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Hazard Analysis and Risk-Based 

Preventive Controls for Human Food: 

Draft Guidance for Industry1

This draft guidance, when finalized, will represent the current thinking of the Food and Drug 

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

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

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

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

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

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 entity’s food safety processes 

and procedures. 

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

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

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

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

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

Calendar day: Every day shown on the calendar.

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

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

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

prevent affected food from entering commerce).

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

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

an acceptable level.

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

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

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

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

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

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

minimize the environmental pathogen. Examples of environmental pathogens include Listeria 

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

bacteria.

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

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

1, subpart H.

Farm: Farm as defined in 21 CFR 1.227.

FDA: Food and Drug Administration.

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

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

ingredients.

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

and Cosmetic Act.

2

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

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

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

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

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

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

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

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

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

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

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

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

number.

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

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

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

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

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

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

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

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

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

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

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

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

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

potential to cause illness or injury.

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

person knowledgeable about the safe manufacturing, processing, packing, or holding of food 

would, based on the outcome of a hazard analysis (which includes the severity of the illness or 

injury if the hazard were to occur and the probability that the hazard will occur in the absence of 

preventive controls) establish one or more preventive controls to significantly minimize or 

prevent the hazard in a food and components to manage those controls (such as monitoring, 

corrections or corrective actions, verification and records) as appropriate to the food, the facility 

and the nature of the preventive control and its role in the facility’s food safety system. 

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

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

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

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

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

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

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

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

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

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

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

the facility or the food.

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

code.

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

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

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

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

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

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

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

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

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

harvesting, packing, or holding.

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

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

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

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

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

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

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

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

definition that require the establishment to be registered.

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

control measures are operating as intended.

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

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

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

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

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

Pathogen: A microorganism of public health significance.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

regulations in 21 CFR part 1, subpart M.

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

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

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

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

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

consumers at such restaurant or retail food establishment.

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

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

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

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

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

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

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

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

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

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

117.5(a).

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

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

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

employee of the establishment.

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

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

Drug, and Cosmetic Act3.

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

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

without further processing that would significantly minimize biological hazards.

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

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

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

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

suitable for use as food.

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

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

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

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

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

microorganisms.

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

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

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

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

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

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

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

company.

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

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

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

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

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

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

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

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

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

implemented, is capable of effectively controlling the identified hazards.

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

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

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

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

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

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

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

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

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

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

temperature.

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

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

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

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

activities before acceptance for use).

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

B. Other Terms that FDA Uses in This Guidance

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

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

elsewhere.

Adequate cooking instructions: Cooking instructions that are adequate to significantly 

minimize biological hazards.

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

prevent illness.

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

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

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

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

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

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

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

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

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

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

added to cookies).

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

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

Guidance for Industry.

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

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

allergen.

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

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

requirements of part 117, subpart G.

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

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

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

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

certain specifications.

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

produced on the same processing line.

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

from a surface.

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

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

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

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

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

production area to a designated cleaning area.

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

Safety Control Measures (CXG 69-2008).”

Commercial entity provisions: Provisions of 21 CFR 117.136.

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

mixture in preparation for analytical testing of the mixture.

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

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

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

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

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

controlled. 

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

boiling, or microwave cooking).

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

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

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

and prevent affected food from entering commerce). 

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

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

safety regulation.

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

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

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

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

requiring a preventive control. 

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

factor.

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

first consignee in a recalling firm’s distribution chain.

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

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

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

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

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

5): Guidance for Industry (Draft Guidance).

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

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

vacuuming the residues) without water.

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

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

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

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

environmental pathogen or an appropriate indicator organism.

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

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

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

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

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

to help production personnel select the correct label.

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

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

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

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

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

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

safety system. See 21 CFR 117.126 and 117.140.

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

elements.

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

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

identification, evaluation, and control of food safety hazards. 

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

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

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

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

4

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

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

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

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

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

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

Intrinsic properties: Parameters inherent to a food.

Kill step: Lethal processing to significantly minimize biological hazards.

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

processing, packing, or holding of food.

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

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

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

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

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

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

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

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

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

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

Act.

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

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

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

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

its surrogate.

NACMCF guidelines for conducting microbial challenge studies: National Advisory 

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

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

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

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

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

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

established for reasons other than food safety. 

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

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

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

step.

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

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

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

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

117.3. (See section III.B.)

Prerequisite programs: Procedures, including Current Good Manufacturing Practices 

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

the Food Safety Plan.

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

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

panel of a food product. See 21 CFR 101.1.

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

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

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

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

consumption in the produce safety regulation.

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

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

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

7.3(g).)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

measures that are not preventive controls.

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

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

and prevent a recurrence of the event.

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

contamination event6 by investigating all aspects of the manufacturing process, including the 

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

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

prevent the problem from recurring.

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

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

the FD&C Act.

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

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

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

achieve control. 

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

the production system. 

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

applicable, sanitize) FCSs and non-FCSs. 

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

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

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

consequences or death to humans. 

Severity: The seriousness of the effects of a hazard. 

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

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

being evaluated. 

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

validation study. 

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

the receiving facility or the supplier. 

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

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

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

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

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

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

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

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

IV. Abbreviations

Table 2: Abbreviations Used in This Guidance

Abbreviation What It Means 

ABC Almond Board of California 

aw Water activity
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Abbreviation What It Means 

BHA Butylated hydroxyanisole 

BHT Butylated hydroxytoluene 

CBA Consumer Brands Association (formerly Grocery Manufacturers 

Association) 

CBA LowMoisture Foods 

Guidelines

CBA “Control of Salmonella in Low-Moisture Foods Guidance 

Document” 

CCP Critical control point

CDC Centers for Disease Control and Prevention 

CIP Clean in place

CFIA Canadian Food Inspection Agency 

CFR Code of Federal Regulations 

CGMP Current good manufacturing practice 

CFSAN Center for Food Safety and Applied Nutrition 

CL Critical limit

COA Certificate of Analysis

Codex Codex Alimentarius Commission

COP Clean out of place 

CP Control point 

CPG Compliance Policy Guide 

D-value Decimal reduction time

DON Deoxynivalenol 

EDTA Ethylene-diaminetetraacetate
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Abbreviation What It Means 

EMP Environmental monitoring program 

EPIPT End-Point Internal Product Temperature 

EPA U.S. Environmental Protection Agency 

ECDPC European Centre for Disease Prevention and Control 

EFSA European Food Safety Authority 

FALCPA Food Allergen Labeling and Consumer Protection Act 

FAO Food and Agriculture Organization of the United Nations 

FCS Food-contact surface

FDA U.S. Food and Drug Administration 

FDA’s Listeria

guidance* 

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

Guidance for Industry 

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

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

Agriculture

FSMA FDA Food Safety Modernization Act 

FSP Food safety plan 

FSPCA Food Safety Preventive Controls Alliance 

FSVP Foreign Supplier Verification Programs 

GE Glycidyl Esters

GMA Grocery Manufacturers Association (now Consumer Brands 

Association) 

HACCP Hazard Analysis and Critical Control Point 

HPP High Pressure Processing 
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Abbreviation What It Means 

ICMSF International Commission on Microbiological Specifications for 

Foods 

IFT Institute of Food Technologists 

ILSI International Life Sciences Institute 

ILSI Europe International Life Sciences Institute Europe 

IQF Individually quick frozen 

IRAC Interagency Risk Assessment Consortium 

ISO International Organization for Standardization 

JECFA Joint Food and Agriculture Organization/World Health 

Organization Expert Committee on Food Additives 

Juice HACCP 

guidance 

Guidance for Industry: Juice HACCP Hazards and Controls 

Guidance 

LACF Low-acid canned food

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

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

NACMCF National Advisory Committee on Microbiological Criteria for 

Foods 

NRTE food Not ready-to-eat food

Part 117 Current Good Manufacturing Practice, Hazard Analysis, and 

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

117) 

PCBs Polychlorinated biphenyls 

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

part 117 for hazard analysis and risk-based preventive controls 

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

Act) 
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Abbreviation What It Means 

PCQI Preventive controls qualified individual 

PDP Principal display panel on a food label 

PFAS Per- and polyfluoroalkyl substances 

ppb Parts per billion

ppm Parts per million

PPO Propylene oxide 

QC Quality control 

RAC Raw agricultural commodity

ROP Reduced oxygen packaging 

RPM FDA’s Regulatory Procedures Manual 

RTD Resistance temperature detector

RTE food Ready-to-eat food 

SAHCODH Serious adverse health consequences or death to humans

SAHCODH

hazard

Serious adverse health consequences or death to humans hazard

Seafood HACCP 

guidance 

Fish and Fishery Products Hazards and Controls Guidance 

SME Subject matter expert

STEC Shiga-toxin producing E. coli

TCS food Time/Temperature Control for Safety Food 

TDT Thermal Death Time

USDA U.S. Department of Agriculture 

WHO World Health Organization 
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Abbreviation What It Means 

WIP Work-in-process

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

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

factor of 10)

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

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

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

specifying its status as draft guidance or final guidance. 

V. Training

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

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

which establishes requirements for: 

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

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

assigned duties (21 CFR 117.4(a)); 

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

food to: 

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

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

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

117.4(b)(1)); and 

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

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

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

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

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

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

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

and

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

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

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

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

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

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

CFR 117.180(c)(2)); and

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

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

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

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

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

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

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

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

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

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

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

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

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

component of the food safety plan.

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

individual’s assigned duties. For example:

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

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

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

personnel receive training necessary to perform their assigned functions; 

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

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

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

ingredients that they purchase;

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

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

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

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

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

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

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

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

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

performed correctly or was not effective; 

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

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

actions to take if there is a problem during production; 

• Personnel with responsibilities for sampling surfaces for environmental pathogens should 

have adequate training in the procedures for collecting the samples;

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

should have adequate training in conducting that laboratory testing; 

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

safety plan, applicable to their supervisory responsibilities; and

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

VI. Resources 

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

implementing your food safety plan. These resources are available as of the date that we make 

this guidance available. We have verified the website addresses listed for these resources, as of 

the date that we make this guidance available, but websites are subject to change over time. In 

addition, the policies, recommendations, and information in these resources can change over 

time. We recommend that you periodically review websites listing FDA’s CPGs, FDA’s 

Guidance for Industry, FDA’s Compliance Programs and Import Alerts, and Codex Standards, 

Codes of Practice, and Guidelines for new or modified policies, recommendations, and 

information. 

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

Topic CPG Link 

Aflatoxin M1 CPG Sec 527.400 Whole Milk, Lowfat Milk, 

Skim Milk - Aflatoxin M1. November 2005. 

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

Aflatoxins CPG Sec. 555.400 Aflatoxins in Human Food: 

Guidance for FDA Staff. June 2021. 

https://www.fda.gov/media/149666/download
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 24 

Topic CPG Link 

Aflatoxins – Brazil 

nuts

CPG Sec. 570.200 Aflatoxins in Brazil Nuts: 

Guidance for FDA Staff. June 2021

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

Aflatoxins – 

Pistachio nuts

CPG Sec. 570.500 Aflatoxins in Pistachio Nuts: 

Guidance for FDA Staff. June 2021. 

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

Aflatoxins - Peanuts CPG Sec. 570.375 Aflatoxins in Peanuts and 

Peanut Products: Guidance for FDA Staff. June 

2021. 

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

Aflatoxins – Animal 

food

CPG Sec. 683.100 Action Levels for Aflatoxins 

in Animal Food: Guidance for FDA Staff. 

March 2019. 

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

Food allergens CPG Sec. 555.250 Statement of Policy for 

Labeling and Preventing Cross-contact of 

Common Food Allergens. 2005. 

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

Food allergens CPG Sec 555.250 DRAFT: Major Food 

Allergen Labeling and Cross-contact. 2023.**

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

Hard or sharp foreign 

objects

CPG Sec. 555.425 Foods, Adulteration 

Involving Hard or Sharp Foreign Objects. May 

2005. 

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

Hypoglycin A Toxin CPG Sec. 550.050 Canned Ackee, Frozen 

Ackee, and Other Ackee Products - Hypoglycin 

A Toxin. April 2014. 

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

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

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

March 2008. 

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

Mercury - Grain CPG Sec. 578.400 Treated Grain Seed - 

Mercury Residue. October 1980. 

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

Microbiological 

hazards – Dairy 

products

CPG Sec. 527.300 Dairy Products - Microbial 

Contaminants and Alkaline Phosphatase 

Activity. December 2010.

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

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

Concentrates, and Apple Juice Products - 

Adulteration with Patulin. November 2005. 

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

PCBs CPG Sec. 565.200 Red meat adulterated with 

PCBs. November 1987. 

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

CompliancePolicyGuidanceManual/ucm074589.htm

Pesticides CPG Sec. 575.100 Pesticide Residues in Food 

and Feed - Enforcement Criteria. March 1995.

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

Pesticides CPG Sec. 575.100 Pesticide Chemical Residues 

in Food - Enforcement Criteria (CPG 7141.01) 

(Draft Guidance)*** January 2008. 

https://www.fda.gov/media/77986/download 
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, Resources, and References - Page 25 

Topic CPG Link 

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

Imported and Domestic - Adulteration Involving 

Mold, Insect Excreta, Sour, Dirty, Worthless and 

Pits. 2005. 

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

Pits - Olives CPG Sec. 550.600 Olives - Adulteration 

Involving Pits; Rot; Insect Infestation. 2005. 

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

Pits and pit fragments

- Prunes

CPG Sec. 550.700 Dried Prunes, Dehydrated 

Low Moisture Prunes, and Pitted Prunes - 

Adulteration Involving Insects; Decomposition; 

Dirt; Pits; and Pit Fragments. 2005. 

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

Radionuclides CPG Sec. 555.880 Guidance Levels for 

Radionuclides in Domestic and Imported Foods. 

2005. 

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

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

- Adulteration with Salmonella. March 1995. 

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

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

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

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

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

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

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

cross-contact.

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

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

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

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

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

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

Topic Guidance Link 

Acidified foods Guidance for Industry: Submitting Form 

FDA 2541 (Food Canning Establishment 

Registration) and Forms FDA 2541d, 

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

(Food Process Filing Forms) to FDA in 

Electronic or Paper Format. November 

2016.

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

Acrylamide Guidance for Industry. Acrylamide in 

Foods. March 2016.

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

Draft-Not for Implementation

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

Topic Guidance Link 

Antimicrobial substances Guidance for Industry: Antimicrobial 

food additives. 1999.

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

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

inorganic arsenic in rice cereals for 

infants. August 2020. 

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

Arsenic – Apple juice Guidance for Industry: Action Level for 

Inorganic Arsenic in Apple Juice. 2023.

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

Bottled water (Allowable 

levels for inorganic substances

in accordance with 21 CFR 

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

Small Entity Compliance Guide: Bottled 

Water and Arsenic. April 2009.

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

Chemical hazards Guidance for Industry: Action Levels for 

Poisonous or Deleterious Substances in 

Human Food and Animal Feed. August 

2000.

https://www.fda.gov/FoodGuidances

Cochineal extract and carmine Cochineal extract and carmine: 

Declaration by name on the label of all 

foods and cosmetic products that contain 

these color additives; Small Entity 

Compliance Guide. April 2009.

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

Enforcement policy Policy Regarding Certain Entities Subject 

to the Current Good Manufacturing 

Practice and Preventive Controls, 

Produce Safety, and/or Foreign Supplier 

Verification Programs: Guidance for 

Industry. 2018.

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

Enforcement policy Current Good Manufacturing Practice 

and Preventive Controls, Foreign 

Supplier Verification Programs, 

Intentional Adulteration, and Produce 

Safety Regulations: Enforcement Policy 

Regarding Certain Provisions. 2022.

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

Food allergens Guidance for Industry: Questions and 

Answers Regarding Food Allergens, 

Including the Food Allergen Labeling 

and Consumer Protection Act of 2004. 

Edition 5. 2022. 

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

Food allergens Questions and Answers Regarding Food 

Allergens, Including the Food Allergen 

Labeling Requirements of the Federal 

Food, Drug, and Cosmetic Act (Edition 

5): Guidance for Industry (Draft 

Guidance). 2022.**

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

Food labeling (refrigerated 

foods) 

Guidance on Labeling of Foods That 

Need Refrigeration by Consumers. 1997.

(Also available at 62 FR 8248, February 

24, 1997) 

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

Draft-Not for Implementation

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

Topic Guidance Link 

HACCP systems - Seafood Fish and Fishery Products Hazards and 

Controls Guidance. June 2022. 

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

HACCP systems - Juice Guidance for Industry: Juice HACCP 

Hazards and Controls Guidance. 

February 2004.

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

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

Animal Food: Draft Guidance for 

Industry #239**

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

Lead - Candy Guidance for Industry: Lead in Candy 

Likely To Be Consumed Frequently by 

Small Children: Recommended 

Maximum Level and Enforcement 

Policy. November 2006.

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

Lead - Juice Draft** Guidance for Industry: Action 

Levels for Lead in Juice. April 2022.

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

Lead – Food for babies and 

young children

Draft** Guidance for Industry: Action 

Levels for Lead in Food Intended for 

Babies and Young Children

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

Microbiological hazards – 

Fresh-cut produce

Guidance for Industry: Guide to 

Minimize Microbial Food Safety Hazards 

of Fresh-cut Fruits and Vegetables. 2008.

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

Microbiological hazards – 

Fresh-cut produce

Draft** Guidance for Industry: Guide to 

Minimize Food Safety Hazards of Freshcut Produce. 2018.

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

Microbiological hazards - 

LACF

Guide to Inspections of Low Acid 

Canned Food Manufacturers Part 1 - 

Adminstrative Procedures/Scheduled 

Processes

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

Listeria monocytogenes Control of Listeria monocytogenes in 

Ready-To-Eat Foods: Guidance for 

Industry (Draft Guidance). 2017.**

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

Mycotoxins - Fumonisin Guidance for Industry: Fumonisin Levels 

in Human Foods and Animal Feeds. 

November 2001.

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

Draft-Not for Implementation

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

Topic Guidance Link 

Mycotoxins - DON Guidance for Industry and FDA: 

Advisory Levels for Deoxynivalenol 

(DON) in Finished Wheat Products for 

Human Consumption and Grains and 

Grain By-Products used for Animal Feed. 

July 2010.

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

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

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

Recalls Initiation of Voluntary Recalls Under 21 

CFR Part 7, Subpart C. Guidance for 

Industry and FDA Staff. 2022. 

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

Recalls Product Recalls, Including Removals and 

Corrections. Guidance for Industry. 2020.

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

Recalls Public Availability of Lists of Retail 

Consignees to Effectuate Certain Human 

and Animal Food Recalls Guidance for 

Industry and FDA Staff. 2020.

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

Recalls Public Warning and Notification of 

Recalls Under 21 CFR Part 7, Subpart C. 

Guidance for Industry and FDA Staff. 

2019.

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

Recalls Questions and Answers Regarding 

Mandatory Food Recalls: Guidance for 

Industry and FDA Staff. 2018.

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

Recordkeeping required by 21 

CFR part 1, subpart J

Guidance for Industry: Questions and 

Answers Regarding Establishment and 

Maintenance of Records By Persons Who 

Manufacture, Process, Pack, Transport, 

Distribute, Receive, Hold, or Import 

Food (Edition 5). February, 2012.

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

Registration of food facilities Guidance for Industry: Questions and 

Answers Regarding Food Facility 

Registration (Seventh Edition). August 

2018.

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

Draft-Not for Implementation

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

Topic Guidance Link 

Reportable Food Registry Guidance for Industry: Questions and 

Answers Regarding the Reportable Food 

Registry As Established by the Food and 

Drug Administration Amendments Act of 

2007. 2009.

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

Reportable Food Registry Draft Guidance for Industry: Questions 

and Answers Regarding the Reportable 

Food Registry As Established by the 

Food and Drug Administration 

Amendments Act of 2007 (Edition 2). 

2010.

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

Salmonella spp. - Peanutderived productGuidance for Industry: Measures to 

Address the Risk for Contamination by 

Salmonella Species in Food Containing a 

Peanut-Derived Product as an Ingredient. 

March 2009.

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

Salmonella spp. - Pistachioderived productGuidance for Industry: Measures to 

Address the Risk for Contamination by 

Salmonella Species in Food Containing a 

Pistachio-Derived Product as an 

Ingredient. September 2011.

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

Salmonella spp. - Testing Guidance for Industry Testing for 

Salmonella Species in Human Foods and 

Direct-Human-Contact Animal Foods. 

March 2012.

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

Third-party certification Guidance for Industry and FDA Staff: 

Model Accreditation Standards for ThirdParty Certification Body Accreditation 

for Food Safety Audits. 2022.

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

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

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

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

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

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

Draft-Not for Implementation

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

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

Guidance** 

Topic Title and Link

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

residues

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

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

Mycotoxins Published Date: 06/06/2022 

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

Mycotoxins Compliance Program 7307.001 Mycotoxins in Domestic and Imported Foods

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

Toxic 

elements

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

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

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

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

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

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

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

Draft-Not for Implementation

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

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

Guidance*, ** 

Topic Title Link 

Acrylamide Code of Practice for 

the Reduction of 

Acrylamide in Foods. 

CXC 67-2009.

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

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

Aflatoxin – 

Tree Nuts

Code of Practice for 

the Prevention and 

Reduction of 

Aflatoxin 

Contamination in 

Tree Nuts. CAC/RCP 

59-2005.

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

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

Aflatoxin - 

Peanuts

Code of Practice for 

the Prevention and 

Reduction of 

Aflatoxin 

Contamination in 

Peanuts. CAC/RCP 

55-2004.

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

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

Aflatoxin – 

Dried Figs

Code of Practice for 

the Prevention and 

Reduction of 

Aflatoxin 

Contamination in 

Dried Figs. CAC/RCP 

65-2008.

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

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

Arsenic - Rice Code of Practice for 

the Prevention and 

Reduction of Arsenic 

Contamination in 

Rice. CXC 77-2017.

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

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

Cadmium – 

Cocoa Beans

Codex Code of 

Practice for the 

Prevention and 

Reduction of 

Cadmium 

Contamination in 

Cocoa. CXC 81-2022

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

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

Contaminants 

and toxins

General Standard for 

Contaminants and 

Toxins in Food and 

Feed. CXS 193-1995. 

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

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

Food allergens Codex Code of 

Practice on Food 

Allergen Management 

for Food Business 

Operators. CXC 80-

2020

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

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

Draft-Not for Implementation

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

Topic Title Link 

HACCP 

systems

General Principles of 

Food Hygiene. CXC

1-1969.

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

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

Lead Code of Practice for 

the Prevention and 

Reduction of Lead 

Contamination in 

Foods. CXC 56-2004

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

3-

Monochloropr

opane-1,2- 

Diol (3-

MCPD) 

Code of Practice for 

the Reduction of 3-

Monochloropropane1,2- Diol During the 

Production of AcidHVPs and Products 

That Contain AcidHVPs. CXC 64-2008

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

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

3-

Monochloropr

opane-1,2- 

Diol Esters (3-

MCPDEs) and 

Glycidyl 

Esters (GEs)

Code of Practice for 

the Reduction of 3-

Monochloropropane1,2- Diol Esters (3-

MCPDEs) and 

Glycidyl Esters (GEs) 

In Refined Oils and 

Food Products Made 

with Refined Oils. 

CXC 79-2019.

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

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

Mycotoxin Code of Practice for 

the Prevention and 

Reduction of 

Mycotoxin 

Contamination in 

Cereals. CXC 51-

2003. 

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

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

Mycotoxins Code of Practice for 

the Prevention and 

Reduction of 

Mycotoxins in Spices. 

CXC 78-2017.

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

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

Ochratoxin A - 

Coffee 

Code of Practice for 

the Prevention and 

Reduction of 

Ochratoxin A

Contamination in 

Coffee. CAC/RCP 

69-2009. (CXC-69-

2009)

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

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

Draft-Not for Implementation

Topic Title Link 

Ochratoxin A - 

Cocoa

Code of Practice for 

the Prevention and 

Reduction of 

Ochratoxin A 

Contamination in 

Cocoa. CAC/RCP 72-

2013. (CXC 72-2013)

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

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

Pits (stones) - 

Olives

Standard for Table 

Olives. CXS 66-1981.

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

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

Pits (stones) - 

Dates

Standard for Dates. 

CXS 143-1985. 

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

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

Pits (stones) – 

Stone fruits

Standard for Canned 

Stone Fruits. CXS 

242-2003. 2017.

(Applies to stone

fruits of the genus

Prunus)

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

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

Salmonella

spp.

Codex Code of 

Hygienic Practice for 

Low-Moisture Foods. 

CXC 75-2015. 

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

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

Salmonella

spp. and 

Cronobacter

spp. 

Codex Code of 

Hygienic Practice for 

Powdered Formulae 

for Infants and Young 

Children. CAC/RCP 

66-2008. (CXC 66-

2008)

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

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

Validation Guidelines for the 

validation of food 

safety control 

measures. CXG 69-

2008. 

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

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

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

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

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

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

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

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

Practice, or Guideline.

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

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

particular food or group of foods. 

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

Draft-Not for Implementation

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

Table 7. Resources for Designing Validation Studies

Organization Document How to Access Applicability

Alliance for Innovation 

& Operational 

Excellence (AIOE)

Anderson, D and LA Lucore. 2020.

Validating the reduction of Salmonella

and other pathogens in heat processed 

low-moisture foods

Available from the OpX website by 

registering (free):

https://www.opxleadershipnetwork.org/qu

ality/download/pathogen-reductionvalidation

Thermal processes

Low moisture foods

American Frozen Foods 

Institute (AFFI)

Process validation 

- Considerations for In-Plant 

Blanching Study

- Considerations for Lab-Scale

Blanching Study

- How to Validate Your Blancher 

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

Almond Board of 

California

- Guidelines for Validation of

Blanching Processes, v1.0, April 13,

2007.

- Guidelines for Validation of Oil

Roasting Processes, v1.0, April 13,

2007. 

- Guidelines for Validation of Dry 

Roasting Processes, v1.2, October

23, 2007. 

- Guidelines for Process Validation 

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

- Guidelines for Validation of

Propylene Oxide Pasteurization,

v3.0, October 1, 2008.

- Guidelines for Validation of

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

2008.

- Guidelines for Process Validation 

Using Enterococcus faecium NRRLB-2354 as a Surrogate 

Microorganism in Almond Process

Validation, 2014.

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

Tree nuts and other 

low moisture foods (as 

appropriate)

Chilled Foods 

Association 

Guidelines for setting shelf life of 

chilled foods in relation to nonproteolytic Clostridium botulinum. 

2018.

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

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

Chilled foods

Codex Alimentarius 

Commission (Codex)

Codex. Guidelines for the validation of 

food safety control measures (CXG 

69-2008)

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

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

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

2Fcodex%252FStandards%252FCXG%2

B69-2008%252FCXG_069e.pdf 

General applicability
Contains Non-binding Recommendations 

Draft-Not for Implementation

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

Organization Document How to Access Applicability

European branch of the 

International Life 

Sciences Institute, ILSI 

Europe

Ceylan, E., A Amezquita, N. 

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

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

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

den Besten. 2021. Guidance on 

validation of lethal control measures

for foodborne pathogens in foods.

Compr. Rev. Food Sci. Food Saf. 

20:2825–2881. DOI: 10.1111/1541-

4337.12746. Available at: 

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

10.1111/1541-4337.12746

General applicability; 

describes product and 

process factors 

essential in designing 

a validation study, 

selection criteria for 

identifying an 

appropriate target 

pathogen or surrogate 

organism. 

Institute for Food 

Safety and Health 

(IFSH)

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

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

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

Varley; K. Deng. 2017.Guidelines to

validate control of cross-contamination

during washing of fresh-cut leafy 

vegetables.

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

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

Commercial 

packinghouse and 

fresh-cut wash 

systems

Institute for Food 

Safety and Health 

(IFSH) 

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

Tortorello. 2017. Approaches toward 

identification of surrogates to validate 

antimicrobial washes as preventive 

controls for fresh-cut leafy greens.

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

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

Commercial 

packinghouse and 

fresh-cut wash 

systems

International 

Commission on 

Microbiological 

Specifications for 

Foods (ICMSF)

ICMSF. 2011. Microorganisms in 

Foods 8, Use of Data for Assessing 

Process Control and Product 

Acceptance. Chapter 2-Validation of 

Control Measures

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

41993731

Book and individual chapters can be 

purchased.

General applicability

International 

Association for Food 

Protection (IAFP)

Consortium of Food Process 

Validation Experts. Validation of 

Antimicrobial Interventions for Small 

and Very Small Processors: A How-to 

Guide to Develop and Conduct 

Validations

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

104.

General Applicability

National Advisory 

Committee on the 

Microbiological 

Criteria for Foods 

(NACMCF)

NACMCF. 2010. Parameters for 

determining inoculated pack/challenge 

study protocols. 

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

for studies that 

involve inoculation of 

product.

PMMI OpX Leadership 

Network Products 

Safety Solutions Group 

Validating the Reduction of 

Salmonella and Other Pathogens in 

Heat Processed Low-Moisture Foods: 

Spotlight on Baking

https://www.opxleadershipnetwork.org/qu

ality/download/spotlight-baking

Baking Processes

University of 

California, Davis

Theofel, C, S Yada, and LJ Harris. 

Surrogate organisms for low moisture 

foods – published treatments [tables 

and references]

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

es/dgvnsk7366/files/inlinefiles/303737.pdf 

Low-moisture foods 
Contains Non-binding Recommendations 

Draft-Not for Implementation

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

Table 8. Additional Resources Cited in this Guidance

Topic Source Resource Title Resource Link

Animal drugs FDA 

website

Search animal 

drugs

https://animaldrugsatfda.fda.gov/

Audits International 

Featured 

Standards 

(IFS) 

website

IFS Food 7 – 

English* 

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

CGMP Eastern 

Research 

Group. 

2004.

Good 

Manufacturing 

Practices (GMPs) 

for the 21st 

Century - Food 

Processing. 

Section Four. 

Common Food 

Safety Problems 

in the U.S. Food 

Processing 

Industry: A 

Delphi Study. 

2004.

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

Chemical 

contaminants

FDA 

website

Chemical 

Contaminants & 

Pesticides

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

Chemical 

contaminants

FDA 

website

FDA Total Diet 

Study (TDS)

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

Color additives FDA 

website

Color additive 

status list 

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Data and tools in 

support of food 

safety risk 

assessment 

efforts 

Foodrisk.org

website

Open Data & 

Tools

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

Environmental 

contaminants

Code of 

Federal 

Regulations

21 CFR 109.30 

Tolerances for 

polychlorinated 

biphenyls (PCBs)

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

Environmental 

contaminants

FDA 

website

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

Environmental 

contaminants

FDA 

website

Per- and 

Polyfluoroalkyl 

Substances 

(PFAS) 

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

Food additives FDA 

website

Food additive 

status list 

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

Food allergens FDA 

website

Food 

Allergens/GlutenFree Guidance 

Documents & 

Regulatory 

Information 

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

Food allergens FDA 

website

Label Declaration 

of Allergenic 

Substances in 

Foods; Notice to 

Manufacturers.

1996

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

n/Allergens/ucm106546.htm

Food allergens GMA (now 

Consumer 

Brands 

Association)

Managing 

allergens in food 

processing 

establishments

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Food Code FDA 

website

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

Food fraud United 

States 

Pharmacopei

al 

Convention 

website

Food fraud 

mitigation 

guidance

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

Food fraud Food Fraud 

Advisors 

website

Food Fraud 

Databases 

Compared

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

Food safety FAO 

website

Food safety & 

quality

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

Food safety WHO 

website

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

Food safety

forms and 

training manual

FSPCA 

website

Food Safety 

Preventive 

Controls Alliance

https://www.fspca.net

Food ingredient 

standards

Food 

Chemicals 

Codex

Food Chemicals 

Codex

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

Foreign material U.S. 

Department 

of 

Agriculture, 

Agricultural 

Marketing 

Service

Foreign Material 

Manual

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Game meat FSIS 

website

FSIS Cooking 

Guideline for 

Meat and Poultry 

Products (Revised 

Appendix A).

2021.

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

Game meat FSIS 

website

FSIS Stabilization 

Guideline for 

Meat and Poultry 

Products (Revised 

Appendix B).

2021.

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

GRAS 

substances

FDA 

website 

Generally 

Recognized as 

Safe (GRAS)

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

HACCP systems FSIS 

website

Meat and Poultry 

Hazards and 

Controls Guide. 

2018.

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

HACCP systems FSIS 

website

FSIS compliance 

guideline HACCP 

systems 

validation. 2015.

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

HACCP systems Codex 

website

Hazard analysis 

and critical 

control point 

(HACCP) system 

and guidelines for 

its application. 

Chapter Two in 

CXC 1-1969. 

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

C%2B1-1969%252FCXC_001e.pdf

Information for 

consumers

FDA 

website

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Information for 

consumers

FDA 

website

Raw Dough's a 

Raw Deal and 

Could Make You 

Sick

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

International & 

Interagency 

Coordination

FDA 

website

International & 

Interagency 

Coordination

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

International & 

Interagency 

Coordination

FDA 

website

International 

Arrangements

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

International & 

Interagency 

Coordination

FDA 

website

International 

Cooperation on 

Food Safety

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

International & 

Interagency 

Coordination

FDA 

website

Systems 

Recognition 

(Food)

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

Irradiation FDA 

website

Irradiation of 

Food & Packaging

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

Irradiation FDA 

website

Understanding 

food irradiation: 

What industry 

needs to know

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

Metal detection Loma 

Systems 

website

Guide to Metal 

Detection

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Metal detection Mettler 

Toledo 

website

- The Metal

Detection Guide.

Building an

Effective

Programme

- Understanding

Sensitivity In

Metal Detection

-How to Correctly

Test Your

Industrial Metal

Detector

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

Microbiological 

hazards

Combase 

website

A Web Resource 

for Quantitative 

and Predictive 

Food 

Microbiology

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

Microbiological 

hazards

FDA 

website

Bad Bug Book. 

2012.

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Microbiological 

hazards

FDA 

website (A 

Report of the 

Institute of 

Food 

Technologist

s for the 

Food and 

Drug 

Administrati

on of the 

United 

States 

Department 

of Health 

and Human 

Services.

IFT/FDA 

Contract No. 

223-98-

2333; Task

Order No. 4)

Evaluation and 

definition of 

potentially 

hazardous foods: 

Chapter 3 Factors 

that influence 

microbial growth

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

Microbiological 

hazards

USDA/ ARS 

website

Pathogen 

Modeling 

Program 

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

Microbiological 

hazards - LACF

FDA 

website

Guide to 

Inspections of 

Low Acid Canned 

Food 

Manufacturers 

Part 1 - 

Administrative 

Procedures/Sched

uled Processes

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

Outbreaks CDC 

website

Estimates of 

Foodborne Illness

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Outbreaks CDC 

website

Foodborne 

outbreaks

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

Outbreaks European 

Food Safety 

Authority

website

Monitoring of 

foodborne 

diseases

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

Outbreaks and 

Recalls

FDA 

website

Recalls, 

Outbreaks & 

Emergencies

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

Outbreaks and 

Recalls

Food 

Safety.gov 

website

Recalls and 

Outbreaks

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

Pasteurization of 

milk

FDA 

website

Grade "A" 

Pasteurized Milk 

Ordinance

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

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

Pesticides FDA 

website

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

Pesticides FDA 

website

Pesticide Residue 

Monitoring 

Program Reports 

and Data

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

Pesticides Code of 

Federal 

Regulations 

(e-CFR) 

website

40 CFR Part 180 - 

Tolerances and 

Exemptions for 

Pesticide 

Chemical 

Residues in Food

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Pesticides EPA website Indexes to Part 

180 Tolerance 

Information for 

Pesticide 

Chemicals in 

Food and Feed 

Commodities

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

Pesticides EPA website Regulation of 

pesticide residues 

on food

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

Physical hazards 

(glass 

fragments)

News 

website

Seavin voluntarily 

recalls select 

wines due to 

potential small 

pieces of glass in 

bottles

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

Process 

contaminants

FDA 

website

3-

Monochloropropa

ne-1,2-diol 

(MCPD) Esters 

and Glycidyl 

Esters

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

Process 

contaminants

FDA 

website

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

Recalls FDA 

website

Recalls, Market 

Withdrawals, & 

Safety Alerts

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

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 7

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 

7, Exhibit 7-1, 

Model 

Effectiveness 

Check Letter 

(Industry). 

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

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 

7, Exhibit 7-2, 

Model 

Effectiveness 

Check Response 

Format (Industry).

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

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 

7, Exhibit 7-3, 

Model 

Effectiveness 

Check 

Questionnaire for 

Telephone or 

Personal Visits 

(Industry). 

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

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 

7, Exhibit 7-4, 

Model Recall 

Letter (Generic, 

All Centers).

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Recalls FDA 

website

Regulatory 

Procedures 

Manual, Chapter 

7, Exhibit 7-5, 

Model Recall 

Response Form.

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

Recalls FDA 

website

Office of 

Regulatory Affairs 

(ORA) Recall 

Coordinators

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

Recalls FSIS 

website

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

Recalls New 

Zealand 

Food Safety, 

Ministry for 

Primary 

Industries 

website

Food recall 

documents

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

Reportable food FDA 

website

FDA-TRACK: 

Reportable Food 

Registry Data 

Dashboard

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

Sanitary 

transportation of 

food

FDA 

website

FSMA Final Rule 

on Sanitary 

Transportation of 

Human and 

Animal Food

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

Sanitation 3-A Sanitary

Standards,

Inc. website

3-A Sanitary

Standards and

Accepted

Practices*

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Sanitation American 

Meat 

Institute

website

Food Safety 

Equipment Design 

Principles 

CHECKLIST & 

GLOSSARY. 

2021. 

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

Sanitation GMA (now 

Consumer 

Brands 

Association) 

Control of 

Salmonella in 

Low-Moisture 

Foods Guidance 

Document.**

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

Sanitation European 

Hygienic 

Engineering 

and Design 

Group 

(EHEDG)

website

EHEDG 

Guidelines Doc 8. 

Hygienic Design 

Principles. Third 

Edition. 2018.

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

Sanitation Lelieveld, 

HLM, 

Holah, JT 

and Napper, 

D (Eds.) 

(Elsevier 

Publishing) 

Hygiene in Food 

Processing: 

Principles and 

Practices. 2014.*

N/A

Sanitation Marriott, 

NG, 

Schilling, 

MW, and 

Gravani, 

RB. 

(Springer 

International

) 

Principles of Food 

Sanitation, Sixth 

Ed. 2018.*

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

Draft-Not for Implementation

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

Topic Source Resource Title Resource Link

Sanitation Schmidt, RH 

and DJ 

Erickson, 

Food 

Science and 

Human 

Nutrition 

Department, 

Florida 

Cooperative 

Extension 

Service, 

Institute of 

Food and 

Agricultural 

Sciences, 

University 

of Florida

Sanitary Design 

and Construction 

of Food 

Equipment. 2005.

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

Spices American 

Spice Trade 

Association 

(ASTA)

website

Clean, Safe Spices 

Guidance 

Document

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

Spices FDA 

website

Risk Profile: 

Pathogens and 

Filth in Spices

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

Supplier 

evaluation

FDA 

website

Firm/Supplier 

Evaluation 

Resources for 

FSMA Rules

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

Substance 

intentionally 

introduced for 

purposes of 

economic gain

FDA 

website

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

Draft-Not for Implementation

Topic Source Resource Title Resource Link

Toxic elements FDA 

website

Metals and Your 

Food

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

Toxic elements FDA 

website 

Closer to Zero: 

Reducing 

Childhood 

Exposure to 

Contaminants 

from Foods

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

Validation FSIS 

website

FSIS compliance 

guideline HACCP 

systems 

validation. 2015.

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

Various European 

Union 

website

Rapid Alert 

System for Food 

and Feed 

(RASFF)

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

Various FDA 

website

Food Defect 

Levels Handbook

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

Various FDA 

website

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

Various FDA 

website

Regulatory 

Procedures 

Manual

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

X-ray detection Loma 

systems 

website

Guide to X-Ray 

Inspection

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

*Available for purchase.

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

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

Prot Trends, 29:342–353.

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

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

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

Draft-Not for Implementation

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

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

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

Draft-Not for Implementation

VII. References

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

includes a website address, FDA has verified the website address, as of the date that the Notice 

of Availability for the Introduction of this guidance publishes in the Federal Register, but 

websites are subject to change over time.

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

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

publications such as scientific journals or books. 

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

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

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

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

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

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

pasteurization. Available at

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

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

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

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

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

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

Publishing. 

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

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

Survey Scientific Investigations Report 2007-5037. Available at

https://pubs.usgs.gov/sir/2007/5037/.

Bair EC. 2022. A narrative review of toxic heavy metal content of infant and toddler foods and 

evaluation of United States policy. Front Nutr 9:919913. Available at 

https://doi.org/10.3389/fnut.2022.919913 

Baert L, P McClure, A Winkler, J Karn, M Bouwknegt, and A Klijn. 2021. Guidance document 

on the use of whole genome sequencing (WGS) for source tracking from a food industry 

perspective. Food Control 130:108148. Available at 

https://doi.org/10.1016/j.foodcont.2021.108148 

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 51 
Contains Non-binding Recommendations 

Draft-Not for Implementation

Introduction: Purpose, Glossary, Abbreviations, and Resources - Page 52 

Bansal, A, TM Jones, SJ Abd, MD Danyluk, and LJ Harris. 2010. Most-probable-number 

determination of Salmonella levels in naturally contaminated raw almonds using two sample 

preparation methods. J Food Prot 73:1986–1992. 

Berk, Z. 2009. Ionizing irradiation and other non-thermal preservation processes. In Food 

Process Engineering and Technology, 533-544, Elsevier. 

Beuchat, LR, 1996. Pathogenic microorganisms associated with fresh produce. J. Food Prot 59, 

204–216. 

Beuchat LR, E Komitopoulou, H Beckers, RP Betts, F Bourdichon, S Fanning, HM Joosten,and 

BH ter Kuile. 2013. Low-water activity foods: increased concern as vehicles of foodborne 

pathogens. J Food Prot 76(1):150–72. Available at https://doi.org/10.4315/0362-028X.JFP12-211.

Bosch, A, E Gkogka, FS Le Guyader, F Loisy-Hamon, A Lee, L van Lieshout, B Marthi, M 

Myrmel, A Sansom, AC Schultz, A Winkler, S Zuber, and T Phister. 2018. Foodborne 

viruses: Detection, risk assessment, and control options in food processing. Int. J. Food 

Microbiol. 285: 110-128. Available at https://doi.org/10.1016/j.ijfoodmicro.2018.06.001 

Bourdoux, S, D Li, A Rajkovic, F Devlieghere, and M Uyttendaele. 2016. Performance of 

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