dried, Ground,  Includes chili powder, cumin, 
Spices  1  Ambient    X         
Cracked, or Whole  oregano 
Dried, Ground,  Includes chilis/chili powder, cumin, 
Spices  1  Ambient      X       
Cracked, or Whole  oregano 
Includes aniseed, chili powder, 
Dried, Ground,  cinnamon, coriander, cumin, curry, 
Spices  1  Ambient        X1     
Cracked, or Whole  ginger, five spice, red hot pepper, 
turmeric 
Includes capsicums (which include 
Dried, Ground, 
Spices  1  Ambient          X2    cayenne, chili, paprika), ginger, 
Cracked, or Whole 
nutmeg, turmeric  
Includes basil, bay leaves, 
Herbs  2a  Fresh and Dried  Ambient            X 
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.) 
   
Appendix 1 (Known or Reasonably Foreseeable Hazards (Potential Hazards)) - Page 95  
 
  Contains Non-binding Recommendations 
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Table 2P: Known or reasonably foreseeable (potential) food-related chemical hazards for Food Sweeteners (Nutritive and 
Non-Nutritive) 
s   s 
Category  #  Subcategory  CoSntodriatigoen s  rug residue Arsenic  Cadmium  Lead  Mercury  Mycotoxins/atural toxin Pesticides  Comments 
D N
      Includes all 
Food Sweeteners 
varieties and forms 
(Nutritive and  1c  Honey (Liquid)  Ambient  X      X 
(e.g., comb, 
Non-Nutritive) 
strained, whipped) 
 
 
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Appendix 1 (Known or Reasonably Foreseeable Hazards (Potential Hazards)) - Page 97  
 
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Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs 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. 
Appendix 2 (Food Safety Plan Forms) - Page 1  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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 FSPCAs 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 FSPCAs 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: 
  Your identification of each hazard requiring a preventive control; and  
o
  The types of preventive controls applied; 
o
  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.  
Appendix 2 (Food Safety Plan Forms) - Page 2 
  Contains Non-binding Recommendations 
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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 ready-
to-eat (RTE), frozen; factors that can influence growth of pathogens, such as whether the food has a 
low pH or a  or contains preservatives.   
w
  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 ready-
to-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.  
 
   
Appendix 2 (Food Safety Plan Forms) - Page 3 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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: ___________________________________________________________________ 
 
   
Appendix 2 (Food Safety Plan Forms) - Page 4 
  Contains Non-binding Recommendations 
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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. 
 
   
Appendix 2 (Food Safety Plan Forms) - Page 5 
  Contains Non-binding Recommendations 
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FORM 2-B HAZARD ANALYSIS* 
PAGE _________ 
PRODUCTS:  ______________________________________________________________ 
PLANT NAME: _____________________________________________________________ 
ADDRESS: ________________________________________________________________ 
ISSUE DATE: (mm/dd/yy)_____________________________________________________ 
SUPERSEDES: (mm/dd/yy)____________________________________________________ 
 
(1)  (2)  (3)  (4)  (5)   (6) 
Ingredient /  Identify potential  Are  Justify your  What preventive  Is the 
Processing  food safety  any potent decision for  control measure(s)  preventive 
Step  hazards  ial  column 3  can be applied to  control applied 
introduced,  food  significantly minimize  at this step? 
controlled or  safety  or prevent the food  (Yes/No) 
enhanced at this  hazards  safety hazard? 
step  requiring  Process including CCPs, 
B = biological   preventive  Allergen, Sanitation, 
C = chemical,  control?  Supplier, other preventive 
control 
including  (Yes/No) 
radiological  
P = physical 
           
           
* 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). 
 
 
   
Appendix 2 (Food Safety Plan Forms) - Page 6 
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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).  
Appendix 2 (Food Safety Plan Forms) - Page 7 
  FORM 2-C  PROCESS CONTROLS 
PAGE _________ 
PRODUCTS:  ______________________________________________________________ 
PLANT NAME: _____________________________________________________________ 
ADDRESS: ________________________________________________________________ 
ISSUE DATE: (mm/dd/yy)_____________________________________________________ 
SUPERSEDES: (mm/dd/yy)____________________________________________________ 
 
Process  Frequency 
Who  Corrective 
CSontetpro l  Hazard(s)  Critical Limits  What to Monitor  How to Monitor  Moniotof ring  Monitors  Action  Verification  Records 
                   
8 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Process  Frequency 
Who  Corrective 
CSontetpro l  Hazard(s)  Critical Limits  What to Monitor  How to Monitor  Moniotof ring  Monitors  Action  Verification  Records 
                   
 
 
Appendix 2 (Food Safety Plan Forms) - Page 9 
  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.   
10 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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: ____________________________________________________________________ 
 
Appendix 2 (Food Safety Plan Forms) - Page 11 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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. 
   
Appendix 2 (Food Safety Plan Forms) - Page 12 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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  
 
   
Appendix 2 (Food Safety Plan Forms) - Page 13 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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  
e)  e)  ket  ns ary 
Egg  Milk  Soy  Wheat  Tree Nut market nam Peanut  Fish  market nam (marellfish name)  od AllergePrecautionLabeling 
( ( Sh Fon 
Raw Material Name  Supplier  i
     
               
     
               
     
               
     
               
     
               
     
               
 
   
Appendix 2 (Food Safety Plan Forms) - Page 14 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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:
 
 
   
Appendix 2 (Food Safety Plan Forms) - Page 15 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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)____________________________________________________ 
 
e)  e)  e) 
Egg  Milk  Soy  Wheat  Tree Nut arket nam Peanut  Fish arket nam Shellfish arket nam
m m m
(   ( (
Product Name  Production Line  
                   
 
                   
 
                   
 
 
   
Appendix 2 (Food Safety Plan Forms) - Page 16 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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). 
Appendix 2 (Food Safety Plan Forms) - Page 17 
  FORM 2-H FOOD ALLERGEN CONTROLS 
PAGE _________ 
PRODUCTS:  ______________________________________________________________ 
PLANT NAME: _____________________________________________________________ 
ADDRESS: ________________________________________________________________ 
ISSUE DATE: (mm/dd/yy)_____________________________________________________ 
SUPERSEDES: (mm/dd/yy)____________________________________________________ 
 
Allergen Frequency 
Who  Corrective 
CSontetpro l  Hazard(s)  Criterion  What to Monitor  How to Monitor  Moniotof ring  Monitors  Action  Verification  Records 
                   
18 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
Allergen Frequency 
Who  Corrective 
CSontetpro l  Hazard(s)  Criterion  What to Monitor  How to Monitor  Moniotof ring  Monitors  Action  Verification  Records 
                   
 
 
Appendix 2 (Food Safety Plan Forms) - Page 19 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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 suppliers 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 
   
Appendix 2 (Food Safety Plan Forms) - Page 20 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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  Approved  Hazard(s) requiring  Date of  Verification  Verification 
(requiring  Supplier  supply-chain- Approval  method  records 
supply-chain- applied control 
applied control) 
           
           
           
Receiving Procedure for Ingredients Requiring a Supply-chain-applied 
Control  
[Document procedures used for receiving ingredients requiring a supply-chain-applied control.]  
 
Appendix 2 (Food Safety Plan Forms) - Page 21 
  Contains Non-binding Recommendations 
Draft-Not for Implementation 
Hazard Analysis and Risk-Based 
Preventive Controls for Human Food: 
1
Draft Guidance for Industry  
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 FDAs 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 (a ), minimum and maximum pH, 
w
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. 
Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 1  Contains Non-binding Recommendations 
Draft-Not for Implementation 
 
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 158F (70C) (using a z = 13.5F (7.5C)).  For 
example, 1 minute at 145F (63C) is 0.117 times as lethal as 1 minute at 158F (70C).  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 194F (90C) (for temperatures less than 194F (90C), z = 12.6F (7.0C); for 
temperatures above 194F (90C), z = 18F (10C)).  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.   
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Table 3-A Limiting Conditions for Pathogen Growth 
Max. % 
Min. a  
w Min.   Max.   Water  Min.  Max.  Oxygen  
Pathogen  (using 
pH  pH  Phase  Temp.  Temp.  Requirement 
salt) 
Salt 
Bacillus  39.2F   131F1   facultative 
0.92  4.3  9.3  10 
cereus  4C  55C  anaerobe4 
Campylo- 86F  113F  micro- 
0.987  4.9  9.5  1.7 
bacter jejuni  30C  45C  aerophile2 
Clostridium 
botulinum,  
type A, and  50F   118.4F  
0.935  4.6  9  10  anaerobe3 
proteolytic  10C  48C 
types B and 
F 
Clostridium 
botulinum,  
type E, and 
37.9F   113F  
non- 0.97  5  9  5  anaerobe3 
3.3C  45C 
proteolytic 
types B and 
F 
Clostridium  50F   125.6F  
0.93  5  9  7  anaerobe3 
perfringens  10C  52C 
Pathogenic 
strains of   43.7F   120.9F   facultative  
0.95  4  10  6.5 
Escherichia  6.5C  49.4C  anaerobe4 
coli 
Listeria 
31.3F   113F   facultative  
monocyto- 0.92  4.4  9.4  10 
-0.4C  45C  anaerobe4 
genes 
Salmonella  41.4F  115.2F   facultative  
0.94  3.7  9.5  8 
spp.  5.2C  46.2C  anaerobe4 
43F   116.8F  facultative  
Shigella spp.  0.96  4.8  9.3  5.2 
6.1C  47.1C  anaerobe4 
Staphylo-
coccus  44.6F   122F   facultative  
0.83  4  10  20 
aureus  7C  50C  anaerobe4 
growth 
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Max. % 
Min. a  
w Min.   Max.   Water  Min.  Max.  Oxygen  
Pathogen  (using 
pH  pH  Phase  Temp.  Temp.  Requirement 
salt) 
Salt 
Staphylo-
coccus  50F   118F   facultative  
0.85  4  9.8  10 
aureus toxin  10C  48C  anaerobe4 
formation 
Vibrio  50F   109.4F  facultative  
0.97  5  10  6 
cholerae  10C  43C  anaerobe4 
Vibrio 
41F   113.5F   facultative  
parahaemo- 0.94  4.8  11  10 
5C  45.3C  anaerobe4 
lyticus 
Vibrio  46.4F   109.4F   facultative  
0.96  5  10  5 
vulnificus  8C  43C  anaerobe4 
Yersinia 
29.7F   107.6F   facultative  
enterocoliti- 0.945  4.2  10  7 
-1.3C  42C  anaerobe4 
ca 
1Has significantly delayed growth (>24 hours) at 131F (55C). 
2Requires limited levels of oxygen. 
3Requires the absence of oxygen. 
4Grows either with or without oxygen. 
 
Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 4 
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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  39.2-43F (4-6C)  5 days 
Bacillus cereus  44-59F (7-15C)  1 day 
60-70F (16-21C)  6 hours 
Above 70F (21C)  3 hours 
Growth of Campylobacter jejuni  86-93F (30-34C)  48 hours 
Above 93F (34C)  12 hours 
Germination, growth, and toxin  50-70F (10-21C)  11 hours 
formation by Clostridium  Above 70F (21C)  2 hours 
botulinum type A, and proteolytic 
types B and F 
Germination, growth, and toxin  37.9-41F (3.3-5C)   7 days  
formation by Clostridium  42-50F (6-10C)  2 days 
botulinum type E, and non- 51-70F (11-21C)  11 hours 
proteolytic types B and F  Above 70F (21C)  6 hours 
Growth of Clostridium  50-54F (10-12C)   21 days 
perfringens  55-57F (13-14 C)  1 day 
58-70F (15-21C)  6 hours1 
Above 70F (21C)  2 hours 
Growth of pathogenic strains of  43.7-50F (6.6-10C)  2 days  
Escherichia coli  51-70F (11-21C)  5 hours 
Above 70F (21C)  2 hours 
Growth of Listeria  31.3-41F (-0.4-5C)  7 days 
monocytogenes  42-50F (6-10C)  1 day 
51-70F (11-21C)  7 hours 
71-86F (22-30C)  3 hours 
Above 86F (30C)  1 hour 
Growth of Salmonella species  41.4-50F (5.2-10C)  2 days 
51-70F (11-21C)  5 hours 
Above 70F (21C)  2 hours  
Growth of Shigella species  43-50F (6.1-10C)  2 days 
51-70F (11-21C)  5 hours 
Above 70F (21C)  2 hours 
Growth and toxin formation by  50F (7-10C)  14 days 
Staphylococcus aureus  51-70F (11-21C)  12 hours1 
Above 70F (21C)  3 hours 
Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 5 
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Potentially Hazardous Condition  Product Temperature  Maximum Cumulative  
Exposure Time 
Growth of Vibrio cholerae  50F (10C)   21 days 
51-70F (11-21C)  6 hours 
71-80F (22-27C)   2 hours 
Above 80oF (27oC)  1 hour2 
Growth of Vibrio  41-50F (5-10C)  21 days  
parahaemolyticus  51-70F (11-21C)  6 hours 
71-80F (22-27C)   2 hours 
Above 80oF (27oC)  1 hour2 
Growth of Vibrio vulnificus  46.4-50F (8-10C)   21 days 
51-70F (11-21C)  6 hours 
71-80F (22-27C)   2 hours 
Above 80oF (27oC)  1 hour2  
Growth of Yersinia enterocolitica  29.7-50F (-1.3-10C)  1 day 
51-70F (11-21C)  6 hours 
Above 70F (21C)  2.5 hours 
1 Additional data needed. 
2Applies 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 50F (10C) but below 135oF (57.2oC)) 
If the food is a ...  And the food is  Then you should  Or, if  As long as ... 
held at an internal  limit the  Staphylococcus 
temperature ...  exposure time to  aureus (S. aureus) 
...  is the only 
pathogen of 
concern, then you 
should limit the 
exposure time to ... 
Raw, RTE  Above 70F  2 hours  3 hours   N/A 
ingredient or food  (21.1C) 
product  
Raw, RTE  Above 70F  4 hours  N/A  No more than 2 
ingredient or food  (21.1C)  of those hours 
product   are between 70F 
(21.1C) and 
135oF (57.2oC) 
Raw, RTE  At any time above  5 hours  12 hours   N/A 
ingredient or food  50F (10C) but 
product  never above 70F 
(21.1C) 
Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 6 
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If the food is a ...  And the food is  Then you should  Or, if  As long as ... 
held at an internal  limit the  Staphylococcus 
temperature ...  exposure time to  aureus (S. aureus) 
...  is the only 
pathogen of 
concern, then you 
should limit the 
exposure time to ... 
Raw, RTE  At internal  N/A  N/A  N/A 
ingredient or food  temperatures (or at  
product  ambient air 
temperatures) 
below 50F (10C) 
throughout 
processing 
Cooked, RTE  At any time above  1 hour  3 hours  N/A 
ingredient or food  80F (26.7C) 
product 
Cooked, RTE  At any time above  4 hours  N/A  No more than 1 
ingredient or food  80F (26.7C)  of those hours is 
product  above 70F 
(21.1C) 
Cooked, RTE  At any time above  2 hours  3 hours  N/A 
ingredient or food  70F (21.1C) but 
product  never above 80F 
(26.7C) 
Cooked, RTE  Never held above  4 hours  N/A  No more than 2 
ingredient or food  80F (26.7C)  of those hours 
product  are above 70F 
(21.1C) 
Cooked, RTE  At any time above  5 hours  12 hours  N/A 
ingredient or food  50F (10C) but 
product  never above 70F 
(21.1C) 
Cooked, RTE  At internal  N/A  N/A  N/A 
ingredient or food  temperatures (or 
product  ambient air 
temperatures) 
below 50F (10C) 
throughout 
processing 
 
Note that the preceding recommended critical limits do not address internal product 
temperatures between 40F (4.4C), which is the recommended maximum storage temperature 
for refrigerated food products, and 50F (10C).   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.   
Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 7 
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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.  
Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 8 
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Table 3-D Inactivation of Listeria monocytogenes 
Internal Product  Internal Product  Lethal  Time for 6D Process 
Temperature (F)  Temperature (C)  Rate  (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 = 13.5F (7.5C).  
Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 9 
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Table 3-E Inactivation of Non-Proteolytic Clostridium botulinum Type B 
Internal Product  Internal Product  Lethal  Time for 6D Process 
Temperature (F)  Temperature (C)  Rate*  (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 194F (90C), z = 12.6F (7.0C); for temperatures above 
194F (90C), z = 18F (10C). 
Appendix 3 (Bacterial Pathogen Growth and Inactivation) - Page 10 
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